Ireland

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Independent cold stores handling dairy products requiring temperature-controlled condi- tions are only registered and not approved by the CA, as required by Article 4 of Regu- lation (EC) No 853/2004. The DAFM representatives stated that currently 15 cold stores fall under such conditions and are subjected to risk-based official controls.

Contrary to the EU legislation, cold stores handling dairy products requiring tempera- ture-controlled conditions are not subjected to approval requirements of Article 4 of Regulation (EC) No 853/2004.

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Cattle were correctly identified, whilst in the goat farm more than 50% of the adult ani- mals and almost the totality of the younger ones were not tagged or identified by an al- ternative method. Moreover, no actions had been taken by the private veterinarian con- tracted by the farmer, or by the private veterinarian in charge of animal health testing, to remedy the situation. This is not in line with the requirements in Article 14 of Commis- sion Implementing Regulation (EU) 2021/520. The DG SANTE audit team requested further information on this regard, which was provided in the action plan of the CA.

The lack of proper identification of goat animals jeopardises both the reliability of rec- ords of medical treatments and of the animal health tests. 10

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With respect to the assessment of critical controls points, as part of the validation procedure, official controls overlooked their absence and/or their incorrect designation, contrary to requirements of Article 29 of Regulation (EC) No 1069/2009, Chapter III point G in Annex IV and point 1 of Section 2 of Chapter I of Annex XVI to Commission Regulation (EU) No 142/2011.

With respect to validation on processing parameters (for method 7 in continuous system) and validation checks, official controls overlooked that operators lacked supporting evidence to demonstrate the capacity of the processing method to reduce identified hazards to a level which does not pose any significant risks to public and animal health. This is not in line with requirements for validations laid down in Section 2 in Chapter I of Annex XVI to Regulation (EU) No 142/2011.

Regarding ABP processing plants, while official controls satisfactorily verify compliance with hygiene and infrastructural requirements, the audit team found that such controls overlooked incomplete or incorrect validation of processing methods by the operators. This limits the capacity of official controls to verify whether the processing methods can reduce relevant hazards to a level which does not pose any significant risks to public and animal health.

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Control measures for positive cases: Animal movement control, quarantine, containment, and hygiene practices.

Control of movements of animals between farms with different disease status.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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The audit team examined documents accompanying consignments of ABP destined for the manufacture of petfood. On the evidence provided, the team inferred that the official controls in some of the meat-producing establishments supplying raw material to the petfood industry were ineffective given the observed non-compliances with the requirements for commercial documents and health certificates, identification and categorisation of ABP, and the collection and transport of ABP. Examples included: a. Contrary to the requirements set out in Article 21(2) and (3) of Regulation (EC) No 1069/2009 and Article 17 and Chapter III of Annex VIII to Regulation (EU) No 142/2011, consignments were either shipped without the commercial documents/health certificates that should accompany the consignments during transport, or with incomplete (incorrectly filled-in) documents. Missing data in these documents included the approval numbers of the dispatching and/or the receiving establishment/plant, the category of ABP, information on the species of origin of the ABP and the intended use of the ABP. b. Contrary to the requirements of Article 21(1) of Regulation (EC) No 1069/2009 and Article 17 and Chapter II of Annex VIII to Regulation (EU) No 142/2011, the consignments of ABP dispatched to petfood plants were not appropriately identified and notably, the obligatory warning sentence for the category of ABP describing its permitted use was missing on the containers holding the ABP. c. Rules for classification of ABP were not followed, resulting in incorrectly categorised ABP being dispatched to ABP processing plants supplying derived products to the petfood industry (see finding 44.a). 5.2.3.2 Official controls in ABP plants and petfood manufacturers

In the petfood plants, the audit team examined the operators' compliance with the requirements regarding commercial documents and health certificates, identification, the collection and transport of ABP and traceability and compared what they saw with what 9 was recorded in the inspection reports. The reports omitted the following non- compliances: a. For the manufacture of petfood, operators accepted ABP arriving either without or with incomplete commercial documents/health certificates (see finding 36.a). In particular, the documents accompanying consignments of ABP destined for the production of raw petfood did not contain information demonstrating that the ABP consisted of exclusively Category 3 material (sub-category defined in Art.10(a), (b)(i) and/or (ii) of Regulation (EC) No 1069/2009). b. Operators also used ABP that arrived in packaging or in containers which were not properly identified (i.e., concerning the category of ABP and the warning sentence which were missing) (see finding 36.b).

The audit team also noted that as regards the overall hygiene, cleanliness and maintenance of the plant equipment, the reports of the official controls indicated that these aspects were compliant, in marked contrast to what the audit team encountered in the establishments. It found (i) dirty containers used for collection of ABP resulting from the plant operations, (ii) dirty crates and racks used for the handling of ABP destined for thermal treatment and (iii) dirty chambers used for thermal treatment.

With regard to the operators' written procedures based on HACCP principles, the reports of the official controls did not indicate any particular issues, whereas the audit team noted that: a. Some petfood operators had in place HACCP-based procedures that were generic and not reflective of the practices taking place in the plant. For example, whilst the transport temperature for arriving ABP was considered as a critical control point (CCP), it was not monitored by the operator and the storage temperature limit which would trigger an alarm was at a much higher temperature than the limit established as a CCP. b. In all of the petfood plants visited, the HACCP-based procedures were deficient with respect to the categorisation of the ABP present in these plants. Whilst the plants generated some Category 2 material, operators collected, stored and dispatched all ABP as Category 3 material, contrary to requirements laid down in Articles 7 and 9(g) of Regulation (EC) No 1069/2009. With one exception, the operators dispatched to ABP processing plants approved for Category 3 material (and producing processed animal protein, also destined for the manufacture of petfood), ABP which they considered to be Category 3 material, even though this consisted of a mixture of Category 2 and Category 3 materials or partly decomposed Category 3 material.

