Czech Republic

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The auditors noted based on data from TRACES, that 60% (391 of 648) of consignments of chilled goods of non-animal origin intended for human consumption entered the EU at the airport BCP Prague-Ruzyne, which is not designated for that category of goods (see also finding No. 23).

The auditors, however, made the following observations at one control point visited regarding consignments of rice from Pakistan, subject to the conditions and measures laid down in Implementing Regulation (EU) 2019/1793 that were authorised for transfer from BCPs in another Member State to the control point, on the request of the food business operator pursuant to Article 3(1)(a) of Commission Delegated Regulation (EU) 2019/2123: a. The consignments did not arrive at this control point, although the competent authorities responsible for checks at the control point indicated the arrival at this control point in part III of the relevant CHEDs, which is not in line with Article 6(2) of Delegated Regulation (EU) 2019/2123. The consignments arrived instead at its destination; the food business operator visited. The premises of the food business operator were not designated by CAFIA as control point for goods of non-animal origin. b. The food business operator had created subsequent CHEDs in line with Article 2(1)(d) of Delegated Regulation (EU) 2019/2123 and had indicated the control point visited as place of control. The identity and physical checks, including sampling were however actually carried out at the food business operator's premises and not 7 at the control point, which is not in line with Article 6(1) and (3) of Delegated Regulation (EU) 2019/2123. c. The competent authority stated that reason for performing checks at the food business operator's premises instead of the control point was that the control point visited did not have access to the necessary equipment to unload and sample consignments, which are in large volume flexi-tanks, which the food business operator has. d. According to TRACES, in the period between January 2024 and November 2025 only 10% (11 out of 108) of consignments that were transferred to the control point, on request by the operator responsible for the consignment, for the performance of identity and physical checks, including sampling, had actually been subject to such checks, which is not in line with Article 6(1) of Implementing Regulation (EU) 2019/1793, in conjunction with Article 3(1) of Delegated Regulation (EU) 2019/2123. 5.3.2 Decisions on consignments and follow-up

The competent authorities ensured that official controls on animals and goods entering the EU are implemented in line with relevant EU legislation and documented procedures in place with the exception of official controls on consignments of goods of non-animal origin intended for human consumption transferred by BCPs in another Member State to the sole control point designated for goods of non-animal origin and the controls on consignments of chilled goods of non-animal origin which are carried out at BCPs not designated for this category of goods.

The auditors made the following observations at the airport BCP Prague-Ruzyne: a. based on data in TRACES, in the period January 2024 to November 2025, 60% (391 of 648) of consignments of good of non-animal origin intended for human consumption entered the EU at this BCP were chilled. The authorities performed official controls on such goods at the airport BCP despite the fact that Czechia did not designate the airport BCP for performing official controls on the category chilled goods of non-animal origin intended for human consumption (food), which is not in line with Article 59(1) in conjunction with Article 64(3)(b) of the OCR. b. the inspection area for controls on goods of non-animal origin is not equipped with a supply of hot and cold running water and facilities for washing and drying hands, 9 which is not in line with Article 64(3)(c) of the OCR and Article 3(1)(b) of Implementing Regulation (EU) 2019/1014.

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The auditors made the following observations at the airport BCP Prague-Ruzyne: a. based on data in TRACES, in the period January 2024 to November 2025, 60% (391 of 648) of consignments of good of non-animal origin intended for human consumption entered the EU at this BCP were chilled. The authorities performed official controls on such goods at the airport BCP despite the fact that Czechia did not designate the airport BCP for performing official controls on the category chilled goods of non-animal origin intended for human consumption (food), which is not in line with Article 59(1) in conjunction with Article 64(3)(b) of the OCR. b. the inspection area for controls on goods of non-animal origin is not equipped with a supply of hot and cold running water and facilities for washing and drying hands, 9 which is not in line with Article 64(3)(c) of the OCR and Article 3(1)(b) of Implementing Regulation (EU) 2019/1014.

The auditors made the following observations at the control point visited, designated by CAFIA for ambient goods of non-animal origin intended for human consumption: · There was no dedicated inspection room or area with a supply of hot and cold running water and facilities for washing and drying hands, which is not in line with Articles 53(1)(a) and (2) and 64(3)(c) of the OCR and Article 3(1)(b) of Implementing Regulation (EU) 2019/1014; and · The control point has no equipment to handle and sample large volume flexi-tanks referred to in finding No. 16 nor were such consignments excluded in their specification. Conclusion on the compliance of border control posts and control points with minimum requirements

The competent authorities, however, did not ensure that BCPs and control points designated for categories of goods of non-animal origin are only listed if compliant with the rules on minimum requirements for BCPs.

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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.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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CISTA considers the substances that are candidates for substitution to be the active substances of particular concern referred to Article 4.1 of the SUD, and their comparative assessment, in line with Article 50 of Regulation (EC) No 1107/2009, as fulfilling the requirements of that article. While data on the consumption of all active substances are available to monitor their use5, timetables and targets for the reduction of use for active substances of particular concern have not been established as stipulated by Article 4(1) second subparagraph of Directive 2009/128/EC. However, additional active substances that are either widely used or used in specific crops have been selected for close monitoring of their sales. Under Target IV, low-risk substances and their placing on the market has been facilitated by carrying out a free evaluation in the case of micro-organisms or reduced evaluation fees. Conclusions on the National Action Plan

The NAP addresses all necessary aspects of the SUD and sets quantitative objectives, targets, measures and timetables to reduce risks and impacts of PPP use, with the exception of active substances of particular concern. Interim review reports of the NAP allow for a comprehensive assessment of its implementation at the end of each five- year cycle. For the period 2018-2022, the review concluded that 90% of the measures were fully or partially implemented.

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In 2014, CISTA made an initial attempt to assess the implementation of each of the general principles of IPM for field crops by introducing a point-based system. Under this system, failure to reach a minimum required score resulted in penalties. However, the initiative was eventually abandoned due to its administrative burden and the difficulty with enforcing strict rules against the general principles in the SUD. In addition, CISTA also stated that the usefulness of the results produced following this process is questionable.

Building on this experience, the monitoring of the implementation of IPM general principles in Czechia is now carried out through an annual survey of a representative sample of 104 arable crop producers. Since a large proportion of fruit and vine growers voluntarily participate in the integrated crop production system, they are not included in the IPM survey carried out by CISTA. This approach is not in line with Article 14(4) of the SUD stipulating that the MS should ensure that the general principles of the IPM set out in Annex III of the SUD are implemented by all professional users. In addition, this approach does not provide for the penalties required by Article 17 of the SUD (and Article 139 of Regulation (EU) 2017/625) when IPM is inadequately implemented.

The questionnaire used in the annual survey provides a detailed breakdown of the components of the general principles of IPM. The data collected offers insights into soil and fertilisation practices, cultivation strategies, and plant protection methods. Completing the questionnaire is mandatory. Responses indicating non-compliance with the IPM principles do not result in penalisation of the farmers. This approach ensures that the data collected is unbiased. Based on the survey results, it has been estimated that farmers with arable crops implement on average 54% of the detailed breakdown of the IPM general principles. It should be noted that not all IPM elements are necessarily compatible with every crop or cultivation system, e.g. crop rotation is not feasible in perennial tree crops. MoA stated that they are aiming to increase that percentage by 5% as stated in the fourth bullet point in Target IV of the NAP (see also paragraph 12 above).

The Research Institute for Forest Management is responsible for implementing IPM in forestry. IPM implementation for non-agricultural uses does not fall under the competence of CISTA and is therefore not included in the survey or in any specific scheme, such as those for vineyards and orchards. Conclusions on Integrated Pest Management

For arable crops, the CAs have converted the general principles of IPM into practical and measurable criteria. However, these criteria are not verified during on-farm inspections. Only agricultural practices that relate to specific obligations under certain SMRs and GAECs are verified by inspection. Fruit and vine growers may voluntarily participate in IPM accreditation schemes. Consequently, the enforcement of the general 17 principles of IPM is limited.

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The 2018-2022 evaluation report regarding the implementation of the NAP highlights that in Czechia there is no legally established obligation to report acute or chronic poisoning incidents of persons exposed i.e. to spray drifts. IHIS is the only source of information concerning poisoning associated with hospitalisation. However, incidents are usually registered under a clinical diagnosis and not as poisoning by PPPs. Therefore, it is common to underestimate or not find the actual cause of reported poisoning incident. MoH stated that collecting data on PPP acute and chronic poisoning from the National Register of Occupational Diseases is problematic as the reason that 18 caused the poisoning incident cannot always be established. In addition, poisoning incidents cannot be identified with certainty as caused by a PPP, when the active substance in question has both biocidal and PPP uses.

There is no system in place for gathering information specifically for PPPs acute poisoning incidents and the records available do not distinguish between acute incidents caused by PPPs or biocides. There are no implementing provisions in place to inform persons who might be exposed to PPPs other than those indicated in the PPP labels.

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With regard to method validation, the audit team observed that while the majority of requisite validation parameters (60) had been adequately addressed in the corresponding method validation files, a number of deficiencies were identified: 1. In one laboratory, there was a sufficient number of measurements for the assessment of the recovery and the reproducibility at all of the (>three) fortification levels. However, and contrary to EU requirements (61), the reproducibility was calculated for only one of the levels and even this single value was not systematically assessed against the criteria set in the legislation (62). Furthermore, the audit team saw two methods where the reproducibility exceeded said legal criteria ­ however, impact of those deviations on the outcome of the validation was not analysed in a documented traceable manner (63). Similar deficiency was observed for recoveries detected beyond the acceptability ranges (64)(65). 2. In another laboratory, for the assessment of reproducibility, only one or two series of measurements for each of three fortification levels were performed for all of the methods scrutinised which contradicts pertinent requirements (66) (that at least three series shall be assessed for the within-laboratory reproducibility). In this way, the statistical confidence of the reproducibility assessment was not at the level required in said legislation. Furthermore, reproducibility was calculated as one value for all concentrations which is not in line with the procedure set in legislation (65). Moreover, no assessment of the relation between the repeatability and reproducibility was performed systematically, the (60) For pharmacologically active substances ­ Table 5 in part 2.1. of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. For pesticides ­ Analytical quality control and method validation procedures for pesticide residues analysis in food and feed (SANTE 11312/2021). For contaminants ­ Commission Regulation (EC) No 333/2007, Commission Regulation (EC) No 401/2006, Commission Implementing Regulation (EU) 2023/2782 and Commission Regulation (EU) 2017/644. (61) Part 2.2.1.4(6). of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. (62) Part 1.2.2.2. of Chapter 1 of Annex I to Implementing Regulation (EU) 2021/808. (63) Article 3 of Implementing Regulation (EU) 2021/808. (64) Part 1.2.2.1. of Chapter 1 of Annex I to Implementing Regulation (EU) 2021/808. (65) In its response to the draft report, the competent authority stated that the deficiencies (e.g., missing calculation for all spiking levels and record on assessment against criteria, including comments on validation results out of specification) would be rectified in validation files for all methods within one year. (66) Part 2.2.1.4(5). of Chapter 2 of Annex I to Implementing Regulation (EU) 2021/808. 14 audit team noted a number of cases where repeatability exceeded reproducibility, which is not in line with legal requirements (62). The documentation seen by the audit team did not contain any comments on these deviations and their impact on the outcome of the validation(s) (67). 3. In relation to the stability of analytes in matrix which is a mandatory validation performance characteristic (68), the audit team noted that solely available external data had been gathered (e.g., reports from proficiency test providers), and that in the materials seen, in a number of cases there was no detailed information on storage conditions, or those were not identical to the conditions adopted in the laboratories and thus not applicable (66). Furthermore, the external data covered a very limited number of analytes compared to the scope of the analytical methods concerned (69).

Notwithstanding that that all of the testing laboratories are accredited to ISO 17025:2018, designated as official laboratories, have all of the analytical methods included in their respective scopes of accreditation and largely successfully participate in regular proficiency tests, some shortcomings in analytical method validation and in the operation of the internal quality control system weaken the confidence that the competent authority can have in the reliability of the results generated.

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With regard to internal quality control for the methods scrutinised, the audit team observed that a sufficient number of negative and positive control samples, fortified at the level of interest (70), was routinely included in analytical sequences, which is in line with EU requirements (71). Nevertheless, in one laboratory, contrary to legal requirements (68), trueness (on basis of fortified samples) of target analytes in the positive control samples was not evaluated by means of quality control charts; the audit team considered that other parameters used (e.g., coefficient of determination R2 of the calibration curve) did not provide sufficient information for the ongoing method performance verification. In another laboratory, the assessment criteria seen on the quality control charts (rightly created and maintained on the basis of recoveries of fortified samples) differed from those required in the laboratory's own quality control manual.

Notwithstanding that that all of the testing laboratories are accredited to ISO 17025:2018, designated as official laboratories, have all of the analytical methods included in their respective scopes of accreditation and largely successfully participate in regular proficiency tests, some shortcomings in analytical method validation and in the operation of the internal quality control system weaken the confidence that the competent authority can have in the reliability of the results generated.

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In all of the establishments visited, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on their assessment of the operators' HACCP plans. The audit team noted that the inspectors' assessment of the hazard identification part of the HACCP plan was deficient in several establishments. In general, the hazard identification part of the operators' HACCP plans was generic (e.g., the same hazards were identified for all incoming feed materials and other ingredients with an identical risk score) without the level of detail necessary for a proper hazard identification (as required by Article 6(2)(a) of Regulation (EC) No 183/2005) and consequent risk assessment. Moreover, certain relevant hazards were not identified by the operators (e.g., pesticides and genetically modified organisms in feed materials of plant origin, heavy metals in feed additives/premixtures of mineral origin or obtained via chemical synthesis). This issue was not reflected in any of the inspection reports seen and operators were thus unaware that there were deficiencies in their HACCP plans. The audit team noted that, during the interviews, some inspectors correctly identified these deficiencies.

In one feed material producer, the operator used direct drying. In the hazard analysis of this processing step, the assessment of the possible occurrence of dioxins/polychlorinated biphenyls (PCBs) had not been carried out and, consequently, there were no measures in place to monitor/control that relevant hazard. This omission was overlooked in the records of the previous official controls.

While the planning of inspections is largely based on appropriate risk-related factors and official controls are carried out on all operators on a risk basis and with an appropriate frequency, the effectiveness of controls is weakened by some shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, and (ii) operators' traceability systems (in particular collection and storage of retained samples). 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

Dne 23. 5. 2023 byli pracovníci, provádjící úední kontroly krmiváských provoz, proskoleni jak hodnotit plány HACCP, zejména cást týkající se identifikace nebezpecí provozovatelem. Dále byli proskoleni, aby zapisovali veskeré zjistné skutecnosti do zpráv z kontrol ve vtsím rozsahu. Do 31. 8. 2023 bude doplnna metodika 06/KRM Metodika posouzení systému HACCP v krmiváském provozu v cásti ukládající kontrolu pozadavk na identifikaci nebezpecí provozovatelem.

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Routine inspections include a verification of operators' traceability systems, including the operators' obligation to take samples of ingredients and from each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities, using a procedure pre-established by the manufacturer (hereinafter `retained samples'). This is required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised the operators' documentation on collection, packaging, labelling and storage of retained samples, interviewed the feed inspectors who usually control those establishments and made the following observations: · in several establishments, a significant number of the retained samples were not adequately sealed; · in general, the retained samples were formed after the material had been tested within each operator's own control programme thus the material had been subject to diverse manipulations before being retained; · in one feed material producer, no retained samples were collected (and stored) from liquid feed materials; · in another feed material producer, the retained samples were formed by aggregating material from several consecutive batches manufactured. These observations are not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and were not identified in any of the recent inspection reports seen.

While the planning of inspections is largely based on appropriate risk-related factors and official controls are carried out on all operators on a risk basis and with an appropriate frequency, the effectiveness of controls is weakened by some shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications within their hazard analyses and critical control point plans, and (ii) operators' traceability systems (in particular collection and storage of retained samples). 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

Medlemsstatens svar

Dne 23. 5. 2023 byli pracovníci, provádjící úední kontroly krmiváských provoz, proskoleni ohledn pozadavk na uchováváni zálozních vzork provozovatelem, zejména jejich odbr a uchovávání vcetn pecetní. Inspektoi byli také proskoleni o nutnosti uvádt veskeré nedostatky zjistné pi kontrole do zpráv z tchto kontrol.

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CISTA has prepared guidance on official sampling, including a sampling report template, based on the requirements laid down in Annex I to Regulation (EC) No 152/2009. However, the audit team noted that the sizes of aggregate and final samples, established for feed additives and premixtures, were considerably lower than the requirements laid down in parts 6 and 7 of Annex I to Regulation (EC) No 152/2009. No explanations were given for this discrepancy with the EU legal requirements.

The audit team observed official sampling being conducted in three compound feed manufacturers visited (the matrix and parameters to be controlled were suggested by the audit team). In all of the establishments, the feed inspectors sampled for analytes likely to be non- uniformly distributed in the matrix. The audit team noted that all of the inspectors adequately implemented the pertinent legal requirements, as established in Regulation (EC) No 152/2009. However, during the preparation of the final samples, none of the inspectors used a divider (and did not have one), as required by part 9.4 of Annex I to Regulation (EC) No 152/2009.

In the visited laboratories, validation documentation for nine analytical methods (e.g., determination of coccidiostats, heavy metals, mycotoxins, vitamins, etc.) was examined by the audit team. For eight of these there was no documented evidence on sufficient characterisation which is not in line with the requirements laid down in Article 34(4) of Regulation (EU) 2017/625. The audit team pointed out that, for standardised methods (e.g., those complying with relevant internationally recognised rules or protocols including those of the European Committee for Standardisation (CEN)), such information could be retrieved from the relevant publications.

Medlemsstatens svar

Dne 24. 5. 2023 byli pracovníci, provádjící úední kontroly krmiváských provoz, proskoleni ohledn úedního odbru vzork. Pokud jde o odbr konecných vzork doplkových látek a premix, byli pouceni o nutnosti uvést do protokolu o odbru vzorku veskeré odchylky od postupu odbru vzork podle naízení 152/2009. Dále byli pracovníci, provádjící úední kontroly krmiváských provoz, proskoleni, aby pouzívali vhodné dlice pi píprav konecných vzork krmiv, u kterých se pedpokládá nerovnomrné rozlození sledovaných látek. Tyto dlice jiz mají inspektoi na regionálních oddleních k dispozici. Page: 1 ns of report ref. DG(SANTE) 2023-7697 of the audit carried out from 06 controls on feed hygiene Action Proposed by the competent authority Do 31. 8. 2023 bude doplnna metodika 01/KRM Odbr a zacházení se vzorky krmiv, pokud jde o uvádní veskerých odchylek od naízení 152/2009 do protokolu a také pokud jde o nutnost pouzívat vhodné dlice pi píprav konecných vzork.

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In the visited laboratories, the audit team scrutinised the system of preparation of the final samples submitted for testing. In neither was there documentary evidence that the amounts weighed out, as provided for in the methods of analysis, were homogeneous and representative of the final samples. This is a requirement laid down in part A.1. of Annex II to Regulation (EC) No 152/2009. In one laboratory, a homogeneity study report for sample preparation of food samples for mycotoxin testing was presented to the audit team. The team identified that complete homogenisation had not been achieved for ochratoxin A, and that aflatoxin B1 (regulated in feed) had not been included in the study.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are appropriately designated and accredited, shortcomings in the implementation of sampling and especially in the preparation and testing of official feed samples, combined with the absence of reporting the analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

Laborato postupuje v souladu s Annex II v Naízení komise (ES) c. 152/2009, kde není postup podrobn specifikován. Detailní popis je uvedený v Jednotných pracovních postupech. Vzhledem k tomu, ze auditor se snazil splnit vsechny body svého velmi ambiciózního programu, nebylo mozné tento bod ádn diskutovat a dolozit. Nicmén v pípad mykotoxin má opravdu uvedená studie nedostatky a bude provedena znovu. Studie bude doplnna o vliv velikosti navázky a v pípad poteby budou upraveny nase Jednotné pracovní postupy. Dokoncení studie bude do konce roku 2023. Vzhledem k tomu, ze jde o administrativní pochybení, výsledky a kvalita práce nebyly ohrozeny, pouze je poteba zlepsit stav dokumentace.

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In the visited laboratories, validation documentation for nine analytical methods (e.g., determination of coccidiostats, heavy metals, mycotoxins, vitamins, etc.) was examined by the audit team. For eight of these there was no documented evidence on sufficient characterisation which is not in line with the requirements laid down in Article 34(4) of Regulation (EU) 2017/625. The audit team pointed out that, for standardised methods (e.g., those complying with relevant internationally recognised rules or protocols including those of the European Committee for Standardisation (CEN)), such information could be retrieved from the relevant publications.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are appropriately designated and accredited, shortcomings in the implementation of sampling and especially in the preparation and testing of official feed samples, combined with the absence of reporting the analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

Validacní parametry metod byly dostupné, ale pipoustíme, ze nebyly dostatecn dokumentované. Situace bude napravena tím, ze validace budou doplnny tak, aby byly kompletní a dále budou doplnny odkazy na parametry uvádné ve validaci konkrétních postup v Naízení komise (ES) c. 152/2009 nebo EN. Termín do konce roku 2023. Vzhledem k tomu, ze metody jsou validovány, výsledky a kvalita práce nebyly nedostatky ve validacní dokumentaci ohrozeny. Nedostatky v dokumentaci budou napraveny.

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For the nine analytical methods the audit team examined the internal quality control systems in place and noted that (i) the matrices used for the preparation of fortified (positive) control samples had not been identified in a documented traceable manner and thus were not metrologically traceable, (ii) two commercial reference materials had been used beyond the the validity period established by the supplier without supporting documentation proving unaltered values of the reference materials, and (iii) in one laboratory, there was no system on evaluating the acceptability of the results of multiple parallel runs; there was a system in the second laboratory visited and for LC-MS/MS methods the majority of the results of the parallel runs were consistently rejected by the statistical software due to unacceptable variation between the values. However, the methods were considered to be properly validated, accredited, and used for the purposes of the testing of official feed samples. Neither of these approaches allows for reliable assessment of the consistency of ongoing method performance.

