Poland

Rekommendationen anger som grund

The competent authorities ensured that official controls on animals and goods entering the EU are implemented in line with relevant EU legislation, competent authorities' documented procedures and arrangements in place albeit with shortcomings noted related to the frequency of physical checks on certain consignments of goods of animal origin and the follow-up of consignments of food of non-animal origin transferred to control points. The competent authorities took immediate corrective actions to address those shortcomings, thereby minimising the risk of non-compliant goods entering the EU through BCPs in Poland. 12

The audit team carried out on-the-spot visits to the three BCPs Gdask port, Gdynia port and Koroszczyn, including seven inspection centres thereof, and two control points detailed in the following table, to verify their compliance with the applicable minimum requirements for BCPs and control points. BCP / control TRACES Type of Inspection centre Categories of animals point code transport IC1 and goods for which the Gdask PL GDN 1 P BCP is designated (7) POA-HC(2) Gdynia PLGDY1 Magazyn celny Baltic Hub POA-NHC Container Terminal Sp. z o. PNAO-NHC(feed)-NT o. PNAO-HC(food)-NT Sklad celny Atlanta Poland PNAO-NHC(other) S.A. P, PP, PP(WP), OO Magazyn celny Terramar PNAO-HC(food)-NT Spedycja Midzynarodowa PNAO-NHC(other) Sp. z o.o P, PP, PP(WP), OO Magazyn celny Greenyard Logistics Poland Sp. z o.o P, PP, PP(WP), OO P POA-HC Magazyn 25 Baltycki POA-NHC Terminal Kontenerowy PNAO-NHC(feed)-NT LA-U, E, O Koroszczyn PLKOR3 R - PNAO-HC(food) PNAO-NHC(other) - P, PP, PP(WP), OO POA-HC rampa do kontroli POA-NHC fitosanitarnej, usytuowana PNAO-NHC(feed)-NT bezporednio przy budynku LA-U, E, O OG w Koroszczynie PNAO-HC(food)-NT PNAO-HC(food)-T(CH) Control point 1 PNAO-NHC(other) Control point 2 P, PP, PP (WP), OO PNAO-HC(food)-NT PNAO-HC(food)-NT

The audit team noted that the road BCP Koroszczyn was generally compliant with the minimum requirements for BCPs for the categories of animals, goods of animal origin and feed of non-animal origin for which it had been designated, but not for food of non-animal origin, food contact materials and plants, plant products and other objects for the following main reasons: · There were no compliant areas or rooms suitable for storage of ambient and chilled food of non-animal origin and food contact materials, which is not in line with Article 64(3)(b) and (h) of the OCR and Article 3(1)(c) of Implementing Regulation (EU) 2019/1014; · There were no suitable ambient and chilled storage rooms at the inspection centre Rampa do kontroli fitosanitarnej, usytuowana bezporednio przy budynku OG w Koroszczyn used for controls on plants, plant products and other objects which is not in line with Article 64(3)(b) and (h) of the OCR and Articles 3(1)(c) and 8(2) of Implementing Regulation (EU) 2019/1014. A similar observation was made during an audit carried out in 2021 to evaluate the system of import controls for plant health, ref. DG(SANTE) 2021-7273 (8). The competent authority at the time submitted an action plan indicating that new facilities would be constructed and in use in early 2022. However, due to financial constraints these have not yet been constructed. The competent authority in a further update informed that they would use the storage facilities of another inspection centre and a commercial storage facility, neither of which is located in this inspection centre visited and consequently this non-compliance was not effectively addressed. (8) https://ec.europa.eu/food/audits-analysis/audit-report/details/4460 14

The audit team found that the proposed actions were effectively implemented and noted that the competent authorities have issued further documentary procedures for the implementation of official controls on animals and goods. 5.5.2 Recommendation 2020-7004-2

Rekommendationen anger som grund

At the time of the audit, there was no prescription template laid down in domestic legislation. The prescriptions seen by the audit team were often based on a former national template, adapted to cover the information required under Annex V to Regulation (EU) 2019/4. However, the audit team noted that none of these prescriptions had a dedicated section that could be filled in by veterinarians in case of use of antimicrobials in accordance with Article 107(4) (metaphylaxis) or Articles 112, 113 or 114 (cascade) of Regulation (EU) 2019/6.

The private veterinarians interviewed by the audit team routinely prescribed medicated feed for treatment of diseases in pigs. The audit team noted that in most cases, antimicrobials used in medicated feed, such as tylosin, were prescribed following a metaphylactic approach as groups of pigs (e.g. 700 to 1400 animals) containing both sick animals and animals in close contact which may already be subclinically infected, were treated with antimicrobials. The veterinarians interviewed did not specify on the prescriptions issued that these animals followed a metaphylactic treatment, contrary to the requirements of Article 16(6) and point 7 of Annex V to Regulation (EU) 2019/4. The audit team noted that none of the prescriptions for treatment of groups of pigs with antimicrobials that were reviewed during the audit contained a reference to metaphylaxis. This was overlooked during past official controls.

While inspections cover requirements for veterinary prescriptions, they overlooked that, although medicated feed was routinely prescribed for metaphylaxis, the veterinary prescriptions did not contain a statement to that effect. 5.2.3 Actions taken on non-compliances

Rekommendationen anger som grund

Planning of the BCP sampling is based solely on the number of consignments received in the previous year, and not on the number of actual eligible consignments from different countries of origin arriving in each BCP (see point 19). Additionally, although 11 consignments of bovine meat from a single country of origin arrived in a BCP in 2022, no sampling was planned in that BCP for 2023. This approach is not aligned with point 3.3 of Part A of the Annex which states "proportionate stratified sampling of consignments and meat samples per border control post and country of origin with an even distribution over the monitoring year of the consignments of imported fresh meat sampled at border control posts level."

Regarding sampling at BCPs: i. 12 BCPs are designated for products of animal origin; the majority of the meat arrives in through the following road BCPs: Hrebenne, Korczowa and Dorohusk, and Warsaw airport. ii. The selection of eligible consignments for sampling is based on the list of CN codes for fresh meat, as discussed during the drafting of the EU Decision. iii. Isolates recovered in 2021 and 2022 were subjected to AST and reported to EFSA. iv. There were no samples taken in 2023 as there was no land transport of beef or pork during this time. However, a small number of beef consignments (18) that arrived in the BCP in Warsaw airport would have been eligible for sampling. v. The competent authority confirmed that sampling is solely based on BCPs identified in the sampling plan which, in turn, is based on the previous year's data (see point 12). Therefore, any consignments arriving at a BCP from a country that did not export to Poland via that BCP in the previous year are not considered. This means that some consignments were not identified, affecting the representativeness of samples, and it is not in line with point 3.3(a) of Part A of the Annex to the EU Decision. vi. In addition, the instructions for the BCP sampling did not state that the sampling frequency is calculated based on consignments and not batches. As a result, 3 samples were correctly taken from different batches of each consignment but counted individually, which resulted in the repetition of the epidemiological unit. This affects the representativeness of samples taken and it is not in line with point 3.3(b) of Part A of the Annex to the EU Decision as regards annual sampling frequency rates of consignments. Conclusions on sampling

The design of the sampling plan precludes the sampling at certain (new) BCPs and (new) countries of origin. In addition, the sample size at BCPs is not correctly calculated. These gaps affect the representativeness of sampling at this level. 7

Rekommendationen anger som grund

Designated veterinarians can have different control tasks in the scope of the audit, e.g. controls for export certification and food hygiene controls at operators. This depends on the needs of the DVI. For the designated veterinarians, however, no structured training program is in place. The GVI stated, that currently online training is in preparation which will be available for all staff. Documented procedures and control activities and methods

However, gaps were noted in training for designated private veterinarians and there was a lack of knowledge on environmental sampling for Listeria monocytogenes (necessary for the proper verification of the suitability of operator microbiological own checks).

Medlemsstatens svar

nie umowy w zakresie wyznaczenia do konkretnych Stycze 2025 czynnoci moe nastpi dopiero po odbyciu odpowiedniego stau szkoleniowego lub praktyki. W umowach z wyznaczonymi prywatnymi lekarzami weterynarii zostal zawarty obowizek uczestnictwa w szkoleniach wskazanych przez Powiatowych Lekarzy Weterynarii. W zwizku z koniecznoci biecego doszkalania powstaje Platforma Szkoleniowa GIW ­ obecnie jest w trakcie testów ­ uruchomienie w pelnym zakresie stycze 2025 W latach 2022-2024 odbyly si cykle szkoleniowe warsztatów HACCP (tura I i II): SUMA I TURY w latach 2022-24 ( w sumie 9 cykli) PIW 434 WIW 27 GIW 13 SUMA II TURY W ROKU 2024 (4 cykle) PIW 216 WIW 20 GIW 8 SUMA OGÓLNA PRZESZKOLONYCH za lata 2022-24 (lcznie 13 cykli) PIW 650 WIW 47 GIW 21 Page: 1 o the recommendations of report ref. DG(SANTE) 2024-8020 of the audit carried out from 27 May 2024 to control systems in place governing the production and placing on the market of fishery products tion Proposed by the competent authority Proposed action plan deadline kolenie dla terenowych inspektorów IW ,,Wybrane procesy róbki cieplnej stosowane w przetwórstwie ywnoci chodzenia zwierzcego ­ aspekty technologiczne i krobiologiczne" ­ szkol

Medlemsstatens svar

eczno wdroenia dziala na szczeblu centralnym - Stycze 2025 ieszczono te wymaganie w listach kontrolnych SPIWET ekcja VIII) jako koniecznego do weryfikacji podczas ntroli kompleksowych. Na chwil obecn nowy SPIWet st w trakcie konsultacji.

Rekommendationen anger som grund

The changes in the national legislation on the remuneration system of AVs supervising the slaughter of animals announced in the AP have been partially introduced: in slaughterhouses without automatic conveyor belt the AVs are paid per hour. However, in slaughterhouses with automatic conveyor belt it still depends on the number of animals slaughtered. This is not in line with Art. 5(1)(b) of Reg. (EU) 2017/625 as compromises the impartiality of staff performing official tasks. Concerning this latter system, the audit 4 team was informed that almost all the slaughterhouses in Poland use it. Very few and very small slaughterhouses do not have the automatic conveyor belt and remuneration per hour is mainly applied in cutting establishments, where the permanent presence of veterinarians is not compulsory.

During the General Follow-up Audit, MARD confirmed ongoing efforts to ensure veterinarians in slaughterhouses with automatic conveyor belts would receive hourly wages and aimed to implement this legislation within a year (i.e. October 2024). In the current audit, the GVI stated that the legal act is yet to be passed, with discussions still taking place with stakeholders, leaving the approval date of the legal act unknown. Conclusions on recommendation No 2 of the 2021 audit

As regard the remuneration system of staff performing official tasks in slaughterhouses with automatic conveyor belt, the measures announced in the AP, and that will address the relevant part of the recommendation, have not been introduced. No deadline is foreseen for solving this long-standing situation. Furthermore, it is particularly worrying that the scale of this non-compliance appears to affect most of the slaughterhouses in the country.

Rekommendationen anger som grund

The CVO received feedback from the NPO in February 2024. The document indicated that from 2020 to October 2023, the prosecutor's offices handled 1 928 cases concerning the violation of the animal welfare law. All these cases were initiated by the VI, and following their verification were discontinued at their initial stage. The primary reason for not proceeding with the cases was that the acts in question did not constitute a criminal offense. The audit team noted that the document lacked detailed analyses or explanations to help the DVOs understand the reasons behind the dismissals and prevent similar situations from occurring in the future.

During the meetings the audit team had with the DVOs and RVOs they noted that it is difficult to monitor the prosecutors' duties, as they are independent from any other governmental body, and explain that they usually do not receive information about the follow up of the cases they transmitted to the NPO. One of the DVOs met provided figures of the number of cases transmitted to the enforcement authorities and number of cases 8 dismissed/rejected during the investigation phase (e.g. in 2023, 180 cases were notified, 80 cases dismissed/rejected and no information on 29 cases). The DVO lodged 19 complaints for the refusal to open an investigation or closure of the case at the pre-trial stage. Examples of the penalties the enforcement authorities imposed to two operators that transported unfit bovine animals to the slaughterhouse were provided: in one case (two animals involved) the fine imposed was 700 PNL (168 Euros) and in the other case (one bovine animal involved) was 100 PNL (23.35 Euros).

According to the DVO and RVO when they identify non-compliance related to animal welfare, they do not take into account whether the same operator has repeatedly committed these breaches, nor do they maintain any records. Consequently, they lack awareness of whether an FBO has a history of repeated offenses and are unable to include this information in their notifications to the NPO.

Despite nearly all the actions from the AP being implemented and GVI's' efforts to strengthen enforcement measures for non-compliance with animal welfare rules, significant progress has not been made. Many cases are still being dismissed or rejected by enforcement authorities. According to the Polish legal system, the VI has no competence on this matter. 9

Rekommendationen anger som grund

Nevertheless, at the poultry slaughterhouses visited the audit team observed the following situations, that do not meet some of the requirements of Annex II to Regulation (EC) No 852/2004 of the European Parliament and of the Council and that represent a risk of contamination of the poultry meat, which had not been detected/recorded during the DVOs' controls: a) in all the slaughterhouses, after the scalding and plucking of birds the slaughter line (with the exposed carcases) continued to remain for a long time in this area (considered as dirty area by the FBOs). In one case the cutting off heads of the carcases took place in this area. This area was heavily contaminated, especially in two out of the three slaughterhouses visited and in one case it was not completely separated from the bleeding line and the hanging line of alive birds. b) in one slaughterhouse, extensive condensation was observed.

Other non-compliances, neither detected/recorded during the DVOs' controls, were also noted at the poultry slaughterhouses: a) In one slaughterhouse, several carcases considered unfit for human consumption were removed and immediately discarded by slaughterhouse staff, before the PMI so, the AVs could not check them and know the reasons for which they were rejected. This is not in line with Article 25(1) of Regulation (EU) 2019/627 that requires all poultry carcases to undergo PMI. b) In two slaughterhouses the carcases were washed after the evisceration and before the PMI. This is not in line with EU requirements as washing prevents from assessing possible faecal contamination, and EU legislation requires that the operator must take measures to prevent the spillage of digestive tract contents during evisceration in line with Point 5, Chapter IV, Section II of Annex III of Regulation (EC) No 853/2004. 10 c) In one slaughterhouse, the meat remained in the cutting area for long periods as extensive quantities of meat were processed. This could lead to temperature abuse. d) In one slaughterhouse the area of uploading of birds was also used for the cleaning of vehicles and the cleaning and storage or clean crates used for the transportation of birds. No precautionary measures were used for avoiding the contamination of clean crates during these works.

Regarding the CAs' ability to assess the adequacy of HACCP-based procedures at the poultry slaughterhouses the audit team noted improvements as, overall, all the relevant hazards were considered in the HACCP plans. However, the following aspects observed by the audit team had not been noted or recorded in the inspection reports the CAs drafted during the last year: a. Two slaughterhouses accept only Salmonella spp negative flocks and, based on that, HACCP plans consider Salmonella as a medium or low risk hazard. Therefore, preventive measures to avoid Salmonella contamination indicated in the plans were limited (e.g. PMI, washing of carcases and temperature control). However, several Rapid Alert System for Food and Feed (RASFF) notifications for Salmonella spp had been issued for these slaughterhouses during the last years and the HACCP plans did not take into account the risk of receiving Salmonella positive flocks. In one of these slaughterhouses the FBO expressed some doubts about the test results indicated in the documents accompanying the flocks. For this reason, they test all flocks (neck skin samples), daily, as well as the trucks and cages transporting the animals (swab tests). Moreover, a list with farmers that were involved in Salmonella RASFF notifications is kept and birds coming from these farms are slaughtered at the end of the day. In this slaughterhouse, the number of RASFF notifications due to presence of Salmonella in meat has decreased considerably. The audit team was informed that the price of birds coming from positive Salmonella farms is 20% lower than the price from Salmonella negative ones. b. In another slaughterhouse, the Salmonella preventive measures applied at control points or critical control points, could not be validated as being effective for the control of pathogens. Such measures, for example, are the visual inspection of carcases before the air chilling (in order to detect faecal contamination) and the temperature control at the beginning and the end of the water chiller. c. In two slaughterhouses, the FBOs failed to validate or verify their HACCP plans. Despite the repeated detection of Salmonella spp in end products like chicken fillets, there were no significant modifications to the HACCP plans or the company's routine cleaning and disinfection methods.

The audit team found evidence that the HACCP training and workshop on official verification of the HACCP system for RVOs and DVOs in charge of supervising food sector establishments, as announced in the AP, took place. At a poultry slaughterhouse, the audit team met two DVOs who had participated in the HACCP training session. However, it was noted that the evaluation of HACCP documentation and records was incomplete in some areas (e.g., hazard analysis validation, monitoring procedures, and verification of the FBO's microbiological sampling). For instances, at this slaughterhouse the microbiological sampling on process hygiene criteria revealed Salmonella contamination. The DVO did not note/record that FBO had not taken corrective actions/measures for investigating the cause and no actions had been taken when the rolling window exceeded the legislative limits for Salmonella spp. A GVI representative explained that the HACCP training is not yet complete, as it consists of two parts, and only the first one has been delivered.

The implementation of most actions listed in the AP to address this recommendation has led to improvements in establishments' compliance with EU standards and in HACCP plan assessments. Nonetheless, the shortcomings noted in HACCP plans and during the production of poultry meat in some establishments indicate that the measures currently in place are either not effective enough or not delivering the expected results.

Despite the given explanation, the audit team found that the DVOs at the two slaughterhouses accepting only Salmonella-negative flocks (see paragraph 34a) considered their HACCP plans adequate. The risk of receiving Salmonella positive flocks, for example due to contamination during the 21-day timeframe, was not considered in the assessment of these HACCP plans.

Rekommendationen anger som grund

In all the poultry slaughterhouses visited the implementation of the measures and corrective actions provided in the HACCP plans in case of Salmonella detection could not identify the source of the contamination and prevent recurrence. It was noted that the FBO's actions and investigations were repeatedly focused on primary production (e.g. visits to farms and verification of the biosecurity measures) and did not pay attention, for example, to possible cross contamination points or production shortcomings at establishment level.

During the DVO visits, they confirm the FBOs' actions implemented to identify the source of the contamination and prevent recurrences. However, they did not assess the adequacy of these actions, as there was no comprehensive evaluation of the establishment's HACCP systems. For instance, the audit team found in two slaughterhouses where Salmonella spp was found in chicken fillets, the FBOs' investigations overlooked potential cross- contamination risks during the slaughter and cutting processes (see also paragraph 36). This issue was neither identified nor documented during the DVO's inspections. Conclusions on recommendation No 8 of the 2021 audit

Although the measures from the action plan were implemented and improvements have been observed since the 2021 audit, the actions are not effective or do not have the expected results. They often fail to identify the source of contamination or prevent its recurrence, suggesting that the measures taken by the FBOs to address this recommendation are not adequate and/or sufficient.

Rekommendationen anger som grund

Although the measures implemented seem adequate for addressing the issues covered by this recommendation, there continues to be discrepancies on results obtained in the parallel testing, with the percentage of positive official samples to Salmonella several folds higher than the corresponding in FBO samples. The table 1 below reports the number of parallel samples taken from 2022 to 2024, by semester, and the Salmonella results of the official and FBOs analysis: Table 1 Year No No of Percentage No of Percentage Official/FBO Semester parallel results with of results positive of positive Testing Salmonella results tests with SE/ST results performed spp Salmonella SE/ST spp 643 154 23,95% 26 4,04% Official testing 5,13% 2022a 33 22,66% 7 1,09% FBO's testing 5,66% 459 104 20,19% 29 6,32% Official testing 6,65% 2022b 26 23,59% 5 1,09% FBO's testing 5,90% 2023a 421 85 19,00% 17 4,04% Official testing 5,60% 28 6 1,43% FBO's testing 390 92 6 1,54% Official testing 2023b 23 0 0,00% FBO's testing 2024a 413 79 5 1,20% Official testing 23 0 0,00% FBO's testing SE: Salmonella Enteritidis ST: Salmonella Typhimurium

At the poultry slaughterhouses visited the audit team confirmed that the parallel testing and collation and analysis of results continues to be in place (see table 2), although the number of samples taken in parallel has been decreasing during the last years. 3 Official samples to test for Salmonella are taken from the neck skin of poultry carcases in parallel with the own- check samples (i.e. on the same day, from carcases from the same flock), and in line with the plan specified in Row 2.1.5 of Chapter 2 of Annex I to Regulation (EC) No 2073/2005. 16 Table 2 SE: Salmonella Enteritidis ST: Salmonella Typhimurium

The discrepancy between the parallel sampling results, where test outcomes consistently favour the FBOs, raises concerns about the reliability of the FBOs' testing. In this regard, the CAs' explanation that this fact could be due to the natural variation in microorganism distribution seems insufficient, given the one-sided nature of the discrepancies and the significant differences observed. The GVI noted that a new instruction on sample collection, aimed to bring more accuracy and fairness in verifying FBOs' test results, have been introduced as of October 2024. This updated protocol mandates that both official and FBO samples are to be taken from the same neck skin of poultry carcases to ensure the samples are truly representative and comparable.

The audit team observed parallel sampling procedures at two slaughterhouses, revealing differences in practice. In one instance, the AV followed the new instruction, taking a single neck skin sample from a carcase and dividing it into two separate samples: one for official purposes and the other for the FBO use. In contrast, the other slaughterhouse adhered to the previous procedure, collecting FBO and official samples from different carcases of the same flock4. Furthermore, it was noted that disinfectant was used to clean the area before sampling at one of the slaughterhouses, compromising the quality of the sample and, consequently, the validity of the test result.

The audit team visited two approved laboratories. The visit to one laboratory was ineffective as it was not involved in Salmonella parallel testing of neck skin samples for demonstration of compliance with Reg. 2073/2005, and no neck skin samples were available or were being tested at the time of the visit. The second laboratory performs parallel testing of samples from one of the visited slaughterhouses. This laboratory has a large throughput of samples daily for microbiological analysis. Despite the 4 In its response to the draft report, the competent authority stated that During the audit in November 2024, the Office for the Safety of Food of Animal Origin, responsible for the guidelines of the CVO of 31 January 2018 for OVs on the rules of procedure for the control of sampling and performance of microbiological tests of food of animal origin and composite food produced by food enterprises subject to the supervision of the Veterinary In- spection, provided DVOs with information on the change in the method of sampling for testing as part of official verification in relation to the indicated guidelines. According to the change, samples taken as part of official verification are to be taken from the same carcasses and divided evenly between official and owner testing. How- ever, the effect of this change may be visible in 2025, after the results for the first and second half of the year have been developed. 17 microbiological section audited not being operational on the day of the audit visit, the following findings were observed: a. Sample reception was not identifying all samples in a submission, only the first one, with the rest of the labels being left to the analysts at sample preparation. Therefore, there is potential for mislabelling, especially considering the high volumes of samples tested. b. Sample reception was not taking the temperature of samples and relied on the refrigerated vehicles register of temperatures. However, the audit team observed that some clients delivered samples that arrived in vehicles without a temperature record. The temperature was not checked as there are not instruments available. c. Sample preparation was witnessed for a poultry neck skin sample that was not adequately packaged and consisted of large pieces of neck skin and fat, much larger than three 10 g pieces. The analyst preparing the sample was not aware of what constituted a neck skin sample under the microbiological criteria regulation. There were no clear acceptance criteria for neck skin samples, and there is a risk that 25 g could be taken from only one of the neck skin pieces in such large samples. d. The laboratory does not use a batch positive quality control sample. Therefore, the validity of the tested samples cannot be assured. This is particularly concerning ruling out false negative results, which could occur if the testing conditions are not optimal, such as when the laboratory is overwhelmed with a high volume of samples. The absence of a positive quality control sample can lead to an unintended mistake going unnoticed. In addition, the use of positive control organisms is an integral part of ISO 72185 standard (Point 16.2.2.3). This standard is included in the normative references of ISO 6579-1:20176, the analytical reference method for Salmonella of Regulation (EC) No 2073/2005. This finding was also observed in the other laboratory visited.

As of 2021, the GVI requested several checks to be performed by the NRL in some of the laboratories where discrepancies in the parallel sampling were observed. In 2023, the NRL performed an unannounced inspection in the laboratory performing parallel tests visited. The NRL' inspection report drafted after this control shows that the inspection: a. Focussed mainly on the laboratory compliance with the requirements for being approved according to the national rules. This was also the case for other NRL's reports the GVI provided to the audit team. b. Did not look for findings that could explain potential false negative Salmonella results or did not investigate the root cause that could explain the discrepant results. 5 ISO 7218, on Microbiology of food and animal feeding stuffs -- General requirements and guidance for micro- biological examinations 6 ISO 6579-1:2017 on Microbiology of the food chain. Horizontal method for the detection, enumeration and serotyping of Salmonella Detection of Salmonella spp. 18 Reasons that could impact on the reliability of the results could be related to the sample (e.g. sample traceability, sample `quality' and sample preparation steps) and the method performance (e.g. media quality, the correct time and temperature of incubation steps). If the optimal conditions are not met, Salmonella may fail to grow giving rise to false negative results. c. Did not detect, or record, any of the shortcomings the audit team observed during the visit to the laboratory (see paragraph 58).

Despite the implementation of measures aimed at addressing this recommendation, the persistence of discrepancies in the results obtained in the parallel testing shows that they are not having the desired effect and/or are not sufficiently effective. The failure to resolve this ongoing issue undermines confidence in the reliability of the results of microbiological tests on which the FBOs rely to validate and verify the correct functioning of their procedures based on HACCP principles and good hygiene practices, raising concerns about the safety assurances provided for poultry meat production.

Rekommendationen anger som grund

The petfood and processing plants visited maintained HACCP-based procedures as re- quired by Article 29 of Regulation (EC) No 1069/2009. However, the audit team noted that these procedures were deficient in several areas: (a) incomplete process flow dia- gram, (b) insufficient monitoring arrangement for critical control points or (c) missing critical control points required by EU rules on ABP and DP for processing plants im- plementing continuous processing methods. These issues were overlooked during past official controls.

Official controls at ABP plants cover HACCP-based procedures when required but they are not sufficient to reliably verify the operators' level of compliance with all of the key requirements of these procedures, resulting in incomplete identification of hazards by ABP operators.

Medlemsstatens svar

1. The request regarding the implementation of individual recommendations DVO official the DG SANTE audit was submitted for implementation to all district controls ­ to the end of 2024 and voivodeship veterinary officers in the letter of the Chief Veterinary RVI official DVO Officer, reference number WU.510.10.2024 of June 13, 2024 (attached) controls ­ January - December 2025 2. The Chief Veterinary Inspectorate plans to organize regular meetings with voivodeship inspectors for feed and rendering. The following activities will be carried out during these meetings: - conducting training on topics specified in the recommendations after the 4th quarter 2024

Rekommendationen anger som grund

The audit team noted that commercial documents accompany ABP and DP during transport, as required by Article 17 of Regulation (EU) No 142/2011. In most cases, they contained the necessary information. However, in one of the petfood plant visited (raw petfood), ABP commercial documents were missing for most of the category 3 materials used in the production of petfood. The audit team noted that GVI had taken action to avoid that such situation is widespread and had informed (by means of circular letters) all food business operators where ABP are generated and collected that ABP commer- cial documentation should be used in all cases. In addition, the audit team noted that all inspectors met were aware of such requirements and routinely verified the presence and completeness of commercial documentation during their inspections. 8

In relation to categorisation and handling of ABP, past inspections carried out in some of the petfood and intermediate plants visited overlooked that, contrary to the require- ments of Article 9 of Regulation (EC) No 1069/2009, operators considered as Category 3 material the following materials: (a) material of animal origin collected from unclean sections (floor) and (b) Category 3 material containing foreign bodies. Some of these in- correctly categorised materials were recycled in the production of petfood or dispatched to processing plants for Category 3 material from which derived products may be used in feed. The audit team noted that the quantities of ABP incorrectly categorised as Cate- gory 3 were limited compared to the overall quantities of Category 3 material used by the operators.

During the review of files concerning actions taken by DVIs in cases of petfood contam- inated with Salmonella or exceeding the acceptable values for Enterobacteriaceae, the audit team noted that some of these non-compliant petfood (Category 2 material) was disposed of accompanied by commercial documentation stating these were Category 3 material, contrary to the provisions of Article 9 of Regulation (EC) No 1069/2009. However, despite this incorrect categorisation, the audit team noted that such petfood had been processed in Category 1 and 2 processing plants, which prevented their diver- sion back into the feed chain.

In one of the petfood plant visited (canned petfood), the audit team noted that the opera- tor's procedures for dealing with ABP that were unfit for production of petfood (e.g. Category 2 material) were very succinct and did not allow for an unequivocal identifica- tion of the crates to be used for collecting such ABP. As a result, the audit team noted that containers of various colours were used, some being identified with paper labels that could easily be removed. In particular, crates for storing raw material fit for use and material unfit for production of petfood were identical, except for a paper label glued on the crate and bearing the mention `kat. 2'. On the day of the visit, the audit team noted that crates identified as holding Category 2 material were being used for the production of petfood. Previous official controls did not identify the aforementioned issues. After the visit, DVI inspectors conducted an inspection and established that the products used on the day of the visit were Category 3 material but that the operator had used crates wrongly labelled as storage for Category 2 material.

Official controls verify that operators use the correct category and types of ABP for manufacturing petfood. However, such controls are not sufficient to identify instances of incorrect categorisation and handling of ABP by some operators. This resulted in limited quantities of ABP being used for the production of feed or petfood while they are not allowed for such use under EU rules.

Medlemsstatens svar

DG SANTE audit. Then, training in this area will be conducted in a cascade by voivodeship to district inspectors for feed and rendering. - meetings organized in 2025 - monitoring progress in the implementation of year 2025 the above-mentioned recommendations in individual voivodeships. 3. The Chief Veterinary Inspectorate is planning to conduct training for 4th quarter 2024 approximately 80 veterinary inspectors at the district and voivodeship level in the field of the HACCP system in plants producing pet food. The training will consist of a theoretical and practical part (lectures and study visits to selected plants producing pet food).

Rekommendationen anger som grund

According to personnel from the General Veterinary Inspectorate (GVI), the designation of the competent authority responsible for checking that antimicrobials reserved for the treatment of certain infections in humans are not prescribed for animals is contingent on having national legislation in place incorporating the requirements of the VMPR. Work is still in progress in that regard, and it is expected to be finished during the first half of 2026. This is not in line with Article 137(1).

Although the new instructions to conduct controls on the use of VMPs include the need to check whether antimicrobials in the reserved list have been prescribed, the competent authorities responsible for these types of checks have not been designated yet. Therefore, recommendation 1 of report DG(SANTE) 2023-7694 has not been addressed.

Rekommendationen anger som grund

According to personnel from GVI, they will not be able to impose efficient penalties applicable to infringements of the VMPR until national legislation is in place, incorporating the requirements of the VMPR, which is not expected to happen before the first half of 2026 (see point 1). This is not in line with Article 135(1).

Despite the number of veterinarians referred to the relevant regional veterinary chambers, the lack of national legislation still prevents GVI to impose dissuasive penalties applicable to infringements of the VMPR. Therefore, recommendation 3 of report DG(SANTE) 2023-7694 has not been addressed. 4

Rekommendationen anger som grund

Poland has extended the registration requirements since the last audit. This way, a wider range of operators are subject to the annual surveys. The risk from non-registered producers is not taken into account appropriately during the annual surveys, as their places of production function as a reservoir for C. sepedonicus and contribute to the spread of the pest.

Medlemsstatens svar

IPHSIS has issued a guideline (letter ref: WOP.010.1.2023 of 29.12.2023), in which it has obliged all VIPHSIS to: erify (by 31.03.2024), data/information on producers not included in the official register of professional operators that grow potatoes on an area of less than 1.5 hectares, according to their applications for payment (CAP) to the relevant Polish Agency - to determine the number of such producers in each VIPHSIS field office, in the following groups: 1) area of potato cultivation up to 0.30 ha 2) area of potato cultivation from 0.31 ha to 0.5 ha 3) area of potato cultivation from 0.51 ha to 1.0 ha 4) area of potato cultivation up to 1.01 ha to 1.5 ha; 2. to develop an inspection plan for at least all the identified producers in included in the groups of points 3) and 4), so as to inspect all of them within a period of 3 years, in order to carry out a visual inspection of the tubers and check the management of the potato yield harvested (to verified if they do not place potatoes on the market); 3. taking in 2024 at least 2 samples of potatoes for C. sepedonicus testing from non-registered producers - in each VIPHSIS field offices (nationwide, this will be min. 508 sample

Rekommendationen anger som grund

For the first detection test, the laboratories mostly use the immunofluorescence (IF) test. Where the result is positive, the second detection test is by conventional PCR for seed potatoes, for other potatoes it is mostly the fluorescence in situ hybridisation (FISH) test. The laboratories inform the VIPHSIS about positive results and the suspected presence of C. sepedonicus in the form of a test report, which is issued when all detection tests are finished. The laboratories do not inform immediately the VIPHSIS when the first detection test result is positive, even though, based on Annex I. point 1.1 of Regulation (EU) 2022/1194, the presence of C. sepedonicus is suspected where a positive result is obtained in the first detection test.

The MIPHSIS provided detailed information on the diagnostic and administrative steps of 48 samples connected to 43 places of production where C. sepedonicus was recently detected. This is equal to approximately 10% of the places of production where C. sepedonicus was detected in 2022. The laboratories issued the test report more than one week later, after the positive result of the first detection test for more than 25% of these samples. In some cases, this period was longer than two weeks. At the end of the identification test, the test result on the confirmed presence of C. sepedonicus was issued over one week later for 20% of these samples. The delayed information prevents the VIPHSIS from performing official activities in a timely manner (see also findings 21 and 25). The NRL explained the delays were due to the large number of samples, economic and personnel issues.

The laboratories do not inform the VIPHSIS about the positive result of the first detection tests and there are delays with the issuance of the test results. There are cases when the presence of C. sepedonicus is confirmed based on two detection tests other than molecular ones. The delayed information prevents the VIPHSIS from performing timely follow-up measures, which can contribute to the spread of C. sepedonicus.

The laboratories do not inform the VIPHSIS about the suspected presence of C. sepedonicus at the time of the positive result of the first detection test (see also finding 9). This way, the VIPHSIS do not implement official measures when the presence of C. sepedonicus is suspected, contrary to Article 4 (2) of Regulation (EU) 2022/1194. There are cases when the results of the tests reach the VIPHSIS with a considerable delay (see also finding 10). Consequently, this delays the start of the required official measures by VIPHSIS. Since the movement of ware potatoes is not limited after sampling (see also finding 17), infected or potentially infected lots may be sold within Poland.

The VIPHSIS trace the origin of the suspected presence of the pest in line with official guidelines. · Tracing is mandatory in case of; every level of seed potato production, when ware potatoes were produced from seed potatoes certified as Union grade A or higher, and, in specified cases when ware potatoes were produced from seed potatoes certified as Union grade B. · To reduce the burden on the VIPHSIS, the inspectors may assume that the origin of the infection is the place of production when potatoes were produced from tubers originated in the same place of production. · For ware potatoes produced from certified seed potato lots of Union grade B, the VIPHSIS may assume that the origin of the infection is the place of production, and do not trace the potential origin, when the following conditions are met: i. the planted seed potato lots were not the subject of any tracing activities, ii. samples were not tested from that place of production during the previous three years, or iii. the place of production is already under quarantine measures because of an earlier detection of C. sepedonicus. 8 However, these certified seed potatoes originated outside of that place of production and other producers might also have planted seed potato from the same lot. Consequently, potential further outbreaks of C. sepedonicus are not detected. Although the MIPHSIS stated that the exemptions are implemented to rationalise the work and cost of the operations, this procedure does not comply with Article 4 (2)(b) of Regulation (EU) 2022/1194. Conclusions on the measures in case of suspicion of the presence

The VIPHSIS often start to implement the required official measures with considerable delays when the presence of C. sepedonicus is suspected and in certain cases they do not trace the origin of this suspected presence. The delayed and non-compliant official measures do not prevent the spread of C. sepedonicus.

Medlemsstatens svar

nce January 2023, the Central Laboratory has been using a new s are LIMS-type IT system to handle phytosanitary test documentation. rom July 10, 2023 electronic signature was implemented. Letter nspector, No. WI.042.3.2023 of June 30,2023 r. Test gned with a qualified electronic signature by sons and sent by e-mail to the relevant SPHSIS tion led to a shortening of the time from issuing the tion to providing it to VIPHSIS to start procedure sing of official measures. eptember 27, 2023 all branches of Central e informed about the obligation to provide information about the course of the test" after the t of first detection test (Letter No. 23.1.). lso issue guidelines for VIPHSIS to recommend dures of proceeding from sampling through ting, contributing to faster implementation of official e case of a suspected presence of C.sepedonicus, IPHSIS to follow and do not violate the relevant the Administrative Procedure Code. This guidelines fy the recommendations of MIPHSIS to waive the pected occurrence (Article 4(2)b of Regulation adline for guideline preparation it's by the end of ter of 2024. Page: 2 024 t ref. DG(SANTE) 2023-7676 of the audit carried out from 13 September osed by the

Rekommendationen anger som grund

The MIPHSIS provided detailed information on the diagnostic and administrative steps of 48 samples connected to 43 places of production where C. sepedonicus was recently detected. This is equal to approximately 10% of the places of production where C. sepedonicus was detected in 2022. The laboratories issued the test report more than one week later, after the positive result of the first detection test for more than 25% of these samples. In some cases, this period was longer than two weeks. At the end of the identification test, the test result on the confirmed presence of C. sepedonicus was issued over one week later for 20% of these samples. The delayed information prevents the VIPHSIS from performing official activities in a timely manner (see also findings 21 and 25). The NRL explained the delays were due to the large number of samples, economic and personnel issues.

The laboratories do not inform the VIPHSIS about the positive result of the first detection tests and there are delays with the issuance of the test results. There are cases when the presence of C. sepedonicus is confirmed based on two detection tests other than molecular ones. The delayed information prevents the VIPHSIS from performing timely follow-up measures, which can contribute to the spread of C. sepedonicus.

Where the presence of C. sepedonicus is confirmed, Article 5(2) of Regulation (EU) 2022/1194 requires that the CA shall establish a DA without delay. In the case of the assessed samples (see also finding 10), more than 15% of the test reports were issued over one week after the test was finished. Contrary to the above-mentioned requirement, the VIPHSIS established more than 50% of the DAs with a considerable delay, more than one month after the presence of C. sepedonicus was confirmed. The NPPO explained the delays were due to administrative and organisational issues.1

The VIPHSIS make considerable efforts and carry out extensive investigations in order to eradicate the outbreaks, but the delayed establishment of the DAs decreases the efficacy of the measures applied and can contribute to the spread of C. sepedonicus. 1 In its response to the draft report, the competent authority noted that the SPHSIS, as a public administration, is obliged to comply with national administrative procedure rules (Code of Administrative Procedure). These rules set out the administration's rules of conduct for, inter alia, the issuance of administrative decisions, which are an established way of imposing obligations (e.g., prohibition of movement of tubers suspected of being contaminated or quarantine measures) on operators, in accordance with national plant health legislation. 9

Medlemsstatens svar

IPHSIS will also issue guidelines for VIPHSIS to recommend ssible procedures of proceeding from the receipt by VIPHSIS ve test result report to the issuance of administrative posing official measures due to the C.sepedonicus and allowing VIPHSIS to follow and do not violate t provisions of the Administrative Procedure Code. r guideline preparation it's by the end of the first 2024. d with regard to recommendation No. 2, MIPHSIS he Ministry of Agriculture and Rural Development k: BNFiWM.0210.14.2023 of 27.10.2023) to consider e national law on plant protection against pests that for exceptions of SPHSIS to follow certain provisions nistrative Procedure Code to simplify and shorten the ion administrative procedures.

Rekommendationen anger som grund

The laboratories do not inform the VIPHSIS about the positive result of the first detection tests and there are delays with the issuance of the test results. There are cases when the presence of C. sepedonicus is confirmed based on two detection tests other than molecular ones. The delayed information prevents the VIPHSIS from performing timely follow-up measures, which can contribute to the spread of C. sepedonicus.

Medlemsstatens svar

fulfil requirement the provisions of the Regulation (EU) all 13 Divisions of Central Laboratory were informed Page: 3 024 t ref. DG(SANTE) 2023-7676 of the audit carried out from 13 September competent authority t the second detection test must be the PCR test (letter of mber 21, 2023, no. CL.711/89.2023.1 signed by Chef day on, all the 13 Central Laboratory st as the first detection test and then the PCR rmed by 8 CL branches accredited for this 5 branches will implement this method by ermore, method TaqMan PCR will be of CL in 2024. Page: 4

Rekommendationen anger som grund

Interviewed officials indicated that, pending dispatch to the laboratory, the samples could be stored in refrigerators, freezers or at ambient temperature (e.g., honey). The audit team noted that, in the national sampling instruction, there were no guidelines on the suitable storage and transport conditions for any sample/analyte/matrix combination leading to the observation that practices adopted in the three regions visited were somewhat different (e.g., a similar analyte/matrix sample could be stored chilled in one region but frozen in another). The absence in the NRCP of clear instructions on the suitable storage and transport conditions does not ensure full compliance with pertinent legal requirements (15). Furthermore, the absence of temperature measurements/checks by both the samplers (at dispatch) and the laboratory (upon receipt) of the samples, combined with the absence of information on analyte stability in matrix in all but one of the validation files scrutinised in the laboratories (see findings 31 and 35), raises the question whether this approach sufficiently ensures the compliance of the NRCP samples with the relevant legal requirements (16).

Whilst the NRCP is generally implemented promptly and in full accordance with planned arrangements and in line with EU rules, some shortcomings, i.e., absence of clear provisions on the suitable storage and transport conditions for the NRCP samples, and the erroneous interpretation of the reference point for action concept, have the potential to compromise the effectiveness of the plan.

The acceptance procedures for incoming samples at both laboratories visited addressed the checks on completeness of accompanying documentation, the seals and general status of arriving samples. The temperature status of the NRCP samples was recorded as "frozen" or "chilled" without more detailed information on the temperature of the samples at the time of reception. In combination with absence of temperature measurement prior to arrival at the laboratory (see finding 18) and lack of data on analyte stability in matrix in the validation files (see finding 35), these arrangements do not fully meet the provisions established by EU legislation (28) to ensure analyte stability and sample integrity, and, furthermore, the samples' legal, scientific and technical validity.

Medlemsstatens svar

The Chief Veterinary Officer will verify the provisions in the Monitoring Instruction (Instruction of the CVO No. BP.0200.1.11.2021 of May 26, 2021) in point 6 regarding the method of sampling, part F - Storage, transport and acceptance of samples to the laboratory. New entry in point 1: "When storing samples, the temperature should be monitored until they are delivered to the laboratory. Measurements of temperature values of storage conditions in a refrigerator/freezer should be made at least once a day (except for holidays) and recorded in the temperature register of stored samples. Temperature ranges of stored samples: - Durable products: 18 to 27°C - Frozen and deep frozen products: -18°C - Animal tissues, milk and water (intended for testing for antimicrobial residues): 8°C (except eggs and honey, which cannot be frozen) - Other perishables: 1 to 8°C" New entry in point 4: The person accepting the samples in the laboratory will check and note on the sample collection report the condition of the seal and its compliance with the specimen in the sample collection report, the temperature and condition of the sample, the consistency of the number of samples sent with the amount giv

petent Authority response received on 23 May 2023 The Chief Veterinary Officer will verify the provisions in the Monitoring Instruction (Instruction of the CVO No. BP.0200.1.11.2021 of May 26, 2021) in point 6 regarding the method of sampling, part F - Storage, transport and acceptance of samples to the laboratory. New entry in point 1: "When storing samples, the temperature should be monitored until they are delivered to the laboratory. Measurements of temperature values of storage conditions in a refrigerator/freezer should be made at least once a day (except for holidays) and recorded in the temperature register of stored samples. Temperature ranges of stored samples: - Durable products: 18 to 27°C - Frozen and deep frozen products: -18°C Page: 1 es of Poland in response to Report ref. DG(SANTE) 2023-7682 of the audit carried out from 30 e control of residues and contaminants in live animals and animal products posed by the competent authority Updated action proposed by the competent authority issues, milk and water (intended for r antimicrobial residues): pt eggs and honey, which cannot rishables: 1 to 8°C" in point 4: accepting the samples in the will check and note on the sam

Rekommendationen anger som grund

The audit team noted that for those analytes, where reference points for action had been established (17), the respective levels of action were set at concentrations equal to the relevant reference points for action meaning that no action would be taken in case of a measurable analytical result below the respective reference point for action. This approach was confirmed in the interviews with officials in two of the three regions visited. In the third region, the officials interviewed stated that any confirmed concentrations of the analytes with reference point for action would be considered as a non-compliance and result in prohibition of placing the product on the market. The (11) Part 3 of Annex II to Regulation (EU) 2021/808. (12) Available at https://eklient.piwet.pulawy.pl/ (no public access). (13) Parts 5 and 6 of Annex II to Regulation (EU) 2021/808. (14) Part 4 of Annex II to Regulation (EU) 2021/808. (15) Article 6 and Part 7 of Annex II to Regulation (EU) 2021/808. (16) Article 34(5) of Regulation (EU) 2017/625. (17) Regulation (EU) 2019/1871. 4 audit team pointed out that both interpretations were not fully in line with pertinent legal requirements (18).

Whilst the NRCP is generally implemented promptly and in full accordance with planned arrangements and in line with EU rules, some shortcomings, i.e., absence of clear provisions on the suitable storage and transport conditions for the NRCP samples, and the erroneous interpretation of the reference point for action concept, have the potential to compromise the effectiveness of the plan.

Medlemsstatens svar

Due to the change from November 28, 2022 of the reference points for for control activities set out in the annex to Commission ne Regulation (EU) 2019/1871 of November 7, 2019 on reference points for control activities regarding unauthorized pharmacologically active substances present in food of animal origin and repealing Decision 2005/34/EC, the Chief Veterinary Officer will verify the provisions in the Monitoring Instruction (Instruction CVO No. BP.0200.1.11.2021 of May 26, 2021) by adding in point 6. on the method of sampling, another point on the interpretation of results in the case of detection of substances for Page: 2 port ref. DG(SANTE) 2023-7682 of the audit carried out from 30 January 2023 nants in live animals and animal products by the competent authority een established (Chloramphenicol, Malachite furans and their metabolites). stances for which RPA has been established - control activities: result of substances for which RPA is established is ion limit (CC) of the method - the tested food and mal origin are considered to comply with EU t of testing substances for which RPA is established cision limit (CC) of the method but below the RPA ted food and products of anim

Competent Authority response received on 23 y 2023 Due to the change from November 28, 2022 of the reference points for control activities set out in the annex to Commission Regulation (EU) 2019/1871 of November 7, Page: 3 es of Poland in response to Report ref. DG(SANTE) 2023-7682 of the audit carried out from 30 e control of residues and contaminants in live animals and animal products ion Proposed by the competent authority Updated action proposed by the competent authority 9 on reference points for control activities arding unauthorized pharmacologically ive substances present in food of animal gin and repealing Decision 2005/34/EC, Chief Veterinary Officer will verify the visions in the Monitoring Instruction struction CVO No. BP.0200.1.11.2021 of 26, 2021) by adding in point 6. on the hod of sampling, another point on the erpretation of results in the case of ection of substances for which RPA has n established (Chloramphenicol, achite Green and Nitrofurans and their abolites). ults for substances for which RPA has n established - benchmarks for control ivities: If the test result of substances for which is established is below the decision limit ) of the method - the tested

Rekommendationen anger som grund

The audit team noted that, at the time of the audit, none of the testing laboratories, including the NRL, was formally designated as an official laboratory, which is not in line with the requirements of EU legislation (25).

Notwithstanding the fact that the testing laboratories are accredited, operate methods included in their scopes of accreditation and perform well in proficiency tests, the absence of their official designation, deficiencies in the validation of analytical methods, in the operation of internal quality controls and in the reporting of analytical results undermine the reliability of the results and the subsequent enforcement decisions taken.

Medlemsstatens svar

cial The Chief Veterinary Officer will designate official laboratories yses, tests and laboratory diagnostics on samples national control programs for the use of ly active substances approved as veterinary cts or as feed additives, as well as prohibited or armacologically active substances and their minants and pesticides in animals, in food and Page: 3 port ref. DG(SANTE) 2023-7682 of the audit carried out from 30 January 2023 nants in live animals and animal products oposed by the competent authority of animal origin as well as other official activities in e with Article 37 of Regulation (EU) 2017/625. nation of a laboratory shall be in writing and shall detailed description of the tasks performed by the y as an official laboratory, the conditions under which it its tasks and the arrangements necessary to ensure and effective coordination and cooperation between the y and the competent authorities. (finding no. 28) n date: December 2023

ompetent Authority response received on 23 Reply from GVI: f Veterinary Officer will designate The Chief Veterinary Officer will designate laboratories to conduct analyses, tests official laboratories by 11 August 2023. ratory diagnostics on samples taken e national control programs for the Page: 5 es of Poland in response to Report ref. DG(SANTE) 2023-7682 of the audit carried out from 30 e control of residues and contaminants in live animals and animal products posed by the competent authority Updated action proposed by the competent authority rmacologically active substances s veterinary medicinal products or ditives, as well as prohibited or ed pharmacologically active and their residues, contaminants ides in animals, in food and f animal origin as well as other ctivities in accordance with Article lation (EU) 2017/625. ation of a laboratory shall be in d shall contain a detailed n of the tasks performed by the as an official laboratory, the under which it performs its tasks rangements necessary to ensure and effective coordination and n between the laboratory and the authorities. (finding no. 28). date: December 2023

Rekommendationen anger som grund

The acceptance procedures for incoming samples at both laboratories visited addressed the checks on completeness of accompanying documentation, the seals and general status of arriving samples. The temperature status of the NRCP samples was recorded as "frozen" or "chilled" without more detailed information on the temperature of the samples at the time of reception. In combination with absence of temperature measurement prior to arrival at the laboratory (see finding 18) and lack of data on analyte stability in matrix in the validation files (see finding 35), these arrangements do not fully meet the provisions established by EU legislation (28) to ensure analyte stability and sample integrity, and, furthermore, the samples' legal, scientific and technical validity.

In most of the validation files scrutinised, no information was available on the animal species from which the matrices included in the validations had originated. The absence of this basic data undermines claims that the methods in question were appropriately validated for relevant species/matrix combinations.

In all, but one, of the validation files scrutinised, stability was not addressed either in solution or in matrix. This is not in line with EU legislation (30). The audit team pointed out that, if stability data are available from scientific literature or from another laboratory, these data do not need to be determined again by the concerned laboratory, provided that identical conditions apply (30).

In all of the validation files scrutinised, ruggedness was not formally addressed/assessed while the data collected allowed this to be done. This is not in line with pertinent EU requirements (30).

In one laboratory visited, in most of the validation files scrutinised, the audit team noted that only two series, on two different days, were included for reproducibility studies, which is different from EU requirements necessitating three series (31). The GVI representative explained that it was most likely due to an ambiguous translation to Polish of the relevant part of said legislation. However, the audit team noted that the second laboratory visited had correctly included three series in all of the relevant studies.

The audit team observed a number of cases where (within-day) repeatability and (between-day) reproducibility values were either similar or identical. While single values can indeed be similar, it cannot be a systemic phenomenon due to the very nature of the repeatability and reproducibility conditions, which is reflected in EU requirements (32). The possible impact of these observations on the conclusion, that the said methods were fit for their intended use, was not commented on, or discussed in any of the validation reports seen by the audit team.

In most of the validation files scrutinised, the criteria for recovery were different from the performance criteria set by EU legislation (33). The impact of such a deviation on the intended use of the methods was neither discussed nor evaluated in the validation reports.

In all of the validation files (except for the antimicrobial substances in milk method with a commercial bioassay) which were based on the preceding EU legislation (34), the audit team checked the calculation of the decision limit (CC) since the protocol used for the calculation of the detection capability (CC) had required knowledge of (30) Part 2.1. of Chapter 2 of Annex I to Regulation (EU) 2021/808. (31) Part 2.2.1.4. of Annex I to Regulation (EU) 2021/808. (32) Part 1.2.2.2. of Annex I to Regulation (EU) 2021/808. (33) Part 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (34) Commission Decision 2002/657/EC (was in force in the time of the validations). 7 the CC. The audit team observed that the CC calculations did not follow either of the approaches laid down in EU legislation (35). In two validation files (for screening methods) stated to be based on current legal requirements (36), the audit team checked the CC calculations and observed that the calculations did not follow any of the approaches laid down in said legislation (37).

The audit team noted that during routine use of the method for thyrostats, there was no consideration of analyte instability during freezing/thawing cycles and during storage in a freezer (38) which may undermine the validity of the results (i.e., truly non- compliant samples may not be detected).

Notwithstanding the fact that the testing laboratories are accredited, operate methods included in their scopes of accreditation and perform well in proficiency tests, the absence of their official designation, deficiencies in the validation of analytical methods, in the operation of internal quality controls and in the reporting of analytical results undermine the reliability of the results and the subsequent enforcement decisions taken.

