Estonia

The recommendation states as its basis

The findings of the audit team in two establishments visited compared with the inspec- tions reports of the inspections/audits carried out by the regional milk specialists in two of the four regions visited (see chapter 5.6) indicate that the supervision by the central level (as foreseen in Article 5(1)(a) and (b) of Regulation (EU) 2017/625) has not been sufficient to detect weaknesses in the control system.

The procedures and mechanisms in place ensure that controls are carried out uniformly and consistently, but do not guarantee that the controls are sufficiently thorough and in depth to detect shortcomings.

The supervision arrangements are not robust enough and have covered only narrow scopes and thus have not fully ensured the effectiveness, appropriateness, and quality of official controls, as required by Article 5(1)(a) and (b) of Regulation (EU) 2017/625.

The audit team visited three dairy cow and one dairy sheep farm which had been in- spected by official veterinarians quite recently. The inspection reports reflected the ob- servations of the audit team related to three farms, where the conditions of milking hy- giene and use of VMPs and records kept were assessed as satisfactory. However, in one farm, milking hygiene was not complying with all requirements of Regulation (EC) No 7 852/2004. This was not recorded in the inspection report and consequently no corrective actions were requested. The CA ensured that an additional inspection would take place, and the necessary measures will be taken. Conclusions on controls over milk and colostrum production holdings

The official controls on compliance of dairy holdings with the legal requirements on an- imal health and welfare, identification and registration as well as the use of VMPs and milking hygiene are adequate and, with some exceptions, carried out correctly and well documented.

Some of the shortcomings noted by the DG(SANTE) audit team had not been identi- fied/recorded during previous inspections in relation to premises, hygiene, HACCP- based procedures, microbiological criteria, traceability and labelling (more details be- low). 5.6.3 General and specific hygiene requirements Legal requirements Article 4 of, and Annex II to Regulation (EC) No 852/2004. Article 3 of, and Section IX of Annex III to Regulation (EC) No 853/2004. Findings

Major maintenance and general hygiene issues were noted by the audit team in one dairy establishment visited (producing ready-to-eat dairy products). The inspector had not recorded any non-compliances in the reports. The CCA accompanying the audit team in- formed on-spot that immediate actions are taken to suspend its activities.

Another dairy establishment visited was storing dairy products in a warehouse which had not been inspected by the milk specialist. The blueprint seen by the audit team did not indicate it was used for storing of milk products. 5.6.4 Hazard Analysis and Critical Control Points based systems Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings

The audit team noted that the pest control programme in one establishment visited was insufficient. The inspection reports showed constant rodent activity but there was no root cause analysis to detect the reason (which was probably the access of rodents to milk powders in the storage containers for milk powder samples). 5.6.5 Microbiological criteria for foodstuffs Legal requirements Articles 3 and 4, and Annex I to Regulation (EC) No 2073/2005. Findings

In one establishment visited, the audit team noticed that raw material packages (cheese in vacuum) in big carton boxes did not bear an identification mark and thus lacked relia- ble traceability. The operator stated, based on the accompanying documents, that these cheeses had been cut (sometimes also sliced or graded) and repacked in an approved es- tablishment. The later did not appear on the list of milk establishments, but on the list for packing establishments (see also paragraph 27) (2). The CA agreed to take measures regarding the non-compliant identification marking.

In one of the establishments visited, a dry store that had not been inspected by the re- gional milk specialist had approximately 50 tonnes of different types of milk and milk products powders without traceability or any other clear indication of their content as well as the purpose for use (for human consumption, feed or destruction). Some of the packages had passed their best before dates. In the same establishment, the audit team detected two milk powder packages in the main storage facility for which traceability could not be provided. The CA initiated investigations and measures immediately. Conclusions on official controls on FBOs' compliance with hygiene rules

The controls were not sufficiently in-depth in two of the four regions visited to detect all relevant shortcomings and/or, if detected, not recorded. In one establishment visited the enforcement measures available had not been applied although the plant had long- standing shortcomings and was not in compliance with EU requirements and its prod- ucts could pose a food safety risk. In another establishment, there were significant short- comings in relation to traceability and the categorisation of a large amount of products. These had not been covered by official controls and lacked the guarantees of being safe for human consumption.

The recommendation states as its basis

The audit team noted the following shortcoming in relation to requirements of Regula- tion (EC) No 2073/2005 on sampling and testing for Listeria monocytogenes (L. mono- cytogenes): a) Only one product (five subsamples) once in a year was send for detection of L. mon- ocytogenes while the operator produces a wide range of ready-to-eat products. This is not sufficient to ensure the safety of products; b) The operators had carried out shelf-life studies maintaining the samples at the low temperatures indicated for the storage on the packages (e.g.1 - 6°C) from their pro- duction until the end of shelf-life instead of taking into account of reasonably fore- seeable conditions of distribution, storage and use when determining the shelf-life of ready-to-eat products supporting the growth of L. monocytogenes; c) In some cases, analysis was carried out for compliance with 100 cfu of L. monocyto- genes, instead of absence in 25 g, although the FBO was not able to demonstrate, to the satisfaction of the CA, that the product will not exceed the limit of 100 cfu/g throughout the shelf-life; d) The samples in the studies seen comprised only testing a limited number of samples; e) An establishment, selling raw milk in retail packages, had established a shelf-life of six days and had sent only one subsample for Listeria analysis asking for numera- tion. The official had noted this non-compliance and had instructed to follow the rule for "not detected in 25 g". However, as only one sample had been sent for analysis the testing was still non-compliant as for a ready-to-eat products when five subsam- ples are required.

The audit team noted that environmental samples taken by the FBOs to detect the possi- ble presence of L. monocytogenes followed the Guidelines of the EU Reference Labora- tory on sampling as samples are taken during processing and included the drains as well, except in one case, where sampling takes place after cleaning. 5.6.6 Traceability, labelling and identification marking Legal requirements Article 18 of Regulation (EC) No 178/2002. Article 5 of, and Chapter IV, Section IX, Annex III to Regulation (EC) No 853/2004. Article 5 of Regulation (EU) 2019/627. Findings

The controls have not been thorough enough in order to ensure that operators' sampling schemes for Listeria provide reliable results regarding the safety of ready-to-eat food. 2 In their response to the draft report, the competent authority stated that according to the implementation guide for Regulation (EC) 853/2004, operations related to the unpacking and repackaging of products of animal origin (slicing and cutting) may take place at the repackaging plant. 14

The recommendation states as its basis

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The citation could not be resolved to a numbered paragraph in the report.

The recommendation states as its basis

Inspectors met were in general familiar with the legal requirements and aspects pertaining to the production of fishery products. However, the audit team noted that some inspectors had knowledge gaps in relation to the assessment of the procedures based on hazard analysis and critical control points (HACCP) principles, in particular the hazard analysis, or varying views in relation to general hygiene requirements and pre- requisite programmes, such as pest control, cleaning and disinfection.

The audit team noted the following: a. For each sectoral evaluation, only one person is responsible for the evaluation. These persons, in most cases the chief specialist on a topic, are basically required to assess their own work, without any input or scrutiny (even of the reports drafted after a sectoral evaluation) from other services of the CA (e.g., the quality control unit). b. Sectoral evaluations focus on the process as a whole, assessing its effectiveness, but do not deal with the performance of individual inspectors in order to identify and address performance weaknesses of individual inspectors (see paragraph 55). This is of particular importance due to the exclusive role of individual inspectors in the approval and official controls of establishments under their control (see paragraphs 20 and 55). This is not in line with the requirements of Article 5(1)(a) and (b) of Regulation (EU) 2017/625. c. It was overlooked that the two sectoral evaluations (referred to in paragraph 11) deviated from the instructions and recommendations of the relevant guideline. One of the sectoral evaluations did not follow the instructions and recommendations of the guidance document, while the other drew certain conclusions that were not supported by the findings described. Conclusions on competent authorities

The supervision arrangements put in place, as currently implemented, lead to a variable 5 effectiveness of official controls, as they do not allow for the detection of quality, consistency, effectiveness, and appropriateness issues arising from weaknesses in the performance of individual inspectors.

The audit team noted that the entire approval process, from the assessment of the documents and plans to the on-site verification and control, is under the sole responsibility of each inspector in a regional department, without any involvement of the central level. According to the CA, staff from central level may get involved in the approval process (on-site verification) if the regional inspectors so demand. 6

The audit team noted that this practice entails the risk that the conditions of approval of fishery products establishments are assessed differently by each inspector responsible. This is because the supervision system, as currently implemented, is not designed to identify and tackle performance weaknesses of individual inspectors (see paragraph 12.b) and, as observed by the audit team during the on-site verification, some inspectors had different understanding and views on certain topics (i.e., hazard analysis, pre- requisite programmes and documentation requirements, traceability) than other inspectors had on the same topics (see paragraph 55).

Furthermore, the fact that the entire approval process of an establishment is under the responsibility of a single inspector, together with the identified weaknesses of the supervision arrangements in place (see paragraph 15), weakens the ability of the CA to ensure that the requirements are assessed equally across all regional departments. (6) In their response to the draft report the CA indicated that they monitor the situation in the establishment and official controls for that purpose are carried out. However, the official control reports submitted as evidence demonstrated that the operational compliance of the establishment could not be assessed as the establishment did not yet commence with the production. 7

The audit team noted that certain elements in the establishments visited were assessed differently by the inspectors involved. These concerned, labelling and traceability requirements, pest control programmes, pre-requisite programmes and their documentation. a. Labelling and traceability: while one inspector considered as adequate the presence of a single label on the very first pallet of a row of pallets extending over several layers high, another inspector (in a different establishment visited) considered as adequate labelling (and required) the presence of at least one label on every pallet. b. Pest control programmes: Inspectors had different expectations as to how pest control programme design, implementation, and documentation should look. This resulted, in establishments visited by the audit team, in one establishment having in place a properly designed, implemented, monitored, and documented pest control plan, while another establishment had in place a poorly designed, implemented and documented one. c. Pre-requisite programmes documentation: While most of the inspectors met indicated that the implementation of pre-requisite programmes needs to be documented, one inspector met considered that it is necessary to keep records only for critical control points' monitoring. d. Pre-requisite programmes: While some inspectors required and verified the existence of a plan, acceptance criteria and controls of incoming fishery products (raw materials) in an establishment, another inspector did not consider their absence a non-compliance, contrary to what is also highlighted in the relevant checklist (points 2.1 and 2.2 of checklist of Part A-II of the NVH). Incidentally, the inspector accepting the absence of checks on incoming raw materials was the inspector who refrained from consulting the checklists (see paragraph 51). The temperature control records of incoming raw materials seen by the audit team in one establishment visited, which had in place acceptance criteria and controls, were not reliable. 12

Infrastructure, hygiene conditions and level of compliance in establishments visited varied but were in most establishments largely satisfactory. The audit team noted that official controls detected regularly non-compliances, which were reported and followed up by inspectors, either through additional inspections or through receiving evidence of the corrective actions (e.g., photos) from the operators. However, the audit team noted the following issues, which were not detected by the official controls: a. Bad practices of operators who were washing surfaces and equipment with the hose while unprotected fishery products were in the vicinity and exposed to the risk of contamination from splashing water. b. Fish fillets were left for long periods without ice with their temperature rising to 11 ; packaged ready-to-eat fishery products (spiced sprat fillets) were left outside the chiller for as long time as it was necessary to pack and assemble an entire pallet with the product. c. In one establishment visited, the inspector accepted the operator's practice to use the automatic cleaning programme of the smoking oven to clean, at the same time, the grates used for smoking the fish fillets. Due to the inadequate cleaning, the "cleaned" grates were so covered in protein and fat residues from the smoking process, that it was not evident that they were made of stainless steel. d. Presence of high number of insects (flies), especially in rooms handling ready-to- eat products, as the pest control measures (i.e., fly traps) were inadequate. The operator kept a container outside the establishment, where animal by-products were stored for several months before being collected for disposal, creating favourable conditions and a breeding site for insects. e. Inspectors relied on operators' statements or records with regard to the temperature in cold stores, without verifying the temperature of the products stored or without requiring that i) the operators demonstrate that the measuring probes have been placed in the warmest spot of the cold chamber or, ii) the results of calibration of probes had been taken into account. In one establishment visited, although the temperature recorded in the cold store in September 2024 ranged between -17 and -18.5 , the temperature of the fishery products stored that was measured during the audit was -13.9 , which is not in line with the requirements of Annex III, Section VIII, Chapter VII, point 2 of Regulation (EC) No 853/2004.

The current system's design and implementation, in which inspectors are responsible for official controls in the same establishments and vessels for years, renders it vulnerable to familiarity bias and performance-dependent outcomes. The recently introduced requirement for inspectors to rotate may help address these concerns, but its effectiveness remains to be evaluated.

Although official controls regularly identified non-compliances and followed-up the operators' corrective actions, at the same time, some non-compliances pertaining to labelling and traceability, temperature control and temperature requirements for frozen fishery products, pre-requisite programmes (pest control and cleanliness of equipment) were overlooked, or subject to a different interpretation between the inspectors.

The recommendation states as its basis

Inspectors met were in general familiar with the legal requirements and aspects pertaining to the production of fishery products. However, the audit team noted that some inspectors had knowledge gaps in relation to the assessment of the procedures based on hazard analysis and critical control points (HACCP) principles, in particular the hazard analysis, or varying views in relation to general hygiene requirements and pre- requisite programmes, such as pest control, cleaning and disinfection.

The audit team noted that in all establishments visited, a common issue that inspectors overlooked concerned the establishments' hazard analysis. The latter did not identify explicitly all relevant specific hazards likely to occur at every step of the process. (7) In their response to the draft report the CA indicated that the Guidelines for the planning of official controls in fishery establishments sets out that the (NVH) checklist is used as `support material', which means, according to the CA, that it is not mandatory to use the checklist. 11 Instead, they were always referring in a generalised form to `microbiological', `chemical' and `physical' hazard. As a result, control measures described, if at all, were in many cases not particularly relevant for a specific hazard (e.g., histamine ­ acceptance criteria for raw materials, or Listeria monocytogenes ­ variability of chemical characteristics (pH) of products). On one occasion, it was noted by the audit team that some process steps were omitted from the hazard analysis of the HACCP plan.

Weaknesses in the operators' hazard analyses, a fundamental element for the development of procedures based on the HACCP principles were systematically overlooked by the official controls. (8) The guidance document is accessible at: https://food.ec.europa.eu/system/files/2021- 07/biosafety_fh_mc_tech-guide-doc_listeria-in-rte-foods_en_0.pdf 14 5.3.2 Official controls of fishery products Legal requirements Council Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EU) 2023/915. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapters I and II of Annex VI to Implementing Regulation (EU) 2019/627. Findings

The recommendation states as its basis

In all five establishments visited, the audit team scrutinised the most recent inspection reports, the operators' HACCP plans and interviewed the inspectors on their assess- ment of these plans. In every inspection report the audit team identified deficiencies in the inspectors' assessment of the hazard identification part of the operators' HACCP plans. Whilst some of the inspectors were able to correctly identify these deficiencies when interviewed, the inspection reports did not refer to these. The audit team saw 5 that the hazard identification part was either incorrect (certain hazards which would be relevant for the product being manufactured were not mentioned e.g., pesticides, my- cotoxins, dioxins and heavy metals) or was insufficiently specific (lacking the level of detail necessary for a proper hazard identification (as required by Article 6(2)(a) of Regulation (EC) No 183/2005) and the consequent risk assessment. The operators were thus unaware that there were shortcomings in the hazard identification part of their HACCP plans.

The planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with and appro- priate frequency. The effectiveness of inspections was, however, weakened by short- comings in inspectors' assessment of feed business operators' hazard identifications within their HACCP systems and failure to enforce operators' obligations on the col- lection and storage of retained samples. 7 5.2.2. Sampling and analysis 5.2.2.1. Planning of official sampling

Member state response

Juhendite täiendamine ja ametnike koolitamine viiakse läbi 2024 aasta 30. septembriks. PTA korraldab söödakäitlejatele teabepäeva, kus jagatakse infot HACCPi rakendamisest ja sealhulgas ka infot, et kõik toorainete, söödalisandite, eelsegude ohud tuleb hinnata eraldi ja üksikasjalikult. Teabepäev viiakse läbi 2024 aasta 30. septembriks. 2024 aasta detsembris teostatavte kontrollkäikude raames hinnatakse söödakäitlejate enesekontrolliplaane veendumaks, et söödakäitlejad on muudatused sisse viinud ning rakendanud vastavad tegevused.

The recommendation states as its basis

Routine inspections include a check on 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'), as required in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005. The au- dit team scrutinised operators' documentation on the collection, packaging, labelling 6 and storage of retained samples, interviewed inspectors who usually control those es- tablishments and saw that: · in one establishment, retained samples (ingredients and products) were not col- lected (and stored) at all; · in one establishment, retained samples of ingredients were not stored or col- lected; · in three establishments, a significant number of the retained samples were not adequately sealed. These 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. Furthermore, these shortcomings were overlooked during previous official inspections (i.e., no reference was made in the corresponding inspection reports).

The planning of inspections is based on appropriate risk-related factors and allows for official controls to be carried out on all operators on a risk basis and with and appro- priate frequency. The effectiveness of inspections was, however, weakened by short- comings in inspectors' assessment of feed business operators' hazard identifications within their HACCP systems and failure to enforce operators' obligations on the col- lection and storage of retained samples. 7 5.2.2. Sampling and analysis 5.2.2.1. Planning of official sampling

Member state response

Juhendite täiendamine ja ametnike koolitamine viiakse läbi 2024 aasta 30.septembriks. PTA korraldab söödakäitlejatele teabepäeva, kus jagatakse infot HACCPi rakendamisest ja sealhulgas ka infot, et enesekontrolli raames võetavad proovide võtmise ja säilitamise kohta. Teabepäev viiakse läbi 2024 aasta 30. septembriks. 2024 aasta detsembris teostatavate kontrollkäikude raames hinnatakse söödakäitlejate enesekontrolliplaane veendumaks, et söödakäitlejad on muudatused sisse viinud ning rakendanud vastavad tegevused.

The recommendation states as its basis

The audit team observed official sampling in two compound feed manufacturers visit- ed (the matrix and parameters to be controlled were suggested by the audit team). In one case the inspector implemented the official sampling procedure on the whole batch, even though some parts of the batch were not accessible with the sampling equipment and therefore could not be sampled. The inspector did not use the official sampling procedure based on the sampled portion. This is not in line with the require- ments of part 8.3 of Annex I to Regulation (EC) No 152/2009.