For eight of the nine methods there were control charts which largely allowed for adequate performance monitoring. For the remaining method (pesticides) negative and positive control samples were used in all of the analytical series. Notwithstanding this, the approaches to create, maintain and interpret the control charts in both laboratories were not fully in line with their own Standard Operating Procedures.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are appropriately designated and accredited, shortcomings in the implementation of sampling and especially in the preparation and testing of official feed samples, combined with the absence of reporting the analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

Ke zjistní uvedeném v bode 41, bod i) uvádíme, ze text ID c. 15 mrnice NRL ÚKZÚZ "Zajistní kvality výsledk zkousek v NRL" bude doplnn o moznost pouzít obohacené reálné vzorky k vedení regulacních diagram výtzností. K bodu ii) ­ zde doslo jednoznacn k nepochopení. Odpovdný Page: 2 ns of report ref. DG(SANTE) 2023-7697 of the audit carried out from 06 controls on feed hygiene ction Proposed by the competent authority racovník nestihl dolozit píslusné protokoly dokládající rodlouzení doby platnosti referencních materiál. Dokumenty yly na pracovisti dostupné, ale celkový prbh auditu neumoznil a vsechny pozadavky auditora dostatecn rychle reagovat. bod iii) jde o nedorozumní. Labsystém pi prohlízení vzorku znacuje cerven vzorky s výsledky mimo deklaraci. evyhovující odchylka paralelních stanovení je uvedena mezihodnotách. Uvádné zamítnutí na základ rozdíl aralelních stanovení nebylo ani v jednom z uvedených pípad. zdy slo o výsledek mimo deklaraci. Systém hodnocení aximáln pípustných rozdíl paralelních stanovení je amozejm zaveden ve vsech laboratoích a je uvedený v ID c. 15 mrnice NRL ÚKZÚZ "Zajistní kvality výsledk zkousek NRL". omocné linie 1s nejsou pro vtsí pehlednost regulacních i

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The audit team noted that the commodity experts, in order to assess compliance, did not take into account recovery rates achieved during the analytical determinations. This information (including on correction for recovery) was not specified in the analytical reports (see finding 43). This is not in line with the legal requirements laid down in point 6 of Annex II to Regulation (EC) No 152/2009. 5.2.2.3 Testing of official feed samples

The audit team scrutinised a substantial number of analytical tests (with related raw data) and reports related to undesirable substances within the meaning of Directive 2002/32/EC and observed that, when relevant, the moisture content had been determined, the result had been accordingly recalculated to a feed with a moisture content of 12% and expanded measurement uncertainty had been properly reported. However, in none of the analytical reports seen, 9 including where non-compliances had been established, had the analytical recovery rate been indicated and the result had not been corrected for recovery. Such an approach is not in line with the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are appropriately designated and accredited, shortcomings in the implementation of sampling and especially in the preparation and testing of official feed samples, combined with the absence of reporting the analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. Cumulatively, these shortcomings weaken the overall effectiveness of the official feed control system. 5.2.3 Actions taken on non-compliances

Medlemsstatens svar

V tomto pípad bylo vzdy postupováno v souladu s Annex II Naízení komise (ES) c. 152/2009, bod C, cást 6. ude upraven vzor protokolu a ID c. 16 Smrnice NRL ÚKZÚZ Pravidla pro uvádní výsledk v Národní referencní laboratoi KZÚZ". pípad, kdy je podle Naízení komise (ES) c. 152/2009 Page: 3 ns of report ref. DG(SANTE) 2023-7697 of the audit carried out from 06 controls on feed hygiene Action Proposed by the competent authority pozadována korekce výsledk stanovení na výtznost, bude tato informace v protokolu uvádna. Termín do konce záí 2023.

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Approximately 1% of the official controls identified serious non-compliances (e.g., cross- contamination with coccidiostats/veterinary medicinal products, quality problems with produced feed). The audit team reviewed three feed safety-related non-compliances (all concerns samples taken during routine controls). Whilst the feed inspectors could provide evidence (official reports) that follow-up of these non-compliances had been carried out, the reports did not adequately indicate that the origin and extent of the non-compliance had been determined, or that the competent authority had taken appropriate measures to ensure that the operators had remedied the non-compliances and prevented further occurrences of such non- compliances. This is not in line with the requirements laid down in Article 138(1) of Regulation (EU) 2017/625.

The audit team noted that, at the time of the above-mentioned follow-ups and the audit, the central level of CISTA did not have arrangements in place to ensure the quality and consistency of the follow-up investigations carried by its regional departments. This is not in line with the requirements laid down in Article 5(1)(b) of Regulation (EU) 2017/625. The CISTA representative explained to the audit team that such a system had existed before COVID and that there is an intention to reactivate its functioning.

The audit team noted that, in another case the FeBO had not been informed by the competent authority about the non-compliance identified through official sampling. This is not in line with the requirements laid down in Article 13(2) of Regulation (EU) 2017/625. 10 Conclusion on the actions taken on non-compliances

Notwithstanding the fact that the competent authority took actions when non-compliances had been identified in the course of official controls, the competent authority did not ensure the quality and consistency of official controls in relation to (i) determination of the origin and extent of the non-compliances, (ii) operator remediation of the non-compliance, and (iii) prevention of their further occurrences. Collectively these shortcomings weaken the effectiveness of the system of official controls on feed.

Medlemsstatens svar

Dne 23. 5. 2023 byli pracovníci, provádjící úední kontroly krmiváských provoz, proskoleni ohledn prosetování nesouladu zjistného pi úedních kontrolách. Zejména byli proskoleni o nutnosti ve zprávách dostatecn dokumentovat, ze 1. byl urcen pvod/pícina a rozsah nesouladu, 2. byla pijata vhodná opatení, která nesoulad napraví 3. byla pijata vhodná opatení, která zabrání dalsímu výskytu takového nesouladu. Dále byli proskoleni o nutnosti uvádt v protokolech veskeré údaje nutné k identifikaci provozovatel odpovdných za krmivo tak, aby mohli být vsechny clánky etzce informovány v pípad zjistní nesouladu v úedním vzorku. Také byly stanoveny lhty, ve kterých musí být vzorek po odbru dopraven do laboratoe, a lhta od oznámení nevyhovujícího výsledku vedoucímu regionálního oddlení po setení nesouladu v krmiváském provozu, aby se zamezilo dalsímu prodlení. Bude obnovena supervize regionálních pracovis metodickým vedením, která povede k zajistní kvality a konzistence následných setení provádných regionálními oddleními. Tyto supervize se na vybraných regionálních pracovistích uskutecní jiz v roce 2023 a budou pokracovat i v následujících letech. Do 31. 8. 2023 bude doplnna metodika 09/KRM Hodnoc

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It was confirmed that the Czech Agriculture and Food Inspection Authority (CAFIA) cross report MRL exceedances to CISTA and this in turn triggers extraordinary controls on professional users. These extraordinary controls are carried out without any prior notice. However, the results of the annual residue monitoring programme are not used to enhance the risk based elements of choosing which professional users to inspect as required by Article 24 (2)(a) of Regulation (EU) 2017/625.

The CAs consider almost all relevant risks when developing the plan of controls on the marketing and use of PPPs, however the pesticide residues monitoring programme does not feed into the development of the professional user control plan as required by Article 24 (2)(a) of Regulation (EU) 2017/625 and entities for national controls are chosen at random.

Medlemsstatens svar

Plánované opatení k doporucení c. 1: ÚKZÚZ pi vypracování dalsích plán kontrol pouzívání POR u rofesionálních uzivatel (od roku 2023) zohlední výsledky výrocní zprávy o reziduích pesticid, které se budou týkat komodit vypstovaných v Ceské republice. K tomu vyuzije výrocní zprávy zveejnné Státní zemdlskou a potravináskou inspekcí a výsledky monitoringu pesticid v krmivech stlinného pvodu získané z oddlení krmiv v rámci ÚKZÚZ. Státní zemdlská a potravináská inspekce | Výsledky hledání: (gov.cz)

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The official controls are routinely performed with up to two or three days prior notice being given which is in conflict with Article 9 (4) of Regulation (EU) 2017/625, which requires no prior notice be given before controls are carried out except where particular circumstances require that notice is given. This was further confirmed by the inspectors from the regional departments. However, official controls are carried out in a way that minimises disruption or administrative burden to the entities inspected as required by Article 9 (5) of Regulation (EU) 2017/625. 10

Official controls at professional user level with the exception of extraordinary controls, are performed with prior notice, as are the majority of official controls carried out at PPP manufacturing and distribution level, thus taking away from the overall effectiveness of the control programme.

Controls are generally carried out with at least some level of prior notice. This can be as little as twenty-four hours or as much as a few weeks depending on the circumstances. It is more routine that two to three days' notice is given to the entity being inspected which is not coherent the requirement laid down by Article 9(4) of Regulation (EU) 2017/625. Importation of PPPs for use in other MSs or third countries

The audit team observed 3 routine controls of professional users of PPPs and all incorporated the use of both control questionnaires mentioned in the preceding paragraphs. Two of the controls involved farming companies and the other control was carried out on a company involved in managing and maintaining private and public spaces. The same main process was used in all three controls by different inspectors. To avoid wasted journeys and wasting time it is routine that controls are announced in advance. This prior notice can be as little as 1 day but is more generally 2-3 days. It was noted that "extraordinary controls" are performed without any prior notice. Professional users are required by law to record their PPP use by the following working day after the application, therefore when a control takes place the professional user should have the most up to date records available at hand. However, it is routine that professional users are afforded some additional time to provide these records to the inspector in electronic form.

Medlemsstatens svar

V pípad kontrol distribuce pípravk bude více dbáno na to, aby byly dodrzeny pozadavky naízení (EU) 2017/625 i metodických pokyn ÚKZÚZ, které pozadavek na pednostní vádní kontrol bez pedchozího oznámení také obsahují. Pedchozí oznámení bude pouzíváno pouze tam, kde je to úcelné s ohledem na zdárné provedení kontroly, tedy nálezit odvodnné. Z pohledu jednotnosti provádní úedních kontrol upravíme postupy tak, aby byly kontroly pouzívání pípravk na ochranu rostlin provádny pednostn bez pedchozího ohlásení. V pípad, ze u neohlásené kontroly nebude kontrolovaná osoba, popípad povinná osoba na míst zastizena, bude zasláno písemné oznámení o zahájení kontroly podle § 5 odst. 2 písm. b) zákona c. 255/2012 Sb., o kontrole (kontrolní ád), ve znní pozdjsích pedpis. Níze jsou úpravy v Metodickém pokynu c. 15/POR. Page: 1 ort ref. DG(SANTE) 2023-7840 of the audit carried out from 14 June 2023 to rotection Products ction Proposed by the competent authority

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The CISTA provided the audit team with a comprehensive set of lists which act as a basis for the PPP marketing control programme. It was explained during the course of the audit that the lists do contain some overlaps, which is understandable as some operators may function in multiple ways. However, it is conceivable that a manufacturer, not registered as a professional use PPP distributor will not be automatically inspected annually. They may be picked for inspection each year, but this is dependent on each individual regional department. It is also the case that some of the manufacturers and other operators offer products for sale on-line, but yet do not appear on the "on-line" list. Nevertheless, these entities will have their on-line element examined during the course of a normal inspection. 7

The CISTA operates a system that requires all distributors of professional use PPPs to be notified to them. This enables the CISTA to have a working list from which to base their control plan. This is a good practice and having lists of entities to control is a fundamental basis on which to build a control plan. There are lists of distributors, re- packers, manufacturers, importers and online sellers maintained by the DAIC of the CISTA, however, during the course of the audit it was found that in some cases the lists were incomplete or at very least not up to date.

One such example is where the actual full list of premises associated with at least three distributors was not up to date. It was observed during the two distributor inspections, where each premises visited was also acting as a PPP store on contract for another 15 entity. Therefore, the premises that we visited should have been listed for a number of different legal entities but was not. Furthermore, the PPPs that were owned by those third party entities and present in the same store as the entity being inspected, were not considered or subjected to the control the audit team observed. It was also confirmed by the entities being controlled that while they did not actually own these products, they still considered them as stock which could be sold to a customer. This would then trigger a sale of such product from the third party to the distributor and then to the professional user.

There are lists of distributors, re-packers, manufacturers, importers and online sellers as previously mentioned. However, only distributors of professional use PPPs are guaranteed annual inspection. While some of the re-packers and manufacturers are also registered as distributors of PPPs there are a number who are not. Consequently, there is a significant number of manufacturers and re-packers who are not automatically subject to annual controls. Formulation Analysis

The CISTA has lists for all entities marketing PPPs, thereby having the necessary information on which to base controls, however, some of these lists provided to the audit team were found to be somewhat incomplete, resulting in the stores of some distributors being less subject to control than others.

Medlemsstatens svar

ficial ÚKZÚZ, prostednictvím oddlení kontroly a aplikacní techniky, zajistí, aby byly seznamy subjekt pouzívané pro plánování as kontrol uvádní pípravk na trh ádn aktualizovány. edpoklad je aktualizace neprodlen po zjistní nových kutecností vedoucích ke zmn v seznamech, minimáln vsak ednou za rok. Page: 2 ort ref. DG(SANTE) 2023-7840 of the audit carried out from 14 June 2023 to rotection Products ction Proposed by the competent authority

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One such example is where the actual full list of premises associated with at least three distributors was not up to date. It was observed during the two distributor inspections, where each premises visited was also acting as a PPP store on contract for another 15 entity. Therefore, the premises that we visited should have been listed for a number of different legal entities but was not. Furthermore, the PPPs that were owned by those third party entities and present in the same store as the entity being inspected, were not considered or subjected to the control the audit team observed. It was also confirmed by the entities being controlled that while they did not actually own these products, they still considered them as stock which could be sold to a customer. This would then trigger a sale of such product from the third party to the distributor and then to the professional user.

Controls being performed on a distributor also storing PPPs for a third party, only include the PPPs owned by the distributor being inspected, resulting that in some cases that the majority of PPPs present in the store are not subject to controls, which undermines the entire inspection. 5.2.2. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 138 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67 (1) of Regulation (EC) No 1107/2009 on the proper use of PPPs Article 5 of Directive 2009/128/EC Article 67 (1) of Regulation (EC) No 1107/2009, Article 4 (1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council, and Annex I, Part A.III of the same Regulation on keeping records of the PPP use Findings Professional user controls

Medlemsstatens svar

g V pípad skladování pípravk pro více distributor na jednom t to míst bude stanoveno metodicky provedení kontroly vsech by tchto distributor v jeden okamzik. Tím bude zajistna kontrola sech skladovaných pípravk v daném sklad. ktualizace metodického pokynu je plánována na konec roku 023. íze jsou zobrazeny navrhované úpravy v Metodickém pokynu . 04/POR. Page: 3

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The information kept in the database makes possible full traceability of PDO and PGI wines. CAFIA verifies the origin and the quality of PDO wines and issues administrative decisions for the classification and marketing of PDO wines. Such controls are not required for wines intended to be marketed as PGI (see also paragraphs 33, 46 and 66 below). The eligibility for using PDO/PGI designations is also checked when the products are placed on the market, particularly in the retailers' chain.

Operators wishing to market their wine as PDO have to request the classification of every batch of wine produced by CAFIA. This is achieved at the expense of an administrative fee paid to CAFIA, which becomes income of the state budget. The classification procedure is based on the verification of grapes and on analytical and organoleptic testing. The wine classification carried out by CAFIA ensures the traceability of the origin and the quality of every batch of wine intended to be marketed as PDO (e.g. "quality wine" or "quality wine with an attribute"). However, such a system is not in place for PGI wines.

The authenticity of the marketed wines is verified through official analytical testing carried out in the laboratory of CAFIA. The sensory commission of CAFIA carries out organoleptic testing. Where the traceability of sampled wines cannot be otherwise verified, the laboratory is requested to carry out isotopic analysis of wine samples. However, the examination of the authenticity is not an option for PGI wines, as no classification involving at least sampling for analytical testing is carried out for wine batches intended to be marketed as PGI products. Samples of PGI wines taken during production and marketing aim to verify that they meet the general conditions of the relevant product specification.

Although the inspections serve to validate the approval procedure for PDO wines and the organoleptic and analytical testing required by point (a) of first subparagraph of Article 19(1) of Regulation (EU) 2019/34, the batches of domestically produced wines sampled upon suspicion, are not blocked until the results of the testing verify their compliance. This is not in line with point 4(a) of Article 19 of Regulation 2019/34, which requires that a product cannot use the PDO/PGI designation relating to it unless the results of the official organoleptic and analytical testing prove that the product in question complies with the conditions in the product specification and possesses all the appropriate characteristics of the PDO/PGI designation concerned. The consequence is that when the CA detects non-compliant PDO/PGI wines, these might have already been marketed thus not all quantities can be recalled, as noted by the audit team during interviews with CAFIA inspectors. Although for PDO wines this is somewhat mitigated by the classification system, this is not the case for PGI wines. 18

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SVA and CAFIA have put staff training arrangements in place, addressing one of the recommendations from the 2013 audit. Any newly recruited veterinary official in SVA is required to pass an attestation within three years, which includes generic knowledge on legislation, hygiene (including a two hour HACCP module) as well as animal welfare and animal health. SVA and CAFIA also provided examples of the staff participation in the European Commission Better Training for Safer Food programme.

SVA provides compulsory annual training on selected topics and asks staff to choose additional voluntary training from a catalogue of training topics. The training catalogue offered 106 courses in 2019, 112 in 2020 and 128 in 2020. The audit team noted that no specific training in fishery products or HACCP was available in the catalogue.

The Ministry of Agriculture organises online training since 2011, available to SVA and CAFIA officials, which includes module No. 9 on HACCP-based procedures. According to the CA, this module requires about 6 hours of self-study and a final test. This online training was followed by 88 and 79 officials in 2020 and 2021, respectively. 4

The audit team noted a solid HACCP knowledge in the officials performing the FBOs audits. These auditors receive compulsory training on basic HACCP (23 hours) to be lead auditors, and are offered voluntary training on advanced HACCP (15 hours). The audit team also reviewed the HACCP training provided in 2018 and new training sessions scheduled in 2022 and found these satisfactory.

According to SVA statement, within routine inspections, inspectors need basic knowledge about HAACP, as they must assess FBO HACCP basic elements such as layout, critical control points, surveillance records, corrective action taken, etc.

The audit team interviewed SVA inspectors from two RVAs, with different years of experience, taking part in routine inspections, noting that in some cases, inspectors lacked sufficient knowledge of the HACCP principles to perform the assigned tasks. This is not in line with Article 5.4(c) of Regulation (EU) 2017/625, in respect of the subject matter included in its Annex II, Chapter I points (5) and (7). Transparency and confidentiality

Training programmes are in place and officials have in general sufficient knowledge and experience to perform official controls. However, the training provided was not sufficient to enable inspectors performing routine inspections to reliably check basic aspects of the FBO's HACCP.

Medlemsstatens svar

SVS zajisuje pravidelné skolení úedních veterinárních léka. Kazdý nov píchozí veterinární léka musí mimo jiná skolení absolvovat do tí let od nástupu atestacní vzdlávání (a následn vykonat zkousku) jehoz soucástí je mimo jiné i systém HACCP a kontrola produkt rybolovu. Aktuální problematika produkt rybolovu je vzdy esena na poradách s KVS. Zápisy z tchto porad jsou vsem inspektor dostupné na PORTÁLU SVS. Auditovaná inspektorka nastoupila k SVS v dubnu 2020. V této dob byl v CR lockdown z dvodu COVID ­ 19 a byly provádny jen nejnutnjsí kontroly (prohlídky na jatkách). Inspektoi vykonávali administrativní cinnost prací z domova. Daná inspektorka, která má v náplni práce zejména cinnost na drbezích porázkách se v roce 2021 úcastnila kontroly zpracovny ryb v rámci zaucení a to ve spolupráci (pod dozorem) s inspektorem, který v dané provozovn vykonává pravidelný dozor. Rovnz se tato inspektorka jest nezúcastnila online skolení, které poádá Ministerstvo zemdlství (obsahuje i systém HACCP). V pípad dobré epidemiologické situace se obnoví vsechna skolení, tak jako ped epidemií Covid-19. To znamená, ze budou pravidelná skolení se zamením na produkty rybolovu, tak jako v pedchozích letech (n

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SVA and CAFIA produce reports after every visit: inspections, audit, sampling, etc. The audit team assessed inspection reports from SVA, noting that the template used, scope/checks performed and details varied significantly between different officials, between regions but also within regions. The same internal inconsistencies were also noted during the interviews with inspectors.

According to SVA all the approval conditions must be assessed in the course of the yearly inspections (usually six visits/year), but it is up to the inspectors to decide which requirements are checked during each individual inspection. Based on the reports checked, inspections typically take between one and three hours. In one region, an annual work plan for an FBO was provided, stating the number of visits as well as some guidance about the 5 SVA website: https://en.svscr.cz/ and CAFIA website https://www.szpi.gov.cz/ 5 controls to be performed. However, the CA could not demonstrate that all conditions of approval were covered consistently, despite regular visits.

The audit team noted that the lack of such instructions addressing specific tasks to be performed during the inspections in fishery products processing establishments affects the consistency of the official controls. This is not in line with Article 12 points (1) and (3) of Regulation (EU) 2017/625 which states that CA shall perform official controls in accordance with documented procedures and shall contain instructions for staff performing official controls

Documented procedures for relevant control tasks are in place but do not specifically cover fishery products, resulting in inconsistencies and gaps in the performance of the controls. SVA has recently developed and adopted new and specific guidance for fishery products which should address this, but which was not yet implemented at the time of the audit.

Medlemsstatens svar

al ODBOR VETERINÁRNÍ HYGIENY A OCHRANY ÉHO ZDRAVÍ todický návod c. 7/2017 konkrétn clánek 6 (viz píloha 1) ation stanoví zamení kontrol, kdy vypoctený/nastavený pocet kontrol zajistit, aby v kazdém potravináském podniku dle relevance zkontrolovány a v protokolu o kontrole zaznamenány oly zamené na vsechny vyjmenované body tohoto clánku. veterinární hygieny SVS vydal v beznu 2021 dokument ke ole podízených, který stanoví jednotlivé body, které musí ený u podízených kontrolovat. Jedním z bod je i kontrola dní úedních kontrol (vcetn dodrzení stanovené frekvence ol, zápis v protokolech o kontrole a zda jsou kontrolovány ré pozadavky legislativy). ka, která byla vydána v prosinci roku 2021 (Pírucka ke ole produkt rybolovu) vcetn check list bude revidována a ena do inspekcní cinnosti veterinárníich inspektor do konce 2022. ní veterinární správa (CVA) bude od roku 2023 provádt oly, zda je inspekcní cinnost v oblasti produkt rybolovu dna v souladu s touto píruckou. ktoi SVS budou v roce 2022 seznámeni s výsledkem tohoto u (2022-7450). Page: 2 tions of report ref. DG(SANTE) 2022-7450 of the audit carried out from 24 systems in place governing the production and placing on the market of fish

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SVA publishes a list of Food establishments ­ according to EU specifications, including section: VIII Fishery Products7. In this list, the audit team noted four approved establishments of fishery products that had not been in operation since 2019 or before. The published list does not capture this information and as result, is not possible to know if a particular establishment from the approved list is in operation (subject to regular SVA checks) or not (SVA checks suspended).