With regard to the official assessments of the operators' own-checks, in some of the petfood plants, the inspection reports did not record non-compliances identified by the audit team: a. Sampling for Salmonella and Enterobacteriaceae did not follow the appropriate sampling protocol ­ the operator collected one instead of five samples. 10 b. Notwithstanding the above, the operators also incorrectly interpreted the examination results when determining the compliance of the sampled batch of petfood, contrary to the requirements laid down in point 5 (dogchews) and point 6 (raw petfood) of Chapter II of Annex XIII to Regulation (EU) No 142/2011. For instance, the operators did not consider a result with three or more samples with a bacterial count (Enterobacteriaceae) between 10 and 300 colony forming units (cfu) in 1 gramme (dogchews) or between 500 and 5,000 cfu in 1 gramme (raw petfood) as non-compliant. Only results with bacterial counts higher than 300 or 5,000 cfu respectively were considered non-compliant. c. There was a mismatch between the examination results on microbiological standards and the information recorded for the produced batches of petfood. While the operator had results of all sampled production batches, some results could not be linked to any of the production batches, because these were not recorded in the production records.

The one ABP plant visited which was processing Category 3 material and supplying derived products (processed animal proteins of mixed species) to the petfood industry was subject to bi-annual controls (see finding 30) and daily controls were performed by the DAFM official who is present in this particular plant on a daily basis (see finding 24). The reports of these controls indicated that the plant was compliant. However, the audit team identified numerous non-compliances related to the categorisation of ABP. The overall cleanliness and hygiene in the plant was poor as was the maintenance of the processing equipment.

With respect to the categorisation of ABP, the audit team noted that Category 2 material was being used for production of mixed processed animal proteins: a. ABP from slaughterhouses arriving as Category 3, contained Category 2 material such as (i) digestive tracts with their contents, (ii) animals' heads with attached plastic eartags, (iii) animal tissues mixed with plastic and paper and (iv) by- products in a state of decomposition. b. Category 2 material originating in the processing plant was recycled into the Category 3 processing line. This Category 2 material consisted of (i) the sludge collected from water traps, (ii) ABP from another line processing material of poultry origin, and rejected due to the presence of foreign bodies, and (iii) pieces of ABP recovered from the floor and derived products (processed animal proteins) which had spilled out and was then collected from the floor.

The issues on incorrect categorisation of ABP identified in the finding above were also seen in the 2018 audit report (DG SANTE 2018-6334) and on which a recommendation (#4) was made. The actions taken by DAFM have not been effective given the recurrence of the issue.

Whilst official controls are performed on the ABP operators supplying the petfood industry and those manufacturing petfood, they are ineffective, as evidenced by the numerous non-compliances identified by the audit team in establishments deemed to be compliant by the competent authority. The fact that these issues had not been identified in the context of the regular supervisory activities or in the DAFM internal audit of the sector, additionally raises concerns about the operation of the official control system in this sector. Furthermore, some of the non-compliances were identified in the previous Commission audit, indicating that the measures taken by the competent authority to address them were ineffective. Collectively, these findings undermine official 12 assurances that operators involved in petfood production in Ireland comply with EU requirements.

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The audit acknowledged that all elements needed for an effective official control system are in place, but it was not always effective at plant level. The Department has noted the specifically referenced findings and conclusion on which this recommendation is based. With that in mind the Department has initiated actions to ensure that these matters are successfully addressed and that this is sustained going forward. ons taken to ensure effectiveness of official controls 1. Oversight Group - A High-Level Oversight Group has been Q3 2024 established which will be chaired by the Chief Veterinary Officer of the Department, to monitor and ensure implementation of, and reporting on, the agreed action plan in response to this audit report and to ensure enhanced levels of communication within the control system. 2. Verification System - DAFM are in the process of developing Q3 2024 a new system of verification inspections which will remain in place going forward and which will be subject to review after Q2 2025. All petfood and Category ( Cat) 3 rendering plants will receive a verification inspection before the end of 2024, and at least one further verification inspection in the first half

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Sampling of imported fresh meat covered sampling at two seaport BCPs only. Contrary to the requirements of point 3.3 (a) of part A of the Annex to the EU Decision, the two airport BCPs designated for imports of fresh meat were not included in the sampling plan. In 2021 and 2022, a small number of consignments were received at Dublin Airport. These consisted of a small number of boxes and were considered by the DAFM as possibly high value food samples. It could not be established if any of the consignments were eligible for sampling.

A very limited number of samples were taken at the seaport BCPs in 2021 and 2022. This number was well below the minimum numbers set out in the EU Decision. According to the DAFM, among other things, the following reasons contributed to that low number: a) The relevant SOPs advised that i) only packed meat could be sampled, and ii) samples were to be taken only if they could be sent to the laboratory in their original sealed packaging. This excluded some commercial presentations, such as bulk consignment with loose cuts of meat or whole carcasses (7,8). This exclusion is not (6) In their response to the draft report, the competent authorities noted that the SOP for sampling of meat at retail has been amended to include sampling of loose meat. (7) The DAFM stated that aside from being considered unpacked meat, whole carcasses were also excluded from sampling because of health and safety concerns (for frozen meat) and the risk of damaging a high value product. (8) In their response to the draft report, the competent authorities noted that the SOP for sampling of meat at BCPs has been amended to include sampling of loose packed meat. 10 in line with the relevant provisions of point 3.3 (a) of part A of the Annex to the EU Decision and EFSA technical specifications. b) The complexities derived from Brexit. These included i) the Trade Control and Expert System - New Technology (TRACES-NT) did not capture consignments from the United Kingdom before it became a third country ii). Brexit caused a very substantial increase in the consignments of products of animal origin intended for human consumption presented to Dublin Port BCP, iii) specific type of mixed consignments which made identifying the eligible consignment and product at documentary checks and on presentation for inspection very resource intensive, and iv) peak BCP workloads and resource requirements, inspecting United Kingdom origin consignments, as multiple ferries arrive within short time periods. Conclusions on sampling

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in the EU Decision, and this implementation is largely satisfactory. However, the exclusion of unpacked meat at BCPs and the exclusion of small BCPs from the sampling plan negatively affects the representativeness of the data.

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The audit team identified a designation gap concerning the competencies on public health controls for aquaculture farms that are not formally assigned in the service contracts from FSAI to MI or DAFM. According to MI, they are the CA for the implementation of aquatic animal health controls and have no role in public health. This designation gap is not in line with Article 4 of Regulation (EU) 2017/625.

The MI documented procedures for aquaculture farms are designed for fish health controls and not for public health. Nonetheless, the current checks for biosecurity in fish health broadly cover the public health requirements for primary production (e.g. hygiene and disinfection, waste removal, staff training, excessive mortality etc.). However, in the absence of dedicated public health procedures (e.g. checklists), from a cursory review of documentation the audit team could not readily verify to what extent public health issues are taken into account during controls nor of the obligation to do so.