The audit team reviewed several sampling protocols and observed that while only part of the batch was sampled, the reports did not contain information on the sampled por- tion as required in part 10 of Annex I to Regulation (EC) No 152/2009. 8 5.2.2.3. 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 accredited with the vast majority of analytical methods included within their respective scopes of accreditation, short- comings in the designation of official laboratories, the recording of the sampled por- tion and in the reporting of certain test results undermine the legal and technical va- lidity of some of the official samples taken. 10 5.2.3. Actions taken on non-compliances

Member state response

04.2024 toimus ametnike söödast proovide võtmise koolitus. Täiendatud proovivõtu juhendmaterjali 2.04.2024. Page: 1 ref. DG(SANTE) 2024-8072 of the audit carried out from 11 March 2024 eed hygiene ion Proposed by the competent authority and deadline by ch it will be completed

The recommendation states as its basis

The Agricultural and Food Board has designated the Estonian laboratories. At the time of the audit, none of the four external contracted laboratories had been designated. The auditors were informed that the process of designation for these laboratories had start- ed, but the completion date was not confirmed. The audit team scrutinised the designa- tion documentation for the Estonian laboratories and found that the content was in line with the requirements laid down in Article 37 of Regulation (EU) 2017/625.

The designation decisions for the two Estonian laboratories contain a clause stating that the AFB may audit the laboratory. To date no audits have been conducted. The AFB avails of the opportunity to rely on the annual accreditation body audits as al- lowed under Article 39 of Regulation (EU) 2017/625. ISO/IEC 17025. Under the written designation procedures, the laboratories are obliged to maintain their EN ISO/IEC 17025 accreditation and to notify the competent authority where issues arise in respect of their accreditation status.

Notwithstanding the risk-based approach adopted for the planning of official sampling and the fact that the laboratories used for testing are accredited with the vast majority of analytical methods included within their respective scopes of accreditation, short- comings in the designation of official laboratories, the recording of the sampled por- tion and in the reporting of certain test results undermine the legal and technical va- lidity of some of the official samples taken. 10 5.2.3. Actions taken on non-compliances

Member state response

metlike laborite määramine toimub 2024 aasta jooksul.

The recommendation states as its basis

Neither laboratory took account of recovery correction requirements in respect of heavy metals or pesticides in official feed samples. On inspection of the validation da- ta, the auditors found that the calculated recovery values for certain analytes, including lead, mercury, aldrin and endosulfan, were outside the range of 90-110% and therefore would necessitate recovery correction to be applied to those results reported at or in excess of 50% of the control specification for these analytes as described 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 accredited with the vast majority of analytical methods included within their respective scopes of accreditation, short- comings in the designation of official laboratories, the recording of the sampled por- tion and in the reporting of certain test results undermine the legal and technical va- lidity of some of the official samples taken. 10 5.2.3. Actions taken on non-compliances

Member state response

aelu Teadmuskeskuse (METK) vastus: or lisab analüüsiptotokollile raskmetallide puhul ka saagise % g märkuse, et tulemus saagisega läbi arvutamata. Lisatud rde Analüüsiprotokoll. 24-885-1.pdf gi Laboriuuringute ja Riskihindamise Keskuse (LABRIS) tus: Laboris on koostatud kvaliteedijuhend KJ-Y30 « Laborisse buvate söödaproovide kaalumine », labori personalile on läbi dud koolitus ning nüüdsest toimub laborisse saabuvate daproovide kaalumine ning mõõdetud kaalutise märkimine skirjale. Kaalutise tulemus märgitakse ka katseprotokollile. proovi kaalutis on väiksem kui miinimumkoguse nõue, siis endihalduse büroo spetsialist võtab ühendust proovi saatnud elevalve ametnikuga. Nüüdsest esitatakse labori poolt soovimatute ainete lüüsitulemused katseprotokollil saagisega korrigeeritult 12% Page: 2 ref. DG(SANTE) 2024-8072 of the audit carried out from 11 March 2024 eed hygiene Proposed by the competent authority and deadline by it will be completed sesisalduse juures. Lisaks analüüsitulemusele kuvatakse rotokollil saagise %, proovi niiskusesisalduse väärtus ning ääramatuse hinnang.

The recommendation states as its basis

The audit team reviewed documentation for six sampling and inspection-related feed safety and feed quality non-compliances. The feed inspectors could provide evidence (official reports) that follow-up of these non-compliances had been carried out and that, in the context of follow-up, the FeBOs had submitted evidence of the corrective actions they had taken. The audit team noted that in five of the cases the follow-up was not effective ­ i.e., the non-compliance persisted and thus the measures taken by the competent authority to ensure operator remediation and prevent further non- compliances, as required by Article 138(1) of Regulation (EU) 2017/625, were inef- fective. For example, in a case where the label of compound feed was identified by the feed inspectors as incorrect, the FeBO subsequently modified the label, but the label remained inaccurate even after this modification and the new error had not been spot- ted by the feed inspector. In another case, the root cause of the non-compliance was that the FeBO had used a premixture (for the production of compound feed) which contained some feed additives at a lower concentration than declared on the label. The FeBO continued to use this premixture for production of further batches of compound feed without changing either the recipe or the label and thus the non-compliance per- sisted. 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 au- thority's measures to ensure that the operator remedied the non-compliance and pre- vented further occurrences were ineffective.

Member state response

tkse sööda valdkonna juhend kontrollimääruse artikli 138 täitmiseks, tähtaeg 31.10.2024. valveametnike koolitamine, tähtaeg 30.11.2024. ke hindamine antud nõude täitmise osas viiakse läbi 2025 jooksul. Page: 3

The recommendation states as its basis

The auditor reviewed in detail the screening methods for antimicrobials (Group B1a) in milk (commercially available assay) and in kidney. The approach to verify the performance of the methods in the provided reports was generally acceptable, however comparison of the CC for these methods to the maximum residue limit (MRL) set out in EU legislation (13), indicat- ed that neither method met the required level of sensitivity for a number of analytes, which is not in line with pertinent EU requirements (14). Conclusions on laboratories and method validation

Notwithstanding the progress that has been made and that the actions taken to rectify defi- ciencies identified during the 2021 audit concerning method validation are largely sufficient, shortcomings in relation to the sensitivity of the screening methods for antimicrobials and the approach used to evaluate relative matrix effect undermine the effectiveness of the cor- rective actions taken.

Member state response

es testing are fit for Kasutatavad analüütilised meetodid on üle vaadatud ja praegu kasutusel olevad farmakoloogiliste veterinaarravimijääkide skriining-meetodid asendatakse alates 2025. aasta algusest kromatograafiliste meetoditega. Suhtelise maatriksefekti hindamise protseduur on üle vaadatud, tööprotokoll maatriksefekti hindamiseks on korrigeeritud 05.2024 vastavaks EL 2021/808 punktile 2.10, milles suhteline maatriksefekt hinnatakse analüüdivaba maatriksi ekstraheerimisjärgse ekstrakti rikastamisel analüüdiga sihtväärtusel (MRL, MMPR, RPA), ja selle võrdlusel maatriksivaba solvendilahusega. Maatriksefekti hindamine viiakse läbi osana metoodikate revalideerimisel 2024-2025 aastal. Page: 1

The recommendation states as its basis

There has been one sectoral evaluation covering slaughter hygiene in 2018 and the most recent one, in August 2023, covering post-mortem inspection of adult bovine animals that has not yet been completed at the time of this DG Health and Food Safety audit. The audit team noted that the 2018 sectoral evaluation report identified some weaknesses. Some of the conclusions are: The slaughter hygiene checks are insufficiently carried out and/or the results of the checks are not recorded in accordance with established procedures, operators do not comply with requirements set in the precepts (i.e. an order to correct a non-compliance), RDs' specialists have not set deadlines correctly in the precepts and have not used the possibility of imposing a penalty payment to induce their enforcement.

The audit team noted that one of the main conclusions of the above-mentioned sectoral evaluation report was that "the effectiveness of controls depend solely on the controller". No corrective actions/follow up activities to address this issue were included in the sectoral evaluation report. In addition, the CA explained that the current system in place does not include a direct supervision of OVs and OAs in order to verify the effectiveness and efficiency of the controls they carry out and to ensure that these controls are carried out in a harmonised and consistent way. 5.2.6 Enforcement

In addition, the internal audit and sectoral evaluation systems and related procedures are in place to supervise the activities carried out by official staff. However, slaughter hygiene and meat inspection have not been subject to sectoral evaluations in depth and frequency to provide the CA with a reasonable level of confidence that controls at establishment level are, as required by Article 5 of Regulation (EU) 2017/625, effective and that non-compliances are identified, and corrective action taken if/when necessary. The lack of a direct supervision of staff performance undermines the capability of the CA to provide guarantees about the effectiveness of the official controls.

Member state response

2024.a lõpuks vaadatakse üle valdkonna hindamise süsteem ning täiendatakse juhised ametlike kontrolldie verifitseerimise osas, et order oleks tagatud ametlike kontrollide efektiivsus, mõjusus ning ühetaolisus.

The recommendation states as its basis

The PPFD is responsible for formulating an annual plan of controls on the marketing and use of PPPs. Different frequencies of inspections are allocated to various operators: once per year for large-scale distributors, once every two years for other distributors, and a variable frequency not greater than every three years for professional users. The latter are inspected taking into account the following criteria: company size, crops grown, outcomes of previous inspections, having a valid PPP training certificate and pesticide application equipment (PAE) inspected. Nonetheless, particularly for professional users, different frequencies of inspection are not clearly associated to a risk classification of the operators and, in general, the reliability of own controls performed by the operators is not one of the risk criteria considered. This is not in line with Articles 9(2) and 9(1)(d) of Regulation (EC) No 625/2017.

Comprehensive instructions have been devised by AFB to guide Customs officers in carrying out PPP controls. These complement the control tasks described in the already mentioned agreement between AFB and the Customs (finding 2). Conclusions on planning of official controls

Member state response

2023 aasta 9 · Täpsustame riskikriteeriumid ning määrame erinevate riskiastmetega ettevõtete osakaalu kontrollitavate ettevõtete valimis. · Alustame erinevate kontrollisageduste määramisega vastavalt ettevõtete riskihindamise skoorile ning kontrollisageduse sidumise juba konkreetse ettevõtte riskiastmega. Vajalik on välja töötada nii sisuline tegevus kui ka tehnilise lahendus. · Alustame info kogumise ja eeluuringuga, kas ja kuidas on võimalik võtta arvesse ettevõtjate enesekontrollide tulemusi. 2024 aasta · Kontrollisagedus on määratud vastavalt riskihindamise skoorile. · Kontrollivalimi koostamisel arvestatakse määratud kontrollisagedusi. · Hindame kogutud infot ettevõtjate enesekontrollide kohta ja võimalusel lülitame tulemused riskihindamise kriteeriumite hulka.

2023 aasta 9 · Täpsustame riskikriteeriumid ning määrame erinevate riskiastmetega ettevõtete osakaalu kontrollitavate ettevõtete valimis. · Alustame erinevate kontrollisageduste määramisega vastavalt ettevõtete riskihindamise skoorile ning kontrollisageduse sidumise juba konkreetse ettevõtte riskiastmega. Vajalik on välja töötada nii sisuline tegevus kui ka tehnilise lahendus. · Alustame info kogumise ja eeluuringuga, kas ja kuidas on võimalik võtta arvesse ettevõtjate enesekontrollide tulemusi. 2024 aasta · Kontrollisagedus on määratud vastavalt riskihindamise skoorile. · Kontrollivalimi koostamisel arvestatakse määratud kontrollisagedusi. · Hindame kogutud infot ettevõtjate enesekontrollide kohta ja võimalusel lülitame tulemused riskihindamise kriteeriumite hulka.

The recommendation states as its basis

There are 254 wholesalers and retailers marketing PPPs in Estonia. In 2020, out of the 180 inspections planned on these operators, 153 were carried out (corresponding to 85%). In 2021, 150 controls were planned and 155 performed (103%). Nonetheless, 38 inspections in 2020 and 39 in 2021 (25% of those carried out) were preceded by a phone call or an email from the inspector a few days (on average between three to five days) 2 In their response to the draft report the Competent Authority noted that the Estonian Veterinary and Food Laboratory (from 01.01.2023 National Center for Laboratory Research and Risk Assessment) has been designated as a laboratory for analyzing samples taken during official inspections and other official operations in accordance with Article 37(1) of Regulation (EU) No. 2017/6251 of the European Parliament and of the Council, and as of 20.01. 2023 also AFB took the decision to authorize the laboratory. 10 before the inspection. This is not in line with the requirement laid down by Article 9(4) of Regulation (EU) 2017/625.

Official controls on distributors and manufacturers are carried out according to the annual programmes, inspectors use checklists and relevant manual as guidance and, in case of non-compliances, adequate actions are taken and properly followed-up. This confirms a general solidity and harmonisation of the system of controls on these operators, nonetheless, its effectiveness is partly undermined by the fact that a non- negligible number of inspections (around 25%) is carried out with a prior notice between three to five days in advance. 5.2.2. Controls on the use of plant protection products Legal Requirements Articles 9(4), 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 Articles 5 and 8 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

However, approximately 80% of inspections carried out in 2020, 2021 and 2022 were preceded by a phone call or an email made by the inspectors a few days before the inspections (on average between three to five days). This is not in line with the requirement laid down by Article 9(4) of Regulation (EU) 2017/625.

Official controls on professional users of PPPs are carried out according to the annual programmes, inspectors use checklists and relevant manual as a guidance and, in case of non-compliances, adequate actions are taken and properly followed-up. However, the effectiveness of this system is undermined as that the majority of inspections are pre- announced, and certain PAE are not subject to regular inspections, which is not in line with Article 8 of the SUD.

Member state response

2023.a · Tutvume teiste valdkondade praktikatega etteteatamata kontrollide läbiviimisel. · Otsime erinevaid võimalusi etteteatamata kontrollide läbiviimiseks kasutajate juures ja hulgiladudes. · Käsiraamatus kirjeldatakse etteteatamata kontrollide läbiviimise võimalused sh erandid, vajadusel uuendatakse kehtivaid suuniseid. · Kauplustes tehakse vaid etteteatamata kontrolle, va erandolukorrad, mis fikseeritakse käsiraamatus ja vajavad inspektori poolt eelnevat kooskõlastamist taimekaitse- ja väetiseosakonnaga. Page: 1 ort ref. DG(SANTE) 2022-7476 of the audit carried out from 09 November e of plant protection products Action Proposed by the competent authority · Käsitleme inspektorite õppepäevadel etteteatamata kontrollidega seonduvat temaatikat ja rakendamise võimalusi. Arutelu olukorrast ja lahenduste leidmise diskussioon. · Aasta lõpus tagasivaade ja analüüs, kas etteteatamata kontrollide läbiviimise osakaal võrreldes varasemaga suurenes. Olukorra analüüs, täiendavate parendustegevuste leidmine. Arutelu. · Etteteatamata kontrollide osakaal on seatud mõõdikuks PTA tegevuskavas. See aitab hoida tegevuse pideva monitoorimise ja kontrolli all ning hinnata saavutatud tulemusi. 2024.a

2023.a · Tutvume teiste valdkondade praktikatega etteteatamata kontrollide läbiviimisel. · Otsime erinevaid võimalusi etteteatamata kontrollide läbiviimiseks kasutajate juures ja hulgiladudes. · Käsiraamatus kirjeldatakse etteteatamata kontrollide läbiviimise võimalused sh erandid, vajadusel uuendatakse kehtivaid suuniseid. · Kauplustes tehakse vaid etteteatamata kontrolle, va erandolukorrad, mis fikseeritakse käsiraamatus ja vajavad inspektori poolt eelnevat kooskõlastamist taimekaitse- ja väetiseosakonnaga. Page: 1 ref. DG(SANTE) 2022-7476 of the audit carried out from 09 November f plant protection products ction Proposed by the competent authority Käsitleme inspektorite õppepäevadel etteteatamata kontrollidega seonduvat temaatikat ja rakendamise võimalusi. Arutelu olukorrast ja lahenduste leidmise diskussioon. Aasta lõpus tagasivaade ja analüüs, kas etteteatamata kontrollide läbiviimise osakaal võrreldes varasemaga suurenes. Olukorra analüüs, täiendavate parendustegevuste eidmine. Arutelu. Etteteatamata kontrollide osakaal on seatud mõõdikuks PTA egevuskavas. See aitab hoida tegevuse pideva monitoorimise a kontrolli all ning hinnata saavutatud tulemusi. 024.a ­ 2025.a 2023.a al

The recommendation states as its basis

Moreover, during the visit to an agricultural user of PPPs the audit team became aware that certain types of PAE, namely, seed coating equipment and slug pellet application equipment, were not subject to regular inspections as required by Article 8 of the SUD. Representatives from the CAs justified this lack of inspections due to the limited number of these PAE, the training provided to users and the relatively low risk associated with these types of equipment.

Official controls on professional users of PPPs are carried out according to the annual programmes, inspectors use checklists and relevant manual as a guidance and, in case of non-compliances, adequate actions are taken and properly followed-up. However, the effectiveness of this system is undermined as that the majority of inspections are pre- announced, and certain PAE are not subject to regular inspections, which is not in line with Article 8 of the SUD.

Member state response

Selle olukorra muutmiseks on vajalik tehnilise kontrolli praktikate ajakohastamine ja see ei eelda taimekaitseseaduse muudatust, sest § 87 lõike 1 kohaselt peab kasutuses olev taimekaitseseade olema läbinud korralise tehnilise kontrolli iga kolme aasta järel (puhtimisseade ja udutaja iga viie aasta järel). Seniste praktikate tagamaid on eelpool kirjeldatud. Praktikate muutmine on saavutatav põllumajandusministri määruse nr 51 ,,Taimekaitseseadmete tehnilise kontrolli kord" muutmisega ja vastav eelnõu on käesoleva aasta õigusloome tööplaanis tähtajaga detsember 2023. Page: 2

elle olukorra muutmiseks on vajalik tehnilise kontrolli praktikate jakohastamine ja see ei eelda taimekaitseseaduse muudatust, sest 87 lõike 1 kohaselt peab kasutuses olev taimekaitseseade olema äbinud korralise tehnilise kontrolli iga kolme aasta järel puhtimisseade ja udutaja iga viie aasta järel). Seniste praktikate agamaid on eelpool kirjeldatud. Praktikate muutmine on aavutatav põllumajandusministri määruse nr 51 ,Taimekaitseseadmete tehnilise kontrolli kord" muutmisega ja astav eelnõu on käesoleva aasta õigusloome tööplaanis tähtajaga etsember 2023. aame kinnitada, et põllumajandusministri määruse nr 51 ,Taimekaitseseadmete tehnilise kontrolli kord" muutmine on Page: 2 ref. DG(SANTE) 2022-7476 of the audit carried out from 09 November f plant protection products vastu kavas on lisast e suunistes. alt the a.

The recommendation states as its basis

The audit team noted that the checklist for primary producers covers both sprout- producing establishments and other primary producers of FNAO. The audit team noted that this checklist has included the general questions from Annex I of Regulation (EC) No 852/2004 for primary production (questions 5(a) to (g) of part A.II on hygiene provisions). However, these general questions have not been deployed into more specific control points and inspectors lack of criteria regarding the suitability of measures to be implemented by operators to address microbiological risks.