As a consequence, there are approved establishments included in the list, without regular controls, on the basis that they are not in operation. SVA could not provide assurances that those establishments continue to comply with the approval requirements. This is not in line with Article 4(1)(a) of Regulation (EC) No 853/2004 and Articles 18(1) and 148(5) of Regulation (EU) 2017/625.

According to SVA, there is a system in place to keep track of the inoperative approved establishments with a record of this in the OIS information system, in the T02 list (self- discontinued establishments). SVA inspectors have access in the OIS system to establishments data such as address, list of individual establishments, whether or not they are active, list of approved/registered activities, etc. They have limited access to the OIS information system only as regards inspection findings. Restrictions are applied at the district and the regional level according to staff hierarchy. Therefore, the T02 list is only available within the SVA but not for CAFIA, consumers or other member states' officials. 6 This conditional approval list covers fishery products and other sectors 7 https://en.svscr.cz/registered-subjects/ 8

However, the list of inoperative establishments is not available to CAFIA's inspectors, consumers, and other member states' officials. The published list of establishments does not clearly identify those that retain their approval despite being inoperative for prolonged periods and, as a consequence are not subject to official controls. This limits the capability of the CA (CAFIA), but also of other member states' officials and EU consumers, to detect the possible placing on the market of product from inoperative establishments.

Medlemsstatens svar

ádáme o vyskrtnutí daného bodu z následujících dvod: poskytnutý seznam v dotazníku je seznam podnik chválených. Veterinární inspektoi mají informace o subjektech, teré na vlastní zádost pozádaly o pozastavení cinnosti. O této kutecnosti musí provozovatel potravináského podniku nformovat SVS (§3 odstavec 1 písm. i) zákona c. 110/1997 Sb., potravinách), tedy oznámit v listinné nebo elektronické podob ahájení, zmny nebo ukoncení výkonu pedmtu podnikání ejpozdni v den, kdy tyto skutecnosti nastaly. Na základ této kutecnosti je tento podnik v informacním systému OIS zaazen ovnz na seznam T02 (závody s cinností z vlastního rozhodnutí erusenou) a od této chvíle nejsou v tomto podniku porvádny ontroly a ani být nemzou, protoze v závod není provádna innost. Inspektor mze pi namátkové kontrole ovit, zda je pravdu závod v necinnosti. Mze se stát, ze podnik, který ozádal o pozastavení cinnosti a nejsou zde tedy provádny ontroly pesto cinnost vykonává. V takovém pípad je zahájeno právní ízení. Pípad takového porusení byl auditorm poskytnut. Page: 3 tions of report ref. DG(SANTE) 2022-7450 of the audit carried out from 24 systems in place governing the production and placing on the market of fis

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The audit team found an internal regulation (Order 366/2005 of 5 September 2005 concerning requirements applicable to certain frozen foods) that permits the temperature of frozen fishery products in approved cold storage facilities to fluctuate between -15°C and -18°C when handed during storage. This is not in line with Chapter VII, Section VIII, Annex III from Regulation (EC) No 853/2004.

The CA stated that this is an obsolete order which should be amended as soon as possible, and that the above requirement from Regulation (EC) No 853/2004 is consistently applied during controls, so premises are not approved unless they comply with the -18°C requirement. The audit team noted compliance with this requirement in the examples provided (see paragraph 33).

The internal Order 366/2005 contravenes pertinent provisions in EU law and could lead to FBOs operating storage conditions for frozen products which would render these products non-compliant with applicable EU requirements.

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Vyhláska c. 366/2005 Sb., o pozadavcích vztahujících se na y VII, nkteré zmrazené potraviny z roku 2005 je provádcím pedpisem k zákonu c. 110/1997 Sb., o potravinách a tabákových výrobcích, ve znní pozdjsích pedpis. Podle § 3 odst. 1 písm. k) zmínného zákona je provozovatel potravináského podniku povinen uchovávat potraviny pi teplotách stanovených naízením (ES) c. 853/2004 nebo provádcím právním pedpisem, a pokud tyto pozadavky nejsou právními pedpisy stanoveny, uchovávat potraviny pi teplotách stanovených provozovatelem potravináského podniku, který potravinu vyrobil. Do provádcí vyhlásky c. 366/2005 Sb., byla transponována smrnice Rady 89/108/EHS z 21. 12. 1988 o sblizování právních pedpis clenských stát týkajících se hluboce zmrazených potravin urcených k lidské spoteb. Obecn platí, ze v Ceské republice je zákon nadazen vyhlásce a v pípadech, kdy je ustanovení národního pedpisu v rozporu s pozadavky stanovenými v naízení, platí vzdy pozadavky z naízení. V daném pípad se jedná o pozadavky stanovené ve výse zmínné vyhlásce pro výkyv teploty pi manipulaci v rámci skladování a v naízení (ES) Page: 5 tions of report ref. DG(SANTE) 2022-7450 of the audit carried out from 24 systems i

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The audit team reviewed the approval document of a milk collection centre (MCC). The CCA and RVA explained that this MCC was also storing on its premises, separately, a mix of condensed milk and raw milk, although MCCs are establishments where raw milk may be collected and possibly cooled and filtered. The mixture is supplied by a different establishment, stored at the MCC at controlled temperature for being dispatched later to other FBOs. The establishment was approved exclusively as a MCC as, in the CAs' opinion, it was not necessary to approve it for any additional activity because the product stored falls within the definition of raw milk and therefore the same hygiene requirements and microbiological risk as for raw milk applies. However, a condensed milk/raw milk mix can provide circumstances for the multiplication of some pathogens, as the normal flora of the condensed milk has been destroyed by heat- treatment.

The list of approved dairy establishments, in Czech, is publicly available at the following link: https://www.svscr.cz/registrovane-subjekty-svs/zpracovatele- zivocisnych-produktu-schvalene-pro-eu/. It comprises 223 establishments. An English version of this list, which complies with the required technical specifications laid down in DG Health and Food Safety's document ref. SANCO/2179/2005, is available at the following link: https://en.svscr.cz/registered-subjects/subeu/. The number of approved premises listed in the English version (246) does not match the number (223) in the Czech list, and the names of some of the establishments also differed. 10

In relation to the above, the CCA explained that sometimes the establishments might be listed with the name of the company group and/or with the name of the local establishment and that the two lists are currently under review. They also added that some of these discrepancies are due to the seasonal activities of the establishments or to sanctions leading to the suspension of production, during which the establishments are not included in the Czech list as this list is used for the organisation of official controls. However, these establishments remain on the English version of the list, as some of their dairy products could still be on the market. The CCA committed to updating both lists in order to show the same data.

The approval of a storage facility that stores a product comprising a mix of condensed milk and raw milk as a MCC is not in line with EU requirements, as a separate approval as a storage facility for this intermediate product would be required.

The information on the lists of establishments approved and available on the CCA's website is not accurate as there are discrepancies in the names and number of establishments listed. Nevertheless, the CCA committed to correct this issue.

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e, This case concerns an establishment which handles milk which has not undergone heat treatment of more than 40 °C according to the Regulation No 853/2004, it is raw milk. Moreover, for more than a year, no consignment of such milk has been dispatched from CZ 61850235. The SVA therefore insists on the approval issued by the RVA. Inconsistencies between old and new lists were caused by the publication or non-publication of temporarily suspended establishments. Currently, both lists are identical.

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Concerning FBOs verification of raw milk criteria in sheep and goat farms, the CCA explained that most of the milk is processed by registered farmers, in the course of a marginal and limited activity, for direct sale at local level. According to the CCA, these farmers are engaged in retail activities only and the provisions of Regulation (EC) No 853/2004 do not apply to them. The national legislation in force (Decree No 128/2009) requires these farmers to take and analyse annually at least two samples of their own raw milk: the composite samples of raw milk shall be taken after milking of all animals, with an interval of not less than 2 months between the tests. The CCA states that 224 sheep and goat holdings were registered in 2020. The frequency of FBOs' controls, which should be carried out in accordance with the frequencies laid down in EU legislation, is limited to a small number of approved FBOs (currently 14, according to the list of approved establishments), not carrying out marginal and limited activities, nor retail activities only. The limited number of tests for PC documented by the CCA is not sufficient to ensure compliance with the requirements of EU and national legislation (see paragraph 73). 16

The frequency of FBOs verification of small ruminants raw milk criteria is not in line with requirements at point 3(a)ii, Chapter I, Part III, Section IX of Annex III to Regulation (EC) No 853/2004.

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Farmers who deliver milk to an approved milk processing ation establishment shall examine milk in accordance with Regulation (EU) No 853/2004. Farmers who process milk, and this activity is limited and marginal at local level (retail - registered mini-dairy establishment), examine milk in accordance with Decree No 128/2009, which was notified to the EC. The SVA has not found a contradiction with EU legislation. Page: 1

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The audit team examined a number of approval files and noted that, with the exception of one processing plant, SVA carried out these approvals in line with the rules for registration and approval laid down in Articles 23, 24 and 44 of Regulation (EC) No 1069/2009. However, in the case of one processing plant, the competent authority granted approval while the audit team noted that it should not have been the case, as: a. the layout of the plant did not comply with requirements applicable to the functioning of a plant processing Category 3 and Category 1 materials in the same premises, and b. neither the operator nor the authority did take into account and addressed the relevant risks to public and animal health associated with handling, processing and storage in the same premises of raw ABP and DP of Category 1 material and Category 3 material. Consequently, there was a direct risk of possible cross-contamination between the Category 3 and the Category 1 material in this plant. The above are not in line with requirements of Articles 24(2)(b)(i) and 25(3)(a) of Regulation (EC) No 1069/2009, and Point 2 in Section 4 of Annex IV to Regulation (EU) No 142/2011. The audit team clarified that this situation resulted from an incorrect interpretation, by the competent authority, of the applicable requirements. The SVA representative explained that during its operations, the operator had in place some procedures mitigating the risk of cross-contamination; moreover, the entire production of Category 3 DP was destined for production of pet food. SVA presented also evidence that, at the time of this audit, the operator was conducting some infrastructure works on the layout of the plant and installations used for processing. Consequently, SVA would carry out a new approval process.

The registration and approval process implemented by SVA was, with one exception, effective and provides assurance that ABP operators, establishments and plants meet their respective obligations.

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On 15 November 2021, a meeting was held among Central n Veterinary Administration, RVA and the operator of the processing plant. The scope of the meeting was to find a technical solution and ensure the compliance with the requirements of the C) legislation for the processing of multiple categories of ABP at the same place. During the DG audit, it was mentioned that the operator already started in the first half of 2021 the construction and technological modifications of the plant with the aim to completely separate the processing of Category 1 ABP from Category 3 ABP. Currently, 2 parts of the processing lines are still problematic and unsolved. However, the operator has started negotiation with the supplier of the necessary technology. The delivery and installation of the new technology depends on the capacity and capabilities of the technology supplier, however, the intention is to have the implementation done as soon as possible (during 2022). In the meantime, the operator will ensure that all existing measures to prevent cross-contamination, which have so far proven sufficient and effective according to the results of regular laboratory testing on ruminant CNS tissue, are imple

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Most of the staff interviewed during this audit had a good knowledge of the tasks that they have to carry out and the applicable EU and national legislation. Despite the training provided, in one of the three slaughterhouses the OV in charge, was not familiar with the applicable official procedure in case of bovine animals with traceability issues (e.g. lost ear tags) detected at AMI. 5.2.5 Supervision and Audits

Cooperation and coordination arrangements between and within the CAs involved in the controls for the areas covered by this audit are in place. The mechanisms in place (such as documented procedures and training) give the CAs a reasonable level of assurance that controls are carried out uniformly and consistently. However, the audit team noted, in one of the three slaughterhouses, some weaknesses related to the knowledge of SVA staff on these documented procedures.

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SVA (CCA) will inform the directors/heads of the Department of n Hygiene of RVA about findings of the audit at a meeting held on 12 October 2021. The directors/heads of the Department of Hygiene of RVA will hand over obtained information to all al responsible official veterinarians and FBOs. vine SVA (CCA) will inform the official veterinarians responsible for controls at big capacity slaughterhouses and meat processing establishments about findings of audit DG(SANTE) 2021-7317 at a meeting held on 2. - 3. November 2021. Training on the operating rules for veterinary supervision in the slaughterhouses "Operating and organizational rules" will also take place during this meeting. In 2022 and 2023 the SVA (CCA) will verify the proper implementation of this rules at the level of RVA. Page: 1

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The Czech Multi-Annual National Control Plan (MANCP) (2016-2018 - latest version), section 3.3, Strategic Objectives, includes a policy objective relevant for animal welfare: Objective two: "Ensure a high level of protection of human and consumer interests, animal health, animal welfare and plant health." There is no further description of what the SVA considers a high level of protection or how this should be measured.

The first operational objective of the MANCP related to on farm controls aims to ensure the keeping of farm animals in accordance with the minimal requirements - ensuring compliance with the requirements of the national and EU legislation.

The second operational objective of the MANCP focuses on raising awareness about the activities and powers of the competent authorities; responsibilities of breeders and general public involvement. A third aims for more effective procedures and enhanced cooperation between competent authorities: SVA, Regional Veterinary Authorities (RVAs) and Municipalities with extended powers (those that are legally entitled to enforce and sanction legislative requirements for farm welfare laws).

As the first MANCP operational objective on farm welfare solely reflects basic monitoring of compliance, there is no link between the planned prioritisation of controls and the allocation of resources to reflect strategic objective two of the MANCP described in paragraph 1 of this report or any of the operational objectives described in paragraphs 2 and 3 of this report. This is not in line with article 110 (2) (a) of Regulation (EU) 2017/625 that requires the prioritisation of controls and allocation of resources to reflect the strategic objectives of the MANCP.

There are no baselines set to measure if outcomes for animal welfare meet strategic or operational objectives. For example, the SVA has been monitoring post-mortem indicators in broiler slaughterhouses from each production unit (flock and house) since 2011. From 2013 this data was used to target the poorest performing farms and from 2017 it started including also the incidence of footpad dermatitis (FPD). According to the SVA thresholds, the data indicate unsatisfactory scores for lesions of approximately 75% of flocks sent to slaughter in 2017, 2018 and 2019. The SVA had access to full data from the end of 2018. The use of the indicators to target inspections has had no impact on the outcome of compliance levels since the end of 2017, which remains unchanged (as farms inspected continued to register unsatisfactory scores). Thus, the SVA carries out controls but sets no targets for ensuring compliance with its minimum requirements, nor has it adapted policy objectives to address the situation found from its own monitoring.

There are no specific, measureable strategic or operational objectives or targets indicated in the MANCP on what the Czech Republic wants to achieve for animal welfare outcomes. Examples could include: reduce incidence of tail docking by x%; reduce FPD levels by x%; decrease lameness levels in cattle by x% through official controls and related actions. These could include targeted training for poorly performing sectors, 3 targeted enforcement campaigns on certain issues or; liaison with the relevant sector to set agreed targets for improvement, etc.

The Competent Authorities' approach to the setting of objectives in the MANCP is mainly operational with no defined targets, indicators or measurement of progress and, as such, they are insufficient to bring about measureable change.

There is a good well-developed prioritisation of controls and allocation of resources even though these do not link to clear objectives or targets in the MANCP or annual inspection plans.

Planning of cross compliance and animal welfare controls are well formulated on a demonstrable risk profiling basis using a range of risk criteria that target official resources to inspecting the potentially worst offenders. However, the introduction of post-mortem indicators as a risk criterion to target broiler farm inspections has had no impact on improving animal welfare outcomes for footpad dermatitis over a three- year period.

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There are no official control procedures for animal welfare controls on pig or broiler farms. There are no procedures for assessing documentation accompanying broiler flocks to slaughter. There is some specific guidance on measuring microclimate on broiler farms and a specific instruction on the assessment of FPD and a requirement to follow up on unsatisfactory scores. The SVA has made available information documents relating to tail docking of pigs but these are not procedures for official controls. The SVA considers that inspectors should base their assessment primarily on legislative requirements. Although the SVA has given training and held meetings with RVAs, it provided no further documentation to them to ensure they carry out inspections in a comprehensive and consistent manner. Inspectors met indicated that the templates and guidelines for reporting and evaluation of non-compliances for cross compliance inspections ensured consistency and transparency of implementation in this area.

The lack of procedures described in paragraph 13 is not in compliance with 1) Article 5 and 2) Article 12 (1) of Regulation (EU) 2017/625 which require that: 1) Competent authorities... shall: (a) have procedures and/or arrangements in place to ensure the effectiveness and appropriateness of official controls and other official activities; and (b) have procedures and/or arrangements in place to ensure the impartiality, quality and consistency of official controls and other official activities at all levels; and 2) Competent authorities shall perform official controls in accordance with documented procedures, and that those procedures shall cover the subject areas for control procedures set out in Chapter II of Annex II and shall contain instructions for staff performing official controls.

The Methodology does not provide mandatory compliance criteria. Although farmers are taking some actions, it is insufficient to comply with the legal requirements relating 5 to risks for tail biting. The lack of binding criteria and detailed procedures for inspectors does not enable them to reliably, and consistently, address the legal requirements relating to risks for tail biting and the effectiveness of improvement measures. As a result inspectors cannot effectively enforce Point 8 of Annex I, Chapter I to Council Directive 2008/120/EC as to whether the mutilation should have been carried out in the first place.

For example: the pig premises visited was part of a larger group structure and fattened tail docked pigs received from its breeding premises. Tail biting on the fattening farm was extremely low (0.08%). The company carried out a trial of rearing pigs with intact tails in one batch on one of the four breeding farm locations in the group. This resulted in poor production results and increased tail biting compared to the docked pigs on site. However, the company did not substantially alter farm conditions prior to the trial. They reduced the stocking density by 4.5% and added some basic additional enrichment (sisal ropes) and barley grain to the trial batch. The company veterinarian made an assessment of risk factors for tail docking only after the trial was completed. She drafted a list of recommendations for all of their premises, which addressed the main risk factors, but in a non-specific way: optimise x, improve y etc. However, the group manager undermined the requirements for enrichment material specified by the veterinarian by issuing an instruction to all farm managers following an RVA inspection visit by asking them to ensure all pens had a chain and or a plastic bottle attached to a chain to ensure farms complied with minimum requirements for enrichment material. The Head of the animal welfare department in the RVA of the first region visited viewed these arrangements as satisfactory even though they did not comply with the Methodological guidelines in a number of areas.

The SVA issued new instructions for slaughterhouse OVs on the assessment and scoring of FPD lesions, and the setting, and monitoring of thresholds. However, the procedures do not indicate when to take enforcement action for unsatisfactory results. It requires that "unsatisfactory" FPD scores should be included in the "feedback report" sent to the official services in charge of supervising the farm of origin. This had not been necessary for any flock slaughtered in the slaughterhouse visited in the last 3 years. Nevertheless, national level data showed that broilers from farms within this region had been slaughtered in other regions and had frequently been assessed as "Unsatisfactory". Despite this, no corresponding "Feedback reports" from the other regions had been received in the region where the birds originated in the last 3 years. See also paragraph 5 of this report.

The OV at the slaughterhouse visited did not specifically check the plausibility of cumulative daily mortality rates and accepted the value as declared in the food chain information document. The food chain information document accompanying the poultry to the slaughterhouse always included the cumulative daily mortality rates, in line with legal requirements. The OV at the slaughterhouse stated that although this is not indicated in any procedures for monitoring food chain information, the SVA and RVAs agreed in meetings that if cumulative daily mortality rates exceeded 3% this should be 6 notified by the slaughterhouse OVs to the official services responsible for supervising the farm or origin. There had been one case where the cumulative daily mortality rate was 6.35% but no follow-up action had been recorded for this batch as the farm was on the same site as the slaughterhouse.

The animal welfare fields in the SVA information system for animal welfare checks at the slaughterhouse can indicate "compliant", "not compliant" or "not checked". However, for a number of the parameters evaluated, such as "mortality" (birds dead on arrival), or "fitness and condition of the animal", or "unloading" there is no objective guidance or instruction on how compliance should be assessed. Individual OVs at each slaughterhouse are responsible for deciding what is "compliant" or "non-compliant" and for when they should take enforcement action.

The absence of procedures and templates hinders consistent and effective implementation and enforcement of controls to prevent routine tail docking of pigs and follow up enforcement of unsatisfactory results found during post-mortem inspections of broilers. 7

RVAs used different formats for reporting animal welfare inspections on pig farms in the two regions visited. In the first region, inspectors used a template form with prepopulated areas for inspection findings printed on the form and expanded these with free text when they noted non-compliances. The other region used a free text style that had no standard reporting format, leaving the option to individual inspectors to complete the findings. The lack of standard report templates and procedures for carrying out and reporting on inspections does not ensure consistent implementation of controls, scope of inspections and reporting, and calls into question the consistency of the data reported for farm controls.

The assessment of non-compliances detected during cross-compliance controls gives a clearer picture of animal welfare problems as it gives conclusions on the severity, 10 extent, permanence and recurrence of the non-compliance. The planning of other animal welfare controls could benefit from the use of this methodology.

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The annual report on the MANCP gives statistics on compliance for each of the areas covered by Regulation (EU) 2019/723. However, although it does contain enforcement action and its results, it does not indicate the measures taken to ensure effective operation of the MANCP, as required under Article 113 (1) (d) of Regulation (EU) 2017/625.

The Annual Report on implementation of the MANCP and the report on animal welfare required under Regulation (EU) 2019/723 provide a partial analysis of the results of official controls on animal welfare. The former does not address whether the activities are suitable to reach the strategic and operational objectives and ensure effective operation of the MANCP, even if it does include enforcement action and its results. The latter does not provide measureable, focussed actions to target recurrent non-compliances in specific areas.