The CAs are designated for the performance of official controls throughout the production chain, except for public health controls at aquaculture farms. Consequently, in the controls in the aquaculture area there is a reliance on controls that are designed and carried out primarily for animal health purposes.

Medlemsstatens svar

Response of 28/08/2023: Satisfactory lly Assessment of the response of 28/08/2023: Article The FSAI notes the and accepts the d recommendation. The proposed measures are deemed ontrols satisfactory to address the recommendation Since receiving the recommendation, the once effectively implemented. FSAI has: Your services are kindly invited to provide, · Met with the Sea-Fisheries Protection once fully developed and implemented: (SFPA) Authority and the Marine Institute The new scheme of delegation, highlighting (MI) to discuss the recommendation. the changes, and including the link to the official publication. · Hosted a meeting with SFPA, MI and the Confirmation that the relevant services Department of Agriculture, Food and the contracts have been amended. Marine (DAFM) to begin the process of resolving the issues raised. As a result of these initial meetings, the decision has been made to prepare and put in place a scheme of delegation, consistent with the requirements of Chapter III of Regulation (EU) 2017/625, the Sea-Fisheries and Maritime Jurisdiction Act 2006, and the Food Safety Authority of Ireland Act 1998. Further consideration and elaboration of the issues will be requir

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According to FSAI, extensive training was provided in 2016 to DAFM officials responsible for cold stores, to address the 2014 audit report findings, but there is no training plan. An induction training for newcomers is in place. It consists of a 200 hours "mentoring programme" provided by a senior official and general training, which includes a ten-hour module for cold stores. However, the audit team noted that the training records provided do not include any reference to fishery products requirements. The DAFM officials interviewed (newcomers and seniors officials) were not knowledgeable on basic requirements applicable to fishery products. This situation was acknowledged by DAFM representatives. This is not in line with Article 5(4) of Regulation (EU) 2017/625.

The gaps in the training and knowledge on fishery products of DAFM officials responsible for performing controls in stand-alone cold stores, combined with the lack of requirements/instructions for fishery products, has led to the absence of official controls on key requirements for fishery products in such establishments.

According to DAFM inspectors, they never check and or ask the operator to check the core temperature of the fishery products. One cold store operator had a "goods intake procedure" setting a maximum temperature of -15°C for frozen products, but without setting corrective actions for products not reaching this temperature. This is not in line with Section VIII, Chapter VII (2), and Chapter VIII (1)(b) of Annex III to Regulation (EC) No 853/2004. DAFM inspectors were not aware of these requirements. According to the cold store representative, frozen fish received at any temperature above -15°C is accepted and undergoes blast freezing.

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ing Response of 28/08/2023: adequate for In collaboration with FSAI & SFPA, DAFM Assessment of the response of 28/08/2023: d, in will ensure that all inspectors carrying out The response addresses partially the official controls in cold stores will receive recommendation. Considering the content of adequate training regarding the relevant requirements for fishery products and the finding No.7 and despite the extensive operations performed, in line with Article 5 (4) of Regulation (EU) 2017/625. training provided in 2016 to DAFM officials, please provide an updated response including the following: · Details on the training to be Trilateral discussions have taken place provided to the DAFM officials . Please clarify: between FSAI, DAFM and SFPA to · The criteria that DAFM will use to formulate a training plan and timeframe to select the officials attending the training. address the deficiencies identified. · If all the DAFM's officials working in those Cold Stores (approved to receive The FSAI Training Programme provided to fish), will be included in the training. Page: 2 submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2023-7716 of arch 2023 in

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DAFM checklists or inspectors' instructions for cold stores do not include references to the basic requirements for fishery products for the activities performed in such establishments. DAFM acknowledged this situation. This is not in line with Article 12 of Regulation (EU) 2017/625.

The gaps in the training and knowledge on fishery products of DAFM officials responsible for performing controls in stand-alone cold stores, combined with the lack of requirements/instructions for fishery products, has led to the absence of official controls on key requirements for fishery products in such establishments.

According to DAFM inspectors, they never check and or ask the operator to check the core temperature of the fishery products. One cold store operator had a "goods intake procedure" setting a maximum temperature of -15°C for frozen products, but without setting corrective actions for products not reaching this temperature. This is not in line with Section VIII, Chapter VII (2), and Chapter VIII (1)(b) of Annex III to Regulation (EC) No 853/2004. DAFM inspectors were not aware of these requirements. According to the cold store representative, frozen fish received at any temperature above -15°C is accepted and undergoes blast freezing.

The audit team noted several boxes of smoked salmon labelled "refrigerated 0-4°C". The expiry date on the label was exceeded by five months at the time of the visit. According to DAFM and SFPA the product was received chilled, and blast frozen at the owner's request.

The salmon's producer sets a use-by period of 28 days for refrigerated smoked salmon. If the salmon is later frozen, they would relabel the product, modifying the batch code to add 9 "defrosted" and indicating a new use-by period of 21 days after thawing. In the meanwhile, the product is kept in the cold store with the old label, even if the date has expired, with no indication of the maximum period that it can be kept frozen.

The actions taken by DAFM and SFPA officials to investigate this finding, at the audit team's request, were satisfactory. According to the information provided by the CA, the operator did not avail of a validated shelf study to demonstrate compliance with the relevant microbiological criteria set out in Annex I of Regulation (EC) No 2073/2005 (supporting the 21 days period for the use-by date of the thawed smoked salmon, after being frozen and defrosted). 5.3.1.6 Freezer and factory vessels

The DAFM official controls in stand-alone cold stores do not cover the relevant requirements for fishery products. 5.3.2 Official controls of fishery products Legal requirements Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

According to the DAFM officials, they regularly take samples at the request of the DAFM laboratories. However, in the cold store visited, they have never carried out controls on fishery products, taken samples for analysis or checked the specific labelling requirements for fishery products. This is not in line with Article 70 and Chapter I of Annex VI to Regulation (EU) 2019/627. Conclusion on official controls of fishery products

While official controls of fishery products include all the relevant elements, these controls are generally applied throughout the supply chain, with the exception of stand-alone cold stores under DAFM responsibility.