The inspectors interviewed during the audit were aware of the guidance document on addressing microbiological risks in fresh fruits and vegetables at primary production through good hygiene (2017/C 163/01 (2)). However, the CA has not availed of the opportunity to deploy this guidance document into the inspection procedure. Inspectors have not received formal training regarding this guidance, and no specific guide or instruction has been given to set clear criteria to have a common and consistent understanding on what measures are expected to be found in primary production establishments and how to assess their suitability for reducing microbiological risks. Seeds for sprouting and sprout-producing establishments

The official control system is able to identify and rectify shortcomings of processors of FNAO. However, the lack of sufficiently detailed guidance for the use of existing checklists for controls of primary producers, compromises the consistency of official controls aimed at verifying that operators have taken appropriate measures to minimise microbiological risks, pre-farm gate. This hinders the capacity of the CA to identify and react to non-compliances. 15

The audit team noted that control points within the checklist for primary producers of FNAO are not detailed enough to guide the inspector in the type of measures that are expected to be implemented by primary producers to reduce microbiological risks associated with activities prior to and during harvest. As such, this checklist does not specifically address, among others, the need for "field toilets" and "handwashing facilities" for farms growing crops to be eaten raw and considered of high risk (see paragraphs 54 and 55). As such, and in the absence of specific notes uploaded to the system, it is not possible to corroborate whether such measures have been systematically verified during the official control. The internal audit on FNAO in 2019 also concluded 19 that "it is not clear from the inspection reports what exactly was assessed in terms of primary production and what weaknesses existed in terms of primary production". Conclusion on procedures for performance and reporting of official controls and other official activities

The CA has procedures, instructions and checklists that enable the CAs to perform official controls of FNAO establishments and for establishments seeking approval, in a uniform fashion. However, checklists lack sufficient guidance to address specific measures taken by operators to prevent microbiological risks pre-farm gate. This can compromise the consistent performance of official controls by the inspectors.

The recommendation states as its basis

In two of these FBOs, some of the test results showed positive findings for Listeria monocytogenes, and operators were requested to take measures to address this problem. Operators agreed to carry out deep cleaning and sanitation and additional samples were taken with negative results. According to the recorded information on the official control reports, own-check monitoring plans were amended, increasing the number of environmental samples to detect Listeria monocytogenes from once a year to once every quarter. In another case, the frequency set by the FBO was twice a year. These proposed FBOs' own-control plans were accepted by the CA.

However, this is not in line with an expert opinion on surface sampling which is embedded in the Estonian document "Guidance on planning and reporting on sampling and reporting of microbiology and gluten-free labelled food during monitoring in 2021". This Estonian expert opinion indicates that if there is a positive Listeria monocytogenes result, the frequencies for analysis (environmental sample, end-product) should be much higher i.e. once a week. Other Control Systems

The CA has properly included in the official controls the monitoring of environmental samples to detect Listeria monocytogenes. However, its acceptance of monitoring plans from FBO where positive results had been found which proposed only a marginal increase in the frequency of tests (and moreover much lower than frequencies suggested in national guidance), calls into question the appropriateness of its measures to ensure that operator effectively remedies the situation and demonstrates effective preventive measures, as required by Art. 138(1) of Regulation (EU) No 2019/625. This, in turn, impacts on the overall effectiveness of the official controls. 5.2.5 Official sampling Legal requirements Articles 34 and 35 of Regulation (EU) 2017/625. Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

The recommendation states as its basis

Staff met were familiar with the instructions for sampling. Nevertheless, while instructions stated, in line with the requirements (15), that sampling visits should be unannounced, in some situations sampling staff were obliged to announce visits for practical reasons (e.g. to ensure farmers were present and that livestock could be restrained for sampling). In these cases, in the absence of specific instructions on how to make such announcements, practices among the staff met by the audit team varied. In most cases, the staff indicated that any advance notice would be as short as possible and that the specific purpose of the visit would not be announced. However, in one case the sampling official indicated that the purpose of the visit would be announced in advance.

The residue monitoring plan is generally implemented in accordance with planned arrangements. However, some identified shortcomings (i.e. inconsistencies regarding announcement of sampling visits to farms, delays sending samples to laboratories, the lack of supervision from the central and regional competent authorities to ensure that sampling in aquaculture takes place at all stages of production and, for other commodities, that repeated sampling of the same producer is avoided), cumulatively have a negative bearing on the effectiveness of official controls on residues.

Member state response

t Oleme täiendanud 19.01.2022. a Põllumajandus- ure ja Toiduameti 02. märtsi 2021. a käskkirja nr 1.1- it, 2/49 ,,Juhend loomsest toidust ja umajandusloomadelt uuritavate saasteainete eireplaanis ettenähtud proovide võtmiseks" p 4 III to Põhiaspektid saasteainete seireplaanis ettenähtud roovide võtmisel järgmises sõnastuses: de võtmine peab toimuma üldjuhul ette eatamata ja ootamatult, et tagada kontrollimistes idev üllatusmoment. Erandlikel juhtudel näiteks ui on vaja loom fikseerida proovi võtmiseks jne, n lubatud kontrollist ette teatada, kuid sel juhul metnik teavitab äitlejat/loomakasvatusettevõtet, et toimub ontroll, kuid kontrollkäigu konkreetset eesmärki a ei avalda, sh ametnik ei teavita ette, et ta tuleb roovi võtma. Ette teavitamise aeg peab olema iiski võimalikult lühikene.

The recommendation states as its basis

Pending dispatch to the laboratory, samples can be stored in fridges or freezers, depending on the matrix and analyte concerned, under the control of the official sampler. Interviewed officials indicated that samples taken at slaughterhouses were sometimes be placed into the transportation boxes without preceding chilling/freezing.

National instructions do not specify any time limit between sampling and sample dispatch to the laboratory and, at the time of the audit, the time taken between sampling and dispatch was not actively monitoring by the AFB or Regional Specialists. Data requested by the audit team showed that, although most samples arrived at the laboratories on the day of sampling or one to two days afterwards, in some cases the time between sampling was much longer (up to 42 days). The AFB immediately responded to this new information, identified the main source of the delays and put in place corrective action.

The residue monitoring plan is generally implemented in accordance with planned arrangements. However, some identified shortcomings (i.e. inconsistencies regarding announcement of sampling visits to farms, delays sending samples to laboratories, the lack of supervision from the central and regional competent authorities to ensure that sampling in aquaculture takes place at all stages of production and, for other commodities, that repeated sampling of the same producer is avoided), cumulatively have a negative bearing on the effectiveness of official controls on residues.

The audit team checked the acceptance/rejection system for incoming samples by the three national laboratories and saw that this generally addressed control of the accompanying documentation, checks of the seals and general condition of the samples. Temperature of the samples at the time of reception was not controlled in any of the laboratories thus the provisions established by EU legislation (25) to ensure the samples' legal, scientific and technical validity were not fully addressed. During the audit, representatives of two national laboratories stated that temperature control of all incoming samples would commence from 1 October 2021 and that a pertinent quality control document was under preparation.

Notwithstanding the fact that all of the laboratories are duly accredited, operate methods included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of internal quality control procedures, combined with the absence of designation of sub-contracted laboratories and lack of temperature controls on incoming samples, weaken confidence in the reliability of analytical results and thus the effectiveness of the residue control system.

Member state response

e täiendanud 19.01.2022. a Põllumajandus- ja Toiduameti 02. märtsi 2021. a käskkirja nr 1.1- and 2/49 ,,Juhend loomsest toidust ja the põllumajandusloomadelt uuritavate saasteainete re seireplaanis ettenähtud proovide võtmiseks" bility punkti 7. Seireproovi võtmine, pakkimine, märgistamine ja saatmine laboratooriumisse ärgnevalt: II to Proovid peavad jõudma laboratooriumisse iljemalt 72 tunni jooksul peale proovi võtmist va Page: 1 y 2022 ties of Estonia to the recommendations of report ref. DG(SANTE) 2021-7199 of the audit carried out from 30 August 2021 evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent authority proovid, mis on mõeldud B3f alagrupi analüüsimiseks. . Kõik laboratooriumid on kas oma juhendeid täiendanud ja laboratooriumisse saabunud proovide temperatuuri juba mõõdetakse või sellega tegeletakse: - laboratoorium, kus uuritakse 93% proovidest - proovide temperatuuri mõõdetakse alates 01.10.2021 vastavalt kvaliteedijuhtimissüsteemi protseduurile. - teine laboratoorium: Proovide temperatuurikontroll on laboris nüüd kirjas tööjuhendi ,,TJ ­ PMK LAB 5 ­ Proovide vastuvõtu kord, nõuded proovidele" punktis

The recommendation states as its basis

For aquaculture, instructions indicate that for samples to be analysed for group A substances, juvenile fish should also be sampled. The degree to which this instruction is followed was not actively verified by the AFB or Regional Specialists, and it was therefore not possible to verify the extent to which all stages of production were covered by the residue monitoring sampling.

Member state response

e täiendanud 19.01.2022. a Põllumajandus- or ja Toiduameti 02. märtsi 2021. a käskkirja nr 1.1- Page: 2 y 2022 ties of Estonia to the recommendations of report ref. DG(SANTE) 2021-7199 of the audit carried out from 30 August 2021 evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent authority ,,Juhend loomsest toidust ja ages põllumajandusloomadelt uuritavate saasteainete seireplaanis ettenähtud proovide võtmiseks" punkti 8. Minimaalsete proovide koguste, kasutatava taara ja analüüse teostavate laborite loetelu t: B-grupi ainete määramiseks võetavad proovid tuleb võtta turustamiseks valmis olevatest kaladest, v.a proovid B3e alagrupi ehk värvide uurimiseks. Neid proove võib võtta kõikides arengustaadiumides olevatest kaladest. Proovivõtuprotokollile tuleb märkida prooviks võetud kala/kalade vanus.

The recommendation states as its basis

The audit team noted that the designation of the national official laboratories was in line with the requirements of EU legislation (22). Contrary to that, none of the three laboratories located in other EU Member States was designated as an official laboratory by the Estonian central competent authority.

Notwithstanding the fact that all of the laboratories are duly accredited, operate methods included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of internal quality control procedures, combined with the absence of designation of sub-contracted laboratories and lack of temperature controls on incoming samples, weaken confidence in the reliability of analytical results and thus the effectiveness of the residue control system.

Member state response

Pädev asutus lähtub laborite määramisel määruse of (EL) 2017/625 art 37 nõuetest ja koostame ka stavad kirjalikud otsused. es. eme tekitab aga välislaborite volitamine, kuna paljud välisriikide eralaborid on küll meile s analüüsideks akrediteeritud ja analüüsimine vastab ka muudest õigusaktidest tulenevatele nõuetele, kuid nad ei ole sageli labori asukohariigi pädeva asutuse poolt ametlike laboritena volitatud. Seega ei ole määruse (EL) 2017/625 art 37 lõike 2 tingimuse täitmine nende laborite volitamiseks meie jaoks täidetud. Ka on üsna paljude välisriikide laborid, kes teevad samas riigis ka ametliku kontrolli analüüse, volitatud referentlaborina (EL) 2017/625 art 100 alusel, kuid ei ole volitatud ametlikeks laboriteks vastavalt artiklile 37 lg 1. Seetõttu on see Page: 3 y 2022 ties of Estonia to the recommendations of report ref. DG(SANTE) 2021-7199 of the audit carried out from 30 August 2021 evaluate the control of residues and contaminants in live animals and animal products ction Proposed by the competent authority lus meile välislaborite volitamiseks seatud e (EL) 2017/625 art 37 lõike 2 usega. i ole veel käivitunud ka Euroopa Liidus ke laborite nimekirja sisaldav andmebaas

The recommendation states as its basis

The screening method for aminoglycosides in muscle was initially validated as a confirmatory method in line with pertinent EU requirements (26). However, due to consistently and unacceptably high reproducibility levels, the conclusion stated that the method would be used only as a semi-quantitative screening method. The audit team noted that no further elaboration/evidence was provided in a documented traceable manner to demonstrate that the method had a false compliant rate lower than or equal to 5 % ( error) (27).

The screening method for antibacterial agents in kidney was verified in line with applicable EU provisions (28). However, the documentation submitted for the screening method for antibacterial substances in milk suggested that only 12 samples (per concentration) were used for the verification, which did not correspond to the minimum number of 20 samples required to ensure that the method had a false compliant rate lower than or equal to 5 % ( error) (27).

The documentation submitted regarding the method for hormones in urine and serum demonstrated that the repeatability and reproducibility values were consistently identical which is not in line with EU requirements (29). These phenomena were not commented on or discussed in the validation report and the method was considered fit for purpose as a confirmatory method. The situation with non-commented identical repeatability and reproducibility values was seen for certain fortification levels in several other validation files scrutinised by the audit team, questioning the validity of the laboratory's conclusion that said methods were fit for their intended use.

The audit team noted numerous occasions where recovery or/and reproducibility values exceeded the ranges established in the EU legislation (30), e.g. for diclazuril and salinomycin in the coccidiostats confirmatory method. These occurrences were largely not evaluated/discussed in the validation files and consequently not taken into account for the decisions on methods' fitness for purpose.

The audit team noted that in all of the validation files scrutinised, stability was mentioned as a performance characteristic. However, the procedure for its assessment was substantially different from the protocol suggested in EU law (31) and essentially not adequate to provide sufficient knowledge on the stability of analytes, in particular in matrix. Combined with the absence of a temperature check on the incoming samples (see finding 51), this might influence the test results. The audit team pointed out that, if stability data for analytes in a matrix are available from scientific literature or from another laboratory, these data do not need to be (26) Chapter 2 of Annex I to Regulation (EU) 2021/808. (27) Point 1.1.2. of Annex I to Regulation (EU) 2021/808. (28) Article 3 and Part 1.1. of Annex I to Regulation (EU) 2021/808, and Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer), Community Reference Laboratories (CRLs) Residues 20/1/2010. (29) Part 1.2.2.2. of Annex I to Regulation (EU) 2021/808. (30) Parts 1.2.2.1. and 1.2.2.2. of Annex I to Regulation (EU) 2021/808. (31) Part 2.5. of Chapter 2 of Annex I to Regulation (EU) 2021/808. 10 determined again by the concerned laboratory, provided that identical conditions apply (32).

Notwithstanding the fact that all of the laboratories are duly accredited, operate methods included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of internal quality control procedures, combined with the absence of designation of sub-contracted laboratories and lack of temperature controls on incoming samples, weaken confidence in the reliability of analytical results and thus the effectiveness of the residue control system.

Member state response

nalüüsimetoodika aminoglükosiidide miseks on täiendamisel ja revalideeritakse d vastavalt EL määruse 808/2021 nõuetele miseks sõeluuringu ja kinnitava toodikana. Tähtaeg: märts 2022. Analüüsimetoodika aminoglükosiidide amiseks on täiendamisel ja revalideeritakse vastavalt EL määruse 808/2021 nõuetele miseks sõeluuringu ja kinnitava toodikana. ähtaeg: märts 2022. gumeetod piimas leiduvate kroobsete ainete jääkide tuvastamiseks Page: 4 y 2022 ties of Estonia to the recommendations of report ref. DG(SANTE) 2021-7199 of the audit carried out from 30 August 2021 evaluate the control of residues and contaminants in live animals and animal products Action Proposed by the competent authority 6 reverifitseeritakse vastavalt määruse EÜ nr 2021/808 nõudeid ja CEN ISO/TS 23758 juhiseid silmas pidades. Tähtaeg: märts 2022. Analüüsimetoodikate valideerimisel on lähtutud sel hetkel kehtivast määrusest (EÜ/657/2002). Korduvuse ja korratavuse parameetrite sõnastus on ajas uue määruse (EU/2021/808) jõustumisel muutunud, samuti aktsepteerimise nõuded. Labor revalideerib oma metoodikad vastavalt EU/2021/808 nõuetele üleminekuperioodi jooksul vastavalt kvaliteedijuhtimissüsteemi metoodilise töö plaanil

The recommendation states as its basis

The audit team scrutinised the implementation of internal quality controls for four samples (analysed in 2020-2021 by the largest national laboratory) where measurable quantities of veterinary medicinal products were found. In two of the four samples (diclofenac in bovine muscle and antibacterial substances in raw milk, both from 2020), the audit team observed that no matrix-based `positive control' samples were included in the analytical runs, which is not fully in line with EU requirements (33). The laboratory representative explained that this was due to absence of pertinent control samples and that this practice was discontinued since the beginning of 2021.

The audit team observed the control charts for the methods used for the four samples scrutinised and found that: a. in the control chart for penicillin V, the trueness based on results of more than 30 analytical runs was 184%, which substantially exceeds the range established in EU law (80-120%) (34). While the laboratory representative was aware about that breach, no action had been taken to address the situation. b. for the non-steroidal anti-inflammatory drugs method, very few points were available due to the low number of analytical series (since the relevant samples are collected during a narrow time window to ensure that the laboratory processes those in one go). This precluded the creation of a functional control chart.

For the screening method for antibacterial substances in milk, no sufficient evidence was submitted that quality control samples had been regularly used for the purpose of verifying ongoing method performance, which contradicts pertinent EU requirements (33).

For the same method, the audit team noted that once a suspect non-compliant result was identified, the same sample was run up to three times more before a decision was made to confirm the screened positive result with a chemical confirmatory method. This practice may lead to the situation where non-compliant results would not be identified due to false-compliant outcome of screening testing, is not in line with legal requirements (27), and contradicts the bioassay manual.

Notwithstanding the fact that all of the laboratories are duly accredited, operate methods included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of internal quality control procedures, combined with the absence of designation of sub-contracted laboratories and lack of temperature controls on incoming samples, weaken confidence in the reliability of analytical results and thus the effectiveness of the residue control system.

Member state response

datakse tööjuhendi protseduurilisamiskatse dega maatriksile nn lisamiskatse positiivne e, kontroll-proov. Metoodikate täiendamisel ähtutakse EURL juhenddokumendist "EURL guidance document on the quality control during analysis". aeg: 01.03.2022. Kontrollkaartide koostamise ja regulaarse itoorimise kord vaadatakse üle ja kse vajadusel (EL) 808/2021 nõudeid estades. Viiakse läbi töötajate koolitus. d Tähtaeg: 30.04.2022. Page: 6 y 2022 ties of Estonia to the recommendations of report ref. DG(SANTE) 2021-7199 of the audit carried out from 30 August 2021 evaluate the control of residues and contaminants in live animals and animal products d by the competent eriaalsete ainete tuvastamise odi puhul on labor kasutanud analüütilise toimivuse iga analüüsiseeria puhul olliproove (negatiivne oov ja positiivne t toimeainet sisaldav proov). hta said auditi ajal esitatud. ntrollproovide kasutamine ki veelkord üle ning muudetakse , et see oleks kõigis punktides se (EL) 808/2021 nõuetega. 2022. eriaalsete ainete tuvastamise odi tööjuhend ajakohastatakse rjutatakse välja võimalus analüüsi saks tehti otsus, et alates kse kõik piima antibakteriaalsete ise sõel- ja kinnitavad uuringud is, mis võimalda

The recommendation states as its basis

OBJECTIVES The objective of the audit was to evaluate the control systems in place for organic production and labelling of organic products and in particular the implementation of the requirements set out in Council Regulation (EC) No 834/2007 concerning: · All stages of production, preparation and distribution of organic products, including controls at import and · The use of indications referring to organic production in labelling and advertising. In pursuit of these objectives, the following meetings took place: 1 Meetings Comments Central Competent Authority Ministry of Rural Affairs 8 Control Authorities Estonian Agricultural Board (EAB) 8 Veterinary and Food Board (VFB) 8 Operators´ files reviewed Producers 10 Inspection reports and files related to sampling, application of exceptional rules and Processors enforcement measures. Retailers/traders/importers 6 Inspection reports and files related to sampling, follow-up of irregularities and enforcement measures. 6 Inspection reports and files related to sampling, follow-up of irregularities and enforcement measures. In terms of scope, the audit assessed the performance of the competent authority, as well as the organisation and implementation of the controls carried out by the CtrlAs. including import controls, controls of operators producing, preparing and distributing organic products and controls on the labelling and marketing of organic products. The audit also addressed verification procedures and audits.