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The CA introduced a requirement in 2019 for the monitoring of docked/undocked pigs and tail injuries at slaughter that could feed into policy development and objective setting once data reliability (calibration of scoring) and analysis of the data is complete.

In an extract from the 2019 Annual Report on implementation of the MANCP, the report on farm controls for 2018 indicated: Free Barn Enriched Calves Pigs range cage 10,515 2,393 603 334 Holdings subject to inspection 20 36 53 549 275 2 Inspected holdings 10 52 2 Production sites without non- 10 50 compliance 8 These inspections resulted in the following enforcement action: Category of Non-Compliance* Free Barn Enriched Calves Pigs range cage Non-compliance A 0 0 0 0 0 Non-compliance B 0 0 1 16 7 Non-compliance C 0 0 6 67 74 * Annex III to Commission Decision 2006/778/EC defined administrative categories of non-compliance The SVA concluded that the major problematic areas for most livestock species related to housing conditions and the provision of feed and water. The action plan to address these focusses on better planning of inspection to focus on the problematic areas and proposes some additional action to address the underlying causes through awareness raising activities for breeders and private veterinarians. The emphasis is on prevention; promotion of public awareness on keeping farm animals; and cooperation with breeders' associations.

However, the SVA did not analyse why inspections on pig or calf farms resulted in higher rates of non-compliance than equivalent inspections on holdings for laying hens (18% for pigs and 9% for calves compared to 2-4% for laying hens). There is no indication as to why there were much higher percentages of serious non-compliances in category C for pigs and calves and not in other categories, or what can and should be done to address them.

There is potentially useful data within this framework but the reporting is not always reliable. For example, the report indicated that there was 100% compliance for the category "mutilations" in pigs. This is not the case as: approximately 99% pigs are routinely tail docked; the incidence of tail biting reported on farm and at slaughter was very low (from the sample reviewed); and only rudimentary efforts are being made in terms of complying with minimum requirements; including risk assessment, improvement measures, and enforcement.

The SVA explained that the inspection plan prioritised pig farms with fattening pigs for inspection. It considers that farms receiving tail-docked piglets are compliant with tail docking provision. However, the requirements of Point 8 of Chapter I of Annex I to Directive 2008/120/EC on the prohibition of routine tail docking apply to all pigs on either breeding or fattening farms. Even fattening farms that receive piglets already tail docked must have evidence that: there was tail biting on the fattening farm; they have taken improvement measures which attempted to improve the situation and attempted rearing full tailed pigs on site not at another farm under different conditions. The Directive calls for a process of continuous improvement to eliminate or reduce the risk of tail biting to enable the rearing of pigs with intact tails. Clearly one trial on a different farm under different conditions does not meet these requirements. 9

Holdings selected for cross compliance inspections on animal welfare are identified using a number of risk criteria including animal-based indicators such as post-mortem lesions in ruminants and numbers of animals sent to rendering plants. Indications of severity, duration and frequency are used when assessing and reporting welfare non- compliances detected during cross compliance inspections, and the information is used to establish payment reductions as required by EU legislation.

The Annual Report on implementation of the MANCP and the report on animal welfare required under Regulation (EU) 2019/723 provide a partial analysis of the results of official controls on animal welfare. The former does not address whether the activities are suitable to reach the strategic and operational objectives and ensure effective operation of the MANCP, even if it does include enforcement action and its results. The latter does not provide measureable, focussed actions to target recurrent non-compliances in specific areas.

One quality assurance (QA) scheme for pigs and cattle has recently started in the Czech Republic and includes mainly on-farm resource requirements. For example, in the case of pigs keepers must provide partially solid flooring or mats for pigs up until weaning no earlier than 28 days. The QA company audits the slaughterhouses who in turn audit the suppliers' compliance with the QA standard. There is no monitoring of animal-based indicators in the standard.

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There are no official control procedures for animal welfare controls on pig or broiler farms. There are no procedures for assessing documentation accompanying broiler flocks to slaughter. There is some specific guidance on measuring microclimate on broiler farms and a specific instruction on the assessment of FPD and a requirement to follow up on unsatisfactory scores. The SVA has made available information documents relating to tail docking of pigs but these are not procedures for official controls. The SVA considers that inspectors should base their assessment primarily on legislative requirements. Although the SVA has given training and held meetings with RVAs, it provided no further documentation to them to ensure they carry out inspections in a comprehensive and consistent manner. Inspectors met indicated that the templates and guidelines for reporting and evaluation of non-compliances for cross compliance inspections ensured consistency and transparency of implementation in this area.

The SVA drafted a set of non-binding guidance documents (hereafter the "Methodology") for farmers and officials as part of the Action Plan on tail docking of pigs and sent it to farmers' organisations and RVAs in November 2018. The Methodology included requirements to assess risk factors for tail biting and listed some welfare indicators, both animal and resource based to take into consideration, but they are not mandatory for farmers and cannot be legally enforced by RVAs.

The Methodology does not provide mandatory compliance criteria. Although farmers are taking some actions, it is insufficient to comply with the legal requirements relating 5 to risks for tail biting. The lack of binding criteria and detailed procedures for inspectors does not enable them to reliably, and consistently, address the legal requirements relating to risks for tail biting and the effectiveness of improvement measures. As a result inspectors cannot effectively enforce Point 8 of Annex I, Chapter I to Council Directive 2008/120/EC as to whether the mutilation should have been carried out in the first place.

For example: the pig premises visited was part of a larger group structure and fattened tail docked pigs received from its breeding premises. Tail biting on the fattening farm was extremely low (0.08%). The company carried out a trial of rearing pigs with intact tails in one batch on one of the four breeding farm locations in the group. This resulted in poor production results and increased tail biting compared to the docked pigs on site. However, the company did not substantially alter farm conditions prior to the trial. They reduced the stocking density by 4.5% and added some basic additional enrichment (sisal ropes) and barley grain to the trial batch. The company veterinarian made an assessment of risk factors for tail docking only after the trial was completed. She drafted a list of recommendations for all of their premises, which addressed the main risk factors, but in a non-specific way: optimise x, improve y etc. However, the group manager undermined the requirements for enrichment material specified by the veterinarian by issuing an instruction to all farm managers following an RVA inspection visit by asking them to ensure all pens had a chain and or a plastic bottle attached to a chain to ensure farms complied with minimum requirements for enrichment material. The Head of the animal welfare department in the RVA of the first region visited viewed these arrangements as satisfactory even though they did not comply with the Methodological guidelines in a number of areas.

The absence of procedures and templates hinders consistent and effective implementation and enforcement of controls to prevent routine tail docking of pigs and follow up enforcement of unsatisfactory results found during post-mortem inspections of broilers. 7

The SVA explained that the inspection plan prioritised pig farms with fattening pigs for inspection. It considers that farms receiving tail-docked piglets are compliant with tail docking provision. However, the requirements of Point 8 of Chapter I of Annex I to Directive 2008/120/EC on the prohibition of routine tail docking apply to all pigs on either breeding or fattening farms. Even fattening farms that receive piglets already tail docked must have evidence that: there was tail biting on the fattening farm; they have taken improvement measures which attempted to improve the situation and attempted rearing full tailed pigs on site not at another farm under different conditions. The Directive calls for a process of continuous improvement to eliminate or reduce the risk of tail biting to enable the rearing of pigs with intact tails. Clearly one trial on a different farm under different conditions does not meet these requirements. 9

There was clear evidence of routine tail docking noted in inspection reports but due to the SVA guidance on farms receiving tail docked pigs, or the non-binding nature of the Methodology, inspectors indicated that these farms were compliant.

RVAs used different formats for reporting animal welfare inspections on pig farms in the two regions visited. In the first region, inspectors used a template form with prepopulated areas for inspection findings printed on the form and expanded these with free text when they noted non-compliances. The other region used a free text style that had no standard reporting format, leaving the option to individual inspectors to complete the findings. The lack of standard report templates and procedures for carrying out and reporting on inspections does not ensure consistent implementation of controls, scope of inspections and reporting, and calls into question the consistency of the data reported for farm controls.

The SVA will consider how the above and future QA schemes could complement the system of official controls once they are operational. Regulation (EU) 2017/625 requires competent authorities to consider such schemes as part of the risk basis for performing official controls from 14 December 2019.

The SVA has included a number of animal welfare indicators in its Methodology guidance for farmers and officials (on the prohibition of routine tail docking) but the non-mandatory nature of the document severely limits its effectiveness and impact.

The introduction of requirements in 2019 for the monitoring of docked/undocked pigs and tail injuries at slaughter is a good indicator. This could feed into policy development, and objective setting, if the CA ensures the reliability of the data (calibration of assessment); completes analysis of the data; and uses it effectively, which had not been done for the monitoring of footpad dermatitis. 12

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The facilities are shared for food and feed of non-animal origin. CAFIA and CISTA informed the audit team that arrangements are in place to prevent risks, which may result in cross-contamination, in particular, time separation is used between the handling of different goods and the inspection facilities are cleaned and disinfected between consignments in line with Article 3(9)(b)(ii) of Regulation (EU) 2019/1014.

The audit team noted that the facilities and equipment at the BCP did not meet the minimum requirements for performing official controls of food and feed of non-animal origin. There are no dedicated storage rooms for commodities to be kept frozen or at ambient temperature under control of CISTA, and the arrangements in place for the shared facilities do not guarantee that CISTA and CAFIA have dedicated storage available to detain food and feed of non-animal origin under their control, in line with Article 64 of the OCR and Article 3(1) of Regulation (EU) 2019/1014. CAFIA did not have information available on the location of the dedicated storage rooms.

The Border Inspection Post has been re-designated following the introduction of the OCR. The facilities, equipment and arrangements in place concerning animals and goods of animal origin for which the BCP was designated are satisfactory.

However, there were shortcomings in the facilities and arrangements in place concerning products of non-animal origin for human, and non-human consumption, and in the abbreviations used to indicate the categories of goods for which the BCP had been designated. Although the volume of imports through the BCP is low, the shortcomings identified may have an adverse impact on the hygienic handling and storage of goods for which the BCP has been designated.

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The SVA and CISTA perform the documentary checks at the BCP while CAFIA indicated that their documentary checks for consignments of food of non-animal origin subject to special import conditions, are carried out at their office in Prague and not at the BCP, which is not in line with Article 49(1) of the OCR.

However, there were weaknesses in the notification of import and the implementation of certain documentary checks and reduced frequency of physical checks. While these were not sufficient to affect the validity of the decision to allow importation, the document checks for feed of non-animal origin are not carried out at the BCP as required. 15

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The lack of clear instructions and guidance on the follow-up investigations needed to trace the possible human-mediated spread of disease to and from outbreak holdings is likely to hinder the detection of secondary outbreaks. This would be particularly important in an epizootic involving zoonotic HPAI. 9 5.1.2 Diagnosis of avian influenza

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Official veterinarians were informed about the importance of ted epidemiological enquiries at a meeting in 2019. The importance s of thorough investigation of all possible sources of infection (especially in contact holdings) and realization of appropriate follow-up measures was reminded the Regional Veterinary nistrations (RVA). The updated contingency plan for avian influenza (with the document on the epidemiological enquiries in the outbreak of the disease) will be submitted for approval to the European Commission during 2020.

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On the other hand, arrangements in place for the completion of the census of holdings within protection and surveillance zones did not ensure that reliable information concerning the health situation on these holdings was collected as soon as possible. This could lead to delays in the detection of outbreaks in future. 5.1.4 Animal depopulation for the purpose of disease control

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In case of occurrence of avian influenza in the Czech Republic, an online form will be available on the website of the State Veterinary Administration (SVA) to create a census of all commercial and non-commercial holdings in restricted zones. It is a much faster system than the previous paper-based procedure. Municipal authorities are responsible for ensuring performing of emergency veterinary measures in their territory according to the Veterinary Act and i.e. for drawing up the census of holdings. All big mmercial holdings in protection zones will be visited by RVA for clinical examination and laboratory sampling. A number of non-commercial holdings in protection zones is usually very high (over 1000 non-commercial holdings in one protection zone). The SVA does not have the personnel capacity to visit all of non- commercial holdings and to perform audits or on the-spot checks of municipal authorities. These non-commercial holdings in protection zones will be selected for inspection by official veterinarians based on risk analysis (number and kind of birds kept on holdings, presence of open-water areas near holdings, etc.). These new provisions will be in force from 1 January 2020

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A misinterpretation of the requirements concerning the categorisation of commercial and non-commercial holdings meant that the veterinary surveillance on some commercial holdings affected by the epizootic was inadequate.

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The SVA would like to comment paragraphs 78 and 80 of the draft report of the audit. In the Czech Republic, all poultry breeders keeping more than 500 head of any poultry are obliged to register with the Ministry of Agriculture of the Czech Republic. They are not only broilers and fattening turkeys as referred to in paragraph 78 (first line of the table). The registration requirements do not apply to keepers supplying smaller quantities of eggs from own holding (only keepers with maximum 50 head of laying hens in e holding) or birds intended directly to the final consumer or to retail shops. Measures on commercial holdings will be applied as described in number 2.

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The official control system did not prevent the dispatch to another Member State of consignments of hatching eggs from a holding located within a surveillance zone during the period of risk. This omission could have resulted in the long-distance spread of disease with serious consequences for the Member State of destination. 9 In their response to the draft report the competent authority noted that the grandparent breeding flock exclusively supplied hatching eggs to a hatchery under the same ownership in a neighbouring Member State. The biosecurity conditions on the holding were high and it was not in proximity to any other poultry holdings or water bodies used by wintering wild birds. The holding was supervised by a full-time private veterinarian and was subject to regular official controls. Throughout the period in question the flock was subject to regular (weekly) virological tests and serological surveillance with favourable results. 22

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for The necessity of compliance with certification requirements for live poultry and hatching eggs was reminded at the meeting on 27 August 2019. At the same time, all recommendations that emerged from the audit mission were presented. National Reference Laboratory for Influenza taking f Health coordination, Ministry of Health works Page: 2

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The audit team noted non-compliances in the abovementioned slaughterhouse related to PMI. The birds fallen from the line before PMI, are not presented for PMI as required in point 1, Part B, Chapter V, Section IV of Annex 1 to Regulation (EC) No 854/2004, but are disposed as unfit for human consumption. Furthermore, all carcases are washed after evisceration before entering PMI (the same non-compliance was detected by the audit team also in another slaughterhouse visited). These non-compliances related to PMI were not noted by the OVs or by the RVA inspectors during their audits.

However, the level of detection by officials of certain non-compliances in the operation of establishments was low. This mainly concerned carcase washing after evisceration 7 and before PMI (see 5.5), discarding fallen carcases before PMI, production hygiene and maintenance of the cold chain, consequently leading to a situation where corrective measures are not taken or imposed.

The audit team noted in two out of three slaughterhouses visited that washing of carcases takes place after evisceration and before PMI. This non-compliance was not detected by any level of CAs. This is a repeated finding from the audit carried out in 2010 when measures were not taken during slaughter to prevent contamination of meat, in particular, the spillage of digestive tract contents during evisceration, as required in point 5, Chapter IV, Section II of Annex III to Regulation (EC) No 853/2004.

As the poultry carcases are washed beforehand, PMI of the slaughtered birds cannot be performed as required in point 6, Chapter IV, Section II of Annex III to Regulation (EC) No 853/2004. This prevents the officials from taking the appropriate decision concerning meat. Under EU legislation, meat showing signs of faecal contamination shall be declared unfit for human consumption (see point 1(s), Chapter V, Section II of Annex I to Regulation (EC) No 854/2004). 10 Conclusions on contamination of carcases

Washing carcases undermines slaughter hygiene and prevents official staff from a) rejecting carcases showing faecal contamination during PMI, and b) from notifying and requiring the operator to take the necessary corrective measures, in order to safeguard food safety and hygiene of production. Therefore, Recommendation No 5 has in practice not been addressed effectively.

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SVA (CCA) informed the directors/heads of the Department of Hygiene of RVA about preliminary findings of the audit at a meeting held on 28 - 29 November 2019. The directors/heads of the Department of Hygiene of RVA will hand over obtained ormation to all responsible official veterinarians and FBOs. A informed SDP (Associations of Poultry Producers) about preliminary findings of the audit. Although these poultry lines are supplied throughout the EU, the SVA and the SDP will make efforts to have these lines reconstructed so that poultry carcases are not washed before post- mortem inspection. The SVA will carry out checks to address this deficiency. It has to be taken into consideration that such a reconstruction will last certain time, so gradually old lines with partly inappropriate technological solution (washing before PMI) will be replaced by new ones fully in line with current requirements.

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However, the level of detection by officials of certain non-compliances in the operation of establishments was low. This mainly concerned carcase washing after evisceration 7 and before PMI (see 5.5), discarding fallen carcases before PMI, production hygiene and maintenance of the cold chain, consequently leading to a situation where corrective measures are not taken or imposed.

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SVA (CCA) informed the directors/heads of the Department of f Hygiene of RVA about preliminary findings of the audit at a meeting held on 28 - 29 November 2019. The directors/heads of the Department of Hygiene of RVA will hand over obtained information to all responsible official veterinarians. SVA (CCA) will incorporate this responsibility in the document prepared centrally for all slaughterhouses named "Operational rules and rules for organization - poultry". The birds fallen from Page: 1 ndations of report ref. DG(SANTE)/2019-6667-MR of the audit carried out from actions taken in response to the previous audits on official controls over production control programmes in particular poultry populations tion Proposed by the competent authority e line shall be presented for PMI before they are sorted in propriate category of ABPs. of 2020, the SVA (CCA) ­ Department of Internal Audit will rify the proper implementation of this rules at the level of A (slaughterhouses).

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The OVs met, in general, are capable of detecting deficiencies and are aware of legal requirements. Nonetheless, the audit team noted certain non-compliances during the on- site visits not detected and / or recorded by the officials.

In one slaughterhouse visited, the audit team noticed non-compliances related to stunning (level of water in electrical water bath did not allow immersion of the birds up to the base of the wings) which was not noted by the OV during a daily control. In addition, when the FBO staff demonstrated the check on stunning, the person took a bird from the line after stunning and explained that the bird should wake up in 90 seconds. When the person was advised to check e.g. cornea reflex by the audit team, the person did not perform the check correctly. The OV did not correct the person and explained later that the person was not the animal welfare officer.

The audit team noted non-compliances in the abovementioned slaughterhouse related to PMI. The birds fallen from the line before PMI, are not presented for PMI as required in point 1, Part B, Chapter V, Section IV of Annex 1 to Regulation (EC) No 854/2004, but are disposed as unfit for human consumption. Furthermore, all carcases are washed after evisceration before entering PMI (the same non-compliance was detected by the audit team also in another slaughterhouse visited). These non-compliances related to PMI were not noted by the OVs or by the RVA inspectors during their audits.

The audit team noted in the same establishment that, due to current reconstruction works on that day, the cutting room has no hand-washing facilities. FBO explained that the cutting room is being reconstructed due to the age of the facilities and increased slaughtering capacity. Therefore, personal hygiene is organised in other ways and the OV was aware of this exceptional procedure. The audit team noted in the cutting room 5 that knife disinfection is done by using alcohol spray, in accordance with the FBO's HACCP plan. Washing instructions of knives before disinfection are not included in the plan. The official staff had not noted/recorded this deficiency. During the visit, the hand washing facility in the packing room of fresh poultry meat had no running water. The FBO took immediate action to correct this.

The audit team reviewed some OV records of temperatures of the cold storage rooms in the same slaughterhouse. The audit team saw evidence that the OV had detected a deficiency in cold chain in one freezer (temperatures between -9,6 and -11,9 for five hours as the minimum should be -18) and had informed the FBO. The FBO had explained to the OV that air temperature in this freezer fluctuates when the door is open. The OV had not recorded this non-compliance in a logbook and therefore, there was no evidence if any corrective action had been requested and / or taken.

In the abovementioned slaughterhouse, the inspection frequency is six times per year (the baseline frequency). However, the audit team saw deficiencies in hygiene (as listed above but also due to ongoing reconstruction) that might indicate higher risk and therefore should result in increased inspection frequency.

However, the level of detection by officials of certain non-compliances in the operation of establishments was low. This mainly concerned carcase washing after evisceration 7 and before PMI (see 5.5), discarding fallen carcases before PMI, production hygiene and maintenance of the cold chain, consequently leading to a situation where corrective measures are not taken or imposed.

The audit team noted in two out of three slaughterhouses visited that washing of carcases takes place after evisceration and before PMI. This non-compliance was not detected by any level of CAs. This is a repeated finding from the audit carried out in 2010 when measures were not taken during slaughter to prevent contamination of meat, in particular, the spillage of digestive tract contents during evisceration, as required in point 5, Chapter IV, Section II of Annex III to Regulation (EC) No 853/2004.

Washing carcases undermines slaughter hygiene and prevents official staff from a) rejecting carcases showing faecal contamination during PMI, and b) from notifying and requiring the operator to take the necessary corrective measures, in order to safeguard food safety and hygiene of production. Therefore, Recommendation No 5 has in practice not been addressed effectively.

In general, the establishments visited comply with EU requirements or the corrective actions have been taken and are in place to reach the adequate compliance level. The control procedures are adopted by officials. Nonetheless, the audit team detected during the on-site visits certain non-compliances which are described in detail in chapter 5.2. 11

The audit team noted in one slaughterhouse visited that the premises need reconstruction due to the age of the building and the increased production capacity. The audit team saw the FBO's reconstruction plan and some of those planned changes had started by the time of the audit. In another slaughterhouse, speed of the slaughter line in relation to the capacity of chilling and cutting of carcases had a negative impact on progression of cutting and maintenance of the required temperature in meat (the same non-compliance was noted during 2010 audit). Conclusions on FBO's compliance with EU hygiene requirements

Recommendation No 6 is only partially addressed. The corrective actions taken by the CA have not been sufficiently effective to ensure that all deficiencies recorded in the 2010 audit report are corrected, such as issues regarding temperature of meat during cutting. In addition, the official control system in place is not sufficiently responsive, in particular, to new deficiencies related to increased slaughter and production speeds which require reconstruction of the facilities and increased capacity for chilling and cutting carcases to ensure progression of cutting and, consequently, maintenance of the required temperature of the meat.