Medlemsstatens svar

h all The National Reference Laboratory (NRI-NRI) will review and e instruction for validation of methods in accordance sion with the current requirements of EU law. The instruction will be er to the Regional Veterinary Laboratory (ZHW), and on the new edition of the instruction will also be . n date: December 2023 atories will review the validation documents and plan /new method validations. coming validations of test methods, which will be on the basis of Regulation (EU) 2021/808 (and the new on developed by NVRI), the comments contained in the ll be taken into account, including: g no. 34) the species/matrix system will be preserved, g no. 36) the robustness parameter of the method will be o account, g no. 37 and 38) the method of calculating repeatability ducibility will be unified, g no. 39) the correct recovery criteria will be taken into Page: 4 port ref. DG(SANTE) 2023-7682 of the audit carried out from 30 January 2023 nants in live animals and animal products on Proposed by the competent authority inding no. 40) the correct way to calculate the CC and CC es will be used. letion date: 2026 National Reference Laboratory (NRI-NRI), based on data EURL laboratories, information

Competent Authority response received on 23 ay 2023 al Reference Laboratory (NRI- review and update the instruction Page: 6 es of Poland in response to Report ref. DG(SANTE) 2023-7682 of the audit carried out from 30 e control of residues and contaminants in live animals and animal products Action Proposed by the competent authority Updated action proposed by the competent authority or validation of methods in accordance with the current requirements of EU law. The instruction will be handed over to the Regional Veterinary Laboratory (ZHW), and training on the new edition of the instruction will also be conducted. Completion date: December 2023 ZHW laboratories will review the validation documents and plan additions/new method validations. In the upcoming validations of test methods, which will be performed on the basis of Regulation (EU) 2021/808 (and the new instruction developed by NVRI), the comments contained in the report will be taken into account, including: - (finding no. 34) the species/matrix system will be preserved, - (finding no. 36) the robustness parameter of the method will be taken into account, Page: 7 es of Poland in response to Report ref. DG(SANTE) 2023-7682 o

Rekommendationen anger som grund

The audit team scrutinised the implementation of internal quality controls for analytical runs including a number of non-compliant results generated in 2020-2022 by the two laboratories visited and observed the following: a. In both laboratories, largely in line with EU requirements (40), quality control samples were included, quality control charts were timely created and maintained. b. While in one laboratory there was a clear written procedure on the criteria to be used for the on-going evaluation of the quality control charts, there was no such procedure in the second laboratory. It was not clear what actions would be taken in the event of deviating results on the quality control charts. This is not fully in line with pertinent legal requirements (40). c. In both laboratories, the matrices used for in-house positive (fortified) control samples were not adequately identified in the documentation provided. d. In both laboratories, when parallel runs of positive (fortified) control samples and/or routine samples with measurable amounts of residues were carried out, there were no procedures and practice to assess whether the difference between the parallel results did not exceed the methods' within-laboratory reproducibility. Consequently, no evaluation of the possible impact of that phenomenon on the analytical and legal validity of results was made.

Notwithstanding the fact that the testing laboratories are accredited, operate methods included in their scopes of accreditation and perform well in proficiency tests, the absence of their official designation, deficiencies in the validation of analytical methods, in the operation of internal quality controls and in the reporting of analytical results undermine the reliability of the results and the subsequent enforcement decisions taken.

Medlemsstatens svar

tems The National Reference Laboratory (NRI-NRI) will provide testing guidelines in the form of instructions regarding the requirements confirming the validity of results (including criteria for the oing assessment of control charts, determination of matrices for internal quality control) as well as for conducting irmatory analysis (criteria for assessing differences between llel test results) (finding No. 43). letion date: December 2023

mpetent Authority response received on 23 May 2023 Reply from GVI: National Reference Laboratory (NRI- The instructions prepared in the NRL will be will provide guidelines in the form of sent to the Commission by 31 December ructions regarding the requirements for 2023. irming the validity of results (including eria for the ongoing assessment of control ts, determination of matrices used for rnal quality control) as well as for ucting confirmatory analysis (criteria for ssing differences between parallel test lts) (finding No. 43). letion date: December 2023

Rekommendationen anger som grund

The audit team noted that the interpretation of the analytical results was made by the DVIs. The audit team checked a large number of laboratory testing reports, including those related to the non-compliant samples scrutinised, and observed that, in the (35) Part 3.1.2.5. of Annex I to Decision 2002/657/EC (was in force in the time of the validations). (36) Regulation (EU) 2021/808. (37) Part 2.7 of Annex I to Regulation (EU) 2021/808. (38) EURL Refection paper 2014: Natural growth promoting substances in biological samples, Chapter 2, paragraph 2.2. (39) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, Version 2.0, June 2022; available at https://sitesv2.anses.fr/en/system/files/EURL_MMPR_guidance_endorsed_v2_June2022.pdf. (40) Chapter 3 of Annex I to Regulation (EU) 2021/808. (41) Article 4 of Regulation (EU) 2021/808 and Article 38(2) of Regulation (EU) 2017/625. 8 majority of the reports, the relevant CC values had not been reported which did not ensure compliance with EU interpretation requirements (42).

Notwithstanding the fact that the testing laboratories are accredited, operate methods included in their scopes of accreditation and perform well in proficiency tests, the absence of their official designation, deficiencies in the validation of analytical methods, in the operation of internal quality controls and in the reporting of analytical results undermine the reliability of the results and the subsequent enforcement decisions taken.

Medlemsstatens svar

mation The National Reference Laboratory (NRI-NRI) will provide elines (including the provision of CC values) in the form of ructions on how to present test results in all laboratories Page: 5 port ref. DG(SANTE) 2023-7682 of the audit carried out from 30 January 2023 nants in live animals and animal products ent authority lementing the National Residue Control Program (finding no. 3 Page: 6

ompetent Authority response received on 23 2023 Reply from GVI: National Reference Laboratory (NRI- The instructions prepared in the NRL will be will provide guidelines (including the sent to the FVO by 31 December 2023. ision of CC values) in the form of ructions on how to present test results in Page: 9 es of Poland in response to Report ref. DG(SANTE) 2023-7682 of the audit carried out from 30 e control of residues and contaminants in live animals and animal products posed by the competent authority Updated action proposed by the competent authority tories implementing the National ntrol Program (finding no. 45). date: December 2023 Page: 10

Rekommendationen anger som grund

Personnel from GVI also stated that there were discussions between GVI and the Chief Pharmaceutical Inspectorate to decide which authority is responsible to check that veterinarians do not prescribe antimicrobials listed in the Annex to Implementing Regulation (EU) 2022/1255. However, such a decision had not yet been made (see point 10). This is not in line with Article 137 of the VMPR. 4 Conclusion on the competent authorities

The competent authorities for carrying out controls in areas related to this audit have long been designated, with the exception of those responsible for checking that antimicrobials reserved for the treatment of certain infections in humans are not prescribed for animals (see point 19).

No checks have been planned or carried out to confirm that veterinarians do not prescribe antimicrobials listed in the Annex to Implementing Regulation (EU) 2022/1255, given that there is no clarity as to the competent authority responsible (see point 5). This is not in line with Article 123(1) and (2) of the VMPR.

Even though checks done in accordance with national legislation enacted before 2019 cover the trade and use of VMPs, the absence of planning and implementation of controls to verify compliance with most of the requirements under the scope of this audit, notably those on the use of antimicrobials, does not allow the authorities to contribute to a more prudent use of antimicrobials through the enforcement of the VMPR.

Rekommendationen anger som grund

The GVI confirmed that they have not yet started planning and organising controls to check compliance with many of the legal requirements under the scope of this audit, in particular those that were not included in previous EU legislation or that have been modified by the VMPR. This refers notably to the requirements on the use of antimicrobials and when applicable, how veterinary prescriptions must reflect that use (Articles 107, 112 to 114 and the corresponding points in Article 105). This is not in line with Article 123(1) and (2) of the VMPR (6).

No checks have been planned or carried out to confirm that veterinarians do not prescribe antimicrobials listed in the Annex to Implementing Regulation (EU) 2022/1255, given that there is no clarity as to the competent authority responsible (see point 5). This is not in line with Article 123(1) and (2) of the VMPR.

From the descriptions of the above-mentioned checks, it was clear that no other controls are done to verify whether antimicrobials are used in accordance with Article 107(1) to (4) or Articles 112 to 114 and, when applicable, whether that use is reflected in the veterinary prescription, as laid down in Article 105(5)(l) and (m). This is not in line with Article 123(2) of the VMPR (8).

Personnel from the District Veterinary Inspectorate met explained that around 1 to 3 % of farms in their district are selected annually to carry out controls that include checks on the records reflecting the use of antimicrobials. The said officials declared that those checks do not go deep into the content but focus instead on the completeness of the records. These controls do not then include checks to verify if the use of antimicrobials (8) In its response to the draft report, the competent authorities noted that controls concerning animal keeping conditions and animal welfare are carried out at the level of district veterinary inspectorates (requirements of Article 107(1) and (2) of Regulation (EU) 2019/6). 6 comply with the provisions of Article 107(1) to (4) or Articles 112 to 114 and, when applicable, whether that use is reflected in the veterinary prescription, as laid down in Article 105(5)(l) and (m). This is not in line with Article 123(2) of the VMPR.

Even though checks done in accordance with national legislation enacted before 2019 cover the trade and use of VMPs, the absence of planning and implementation of controls to verify compliance with most of the requirements under the scope of this audit, notably those on the use of antimicrobials, does not allow the authorities to contribute to a more prudent use of antimicrobials through the enforcement of the VMPR.

Rekommendationen anger som grund

The GVI declared that the current system in place to impose penalties to operators that use or trade VMPs is not always efficient. The main reason for that is that, at present, the Veterinary Inspection Service cannot impose penalties directly on the operators trading in VMPs found to be non-compliant after inspections. Instead, these penalties can only be imposed by law enforcement agencies, who according to the GVI tend to focus only on (very) serious breaches of the applicable legislation. These do not include infringements of the requirements in the scope of this audit. This is not in line with Article 135(1) of the VMPR. Conclusions on actions in case of non-compliance

The current system in place to impose penalties applicable to infringements of the VMPR is not efficient enough to deter operators from prescribing or using antimicrobials in a non-prudent manner.

Medlemsstatens svar

1) In connection with the upcoming autumn action of oral vaccination of foxes against rabies, a meeting with representatives of Voivodeship Veterinary Inspectorates will be organized in September 2022, devoted to analyzing the findings, conclusions and recommendations of this audit report in order to develop an appropriate action plan in each of the regions covered by the oral vaccination campaign of foxes against rabies as part of the modification of the current vaccination strategy. The action plan will aim to identify risk areas on the basis of the experience gained so far, and to define preventive actions in the event of risk occurrence. In the first place, it is planned to develop a preliminary plan for the autumn vaccination campaign in 2022, and then to verify the assumptions and implementation of the plan adopted in the plan by December 31, 2022, in order to apply the methodology in subsequent vaccination campaigns. The GVI will prepare and provide the Regional Veterinary Inspectorates with the framework of the above-mentioned plan. 2) As part of the analysis and identification of the risk areas referred to in point 1, the representativeness of sampling for monitoring purpo

Medlemsstatens svar

es as above. Page: 2 port ref. DG(SANTE) 2022-7507 of the audit carried out from 21 March to 5 rabies eradication programme. n Proposed by the competent authority

Rekommendationen anger som grund

The audit team looked at more detailed data on monitoring. Those show important variations between the regions regarding the percentage of the target they were achieving. One region (Masovian) was constantly not reaching the targets. This indicates a persistent issue with sampling, in particular in one district that had reported a lower density of foxes. 10

The fact that some districts do not collect and analyse the necessary number of samples and the geographical bias (i.e. samples taken only from some hunting grounds), can reduce the representativeness and reliability of the results obtained from their analysis and the validity of the conclusions drawn up at regional and district level on the levels of immunity reached.

The values of sero-positivity in young foxes demonstrates that, in some regions, oral vaccination campaigns have not successfully reached the young fox population. There is an important variation between authorities regarding the use of hunting data. This likely means that the difference between districts regarding the quality of their planning and monitoring is increasing, with those using hunting data to fine-tune the actions planned in the eradication programme achieving better results.

The insufficient monitoring of vaccination effectiveness in some areas of the country weakens the authority's capability to detect promptly potential issues in the rabies eradication, in particular in oral vaccination of wild carnivores.

Medlemsstatens svar

m In accordance with the recommendations of the auditors, idual areas of the rabies eradication program will be sed, and in the event that the conditions necessary for g temporary changes to the program in force in the years 2023 are found (Regulation of the Minister of Agriculture d Rural Development of March 1, 2022 on the introduction of abies control program on 2022 and 2023), the General inary Inspectorate will submit a draft amendment to the am for 2023 to the Ministry of Agriculture and Rural opment. An in-depth comprehensive analysis including ical and epidemiological information in order to implement mendation 3 will be carried out in 2023 before the opment of the rabies control program for the following . Page: 3

Rekommendationen anger som grund

Several national measures regulate the production of dairy products in establishments availing of the flexibility possibilities provided for in EU legislation. However, one of these has not been notified to the European Commission and Member States, contrary to the provisions of Directive (EU) 2015/1535.

Medlemsstatens svar

h Odpowied MRiRW: Projekt ustawy o zmianie niektórych ustaw w celu ulatwienia prowadzenia przez rolników rolniczego handlu detalicznego al notyfikowany Komisji Europejskiej 5 sierpnia 2021 r. pod numerem 2021/0535/PL. Planowana jest równie jeszcze w tym roku notyfikacja rozporzdzenia wykonawczego do ww. ustawy. Rozporzdzenie to zastpi obecnie obowizujce rozporzdzenie MRiRW z dnia 16 grudnia 2016 r. w sprawie maksymalnej iloci ywnoci zbywanej w ramach rolniczego handlu detalicznego oraz zakresu i sposobu jej dokumentowania (Dz.U. 2016 poz. 2159).

MRiRW

Rekommendationen anger som grund

BACKGROUND The last two audits in Poland, in order to evaluate the official controls related to, inter alia, the safety of milk and dairy products were carried out in 2008 (ref. DG(SANCO)/2008-7810) and 2013 (ref. DG(SANCO)/2013-6874). The reports of these audits are available at the following links: https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=2224 https://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3268. Commission Implementing Regulation (EU) 2021/620 recognises Poland as officially free from Brucella abortus, Brucella melitensis and tuberculosis. The CCA provided the following data on the dairy herds in Poland: Cattle Sheep / Goat Buffaloes - 201 266,223 1,340 / 4,431 - 8 - - Number of dairy 201 246,962 1,319 / 4,666 - herds 9 - Milk production 202 234,211 1,371 / 5,016 (in tonnes) 0 201 14,171,150 0.61 / 7.45 8 201 14,502,76 0.57 / 8.16 9 202 Not provided 0 The production of dairy products is summarised below (in tonnes): Combined Nomenclature (CN) code and 2018 2019 commodity 1,778,550 1,892,170 0401 Liquid milk and cream (253,690 of (253,490 of cream) cream) 3 Combined Nomenclature (CN) code and 2018 2019 commodity 196,000 194,150 532,240 538,640 0402 Powdered milk and cream 1,522,260 1,609,960 222,660 224,450 0403 Fermented milk 854,770 867,160 0404 Whey powder and liquid whey, milk protein concentrates 0405 Butter and other fats and oils derived from milk 0406 Cheese and curd

The national measures in place that provide for the trade at national level of dairy products produced at farm level or private dwellings, and of dairy products with traditional characteristics produced in non-approved establishments, are not in line with EU legislation.

The procedures in place for the approval, registration and listing of facilities/FBOs dealing with milk and dairy products are not fully in line with the EU rules, as FBOs producing milk and processed dairy products and placing them on the market in the whole territory of Poland, are registered instead of approved.

Medlemsstatens svar

dpowied MRiRW: Strona polska odrzuca t rekomendacj jako nieuzasadnion. Do dzialalnoci, których zasady prowadzenia okrelaj przepisy krajowe wydane na podstawie art. 1 ust. 5 lit. a i lit b (ii) rozporzdzenia nr 853/2004, z zaloenia, zgodnie z przepisami UE, nie maj zastosowania przepisy rozporzdzenia nr 853/2004, dlatego te nie ma podstaw aby wymaga, eby zaklady prowadzce dzialalno na podstawie przepisów krajowych, wydanych na podstawie art. 1 ust. 5 lit. a i lit b (ii) rozporzdzenia nr 853/2004 podlegaly procedurze zatwierdzenia. Zaklady te podlegaj procedurze rejestracji. Ponadto do zakladów, które korzystaj z odstpstw od niektórych przepisów rozporzdze nr 853/2004 i nr 852/2004 zgodnie z przepisami rozporzdze krajowych (rozporzdzenie MRiRW z dnia 7 lipca 2010 r. w sprawie wymaga weterynaryjnych przy produkcji produktów mlecznych o tradycyjnym charakterze (Dz.U. 2017 poz. 1259); Page: 1 eport ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 safety of milk and dairy products authority ca 2007 r.w sprawie w ga higienicznych w cyjn pochodzenia estracji i zatwierdzania, przepisy lujce te kwestie. ukturalnego od wymaga nego np. w rozporzdzeniu przy produkcji produkt

iRW

Rekommendationen anger som grund

In relation to the milk and dairy sector, limited training had been organised in the last 6 years by the CCA (with the exception of two regions one of which was implicated in a Rapid alert system for food and feed (RASFF) notification). The audit team noted gaps in relation to the understanding and/or the knowledge of some of the inspectors interviewed in certain areas (e.g. assessment of microbiological criteria - Listeria monocytogenes (L. monocytogenes) in dairy products, and Hazard analysis and Critical Control Points (HACCP)-based procedures in the dairy sector)4. 3 In their response to the draft report the Competent Authority noted that the training plans implemented by the PIWet-PIB under the multi-annual programmes `Protection of animal health and protection of public health', prior to their approval by the MARD and the allocation of funds for their implementation, are always agreed with the CVO with account taken of the needs of the VI. They also noted that the VI staff provide lectures on certain subjects. 4 In their response to the draft report the Competent Authority noted that the training to be provided by the PIWet-PIB under the 2019-2023 multi-annual programme `Protection of animal health and protection of public health' includes, inter alia, the following two-day thematic modules: 1) The basics of food processing and processing technologies for food of animal origin that covers among others, the dairy technology and the heat treatment of food of animal origin, and 2) Microbiological hazards in the production of food of animal origin that covers, among others, the microbiological food safety and process hygiene criteria, the food quality and safety assessment ­ test methods, the official control programmes for the presence of microbiological contaminants in food and the results of official food testing. 9

No procedures are in place to ensure that inspectors responsible for controls of dairy establishments and holdings have adequate knowledge of the specific requirements to ensure food safety of milk and dairy products. A training system is in place for the officials but no specific training has been organised and provided centrally in recent years in relation to the specific requirements and particularities of the dairy sector. This could have an impact on the level of competence of staff responsible for official controls of the dairy sector.

According to the CVO Instructions, the DVOs have to assess the operation of the raw milk laboratories used by the FBOs for raw milk analysis during their official controls6. However, there were no guidelines available to the DVOs, detailing, for example, the standards against which they assess the laboratory procedures or the laboratory methods used. The practical value of the instruction is thus limited and the understanding of the DVI inspectors interviewed by the audit team on the relevant requirements and the necessary controls to be carried out was insufficient. Conclusions on controls of raw milk upon collection

The monitoring is impaired by the lack of guidelines for the DVIs on the assessment of raw milk laboratories' performance and by the lack of inspectors' knowledge of this topic. 5.6. OFFICIAL CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH HYGIENE RULES Legal requirements Articles 8, 9, 10, 11, 12, 13, 14, 15, 137, 138 and 139 of Regulation (EU) Regulation (EU) 2017/625. Articles 3 and 4 of Commission Implementing Regulation (EU) 2019/627. Findings 5.6.1 General organisation of official controls

The audit team noted that specific verification controls on the critical controls points (CCPs) are carried out by the official inspectors. However, not all relevant aspects were consistently covered during these controls. In particular: a. In relation to the verification of the FBOs' monitoring of pasteurisation, the inspectors interviewed had insufficient knowledge of the technical details that need to be checked regarding heat treatments. For example, the inspectors interviewed could not explain the function of the pasteurisation chart, the parameters displayed and monitored (temperature and milk flow) and the specifications and operation of flow diversion valves. Furthermore, they were not aware of the technical details regarding drying of milk powder. b. The official controls on the adequacy of the CCPs and their controls by the FBOs was not always sufficient (e.g. the absence of any other CCP, such as the monitoring of the effectivity of drying, in addition to monitoring of the effectivity of pasteurisation in milk/whey powder production, was not considered an issue by the official inspector; the use of alkaline phosphatase testing was considered as the monitoring (and not the verification) step of pasteurisation). 5.6.2.3 Microbiological criteria for foodstuffs Legal requirements Articles 3 and 4, and Annex I to Regulation (EC) No 2073/2005. Findings

However, in the case of a RASFF notification in which L. monocytogenes was detected in dairy products, the CA had only noted non-compliances in relation 22 to the pathogen after 20 days (see also paragraph 113). This delay was linked to the CA's misunderstanding of the requirements and the actions to be taken for Listeria positive samples below the 100 cfu/g limit (whether the test results were satisfactory or not).

Official controls on certain aspects of the HACCP-based systems, in particular in relation to heat treatments and microbiological criteria, were less effective due to the lack of technical knowledge of the OVs and the lack of specific guidelines.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

e e

Szkolenia prowadzone przez Pastwowy Instytut Weterynaryjny ­ Pastwowy Instytut Badawczy (PIWet-PIB) w ramach programu wieloletniego na lata 2019-2023 "Ochrona zdrowia zwierzt i hrona zdrowia publicznego" obejmuj m.in. nastpujce dwudniowe bloki tematyczne: 1) Podstawy przetwórstwa spoywczego i technologia ywnoci pochodzenia zwierzcego oraz 2) Zagroenia mikrobiologiczne w produkcji ywnoci pochodzenia zwierzcego. W ramach pierwszego z ww. bloków co roku s realizowane m.in. tematy: - technologia mleczarstwa, - obróbka cieplna ywnoci pochodzenia zwierzcego. W ramach drugiego z ww. bloków co roku s realizowane m.in. tematy: Page: 1 t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products on w a W ziala nes . t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products la k/g L. t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products z ych i nie giena 4-6 t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products Action Proposed by the competent authority Jednoczenie pragniemy wskaza, e cz praktyczna szkolenia dotyczca m

Rekommendationen anger som grund

The audit team noted that the instructions do not detail the requirements on supervision of PVPs and do not provide the necessary safeguard measures on the avoidance of conflict of interest and assurance of impartiality as required by Articles 5 and 30 of Regulation (EU) 2017/625. In the DVIs, chosen as examples by the audit team, it was noted that: a. The PVPs had signed a declaration of the absence of conflict of interest. The declarations lacked the above-mentioned additional provisions. The DVOs interviewed had not recognised some circumstances that could be regarded as causing a conflict of interest (e.g. delegating official tasks to PVPs who have professional relations with the establishments in question, who work as practitioners in the farms supplying milk to those 10 establishments, or who have been delegated to collect raw milk samples from holdings which are their clients). b. The DVOs supervision of the delegated veterinarians was limited and there was no formal system in place to ensure that supervision. The DVOs carried out less than one documented supervision visit annually in order to assess their performance of PVPs (i.e. audits or inspections of the delegated officials as required in Article 30 of Regulation (EU) 2017/625).

The PVPs are not invited to participate in the training activities organised by the CCA for official veterinarians (OVs). They can, however, participate in training activities organised at regional and district level. Conclusions on competent authorities

PVPs have been designated to carry out several official control tasks in dairy establishments. The conditions for designations are not fully appropriate nor fully in line with the requirements of the EU legislation, as they are not sufficiently detailed and do not fully ensure their impartiality. This could impair the effective enforcement of the relevant EU legislation.

Medlemsstatens svar

Odpowied MRiRW: Aktualnie procedowany projekt ustawy o zmianie ustawy o Inspekcji Weterynaryjnej oraz niektórych innych ustaw (nr w Wykazie prac legislacyjnych i programowych Rady Ministrów: UC59), zawiera projekt regulacji, która ma na celu zapewnienie, aby osoby wyznaczone przeprowadzajce kontrole urzdowe i inne czynnoci urzdowe byly wolne od konfliktu interesów oraz podejrze o brak bezstronnoci. W zwizku z powyszym, wymieniony projekt przewiduje skladanie przez wyznaczonych lekarzy weterynarii, pod rygorem odpowiedzialnoci karnej za skladanie falszywych owiadcze, owiadcze dotyczcych Page: 3 eport ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 safety of milk and dairy products ion Proposed by the competent authority onywania przez nich innych zaj zarobkowych oraz adcze o zmianie danych zawartych w wyej wymienionych adczeniach ­ w kadym przypadku, gdy wystpila taka ana danych. rojekcie ustawy wprowadza si równie obowizek adania przez kady podmiot, na wniosek powiatowego lekarza erynarii, pod rygorem odpowiedzialnoci karnej za skladanie szywych owiadcze, owiadczenia zawierajcego dane o ciach zarobkowych wykonywanych na rzecz tego podmiotu ez danego lekarza wet

MRiRW

Rekommendationen anger som grund

According to the CCA, during the periodic controls, the general hygiene requirements for holdings are documented on the basis of checklists drawn up at local level. The audit team saw some examples of inspections reports in which these requirements were covered. The CCA also provided general data on the non-conformities detected annually at national level. However, no such checklists were used by the DVIs assessed by the audit team.

The results of raw milk sampling and testing from the dairy companies and MCCs were not available on the dairy holdings and were not included in the documentation assessed by the official inspectors during their controls. The audit team was informed that farmers usually only receive the results as text messages to their mobile phones.

In relation to the controls on milk traceability, there is not a formal requirement for the farmer to keep data on the fate of raw milk that is not in 14 compliance with the raw milk criteria and therefore cannot be placed in the market (e.g. due to residues of antibiotics). In the case examined by the audit team it was stated by the DVI interviewed that a farmer's oral declaration, on the actions taken in relation to non-compliant milk, is sufficient.

The lack of harmonised checklists impair the uniformity and consistency of controls and reporting thereof.

According to the CVO Instructions, the DVOs have to assess the operation of the raw milk laboratories used by the FBOs for raw milk analysis during their official controls6. However, there were no guidelines available to the DVOs, detailing, for example, the standards against which they assess the laboratory procedures or the laboratory methods used. The practical value of the instruction is thus limited and the understanding of the DVI inspectors interviewed by the audit team on the relevant requirements and the necessary controls to be carried out was insufficient. Conclusions on controls of raw milk upon collection

The monitoring is impaired by the lack of guidelines for the DVIs on the assessment of raw milk laboratories' performance and by the lack of inspectors' knowledge of this topic. 5.6. OFFICIAL CONTROLS OVER FOOD BUSINESS OPERATORS' COMPLIANCE WITH HYGIENE RULES Legal requirements Articles 8, 9, 10, 11, 12, 13, 14, 15, 137, 138 and 139 of Regulation (EU) Regulation (EU) 2017/625. Articles 3 and 4 of Commission Implementing Regulation (EU) 2019/627. Findings 5.6.1 General organisation of official controls

The audit team noted that, in addition to the CVO Instructions, there were no specific guidelines available to the dairy inspectors regarding dairy-specific technical issues and, in particular, in relation to the implementation of HACCP systems in dairy establishments.

Official controls on certain aspects of the HACCP-based systems, in particular in relation to heat treatments and microbiological criteria, were less effective due to the lack of technical knowledge of the OVs and the lack of specific guidelines.

Medlemsstatens svar

e: 4 eport ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 safety of milk and dairy products Action Proposed by the competent authority

1)Zostal przygotowany projekt listy kontrolnej SPIWET dla gospodarstw pozyskujcych mleko, który obejmuje odpowiednie wymagania zalcznika I do rozporzdzenia 852/20049, wymagania zawarte w rozdziale I sekcji IX, zalcznika III do rozporzdzenia 853/2004 oraz wymagania zawarte w przepisach krajowych. Projekt zostal skierowany do zaopiniowania przez WLW i PLW oraz po naniesieniu poprawek wynikajcych z uwag terenowych organów IW zostanie skierowany do Biura Prawnego do oceny pod wzgldem formalno-prawnym. Wejcie w ycie planowane jest w IV kwartale 2021. 2) Zostal przygotowany projekt zmienionej listy kontrolnej SPIWET dla zakladów zatwierdzonych i zarejestrowanych, który zostal uzupelniony o wymóg sprawdzenia przez PLW: - czy laboratorium wykonujce badania surowego mleka na rzecz PPPS w kierunku liczby drobnoustrojów, liczby komórek somatycznych oraz pozostaloci antybiotyków i innych substancji przeciwbakteryjnych wchodzi w sklad systemu Page: 5 t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products on Proposed by the competent authority ratoriów urzdowych, o których mowa w art. 25 ust. 2 wy o IW, albo to laboratorium wpisane do rejestru prowad

Rekommendationen anger som grund

The audit team noted that specific verification controls on the critical controls points (CCPs) are carried out by the official inspectors. However, not all relevant aspects were consistently covered during these controls. In particular: a. In relation to the verification of the FBOs' monitoring of pasteurisation, the inspectors interviewed had insufficient knowledge of the technical details that need to be checked regarding heat treatments. For example, the inspectors interviewed could not explain the function of the pasteurisation chart, the parameters displayed and monitored (temperature and milk flow) and the specifications and operation of flow diversion valves. Furthermore, they were not aware of the technical details regarding drying of milk powder. b. The official controls on the adequacy of the CCPs and their controls by the FBOs was not always sufficient (e.g. the absence of any other CCP, such as the monitoring of the effectivity of drying, in addition to monitoring of the effectivity of pasteurisation in milk/whey powder production, was not considered an issue by the official inspector; the use of alkaline phosphatase testing was considered as the monitoring (and not the verification) step of pasteurisation). 5.6.2.3 Microbiological criteria for foodstuffs Legal requirements Articles 3 and 4, and Annex I to Regulation (EC) No 2073/2005. Findings

However, in the case of a RASFF notification in which L. monocytogenes was detected in dairy products, the CA had only noted non-compliances in relation 22 to the pathogen after 20 days (see also paragraph 113). This delay was linked to the CA's misunderstanding of the requirements and the actions to be taken for Listeria positive samples below the 100 cfu/g limit (whether the test results were satisfactory or not).

Official controls on certain aspects of the HACCP-based systems, in particular in relation to heat treatments and microbiological criteria, were less effective due to the lack of technical knowledge of the OVs and the lack of specific guidelines.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

all

zwizku z niewystarczajc wiedz urzdowych lekarzy terynarii na temat niektórych aspektów systemu HACCP, w ególnoci w odniesieniu do obróbki termicznej mleka i ll produktów mlecznych, w szkoleniu z technologii mleczarstwa, e bdzie realizowane w latach 2022 i 2023 w ramach ramu wieloletniego "Ochrona zdrowia zwierzt i ochrona wia publicznego" tematy te zostan szczególowo omówione. erwcu 2021 r. zorganizowane zostaly przez GLW trzy tury lenia w formie zdalnej pt. ,,Weryfikacja dziala dsibiorstw spoywczych podejmowanych w celu wnienia zgodnoci z wymogami rozporzdzenia (WE) nr /2005 w zakresie bada w kierunku Listeria monocytogenes enterotoksyn gronkowcowych" dla pracowników GIW, PIW oraz wyznaczonych urzdowych lekarzy weterynarii ujcych si bezpieczestwem ywnoci pochodzenia rzcego. Wicej informacji na ten temat zostalo kazanych w pkt 3. Page: 6 t ref. DG(SANTE) 2021-7180 of the audit carried out from 01 March 2021 ty of milk and dairy products ion Proposed by the competent authority

Rekommendationen anger som grund

The guidelines do not cover coagulase positive Staphylococci and not all regions have a policy to test such samples in line with the provisions of Regulation (EC) No 2073/2005. One RVO mentioned that in 2019 they realised that samples that exceed the 100,000 colony forming units (cfu)/g limit for coagulase positive Staphylococci were not tested for enterotoxins as the regional laboratory did not have that testing capacity. The CA of that region has since put in place a system by which non-compliant samples are tested in one of the two laboratories in the country that have this capacity. The CCA stated that they intend to also extend this system to other regions.

The official tests for process hygiene criteria in dairy products in 2018-2019 detected: a. Coagulase positive Staphylococci in 33 batches out of 1,146 sampled and tested (the CAs did not have the actual testing values in order to assess if some of these 33 batches had exceed the 100,000 cfu/g limit and would have required enterotoxin testing as specified in Annex II to Regulation (EC) No 2073/2005); b. Escherichia coli in 22 batches out of 757 sampled and tested; c. Enterobacteriacae in 18 batches out of 566 tested.

The audit team assessed the actions taken in the case of two RASFF notifications (Salmonella and Listeria contaminations). It was noted that the above-mentioned guidelines have been, in general, followed. with the exception of official sampling linked to the presence of unsatisfactory hygienic conditions during the production process (see paragraph 112).

The CAs have not established a minimum frequency for official sampling and testing of alkaline phosphatase to verify the efficacy of heat-treatment (pasteurisation). Samples may be taken by DVOs on the basis of risk-analysis. However, no official sampling and testing took place in recent years. The CAs interviewed stated that they had not verified if the method used by the FBO had been validated against the ISO method as required in the EU legislation (they only check if the FBO follows the producer's instructions). The system does not allow the CAs to detect related shortcomings in FBOs' testing for this parameter7. 5.7.2 Official laboratories Findings

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

in sed icle

n Naley wyjani, e niejednoznacznie wskazano w przekazanym ed auditorom wykazie wyznaczone laboratoria urzdowe w tym cle zakresie (poza glównymi siedzibami zostaly wskazane take, zialy ZHW, które nie wykonuj bada surowego mleka). tego bldnie odczytano w czasie auditu uczestnictwo tych oratoriów w badaniach biegloci (PT), a take w szkoleniach i inariach organizowanych dla tych laboratoriów przez KLR. rzyczyn organizacyjnych zwizanych z epidemi seminaria w 0 r. dla tych laboratoriów zostaly zawieszone. przedstawil ofert i harmonogram bada biegloci ewniajcych uczestnictwo w PT dla laboratoriów dowych i laboratoriów z rejestru GLW zgodnie z aganiami ustawy z dnia 29 stycznia 2004 r. o Inspekcji erynaryjnej. Dzialania te s wlaciwie realizowane i liwiaj udzial w PT laboratoriom w zakresie wszystkich aganych parametrów (liczba drobnoustrojów i komórek atycznych oraz obecno antybiotyków), kierunków bada aganych kryteriów mikrobiologicznych mleka i produktów cznych (higieny procesu i bezpieczestwa) oraz matryc i od badania. Naley wyjani, e to laboratorium urzdowe laboratorium z rejestru ma obowizek zglosi swój udzial dnie z harmonogramem przygotowanym przez KLR, w resie wlaciwym do wykonywan

Rekommendationen anger som grund

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

To ensure that official sampling and testing covers all the relevant parameters of EU legislation and that in the case of detection of non- compliances the actions taken are sufficient and swift and that they ensure that the necessary measures aimed at ensuring that no contaminated product can reach the market are taken, as required by Article 138 of Regulation (EU) 2017/625. Recommendation based on conclusions Nos 107, 108 and 116 Associated findings Nos 94, 96, 97, 98 and112

smem GIW.WNBPZ.501.15.5.2021 z dnia 31 marca 2021 r. -ca GLW przypomnial WLW i PLW zasady pobierania próbek i konywania bada urzdowych produktów mlecznych w erunku gronkowców koagulazododatnich oraz enterotoksyn onkowcowych. Ponadto wymagania dotyczce wykonywania . bada zostaly równie omówione w trakcie szkolenia pt. Weryfikacja dziala przedsibiorstw spoywczych dejmowanych w celu zapewnienia zgodnoci z wymogami zporzdzenia (WE) nr 2073/2005 w zakresie bada w kierunku steria monocytogenes oraz enterotoksyn gronkowcowych". smem GIW.WNBPZ.501.15.4.2021.3 z dnia 26 sierpnia 2021 z-ca GLW zlecil przeprowadzenie weryfikacji skutecznoci steryzacji mleka krowiego w zakladach zatwierdzonych. Do ca tego roku w kadym zakladzie mleczarskim twierdzonym, poddajcym mleko krowie pasteryzacji w celu odukcji mleka spoywczego lub innych produktów mlecznych stan pobrane próbki i wyslane do bada do Pastwowego stytutu Weterynaryjnego - Pastwowego Instytutu dawczego w Pulawach. Badania bd przeprowadzone metod uorymetryczn wedlug normy EN ISO 11816 -1 Mleko i zetwory mleczne. Oznaczanie aktywnoci fosfatazy kalicznej. Cz 1: Metoda fluorymetryczna dla mleka i pojów na bazie mleka. niki ww. bada urzdowych z

Rekommendationen anger som grund

The draft Act, announced in the AP, has been suspended due to the high financial impact of the project. This Act was to include: · further wage increases for official staff in the CAs; · an increase in the number of official veterinarians (OVs) supervising slaughterhouses; · additional increases in the number of staff at the level of DVIs (i.e. aimed at increasing district veterinary officers' (DVOs) supervision capacity of official controls carried out by authorised veterinarians (AVs)).

The CCA provided data that shows that the number of AVs has increased considerably since the beef audit (from around 3 300 AVs in 2019 to 5 800 in 2021), while the number of official staff in the CAs has decreased slightly.

The audit team found evidence demonstrating the importance of the supervisory role of the CAs (see paragraph 6 on targeted controls on the AVs' performance and paragraphs 43, 57 and 58 on DVOs' inspections and GVI's audits carried out in some poultry slaughterhouses). (1) The new legal basis of this recommendation is Article 5(1)(e) of Regulation (EU) 2017/625. 7 Conclusion on recommendation No 1 of the beef audit

The actions, provided in the AP for addressing Recommendation No 1, have not been implemented. On the contrary, the reduction of the staff in the CAs leads to a further reduction of the supervision over the official controls at different levels and, in particular the supervision over a now substantially increased number of AVs. This further compromises assurances about the correct and effective implementation of official controls.

Medlemsstatens svar

MRiRW: rodki budetowe dla Inspekcji Weterynaryjnej przewidziane na 2022 rok w kwocie 1 963 904 tys. zl w porównaniu z pierwotnym planem wydatków na 2021 wzrosly o 715 084 tys. zl, w tym w rezerwie celowej przeznaczonej na zwalczanie chorób zakanych zwierzt (w tym finansowanie programów zwalczania), badania monitoringowe pozostaloci chemicznych i biologicznych w tkankach zwierzt, produktach pochodzenia zwierzcego i paszach, finansowanie zada zleconych przez Komisj Europejsk oraz dofinansowanie kosztów realizacji zada Inspekcji Weterynaryjnej, w tym na wyplat wynagrodze dla lekarzy, wyznaczonych na podstawie art. 16 ustawy o Inspekcji Weterynaryjnej, kwota rodków w wysokoci 432 344 tys. zl wzrosla do wysokoci 548 768 000 zl, tj. o 116 424 tys. zl. Zabezpieczono dodatkowe rodki na wynagrodzenia i pochodne od wynagrodze, w tym z przeznaczeniem na zwikszenie zatrudnienia Inspekcji Weterynaryjnej. Na zwikszenie wydatków na wynagrodzenia wraz z pochodnymi w 2022 r. zaplanowano kwot 65 362 tys. zl w zwizku z utworzeniem 604 nowych etatów, z tego dla: ­ Glównego Inspektoratu Weterynarii ­ kwot 1 769 tys. zl na utworzenie 15 nowych stanowisk pracy, ­ powiatowych inspektoratów weterynarii ­ k

Rekommendationen anger som grund

Poland introduced a national transitional period up to 1 December 2021 during which time many of the requirements of the ASF Regulation were not implemented (the ASF Regulation entered into force on April 21 2021). After 1 December, non-compliances will continue to exist related to a derogation (with no deadline) from the requirement for stock- proof fencing, deficiencies in the biosecurity plan required for holdings with an annual throughput of 300 or less pigs. This increases the risk of the disease spreading, as it creates a situation in which an unknown proportion of non-compliant live pigs and their meat would continue to be allowed to move outside restricted zones II and III.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

e national transitional period Okres przejciowy na stosowanie odstpstwa dla planu equirements of Commission bezpieczestwa biologicznego nie zostal przedluony. Okres przejciowy zakoczyl si 30 listopada 2021 r. and associated finding 48. Wg aktualnego stanu ok. 23 % gospodarstw znajdujcych si na obszarach objtych ograniczeniami II i III deklaruje brak zainteresowania wysylkami wi poza te obszary ­ w takich przypadkach obrót winiami ograniczony jest do obszarów objtych ograniczeniami. Takie gospodarstwa zobowizane s do spelniania krajowych wymogów bioasekuracji, które podlegaj regularnym kontrolom wykonywanym przez IW.

Rekommendationen anger som grund

Poland introduced a national transitional period up to 1 December 2021 during which time many of the requirements of the ASF Regulation were not implemented (the ASF Regulation entered into force on April 21 2021). After 1 December, non-compliances will continue to exist related to a derogation (with no deadline) from the requirement for stock- proof fencing, deficiencies in the biosecurity plan required for holdings with an annual throughput of 300 or less pigs. This increases the risk of the disease spreading, as it creates a situation in which an unknown proportion of non-compliant live pigs and their meat would continue to be allowed to move outside restricted zones II and III.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

th the relevant movement Wikszo gospodarstw zainteresowanych wysylkami poza h mark to pig meat from pigs that obszary znajdujce si w obszarach objtych ogranczeniami ted zones II & III that do not posiada ju ogrodzenia (ok. 92%). Jednake, w zwizku z , point 2. (h) of Commission faktem, i wielko obszaru objtego ograniczeniami nie jest i.e., requirement for stock stal i zmienia si w zwizku ze zmianami regionalizacji, nie jest moliwe osignicie 100% dostosowania w kadym przypadku and associated finding 49. rozszerzania obszarów. Budowa ogrodze wymaga czasu, nakladu rodków finansowych oraz czsto wydania pozwole na budow, dlatego te, wybudowanie ogrodzenia natychmmiast po ustanowieniu obszarów nie jest wykonalne.

Medlemsstatens svar

th the relevant requirements Okres przejciowy na stosowanie odstpstwa dla planu he oval health mark to pig meat bezpieczetwa biologicznego zakoczyl si. Od 1 grudnia 2021 ents in restricted zones II & III r. wszytkie gospodarstwa zainteresowane wysylkami wi poza of Annex II, 2.(i), (iii) and obszary objte ograniczeniami II i III musz spelnia wymóg tion (EU) 2021/605 (i.e. posiadania ww. planu. W chwili obecnej przygotowywane s zmiany do planu and associated finding 50. bezpieczestwa biologicznego dla malych gospodarstw i m. in. uzupelnienie wzoru o zapisy w zakresie wlaciwego przeprowadzania czyszczenia i dezynfekcji, zgodnie z ustaleniem Page: 1 and to the recommendations of report ref. DG(SANTE) 2021-7240 of the audit carried out from 16 to 25 mentation of animal health controls in relation to African swine fever e competent authority zarzutu dotyczcego niezgodnego z nia 2021/605 wzoru planu cznego dla gospodarstw utrzymujcych zostalo przekazane pismem z dn. 10 hZZ.432.500.2021 (w zalczeniu).

Rekommendationen anger som grund

A representative from National Tax Administration (NTA) informed the audit team that the Heads of Customs and Fiscal Office (CFO) which is the regional body of the NTA is the designated CA for carrying out phytosanitary controls on passenger luggage consignments at BCPs and checks on WPM at BCPs and border crossings other than 5 those that are designated BCPs or CPs, as per Article 3 of Act of 13 February 2020 on State Plant Health and Seed Inspection Service to carry out tasks under Article 44(1) of Regulation (EU) 2017/625. 5.1.2. Staffing and training

Customs carry out plant health related controls on goods which form part of passenger luggage at all border crossings under Article 53(d)(ii) of Regulation (EU) 2017/625. Customs stated that checks in relation to plants for planting and seeds in personal luggage that are accompanied by a phytosanitary certificate must be carried out at the BCP as they are not exempt from controls at the BCP as specified under Regulation (EU) 2019/2122. The items are treated as commercial consignments whereby the private individual must register with the VIPHSIS, TRACES (NT) and make a customs declaration. These requirements are outlined in the memorandum of understanding (MOU) with customs and national legislation.

Non-compliant goods which form part of passenger luggage are reported to the VIPHSIS via Head of Customs and Fiscal Office in collated form at the end of the year. However, Customs stated that these interceptions are not reported in TRACES interceptions in line with the requirements of Article 40(4) and 41(4) of Regulation (EU) 2016/2031. The CA informed the audit team that since 14 December 2019 there were 4,651 confiscated/non-compliant items recorded with a total weight of 46 tonnes.

The VIPHSIS in co-operation with Customs carry out regular checks for prohibited and non-declared items at various levels within the framework of procedures for import controls as per the MOU with Customs.

Customs also carry out checks of prohibited and non-declared items at the postal service, courier imports and in personal luggage at the airports, and other points of entry. All findings of these items are notified to the respective VIPHSIS.

Poland implements IMSOC, however interceptions of non-compliant passenger luggage are not reported contrary to the EU requirements. As none of these interceptions are notified on TRACES this data cannot be taken into account by MS when planning their controls.

Medlemsstatens svar

on- Answer of National Tax Administration: ostal In regard of recommendation that plants and plant products and other objects retained by customs authorities, that may be the habitat of pests, carried in travelers' personal luggage and as part of postal and courier services are not reported in the TRACES (NT) system and other Member States cannot take these data into account when planning inspections, NTA notes that it is not technically possible in the EU TRACES system to complete the CHED-PP Community Health Entry Document for detained products. In the opinion of NTA, the matter of registration the above-mentioned goods in TRACES remains an open question for which a proposal for a solution at the EU level must be developed. , 36, Nevertheless, in the assessment of NTA, the legitimacy of the recommendation raises doubts, the more so that the customs authorities keep records of detained plants and plant products and are in any time able to present data of the scale of interception of non-compliant shipments transported in personal luggage as well as postal and courier services. For the correctness of the above arguments, it is worth quoting the statistical data (collected by NTA) r

A response of 2021 November 30 Answer of National Tax Administration: In regard of recommendation that plants and plant products and other objects retained by customs authorities, that may be the habitat of pests, carried in travellers' personal luggage and as part of postal and courier services are not reported in the TRACES (NT) system and other Member States cannot take these data into account when planning inspections, NTA notes that it is not technically possible in the EU TRACES system to complete the CHED- PP Community Health Entry Document for detained products. In the opinion of NTA, the matter of registration the above-mentioned goods in TRACES remains an open question for which a proposal for a solution at the EU level must be developed. Nevertheless, in the assessment of NTA, the legitimacy of the Page: 1 tted by the competent authorities of Poland in response to Report ref. DG(SANTE) 2021-7273 of 1 in order to evaluate the system of import controls for plant health ority e so ords of d are in scale of ts ll as ments, it (collected eriod rce of r 10, PLN l of ess, cording quantities Page: 2 tted by the competent authorities of Poland in response to Report ref. DG(SANTE)

Rekommendationen anger som grund

The Chief Inspector of MIPHSI designated the laboratory, being satisfied that the laboratory had the necessary expertise, equipment and infrastructure and a sufficient number of suitably qualified, trained and experienced staff to conduct the required range of analysis in an impartial and timely manner as required by Article 37 (4) (a) (b) (c) and (d) of Regulation (EU) 2017/625. The laboratory is not accredited in accordance with the EN ISO/IEC 17025 standard by a national accreditation body operating in accordance with Regulation (EC) No 765/2008 as required by Article 37 (4) (e) of Regulation (EU) 2017/625. The laboratory confirmed that it was working towards achieving accreditation for formulation analysis, with a view to achieving this goal by the end of 2021.

While the designated formulation analysis laboratory is not accredited as required, it performs satisfactorily in inter-laboratory proficiency tests and is capable of conducting the wide range of analysis required by the CAs and is an important component of the overall control system on the marketing of PPPs. 13

Rekommendationen anger som grund

In 2020, the laboratory processed samples in an average of 34 days from receipt of the sample to reporting the results. The laboratory explained that analysis can take considerably longer (up to six months) in a small number (circa. 5%) of cases. This occurs in cases where the laboratory requests the formulation details from MARD and there are delays in receiving this information. This information is necessary for the laboratory to conduct the most appropriate analysis and to determine if the analytical result demonstrates compliance. On average, MARD provided this information in 28 days in 2020, but in a quarter of all cases, it took 37 days or longer, which is significant in the context of the average turnaround time of 34 days. These administrative delays during 2020 acted as an impediment to the laboratory delivering analysis results in a timely manner as required by Article 37 (4) (d) of Regulation (EU) 2017/625. MARD explained that there were particular challenges in this area in 2020, as this information is confidential, and was difficult to access for staff working from home due to restrictions related to Covid-19.

The administrative delays in providing formulation details to the formulation laboratory during 2020 delayed the timely delivery of analytical results, and weakened the overall effectiveness of the control programme.

Rekommendationen anger som grund

The system lacks appropriate and dedicated training and procedures for the official controls (animal welfare) on breeder and pullet farms and on hatcheries. As a result, the competent authorities do not control systematically and effectively animal welfare on those areas (e.g. beak trimming in hatcheries and pullet farms, killing of day old chicks).

There is an incomplete methodology for risk-based planning of official controls (does not take into account all relevant risks). Moreover, in the regions visited whilst there is a high proportion of laying hens farms checked every year, there was no evidence that those farms are inspected on a risk basis (with the exception of a district area). This may have implications on the efficient allocation and use of resources (meaning that perhaps controls could be better streamlined and targeted).

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

The internal audit programme did not include animal welfare at laying hens sector in recent years. Synergies with third party and private quality assurance schemes Private quality 18. The competent authority stated that there are no relevant quality assurance assurance schemes in the laying hens sector therefore; they do not take into account any existing third party quality schemes. schemes are not used. Implementation of the Official Control Plan 10 Official 19. The competent authorities have arrangements to ensure compliance with controls Article 138 of the OCR. According to Polish law, the competent include a high authorities have to perform official controls on 5 % of the farms each year. proportion of If the official controls identify non-compliances then there has to be a inspections at follow-up inspection within the same or next year. The actual percentage laying hens of farms inspected each year reaches approximately 40 % of the total establishments. number of farms. This helps the authorities to identify existing animal welfare issues

Article 13(1) of the OCR requires that "Competent authorities shall draw up written records of every official control that they perform". Official inspectors use the checklist for laying hens, for breeders and pullets checks during their inspections. For the pullet/breeder/hatchery checks, the inspectors fill in the first part of the checklist but they lack guidance to record any specific control they implement, as there are no specific instructions for the controls on those areas.

The Central competent authority based its supervision of the performance of the official controls delivered by the local competent authorities on the compliance with the minimum percentage of farms inspected (i.e. 5%). As all the local competent authorities achieved that criteria, the central 11 The verification competent authority have not identified any performance issue or areas for of the improvement. implementation 23. The competent authorities have a control verification procedure in place of the controls to ensure the effectiveness and appropriateness of the official controls. is inadequate However, this is not sufficiently detailed and does not provide guidance on what to check and which methodology to follow. This is not in line with and does not the requirements of Articles 5(1) and 12(2) of the OCR. The lack of contribute specified methodology for the performance of the supervision undermines the potential of this activity to detect deficiencies in the performance of significantly to the official controls. As a result, the vast majority of supervision activities identify do not identify any shortcomings in the performance of the official controls. The audit team noted that the checklist for inspections of welfare performance on laying hens farms allows for errors in the evaluation of the usable area shortcomings. in caged hens farms. Some other deficiencies identified during this audit were not spotted during the supervisions conducted by the competent authority.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

The reports of official controls (checklists) indicate a high level of compliance in most of the areas visited during this audit. However, the audit team noted that in most of the areas visited the absence of non- compliances during farm inspections in several areas (in which the audit team identified shortcomings), for a long period, may indicate a reduced capacity of the system to identify shortcomings and address animal welfare issues that may exist. Animal-based welfare indicators in laying hens Animal-based 25. The competent authority does not currently use animal-based welfare indicators are indicators to measure the animal welfare at laying hens farms. not 26. The competent authorities discussed the main challenges they face in systematically developing and implementing policies and objectives related to animal used for animal welfare controls in the laying hens sector. They mentioned the difficulties in keeping staff up to date in their area of competence and the challenge welfare. of ensuring animal welfare in the breeder/hatchery/pullet activities as the legislation is not detailed. In addition, they mentioned the importance of 12 Official fully integrating OCR in official controls in the country, the challenge of controls at retaining highly competent staff and the economic impact and implications abattoirs are of avian influenza. not 27. Although mortality at the farm is assessed when official controls are systematically carried out, there is no requirement of recording the mortality at the laying hens farms in the Food Chain Information, therefore missing the assessing opportunity of targeting farm inspections at farms with high mortality. indicators of 28. There are 161 approved slaughterhouse potentially processing end-of-lay potential hens. Although there is no a systematic assessment of indicators of welfare welfare issues at farm for hens, if the official veterinarian at the slaughterhouse would suspect a legislative breach at farm, it would trigger an investigation. at farm. Reporting of official controls Annual reports 29. The required annual reports to the European Commission with the number submitted to the of inspections per housing method include the official control on animal Commission on welfare at caged systems, free range and barns. animal welfare at laying farms 30. As the hatcheries, rearing & breeding establishments are not included in the CVO requirement for 5% inspection of animal welfare, the checklist covers all the does not cover those areas of activities. This means that whilst there might farming be some checks done, there is no record or information on whether there methods. is an appropriate implementation of beak trimming procedure, and of day- old chick culling. The controls fail to identify 31. In line with Article 13(1) of the OCR the official inspectors fill in the some important checklist for AW checks. The audit team noted that the records assessed included thoroughly and correctly completed checklist forms in general. compliance However, in some cases there were some discrepancies, related to issues. shortcomings that the audit team noted (which have not been spotted by the official controls nor by supervision activities). The most important are: the registration of laying hens farms (not updated, missing, mistaken in some sampled cases), the deficient evaluation in some cases of the stocking density requirements in the farms, and the deficient evaluation of the requirements for the nests' floor in caged hens farms. 13

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

ber 25-26, 2021, a training course was held at the GVI on the control of farms keeping laying hens, hatcheries, ductive herds and rearing houses. Both RVI and DVI employees participated in the training. A total of 120 people ained. The training materials were made available to participants for use in further training. The next training is scheduled for the first half of 2022.

Rekommendationen anger som grund

The competent authority, in order to draw up the official control plan has to consider relevant risks (e.g. size of the population of birds, changes in the stocking density, the results of previous year's checks etc.). The specified methodology for risk-based planning of official controls is not sufficiently detailed. It does not take into account all relevant risks contrary to Article 9 (1) of the OCR. For example, it does not consider the 8 Shortcomings location of the activities or operations of operators nor the activities of the in training and operators (e.g. an operator that has both a free range or barn system and a caged system). In respect of the operator's past record it foresees only procedures taking into account the results of official controls of the previous year and translate into not of past records as described in OCR. Moreover, in the regions visited, whilst there is a high proportion of laying hens farms checked every year, the control there was no evidence that those farms are inspected on a risk basis (with system not the exception of one district area). Overall, GIW has no oversight of which non-compliances identified during the official controls derive from covering random and from risk-based controls. The above means that there may properly animal exist implications on the efficient allocation and effective use of resources and controls could be better streamlined and targeted. welfare in hatcheries, 11. In line with Article 12(1) of the OCR, the competent authorities perform pullet and the official controls in accordance with documented procedures. The breeder farms. official controls are preformed using the instruction issued by GIW's Chief Veterinary Officer and the accompanying checklist. This instruction describes the conduct of district veterinary officers when carrying out animal welfare checks on holdings keeping animals and reporting on animal welfare inspections carried out on holdings keeping animals with elements to combat infectious diseases. The instruction does not cover day-old chicks, pullets and breeders and those are not included in the requirement of 5% inspection of establishments per year.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

During the above-mentioned training, proposed parameters of the risk analysis for selecting farms keeping broilers and laying hens for inspection were presented. In January of 2022, the CVO will provide the above-mentioned parameters for use by DVO.