Estonia has made use of Article 28(2) of Regulation No. 834/2007 to exempt from controls retailers who sell directly to the final consumer, and has made this decision, together with the conditions needed for the exemption, publicly available on the VFB website. As described in section 1(2)(5) of Regulation 26 of the Ministry of Agriculture, retailers selling unpacked organic products must apply for registration to VFB. This means that in practice, retailers who sell pre-packed products can be exempted without fulfilling all the conditions of Article 28(2). As a consequence, retailers who prepare or store pre-packed products other than in connection with the point of sale or who import organic products or subcontract any of these activities might be incorrectly exempted from controls.

Member state response

nts to Mahepõllumajanduse seaduse § 5 lõikes 2 on sätestatud, et only tunnustatud ei pea olema nõukogu määruse (EÜ) nr 834/2007 f Regulation artikli 28 lõikes 2 nimetatud isiku ettevõte juhul, kui ettevõttes tegeletakse üksnes müügipakendis toodete müügiga. Põllumajandusministri 20. veebruari 2009. a määruse nr 26 ,,Mahepõllumajanduse valdkonnas tegutsemiseks tunnustamise taotlemine ja taotluse menetlemise kord" paragrahvi 1 lõike 2 punkti 5 kohaselt peavad Põllumajandus- ja Toiduametile (edaspidi PTA-le) tunnustamise taotluse esitama pakendamata mahepõllumajanduslikke tooteid müüvad jaemüüjad. Põllumajandusministri määrus nr 26 on vastu võetud mahepõllumajanduse seaduse § 7 lõike 6 alusel ning sellega kehtestatakse taotluse menetlemise kord ning taotluse esitamise tähtaeg. Vaatamata sellele, et määruses ei ole täpsustatud, et tunnustamise taotluse peavad PTA-le esitama lisaks pakendamata mahetoodete jaemüüjatele ka need ettevõtjad, kes ei ole määruse (EÜ) nr 834/2007 artikli 28 lõike 2 kohaselt kontrollsüsteemi kuulumisest vabastatud, tuleb seda järgida, sest see on sätestatud mahepõllumajanduse seaduses. Seega on riigisisesed nõuded kooskõlas ELi nõuetega ning mahepõllumajandusto

The recommendation states as its basis

BACKGROUND This was the first audit of Estonia regarding organic production since it became a Member State (MS) of the European Union (EU).

In addition, the audit team noted a lack of coordination between EAB and VFB to plan controls at the 71 operators whose activities are under control of both CtrlAs. As stated by both CtrlAs, multiple activities should be regarded as a risk criterion, however in practice EAB has not introduced it as part of their risk assessment and VFB does not take it into account for the rating of the operator (see paragraph 37). Moreover, the results of controls of such operators are not systematically shared between EAB and VFB. Conclusions on planning and prioritisation of inspections

Member state response

thorities Alates 1.01.2021 alustas tööd PTA, mis täidab kõiki d Põllumajandusameti ning Veterinaar- ja Toiduameti seniseid (EU) No ülesandeid. Ametite ühendamise tulemusena korraldab e valdkonna ametlikke kontrolle senise kahe semel üks PTA osakond (mahepõllumajanduse ja Selle tulemusena muutub mahepõllumajanduse lide koordineerimine veelgi tõhusamaks ja de järjepidevus. e arvesse Komisjoni soovitusi ja ahepõllumajanduse kontrollisüsteemis olevate e hindamist. 21 onide kataloogi lisati tegevuse kirjeldus, mille ooni järelevalveametnik teavitab koheselt lumajanduse nõuete rikkumistest, mis mõjutab janduslikku staatust, keskasutust ning ab pädeva asutust. Page: 2 ved 26 March 2021 ons of report ref. DG(SANTE) 2020-7043 of the audit carried out from 09 November r organic production and labelling of organic products ction Proposed by the competent authority egevus: Pädevale asutusele edastatakse edaspidi igal aastal iskipõhiste lisakontrollide plaan ja proovivõtu plaan. ähtaeg:15.06.2021

The recommendation states as its basis

MoRA is also responsible for the allocation of sufficient budget for controls and for the supervision of the control and certification tasks conferred to EAB and VFB. Supervision must take place once every five years in accordance with national rules. It is carried out either by MoRA´s internal audit team or by outsourcing it to external companies. In the period 2015-2020 an internal audit was carried out by MoRA to EAB, however no audits of VFB were carried out. MoRA and VFB stated that although an audit of VFB was in 5 principle planned to take place during 2020, it was deemed not necessary as the DG Health and food safety audit was considered to have similar value for the purpose of supervision.

The audit team found that the internal audit carried out of EAB by MoRA was well- structured and detailed and with good follow-up which allowed for the closing of most of the recommendations. However, its scope did not cover the most relevant aspects of the tasks conferred to this CtrlA. For example, the effectiveness of inspections, sampling and laboratory testing and the certification activities were not covered. It also did not include on-the-spot activities at operators to observe inspections performed by EAB. However, the audit team considered that documentary checks only would not allow MoRA to evaluate how controls are carried out, as the inspection reports, in particular EAB´s, lack the detail necessary to support effective supervision (see paragraph 48).

However, the reports issued by EAB inspectors lack detail on how verification takes place, with no objective evidence attached to the reports except in cases of non-compliance. The reports consist of a digital template where inspectors tick off the aspects verified with no further description of, or references made, to the documents or records checked.

For example, the audit team reviewed a report of an additional inspection carried out at an operator who runs conventional and organic units as described in paragraph 35 above. The inspector stated that she focused on the verification of proper cleaning of the harvesting machinery and equipment shared between the conventional and organic units. The inspector also stated that she followed the guidance in the handbook of procedures and monitored the purchase and use of inputs, as well as the balance between the organic products harvested against their sales, to confirm that only the products sold as organic were those produced in the organic unit. However, these statements were not supported by evidence as the reports lack details on how the checks had been made. This lack of detail prevents effective supervision as there is no evidence that can be objectively assessed. 12 Conclusions on controls of operators

Member state response

quired by Tegevus: Arvestatakse Komisjoni soovitusega tagatakse kõikide ervision of asjakohaste tegevusvaldkondade ja määrusega (EL) 2017/625 eguleeritud pädevate asutuste piisav siseaudititega hõlmatus e in sobiva riskipõhise sagedusega vähemalt kord viie aasta jooksul. e Auditite kavandamisel lähtutakse muuhulgas kahest järgnevast õhimõttest: auditi ulatus peab katma kõik olulised kontrollisüsteemi elemendid; auditi ulatusse kaasatakse vajaduse korral ja vastava võimaluse olemasolul ka kontrollkäikude vaatlus. õttes arvesse riskipõhise sagedusega vähemalt kord viie aasta ooksul siseaudititega hõlmatuse põhimõtet ja Komisjoni auditi ulemusi, viiakse järgmisel aastal läbi mahepõllumajanduse aldkonna audit. ähtaeg: 31.12.2022. egevus: Et kinnitada ettevõtte vastavust nõuetele, hindab ärelevalveametnik kõiki mahepõllumajanduse valdkonna õudeid, mis on asjakohased kontrollitavale ettevõttele. Nõuetele astavuse hindamisel kasutab järelevalveametnik nõuetele astavuse hindamise töölehti või käsiraamatus olevaid juhiseid, us on toodud, mida peab iga nõude puhul kontrollima. ontrollitavad nõuded on kuvatud järelevalve infosüsteemis, ontrollitavad taime- ja loomakasvatuse nõuded kuvatakse l

The recommendation states as its basis

The audit team noted that the manner in which inspections are announced to operators differ between EAB and VFB. VFB generally carries out all inspections unannounced while EAB allows for short prior warning of up to 48 hours being given to farmers, even for additional inspections that according to Article 65(4) of Regulation (EC) No 889/2008 should be primarily unannounced. Although the audit team fully understood the reasons given by EAB that in some cases it is difficult to carry out an inspection at farmers without prior warning, this should be the exception (for duly justified cases) rather than the rule. 9 As a consequence of this shortcoming, Estonia is not in the position to fulfil the requirement of Article 92c(2)(c) and (d) of Regulation (EC) No 889/2008 that at least 10% of total inspections and visits are carried out unannounced, and that these are planned according to the level or risk.

Additional inspections are planned at the beginning of the year by EAB and VFB. The audit team noted that both CtrlAs generally achieve the number of inspections planned. However, the manner in which EAB and VFB select operators for additional inspections differ greatly. VFB follows the working document agreed by Member States and issued by the European Commission, which instructs how to classify operators in risk categories following risk assessment made of them all. VFB thus uses a number of criteria (e.g quantities produced or traded, past non-conformities, potential of exchange of products, e-commerce, sales or pre-packed or unpacked products, subcontracted operations).

Every operator is rated for each criterion and given a final score based on the aggregated scores. The operators are selected for additional inspections in descending order starting with the one with the highest score. There are also additional factors that can be taken into account but not rated with points (e.g. textual remarks from the inspector, operator under control of EAB and VFB).

EAB sets up the risk criteria annually, with some criteria being used each year (e.g. past irregularities, risk of mixing organic and non-organic products) while others are introduced based on a thematic approach for the year in question (e.g. small potato growers with land area between 10-50 hectares for which complaints were received). EAB 10 then groups the operators under each of the criteria. Operators may be selected for additional controls based on one criterion only, also taking into account input from inspectors. This not in line with Article 65(4) of Regulation (EC) No 889/2008, as no individual assessment is made to determine the risk profile defined for each operator, taking into account all the criteria established by EAB, or at least the three compulsory criteria required by the said article.

Even if selecting the operators based on one criterion only can be useful to detect non- compliant operators, the inspections carried out on this basis should not be counted as part of the minimum, required by Article 92c(2)(b) of Regulation (EC) No 889/2008, of 10% of operators that must be subject to additional inspections based on their risk profile.

Member state response

visits Tegevus: Seoses Põllumajandusameti ning Veterinaar- ja , as required Toiduameti ühendamisega ja võttes arvesse Komisjoni tepanekuid korrigeeritakse mahepõllumajanduse ntrollisüsteemi kuuluvate ettevõtete riskide hindamist. tevõtete puhul, kus tegeletakse mitme tegevusvaldkonnaga (nt matootmine ja töötlemine), võetakse riskitaseme määramisel vesse teiste tegevusetappide kontrollimisel tuvastatud rikkumisi t kui esmatootmise järelevalve käigus tuvastati rikkumine, etakse see arvesse töötlemise järelevalve läbiviimisel) ning jadusel muudetakse jooksvalt ettevõtte riskitaset. htaeg:15.06.2021

The recommendation states as its basis

The audit team noted that the manner in which inspections are announced to operators differ between EAB and VFB. VFB generally carries out all inspections unannounced while EAB allows for short prior warning of up to 48 hours being given to farmers, even for additional inspections that according to Article 65(4) of Regulation (EC) No 889/2008 should be primarily unannounced. Although the audit team fully understood the reasons given by EAB that in some cases it is difficult to carry out an inspection at farmers without prior warning, this should be the exception (for duly justified cases) rather than the rule. 9 As a consequence of this shortcoming, Estonia is not in the position to fulfil the requirement of Article 92c(2)(c) and (d) of Regulation (EC) No 889/2008 that at least 10% of total inspections and visits are carried out unannounced, and that these are planned according to the level or risk.

The audit team noted that according to the Organic Farming Act, samples may be taken in the framework of horizontal controls and not necessarily with the purpose of verifying compliance of operators with the requirements of the organic regulation. For example, VFB elaborates its sampling plan in the framework of food safety controls, which generally include testing for the detection of multi-residues of plant protection products.

When the products sampled happen to be organic, the samples are counted for the 5% target required by article 65(2) of Regulation (EC) No 889/2008. The products selected for sampling are categorised according to pre-defined criteria (products most commonly purchased by Estonian consumers, results of samples from the previous years, OFIS (Organic Farming Information System) notifications and internal detections, risk of use 14 of substances extensively used in conventional production, products not tested before) and covering all stages of the food chain). However, VFB does not use the risk assessment described in paragraphs 36 and 37 to select the operators, which is not in line with the said article.

Moreover, VFB also counts the samples of products of animal origin, taken by VFB at primary producers in the framework of food safety controls, towards the 5%. This is not correct as the legal requirement refers to the taking of samples at operators under organic controls (and according to risk assessment under organic legislation) and not under food safety controls. VFB does not know the risk profile of primary producers as they are not under its control and this information is not shared by EAB.

EAB selects the operators based on the risk assessment implemented for deciding on additional inspections. However, as described in paragraph 38, the assessment is not fit for purpose and does not serve to identify the operators who pose the highest risk.

Moreover, EAB takes samples from final products intended for consumption and rarely from soil or non-edible plant parts. This and the fact that many samples are taken during storage of harvested products (e.g. 40% in 2020) reduces the likelihood of detecting substances not authorised in organic production. This is because the presence of residues of plant protection products decreases from the moment of application, and even faster from fruits than from plant parts or soil. Furthermore, if the sample is positive, it may be more difficult to determine from a sample taken from storage whether the cause was spray drift from neighbouring fields or use on the field itself, since it normally cannot be determined from where in the field the sampled material came. As described in paragraph 34, EAB does not take samples from products of animal origin at primary producers.

The fact that samples are not taken at the most risky operators or at the most suitable time and place can explain the low number of samples that have tested positive for the presence of unauthorised products in the 2020 and 2019 campaigns. As an example, there were only four positive results in 2020 out of 147 samples taken. Of these, two were taken on suspicion by the EAB inspector and one taken by VFB at catering facilities not in the control system).

Moreover, the procedures for the taking of samples mentioned in paragraph 53 do not contain detailed guidance on how to collect samples from the fields or to evaluate the results of the samples taken. Both CtrlAs stated that any presence of unauthorised substances is considered as a potential irregularity and an investigation is launched in all cases. As an example of this, the audit team was shown a case where an operator raised a complaint to EAB against a wheat producer following the analytical results of a sample taken during the operator's own checks. EAB launched an investigation including a visit to the wheat producer, who attributed the presence of the residue to spray drift from a non- organic neighbouring plot. EAB asked the plant protection and fertilisation department (responsible for horizontal controls at the non-organic farmer) to follow-up and confirm whether the thesis of spray drift was plausible or not. Based on the reply of the plant 15 protection and fertilisation department, EAB concluded that the spray drift was not plausible (see also paragraph 84).

The case above shows good internal co-operation within EAB and enabled it to take a correct ad-hoc decision. However, it alone cannot ensure that an appropriate decision is made in all cases without a specific sampling methodology allowing for the assessment of the laboratory results to conclude that the presence of the unauthorised substance was the result of its use or spray drift. Conclusions on sampling and laboratory analysis

Member state response

ion (EC) Tegevus: Riskitasemete uuendamine ja iga-aastase proovivõtu va koostamine. tevõtete riskitasemete uuendamise ja rakendamise käigus akse määrusega kooskõlas olevad uuendatud riskikategooriad, l hinnata erinevate valdkondadega tegelevate ettevõtete Page: 4 ved 26 March 2021 ons of report ref. DG(SANTE) 2020-7043 of the audit carried out from 09 November r organic production and labelling of organic products by the competent authority muti koostatakse vastavalt riskide hindamisele sevahendite jääkide proovivõtu iga-aastane kava. Proove millal on kõige suurem tõenäosus tuvastada uslikus tootmises lubamatute ainete kasutamist. l arvestatakse ka Komisjoni tehtud ettepanekuga, ne oleks kooskõlas määruse (EÜ) nr 889/2008 ega 2. 2021 võtu metoodikate ühtlustamine, uuendamine ja damine. isega ühtlustatakse proovivõtu metoodikad ja a uued metoodikad. Ühtlustamine leiab aset nii ustest võetavate proovide kui ka teistest õetavate proovide puhul. Olemasolevate ndamise puhul tehakse koostööd nii PTA dade kui ka teiste liikmesriikidega (näiteks ks ühesugune lähenemine. Lisaks metoodikate satakse detailsed kirjeldused ja juhendid ka PTA käsiraamatusse. 2021

The recommendation states as its basis

With regard to tethering of animals, the handbook refers to article 39 of Regulation (EC) No 889/2009 and to the relevant national provisions implemented to further develop the requirements of the said article, including the definition of what small holdings are. For granting the derogations EAB checks that, in addition to being small holdings, animals have access to pasturage during the grazing period and to open air areas at least twice a week if grazing is not possible. The decisions issued to operators contain background information of the applicant as well as the rationale for the decision taken, which includes a reference to the fulfilment by operators of the above-mentioned requirements. However, the rationale of the decisions do not include fulfilment by operators of the requirements of Article 22(2)(a) of Regulation 834/2007 (which requires that such exceptions can only be provided for to holdings confronted with climatic, geographical or structural constraints). This and the fact that the handbook does not refer to Article 22(2)(a) and does not set up concrete criteria to be fulfilled by operators in this regard raise concerns that, although the CA may take into account these requirements, they are not a pre- requisite to grant derogations for the tethering of animals. Conclusions on exceptional production rules and other derogations

Member state response

ranted taking Määruse nr 834/2007 artikli 14 kohaselt on kariloomade tion (EC) lõastamine või teistest eraldamine keelatud, välja arvatud üksikute iiratud ajavahemikuks, niivõrd kuivõrd see on va-, heaolu- või veterinaarkaalutlustega. Seega kkel ette võimalust lõastada loomi ajutiselt teatud äiteks veterinaartoimingute läbiviimiseks, s, kuid ei näe ette selleks loa küsimist. Page: 5 ved 26 March 2021 ons of report ref. DG(SANTE) 2020-7043 of the audit carried out from 09 November r organic production and labelling of organic products tion Proposed by the competent authority äruse nr 889/2008 artikkel 39 näeb ette võimalust loomade astamiseks väikeettevõtetes, kui karja ei ole võimalik hoida nde käitumuslike vajadustega sobivates rühmades ning selleks a küsimist. Põllumajandusministri 20. veebruari 2009. a äruse nr 25 ,,Mahepõllumajandusliku tootmise nõuded" § 8 ike 2 kohaselt käsitatakse komisjoni määruse (EÜ) nr 889/2008 tiklis 39 nimetatud väikeettevõttena ettevõtet, kus peetakse kuni veist, välja arvatud noorloomad. Määruse nr 889/2008 artiklis ei ole kohustust anda luba tähtajaliselt. Igal aastal ntrollitakse plaanilise kontrolli käigus, kas ettevõte vastab tkuvalt väikeettevõt

The recommendation states as its basis

There is good co-operation and communication between EAB and VFB, except for the planning for controls carried out to operators that have primary and processing activities (see paragraph 40). The audit team noted that EAB and VFB do not immediately notify MoRA in all cases of severe irregularities, but only when this information is to be shared with the Commission and other Member States. MoRA receives information about any other severe irregularity only during the quarterly meetings with EAB and VFB. Although in practice this does not have any immediate negative impact on the enforcement measures taken (see paragraph 86 below), it is not in line with Article 92(4) of Regulation (EC) No 889/2008. The lack of timely communication prevents MoRA from having a proper overview of the measures taken by the CtrlAs, which would have been valuable for their supervision. Conclusions on competent authorities, organic control authorities and control bodies

Member state response

lay of Tegevus: Sanktsioonide kataloogi lisati tegevus, mis näeb ette of products PTA regiooni järelevalveametniku poolt keskasutuse kohest n (EC) No teavitamist ja omakorda keskasutuse poolt pädeva asutuse kohest avitamist sellistest rikkumistest, mis mõjutavad toote hepõllumajanduslikku staatust. htud.