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SVA (CCA) informed the directors/heads of the Department of oint Hygiene of RVA about preliminary findings of the audit at a eting held on 28 - 29 November 2019. The directors/heads of he Department of Hygiene of RVA will hand over obtained nformation to all responsible official veterinarians. the establishments where deficiencies were identified during e FVO audit, corrective measures have been imposed, their lfilment will be supervised by the RVA and SVA (CCA). e SVA (CCA) will continue to verify the proper implementation this rules at the level of RVA. e SVA has reassessed the system of recording fects/deficiencies. All shortcomings, always with corrective tion and removal date, will be included in the CP (control otocol), control sheets or daily books. The removal of ficiencies must subsequently be verify by the official terinarian. 2020 the Department of Internal Audit of the SVA will verify llowing: Page: 2 ndations of report ref. DG(SANTE)/2019-6667-MR of the audit carried out from actions taken in response to the previous audits on official controls over production control programmes in particular poultry populations tion Proposed by the competent authority Fulfilment of fr

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The audit team noted non-compliances in the abovementioned slaughterhouse related to PMI. The birds fallen from the line before PMI, are not presented for PMI as required in point 1, Part B, Chapter V, Section IV of Annex 1 to Regulation (EC) No 854/2004, but are disposed as unfit for human consumption. Furthermore, all carcases are washed after evisceration before entering PMI (the same non-compliance was detected by the audit team also in another slaughterhouse visited). These non-compliances related to PMI were not noted by the OVs or by the RVA inspectors during their audits.

The audit team noted in the same establishment that, due to current reconstruction works on that day, the cutting room has no hand-washing facilities. FBO explained that the cutting room is being reconstructed due to the age of the facilities and increased slaughtering capacity. Therefore, personal hygiene is organised in other ways and the OV was aware of this exceptional procedure. The audit team noted in the cutting room 5 that knife disinfection is done by using alcohol spray, in accordance with the FBO's HACCP plan. Washing instructions of knives before disinfection are not included in the plan. The official staff had not noted/recorded this deficiency. During the visit, the hand washing facility in the packing room of fresh poultry meat had no running water. The FBO took immediate action to correct this.

The audit team reviewed some OV records of temperatures of the cold storage rooms in the same slaughterhouse. The audit team saw evidence that the OV had detected a deficiency in cold chain in one freezer (temperatures between -9,6 and -11,9 for five hours as the minimum should be -18) and had informed the FBO. The FBO had explained to the OV that air temperature in this freezer fluctuates when the door is open. The OV had not recorded this non-compliance in a logbook and therefore, there was no evidence if any corrective action had been requested and / or taken.

In 2018 the same FBO had carried out a validation of the temperature and time limits for meat in cutting room and based on the results, provided a procedure setting a temperature for meat in cutting room of up to +6,5 maximum for two hours in an ambient temperature of +12. The RVA audit report in 2018 does not mention any non- compliance related to temperature of meat, nor an assessment of the validation. The official staff have records of meat temperatures in the cutting room over + 4 but below 6 +6,5. However, the audit team noted during the on-site visit fluctuation of temperature of meat of over +4 while cutting and wrapping/packaging, up to +8,6. This is not in line with the FBO's own procedures or with EU legislation, which does not provide an for an exemption of a validation which allows the meat temperature to rise up to +6,5 for two hours during cutting.

However, the level of detection by officials of certain non-compliances in the operation of establishments was low. This mainly concerned carcase washing after evisceration 7 and before PMI (see 5.5), discarding fallen carcases before PMI, production hygiene and maintenance of the cold chain, consequently leading to a situation where corrective measures are not taken or imposed.

The audit team noted in two out of three slaughterhouses visited that washing of carcases takes place after evisceration and before PMI. This non-compliance was not detected by any level of CAs. This is a repeated finding from the audit carried out in 2010 when measures were not taken during slaughter to prevent contamination of meat, in particular, the spillage of digestive tract contents during evisceration, as required in point 5, Chapter IV, Section II of Annex III to Regulation (EC) No 853/2004.

Washing carcases undermines slaughter hygiene and prevents official staff from a) rejecting carcases showing faecal contamination during PMI, and b) from notifying and requiring the operator to take the necessary corrective measures, in order to safeguard food safety and hygiene of production. Therefore, Recommendation No 5 has in practice not been addressed effectively.

Medlemsstatens svar

A (CCA) informed the directors/heads of the Department of giene of RVA about preliminary findings of the audit at a 54 meeting held on 28 - 29 November 2019. The directors/heads of e Department of Hygiene of RVA will hand over obtained formation to all responsible official veterinarians. the establishments where deficiencies were identified during e FVO audit, corrective measures have been imposed, their lfilment will be supervised by the RVA and SVA (CCA). e SVA (CCA) will continue to perform verification on the A. 2020 the Department of Internal Audit of the SVA will verify at all revealed shortcomings are properly ted/mentioned/notified. Page: 3

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Despite these risk analyses, that should in principle prevent routine confirmatory sampling, all FBO positive results in breeder flocks and the majority (15 out of 21) of FBO positive results in laying hen flocks were still subjected to confirmatory sampling; the few exceptions reviewed were small holdings where the flock had become infected at the end of production cycle. This is not in line with Point 2.2.2.2 (c), Annex to Regulation (EU) No 200/2010 as confirmatory sampling in breeders should only be carried out in exceptional cases where the CA has reason to question the results of the testing (such as false positive or false negative results); Point 4, Part D of Annex II to Regulation (EC) No 2160/2003 as confirmatory sampling in laying hens should only be carried out to exclude false positive initial results.

The audit team evaluated the 10 risk criteria in the SVA instruction and could see that five of them generally addressed a size or type of holding and available processing capacity for eggs, i.e. criteria not directly related to the higher risk of false positive results. The other five criteria related to a higher risk of false positives. Nevertheless, using all 10 criteria in the 2015 instruction still resulted in routine confirmatory sampling in breeding and laying hen flocks, contrary to EU requirements. In addition, according to the national legislation, a compensation for depopulation of Salmonella positive houses 6 can be paid only when a confirmatory sample is positive for relevant Salmonella and extraordinary veterinary measures to depopulate holdings have been issued. Therefore, the national legislation on compensations is a deterrent to exceptional confirmatory sampling. 5.2.2 Laboratories Legal requirements Article 33 of Regulation (EC) No 882/2004 Articles 11 and 12 of Regulation (EC) No 2160/2003 Findings

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The SNCP is not as precise in the indication of the type of sampling to be performed as is done in Reg. 200/2010 and neither is in line with the Salmonella approved programme for obtaining EU financial contribution, namely: Reg. 200/2010 requires that in a case of suspicion of false results (positive or negative) the confirmatory sampling done should follow the testing prescribed in point 2.2.2.2. b) of its Annex, including the points on additional sampling and non-confirmed source of infection; while The SNCP describes some of the requirements of point 2.2.2.2. b) but not the one concerning the non-confirmed source of infection. 12

Since 2017, the CA has carried out confirmatory sampling in all suspect breeding flocks (three flocks) using the same sampling protocol as for routine sampling. In one case the confirmatory sampling gave negative results for targeted Salmonella. As this confirmatory sampling was done in line with the SNCP, trade restrictions were lifted without the antimicrobial testing or new bacteriological testing that is required in the Annex to Reg. 200/2010, point 2.2.2.2. b) for a non-confirmed source of infection.

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Despite these risk analyses, that should in principle prevent routine confirmatory sampling, all FBO positive results in breeder flocks and the majority (15 out of 21) of FBO positive results in laying hen flocks were still subjected to confirmatory sampling; the few exceptions reviewed were small holdings where the flock had become infected at the end of production cycle. This is not in line with Point 2.2.2.2 (c), Annex to Regulation (EU) No 200/2010 as confirmatory sampling in breeders should only be carried out in exceptional cases where the CA has reason to question the results of the testing (such as false positive or false negative results); Point 4, Part D of Annex II to Regulation (EC) No 2160/2003 as confirmatory sampling in laying hens should only be carried out to exclude false positive initial results.

The audit team evaluated the 10 risk criteria in the SVA instruction and could see that five of them generally addressed a size or type of holding and available processing capacity for eggs, i.e. criteria not directly related to the higher risk of false positive results. The other five criteria related to a higher risk of false positives. Nevertheless, using all 10 criteria in the 2015 instruction still resulted in routine confirmatory sampling in breeding and laying hen flocks, contrary to EU requirements. In addition, according to the national legislation, a compensation for depopulation of Salmonella positive houses 6 can be paid only when a confirmatory sample is positive for relevant Salmonella and extraordinary veterinary measures to depopulate holdings have been issued. Therefore, the national legislation on compensations is a deterrent to exceptional confirmatory sampling. 5.2.2 Laboratories Legal requirements Article 33 of Regulation (EC) No 882/2004 Articles 11 and 12 of Regulation (EC) No 2160/2003 Findings

Since 2016, confirmatory sampling was carried out in 15 of 21 laying flocks that had FBO samples with results positive for Salmonella. Only two confirmatory samples returned positive for relevant Salmonella serotypes with the remaining 13 reported as negative. The impact on Salmonella prevalence rate in laying hens is that if the FBO positive results had been included (instead of discarded after the confirmatory sampling 8 returned negative for 13 out of 15 flocks) in 2016 the prevalence rate in Czech Republic would go above the 2% EU target.

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The official confirmatory sampling is carried out according to Annex II, part D, point 4 of Reg. 2160/2003. However, instead of five faecal samples and two dust samples (as in the EU co-financed programme) usually, only seven faecal samples were taken. Since 2014 there were only three occasions when sampling protocol duly followed the relevant EU technical specification; in other instances the CA allowed replacement of two dust samples (250 ml per one sample as in the technical specification) by faecal samples to compensate for an insufficient amount of available dust in affected poultry houses. The lack of dust in sampling can result in lower detection sensitivity to Salmonella with a higher likelihood of negative results.

In other instances reviewed by the audit team when Salmonella enteritidis was detected in FBO sample, the RVA carried out official confirmatory sampling by using the sampling protocol laid down in point 4(b) of Annex II Part D to Regulation (EC) No 2160/2003 except it was noted that only faecal samples were taken and not dust.

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However for official samples the data and results since 2016 show that not all holdings with more than 1,000 birds were sampled and tested for Salmonella (see tables under Point 5 in Annex 2) contrary to the requirement in point 2.1 of the Annex to Regulation (EC) No 517/2011. According to the SVA analysis, in 2017 only 56 out of 71 eligible holdings were officially sampled. This issue was discussed in one RVA visited where in 2017 no official sample was taken, and in 2018 only some eligible holdings were officially sampled; in that period the RVA diverted available resources to other more urgent issues.

The audit team reviewed results since 2016 (see tables under Point 6 in Annex 2) and in general the number of holdings officially sampled and tested for Salmonella reached the targets in the SNCP. However, in 2018 in two of the 14 regions the RVA had not reached that target (sample 10% of broiler holdings); in one region only two holdings were tested instead of five; in another region instead of two none were officially sampled. The CCA was aware of this deficiency, but since the overall number of planned official samples for the whole country had already been achieved it instructed the RVA not to take the samples.

The FBO monitoring and sampling schemes are implemented in line with the approved SNCPs. The central level has tools to monitor and continuously review the progress of the programmes, including official actions. However, some RVAs did not fully respect the planned official sampling frequency in the last two years, in particular for laying hens and broilers.

The central level has tools to monitor and continuously review the progress of the programmes. Results and their analysis are discussed during the regular meetings with the RVAs. Despite this, some RVAs, responsible for implementation of the programmes, did not fully respect the planned official samplings in the last two years, in particular for laying hens and broilers (see findings 34 and 44). These failures in implementation of the official sampling were either not detected at an early stage or were detected but not swiftly addressed.

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Since 2016, confirmatory sampling was carried out in 15 of 21 laying flocks that had FBO samples with results positive for Salmonella. Only two confirmatory samples returned positive for relevant Salmonella serotypes with the remaining 13 reported as negative. The impact on Salmonella prevalence rate in laying hens is that if the FBO positive results had been included (instead of discarded after the confirmatory sampling 8 returned negative for 13 out of 15 flocks) in 2016 the prevalence rate in Czech Republic would go above the 2% EU target.

For confirmatory sampling the CA is required (point 2.2 of the Annex to Regulation (EC) No 517/2011) to carry out further checks namely by laboratory tests or documentary checks to ensure that the results are not affected by the use of antimicrobials. The RVAs did not take additional samples of birds for antimicrobial residues or bacterial growth inhibitors in any of the confirmatory samplings reviewed. Instead in all cases they relied on the results of documentary checks on the holdings - verification of treatment records - that showed no antimicrobial treatment of birds. Although EU legislation allows using documentary checks the use and results from laboratory tests can significantly contribute to identifying the root causes for such a low Salmonella detection rate in official confirmatory sampling.

Test results provided by the CA for 2018 show that when comparing results of official sampling with FBO sampling,, the detection rate was approximately 15 times higher from official samples,of 3.48% (3 of 86 tests) versus 0.22% (1 of 453 tests). The CCA accredits the higher prevalence in official samples to the higher detection sensitivity of official sampling (additional faecal sample taken). The CCA had decided not to replace one faecal sample or one pair of boot swabs with a dust sample as allowed in point 2.2.2. of the Annex to Regulation (EC) No 517/2011; inclusion of dust in the official sampling would provide the CA with a more sound basis to establish if the difference in detection rates is reasonable and its potential reasons. 5.2.5 SNCP for broilers Legal requirements Article 5 of Regulation (EC) No 2160/2003 Article 1 of Regulation (EC) No 200/2012 Findings

The CCA provided their view on potential reasons for the increasing prevalence trend in recent years and the above target prevalence in broilers in the last two years as being: feed for parent flocks had not been heat treated (only acidity used); in some instances a lack of adequate biosecurity measures had been applied on the holdings and a recurrence of Salmonella infection; in particular rather small holdings seem to be more vulnerable to the infection.

Test results for 2018, show a Salmonella positive detection rate approximately five times higher than official samples of 8.1% (4 of 36 tests) versus 1.6% (75 of 4 667 tests) from FBO samples. The CA has been aware of this difference in detection rates for several years but cannot identify a reason. To some extent this difference may be explained by the selection of broiler holdings with a high risk for Salmonella in official controls (holdings with recurrence of Salmonella).

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Between June 2017 and February 2018, 373 and 109 domestic pigs were tested in Part II under active and passive surveillance respectively. In Part I, 129 and 255 pigs were tested under active and passive surveillance respectively. In the remainder of the country, only 5 pigs were tested for ASF under passive surveillance during the same period (see Annex 2). This is not in accordance with the ASF Strategy for Eastern part of EU which recommends enhanced passive surveillance in the whole country.

Although not all home slaughter in Part II receives official inspection, surveillance arrangements for domestic pigs in this area should make early detection of ASF possible. Outside the infected area, passive surveillance for early detection of ASF in domestic pigs is weakened by the fact very few samples are tested. This will hamper the early detection of ASF in this population should it occur.

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Holding registers were available on the three holdings visited by the audit team. These registers followed a national template and recorded number of pigs present and dates of events e.g. date of movement on / off and slaughter for own consumption. In both the large commercial farm and one of the smaller holdings visited, entries to holding registers recorded that more than one pig (between 2 - 8 pigs) had moved to non- registered holdings in single movement events. The ultimate destination of these pigs 6 In their comments to the draft report the Competent Authorities added that: "Currently [July 2018], based on the Extraordinary Veterinary Measures (EVM) adopted, keeping of pigs in non-registered holdings in Part II (infected area) is forbidden". 7 In their comments to the draft report the Competent Authorities indicated that the central database has a data field "statutes of holding infections" ("statuty nákaz chovu") where sanitary information can be inserted. 5 was not clear e.g. the large commercial farm had name and address of person they sold pigs to but competent authority considered these persons were acting as an agent and supplying pigs onwards. These were not always local transactions, in one case, the person buying the pigs lived 50 km from the large commercial holding.8 5.1.2 Movement restrictions

The fact that holdings with more than one pig are not registered, and consequently are not under official control represent a weak point in the control system. Outside of Part I and II, these non-registered holdings are unknown in terms of number and location. This, along with incomplete holding registers, will represent a challenge in tracing pigs and containment of disease in the event of an outbreak. 11

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National provisions relating to wild boars15, allows the movement of wild boar carcases from Part II to other areas of territory of Czech Republic for processing. While this movement of fresh meat from feral pigs is hypothetical (all wild boar carcases from Part II are rendered), it is not in accordance with Article 15 of Decision 2014/709/EU.16

National rules allow dispatch of meat from wild boars which originated in Part II. However, by rendering all wild boar carcases from Part II, the authority mitigates the risk of spread of infection by meat / meat products and the inappropriate handling of those carcases.

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The authorities confirmed that herd owners who carry out home slaughter must inform the Regional Veterinary Administration three days in advance and that the authorities do not supervise all such events. In Part II (2017), central database recorded 77 home slaughtering events of which 60 were notified to the authorities and 24 of these received official post mortem examination on farm. This is not in accordance with ASF Strategy for Eastern Part of the EU which requires home slaughtering only under veterinary supervision in Part II.13 5.2.3 Laboratory testing

Although not all home slaughter in Part II receives official inspection, surveillance arrangements for domestic pigs in this area should make early detection of ASF possible. Outside the infected area, passive surveillance for early detection of ASF in domestic pigs is weakened by the fact very few samples are tested. This will hamper the early detection of ASF in this population should it occur.

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The audit team noted that, when developing the audit programme, SVA has not properly defined all relevant audit areas (the audit areas are not sufficiently detailed e.g. animal health is determined as an audit area although this could be further broken down to different animal species, activities, diseases etc.) and the audit programme development process is not well-documented as regards risk-based prioritisation (it is not evident whether all relevant areas were considered and on which basis decision on selection of audit topics was made).

The audit areas in CAFIA audit system are expanded since 2011, and the annual audit programme indicates an addition of new audit topics. The topics include microbiological sampling, traceability, genetically modified organisms in food, risk-based planning of official controls etc. The audit team noted that there is no evidence on how new topics are determined and there is no overview of the areas that need to be considered in the audit programme. In addition, there is no evidence that the development of the audit programme has considered all relevant areas, and it is not evident how this results in risk based prioritisation and effective coverage of all areas in a reasonable timeframe.

The audit team noted that CISTA has not adequately defined the areas that need to be covered by the audit activities. In addition although the planned arrangements refer to risk based planning of audit programmes, CISTA could not demonstrate that audit programmes resulted from a risk-based prioritisation.

All three CCAs have developed and implemented processes for establishing annual and multiannual audit programmes. These processes are not adequately documented thus the CCAs cannot demonstrate that all relevant areas have been considered, an adequate coverage in a reasonable timeframe has been achieved and that audit programmes result from a risk-based prioritisation.

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. The SVA will establish audit systems / audit domains covering all areas of official controls performed by the SVA. Audited systems/domains will be divided into more detailed audit areas. This will be supported by a documentation ­ audited systems/domains will be will be part of updated Guidelines of the State Veterinary Administration No 1/2013 concerning the management and performance of internal audits on the SVA official control system as a separate Annex; detailed audit areas will be drawn up as a separate working document of the Department of Internal Audit and Control of the Central Veterinary Administration of the SVA. Deadline: 31 December 2017 2. The SVA will establish and set up a systematic procedure of a regular evaluation of results of audits on official controls for a calendar year, as well as for a systematic evaluation of data from the professional information system of the SVA (PIS). The SVA will perform a comprehensive review and evaluation of results of audits on official controls for the previous calendar year and will evaluate data from the PIS aimed at recurrent infringements in individual professional fields with a view to the comparison of control activiti

SVA 1. The SVA will establish audit systems / audit domains covering all areas of official controls performed by the SVA. Audited systems/domains will be divided into more detailed audit areas. This will be supported by a documentation ­ audited systems/domains will be will be part of updated Guidelines of the State Veterinary Administration No 1/2013 concerning the management and performance of internal audits on the SVA official control system as a separate Annex; detailed audit areas will be drawn up as a separate working document of the Department of Internal Audit and Control of the Central Veterinary Administration of the SVA. 2. The SVA will establish and set up a systematic procedure of a regular evaluation of results of audits on official controls for a calendar year, as well as for a systematic Page: 1 ity on 1 November 2017 ent authorities of the Czech Republic in response to Report ref. 2017 in order to evaluate the system put in place to implement article 4(6) uthority sional ). ve f audits on calendar he PIS n individual the n individual results, as m the PIS in e the basis of n of the results, as m the PIS ents rnal Audit ary tation and ed analysis Page: 2 ity on 1 N

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The CCAs described the cases of external assessments (annual surveillance audits) performed by the ISO certification bodies in the context of the certification schemes for ISO 9001:2015 standard. The audit team noted that those assessments cover the internal audit functions within the context of the relevant requirements of the ISO standard.

There is no particular focus (in the external assessment done to date) on the audit process to ensure that the process is capable of producing objective results and meeting its obligations under Regulation (EC) No 882/2004 (e.g. no assessment of the risk-based planning and of the independence of the audit process and auditors, no opinion on effectiveness of the audit process etc). The audit team considered that the CCAs have inadequate arrangements in place to fulfil the requirement of Article 4(6) of Regulation (EC) No 882/2004 as regards the independent scrutiny of the audit process. 9 Conclusions

All CCAs have arrangements in place to ensure independent scrutiny of their quality management systems through the ISO certification external audits that they receive. However, those arrangements do not sufficiently cover the audit processes contrary to the requirements of Article 4(6) of Regulation (EC) No 882/2004. 5.2.3 Auditor competence 5.2.3.1 Legal requirements 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 of Commission 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." 5.2.3.2 Findings

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he SVA proposes a correction measure at an external level ­ an ndependent scrutiny of the audit process performed by an xternal audit organisation by means of an external paid audit, in he form of an external paid contract. he SVA will perform an enquiry in order to discover whether ny of audit organisations in the Czech Republic is competent in he professional field of Regulation (EC) No 882/2004. Page: 2 8 September 2017 ions of report ref. DG(SANTE)/2017-6022-MR of the audit carried out from lement article 4(6) of Regulation (EC) No 882/2004 (national audit system) ion. andard 9001 IA, not fulfil egulation Page: 3

A d The SVA proposes a correction measure at an external level ­ an independent scrutiny of the audit process performed by an external audit organisation by means of an external paid audit, in the form of an external paid contract. The SVA will perform an enquiry in order to discover whether any of audit organisations in the Czech Republic is competent in the professional field of Regulation (EC) No 882/2004. 1. Enquiry about a competent external audit Page: 5 ity on 1 November 2017 ent authorities of the Czech Republic in response to Report ref. 2017 in order to evaluate the system put in place to implement article 4(6) uthority most crutiny with the ion that 9001 (CSN lation A, the y principle Article 4(6) EC) No. Page: 6 ity on 1 November 2017 ent authorities of the Czech Republic in response to Report ref. 2017 in order to evaluate the system put in place to implement article 4(6) uthority oration of d to the field of atter into tions), thus of R. No. will also o be subject requently ification body. bject in he matter spection) to d to higher s; it rom Page: 7 ity on 1 November 2017 ent authorities of the Czech Republic in response to Report ref. 2017 in order to evaluate the s

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A few shortcomings in the methodological guidelines were noted such as the request that only one driver's certificate of competence was required and checked for approved journey plans that would require two drivers. The audit team saw several examples of the RVAs implementing these controls as set out in the methodological guidance.