Rekommendationen anger som grund

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

The training referred to in point 1 covered all the requirements for the keeping of laying hens, including those irregularities in that were found during the audit, ie farm registration and data update, requirements concerning nests and how to terminate the maximum stocking density. Enclosed is the list of people participating in the training, the training agenda and presentations (regarding laying hens, hatcheries, breeding and rearing flocks and about typing)

Rekommendationen anger som grund

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

Page: 1 DG(SANTE) 2021-7323 of the audit carried out from 24 May 2021 to stages of production sed by the competent authority

Rekommendationen anger som grund

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Medlemsstatens svar

Page: 2

Rekommendationen anger som grund

In terms of procedures to verify the implementation of control tasks, the GVI indicated that its audit office carries out supervision over the regional and district levels (thematic controls), throughout a documentary assessment, which may include an on-the-spot assessment. These controls can be planned or non-planned, the former based on a risk analysis and the latter carried out to address specific emergent issues. GVI stated that no thematic controls have been recently carried out to the regions and districts involved in the current audit. In addition, the GVI also stated that it has in place other mechanisms with a view of co-ordination and supervision, which include regular meetings between the different Officers and exchange of correspondence by conventional and electronic mail.

The audit office of GVI carries out internal audits to the services performing official control tasks. These audits are carried out annually and cover particular topics and services. The audit office intends to cover all relevant topics within a five-year period. The last internal audit that covered fishery products matters, including smoked fishery products, was carried-out in 2015.

The authority has in place certain supervision mechanisms as well as internal audits. However, in relation to the controls of smoked fishery products, the implementation of these mechanisms had not been used in recent years and as such, potential deficiencies of the control system were not identified.

The audit team noted that for each individual establishment involved in the iRASFF notifications, the competent authority increased its awareness of the deficiencies that could justify the contamination of the products with L. monocytogenes but it took time 18 for the competent authority to progress in terms of identification and correction of deficiencies. The initial iRASFF notifications dated from 2017 and the training to official staff was provided in 2019 (see paragraph 12) which is coincident with increased detection of non-compliant results during the official sampling (see paragraph 69). Also at the beginning of 2019 the guidance document indicated in paragraph 35 was updated (in particular its annex 5). However, as indicated in paragraphs 61 to 63 official staff is not always able to correctly assess shelf life studies.

Despite of all the progress done in the control of the concerned establishments, the audit team did not find evidence that this progress was adequately captured and disseminated within the relevant levels of the VI. This would enhance the ability of official control staff to identify similar issues in establishments, other than the ones implicated in the iRASSF notifications, in advance, and if possible prevent the occurrence of the same type of outbreaks. Conclusions on measures in case of non-compliance and follow up of iRASFF notifications

At national level, the authority provided training on official sampling and improved the guidance documents, but the audit team did not find evidence that the improvements observed in the official controls carried out in particular establishments would be disseminated throughout the relevant levels of VI across Poland.

Rekommendationen anger som grund

The procedures in place for approving and/or registering facilities/FBOs dealing with smoked fishery products is largely in line with the EU rules. Lists of those facilities/operators are available in the webpages of the relevant competent authorities and are updated. However, the deadlines set for a first visit within the conditional approval process do not follow the requirements of Article 148(4) of Regulation (EU) 2017/625.

Rekommendationen anger som grund

The official control system in place covers the production chain of fishery products. This system seems to cover adequately all the applicable requirements, except for the temperatures allowed for the storage of frozen products and the controls on FBOs shelf life studies.

Rekommendationen anger som grund

Additionally, the audit team requested access to the studies carried out by the FBOs to investigate compliance with the L. monocytogenes criteria throughout the shelf life of ready-to-eat smoked fish of three establishment involved in the iRASFF notifications and noted some shortcomings.

The official control system in place covers the production chain of fishery products. This system seems to cover adequately all the applicable requirements, except for the temperatures allowed for the storage of frozen products and the controls on FBOs shelf life studies.

The competent authority's limited assessment of FBOs shelf life studies on L. monocytogenes on ready-to-eat smoked fish/salmon impacts the ability of the control system to detect when the conclusions of these studies are incorrect or inadequately justified. This calls into question the suitability and/or the validity of the shelf life period of products concerned which, in turn, may impact on the safety of those products. Moreover, during the official control visits, official staff did not identify non- compliances that may have an impact on the control of L. monocytogenes.

Rekommendationen anger som grund

The competent authority's limited assessment of FBOs shelf life studies on L. monocytogenes on ready-to-eat smoked fish/salmon impacts the ability of the control system to detect when the conclusions of these studies are incorrect or inadequately justified. This calls into question the suitability and/or the validity of the shelf life period of products concerned which, in turn, may impact on the safety of those products. Moreover, during the official control visits, official staff did not identify non- compliances that may have an impact on the control of L. monocytogenes.

Rekommendationen anger som grund

Additionally, the audit team requested access to the studies carried out by the FBOs to investigate compliance with the L. monocytogenes criteria throughout the shelf life of ready-to-eat smoked fish of three establishment involved in the iRASFF notifications and noted some shortcomings.

The competent authority's limited assessment of FBOs shelf life studies on L. monocytogenes on ready-to-eat smoked fish/salmon impacts the ability of the control system to detect when the conclusions of these studies are incorrect or inadequately justified. This calls into question the suitability and/or the validity of the shelf life period of products concerned which, in turn, may impact on the safety of those products. Moreover, during the official control visits, official staff did not identify non- compliances that may have an impact on the control of L. monocytogenes.

However, the increased detection of non-compliant test results, did not impact on the overall organisation and implementation of the controls.

At national level, the authority provided training on official sampling and improved the guidance documents, but the audit team did not find evidence that the improvements observed in the official controls carried out in particular establishments would be disseminated throughout the relevant levels of VI across Poland.

Rekommendationen anger som grund

The audit team noted that the documentary checks had not identified certain minor errors in a small number of entry documents. The errors in the documents were not sufficient to affect the validity of the decision to allow importation of the animals or goods concerned. In light of that finding, the Chief Veterinary Officer issued an instruction to BVIs on 18 December 2020, to take measures to minimise errors and inconsistencies in the entry documents and accompanying documents. The VI also confirmed that Section 5 of the BIP Manual concerning documentary checks would be revised and that the issue would be included in future training programmes for border inspectors, in line with Article 12(3) of the OCR.

The audit team also noted that the net weight declared in the CVED accompanying a consignment of frozen prawns, included the weight of the ice-glaze, although the 16 accompanying health certificate indicated the net weight without the ice-glaze, which in this case amounted to a difference of 3,584 kg. The VI informed the audit team that in- line with internal guidance, it was acceptable for the declared weight to be inclusive of glaze, and therefore the CVED was not rejected. The audit team noted that such guidance is not consistent with the clarification previously provided by DG Health and Food Safety to Member States, that in order to ensure consistency between Regulation (EU) No 1169/2011 of the European Parliament and of the Council and the information on the food label, `the net weight indicated on the health certificate and CVEDs for glazed food must ... be exclusive of the glaze'. The VI stated that the interpretations of the European Commission and of Poland differed in this case, and that had been communicated in writing to the Commission by the Chief Veterinary Officer. The audit team noted however that documentary checks of glazed food, carried out in-line with the internal guidance, do not ensure that the information in the entry document corresponds to the information provided in the official certificates, official attestations and other documents accompanying the consignment, in-line withArticle 2(3) of Regulation (EU) 2019/2130. Conclusions on the implementation of official controls on imports/transits of animals and goods

However a number of shortcomings were noted in the application of the prior notification of arrival of consignments and the implementation of certain documentary and physical checks. The authorities have taken immediate action, or plan to take action, to address the majority of those, however the documentary checks of glazed foods carried out in-line with internal guidelines do not ensure consistency between the entry document and documents accompanying the consignment.

Rekommendationen anger som grund

The audit team noted that no storage facilities are available at the rail location at BCP Dorohusk/Dorohusku. The competent authorities confirmed that storage in the means of transport in which the goods were brought to the BCP is permitted under their control 18 instead, in line with Article 3(13) of Regulation (EU) 2019/1014, and that in their view, there is no need for storage areas or rooms.

The audit team noted that while such storage is permitted, Article 3(13) of Regulation (EU) 2019/1014 does not derogate from the requirement for BCPs to have fixed storage areas or rooms, appropriate to the categories of goods for which the post has been designated, in line with Articles 3(1)(c), 3(2) and 6(2) of that Regulation. Conclusions on minimum requirements for border control posts

The absence of appropriate storage rooms or areas at one rail BCP is not in line with EU legislation and may have an adverse impact on the official controls and the hygienic handling of products for which that BCP has been designated.

Rekommendationen anger som grund

The identification system for pigs and the Agency for Restructuring and Modernisation of Agriculture (ARMA) database are described in reports from previous Commission audits related to this area, i.e. DG(SANTE)/2017-6114-MR, DG(SANTE)/2016-6114- MR and DG(SANTE)/2014-7294-MR.

In response to Recommendation No 3 from report DG(SANTE)/2017-6114-MR, i.e., "To improve the accuracy and quality of the tools for the traceability of pigs, in order for them to be effective tools for animal health controls", Poland proposed a public procurement procedure for the design and development of a new database, i.e. "e-IRZ Plus". ARMA informed the audit team that a tender process had been opened in 2017 and then cancelled. A decision was taken during 2018 to modify the existing database and create "IRZ Plus". This modification improved electronic data exchange with livestock owners. However, it did not improve the functionality for adding animal health information and official veterinarians still have limited direct access to statistical data on the database, both of which would support planning and implementation of official disease control programmes. The audit team was told that "IRZ Plus" could still become a reality in the future if funding was to become available. The system currently maintained by ARMA was never designed as a system to contain information on animal health (its main task is to cover the whereabouts and movements of animals -- Article 3(2) of the Law of 2 April 2004 on the animal identification and registration system). The DEPiRZ (Producer Register and Animal Registration System Department) issues various statistics required by the GVI. In addition, the Agency made available the application platform and the `IW SIRZ' browser, which are tools allowing an overview and analysis of data from the IRZ database. 4

As described in previous reports, the GVI maintains its own separate database ("Vetlink") which includes animal health information and is used to support District Veterinary Offices (DVOs) to manage disease control programmes including ASF. There is limited access to data on Vetlink from areas outside the region in which holdings are located. The GVI have plans to expand the capabilities of the system.

The high number of visits to holdings in the ASF affected area has provided an up-to- date picture of pig numbers on holdings. This has allowed a cross check with the information on the central database and the removal of many holdings that no longer 5 keep pigs which has also contributed considerably to the reduced numbers of pig holdings. (A similar exercise has not taken place in the ASF free area and therefore the accuracy of pig holding information in the database would be lower.)

DVOs produce annual reports on how many such visits are carried out and the main non-compliances detected. They do not confirm the extent to which the target of twice annual visits was achieved, e.g. percentage of holdings visited twice. The reports do not include data on the number of holdings that should have been inspected and the reasons why inspections did not take place as planned. The competent authority did say that many holdings on the list may not have pigs when contacted to arrange a visit but records viewed by the audit team in DVOs did not include this information.

The existence of two pig databases complicates the proper planning and implementation of official controls. The fact that the pig holding data is not accurate in the ARMA database for the ASF free area of the country will slow down the application of control measures should the disease spread to it.

Rekommendationen anger som grund

In response to Recommendation No 5 from DG(SANTE)/2017-6114-MR, i.e., "To ensure that all measures under the ASF approved programme, including the feed ban are subjected to official controls in order to ensure their effective implementation.", Poland proposed that the Polish Hunting Association (PHA) would supervise the activities of hunting clubs including compliance with the biosecurity rules. The PHA would provide the GVI with reports on those checks and a summary of those reports were to be submitted to the ASF expert group for evaluation.

According to the competent authority, the PHA checked the implementation of the biosecurity rules by hunters in 371 hunting clubs during the 2017/2018 hunting season. The PHA forwarded reports to the GVI but in the absence of a national template, the 9 reports varied greatly and the information they contained could not be compared or assessed by the ASF expert group. The audit team was informed that a proposal for a national template for reporting inspections on hunting grounds/carcase collection points is being discussed between the PHA and the GVI with June 2019 as the current target for agreement and subsequent use.

The absence of a national template for reporting on the implementation of biosecurity measures at hunting grounds made the system ineffective, as the ASF expert group cannot compare the information and use it to provide further advice.

Rekommendationen anger som grund

A system has been implemented for the dispatch from Part III of ABPs from porcine animals based on the requirements of Article 7 of Decision 2014/709/EU. The GVI confirmed that they do not require that compartments in lorries are sealed by an Official 11 veterinarian nor have they designated disinfection points at the exit from Part III, which are requirements in Article 7(c) and (e) respectively.

The likelihood of the disease spreading through movement of ABPs of domestic and 12 wild boar is low due to the controls over these products, although the system presents weaknesses due to the absence of official sealing and of designated disinfection points for the lorries.

Rekommendationen anger som grund

The audit team visited two slaughterhouses, both in Part II, which received pigs from different areas, including Part III. The movement documents examined by the audit team were in compliance with the relevant requirements of Decision 2014/709/EU with the exception of Article 4.3 which requires that "the pigs are transported for immediate slaughter directly, without stopping or unloading, to a slaughterhouse...". Many of the consignments had passed through "collection points" which is specifically allowed under current national law. According to the competent authority, pigs from smaller holdings would be taken to "collection points" by their owner and reloaded onto larger lorries and then taken to the slaughterhouse.

The system in place to implement the requirements and derogations to dispatch live pigs and pig meat/products from the ASF restricted area generally works as intended. There is a provision in national law allowing live pigs from Part III to move to slaughter via "collection points" instead of directly to the slaughterhouse. This intermediate stop of animals from infected area increases the risk of spreading the disease within the country.

Rekommendationen anger som grund

The audit visited a game collection centre in Part I where wild boar carcases from Part I are stored after they receive a negative result for ASF (was previously stored in a "carcase collection centre" ­ see finding 31). The centre was also used to store wild boar carcases from the free area and the carcases from Part I and the free area were destined for a game processing establishment in the free area. Based on discussions with the operator of the game collection centre, only about 5-10% of hunted wild boar carcasses were sent to game processing establishments with the rest being consumed locally. Although the risks are minimal, Article 15.1(b) of Decision 2014/709/EU does not allow wild boar carcases from a free area to enter Part I and then return to the free area as no derogation exists in the Decision unlike for example carcases from wild boar shot in Part I which can leave Part I if tested with negative result for ASF.

There are no wild boar farmed and hence no trade. The system in place generally ensures that wild boar meat can only leave restricted regions if it complies with all the requirements. However, there are instances where wild boar carcases go out to the free area and then return back again, increasing the risk of introducing the disease.

Rekommendationen anger som grund

The audit team noted that the Instruction of the CVO No GIWhig-500-4/08 on the methodology of official controls advises prior notice to be given for "comprehensive controls". In two FeBOs visited, the inspector (same for the both operators) stated that prior notice had been given to the FeBOs on the controls to be carried out by the DVI. The official explained that this had been given to ensure the availability of the necessary staff and access to relevant documentation. The audit team pointed out that while such an approach can be justified in rare cases (remote locations, irregular working hours, etc.), providing FeBOs with prior notice is not in line with the requirements laid down in Article 3(2) of Regulation (EC) No 882/2004.

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis, with an appropriate frequency and, as such are suitable to verify operators' traceability and correctness of labelling. However, the effectiveness of inspections is weakened by several elements including the giving of notice to establishments prior to inspections, and inadequate assessment of operators' HACCP-plans. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Medlemsstatens svar

1) wdroenie nowej Instrukcji Glównego Lekarza Weterynarii w sprawie metodologii urzdowych kontroli opartej o wymogi art. 9 ust. 4 rozporzdzenia 2017/625. W instrukcji tej przewidziano bezwzgldny zakaz informowania podmiotu o planowanej kontroli bez wzgldu na jej charakter (np. kompleksowa czy dorana); 2) instrukcja w sposób szczególowy opisuje sytuacje, w których PLW bdzie mógl skorzysta moliwoci uprzedniego zawiadomienia; 3) w roku 2020 Glówny Lekarz Weterynarii zaplanowal przeprowadzenie 2 dniowych szkole dla wszystkich wojewódzkich i powiatowych inspektorów ds. pasz w zakresie metod i technik kontroli (pobieranie próbek pasz) ­ zgodnie z zal. II rozp. 2017/625. W trakcie tego modulu szczególna uwaga bdzie zwracana na to, i kontrole powinny by prowadzone bez wczeniejszego uprzedzenia. Szkolenie bdzie realizowane w kooperacji z Krajowymi Laboratoriami Referencyjnymi. Cz teoretyczna bdzie realizowane w Pastwowym Instytucie Weterynaryjnym ­ Pastwowy Instytut Badawczy (1 dzie). Cz praktyczna bdzie realizowana w wytwórni pasz zlokalizowanej ok. 50 km od Pulaw (2 dzie). 4) w 2 dniu szkolenia realizowanym w wytwórni omówione bd zasady dzialania systemu HACCP, funkcjonujcego w wizytowane

Rekommendationen anger som grund

In every establishment visited, the audit team checked the DVIs' feed inspectors' assessment of the operators' HACCP-plans. In one case, the inspector's assessment was (7) Available at https://www.wetgiw.gov.pl/nadzor-weterynaryjny/listy-kontrolne-spiwet---sektor-paszowy 5 sufficient. However, in 10 of the 11 establishments visited, the audit team noted shortcomings in relation to the adequacy of the hazard identification for some ingredients and processing aids used for the production of feed additives (predominantly contaminants of chemical origin, e.g., heavy metals, dioxins/polychlorinated biphenyls (PCBs), etc., but also the necessity to verify the authorisation of the microbial strain(s) used for production of certain feed additives where fermentation process had been applied). The failure of the operators to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was neither spotted by the inspectors met during the audit nor had been identified in any of the previous inspection reports reviewed by the audit team.

The audit team noted that the operators' quality assurance systems seen rarely contained unambiguous provisions on ensuring that the raw materials and ingredients are sourced from registered or approved FeBOs. This contradicts the requirements laid down by Article 5(6) of Regulation (EC) No 183/2005. This was neither spotted by the inspectors met during the audit nor had been identified in any of the previous inspection reports.

The audit team noted that the CVO has developed detailed guidance on the assessment of homogeneity of compound feed. The purpose of the document is to determine rules for assessing homogeneity of compound feed based on the degree of mixing of the key ingredient(s). While most of the inspectors met demonstrated good knowledge of verification of establishments' controls on this aspect, the audit team encountered instances when the inspectors did not possess adequate knowledge on the assessment criteria for homogeneity. Consequently, the inspectors could not adequately verify that the requirements laid down in part 3(b) of the section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005 were respected by the FeBOs.

The audit team noted that there was no dedicated guidance on the assessment of carry- over. At all operators visited, where the risk for carry-over was relevant, the inspectors interviewed were struggling with the assessment of the operators' control for the carry- over, specifically of coccidiostats to non-target feed. For example, two operators used markers which were irrelevant to assess carry-over of coccidiostats ­ this was not spotted by the inspectors interviewed. As a result, the inspectors could not adequately verify that the requirements laid down in part 2(b) of the section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005 were respected by the FeBOs.

The audit team noted that many inspectors interviewed experienced difficulties in verifying that establishments' controls on scales and metering devices (in form of a check of documented and traceable procedures for testing/calibration and its completeness/adequacy) were appropriate. Thus, the requirements laid down by part 3(a) of the section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005 could not be properly verified by the inspectors. 6 5.2.1.3 TRACEABILITY

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis, with an appropriate frequency and, as such are suitable to verify operators' traceability and correctness of labelling. However, the effectiveness of inspections is weakened by several elements including the giving of notice to establishments prior to inspections, and inadequate assessment of operators' HACCP-plans. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Medlemsstatens svar

usiness 1) Glówny Lekarz Weterynarii poleci wszystkim Wojewódzkim ol Lekarzom Weterynarii, aby zorganizowali w podleglych województwach szkolenia dla wszystkich powiatowych d, as inspektorów ds. pasz nt. zasad analizy zagroe i krytycznych punktów kontroli, w sektorze paszowym. GLW opracuje wytyczne, które powinny by wzite pod uwag, aby ujednolici zakres szkolenia i uwzgldni rekomendacje DG Sante m.in. konieczno weryfikacji zezwole na stosowanie szczepów bakteryjnych czy te identyfikacj zagroe zwizana z charakterem stosowanych skladników pasz np. pochodzenia mineralnego, rolinnego itd. W trakcie szkole bdzie podnoszona kwestia koniecznoci weryfikacji zakladowych systemów HACCP, pod ktem jednoznacznych zapisów, dotyczcych zapewnienia, aby surowce i skladniki pochodzily od zarejestrowanych lub zatwierdzonych podmiotów dzialajcych na rynku pasz. 2) We wlaciwych listach kontrolnych SPIWET, wprowadzony bdzie zapis, który zobliguje wszystkich inspektorów do weryfikacji, czy zakladowa dokumentacja HACCP zawiera ww. zapisy. 3) W trakcie szkole organizowanych w roku 2020 w Pulawach, przewidziano modul interpretacja wyników bada, w ramach którego szczególowo omówione bd zasady oceny jednorodn

Rekommendationen anger som grund

In every establishment visited, the feed inspectors met were interviewed in relation to the sampling provisions laid down by Article 1 of, and Annex I to, Regulation (EC) No 152/2009. The feed inspectors interviewed could in general demonstrate good knowledge and implementation of the respective requirements. In many of the cases the inspectors used the mobile application (see finding 40). However, in several cases the inspectors interviewed experienced difficulties in establishing the distribution pattern of chemical contaminants and displayed weak knowledge of the concept of 'sampled portion', which resulted in (i) erroneous identification of the number of incremental samples to be taken, and (ii) inappropriate preparation of final samples from the aggregate samples for the control of substances where non-uniform distribution of the analyte/substance is presumed. In the latter case, some inspectors interviewed erroneously suggested simple manual mixing would ensure appropriate homogenisation (8) Available at https://www.wetgiw.gov.pl/nadzor-weterynaryjny/badania-kontrolne-monitoring-pasz 9 rather than using special equipment (e.g., mechanical or automatic dividers) which is required by part 9(4) of Annex I to Regulation (EC) No 152/2009. For substances with a non-uniform distribution, simple manual mixing alone cannot ensure complete homogenisation of the aggregate sample. The audit team noted that mechanical dividers were available in all of the districts visited.

The audit team noted that most of the sampling protocols seen contained all of the mandatory parameters required by part 10 of Annex I to Regulation (EC) No 152/2009. However, in one district visited, an old template, not containing the mandatory field for the size of the sampled portion, was in use.

The official laboratories send the analytical reports to the DVIs where the district feed inspectors interpret the results obtained. Certain guidance on the topic is available in Chapter VI of the NFCP. However, the guidance does not consistently explain the role of analytical measurement uncertainty, recovery rate and moisture content in the interpretation of the test results. Consequently, the interpretation does not take account of all of the relevant criteria as required by part 6 of Annex II to Regulation (EC) No 152/2009 (this situation was confirmed during the interviews with the district feed inspectors met). The audit team saw several analytical reports and could conclude that the data required by part C(5) and C(6) of Annex II to Regulation (EC) No 152/2009 were not always provided.

The system in place for planning of official sampling is effective and risk-based. However, the effectiveness of the sampling is weakened by the fact that the representativeness of the sampling, and thus the samples' legal and analytical validity, is not consistently ensured, especially for controls on substances with a non-uniform distribution.

The interpretation of the analytical results does not take into account all required parameters thus weakening the legal validity of the decisions made by the competent authorities. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

the 1) w roku 2020 Glówny Lekarz Weterynarii zaplanowal ticle przeprowadzenie 2 dniowych szkole dla wszystkich wojewódzkich nspektorów ds. pasz w zakresie metod i technik ranie próbek pasz) ­ zgodnie z zal. II rozp. enie bdzie realizowane w kooperacji z Krajowymi eferencyjnymi. Cz teoretyczna bdzie astwowym Instytucie Weterynaryjnym ­ ut Badawczy (1 dzie). Cz praktyczna bdzie ytwórni pasz zlokalizowanej ok. 50 km od Pulaw y program szkolenia bdzie przedstawial si pobierania pasz i sposób zabezpieczania próbek oci próbek pierwotnych i tworzenie próby kocowej mieszczone i niejednolicie rozmieszczone), zal. II nia aplikacji mobilnej ,,Pobieranie próbek" wyników bada, w tym oceny jednorodnoci wych ej certyfikacji w wietle rozp. 2017/625 Page: 3 report ref. DG(SANTE) 2019-6632 of the audit carried out from 01 October 2019 es, their ingredients and traceability Action Proposed by the competent authority Dzie 2 - pobieranie próbek pasz ­ wiczenia praktyczne (realizowane w wytwórni pasz) - HACCP w wytwórni pasz ­ omówienie na przykladzie systemu funkcjonujcego w wizytowanej wytwórni 2) We wzorze protokolu pobrania próbek (w legendzie) bdzie umieszczony odnonik z informacj, w których kierun

Rekommendationen anger som grund

The audit team examined three RASFF notifications (one originated from Poland and two which were sent to Poland due to the distribution of the affected products) and the actions taken by the relevant competent authorities (mainly by the DVIs). In general, the actions taken to ensure rectification of the non-compliances were sufficient and timely and in agreement with the requirements laid down in Article 54 of Regulation (EC) No 882/2004. However, in one case the audit team noted that the retained sample was analysed as a commercial sample sent by the operator thus creating the possibility for questioning the legal validity of the decision made by the DVI.

In every establishment visited, the audit team studied non-compliances from previous inspections (if any had been identified). Examples included deficient labelling, HACCP- related deficiencies, etc. The audit team noted that in several cases the inspection reports and communication with the FeBOs did not unambiguously specify any timeframe for the FeBO to remedy the deficiency(ies). In all of the non-compliances scrutinised, no evidence was observed that the operators had been requested to identify the reason(s) for the deficiency(ies) and take adequate actions to amend their quality systems to eliminate the risk of repetition. The follow-ups seen were not necessarily comprehensive and complete (in one case with an expired product, it was not verified that the product had been adequately disposed of by the operator; in another case, a deficiency with traceability was allegedly mentioned orally but was not documented and never followed up (see finding 28). The situation observed is not fully in line with the requirements laid down by Article 54 of Regulation (EC) No 882/2004.

A lack of comprehensiveness and completeness of actions taken on non-compliances weakens the effectiveness of the overall control system. 5.2.4 Establishments producing/trading non-authorised (in the EU) feed additives but are exporting or re-exporting them from the EU to a third country

Medlemsstatens svar

1) wdroenie nowej Instrukcji Glównego Lekarza Weterynarii w y sprawie metodologii urzdowych kontroli opartej o wymogi o rozporzdzenia 2017/625. Instrukcja zawiera zapisy o koniecznoci, kadorazowej weryfikacji, czy podmiot wdroyl wlaciwe dzialania zaradcze w okrelonym przez inspektora terminie. Weryfikacja powinna odbywa si niezwlocznie po uplyniciu terminu okrelonego przez inspektora. Czas wykonania: Ad. 1) 1.01.2020 Page: 4

Rekommendationen anger som grund

During the on-site visits, the audit team was able to verify the implementation of the requirements, both with regard to the obligations of the FBO and of the duties of the OVs. Documented evidence was available, confirming that deficiencies are identified and that action is taken, including destruction of carcases with missing identification or for issues related to passports. Treatments were hardly ever recorded in the passports of horses that remain eligible for slaughter.

During the visit to the horse clinic, the audit team also collected information that almost every serious treatment of horses performed due to the absence of specific medication destined for horses, results in the exclusion of these horses from the food chain. Typically, that information is introduced in the passport, if the passport is available, or if this is not possible then that is communicated in a documented way to the owner who then has the responsibility to sign the passport and inform the CBDK about the exclusion of the horse from the food chain.

The audit team checked over 100 passports at the different locations visited (i.e. slaughterhouses, horse dealer, assembly centres). With very few exceptions, no medical treatments were recorded, even when horses were more than ten years old. In the audit team's view, this near-absence of records appears very unrealistic, even if the EU legislation requires that only certain veterinary medications must be recorded in the passport. The CA acknowledged the finding.

In a case of non-permitted treatments, the exclusion of the animal from the food chain should be recorded and the information transmitted to the relevant authorities and/or passport issuing body in order to update their database. The CBDK stated that this is (9)Part III of Section II of the identification document issued in accordance with Regulation (EU) No 2015/262 or Part III of Section IX of the identification document issued in accordance with Regulation (EC) No 504/2008 (no longer in force). 28 hardly ever done, neither by the owner nor the veterinarian and indicated that, based on their data, the main reason for the exclusion of horses from the food chain, is because of late registration or of the need to issue a duplicate or replacement passport.

The audit team was informed by the CAs that, so far, treatments given to horses were not explicitly targeted during the RVI controls. To date, there is no cross-reference to verify that the treatments indicated in the records kept by the clinics were transferred when required to the passports and if this is communicated to the CBDK in cases where the treatment would exclude the horse from the food chain. Additionally, it was explained that the RVI do carry out inspections in holdings, during which the treatments records are checked but that those controls focus only on poultry, pigs and cattle.

Additionally, the audit team requested data from the CCA about the total amount of phenylbutazone (10) used on an annual basis. At present, three veterinary medicinal products for horses that contain this active substance are authorised for use in horses and the volume imported into the country was, for the years 2017, 2018 and 2019 (first three quarters) 122.8kg, 2,514.9kg and 2,147.1kg respectively (11). These amounts cannot be justified when compared to the number of horses excluded from the food chain, which as explained is relatively low (6% on a yearly basis) and mainly because of late registration. The number of horses excluded based on the information in the CBDK was 2,629, 2,532 and 2,289 for 2016, 2017 and 2018 respectively. Conclusions on organisation and implementation of official controls

During official controls in slaughterhouses, the CA carries out the verification of the eligibility of horses for slaughter for human consumption in a meticulous way, allowing for the detection of non-compliances. The system provides assurances that only horses with the correct identification and clearance for slaughter enter the food chain. The absence of any records of medicinal treatments in the passports coupled with, on the one hand, the lack of awareness of what constitutes essential medicinal substances for horses and the conditions associated with their use and, on the other, the ineffective controls in this area, imply that the residue status of the horses (10) Phenylbutazone use is permitted in veterinary medicine in some MS for pain relief and to reduce inflammation in non-food producing animals (dogs, sport horses). Phenylbutazone is not permitted to be used in the treatment of animals destined for the human food chain and any presence of the substance in food of animal origin therefore results from the illegal use of carcases of treated horses. (11) Volumes only concern phenylbutazone mixtures for per os administration specifically for horses and not any other forms (i.e. injectable). 29 presented for slaughter (and therefore, their eligibility) cannot be reliably ascertained.

The official controls pay limited attention to the veracity of the information in passports concerning medical treatments. This diminishes the effect of the otherwise robust controls in the slaughterhouses.

In the second case, an investigation was carried out in order to define whether the specific horse from which the sample was taken after slaughter had been treated. The supplier, the previous owner and the private veterinarian taking care of the animal were all questioned, but it was not possible to justify the presence of diclofenac in the meat of the specific horse. The passport accompanying the animal did not contain any information about such a treatment, nor did the documents kept by the veterinarian. Conclusions on RASFF

The system for follow-up of RASFF notifications and for food incidents is able to provide assurances that adequate actions are taken by the CAs in cases where these notifications/incidents are linked to horse meat, particularly concerning follow-up and measures taken regarding the products involved. In certain cases, the measures taken are ineffective since it still remains a challenge for the CAs to properly control and enforce the requirement for the prudent use of veterinary medicines in horses.

Medlemsstatens svar

GLW wyslal pismo do Krajowej Izby Lekarsko Weterynaryjnej, która nadzoruje lekarzy weterynarii wolnej praktyki, z prob o przypomnienie wszystkim lekarzom weterynarii wolnej praktyki, w szczególnoci tym którzy zajmuj si leczeniem zwierzt koniowatych, o obowizku ustalenia przed przystpieniem do leczenia wierzcia, jaki status zwierz posiada. Ponadto, w pimie wskazano, i w przypadku, gdy podczas leczenia danego koniowatego konieczne bdzie uycie produktów leczniczych niedopuszczonych w przypadku zwierzcia przeznaczonego do uboju w celu spoycia przez ludzi, lekarz weterynarii zapewnia, aby przedmiotowe zwierz zostalo przed leczeniem uznane w sposób nieodwracalny za nieprzeznaczone do uboju w celu spoycia przez ludzi poprzez: a) wypelnienie i podpisanie sekcji II czci II dokumentu identyfikacyjnego; oraz b) uniewanienie sekcji II czci III dokumentu identyfikacyjnego zgodnie ze wskazówkami przewidzianymi w sekcji II czci III. Ponadto, GLW zglosil propozycj zmian przepisów w Page: 1 t ref. DG(SANTE) 2019-6670 of the audit carried out from 12 November ning the production of horse meat Action Proposed by the competent authority zakresie IRZ-u koni, w tym take w zakresie naloenia na lekarzy we

Rekommendationen anger som grund

The measures provide for a system of approval of certain establishments to trade their products only in the national market with the use of a round national identification mark on their products. However, this is not in line with EU legislation.

At the time of this audit, there were 56 establishments on this list including 10 PM/PMP establishments (mainly cutting plants). The CCA informed the audit team that 44 establishments are in operation out of the 56 listed. The audit team noted that the list contains one poultry slaughterhouse which has been suspended since 1 December 2017.

Poland has issued national legislation and guidelines necessary to implement EU requirements relevant to PM/PMP and, from a summary analysis, with the exception of the national measures, which allow the use of a round national identification mark in low throughput establishments, they are in line with EU legislation.

Medlemsstatens svar

W odniesieniu do przedmiotowej rekomendacji Ministerstwo Rolnictwa i Rozwoju Wsi uprzejmie informuje, e podtrzymuje swoje wczeniejsze stanowisko w odniesieniu do przedmiotowej kwestii wyraone w odpowiedzi na rekomendacje zawarte w sprawozdaniu z audytu DG(SANTE)2014­7160­MR. Niezalenie od powyszego Ministerstwo informuje, e w rozporzdzeniach Ministra Rolnictwa i Rozwoju Wsi: z dnia 19.05.2010 r. w sprawie niektórych wymaga weterynaryjnych, jakie powinny by spelnione przy produkcji produktów pochodzenia zwierzcego w rzeniach o malej zdolnoci produkcyjnej (Dz. U. poz. 630) oraz z dnia 19.05.2010 r. w sprawie niektórych wymaga weterynaryjnych, jakie powinny by spelnione przy produkcji produktów pochodzenia zwierzcego w okrelonych zakladach o malej zdolnoci produkcyjnej (Dz. U. poz. 629) okrelone zostaly niektóre wymagania weterynaryjne dotyczce konstrukcji, rozplanowania i wyposaenia, jakie powinny zosta spelnione przy produkcji produktów pochodzenia zwierzcego w zakladach o malej zdolnoci produkcyjnej, które to wymagania stanowi rozwizania alternatywne w odniesieniu do wymaga dotyczcych konstrukcji, rozplanowania i wyposaenia, o których mowa w rozporzdzeniu (WE) nr 853/2004. Biorc po

Rekommendationen anger som grund

The audit team was informed by the DVOs in the districts visited that all AVs are paid from the state budget and that no direct payments from FBOs occur. However, their remuneration is based on the number of animals inspected or on the amount of meat introduced to the cutting plant they supervise. If the activity of the establishment where they perform their duties is stopped for any reason, they are not paid for the period concerned. Therefore, this payment system undermines the AVs' independence in those situations where the required enforcement measures to be taken on the spot would imply or include e.g. stopping of the slaughter operation (see paragraphs 77 and 92).

The CCA informed the audit team that the total number of AVs involved in official controls of meat establishments (including slaughterhouses) was 3,318 in 2018. The audit team noted that this number remained constant between 2016 and 2018 (3,320 in 2016 and 3,279 in 2017). However, during the same period the number of permanent official veterinarians decreased by 141, most of them (90) in the districts, from 2,172 (1,638 in the districts) in 2016 to 2,031(1,548 in the districts) in 2018.

In particular, in 2018, in all 305 districts, there were 396 full time employed official veterinarians in charge of food safety. In each district visited, the audit team noted that there are vacant posts (in some cases for years) which cannot be filled in the absence of applicants, due to non-competitive salaries. In at least two districts visited, only one Food Safety official was available, while there were two posts assigned for the performance of the planned activities.

Despite the shortage of permanent staff declared in all of the districts that were visited, the audit team was informed and saw evidence that the DVIs were able to achieve the number and scope of controls for the establishments visited. Nevertheless, this did not always result in reaching the quality of controls necessary to verify compliance of the FBOs concerned (see Chapter 5.4.2.1). 5.2.4 Training

Decreasing number of official staff, their low salaries, as well as the production related remuneration for AVs impact on the enforcement of the relevant EU legislation.

In one of these (in addition to the deficiencies related to post-mortem inspection - see paragraph 92) the CA did not identify the existing structural problems in the slaughterhouse and the cutting plant (rooms were not large enough for the hygienic performance of the activities carried out (see paragraph 55). The DVI official performing a control, in the presence of the audit team, was able to detect relevant non- compliances but not to make a conclusion concerning the overall situation in the establishment.

In the other establishment, the audit team noted several non-compliances which had not been previously noted by any level of CA controls (i.e. by the permanently present AV, the DVI or the RVI) before the visit of the audit team, or which, in any event, had not been corrected. For example, the audit team noted: inefficient cleaning and unsatisfactory flow for dirty crates, poor hygienic practices with regard to cleaning of equipment and premises, the structural elements of the old part of the establishment were worn out, with rusty support elements, damaged wall to floor junctions, surfaces of walls, floors and equipment were not clean and not easy to clean and disinfect, an extensive leakage of water from the ceiling above exposed products. Although this issue had already been noted during the DVI control carried out 10 days before the visit of the audit team, no corrective action was taken.

Moreover, in the evisceration room, the audit team noted the absence of adequate ventilation causing huge condensation above exposed products with high risk of cross- contamination. Although the AVs are obliged to verify the pre-operational and operational conditions, the slaughter operation was authorised to start and was not stopped until the visit of the audit team (see also paragraph 24).

Official controls for verification of FBOs' compliance with the relevant EU requirements (including: hygiene, HACCP, own-check sampling, animal welfare, traceability, labelling, food additives, identification marking, etc.) in PM/PMP establishments are in place and in general can provide guarantees that the establishments meet those requirements. However, there were two exceptions, where establishments presented serious structural and hygiene requirements which had not been detected by any level of the CA controls.

Ante-mortem and post-mortem inspections are, in general, carried out in compliance with the requirements of Regulation (EC) No 854/2004, with the exception of significant failure in performing post-mortem inspection in one establishment visited.

Medlemsstatens svar

Na wniosek Ministra Rolnictwa i Rozwoju Wsi pozyskane zostaly om dodatkowe rodki na nowe etaty i wzrost wynagrodze w Inspekcji Weterynaryjnej w ujciu rocznym: w kwocie 52 125 367 zl na wzrost wynagrodze pracowników Inspekcji Weterynaryjnej, w kwocie 9 377 384 zl na wzmocnienie kadrowe i finansowe w Glównym Inspektoracie Weterynarii i Powiatowych Inspektoratach Weterynarii w 10 województwach oraz na kadrowe i finansowe wzmocnienie dla Wojewódzkich Inspektoratów Weterynarii ­ Zakladów Higieny Weterynaryjnej. Ponadto trwaj prace legislacyjne zmierzajce do wzmocnienia nadzoru nad ubojem zwierzt rzenych oraz bezpieczestwem produktów pochodzenia zwierzcego. Wzmocnienie to bdzie w zakresie funkcjonowania Inspekcji Weterynaryjnej realizowane poprzez kolejne dzialania majce na celu: - wzmocnienie kadrowe tej instytucji przede wszystkim na szczeblu powiatowym i wojewódzkim, oraz granicznym ­ projektowane jest utworzenie 2 535 nowych etatów, - podniesienie i regulacj plac wszystkich pracowników Inspekcji Weterynaryjnej. Page: 3 ef. DG(SANTE)/2019-6671-MR of the audit carried out from 25 March e governing the production and placing on the market of poultry meat and zyni w nej przez ca rem ef.

Rekommendationen anger som grund

In one of these (in addition to the deficiencies related to post-mortem inspection - see paragraph 92) the CA did not identify the existing structural problems in the slaughterhouse and the cutting plant (rooms were not large enough for the hygienic performance of the activities carried out (see paragraph 55). The DVI official performing a control, in the presence of the audit team, was able to detect relevant non- compliances but not to make a conclusion concerning the overall situation in the establishment.

In the other establishment, the audit team noted several non-compliances which had not been previously noted by any level of CA controls (i.e. by the permanently present AV, the DVI or the RVI) before the visit of the audit team, or which, in any event, had not been corrected. For example, the audit team noted: inefficient cleaning and unsatisfactory flow for dirty crates, poor hygienic practices with regard to cleaning of equipment and premises, the structural elements of the old part of the establishment were worn out, with rusty support elements, damaged wall to floor junctions, surfaces of walls, floors and equipment were not clean and not easy to clean and disinfect, an extensive leakage of water from the ceiling above exposed products. Although this issue had already been noted during the DVI control carried out 10 days before the visit of the audit team, no corrective action was taken.

Moreover, in the evisceration room, the audit team noted the absence of adequate ventilation causing huge condensation above exposed products with high risk of cross- contamination. Although the AVs are obliged to verify the pre-operational and operational conditions, the slaughter operation was authorised to start and was not stopped until the visit of the audit team (see also paragraph 24).

Official controls for verification of FBOs' compliance with the relevant EU requirements (including: hygiene, HACCP, own-check sampling, animal welfare, traceability, labelling, food additives, identification marking, etc.) in PM/PMP establishments are in place and in general can provide guarantees that the establishments meet those requirements. However, there were two exceptions, where establishments presented serious structural and hygiene requirements which had not been detected by any level of the CA controls.

Medlemsstatens svar

dwóch zakladów, w których stwierdzono powane uchybienia rukturalne i higieniczne, wydano decyzje administracyjne zujce usunicie uchybie. Z poziomu Glównego ektoratu Weterynarii odbyla si kontrola dorana majca na weryfikacj nadzoru PLW nad ww. zakladami. Sprawozdania ntroli s w trakcie opracowania. dto, GLW wystosowal pismo do terenowych organów IW z pozostalych uchybie stwierdzonych przez inspektorów DG E w trakcie kontroli z zaleceniem przeprowadzenia ekcji w podmiotach sektora drobiarskiego z ich szczególnym ldnieniem (pismo w zalczeniu).

Rekommendationen anger som grund

In order to address Recommendation 6(13) of DG(SANTE)2014-7160 audit report (PM/PMP), the above mentioned guidelines require that FBOs take actions to investigate the cause of the non-compliance (i.e. source of contamination). Although the audit team noted that in general, all these procedures were implemented in the establishments visited, in the cases reviewed, the investigations were not able to identify the cause of the non-compliance. 13 The CA should ensure that when the results of testing against the criteria set out in Chapter I of Annex I of Regulation (EC) No 2073/2005 are unsatisfactory, the FBOs take measures to find the cause of the unsatisfactory results in order to prevent recurrence of the unacceptable microbiological contamination, as required by Article 7.1 of Regulation (EC) No 2073/2005. 18 5.4.2.3 Own-check sampling

The audit team reviewed several cases of RASFF notifications and food incidents related to PM/PMP which did not reach RASFF (in most cases due to Salmonella spp.) and noted that the CA procedures were followed: an adequate investigation was carried out at establishment level and corrective actions were taken by the FBOs. Although CA actions were prompt and comprehensive, in most cases, they were not effective regarding prevention of reintroduction of the hazards (Salmonella). 25 Conclusions on RASSF

The system for follow-up of RASFF notifications and for food incidents, implemented in Poland, provides guarantees that adequate actions are taken by the CAs in case these notifications/incidents are linked to PM/PMP, particularly concerning their follow-up and measures adopted regarding the products involved. However, these actions are not effective in preventing the re-introduction of Salmonella in the poultry meat processing chain which is evidenced by the continuously high number of RASFF notifications linked to this commodity.

Medlemsstatens svar

ku 2019 GIW zaproponowal zmian do ,,Krajowego ogramu zwalczania niektórych serotypów Salmonella w stadach lerów gatunku kura (Gallus Gallus)" polegajc na skróceniu inu, w jakim ma nastpi badanie drobiu kierowanego do zeni na ubój, z 3 tygodni przed planowanym ubojem do 14 dni. to podyktowane tym, e biorc pod uwag, e przecitny czas ymywania stad brojlerów wynosi ok. 6-7 tygodni, badanie na godnie przed planowanym ubojem jest malo miarodajne. i temu skróci si czas od badania do uboju, tak aby wyniki nia próbek pobranych Page: 5 ef. DG(SANTE)/2019-6671-MR of the audit carried out from 25 March e governing the production and placing on the market of poultry meat and m d h, nku ie, ef. DG(SANTE)/2019-6671-MR of the audit carried out from 25 March e governing the production and placing on the market of poultry meat and od

Rekommendationen anger som grund

The CSI informed the audit team that due to shortages in resources the official control frequencies for primary production could not be fully implemented. CSI stated, that this was caused by the increasing workload (e.g. increase of registered primary producers) without increasing the number of staff. This was already stated in 2016 during the last audit.

The database system implemented at central level of SSI collects general information and does not support the collection and in place to manage the registration of primary producers, the approval of processing/freezing establishments or for the does not support the collection of inspection and sampling results for FNAO primary producers, ready-to- eat and freezing establishments. This limits the availability of information that could be (3) Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene 6 used for future planning of inspection and supervision purposes. The CSI stated, that some of the VSES and PSES have individual IT based systems to collect detailed data. The audit team noted at the PSES visited that excel sheets developed by the local inspectors were used. Other CAs involved in controls in the scope of the audit

However, the capability to implement an effective system for official controls is limited by the lack of adequate tools to gather process and analyse information on registration, approval and inspection results for primary producers, ready-to-eat producers and freezers this undermines efficient planning and targeting of controls in particular for primary producers. This is of particular relevance given that staff numbers had not increased in parallel to the increased work load in recent years.

In addition, the limited cooperation between SSI and ARMA results in a further limitation of relevant information being available for the purposes of planning and implementing effective controls, and is in contrary to the requirements of Article 4(5) of Regulation (EC) No 882/2004. 5.2.2 Registration / Approval of Food Establishments Legal requirements Article 6 of Regulation (EC) No 852/204, Article 2 of Regulation (EU) No 210/2013 and Article 31 of Regulation (EC) No 882/2004. Findings Registration of food establishments Primary producers

The CSI is aware that not all primary producers are registered. CSI stated that they do not know the number of un-registered primary producers. This is the same situation as encountered by the audit teams in 2013 and 2016.

At one PSES visited, an establishment processing and freezing vegetables and soft fruit was involved in several RASFF notifications, the last one in 2018 regarding the presence of norovirus in a consignment of frozen red currants. 23 primary producers of this district had been identified as suppliers for this consignment. None of these suppliers was registered at the time of the RASFF notification. The audit team noted after document cross-checks that the freezer/processor's supplier list for 2019 still contained unregistered primary producers of soft fruit. One of these produced on more than four hectares, which is considered a medium to big producer in this district. Although it was known to inspectors that un-registered producers were involved in a RASFF notification in 2018 the processor could persist in this practice in 2019, unnoticed by the PSES. PSES informed the audit team that controls at these primary producers were scheduled for 2019.

At the VSES visited, most of the processors are categorised low risk, some medium and none high risk. At central level exact figures were not available level because of the lack of a central database. 12

There is an official control system in place covering the production chain of FNAO. In principle the controls are risk based. However, regarding primary producers, the risk assessment system is less efficient because of the lack of key parameters at registration (e.g. crop surface, production volumes) and does not allow the system to direct the limited resources to the riskiest primary producers. regarding processing establishments the audit team concluded that the risk scoring system for processors does not reflect sufficiently the potential risks in particular regarding the weighing factor for more risky crops and their intended use of it (e.g. ready-to-eat), contrary to the requirements of Article 3(1) of Regulation (EC) No 882/2004. This weakens the effectiveness of the official control system.

Currently there are 283 FNAO freezing processors approved in Poland. 512 inspections were carried out in 2018. The SSI could not provide the audit team with an overview of the risk categories assigned to the processors, the number of non-compliances and their nature, mainly due to the absence of a central database for risk categorisation and inspection results.

Three inspections were carried out by the PSSE in April and May 2019 to verify the implementation of traceability and corrective measures in the framework of a RASFF notification (norovirus in red currants). The single non-conformity noted by the PSES was the fact that the operator had failed to inform the PSES immediately about the incident and was fined with 300 PLN for that. The audit team noted further: no non-compliances had been documented since 2016; no dedicated storage for cleaned crates was assigned; openings to the outside under the entrance doors in the preparation room, not identified previously; the general state of the reception room was dirty and not easy to clean and disinfect. Wooden pallets used to transport fruit crates were damaged/in decay, equipment and floor were dirty; in a clean room with finished produce (after freezing) water from the ceiling was dripping in a steady flow in the vicinity where open produce was packaged (frozen paprika cubes and frozen strawberries); massive ice had formed in all three cold stores visited with drip marks on cartons, and the presence of open cartons; environmental sampling to detect Listeria monocytogenes by the operator was not carried out according the ISO norm and was not suitable to detect Listeria (no sponges used, wrong medium).

PSES staff stated that: the water drip had never occurred before; (6) paragraph 71 of the draft report was deleted on request of the Polish competent authority. 15 the ice forming situation in the cold stores was considered as unavoidable and therefore acceptable; that they had insufficient specific knowledge about Listeria monocytogenes swabbing, and had not received relevant training for it.

PSES staff had identified non conformities in former inspections but they were not relevant to the deficiencies seen by the audit team. The last control in the establishment was undertaken shortly before the audit. The audit team noted: heavy condensation from the ceiling in a reception room near open produce in crates (red and black currants); some ice forming in the cold stores and open cartons; carton boxes were prepared to be filled with plastic bags and stacked in such a way that the bottom of the boxes could contaminate the clean bags inside (before the produce was filled in); environmental swabs for Listeria are outsourced to a laboratory, the description of the sampling by the operator suggested that the correct method was used. Third freezing establishment

No non-compliances had been documented since 2016. The audit team noted that: there were no adequate facilities nor a procedure for cleaning and storage of external containers. Containers were sorted in the yard surrounded by trees inhabited with numerous birds. The operator stated that cleaning of containers was the responsibility of the supplier; the processing room was in good condition but not entirely pest proof and a bird was seen flying inside; environmental swabs for Listeria monocytogenes were outsourced to a laboratory, the description of the sampling by the operator suggested that an incorrect method was used; the packaging for final consumers were labelled with a cooking advice; In this establishment very thorough measures were taken by the SSI including sampling of products and swabs for Listeria taken in 2018 due to the RASFF.

During official controls national checklists and instructions were used at all levels of SSI. This allows, in principle, for a uniform way of official control. However, without comprehensive background knowledge inspectors can easily overlook aspects relevant for prevention of microbiological risks at primary production and processing of FNAO.

Official controls of processors showed that non-compliances were rarely detected. During the inspections carried out by the PSES observed by the audit team, important shortcomings were noticed.

Because most inspectors control only a very limited number of FNAO freezer establishments, a lack of theoretical and practical knowledge was observed (e.g. no knowledge about Listeria monocytogenes swabs and certain basic hygiene requirements). This further weakens the effectiveness of official controls in the field of FNAO.

Medlemsstatens svar

1) W styczniu 2020r GIS wystpi do ARMIR o udostpnienie danych dotyczcych podmiotów prowadzcych produkcj pierwotn. W styczniu równie zorganizowane zostanie spotkanie w tej sprawie w celu ustalenia moliwoci, w tym równie legislacyjnych. KE bdzie informowana w I pólroczu 2020 o efektach wystpienia GIS i ustale z ARMIR. 1) GIS aktualnie rozpoczl cykle szkoleniowe dla WSSE i PSSE (szczególy pkt. 2). Osoby uczestniczce z ramienia WSSE bd odpowiedzialne za wlaciwy nadzór nad dzialaniami koordynacyjnymi GIS-WSSE-PSSE w zakresie nadzoru nad zakladami produkcji ywnoci. GIS planuje organizowane wicej szkole dla PSSE, a take wiksze zaangaowanie WSSE w organizacj szkole celowanych, nie tylko kaskadowych. . GIS w planie na rok 2020 dla PIS zalecil WSSE organizacj szkole dla pracowników WSSE i PSSE z zakresu wymaga mikrobiologicznych oraz wchodzcego w ycie Rozporzdzenia UE 625/2017. 2) Zorganizowane zostalo w dniach 18-19.09.19 spotkanie kierowników dzialów zajmujcych si bezpieczestwem ywnoci WSSE i przedstawione zostaly wnioski z przedmiotowego raportu. 3) W kontrolach i audytach prowadzonych w WSSE i PSSE w roku 2019 i latach kolejnych, szczególna uwaga bdzie zwracana na koordynacj, przekazywan

Rekommendationen anger som grund

At one PSES visited, an establishment processing and freezing vegetables and soft fruit was involved in several RASFF notifications, the last one in 2018 regarding the presence of norovirus in a consignment of frozen red currants. 23 primary producers of this district had been identified as suppliers for this consignment. None of these suppliers was registered at the time of the RASFF notification. The audit team noted after document cross-checks that the freezer/processor's supplier list for 2019 still contained unregistered primary producers of soft fruit. One of these produced on more than four hectares, which is considered a medium to big producer in this district. Although it was known to inspectors that un-registered producers were involved in a RASFF notification in 2018 the processor could persist in this practice in 2019, unnoticed by the PSES. PSES informed the audit team that controls at these primary producers were scheduled for 2019.