The recommendation states as its basis

The audit team noted several cases where consignments were found during import 18 controls to be labelled as organic, but for which a CoI had not been presented to VFB. VFB provided evidence that the consignments were either returned to their origin or the references to organic were removed from the labels. However, this information was not shared via OFIS with other Member States and the Commission. This is not in line with Article 92a(2) of Regulation (EC) No 889/2008. Conclusions on imports of organic products

Estonia has little imports or trade of organic products with other MSs, with few notifications received from other MSs relating to non-compliant products originating from Estonia. The audit team reviewed two cases and noted that the follow-up actions taken were not adequate. For example, in one of the cases VFB did not signal as a non- compliance that one of the operators who had handled the products was not subject to the control system and the reply, which was sent after the required deadline, was rejected by the notifying MS. Estonia does not have a specific procedure for following up these notifications, or to ensure that replies are sent within the deadline of 30 calendar days required in Article 92a(4) of Regulation (EC) No 889/2008. 20 Conclusions on measures in cases of irregularities and infringements

Member state response

gularities Tegevus: Arvestatakse ettepanekuga ja edaspidi peetakse kinni 30 eva tähtajast. Täpsustatud on tööjuhendeid ja protseduure. Page: 6 ved 26 March 2021 ons of report ref. DG(SANTE) 2020-7043 of the audit carried out from 09 November r organic production and labelling of organic products oposed by the competent authority : Importidavate mahetoodete kontrollimisel tuvastatud evastavustest teavitatakse liikmesriike ja komisjoni OFIS kaudu. Vastav tegevusjuhus on lisatud sanktsioonide loogi. ud. Page: 7

The recommendation states as its basis

Official controls on imports of live animals and feed and food of both animal and non- animal origin were, for the most part, carried out properly by the competent authority with minor shortcomings noted in relation to the implementation of documentary checks. The fraudulent honey case, whilst an isolated example, demonstrates that improvements in the system are needed since the failure to notify other Member States in a timely manner may have resulted in more of this falsified material being imported into the Union.

Member state response

on's Training for BIP inspectors was carried out 15.-16. May. Topic of this training were RASFF, Food Fraud and AAC.

The recommendation states as its basis

The facilies, equipment and hygiene of the BCPs were adequate in the Narva and Muuga BCPs. In Luhamaa BIP the facilities and equipment for handling of live animals were adequate the shortcomings identified should be rectified by the planned refurbishment. The BIP Paldiski has not been operational since 2004 and whilst the building is adequate in principle, the fact that it has been stripped of most of the equipment required for conduct of import controls means that it is not fit for purpose and should not remain listed unless refurbished.

Member state response

The Veterinary and Food Board of Estonia sent 13.07.2018 a letter to Tallinna Sadam AS (owner of Paldiski BIP) with request to bring the BIP facilities and equipment in accordance to equirements foreseen by legislation or consider removing the diski BIP from the list of approved BIP-s. Deadline for Tallinna Sadam AS for informing of Veterinary and Food Board about action plan is 31.08.2018 Page: 1

The recommendation states as its basis

On another holding visited, the team noted that pigs were moved to slaughter 4 days after a consignment of pigs were introduced from an area listed in Part II. This holding did not fully comply with the requirements necessary to avoid a standstill period e.g. the implementation of the biosecurity plan was checked every 6 months rather than every 3 months as required by both Article 3b of Decision 2014/709/EU and the authorities staff guidance. 5

The authorities confirmed that they do not require all holdings on the high biosecurity list to observe the 30 day standstill required for movement to slaughter ­ contrary to what is required by Article 11(3) of Decision 2014/709/EU.

Movement controls for live pigs within Estonia allows pig meat from Part II to be dispatched to other Member States and third countries. However, there are weak points regarding how pigs should be selected for ASF sampling and on the application of standstill requirements. These may increase the risk of spread of ASF infection.

The recommendation states as its basis

Holdings reviewed by audit team had records to demonstrate weekly submission of samples from dead pigs for ASF testing in conformity with ASF Strategy for the EU. In one county, turnaround time between sample submission and reporting of test results was 1 ­ 2 days. In two other counties visited, turnaround time within the reference laboratory was usually one day but in some cases it took an additional 4 ­ 7 days to transport the samples to the laboratory. Sampling is performed by the herd owner and the regional veterinary office despatches samples to the laboratory. The authorities confirmed that samples are sent to the laboratory using a bus service and the frequency of bus service impacted directly on sample delivery.

The surveillance implemented for domestic pigs, with holdings regularly submitting samples from dead pigs for ASF testing, contributes to the early detection of ASF. The delays observed in transporting some samples to the laboratory may weaken this early detection and delay measures to control the spread of ASF.

The recommendation states as its basis

In two counties visited by the audit team, authorised veterinarians performed the bi- annual sampling for ASF. There is no national guidance available for them to assist in the interpretation of Chapter IV of the Annex to Decision 2003/422/EC (ASF Diagnostic manual) and no official supervision of their performance. In a third county visited, the official county veterinarian selected pigs to be sampled and oversaw holding employee taking the samples.

The authorities confirmed there is currently no supervision of authorised veterinarians performing ASF sampling duties (see finding 13).

There are satisfactory supervision and verification measures in place related to ASF controls in domestic pigs, which contribute to the effectiveness and consistency of the official checks. The weakest points in the verification relate to how authorised veterinarians deliver their controls and the disposal of ABPs. This prevents the authorities from detecting possible inconsistencies and preventing their recurrence.

The recommendation states as its basis

The audit team reviewed a selection of holdings in ARIB, both commercial and non- commercial, and confirmed the timely recording of farm to farm movements. The authority confirmed there was no field for entering sanitary information as required by Article 1 (1)(e) of Commission Decision 2000/678/EC.

The ARIB database is used by the competent authorities to record movements of pigs between holdings and can be used for tracing these animals. However, movements of pigs to slaughter are not recorded making it more difficult for the authorities to carry out forward tracing. The absence of a field to record sanitary information makes e.g. routine verification of movement restrictions difficult.

The recommendation states as its basis

In 2017, VFB carried out a "one off" series of official controls on hunting grounds related to implementation of biosecurity rules e.g. management of animal by-products and availability of chills for carcase storage. All hunting grounds were covered with 350 out of 353 hunting clubs inspected. The competent authority concluded that 40% of hunting clubs have chills for carcases and 52% have dressing facilities. The authority acknowledged the need to improve these facilities and confirmed that, in early 2019, a rural support scheme would be introduced to provide financial aid to improve them.

Biosecurity in hunting grounds is weakened by the lack of primary processing and chill facilities. This may increase the potential risk of spread of ASF infection through wild boar meat

The recommendation states as its basis

However, the EAB stated that there is no legal basis for inspectors to carry out plant health checks of non-regulated articles and therefore such checks are not carried out (see also section 5.3.7 below). The absence of a legal basis is not in line with Article 13(3) of Directive 2000/29/EC. The EAB also stated that there is no legal basis for inspectors to target or take action against non-regulated harmful organisms, even if they were 2 http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=EE 4 considered to present a phytosanitary risk. Estonia does not have the necessary legal basis to take the measures necessary to prevent the introduction of non-regulated harmful organisms, which is not in line with the objective of the second subparagraph of Article 16(2) of Council Directive 2000/29/EC. The Agricultural Board stated that in both cases, the lack of legal basis was an issue of transposition, and they recognised it as an omission, and stated that this would be remedied with the implementation of the new plant health regime3, due to come into force in December 2019. 5.1.3 Staffing provisions and training

The lack of legal basis to take measures against non-regulated harmful organisms or to carry out checks of non-regulated articles means that the programme of plant health checks cannot quickly be adapted to respond to new or emerging plant health risks.

The EAB informed the audit team that plant health checks of non-regulated articles are not carried out, as there is no relevant legal basis for doing so (see also section 5.1.2). Inspectors at Tallinn airport stated that in general, import trade is stable and cases of new import trade or new entry routes are rare. 5.3.8 Checks for prohibited and non-declared items

No plant health checks are carried out for non-regulated articles due to the absence of a legal basis within Estonia's national legislation. This compromises the opportunity to identify new and emerging plant health risks.

Member state response

Vastavalt taimekaitseseaduse § 4. lõikele 5) käsitletakse ohtliku taimekahjustajana ka reguleerimata taimekahjustajat, mille esinemine tuvastatakse Eestis esmakordselt ning mis võib õhjustada olulist majanduslikku kahju. Antud sätet on võimalik rakendada ka piiril tuvastatud mittereguleeritud taimekahjustaja avastamisel. Läbirääkimiste tulemusena Maksu- ja Tolliametiga (MTA) on sõlmitud kokkulepe, et vastavalt Põllumajandusameti (PMA) riskihinnangule ja PMA/MTA 28.01.2015.koostööleppe nr 10.1/1 punktidele 7.1 ja 7.2 suunatakse edaspidi tolli järelevalve all kontrollimiseks ka kaupu, mis ei ole reguleeritud.

The recommendation states as its basis

Consignments containing WPM imported with specified commodities from China are opened at the point of entry to confirm the presence of WPM and then allowed to customs clear before being moved to places designated by the importer where the plant health checks are carried out. In all cases, the subsequent movement is supervised by the plant health service (see section 5.3.3 below). The release from customs supervision before completion of plant health checks is not in line with Article 13(1) of Directive 2000/29/EC. 9 5.3.3 Implementation of Directive 2004/103/EC

The EAB informed the audit team that WPM imported with specified commodities from China, is allowed to customs clear at the point of entry and move to a place designated by the importer. Before this movement, a check is made to confirm that the consignment actually contains WPM. The audit team visited one importer of such consignments. The operator stated that on average, 60% of consignments are checked at his premises and the rest of the plant health checks are carried out at sites specified by his customers, such as construction sites. The importer stated that there are no specific conditions, imposed by the plant health service, on the sites where the consignments are moved to. The movement of consignments to places not established in accordance with Directive 2004/103/EC is not in line with Article 3 of Decision 2013/92/EU.

However, in some cases, in particular WPM from China, consignments are customs cleared before plant health checks are completed and moved to places of destination which are not established in line with Directive 2004/103/EC. The supervision, guarantees and minimum conditions for carrying out checks, provided for in the Directive, are not ensured, and so the risk associated with these movements is not appropriately managed.

Member state response

Hiina kivimitega kaasneva pakkematerjali kontrolliprotseduuri jatöötamisel lähtuti asjaolust, et tegemist on kõrge riskiga kaubaga ja kontrollida tuleb võimalikult palju partiisid, võimalusel 0%. Samas peaks kontroll olema läbi viidud viisil, mis annab piisava kindluse, kuid oleks ettevõtjatele kõige vähem koormav. se kontrolli läbiviimiseks kivimite väljatõstmine sadamas tooks ettevõtjale märkimisväärseid täiendavaid kulutusi, sageli on tegemist mittestandardsete ja erikujuliste pakenditega, mistõttu on nende välja- ja uuesti peale tõstmine konteinerist keeruline ning iga täiendav maha- ja peale laadimine suurendab oluliselt kivimite kahjustumise või purunemise tõenäosust. Siiski olukorras, kus kaubale on tagatud piisav juurdepääs või kaubasaadetis jagatakse sadamas osadeks, viiakse kivimite pakkematerjali kontrollid läbi sisseveopunktis. Nii kontrolliti ajaperioodil 01.04.2017 kuni 31.03.2018 sisseveopunktis tolli Page: 1 8 ort ref. DG(SANTE)/2018-6479-MR of the audit carried out from 22 January plant health Action Proposed by the competent authority järelevalve all 52 Hiina kivimite kaubasaadetist, kokku saabus sel perioodil 150 kaubasaadetist, mis vastab Komisjoni otsuse nr 201

The recommendation states as its basis

The audit team noted that section 4.3.8 of the 2016 national programme states that: "Wild boars which are shot for hunting purposes are kept in refrigerated cooling places which 10 belong to hunting organisations until lab results. When test results are positive then carcasses are taken to above mentioned containers. If the tests results are positive then storage place, all equipment and transportation means are disinfected under the supervision of veterinary inspector/official veterinarian." Via discussions with the VFB and hunters, it was established that not all aspects of the above plan are being implemented, e.g.: Only about 25% (80/318) of hunting grounds in Parts II and III have "refrigerated cooling places." Most carcases are stored in rooms in hunting lodges or at hunters own property. The majority of wild boar carcases that test positive for ASF are disposed of via burial and not in containers. There is no supervision by the competent authority for this. The disinfection of "storage places, all equipment and transportation means" is not routinely supervised by authorised or official vets. 5.3.2 Biosecurity in relation to pigs

Several measures related to hunting wild boar included in the 2016 national programme for the control and eradication of ASF submitted for obtaining EU co-financing are not being implemented as stated in the plan and they might have negative impact on stopping the spreading of the disease.

Member state response

ded in 58 fridges has Veterinary and Food Board bought in cooperation with and Estonian Hunters`Society. Fridges have been given to those hunting clubs with the biggest need. Most of the hunting clubs have their own quipment for storing hunted wild boars. More detailed information we can give after we have inspected all 327 hunting clubs and their hunting grounds/lodges. We have drawn up check-list and guidelines for such an inspection (Decree of Director General of Veterinary and Food Board No 37 from 08.02.2017). Veterinary and Food Board, based on Regulation 1069/2014, has decided that burying dead wild boars is justified based on our current epidemiological situation, especially in remote areas. Such a possibility is included also into the contract with Estonian Hunters`Society and will be funded. Burials are conducted in the way that further spread of the disease is avoided. Hunted and ASF positive wild boars have to be taken into rendering plant and burial is not allowed. For the distribution of containers the wild boar population and number of ASF positive cases have been taken into account ­ more containers are in places where we get most of our ASF positive cases. To ensur

The recommendation states as its basis

All holdings in Part II or III that send pigs to either an abattoir or to another holding have to obtain a certificate for the movement, usually issued by an authorised veterinarian, i.e. a "9T" in the case of animals moving from a holding to an abattoir or a "7E" in the case of animals moving between holdings. Both certificates are used to demonstrate compliance with the requirements of various Articles in Decision 2014/709/EU, e.g. articles 3 or 4. These certificates provide information on the ASF testing history (either on a holding or consignment basis) and confirmation of the clinical health of the animals in the consignment. However, there is no certification of compliance with other relevant rules such as 30 day residency of animals, no introduction of new animals on to the holding within 30 days prior to certification or respect of biosecurity rules.

The pre-movement certification of all live pigs provides, in principle, guarantees of compliance with movement rules and thus reduces the risk of disease spread between holdings. However, as authorised veterinarians do not perform pre-certification checks correctly (i.e. sampling procedures and verification of residency periods) and the verification system does not pick-up failures in the system, the measure is not very effective, which hinders this reduction of risk.

All live pigs arriving at an abattoir are accompanied with a "9T" health certificate as described in finding 29. The official vet in an abattoir relies on the "9T" and the list of holdings which comply with Article 3, 3a or 4 of Decision 2014/709/EU in order to assess whether pigs are eligible for the derogations under this Decision. If deemed eligible, a triangular national health mark is used for fresh pig meat, pig meat preparations and pig meat products from III which allows circulation on the national market. Eligible pigs from Part II receive the oval health mark and can circulate on the EU market.

For pig meat, the reliability of this system is undermined by the insufficient assurance that pigs comply with residency and standstill requirements. 17

Member state response

With the Decree of Director General of Veterinary and Food Board No from 22.02.2017 we have established more precise rules for issuing levant veterinary certificate SV that ensures that standards defined in Articles 3, ent 4 and 8 of Commission Implementing Decision 2014/709 /EU are followed. 29 On 08.11.2016 we had a seminar/training for our animal health inspectors and the aim of it was once again stress out the current rules for controls and sampling. Decree of Director General of Veterinary and Food Board No 45 from 22.02.2017

The recommendation states as its basis

Veterinary practitioners submit blood samples and organ samples from dead pigs to the official laboratory for ASF testing without informing the local official vets and the holdings may not be subjected to any restrictions or recorded as suspicions.

A special system for notifications was implemented in 2016 in which seven holdings were recorded as official suspicions following phone/e-mail contact with the competent authority. Four of those seven holdings received official restrictions before the laboratory results arrived.

There is a national instruction which states that organ samples should be taken from dead suspects and blood from live ones in line with the requirements of point A.4 of chapter IV of the Annex to Commission Decision 2003/422/EC. Official and authorised veterinarians were reminded of the national instruction during training in September 2016 as this had not been followed in two outbreaks in July and August 2016. 5.4.3 Laboratory testing

The system for managing suspicions of ASF on holdings is not being implemented as intended and ASF diagnostic samples are submitted without any involvement or knowledge of the local veterinary office. This might impair the quick containment of the disease in new outbreaks as officials cannot impose restriction of movements before results are available.

Member state response

We have specified the point 10.1 in Decree of Director General of of Veterinary and Food Board No 83 from 01.07.2016 (Contingency plan for ASF), which specifies rules for the management of outbreaks in slaughterhouse. In the seminar/training mentioned in point 2, we also covered the rules for establishing ASF suspicion and notification procedures. In addition Veterinary and Food Board is considering the possibilities how to organise farm inspections in the way that since 01.01.2018, the current authorised veterinarian system can be replaced with controls by animal health inspectors from county veterinary centres. By the Decree of Director General of Veterinary and Food Board No 10 from 13.01.2017 the working party for finding out suggestions and solutions for such a replacement has been formed and they will present their first outcomings by the end of March. Decree for the formation of working party: According to §9 in Infectious Animal Disease Control Act the owner of the animal has obligation to notify sickness or death of the animal. Already today some control checks are done by animal health inspectors and in 2018 all control checks are done by inspectors. With that kind or Pag

The recommendation states as its basis

Veterinary practitioners submit blood samples and organ samples from dead pigs to the official laboratory for ASF testing without informing the local official vets and the holdings may not be subjected to any restrictions or recorded as suspicions.