Medlemsstatens svar

Response of 28/08/2023: Satisfactory DAFM in conjunction with SFPA will review Assessment of the response of 28/08/2023: on the documented procedures to include The proposed measures are deemed ing to relevant requirements for fishery products in satisfactory to address the recommendation line with Article 12 of Regulation (EU) once effectively implemented. Page: 3 submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2023-7716 of arch 2023 in order to evaluate the food safety control systems in place governing the production and Action Proposed by the competent authority Commission services' assessment of the competent authority's response 2017/625, before end of Q1 2024. Your services are kindly invited to provide, rage when available: res DAFM inspection forms, check sheets and A list with the DAFM's updated documented associated guidance notes will be updated procedures. 53 prior to the March 2024 rollout of training An example, of controls over freezing in and will be available for use in cold stores by cold stores, sending the check sheet, nd 56. inspectors upon completion of training. instructions and guidance provided to inspectors. Followin

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SFPA officials are skilled and knowledgeable of the relevant requirements concerning fishery products. The induction training for new recruits is comprehensive and includes training in HACCP. Additional training is provided (sometimes in collaboration with FSAI) through "fish-bites" (short, online training), training refreshments, updates and specialised training, including HACCP. However, the training provided was not effective (3) Country profile available at the following link: https://ec.europa.eu/food/audits-analysis/country/profile/details/IE. 3 concerning the assessment of the applicable temperature requirements included in the HACCP as Critical Control Points (CCPs) (see paragraph 34).

Officials are generally knowledgeable and avail of documented procedures that are fit for purpose. However, gaps in knowledge, combined with some SFPA documented procedures setting temperatures for fish that are not in line with EU rules, has an impact in the effectiveness of the official controls.

In three of four establishments visited, the operators set CCPs with a critical limit not in line with the EU requirements, which had been accepted by the inspectors. A critical limit of -12°C was set for the reception of frozen products by the supplier and a critical limit of 8 +4°C for fresh and chilled products, the latter being in line with the instructions for official control (see paragraph 8).

According to the inspectors interviewed, when an operator presents an assessment and sets the critical limit, the CAs accept it. In three of four establishments visited, the officials stated that they have not reassessed the critical limits set by the operator to verify that they comply with Article 3, point 5(a) of Regulation (EU) 2019/627.

The official controls do not consistently ensure that operator HACCP plans are assessed correctly with regard to their setting of critical limits for chilled and frozen fishery products. 11

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als in Response of 28/08/2023: Satisfactory es SFPA has commenced a review of Assessment of the response of 28/08/2023: operational procedures such as Standard The proposed measures are deemed operating procedures and checklists for the satisfactory to address the recommendation hilled inspection of vessels, land -based once effectively implemented. rols. establishments and transport. Follow up action from the review will be to incorporate Your services are kindly invited to provide, as necessary specific questions around when available: A list with SFPA's updated documented temperature controls and validation of these procedures . An example of checklist/instruction/guidance Page: 4 submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2023-7716 of arch 2023 in order to evaluate the food safety control systems in place governing the production and Action Proposed by the competent authority Commission services' assessment of the competent authority's response checks. This review and update will be completed by Q1 2024. highlighting the changes regarding the temperature for fresh chilled and thawed Refresher training on Auditing Seafood products. Pre

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DAFM, SFPA and MI have the required powers to access on-land premises. Regarding vessels, SFPA shall be informed of any vessel calling to a port with a four-hour prior notice and can perform ad-hoc visits regarding their fisheries competencies. SFPA's inspectors make case-by-case arrangements with the vessel's owner to perform an announced public health inspection. The SFPA has the power to inspect vessels when berthed.

SFPA performs inspections, generally with prior notice, which should cover all the relevant requirements during the year. In the two SFPA regions visited, 84% of inspections in one and 80% in the other, in 2022, were performed with prior notice. Up to 64% of the operators only received inspections with prior notice. The audit team identified 4 operators in different SFPA regions that underwent prior notice inspections for a period of 3 years 7 (covering up to 9 inspections) without having been "duly justified", as required by Article 9(4) of Regulation (EU) 2017/625.

According to officials, the main reason for prior notice inspections is to guarantee that the premises are in operation and those responsible are available, especially in remote areas. However, the establishments visited (mainly subject to prior notice) were not in remote locations, had predictable working shifts and the responsible staff (e.g. the quality manager) was present on a daily basis during operation. 5.3.1.2 Primary production fishing vessels

According to officials, the inspections take place with prior notice after consultation with the owner, usually when the vessel is not in operation. Inspections are generally avoided during landing to reduce the extra burden on operators and, in some regions, are clustered during low season. The audit team noted unannounced inspections at the time of berthing, despite the fact that operators did not consistently provide the four-hours prior notice of arrival.

The majority of SFPA inspections are carried out with prior notice, despite the fact that this is contrary to their own instructions and that unannounced visits could be readily performed on land-based establishments. This can negatively impact the effectiveness of official controls.

Medlemsstatens svar

Response of 28/08/2023: Satisfactory ly egulation The SFPA Food Safety Control Plan specifies Assessment of the response of 28/08/2023: the requirement for unannounced inspections The proposed measures are deemed as per Article 9(4) of Regulation (EU) satisfactory to address the recommendation 2017/625. During Quarter 4 2023 the SFPA once effectively implemented. will review and update the Food Safety Your services are kindly invited to provide, Control Plan to reinforce the requirement for when available: Page: 5 submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2023-7716 of arch 2023 in order to evaluate the food safety control systems in place governing the production and Action Proposed by the competent authority Commission services' assessment of the competent authority's response unannounced inspections. The updated Food Safety Control Plan In addition, a reminder will be issued to regarding unannounced inspections, with operational staff on the requirement as per the changes highlighted. Food Safety Control Plan that inspections are Summary table of the dashboards (broken by performed without prior notice. Operational ports), with the dif

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The SFPA provided examples of approvals, in which conditional approvals were granted providing the premises met, at minimum, the structural and equipment conditions. The maximum period of 3 plus 3 months (6 plus 6 months for vessels) was not exceeded.

The audit team noted from approval reports of freezer vessels (glazing prawns) that the relevant requirements concerning potable water were not consistently assessed during approval. The inspectors requested clarification from SFPA's headquarters in relation to the assessment of potable water, but at the time of the audit, a final decision was not available.

The two vessels visited produced glazed frozen prawns and applied additives by immersion into a tank with additives. In both vessels, the approval procedures, as implemented, covered the application of additives. However, the report of the approval inspection did not document the assessment of the FBO's validation process for additive application; the inspectors acknowledged that they do not assess this and relevant equipment during approval. (see paragraph 46).