The audit team found the methodological guidance to be generally aligned to the relevant legal requirements. A shortcoming was noted resulting in checks in driver's certificate of competence being insufficient, as only one driver was checked instead of the two required, for the approved long distance journeys. This shortcoming undermines the assurances necessary for the protection of animals during transport.

The RVAs systematically check organisers' plans to rest the animals during the journey and provide them with feed and water (Article 14 of Regulation (EC) No 1/2005): In April 2017 the SVA issued an instruction that the journey plan has to be until the final place of destination in the non-EU country, as indicated by the Zuchtvieh judgement1. The audit team noted that in one of the regions visited the stamped journey plans extended only until the exit point from the EU, and that local officials were unaware of such a requirement; In the other region visited, the journey plans were until the final place of destination. When assessing these journey plans the RVA officials rightly took into account the amount of time needed to clear Turkish official controls at the border (6 hours). Nevertheless, they were only partially aware of the limited opening hours operated by the Turkish veterinary authorities. This had resulted in stamped journey logs that were unrealistic and that would therefore exceed maximum permitted travelling times before reaching the final place of destination. In March 2017 the SVA issued instructions that a copy of confirmation of the booking of the control post in Svilengrad must be systematically requested. This is a good practice. The RVAs have gone beyond these instructions and are requesting a copy of confirmation of the booking of any control post.

There is a system in place to systematically assess planned and actual resting and travelling times before and after the journey. This system is nevertheless weakened by the failure to ensure that all journey plans always cover the full journey until the final place of destination, in contradiction to the methodological guidance, and that approved journey plans are realistic and achievable as working hours at the Turkish border inspection post are not being taken into account. There is therefore the risk that travelling times are exceeded once past the EU border.

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There is a system in place to systematically assess planned and actual resting and travelling times before and after the journey. This system is nevertheless weakened by the failure to ensure that all journey plans always cover the full journey until the final place of destination, in contradiction to the methodological guidance, and that approved journey plans are realistic and achievable as working hours at the Turkish border inspection post are not being taken into account. There is therefore the risk that travelling times are exceeded once past the EU border.

A relatively successful system has been set up to obtain journey logs back from foreign transporters (97% of transporters used). Whilst retrospective checks are being performed the assessment that journeys have been carried out as originally planned is weak.

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The RVAs systematically check organisers' plans to rest the animals during the journey and provide them with feed and water (Article 14 of Regulation (EC) No 1/2005): In April 2017 the SVA issued an instruction that the journey plan has to be until the final place of destination in the non-EU country, as indicated by the Zuchtvieh judgement1. The audit team noted that in one of the regions visited the stamped journey plans extended only until the exit point from the EU, and that local officials were unaware of such a requirement; In the other region visited, the journey plans were until the final place of destination. When assessing these journey plans the RVA officials rightly took into account the amount of time needed to clear Turkish official controls at the border (6 hours). Nevertheless, they were only partially aware of the limited opening hours operated by the Turkish veterinary authorities. This had resulted in stamped journey logs that were unrealistic and that would therefore exceed maximum permitted travelling times before reaching the final place of destination. In March 2017 the SVA issued instructions that a copy of confirmation of the booking of the control post in Svilengrad must be systematically requested. This is a good practice. The RVAs have gone beyond these instructions and are requesting a copy of confirmation of the booking of any control post.

Regarding retrospective checks to verify the travelling and resting times to provide water, feed and rest to the animals: The RVAs systematically ask for journey logs to be returned for all exports to Turkey. They indicated that approximately two-thirds of journey logs are returned. The number of returned journey logs has increased since they started providing written letters to the drivers (in Czech and in the drivers' native language) at time of departure, reminding them of this obligation. The address of the RVA is provided on the letter in the form of a stamp or in print; According to the Multi-Annual National Control Plan a minimum 5% retrospective checks are to be carried out on returned journey logs with the priority given to journeys with reported non-compliances; The audit team reviewed a number of returned journey logs with non-compliances reported at the Bulgarian exit point. Upon the receipt of the non-compliance report, the Czech NCP carries out an initial screening and investigation before this is communicated to the responsible RVA for further investigation; 1 Judgement of the European Court of Justice (Fifth Chamber) of 23 April 2015 ­ Case C424/13. 7 In both regions visited, the official veterinarians could not identify at what stage of the journey the non-compliances on travelling times, reported by the Bulgarian exit point, had or would have occurred. This was generally related to the limited opening hours of the Turkish border inspection post. Conclusions on resting

The RVAs have adopted the policy to check transporters' contingency plans for each journey and this is a good practice. Whilst the plans are fairly comprehensive, they fail to cover the eventuality of unexpected long delays at the border and this is not being checked by the RVAs. There are therefore inadequate assurances that the needs of animals blocked at the border can be met in these instances.

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SVA: A course has been organized by the CVA SVA during its national meeting of directors/heads and deputies of hygiene departments of RVAs on April 27, 2016. The preliminary outcomes, findings gained and conclusions of this mission were one of the themes of that course. The principles of uniformity of rols performed including food sampling procedures following current legislation were emphasized. CAFIA: CAFIA representatives are of the opinion that this point does not concern CAFIA. They suggest that all provisions (including this Recommendation) are removed or appropriately amended. In case they are kept in the Report, CAFIA representatives ask for a verifiable proof demonstrating the lack of qualifications and insufficient training of inspectors which is described in the Draft Report. See comments on Points 13, 14, 34 a 43 (and related detections in Points 11, 12, 31, 32, 41, 55) in ANNEX II.

receives appropriate CAFIA representatives are of the opinion that this point does not zards in food production, concern CAFIA. They suggest that all provisions (including this cedures and the Recommendation) are removed or appropriately amended. In case esults, as required by they are kept in the Report, CAFIA representatives ask for a verifiable proof demonstrating the lack of qualifications and paragraph 13, 14, 34 insufficient training of inspectors which is described in the Draft Report. , 12, 31, 32, 41 and 55. See comments on Points 13, 14, 34 a 43 (and related detections in Points 11, 12, 31, 32, 41, 55) in document CAFIA Comments on Audit Draft Report - DG(SANTE)/2016-8736. Overall training of inspectors for sampling was held on 7th ­ 8th November 2016. CAFIA intends to provide its inspectors with training focused on Regulation on sampling for determination of contaminants (in particular Reg. (EC) No. 401/2016 and Regulation (EC) No. 333/2007); the staff of CAFIA laboratory in Prague will be also involved and appropriately instructed. (EC reply: page 4, Section Para 13, 14). Within the training focused on the Regulation on sampling for determination of contaminants (see ab

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s SVA: A course has been organized by the CVA SVA during its national meeting (see above). Principles of sampling of food of imal origin for chemical analysis following the Regulation No 333/2007 especially underlining the sampling for detection of PAH (representability of number of samples/partial samples in relation to the batch size, weight of entire sample). During the meeting a course aimed to the interpretation of laboratory protocols took place (evaluation of the result in relation with limits given by legislation, the compulsory content of the laboratory protocol). The head inspectors who attended the course (in total 36 inspectors) will further transmit the lessons learned to inspectors performing official controls in food processing facilities. During the national meeting of coordinators for national Page: 1 ations of report ref. DG(SANTE)/2016-8736-MR of the audit carried out from ants in food monitoring of residues and contaminants (Directive 96/23) in May 30-31st, 2016, two lectures were presented: ,,PAH-sampling and interpretation/evaluation of laboratory tests", ,,Methods of sampling and methods of analysis for the official control following Regulation No 333/2007".

of the levels of mycotoxins CAFIA representatives do not suggest any steps related to this dance with the methods set Recommendation. Page: 1 Republic to the recommendations of report ref. DG(SANTE)/2016-8736-MR of the audit carried out from e the controls on contaminants in food ­ version 2 nd Annex to Regulation See comments on Points 36 and 39 in document CAFIA Comments on Audit Draft Report - DG(SANTE)/2016-8736. paragraph 43. See the Recommendation No. 1 above. 38, 39, 41 and 55.

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SVA: NRL for PAH: this ensures correct application of the requirements for the preparation and analysis of samples (Commission Regulation no. 333/2007) in accordance with the above remarks concerning paragraphs 56 ­ 62 and 66 ­ 67. d CAFIA: Based on comments on Points 54 and 66, CAFIA representatives propose that Recommendation No. 3 is appropriately modified, e. g. references to Points 54 and 66 are erased. See comments on Points 36 and 39 in ANNEX II. Page: 2

on (EC) No 882/2004, that CAFIA: Based on comments on Points 54 and 66, CAFIA rements on sample representatives propose that Recommendation No. 3 is to Regulation (EC) No appropriately modified, e. g. references to Points 54 and 66 are EC) No 333/2007. erased. paragraph 66 and 67. See comments on Points 36 and 39 in document CAFIA 56, 57, 58, 59, 60, 61 and Comments on Audit Draft Report - DG(SANTE)/2016-8736). As regards this point, CAFIA laboratory in Prague will comply with the requirements of the Regulation. However, CAFIA insists that Regulation (EC) No. 401/2006 laying down the methods of sampling and analysis for the official control of the levels of mycotoxins in foodstuffs shall be modified (EC reply: page 12. Para 54 + 13, Para 66). CAFIA regards Regulation No. 401/2006 as a technical piece of legislation. In this context, we are of the opinion the Regulation stipulates (makes more specific) that replicate samples shall be taken from homogenised material, not that Member States shall take duplicate and reference samples. We are of the opinion that the interpretation of the Regulation that was practised during the mission was not correct. An audit of the laboratory of the

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Control of incoming goods. In several establishments visited, the FBOs did not ensure that all mandatory information on food supplied was available. Examples were seen where the date of dispatch and/or a reference identifying the lot, batch or consignment and/or the address of the consignee were missing, which is not compliant with the provisions of Regulation (EU) No 931/2011. In one establishment the description of the game meat received was incomplete: the documents did not mention that the products were frozen. This was identified by the official veterinarian. In addition there was a discrepancy between the descriptions of the game meat on the checklist on arrival of game meat against the internal document of acceptance, mentioning 75% and 65% respectively (lean meat%/fat). The delivery documents did not mention the meat/fat content. In the same establishment, fresh meat was received from an establishment approved for cutting only2, whilst the meat was processed. The delivery document mentioned frozen pork trimmings 85/15. The SVA investigated this case and confirmed at the final meeting that it concerned minced meat (trimmings mixed with fat in the mincer) instead of trimmings. In another establishment the FBO had a procedure for recording incoming meat. For one consignment verified, bone-in meat received was recorded as boneless meat, thus making the quantity of meat appear greater than that actually received. In one game handling establishment, wild game was received from different wild game collection centres of which one was not registered in the SVA database. From this collection centre one stag was collected which arrived at the game 2 In their response to the draft report the CA noted that: "the establishment has been approved for cutting, storing, processing, transporting and selling to the final consumer since 12 May 2010. However, the official veterinarian has not inserted this information properly into the IT system". 11 handling establishment on 21 September 2015, the animal was shot on 21 August 2015, but examined by the trained hunter on 9 September 2015 only. Examples were noted where other wild game were examined the following day after killing. Some wild game was collected by the operator at collection centres, but the commercial documents only mentioned details of the hunting e.g. date and area of hunting, date and results of examinations by a trained hunter, etc. These shortcomings were not observed during official controls. It was also noted that wild game was being processed without any records of the arrival date in the establishment.

Routine CA controls are effective in identifying most deficiencies relating to traceability (one step backwards ­ one step forwards) but failed to detect some systemic non- compliances in some establishments.

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rators handling wild SVA (CCA) informed the directors/heads of the Department of ents of Chapters I Hygiene of RVA about preliminary findings of the mission at a No 854/2004 to meeting held on 18. - 20. November 2015. The directors/heads of n, before storage the Department of Hygiene of RVA transmit obtained information to all responsible official veterinarians. In the establishment where deficiencies were identified during the FVO audit corrective measures have been imposed. Their fulfilment will be supervised by the RVA and SVA (CCA). The SVA (CCA) will continue to perform verification on the RVA.

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The CAFIA uses for its comprehensive inspections guidance No 001/2007. This guidance includes a checklist which is not mandatory for use by the inspectors at retail outlets. The document 001/2007 provides guidance on the conduction of official checks on traceability but not on labelling. The CAFIA issued a letter to its staff on 24 June 2015 on the methodology for an extraordinary control from 1 to 31 July 2015 on the origin of fresh meat, packed or pre-packed.

This audit checklist forms the basis for official SVA controls, but is not mandatory to be followed during inspections. Inspectors may decide which topic on the checklist is to be covered during an inspection The guidelines comprise several points on traceability according to Regulation (EC) No 178/2002 (one step backward - one step forward), but do not include controls of traceability systems within the food businesses. In one region visited, the RVA had issued their own checklist for routine inspections, which were used by the district officers.

Within their competence, both the CAFIA and the SVA provided information concerning the tracing to the establishments involved for all 12 randomly chosen samples. The CAFIA provided information on traceability (one step backward) from the retail outlet to the previous supplier, the labelling requirements in general (this did not include verification of the ingredients used versus the recipe, the use of additives and heat treatment of the products). The CCAs concluded as follows: tracing (one step back ­ one step forward): four samples were found non-compliant (missing references on delivery notes, no exact description of the product or of the physical status); regarding quantities of meat and products thereof and other ingredients used: two were found non-compliant. In one case no production records were available to justify the content mentioned on the label. In the second case the quantities of additives used were not recorded and therefore the maximum limits could not be verified; labelling: out of twelve samples eight were identified with non-conformities (ingredients were missing, including one allergen, format of the batch number was incorrect, one batch number was found illegible, labels missing on some pieces of rabbit meat due to peeling off, label in the Czech language was partially covered on one product and labels did not or not correctly mention some additives); additives: three products were chosen for which additives were not used. Out of the remaining nine samples the CA had findings for four (some specifications were missing, incomplete or out of date, some additives for which the carry-over principle applies were not taken into account by the FBO).

The FVO audit team examined the documentation of these 12 cases. The outcome of this exercise was as follows: tracing (one step backward ­ one step forward): In three cases, the CA did not observe that links were missing, this was particularly the case when traders were involved. In another case the CA did not complete the evaluation. The FVO audit 8 team confirmed the other CA findings. However, the CA considered some retail outlets and the distribution centres used by them as a single food business, even though the locations have different registration/approval requirements and are physically located on different sites. The CA stated that consequently there was no need to ensure traceability for physical movement of products. References for the products, which were not mentioned on the commercial documents were subsequently provided by email by the FBO and were found to be satisfactory by the CAFIA. On the other hand examples were seen where the retail outlets shared IT systems with the suppliers and these systems provided the relevant information requested by Regulation (EU) No 931/2011; available documentation to verify the physical flow of the products within the establishments such as production data for reconciliation, the product recipes, the technical specifications of the additives used: the FVO audit team confirmed the CA finding in all but one case, where the CA did not complete its evaluation; labelling: the FVO audit team confirmed the CA findings based on the documentation provided. For one sample (imported rabbit meat), the absence of labels had been identified during previous SVA inspections at destination in early 2015. The SVA had requested the FBO to take appropriate corrective actions. The SVA stated that the sample taken formed part of the same consignment and the labels were missing due to peeling-off; additives: the FVO audit team confirmed the CA findings based on the documentation seen.

The FVO audit team selected 3 of the 12 cases for on-the-spot verification of the data provided by the CA. The additional findings of this exercise were as follows: tracing (one step backward ­ one step forward) was not satisfactory in one of the three cases: commercial documents for supplied meat did not mention references for batch or lot identification, which is not in line with the requirements laid down in Regulation (EU) No 931/2011. Commercial documents for dispatched composite products containing meat products did not include a reference number. For the two other cases, the FVO audit team confirmed the CA evaluation; reconciliation of the quantities of meat and products thereof and other ingredients used versus the products produced: in one case there was a discrepancy between the labelling and the recipe regarding the amount of meat, fried onion and parsley. The quantities of meat and other ingredients used were not recorded and reconciliation of meat and other ingredients was not possible. Despite the FBO having an internal quality scheme in place, these deficiencies remained unidentified. For the other two cases, the FVO audit team confirmed the CA evaluation; in one out of the three cases, the FVO audit team confirmed the evaluation of the labelling carried out by the CA. For the two other cases, the food labelling was not compliant: for one meat product the label did not specify that it was a smoked product (non-smoked varieties of this product are marketed); for a second meat 9 product, E412 (guan gum) was incorrectly specified on the label as a stabiliser, rather than a thickener; in addition the FVO audit team identified that the official veterinarian and the FBO of one establishment visited calculated the input of nitrite (E250) based on the amount specified in the recipe and not on the actual quantity of meat used in the production1.

The CA was able to trace back all twelve samples of meat and products thereof taken at retail outlets through the FBO's record systems to the slaughterhouse of origin or to the point of entry in the Czech Republic (one step backward ­ one step forward). Notwithstanding the non-compliance identified, official controls have, during this audit, been generally effective in enforcing the requirement to be able to trace meat and products thereof along the production chain ("one step backwards ­ one step forwards").

Control of incoming goods. In several establishments visited, the FBOs did not ensure that all mandatory information on food supplied was available. Examples were seen where the date of dispatch and/or a reference identifying the lot, batch or consignment and/or the address of the consignee were missing, which is not compliant with the provisions of Regulation (EU) No 931/2011. In one establishment the description of the game meat received was incomplete: the documents did not mention that the products were frozen. This was identified by the official veterinarian. In addition there was a discrepancy between the descriptions of the game meat on the checklist on arrival of game meat against the internal document of acceptance, mentioning 75% and 65% respectively (lean meat%/fat). The delivery documents did not mention the meat/fat content. In the same establishment, fresh meat was received from an establishment approved for cutting only2, whilst the meat was processed. The delivery document mentioned frozen pork trimmings 85/15. The SVA investigated this case and confirmed at the final meeting that it concerned minced meat (trimmings mixed with fat in the mincer) instead of trimmings. In another establishment the FBO had a procedure for recording incoming meat. For one consignment verified, bone-in meat received was recorded as boneless meat, thus making the quantity of meat appear greater than that actually received. In one game handling establishment, wild game was received from different wild game collection centres of which one was not registered in the SVA database. From this collection centre one stag was collected which arrived at the game 2 In their response to the draft report the CA noted that: "the establishment has been approved for cutting, storing, processing, transporting and selling to the final consumer since 12 May 2010. However, the official veterinarian has not inserted this information properly into the IT system". 11 handling establishment on 21 September 2015, the animal was shot on 21 August 2015, but examined by the trained hunter on 9 September 2015 only. Examples were noted where other wild game were examined the following day after killing. Some wild game was collected by the operator at collection centres, but the commercial documents only mentioned details of the hunting e.g. date and area of hunting, date and results of examinations by a trained hunter, etc. These shortcomings were not observed during official controls. It was also noted that wild game was being processed without any records of the arrival date in the establishment.

Routine CA controls are effective in identifying most deficiencies relating to traceability (one step backwards ­ one step forwards) but failed to detect some systemic non- compliances in some establishments.

Measures taken following detection of non-compliances relating to traceability, labelling, and particularly concerning the requirements of Regulation (EU) No 931/2011, were not sufficiently rigorous to enforce prompt and effective remedial action.

Medlemsstatens svar

rators producing SVA (CCA) informed the directors/heads of the Department of the relevant Hygiene of RVA about preliminary findings of the mission at a 18 of Regulation meeting held on 18. - 20. November 2015. The directors/heads of 931/2011, in the Department of Hygiene of RVA will transfer obtained he relevant findings information to all responsible official veterinarians. SVA (CCA) informed the official veterinarians responsible for controls at big capacity slaughterhouses and meat processing establishments about preliminary findings of the FVO audit at a meeting held on 12. - 13. November 2015. SVA (CCA) will prepare a recommended procedure for checking the traceability and labeling of food. In the establishments where deficiencies were identified during the FVO audit corrective measures have been imposed their fulfilment will be supervised by the RVAs and SVA (CCA). Page: 1 ic to the recommendations of Report ref. DG(SANTE)/2015-7376-MR of the audit carried out valuate the operation of official controls over the post-slaughter traceability of meat, meat The SVA (CCA) will continue to perform verification on the RVA.

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The FVO audit team selected 3 of the 12 cases for on-the-spot verification of the data provided by the CA. The additional findings of this exercise were as follows: tracing (one step backward ­ one step forward) was not satisfactory in one of the three cases: commercial documents for supplied meat did not mention references for batch or lot identification, which is not in line with the requirements laid down in Regulation (EU) No 931/2011. Commercial documents for dispatched composite products containing meat products did not include a reference number. For the two other cases, the FVO audit team confirmed the CA evaluation; reconciliation of the quantities of meat and products thereof and other ingredients used versus the products produced: in one case there was a discrepancy between the labelling and the recipe regarding the amount of meat, fried onion and parsley. The quantities of meat and other ingredients used were not recorded and reconciliation of meat and other ingredients was not possible. Despite the FBO having an internal quality scheme in place, these deficiencies remained unidentified. For the other two cases, the FVO audit team confirmed the CA evaluation; in one out of the three cases, the FVO audit team confirmed the evaluation of the labelling carried out by the CA. For the two other cases, the food labelling was not compliant: for one meat product the label did not specify that it was a smoked product (non-smoked varieties of this product are marketed); for a second meat 9 product, E412 (guan gum) was incorrectly specified on the label as a stabiliser, rather than a thickener; in addition the FVO audit team identified that the official veterinarian and the FBO of one establishment visited calculated the input of nitrite (E250) based on the amount specified in the recipe and not on the actual quantity of meat used in the production1.