A special system for notifications was implemented in 2016 in which seven holdings were recorded as official suspicions following phone/e-mail contact with the competent authority. Four of those seven holdings received official restrictions before the laboratory results arrived.

There is a national instruction which states that organ samples should be taken from dead suspects and blood from live ones in line with the requirements of point A.4 of chapter IV of the Annex to Commission Decision 2003/422/EC. Official and authorised veterinarians were reminded of the national instruction during training in September 2016 as this had not been followed in two outbreaks in July and August 2016. 5.4.3 Laboratory testing

The system for managing suspicions of ASF on holdings is not being implemented as intended and ASF diagnostic samples are submitted without any involvement or knowledge of the local veterinary office. This might impair the quick containment of the disease in new outbreaks as officials cannot impose restriction of movements before results are available.

Member state response

ASF We have specified the points 3.1 and 3.3.1 in Decree of Director General e of Veterinary and Food Board No 83 from 01.07.2016 (Contingency plan for ASF) about clinical examination and sampling. Contingency plan is available at http://www.vet.agri.ee/?op=body&id=1150

The recommendation states as its basis

Pig keepers must provide census information on numbers of pigs kept on an annual basis (1st May). There is a requirement for both the seller and the buyer to notify the database within 7 days when pigs move between holdings. There is no requirement for notification when pigs move from a holding to an abattoir which does not comply with the requirements of Article 18(c) of Council Directive 64/432/EEC. 6

In general, the national system for holding registration, animal identification and movement controls provides a solid basis to support ASF-related controls. The fact that movements of pigs to abattoirs do not have to be notified to the national database decreases the amount of information in the database available to the competent authority and makes the forward tracing of pigs difficult.

Member state response

In our opinion the current legislation and regular controls done by of veterinary and Food Board are sufficient to ensure the implementation of Art.18(3) of Directive 64/432/EEC. Estonia has asked European Commission clarifications on the implementation of that article and we have preparedness to change out legislation if the outcome needs that. Page: 4

The recommendation states as its basis

Both farms visited by the audit team had been inspected recently without any non- compliances being reported. One farm had less than 50 cattle in total (dairy cows, calves and heifers), kept tethered when indoors but grazing at pasture at the time of the visit, and produced milk exclusively for direct sale. The other had over 1000 dairy cows kept in loose housing conditions: In the smaller farm the cattle stalls were too short for the length of the animals present but, although both the AV and the County veterinarian agreed with this assessment, neither the County veterinarian nor the AV had reported it as a non- compliance nor required in writing any actions to rectify the problems (which is not in line with the requirements of Article 9 and 54 of Regulation (EC) No 882/2004). This was because the farmer was aware of the issue and had a refurbishing project that was supposed to address it for at least some of the animals but nevertheless had not yet done so at the time of this visit. Bedding was present in the stalls and the audit team noted that the animals did not show significant lesions on their hind legs that would indicate inadequate welfare due to the shortness of the stalls. 10 In the larger farm the housing facilities were in line with requirements, and the cattle showed no signs of inadequate welfare other than some indications of mild lameness. Farm management informed the audit team that lameness was indeed an issue as there was a relatively high incidence of digital dermatitis which they had been addressing (and managing to decrease the trend) but had until now been unable to fully control.

The recommendation states as its basis

Official controls on animal welfare of dairy cattle are performed on a regular basis, based on risk-assessment (see also paragraphs 16 and 17): by County veterinarians on the welfare of calves, in the case of farms with more than six calves; by AVs for all other types of cattle, so all of both dairy and beef cattle of all ages. 8 Or ad-hoc, by County veterinarians: to follow up on reported non-compliances by the AVs who are not empowered to impose sanctions. Due to that, if sanctions are envisaged, any non-compliance with animal welfare requirements reported by an AV must be confirmed by a County veterinarian; or as a consequence of complaints.

County veterinarians informed the audit team that the ad-hoc control focuses in principle on confirming the presence of the reported non-compliance, or the cause of the complaint. A full animal welfare control (which would use the instruction and checklists for County veterinarians that has the complete requirements for cattle instead of only those from Directives 98/58/EC and 2008/119/EC) may be done during these ad-hoc visits but usually only if additional non-compliances are noticed during the visit.

The number of animal welfare non-compliances in dairy farms reported by the AVs and County veterinarians is low: out of 2006 controls in 2013 and 1487 controls in 2013 in cattle farms (dairy and beef cattle) there were respectively 51 (2.5%) and 30 (2%) animal welfare non-compliances reported. Additionally, in the two Counties visited there were almost no complaints related to animal welfare issues in dairy farms within the last three years. Since the regular controls of dairy cattle other than calves are carried out by the AVs and their instructions and checklists do not include the complete cattle requirements (see also paragraph 13), there is no regular verification of compliance with 9 those complete requirements in dairy cattle, other than calves, except in exceptional circumstances.

Member state response

IAD of the Ministry of Rural Affairs has been assessed by Ministry of Finance and complies with the IIA (Institute of Internal Auditors) definition of Internal Auditing, Code of Ethics and Standards from 2010. The external quality assessment has to be carried out at least every five years period. During the next external quality assessment more focus will be given to the requirements based on Article 4(6) of Regulation (EC) No 882/2004 and section 5.4 of the Annex to Commission Decision 2006/677.

The recommendation states as its basis

A training system aimed at ensuring that official staff is able to carry-out its tasks adequately is in place. However, based on the findings noted during the audit, it does not seem to be effective. 5.1.8 Enforcement measures Legal requirements Article 54 of Regulation (EC) No 882/2004. Findings

Member state response

The recommendation has been taken into account. After the audit the workshop-training for all milk hygiene specialists took place 14.09 ­ 15.09.2016 where the referred finding and recommendation were performed and corrective measures designed. Additional training for the staff performing official controls will be organised by the CCA during II quarter of 2017. Effectiveness of the trainings will be verified by the improved internal verification procedure.

The recommendation states as its basis

This establishment was fully approved by the CA on 11 September 2015 as fulfilling all the structural and operational requirements. However, on 14 March 2016, the CA carried out a comprehensive inspection and a list of 15 shortcomings was noted. This list contained among others shortcomings related to Hazard Analysis and Critical Control Points (HACCP), labelling, traceability, cold chain, food contact materials, water quality and other prerequisites.

The audit team visited three small establishments and noted they did not meet all the relevant EU requirements. Two establishments in particular had significant shortcomings related to structure and lay-out (see chapter 5.2.1) Conclusion on registration / approval of FBOs

There is a system in place for approval and registration of establishments. However, the implementation of the approval procedure is not satisfactory as it does not ensure that approved establishments fulfil all the relevant EU requirements.. 5.1.4 Prioritisation of official controls Legal requirements Article 3 of Regulation (EC) No 882/2004. 4 Findings

Nevertheless several shortcomings identified by the audit team, mostly related to approval and pasteurisation procedures/process had not previously been identified by the CAs.

In two of the four counties visited, the official reports did not reflect the non- compliances identified by the audit team in the four establishments visited. The officials in charge of the establishments concerned completed the control checklists without identifying any relevant shortcomings present in the establishments. Also the approval of three establishments visited in these counties had not been carried out correctly (establishments approved without fulfilling all the relevant requirements, see paragraphs 19 and 20)

The audit team noted in particular:- - In two milk processing establishments, none of the lay-out and structural shortcomings had been identified by the CA. Lay-out and structure did not prevent crossing of flows of operations and possible cross-contamination of raw/pasteurised and packed/unpacked products. In one of these establishments, the critical control point for pasteurisation was not properly identified and not properly monitored. In the other establishment, evidence could not be provided to the audit team that the time-temperature combination (67o-69o for 10 minutes) applied by the FBO had an equivalent effect to those indicated in EU legislation for achieving pasteurisation. The CA stated that this equivalency was verified by the FBO by performing an alkaline phosphatase test, however the FBO failed to produce any results of this test. In addition, the audit team noted that the heat treatment process was not continuously monitored by the FBO. - In another establishment the critical control point for pasteurisation had been properly identified but the recorded monitoring procedure was different from the real one. The pasteurisation temperature was much lower than the one described in the HACCP plan. However, this situation did not pose a risk to public health as the initial temperature was sufficiently high. - In another establishment, a similar situation occurred. However, in this instance the audit team noted that the temperature applied by the FBO fell below legal requirements. Evidence that such heated though unpasteurised milk had not been 10 used in the production of dairy products could not be provided to the audit team. The audit team was informed that this situation was caused by a failure of the automatic equipment, and/or the recording system, which had not been noted or assessed by the FBO and not recorded by the CA. - In another establishment the FBO could not provide evidence that the time ­ temperature combination used for pasteurisation met legal requirements. - The size of premises in one establishment, and in particular the number /size of the maturation rooms, were inadequate in relation to the volume of products processed.

In one establishment visited, the flow and space available for crates used for finished products was not satisfactory. Dirty crates were used for packing of products. The CA had identified the problem with storage, but had not drawn any conclusions or made written recommendations for the correction of the problem.

In one establishment, with limited space and with intermediate products exposed to cross-contamination, black mould was noted on wooden support structures in the maturation room.

In two establishments visited, the water sampling plan had, according to the local CA, been approved and is controlled by the Health Board. The FBO had implemented the water sampling in accordance with their plans. However, in both cases the monitoring for chemicals, under this sampling plan, did not cover all the parameters foreseen in Directive 98/83/EC, and in particular acrylamide, vinyl chloride, and bromate. The CA referred to an explanation provided by the Health Board, according to which analyses of these parameters was found to be unnecessary in dairy establishments and as such, these were not required.

In one case, based on the establishment's water consumption, organoleptic and microbiological parameters (check monitoring) should have been checked quarterly and all parameters in Article 5 of Directive 98/83/EC (audit monitoring) annually. Instead, the check monitoring had been carried out by the FBO once a year and the audit monitoring every ten years. The CA and the FBO were unable to explain the reason for this reduced frequency. Conclusion on general and specific hygiene requirements

Official controls for verification of FBOs compliance with the general and specific hygiene requirements are in place. However, the controls are not effective as they are not able to identify significant problems at establishment level. As a consequence the system in place does not satisfactorily verify that the establishments comply with the relevant EU requirements. 5.2.2 Hazard Analysis and Critical Control Points based systems Legal requirements Article 5 of Regulation (EC) No 852/2004 and Articles 4 of Regulation (EC) No 854/2004. 11 Findings

Member state response

The CA would like to explain the background for the referred findings Nos 18 and 20. The procedures for approval of establishments handling food of animal origin are laid down in Decree no 104-2014 of the Director General of VFB. When the ownership of an approved establishment changes, the new food business operator receives a different commercial registration number, then it will be a new food handler for JVIS and the system will give a new approval number. It is possible to keep the first approval number when the county authority decides to keep it. The shortcoming of performance in particular case was presented at the workshop-training for CA milk hygiene specialists 14.09 ­ 15.09.2016. Concerning finding No 63 and recommendation 68 the corrective measures were proposed and agreed during workshop-training for CA milk hygiene specialists 14.09 ­ 15.09.2016. Effectiveness of the trainings will be verified by the improved internal verification procedure.

The recommendation states as its basis

However, in five plans reviewed by the audit team significant risks and corresponding critical control points had not been identified by the FBO and this situation was not noted by the CA (see paragraph 63).

In several cases, the FBO did not follow the procedures as described in the HACCP programme. In particular, for pasteurisation procedures, where a certain amount of unpasteurised milk could go for products supposed to be made exclusively from pasteurised milk. This was not identified by the CA.

In one establishment records on the pasteurisation and the cleaning programme were kept both on paper and on computer. However, the times recorded did not reflect in all cases the action being carried out. Thus, for example, the time of pasteurisation as recorded on paper could be logged as cleaning time in the computer. Based on these records it was impossible to determine if the current activity at any given time was pasteurisation or cleaning. This brings confusion concerning the amount of milk really pasteurised. Conclusion on Hazard Analysis and Critical Control Points based system

The official controls cover the HACCP systems applied by the FBOs. However their effectiveness is compromised as the CA had not identified some non-compliances in the design and implementation of the HACCP-based procedures. As a consequence FBOs who had not identified properly all relevant critical control points were not monitoring all risks associated with production and were not in a position to take appropriate corrective actions when necessary. 5.2.3 Microbiological criteria for foodstuffs Legal requirements Article 4 of Regulation (EC) No 854/2004. Regulation (EC) No 2073/2005 Finding

Member state response

he recommendation has been taken into account. During the post audit workshop-training (14.09 ­ 15.09.2016) the eferred finding and recommendation were performed and corrective measures designed. During further official controls CA Page: 1 port ref. DG(SANTE)/2016-8851-MR of the audit carried out from 27 June ntrols related to the safety of food of animal origin, in particular milk and milk ing to pay special attention to the verification of HACCP systems (especially for pasteurisation procedures) etc. ional training for the staff performing official controls will ganised by the CCA during II quarter of 2017.

The recommendation states as its basis

However there are concerns regarding its effectiveness as the CA was not able to detect some important shortcomings during the official controls, in particular concerning the inaccuracy of own-checks test results transmitted by the laboratory to FBOs, and does not guarantee that appropriate actions are taken by FBOs when non-compliances are detected during the controls. 5.2.7 Animal by-products Legal requirements Article 5 of Regulation (EC) No 854/2004. Articles 21 and 22 of Regulation (EC) No 1069/2009. Findings

Member state response

ecommendation has been taken into account. tely after the audit the CA requested FBO to fulfil their obligations concerning the quality criteria about the samples ults according to the legislation. ring the post audit workshop-training (14.09 ­ 15.09.2016) this opic was under discussion. During future inspections CA is going y special attention to that topic. Page: 2

The recommendation states as its basis

The deficiencies detected by the CAs in relation to compliance with the requirements set out in Article 3 of Regulation (EU) No 931/2011 were confirmed. In addition in the 5 documentation provided for one establishment, discrepancies were found between the quantities of meat in the recipe and the content of the label. Conclusion on official controls on food processing chain

Three of the establishments visited had effective traceability systems in place: In one, the traceability system covered all processing steps and the FBO was able to demonstrate, through different exercises carried out by the audit team that this system was reliable. Two distribution centres/warehouses visited had robust traceability systems in place, allowing them to follow in real time the goods entering and exiting their warehouses. Both companies had in place a system for detecting anomalies in the matching of incoming and exiting quantities of goods. The audit team noted that the CA in charge of the establishments did not carry out physical checks in the storage/distribution areas when evaluating the traceability system of the companies. The CA stated that due to the working hours of the distribution centres, these on the spot checks could 6 not be carried out. When visiting the storage/distribution areas the audit team was able, using goods physically present, to test of the traceability systems of the companies, with satisfactory results. In another establishment, the traceability system in place was partially effective. All data were recorded manually in different sheets/registers. In principle, this system contained all appropriate information to enable tracking of the identity and quantity of all goods produced, received, processed or dispatched from the establishment. In relation to meat produced in the establishment, the FBO was able to demonstrate that the system functioned as intended. However, in relation to meat sourced from another Member State, used for the production of sliced beef hams, some deficiencies were identified: no document had been issued by the cold store as required by Regulation (EU) No 931/2011; the production batch number was not registered at the heat treatment stage and in storage; and, in addition, the quantities of finished product could not be correlated with production data.

In five of the establishments visited, discrepancies in the quantities of meat used in production were identified by the audit team: In one establishment visited, the traceability relating to a product containing minced meat produced from beef and pig meat (data for four different production days were examined). The documentation presented by the FBO could not demonstrate that the quantity of beef meat used was sufficient for the production of the final product (the discrepancy ranged from 2% to 10 %). The product was labelled as containing beef 50%, pig meat 50%. However, in all cases, pig meat constituted more than 50%. The CAs (central and local level) stated that they had never checked that the quantities recorded as being used were sufficient for the daily production. The CA carried out a 7 follow inspection in the establishment. During this inspection, the FBO stated that the deficiency identified was due to the systematic use of pig meat for standardising the production and not a mix of pig and beef meat in the proportions mentioned in the recipe. The CA confirmed that the FBO had taken action to eliminate the deficiency identified and that a follow up inspection would be carried out at a later stage to verify the implementation of the corrective action; In a second establishment, producing dried meat and frozen cubes of cut meat for supply to catering companies, the quantities of meat, as specified on the consumer did not correspond to the production data. The recipe indicated that 279g of beef meat should be used to produce 100g of final product. However, the quantities actually used were frequently less than specified in the recipe (for example 239g. and 262g.) and occasionally more (for example 303g.). The FBO attributed these discrepancies to differences in the quality of meat bought for the process, stating that the specification of 279 gr of meat yielding 100gr of products had been calculated based on real tests regularly carried out. When reviewing the labelling the audit team was informed by the official responsible of the establishment that this non correspondence between the data contained in the recipe and the data on the label had been identified and that follow up action had already been initiated; In a third establishment visited, producing paprika sausages, the representative of the company responsible for traceability controls, had difficulties in describing the system and its documentation. At the end of the evaluation, the conclusion was that production losses "(animal by-product category 3 material) amounted to 16,5%, exceeding the documented FBO's specifications that these losses should not exceed 5 %; In relation to a composite product for which, based on the recipe, the quantity of ingredients used should have resulted in the production of 750 consumers portions, the number of potions produced was 831. As a consequence, the quantities of ingredients mentioned on the label were not accurate. In particular the quantity of meat present in the composite product was less than 10% although the label stated a meat content of 14%. The composition of two other composite products was checked: for one there was a slight discrepancy between the stated (11 %) and the actual (10.7 %) meat content; for the other, the labelled meat content was correct.

FBOs have implemented the "one step back ­ one step forward" principle of traceability. However, official controls have not been fully effective in detecting some significant deficiencies in the traceability systems in place (see paragraphs 31 ­ 32 below).

The significant deficiencies in the controls (both by FBOs and the CAs) over quantities of meat and ingredients have resulted in inaccurate and misleading labelling of products supplied to consumers

Member state response

iled checklist for checking that the quantities of meat and other edients actually used in production match the recipe and the label be prepared during second quarter of 2016 and will be implemented 017.