SFPA applies satisfactorily their documented approval procedures. Nonetheless, and contrary to Article 148 of Regulation (EU) 2017/625, there are gaps in the application of these procedures for freezer vessels, notably related to the assessment of certain operators' validation procedures (use of additives). 6

In two of four establishments visited under SFPA control, some activities included in the approval certificate had been discontinued up to 9 years ago and were not covered by the operators' HACCP. In another case, a new activity, not fully covered by the HACCP plan, had been included in the approval certificate. This is not in line with Article 5 of Regulation (EC) No 852/2004.

In the two freezer vessels visited, the dipping procedure documented in the HACCP plan was not the one applied in practice by the operative responsible.

Concerning the dipping procedure for additives, the audit team identified the following shortcomings, which were not detected by the inspectors during the visit, in at least one of the vessels: · The timer used to control the immersion bath did not work properly; · The indicated time for prawn immersion is the minimum to be used but a maximum time is not specified; · There was not a clear indication of the level to which the tank should be filled according to the dipping procedure. Therefore, the actual concentration of additive used for dipping is unclear; · Evidence of calibration of the scales was not in place; · The operator's explanation of the quantity of additive used and how it was weighed was inconsistent and was not according to the procedure; · The dipping procedure does not consider the maximum quantity of prawns that can be dipped in one bath, before discharging it; · The dipping procedure was established for a water temperature different to the standard range of temperature of the seawater in the fishing grounds. 10 The elements described above, can be a source of variability in the final concentration of additives. They are not sufficiently addressed during the assessment of the validation process carried out by the operator. In these circumstances, they may significantly influence the outcome of the dipping step and in some circumstances may lead to sulphites levels in excess of the EU limits, as detected in six RASFF alerts. This source of variability is mitigated by monitoring programmes, undertaken (in the cases seen, by the associated co-operatives) with satisfactory results.

The two freezer vessels visited were of a generally sound infrastructure. In the first vessel SFPA officials conducted an announced inspection and shortcomings of limited relevance were detected. In the second vessel, an unannounced inspection was carried out. In this case, the inspector identified a number of relevant shortcomings (i.e. the fish hold had a strong fish odour and was dirty and mouldy, with exposed wooden pallets, the concrete floor was poorly maintained, the ice machine and the pipes were rusty, and stored ice was not clean, the blast freezer presented a layer of 20 centimetres of ice on the floor containing prawns. The inspector thoroughly followed the checklist and guidance, identifying the shortcomings. However, a similar range of shortcomings had been identified in a previous inspection to this vessel (unannounced) but the audit team did not find evidence of shortcomings correction. Conclusions on official controls of production and placing on the market

In operators under SFPA control, the approval conditions, in particular concerning HACCP, are not consistently kept under review with the operation of the premises.

In some cases, the controls carried out by the inspectors on the freezing vessels do not verify that the operators follow their own procedures concerning the use of additives and that these procedures have being properly validated. As a consequence, and despite the monitoring programmes in place, there is a risk that the EU limits for additives may be exceeded.

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Response of 28/08/2023: Satisfactory ss ith SFPA has commenced conducting a full Assessment of the response of 28/08/2023: is review of FBO's and what activities they are The proposed measures are deemed cial approved for. This review will be completed satisfactory to address the recommendation ) of by end Q3 2023. The approval certificates once effectively implemented. will be amended accordingly by end Q4 50 2023. Update internal procedures including Your services are kindly invited to provide, when available: 46 and relevant guidance documents and inspection An example of a checklist, instruction and checklists to ensure ongoing verification of guidance, regarding the control of the FBO activities. Associated training on this activities approved, highlighting the changes. Summary table, with the number of FBOs will be delivered in Q4 2023. approved for fishery products, number of FBOs with a review of the activities during 2024, number of incidences detected and actions taken (if any). Page: 6

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The audit team noted that, among various risk criteria used by DAFM to plan their controls, the results of the water monitoring carried out for the purpose of Article 8 of Directive 2000/60/EC of the European Parliament and of the Council are not taken into account. This is not in line with Article 24(2)(a) of the OCR. In a position paper2 from 2019, regarding pesticides in drinking water developed by Ireland's Health Service Executive and Environmental Protection Agency, a reference is made to a total of 19 individual pesticides that account for all pesticide exceedances in drinking water reported in Ireland by the end of 2018. While at the time of development of that position paper the levels of pesticides found in Irish drinking water had not presented an 2 https://www.epa.ie/publications/compliance--enforcement/drinking-water/advice-- guidance/EPA_HSE_JPP_Pesticides_DrinkingWater---FINAL.pdf 8 appreciable risk to human health, it is stated in the position paper that any exceedance of EU parametric limits is undesirable and must be managed proactively.

The CA considers most of the relevant risks when developing the plan of controls on the marketing and use of PPPs, but the results of monitoring activities carried out for the purpose of Article 8 of Directive 2000/60/EC, as required by Article 24(2)(a) of the OCR are not taken into account, this oversight potentially compromises the protection of water bodies.

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Action: 1. The Competent Authorities (CA's) procedures manual has been updated to ensure that results of Ireland's Water Framework Directive (WFD) monitoring programme which is conducted by the Environmental Protection agency (EPA) are taken into account. Please see separate attachment 1 - a copy of the relevant section of the procedures manual communicating the updates. Timeline: Completed

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ction: 1. In May 2024, inspectors will receive a briefing on the most recent changes and to ensure consistent inspections across the divisions. (Date to be confirmed). Procedure documents will be updated accordingly as necessary. Timeline: By 31st May 2024

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omment: The CA maintains a record of all Professional Users (PU's) in a register in accordance with S.I. 155 of 2012 and as required by Article 10(2) of Regulation (EU) 2017/625 . This register captures information about the Page: 1 2024 ef. DG(SANTE) 2023-7839 of the audit carried out from 08 May 2023 to ion Products Proposed by the competent authority and deadline by it will be completed PU such as usage category ­ Farmer/Grower, Landscaper, Local authority, Golf club, Forester etc. The CA also maintains a comprehensive contact list of relevant businesses where professional use PPPs may be used. (e.g. Landscapers, Local authorities, Golf courses etc.) by registered PU's. : The CA updates its contact list based on any new available data and has included procedures to continue to review the list annually as part of the official control planning. The annual inspection and sampling plan will continue to be risk based as required by Article 9(1) of Regulation (EU) 2017/625, taking information from the PU register and updated list. Please see separate attachment 2 - a copy of the relevant section of the 2024 inspection and sampling plan showing reference to the annual review of the lis