This happened despite the fact that suppliers are legally obliged to be registered. Furthermore the PSES were clearly instructed by the central CSI that only registered suppliers are eligible to deliver to processors as it is a legal obligation.

The inspection reports for this processor had not recorded non-compliances in the last years including lack of registration of suppliers ­ primary producers.

Three inspections were carried out by the PSSE in April and May 2019 to verify the implementation of traceability and corrective measures in the framework of a RASFF notification (norovirus in red currants). The single non-conformity noted by the PSES was the fact that the operator had failed to inform the PSES immediately about the incident and was fined with 300 PLN for that. The audit team noted further: no non-compliances had been documented since 2016; no dedicated storage for cleaned crates was assigned; openings to the outside under the entrance doors in the preparation room, not identified previously; the general state of the reception room was dirty and not easy to clean and disinfect. Wooden pallets used to transport fruit crates were damaged/in decay, equipment and floor were dirty; in a clean room with finished produce (after freezing) water from the ceiling was dripping in a steady flow in the vicinity where open produce was packaged (frozen paprika cubes and frozen strawberries); massive ice had formed in all three cold stores visited with drip marks on cartons, and the presence of open cartons; environmental sampling to detect Listeria monocytogenes by the operator was not carried out according the ISO norm and was not suitable to detect Listeria (no sponges used, wrong medium).

PSES staff stated that: the water drip had never occurred before; (6) paragraph 71 of the draft report was deleted on request of the Polish competent authority. 15 the ice forming situation in the cold stores was considered as unavoidable and therefore acceptable; that they had insufficient specific knowledge about Listeria monocytogenes swabbing, and had not received relevant training for it.

PSES staff had identified non conformities in former inspections but they were not relevant to the deficiencies seen by the audit team. The last control in the establishment was undertaken shortly before the audit. The audit team noted: heavy condensation from the ceiling in a reception room near open produce in crates (red and black currants); some ice forming in the cold stores and open cartons; carton boxes were prepared to be filled with plastic bags and stacked in such a way that the bottom of the boxes could contaminate the clean bags inside (before the produce was filled in); environmental swabs for Listeria are outsourced to a laboratory, the description of the sampling by the operator suggested that the correct method was used. Third freezing establishment

No non-compliances had been documented since 2016. The audit team noted that: there were no adequate facilities nor a procedure for cleaning and storage of external containers. Containers were sorted in the yard surrounded by trees inhabited with numerous birds. The operator stated that cleaning of containers was the responsibility of the supplier; the processing room was in good condition but not entirely pest proof and a bird was seen flying inside; environmental swabs for Listeria monocytogenes were outsourced to a laboratory, the description of the sampling by the operator suggested that an incorrect method was used; the packaging for final consumers were labelled with a cooking advice; In this establishment very thorough measures were taken by the SSI including sampling of products and swabs for Listeria taken in 2018 due to the RASFF.

During official controls national checklists and instructions were used at all levels of SSI. This allows, in principle, for a uniform way of official control. However, without comprehensive background knowledge inspectors can easily overlook aspects relevant for prevention of microbiological risks at primary production and processing of FNAO.

Official controls at primary producers were mostly conducted during harvest but some inspectors were uncertain about the relevance of findings during inspection, and non- compliances were rarely detected.

Official controls of processors showed that non-compliances were rarely detected. During the inspections carried out by the PSES observed by the audit team, important shortcomings were noticed.

Because most inspectors control only a very limited number of FNAO freezer establishments, a lack of theoretical and practical knowledge was observed (e.g. no knowledge about Listeria monocytogenes swabs and certain basic hygiene requirements). This further weakens the effectiveness of official controls in the field of FNAO.

This indicates that the official control system is insufficiently effective to identify and rectify shortcomings contrary to the requirements of Article 54(1)(2) of Regulation (EC) No 882/2004.

The audit team observed two official samplings for microbiology which were overall satisfactory. One was conducted on 25 kg bags of bulk frozen product. The audit team observed that a suitable probe was used to get into the bags, however, the disinfection liquid used for the probes was not used with the required waiting times.

The sampling witnessed showed a deficiency in the practical implementation; therefore the official sampling procedure cannot fully ensure the integrity of the samples for microbiological analysis of bulk produce.

Medlemsstatens svar

ie szkole, aktualnie rozpoczly si nastpujce dzialania: 2019r realizowane s trzy 3-dniowe szkolenia dla pracowników PSSE rujcych zaklady produkujce mroone owoce i warzywa. Szkolenia uj: kryteria mikrobiologiczne, wytyczne do stosowanej w PIS listy olnej dla kryteriów mikrobiologicznych, sposoby pobierania próbek ­ ów oraz próbek ywnoci, weryfikacja wdroenia wymaga nicznych (852/2004), w oparciu o przyklady niezgodnoci stwierdzanych w dzie produkcyjnym, który mrozi warzywa i owoce, a take kontrola iania przez zaklad wymaga Rozporzdzenia 2073/2005, w tym równie rania wymazów i próbek ywnoci przez przedsibiorców. Szkolenie uje take wyklad technologa pracujcego w zakladzie, aby przybliy ki produkcji. W dniu 2-gim realizowane s wyklady dowiadczonego ktora nadzorujcego zaklad mroonek, który szczególowo omawia e niezgodnoci w zakresie higieny, i zwizane z tym ryzyko czyszczenia Listeria m. tnicy: Inspektorzy z PSSE, którzy nadzoruj zaklady produkujce ki. Zostali oni zidentyfikowani, wyselekcjonowani przez GIS/WSSE. to, uczestnicz osoby z WSSE, które zostan zobligowane do dalszego azania wiedzy. W ww. szkoleniach w 2019r. uczestnicz priorytetowo ktorzy z województw, które maj na swoim teren

Rekommendationen anger som grund

The database system implemented at central level of SSI collects general information and does not support the collection and in place to manage the registration of primary producers, the approval of processing/freezing establishments or for the does not support the collection of inspection and sampling results for FNAO primary producers, ready-to- eat and freezing establishments. This limits the availability of information that could be (3) Commission notice on guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene 6 used for future planning of inspection and supervision purposes. The CSI stated, that some of the VSES and PSES have individual IT based systems to collect detailed data. The audit team noted at the PSES visited that excel sheets developed by the local inspectors were used. Other CAs involved in controls in the scope of the audit

A uniform model to register is used in Poland for FNAO. The data requested by the model requires general information of the primary producers, e.g. name, official identification numbers and some regarding the crop. More specific information which would allow making risk-assessments is not requested by the model (e.g. crop surface, volume of production, implemented private standards).

The CSI is aware that not all primary producers are registered. CSI stated that they do not know the number of un-registered primary producers. This is the same situation as encountered by the audit teams in 2013 and 2016.

Therefore, the SSI organised multiple public awareness campaigns to get primary producers registered. The actions comprised leaflets, social media and information 8 during church services. SSI provided training for primary producers concerning hygiene risks and their prevention. The number of registrations of primary producers increased from around 57 000 in 2016 to 85 000 in 2019; 43 000 of these were primary producers of FNAO intended to be eaten raw. CSI has no access to other official databases of primary producers. The CSI stated that the total number of primary producers in Poland is estimated about 700 000 (animal holdings and non-food producers included).

The control system is described in the Polish multi-annual control plan, the current version of which covers the period 2015 to 2019 (5).

There is a database for collection of inspection results in place. However, the database is not detailed and do not contain data as e.g. production volumes, history of compliance and consumers claims. The CSI stated that there are in some VSES such detailed databases developed locally.

There is an official control system in place covering the production chain of FNAO. In principle the controls are risk based. However, regarding primary producers, the risk assessment system is less efficient because of the lack of key parameters at registration (e.g. crop surface, production volumes) and does not allow the system to direct the limited resources to the riskiest primary producers. regarding processing establishments the audit team concluded that the risk scoring system for processors does not reflect sufficiently the potential risks in particular regarding the weighing factor for more risky crops and their intended use of it (e.g. ready-to-eat), contrary to the requirements of Article 3(1) of Regulation (EC) No 882/2004. This weakens the effectiveness of the official control system.

Medlemsstatens svar

tosowanie procedur urzdowej kontroli ywnoci ­ proces II etapowy: tap ­ w terminie do dnia 31.12.2019 r. wprowadzenie w procedurze urzdowej stosowujcych do przepisów rozporzdzenia UE 2017/625 egajca na aktualizacji protokolów kontroli i innych dokumentów ch przez organy PIS w trakcie czynnoci kontrolnych a take zmiana arkusza oraz wprowadzenie nowych kryteriów oceny zakladu, w szczególnoci i zakladów RTE ) projekt procedur i zarzdzenia GIS (Annex 14, 15 i 16) zowania zasad kategoryzacji zakladów wprowadzone zostaly zmiany w a take w kryteriach oceny zakladów. y: profilu dzialalnoci ­ wydzielone zostaj 2 odrbne kategorie zakladów enci ala dzialalno ane zostaj tym grupom nowe punkty wagowe w oparciu o które t ocena. szu dodany zostaje dodatkowy element kontroli, szczególnie istotny z a oceny ryzyka w danym zakladzie, zgloszenia do systemu RASFF i rkusza przyjto ponadto dodatkowe nastpujce zaloenia: ypadku gdy producent produkuje ywno przeznaczon do a ostatecznego, która kwalifikuje si do kryterium mikrobiologicznego znik 1 do Rozporzdzenia 2073/2005 ­ niezalenie od typu zakladu ci wskazanych poniej, naley nada mu ryzyko Wysokie; zgloszenia powiadomienia do sieci powiadamiania i wspólp

Rekommendationen anger som grund

The method for STEC (ISO/TS 13136:2012) and the method for the detection of Norovirus/Hepatitis A virus in soft fruit, leaf, stem and bulb vegetables (ISO 15216- 2:2013) are established in the VSES in Bydgoszcz. Modifications where carried out in the method for the detection of STEC according to the technical protocol of the European Reference Laboratory: "Summary detection of Norovirus and Hepatitis A in bivalve molluscs, Issue 6 of 05.07.2016. The amendment of the methodology does not apply to food of plant origin with regard to ISO/TS 15216-2: 2013. The ISO method for Norovirus/Hepatitis A virus requires the indication of the extraction efficiency in the analytic report. The extraction efficiency was not indicated in the analytical reports.

The analytical reports for norovirus and hepatitis A are not fully compliant regarding the notification of the extraction efficiency and the adapted analytical methodology. 5.2.7 Procedures for Performance and Reporting of Control Activities Legal requirements Article 8 and Article 9 of Regulation (EC) No 882/2004. Findings

Medlemsstatens svar

wniosku dotyczcego dzialalnoci Laboratorium Referencyjnego izy norowirusa i wirusowego zapalenia wtroby typu A nie s w amiania o wydajnoci ekstrakcji i dostosowanej w raportach z bada, nie byly jednak przedstawiane bada". Wydajno ekstrakcji obliczana jest warta jest w dokumentacji badania. macja o zmianie metodyki w odniesieniu do ISO/TS na sprawozdaniu, jednak po uzyskaniu akredytacji na ie bylo bada w tym kierunku, w zwizku z czym nie z bada. nych z Procedur Laboratoryjn PL-03 z formularzy F/WSSE/LEM/PL-03/IR-01/08 z w bada" oraz F/WSSE/LEM/PL-03/IR-01/01 z z bada". ych formularzach w zakresie dodania i ekstrakcji oraz przygotowanie wniosku do mu Jakoci o zmian dokumentacji w której ormularzy do stosowania. maly umieszczenie na ,,Sprawozdaniu z bada" dyce ISO/TS 15216-2:2013 oraz wprowadzonej Page: 7 tions of report ref. DG(SANTE)/2019-6675-MR of the audit carried out from 25 June controls relating to microbial safety of food of non-animal origin y okolem technicznym NRL Cefas pt. ,,Ilociowe ego Zapalenia Wtroby typu A w malach", zakoczenia prac do koca 2019r.

Rekommendationen anger som grund

With regard to the fulfilment of the requirements for the minimum number of samples and isolates and caecal samples to be tested and reported for the mandatory categories, the situation was as follows: Salmonella: The minimum 170 isolates were achieved and exceeded only in 2016 for those isolates derived from samples taken at laying hen farms under the SNCP. 4 According to personnel from the NRL, there are different reasons to explain why the number of isolates was not reached in the other 2 years for either of the 2 groups of required Salmonella isolates (see point 15). E. coli: For 2014, 2015 and 2016, the minimum isolates were achieved and for the relevant combination of bacterial species and type of samples. C. jejuni: The minimum 170 isolates were achieved for broilers and turkeys in 2014 and 2016. ESBL-, or AmpC- or carbapenemases- producing E. coli: In 2015, 299 caecal samples at slaughterhouses were collected from pigs, as well as from pork and beef meat from retail outlets. In 2016, the required 300 caecal samples were achieved for broiler and turkey slaughterhouses as well as from broiler meat from retail outlets. 5.2.1.2.2 Representativeness of sampling Salmonella isolates from samples collected at poultry primary production

Contrary to the requirements of point 2.3.2 of part A of the Annex to Decision 2013/652/EU, less than 170 of the isolates from the SNCP were subject to AST in 2014 and, except for laying hens, in 2016. According to data provided by the Veterinary Inspectorate, during these 2 years a number of available isolates for each category of animals (broilers, turkeys and laying hens) were not reported. This is because: The NRL does not know the total number of available isolates. Although in a given year the Veterinary Inspectorate gathers information on the total number of isolates obtained in the regional veterinary laboratories participating in the SNCP, this information is not complied as such and sent to the NRL. The system used by farmers to identify a flock is not considered to be fully reliable. As a consequence and to avoid sampling more than once from the same flock, it has been decided that if in doubt, only one isolate from the whole farm is subjected to AST. However, the audit team saw examples from turkey caecal samples where several isolates were obtained from the same epidemiological units, subject to AST and reported (see point 20). Some of the isolates received were lacking the necessary epidemiological information required for reporting to EFSA. Salmonella isolates from carcass samples collected at slaughter

According to data provided by the Veterinary Inspectorate, the number of isolates available from the samples taken was much higher than the actual number of isolates subject to AST and reported. The reasons for not subjecting to AST and reporting the remaining isolates were as follows: It was difficult to ascertain the flock or herd of origin (as applicable) because this information was not clearly included in the form that accompanied the samples to regional veterinary laboratories. In the case of samples taken from broiler and turkey carcasses, and due to the sampling methodology, not all isolates obtained could be used from one positive sample to Salmonella. This is because they could easily come from birds from the same epidemiological unit (flock). In accordance with national rules applicable to the financing of laboratory testing, only the isolates obtained in regional veterinary laboratories can be subject to AST. The audit team noted that in the broiler and pork slaughterhouses visited, several isolates were obtained from the sampling carried out by the operators (one in the pork slaughterhouse, and six in the broiler slaughterhouse). Contrary to the requirements of point 2.3.2 of part A of the Annex to Decision 2013/652/EU, these isolates were not subject to AST and reported. Isolates gathered from caecal samples collected at slaughter

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in Decision 2013/652/EU, and this implementation is largely satisfactory. However, there were some shortcomings that affected the representativeness of the data obtained. These concerned the lack of randomisation of the sample days, the lack of distribution of the latter over the whole year and the repeated sampling of epidemiological units. In addition, the measures in place to gather Salmonella isolates and to subject them to susceptibility testing were not always sufficient to achieve the objectives of the legislation. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Articles 12 and 33 of Regulation (EC) No 882/2004. Findings

Medlemsstatens svar

has been strengthening the system for Salmonella strains and of Part A of epidemiological data collection in the years following audited lable period. It can be seen in the number of pig meat isolates tested in testing, 2017. Further improvement is foreseen for 2018. However, constrains due to national regulation do not allow to include Salmonella isolated from meat and NSCP samples in FBO testing performed in designated private laboratories. Since most of FBO testing is performed in this category of laboratories, GVI still seeks for possible solution allowing for enrolment of those isolates into AMR monitoring.

es is NRL has been strengthening the system for More detailed information is required to ting as Salmonella strains and epidemiological data assess the actions taken to address this nex to collection in the years following audited recommendation. Please note that the ll period. It can be seen in the number of pig findings on the report describing the o meat isolates tested in 2017. Further shortcomings with regards to the gathering the improvement is foreseen for 2018. of Salmonella isolates and their subjecting to However, constrains due to national AST highlight different problems. The regulation do not allow to include Salmonella competent authority should therefore provide isolated from meat and NSCP samples in detailed information on the steps that have FBO testing performed in designated private been or will be taken to address the laboratories. Since most of FBO testing is following: Finding 16 (isolates from poultry performed in this category of laboratories, farms): GVI still seeks for possible solution allowing a) how the NRL will become aware of all the for enrolment of those isolates into AMR available isolates: monitoring. CVO regularly provides NRL with the detailed l

Rekommendationen anger som grund

The Veterinary Inspectorate informed the audit team that these instructions were signed and distributed around March or April, only after the Grant Decision (which details the EU funds that would become available for the co-financing of the plan) is published. As a consequence, both the sampling at slaughterhouses and at retail outlets did not start before April in any of the years that the plan has been running (see points 20 and 21). This does not comply with the requirements set out in Part A, point 2.3 of the Annex to Decision 2013/652/EU, which requires, among other things, that samples are evenly distributed over each month of the year.

In contrast to the requirements laid down in point 2.3 of Decision 2013/652/EU, the collection of samples at the slaughterhouses was not representative due to the following: The caecal samples gathered were not evenly distributed over each month of the year. Aside from the late start, (see point 10) the audit team noted that in the slaughterhouses visited, the total number of allocated samples were taken in 2 months (2014) and in 4 months (2016) in 1 of them, and in 6 months in the other 2 6 (2016). Personnel from the Veterinary Inspectorate declared that this early finish was mainly due to the total number of samples needed in Poland being achieved before December. Unlike the selection of slaughtering batches to be sampled, a lack of randomisation in the collection of samples was noted. The work instructions drafted by the CVO for the years 2014-2017 stated that samples should preferably be taken on Mondays, Tuesdays or Wednesdays. This is to allow the laboratories to complete their processing within the 5 working days of the week. In the slaughterhouses visited, samples were mainly taken on Mondays and Tuesdays and, in some cases, only on one of these 2 days. Officials from each slaughterhouse visited declared that they organised their sampling to avoid repeating epidemiological units. However, the audit team noted that in two of the slaughterhouses visited this repeated sampling had occurred. This was particularly the case in the turkey slaughterhouse, where the high number of samples to be taken each month in the only day allocated for that (due to the vehicle available to transport the samples to the laboratory being available only once per month) made it very difficult for the inspector not to sample repeated epidemiological units 2. Isolates from meat samples collected at retail

For the same reasons stated in point 10, retail samples were not taken over the entire year, which does not comply with point 2.3 of Decision 2013/652/EU. In addition, and contrary to what is recommended in EFSA technical specifications 3, in each sampling year, samples were not allocated proportionally to the population of the relevant administrative divisions. Instead, each of these was allocated the exact same number of samples.

The audit team noted from the documentation seen that the right type of meat and from the right type of outlets was collected. However, the Sanitary Inspectorate decided that only unpacked meat could be sampled. As a result, only butcher shops (including the butchery department in the supermarkets) selling unpacked fresh meat were sampled, which created problems to identify the batch of the meat. The audit team noted that in almost half of the sampling forms checked, the batch identification had not been included. This was not detected in the NRL, which accepted all the samples sent from the region visited. In the examples seen, sampling was carried out mostly on Tuesdays, as Mondays were systematically excluded to avoid problems with the expiry date of the meat collected. This does not meet the requirements laid down in point 2.3 of Decision 2013/652/EU. 2 This was further complicated because birds from different flocks could be comingled in the same lorry to the slaughterhouse. 3 http://www.efsa.europa.eu/en/efsajournal/pub/3686.htm 7 Conclusions on national measures and sampling design

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in Decision 2013/652/EU, and this implementation is largely satisfactory. However, there were some shortcomings that affected the representativeness of the data obtained. These concerned the lack of randomisation of the sample days, the lack of distribution of the latter over the whole year and the repeated sampling of epidemiological units. In addition, the measures in place to gather Salmonella isolates and to subject them to susceptibility testing were not always sufficient to achieve the objectives of the legislation. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Articles 12 and 33 of Regulation (EC) No 882/2004. Findings

Medlemsstatens svar

s CAs (GVI, SSI and NVI-NRI in Pulawy) will seek for possible rt A of the solutions allowing to initiate AMR monitoring from January 2019 ribution and distribute sampling over the year. Efforts for randomisation of , the sampling days has already been done, although some limitations the results from slaughter process and logistic issues. Data collection s sampled. system has been already improved considerably to avoid replicate sampling in 2018 (repeated samples are rejected and the rejection reason recorded). Further, CA agreed that starting from 2019 retail sampling will be allocated proportionally to population in NUTS3 areas. CVO reminded voivodship and poviat inspectors involved in the implementation of AMR monitoring the rules of sampling for laboratory tests. In cooperation with the laboratory performing sample analyzes, Sanitary Inspection will make the guidelines for sampling for the monitoring of antimicrobial resistance of zoonotic pathogens and commensal bacteria. PIWet-PIB introduced changes to the sample registration system to avoid sampling the same lots. In the planning process for 2019, implementation of the tool to ensure proportional distribution of samples depen

and CAs (GVI, SSI and NVI-NRI in Pulawy) will More detailed information is required to ed by seek for possible solutions allowing to initiate assess the actions proposed. Please provide Annex AMR monitoring from January 2019 and more details on the following: the distribute sampling over the year. Efforts for a) the solutions being considered to start the the randomisation of sampling days has already AMR monitoring programme in January dance been done, although some limitations results (2019): units, from slaughter process and logistic issues. In December this year CVO will prepare an o the Data collection system has been already instruction on monitoring the antimicrobial improved considerably to avoid replicate resistance of commensal and zoonotic sampling in 2018 (repeated samples are bacteria in 2019. Regardless of the European rejected and the rejection reason recorded). Commission's financial decision (grand Further, CA agreed that starting from 2019 decision for 2019) the antimicrobial retail sampling will be allocated resistance monitoring program will start in proportionally to population in NUTS3 areas. January 2019. CVO reminded voivodship and poviat b) the efforts made

Rekommendationen anger som grund

The different laboratory procedures were available on-the-spot and largely followed the relevant international standards. The audit team noted however a number of deviations from these standards (ISO 20776-1:2006, Clinical and Laboratory Standards Institute or the EURL for AMR) which, in the absence of validation, is contrary to the requirements of point 4 of Part A of the Annex to Decision 2013/652/EU. These concerned the following issues: The use of reference strains and colony counts on inoculum suspensions for MIC determination for E. coli were performed with a different frequency to that indicated in the relevant standard. This alternative frequency was not validated. Incubation time and temperatures combinations differed from the applicable standards for Campylobacter MIC determination. This alterative arrangement has not been validated. The procedures for the media validation for the selective growth of ESBL-, or AmpC producing E. coli were not fully in line with the EURL protocol as required. Although the reference strains were regularly used to validate the media after its preparation, the self-life validation was not documented. The procedures for the detection of presumptive E. coli producing ESBL and AmpC enzymes were not fully in line with the EURL protocol. The sub- cultivation step in MacConkey agar with cefotaxime was not systematically performed. The audit team noted that a number of unusual combinations of MIC (atypical phenotypes) reoccurred, often in different years 4. These combinations were not detected by the NRL and therefore no action was taken to ensure that the results obtained did not reflect a deviation from the relevant standard operating procedures. Conclusions on official laboratories

The NRL performs largely satisfactorily. However, the reliability of the results reported to EFSA is affected by the use of some non-validated laboratory practices that are not aligned to the relevant international standards, and by the overlooking of atypical phenotypes. 4 Examples of the combinations found are as follows: a) resistance to ciprofloxacin and susceptibility to nalidixic acid for Campylobacter in 2014 and 2016, b) resistance to erythromycin in Campylobacter in 2014 and 2016, c) resistance to colistin in Salmonella and/or E. coli in 2014, 2015 and 2016, d) resistance to azithromycin in 2015 and 2016 and e) resistance to tigecycline in E. coli 2016. 9

Medlemsstatens svar

y level are NRLs implemented measures to fully adjust laboratory methods to to relevant ISO and EURL recommended procedures. This includes said repeated testing of atypical phenotypes, although it is not n 2013/652/EU.

ied out NRLs implemented measures to fully adjust Please send an electronic copy of the ith laboratory methods to relevant ISO and laboratory SOP highlighting the parts (or EURL recommended procedures. This pages) that have been updated to adjust the th includes repeated testing of atypical methods to ISO standards or EURL phenotypes, although it is not mentioned in recommended procedures. Decision 2013/652/EU. SOPs recommendation no 3.zip

Rekommendationen anger som grund

Although most of the information reported to EFSA generally follows the requirements set out in the reporting manual and data dictionary, the audit team identified a number of frequently reoccurring gaps regarding reporting practices, which is not in line with point 2, Part B of the Annex to Decision 2013/652/EU: Atypical phenotypes, as described in EFSA's business rules, are not routinely retested before reporting them to ensure that the MIC values obtained are correct. Salmonella isolates obtained in poultry slaughterhouses, other than those from neck skin samples, are reported under the programme code AMR MON. Most of the information required by the text forms was provided in 2015 and 2016. However, the descriptions under a) stratification procedures per animal population and food category, b) randomisation procedures per animal population and food category and c) description of sampling designs sent in 2015 and 2016 did not fulfil the relevant requirements. Although measures were in place to exclude repeated epidemiological units from being subject to AST, isolates obtained from the same epidemiological units were eventually reported. HACCP and own controls was wrongly used as a code to describe the sampler in Salmonella isolates from the SNCP in 2014 and 2016. Conclusions on assessment and reporting of AMR

Although the basic guidelines described in EFSA's reporting manual and data dictionary are followed when reporting data, a number of reoccurring mistakes hampers the ability of the competent authority to provide harmonised and comparable data on AMR.

Medlemsstatens svar

lished by NRL has improved data collection system to reflect dictionaries as a set out in point 2 of Part B of the Annex to Decision2013/652/EU. ision More attention is payed to proper sample description prior to (see: Actions taken for recommendation No. ent of internal procedures prior to the ta has already been scheduled to improve ure comparable data of AMR monitoring. Page: 2

NRL has improved data collection system to Please describe in more detail or send an Food reflect dictionaries as set out in point 2 of Part electronic copy of the changes in the internal ata B of the Annex to Decision 2013/652/EU. procedures on the checking of data prior to of the More attention is payed to proper sample their submission. Please include also an description prior to laboratory analyses (see: estimated deadline for the implementation of Actions taken for recommendation No. 2). these changes. Further improvement of internal procedures As described above the amount and QC of prior to the submission of the data has already data was considerably increased. been scheduled to improve final checks and There is no internal procedures for checking ensure comparable data of AMR monitoring. the data before submission, but IT team puts major effort to apply correct codes according to EFSA technical specification i.e. doi:10.2903/sp.efsa.2018.EN-1368. Further, IT Team is in constant email contact with EFSA support team. Page: 6 d from the competent authorities on 12 October 2018 submitted by the competent authorities of Poland in response to Report ref. DG(SANTE)/2018-6308-MR Ap

Medlemsstatens svar

W 2018 oraz w pierwszej polowie 2019r. trwaly prace nad tworzeniem nowych formatów wszystkich planów gotowoci. W styczniu 2019r. zostala powolana grupa robocza skladajaca si ze specjalistów pracujcych w wojewódzkich i powiatowych inspektoratach weterynarii, która oceniala i zbierala dowiadczenia nabyte w czasie zwalczania HPAI w 2016/2017r. W lipcu 2019r. planowane jest spotkanie grupy roboczej na którym zostan omówione dotychczasowe prace. W sierpniu br. zmienione documenty zostan przedstawione do szerokich konsultacji z wymaganymi prawem podmiotami. We wrzeniu/padzierniku 2019r. (w zalenoci od liczby uwag wnoszonych do GIW) zostan sporzdzone documenty po konsultacjach. Na przelomie padziernika i listopada 2019r. znowelizowany plan gotowoci HPAI zostanie przedstawiony do akceptacji GLW. W grudniu br. nowy plan gotowoci HPAI zostanie wyslany do KE.

Rekommendationen anger som grund

During the 2016 outbreak this laboratory needed additional days (up to 3 weeks) from the detection of Salmonella to provide the results on serotyping. This was caused by different factors including the very high number of additional samples to be serotyped at this crisis period and to exhausting the stock of reagents. In both laying hen holdings visited affected by the 2016 outbreak and with samples tested at this laboratory, the measures restricting marketing of eggs from these holdings as class A eggs (for direct human consumption) had been implemented at the time of Salmonella detection (without waiting for serotyping) therefore preventing additional risk for consumers. 5.2.3 SNCP for breeding flocks of Gallus gallus Legal requirements Article 5 of Regulation (EC) No 2160/2003. Article 1 of Regulation (EC) No 200/2010. Findings

The fact that during the 2016 Salmonella outbreak some serotyping test results were issued with delays of up to 3 weeks, indicates that the system in place did not satisfactorily deal with high demand on its capacities in crisis times, in particular to assure timely testing. The measures implemented still prevented additional risk to consumers, nevertheless, without the serotyping result, the competent authorities could have faced legal difficulties in imposing the necessary marketing restrictions.

Rekommendationen anger som grund

Some points in the animal welfare instructions are unclear, such as: The instruction to check that journeys are planned until "final place of destination". Two of the districts visited were correctly evaluating journey plans until the final place of destination in the non-EU country. In the other district visited journey plans to non-EU countries did not include the non-EU leg of the journey and the exit point but were still incorrectly stamped as satisfactory by that district; When supervising transporters, the instructions indicate "compare SNS data with completed journey logs". This is a verification of coherence between different registers which is useful but does not address the main intent of verifying if SNS data and completed journey logs show that effective journey times were realistic and complied with EU requirements, as required by Article 15(1) of Regulation (EC) No 1/2005.

Poland has detailed documented procedures for official controls on animal welfare at all stages of transport and on animal health certification, even though with a few shortcomings. Some instructions for those procedures are also not sufficiently clear and thus differently understood by the different districts resulting in a non-harmonised approach in carrying out official controls.

Regarding the organiser's plans to rest the animals during the journey and provide them with feed and water (Article 14 of Regulation (EC) No 1/2005): 7 Journey plans seen by the audit team generally used the same regular routes for specific destinations. This facilitates the evaluation of the journey plans considering, in particular, that the OV only receives such plans at the moment of loading, contrary to Point 3(b)(ii) of Annex II of Regulation (EC) No 1/2005; The GVI indicated that their interpretation since entry into force of Regulation (EC) No 1/2005 is that the journey plan has to be until the final place of destination in the non-EU country, as confirmed in 2015 in a judgement by the European Court of Justice1. This was however not implemented at one of the DVOs visited, as the audit team noted that stamped journey plans for exports to a non-EU country did not include the exit point from the EU and the non-EU leg of the journey until final destination; Planned travelling times in the other two districts were in compliance with EU requirements.

Although the central competent authority indicated that the journey plan must be until the final place of destination in the non-EU country and that this has been always their interpretation, this was not clear to all DVOs and therefore there is a risk that travelling times are sometimes exceeded once past the EU border.

There is a system in place to assess planned and actual resting and travelling times before and after the journey. Assurances given by this system are nevertheless weakened by the failure to ensure that all journey plans cover the full journey until the final place of destination in the non-EU country and by the lack of evidence that the prescribed retrospective checks have been carried out.

Rekommendationen anger som grund

A few shortcomings in the animal welfare instructions were noted: The instructions do not require journey plans to be submitted to the districts at least within two working days before the intended date of departure. This is required by Point 3(b)(ii) of Annex II of Regulation (EC) No 1/2005 (see paragraph 18); When carrying out controls during transport the instructions do not require the OV to check the suitability of drinking devices for the categories of animals being transported. This is nevertheless included in the relevant checklist annexed to the guidelines; When a long journey includes the use of livestock vessels the guidelines do not instruct the OVs to request a copy of the vessel's approval certificate to verify that it is approved to carry live animals, contrary to the requirement of Article 14(1)(a)(i) of Regulation (EC) No 1/2005. There is therefore the risk that the journey of live animals transported through a port would not operate smoothly due to poor planning and lengthen the journey contrary to the requirements of Article 3(a) of Regulation (EC) No 1/2005.

Some points in the animal welfare instructions are unclear, such as: The instruction to check that journeys are planned until "final place of destination". Two of the districts visited were correctly evaluating journey plans until the final place of destination in the non-EU country. In the other district visited journey plans to non-EU countries did not include the non-EU leg of the journey and the exit point but were still incorrectly stamped as satisfactory by that district; When supervising transporters, the instructions indicate "compare SNS data with completed journey logs". This is a verification of coherence between different registers which is useful but does not address the main intent of verifying if SNS data and completed journey logs show that effective journey times were realistic and complied with EU requirements, as required by Article 15(1) of Regulation (EC) No 1/2005.

Poland has detailed documented procedures for official controls on animal welfare at all stages of transport and on animal health certification, even though with a few shortcomings. Some instructions for those procedures are also not sufficiently clear and thus differently understood by the different districts resulting in a non-harmonised approach in carrying out official controls.

Organisers notify the DVO well in advance of the intention to transport animals over long distances. This notification: Indicates the date and place of departure, the place of destination, the number of animals to be transported, the transporter and the vehicle number plate; Does not include a properly completed signed copy of Section 1 of the journey log, contrary to the requirements of Point 3(b)(ii) of Annex II of Regulation (EC) No 1/2005. The OVs therefore cannot check in advance if the planned journey is realistic and complies with the requirements of Regulation (EC) No 1/2005, in particular with travelling and resting times.

Under the current system of official controls, the journey plan can only be evaluated at the moment of loading. This is not in line with EU requirements and places the OV under unnecessary pressure as this is the only stage at which all the necessary welfare checks are carried out prior to departure.

There is a system in place to assess planned and actual resting and travelling times before and after the journey. Assurances given by this system are nevertheless weakened by the failure to ensure that all journey plans cover the full journey until the final place of destination in the non-EU country and by the lack of evidence that the prescribed retrospective checks have been carried out.

Rekommendationen anger som grund

Certificates of approval of vehicles for long journeys do not distinguish between adult and unweaned animals, contrary to Chapter IV Annex III of Regulation (EC) No 1/2005. This implies that unweaned animals may be transported on vehicles that are inadequate for this category of animals with the biggest risk being the inability to access liquids due to unsuitable drinking devices (Point 2.2 of Chapter VI, Annex I of Regulation (EC) No 1/2005).

Certificates of approval of vehicles for long distance journeys do not distinguish between adult and unweaned animals. As a result unweaned animals may not have access to liquid and be if necessary fed during long distance journeys. This shortcoming may negatively impact journeys starting from another Member State, if in that Member State the suitability of the vehicles is not also systematically verified at the moment of loading.

Rekommendationen anger som grund

Regarding retrospective checks to verify the travelling and resting times to provide water, feed and rest to the animals (Articles 15(1) and 15(4) of Regulation (EC) No 1/2005): According to the animal welfare instructions each DVO has to carry out retrospective checks on 20% of journeys departing from and arriving at the district. Returned journey logs were available for all exports examined by the audit team. The audit team saw evidence of retrospective checks carried out on those journeys for which notifications of non-compliances had been received. However, there was no evidence of retrospective checks done on returned journey logs for which there was no notification of non-compliance. One DVO visited did not require the planning to include the final place of destination when it was a non-EU country. Here, the audit team detected that several returned journey logs for unweaned calves going to a non-EU country showed that during the non-EU leg the journeys had exceeded the maximum times set out in Chapter V Annex I of Regulation (EC) No 1/2005.

The regional CAs collect summary reports from their DVOs on the number of checks carried out during transport: These summary reports are collated and forwarded to the GVI to analyse the main non-compliances, as required by Decision 2013/188/EU; One of the DVOs visited reported having done retrospective checks on 100% of consignments in 2016 and 2017; The other two DVOs visited reported that they had not carried out retrospective checks in 2016 and 2017. The corresponding supervising regional CAs had not 1 Judgement of the European Court of Justice (Fifth Chamber) of 23 April 2015 ­ Case C424/13. 8 detected that the DVOs had not respected the 20% minimum. One of the regional CAs investigated this during audit and confirmed that retrospective checks had not been carried out by the DVO in 2016 whereas 10 checks had been carried out in 2017. This lack of detection can undermine the validity of the data collected by the GVI. Conclusions on resting

The regions' ineffective verification of the reports submitted on the number of checks during transport can undermine the validity of the data collected and negatively affect the analysis of data that the GVI is required to perform.

Rekommendationen anger som grund

Calves were being transported from one of the districts visited to a non-EU country (other than Turkey). According to the documented dates of birth calves younger than ten days of age (as young as four days) were being transported for journeys longer than 100km. This is contrary to point 2(e) of Chapter I of Annex I to Regulation (EC) No 1/2005: The OV explained that he always checks if the navel is completely healed, as envisaged by 2(d) of Chapter I of Annex I to Regulation (EC) No 1/2005 and that this has always been the case. The OV also explained that these animals were actually older than ten days. That being the case, the animals were transported with documentation holding incorrect age information thus increasing the likelihood of delays during the journey, namely at the EU borders. The CA indicated that most probably the farmers introduced wrong dates of birth when registering the animals and that they had not been notified of any delays at the EU's borders because of this issue. The OV did not record that he had carried out the above mentioned verification of the navel as one of the means of confirming the fitness (as required in Annex I, Chapter I, (1) of Regulation (EC) no 1/2005) and the age of the animals, prior to issuing the export health certificate.

Assurances given by official controls when issuing animal health certificates for exports were satisfactory. However, if the organisers provide incorrect accompanying age documentation and that documentation is forwarded without any official remark there is the risk of animals being detained in a stationary truck at the EU borders.

Rekommendationen anger som grund

Concerning contingency plans (Article 11(1)(b)(iv) of Regulation (EC) No 1/2005): The animal welfare instructions concerning the authorisation of Polish transporters list details that must be included in contingency plans. These include: names and phone numbers of persons responsible for taking decisions, description of strategies for the change of means of transport, procedures to be followed in the event of unexpected stops and in case assistance is needed to care for the animals. The contingency plan of the transporter visited was of good quality and included procedures to follow, both for the driver and for the person responsible at the transporter's headquarters. Contingency plans however do not include information on how to deal with unexpected long delays at EU borders where there is a high risk of unexpected delays (e.g. Turkey), in particular on how to obtain and provide bedding, feed and water to see to the animals' needs at this location. Arrangements to meet the animals' needs in the case of unexpected long delays at the border are therefore not in place contrary to Article 3(a) of Regulation (EC) No 1/2005. 11 Conclusions on unexpected delays at the border

Transporter's contingency plans, as required by Regulation (EC) No 1/2005, do not include measures to provide bedding, feed and water to the animals in the eventuality of unexpected long delays at those EU borders where this risk is high, such as Turkey. There are therefore inadequate assurances that the needs of animals can be met if blocked at the border on board Polish vehicles and that these animals are not caused unnecessary suffering.

Rekommendationen anger som grund

Although in each establishment visited, PSES inspectors provided the audit team with evidence (i.e. training certificates) on their participation in training sessions relevant to official controls of RTE food, these were not effective as the audit team noted some 8 weaknesses in their knowledge regarding the relevant requirements. For example: in one establishment visited, the audit team noted that when carrying out verification on the FBO's own-check sampling programme for microbiological analyses, the PSES inspector was not familiar with the existing CCA Order on this subject (see paragraph 64). The inspector attributed the lack of knowledge of the CCA Order to the absence of adequate training; in other establishments visited PSES inspectors had lack of knowledge on certain provisions of Regulation (EC) No 2073/2005 (number of sample units to be taken and how to evaluate FBOs' shelf-life studies) and on the CCA guidelines on environmental sampling and testing for Listeria monocytogenes (see paragraphs 74, 77 and 78).

A training system, also covering issues related to the RTE food sector, aimed at ensuring that official staff can execute their tasks effectively is in place. However, the system could not ensure in some cases that official controls are carried out in a consistent manner; in particular, weaknesses were noted in the knowledge of SSI staff on the procedures and guidance for official controls to verify the FBOs' compliance with Regulation (EC) No 2073/2005.

The audit team noted disagreement between GSI and VSES/PSES officials regarding the interpretation of the CCA procedure to be followed. GSI informed the audit team that frequency of inspections should be determined based on the result of the risk assessment (as described above). However, the VSES visited informed the audit team that when calculating the frequency of visits PSES inspectors should take into account further risk elements (e.g. volume of production, if the establishment is one of the major producers in the district, etc.).

The cases reviewed by the audit team showed an adjustment of inspection frequency by the PSES inspectors, resulting in a higher frequency of planned visits than based solely on risk assessment. However, in the absence of clear CCA procedures on determining the frequency of inspection, this result is not guaranteed in the future. Nevertheless, GSI informed the audit team of their commitment to review the risk assessment procedure in the light of the findings and conclusions of this audit (see Chapter 7). 5.4.1.2 Procedures for official controls VI

In one of the establishments visited (under the control of SSI) that produced certain RTE products able to support the growth of Listeria monocytogenes, the food safety criterion of point 1.2, Chapter 1, Annex I to Regulation (EC) No 2073/2005 was applied, with the limit to be 100 cfu/g during the shelf-life of products. The audit team noted however, that the CA inspector accepted the use of this limit without the FBO's adequate demonstration that the product will not exceed the limit 100 cfu/g throughout the shelf- life, which is in breach of footnote 5 of point 1.2, Chapter 1, Annex I to Regulation (EC) No 2073/2005 (see paragraph 96).

The audit team noted in one establishment visited under SSI supervision that the FBO took one sample from RTE products instead of the required five for microbiological 16 analysis without being able to demonstrate to the CA by historical documentation that it has effective HACCP-based procedures (which is in breach of Article 5(3) of Regulation (EC) No 2073/2005).

Moreover, in two establishments visited under SSI supervision, the FBOs regularly took swab samples from processing areas and equipment and analysed them for Listeria monocytogenes. However, all these samples were taken after cleaning and disinfection. This is neither in line with SSI guidelines on this issue nor with the guidelines of the EU Reference Laboratory (EURL) (Guidance on sampling the food processing area and equipment for the detection of Listeria monocytogenes) which recommends (in order to increase the probability of detecting a persistent strain) that the sampling should be carried out during processing. Sampling only after cleaning and disinfection makes the detection of the pathogen difficult and can lead to a false sense of security. These practices had not been noted during official controls as the CA inspectors were not familiar with the provisions of the above mentioned SSI guidelines. 5.4.1.4 Official sampling and laboratory analysis

The CAs put in place a system of risk based official controls over production of RTE foods, supported by comprehensive documented procedures and guidance. Although these procedures do not fully take into account the specific risks related to RTE food (in particular those identified by the CAs as high risk RTE), the impact is mitigated by the frequent and efficient controls in place. Some inconsistencies in the implementation of GSI procedures for risk assessments to determine inspection frequencies were noted.

Official controls and enforcement actions over RTE foods were satisfactory. However, shortcomings in the official controls to verify FBOs' compliance with Regulation (EC) No 2073/2005 were noted in particular for GSI.

Medlemsstatens svar

Procedura wewntrzna PIS dot. urzdowej kontroli okrelona w zarzdzeniu nr es 104/17 Glównego Inspektora Sanitarnego z dnia 8 maja 2017 r. w sprawie procedury przeprowadzania urzdowej kontroli ywnoci oraz materialów i wyrobów przeznaczonych do kontaktu z ywnoci, jest aktualnie poddawana rewizji i kompleksowym zmianom. Do 15 kwietnia 2019 r. zbierane s uwagi i propozycje zmian procedury (zalcznik 1 ­ kopia pisma do WSSE; GIS-B-PR-022-5/KA/19/1 z dnia 15 stycznia 2019 r.). Zmiana uwzgldni równie wnioski i rekomendacje z przedmiotowej misji, zostanie take uproszczona. pnie propozycje zmian zostan przedyskutowane z przedstawicielami WSSE. Planowane jest przeprowadzenie pilotaowego wdroenia procedury w III-IV kwartale br. Po naniesieniu ostatecznych poprawek, znowelizowana procedura powinna zosta wdroona od 2020 roku. W grudniu 2019 r. oraz w I polowie 2020 roku zostanie przeprowadzony cykl szkole dla pracowników organów Pastwowej Inspekcji Sanitarnej w celu jednolitego stosowania procedury.

Rekommendationen anger som grund

The audit team checked a total of 33 files related to import of products of non-animal origin and noted that the documentary checks had been performed correctly using all available information with the following four exceptions: 1 In its response to the draft report, the competent authority stated that during the checks, it informed the operators which, under current EU legislation, were supposed to pre-notify consignments at the required time. The operators informed the competent authority that in some cases they were not able to prepare the common entry documents (CED) in advance because the requisite documents whose numbers they needed to enter in box I.10 of the CED were not available. It was not until the operators had received the full set of documents that they were able to fill out the CED as required. 7 In one airport DPE one consignment of hazelnuts falling under provisions of Commission Implementing Regulation (EU) No 884/2014 had been imported without the number of the health certificate issued by the non-EU country having been entered in box I.10 of part I of the CED. In one port DPE one consignment of liquid spices falling under provisions of Commission Implementing Decision 2011/884/EU had been imported although the analytical report the date of issue was not specified. In one port DPE several consignments of nuts falling under provisions of Commission Implementing Regulation (EU) No 884/2014 had been imported without having reference to the health certificate number and lot number in the analytical report issued by the non-EU country official laboratory. In one port DPE several consignments of peanuts from Argentina had been correctly rejected by the DPE staff as the consignments had been presented for the controls with an expired health certificate. This is in line with the provisions of the Article 9(3) of Commission Implementing Regulation (EU) No 884/2014. However, following of an appeal of the importer, the VSES decided to sample these consignments and to accept new health certificates issued by the competent authority of the non-EU country of origin after the arrival of consignments at the DPE and finally to allow importation into EU. This is contrary to the provisions of Article 9(3) of Commission Implementing Regulation (EU) No 884/20142.

There are adequate mechanisms in place to ensure that consignments are presented for official controls and with few exceptions (in DPEs), the implementation of documentary checks was carried out correctly in the BIPs and DPEs visited, being performed using all available information.

However, in some cases of imported food of non-animal origin the competent authority did not take the appropriate actions, which is contrary to the requirements of Article 54 of Regulation (EC) No 882/2004 (see finding 33).

On the whole, actions taken when non-compliant goods are detected during documentary check, are appropriate and, with few exceptions, are in line with Union rules.

Medlemsstatens svar

W zwizku ze stwierdzon niezgodnoci, polegajca na uchyleniu przez Pomorskiego Pastwowego Wojewódzkiego Inspektora Sanitarnego prawidlowo wydanych przez Pastwowego Granicznego Inspektora Sanitarnego w Gdyni decyzji administracyjnych zakazujcych wprowadzenia do obrotu przesylek orzechów ziemnych z Argentyny, Glówny Inspektor Sanitarny (pismem z dnia 28.11.2017 r., znak: GIS-B-RA-426-308/A/17) przedstawil wlaciw interpretacj rozporzdzenia wykonawczego Komisji (UE) nr 884/2014 z prob o uwzgldnienie przedstawionych informacji przy realizacji przyszlych zada wykonywanych przez ww. organ odwolawczy w II instancji (zalcznik 1) Ponadto Glówny Inspektor Sanitarny wystosowal równie pismo (z dnia 28.11.2017, znak: GIS-B-RA-426-308/A/17/1) do wszystkich Pastwowych Wojewódzkich Inspektorów Sanitarnych w którym zostali oni poproszeni o zwracanie szczególnej uwagi w postpowaniach odwolawczych prowadzonych w II instancji na przepisy prawne w sprawie specjalnych warunków dotyczcych przywozu niektórych rodzajów ywnoci z niektórych pastw trzecich (zalcznik 2). Ww. pisma byly przeslane do audytorów DG SANTE drog e-mailow w dniu 27.11.2017 r. Przedmiotowa kwestia, jak równie wstpne wnioski z misji Sante

Rekommendationen anger som grund

The audit team noted that none of the consignments imported from Japan in last three years in the visited DPEs and falling under provisions of Commission Implementing Regulation (EU) No 2016/6 had been sampled as required by the Article 10(1)(b) of said Regulation2. Conclusion on the implementation of documentary checks

The lack of sampling of products of non-animal origin from Japan as required by EU legislation could lead to the import of products which do not comply with the EU health requirements. 2 After the audit and in advance of the production of the draft report of the audit, the competent authority provided additional information on 28 November 2017 indicating that it had already taken some measures to rectify the deficiencies described in the fourth bullet point of finding 33 and finding 34. 8

Medlemsstatens svar

em z dnia 24.11.2017 r., znak: GIS-B-PR-022-346/AK/17/1 (zalcznik 4) Glówny Inspektor Sanitarny polecil wszystkim Granicznym Inspektorom Sanitarnym realizacj art. 10 rozporzdzenia Komisji (UE) 2016/6 wprowadzajcego specjalne warunki regulujce przywóz paszy i ywnoci pochodzcych lub wysylanych z Japonii w nastpstwie wypadku w elektrowni jdrowej Fukushima i uchylajcego rozporzdzenie wykonawcze (UE) nr 322/2014, poprzez zalecenie pobierania próbek produktów pochodzcych lub wysylanych z Japonii do bada laboratoryjnych z czstotliwoci 5%. Ww. pismo bylo przeslane do audytorów DG SANTE drog e-mailow w dniu 27.11.2017 r. Przedmiotowa kwestia zostala równie poruszona na ww. szkoleniu dla kierowników oddzialów Nadzoru Higieny ywnoci, ywienia i Przedmiotów Uytku Wojewódzkich i Granicznych Stacji Sanitarno ­ Epidemiologicznych, które odbylo si w dniach 5-7 grudnia 2017 r. (zalcznik 3). Czstotliwo ta bdzie poddana weryfikacji w lipcu 2018r oraz w skali roku przez GIS, jak równie analizowana w trakcie ewentualnych audytów w GSSE. Page: 2

Rekommendationen anger som grund

The CAs are designated for the official controls of PDO/PGI/TSG and are adequately staffed and trained. However, the exchange of information between regional and/or central level was not always effective. This increases the risk that non-compliant products continue to be marketed. 5.2.2 Control Bodies

Rekommendationen anger som grund

Electronic files containing actual flight routes and bait drop locations were received and verified by official from the Regional Veterinary Inspectorates within 24 hours of the flight. Not all checks were carried out in accordance with the instructions from the CCA and the Commission services. In one region, a flight expert had been employed for this task and he carried out these controls in the airfield directly after each flight. This expert swiftly demonstrated how flight-lines and bait drops were checked and compared, using data for the most recent flights. In the second region, at the end of each distribution day the operators prepared a file with all data for the official veterinarian who delivered the data to the Regional Veterinary Inspectorate. In this region, the inspector was notified when the files were uploaded into the system and checked the data within 24 hours of the flights. However, when demonstrating how this was done it was evident that only the bait drop locations and visual densities were checked and these were compared to printouts of the planned routes, not to actual flight data. However, this was not a technical problem since the flight lines and bait drop locations could be superimposed and visualised using the software in the regional office, when requested by the audit team. Once printouts of the actual flights were obtained there were no indications that the bait drop locations deviated from the flight lines and the flight lines bore all signs of being actual recordings. The CCA was not aware of the practice in the second region as this had not been evident in the reports submitted from this region to the CCA after each ORV campaign.

Despite clear instructions from the central competent authority one of the regions subject to intensified ORV campaigns did not carry out sufficient daily controls comparing actual flight lines to recorded bait drop locations. This indicates that the central competent authority may have failed to explain the importance of these checks, and has not verified that the checks are carried out as instructed.

Medlemsstatens svar

fications Glówny Lekarz Weterynarii przekazal Wojewódzkim Lekarzom Weterynarii pismo znak GIWz-0810-1/2017(10) z dnia dication 11 sierpnia 2017 r. wskazujce, i niezbdne jest przeprowadzanie ainst przez Wojewódzkie Inspektoraty Weterynarii weryfikacji danych pozyskanych z urzdzenia nawigacyjnego i urzdzenia rejestrujcego zrzut szczepionki. Zgodnie z pismem jedn z czynnoci, które pracownik Wojewódzkiego Inspektoratu Weterynarii nadzorujcy zrzut szczepionki powinien wykona w ramach weryfikacji danych, jest sprawdzenie, czy trasy lotu (tracki z urzdzenia nawigacyjnego) pokrywaj si z danymi z urzdzenia rejestrujcego zrzut szczepionki. Powinno si to odbywa poprzez naloenie na siebie danych (pozyskanych z ww. urzdze) na elektronicznej mapie wygenerowanej za pomoc oprogramowania GIS. Pliki powstale w wyniku naloenia tych danych powinny zosta zachowane w celu ewentualnej kontroli lub audytu, które mog zosta przeprowadzone przez jednostki zewntrzne. Wojewódzcy Lekarze Weterynarii zostali równie poinformowani, e opisane dzialania weryfikacyjne s wymagane przez Komisj Europejsk oraz maj sluy m.in. wykluczeniu ingerencji wykonawcy zrzutu w dane pochodzce z wyej opisanych urzdze. Page: 1

Rekommendationen anger som grund

In general, the ASF expert group exercises the functions set out by the ASF control Directive. In particular, the expert groups did assist the competent authorities in defining infected areas as required by the EU legislation and in defining additional control measures to combat ASF disease. The members of expert groups receive regular updates on the evolvement of ASF epidemiological situation. However, the ASF group had not yet received the results of some official controls (e.g. on compliance with biosecurity measures for hunting and on pig holdings) in a manner that would allow them to fully evaluate the effectiveness of those additional measures, although this is required by Article 15(2)(a) fourth indent of Directive 2002/60/EC.

The system of internal audits, supervision and analysis contributes to the harmonisation of official checks and to the detection of weaknesses in the implementation of disease control measures. There is a limited quantitative analysis of the results of official controls by both central competent authority and ASF expert group which limits the capacity to ascertain the effectiveness of the implemented activities. This analysis at central level is particularly weak in assessing the effectiveness of biosecurity measures implemented by hunters and, to a lesser extent, by pig holdings. This hinders the central authority's ability to identify potential gaps and to fine-tune its measures.