Use of additives: Examples were seen of specifications of additives, which did not allow the FBO to justify the exact quantities used, in particular, for those additives for which a legal maximum limit has been established. For one meat product verified, the FBO could not provide information on the type of smoke flavouring in the additive mixture used. The CCA provided specifications of the additives used after the audit was completed. For the products verified in the establishments visited, no cases were seen where the additives used exceeded the legal maximum limits set out in Regulation (EU) No 1333/2008. The CCA is aware of similar non-compliances in the meat sector and corrective actions are being taken.

Measures taken following detection of non-compliances relating to traceability, labelling, and particularly concerning the requirements of Regulation (EU) No 931/2011, were not sufficiently rigorous to enforce prompt and effective remedial action.

The CCA is aware of similar non-compliances identified on the use of additives and corrective actions are being undertaken. 13

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operators producing SVA (CCA) informed the directors/heads of the Department of pe the relevant Hygiene of RVA about preliminary findings of the mission at a ucts laid down in meeting held on 18. - 20. November 2015. SVA (CCA) informed the official veterinarians responsible for controls at big capacity slaughterhouses and meat processing establishments about preliminary findings of the FVO audit at a meeting held on 12. - 13. November 2015. SVA (CCA) is currently preparing a new Methodological instruction for RVAs to unify procedure, which will focus on controls of using additives, premixes and smoke flavourings in foods of animal origin. SVA (CCA) commenced to train inspectors of RVA/LVA who are responsible for the control of additives, smoke flavourings and premixes in products of animal origin. Until now, the training has taken place in 10 regions. The inspectors in remaining two regions will be trained by the end of 2015. As of 2016, the SVA (CCA) will start to perform verification on the RVA/LVA.

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Within their competence, both the CAFIA and the SVA provided information concerning the tracing to the establishments involved for all 12 randomly chosen samples. The CAFIA provided information on traceability (one step backward) from the retail outlet to the previous supplier, the labelling requirements in general (this did not include verification of the ingredients used versus the recipe, the use of additives and heat treatment of the products). The CCAs concluded as follows: tracing (one step back ­ one step forward): four samples were found non-compliant (missing references on delivery notes, no exact description of the product or of the physical status); regarding quantities of meat and products thereof and other ingredients used: two were found non-compliant. In one case no production records were available to justify the content mentioned on the label. In the second case the quantities of additives used were not recorded and therefore the maximum limits could not be verified; labelling: out of twelve samples eight were identified with non-conformities (ingredients were missing, including one allergen, format of the batch number was incorrect, one batch number was found illegible, labels missing on some pieces of rabbit meat due to peeling off, label in the Czech language was partially covered on one product and labels did not or not correctly mention some additives); additives: three products were chosen for which additives were not used. Out of the remaining nine samples the CA had findings for four (some specifications were missing, incomplete or out of date, some additives for which the carry-over principle applies were not taken into account by the FBO).

The FVO audit team selected 3 of the 12 cases for on-the-spot verification of the data provided by the CA. The additional findings of this exercise were as follows: tracing (one step backward ­ one step forward) was not satisfactory in one of the three cases: commercial documents for supplied meat did not mention references for batch or lot identification, which is not in line with the requirements laid down in Regulation (EU) No 931/2011. Commercial documents for dispatched composite products containing meat products did not include a reference number. For the two other cases, the FVO audit team confirmed the CA evaluation; reconciliation of the quantities of meat and products thereof and other ingredients used versus the products produced: in one case there was a discrepancy between the labelling and the recipe regarding the amount of meat, fried onion and parsley. The quantities of meat and other ingredients used were not recorded and reconciliation of meat and other ingredients was not possible. Despite the FBO having an internal quality scheme in place, these deficiencies remained unidentified. For the other two cases, the FVO audit team confirmed the CA evaluation; in one out of the three cases, the FVO audit team confirmed the evaluation of the labelling carried out by the CA. For the two other cases, the food labelling was not compliant: for one meat product the label did not specify that it was a smoked product (non-smoked varieties of this product are marketed); for a second meat 9 product, E412 (guan gum) was incorrectly specified on the label as a stabiliser, rather than a thickener; in addition the FVO audit team identified that the official veterinarian and the FBO of one establishment visited calculated the input of nitrite (E250) based on the amount specified in the recipe and not on the actual quantity of meat used in the production1.

The CA was able to trace back all twelve samples of meat and products thereof taken at retail outlets through the FBO's record systems to the slaughterhouse of origin or to the point of entry in the Czech Republic (one step backward ­ one step forward). Notwithstanding the non-compliance identified, official controls have, during this audit, been generally effective in enforcing the requirement to be able to trace meat and products thereof along the production chain ("one step backwards ­ one step forwards").

Labelling: 12 One FBO could not justify the amount of ingredients indicated on the label of a composite product. The label did not match with the recipe and no production records were present.

Measures taken following detection of non-compliances relating to traceability, labelling, and particularly concerning the requirements of Regulation (EU) No 931/2011, were not sufficiently rigorous to enforce prompt and effective remedial action.

Health marking of carcasses in one establishment was not in compliance with requirements.

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operators, producing SVA (CCA) informed the directors/heads of the Department of include within their Hygiene of RVA about preliminary findings of the mission at a products laid down in meeting held on 18. - 20. November 2015. The directors/heads of the Department of Hygiene of RVA will transfer obtained 47. information to all responsible official veterinarians. SVA (CCA) informed the official veterinarians responsible for Page: 2 ic to the recommendations of Report ref. DG(SANTE)/2015-7376-MR of the audit carried out valuate the operation of official controls over the post-slaughter traceability of meat, meat controls at big capacity slaughterhouses and meat processing establishments about preliminary findings of the FVO audit at a meeting held on 12. - 13. November 2015. SVA (CCA) will prepare a recommended procedure for checking the traceability and labeling of food. In the establishments where deficiencies were identified during the FVO audit corrective measures have been imposed, their fulfilment will be supervised by the RVA and SVA (CCA). The SVA (CCA) will continue to perform verification on the RVA.

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According to the data provided by CAFIA, the number of registered primary producers has increased from 1 281 in 2012 to 2 019 in May 2015. The CA explained that the reason for this increase is mainly due to the fact that since CAFIA was delegated to conduct inspections on behalf of the payment agency for Cross Compliance (CC), more FBOs have become known to CAFIA. In relation to primary production, the registration database contains details whether the FBO is dealing with fruit and/or vegetables, but there is no information available on the specific crop being grown which precludes the possibility of planning official controls on an appropriate risk basis as required by the Article 3 of Regulation (EC) No 882/2004. 6

There is a system in place for registration of food establishments. However, the lack of information on the crops grown by primary producers weakens the effectiveness of the risk based planning of official controls as required by Regulation (EC) No 882/2004.

CAFIA informed the FVO audit team that primary production sectors are included in the scope of the current risk assessment for inspections. However, individual primary producers are currently not entered in the database that is used for the selection of FBOs to be audited. Consequently primary producers have not been subject to risk based controls at the time of the audit as required by Regulation (EC) No 882/2004. The CA informed the FVO audit team that the database would be adapted in June 2015. The regional inspectorates of CAFIA are responsible for planning of "ad hoc" inspections to primary producers. The FVO audit team was informed that the same principles for the risk assessment are applied by the Regional Inspectorates. However, it was noted that the current registration system for primary producers does not include either information regarding actual crops grown by the growers or information related to private certification schemes the grower may be adhered to. After an inspection takes place, information related to these aspects is recorded for future planning.

In one of the Regional Inspectorates visited during the audit, roughly 400 FBOs were registered for primary production and 6 so-called comprehensive inspections were conducted in 2014. The crops involved were combinable crops, sugar beet and potato. Additionally two inspections were conducted in 2014 based on consumer complaints related to crops like garlic, onion, potatoes and apples. The comprehensive inspections were not targeting high priority crops identified by the EFSA Opinions on the matter.

CISTA informed the FVO audit team that the inspections conducted at growers were under three different inspection frameworks, CC, Delegated Inspections and National Controls. The inspections conducted for CC and National Control schemes control contamination arising from fertilisers (as defined within Annex I Part A, II, point 3 (a) of Regulation (EC) No 852/2004) such as the use of manure and sewage sludge which is banned for use in soil where vegetables and fruits are grown. The inspections for CC were planned to reach 1% of the registered growers and for National Controls between 400 and 500 inspections were conducted each year. However, the CISTA representative stated that the risk assessments for the planning of such inspections do not take into consideration the microbiological contamination to target the producers and/or crops to be inspected. 9

Official controls on primary producers were not in place to target crops with higher microbiological risks and this may compromise the ability of the CA to detect non- compliances with the food law and verify that unsafe food is not placed on the market. 5.2.4 Implementation of Official Controls over FBO's Obligations Legal requirements Article 10(2)(b)(i), Article 10(2)(c), Article 10(2)(d) and Article 15(1) of Regulation (EC) No 882/2004, Article 4(1), Article 7, Article 8 and Part B of Annex I of Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Commission Implementing Regulation (EU) No 208/2013, Regulation (EU) No 211/2013 and Annex I of Commission Regulation (EC) No 2073/2005 Findings

The controls on primary producers are not effectively planned to address the risks on microbiological contamination.

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· Plánování úedních kontrol primární produkce bude provádno na základ rizikových faktor dle bodu 24 zprávy s ohledem na pstovanou plodinu v daném období. · Budou zahrnuty rizikové plodiny (nov posouzené EFSA) do kazdorocní plánované mikrobiologické kontroly

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tdated MoA: In our opinion national legislation in the Czech Republic does not include outdated provisions. National legislation lays gs down rules for case when possibility of moving animal is not lusions contrary with special legislation. Under annex III article 1.11 of the Regulation 1099/2009 animals which are unable to walk shall not be dragged to the place slaughter, but shall be killed where they lie. In our opinion If there is not unnecessary suffering for animals is better moving of animal by transport (not be dragged) to the regular place slaughter. This is more safe and better for environment. Killing of pig in transport space of a vehicle where others pigs are is not adequate to animal welfare. Under annex III article 1. 1. the Regulation 1099/2009 the welfare conditions of each consignment of animals shall be systematically assessed by the animal welfare officer or a person reporting directly to the animal welfare officer upon arrival in order to identify the priorities, in particular by determining which animals have specific welfare needs and the corresponding measures to be taken.

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y SVA: The preliminary conclusions of the mission have been presented to the RVA animal welfare inspectors during the ect non- meeting of the head RVA inspectors (Benice, 2 ­ 3 September cle 2014) and during the annual meeting of all inspectors specialized on animal welfare (Brno, 8 - 9 October 2014). The most important issues mentioned also in the draft report will be discussed with the OVs for red meat SHs (Kutna Hora, 18 - 19 November 2014) and later with OVs for poultry meat SHs. The documented procedures for official controls will be further developed in this area; the guidelines on controls of welfare at SH will be developed.

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VA: The OVs for red meat slaughterhouses as well as poultry Page: 1 ommendations of Report ref. DG(SANCO)/2014-7060 -MR of a/an audit carried out are controls in place at slaughter and during related operations. laughterhouses will be instructed to discuss with the business operators/animal welfare officers the relevant requirements of onding Regulation (EC) No 1099/2009 with the deadline March 2015. The checks on SOPs and control operations will be addressed in the multi annual national control plan for the 2015.

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SVA: The instructions and guidance for approval of tion slaughterhouses will be amended in the line with recommendation with the deadline February 2015. gs

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and MoA: Under article 8 of the Regulation 1099/2009 equipment e shall only be sold when accompanied by appropriate instructions via the concerning their use in a manner which ensures optimal conditions for the welfare of animals this requirement shall apply 4, after 1 January 2013 in the Czech Republic. Those instructions can be made publicly available by the manufacturers via the Internet. Ministry of Agriculture is not competent for this issue. Requirement of article 8 of the Regulation 1099/2009 is discussed with The Czech Trade Inspection Authority and will be inspected.

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otid SVA: The SVA is collecting data as regards neck cutters as well utters as the waterbath stunning parameters used at poultry SHs. The s are data will be evaluated until the end of the year 2014. In case of ssary technology adaptations the RVA will issue a binding dings instruction to business operators with a feasible term to change the system to be in compliance with Regulation.

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x I SVA: The SVA is collecting data as regards neck cutters as well are as the waterbath stunning parameters used at poultry SHs. The s and data will be evaluated until the end of the year 2014. In case of necessary technology adaptations the RVA will issue a binding instruction to business operators with a feasible term to change the system to be in compliance with Regulation. Page: 2 ommendations of Report ref. DG(SANCO)/2014-7060 -MR of a/an audit carried out are controls in place at slaughter and during related operations.

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- SVA: The instructions (guidelines) will be provided to the (1) RVAs/OVs on the issues of assessment of ante-mortem as well as s paid pathological findings in broilers, including footpad dermatitis. leads to The trigger system will be modified to be more useful for the ns in the everyday inspections to be more effective as regards feedback s well as the evaluation for certain period. The data for 2014 will be evaluated and used for the selection of farms for measurement of animal hygiene conditions in broiler farms according to Article 11 of Decree no. 208/2004 Coll. on minimum standards for the protection of farm animals.

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al SVA: The SVA audit team will be provided with the information as regards this recommendation to focus on the findings of the , and controls during audits in 2015. The RVAs inspectors carrying out required the annual checks at SHs have been instructed during meeting in , 8 - 9 October 2014 and this will be addressed in the multi annual national control plan for the 2015. Page: 3

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No systematic controls of transporters are in place and while random checks on transporters are carried out at the place of origin and at the place of destination of ABP/DP, these checks focus on the presence of commercial documents and the registration status of transporters. According to the SVA representatives, transporters are informed about their duties at registration. 5 a) The first road haulier visited involved in transport of Category 1 fat, had been informed by the regional veterinary inspectors of the relevant legal requirements at the time of his application for registration. The operator held a register of all commercial documents for the previous two years as this had been required by the regional inspectors. Although the operator was not subject to official controls, the audit team saw evidence that this particular haulier had been controlled at a technical plant visited. Moreover, all inspectors met during the audit declared that they check the registration status of transporters and the completeness of commercial documents at the place of origin or at the place of destination. b) At the second transporter visited, involved in transport of Category 3 dairy products, the audit team confirmed that the operator had received information concerning his legal obligations regarding traceability requirements. Moreover, the regional inspectors provided evidence that traceability requirements had been checked at the place of loading. The audit team noted that the operator kept a register of the commercial documents as required by EU legislation.

Although the audit team noticed a satisfactory level of compliance as regards the registration status of transporters and their compliance with the requirements for commercial documents, the absence of regular official controls for carriers transporting certain types of ABP/DP is not in line with the requirements laid down in Article 45 of Regulation (EC) No 1069/2009.

According to SVA, paper traders of ABP/DP are not subject to regular official controls as required by article 45 to Regulation (EC) No 1069/2009, because they may be difficult to locate and, in some cases, they are shown on the commercial documents as receivers or dispatchers of derived products for reasons of commercial confidentiality, although the products are never held on their premises (in most cases there are no premises where ABP/DP could be kept). The audit team noted the following: a) At one rendering plant visited, approximately 2.250 tonnes of Category 2 MBM were sold to a non-registered paper trader in 2013. The final destination given in the commercial documents was the office of this trader which lacked the storage facilities needed if this were the actual physical destination of the consignments. In the same way, additional consignments of Category 2 MBM declared as OF/SI had also been sent to this paper trader from another rendering plant. Official controls at the rendering plants from which these consignments were dispatched had not identified these issues. Additional information provided to the SVA following a traceability exercise indicated an office to be the final destination of approximately 1,900 tonnes of Category 2 MBM sold by a rendering plant to a non-registered trader in the Czech Republic. Only approximately 20% of the consignments of ABP shown in TRACES as arriving at the rendering plant in 2013 and 2014 had been confirmed as required. b) At a second rendering plant visited, the audit team compared the commercial documents and the TRACES notifications of two consignments of ruminant PAP. According to the commercial documents prepared by the rendering plant, the place of destination for these consignments was a registered paper trader. However, the TRACES notifications (drawn up by the trader) gave a destination in another Member State. According to data extracted from TRACES, the trader concerned had received approximately 580 such consignments in 2013 and no confirmation checks were encoded in TRACES for that year. Data extracted from TRACES for the first nine months of 2014, showed that approximately 170 out of 900 consignments were checked at this trader. 6

Adequate arrangements are in place to enable the organisation and planning of regular official controls to monitor and verify that most operators comply with the requirements relating to the traceability of ABP/DP. However, the fact that paper traders and carriers transporting ABP/DP by road are not subject to regular official controls as required, limits the ability of the competent authorities to ensure the traceability of ABP/DP handled by these operators.

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SVA: Information from the DG(SANCO) mission, as well as the findings/conclusions of the FVO inspectors concerning the duties of the carriers of and traders in the ABP/DP, and the supervision on such activities, were communicated and subsequently discussed within the meeting held on 12 November 2014. Based on remarks, the minimum frequency of checks on establishments handling ABP/DP was altered within the Uniform integrate multiannual national control plan for the year 2015. Checks on the carriers of and traders in the ABP/DP were included in the plan.

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According to data extracted from TRACES for 2013 by the audit team, approximately 3.600 commercial document notifications were sent to the Czech Republic from several Member States and the arrival of around 860 (24%) of these consignments was confirmed. Approximately 90% of these confirmations (770 out of 860) concerned Category 1 fat arriving at two technical plants and raw ABP arriving at one rendering plant visited. Based on this, only 4% (90 out of 2360) of the remaining consignments of ABP/DP traded to the Czech Republic in 2013 were confirmed in TRACES. Data extracted from TRACES show that in the first nine months of 2014, the situation had improved as 33% (1260 out of 3680) of consignments arriving in the Czech Republic were checked. Nevertheless, as the majority of consignments are not notified, the requirements of Article 48(3) of Regulation (EC) No 1069/2009 are not met.

SVA representatives stated that they are not in a position to comply fully with the requirements of Article 48(3) of Regulation (EC) No 1069/2009 as to do so would place a considerable administrative burden on the official services and require additional resources, especially in those plants which receive many consignments. Moreover, SVA considered it would be more appropriate that operators should confirm the arrival of consignments in TRACES and that risk-based checks that this had been done could be carried out during official controls. The officials met in the regional offices and plants visited supported the SVA position that the need to confirm the arrival of all consignments of ABP/DP as required by Article 48 of Regulation (EC) No 1069/2009 placed an undue administrative burden on them.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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of SVA: Information from the DG(SANCO) mission, as well as the is findings/conclusions of the FVO inspectors concerning the requirements of Article 48(3) of Regulation (EC) No 1069/2009, were communicated and subsequently discussed within the meeting with the RVA representatives held on 12 November 2014. The RVA inspectors were notified of the duty to confirm the arrival of each consignment to the place of destination in the Czech Republic when information of its dispatch was entered in the TRACES system at the place of dispatch in another Member State. Furthermore, they were informed of correct completion of commercial documents by establishment operators ­ both national for the Czech Republic, and harmonised for the trade with the EU Member States. It was emphasized that a paper trader cannot be indicated as the place of destination instead of an approved or registered establishment listed in the list of approved establishments where the ABP/DP can be physically kept/stored (store, processing plant, etc.) of the relevant EU Member State. Page: 1

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ion will be improved with the aim of ing that CBs are working properly with s and using it as a basic tool in planning additional controls and sampling. The Ministry of Agriculture is updating Methodological Guideline No 2/2013 to clarify and more clearly specify the use and creation of risk analysis (the principle thereof and its subsequent use in planning controls and sampling). The aim of updating Methodological Guideline No 2/2013 is also to clarify and set deadlines for reporting major non- conformities and examining complaints. Supervize, které probíhají v roce 2015, jiz byly zlepseny a zameny na efektivnjsí dohled nad provádním kontrolní cinnosti povených kontrolních organizací na základ pokynu vedoucích pracovník oddlení ekologického zemdlství. mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic Aktualizace uvedeného Metodického pokynu c. 2/2013 bude provedena do konce roku 2015, aktuáln probíhají analýzy pedcházející tvorb textu aktualizovaného metodického pokynu. Dne 5. 3. 2015 probhlo na Ministerstvu zemdlstv

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inistry of Agriculture is updating ological Guideline No 2/2013 to y and more clearly specify the use and eation of risk analysis. y is organising training for all ntrol bodies, during which the issue of risk alysis will be explained in detail, including s subsequent correct use in planning mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic additional controls and sampling. In updating the Methodological Guideline, the planning of controls will also be more clearly specified, particularly with regard to businesses with simultaneous non-organic production (planning controls at processors so that the control takes in both organic and non- organic production), with planning as part of regular and additional controls. Aktualizace uvedeného Metodického pokynu c. 2/2013 bude provedena do konce roku 2015, aktuáln probíhají analýzy pedcházející tvorb textu aktualizovaného metodického pokynu. Dne 5. 3. 2015 probhlo na Ministerstvu zemdlství jednání, kterého se zúcastnili zástupci kontrolních organizací, na kterém byly se zástup

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inistry of Agriculture is updating logical Guideline No 2/2013 to efine unannounced controls in accordance ion o do konce lýzy zovaného

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The Ministry of Agriculture is updating odological Guideline No 2/2013 to that they tantial changes, line with 9/2008. o do konce lýzy zovaného erstvu castnili na kterém mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic byly se zástupci kontrolních organizací podrobn projednány vsechny nedostatky zjistné v prbhu auditní mise FVO a byla stanovena opatení vedoucí k náprav nevyhovujícího stavu - zápis z tohoto jednání je pilozen. Kontrolním organizacím bylo na tomto jednání ze strany Ministerstva zemdlství ulozeno, aby zajistily, ze jim podniky budou hlásit neprodlen veskeré zmny v opateních podle cl. 63 naízení Komise (ES) c. 889/2008. Zástupci kontrolních organizací na tomto jednání sdlili, ze se tak jiz dje.