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In the context of Ireland's comments in relation to this finding, an e- information system has been designated by the CA, to facilitate notification to DAFM of consignments subject to requirements of Article 37 (4a) of Commission Delegated Regulation (EU) 2019/2124 and which provides for verification of compliance by operators with all provisions of Article 37 regarding re-entry to the EU following transit through a Third Country. The system provides information to the CA at the BCP via the process detailed below. - Customs system (NCTS) allows operators to provide the information required in Article (4a)(b). - By way of an automatic download from NCTS into DAFM's AFIT system, DAFM officials are provided with a copy of all T2 transit declarations submitted to NCTS for goods with a destination of EU re-entry through a BCP in Ireland. - This enables DAFM officials to assess the information provided by operators as required by Article (4a)(c)(i) - DAFM systems of communication with Revenue enable operators to be informed through the Revenue Ferry Vehicle Management System when consignments need to be presented for additional checks in accordance with Article (4a)(c)(ii). A more detail

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The audit team evaluated 17 CHED-Ps for consignments of goods of animal origin entering the EU and noted that all consignments were subject to documentary checks, and identity checks, in line with Article 49(1) of the OCR. The identity checks were either full identity checks or seal checks in line with Article 3(2) of Regulation (EU) 2019/2130. The CHEDs had, with only minor exceptions, been correctly completed and finalised in line with Article 56 of the OCR.

The system in place ensures that consignments of animals and goods entering the EU are presented for official controls, and that controls with few exceptions are generally carried out in line with guidelines and documented procedures and Union legislation.

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Since the audit has taken place, DAFM has implemented corrective actions aimed at overcoming the unique and specific logistical challenges faced in performing physical inspections on RoRo consignments destined for retail establishments containing small quantities of various products, to meet the baseline frequencies prescribed by Regulation (EU) 2019/2129 The measures taken at Dublin Port to achieve compliance with the requirements of Regulation (EU) 2019/2129 include, but are not limited, to the following: - Assignation of a dedicated OV to oversee and monitor the performance of physical checks; - Frequent (at least monthly) review of physical check frequencies with comparison to 2019/2129 baseline frequencies to identify trends and rectify shortcomings; - OVs specifically assigned between 06.00 and 22.00 to perform physical checks only; - Targeted selection of containers/consignments whose commodities have physical check frequencies as per TRACES NT are either below or not more than 5% above the baseline frequency in Annex I of CIR (EU) 2019/2129; - Targeted selection of containers with multiple consignments of interest to allow efficiency of physical checks; - Page: 2 f report r

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The system in place ensures that consignments of animals and goods entering the EU are presented for official controls, and that controls with few exceptions are generally carried out in line with guidelines and documented procedures and Union legislation.

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uivalent DAFM acknowledges the finding and expresses its commitment to taking effective corrective actions. These actions will ensure that all official certificates are presented in their original form and thereafter kept by the CA for appropriate duration. The corrective and measures will comprise several steps, including reminding business operators that that original official certificates must be presented to the competent authorities of the Border Control Post (BCP). Additionally, DAFM will undertake a review of its existing procedures for ensuring the presentation of official certificates to ensure compliance with Article 50(1) of Regulation (EU) 2017/625, Article 11 and Annexes II and IV to Regulation (EU) 2019/1793. These corrective actions will be fully implemented by September 1, 2023. In the interest of consistency and coordination, the Department will collaborate with other state authorities, such as the Health Service Executive (HSE), with respect to consignments that are subject to dual control by both agencies. HSE EHS will develop a procedure to ensure that the original official certificates, which are required to accompany consignments of food of non ­ animal origin

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te of operating procedures and upgrade of the AFIT IT computer system such that when verification of an official control has taken place at a regional level, the supervising officer can add this information to the official control record in AFIT, identifying that the check was subjected to a verification process and recording the outcome of the verification. (31st December 2024)

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· Introduction of a Contingency Plan Checklist and Type 2 Authorisation SOP accordingly. (31st May 2024)

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There are records of the official controls, but the authorities do not record the outcome of the verification of these controls. This does not allow to confirm whether the controls are effective in achieving their intended purpose, whether verification checks detect any issues and whether the authorities take timely corrective actions to improve the effectiveness of official controls when needed.

The competent authorities use the wide range of effective and proportionate enforcement actions available when non-compliances are detected. They promptly suspend transporters, drivers and/or vehicle certificates if necessary to bring operators to take the desired corrective actions and comply with EU animal welfare requirements. However, as the Irish authorities do not interpret Regulation (EC) No 1/2005 as creating a legal obligation to feed unweaned calves on a ferry journey from Ireland to neighbouring Member States, they do not enforce feeding the animals on the ferry. 6 FINDINGS ON FRAMEWORK FOR OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES The key strengths of the official control system are comprehensive documented procedures prioritising the transport of unweaned calves and introducing stricter and additional measures and controls, effective and proportionate enforcement actions, and regular communication and cooperation with the French competent authorities. The key weaknesses are a few gaps in documented procedures particularly on feeding unweaned calves during the sea part of the journey on roll-on roll-off vessels, and the lack of records on the outcome of verification of official controls.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

Citeringen kunde inte upplösas till ett numrerat stycke i rapporten.

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rating procedures such that verification is carried out that calves are fed 2-3 hours before starting a long journey. (1st December 2024) · Amend operating procedures such that official veterinarians must verify that vehicles transporting unweaned calves to the Netherlands are carrying flexible rubber teats (1st December 2024) · Amend the "Guidelines for vehicles seeking approval for transportation of livestock by road and ferry off the island of Ireland" such that they indicate where to best place sensors to detect maximum and minimum temperatures reached inside the vehicle, and how to check if the temperature alarm system is operating properly. (1st December 2024) · In relation to associated finding 9 Ireland does not share DG SANTEs interpretation of the regulation that the additional 2 hours extension to journey time, in the interests of the animals taking into account proximity to destination mentioned in Point 1.8 of Chapter V, Annex I to the Regulation, only applies during unforeseen circumstances that arise once the journey has already commenced. It is our view that the text is absolutely clear on this point.