Rekommendationen anger som grund

The movement documents reviewed by the audit team demonstrated compliance with movement restrictions. However, the official veterinarian in one district visited who was in charge of health certification in this district did not apply the criteria for selection of pigs to be sampled as foreseen in the plan for eradication of ASF (Article 3 (2) of Decision 2014/709/EU). When pigs were moving from the infected area, the veterinarian performed pre-movement ASF testing, selecting pigs randomly instead of considering whether there had been a recent occurrence of sick animals. This is the same finding noted in the 2014 Commission report (DG(SANCO) 2014-7294).

The strengthened controls on the movements of live pigs reduce the risk of disease spread between holdings. Pre-movement testing is inadequately targeted, and thus provides less guarantees than it could in reducing the spread of diseases due to the movement of pigs from the infected area.

Rekommendationen anger som grund

Commission audit reports (DG(SANCO) 2014-7294 and DG(SANTE) 2016-8776 describe the identification and registration system for pigs in Poland, highlighting the 4 following: there were two pig registers/databases in the country, with different systems for entry and control of information and managed by different authorities ­ a pig database required by EU legislation and maintained by Agency for Restructuring and Modernising Agriculture (ARMA) and the registers required by national legislation kept by individual District Veterinary Offices (DVOs). Both of them had limitations in their use as a disease management tool. Since then this situation has not changed as was evidenced during this audit (for more see paragraphs 14, 40 and 102). DVOs still use their own database for the planning of inspections on farms, as they consider data in the ARMA database outdated.

The Polish authorities had already scheduled the development of the new system called e-IRZ to address the limitation of the ARMA database and a tender for this system has been prepared. The new system should include functionalities to fulfil the new requirements for identification and registration introduced in 2016, enhance support to the veterinary services, improve the efficiency of electronic data exchange between the authorities involved, and provide for implementation of two-way communication with the livestock owners. The timeframe to have e-IRZ ready is a year after the tender is awarded.

Farms still keep two holding registers - required by the legislation, which creates an additional burden for pig keepers, and leads to a double registration system. Movement restrictions

The existence of two pig databases complicates the proper planning and implementation of official controls. The amendment of functionalities of the ARMA database should address the majority of the problems, but it will take more than one year to implement.

Rekommendationen anger som grund

Article 7 of the Decision 2014/709/EU (related to the derogation from the prohibition on the dispatch of consignments of animal by-products from porcine animals from the areas listed in Parts III and IV of the Annex) has been transposed in the national legislation. One DVO visited and in charge of some areas listed in Part III of the Decision No 2014/709/EU acknowledged that the measures and controls included in Article 7 have not been implemented (e.g. registration of vehicles used for the transport of animal by- products, satellite navigation system on those trucks, etc). At the final meeting the central competent authority presented new instructions for both DVOs and business operators aimed at ensuring the adequate implementation of these requirements. Conclusions on ABPs

The absence of practical arrangements for the collection and transport of animal by- products from Part III pose a risk for the spread of the disease through potentially contaminated products.

Rekommendationen anger som grund

The Polish hunting association and State Forest informed their members on the decision taken at the ASF expert group to ban the feeding of wild boar in the WAMTA and requested them to keep appropriate records on baiting, for future inspections carried out by the DVO. To date, there have been no checks to verify the implementation of the ban which is not in line with the ASF approved programme.

The authorities successfully implemented measures regarding management and handling of wild boar in ASF restricted areas (Parts I, II and III). The absence of checks on the implementation of the feed ban for wild boars constitutes a weak point in ensuring correct management. The decrease in wild boar density together with the biosecurity measures applied contributed to the slowing down of the advance of the disease in this region. 11

Rekommendationen anger som grund

Antibodies have been tested only in 6,876 wild boars which represent 68.80% of hunting bags which is not line with the national ASF eradication programme and ASF Strategy for Eastern Part of the EU (SANTE/7113/2015-Rev 4) that require testing of all shot wild boars in ASF restricted areas for antibodies against ASF virus. The partial testing hinders from drawing conclusion on the apparent increase of seropositivity rate between 2015 and 2016. The central CA is aware of this last weakness and as remedial action updated (at the end of 2016) procedures for sampling of wild boar. 5.2.2 Surveillance in pig holdings

The effective and well implemented passive surveillance in wild boar provides assurances that new cases of ASF will be detected at an early stage. The competent authority has access to updated data on the epidemiological situation and geographical spread of the infection. The system benefits from good cooperation between hunters and competent authorities and the active role of the ASF expert group. However, the insufficient serological tests performed reduce the amount of epidemiological information available to follow the evolution of the disease in the region.

Rekommendationen anger som grund

Currently there is no concrete target or action plan for the systematic reduction of incidence and the ultimate eradication of ring rot. However, Art. 1 of Directive 93/85/EEC requires Member States to take measures in order to eradicate the disease. Table 3 below shows the results by 10/3/2017 of surveys for ring rot and brown rot carried out in Poland in the 2016 potato harvest. Table 3. Results for the annual survey for Cms and Rs in seed and ware potatoes harvested in 2016 Category of Total Laboratory testing Visual inspection of tubers potatoes cropping No of No of lots Cms positive Rs positive No of Cms Rs area (ha) lots samples* lots samples positives positives Breeding/research 102.7 428 390 0 0 340 0 0 Pre-basic seed 121.9 206 80 0 0 206 0 0 Basic seed 1,780.1 2,859 619 0 0 2,358 0 0 Certified seed 3,974.6 5,492 1,489 7 0 3,767 0 0 Ware (early) 24,148 737 484 17 0 591 0 0 Ware (other) 227,909 7,681 5,535 536 1 8,091 14 0 Industrial 48,380 10,432 2,106 28 1 5,841 0 0 Farm saved seed 4,283 1,205 1,133 36 0 1,061 0 0 *indicates the number of samples tested only for Cms or Rs or both Cms and Rs (by 10/3/2017)

For the last three growing periods, the samples taken for laboratory testing from non- registered producers, representing 90% of the total number of producers and almost half of the potato area in Poland, accounted for approx. 3.5% of the total number of samples in the ware potato production sector. This is not in line with Art. 2.1 of Directive 93/85/EEC as the particularities of the ware potato production system in Poland (very high proportion of non-registered production) are thus still not taken adequately into consideration during the elaboration of the annual surveillance plans. For the same period, the average ring rot percentage in the fraction of non-registered ware potato producers (16.8%), is more than double that of registered ones (7.6%). This indicates that the risk of ring rot contamination remains significantly higher amongst non- registered producers. Table 4. Breakdown distribution of samples tested for Cms from registered (R) and non-registered (non- R) ware/other potato producing farms and ring rot positives Crop area 2014 2015 2016 (by 10/3/2017) in (ha) R Positives non-R Positives R Positives non-R Positives R Positives non-R Positives <1 2,433 501 194 25 2,268 502 457 100 2,611 370 232 27 1 ­ 4.99 3,182 263 26 1 2,834 215 26 5 2,769 178 21 3 5 ­ 19.99 1,228 36 1 0 1,375 26 0 0 1,372 11 0 - 20 - 50 378 0 0 0 596 3 0 0 1,556 4 1 0 >50 513 0 0 0 1,652 0 0 0 3,267 14* 0 - Total 7,734 800 221 26 8,725 746 483 105 11,575 577 2544 30 Proportion 10.3% 11.8% 8.5% 21.7% 5% 11.8% of positives *All samples were taken from one infested variety - size of infected lot 1,700 t (37 ha), the area planted with potatoes on the farm in 2016 - 692 ha

Table 5 below provides details of sampling densities (ha/sample) and ring rot incidence calculated as number of positive lots compared to total number of samples taken in Poland between 2014 and 2016. The table is based on the analysis of data provided by 4 In their comment on the draft report the competent authority indicated that at the time of finalisation of the report 293 samples from the 2016 harvest had been taken from small, non-registered growers. 12 the SPHSIS in the annual survey reports that have been submitted to the Commission for the harvesting periods of 2014-2016. When compared to the previous audit the density of seed potato sampling continues to be amongst the highest within Member States affected by ring rot and constantly less than 0.7 ha/sample, whilst for ware/other potatoes has increased to 21.4 ha/sample (compared to 45 ha/sample in the harvest of 2013). The percentage of samples positive for ring rot and the ring rot incidence in tables 4 and 5 are significantly lower compared to 2015. Table 5. Sampling density (ha/sample) and ring rot incidence (No of contaminated lots / total No of samples x 100%), 2014-2016 Type 2014 harvest 2015 harvest 2016 harvest Density Incidence Density Incidence Density Incidence Seed PL 0.67 0.10% 0.69 0.22% 0.62 0.08% Ware/Other PL 42.6 10.2% 35.0 9.12% 21.4 5.39% Seed EU-Cms 1.54 0.07% 1.49 0.07% 1.38 0.04% Ware/Other EU-Cms 49.7 6.08% 47.6 5.03% 37.2 3.73%

A reduction of ring rot incidence at registered potato producers has been achieved over the last years although it still is fairly high. The statistics available for non-registered producers indicate that the incidence in that segment of the production is much higher and being significantly reduced. There is no concrete action plan for the systematic reduction and ultimate eradication of ring rot.

Medlemsstatens svar

esponse was prepared by the Department of Plant Breading and Protection, Ministry of Agriculture and Rural Development d Responding to the abovementioned recommendation one should note that Poland is a h large country with numerous and diverse agricultural holdings. Therefore, in order to reduce the incidence of Cms in Poland a systemic, comprehensive and concerted action Those include inspections carried out by State Plant Health and Seed Inspection Service aimed at eradicating bacteria outbreaks; information campaigns aimed chiefly at agricultural producers; financial support for agricultural producers; as well as scientific support. The scope of actions is dependent on the capacity of the state budget ­ one should remember that there are ab. 400,000 (professionals and non-professionals) growing potatoes in Poland. The body solely responsible for the detection and eradication of Cms outbreaks is SPHSIS, the National Plant Protection Organisation in the meaning of International Plant Protection Convention. It should be underlined here, that action taken by Poland in this respect are very intensive which is reflected, inter alia, in the growing number of samples taken every year fo

Reply prepared by the Ministry of Agriculture and Rural Development. e Cms containment plan in Poland is being implemented in stages with consideration ng given to the epidemiology of the disease, production structure and size, and human and financial resources. Having regard to the importance of healthy planting material for the containment of the bacteria control measures were focused primarily on eradicating the contamination from seed potato production. The said measures, including inspections by the State Plant Health and Seeds Inspection Service (SPHSIS), de minimis support for farms using certified seed, as well as information and education, brought about notable and concrete results in the form of reduced contamination of seed potatoes. In 2004 Cms infection rate in seed production was as much as 7.5%, while currently (as noted in the report concerned) only 0.08% of seed potato samples from the 2016 harvest were found to be contaminated (i.e. the infection level dropped over 90-fold). The abovementioned Page: 1 ions (updated) received 13 November 2017 mitted by the competent authorities of Poland in response to Report ref. DG(SANTE)/2017-6164-MR arch 2017 in order to evalua

Rekommendationen anger som grund

For the last three growing periods, the samples taken for laboratory testing from non- registered producers, representing 90% of the total number of producers and almost half of the potato area in Poland, accounted for approx. 3.5% of the total number of samples in the ware potato production sector. This is not in line with Art. 2.1 of Directive 93/85/EEC as the particularities of the ware potato production system in Poland (very high proportion of non-registered production) are thus still not taken adequately into consideration during the elaboration of the annual surveillance plans. For the same period, the average ring rot percentage in the fraction of non-registered ware potato producers (16.8%), is more than double that of registered ones (7.6%). This indicates that the risk of ring rot contamination remains significantly higher amongst non- registered producers. Table 4. Breakdown distribution of samples tested for Cms from registered (R) and non-registered (non- R) ware/other potato producing farms and ring rot positives Crop area 2014 2015 2016 (by 10/3/2017) in (ha) R Positives non-R Positives R Positives non-R Positives R Positives non-R Positives <1 2,433 501 194 25 2,268 502 457 100 2,611 370 232 27 1 ­ 4.99 3,182 263 26 1 2,834 215 26 5 2,769 178 21 3 5 ­ 19.99 1,228 36 1 0 1,375 26 0 0 1,372 11 0 - 20 - 50 378 0 0 0 596 3 0 0 1,556 4 1 0 >50 513 0 0 0 1,652 0 0 0 3,267 14* 0 - Total 7,734 800 221 26 8,725 746 483 105 11,575 577 2544 30 Proportion 10.3% 11.8% 8.5% 21.7% 5% 11.8% of positives *All samples were taken from one infested variety - size of infected lot 1,700 t (37 ha), the area planted with potatoes on the farm in 2016 - 692 ha

Non-registered producers representing the vast majority of farmers and almost half the potato cropping area in Poland are still not adequately represented in the annual survey plans and they are only tested occasionally. The number of samples taken from non- registered potato producers remains insufficient for accurately establishing the actual ring rot incidence in this sector. 5.2.2 Handling of suspected and confirmed Cms and Rs outbreaks Legal requirements Articles 3, 4, 5, 6 and 7 and Annex V of Directive 93/85/EEC. Articles 3, 4, 5 and 6 and Annex VII of Directive 98/57/EC. Articles 16.1 and 16.2 of Council Directive 2000/29/EC. ISPM No. 5. Findings Ring rot and brown rot outbreaks in potato crops

Medlemsstatens svar

tent This response was prepared by the Main Inspectorate of Plant Health and Seeds tion Rules of the Clavibacter michiganensis ssp. sepedonicus control system in the potato d sector, including the requirement to sample tubers also from small unregistered "producers", were included by the Main Inspectorate of Plant Health and Seeds ed Inspection in the guidance materials for field inspectors responsible directly for f the Chief Inspector no. 1/2016 of 9 February 2016 "Programme ate the Occurrence, to Control and Contain Clavibacter michiganensis ssp. tonia solanacearum in Poland"). Recommendations to verify the re also included in guidelines for the development of Voivodeship l work plans for the coming years. This resulted in, inter alia, 483 from 2015 harvest being tested than in the previous years, as well the 2016 harvest and being taken from small, nonregistered Page: 3 s received 30 August 2017 commendations of report ref. DG(SANTE)/2017-6164-MR of the audit carried out from 28 February th controls applied in the potato sector owers. The sampling rate is set taking into the account technical capacities of HSIS (available staff and financial resources) and it is adjusted to pri

MIPHSI, in collaboration with VIPHSIs and sp. considering the current financial and human of resources, verified the Cms inspection programme with the view to addressing the said recommendations. It was agreed, that since Cms occurrence among registered Page: 4 ions (updated) received 13 November 2017 mitted by the competent authorities of Poland in response to Report ref. DG(SANTE)/2017-6164-MR arch 2017 in order to evaluate the Plant Health controls applied in the potato sector ction Proposed by the competent authority Commission services' assessment of the competent authority's response roducers is decreasing, the inspection rate in his sector may be reduced from 10% to 7% f the total number of such producers per ear. Resources that will be freed up in this ay will be redirected to surveillance of maller, non-registered operators. A uggestion was made to increase the number f samples for laboratory testing taken from otatoes grown by such operators in ccordance with the following rules: in 2018 ach field unit will take at least 5 samples of his type, in 2019 ­ 7 samples, and in 2020 ­ 0 samples. In total, there are 255 field units cross Poland. However, planned scope of nspectio

Rekommendationen anger som grund

However, the audit team also noted that the action taken by VIPHSI to enforce and prevent re-occurrence of ring rot is often not effective and in particular: In a place of production following a ring rot finding, no further testing of other potato lots to fully determine their plant health status and the extent of contamination was carried out. Other potato lots having clonal links with contaminated material were only assumed being probably contaminated without testing; In the same place of production this resulted in pronouncing two fields, the contaminated and a neighbouring one operated by the same machinery, as contaminated whilst all other fields of the same place of production were declared probably contaminated, technically allowing for continuing potato cropping already during the next growing period.

Compliance with movement prohibition, cropping restrictions imposed for the next growing period and safe handling / disposal of contaminated and probably contaminated material is not effectively monitored even for registered potato producers. The audit team noted that: Based on commitments undertaken by the farmers, a usual practice for contaminated or probably contaminated material is storage for long periods in the farm for personal consumption or animal feed; The fate of this material is not adequately followed up by the regional competent authorities; it usually results in potatoes remaining in the place of production and in decontamination measures applied too late in the season; In one case certified or tested seed was not used during the next growing period for ware potato production, although this constituted a clear legal requirement set by VIPHSI. No further effective action was taken to enforce and prevent re- occurrence of ring rot in this place of production. 17 Ralstonia solanacearum in places of production of Rosa

The action taken to enforce eradication and prevent re-occurrence of ring rot is only occasionally effective. Following ring rot findings, contaminated warehouses, storage crates and agricultural machinery are subject to decontamination measures. However, this may take place too late in the season as in most cases contaminated or probably contaminated material in practice remains within the premises of the place of production 19 without being controlled. Furthermore, the inappropriate designation of demarcated areas and extent of contamination and probable contamination together with the lack of adequate follow up measures observed in some places of production undermines the efforts to contain and eradicate the disease in the future. 5.2.3 Specific ring rot and brown rot control programme Legal requirements Article 11 of Directive 93/85/EEC and Article 10 of Directive 98/57/EC. Findings

Medlemsstatens svar

This response was prepared by the Main Inspectorate of Plant Health and Seeds Inspection n The current national legislation (i.e. Regulation of the MARD on eradication of CMS . J. of 2014, item 1121 with changes)) is in line with respective provisions of Council ry Directive 93/85/EEC. Detailed guidance in this respect, in line with the EU and national legislation, is included in technical guidelines for SPHSIS inspectors, i.e.: Order of the cle Chief Inspectors no. 1/2016 "Programme to Investigate the Occurrence, to Control and ntain Clavibacter michiganensis ssp. sepedonicus and Ralstonia solanacearum in . SPHSIS inspectors are familiar with the current rules on eradication and ontainment of the abovementioned bacteria and, as a rule, follow them as technically feasible (e.g. feasible, legal ways of disposal of contaminated and probably ntaminated potato tubers). Having regard to the report's recommendations, MIPHSI be will send a message in writing to VIPHSIs to remind them of the current guidelines and it to point out the need to follow stracly those requirements. Also, MPHSI will instruct of the VIPHSIs' management to organise training for all inspectors involved in controllin

he In order to implement this recommendation ing Main Inspectorate of Plant Health and Seeds Inspection launched a training cycle to Page: 5 ions (updated) received 13 November 2017 mitted by the competent authorities of Poland in response to Report ref. DG(SANTE)/2017-6164-MR arch 2017 in order to evaluate the Plant Health controls applied in the potato sector Action Proposed by the competent authority Commission services' assessment of the competent authority's response . In remind SPHSIS inspectors about detailed rules of procedure for control and atory containment of Cms. On 24-25th October or 2017 a meeting was organised with heads of Phytosanitary Surveillance Units at VIPHSIs to discuss EC Experts Audit conclusions and rules of procedure for correct surveillance of e Cms (including all elements pointed out in of Recommendation 3). VIPHSIs were also required to train in the rules all their ll employees whose job descriptions include Cms inspections. Trainings should be iable completed by the end of 2017 and in line exceptional cases (e.g. large number of employees in a VIPHSI) by the end of January 2018 at the latest. place ied Page: 6

Rekommendationen anger som grund

There is an adequate official control system in place covering both primary production 8 and processing of fishery products. However, weaknesses noted in relation to the assessment of hazard analyses may result in some relevant hazards not being considered in food business operators' HACCP-based procedures. 5.3.2 Official control of fishery products Legal requirements Article 7 of Regulation (EC) No 854/2004 Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

Medlemsstatens svar

nie w Glównym Inspektoracie Sanitarnym trwaj prace nad nowelizacj Zarzdzenia nr 153/2014 z dnia 1 lipca 2014 w sprawie procedury przeprowadzania urzdowej kontroli ywnoci oraz materialów i wyrobów przeznaczonych do kontaktu z ywnoci, w przedmiotowym zarzdzeniu, na podstawie analizy ryzyka, zmieniona zostanie czstotliwo kontroli zakladów produkcji pierwotnej. Zarzdzenie zostanie równie uzupelnione m.in. o: list pyta kontrolnych dla zakladów produkcji i obrotu ywnoci w zakresie spelniania kryteriów mikrobiologicznych; list pyta kontrolnych dla podmiotów prowadzcych produkcj pierwotn produktów pochodzenia rolinnego. Ww. listy byly dotychczas stosowane, jednake wymagaj formalnego wlczenia do procedur. Znowelizowane zarzdzenie najprawdopodobniej zacznie obowizywa w I kwartale 2017r. 2. W 2017 roku zostan przeprowadzone szkolenia uwzgldniajce tematyk ww. zaktualizowanych procedur urzdowej kontroli oraz wymaga dla producentów produkcji pierwotnej zawartych w Page: 1 rt ref. DG(SANTE)/2016-8732-MR of the audit carried out from 06 l controls relating to microbial safety of primary production of food of non- zalczniku I do rozporzdzenia Nr 852/2004, wymaga mikrobiologicznych. Szczególny nacis

Medlemsstatens svar

oku 2017 zaplanowane zostalo przez Krajowe aboratorium Referencyjne E. coli (w tym werotoksyczne E. i) zorganizowanie i przeprowadzenie bada biegloci dla Page: 2 rt ref. DG(SANTE)/2016-8732-MR of the audit carried out from 06 l controls relating to microbial safety of primary production of food of non- i Sanitarnej, w kierunku C z wykorzystaniem Page: 3

Rekommendationen anger som grund

The Polish Act of 2 April 2004 on the identification and registration of animals requires pigs born in Poland to be identified with an ear tag or tattoo bearing the 12 digit holding number of birth. If pigs move to another holding, there is no requirement for them to be marked with the 12 digit holding number of the second holding when they leave. This is not in accordance with the requirements of Article 5(2) of Directive 2008/71/EC.

In one pig slaughterhouse visited, carcases observed were identified in a number of ways including : single illegible plastic ear tags, single fully legible ear tags, fully legible 12 digit tattoo of Polish holding number, single fully legible ear tag from another Member State but no tattoo/ear tag with a Polish holding number (even though it arrived at the slaughterhouse from a Polish farm) additionally carcasses were seen with no eartag or tattoo.

Regulation (EC) No. 853/2004, Annex III, chapter IV (3) requires the food business operator (FBO) to ensure animals sent for slaughter are identified so their origin can be traced. In the case of carcases with no ear tag or tattoo, this had not been detected by the operator at ante-mortem examination or by the OV during their verification.

In the slaughterhouse visited, FBO operated an internal traceability system whereby all pig carcases were identified with a FBO batch code which related to the supplier. One batch code reviewed by the audit team demonstrated that pigs presented by one supplier had been sourced from 11 other holdings. The operator was in possession of holding numbers for these 11 suppliers but it was not possible, with the information available in the abattoir, to determine the holding where each pig had been consigned from; for this, as a minimum, each holding register for the 11 holdings would have to be examined.

In case of disease outbreak, the existing weaknesses in pig identification would lead to an increased number of herds being restricted and investigated in order to determine the route and source of infection. Consequently, this would result in increased demands on official services and likely delay in implementing control measures. The necessary backward tracing using holding registers would not be possible where pigs had no identification or illegible identification.

Rekommendationen anger som grund

In the assembly centre visited, the audit team selected and reviewed a sample of certificates from the Trade Control and Expert System (TRACES) and supporting documents for consignments of bovines certified for intra-EU trade and noted the following: one calf had pre-certification from its birth herd and a passport showing it left its birth herd at 21 days of age and arrived at the assembly centre three days later. The passport confirmed the calf had been registered in three holdings before arriving at the assembly centre. records for a second calf showed it arrived at the assembly centre, at 23 days of age, having been registered in three other holdings before arriving at the assembly centre.

The audit team reviewed approximately five intra-trade certificates selected from TRACES and issued from an assembly centre in a different region of Poland and cross checked animal movements in the ARMA database. One calf left its holding of birth at 21 days of age, spent three days at a second holding before moving to an assembly centre and being certified for intra-EU trade the following day. This, along with point (43) above, is not in compliance with the requirements of Article 6 to Council Directive 64/432/EEC. In the final meeting, the competent authority provided a copy of a letter dated 25 January 2016 and addressed to all regional veterinary inspectorates. This letter stated that all animals moving to an assembly centre must move there directly from a farm where they have spent at least the previous 30 days or since birth if less than 30 days of age.

There is a weak system of certification of live bovine for intra-union trade from assembly centres. As all relevant available information is not reviewed by certifying officers prior to issuing veterinary certification, the system does not provide the necessary guarantees and illegible animals (i.e. animals that did not stay 30 days prior to loading or since birth in holding of origin) are certified and traded, which increases the risk of spreading diseases through the EU.

Rekommendationen anger som grund

Data provided by GVI for 2012 - 2014 demonstrated high levels of non-compliance in bovine and ovine holdings inspected. 7 Percentage of holdings where non-compliance found during inspection: Bovine 2012 2013 2014 Ovine 22.5% 39.9% 37.7% 14.5% 27.8% 19.6% GVI confirmed they had not considered increasing the minimum rate of checks in subsequent years where a significant degree of non-compliance exists as required by Article 2(2) of Regulation (EC) No 1082/2003 and Article 2 of Regulation (EC) No 1505/2006.

GVI and ARMA are directing significant resources to implementation of official controls on identification and registration of animals and the verification of data quality in the database. Timeliness of data reporting is improving but despite efforts, weaknesses remain with data quality and actions taken don't appear to be significantly improving data quality.

Rekommendationen anger som grund

The database does not contain the geographic co-ordinates or equivalent geographic indication of the holding as required by Section D(1)(b) of the Annex to Regulation 21/2004 ( sheep and goats) and Article 1(d) of Decision 2000/678/EEC (pigs).

The ARMA database does not include a geographical indication of the holding nor data on ASF restrictions. Holdings could include non-contiguous parcels of land. Thus, the process for tracing back animals is burdensome and time-consuming (e.g. to ascertain whether pigs come from holdings in restricted areas due to ASF, officials would need to cross check manually data from the land register and EU legislation listing restricted districts).

Rekommendationen anger som grund

Neither GVI-CO nor GSI-DFNS have any arrangements in place to perform independent scrutiny of the audit process contrary to the requirement of Article 4(6) of Regulation (EC) No 882/2004. 7

The competent authorities discussed some examples of external assessments that cover the audit functions within the context of administrative review and/or ISO assessments. However, the audit activities form a minor component of these assessments and focus rather on examining the administrative arrangements of the covered departments than the requirements of Regulation (EC) No 882/2004. Conclusions on independent scrutiny

The competent authorities have not put in place arrangements to ensure the independent scrutiny of the audit process which means that they cannot avail of external inputs for promoting continuous improvement of the audit process to ensure that the audit process is capable of producing objective results and meeting its obligations under Regulation (EC) No 882/2004. 5.2.3 Auditor competence Legal requirements and other audit criteria Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex to Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: -- generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, -- specific technical knowledge and skills, -- personal attributes, -- education, -- work experience, -- auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 8 Findings

Medlemsstatens svar

to Odpowied GIW: lanowane jest przeprowadzenie niezalenej kontroli audytu IW (w biecym roku co najmniej 20% jednostek audytujcych), wykonanej przez wylonion w drodze przetargu/zbierania ofert specjalistyczn firm zewntrzn. Uwagi zawarte w raporcie z audytu DG SANTE w Polsce zostan wzite pod uwag podczas zlecenia zadania specjalistycznej firmie zewntrznej. Odpowied GIS: 1. Systematyczne przeprowadzanie niezalenej kontroli audytów wewntrznych przez zewntrzn jednostk/niezalen komórk wewntrzn.

Rekommendationen anger som grund

Neither authority has documented procedures for the preparation of the audit programmes and neither could demonstrate that audit plans result from a risk prioritisation. GVI-CO develops a five year Veterinary Inspection audit programme on the basis of which the annual Veterinary Inspection Audit Programmes are prepared. The Chief Veterinary Inspector approves the audit programme. The VVI do their own selection of the PVI to be audited, based on the audit topics determined centrally by the GVI-CO. The areas to be audited include minced meat and meat preparations, poultry meat, dairy production, animal health, eggs and egg products, African swine fever related matters, supervision of approved establishments, controls on fishery products, feed production, veterinary medicine products and pharmaceuticals. The audit team 10 noted that the areas to be covered are not updated, the priorities remain unchanged over the years and the programme will continue until all are covered. The five-year programme was planned as follows: central level audits cover all VVIs and BVIs as regards the thematic areas indicated in the annual programmes and 20% of the PVIs are selected for a voivodship level audit.

The SSI internal audit programme covers a five-year cycle. The current programme covers the period 2015 ­ 2019. GSI-DFNS initiates and co-ordinates the preparation of the programme. GSI-DFNS requests each VSES to prepare their programmes which must be risk-based and: a) reflect all areas relevant for VSES activity, b) cover activity of BSES (if exists on the VSES territory), and c) contain priority topics determined by GSI-DFNS. GSI-DFNS collects individual audit plans proposed by all VSESs and compiles them in a collective multiannual internal audit programme. The Chief Sanitary Inspector approves the audit programme. Each VSES can update the plan, on an annual basis, if additional areas of interest and/or risks are identified. The audit team noted that for 2015 the local audit programmes proposed by VSES varied in their form. Some referred clearly to areas foreseen for audit while some others referred to legislation without being specific about the topics to be covered. GSI-DFNS representative stated that, in March 2016, GSI-DFNS distributed to VSES the NAS document on risk-based selection and requested VSESs to use the document as guide when preparing individual audit programmes. A GSI-DFNS representative stated that before 2016 VSES had prepared their plans with no guide, instruction or written procedure. In the majority of cases, auditors familiar with ISO standards, thus familiar with the risk-based concept, were involved in the preparation of the local audit programmes.

The audit team noted that neither of the audit systems covers the central level offices related to official controls in the scope of Regulation (EC) No 882/2004. Both competent authorities (CAs) stated that they are not authorised to implement audits at central level departments and that such activities are covered by internal audits in the 11 context of ISO certification and by occasional controls performed by the Supreme Chamber of Control (NIK) (see finding 13).

The CAs have developed and implemented processes for establishing annual and multiannual audit programmes. The processes are not adequately documented and had not considered all relevant areas to be audited in the last five years. The methodology applied for risk based prioritisation of audit planning is still under ongoing development with the aim of addressing this shortcoming.

The audit programmes do not cover the central level of the competent authorities' hierarchies and this means that the audit systems cannot ensure that the objectives of Regulation (EC) No 882/2004 are fully met. 5.2.5 Implementation of the audit process Legal requirements and other audit criteria Article 2(6) of Regulation (EC) No 882/2004 states that "Audit" "means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives." In section 5.1 of the Annex to Decision 2006/677/EC further guidance is provided to Member States on the `Systematic Approach', including: "A systematic approach should be applied to the planning, conduct, follow-up and management of audits. To that end, the audit process should: -- be supported by documented audit procedures and records to ensure consistency between auditors and to demonstrate that a systematic approach is followed, 12 -- include procedures for generating audit findings, including the identification of evidence of compliance and noncompliance, as appropriate, and for preparing, approving and distributing audit reports, -- include procedures to review audit conclusions, in order to identify system-wide strengths and weaknesses in the control system, disseminate best practice and ensure the monitoring of corrective and preventive actions, -- be monitored and reviewed to ensure the audit programme's objectives have been met and to identify opportunities for improvement." Section 6.1 of the Annex to Decision 2006/677 provides guidance on implementation of the Audit Process: "To comply with the requirements of Article 4(6) of Regulation (EC) No 882/2004, the audit system should cover the following three points set out in Article 2(6): (a) Verification of compliance with planned arrangements in order to provide assurances that official controls are carried out as intended and that any instructions or guidelines given to staff carrying out the controls are followed. This may largely be addressed by document review, but will also require on-site verification. The audit team will require good generic audit knowledge and skills to address this audit objective. (b) Verification of the effective implementation of planned arrangements. In order to assess effectiveness, that is the extent to which planned results are achieved, on-site operational implementation must be included. This should include an assessment of the quality and consistency of the controls and should involve on-site audit activities. The audit team will require the relevant technical expertise in order to address this audit objective. (c) The audit system should also seek to assess whether the planned arrangements are suitable to achieve the objectives of Regulation (EC) No 882/2004, and in particular the single integrated multi-annual national control plan. This should include assessing the suitability of official controls, with regard, for example, to their frequency and the methods applied, having regard to the structure of the production chain(s) and to production practices and volume. The audit team should have substantial knowledge and understanding of system auditing, together with relevant technical input to address this audit objective. In order to determine whether the planned arrangements are suitable to achieve the objectives set out in (c) above, the following should be considered: Audit criteria should include strategic objectives stemming from Regulations (EC) No 178/2002 and (EC) No 882/2004 (including the single integrated multi-annual national control plan) and national legislation. The primary focus of audits should be the control arrangements relating to the critical points for control in the production chain(s). The emphasis should be on assessing whether planned arrangements are capable of delivering sufficient guarantees on (a) the safety of the en

Medlemsstatens svar

Odpowied GIW: mat zostal poruszony podczas narady audytorów, odbywajcej si w dniach 10-11 stycznia 2017 r. Zapoznano audytorów z dwoma przetlumaczonymi dokumentami: - ,,Verification of effectiveness" (dok. MANCP) - ,,Risk-based planning for audits of official control systems" (dok. NAS) Opracowano dokument ulatwiajcy typowanie on 19 January 2017 kacji ny IW j i i ryzyka. tala ytu torów w ze nie ji ikacji yzyka ytów do koca ramu ów, nia on 19 January 2017

Rekommendationen anger som grund

The CCA is not complying with the requirements of Article 21 of the Regulation to: ensure that training courses are available for personnel involved in killing and related operations (Article 21(1)(a)); deliver certificates of competence attesting the passing of an independent final examination (Article 21(1)(b)); approve training programmes of the courses (Article 21(1)(c)). The CCA explained that the legal basis to implement these requirements is in a draft national law which is ready to be adopted except for one controversial issue. This law also bans the slaughter of animals without prior stunning and this ban has been challenged by stakeholders. The issue was brought to the Constitutional Court which suspended the application of certain provisions of the Animal Welfare Act that were directly related to the prohibition on the slaughter of animals without stunning. As a consequence the publication of the draft law implementing the requirements of Regulation (EC) No 1099/2009 was suspended. 5.1.2 Scientific support, guides to good practice and provision of certificates of competence Legal requirements Articles 13, 20, 21 and 29(2) of Regulation (EC) No 1099/2009. Findings

The CCA informed the audit team that: it had not identified scientific support for the purposes of Article 20 of the Regulation; at the time of the audit it had not been contacted by stakeholder organisations to assess guides to good practice to facilitate the implementation of the Regulation; although the system for training and provision of certificates of competence, as required by Article 21(1) of the Regulation, is not yet in place new personnel involved in the slaughter of animals and related operations are required to undergo three months practical training in the slaughterhouse of employment. A certificate of training is issued by the local CA at the end of this training. Conclusions on framework for controls

The ruling of the Constitutional Court of Poland against the prohibition of ritual slaughter has delayed the CCA's compliance with the requirements of the Regulation regarding guides to good practice, scientific support for both the CAs and the BOs, and a system for the training, examination for and provision of certificates of competence. Although the three months' obligatory practical training provides a certain level of assurance that persons involved in the slaughter of animals have the required skills in these practices it does not provide full compliance with the training requirements of the Regulation.

Medlemsstatens svar

Zgodnie z informacj otrzyman z Departamentu Bezpieczestwa ywnoci i Weterynarii Ministerstwa Rolnictwa i Rozwoju Wsi, Rzdowe Centrum Legislacji przekazalo do dalszego procedowania projekt ustawy o zmianie ustawy o ochronie zwierzt opracowany na podstawie zaloe przyjtych przez Rad Ministrów w dniu 14 sierpnia 2012 r., który ma na celu wprowadzenie do polskiego porzdku prawnego przepisów wykonujcych rozporzdzenie nr 1099/2009. Zakres zmian proponowanych w ww. projekcie ustawy obejmuje m.in.: - uchylenie bd zmian tych przepisów ustawy z dnia 21 sierpnia 1997

According to the information received from Prace nad projektem ustawy o zmianie e Department of Food Safety and ustawy o ochronie zwierzt opracowanym na Veterinary Medicine within the Ministry of podstawie zaloe przyjtych przez Rad Agriculture and Rural Development, the Ministrów w 2012 r. zostan wznowione po Government Legislation Centre has sent for zaakceptowaniu przez Kierownictwo resortu further processing the draft Act amending the ww. projektu ustawy. W powyszej sprawie aktualne s informacje przekazane mal Welfare Act, which was drafted on wczeniej. the basis of the guidelines adopted by the Council of Ministers on 14 August 2012 and is intended to transpose into Polish national law the provisions implementing Regulation (EC) No 1099/2009. The changes proposed in the above- mentioned draft Act include: - repealing or amending the provisions of the Animal Welfare Act of 21 August 1997 (Journal of Laws 2013, item 856, as amended) which were replaced as of 1 January 2013 by the provisions of Regulation (EC) No 1099/2009. This includes repealing the definitions set out in the Regulation [sic] and rewording Chapter 10 of the Act ('Slaughter, killing and limitation of the animal p

Rekommendationen anger som grund

The CCA informed the audit team that: it had not identified scientific support for the purposes of Article 20 of the Regulation; at the time of the audit it had not been contacted by stakeholder organisations to assess guides to good practice to facilitate the implementation of the Regulation; although the system for training and provision of certificates of competence, as required by Article 21(1) of the Regulation, is not yet in place new personnel involved in the slaughter of animals and related operations are required to undergo three months practical training in the slaughterhouse of employment. A certificate of training is issued by the local CA at the end of this training. Conclusions on framework for controls

The ruling of the Constitutional Court of Poland against the prohibition of ritual slaughter has delayed the CCA's compliance with the requirements of the Regulation regarding guides to good practice, scientific support for both the CAs and the BOs, and a system for the training, examination for and provision of certificates of competence. Although the three months' obligatory practical training provides a certain level of assurance that persons involved in the slaughter of animals have the required skills in these practices it does not provide full compliance with the training requirements of the Regulation.

Medlemsstatens svar

r. o ochronie zwierzt (Dz. U. z 2013 r. poz. 856, z pón. zm.), które od dnia 1 stycznia 2013 r. zostaly zastpione przepisami rozporzdzenia nr 1099/2009, w tym uchylenie definicji okrelonych w rozporzdzeniu oraz nadanie nowego brzmienia rozdzialowi 10 ustawy ,,Ubój, umiercanie i ograniczanie populacji zwierzt"; - dostosowanie poj wystpujcych w ustawie o ochronie zwierzt do poj wystpujcych w rozporzdzeniu nr 1099/2009, w tym wprowadzenie poj ,,umiercania z koniecznoci" zamiast ,,konieczno bezzwlocznego umiercania" oraz ,,ubojnia" zamiast ,,rzenia" ; - uchylenie delegacji zawartej w art. 34 ust. 6 ustawy o ochronie zwierzt zobowizujcej ministra wlaciwego do spraw rolnictwa do okrelenia w akcie wykonawczym kwalifikacji osób uprawnionych do zawodowego uboju, warunków i metod uboju i umiercania zwierzt oraz warunków przemieszczania, przetrzymywania i unieruchamiania zwierzt w celu dokonania uboju lub umiercania; - wskazanie Glównego Lekarza Weterynarii jako organu upowanionego do podejmowania dziala zwizanych z umiercaniem zwierzt z przyczyn zwizanych ze zdrowiem publicznym, zdrowiem zwierzt, dobrostanem zwierzt lub ze wzgldów rodowiskowych oraz wlaciwego m.in. do uczestniczenia w opraco

response as that provided in reply to Prace nad projektem ustawy o zmianie ustawy o ochronie zwierzt opracowanym na Poland, of the audit carried out from 09 to 13 March 2015 in order to evaluate the animal operations commendation 1. podstawie zaloe przyjtych przez Rad Ministrów w 2012 r. zostan wznowione po zaakceptowaniu przez Kierownictwo resortu ww. projektu ustawy. W powyszej sprawie aktualne s informacje przekazane wczeniej.

Rekommendationen anger som grund

The CCA had very recently issued detailed instructions for OVs working in poultry slaughterhouses to monitor animal welfare indicators in broilers as required by Point 2 of Annex III of Directive 2007/43/EC. These instructions include the evaluation of samples of chicken's feet for footpad dermatitis and a relevant scoring system with two trigger levels of action depending on the severity of the welfare conditions of the birds: A trigger level for average welfare conditions, in which the OV at the slaughterhouse reports the findings to the supervising DVO. This information is kept at the supervising DVO and only communicated to the DVO of the farm of origin if a second notification is made. A trigger level of poor welfare conditions, in which the OV at the slaughterhouse reports the findings to the supervising DVO. The DVO in turn communicates the findings to the DVO of the farm of origin for necessary action.

A cumulative daily mortality rate of more than 5% triggers a notification of poor welfare conditions. This value is significantly higher than the maximum permitted CDMR in poultry flocks being kept at stocking densities between 39 and 42 kg/m², as indicated in Point 1(c) of Annex V of Directive 2007/43/EC.

The system that has started being implemented for the monitoring of welfare indicators of broilers at slaughterhouses takes into account the main animal based indicators but there is a risk of having only limited impact on the welfare conditions in farms. This is due to the high trigger values for the CDMR and the lack of availability of this data at the CAs where this matters, namely the DVO of the farm of origin and the CCA.

Medlemsstatens svar

celu zmiany wartoci skumulowanego wskanika miertelnoci iennej w procedurze ,,Kontrola dobrostanu brojlerów w spodarstwie na podstawie badania poubojowego", która owadzi do podjcia dziala ze strony Inspekcji Weterynaryjnej, ówny Lekarz Weterynarii polecil powiatowym lekarzom terynarii zebranie danych w powyszym zakresie z 10% spodarstw utrzymujcych brojlery. Dodatkowo, wystosowal smo do Instytutu Zootechniki z prob o przeslanie informacji siadanych przez ww. instytut, dotyczcych wskanika ertelnoci dla stad brojlerów utrzymywanych w Polsce lub nych danych dotyczcych miertelnoci brojlerów. zebraniu powyszych danych na pocztku 2016 r. Glówny karz Weterynarii wprowadzi ewentualne zmiany w zakresie rtoci skumulowanego wskanika miertelnoci dziennej opracowanej procedurze ,,Kontrola dobrostanu brojlerów Page: 2 rt ref. DG(SANTE)/2015-7420-MR of the Audit carried out from 09 March e at slaughter and during related operations podarstwie na podstawie badania poubojowego".

th a view to modifying the 'cumulative ily mortality rate' under the procedure roiler welfare checks on holdings based on st-mortem inspections' which triggers asures by the Veterinary Inspection rvice, the Chief Veterinary Officer has ucted district veterinary officers to llect data on this matter from 10% of oiler holdings. The CVO has also sent a tter to the Zootechnical Institute, asking it provide data on the mortality rates of oiler flocks in Poland or other information broiler mortality. ce the above data have been collected, at e beginning of 2016, the Chief Veterinary ficer will make any necessary changes to e cumulative daily mortality rate under the ove-mentioned procedure.

Rekommendationen anger som grund

The CCA had very recently issued detailed instructions for OVs working in poultry slaughterhouses to monitor animal welfare indicators in broilers as required by Point 2 of Annex III of Directive 2007/43/EC. These instructions include the evaluation of samples of chicken's feet for footpad dermatitis and a relevant scoring system with two trigger levels of action depending on the severity of the welfare conditions of the birds: A trigger level for average welfare conditions, in which the OV at the slaughterhouse reports the findings to the supervising DVO. This information is kept at the supervising DVO and only communicated to the DVO of the farm of origin if a second notification is made. A trigger level of poor welfare conditions, in which the OV at the slaughterhouse reports the findings to the supervising DVO. The DVO in turn communicates the findings to the DVO of the farm of origin for necessary action.

The data collected in the slaughterhouses on the welfare indicators of broilers is kept at the slaughterhouse unless this requires action according to the trigger system. Conclusions on monitoring of broiler welfare at the slaughterhouse and follow up

The system that has started being implemented for the monitoring of welfare indicators of broilers at slaughterhouses takes into account the main animal based indicators but there is a risk of having only limited impact on the welfare conditions in farms. This is due to the high trigger values for the CDMR and the lack of availability of this data at the CAs where this matters, namely the DVO of the farm of origin and the CCA.

When analysing these reports it is not possible to identify repeat offenders, trends in non-compliances in slaughterhouses of specific characteristics (throughput, species slaughtered, stunning method, etc.). Furthermore, these reports are not accompanied by any data analysis that could have made by the reporting DVO.

Similarly to the reports sent by the DVOs to the RVOs, these are not accompanied by any data analysis that may have been carried out by the reporting RVO. Furthermore, the format adopted by the CCA for the collection of data, including the data categories selected by the CCA, does not allow the CCA to carry out an effective analysis of the results of official controls (e.g. trends in non-compliances detected and repeat offenders). This notwithstanding that Section 9.2.2 of the Annex to Commission Decision 2008/654/EC provides guidance on the analysis of non- compliances for the submission of consistent annual reports to the Commission as required by Article 44 of Regulation (EC) No 882/2004. Conclusions on evaluation and review of official controls

Regional and district CAs are effectively carrying out the evaluation of official controls on compliance with the Regulation. The CCA has put in place a system to collect results of official controls for the purpose of further analysis and review. The process of data collection aggregates data in two phases and as a consequence, some information is lost in the process. From the aggregate data reaching the CCA, it is not possible to effectively analyse certain aspects of compliance e.g. trends in non-compliances or recurring issues. This undermines the CCA's ability to achieve the objectives laid down in point 2(b) and 9.2 of the Annex to Commission Decision 2008/654/EC (to outline progress and analyse non-compliances).

Medlemsstatens svar

celu poprawy systemu zbierania danych dotyczcych kontroli stanu w rzeni, Glówny Lekarz Weterynarii uzupelnil chczasowy raport o rubryk, w której naley wykaza rzenie, rych po raz kolejny stwierdzono te same nieprawidlowoci. ie procedury dotyczcej kontroli dobrostanu brojlerów w , Glówny Lekarz Weterynarii skorygowal sposób owania w przypadku stwierdzenia nieprawidlowoci w ujcy sposób: rzypadku stwierdzenia redniego lub niskiego poziomu stanu, urzdowy lekarz weterynarii informuje powiatowego za weterynarii nadzorujcego rzeni, o wynikach badania i yla komplet dokumentacji dla badanej partii. Powiatowy z weterynarii nadzorujcy rzeni informuje powiatowego za weterynarii nadzorujcego gospodarstwo pochodzenia t o wynikach badania przesylajc otrzyman dokumentacj. rzymaniu powyszej informacji powiatowy lekarz ynarii wlaciwego dla gospodarstwa pochodzenia kurczt: w przypadku stwierdzenia po raz pierwszy redniego poziomu dobrostanu w stadzie pochodzcym z danego gospodarstwa, rozwaa konieczno przeprowadzenia kontroli dobrostanu kolejnego stada utrzymywanego w danym gospodarstwie, biorc pod uwag dotychczasowe wyniki kontroli, wysoko zagszczenia brojlerów oraz wielko stada; w przypadku stwierdze

rder to improve the system for collecting Response from GVI: Poland, of the audit carried out from 09 to 13 March 2015 in order to evaluate the animal operations ta relating to welfare checks in Glówny Lekarz Weterynarii pismem nr aughterhouses, the CVO has added to the rrent report form a box for indicating GIWz- 422-1/2015(5) z dnia 14 wrzenia aughterhouses in which the same regularities have been detected a second 2015 r., przekazal Wojewódzkim Lekarzom me. Weterynarii: zmienion w zakresie dzialania urzdowego lekarza weterynarii procedur Kontrola dobrostanu brojlerów w gospodarstwie na podstawie badania poubojowego. Postpowanie zgodne ze zmienion regards the procedures for checking the procedur powinno wej w ycie od 1 lfare of broilers in slaughterhouses, the O has corrected the approach to dealing padziernika 2015 r., th irregularities detected as follows: zmieniony wzór raportu z kontroli rzeni pod wzgldem dobrostanu zwierzt, w którym dodano kolumn ,,Liczba rzeni, w których stwierdzono ponownie t sam nieprawidlowo". Po raz pierwszy dane na podstawie zmienionego raportu zostan f average or poor welfare conditions are zebrane za rok 2015. (ww. pismo w tected, the official veteri

Rekommendationen anger som grund

There is currently no control system on consignments of EU origin which move between two points in the EU via a third country and re-enter the EU via Poland.

Medlemsstatens svar

ls In his letter GIWb-0810-2/2015(1) of 13 Unsatisfactory August 2015, the Chief Veterinary Officer sent all provincial veterinary officers his The proposed action for drafting guidelines opinion on the rules for carrying out official for border veterinary officers has no deadline controls on food of animal origin imported for completion. We would appreciate if an from other EU Member States (copy appropriate deadline could be provided. attached). This letter referred, inter alia, to the legal bases for carrying out veterinary checks (The recommendation relates to controls at at the place of destination of consignments, the external border of the EU as both Article and to the possibility of requiring supervised 6(1) of Council Directive 89/662/EC and entities to inform the competent body of the Article 7(1) of Council Directive 90/425/EC arrival of goods from another Member State. refer to controls at "places where products Given the increased risk of potential from a third country may be brought into irregularities in the case of consignments that Community territory, such as ports, airports and frontier posts with third countries". have transited through the territory of third So

Rekommendationen anger som grund

There is a system in place to verify official import controls which includes consignments in transit. The activities are effective in detecting the need for improvement but the implementation of corrective actions is not ensured.

Medlemsstatens svar

esponse to recommendation 2, the GVI Satisfactory er Office prepared the Chief Veterinary e Officer's Guidelines on matters relating to Satisfactory m the competent authority on 18 November 2015 tent authorities of Poland on N/A in response to Report ref. DG(SANTE)/2015-7434-MR of the order to evaluate the official controls on consignments in transit ns performed by the district veterinary ers in the TRACES system when placing ompliant product consignments in ms warehouses or removing them from. These guidelines were sent with r GIWbip. 600-37/2015(02) of 22 July and the e-mail of 23 July 2015 to all ncial veterinary officers, who were ucted to forward them to their dinate district veterinary officers for the ses of information and further official The guidelines were also sent by e-mail e border veterinary officers for their mation. itherto applicable Instruction of the Veterinary Officer No GIWpr-02010- 5 concerning the procedures to be wed by the Veterinary Inspectorate s in respect of the approval and vision of customs warehouses, free ouses and warehouses in free zones ded for products of animal origin, nating from third countries, which do not EU import requirements, has been

Rekommendationen anger som grund

Both CBs visited had included in their Manual of Procedure a Standard Operating Procedure (SOP) for inspectors on the risk assessment for prioritising samples for pesticide residue analyses. There were also detailed sampling instructions. CB1 requires a laboratory sample of 500 g only, which is less than the 1-2 kg required for fresh fruits and vegetables in the national Regulations. The SOP of CB2 correctly implemented the national sampling provisions, but two laboratory files for samples of leaves indicated a weight of 32 and 107 grams, respectively, which is less than the 200 grams required for leaves in the national Regulations, and which may not be sufficient for a representative sample. Pesticide residues were detected in these two cases, and enforcement actions considered by the CB. Conclusions on sampling for detecting unauthorised pesticides at Organic Operators

The recent national guidance on pesticide residue control in Organic production provides for a process of harmonising pesticide residue controls within Poland. Both control bodies complied with the requirement of Regulation (EC) No 889/2008 for testing 5 % of the operators. Clear sampling procedures have been specified in national legislation. They were implemented by the CBs visited, except for the minimum weight of the laboratory sample. This can influence the representativeness of the samples and the validity of any enforcement decision.

A file for pesticide detection in 2014 was examined by the audit team at CB1. The producer had been informed of the decertification of her field based on a pesticide residue detection of 0.03 mg/kg of the pesticide pendimethalin. There was no evidence of consultation of the producer concerned, contrary to Article 91(2) of Regulation (EC) No 889/2008. Neither follow-up inspection nor re-sampling was performed. In 2014, a total of 146 samples of organic products had been taken and in two cases only there were pesticides detected. In a further eleven cases, the producer admitted the use of unauthorised pesticides without samples being taken. Conclusions on measures in cases of pesticide residue detections

The national Guidelines will help harmonising investigation procedures across CBs. Files for pesticide residue detections in 2014 show the different approaches taken by CBs at the time. This demonstrates the need for further harmonisation through the new Guidance, in order to achieve consistent investigation procedures compliant with Regulation (EC) No 889/2008.

Rekommendationen anger som grund

The MIAFQI Guidelines (see point 7) specifies that the scope of laboratory analyses should not focus on the price, but on the likelihood to find pesticides. The analyses should also take into account the type of product, the risk of infringement and plant protection measures in conventional farming. The Guidance does not explicitly specify which pesticides should be checked, and the sensitivity of methods as expressed by the Limits of Quantification (LOQs) to be applied by the laboratory. Article 5(2)(a) of Regulation (EC) No 882/2004 requires that the CA may delegate specific tasks to a particular control body only if there is an accurate description of the tasks to be carried out and of the conditions under which it may carry them out. Article 8(1) of the same Regulation requires that CAs carry out official controls in accordance with documented procedures.

The laboratories and an NRL have been adequately designated in line with Article 12 of Regulation (EC) No 882/2004. There were no official criteria for the CBs on the laboratory checks to be carried out, contrary to Articles 5(2)(a) and 8(1) of Regulation (EC) No 882/2004. Consequently, the performance of the analysis is compromised. This affects the range of pesticides checked and the quality control procedure applied.

Rekommendationen anger som grund

The two laboratories are accredited to ISO 17025 with flexible scope in pesticides and commodities by the Polish Accreditation Body (PCA), although a full validation of the methods was only performed in apple. The two laboratories apply the criteria of the EU Quality Control Procedures (SANCO/12571/2013), providing adequate traceability of the sample, matrix matched calibration, adequate identification criteria and quality control activities. Recovery checks were evaluated routinely, but in the private laboratory not all analytes covered by the scope of the MRM were checked regularly and an inadequate calibration process by a single point calibration was observed. Uncertainty values were not applied consistently. The laboratory in Skierniewice follows a specific bottom up approach for estimating uncertainty, as recommended by PCA. In the private laboratory the uncertainty values used are not sufficiently supported by results from quality control and proficiency tests.