The recommendation states as its basis

Three of the establishments visited had effective traceability systems in place: In one, the traceability system covered all processing steps and the FBO was able to demonstrate, through different exercises carried out by the audit team that this system was reliable. Two distribution centres/warehouses visited had robust traceability systems in place, allowing them to follow in real time the goods entering and exiting their warehouses. Both companies had in place a system for detecting anomalies in the matching of incoming and exiting quantities of goods. The audit team noted that the CA in charge of the establishments did not carry out physical checks in the storage/distribution areas when evaluating the traceability system of the companies. The CA stated that due to the working hours of the distribution centres, these on the spot checks could 6 not be carried out. When visiting the storage/distribution areas the audit team was able, using goods physically present, to test of the traceability systems of the companies, with satisfactory results. In another establishment, the traceability system in place was partially effective. All data were recorded manually in different sheets/registers. In principle, this system contained all appropriate information to enable tracking of the identity and quantity of all goods produced, received, processed or dispatched from the establishment. In relation to meat produced in the establishment, the FBO was able to demonstrate that the system functioned as intended. However, in relation to meat sourced from another Member State, used for the production of sliced beef hams, some deficiencies were identified: no document had been issued by the cold store as required by Regulation (EU) No 931/2011; the production batch number was not registered at the heat treatment stage and in storage; and, in addition, the quantities of finished product could not be correlated with production data.

In a number of establishments, deficiencies were found in relation to the allocation and tracking of batch numbers throughout the production process. In one establishment, quantities of meat delivered for production were not allocated to specific production batches but to the whole day's production leading to difficulties in determining the source of the meat in each product. In another establishment, some batch numbers were not used in a consecutive way but simultaneously with others batches. In these cases the registered data could not demonstrate what quantities of what batch was used in a given production. In this establishment also, in a number of cases, the quantities of meat registered as remaining at the end of the production day did not match with the quantities present at the start of the production taking into account the quantities of meat used during the production. Some of these cases could be explained by adding quantities of meat registered in a different line of the register. In one case, where bar code scanning of half carcasses was used to create batches entering the cutting room, the system could not automatically identify when a carcass was double scanned. Although possible, controls to detect double scanning were not carried out manually at the end of each production day.

In five of the establishments visited, discrepancies in the quantities of meat used in production were identified by the audit team: In one establishment visited, the traceability relating to a product containing minced meat produced from beef and pig meat (data for four different production days were examined). The documentation presented by the FBO could not demonstrate that the quantity of beef meat used was sufficient for the production of the final product (the discrepancy ranged from 2% to 10 %). The product was labelled as containing beef 50%, pig meat 50%. However, in all cases, pig meat constituted more than 50%. The CAs (central and local level) stated that they had never checked that the quantities recorded as being used were sufficient for the daily production. The CA carried out a 7 follow inspection in the establishment. During this inspection, the FBO stated that the deficiency identified was due to the systematic use of pig meat for standardising the production and not a mix of pig and beef meat in the proportions mentioned in the recipe. The CA confirmed that the FBO had taken action to eliminate the deficiency identified and that a follow up inspection would be carried out at a later stage to verify the implementation of the corrective action; In a second establishment, producing dried meat and frozen cubes of cut meat for supply to catering companies, the quantities of meat, as specified on the consumer did not correspond to the production data. The recipe indicated that 279g of beef meat should be used to produce 100g of final product. However, the quantities actually used were frequently less than specified in the recipe (for example 239g. and 262g.) and occasionally more (for example 303g.). The FBO attributed these discrepancies to differences in the quality of meat bought for the process, stating that the specification of 279 gr of meat yielding 100gr of products had been calculated based on real tests regularly carried out. When reviewing the labelling the audit team was informed by the official responsible of the establishment that this non correspondence between the data contained in the recipe and the data on the label had been identified and that follow up action had already been initiated; In a third establishment visited, producing paprika sausages, the representative of the company responsible for traceability controls, had difficulties in describing the system and its documentation. At the end of the evaluation, the conclusion was that production losses "(animal by-product category 3 material) amounted to 16,5%, exceeding the documented FBO's specifications that these losses should not exceed 5 %; In relation to a composite product for which, based on the recipe, the quantity of ingredients used should have resulted in the production of 750 consumers portions, the number of potions produced was 831. As a consequence, the quantities of ingredients mentioned on the label were not accurate. In particular the quantity of meat present in the composite product was less than 10% although the label stated a meat content of 14%. The composition of two other composite products was checked: for one there was a slight discrepancy between the stated (11 %) and the actual (10.7 %) meat content; for the other, the labelled meat content was correct.

All the establishments visited had recall procedures in place. Some of them were regularly carrying out recall exercises. Evaluating these exercises was part of the detailed annual evaluation carried out by the CAs. Inadequate management of allocation and tracking of batch numbers impedes rapid and targeted recall procedures (see paragraph 26 above). 8 Conclusions on official controls on FBO obligations

FBOs have implemented the "one step back ­ one step forward" principle of traceability. However, official controls have not been fully effective in detecting some significant deficiencies in the traceability systems in place (see paragraphs 31 ­ 32 below).

Inadequate allocation and recording of batch numbers hinders the implementation of rapid and targeted recall procedures.

Member state response

ining for relevant inspectors will be organized during 2016 and 2017 to enhance their awareness of the topic.

The recommendation states as its basis

The CCA devised and implemented a system for official controls which is risk based and in line with the requirements of Regulation (EC) No 882/2004. Official controls are carried out as required and results are properly documented. A well-organised system for training of official control staff is in place. Nevertheless taking into account all deficiencies identified (see later sections), its effectiveness could be improved. 5.2.2. Implementation of official controls

The CA provided information in a professional, uniform and structured way concerning the tracing to the establishments involved for all 12 randomly chosen samples. This information covered : tracing (one step back ­ one step forward); quantities of meat and products thereof and other ingredients used; labelling; use of additives. The CCA concluded that all samples were traceable and compliant with the labelling and use of additives. Only minor deficiencies in the implementation of Regulation (EU) No 931/2011 have been detected. The audit team analysed the documentation relating to these 12 cases and concluded that, for one case, the documentation did not cover all steps in the process. For the remaining eleven files, the documentation provided was complete in relation to tracing (one step back ­ one step forward) of meat and products thereof and other ingredients used, and in relation to labelling and use of food additives.

The deficiencies detected by the CAs in relation to compliance with the requirements set out in Article 3 of Regulation (EU) No 931/2011 were confirmed. In addition in the 5 documentation provided for one establishment, discrepancies were found between the quantities of meat in the recipe and the content of the label. Conclusion on official controls on food processing chain

Three of the establishments visited had effective traceability systems in place: In one, the traceability system covered all processing steps and the FBO was able to demonstrate, through different exercises carried out by the audit team that this system was reliable. Two distribution centres/warehouses visited had robust traceability systems in place, allowing them to follow in real time the goods entering and exiting their warehouses. Both companies had in place a system for detecting anomalies in the matching of incoming and exiting quantities of goods. The audit team noted that the CA in charge of the establishments did not carry out physical checks in the storage/distribution areas when evaluating the traceability system of the companies. The CA stated that due to the working hours of the distribution centres, these on the spot checks could 6 not be carried out. When visiting the storage/distribution areas the audit team was able, using goods physically present, to test of the traceability systems of the companies, with satisfactory results. In another establishment, the traceability system in place was partially effective. All data were recorded manually in different sheets/registers. In principle, this system contained all appropriate information to enable tracking of the identity and quantity of all goods produced, received, processed or dispatched from the establishment. In relation to meat produced in the establishment, the FBO was able to demonstrate that the system functioned as intended. However, in relation to meat sourced from another Member State, used for the production of sliced beef hams, some deficiencies were identified: no document had been issued by the cold store as required by Regulation (EU) No 931/2011; the production batch number was not registered at the heat treatment stage and in storage; and, in addition, the quantities of finished product could not be correlated with production data.

In five of the establishments visited, discrepancies in the quantities of meat used in production were identified by the audit team: In one establishment visited, the traceability relating to a product containing minced meat produced from beef and pig meat (data for four different production days were examined). The documentation presented by the FBO could not demonstrate that the quantity of beef meat used was sufficient for the production of the final product (the discrepancy ranged from 2% to 10 %). The product was labelled as containing beef 50%, pig meat 50%. However, in all cases, pig meat constituted more than 50%. The CAs (central and local level) stated that they had never checked that the quantities recorded as being used were sufficient for the daily production. The CA carried out a 7 follow inspection in the establishment. During this inspection, the FBO stated that the deficiency identified was due to the systematic use of pig meat for standardising the production and not a mix of pig and beef meat in the proportions mentioned in the recipe. The CA confirmed that the FBO had taken action to eliminate the deficiency identified and that a follow up inspection would be carried out at a later stage to verify the implementation of the corrective action; In a second establishment, producing dried meat and frozen cubes of cut meat for supply to catering companies, the quantities of meat, as specified on the consumer did not correspond to the production data. The recipe indicated that 279g of beef meat should be used to produce 100g of final product. However, the quantities actually used were frequently less than specified in the recipe (for example 239g. and 262g.) and occasionally more (for example 303g.). The FBO attributed these discrepancies to differences in the quality of meat bought for the process, stating that the specification of 279 gr of meat yielding 100gr of products had been calculated based on real tests regularly carried out. When reviewing the labelling the audit team was informed by the official responsible of the establishment that this non correspondence between the data contained in the recipe and the data on the label had been identified and that follow up action had already been initiated; In a third establishment visited, producing paprika sausages, the representative of the company responsible for traceability controls, had difficulties in describing the system and its documentation. At the end of the evaluation, the conclusion was that production losses "(animal by-product category 3 material) amounted to 16,5%, exceeding the documented FBO's specifications that these losses should not exceed 5 %; In relation to a composite product for which, based on the recipe, the quantity of ingredients used should have resulted in the production of 750 consumers portions, the number of potions produced was 831. As a consequence, the quantities of ingredients mentioned on the label were not accurate. In particular the quantity of meat present in the composite product was less than 10% although the label stated a meat content of 14%. The composition of two other composite products was checked: for one there was a slight discrepancy between the stated (11 %) and the actual (10.7 %) meat content; for the other, the labelled meat content was correct.

The significant deficiencies in the controls (both by FBOs and the CAs) over quantities of meat and ingredients have resulted in inaccurate and misleading labelling of products supplied to consumers

Member state response

ll involved inspectors have been informed about the results of the t. Workshop-training for involved inspectors will be organized during 2016 and the food labelling samples collected during the FVO udit will be used during the workshop-training. Page: l

Member state response

g Information regarding derogation from prohibition of despatch of live pigs from Part II to other areas in Estonia has been talked onia. over and reminded in meetings with veterinary inspectors who will forward information to authorized veterinarians.

Member state response

cy The information regarding derogation from prohibition of n despatch of live pigs from Part I to other Member States and third countries has been talked over and reminded in meetings with veterinary inspectors who will forward information to authorized veterinarians.

Member state response

ulation of Ministry of Agriculture No 179 from 23.11.2004 was updated and updated regulation came into force on 10.08.2015. Biosecurity rules in all pig farms will be checked in August 2015. CA has updated control procedures for checking of biosecurity rules (Decree of Director General No 144 from 11.08.2015)

Member state response

Herd register requirements will be reminded and checked in August 2015 when all pig farms will be physically inspected by veterinarians. On national level central ARIB database is available to all veterinary inspectors and veterinarians.

Member state response

by Estonia is aware of the requirement but it is not possible for CA to Page: 1 Report ref. DG(SANTE)/2015-7563-MR of the Audit carried out from 02 March lth controls in relation to African swine fever ch involve third parties (hunters). as issued decree 1-4.1/14/481 from s added to preliminary questionnaire of the hat all wild boars shot in areas listed in Part II ion Implementing Decision 2014/709) are erinary centre.

Member state response

eterinary and Food Laboratory confirmed that starting from does 01.07.2015 in PCR testing the pooling will be done only among mestic pigs and will not exceed 3 samples. Page: 2

The recommendation states as its basis

VFB has drafted a new risk classification of ABP/DP operators applicable from 5 May 2014. The rating goes from very high risk operators (to be inspected four times per year) to very low risk operators (to be inspected only "as necessary"). In this context, VFB distinguishes between traders operating only in the domestic market (classified as very low risk) and traders operating in the EU market (re-classified as low risk). Carriers have been re- classified as low risk and have to be inspected once every three years. VFB and CVC officials stated that those traders classified as very low risk (i.e. to be inspected "as necessary") would only be inspected if a fraudulent activity is suspected or a complaint is received (see paragraph 14). This is not in line with Article 45(1) of Regulation (EC) No 1069/2009.

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 related to the traceability of ABP/DP throughout the chain. However, the fact that those traders operating only in the domestic market are not subject to regular official controls, limits the ability of the competent authority to ensure that ABP/DP handled by them are channelled and used correctly.

Member state response

Decree of Director General No 78 from 05.05.2014 states the principles of supervision and minimum frequency of regular controls in the area of ABP and its derived products. With that decree the previous instructions were updated and the procedure of the control of the persons trading with ABP and its derived products was specified, also few new principles for routine official controls were established. For example establishments that receive products from other member states or send products to other member states are inspected least once a year; transporters and retailers are inspected at least once in 3 years period. Also routine official inspections are carried out in all establishments where ABP and derived products are handled at national level. We think that at the moment the rules for the official controls are optimal for covering all ABP operators, whose processes pose any significant risks, with regular supervision. Also the minimum frequency for those controls is enough to assure optimal supervision over ABP operators. By the time of this audit this new decree had been in force for a short time and therefore we have no proofs for audits carried out according to this new d

c Decree of Director General No 74 from lar 06.04.2015 states the new principles of supervision and minimum frequency of ular official controls in the area of ABP and its derived products. According to Decree of Director General No 74 from 06.04.2015 the traders operating only in the domestic market are classified as low risk and are inspected at least once in 3 years period . Principles of minimum frequency official controls are described in point 3 in the "Principles of supervision, minimum frequency and reporting of regular official controls in the area of ABP and its derived products" (Loomsete kõrvalsaaduste ja neist saadud toodete valdkonna järelevalve ja aruandluse korraldamise põhiprintsiibid, järelevalvesagedus ja aruande vorm") adopted by Decree of Director General No 74 from 06.04.2015. 06_04_2015_KK_nr_ 74.pdf

The recommendation states as its basis

Officials from two CVC visited, declared that the notification of arrival of consignments of products referred to in Article 48(3) consisted only in opening the TRACES document received on-line to check that the the data it contained were correct (e.g. name, address and approval/registration number of the plant of destination). However, physical checks in the plant of destination only took place when the plant was subject to general inspection in accordance with the ABP/DP control plan. The audit team noted that, although the control part in TRACES had been completed for most of the consignments, the time elapsed between the arrival of consignments and the completion of the control part varied from a few days to almost two years. In addition, sometimes, several consignments arriving within several months were controlled in TRACES the same day. These arrangements are not in line with Article 48(3) of Regulation (EC) No 1069/2009. 5.2.2 Operators' obligations regarding identification, transport and traceability

Official controls largely ensure that a) operators comply with the relevant rules, and b) officials are able to follow the flow of ABP/DP through the chain if necessary. In addition, the audit team noted good practices by certain officials, who undertook initiatives to better take into account the risk of diversion or misuse of ABP/DP. Nevertheless, the otherwise robust system ensuring that ABP/DP are only used or disposed of in permitted ways is weakened by i) the fact that the said initiatives cannot be considered an integral part of the system for official controls, and ii) gaps in verifying the arrival of consignments of ABP/DP traded in from other Member States.

Member state response

This subject was discussed in the seminar/training held on 05.06.2014. Written instructions are under development, deadline red is 01.07.2015.

This subject was discussed in the the competent authorites on 4 May 2015 petent Authorities of Estonia on 09 January 2015 in response to Report ref. DG(SANTE)/2014- 21 May 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products. seminar/training held on 05.06.2014. In n addition new procedure has been drawn up d which covers the area regarding control checks of consignments at the arrival at the intended destination (Decree of Director General No 26 from 26.01.2015). Principles of the checks of ABP are described in point 4. 28_01_2015_KK_nr_ 26.pdf

The recommendation states as its basis

Checks which take into account the risk that ABP/DP may be diverted or misused are not systematically done, as this is not included in VFB guidelines, instructions and check-lists for CVC inspectors. This is not in accordance with Article 3 of Regulation (EC) No 882/2004. However, the audit team visited two processing plants where the inspectors were performing, on their own initiative, specific checks (in the form of reconciliation of quantities) to ensure this diversion or misuse did not happen. This is considered good practice. 5.2.3 Actions in case of non-compliance

Member state response

is subject was discussed in the seminar/training held on .06.2014. Written instructions are under development, deadline is 01.07.2015. Page: 1 December 2014 t ref. DG(SANCO)/2014-7066 -MR of a/an audit carried out from 13 cts (ABP) and derived products. Page: 2

This subject was discussed in the y seminar/training held on 05.06.2014. Decree Director General No 74 from 06.04.2015 also includes more specific instructions about cial controls, for example instructions about PAP checks in the case of export. Also the instructions about ABP/DP traceability checks to rule out possible improper use of ABP/DP. Principles of the checks in case of export are described in point 6 in the "Principles of supervision, minimum frequency and reporting of regular official controls in the area of ABP and its derived products" adopted by Decree of Director General No 74 from 06.04.2015. Principles of the traceability checks are described in the "Guidelines for filling the check lists for controls of establishments the competent authorites on 4 May 2015 petent Authorities of Estonia on 09 January 2015 in response to Report ref. DG(SANTE)/2014- 21 May 2014 in order to evaluate the traceability of animal by-products (ABP) and derived products. ABP and mseid eid käitleva a te in the cation use ja idelines General

Member state response

According to the guidance documentation of Regulation (EC) No 852/2004 p. 3.2 and 3.7 we have considered that gutting of fish on fish farms as primary production. At the moment there are 2 fish farms in the list gutting fish as primary product. The amount of gutted fish in these farms falls under the small quantities and this fish is marketed only in Estonia.

Member state response

The Decree No 9 of 15.01.2014 will be amended accordingly after on we have done appropriate risk assessment, deadline January 2015.

Member state response

The Decree No 9 of 15.01.2014 states already that the landing s sites should be controlled once every 2 years. The Decree will be ion amended with the statement that landing sites should be inspected when landing operations are taking place, deadline January 2015.

Member state response

Joint inspections and continuous training for CVC inspectors will be organized by the VFB during this year. During trainings we are ncentrating on the control of HACCP plans of approved t establishments, HACCP principles and etc. Additional controls during regular inspections by CVC inspectors will be carried out at FBOs where described non-compliances ccurred.

Member state response

Present comprehensive check-list for fish processing establishments includes a point which has to be controlled by on inspectors: Self-control plan includes that food business operators must carry out an organoleptic examination of fishery products which must ensure that fishery products comply with any freshness criteria. Distribution of FP takes place according to valid freshness Page: 1 Ref. Ares(2014)2444879 - 23/07/2014 ort ref. DG(SANCO)/2014-7132 -MR of an audit carried out from 10 June lace governing the production and placing on the market of fishery products . ategories (853/2004 Annex III, part VIII, Chapter V, p A). heck-list will be improved according to Regulation (EC) No 54/2004 Chapter II, part A of Annex III in August 2014. uring next inspections of FBOs attention will be paid by CVC nspectors to control if the random organoleptic checks have done t all appropriate stages.