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istry of Agriculture is organising aining for all control bodies, focusing on aceability of raw material flows, so that en carrying out controls, inspectors from ntrol bodies can correctly assess the lance between inputs and outputs on the nancial and other records. the training, inspectors will also be of the obligation for improved fication of compliance with the n when conducting physical checks mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic in the field. The Ministry will focus its supervision more closely on controls to determine whether inspectors have overlooked certain shortcomings in terms of compliance with the Regulation. Supervize, které probíhají v roce 2015, jiz byly zlepseny a zameny na efektivnjsí dohled nad provádním kontrolní cinnosti povených kontrolních organizací na základ pokynu vedoucích pracovník oddlení ekologického zemdlství. Dne 5. 3. 2015 probhlo na Ministerstvu zemdlství jednání, kterého se zúcastnili zástupci kontrolních organizací, na kterém byly se zástupci kontrolních organizací pod

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Ministry of Agriculture is organising aining, including a practical exercise, for all spectors from control bodies, focusing on aceability of raw material flows, so that en carrying out controls those inspectors n correctly assess the balance between puts and outputs on the basis of financial d other records, correctly trace raw terials throughout the processing chain and mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic verify that there has been no mixture or exchange of organic and non-organic products. At the same time, the Ministry has already begun negotiations with the Czech Agriculture and Food Inspection Authority and State Veterinary Administration with the aim of expanding control activity, which these control bodies also carry out in the organic products sector. This expansion of control activity will ensure the mechanism for cross-checks at processors of raw materials of both plant and animal origin. Such a measure will increase supervision and ensure verification of the consistency of controls carried ou

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Ministry of Agriculture is updating thodological Guidelines Nos 2/2013 and 2013 to more clearly specify the conditions d circumstances for sampling, including the e of risk analysis in planning such mpling. tualizace uvedených Metodických kyn c. 2/2013 a c. 3/2013 bude ovedena do konce roku 2015, aktuáln obíhají analýzy pedcházející tvorb xtu aktualizovaného metodického kynu. e 5. 3. 2015 probhlo na Ministerstvu mdlství jednání, kterého se zúcastnili stupci kontrolních organizací, na kterém ly se zástupci kontrolních organizací drobn projednány vsechny nedostatky mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic zjistné v prbhu auditní mise FVO a byla stanovena opatení vedoucí k náprav nevyhovujícího stavu - zápis z tohoto jednání je pilozen.

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Ministry of Agriculture will require m control bodies to verify that e conditions for granting a derogation from anic production rules are met. ertheless, for certain types of intervention animals (horn growth suppression in ves up to four weeks old and tail docking sheep up to eight days old) the Ministry l not require the use of analgesia or esthesia, in accordance with the opinion of State Veterinary Administration. 5. 3. 2015 probhlo na Ministerstvu dlství jednání, kterého se zúcastnili tupci kontrolních organizací, na kterém y se zástupci kontrolních organizací robn projednány vsechny nedostatky stné v prbhu auditní mise FVO a a stanovena opatení vedoucí k náprav yhovujícího stavu - zápis z tohoto mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic jednání je pilozen. Na tomto jednání byli zástupci kontrolních organizací mimo jiné také upozornni, ze je nezbytné vyzadovat od zemdlc vedení a pedlození záznam o provedených zásazích na zvíatech a to zejména za úcelem ovení, ze podmínky stanovené v Rozhodnutí o udlení v

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ry of Agriculture is updating ological Guideline No 2/2013 to tablish an obligation to respond without lay to findings or suspicions of non- mpliance with organic production rules and take all necessary steps to further tigate and resolve the situation and event the placing on the market of products iling to meet the conditions laid down in the gulation with reference to organic mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic production. Aktualizace uvedeného Metodického pokynu c. 2/2013 bude provedena do konce roku 2015, aktuáln probíhají analýzy pedcházející tvorb textu aktualizovaného metodického pokynu. Dne 5. 3. 2015 probhlo na Ministerstvu zemdlství jednání, kterého se zúcastnili zástupci kontrolních organizací, na kterém byly se zástupci kontrolních organizací podrobn projednány vsechny nedostatky zjistné v prbhu auditní mise FVO a byla stanovena opatení vedoucí k náprav nevyhovujícího stavu - zápis z tohoto jednání je pilozen.

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istry of Agriculture is updating hodological Guideline No 2/2013 to blish fixed deadlines for the unication of information to the Ministry e an infringement affecting the organic us of a product is detected. alizace uvedeného Metodického mendations , received 22 June 2015 nt authorities of the Czech Republic on N/A in response to Report ref. DG(SANTE)/2014-7099- ober 2014 in order to evaluate the system for organic production and labelling of organic pokynu c. 2/2013 bude provedena do konce roku 2015, aktuáln probíhají analýzy pedcházející tvorb textu aktualizovaného metodického pokynu. Dne 5. 3. 2015 probhlo na Ministerstvu zemdlství jednání, kterého se zúcastnili zástupci kontrolních organizací, na kterém byly se zástupci kontrolních organizací podrobn projednány vsechny nedostatky zjistné v prbhu auditní mise FVO a byla stanovena opatení vedoucí k náprav nevyhovujícího stavu - zápis z tohoto jednání je pilozen.

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only State Phytosanitary Administration of the Czech Republic (hereinafter "SPA") have changed the f the administrative process. Currently parallel trade permits expire at the same date, when the 52 authorisation of the reference product expires. Periods of grace for disposal, storage, placing on the market and use of existing stocks for those parallel trades are set coincidently with the reference product.

for State Phytosanitary Administration of the Czech Republic (hereinafter "SPA") have n changed the administrative process. Currently, parallel trade permits expire at the same date, when the authorisation of the reference product expires. Periods of grace for disposal, storage, placing on the market and use of existing stocks for those parallel trades are set coincidently with the reference product.

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icle SPA will propose legislative modification within the amendment of the Act No 326/2004 of the Collection of Laws of the Czech Republic (hereinafter ,,Coll."), on plant health and amendments to ovide certain related acts, as last amended (hereinafter ,,Act No 326/2004 Coll."), to gain knowledge on distributors of Plant Protection Products (hereinafter "PPPs"), placing PPPs on the market on the d territory of the Czech Republic. Till the implementation of this legislative modification SPA will create and update the list of distributors of PPPs with regard to the controls from previous years and controls after the 1st January 2014, when SPA will be integrated into the Central Institute for Supervising and Testing in Agriculture (hereinafter ,,CISTA"). It is planned within the merged organization that the specialized group of inspectors will deal with the issues of the control of the distribution of PPPs and fertilizers.

SPA will propose legislative modification ithin the amendment of the Act No 326/2004 of the Collection of Laws of the Czech Republic (hereinafter ,,Coll."), on plant health and amendments to certain related acts, as last amended (hereinafter ,,Act No 326/2004 Coll."), to gain knowledge on distributors of Plant Protection Products (hereinafter "PPPs"), placing PPPs on the market on the territory of the Czech Republic. Till the implementation of this legislative modification SPA will create and update the ity, 04 March 2014 petent Authorities of the Czech Republic on 13 December 2013 in response to Report ref. 10 September 2013 to 17 September 2013 in order to evaluate controls of pesticides. list of distributors of PPPs with regard to the controls from previous years and controls after the 1st January 2014, when SPA will be integrated into the Central Institute for Supervising and Testing in Agriculture (hereinafter ,,CISTA"). It is planned within the merged organization that the specialized group of inspectors will deal with the issues of the control of the distribution of PPPs and fertilizers.

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icle After the 1st January 2014 joint risk analysis will be carried out within the merged organization CISTA in order to choose the subjects for the control of the use of PPPs and fertilizers in the LPIS at software program. An uniform database of subjects will be created for the purpose planning of controls of professional users, that is: out 1. Database of subjects, which are at the same time the applicants for subsidies, 2. List of persons registered according to the Article 12 of the Act No 326/2004 Coll., which will be for the purpose of the control relevant from the point of view of the object of entrepreneurship, 3. Subjects known from the previous years, which are not the applicants for subsidies (subjects operating services in the plant protection, see dressing stations, subjects using PPPs in other Page: 1 t recommendations, received 17/12/2013 the Czech Republic to the recommendations of Report ref. DG(SANCO)/2013-6647 -MR of a/an audit carried out 13 in order to evaluate controls of pesticides. sectors than agriculture ­ e.g. in transportation - management and maintenance of roads and railways, in energetic ­ solar power stations, energy companies; managers of forest la

fter the 1st January 2014 joint risk analysis will be carried out within the merged organization CISTA in order to choose the subjects for the control of the use of PPPs and fertilizers in the LPIS software program. An uniform database of subjects will be created for the purpose planning of controls of professional users, that is: 1. Database of subjects, which are at the same time the applicants for subsidies, 2. List of persons registered according to the Article 12 of the Act No 326/2004 Coll., which will be for the purpose of the control relevant from the point of view of the object ity, 04 March 2014 petent Authorities of the Czech Republic on 13 December 2013 in response to Report ref. 10 September 2013 to 17 September 2013 in order to evaluate controls of pesticides. of entrepreneurship, 3. Subjects known from the previous years, which are not the applicants for subsidies (subjects operating services in the plant protection, see dressing stations, subjects using PPPs in other sectors than agriculture ­ e.g. in transportation - management and maintenance of roads and railways, in energetic ­ solar power stations, energy companies; managers of forest lands, golf courses, sport

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e of In comparison with the current legislation on the notification of the controls according to the Article 12 paragraph 2 subparagraph a) of the Act No 552/1991 Coll., on the state control, as last amended, n which is valid till 31st December 2013, it will be possible in the connection with the new control code, i.e. Act No 255/2012 Coll., on the controls (control code), effective from the 1st January 2014, to start the control according to the Article 5 of this act by the presentation of the authorisation for the control not only to the controlled person, but also to the duty bound person (e.g. to the employee of controlled person, person supplying or taking the goods from the controlled person) or the control can be started by the act preceding the presentation of the authorisation for the control, e.g. by taking the sample of the plants in the presence of the employee of controlled person, which must immediately precede the presentation of the authorisation for the control to the controlled or duty bound person, which is present on the place of the control. By this the start of the control will be easier in the comparison with the current legislation on the notification of the

e In comparison with the current legislation on e notification of the controls according to e Article 12 paragraph 2 subparagraph a) of e Act No 552/1991 Coll., on the state ntrol, as last amended, which is valid till ity, 04 March 2014 petent Authorities of the Czech Republic on 13 December 2013 in response to Report ref. 10 September 2013 to 17 September 2013 in order to evaluate controls of pesticides. 31st December 2013, it will be possible in the connection with the new control code, i.e. Act No 255/2012 Coll., on the controls (control code), effective from the 1st January 2014, to start the control according to the Article 5 of this act by the presentation of the authorisation for the control not only to the controlled person, but also to the duty bound person (e.g. to the employee of controlled person, person supplying or taking the goods from the controlled person) or the control can be started by the act preceding the presentation of the authorisation for the control, e.g. by taking the sample of the plants in the presence of the employee of controlled person, which must immediately precede the presentation of the authorisation for the control to the controlled or duty bou

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On 1 January 2014 the SPA will merge with the Central Institute for Supervising and Testing in Agriculture (CISTA) The legal department of CISTA will lead any sanction proceedings including sanction proceedings for an area of control distribution and use of plant protection products (PPP) After 1.1.2014, when determining the sanctions in connection with violations relating to the control r of PPP, there will be taken into consideration the importance of the administrative offence, especially the way of its commitment and its consequences and circumstances, at which it was committed, that is in compliance with the provisions of Article 79i paragraph 2 of the Act No 326/2004 Coll., including the acceptance of the recommendation of DG SANCO with regard to the Page: 2 t recommendations, received 17/12/2013 the Czech Republic to the recommendations of Report ref. DG(SANCO)/2013-6647 -MR of a/an audit carried out 13 in order to evaluate controls of pesticides. fact that after 1.1. 2014 the imposed sanctions will be proportionate and will have a dissuasive effect.

n 1 January 2014 the SPA will merge with the Central Institute for Supervising and Testing in Agriculture (CISTA) The legal department of CISTA will lead any sanction proceedings including sanction proceedings for an area of control distribution and use of plant protection products (PPP) After 1.1.2014, when determining the sanctions in connection with violations relating to the control of PPP, there will be taken into consideration the importance of the administrative offence, especially the way of its commitment and its consequences and circumstances, at which it was committed, that is in compliance with the provisions of Article 79i paragraph 2 of the Act No ity, 04 March 2014 petent Authorities of the Czech Republic on 13 December 2013 in response to Report ref. 10 September 2013 to 17 September 2013 in order to evaluate controls of pesticides. 326/2004 Coll., including the acceptance of the recommendation of DG SANCO with regard to the fact that after 1.1. 2014 the imposed sanctions will be proportionate and will have a dissuasive effect. CZ Addition: In 2014 the Legal Department of CISTA will provide a special training for inspectors in order to explain and unify processes wh

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CAFIA in its internal regulation related to official inspections of PDO/PGI/TSG distinguishes between two types of official inspections. The first called "verification of compliance with the product specification before placing the product on the market" relates to Article 37 of Regulation (EU) No. 1151/2012. Within this type of official inspection, compliance with all parameters of the specification is verified. The second one is called "check of observance of specification requirements" and within this inspection, the inspectors carry out inspection of selected products based on the risk analysis. On the branch meeting focused on the matter of PDO/PGI/TSG, the inspectors will be instructed to carry out check of all parameters of the specification when checking selected products at the producer within the "check of observance of specification requirements". This aspect was incorporated into the internal regulation of CAFIA related to official inspections of PDO/PGI/TSG applicable since 1. 8. 2013. Page: 1

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ds the storehouses at the Václav Havel Airport in (b) of Regulation (EC) No. 669/2009 with and extent of their use for these purposes. to the opinion of Ministry of Agriculture of the Czech DPE at the Václav Havel Airport Prague meets the the provision of Art. 4 (b) of the Regulation (EC) No uitable places are provided. Although these are not aces and are not specifically designated for this type of rding the appropriate equipment, inspectors bring all the pment with them. Should the Commission insist on the DPE does not fulfil the provision of Art. 4 (b) of the ) No 669/2009, we would like to ask for clarification of s not fulfilled (own places x what equipment?).

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to th importer data box. This has nto the internal regulation of CAFIA.

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f which Part I will not be clearly linked to Part ough the number of the CED issued by the designated onsignment, will not be released for free Page: 1

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conditions of the CEI: In 2012: The CEI inspectors carry out the inspections during poses are complied vegetation as scheduled in the annual plan. On top of that, according to n with Article 6(8) of the recommendation, the trial sites will be visited during the harvest and/or after the harvest (depending on the CEI capacities). From 2013 on: Each field trial will be visited several times annually. CEI inspectors will focus on compliance with the consent conditions in the course of: - sowing and handling of seeds, - measures taken during vegetation, - harvest and post-harvest treatment of the plot. CEI will draft an annual plan of visits as soon as consent holders notify locations of the trials for the year (approx. in March). The exact days of the inspections will be set after consultation with the consent holders as regards timings of sowing and harvest.

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ised GMO in seed CISTA: By the Act Nr. 219/2003 Coll. seed and planting materials must GMOs, in line with be labelled in accordance with applicable legislation (§14) ­ control of e 4 of Regulation compliance is part of Seed Inspection. All GM varieties are recorded by the MoA.

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for detection of CISTA: All requirements are specified in: Regulation Nr. 129/2012 d by Article 3 of Coll., Regulation Nr. 61/2011 Coll. and Act Nr. 219/2003 Coll. lude certified The main entry from the application for registration of propagating crop (Reg. 129/2012): documents of origin of the propagating material, sequence of foregoing crops, specification of the land (location, area), Page: 1 Republic to the recommendations of Report ref. DG(SANCO)/2012-6310-MR of an audit aluate the official controls of genetically modified organisms, including their deliberate ed by the Competent Authority n of breeder and supplier. These documents are controlled in e in Prague. pection ­ provided by regional inspectors, are part of ing process. in the most appropriate plant developmental stage to teristic features. Stated in Reg. 129/2012 Coll. the field inspections - minimally 1, differs for each maize 4 inspections), stated in Reg. 129/2012 Coll. eld inspection ­ control of: labelling of the crop, sequence crops (plants) ­ controlled 3times, 1st in the office in reeder´s written records, 3rd physically during the field inimal mechanical isolation ­ to prevent the creation of ring the vegeta

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ial GMO laboratories CISTA: The CISTA laboratory will expand the scope of detectable aterial and/or genetic screening sequences by other five elements and the selected ation 619/2011/EC authorised events by approximately eight events till the end 2012. The on 2011/884/EU. other authorised and unauthorised events listed in EC Regulaton ill be introduced into laboratory practice till the end of of Agriculture of the Czech Republic is going to increase upport to the National Reference Laboratory (situated in the Institute) which will enable extending of its analytical ee ANNEX II Page: 3

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as been communicated to all RVAs during a meeting on 3 ­ 4

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as been communicated to all RVAs during a meeting on 3 ­ 4

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been communicated to all RVAs during a meeting on 3 ­ 4

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has been communicated to all RVAs during a meeting on 3 ­ 4 sed version of the Instruction for applying flexibility hygiene package reflecting problems revelled during the ill be issued by the end of September 2012.

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SVA: NRLs associated with SVA, will provide reports from meetings with EU-RL to CAFIA a so it can distribute them to its contract laboratories. ated Since 2013 all laboratories used by SVA participate in proficiency tests organized by NLRs. CAFIA: At the present time laboratories of SVI introduce methods used in the VTEC monitoring. NRL for E.coli will within its scope of activities organise relevant interlaboratory testing and training. Its organisation has already been started. MH: The NRL established by the MH are obliged to prepare the annual report and based on this report their activities will be considered and possible corrective measures will be adopted by the MH. This comment is made despite the fact that it is unclear from the report to which the comment in para "Observations" relates.

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SVA: SVA will pay more attention to requirements of Article 5 of Regulation No. 852/2004 during inspections in the first half of 2013. In case of shortcomings rectification will be required. SVA carried out 998 inspections which were focused on HACCP plans in the first half of e 5 of 2013. Of these inspections 13 did not comply in relation to procedures based on the HACCP principles. Results and non-compliances from this audit were discussed with heads of hygiene department of RVAs on a meeting which was held on 13. 3. 2013. CAFIA: During CAFIA inspections at FBOs, high attention will be paid to elaboration of HACCP plans from the view of identification of all risks including microbiological testing of foodstuffs for production of foodstuffs intended for direct consumption (carried out by the producer or the supplier of the raw-material), currentness of HACCP plans and their observance, definition of criteria for determination of the frequency of autochecks carried out Page: 1 Updated CA response received 13 July 2013 by the Competent Authorities of the Czech Republic on 15 March in response to Report ref. ut from 26 November to 07 December 2012 in order to evaluate the official co

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SVA: Shortcoming discovered by audit team was rectified immediately. The laboratory results e have been expressed < 10 KTJ/g since 1.12.2012 (see attached laboratory result). More of attention will be paid to this issue during official inspection in 2013. if ticle 5

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SVA: The issue has been communicated to official veterinarians, who are responsible for the controls of a slaughterhouses, meat, meat product and meat preparations establishments exes I during a meeting on 13.12.2012. is Report from this meeting was send to participants and is available to all veterinary inspectors. ed in Appropriate enforcement actions were taken at establishment where deficiencies were found during the mission DG (SANCO)/2012-6369. s To improve communication between RVAs and FBOs in relation to controls of results of microbiological analysis in the slaughterhouses SVA created documents (table) for evaluation of analytical results - trend analyses of process hygiene criteria. Documents are available on http://www.svscr.cz/index.php?art =5896. RVAs are responsible for control of implementation of the Commission Regulation (EC) No. 2073/2005 by the FBOs. Since April 2013 there were performed supervisions by the Central Veterinary Administration of SVA in relation to inspections by RVAs. Results and non-compliances from these audits were discussed with heads of hygiene departments of RVAs on a meeting which was held on 13. 3. 2013.

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SVA: More attention will be paid to requirements of the Regulation, including shelf-life Page: 3 Updated CA response received 13 July 2013 by the Competent Authorities of the Czech Republic on 15 March in response to Report ref. ut from 26 November to 07 December 2012 in order to evaluate the official controls on food ion regulation (ec) no 2073/2005) on Proposed by the Competent Authority ies during official inspections in 2013. ng The issue and recommendations from this report will be communicated to all RVAs during a to in meeting on 13.3.2013. tion. Results and non-compliances from these audits were discussed with heads of hygiene rtments of RVAs on a meeting which was held on 13. 3. 2013. NRL for Listeria monocytogenes issued the Methodological guideline on performance of f-life studies for Listeria monocytogenes in ready-to-eat foods". This guideline serves to and to competent authority for evaluation of FBOs shelf-life studies. Document is lable on: ://www.svujihlava.cz/61-novinky.html?zobrazdetail=1&idclankunovinka=931 A: Training focused on the matter of performance of shelf-life studies, performance of s from equipment and producing premises to detect L.monocytogenes purs

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in the framework of approved Salmonella Control breeding flocks is performed in accordance with the Regulations (EC) No 2160/2003 and (EU) No gislation does not exactly determined rules for mpling. In compliance with Regulations (EC) No tent authority may decide to repeat the testing. ith national legislation the emergency veterinary imposed only when suspicion of presence of the ase is confirmed by positive results of official sampling. ask for a compensation of costs and losses only in emergency veterinary measures. Therefore possible result of operator sampling is necessary to excluded by of official sampling. ock is considered as infected with Salmonella enteritidis typhimurium when the presence of Salmonella is icial sample or when the initial positive result of operator firmed by positive result of official sample taken in e the false positive result of operator sampling. The thod is based on technical specifications referred to in mmission Decision 2004/665/EC (5 pooled faeces ooled dust samples separately analysed). pletion of the confirmatory analyses hatching eggs shall Page: 1 s of Report ref. DG(SANCO)/2012-6439-MR of an audit onal Control Programmes in particular poult

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n the framework of approved Salmonella Control in flocks of laying hens is performed in accordance with the Regulations (EC) No 2160/2003 and (EU) No t legislation does not exactly determined rules for ling. In compliance with Regulations (EC) No nt authority may decide to repeat the testing. h national legislation the emergency veterinary mposed only when suspicion of presence of the e is confirmed by positive results of official sampling. k for a compensation of costs and losses only in ergency veterinary measures. Therefore possible sult of operator sampling is necessary to excluded by f official sampling. ng hens is considered as infected with Salmonella almonella typhimurium when the presence of ected in official sample or when the initial positive r sampling is confirmed by positive result of official rder to exclude the false positive result of operator firmation method is based on technical specifications ticle 5 of Commission Decision 2004/665/EC (5 pooled d 2 pooled dust samples separately analysed). etion of the confirmatory analyses table eggs coming are suspected of being infected with targeted Page: 2 s of Report ref. DG(SANCO)/2012-6439-MR of an audit onal Control Pr

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rements set out in Section III of Annex II to Regulation 04 are fulfilled because the required information examination results in the framework of Salmonella mmes on poultry farms are is available for veterinary on at the slaughterhouse in the information system of the SVA urs in advance through a system of electronic exchange ion 5 of Section III of Annex II to Regulation (EC) No ge: 4