The SANCO Quality Control Procedures for pesticide residue analysis are not considered by PCA for the accreditation of the laboratories to ISO 17025. These procedures are regularly revised by DG SANTE and the EU Reference Laboratories (EURLs) for pesticide residues, taking into account the latest scientific information on pesticide residue analysis. Conclusions on laboratory performance

The Accreditation Body did not consider the science-based SANCO Quality Control Procedures for the accreditation of laboratories to ISO 17025. Consequently, the private laboratory visited did not sufficiently apply these procedures. Especially where the laboratories do not participate in the EU proficiency tests, it is not ensured that the reported results are supported by relevant quality control procedures which can undermine the reliability of test results. 7

Rekommendationen anger som grund

The audit team was informed by the CA that, under the SNCPs for all poultry populations, a flock is only considered positive when a relevant Salmonella serotype has been isolated either during official sampling or when positive own-check sample has been confirmed by official sampling and analysed by the official laboratory.

When reviewing the information provided by the CCA the audit team noted that in breeders of Gallus gallus, laying hens and broilers, positive FBO samples are reported as negative flocks if the routine official confirmation is negative. In breeders of turkeys and fattening turkeys, flocks are reported as positive when the own-check result alone is positive. 11 The CCA informed the audit team that the prevalence in 2014 in breeding flocks of Gallus gallus was recorded as 1.54 % (25 positive adult flocks out of 1,627 flocks tested). Seventeen flocks tested positive for relevant Salmonella serotype in the FBO own-check sampling and nine of these seventeen flocks proved negative in confirmatory sampling and were reported as negative flocks. The prevalence in breeders of Gallus gallus would be 2.09 % if all nine own-check positive flocks were included. The CCA informed the audit team that the prevalence in 2014 in laying hen flocks was recorded as 1.90 % (45 positive adult flocks out of 2,364 flocks tested). Fifteen flocks tested positive for relevant Salmonella serotype in the FBO own-check sampling and ten of these fifteen flocks proved negative in confirmatory sampling and were reported as negative flocks. The prevalence in laying hens would be 2.33 % if all ten own-check positive flocks were included. The CCA informed the audit team that the prevalence in 2014 in broiler flocks was recorded as 0.15 % (54 positive adult flocks out of 35,662 flocks tested). Sixty-eight flocks tested positive for relevant Salmonella serotype in the FBO own-check sampling and 45 of these 68 flocks proved negative in confirmatory sampling and were reported as negative flocks. The prevalence in broilers would be 0.28 % if all 45 own-check positive flocks were included. Conclusion on general issues on SNCPs

The routine confirmatory sampling and the reporting policy applied in Poland has an impact on the calculated prevalence of Salmonella compared to other Member States. In particular regarding flocks of breeding Gallus gallus, laying hens and broilers, given that routine confirmatory sampling is applied and that flocks are deemed positive only after official confirmation of positive own-checks.

Medlemsstatens svar

Reply from GVI: All the flocks considered as positive are included in the reports as positive ones. In case of negative result of confirmatory sampling, according to the programmes, a flock is treated (and reported) as a negative one. The programmes, which provide confirmatory sampling, were approved by the Commission. If required change of national law ­ the Act on animal health protection animal diseases eradication ­ will be implemented official confirmatory sampling will be removed from the programmes for 2017 and the following years.

Rekommendationen anger som grund

For the majority of methods in use, the laboratory calculated the control charts separately for every set of 20 quality control results. Therefore, contrary to the requirements of point 5.9.1 of ISO 17025, the laboratory could not identify (long term) trends in the method performance. Only for the method for Group B2d substances were control charts used in a way which allowed the statistical control over trends in the method performance. The audit team noted that, after a recent modification of the Standard Operating Procedure (SOP) for quality control (SOP- PO-11), the laboratory no longer has instructions in place for quality control 5 In its response to the draft report, the competent authority stated that the method is validated in line with Decision 2002/657/EC and covers all analytes relevant to this matrix. Quality controls for streptomycin, oxytetracycline, lincomycin and ciprofloxacin are currently carried out at a level of 5µg/kg. 6 In its response to the draft report, the competent authority stated that the HPLC-FLD method has been withdrawn from the use and from the scope of accreditation. Testing for dyes is carried out with the LC-MS/MS method which was validated at concentration level of 2µg/kg and its accreditation is planned for 2016. 9 routines, in particular maintaining quality control charts and for reviewing of the results. Conclusions on laboratories

Notwithstanding the need to improve quality control procedures in one of the two laboratories visited, the competent authority can have confidence in the reliability of analytical results produced by residue laboratories.

Rekommendationen anger som grund

There is a system of supervision developed within the import control sector, which includes verification of the correct use of TRACES. This includes both local supervision by the head of each BIP and central supervision via supervisory visits to each B IP by the Borders Office (4 BIPs are visited per year). However, this supervision mainly focuses on correcting individual mistakes done by BIP staff. Supervision did not identify the shortcomings described in this report (e.g. use of collective user accounts, control of re-entry horses, follow-up at controlled bodies and destruction plants).

The Border Office also carries out periodic reviews of TRACES from central level using 11 data warehouse and Clickview since December 2012 to monitor the confirmation of receipt and takes appropriate actions when receipt is not recorded as required in respect of consignments imported under Articles 8 and 15 of Directive 97/78/EC.

The regional coordinator stated that TRACES was used for management of economic operators at LVUs and statistical information. Requirements for the regional coordinators do not foresee the supervision duties on the use of TRACES for INTRA-CERTS and control of animal by-products issued and received by LVUs .

At LVUs there is no system of supervision or other activity to assess the correct use of TRACES, therefore shortcomings identified by this audit and described under findings have not been noticed. There is no routine or pro-active analysis/verification of data within TRACES. Records are checked only in response to problems identified by the competent authority of the Member State of destination.

There is a system to assess the use of TRACES in BIPs by means of supervision. At the LVUs level the system of verification does not sufficiently cover the use of TRACES, therefore it is not ensured that deficiencies are detected and corrective actions are implemented when required.

Medlemsstatens svar

elu zapewnienia systemu weryfikacji wiadectw zdrowia, Glówny Lekarz Weterynarii opracowal ,,Procedur weryfikacji wiadectw zdrowia wprowadzanych do systemu TRACES w odniesieniu do: przesylek ywych zwierzt wysylanych w ramach handlu z Rzeczypospolitej Polskiej na terytorium innych Pastw Czlonkowskich UE (cz I oraz II wiadectw zdrowia); przesylek ywych zwierzt wprowadzonych w ramach handlu na terytorium Rzeczypospolitej Polskiej z innych Pastw Czlonkowskich UE (cz III wiadectw zdrowia)" ­ procedura w zalczeniu. Zgodnie z przedmiotow procedur, obowizkiem cotygodniowej weryfikacji wiadectw zdrowia zamieszczonych w systemie TRACES zostal objty Glówny Lekarz Weterynarii oraz wszyscy wojewódzcy lekarze weterynarii.

Rekommendationen anger som grund

In one BIP visited where imported live animals were sent to approved bodies, the confirmation from the place of destination was not received and consignments were not followed-up by BIP staff contrary to the requirements of Annex I of Regulation (EC) No 282/2004. Staff were not aware of this requirement and the instructions do not contain information about it.

GVI provided a number of training courses, as required by Article 6 of Regulation (EC) No 882/2004, relating specifically to the use of TRACES or including it as a part of training themes. Staff also obtain on-the-job training and practice. The training courses were provided to regional services, LVUs and BIPs staff. Evaluation of the training material on control of animal by-products showed that training was sufficient and clear, however training was not effective because it had not improved the awareness of staff on the control of animal by-products at the place of destination and TRACES was not correctly used for those purposes.

The competent authority has suitably qualified and experienced staff, facilities and equipment relating to TRACES activities. Different users of TRACES received appropriate training enabling the correct use of TRACES. In some areas where instructions were not sufficiently detailed for both BIPs and LVUs, the relevant official controls are either not recorded or recorded incorrectly in TRACES.

Several consignments were sent to customs warehouses located in other Member States, but confirmation of arrival in TRACES was not received from the competent authorities at destination, what is not in line with the requirements of Article 2 of Decision 2000/571/EC. However, the BIP staff contacted the Polish customs authorities, who confirmed that consignments had arrived to the place of destination. The data in TRACES were never confirmed and there is no evidence that the consignment was controlled at the warehouse by the veterinary authorities of destination. The lack of feedback from destination is not notified by the BIP to the GVI, since instructions do not foresee follow-up of non- conforming goods transported to the customs warehouses, free warehouses or free zones. 3 In its response to the draft report the competent authority noted that two customs warehouses for storage of non- conforming products of animal origin currently operating in Poland, however there is the third customs warehouse (under supervision of district veterinary office of Gdynia) which is temporary suspended. 6 5.3.3.2 Transhipment/Transfer from BIP/DPE/DPI to BIP/CP and Transhipment to a non-EU country

For consignments re-imported, sent for destruction, transiting and others which need to be followed-up, the BIP of entry follows-up those consignments by contacting the customs services in writing. Customs provide confirmation in writing that the consignments in question arrived to the place of destination. Therefore such consignments were regarded as followed- up although confirmation was not recorded in TRACES.

One BIP visited received consignments of live animals destined for approved bodies in accordance with the national legislation, after the GVI issued an import licence for certain animals. CVEDAs issued were entered into TRACES, but part 3 (Control) of the CVEDA was never completed by an official veterinarian responsible for supervision of the controlled destination contrary to requirement laid down in Part 3 of Annex 1 of Regulation (EC) No 282/2004. 5.3.6.1.2 At destination

LVUs controlling the economic operator at the place of destination do not ensure that the outcome of control on the arriving consignment is correctly recorded in TRACES (this recording is required by Annex III of Regulation (EC) No 136/2004 and Annex I of Regulation (EC) No 282/2004). This requires additional follow-up efforts from the BIPs staff. The low level of confirmation of receipt at the place of destination (e.g. re-imported, sent for destruction, approved bodies) in Traces indicates that LVUs have a low level of controls to follow-up consignments at the place of destination. 5.3.7 Animal welfare checks

In relation to exports of live animals to third countries transiting through other Member States, it was noted: · that they are accompanied only by the certificate to export to the third country (in Polish and in the third country's language). The relevant instruction "Exportation of live animals and animal products to third countries" does not require an INTRA-CERT to be issued. Certifying officers entered data related to the consignment into TRACES as soon as possible after the consignment had departed but this could take a few days and the animals may have left the EU by then. Therefore, the requirements of Article 2(1) of Decision 93/444/EEC which requires consignments of live animals to be accompanied by an INTRA-CERT when being the subject of trade are not complied with. · the INTRA-CERT did not always contain the list of the individual animal identification numbers, contrary to the requirements of Article 3.1 of Decision 2004/292/EC. In the relevant box, it was cross-referenced to an Annex with this information, but the details were not accessible via TRACES. The relevant instruction was amended as from 14 February 2014 and now requires that the individual identification numbers are included in every certificate.

In relation to consignments of live animals arriving from other Member States, it was noted that: · according to the competent authority, all incoming TRACES notifications are checked to verify that the details they contain are acceptable, however in order to implment Article 5(a) of Directive 90/425/EC on non-discriminatory checks, 5 percent of consignments of live animals are physically controlled at destination often in the case of suspicion. · official controls related to ante-mortem inspections or welfare controls at Control Posts are not routinely recorded in TRACES, contrary to the requirements of Article 3.1 of Decision 2004/292/EC. There are currently no national instructions that require these 9 controls to be recorded in TRACES. LVUs inform the designated veterinarians at abattoirs when notifications via TRACES are received and veterinarians inform the LVU when any problems are detected with the consignments and the nature of the problem. The LVU then enters this information into TRACES. The competent authority stated that it was currently revising instructions for this area and that recording data into TRACES would be taken into consideration.

In relation to the movement of specific animal by-products, it was noted that: · The GVI stated that commercial documents were provided via the INTRA-CERT module of TRACES as required. Neither of the LVUs visited during the audit were responsible for controls on trade that would require issuing documents for the outward movement of such animal by-products to other Member States. · There is a national instruction on the requirements of Article 48.3 of Regulation (EC) No 1069/2009 and it was covered in training courses in recent years. However, the GVI did not have an overview to what extent it was being implemented (i.e. the requirement that incoming consignments of certain animal by-products (Categories 1, 2 and processed animal proteins from Category 3) should be controlled and confirmed as having been received at destination in TRACES). The competent authority, on request of the audit team, checked the TRACES database for two separate CN codes. Over two different periods of time, figures of 8 and 29 percent of confirmation of receipt were obtained, despite thorough adequate training having been provided (finding 12) and verification did not cover use of TRACES at LVUs (finding 60). At the two LVUs visited, it was stated that no incoming consignments of animal by-products had been notified in recent years. 5.3.10 DOCOM module

Instructions on use of DOCOMs does not contain information on the requirement of follow- up of consignments of animal by-products received from other Member States contrary to the requirements of Article 48(3) of Regulation (EC) No 1069/2009.

Medlemsstatens svar

Opracowane zostaly wytyczne Glównego Lekarza Weterynarii (pismo GIWbip.600-14/14(1)), regulujce kwesti potwierdzania zez powiatowych lekarzy weterynarii w systemie TRACES przybycia nadzorowanych przesylek do wyznaczonego miejsca przeznaczenia. Wytyczne dotycz przesylek produktów objtych procedur art. 8 dyrektywy Rady 97/78/WE (procedura kanalizacji) oraz procedur art. 15 dyrektywy Rady 97/78/WE (procedura ponownego przywozu), jak równie przesylek produktów nie spelniajcych wymaga UE, kierowanych do zatwierdzonych skladów celnych oraz przesylek odrzuconych podczas weterynaryjnej kontroli granicznej, kierowanych do zakladu utylizacyjnego. Page: 1 cuments have been published as a separate annex and can be found at:http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3305 of Report ref. DG(SANCO)/2014-7002 -MR of a/an audit carried out from 24 RACES system. Wytyczne przekazano za pismem GIWbip.600-14/14(2) z dnia 9 maja 2014 r. oraz mailem w dniu 12 maja 2014 r. wszystkim wojewódzkim lekarzom weterynarii do przekazania wytycznych podleglym powiatowym lekarzom weterynarii celem zapoznania si i dalszego wykorzystania slubowego. Wytyczne przekazano równie mailowo do wiadomoci granicznym

Medlemsstatens svar

Glówny Lekarz Weterynarii podjl prace nad instrukcj w celu ujednolicenia postpowania powiatowych lekarzy weterynarii przy zatwierdzaniu oraz kontroli podmiotów zatwierdzonych zgodnie z dyrektyw 92/65. Glówny Lekarz Weterynarii podjl równie prace nad opracowaniem wytycznych dotyczcych warunków dotyczcych miejsca kwarantanny, rocznego planu kontroli chorób oraz zalece w zakresie przemieszczania zwierzt z i do zatwierdzonych jednostek, w przypadku obrotu zwierztami na terytorium kraju. W chwili obecnej przepisy krajowe nie obliguj do wystawiania dokumentacji towarzyszcej przesylkom zwierzt pomidzy zatwierdzonymi podmiotami w obrocie krajowym.

Medlemsstatens svar

Po przeprowadzonej w dniach 24-28 lutego 2014 r. misji FVO tyczcej stosowania systemu TRACES opracowana zostala ,,Procedura weryfikacji wiadectw zdrowia wprowadzanych do systemu TRACES", która obowizuje od dnia 1 lipca 2014 r. GLW dokona nowelizacji i uzupelnienia tej procedury pod ktem monitorowania prawidlowoci przemieszcze zwierzt pomidzy zatwierdzonymi podmiotami oraz wykrywania nieprawidlowoci i przemieszcze zwierzt, w szczególnoci zwierzt naczelnych do niezatwierdzonych jednostek, instytutów, orodków. Aktualizacja procedury planowana jest w pierwszym pólroczu 2015 r.

Medlemsstatens svar

W polecil wojewódzkim lekarzom weterynarii niezwloczne przekazywanie informacji dotyczcych aktualizacji wykazu podmiotów zatwierdzonych zgodnie z dyrektyw, w tym m. in. zatwierdzenie ­ wpis do wykazu, zawieszenie zatwierdzenia, cofnicie zatwierdzenia, aktualizacja danych podmiotu (pismo nr GIWz-410-186/2014(4) z dnia 14 listopada 2014 r.). Ponadto, Page: 1 (SANCO)/2014-7049 -MR of a/an audit carried out from 22 m in place for bodies, institutes or centres approved in accordance nia 27 stycznia 2015 r. wanie o wystpieniu do dyrektywy 92/65 w (czciowe lub calkowite lczeniu.

Medlemsstatens svar

ie z art.5 ust.5 ustawy z dnia 29 stycznia 2004 roku o Inspekcji Weterynaryjnej zadania i czynnoci zatwierdzonego ach Unii Europejskiej zn. powiatowi lekarze na podstawie umowy o raktyki wyznaczeni do e z art. 16 ustawy. którym wskazano katalog wyznacza lekarzy ono moliwoci ych pracownikami IW logicznych i innych , to podmiot powinien instrumentów atwierdzonego przez o kontrol, którym nie ni pracownicy IW. awnej ynarii wolnej praktyki, si zwierztami w ktyw, aby posiadali oni kierunku wlaciwego domowionymi. odpowiednich ujcych opiek nad , Glówny Lekarz czce sprawowania Page: 2 (SANCO)/2014-7049 -MR of a/an audit carried out from 22 m in place for bodies, institutes or centres approved in accordance nadzoru nad zatwierdzonymi podmiotami, przewiduje zamieszczenie rozdzialu okrelajcego ,,sylwetk dowiadczenia zawodowego" jakie powinien posiada lekarz weterynarii sprawujcy opiek nad zwierztami w podmiocie zatwierdzonym zgodnie z dyrektyw 92/65. Ponadto, GLW skieruje pismo do Krajowej Izby Lekarsko Weterynaryjnej o moliwoci doksztalcania lekarzy weterynarii wolnej praktyki opiekujcych si zwierztami w zatwierdzonych podmiotach w ramach studiów specjalizacyjnych, podyplomowych, kursów i sem

Rekommendationen anger som grund

According to the GVI, a relatively high frequency of official controls is planned for certain types of plants, to encourage compliance with the relevant requirements. The CVO instruction does not provide for the possibility to reduce the frequency of inspections to be carried out in plants with a strong record of compliance with the relevant requirements. The audit team noted that in some cases, the time spent on individual inspections is reduced in order that the required number of inspections can be carried out, leading to some tasks being completed in a superficial manner or not being completed. For example, in one transporter and two traders visited, the inspection reports indicated less than one minute had been spent on each question in the relevant check-list for ABP/DP controls. Although the check-lists provide for checks on incoming and outgoing materials, these had not been carried out sufficiently thoroughly to identify issues noted by the audit team; in an intermediate plant visited, this concerned receiving and stocking more ABP than the actual storing capacity, and in a transporter of fats, the dispatching of less ABP than had actually been received from a slaughterhouse (see paragraphs 21 and 22). In a DVI visited, an official stated that it was not possible to confirm the arrival of consignments of ABP/DP in TRACES owing to the workload.

The competent authorities have the necessary elements, including co-operation, supervision and documented procedures, to maintain and implement a mostly effective system of official controls as required by Regulation (EC) No 1069/2009. Official controls are planned and carried out at a relatively high frequency. Nevertheless, in some cases, in particular in transporters, traders and plants carrying out intermediate activities, these are carried out and recorded rather superficially, which results in non-compliances being overlooked.

In an intermediate plant visited dealing with former foodstuffs (different cuts and parts from slaughtered animals) the audit team noted that the operator was unable to demonstrate to which customers a certain batch of incoming ABP was distributed because apart from the archived commercial documents, no register of incoming and outgoing batches of ABP was kept. In the said plant, stock balance checks were almost impossible. The audit team compared the in-coming and the out-going quantities and found that in certain periods of the year the operator appeared to have more incoming material than could be stored on site. The operator explained that indeed that happens and in those cases they make use of other storage plants but was unable to adequately show that this had happened because no commercial documents were issued for this transfer. Official controls overlooked this issue.

National rules foresee dedicated transport for food or ABP/DP. However, in a transporter visited, the audit team noted that it could not be demonstrated that these requirements were fulfilled and that fats considered as food or ABP were actually kept separately, especially during reloading (the operator could not provide any evidence where reloading took place). This increases the risk that ABP could be diverted to the food chain. These findings were overlooked by official controls. In addition, the audit team noted that the official controls in 7 this establishment were particularly short (less than one hour), which would make a thorough covering of all points on the check-list impossible.

According to a trader of fats visited, his company was the only client of a transport company for the transport of fats. The audit team noted that the number of cistern vehicles owned by the specific transport company and registered as ABP vehicles was very high in comparison to the quantities of fats transported for the trader. In light of the national requirement for dedicated ABP vehicles, no plausible explanation could be provided about the usage of all ABP cistern vehicles which appear to be idle all year round. The audit team noted that official controls did not investigate this issue. It was also noted that official controls were particularly short (between half an hour and an hour) to cover thoroughly all points mentioned in the check-list.

In a trader visited, incoming loads of fish meal were accompanied by commercial documents which did not contain any information about the batch numbers of the product concerned. This was overlooked by the official controls.

Medlemsstatens svar

1.Planowane jest dokonanie zmian w Instrukcji Glównego Lekarza Weterynarii GIWpr ­ 02010-3/2014 z dnia 11 kwietnia 2014 r. w nastpujcym zakresie: n a) zmiana w sposobie realizacji kontroli urzdowych podmiotów sektora utylizacyjnego, poprzez: yfikacj wzorów list kontrolnych SPIWET ­ wdroenie systemu opisowego stanu zastanego w kontrolowanym zakladzie. Kontrole maj by w wikszym stopniu poparte materialami dowodowymi np. dokumentacja fotograficzna lub kserokopie konkretnej dokumentacji która podlegala kontroli; - rozdzielenie kontroli ­ zniesienie obowizku wypelniania calej listy kontrolnej SPIWET w trakcie pojedynczej kontroli - zmniejszenie minimalnej czstotliwoci kontroli przeprowadzanych w cigu roku na rzecz wydluenia czasu pojedynczej kontroli; - wprowadzenie zasady wybiórczego sprawdzania, czy uboczne produkty pochodzenia zwierzcego lub produkty pochodne dotarly do miejsca przeznaczenia (,,cross checking") b) opracowanie i wdroenie odrbnej listy kontrolnej SPIWET HACCP ­ planowana minimalna czstotliwo kontroli systemu - raz na 2 lata; 2. Szkolenie powiatowych i wojewódzkich inspektorów ds. utylizacji w zakresie planowanych zmian w sposobie wykonywania czynnoci kontrolnych podmio

Rekommendationen anger som grund

Since these instructions were issued, GVI has begun supervising the confirmation of arrival of consignments in TRACES. Overall, the audit team noted that although the proportion of consignments of ABP/DP arriving in Poland which are confirmed in TRACES has increased 6 to approximately 50% in 2014, compared to approximately 18% in 2013, there is still a significant number of consignments for which the confirmation is pending.

The official controls carried out throughout the ABP/DP chain are generally able to ensure operators comply with the relevant traceability requirements and recent efforts to increase the confirmation of arrival of consignments of ABP/DP arriving in Poland have enhanced the extent to which the competent authority can be sure ABP/DP are used as intended. In addition, some examples of good practices were observed, which would be beneficial to disseminate more widely. However, there are still many consignments of ABP/DP arriving without the necessary controls being carried out and cases where ABP/DP are accompanied by commercial documents used for food, which undermines the ability to ensure the proper traceability of ABP/DP in some cases. 9 5.3 FOLLOW-UP OF RELEVANT RECOMMENDATIONS MADE IN PREVIOUS FVO REPORT (DG(SANCO) 2012-6475 ­ MR FINAL) Recommendation No Findings 7 To carry out official controls The audit team saw evidence that the competent (including sampling activities) authorities have implemented a sampling plan according concerning the feed ban taking to all relevant risk criteria. At two regions visited, account of all relevant risk criteria documentary evidence was provided of the correct as required by Article 3 of execution of the sampling plan. Moreover, due to Regulation (EC) No 882/2004. increased controls on ABP in general, the competent authorities have increased their level of knowledge about all operators involved. Therefore, the recommendation has been addressed. 8 To carry out adequate follow-up The competent authorities provided several examples of activities in order to ensure that appropriate follow-up activities when breaches to the appropriate action is taken when it feed ban regulations were detected. Those activities were is detected that the requirements closely monitored at central level, therefore, the concerning OF/SI and/or the feed recommendation has been addressed. ban are not met, as required by Article 46 of Regulation (EC) No 1069/2009 and Article 54 of Regulation (EC) 882/2001. 9 To ensure that the sanctions The competent authorities provided evidence that the imposed in case of infringements sanctions imposed concerning OF/SI misuse and feed to the provisions concerning OF/SI ban breaches were effective and dissuasive. Among and/or the feed ban are effective, others, animals which are suspected of having been fed proportionate and dissuasive, as with prohibited proteins of animal origin are killed and required by Article 53 of destroyed. As a result of these dissuasive measures and Regulation (EC) No 1069/2009 follow-up activities and also the correctly implemented and Article 55 of Regulation (EC) sampling, the number of breaches has dropped over the No 882/2004. past two years. The recommendation has therefore been addressed.

Medlemsstatens svar

l 1. Planowane jest dokonanie zmian w Instrukcji Glównego Lekarza terynarii GIWpr ­ 02010-3/2014 z dnia 11 kwietnia 2014 r. w ujcym zakresie: ort ref. DG(SANCO)/2014-7064 -MR of a/an audit carried out from 06 May ts (ABP) and derived products. - wdroenie obowizku weryfikacji danych w zakladce ,,Handlowcy" w systemie TRACES; - wdroenie obowizku kontroli dokumentacji - weryfikacja danych z systemu TRACES z danymi zawartymi w dokumentach handlowych fizycznie towarzyszcych przesylkom; - okrelenie czstotliwoci przeprowadzania kontroli tosamoci przesylek - zalecenie kadorazowej kontroli fizycznej przesylki - w przypadku pierwszego powiadomienia w systemie TRACES (w zalenoci od zasobów kadrowych jednostki kontrolujcej) - ustalenie listy przypadków powiadomie GLW, w przypadku stwierdzenia nieprawidlowoci w systemie TRACES (np. postpowanie PLW w przypadku braku informacji o przesylce w systemie TRACES); 2. Szkolenie powiatowych i wojewódzkich inspektorów ds. utylizacji w zakresie planowanych zmian w sposobie realizacji czynnoci kontrolnych przesylek ubocznych produktów pochodzenia zwierzcego i produktów pochodnych w systemie TRACES (szkolenie 350 inspektorów) Realizacja: Pkt 1 ­ stycze 2015

Rekommendationen anger som grund

The audit team identified that official controls on ABP in slaughterhouses and cutting plants overlooked that certain slaughterhouses or cutting plants were in several cases issuing commercial documents which are used for food products, although the materials being dispatched were destined for an ABP plant and thus the intended use was ABP and not food. This issue was also identified by an RVI inspector during a supervisory official control over DVI inspectors (who overlooked this issue). The RVI has sent letters to the DVIs concerned requiring the proper use of commercial documents in accordance with Article 17 of Regulation (EU) No 142/2011.

The official controls carried out throughout the ABP/DP chain are generally able to ensure operators comply with the relevant traceability requirements and recent efforts to increase the confirmation of arrival of consignments of ABP/DP arriving in Poland have enhanced the extent to which the competent authority can be sure ABP/DP are used as intended. In addition, some examples of good practices were observed, which would be beneficial to disseminate more widely. However, there are still many consignments of ABP/DP arriving without the necessary controls being carried out and cases where ABP/DP are accompanied by commercial documents used for food, which undermines the ability to ensure the proper traceability of ABP/DP in some cases. 9 5.3 FOLLOW-UP OF RELEVANT RECOMMENDATIONS MADE IN PREVIOUS FVO REPORT (DG(SANCO) 2012-6475 ­ MR FINAL) Recommendation No Findings 7 To carry out official controls The audit team saw evidence that the competent (including sampling activities) authorities have implemented a sampling plan according concerning the feed ban taking to all relevant risk criteria. At two regions visited, account of all relevant risk criteria documentary evidence was provided of the correct as required by Article 3 of execution of the sampling plan. Moreover, due to Regulation (EC) No 882/2004. increased controls on ABP in general, the competent authorities have increased their level of knowledge about all operators involved. Therefore, the recommendation has been addressed. 8 To carry out adequate follow-up The competent authorities provided several examples of activities in order to ensure that appropriate follow-up activities when breaches to the appropriate action is taken when it feed ban regulations were detected. Those activities were is detected that the requirements closely monitored at central level, therefore, the concerning OF/SI and/or the feed recommendation has been addressed. ban are not met, as required by Article 46 of Regulation (EC) No 1069/2009 and Article 54 of Regulation (EC) 882/2001. 9 To ensure that the sanctions The competent authorities provided evidence that the imposed in case of infringements sanctions imposed concerning OF/SI misuse and feed to the provisions concerning OF/SI ban breaches were effective and dissuasive. Among and/or the feed ban are effective, others, animals which are suspected of having been fed proportionate and dissuasive, as with prohibited proteins of animal origin are killed and required by Article 53 of destroyed. As a result of these dissuasive measures and Regulation (EC) No 1069/2009 follow-up activities and also the correctly implemented and Article 55 of Regulation (EC) sampling, the number of breaches has dropped over the No 882/2004. past two years. The recommendation has therefore been addressed.

Medlemsstatens svar

1. Opracowanie wytycznych Glównego Lekarza Weterynarii w esie obowizku stosowania dokumentu handlowego, towarzyszcego przesylkom produktów pochodzenia zwierzcego, przeznaczonym do celów niespoywczych. Wytyczne zostan opracowane w oparciu o zapisy art. 2 ust. 1 b) rozporzdzenia Parlamentu Europejskiego i rady Nr 1069/2009; 2. Opracowanie nowych wzorów dokumentów handlowych, towarzyszcych przewozowi ubocznych produktów pochodzenia zwierzcego oraz produktów pochodnych, wylcznie na terytorium Polski ­ wskazanie miejsca zaladunku i miejsca rozladunku ort ref. DG(SANCO)/2014-7064 -MR of a/an audit carried out from 06 May ts (ABP) and derived products.

Medlemsstatens svar

The response prepared by the Ministry of Agriculture and Rural elopment, Department of Plant Breeding and Protection. "The Ministry acknowledges the need to increase the share of the seed material produced in line with seed production regulations in the planting of n potatoes. With regard to the above, legal solutions are implemented with a view to encourage farmers to use such seed material. According to the draft d Regulation of the Council of Ministers on the rates of payments per 1 hectare of arable land sown or planted with seed material of the elite or certified categories (the draft was submitted to the President of the Council of Ministers for signing on March 24th, 2015), it will be possible to obtain ­ within the so called de minimis aid ­ a payment of PLN400 per every hectare planted with the "certified" category seed potato material. However, in relation to the findings of the Audit, the possibility of increasing the amount of support will be further analysed. The possibility of augmenting the said amount depends on the capacity of the state budget planned for 2016 and subsequent years. Another mechanism intended to encourage agricultural producers to use healthy seed p

Medlemsstatens svar

infection The guidelines to the work plan of Voivodeship Inspectorates of Plant Health ed in and Seed Inspection (VIPHSI) for the year 2015 recommend that additional ar, potato samples ­ in relation to the current rules ­ are collected from farms not listed in the register of entrepreneurs. This activity will be continued in ge and subsequent years, as permitted by the financial capacity of the SPHSIS. the Considering the recommendation No. 2, the MIPHSI will apply to the duction. Ministry of Agriculture and Rural Development to consider the possibility of taking action aimed at increasing the financial resources available to SPHSIS and intended for controls and tests in the sphere in question.

Medlemsstatens svar

brown In the majority of cases of finding quarantine organisms or other irregularities, whenever another EU Member State was found to be involved, ) relevant information was submitted to a competent organisation responsible ive for plant health. In order to streamline the procedures adopted by the SPHSIS with a view to ensuring that in every case of finding Clavibacter Page: 2 ved 14 May 2015 ations of Report ref. DG(SANTE)/2014-7204-MR of an Audit carried out from 04 health controls applied in the potato sector michiganensis ssp. sepedonicus and Ralstonia solanacearum bacteria ­ and whenever involvement of another EU Member State is found ­ relevant information is submitted in line with Art. 5.2 of the Council Directive 93/85/EEC, the current rules for submitting such information by the VIPHSI will be subject to a review and an employee of the MIPHSI will be designated as responsible for cooperation with the VIPHSI in this respect and for submitting such information to MS.

Medlemsstatens svar

ng The applicable national laws (i.e. the Regulation of the MARD on the control remain of CMS (O.J. of 2014, item 1121)) are fully compliant with the relevant uted in provisions of the Council Directive 93/85 EEC. § 4.1 of the above mentioned Regulation (constituting a transposition of Art. 4.2 of the Directive) provides grounds for prohibiting the movement of potatoes only in the case of tubers from which samples have been taken for laboratory testing and visual symptoms indicate the possibility of infection with CMS bacteria or the initial results of laboratory tests indicate the possibility of infection with the bacteria until the final results of laboratory tests are obtained. In the cases where the possibility of contamination is suspected exclusively on the basis of clonal or contact links, there is no legal ground to prohibit the movement of potatoes in the event of taking samples for laboratory testing until final results of laboratory tests are available. Considering the recommendation No. 4, the Main Inspectorate of Plant Health and Seed Inspection will apply to the Ministry of Agriculture and Rural Development to consider the possibility of tightening the national laws i

Medlemsstatens svar

n of The applicable national laws (i.e. the Regulation of the MARD on the control in the of CMS (O.J. of 2014, item 1121)) are fully compliant with the relevant provisions of the Council Directive 93/85 EEC. The conditions laid down in to point 4.1.(b) of Annex IV to Directive 93/85/EEC are observed in the opinion of the MIPHSI and the production of seed potatoes is not allowed in the place Page: 3 ved 14 May 2015 ations of Report ref. DG(SANTE)/2014-7204-MR of an Audit carried out from 04 health controls applied in the potato sector of production in the same or in the following year of the designation of contamination. Regarding the recommendation No.5 of the report, the MIPHSI will communicate this guideline to the VIPHSI while pointing out the obligation to abide by those requirements.

Medlemsstatens svar

Odpowied IW: z czstotliwo kontroli w oparciu o zagroenia - do koca br. zostanie znowelizowana Instrukcja GLW dot. ustalania czstotliwoci kontroli w oparciu o analiz ryzyka tak, aby obejmowala ona analiz identyfikowalnoci, etykietowania i stosowania dodatków, z udokumentowane procedury i wskazówki: w dniach 27-28 padziernika 2014 r. w Glównym Inspektoracie Weterynarii odbyla si narada z wojewódzkimi inspektorami ds. bezpieczestwa ywnoci, na której zostaly omówione nieprawidlowoci stwierdzone w trakcie misji FVO. Do koca lipca b.r. zostanie uszczególowiona lista kontrolna SPIWET w zakresie moliwoci ledzenia (traceability). Nowa lista kontrolna dodatkowo bdzie obejmowala zagadnienia zwizane z kontrol procedur zakladowych wycofania produktów niezgodnych z rynku (art. 19 rozporzdzenia (WE) nr 178/2002) i ich realizacji, udostpniania odbiorcom ywnoci i wlaciwym organom informacji, o których mowa w rozporzdzeniu wykonawczym Komisji 931/2011, ustalania zgodnoci iloci produktów otrzymanych, uytych do produkcji, przechowywanych i wyslanych. z metody kontroli - do koca b.r. zostanie znowelizowana instrukcja GLW Nr GIWb-500-1/10 z dnia 23 marca 2010 r. w sprawie przeprowadzania urzdowych kontr

The Veterinary Inspectorate's response: risk-based frequency of controls: by the end of 2015 the Chief Veterinary Officer's Instructions on determining the frequency of controls on the basis of a risk analysis will be amended so that traceability, labelling and the use of additives are also included in the analysis; documented procedures and guidance: on 27-28 October 2014 the General Veterinary Inspectorate held a meeting for provincial food-safety inspectors to discuss the irregularities found during the FVO audit. By the end of July 2015 a detailed SPIWET checklist on traceability will be drawn up. The new checklist will also cover issues relating to the checking of food establishments' procedures for withdrawing non-conforming products from the market (Article 19 of Regulation (EC) No 178/2002) and the implementation of such procedures, the making available to food recipients and competent authorities of the information referred to in Commission Implementing Regulation No 931/2011, and establishing that the quantities of products received, used for production, stored and dispatched tally with each other. control methods: by the end of 2015 the Chief Veterinary Officer's Instruc

Medlemsstatens svar

Odpowied IW: Pismem GIWb-507-92/2014(1) z dnia 30 padziernika 2014 r. erowanym do zwizków branowych zrzeszajcych producentów ywnoci pochodzenia zwierzcego poprosil o zwrócenie uwagi zrzeszonym w zwizkach przedsibiorstwom na uchybienia najczciej stwierdzane podczas kontroli urzdowych, równie kontroli FVO w zakresie przestrzegania przepisów dotyczcych moliwoci ledzenia, znakowania identyfikacyjnego i etykietowania produktów pochodzenia zwierzcego (pismo w zalczeniu). Do koca br. zostanie znowelizowana Instrukcja GLW dot. ustalania czstotliwoci kontroli w oparciu o analiz ryzyka tak, aby obejmowala ona analiz identyfikowalnoci, etykietowania i stosowania dodatków;

recipe tallies with the quantities of ingredients actually used for production, cross-checks on the compliance of the information in the commercial documents with the food establishments' internal records of the reception/dispatch of goods, establishing the compliance of the quantity of products received, used for production, stored and dispatched, and the requirements applicable to frozen foodstuffs of animal origin contained in section IV of Annex II to Regulation (EC) No 853/2004. The Veterinary Inspectorate's response: In its letter GIWb-507-92/2014(1) of 30 October 2014 addressed to the professional associations of producers of food of animal origin, the Veterinary Inspectorate asked that these associations should draw the attention of the businesses that they represented to the infringements most frequently found during official controls and also during FVO audits on compliance with the rules on traceability, identification marking and labelling of products of animal origin (see attached letter). By the end of 2015, the Chief Veterinary Officer's Instructions on establishing the frequency of checks on the basis of a risk analysis will be amended so that traceability, labellin

Medlemsstatens svar

t Odpowied IW: Zgodnie z odpowiedzi udzielon na zalecenie nr 1 nowa lista kontrolna dodatkowo bdzie obejmowala zagadnienia zwizane z kontrol procedur zakladowych wycofania produktów niezgodnych z rynku (art. 19 rozporzdzenia (WE) nr 178/2002). Dodatkowo w dniu 5 marca 2015 r. GLW pismem GIWpr-024-19/2015(2) zglosil propozycje zmian do projektu ustawy o produktach pochodzenia zwierzcego w zakresie uszczególowienia przepisów krajowych dot. wymaga jakie musz by spelnione przy wycofaniu z rynku produktów pochodzenia zwierzcego nie spelniajcych wymaga w esie bezpieczestwa ywnoci.

t The Veterinary Inspectorate's response: tated in the response to recommendation No 1, the new hecklist will in addition cover issues relating to the checking of food establishments' procedures for withdrawing non-conforming products from the market (Article 19 of Regulation (EC) No 178/2002). In addition, in a letter GIWpr-024-19/2015(2) of 5 March 2015, the Chief Veterinary Officer tabled a proposal to amend the draft Act on products of animal origin as regards specifying national rules on the requirements to be met when withdrawing from the market products of animal origin that do not comply with the food safety requirements.

Medlemsstatens svar

wied IW: iach 5-6 marca b.r. zostalo zorganizowane szkolenie dla ad 320 urzdowych lekarzy weterynarii ­ pracowników atowych, wojewódzkich i Glównego Inspektoratu Weterynarii kresu substancji dodatkowych, aromatów dymu wdzarniczego zymów w rodkach spoywczych pochodzenia zwierzcego ­ dy stosowania wg przepisów Unii Europejskiej. Tematyka lenia obejmowala równie postpowanie organów Inspekcji rynaryjnej w przypadku wykrycia nieprawidlowoci czcych stosowania dodatków do ywnoci (harmonogram lenia w zalczeniu). Do koca kwietnia b.r. przeszkolone y przy uyciu przekazanych prezentacji i materialów maj prowadzi szkolenie kaskadowe dla pozostalych pracowników atowych i wojewódzkich inspektoratów weterynarii, jak ie lekarzy wolnej praktyki wyznaczonych do zada owych, zajmujcych si kontrolami zakladów sektora wczego. Materialy ze szkolenia zostaly zamieszczone na nie internetowej GIW. Ponadto do koca lipca b.r. zostanie niona lista kontrolna SPIWET w zakresie stosowania w ci pochodzenia zwierzcego ww. substancji. W biecym planowane s skoordynowane kontrole IW i PIS w zakresie idlowoci stosowania substancji dodatkowych w misie, wych wyrobach misnych, produktach misnych oraz uktach zloonych zawie

The Veterinary Inspectorate's response: On 5-6 March 2015, over 320 official veterinarians (district and provincial employees and General Veterinary Inspectorate staff) attended a training course on food additives, smoke flavourings and enzymes in foodstuffs of animal origin ­ rules for their use in accordance with European Union provisions. The training course also dealt with the procedures followed by Veterinary Inspectorate agencies when they detect irregularities in the use of food additives (see the attached course schedule). By the end of April 2015 those who attended this course are supposed to use the presentations and material they have received as a basis for giving training courses ('cascade training') to pass on what they have learnt to the other staff of the district and provincial veterinary inspectorates and also to veterinarians working in free practice who are designated to perform certain tasks, including conducting checks on food establishments. The training course material has been posted on the General Veterinary Inspectorate's website. Furthermore, by the end of July 2015 the SPIWET checklist on the use of the abovementioned substances in food of animal origin

Medlemsstatens svar

Odpowied PIS, jak wyej. role urzdowe prowadzone przez IJHARS w zakresie jakoci handlowej cj prawidlowoci zdzeniem MRiRW w ostaly do 13 grudnia 2014 r.. one na zgodno z e wiarygodno informacji zakladowych takich jak oli pobierane s równie próbki elu sprawdzenia w zakresie ne s z informacjami i skladników).

The State Sanitary Inspectorate's response, as above. gricultural and Food Quality Inspection's (IJHARS) response: l quality of meat preparations always the packaging (labelling) complies al Development's Regulation on the the provisions of Directive 2000/13/EC hecks currently being conducted are in . The reliability of the information y examining documents from the food ations and recipes. During the checks, the parations for physico-chemical testing in ith the declaration and to detect terials. The test findings are compared (declaration of the ingredient content).

Medlemsstatens svar

Organy IW posiadaj stosowne uprawnienia i rodki do dokonania oceny zapotrzebowania na d to etaty i zapewnienia wlaciwej obsady kadrowej (w tym przesuni kadr z innych jednostek IW) w celu zapewnienia cigloci dziala zwizanych ze zwalczaniem chorób zakanych wierzt i innych czynnoci urzdowych. Ponadto, w 2013 r. opracowano dla kadego powiatu w Polsce list lekarzy weterynarii prywatnej praktyki, których mona zaangaowa w dzialania zwizane z ewentualnym zwalczaniem ASF. Glówny Lekarz Weterynarii poleci aktualizacj przedmiotowej listy.

VI bodies have appropriate rights and measures to assess demand for jobs and to provide o appropriate staff (including shifting personnel from other units of VI), in order to ensure the continuity of actions related to the control of infectious animals diseases and other official vities. Moreover, in 2013, for each District in Poland the list was prepared, consisting of data of private practice veterinarians, that can be engaged in possible actions related to the control of ASF. Chief Veterinary Officer will order an update of the concerned list.

Medlemsstatens svar

Organy IW posiadaj stosowne uprawnienia do wchodzenia na teren gospodarstw i wgldu w dokumentacj dotyczc tych gospodarstw, w tym celu poczyniono stosowne uzgodnienia dotyczce wspólpracy z Policj i zasad postpowania w przypadku utrudnionego dostpu do gospodarstw. W drodze wyjtku organy IW posiadaj ograniczony dostp do gospodarstwa w przypadku prowadzenia w gospodarstwie czynnoci przez organy cigania - organy IW nie posiadaj w takim przypadku dostpu do dowodów sprawy bez zgody w/w organów cigania.

bodies have appropriate rights to enter the holdings and to inspect documentation concerning these holdings, and for this purpose appropriate arrangements were made concerning cooperation with the Police and on rules of conduct in the case of difficult access to ldings. As an exceptional measure, VI bodies have limited access to the holding in the event of activities which are conducted in the holding by prosecution agencies - VI bodies do not have, in this case, access to evidences of the case without permission of the above mentioned prosecution bodies.

Medlemsstatens svar

Glówny Lekarz Weterynarii zmodyfikuje przykladowy wzór dokumentu, odnoszcy si do ormacji dotyczcych lacucha ywnociowego zwierzt kierowanych do uboju, który jest dostpny na stronie internetowej Glównego Inspektoratu Weterynarii. Modyfikacja dotyczy bdzie uwzgldnienia w powyszym dokumencie numeru siedziby stada pochodzenia zwierzt e oraz numerów identyfikacyjnych zwierzt, w celu zapewnienia moliwoci ledzenia wszelkich przemieszcze wi. Naley jednak podkreli, e wzór taki nie jest dokumentem obligatoryjnym, a jedynie zalecanym, ze wzgldu na swobodny przeplyw towarów w Unii Europejskiej (na przyklad wi pochodzcych z innych pastw czlonkowskich przeznaczonych do uboju w Polsce). Ustalony na poziome kraju wzór tego dokumentu móglby stanowi utrudnienie dla przedsibiorców. Podmioty prowadzce rzenie powinny wystpowa u dostawców o udzielenie informacji dotyczcych lacucha ywnociowego, zgodnie z wymaganiami okrelonymi w Zalczniku II sekcji III pkt 3 rozporzdzenia 853/2004. Polska dostrzega potrzeb opracowania na poziomie Unii Europejskiej wzoru dokumentu dotyczcego lacucha ywnociowego do handlu w UE. Obecnie Staly Komitet ds. Rolin, Zwierzt, ywnoci i Pasz w Sekcji: Bezpieczestwo Biologiczne Lacuc

The Chief Veterinary Officer will modify the example model of the document relating to information on food chain of animals intended for slaughter, which is available on the website of the Chief Veterinary Inspectorate. Modification will consist in including in the document the number of the seat of herd, origin of animals and animal identification numbers in order to enable tracking of movements of pigs. It should be stressed that such a model of document is not an obligatory document, but only recommended, due to the free flow of goods in the European Union (for example pigs originate in other Member States and are intended for slaughter in Poland). Model of the document established at the level of the MS could constitute the impediment for entrepreneurs. Slaughterhouse operators should apply to their suppliers to obtain information on food chain, according to the requirements set out in Annex II section III item 3 of Regulation 853/2004. Poland notices the need to develop, at the level of the EU, the model of the document on the food chain for the trade in the EU. Currently, the SCoPAFF, section: Biological Safety of the Food Chain, works on the draft of the Commission Implement

Medlemsstatens svar

Organy IW prowadz wspólprac z ARiMR, m.in. w nastpujcym zakresie: - PLW otrzymuj od biur ARiMR informacj o wszystkich przypadkach padnicia wi lub unieszkodliwienia zwlok wi, gdy liczba zgloszonych zwierzt bdzie stanowi co najmniej be 10% stanu w siedzibie stada; - w ramach ustalania harmonogramów kontroli na 2015 r. do kontroli identyfikacji i rejestracji zwierzt prowadzonych przez organy IW bd wybierane w szczególnoci gospodarstwa, które nie zglaszaj do ARiMR przemieszcze wi; - IW przeslala w kwietniu br. do ARiMR listy gospodarstw sporzdzone podczas perlustracji gospodarstw (prowadzonej w zwizku wystpieniem ASF w województwie Podlaskim) w obszarze objtym ograniczeniami na terenie powiatów sejneskiego, augustowskiego, bialostockiego i sokólskiego; - IW wspólnie z ARiMR prowadzi prace dotyczce stworzenia funkcjonalnoci zwizanej z oznaczaniem w centralnej bazie danych stad, w których obowizuj zakazy odnoszce si do przemieszcze zwierzt po stwierdzeniu ognisk choroby zakanej zwierzt; - Centralna Baza Danych Systemu Identyfikacji i Rejestracji Zwierzt jest wykorzystywana jako podstawowe ródlo danych o liczbie zwierzt i siedzib stad zwierzt; dane te s dodatkowo weryfikowane informacjami

VI bodies cooperate with ARMA, inter alia, in the following scope: -DVOs receive from ARMA offices information on all cases of dead pigs or cases of rendered pig corpses, when the number of reported animals will constitute at least 10% of the number of animals in the herd seat; -under determination of schedules of controls for 2015, for the controls of registration and identification of animals carried out by VI bodies, in particular holdings that do not report movements of pigs to ARMA will be selected; - In April this year VI sent ARMA lists of holdings prepared during inspection of holdings, carried out in connection of ASFin Podlaskie Voivodeship, in the area covered by restrictions, in the area of Sejny, Augustów Bialystok and Sokólka Poviats; -VI, together with ARMA works on creating the functionality in the central database related to labelling herds, where bans are applicable relating to the movements of animals after identification of outbreaks of the contagious disease; -Central Database of the Animal Identification and Registration System is used as a basic source of data on the number of animals and animals herd seats; the data is additionally verified by the use of inf

Medlemsstatens svar

ed W zakresie badania odstrzelonych dzików zapewniono (na polecenie GLW, realizacja olecenia potwierdzona przez WLW), i tusze wszystkich dzików odstrzelonych na obszarze Page: 2 o the recommendations of Report ref. DG(SANCO)/2014-7294-MR of an audit carried out from 09 June ementation of animal health controls in relation to African swine fever. objtym ograniczeniami podlegaj ogldzinom przez urzdowego lekarza weterynarii. Dodatkowo, w zakresie wykonywania bada laboratoryjnych, zgodnie z informacj z PIWet Pulawy): All samples taken from hunted wild boars are sent to National Reference Laboratory and they are tested using Real Time PCR. All samples appropriate for ELISA are tested using this test and in case of positive/questionable results by confirmatory test.

In the scope of testing wild boars shot it was provided (at the request of CVO, execution of the mmendation confirmed by RVO) that all carcasses of wild boars shot in the area covered restrictions are subject to the official veterinarian's visual inspection. Additionally, with regard to laboratory tests, in accordance with the information from Pulawy NVI-NRL): All samples taken from hunted wild boars are sent to National Reference Laboratory and they are tested using Real Time PCR. All samples appropriate for ELISA are tested using this test and in the case of positive/questionable results by confirmatory test. Page: 2 he recommendations of Report ref. DG(SANCO)/2014-7294 -MR of a/an audit carried out from 09 June ntation of animal health controls in relation to African swine fever.

Medlemsstatens svar

W Polsce przyjto - m.in. z uwagi na znaczne odchylenia zagszczenia dzików w obszarach h objtym ograniczeniami i ochronnym w stosunku do parametrów podanych w cytowanym punkcie decyzji Komisji 2003/422/WE - nastpujc strategi pobierania próbek od dzików do da w kierunku ASF: s wskazano obszar, na którym, pobierane s próbki do bada w kierunku ASF od dzików: próbki te pobierane s w OOg i OOch, zgodnie z programem monitoringu ASF na rok 2014; okrelono liczb próbek do bada w kierunku ASF, które naley pobra od dzików: w OOg i OOch badane s próbki pobrane od wszystkich dzików odstrzelonych (jak równie od znalezionych martwych), przy czym liczba dzików, które powinny zosta odstrzelone okrelona jest w planie lowieckim na sezon 2014/2015; liczba dzików, które maj zosta odstrzelone godnie z planem lowieckim - a tym samym poddane badaniu w kierunku ASF - spelnia kryteria okrelone w decyzji Komisji 2003/422/WE, poniewa liczba ta jest zdecydowanie wiksza ni minimalna liczba próbek do pobrania zgodnie z w/w decyzj.

In Poland the following strategy was adopted - among others, due to substantial deviations of ild boars' density in the area covered by restrictions (OOg) and the protection area (OOch) as compared to parameters specified in the quoted item of the Commission Decision 2003/422/EC wild boars sampling for tests for ASF: the area was indicated where samples are taken for tests for ASF in wild boars: These samples are taken in OOg and OOch in accordance with the monitoring program of ASF for 2014; the amount of samples for tests for ASF, which should be taken from wild boars, was established: in OOg and OOch samples taken from all wild boars shot (as well as from the ones found dead) are tested and the number of wild boars which should be shot, is specified in the hunting plan for 2014/2015; the number of wild boars which are to be shot in accordance with the Hunting Plan - and therefore subjected to tests for ASF - meets the criteria specified in Commission Decision 2003/422/EC because this number is definitely greater than the minimum number of samples according to the above mentioned Decision.

Medlemsstatens svar

Wprowadzono obowizek (w Planie zwalczania ASF) poddawania wszystkich wi te- poddawanych ubojowi na uytek wlasny w OOg badaniu przed- i poubojowemu. Ponadto, w uzasadnionych przypadkach (podejrzane objawy kliniczne, zmiany sekcyjne) od wi poddawanych ubojowi na uytek wlasny pobierane s próbki do bada laboratoryjnych. Strategia, która bdzie wdraana w 2015 r. zaklada, e analogicznym badaniom poddawane bd nie tylko winie w obszarze objtym ograniczeniami, ale równie ochronnym. Rejestr wi zgloszonych do uboju na uytek wlasny prowadzony jest we wszystkich powiatach w obszarze objtym ograniczeniami. Page: 3 o the recommendations of Report ref. DG(SANCO)/2014-7294-MR of an audit carried out from 09 June ementation of animal health controls in relation to African swine fever. Badania poubojowe misa - w przypadku uboju wi na uytek wlasny w obszarze objtym ograniczeniami - dokonywane s na jednolitych formularzach przeslanych o terenowych organów IW w na przelomie czerwca i lipca 2014 r.

obligation was introduced (in the plan of the control of ASF), to submit all pigs subjected to slaughter for own purpose in OOg to ante- and post-mortem inspection. Moreover, in tified cases (suspicious clinical symptoms, post-mortem changes) samples for laboratory ests are taken from pigs subjected to slaughter for own purpose. The strategy which will be implemented in 2015 assumes that the same inspection will be conducted on pigs in the area covered by restrictions as well as in the protection area. Register of pigs submitted to slaughter for own purpose is kept in all districts, within the area covered by restrictions. Post-mortem inspection of meat - in the case of slaughter of pigs for own purpose, within the area covered by restrictions - is made using uniform forms which were sent to field VI bodies at the turn of June and July 2014.