Member state response

otification letter to CVC inspectors will be sent by VFB in ugust 2014 to check self-control plan if the histamine sampling s carried out according to Regulation (EC) No 2073/2005. uring the next regular inspections by CVC inspectors more ttention will be paid to control operators' own checks of istamine sampling.

Member state response

otification letter to CVC inspectors will be sent by VFB in ugust 2014 to control during the next regular inspections if the ffective measures described already in self-control plan are mplemented to prevent Baltic Sea fish which may contain ioxins, dl- and ndl-PCBs above the MLs from being placed on he market. oint inspection/training for relevant CVC inspectors will be rganized by VFB. During training more attention will be paid ow to control if the implemented measures carried out by FBO re sufficient and adequate etc. elevant guideline for CVC inspectors has been composed in ugust 2014 by VFB.

Member state response

he guidance document for fish establishments will be reassessed ended respectively. Notification letter to appropriate fish stablishments will be sent by VFB in September 2014 to categorize oversized fish declared as animal by-products unfit for uman consumption according to Regulation (EU) 1069/2009. uring next regular inspections by CVC inspectors more attention ill be paid to this topic. Page: 2 Ref. Ares(2014)2444879 - 23/07/2014 ort ref. DG(SANCO)/2014-7132 -MR of an audit carried out from 10 June lace governing the production and placing on the market of fishery products .

Member state response

of VFL comments: 1. Method validation: the recovery has been calculated during the validation using the FAPAS PT materials (no other available) and has been taken into account within the expanded uncertainty. Only in case if the result exceeds the limit the correction using recovery will be considered, but only when it is outside the 95-110 %. This remark will be added to the appropriate quality document which will be a part of the SOP. 2. In the frame of the internal quality control the following procedures are already used systematically: R-card using the results of routine samples(filled in at least once in a quarter) x-card using the results of the FAPAS control material (T27101) standard addition All these procedures are documented in the quality documents. Page: 3

Member state response

Risk based inspection procedures will be worked out by the end of 014. Risk based inspection procedures will be implemented and regular checks will be carried out from January 2015.

Risk based inspection procedures will be worked out by the end of 2014. Risk based nspection procedures will be implemented and regular checks will be carried out from January 2015.

Member state response

There will be two training days organised in September 2014 for ctors responsible for official food contaminants controls, here they will be given an overview of the food contaminants vered with the Regulation 1881/2006. This training will be arried out by food toxicologist from Estonian University of Life Sciences. Continuous up to date information will be sent to inspectors via e- mails and issues related to food contaminants controls will continue to be one issue discussed at annual meetings with inspectors. In June 2014 an annual meeting of inspectors carrying out controls in meat processing establishments will be held and one topic will be PAH in smoked meat products.

There will be two training days organised in September 2014 for inspectors responsible for official food contaminants controls, where they will be given an overview of the food contaminants covered with the Regulation 1881/2006. This training will be carried out by food toxicologist from Estonian University of Life Sciences. Continuous up to date information will be sent to inspectors via e-mails and issues related to food contaminants controls will continue to be one issue discussed at annual meetings with inspectors. In June 2014 an annual meeting of inspectors carrying out controls in meat processing establishments will be held and one topic will be PAH in smoked meat products. ons received 27/8/2014 etent Authorities of Estonia on 11 June 2014 in response to Report ref. DG(SANCO)/2014-7166 - arch 2014 in order to evaluate controls of contaminants in food of plant origin.

Member state response

plan assessment will be controlled during assessing CVC inspectors.

HACCP plan assessment will be controlled The assessment of HACCP based during assessing CVC inspectors. procedures, including the evaluation of FBOs own controls of contaminants will be discussed during regular annual meetings with inspectors and also when assessing inspectors work the evaluation of HACCP plan assessment will be one focus point.

Member state response

e Continuous training of staff taking samples on the requirements in the Regulations about the sampling methods and sampling weights for samples taken for the analysis of different contaminants. The laboratories will continuously monitor at the reception of samples that the weight/quantity of the sample is adequate as stipulated in the Regulations and in the case there is a deviation, Page: 1 2014 port ref. DG(SANCO)/2014-7166 -MR of a/an audit carried out from 18 food of plant origin. there must be a note on the sample cover letter why inspector has not taken the quantity stipulated in the legislation, otherwise the sample will be rejected at the reception.

ontinuous training of staff taking samples The instructions for inspectors given in the the requirements set in the Regulations decree for contaminants sampling will be about the sampling methods and sampling amended with additional note that the weights for samples taken for the analysis of inspector is responsible for ensuring that the different contaminants. aggregate samples taken are corresponding to the required weight of the aggregate The laboratories will continuously monitor at sample stipulatedin the relevant EU Regulation, otherwise the sample will be the reception of samples that the rejected at the reception in the laboratory. weight/quantity of the sample is adequate as Deadline: beginning of year 2015 stipulated in the Regulations and in the case there is a deviation, there must be a note on Information from Agricultural Research the sample cover letter why inspector has not Center (laboratory): taken the quantity stipulated in the legislation, 1. The laboratory has purchased a new otherwise the sample will be rejected at the scale for weighting the samples in reception. the reception. 2. The sample receptionist informs the laboratory (quality manager/head of lab) ab

Member state response

Recovery and expanded measurement uncertainty will be reported all test protocols as required by Annex II, p. 4.4 of Regulation EC) No 401/2006 (mycotoxins), Annex to Regulation (EC) 1882/2006 (nitrates).

overy and expanded measurement tainty will be reported in all test Information from Health Board Laboratory: tocols as required by Annex II, p. 4.4 of · Procedure "Reporting the test ulation (EC) No 401/2006 (mycotoxins), results" in Chapter 19 of the Quality ex to Regulation (EC) 1882/2006 Manual of HB Laboratory has been trates). amended by adding a requirement for reporting recovery and expanded measurement uncertainty in test protocols of official control samples for food contaminant analyses.

Member state response

During assessment of CVC inspectors work more emphasis will be put on the assessment of the organisation and performance of food contaminants controls by CVC inspectors. The assessment of inspectors work will continue to have two parts: first the documentary checks and second a joint inspection to at least one food processing establishment, where actual control of the FBO takes place and the real life performance of CVC inspector can be assessed. Page: 2

During assessment of CVC inspectors work e emphasis will be put on the assessment the organisation and performance of food ons received 27/8/2014 etent Authorities of Estonia on 11 June 2014 in response to Report ref. DG(SANCO)/2014-7166 - arch 2014 in order to evaluate controls of contaminants in food of plant origin. contaminants controls by CVC inspectors. The assessment of inspectors work will continue to have two parts: first the documentary checks and second a joint inspection to at least one food processing establishment, where actual control of the FBO takes place and the real life performance of CVC inspector can be assessed.

Member state response

CCA is continuing with informing of population trough media. eaflets for travellers are available on each border crossing int. The posters are presented at border crossing points. The CCA informed companies which are managing with international conveyance of passenger

Member state response

the training for customs officials will be carried out on II half of 4 Page: 1

Member state response

d Food Board makes amendments in the procedures and will be organized in 2013.

10/06/2013: ary and Food Board makes amendments the procedures and guidelines. An education/training will be organized in . 25/07/2013: e documents will be amended by the end of and will be applied in 01/01/2014.

Member state response

19 of Regulation (EC) No 183/2005 the authority activities according to Article 9 i.e activity of the stage of rocessing, producing, storage, transport, distribution of feed, cing for own use. legal acts of the registration of FBO in connection with activity field is under consideration.

013: cording to Article 19 of Regulation (EC) No 2005 the authority shall register the activities according to Article 9 i.e activity of the stage of production: processing, producing, storage, transport, distribution of feed, import, producing for own use. Changing the legal acts of the registration of FBO in connection with Page: 1 dated Action Plan received from CA 25 July 2013 - and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3093 nia on 10 June in response to Report ref. to evaluate measures in place for the identification of t Authority under the producer of ing the e already in our ssors). ormation ut drying of t information. 7 Statutes for f Feedingstuffs tion will come ted date). The at new feed fy about drying Page: 2 dated Action Plan received from CA 25 July 2013 - and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3093 nia on 10 June in response to Report ref. to evaluate measures in place for the identification of roposed by the Competent Authority

Member state response

oard prepares amendments in internal guidelines ification of measures on cross contamination with nspectors will be held in 2013. ith feed business operators will be held before the end of Page: 1 Action Plan received from CA on 10 June 2013 CO)/2013-6740-MR of an audit carried out ards and management risks along the feed chain oposed by the Competent Authority

13: ary and Food Board prepares ts in internal guidelines inspectors for verification of measures on ntamination with ry medicines. of inspectors will be held in 2013. ing with feed business operators will before the end of 2013. 13: ments will be amended by the end of will be applied in 01/01/2014.

Member state response

d prepares amendments in internal guidelines verification of measures on homogeneity. tors will be held in 2013. eed business operators will be held before the end of

13: ry and Food Board prepares nts in internal guidelines spectors for verification of measures on ity. of inspectors will be held in 2013. ing with feed business operators will before the end of 13: ments will be amended by the end of Page: 3 dated Action Plan received from CA 25 July 2013 - and can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3093 nia on 10 June in response to Report ref. to evaluate measures in place for the identification of Proposed by the Competent Authority d will be applied in 01/01/2014. 06/2013: rinary and Food Board prepares ents in internal guidelines r inspectors for verification of measures on ing of undesirable ces. g of inspectors will be held in 2013. ting with feed business operators will before the end of 013: uments will be amended by the end of d will be applied in 01/01/2014. 06/2013: erinary and Food Board prepares endments in internal guidelines r inspectors for verification of measures on samples. g of inspectors will be held in 2013. ting with feed business operators will before the end of 2013. 013: Page: 4 dated Action Plan received from CA 25 July 2013 - and can be found at: http://ec.europa.eu/food/fvo/rep_detail

Member state response

d prepares amendments in internal guidelines rification of measures on monitoring of undesirable tors will be held in 2013. eed business operators will be held before the end of

Member state response

Board prepares amendments in internal guidelines rification of measures on keeping samples. tors will be held in 2013. eed business operators will be held before the end of Page: 2 Action Plan received from CA on 10 June 2013 CO)/2013-6740-MR of an audit carried out ards and management risks along the feed chain ed by the Competent Authority

Member state response

Board prepares amendments in internal guidelines HACCP principles. rs will be held in 2013. d business operators will be held before the end of Page: 3

Member state response

oiduamet (VTA) korrigeerib olemasolevaid FMD, BT, ioonplaane, arvestades viidatud õigusaktide

Member state response

me, Leedu ja Läti pädevate ametkondade poole, riikide spetsialiste viidatud õigusaktide nõuetele i töösse. Tänaseks oleme saanud Lätist ja Soomest mõttelist nõusolekut väljendavad vastused. ide koosseisude kindlaksmääramiseks: 31.12.2013

Member state response

orraldab 2015.aastal hädaolukorra seaduse alusel lukorra lahendamise õppuse. Nimetatud õppuse üheks eriti ohtliku loomataudi korral tegutsemist. planeerime FMDga seotud reaalaja õppuse, litakse maakondade valmisolekut taudikoldesse raldame 2013. aasta lõpus SKK ja SAK teemalise

Member state response

aastast on VTA kasutanud maakondlike oolt teostatud ametlike kontrollide nõuetekohasuse protseduuri (kinnitatud VTA peadirektori 21.12.12 Page: 1 SANCO)/2013-6781-MR of an audit carried out elation to animal health, including provisions on the Action Proposed by the Competent Authority 4). Tuginedes sel aastal teostatud auditeerimiste veendunud, et on eelpool nimetatud protseduur luliselt tõhusamalt kontrollisüsteemi hinnata, astavusi tuvastada ning ka kiiresti kohaldada vastavaid gevusi, mistõttu arvame, et selle protseduuri jätkuv isavaks meetmeks nii viidatud kõrvalekallete kui ka vältimiseks edaspidi.

Member state response

u direktiivi 92/35 artiklile 14 ja direktiivi 92/119 elle lisale I vastav labor (NRL) hobuste aafrika katku 2014

Member state response

of the stricter national rules, as required C) No 1099/2009 on 26. August 2013

Member state response

ientific contact point , as required by Article 20 2009, are available on the following ee/?op=body&id=942

Member state response

next scheduled inspection (the first half of not eliminated, the CA will implement all et the parameters of electrical waterbath ers specified in Annex I of Regulation

Member state response

h a meeting at the beginning of 2014. The ties provides to local competent authorities a cting the inspections to ensure that official nts of Article 6 of Regulation (EC) No

Member state response

a meeting at the beginning of 2014. The es provides to local competent authorities a Page: 1 6825-MR of an audit carried out of animals at the time of slaughter g the inspections to ensure that official s in ensuring compliance with the rules as required by Article

Member state response

An official letter was sent to DG SANCO TRACES team on 31.12.2013 with appeal to help to find the solution to this problem 02012013_Problem_ with_warehouses_in_TRACES_European_Commission.pdf Page: 1

03.01.2014 An official letter was sent to DG SANCO TRACES team on 1.12.2013 with appeal to help to find the solution to this problem 02012013_Problem_ with_warehouses_in_TRACES_European_Commission.pdf 03.06.2014 Establishing of new procedures and special topic in BIP manual with deadline 31.12.2014 Page: 1

Member state response

The special training for BIP inspectors related to African swine fever was carried out on 26- 27 November 2013. The training was based on D 2013/426/EU and all requirements established by this regulation were discussed.

Member state response

This issue was discussed in meeting between Veterinary and Food d Board and Tax Customs Board at 10th of December of 2013. At of the Luhamaa BIP the posters are moved to more appropriate place. Currently the posters are presented in the Narva border crossing point but as this border crossing point is under reconstruction then the posters will be displayed to most appropriate place after the finishing of reconstruction at the end of 2014.

Member state response

at This issue was discussed in meeting between Veterinary and Food ion Board and Tax Customs Board at 10th of December of 2013. Tax and Customs Board brought to attention of officials working on the border to seizure and destroying of prohibited products. The issue is described in special instruction for customs officials, which is in force from October 2009.

Member state response

the The BIP inspection check lists will be overviewed and the special box will be added on 1st half of 2014. Inspections of BIPs on 2014 are including verification of the effectiveness of the controls laid down in Regulation (EC) No 206/2009 and Decision 2013/426/EU. Page: 1

Member state response

going to notify Commission services national legislation during next year.

Member state response

of meat there was carried out training on it results. In order to increase efficiency of uring 2013 will be carried out training for . r checks are done to ensure that a spray of machinery and not at the birds.

Member state response

ict of interest (to prevent AVs from performing the animals coming from farms which are clients if signed by every AV will be amended by the end of Page: 1

Member state response

eeps gathering information continuously. y attending closely to the developments and States. Estonia mostly depends on marketing ants (either they want to sell MBM as SI or f compounds and their minimum levels .

ine and confirm the list of acceptable compounds Board shall keep on gathering information tor closely to the developments and progresses in to the decree No 10 of 16th January 2012): not mixed with acceptable components, it is as SI only for a farm which does not keep farmed r on-the-spot risk assessment that SI will be used r farm and there are no risks of feeding animals with naccessible by any other farmed animals. The o market MBM as SI in ready-to-sell packages of weight for a farm which does not keep farmed deline with the complete list will be confirmed at the end of January 2013.

Member state response

talked about the general requirements and control for the officials of animal health. rol of following the feed ban requirements aluate possible cross-contamination are Page: 1

sold in packaging 50 and 1000 kg bags and stered and approved operators are send by the o feed inspector. e improves the risk assessment procedure for the . Working sheets for the control of following nts and cleaning of vehicles to evaluate possible being worked out. Page: 1

Member state response

be Additional notification will be sent to the relevant fish establishments as well to retail shops to strengthen the HACCP system to ensure that enough effective measures are implemented to prevent Baltic Sea fish h may contain dioxin, dl- and ndl-PCBs above maximum level. The notification will be sent no later than the end of the May 2012. Amended HACCP assessment checklist for official controls in fish establishments as well as in retail shops will be implemented in the IV quarter of 2012. An additional workshop-training for relevant inspectors will be organized by the VFB in the III quarter of 2012 to enhance their awareness of the topic. Effectiveness of the training will be verified by the internal verification procedure (based on the Decree of Director General 11.01.2012 No 6). Page: 1

Member state response

will continue to organize trainings he staff performing official controls with the focus on assessment of HACCP procedures. The assessment of beling of allergens will be a subject of discussion and updating the edge on the annual meetings with inspectors during next year.

Member state response

ll continue work in reaching and CA will contact with the food olving the representatives from the business sector during the first business sector to encourage the half-year of 2012. lopment of national guides to good ce for hygiene. CA will work on finding ways to use the experience and know-how of other Member States to facilitate the development of national guides.

Member state response

It is a general requirement stated in national Food Act for all FBO-s to have self-control plan for lementing HACCP principles and Page: 1 mpetent Authority 29/02/2012 bmitted by the Competent Authorities of Estonia on 05 January in response to Report ref. arried out from 24 to 28 October 2011 in order to assess the official control systems in place for food bottled water Action Proposed by the Competent Additional comments by CA Authority CA will continue to carry out checks to ensure all FBO-s are aware of this requirement and follow it. In case of noncompliance appropriate action is taken.

Member state response

CA will continuously carry out CA has in its guides to FBOs of evaluation of the situation concerning how to draw up a self-control plan ntation of HACCP principles taken into account the flexible FBO-s and taking into account the approach to the implementation of knowledge CA will carry on HACCP principles according to the work to set out common position how EU guidance document. A separate litate the implementation of guides has been worked out for e approach to the implementation establishments which sell/store of HACCP principles in certain food food that does not need cool businesses. storage and/or packed food which needs cool storage and/or packed ice-cream and/or serve coffee, tea and other hot drinks of same kind. These guides are for businesses where all the possible risks can be handled through application of prerequisite programs. In these Page: 2 mpetent Authority 29/02/2012 bmitted by the Competent Authorities of Estonia on 05 January in response to Report ref. arried out from 24 to 28 October 2011 in order to assess the official control systems in place for food bottled water Action Proposed by the Competent Additional comments by CA Authority cases it can be conside

Member state response

CA will work out documented procedures to ensure that the method of mpling used in the context of official ng will comply with relevant Community rules by the end of first uarter of 2012. Page: 4 mpetent Authority 29/02/2012 bmitted by the Competent Authorities of Estonia on 05 January in response to Report ref. arried out from 24 to 28 October 2011 in order to assess the official control systems in place for food bottled water Action Proposed by the Competent Additional comments by CA Authority

Member state response

CA will continuously foresee in its cedures that the results of obiological testing are correctly assessed against criteria laid down in Reg. (EC) No 2073/2005, if such criteria exists for analyzed food category in a stage this food sample was taken. Next year in the frames of evaluating the work of inspectors CA will focus on carrying out inner checks to audit sampling procedures and assessment of sampling results by the inspectors. Page: 5