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There are records of the official controls, but the authorities do not record the outcome of the verification of these controls. This does not allow to confirm whether the controls are effective in achieving their intended purpose, whether verification checks detect any issues and whether the authorities take timely corrective actions to improve the effectiveness of official controls when needed.

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· This finding is based on DG SANTE's interpretation of Regulation 01/2005 as creating a legal obligation to feed un-weaned calves on a ferry journey from Ireland to neighbouring Member States by prescribing a maximum feeding interval for unweaned calves during transport. Ireland has a different interpretation of the Regulation. Our legal position is that there is nothing in the legislation that prescribes such a maximum feeding interval and that the legal obligation to feed only arises if feeding is necessary to avoid causing injury or undue Page: 1 t ref. DG(SANTE) 2022-7503 of the audit carried out from 07 June 2022 to journeys ich it will be completed land to other EU countries over the good condition and are thus not he Audit report, it is only the ly interpret EU legislation. continual improvement of e our research project into ways to the ferry voyage from Ireland to f colic, diarrhoea and dehydration thod is identified (timeline will ll include such a requirement in our tion systems.

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Moreover, delays in bringing the national rules in line with other requirements of EU Regulations result in delays or a lack of implementation of certain EU requirements by, and applicable to, the CA (see paragraphs 16, 33, 34, 67, 71, 81, 93 and 94). It should, however, be noted that the CA obligations in relation to a number of the identified issues, highlighted as being associated with more recent EU legislation, were already mandatory under previous EU law and should therefore have already been incorporated. The same applies to certain obligations of the FBOs (e.g. those of Points 2 and 6 of Chapter VI, Section I, Annex III, Point 3 (f), Section III, Annex II to Regulation (EC) No 853/2004).

FSAI and DAFM have mechanisms in place to ensure that EU provisions are subject to official controls and enforced at national level. However, delays occur in making the changes in national rules required to bring them into full compliance with EU legislation, which may affect controls over, and enforcement of, requirements applicable to FBOs and, as established during this audit, the correct and timely implementation of EU requirements in respect of CA controls.

At the time of the audit, discussions on points i. to iii. remained inconclusive and, as a result, outstanding issues related to these points had not been addressed. 5.2.2 Impartiality, freedom from conflict of interest

DAFM started formal training of TVIs in 2019. This initially involved one day class training and then 30 hours on-the-job training in a slaughter plant. The latter has been reduced to 18 hours, with the possibility of further reducing the minimum requirement, as necessary, due to the COVID-19 pandemic. · The class training covers general aspects (e.g. health and safety, conflict of interest) and specifics of TVI role in red meat slaughter (e.g. animal welfare and health, traceability, cleanliness, food chain information (FCI), checks on specified risk material, examples of abnormalities at AMI and PMI) and actions to be taken. The audit team noted that training material for PMI of red meat mentions that the head is to be inspected only if used for human consumption. This is not in line with Article 19 of Regulation (EU) 2019/627 nor, indeed, with the same provisions set out in Regulation (EC) No 854/2004 of the European Parliament and of the Council which preceded it. · Following class training and the on-the-job training, a VI assesses the ability of applicant TVIs to do the job. TVIs that pass are placed on the panel of a slaughter plant.

Unlike DAFM, LAs do not have a system in place to ensure that their LAVIs undergo practical training for a probationary period of at least 200 hours, under the supervision of a qualified OV, before starting to work independently.

The overall operational control framework in LA does not match that of DAFM, either in terms of available resources, training of staff (while performing equivalent (OV) duties), arrangements to avoid/address possible conflict of interest, or supervision of the performance of controls. The considerable differences between the two CAs in respect of the above are detrimental to ensuring consistent official controls over, and enforcement in, the same type of establishments, including of comparable sizes. This results in diverging outcomes of DAFM and LA controls over equally applicable EU requirements, and inadequacies in the LA controls of such establishments.

A number of the above issues have been identified and recognised by the FSAI, which has made proposals aimed at addressing the challenges at LA level and the future delivery of LA controls. The absence of decisions in this respect at the time of the audit impacts on the country's ability to arrive at, and ensure, consistency between DAFM and LA official controls and enforcement of the same legal framework.

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DAFM Response: 1. DAFM are putting in place a procedure to formally appoint their Veterinary Inspectors as Official Veterinarians (OV), so that their current roles in performing official controls are aligned with the provisions of Article 18(2) of Regulation (EU) 2017/625. Letters of Appointment for VI as OV.pdf Timeline: 31/12/2023 2. DAFM are putting in place a procedure that will appoint Temporary Veterinary Inspectors (TVIs) as Official Veterinarians for: i) Ante-mortem inspection ii) Post-mortem inspection iii) On-farm emergency slaughter iv) Ante-mortem inspection at holding of provenance TVI letter of appointment as OV .pdf Timeline: 31/1/2024 3. DAFM is exploring mechanisms to appoint Technical Agricultural Officers and Supervisory Agricultural Officers as Official Auxiliaries for the practical duties they perform relating to assisting the Official Veterinarian in Ante-Mortem inspection. Timeline: 31/3/2024 Page: 1 land to the recommendations of report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 December e the food safety control systems in place governing the production and placing on the market of bovine meat, tion Proposed by the competent authority When th

process of being appointed as OAs. eline: 31/12/2023 Timeline: 31/05/2024 2.DAFM are putting in place a procedure that will appoint A training program has been put in place to complete residual training orary Veterinary Inspectors (TVIs) as Official requirements of the remaining 122 Veterinarians for: personnel. Timeline 31/10/2024 i) Ante-mortem inspection The training module was updated ii) Post-mortem inspection 18/8/2023. iii) On-farm emergency slaughter Screenshot of training material is supplied. Page: 1 authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 valuate the food safety control systems in place governing the production and placing on the market of provenance FSAI Response: t as OV" The FSAI confirms that as of 23.03.2024 a service contract is now in place with the LAs until the 31.10.2024. Link to agreed service contracts. t Technical To address the DG Sante audit ricultural recommendation, the LA service practical duties contract will provide time to assess fficial Veterinarian TVIs training needs and put a system in place to ensure that all TVIs have undergone practical training under the supervision of a qualified