Medlemsstatens svar

le Odpowiednie procedury dotyczce bada klinicznych wi i pobierania próbek w kierunku ASF opisane s w Planie zwalczania ASF. Dodatkowo, przypomniano o obowizku przestrzegania w/w procedur. h

ppropriate procedures concerning clinical tests on pigs and sampling for tests for ASF are ribed in the ASF Control Plan. Additionally, it was reminded about the obligation to comply with the above mentioned procedures. Page: 3 he recommendations of Report ref. DG(SANCO)/2014-7294 -MR of a/an audit carried out from 09 June ntation of animal health controls in relation to African swine fever.

Medlemsstatens svar

ests Odp. PIWet Pulawy: ELISA method is accredited within the scope of ISO 17025 in National Reference Laboratory, in Swine Diseases Department and in Laboratory for Serological Diagnosis. PCR method is accredited within the scope of ISO 17025 in National Reference Laboratory, in Swine Diseases Department. Confirmatory serological test IPT will be accredited by the end of June 2015.

s Reply of Pulawy NVI-NRL: ELISA method is accredited within the scope of ISO 17025 in National Reference Laboratory, in Swine Diseases Department and in Laboratory for Serological Diagnosis. PCR method is accredited within the scope of ISO 17025 in National Reference Laboratory, in Swine Diseases Department. Confirmatory serological test IPT will be accredited by the end of June 2015.

Medlemsstatens svar

Glówny Lekarz Weterynarii przekae wojewódzkim lekarzom weterynarii zalecenia zarówno dla podmiotów gospodarczych [zgodnie z art. 3 rozporzdzenia (WE) nr 853/2004], jak n równie urzdowych lekarzy weterynarii [zgodnie z art. 5 pkt 1 rozporzdzenia (WE) nr the 854/2004], przypominajce o obowizku przestrzegania przepisów odnoszcych si do C) informacji dotyczcych lacucha ywnociowego. f Zgodnie z art. 3 rozporzdzenia (WE) nr 853/2004 podmioty prowadzce rzenie musz przestrzega odpowiednich wymogów okrelonych w zalcznikach II i III do tego rozporzdzenia, czyli ubiega si o udzielenie informacji dotyczcych lacucha ywnociowego dla wszystkich zwierzt poza zwierztami lownymi, wysylanych lub przeznaczonych do wysylki do rzeni, uzyska je, podda kontroli oraz reagowa na te informacje. Page: 4 o the recommendations of Report ref. DG(SANCO)/2014-7294-MR of an audit carried out from 09 June ementation of animal health controls in relation to African swine fever. Natomiast, zgodnie z art. 5 pkt. 1 rozporzdzenia (WE) nr 854/2004, urzdowy lekarz weterynarii wykonuje zadania w zakresie inspekcji w rzeniach, zgodnie z wymogami ogólnymi zalcznika I sekcja I rozdzial II oraz z wymogami szczególnymi sekcji IV

The Chief Veterinary Officer will provide the Regional Veterinary Officers with the recommendations both for business operators [according to Article 3 of Regulation (EC) no. 853/2004] as well as for official veterinarians [according to Article 5 item 1 of Regulation (EC) no. 854/2004], reminding about the obligation to comply with regulations relating to information on food chain. According to Article 3 of Regulation (EC) no. 853/2004 slaughterhouse operators must comply with the relevant requirements set out in appendices II and III of this regulation, i.e. apply for information on food chain for all animals except of game animals sent or intended for dispatch to the slaughterhouse, obtain it, check it and respond to this information. In accordance with Article 5 item 1 of Regulation (EC) no. 854/2004, official veterinarian, performs tasks in the scope of inspection at slaughterhouses, in accordance with the general requirements of Annex I, Section I, Chapter II and with specific requirements of Section IV of this Regulation, in particular with regard to food chain information. In addition, District Veterinary Officers will be obliged to obligate slaughterhouse operators to compl

Medlemsstatens svar

rodek ochrony rolin zawierajcy substancj czynn epoksykonazol zostal poddany ocenie zgodnie z jednolitymi zasadami okrelonymi w dyrektywie Rady 91/414/EWG, w terminie wynikajcym w dyrektywy Komisji 2008/107/WE. Przeprowadzona ocena nie wykazala koniecznoci zmiany warunków udzielonego zezwolenia, dlatego nie podjto dalszych dziala w tej sprawie. MRiRW zapewni, e po dokonaniu procesu ponownej oceny dla wszystkich rodków ochrony rolin bd wydawane decyzje administracyjne potwierdzajce formalne zakoczenie procedury.

jcy substancj czynn epoksykonazol zostal jednolitymi zasadami okrelonymi G, w terminie wynikajcym w dyrektywy zon ponown ocen ezwolenie dla rodka ochrony onazol. wnej oceny dla wszystkich olenia lub decyzje oczenie postpowania.

Medlemsstatens svar

on Przedloone wnioski o wzajemne uznawanie zezwole dotycz rodków 42 of dopuszczonych do obrotu w oparciu o przepisy dyrektywy Rady 91/414/EWG i w wikszoci przypadków raporty wraz z ocen nie uwzgldniaj specyficznych warunków dla Polski. MRiRW dokona w biecym roku reorganizacji systemu rejestracji rodków ochrony rolin celem zapewnienia dotrzymywania terminów zalatwiania spraw, okrelonych w rozporzdzeniu nr 1107/2009 (WE).

jemne uznawanie zezwole dotycz rodków u w oparciu o przepisy dyrektywy Rady wraz z ocen nie ki. Wnioski wymagaj zalatwiania spraw, /2009 (WE), MRiRW patrujcym wnioski koca 2013 r. dokona artamentu poprzez utworzenie dto w 2014 r. planuje si mórce organizacyjnej o 2 osoby, na terminowe rozpatrywanie Page: 1 NCO)/2013-6640-MR of an audit carried out Action Proposed by the Competent Authority

Medlemsstatens svar

MRiRW dokona w biecym roku reorganizacji systemu rejestracji rodków ochrony rolin celem zapewnienia dotrzymywania terminów zalatwiania spraw, okrelonych w rozporzdzeniu nr 1107/2009 (WE).

nia terminów zalatwiania spraw, zdzenia nr 1107/2009 (WE) MRiRW departamencie rozpatrujcym wnioski noczenie MRiRW do koca 2013 r. dokona wewntrznej w/w departamentu poprzez utworzenie cego wnioski. Ponadto w 2014 r. planuje si rudnienia w tej komórce organizacyjnej o 2 osoby, esuni. anizacyjne pozwol na terminowe rozpatrywanie

Medlemsstatens svar

ply MRiRW zapewni, e od 2014 r. wszystkie laboratoria wykonujce badania na pozostaloci rodków ochrony rolin w ramach nadzoru nad stosowaniem tych preparatów bd spelnialy wymogi art. 12 rozporzdzenia nr 882/2004 (WE). Page: 1 s of Report ref. DG(SANCO)/2013-6640-MR of an audit carried out es Action Proposed by the Competent Authority

r. wszystkie laboratoria wykonujce badania na ny rolin w ramach nadzoru nad stosowaniem ialy wymogi art. 12 rozporzdzenia nr 882/2004

Medlemsstatens svar

W celu zapewnienia, e planowanie kontroli stosowania rodków ochrony rolin obejmie wszystkich profesjonalnych uytkowników GIORiN, w oparciu o przygotowywany model statystyczny opracuje wytyczne, które zostan wdroone w 2014 roku. Page: 2

wanie kontroli stosowania rodków ochrony profesjonalnych uytkowników GIORiN, w model statystyczny opracuje wytyczne, które ku. Page: 2

Medlemsstatens svar

ments of Article 6 of Regulation (EC) No W dniach 7-10 kwietnia br. odbylo si szkolenie dla Kierowników on (EU) No 210/2013, the registration Dzialów Nadzoru Higieny ywnoci i ywienia w Wojewódzkich n-animal origin and the approval of Stacjach Sanitarno-Epidemiologicznych, na którym zwrócono uwag na przedmiotowe zalecenie oraz polecono kontynuacj rejestracji producentów ywnoci pochodzenia rolinnego oraz t. 6 rozp. 852/2004 i art. 2 rozp. zatwierdzania zakladów produkujcych kielki zgodnie z rodukcji podstawowej ywnoci wymaganiami rozporzdzenia 210/2013. dzanie zakladów produkujcych Glównym ródlem slucym do identyfikacji producentów produkcji podstawowej ywnoci pochodzenia rolinnego, s informacje uzyskane przez PIS podczas urzdowych kontroli u przetwórców ywnoci, dystrybutorów i sprzedawców detalicznych. Organy PIS podejmuj wspólprac z organami PIORIN, wójtami, proboszczami parafii wiejskich z urzdami gmin w celu uzyskania informacji dot. podmiotów prowadzcych produkcj pierwotn ywnoci pochodzenia rolinnego oraz informowania rolników o obowizku zloenia wniosku o wpis do rejestru zakladów podlegajcych urzdowej kontroli organów PIS. Ponadto na stronach internetowych PSSE zostaly zamieszc

6 On 7-10 April 2014, a training session was . held for the Heads of the Food Hygiene and Zgodnie z danymi zebranymi ze wszystkich Nutrition Departments in the VSESs at which WSSE aktualnie zarejestrowanych jest this recommendation was addressed and 29735 producentów produkcji pierwotnej ­ attendees were instructed to continue with the jak wida ilo zarejestrowanych operatorów registration of producers of food of non- zdecydowanie wzrosla (w 2013 r. przed animal origin and the approval of sprout- przedmiotow misj liczba zarejestrowanych producing establishments in accordance with producentów produkcji pierwotnej wynosila Regulation 210/2013. 5473). Ponadto w Polsce funkcjonuje 9 zakladów produkujcych kielki, wszystkie The main source used to identify primary s zatwierdzone zgodnie z rozporzdzeniem producers of food of non-animal origin is the Komisji (UE) nr 210/2013. GIS na swojej information obtained by the SSI during stronie internetowej official controls of food processors, http://gis.gov.pl/?go=news&id=166 distributors and retailers. The SSI bodies zamiecil informacj dla plantatorów i cooperate with the SPHSIS, heads of punktów skupu owoców i warzyw. Zawiera ona jasne wytyczne

Medlemsstatens svar

at primary production of food of non- W Glównym Inspektoracie Sanitarnym trwaj prace nad nowymi wing stage, are taken into account in zarzdzeniami Glównego Inspektora Sanitarnego w sprawie ing of official controls in line with procedur urzdowych kontroli ywnoci stosowanych przez organy 882/2004. PIS. W ramach procedury zostal stworzony arkusz oceny w oparciu o ocen zagroenia. Jako narzdzie do oceny danego ajce podczas produkcji obiektu zostala opracowana lista pyta kontrolnych dla nnego, w tym równie etap podmiotów prowadzcych produkcj pierwotn produktów g podczas opracowywania pochodzenia rolinnego. Wynikiem oceny bdzie przyznanie z art. 3(1) rozp. 882/2004 odpowiedniej liczby punktów odzwierciedlajcej stopie spelniania obowizujcych wymaga. Na podstawie ogólnej liczby punktów bdzie okrelane ryzyko dla danego obiektu (wysokie, rednie, niskie) i na tej podstawie wyznaczana czstotliwo Page: 2 port recommendations, received 28 April 2014 of Poland to the recommendations of Report ref. DG(SANCO)/2013-6665 -MR of a/an audit carried out from 12 rder to evaluate the official controls in primary production of food of non-animal origin. kontroli dla kadego obiektu. Termin realizacji: Proced

In the Central Sanitary Inspectorate, work is ongoing on new Orders of the Chief Sanitary Jednym z przykladów na wzmocnienie Inspector concerning the procedures for official controls of food by bodies of the SSI. nadzoru nad tymi produktami jest pismo z Under those procedures, a new assessment sheet has been created which is based on a dnia 17 kwietnia 2014 znak: GIS-B-RA- risk assessment. As a tool for assessing a 426-110/MK/14 skierowane do Pastwowych Wojewódzkich Inspektorów Sanitarnych w sprawie kontroli produkcji pierwotnej owoców mikkich. Pismo to given property, a checklist has been zawiera szczególowe wytyczne do developed for primary producers of products prowadzenia skutecznego nadzoru nad of non-animal origin. As a result of the wytwarzaniem bezpiecznych produktów assessment, an appropriate number of points produkcji pierwotnej w Polsce przez organy (reflecting the degree of compliance with the Pastwowej Inspekcji Sanitarnej, przede wszystkim: ity 29 August 2014 petent Authorities of Poland on 30 April 2014 in response to Report ref. DG(SANCO)/2013-6665 - 22 November 2013 in order to evaluate the official controls in primary production of food of non- e awarded. wzmoenie

Medlemsstatens svar

edures (Article 8(1) of Regulation (EC) W Glównym Inspektoracie Sanitarnym trwaj prace nad nowymi ols on primary production of food of non- zarzdzeniami Glównego Inspektora Sanitarnego w sprawie t information and guidance to inspectors procedur urzdowych kontroli ywnoci stosowanych przez organy of Regulation (EC) No 852/2004, PIS. W ramach procedury zostal stworzony arkusz oceny dla Regulation (EC) No 2073/2005. poszczególnych grup obiektów w oparciu o ocen zagroenia. Jako narzdzie do oceny danego obiektu zostala opracowana lista dury urzdowych kontroli (art. 8 pyta kontrolnych (tzw. check list) dla podmiotów prowadzcych i podstawowej ywnoci pochodzenia produkcj pierwotn produktów pochodzenia rolinnego (pod informacji i wskazówek ktem przestrzegania przepisów rozporzdzenia nr 2073/2005, a rozp. 852/2005, rozp. 210/2013, rozp. 852/2005, rozp. 2010/2013). Wynikiem oceny bdzie przyznanie odpowiedniej liczby punktów odzwierciedlajcej stopie spelniania obowizujcych wymaga. Na podstawie ogólnej liczby punktów bdzie okrelane ryzyko dla danego obiektu (wysokie, rednie, niskie) i na tej podstawie wyznaczana czstotliwo kontroli dla tego obiektu. W dniach 7-10 kwietnia br. odbylo si szkolenie

he Central Sanitary Inspectorate, work is ngoing on new Orders of the Chief Sanitary nspector concerning the procedures for fficial controls of food by bodies of the SSI. nder those procedures, a new assessment heet, which is based on a risk assessment, as been created for certain groups of roperties. As a tool for assessing a given roperty, a checklist has been developed for rimary producers of products of non-animal rigin (concerning compliance with egulations No No 2073/2005, 852/2005 and 010/2013). s a result of the assessment, an appropriate umber of points (reflecting the degree of ompliance with the applicable requirements) ill be awarded. Based on the total number of oints, the risk will be indicated for the roperty in question (high, medium, low) and, ased on that, the frequency of controls will e determined for the property in question. n 7-10 April 2014, a training session was eld for the Heads of the Food Hygiene and utrition Departments in the VSESs at which ity 29 August 2014 petent Authorities of Poland on 30 April 2014 in response to Report ref. DG(SANCO)/2013-6665 - 22 November 2013 in order to evaluate the official controls in primary production of food of non- a

Medlemsstatens svar

ls are provided in the written Do czasu zakoczenia audytu FVO, tj. 22 listopada 2013 r. do or microbiological food analysis in RASFF zgloszono od 2010 r. jedno powiadomienie (nr 2013.0806) oach is followed by all the inspectors dotyczce wykrycia norowirusa (GII) w mroonych malinach ation of the analytical results. pochodzcych z Polski oraz 8 powiadomie dotyczcych wykrycia wirusa wirusowego zapalenia wtroby typu A (WZW typu A) w planu pobierania próbek mieszankach mroonych owoców, do produkcji których zególy odnonie wykorzystano surowce m.in. z Polski, ale równie z innych krajów. celu zapewnienia jednolitego Pastwowa Inspekcja Sanitarna prowadzila intensywne dzialania zdowe kontrole ywnoci we wyjaniajce w kadej z przedmiotowych spraw. Wyniki ów analiz. postpowa wyjaniajcych byly na bieco udostpniane poprzez powiadomienia uzupelniajce w RASFF przekazywane do Komisji Europejskiej przez Krajowy Punkt Kontaktowy RASFF w GIS. W zwizku z podejrzeniem wladz Wloch i Irlandii, e jednym z moliwych ródel zakaenia WZW typu A byly owoce z Polski, przedstawiciele Polski przedstawili prezentacj na spotkaniu Stalego Komitetu ds. Lacucha ywnociowego i Zdrowia Zwierzt ­ Sekcja: Bezpieczestwo Biologic

Up to the date on which the FVO audit was . r completed, i.e. 22 November 2013, one RASFF notification (No 2013.0806) concerning the detection of a norovirus (GII) in frozen raspberries from Poland had been submitted since 2010 and 8 notifications concerning the detection of the hepatitis A virus in mixed frozen berries produced from ingredients some of which came from Poland but also from others which came from other countries. The SSI worked intensively to clarify each of the above-mentioned cases. The results of those investigations have been made available on an ongoing basis by means of follow-up ity 29 August 2014 petent Authorities of Poland on 30 April 2014 in response to Report ref. DG(SANCO)/2013-6665 - 22 November 2013 in order to evaluate the official controls in primary production of food of non- notifications in RASFF, sent to the European Commission by the National RASFF Contact Point in the Central Sanitary Inspectorate. As regards the Italian and Irish authorities' suspicion that one of the possible sources of hepatitis A infection was fruit from Poland, the Polish representatives gave a presentation on the investigations conducted by Poland in connection with the

Medlemsstatens svar

d out at any of the stages of production Regulation (EC) No 882/2004 and Patrz odpowied na zalecenia 2 i 3 (prace nad nowelizacj 178/2002. zarzdze Glównego Inspektora Sanitarnego w sprawie procedur urzdowych kontroli ywnoci stosowanych przez organy PIS). zeprowadzane na kadym etapie iami art. 3 rozp. 882/2004 i art. Majc na uwadze definicj rodka spoywczego (ywnoci) okrelon w art. 2 rozporzdzenia (WE) nr 178/2002 PE i Rady z dnia 28 stycznia 2002 r. ustanawiajcego ogólne zasady i wymagania prawa ywnociowego, powolujcego Europejski Urzd ds. Bezpieczestwa ywnoci oraz ustanawiajcego procedury w zakresie bezpieczestwa ywnoci (Dz. U. UE L 31 z 1. 02.2002 z pón. zm.), zgodnie z któr rodek spoywczy nie obejmuje m.in.: pasz, zwierzt ywych (chyba e maj by one wprowadzone na rynek do spoycia przez ludzi) oraz rolin przed dokonaniem zbiorów, Pastwowa Inspekcja Sanitarna, sprawujca nadzór nad bezpieczestwem ywnoci pochodzenia rolinnego rozpoczyna swoje kompetencje po zbiorach. W zwizku z czym, czciowo sprawuje nadzór nad produkcj podstawow, tj. kontroluje magazyny, transport, obróbk wstpn, jak równie dokonuje rejestracji gospodarstw dzialajcych na rynku spoywczym i prowadzcych produkcj podstawo

See the response to recommendations 2 and 3 ork is ongoing on new Orders of the Chief Jak wspomniano powyej, w zalczeniu GIS nitary Inspector concerning the procedures przekazuje tabel (zalcznik 1) dotyczc r official controls of food by bodies of the I). liczby i rodzaju sankcji naloonych na przedsibiorców produkcji pierwotnej przez organy PIS, z której wynika, i prowadzony view of the definition of "food" (foodstuff) jest nadzór w tym zakresie. Sankcje te Article 2 of Regulation (EC) No 178/2002 dotyczyly przykladowo niewlaciwego stanu the European Parliament and of the sanitarno-higienicznego, identyfikowalnoci (traceability), braku toalet, niewlaciwiego uncil of 28 January 2002 laying down the przechowywania rodków ochrony rolin. neral principles and requirements of food Wspomniane powyej pismo (zalcznik 2), w, establishing the European Food Safety zawiera szczególowe wskazówki dot. thority and laying down procedures in kontroli wymaga higienicznych dla tters of food safety (OJ L 31, 1.2.2002, as produkcji pierwotnej. ended), which states that "food" does not W trakcie audytu DG(SANCO)/2014/7013 clude feed, live animals (unless they are to Biuro ds. ywnoci i Weterynarii zostalo

Medlemsstatens svar

t sprout producing establishments cover, W dniach 7-10 kwietnia br. odbylo si szkolenie dla Kierowników pling and preliminary testing of seed batches Dzialów Nadzoru Higieny ywnoci i ywienia w Wojewódzkich hapter 3.3 of Annex I to Regulation (EC) Stacjach Sanitarno-Epidemiologicznych, na którym zwrócono uwag na przedmiotowe zalecenie oraz omówiono (wynikajce z ladów produkujcych kielki zalcznika 1 rozp. 2073/2005 (rozdzial 3.3)) obowizki óbkobrania i wstpnych bada partii przedsibiorców prowadzcych zaklady produkujce kielki, oraz znika 1 rozp. 2073/2005 (rozdzial 3.3) polecono weryfikacj tych obowizków podczas urzdowej kontroli w ww. zakladach. W Glównym Inspektoracie Sanitarnym trwaj prace nad nowymi zarzdzeniami Glównego Inspektora Sanitarnego w sprawie procedur urzdowych kontroli ywnoci stosowanych przez organy PIS. Jako narzdzie do kontroli obiektów zostanie opracowana lista pyta kontrolnych (tzw. check list) dla podmiotów prowadzcych produkcj pierwotn produktów pochodzenia rolinnego w celu zapewnienia prawidlowego kontrolowania przez organy PIS pod ktem przestrzegania przepisów rozporzdzenia nr 2073/2005. Check listy zostan opracowane do koca 2014 r.

n 7-10 April 2014, a training session was held for the Heads of the Food Hygiene and Nutrition Departments in the VSESs at which this recommendation was addressed and the obligations (arising from Annex I to Reg. 2073/2005 (Chapter 3.3)) of sprout-producing establishments was discussed, and orders ity 29 August 2014 petent Authorities of Poland on 30 April 2014 in response to Report ref. DG(SANCO)/2013-6665 - 22 November 2013 in order to evaluate the official controls in primary production of food of non- were given to verify those obligations during official controls at those establishments. In the Central Sanitary Inspectorate, work is ongoing on new Orders of the Chief Sanitary Inspector concerning the procedures for official controls of food by bodies of the SSI. As a tool for inspecting properties, a checklist will be developed for primary producers of products of non-animal origin to ensure that checks are conducted correctly by the SSI bodies as regards compliance with Regulation No 2073/2005. The checklists will be drawn up by the end of 2014.

Medlemsstatens svar

s for VTEC detection are carried out in Do analizy ywnoci pod ktem wykrywania VTEC w Polsce y carry out these analyses as laid down in wyznaczone s 2 laboratoria Pastwowej Inspekcji Sanitarnej: ) No 882/2004. laboratorium w Wojewódzkiej Stacji Sanitarno ­ i w kierunku VTEC, byly Epidemiologicznej w Bydgoszczy oraz w Olsztynie. Laboratoria te aboratoriach, które bd w stanie od 2012 r. prowadz analizy ywnoci w kierunku VTEC w (art. 12 ust. 1 rozp. 882/2004). ramach realizacji zada zwizanych z planem urzdowej kontroli ywnoci, na terenie calego kraju. Page: 10 port recommendations, received 28 April 2014 of Poland to the recommendations of Report ref. DG(SANCO)/2013-6665 -MR of a/an audit carried out from 12 rder to evaluate the official controls in primary production of food of non-animal origin.

In Poland, two SSI laboratories have been s designated to conduct food sample analyses for VTEC detection: the VSES laboratory in Bydgoszcz and the VSES laboratory in Olsztyn. Since 2012, these laboratories have been testing food samples for VTEC - this is one of their tasks under the nationwide official food control plan. ity 29 August 2014 petent Authorities of Poland on 30 April 2014 in response to Report ref. DG(SANCO)/2013-6665 - 22 November 2013 in order to evaluate the official controls in primary production of food of non-

Medlemsstatens svar

taff carrying out official controls have suitable Majc na wzgldzie zapewnienie pracownikom odpowiednich quired by Article 4(2)(c) of Regulation (EC) No kwalifikacji oraz dowiadczenia, Glówny Lekarz Weterynarii przynajmniej 1 raz na 3 miesice organizuje 2-dniowe szkolenie dla Wojewódzkich Inspektorów ds. pasz. Celem tych szkole jest przegld przepisów prawa paszowego, ujednolicenie zasad jego stosowania, kontroli przedsibiorstw sektora paszowego, interpretacji wyników urzdowych kontroli. Wojewódzcy Lekarze Weterynarii i Wojewódzcy Inspektorzy ds. pasz zapewniaj, e przynajmniej 1 raz na 3 miesice odbywa si szkolenie dla Powiatowych Inspektorów ds. pasz. Tematy szkole obejmuj w szczególnoci zagadnienia wskazane w zalczniku nr II Rozporzdzenia (WE) nr 882/2004. W dniach 21-22 listopada 2013 roku odbyla si w Glównym Inspektoracie Weterynarii narada i szkolenie dla Wojewódzkich Inspektorów ds. pasz. Celem spotkania bylo omówienie wyników misji FVO oraz natychmiastowe wdroenie procedur naprawczych zgodnie z rekomendacjami zawartymi w raporcie pokontrolnym FVO. GIWpuf-71-155(1)_1 3.pdf W dniach 17-18 marca 2014 roku odbylo si kolejne spotkanie z Wojewódzkimi Inspektorami ds. pasz. Poniej in

Medlemsstatens svar

ocedures to carry out official controls contain all Glówny Inspektorat Weterynarii zweryfikuje istniejce listy tion and instructions, as required by Article 8(1) of kontrolne SPIWET. Przygotuje take nowe wzory list kontrolnych o 882/2004, in particular for official controls on feed do wykorzystania w trakcie kontroli np. podmiotów sektora ng approval in accordance with the last amendment of spoywczego przeznaczajcych cz swojej produkcji na cele o 183/2005. paszowe, podmiotów produkujcych produkty techniczne przeznaczajcych cz swojej produkcji na cele paszowe, podmiotów zajmujcych si suszeniem materialów paszowych czy podmiotów wymagajcych zatwierdzenia zgodnie z Rozporzdzeniem (WE) Nr 225/2012. Zalecenie to zostanie zrealizowane do koca sierpnia 2014 roku.

Medlemsstatens svar

ports on official controls include details on the control Glówny Inspektorat Weterynarii zmodyfikuje istniejce wzory list notably on the type of information used to conclude kontrolnych SPIWET. Zagadnienia uwzgldnione w listach ment is complied with or not, as laid down by Article kontrolnych SPIWET bd wymagaly szczególowego opisu ze n (EC) No 882/2004. strony kontrolujcego. Sprawozdania z kontroli bd zawieraly informacje na temat sposobu przeprowadzania kontroli urzdowej, na podstawie których bdzie mona si dowiedzie si, jakie konkretnie elementy skontrolowano w celu stwierdzenia, e dany wymóg prawny jest spelniony. Zalecenie to zostanie zrealizowane do koca sierpnia 2014 roku.

Medlemsstatens svar

e measures put in place by feed operators to control Glówny Inspektorat Weterynarii przygotowal instrukcj dotyczc on (carry-over of coccidiostats during production) are wykrywania/oznaczenia zawartoci kokcydiostatyków w paszach Page: 2 from Competent Authority on 25 March 2014 - documents in the Action Plan are published as a separate annex and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3253 the Competent Authorities of Poland to the recommendations of Report ref. DG(SANCO)/2013-6751 -MR of a/an audit carried out from 15 to 25 October 2013 in order to evaluate measures in place for the identification of hazards and management of risks along the feed chain ls, fats and products derived thereof. in line with the requirements laid down in Annex II to Regulation (EC) docelowych i niedocelowych. No 183/2005. GIWpuf-7010-12_20 14(1).pdf Dodatkowo Glówny Inspektorat Weterynarii przygotowal now list kontroln ­ protokól uzupelniajcy, który bdzie obowizkowo wypelniany przez inspektorów w trakcie kontroli przedsibiorstw stosujcych do produkcji pasz kokcydiostatyki. protokól uzupelniajcy.pdf O wynikach kadego prowadzonego dochodzenia wyjaniajcego po stwierdzeniu ni

Medlemsstatens svar

ed business operators, make further progress concerning Glówny Inspektorat Weterynarii skierowal pismo do plementation of the HACCP-based procedures so that Wojewódzkich Lekarzy Weterynarii, w którym polecil, aby w s are adequately controlled, as required by Articles 6 and roku 2014 kontrole w podmiotach sektora paszowego byly EC) No 183/2005. prowadzone ze szczególnym uwzgldnieniem sposobu opracowania i funkcjonowania systemu HACCP. W szczególnoci, czy w ,,diagramach przeplywu" w tych przedsibiorstwach s uwzgldniane wszystkie etapy produkcji i dystrybucji pasz oraz jakie kryteria s brane pod uwag przy ustalaniu Krytycznych Punktów Kontroli (CCP). GIWpuf-7010-20_20 14(1).pdf Page: 4

Medlemsstatens svar

Glówny Lekarz Weterynarii przygotuje instrukcje dla terenowych jednostek pekcji Weterynaryjnej w zakresie analizy potencjalnego zagroenia dla zdrowia wprowadzenia do obrotu niezatwierdzonych modyfikacji, zgodnie z rzepisami art. 3 ust. 1 lit. a Rozporzdzenia (WE) nr 882/2004. Zadanie zostanie zrealizowane do koca sierpnia 2013 roku. Badania pasz zostan rozbudowane o metody rozszerzonego screeningu, która pozwoli na wczesne wykrycie w badanych próbkach modyfikacji nieautoryzowanych. W planie pobierania próbek do badania ywnoci w ramach urzdowej kontroli i monitoringu na 2014 r. zostan uwzgldnione kwestie zwizane z ryzykiem wystpowania nieautoryzowanego GMO oraz potencjalnego zagroenia dla zdrowia z powodu niezatwierdzonych modyfikacji. Na podstawie notyfikacji systemu RASFF zostanie uwzgldnione pobranie dodatkowych próbek ywnoci pochodzcej z krajów trzecich , mogcej zawiera nieautoryzowane w UE GMO (np. papaja, sezam, ry basmati).

adventitious or przez wykryt lini. le traces of authorized GMOs W trakcie przygotowywania minimum threshold may be s odpowiednie zmiany do procedury ch these products shall not have to badawczej, tak by zapewni to the provision in paragraph 1. shall be established according to the wykrycie wszelkich moliwych ose measures, designed to amend kombinacji GMO. Kolejne badania s of this Directive by screeningowe wiosn 2014 r. bd ll be adopted in accordance with prowadzone w calkowitej zgodnoci ure with scrutiny referred to in z rekomendacj i wymaganiami artykulu 4.1 dyrektywy 2001/18/EC.

Medlemsstatens svar

Pismem z dnia 9 maja 2013 r. znak: GIS-B-UE-420-26-PS-13/1 Glówny ia Inspektor Sanitarny zlecil wszystkim Pastwowym Wojewódzkim Inspektorom Sanitarnym oraz Pastwowym Granicznym Inspektorom Sanitarnym by podczas urzdowych kontroli ywnoci, pobieranie próbek pod ktem obecnoci GMO, przeprowadzone bylo zgodnie z istniejcymi wymaganiami prawa UE, w szczególnoci z zaleceniem nr 2004/787/WE (zalcznik 1) 1 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment

ded for direct processing, paragraph Naley podkreli, e traces of authorised GMOs in a stosowane wczeniej podejcie, than 0.9 % or lower thresholds, zaobserwowane podczas trwania races are adventitious or technically audytu, chocia moglo nie dawa shold levels referred to in the first pelnej wiedzy o stosowanych e established. Those measures, nonessential elements of this modyfikacjach, to w adnym nting it, shall be adopted in przypadku nie stwarzalo egulatory procedure with scrutiny niebezpieczestwa przeoczenia i dopuszczenia do obrotu e 30(3). e 21(2) and (3), in chapter 5.2.4 niedozwolonych modyfikacji, gdy seed and propagating material' of wykrycie obecnoci ju jednej linii he audit the control team correctly powodowalo naloenie sankcji na uch thresholds may only be set by material siewny. ction.' e appealed to the wice to set the minimum ntent in seed at the EU level in terpret this issue throughout the form market requirements in ers. In 2006, and subsequently in the Council which clearly stressed ast one threshold value for the eceived from the Competent Authority, 2 August 2013 adventitious presence of authorised GMOs in conventional seed at the European level were adopted. The

Medlemsstatens svar

ria wykonujce badania urzdowe na potrzeby Inspekcji eterynaryjnej z Zakladów Higieny Weterynaryjnej i Krajowe Laboratoria cyjne ds. pasz GMO zobowizane s do stosowania metod oznacze ch GMO zalecanych przez Laboratorium Referencyjne Unii Europejskiej ci i Pasz Genetycznie Zmodyfikowanych (EURL GMFF). Baza tych ostpniona jest na stronie EURL GMFF i zawiera metody oparte na taniu sond TaqMan i aparatów typu studzienkowego do analiz próbek. ony fakt, e laboratoria nie zawsze stosuj metody zalecane przez EURL ika z decyzji podjtych podczas procesu wstpowania do Unii kiej i dostosowywania si laboratoriów do wymogów analitycznych UE. ria Inspekcji Weterynaryjnej zostaly pierwotnie wyposaone w aparaty e PCR typu kapilarnego (Roche Light Cycler 2.0), co okazalo si by est to platforma nie w pelni kompatybilna z typem aparatów kowych, niosca ze sob ograniczenia co do stosowania metod ch przez EURL GMFF lub niekiedy wykluczajca takie metody. Dlatego atoria stosuj niekiedy komercyjne zestawy diagnostyczne do oznacze ch GMO, przeznaczone dla tego typu aparatu lub opieraj stosowane w niach procedury o metody przystosowane do systemu kapilarnego. Metody szoci odbiegaj od metod zalecanych przez EUR

Medlemsstatens svar

de laboratorium badajce GMO w paszach w ramach Urzdowej Kontroli rzdzenia wdroy wiksz ilo metod identyfikacji modyfikacji GM oraz przede wszystkim 3 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment s, pFMV, pat, bar, nptII na E. Krajowe Laboratorium a dla pracowników laboratoriów ria ZHW lub tylko Laboratoria dczynników (sondy, startery oraz ialy referencyjne) do identyfikacji i ych do obrotu modyfikacji, odmian nieautoryzowanych, dla LR-UE oraz dostpne s CRM. nie bdzie dalszym etapem bada po owe na realizacj zalecenia (w h). leceniem numer 3. Regionalne kowanej jest przygotowane do fikacji genetycznych, które 4 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment

Medlemsstatens svar

luba Celna realizuje zalecenie poprzez zaimplementowanie do systemów nformatycznych Sluby Celnej informacji o wymaganiach z ww. decyzji. ymagania wynikajce z przedmiotowej decyzji automatycznie walidowa si d w systemie obslugi zglosze celnych. Informacja o wymaganiach ww. decyzji dzie dostpna równie w przegldarce taryfowej dla przedsibiorców. Skutkiem ej implementacji w systemie obslugi zglosze celnych bdzie odmowa opuszczenia do swobodnego obrotu przesylki, której nie bdzie towarzyszyl okument potwierdzajcy, e w wyniku pobrania próbek i analiz wszystkie partie rzesylki s uwaane za zgodne z prawem UE (kod dokumentu 7P18) albo wiadczenie podmiotu gospodarczego odpowiedzialnego za przesylk twierdzajce, e dana ywno lub pasza nie zawiera ryu, sklada si z niego ani ie zostala z niego wyprodukowana (dokument 7P019). Glówny Inspektor Sanitarny we wspólpracy ze Slub Celn przeprowadzil zialania wyjaniajce odnonie danych pochodzcych z bazy Eurostat. e wstpnych ustale wynika, e dane przedstawione przez Glówny Urzd tatystyczny (wlaciwy organ przedstawiajcy dane statystyczne dotyczce Polski o bazy Eurostat) nie znajduj odzwierciedlenia w systemie zglosze celnych. ajprawdopodobniej zawieraj one

Medlemsstatens svar

lne Laboratorium Bada ywnoci Genetycznie fikowanej w Tarnobrzegu wdroono kontrol zahamowania reakcji PCR z wymogami EN ISO/IEC 24276. Naley zaznaczy, e w/w kontrola jest od stycznia 2013 roku. W trakcie audytu oceniana byla próbka z roku ie jeszcze nie stosowano tej kontroli, poniewa w wikszoci ywano testy do bada GMO (które nie przewidywaly stosowania tej 7 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment i), a nie norm.

Medlemsstatens svar

oria uczestniczce w monitoringu wdro i zwaliduj metodyki oznaczania modyfikacji z listy LLP (12 modyfikacji) zgodnie z iami Rozporzdzenia 619/2011 (RSD R 25%). K zabezpieczone dodatkowe rodki finansowe na realizacj zalecenia.

Medlemsstatens svar

je si zrezygnowa z tak sformulowanej rekomendacji, gdy przepisy okrelaj jak prawidlowo interpretowa wyniki badania przesiewowego w elu wykrycia obecnoci GMO w materiale siewnym. Nie ma równie przepisów, ycznych Komisji Europejskiej skierowanych do pastw czlonkowskich, krelalyby minimalne progi zawartoci GMO w materiale siewnym. Art. 4 dyrektywy 2001/18/WE stanowi, i ,,Pastwa Czlonkowskie, zgodnie z stronoci, zapewniaj podjcie wszelkich wlaciwych dziala w celu ia niekorzystnego wplywu na zdrowie ludzkie i rodowisko naturalne, oglyby by wynikiem zamierzonego uwolnienia lub wprowadzenia do GMO. GMO mog by w sposób zamierzony uwalniane lub wprowadzane tu tylko w zgodnoci odpowiednio z czci B lub C niniejszej dyrektywy". artykuly 21 ust. 2 i 3 teje dyrektywy stanowi co nastpuje: zypadku produktów, w których nie mona wykluczy obecnoci ubocznych uniknionych technicznie ladowych iloci zatwierdzonych GMO, mona i minimalny próg ich zawartoci, poniej którego produkty te nie bd by etykietowane zgodnie z przepisami ust. 1. Poziomy progów zostaj ione w zalenoci od produktu. rodki te, majce na celu zmian ów innych ni istotne niniejszej dyrektywy poprzez jej uzupelnienie, je si zgodnie z procedur

Medlemsstatens svar

Krajowe Laboratorium Referencyjne w Tarnobrzegu zawsze stosowalo alityczne, o których mowa w decyzji 2011/884/UE (tj: badania ewowe przeprowadzane metod PCR w czasie rzeczywistym w odniesieniu do nastpujcych elementów genetycznych: promotora CAMV 35S - wirusa 9 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment iki kalafiora i terminatora NOS - syntazy nopaliny otrzymanego z bacterium tumefaciens). Natomiast w odniesieniu do metody wykrycia noci GMO w produktach pochodzcych z Chin zgodnie z t decyzj piono w dniu 23.04.2013 r. odczynniki CryIAb/CryIAc otrzymanych z llus thuringiensis, które bd wykorzystane do bada ryu pochodzcego z w III kwartale roku 2013 zgodnie z ,,Harmonogramem pobierania próbek".

Medlemsstatens svar

ug obowizujcych procedur inspektor pobierajcy próbki pasz do atoryjnych przygotowuje równie jedn próbk, któr pozostawia iotowi gospodarczemu. W przypadku otrzymania wyniku niezgodnego, dsibiorca moe j przekaza do bada celem ponownej weryfikacji przez ratorium referencyjne. Laboratorium referencyjne wydaje ostateczn decyzj o badanego parametru. Zgodnie z procedur dot. pobierania próbek w ramach biecego nadzoru z organy Pastwowej Inspekcji Sanitarnej - kontrprób w zakladzie pobiera si czenie osoby wydajcej próbk i zawsze w przypadku oceny partii z importu. 13 r. planuje si nowelizacj ww. procedury w celu uszczególowienia sów w ww. zakresie. Zostan równie uszczególowione kwestie dotyczce edury odwolawczej w przypadku uzyskania wyniku niezgodnego.

Medlemsstatens svar

ny Lekarz Weterynarii przygotuje instrukcj dla terenowych jednostek pekcji Weterynaryjnej, w której zostan zobowizane do przeprowadzania 2 analizy i ustalania przyczyny zanieczyszcze paszy materialem GMO w przypadku ymania wyniku bada potwierdzajcego obecno organizmów genetycznie anych w iloci mniejszej ni 0,9%. Powiatowy Lekarz Weterynarii e musial okreli, czy zanieczyszczenie jest przypadkowe, czy te wynika z nków oragnizacyjno-technicznych panujcych w przedsibiorstwie. Zadanie anie zrealizowane do koca sierpnia 2013 roku. W chwili obecnej trwaj prace w Glównym Inspektoracie Sanitarnym nad cowaniem nowych procedur dot. urzdowej kontroli ywnoci. W ramach tych przygotowana zostanie instrukcja odnonie weryfikacji czy obecno 10 endations of Report ref. DG(SANCO)/2013-6819-MR of an audit carried out from 22 to 31 etically modified organisms, including their deliberate release into the environment autoryzowanego GMO poniej poziomu 0,9% jest przypadkowa lub nieunikniona technicznie zgodnie z art. 12 ust. 2 rozporzdzenia (WE) nr 1829/2003 oraz art. 4 ust. 8 rozporzdzenia (WE) nr 1830/2003, jeli nie stosuje si wymogów dotyczcych etykietowania. Planowany termin realizacji: Do koca 2013 r.

Medlemsstatens svar

Glówny Lekarz Weterynarii wyda stosowane polecenie podleglym slubom esie obowizku weryfikacji przyczyn zanieczyszczenia pasz GMO w rzymania wyniku bada potwierdzajcego obecno organizmów yfikowanych w iloci mniejszej ni 0,9%. wili obecnej w Glównym Inspektoracie Sanitarnym trwaj prace nad opracowaniem nowych procedur dot. urzdowej kontroli ywnoci. W ramach tych prac przygotowana zostanie instrukcja odnonie weryfikacji czy obecno autoryzowanego GMO poniej poziomu 0,9% jest przypadkowa lub nieunikniona technicznie zgodnie z art. 12 ust. 2 rozporzdzenia (WE) nr 1829/2003 oraz art. 4 ust. 8 rozporzdzenia (WE) nr 1830/2003, jeli nie stosuje si wymogów dotyczcych etykietowania. Planowany termin realizacji: Do koca 2013 r. 11

Medlemsstatens svar

retations Response of the General Veterinary Inspectorate (GIW): The Chief Veterinary Officer's instruction will be adapted to the amendments to Regulation (EC) No 2073/2005 and supplemented with: - compulsory notification of operators of the right to take a counter sample [Translator's note: referred to as 'contradictory sample' in the draft report]; - risk factors such as pH and water activity; - checking whether establishments verify and validate the HACCP programme, applying the criteria contained in Regulation (EC) No 2073/2005; - verifying whether shelf-life studies take account of common consumer behaviour (conditions of storage, distribution and use of foodstuffs). In view of the entry into force of further amendments to Regulation (EC) No 2073/2005 as regards Salmonella in pig carcases, work on amending the instruction was expected to be completed in the first quarter of 2013. Pending issuing of the amended instruction, the above issues were raised in letter ref. GIWb-0810-6/2013(5) of 30 August 2013 (Annex 3). Response of the Central Sanitary Inspectorate (GIS): The National Meeting of managers in State Sanitary Inspection bodies responsible for food ived 05 December 2013

Medlemsstatens svar

Response of the GIW: ion (EC) f The checklists in the SPIWET veterinary monitoring program will be supplemented with: ithin e, in - the requirement for the official veterinarian to check whether testing is carried out using f the reference methods and, if alternative methods are being used, whether they have been . validated; - a requirement for the official veterinarian to check whether minced meat intended to be eaten cooked is being marked properly. Update by the end of the year. Response of the GIS: Work is ongoing at the Central Sanitary Inspectorate on the next update (following the one which has just been completed - see response to Recommendation 5) of the procedures applied by State Sanitary Inspection bodies for the official control of foodstuffs. The next update will include development of a checklist aimed at ensuring that those bodies correctly check that establishments are complying with Regulation (EC) No 2073/2005. ived 05 December 2013 Competent Authorities of Poland on N/A in response to Report ref. DG(SANCO)/2013-6870 -MR of ril 2013 in order to evaluate the official controls on food safety and process hygiene criteria (commission Deadline for implementing the Re

Medlemsstatens svar

in all Measures in the event of non-compliance - Article 54 of Regulation (EC) No 882/2004. ant Response of the GIS: ired by By letter ref. GIS-B-RA-426-344-MK-13/1 of 29 August 2013 (Annex 1), the Chief Sanitary Inspector reminded the State Sanitary Inspection bodies of the requirements of Article 54(1) of Regulation (EC) No 882/2004 and ordered the provincial State Sanitary Inspection bodies to check, during controls/audits carried out at District [Please note that is has been necessary to delete this text in order to respect the provisions of Article 339 of the Lisbon Treaty] Sanitary and Epidemiological Stations, whether, when non-compliance is found, the district State Sanitary Inspection bodies are properly implementing the provisions of Regulation (EC) No 2073/2005 and thus complying with Article 54(1) of Regulation (EC) No 882/2005. The Chief Sanitary Inspector has required the Provincial Sanitary Inspectors to report to the Central Sanitary Inspectorate on the findings of the controls/audits in question carried out from September 2013 to the end of June 2014, in the context of enforcement of the provisions of Regulation (EC) No 2073/2005 until 15 July 2014. The matter of t

Medlemsstatens svar

Response of the National Veterinary Research Institute (PIW-PIB) and the GIW: elevant Proficiency testing in this area is part of the proficiency testing programme regarding the of microbiology of foodstuffs of animal origin. The 2008-12 period saw nine proficiency rounds covering microbiological testing of milk and dairy products subject to the above Regulation and falling within the remit of the PIW-PIB's Hygiene Unit: - detection of staphylococcal enterotoxins (five proficiency tests at a frequency of one per year - number of participating laboratories: 6, 3, 3, 5, 3) - detection of Salmonella spp. (three proficiency tests at a frequency of one every two years - number of participating laboratories: 25, 24, 26) - detection and quantification of L. monocytogernes (three proficiency tests at a frequency of one every two years - number of participating laboratories: 24, 19, 17) - detection and quantification of coagulase-positive staphylococci, including Staphylococcus aureus (five proficiency tests at a frequency of one per year - number of participating laboratories: 13, 23, 21, 18, 18) - quantification of beta-glucuronidase-positive E.coli (one proficiency test - number of parti

Medlemsstatens svar

ols for Response of the GIS: sure that cases As part of the process of updating the procedures for official controls of food carried out ria as by the State Sanitary Inspection bodies, a new risk assessment model was developed ) No taking account of different branches of the food sector. This model was used to establish a nse received 05 December 2013 Competent Authorities of Poland on N/A in response to Report ref. DG(SANCO)/2013-6870 -MR of ril 2013 in order to evaluate the official controls on food safety and process hygiene criteria (commission new frequency for official food controls. The State Sanitary Inspection bodies are currently being consulted on these procedures. In the fourth quarter of 2013 the procedures will be issued to those bodies with an instruction to implement them in their ongoing work. In the letter GIWb-0810-6/2013(5) of 30 August 2013 (Annex 3) it was ordered to carry out, by the end of 2013, the verification of threats analysis for particular products/ lots of products and procedures of actions to be taken in case of non-compliances, in order to identify all microbiological threats that apply to the products manufactured by the establishment. In this let

Medlemsstatens svar

ard Response of the GIW: verify Letter ref. GIWb-0810-6/2013(5) of 30 August 2013 (Annex 3) ordered the following: EC) No · an assessment of the risk analysis for the various products/product groups and the procedures for taking action in the event of non-compliant results, to ensure identification ived 05 December 2013 Competent Authorities of Poland on N/A in response to Report ref. DG(SANCO)/2013-6870 -MR of ril 2013 in order to evaluate the official controls on food safety and process hygiene criteria (commission risks that apply to the products produced by the establishment in establishments possess a procedure for withdrawing products t of detection of non-compliance with any of the food safety products produced by them (reason for withdrawal, steps that ion of effectiveness of remedial measures); edures as regards whether the information on the steps taken ia (improvements in production hygiene, verification of ed is up to date, and a check on whether the procedures are being microbiological tests are being carried out for each product logical group; stablishments that have been classed in a higher risk group as a th microbiological criteria, the frequency of sampling for (p

Medlemsstatens svar

ge Response of the GIW: f-life x II to The Chief Veterinary Officer's instruction will be adapted to Regulation (EC) No 2073/2005 and supplemented with a check on whether shelf-life studies take account of n ived 05 December 2013 Competent Authorities of Poland on N/A in response to Report ref. DG(SANCO)/2013-6870 -MR of ril 2013 in order to evaluate the official controls on food safety and process hygiene criteria (commission common consumer behaviour (conditions of storage, distribution and use of foodstuffs). Pending issuing of the amended instruction, that issue was raised in letter ref. GIWb- 0810-6/2013(5) of 30 August 2013 (Annex 3). Response of the GIS: Work is ongoing at the Central Sanitary Inspectorate on the next update (following the one which has just been completed - see response to Recommendation 5) of the procedures applied by State Sanitary Inspection bodies for the official control of foodstuffs. The next update will include development of a checklist aimed at ensuring that those bodies correctly check that establishments are complying with Regulation (EC) No 2073/2005. Deadline for implementing the Recommendation: end of 2014.

Medlemsstatens svar

a 2013 r. Glówny Lekarz Weterynarii podpisal zawarte w instrukcji Nr GIWb-500-2/2013 z dnia 26 r. w sprawie postpowania organów Inspekcji j przy zatwierdzaniu, zatwierdzaniu warunkowym i rzedsibiorstw sektora spoywczego oraz zawieszaniu i erdzenia, a take przy wykreleniu tych przedsibiorstw z ylajce postanowienia dotychczas obowizujcej instrukcji rza Weterynarii Nr GIWhig-500-3/08 z dnia 20 marca awie postpowania organów Inspekcji Weterynaryjnej przy zakladów, zatwierdzaniu warunkowym oraz rejestracji ora spoywczego, zawieszaniu i cofaniu zatwierdzenia e w przedmiotowej instrukcji wejd w ycie z dniem 16 ów ww. instrukcji Glówny Lekarz Weterynarii ostal do weryfikacji otrzymywanych od PLW, za WLW uzupelnionych zalczników Instrukcji, zmiany do wykazów zakladów sektora spoywczego. niane s innym pastwom czlonkowskim oraz opinii stronie internetowej Glównego Inspektoratu Weterynarii ww.wetgiw.gov.pl, bez zbdnej zwloki. LW i WLW maj obowizek sprawdza na bieco ieszczane na stronie internetowej Glównego Inspektoratu otyczce wlaciwego powiatu lub województwa, tak aby m zawarte byly jak najbardziej aktualne i odzwierciedlaly y i prawny zakladów. W przypadku stwierdzenia ci podejmuj niezwlocz

Medlemsstatens svar

zakladów w zakresie produkcji MOM z koci bydla, y prowadzone etapami: kolejnoci w kwietniu b.r. przeprowadzono urzdowe 30 zakladach posiadajcych uprawnienia do produkcji zenia wolowego nadane decyzj wlaciwego arza weterynarii lub pomylkowo figurujcych na osiadajce takie uprawnienia. Powysze kontrole zone pod ktem prowadzenia produkcji i do produkcji wlasnej zakladu lub prowadzenia h zakladów (MOM) z przeuwaczy. Powysze rdzily, e w przypadku 29 zakladów nigdy nie ukcji MOM pozyskiwanego z koci bydla, owiec i decyzje administracyjne niezgodne z prawem zostaly u do Zakladu kontrola przeprowadzona przez IW odukcj MOM wolowego, w efekcie czego niezwlocznie stalo powiadomienie RASFF zawierajce listy wydana decyzja o wycofaniu MOM wolowego z rynku tylizacji; du liczb zakladów produkujcych miso anicznie w dalszej kolejnoci tj. do dnia 20 maja zeprowadzone kontrole we wszystkich zakladach enia do produkcji MOM, pod ktem weryfikacji, one produkcji MOM z koci bydla, owiec i kóz; taleniami z inspektorami prowadzcymi misj FVO in te the official controls on food safety and process a (Commission Regulation (EC) No 2073/2005) do dnia staly równie przeprowadzone urzdowe kontrole pod i wprowadzania

Medlemsstatens svar

zialania korygujce zmierzajce do iezgodnoci dotyczcych zamraania schlodzonych h przyjtych do zakladu , Zaklad dokonal zmiany u wlacicielskiego w zakresie przyjcia surowca do dkostnionego mechanicznie. Podczas przyjcia porcji dzonych do temp. nie wikszej ni 4ºC nie bdzie cedura zamraania . Surowiec zostanie przetworzony od daty uboju, a wytworzony MOM zostanie zamroony Page: 5 he provisions of article 287 of the Treaty as regards confidentiality. CA response received 25 September 2013 (SANCO)/2013-6893-MR of an audit carried out ction of mechanically separated meat sed by the Competent Authority wyszej ni ­ 18 ºC i zmagazynowany na okres nie dluszy od daty odkostnienia. W przypadku przyjcia porcji amroonych i wykorzystania ich do produkcji MOM wane wymagane terminy. zwizku z nieprawidlowociami stwierdzonymi podczas az w zwizku z wtpliwociami zglaszanymi przez organy gotowal projekt pisma dotyczcego interpretacji przepisów a 853/2004 w zakresie produkcji MOM. Pismo m.in. walo kwestie wymaga zalcznika III sekcja II rozdzial V porzdzenia (WE) nr 853/2004). Pismo zostanie wyslanie po dpowiedzi KE w kwestii klasyfikacji MOM z dodatkiem soli

Medlemsstatens svar

klasyfikacja MOM z dodatkiem soli peklujcej u misnego budzi nasze wtpliwoci ze wzgldu na przepisami UE regulujcymi stosowanie dodatków do u 12 sierpnia 2013 r. zostalo skierowane pismo do KE o IWb-0810-3/2013(10) (zalcznik nr 6).W pimie strona ala, e cz E zalcznika II do rozporzdzenia Komisji /2011 z dnia 11 listopada 2011 r. zmieniajcego zalcznik zdzenia Parlamentu Europejskiego i Rady (WE) nr przez ustanowienie unijnego wykazu dodatków do U. L 295 z 12.11.2011, str. 1), okrela dopuszczone wnoci oraz warunki ich stosowania w poszczególnych ywnoci. Azotyny (E 249-250), w tym azotyn sodu, nie s do stosowania dla kategorii ,,08.1.2 ­ Surowe wyroby mieniu rozporzdzenia (WE) nr 853/2004". W przypadku a przez KE, e pomimo sprzecznoci z ww. przepisami iem soli peklujcej (w tym MOM pozyskiwany technikami Page: 6 o respect the provisions of article 287 of the Treaty as regards confidentiality. CA response received 25 September 2013 (SANCO)/2013-6893-MR of an audit carried out ction of mechanically separated meat d by the Competent Authority struktury koci) ma by klasyfikowany jako surowy atwierdzenie zakladów zostanie zmienione. W chwili jemy na odpowied.

Medlemsstatens svar

do zakladów, w których zostaly stwierdzone uchybienia e decyzje administracyjne nakazujce ich usunicie i ontrole sprawdzajce ich usuwanie w wyznaczonych zególy w zalczniku dotyczcych dziala podejmowanych do nieprawidlowoci). Page: 7 some text in order to respect the provisions of article 287 of the Treaty as regards confidentiality. CA response received 25 September 2013 (SANCO)/2013-6893-MR of an audit carried out ction of mechanically separated meat Proposed by the Competent Authority , the Chief Veterinary Officer signed Instruction 2013 of 26 August 2013 on the procedure of spection bodies for the approval, conditional approval and of food business establishments as well as the suspension ion of the approval and deletion of these establishments ster, repealing the Chief Veterinary Officer's Instruction -3/08 of 20 March 2008 on the procedure of Veterinary dies for the approval, conditional approval and registration ess establishments and the suspension and cancellation of previously in force. on concerned will enter into force on 16 September this ve-mentioned Instruction, the Chief Veterinary Officer is erify annexes to the Instruction completed by District ficers (DVOs) and s

Medlemsstatens svar

tej sprawie zostalo wystosowane pismo Glównego Lekarza Weterynarii z dnia 23 padziernika 2013 r. skierowane do granicznych lekarzy weterynarii oraz w dniu 31 padziernika skierowane do Ministerstwa Finansów nadzorujcego Slub Celn, w sprawie zwracania szczególnej uwagi podczas kontroli zalcznika II decyzji 2013/426/UE na rodzaj wpisywanego rodka dezynfekcyjnego oraz jego stenia. W przypadku niepelnych informacji oraz braku moliwoci ich uzyskania od obslugujcego/kierowcy pojazdu, pojazd taki powinien by skierowany dezynfekcji lub jeli to nie jest moliwe, odeslany.

Medlemsstatens svar

that Glówny Lekarz Weterynarii zatwierdzil wytyczne w zakresie stosowania decyzji wykonawczej Komisji nr 2013/426/UE z dnia 5 sierpnia 2013 r. w sprawie rodków majcych na celu zapobieenie wprowadzaniu do Unii wirusa afrykaskiego pomoru wi z niektórych pastw trzecich lub czci terytorium pastw trzecich, w których potwierdzono obecno choroby oraz uchylajc decyzj 2011/78/UE (Dz. U. L 211 z 7.8.2013, str. 5, z pón. zm.). Page: 1

Medlemsstatens svar

Pismem z dnia 22 sierpnia 2012 r., znak: GIS-B-UE-420-41/KN/12/1(zalcznik 1) Glówny nspektor Sanitarny zwrócil si z prob do Ministra Rolnictwa i Rozwoju Wsi o podjcie iala majcych na celu rozwizanie problemu nadzoru nad zanieczyszczeniami produktów pochodzenia rolinnego w produkcji pierwotnej przed zbiorem w ramach urzdowej kontroli ywnoci, a nie dobrowolnego systemu - Integrowana Produkcja. Obecnie trwaj uzgodnienia w kwestii objcia przez jeden z resortów (rolnictwa lub zdrowia) ów wlaciwego organu, który prowadzi bdzie kontrole urzdowe produkcji awowej przed zbiorami w zakresie zanieczyszcze.

In a document dated 22 August 2012 Sprawa nie zostala jeszcze ostatecznie GIS-B-UE-420-41/KN/12/1, zakoczona, w dalszym cigu trwaj uzgodnienia Annex 1), the Main Sanitary Inspector w kwestii objcia przez jeden z resortów sted the Minister for Agriculture (rolnictwa lub zdrowia) obowizków wlaciwego al Development to take action to organu, który prowadzi bdzie kontrole the problem of controls on urzdowe produkcji podstawowej przed zbiorami contaminants in plant products at w zakresie zanieczyszcze. primary production level before harvesting in the framework of official food controls, rather than through a voluntary system (Integrated Production). Negotiations are currently under way concerning the designation of one department (agriculture or health) as the Competent Authority with the relevant responsibilities. The department concerned will conduct official controls for contaminants at primary production level before harvesting.

Medlemsstatens svar

Odpowied jak w pkt. 1 12

document dated 22 August 2012 Odpowied w pkt. 1 (ref: GIS-B-UE-420-41/KN/12/1, Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of 1), the Main Sanitary Inspector ted the Minister for Agriculture and Rural Development to take action to resolve the problem of controls on contaminants in plant products at ary production level before ting in the framework of official food controls, rather than through a voluntary system (Integrated Production). Negotiations are currently under way concerning the designation of one department (agriculture or health) as the Competent Authority with the relevant responsibilities. The department concerned will conduct official controls for contaminants at primary production level before harvesting.

Medlemsstatens svar

012r Minister Zdrowia podpisal Rozporzdzenie w sprawie wykazu ratoriów referencyjnych, w którym NIZP-PZH zostal wyznaczony jako laboratorium odniesieniu do WWA (Dz. U. 2012, poz. 728). tut Weterynaryjny w Pulawach w pimie z dnia 28 sierpnia 2012 r. ierdzil zarówno kompetencje do wykonywania bada w kierunku oznaczania WWA w enia zwierzcego jak równie gotowo do wlczenia tego kierunku bada boratoriów referencyjnych. miotowego kierunku bada bdzie moliwe na pocztku 2013 r. z uwagi na prowadzenia procesu akredytacji. 12

9 June 2012 the Minister for Health signed the Regulation on the list of e laboratories, in which the NIPH-NIH was designated as the PAH reference laboratory (Journal of Laws 2012, item 28). Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of In a document dated 28 August 2012, the State Veterinary Institute in Pulawy confirmed its competence to undertake tests to identify PAHs in food of animal origin and stated that it was prepared to include such tests in the tasks of reference laboratories. Inclusion of the above tests will be possible from the start of 2013 as an accreditation process is required.

Medlemsstatens svar

esieniu do zanieczyszcze objtych tematem przedmiotowej misji, Instytut ywnoci i ywienia od lat realizuje zaloenia rozporzdzenia 882/2004/WE w zakresie oznaczania amidu w ywnoci we wspólpracy z laboratoriami Pastwowej Inspekcji Sanitarnej. PZH realizuje zadania wynikajce z art. 33 rozporzdzenie (WE) nr 882/2004. okrelenia wymaga jedynie wspólpraca pomidzy laboratoriami referencyjnymi ­ p. 5 3 rozporzdzenie (WE) nr 882/2004.

As regards the contaminants dealt with in ission, the Food and Nutrition Z przedstawionych dokumentów wynika, e tute has, for many years, been zakres audytu dotyczyl zanieczyszcze rodków ing the requirements of Regulation spoywczych pochodzenia rolinnego (EC) No 882/2004 as regards the wymienionych w rozporzdzeniu Komisji identification of acrylamide in food, in 1881/2006. Zwaywszy na powysze, jak równie cooperation with SSI laboratories. na aktywnoci referencyjne PIWet-PIB, naley The NIPH-NIH NLR undertakes the stwierdzi, e w aden sposób nie nakladaj si tasks described in Article 33 of one na dzialalno referencyjn NIZP-PZH. Dla Regulation (EC) No 882/2004. Specific aktywnoci nadzorowanej przez EuRL w Geel definition is only required for (Belgia) w zakresie metali i mikotoksyn istnieje cooperation between reference pelen rozdzial kompetencji: laboratories ­ Paragraph 5 of Article 33 - ywno rolinnego pochodzenia ­ NIZP-PZH of Regulation (EC) No 882/2004. - pasze ­ PIWet-PIB Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of W powyszej

Medlemsstatens svar

lówny Inspektor Sanitarny pismem z dnia 30 sierpnia 2012 r, znak: GIS-B-UE-420- 12/1 (zalcznik 2) zalecil wszystkim Pastwowym Wojewódzkim Inspektorom rnym podjcie dziala majcych na celu zwikszenie czstotliwoci i prowadzenie atycznych szkole (np. co dwa miesice) dla pracowników powiatowych stacji ­ epidemiologicznych. Szkolenia te powinny swoim programem obejmowa tpujce kwestie stanowice priorytety w nadzorze nad bezpieczestwem ywnoci i · zanieczyszczenia ywnoci (chemiczne i biologiczne), · substancje dodatkowe, · materialy i wyroby przeznaczone do kontaktu z ywnoci, · znakowanie ywnoci z uwzgldnieniem owiadcze ywieniowych i zdrowotnych, · HACCP (ocena procedur i stopnia wdroenia zasad HACCP). Jednoczenie prosz, by dla kadego szkolenia jeden z ww. tematów pelnil rol wiodcego i w szerszym zakresie, uwzgldniajcym szczególy istotne w sprawowanym twie podlaskim dotychczas plany szkole dla PSSE opracowywane przez WSSE rzecitnie 4-5 szkole na rok (minimum 1 szkolenie na kwartal). Ponadto plany e przewiduj organizacj szkole biecych organizowanych doranie w ie przypomnienia, utrwalenia bd przekazania zagadnie z udzialu w szkoleniach 12 h niezbdnych do realizacji w okrelonym temacie. ewództw

a document dated 30 August 2012 ref: GIS-B-UE-420-42/KN/12/1, Annex 2), the Main Sanitary Inspector Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of requested all State Voivodship Sanitary Inspectors to take steps to arrange regular and more frequent training sessions (e.g. every two months) for Powiat sanitary and epidemiological station staff. The programme for these training sessions should include the following priority issues for supervision of food safety and nutrition: - food contaminants (chemical and biological), - additives, - materials and products intended for contact with food, - food labelling with reference to health and nutrition statements, - HACCP (assessment of procedures and degree on implementation of HACCP principles). It was also indicated that one of the above subjects should be the lead topic in each training session and should be dealt with in greater depth, covering essential information for exercising supervision. Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response

Medlemsstatens svar

lówny Inspektor Sanitarny pismem z dnia 11 wrzenia 2012 r, znak: GIS-B-UE-420- N/12/1 (zalcznik 4) zalecil wszystkim Pastwowym Wojewódzkim Inspektorom rnym zapewnienie organom Pastwowej Inspekcji Sanitarnej przeprowadzajcym trole w zakresie zanieczyszcze w ywnoci jak równie pobierajcym próbki ci w ramach programu monitorowania zanieczyszcze, odpowiedniego sprztu do ania próbek zgodnie z wymogiem okrelonym w art. 4 ust. 1 lit. d) rozporzdzenia (WE) nr 882/2004. em z dnia 6 wrzenia 2012 r. (zalcznik 3) Malopolski Pastwowy Wojewódzki Inspektor ecil pastwowym powiatowym inspektorom sanitarnym dokonanie oceny sprztu pod ktem zapewnienia prawidlowoci poboru próbek. owiatowy Inspektor Sanitarny w Krakowie zadeklarowal zabezpieczenie nika dostatecznej dlugoci dla potrzeb pobierania próbek z big ­ bagów. 12

a document dated 11 September 2012 ref: GIS-B-UE-420-45/KN/12/1, Annex 4), the Main Sanitary Inspector requested all State Voivodship Sanitary Inspectors to provide adequate sampling as required by Article 4(1)(d) ation (EC) No 882/2004 for all of the State Sanitary Inspectorate taking official controls for food ants and taking food samples under the contaminants monitoring ogramme as required by Article 4(1)(c) Regulation (EC) No 882/2004. In a document dated 6 September 2012 (Annex 3), the Malopolski Voivodship Sanitary Inspector requested that Powiat Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of State Sanitary Inspectors assess the equipment at their disposal to ensure that it was adequate for sampling. The Kraków Powiat State Sanitary Inspector declared that a probe of the requisite length for sampling from large bags was available.

Medlemsstatens svar

odpowiedzi na zalecenie nr 3, dopiero pod koniec biecego roku w ramach u laboratoriów urzdowych IW bdzie moliwe wykonywanie bada w kierunku WWA kredytowan. W najbliszym czasie GLW rozpocznie opracowywanie procedury j pobieranie próbek urzdowych w kierunku WWA. Bdzie ona konsultowana z ami terenowymi Inspekcji Weterynaryjnej

It follows from the response to endation No 3 that it will only be possible to undertake testing for PAH in official VI laboratories using the ited method at the end of this year. In the near future the Main Veterinary Laboratory will begin to develop procedures for taking official samples for PAH testing. The Veterinary Inspectorate's units in the field will be consulted on this matter.

Medlemsstatens svar

obecnej trwaj prace w Glównym Inspektoracie Sanitarnym nad opracowaniem h procedur dot. urzdowej kontroli ywnoci, które bd stosowane przez organy PIS. ach tych prac przygotowany zostanie nowy model oceny zagroenia z uwzgldnieniem ran sektora spoywczego oraz na podstawie tego modelu ustalona zostanie nowa wo urzdowej kontroli ywnoci. Opracowywane procedury uzupelnione zostan o a kontrolnych (check lists) m. in. dla substancji dodatkowych oraz materialów i zeznaczonych do kontaktu z ywnoci. owanie czstotliwoci kontroli zakladów na terenie województwa podlaskiego odbywa ie z trybem okrelonym pismem GIS nr GIS-B-SP-4212-151/MN/11 z dnia 11r. Wykonanie 2 kontroli w roku 2011 (odpowiednio w kwietniu ­ kontrola na i w sierpniu- - kontrola kompleksowa) oraz zaplanowanie 2 kontroli w Podlaskich h Zboowych w Bialymstoku w roku 2012 (tj. w marcu ­ kontrola kompleksowa i we kontrola tematyczna) wynikalo z koniecznoci pobrania konkretnych próbek do oratoryjnych. I dostarczenia ich w cile okrelonym terminie si bowiem sytuacje, i pobranie próbek jest niezbdne w okrelonym kwartale w przedzialem czasowym, w którym próba ma by dostarczona do bada w 12 wyspecjalizowanym laboratorium badawczym Pastwow

k is currently in progress at the Main ary Inspectorate on the development W chwili obecnej trwaj prace w Glównym ew procedures concerning official Inspektoracie Sanitarnym nad opracowaniem controls, to be implemented by SSI nowych procedur dot. urzdowej kontroli authorities. As part of this work, a new ywnoci, w celu kategoryzacji zakladów w risk assessment model will be developed, aspekcie zagroenia, które bd stosowane przez Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of encompassing various branches of the organy PIS. W ramach tych prac przygotowane food sector. On the basis of that model, zostanie nowe podejcie do oceny zagroenia z new frequencies for official food controls uwzgldnieniem ronych bran sektora will be established. The procedures spoywczego które wygeneruje odpowiedni developed will be accompanied by czstotliwo urzdowej kontroli ywnoci w checklists for additives and material and tych zakladach. Opracowywane procedury bd articles intended for contact with food. zawieraly list pyta kontrolnych (check lists) m. in. d

Medlemsstatens svar

owied jak w pkt. 1

a document dated 22 August 2012 Odpowied w pkt. 1 f: GIS-B-UE-420-41/KN/12/1, ), the Main Sanitary Inspector d the Minister for Agriculture and Rural Development to take action to e the problem of controls on contaminants in plant products at primary production level before harvesting in the framework of official food controls, rather than through a voluntary system (Integrated Production). Negotiations are currently under way concerning the designation of one department (agriculture or health) as the Competent Authority with the relevant responsibilities. The department concerned will conduct official controls Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of for contaminants at primary production level before harvesting.

Medlemsstatens svar

12 jak w pkt. 1

In a document dated 22 August 2012 Odpowied w pkt. 1 (ref: GIS-B-UE-420-41/KN/12/1, 1), the Main Sanitary Inspector requested the Minister for Agriculture and Rural Development to take action to resolve the problem of controls on contaminants in plant products at y production level before harvesting in the framework of official food controls, rather than through a voluntary system (Integrated Production). Negotiations are currently under way concerning the designation of one department (agriculture or health) as the Competent Authority with the relevant responsibilities. The department concerned will conduct official controls for contaminants at primary production level before harvesting.

Medlemsstatens svar

em z dnia 11 wrzenia 2012 r. , znak: GIS-B-UE-420- 45/KN/12/1 (zalcznik 4) nspektor Sanitarny przypomnial wszystkim Pastwowym Wojewódzkim om Sanitarnym aby pobieranie próbek w kierunku badania mikotoksyn przez organy j Inspekcji Sanitarnej podczas urzdowej kontroli ywnoci odbywalo si zgodnie z okrelonymi w rozporzdzeniu (WE) nr 401/2006 z dnia 23 lutego 2006 r. ajcym metody pobierania próbek i analizy do celów urzdowej kontroli poziomów yn w rodkach spoywczych. ch PIS województwa malopolskiego szkolenie dotyczce metod pobierania próbek ujte w planie na rok 2013.

a document dated 11 September 2012 ref: GIS-B-UE-420- 45/KN/12/1 Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of ), the Main Sanitary Inspector nded all State Voivodship Sanitary ctors to ensure that sampling for official controls of mycotoxins by State Sanitary Inspectorate authorities should be carried out according to the requirements laid down in Regulation (EC) No 401/2006 of 23 February 2006 laying down the methods of sampling and analysis for the official controls of the levels of mycotoxins in foodstuffs. Training on sampling methods for SSI authorities in the Malopolskie Voivodship will be incorporated into the 2013 plan.

Medlemsstatens svar

dowe kontrole ywnoci przeprowadzane s przez organy Pastwowej Inspekcji ej (równie w zakresie wlaciwym dla tematyki misji) zgodnie z obowizujcymi i umentowanymi procedurami urzdowej kontroli ywnoci. cy powiatowych stacji sanitarno - epidemiologicznych zapoznaj si z cymi procedurami kontroli w ramach szkole wewntrznych. Skuteczno szkole 12 rawdzana na bieco przez bezporednich przeloonych poprzez ocen prowadzonego ania i tworzonej dokumentacji, ocen pracy w terenie. Przedstawiciele skiego Pastwowego Wojewódzkiego Inspektora Sanitarnego dokonuj oceny noci szkole w trakcie biecej wspólpracy oraz w trakcie audytów. W przypadku zenia istotnych nieprawidlowoci uwagi kierowane s pismami do pastwowych wych inspektorów sanitarnych. nie województwa podlaskiego, obowizuj i s wdroone procedury urzdowej i ywnoci - ujednolicone w calym kraju. Oprócz zapisów ogólnych, wspomniane ty zawieraj swego rodzaju check ­ listy, tj. ,,Arkusze oceny stanu sanitarnego" ­ typów zakladów, uwzgldniajcych specyfik ich dzialalnoci. Kontrole sowe zakladów kadorazowo przeprowadzane s przez pracowników pionu zestwa ywnoci z wykorzystaniem przedmiotowych arkuszy. ie kontroli wizytowanego przez ekspertów FVO zakladu pra

fficial controls of food are carried out Obecnie w GIS oraz w Narodowym Instytucie Sanitary Inspectorate authorities Zdrowia Publicznego- Pastwowym Zakladzie ng in the time period relevant to Higieny (NIZP-PZH) trwaj prace nad sion) in accordance with the opracowaniem instrukcji pobierania próbek nted procedures for official food suszonych, rozcieczonych i zloonych rodków controls currently in force. spoywczych w celu badania w kierunku Powiat Sanitary and Epidemiological zanieczyszcze. Station staff are made aware of the Termin realizacji zalecenia: control procedures in force at internal Pierwsze pólrocze 2013 r. training sessions. The effectiveness of Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of the training is verified on an ongoing basis by immediate superiors through an assessment of the action undertaken and the documentation created. Work in the field is assessed. Representatives of the Malopolskie Voivodship State Sanitary Inspector assess the effectiveness of the training in the course of ongoing cooperation and throug

Medlemsstatens svar

wskazano w projekcie raportu wspólpraca w zakresie zanieczyszcze ywnoci jest realizowana zgodnie z podpisanym porozumieniem ramowym z dnia 21 wrzenia 2007 r. awartym pomidzy Glównym Inspektorem Sanitarnym i Glównym Lekarzem Weterynarii o ialaniu i wspólpracy organów PIS i organów IW. h ww. porozumienia organy szczebla powiatowego obu inspekcji zobowizuj si do 12 wania wzajemnie informacji i dokumentów dotyczcych narusze przepisów owych i krajowych w zakresie bezpieczestwa ywnoci oraz przepisów zych wydanych na ich podstawie, których naruszenie moe spowodowa ie zdrowia publicznego. Strony porozumienia zobowizuj si równie do ania wyników bada laboratoryjnych wskazujcych na niewlaciw jako rodków ch pochodzenia zwierzcego. odstawie ww. porozumienia zawierane s porozumienia na poziomie wojewódzkim wlaciwymi Pastwowymi Wojewódzkimi Inspektorami Sanitarnymi, a kimi Lekarzami Weterynarii. ca organów PIS z organami PIORiN realizowana jest zgodnie z porozumieniem z dnia 1 kwietnia 2009 r. pomidzy Glównym inspektorem Ochrony Rolin i ctwa, Glównym Inspektorem Sanitarnym oraz Glównym Inspektorem Jakoci j Artykulów Rolno ­ Spoywczych . dzi o wspólprac pomidzy organami PIS oraz uwag zawart w rozd

As indicated in the draft report, on concerning contaminants in Wikszo urzdowych kontroli w zakresie bada es place as laid down in the zanieczyszcze przeprowadzanych przez organy amework agreement dated 21 Inspekcji Weterynaryjnej w ywnoci September 2007 between the Main pochodzenia zwierzcego realizowana jest na tary Inspector and the Main podstawie programu monitoringu pozostaloci ry Officer on joint action and opartego o zapisy dyrektywy 96/23. Rodzaj cooperation between SSI and VI pobieranych próbek, ich liczba, zwierzta od authorities. których maj by pobierane, okrelone s w Under the aforementioned agreement, zalcznikach do ww. dyrektywy. Tworzc Powiat level authorities of both program Inspekcja Weterynaryjna przy Inspectorates undertake to share with wspóludziale PIWet-PIB w Pulawach jest przede each other information and wszystkim zobowizana do spelnienia wymaga documentation concerning infringement zawartych w dyrektywie. Próbki pobierane s na of national and Community provisions etapie produkcji, gdzie badaniu poddawany jest on food safety and of the implementing surowiec pochodzenia zwierzcego. Zatem provisions issued in that regard, when rozdzial kompetencji z Pastwow In

Medlemsstatens svar

ny Inspektor Sanitarny pismem z dnia 11 wrzenia 2012 r, znak: GIS-B-UE-420- /1 (zalcznik 4) zalecil wszystkim Pastwowym Wojewódzkim Inspektorom ym by organy Pastwowej Inspekcji Sanitarnej stosowaly przepisy dotyczce ia kar za brak rejestracji w odniesieniu do podmiotów dzialajcych na rynku m i prowadzcych produkcj pierwotn (art. 55 rozporzdzenia (WE) nr 882/2004 . 103 ust. 4 ustawy z dnia 25 sierpnia 2006 r. o bezpieczestwie ywnoci i ywienia 136, poz. 914, z pón. zm.)). W zwizku z powyszym Glówny Inspektor Sanitarny zalecil nawizanie stosownej wspólpracy z organami Pastwowej Inspekcji Ochrony Rolin i 12 nictwa w celu pozyskiwania informacji o gospodarstwach prowadzcych tak

In a document dated 11 September 2012 IS-B-UE-420-45/KN/12/1 4), the Main Sanitary Inspector requested all Voivodship Sanitary Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of Inspectors to ensure that State Sanitary Inspectorate authorities implement the provisions on sanctions for non registration applicable to establishments active on the food market and engaged in primary production (Article 55 of Regulation (EC) No 882/2004 and Article 103(4) of the Act of 25 August 2006 on food safety and nutrition (Journal of Laws No 136, item 914, with subsequent amendments)). In relation to the above, the Main Sanitary Inspector requested that arrangements be made for appropriate cooperation with authorities of the State Inspectorate of Plant Health and Seed Protection in order to obtain information on establishments engaged in such activity.

Medlemsstatens svar

drugim pólroczu 2012 roku zostan przeprowadzone przez Glówny Inspektorat Sanitarny 3 dyty wewntrzne w WSSE w zakresie zanieczyszcze ywnoci. pismem z dnia 11 wrzenia 2012 r, znak: GIS-B-UE- 12/1 (zalcznik 4) zalecil wszystkim Pastwowym Wojewódzkim Inspektorom m realizacj niniejszego zalecenia podczas opracowywania planu audytów oraz dzania audytów w podleglych województwach. czyszcze zostanie wprowadzony w okresowe plany ie ujte w przyszlorocznym okresowym planie kontroli

Three internal audits of the VSES g food contaminants will be ried out by the Main Sanitary Inspectorate in the second half of 2012. In addition, in a document dated 11 September 2012, ref: GIS-B-UE-420-45/KN/12/1 (Annex 4), Page: arch 2013 submitted by the Competent Authorities of Poland on 20 September in response to Report ref. carried out from 05 to 12 June 2012 in order to evaluate controls of contaminants in food of the Main Sanitary Inspector requested all State Voivodship Sanitary Inspectors to implement the above recommendation when developing audit plans and when undertaking audits in the Voivodships for which they are responsible. Residues and contaminants will be introduced into the administration's periodic control plans, which will be included in the Veterinary Inspectorate's periodic control plan for next year. Page:

Medlemsstatens svar

eterynarii przeslal do wojewódzkich lekarzy pismo znak GIWz.400/W-10/18/12 z dnia 3 sierpnia 2012 r., e przez myliwych do Inspekcji Weterynaryjnej gu doustnych szczepie lisów wolno yjcych ie powinny by pozyskiwane i dostarczane j Glównego Lekarza Weterynarii 5/2004 z dnia 24 listopada 2004 roku w sprawie lu do bada monitoringowych okrelajcych doustnych lisów wolno yjcych; ym wyklucza z przedmiotowego monitoringu ej ani plciowej, bowiem wyniki ada powinny by reprezentatywne dla calej y informowani o powyszych wymaganiach co sów, w sposób regularny (przynajmniej raz na rok) której dostarczane próbki nie spelniaj kryteriów nspekcj Weterynaryjn. jnych instrukcji dotyczcych pozyskiwania lisów gu bdzie omawiany podczas regularnych spotka eterynarii z wojewódzkimi inspektorami ds. zwierzt.

Medlemsstatens svar

rynarii przeslal do wojewódzkich lekarzy znak GIWz.400/W-10/18/12 z dnia 3 sierpnia 2012 r., Page: 1 G(SANCO)2012-6391 of an audit carried out from 16 to 20 he Competent Authority edury opisane w rozporzdzeniu Ministra oju Wsi z dnia 7 stycznia 2005 r. w sprawie lizny (Dz. U. Nr 13, poz. 103) powinny by wlocznie oraz odpowiednio udokumentowane; cyzje powiatowego lekarza weterynarii nia wcieklizny powinny by wydawane celu potwierdzenia lub wykluczenia choroby hmiast przekazywane do laboratorium; bd zabite, które podejrzane jest izn) lub zakaenie wirusem wcieklizny naley aboratoryjnym w kierunku wcieklizny; tach kolejnych wojewódzcy lekarze weterynarii wanych planowych kontroli z zakresu zwalczania zwierzt powinni zwróci szczególn uwag na nistracyjne powiatowych lekarzy weterynarii nia wcieklizny, w tym realizacj zapisów wyej porzdzenia. h kontroli przeprowadzonych w 2012 r. przez weterynarii zostanie zebrana przez Glównego celem analizy, która posluy nastpnie przy wego planu kontroli na 2013 r. Plan ten bdzie lomie roku. Nastpnie z poziomu centralnego G(SANCO)2012-6391 of an audit carried out from 16 to 20 ction Proposed by the Competent Authority ostan przeprowadzone kontrole w wyb

Medlemsstatens svar

oratorium Referencyjne ds. Wcieklizny planuje bada porównawczych z zakresu testu TC oraz RFFIT izacji zalecenia: do 30 grudnia 2012 r.

Medlemsstatens svar

ie laboratoria regionalne zapewnily, e badania zwizane giem wystpowania wcieklizny zostan poddane , jeli nie byly jeszcze akredytowane: ium regionalne (Zaklad Higieny Weterynaryjnej) y ­ test TC po audycie w maju 2012 r., natomiast test zgloszony do oceny Polskiego Centrum Akredytacji ym audycie, ium regionalne (Zaklad Higieny Weterynaryjnej) w Lodzi glosi do akredytacji w I polowie 2013 r., ium regionalne (Zaklad Higieny Weterynaryjnej) ­ test izolacji wirusa w hodowli komórek my (RTCIT) poddany bdzie akredytacji w padzierniku ium regionalne (Zaklad Higieny Weterynaryjnej) test izolacji wirusa w hodowli komórek neuroblastomy o audycie akredytacyjnym w maju 2012 r. (Pomimo Page: 3 G(SANCO)2012-6391 of an audit carried out from 16 to 20 a, cji

Medlemsstatens svar

ialania majce na celu wprowadzenie zmian do ustawy z dnia zt oraz zwalczania chorób zakanych zwierzt regulujcej ogramów, dotyczce sposobu wdraania programów do ycie nowelizacji ww. ustawy organem wlaciwym do gramów bdzie minister wlaciwy ds. rolnictwa, a nie jak ozwoli na skrócenie czasu prowadzenia prac legislacyjnych, a wprowadzaniu programów. prace nad opracowaniem instrukcji dla powiatowych lekarzy erania próbek urzdowych w stadach kur hodowlanych, kur i rzenych, zgodnie z rozporzdzeniami Komisji lnych grup produkcyjnych, niezalenie od obowizywania nia programów zwalczania niektórych serotypów Salmonella. ciu o przepisy art. 19 ust. 3 ustawy z dnia 29 stycznia 2004 2010 r. Nr 112, poz. 744, z pón. zm.). Informacje o wprowadzeniu ego obowizku na terenowe jednostki Inspekcji Weterynaryjnej jewódzkimi inspektorami ds. zdrowia i ochrony zwierzt, która

Medlemsstatens svar

opracowaniem instrukcji dla powiatowych lekarzy ania dziala w kadym przypadku stwierdzenia zianych w art. 54 rozporzdzenia (WE) nr 882/2004. acowana do koca czerwca 2013 r. yczne GLW przewidujce, e w przypadku stwierdzenia bdzie wydawal decyzj administracyjn zakazujc Page: 1 port ref. DG(SANCO)/2012-6442-MR of an audit carried out rol Programmes in particular poultry populations (breeders, ompetent Authority ych pochodzcych ze stad, w których stwierdzono wynik dodatni imurium w próbkach urzdowych, z wyjtkiem kierowania takich jaj tan poddane obróbce cieplnej gwarantujcej zniszczenia paleczek owywaniu programów na rok 2014 i lata nastpne, zaproponuje cy, i przy przemieszczaniu do rzeni drobiu, który nie byl badany rozporzdzeniu ustanawiajcym cel unijny oraz wymaganiami ie zdrowia naley zaznaczy fakt pochodzenia drobiu ze stada o ella. Szczególowe wytyczne dla organów terenowych IW, si w opracowywanej instrukcji GLW.

Medlemsstatens svar

pimie GIWz-400-10/2013(1) z dnia 21 lutego 2013 r., okresie obowizywania przepisów wdraajcych w ycie w Salmonella w stadach drobiu obowizuje zakaz stosowania noszcy si do serotypów Salmonella objtych przedmiotowymi azanych w art. 2 ust. 2 Komisji (WE) nr 1177/2006 z dnia 1 rozporzdzenia (WE) nr 2160/2003 Parlamentu Europejskiego i ych stosowania szczególnych metod kontroli w ramach elli u drobiu. Instytutu Weterynaryjnego-Pastwowego Instytutu ) o opini dotyczc skutecznoci eliminacji Salmonella w wdrobnoustrojowych. W wietle przedmiotowej opinii owych w celu eliminacji Salmonella w stadach drobiu jest Page: 2 port ref. DG(SANCO)/2012-6442-MR of an audit carried out rol Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority iatowym lekarzom weterynarii powyszych informacji oraz ich stia ta byla równie poruszana na naradzie GLW z a i ochrony zwierzt, która odbyla si w dniach 4-5 lutego 2013 r.

Medlemsstatens svar

zkolenie pracowników merytorycznych odpowiedzialnych za rajowych programów na poziomie wojewódzkich inspektoratów iedzialnych za wypelnianie tabel finansowych oraz ryjnej odpowiedzialnych za przygotowanie sprawozda z ia wyjaniono wtpliwoci oraz wskazano na co zwraca uwag ajmujcy si ww. programami w Glównym Inspektoracie rdziej wnikliwej analizy sprawozda otrzymywanych z ii.

Medlemsstatens svar

ich inspektorów ds. zdrowia zwierzt i zwalczania chorób ierania próbek w ramach programów. Polecono skadowych dla powiatowych lekarzy weterynarii, w weterynarii oraz lekarzy urzdowych pobierajcych nia 21 lutego 2013 r.). Informacje o liczbie osób kaza GLW do dnia 29 marca 2013 r.; lenie w ramach Programu wieloletniego PIW-PIB w Pulawach ratów weterynarii pt. ,,Zwalczanie i ograniczanie ramów: brojler, nioska, reprodukcja, indyki, trzoda"; arzy weterynarii oraz zwizków branowych GIWb-5011- Page: 3 port ref. DG(SANCO)/2012-6442-MR of an audit carried out rol Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority ia 7 grudnia 2012 r.), w których okrelil zasady cucha ywnociowego, w przypadku stwierdzenia koniecznoci wpisywania do lacucha ywnociowego dla stwierdzonych serotypów Salmonella, bez wzgldu na to lanuje: e w ramach Programu wieloletniego PIW-PIB w Pulawach dla naryjnej; owiatowych lekarzy weterynarii okrelajcej zasady postpowania ze ci w odniesieniu do obowizku pobierania próbek urzdowych rzepisów w sprawie wprowadzenia programów (patrz odp. na dawania decyzji administracyjnych zgodnie z art. 54 rozporzdzenia na rekomendacj nr 2); ur

Medlemsstatens svar

nr 5.

Medlemsstatens svar

nr 5. Page: 5 port ref. DG(SANCO)/2012-6442-MR of an audit carried out rol Programmes in particular poultry populations (breeders, Action Proposed by the Competent Authority Page: 6

Medlemsstatens svar

nr 5.

Medlemsstatens svar

nr 5. port ref. DG(SANCO)/2012-6442-MR of an audit carried out rol Programmes in particular poultry populations (breeders, ity

Medlemsstatens svar

go produktów ubocznych ie NO/PG zapewni rozporzdzenie si w sprawie wymaga weterynaryjnych pszaczy gleby, wytworzonych z zwierzcego, produktów pochodnych Projekt rozporzdzenia znajduje si na dury legislacyjnej. Przepis ten pozwoli . produktami, a take jednolite ich stosowania NO/PG, zgodnie z orzdzeniem wykonawczym 142/2011.

Medlemsstatens svar

omnial podleglym slubom o acji podmiotów dzialajcych w sektorze otu jak równie stosowania ubocznych o oraz produktów pochodnych jako gleby. Podkrelil e wytwarzanie, obrót ch i polepszaczy gleby moe odbywa prawnionymi. Dodatkowo powysze szkolenia organizowanego przez maju i czerwca 2012 r. W szkoleniu

Medlemsstatens svar

owal instrukcj w sprawie zasad , towarzyszcym przesylkom zwierzcego oraz produktów icznych i polepszaczy gleby). ctwem wojewódzkich lekarzy m weterynarii. Zasady obowizujce osed by the Competent Authority owej oraz kontrola takiej lenia organizowanego przez i czerwca 2012 r. W szkoleniu

Medlemsstatens svar

lnictwa i Rozwoju Wsi zalecilo narii w Pulawach przeprowadzenie wego jako domieszki do NO/PG, niesmaczny dla zwierzt lub w mieszaniny do celów ywienia yl w lutym 2012 roku i orzekl, e zanego z PAP/MBM powoduje ania tej mieszaniny. Przeliczenia O) w czystym skladniku owinna wynosi 30%. Przeliczenie e poniewa na rynku dostpne s aO (43 do 80%). tego skladnika CaO w 100 kg o do obliczania dawki nawozu awozu z CaO w kg do nia 100 kg produktu. ie rozporzdzenia Ministra ymaga weterynaryjnych dla gleby, wytworzonych z produktów roduktów pochodnych lub z Action Proposed by the Competent Authority

Medlemsstatens svar

wal instrukcj dotyczc rejestrów, mioty wysylajce, ganiczne i polepszacze gleby. atowych lekarzy weterynarii za erynarii. Dodatkowo omawiane podczas szkole Weterynarii w maju i czerwcu

Medlemsstatens svar

omnial podleglym slubom o larnych kontroli podmiotów wprowadzania do obrotu jak równie epszaczy gleby. Polecil aby podstawie analizy ryzyka, okrelil pismo + zalcznik 7 instrukcji). y w trakcie kontroli w/w ag na prawidlowo andlowych. ie szkolenia organizowanego maju i czerwca 2012 r. W w.

Medlemsstatens svar

strukcj zmieniajc dotychczas oposed by the Competent Authority Pasz w zakresie próbkobrania w ialek w paszach. Zgodnie z eranych bdzie w h zwierzta, wraz z porednio z karmidel oraz pasz a potrzeby wlasne.

Medlemsstatens svar

zce dziala podejmowanych w przypadku iu do nawozów organicznych oraz , zostaly przedstawione w ch co 6 tygodni przez Ministerstwo dilsava Miko, Zastpcy Dyrektora o ds. Zdrowia i Konsumenta.

Medlemsstatens svar

za nieprzestrzeganie tzw. zakazu w Polsce w II polowie 2013 r. d dzialania restrykcyjne polegajce uboju z przeznaczeniem do nych przy uyciu niedozwolonych szych sankcji przedstawiono misji w dniach 2 ­ 5 lipca 2012 r.

Medlemsstatens svar

cji Glównego Lekarza Weterynarii w sprawie zakresu i sposobu owego program bada kontrolnych dioksyn, furanów, ch polichlorowanych bifenyli (dl-PCB) i niedioksynopodobnych w produktach pochodzenia zwierzcego (Instruction of the Chief cer No. GIWlab-83-6/10 of 10 May 2010 on the scope and method tation of the national programme of control tests for dioxins, like polychlorinated biphenyls (dl-PCBs) and non-dioxin-like PCBs products of animal origin) w roku 2013 r. zostanie dodany nowy cy monitoringu dioksyn i PCB w rybach baltyckich oraz gdzie uwzgldnione zostan: przepisy szczególowe ustanawiajce ia próbek do celów kontroli urzdowej poziomów dioksyn i PCB z omisji (UE) nr 252/2012 z dnia 21 marca 2012 r. oraz wytyczne skiej opisujce szczególowo pobieranie próbek ryb do badania chemicznych pa.eu/food/chemicalsafety/contaminansts/diokxins_en.htm).

cji Glównego Lekarza Weterynarii w sprawie zakresu i sposobu owego program bada kontrolnych dioksyn, furanów, ch polichlorowanych bifenyli (dl-PCB) i niedioksynopodobnych w produktach pochodzenia zwierzcego (Instruction of the Chief cer No. GIWlab-83-6/10 of 10 May 2010 on the scope and method tation of the national programme of control tests for dioxins, like polychlorinated biphenyls (dl-PCBs) and non-dioxin-like PCBs products of animal origin) w roku 2013 r. zostanie dodany nowy cy monitoringu dioksyn i PCB w rybach baltyckich oraz gdzie uwzgldnione zostan: przepisy szczególowe ustanawiajce ia próbek do celów kontroli urzdowej poziomów dioksyn i PCB z omisji (UE) nr 252/2012 z dnia 21 marca 2012 r. oraz wytyczne skiej opisujce szczególowo pobieranie próbek ryb do badania chemicznych pa.eu/food/chemicalsafety/contaminansts/diokxins_en.htm).

Medlemsstatens svar

eterynarii w dniu 26 czerwca 2012 roku zwrócil si do owego Instytutu Weterynarii ­ Pastwowego Instytutu Pulawach z prob o zorganizowanie praktycznego szkolenia dla zy weterynarii z zakresu audytowania systemu HACCP w odukujcych ywno pochodzenia zwierzcego. Szczególy ww. alane w chwili obecnej, ale wstpnie ustalono, e zorganizowane e w terminie wrzesie-padziernik 2012 r. dla okolo 120 osób (2 grupy). Page: 1 Action plan received from CA 24 August 2012 ref. DG(SANCO)/2012-6504-MR of an audit carried out , furans and PCBs in fish from the Baltic region tion Proposed by the Competent Authority dzie m.in. zwrócenie uwagi na najczciej wystpujce bldy w rzeprowadzanej przez zaklady dla poszczególnych grup powiednio planach bada wlacicielskich, jak równie poprawa ów weterynaryjnych UE dotyczcych ww. zagadnie. wielu platnych szkole komercyjnych organizowanych dla ii poprzez firmy zewntrzne, Weterynaryjne Centrum lomowego w Pulawach co roku realizuje, w ramach programu chrona zdrowia zwierzt i zdrowia publicznego", szkolenie nt. lekarzy weterynarii dokumentacji systemu HACCP w zakladach pochodzenia zwierzcego. Nabór na ww. szkolenie jest podstawie zglosze zainteresowanych urzdowych lekarzy re

eterynarii w dniu 26 czerwca 2012 roku zwrócil si do owego Instytutu Weterynarii ­ Pastwowego Instytutu Pulawach z prob o zorganizowanie praktycznego szkolenia dla zy weterynarii z zakresu audytowania systemu HACCP w odukujcych ywno pochodzenia zwierzcego. Szczególy ww. alane w chwili obecnej, ale wstpnie ustalono, e zorganizowane e w terminie wrzesie-padziernik 2012 r. dla okolo 120 osób (2 grupy). Page: 1 n plan received from CA on 24/8/2012 and update received re Rec. N°3 on 20/11/2012 ref. DG(SANCO)/2012-6504-MR of an audit carried out , furans and PCBs in fish from the Baltic region tion Proposed by the Competent Authority dzie m.in. zwrócenie uwagi na najczciej wystpujce bldy w rzeprowadzanej przez zaklady dla poszczególnych grup powiednio planach bada wlacicielskich, jak równie poprawa ów weterynaryjnych UE dotyczcych ww. zagadnie. wielu platnych szkole komercyjnych organizowanych dla ii poprzez firmy zewntrzne, Weterynaryjne Centrum lomowego w Pulawach co roku realizuje, w ramach programu chrona zdrowia zwierzt i zdrowia publicznego", szkolenie nt. lekarzy weterynarii dokumentacji systemu HACCP w zakladach pochodzenia zwierzcego. Nabór na ww. szkolenie jest podstawie zglosz

Medlemsstatens svar

rawidlowociami stwierdzonymi przez zespól prowadzcy audyt wanych województw w zakresie systemu HACCP wlaciwy Weterynarii wystosowal pismo do podleglych powiatowych ii nakazujce weryfikacj analizy zagroe w zakladach óbk ryby baltyckiej. Polecono sprawdzenie czy zakladowe zgldniaj wszystkie moliwe zagroenia z uwzgldnieniem ksynami, histamin i benzoapirenem oraz czy badania rowadzone we wlaciwych kierunkach z odpowiedni W przypadku wykrycia nieprawidlowoci polecono podmiotów modyfikacj planu HACCP. Ponadto podczas ge: 2 Action plan received from CA 24 August 2012 ref. DG(SANCO)/2012-6504-MR of an audit carried out , furans and PCBs in fish from the Baltic region the Competent Authority ce po zakoczonym audycie przekazano powiatowym i wyniki audytu na terenie calego województwa, podkrelajc nia w analizie zagroe we wszystkich zakladach ochodzenia zwierzcego zanieczyszcze wymienionych isji (WE) nr 1881/2006 z dnia 19 grudnia 2006 r. dzeniem Komisji (UE) nr 1259/2011 z dnia 2 grudnia 2011 przypadku uzyskania wyniku badania niezgodnego z prawem dj wszelkie dzialania zmierzajce do wycofania z rozpatrzy konieczno przeslania powiadomienia w . programu monitorigu dioksyn, furanów I PCB w 2013

rawidlowociami stwierdzonymi przez zespól prowadzcy audyt wanych województw w zakresie systemu HACCP wlaciwy Weterynarii wystosowal pismo do podleglych powiatowych ii nakazujce weryfikacj analizy zagroe w zakladach óbk ryby baltyckiej. Polecono sprawdzenie czy zakladowe zgldniaj wszystkie moliwe zagroenia z uwzgldnieniem ksynami, histamin i benzoapirenem oraz czy badania rowadzone we wlaciwych kierunkach z odpowiedni W przypadku wykrycia nieprawidlowoci polecono podmiotów modyfikacj planu HACCP. Ponadto podczas ge: 2 n plan received from CA on 24/8/2012 and update received re Rec. N°3 on 20/11/2012 ref. DG(SANCO)/2012-6504-MR of an audit carried out , furans and PCBs in fish from the Baltic region the Competent Authority ce po zakoczonym audycie przekazano powiatowym i wyniki audytu na terenie calego województwa, podkrelajc nia w analizie zagroe we wszystkich zakladach ochodzenia zwierzcego zanieczyszcze wymienionych isji (WE) nr 1881/2006 z dnia 19 grudnia 2006 r. dzeniem Komisji (UE) nr 1259/2011 z dnia 2 grudnia 2011 przypadku uzyskania wyniku badania niezgodnego z prawem dj wszelkie dzialania zmierzajce do wycofania z rozpatrzy konieczno przeslania powiadomienia w . programu mo

Medlemsstatens svar

he first quarter of 2011, GVI is planning to introduce an instruction concerning the procedures to be followed by the Veterinary Inspectorate in crisis situations related to launching unsafe food of animal origin on he market. This deadline has been changed due to the necessity of ended legal consultations regarding the abovementioned instruction. The contingency plan will be specified and implemented by the State Sanitary Inspection by the end of the first half of 2011.

Medlemsstatens svar

ursuant to the procedures specified in the Instruction of the CVO No GIWhig-500-3/08 of 20 March 2008 on the procedures to be followed by the Veterinary Inspectorate authorities during approval, conditional approval and registration of establishments in the food sector as well as suspension and withdrawal of approvals granted to such establishments, upon receiving a request for approval of an establishment, DVO shall conduct an inspection of this establishment in the scope of its compliance with the requirements specified in the provisions of the EU law concerning food. Where the establishment's compliance with these requirements is confirmed, the establishment shall be approved, by way of decision of DVO, for conducting the activity specified in the request. DVO shall submit this information, together with relevant documentation, to RVO. Page: 1 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty control systems in place governing the production and placing on f the received CVO in order to include VO's approval by ion be negative, the gularities in the scope ent, the establishment - 500 - 11/07 of 14 ections of entities in e Veterinary Inspectorate a risk analysis on the

Medlemsstatens svar

Department of Hygiene of Food of Animal Origin at PIWet-PIB, the National Reference Laboratory, organises annual proficiency tests (PT) in directions within the scope of reference under food microbiology, i.e. Salmonella spp., Campylobacter spp., Escherichia coli, including verotoxic E. coli, Listeria monocytogenes, as well as coagulase-positive staphylococci, including Staphylococcus aureus. Participants of these tests include the laboratories of the Veterinary Inspectorate (Department of Veterinary Hygiene) and laboratories approved by the Chief Veterinary Officer for carrying out official tests. Every year, two or three rounds of such PTs take place in the scope of all reference directions, pursuant to the Regulation of the Minister of Agriculture and Rural Development of 23 December 2010 on national reference laboratories. The completion of each round is followed by a report concerning the results obtained by the test participants. These results, depending on the type of the test, are assessed as compliant/incompliant (for qualitative tests) or satisfactory, dubious and unsatisfactory (for quantitative tests). All incompliant, dubious and Page: 3 of Mission Report ref. DG(SANCO

Medlemsstatens svar

DVO shall conduct comprehensive inspections in the establishment ccording to the frequency determined on the basis of the risk analysis. e Should the inspection determine irregularities in the scope of compliance ith the requirements of the food law, DVO shall institute administrative roceedings, imposing a decision on the establishment to remove the rregularities, as well as proceedings concerning a pecuniary penalty in elation to these irregularities. The amount of a given pecuniary penalty hall be determined pursuant to the Regulation of the Minister of griculture and Rural Development on pecuniary penalties for violating rovisions concerning products of animal origin of 19 December 2006 Journal of Laws of 2007 No 2, item 22, as amended) hould pecuniary penalties be ineffective and should the establishment ontinue to violate the requirements or should the violations be material present hazard to the health or life of people), DVO shall issue a ecision withholding the production/suspending the approval of the stablishment. hould the establishment prove that it complies with relevant Page: 5 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty control systems in place gove

Medlemsstatens svar

ticle 4 of Regulation (EC) No 882/2004 was implemented by way of ternal regulation, i.e. Instruction of the Chief Veterinary Officer No 0.2/2010 of 26 November 2010 on internal audit of official controls nducted by the authorities of the Veterinary Inspectorate. According to e instruction, these authorities comprise the Chief Veterinary Officer d regional veterinary officers. Audit management is within the scope competence of audit representatives. The audit schedule for 2011 has en developed for the entire VI by CVO's audit representative, proved by the Chief Veterinary Officer and distributed in order to be plemented. e instruction can be found on the GVI's website, in the Veterinary law b - - Veterinary Inspectorate - National legislation - Instructions of the O - Instruction of the CVO-Internal audit of the VI. is is where the annual schedule of VI audits for 2011 will be blished.

Medlemsstatens svar

n the region, there is an applicable procedure for confirming the ualifications of veterinarians prior to entrusting them with official tions in the scope of supervision over slaughter plants. Once the terinarian has completed the period of service pursuant to the gulation of the Minister of Agriculture and Rural Development on the ope of activities performed by persons who are not the employees of e Veterinary Inspection and on the qualifications of such persons of 22 ril 2004 (Journal of Laws No 89, item 860, as amended), an Page: 7 Ref. Ares(2010)774986 - 04/11/2010 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty control systems in place governing the production and placing on Action Proposed by the Competent Authority examination is run at the RVI in order to confirm that the veterinarian has the knowledge in the scope of conducting ante-mortem and post- mortem inspections. Only upon obtaining a positive examination result does the veterinarian receive a certificate authorising them to be appointed by DVO. Veterinarians are subject to a system of continuous education, carried out by RVI and - in part - by DVI. An agreement with the veterinarian supervising the esta

Medlemsstatens svar

DVO prepares the annual control plan covering all entities in the register t by the District Veterinary Officer. The frequency of inspections of dividual entities is determined on the basis of risk analysis conducted for every establishment pursuant to the Instruction of the CVO No Page: 8 010)774986 - 04/11/2010 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty control systems in place governing the production and placing on osed by the Competent Authority 0 - 11/07 of 14 August 2007 on determining the frequency ons of entities in the food sector under official supervision of

Medlemsstatens svar

ary Inspectorate on the basis of risk analysis. incompliances are determined, administrative proceedings ed at the establishment. t to establishments where incompliances were determined ts carried out by FVO inspectors, proceedings have been n order to remove the irregularities and withhold the production time; these included an order to improve the venting system and ensure appropriate protection of unpackaged products sk of contamination. Administrative proceedings were also ith respect to imposition of pecuniary penalties in relation to ned irregularities. inspected establishments is currently undergoing on (expansion), which is expected to be completed in 2011. As a result, the production will be transferred to the of the premises, compliant with high sanitary and technical The remaining premises will then be excluded from operation comprehensive renovation. Additionally, official ns supervising the establishments have been trained and unconditionally enforce the requirements in the scope of document the determined irregularities. ve inspections are carried out in the establishments Ref. Ares(2010)774986 - 04/11/2010 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty

Medlemsstatens svar

ges Pursuant to the Instruction of the CVO No GIWb - 500 ­ 1/10 of 23 Page: 10 Ref. Ares(2010)774986 - 04/11/2010 of Mission Report ref. DG(SANCO)/2010-8452-MR carried out ty control systems in place governing the production and placing on tion Proposed by the Competent Authority rch 2010 on conducting official controls in the scope of the possibility f tracking products of animal origin and marking them, DVO conducts I inspections at establishments in the scope of identifiability of products, eir correct marking and systems allowing for tracking of the suppliers d customers. ere the product dispatched from or introduced into the establishment not marked correctly - which was the case during the audit conducted FVO inspectors - DVO initiates administrative proceedings. DVO rried out an inspection at the establishment which - during the FVO ntrol - contained 19 crates of deeply frozen product which was correctly marked as well as 3 crates whose labels did not specify the st-before date. DVO ordered that the incompliant products be bmitted to the authority competent for processing by-products of imal origin. By way of administrative decisions, DVO ordered that oducts made at the esta

Medlemsstatens svar

ing the audit, it was found that the provisions of Regulation (EC) No 005 had not been implemented into the establishment's procedures in case of detecting Salmonella rods in poultry carcasses during the inspection of microbiological controls of process hygiene. It erefore ordered, by way of administrative decision, that controls of igin of animals and of biological safety at their holdings of origin roduced. Follow-up recommendations have been fulfilled through entation of a procedure for notifying the owner of the animals detection of Salmonella rods and for sending a recommendation provement of biological safety at the holding. er, official supervision over the establishments has been sed by more frequent verifications of documents related to the tion of implementing the provisions of Regulation No 2073/2005. nt to DVO's instruction, the establishment has presented an d schedule of microbiological tests, which is currently being ed. Page: 12