CA answer of 15 December 2023 DAFM Response: 30/11/2024 DAFM Response: 1. DAFM are The appointment of DAFM VIs and TVIs as Offi- putting in place a procedure to cial Veterinarians (OV) has been completed. 56 of formally appoint their Veterinary the TAOs/SAOs have completed training and are Inspectors as Official Veterinari- ready to be appointed as Official Auxiliaries ans (OV), so that their current (OA). The training syllabus for TAOs/SAOs has roles in performing official con- been expanded to comply with the requirements to trols are aligned with the provi- allow them to be appointed as OA. The remaining sions of Article 18(2) of Regula- 124 TAOs/SAOs are currently undergoing training tion (EU) 2017/625. See attach- and this will be completed by the end of Novem- ber, at which time they can be appointed as OAs. ment "Letter of Appointment for FSAI Response: VI" Timeline: 31/12/2023 2. DAFM are putting in place a pro- OV Appointments cedure that will appoint Tempo- Follow up on the appointment of LA VIs and rary Veterinary Inspectors (TVIs) TVIs as OV continues to be a standing agenda as Official Veterinarians for: i) item at all FSAI/LA liaison meetings. Each of the Ante-mortem

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At the time of the audit, discussions on points i. to iii. remained inconclusive and, as a result, outstanding issues related to these points had not been addressed. 5.2.2 Impartiality, freedom from conflict of interest

In the remaining 19 DAFM and the LA slaughterhouses, TVIs are not required to disclose the names of the farmers for whom they perform private professional duties. VI and LAVIs can therefore not verify TVIs' compliance with the rules on conflict of interest.

In the LAs under review, the TVIs had not declared (possible) conflicts of interest. There is no system to ensure that back-up TVIs (having no conflict of interest) are readily available to perform the AMI and PMI for LAVS, should a TVI declare such a conflict. 5.2.3 Staffing

The overall operational control framework in LA does not match that of DAFM, either in terms of available resources, training of staff (while performing equivalent (OV) duties), arrangements to avoid/address possible conflict of interest, or supervision of the performance of controls. The considerable differences between the two CAs in respect of the above are detrimental to ensuring consistent official controls over, and enforcement in, the same type of establishments, including of comparable sizes. This results in diverging outcomes of DAFM and LA controls over equally applicable EU requirements, and inadequacies in the LA controls of such establishments.

Medlemsstatens svar

DAFM Response: DAFM have put in place a Conflict of Interest protocol for TVIs in DAFM approved slaughter ant. This action was completed on 18/9/2023. N 04 2023 TVI One Off CoI Daily CoI nflict of Interest.pDdefclaration for AnteD-MecolartreamtioInsfpoercAtinotnes-.Mpdofrtem Inspections.pdf Page: 2 land to the recommendations of report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 December e the food safety control systems in place governing the production and placing on the market of bovine meat, Action Proposed by the competent authority Response: 1. Review and amend existing LA standard operating procedures (SOPs) to ensure that the correct certificate signed by an appropriately appointed OV, accompanies the animal to the abattoir. This review process is being facilitated by the LA SOP Working Group, which last discussed this matter at its meeting on the 13.12.2023. Timeline: End of Q1 2024 subject to a new Service Contract being put in place.

sure that new through the UK. to meet relevant A template letter to appoint as OV, has been inserted into Appendix E

CA answer of 15 December 2023 FSAI Response: The actions propro- posed will continue DAFM Response: DAFM have The points raised in relation to CoI and SOP 24 to be progressed put in place a Conflict of Interest have been highlighted with the LA SOPS working over the term of the protocol for TVIs in DAFM ap- group, where they are currently under review. Service Contract proved slaughter plant. This ac- with LAs. tion was completed on 18/9/2023. From the date of transfer the procedures applied in See attachments: "VPN 04 2023 all slaughterhouses will be the responsibility of a TVI Conflict of Interest";"One single competent authority (DAFM). Off CoI Declaration for Ante"; "Daily CoI Declaration for Ante" . Page: 7 e action plan submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of r 2021 to 17 December 2021 in order to evaluate the food safety control systems in place governing the production and including traceability LA Response: 1. Review and amend existing LA standard oper- ating procedures (SOPs) to ensure that the correct certificate signed by an appropriately appointed OV, accompanies the animal to the abattoir. This review process

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New EU Regulations and amendments to existing EU Regulations in the agri-food chain have to be deemed as "food legislation" under national legislation, through amendments of the relevant Schedules in the FSAI Act, before they fall within the remit of the contracts with DAFM and LAVS. The latest amendment of the FSAI Act, at the time of the audit, included EU legislation up to and including 31 March 2021. EU Regulations adopted after that date were not included in the S.I. at the time of this audit. Consequently, the CAs are not legally bound to verify and enforce food business operators (FBOs)'compliance with those provisions applicable to them until such time that they are incorporated into the relevant FSAI Act Schedule.

Moreover, delays in bringing the national rules in line with other requirements of EU Regulations result in delays or a lack of implementation of certain EU requirements by, and applicable to, the CA (see paragraphs 16, 33, 34, 67, 71, 81, 93 and 94). It should, however, be noted that the CA obligations in relation to a number of the identified issues, highlighted as being associated with more recent EU legislation, were already mandatory under previous EU law and should therefore have already been incorporated. The same applies to certain obligations of the FBOs (e.g. those of Points 2 and 6 of Chapter VI, Section I, Annex III, Point 3 (f), Section III, Annex II to Regulation (EC) No 853/2004).

FSAI and DAFM have mechanisms in place to ensure that EU provisions are subject to official controls and enforced at national level. However, delays occur in making the changes in national rules required to bring them into full compliance with EU legislation, which may affect controls over, and enforcement of, requirements applicable to FBOs and, as established during this audit, the correct and timely implementation of EU requirements in respect of CA controls.

At the time of the audit, discussions on points i. to iii. remained inconclusive and, as a result, outstanding issues related to these points had not been addressed. 5.2.2 Impartiality, freedom from conflict of interest

AMI of bovine animals on the holding of provenance, for reasons other than emergency slaughter, is carried out by private veterinary practitioners, not by OVs. When it takes place, the system for emergency slaughter is used (see paragraphs 93 and 94). No arrangements are in place to give effect to the requirements of Chapter VIa of Section I, Annex III to Regulation (EC) No 853/2004, and the provision of Article 31(c) of Commission Implementing Regulation (EU) 2020/2235 in respect of the model certificate to be used for such slaughter, is not implemented.

Nonetheless, the procedures require the private veterinarian (not an OV) to carry out the AMI at the holding of provenance. This is not in line with Article 5(2)(d) of Regulation (EU) 2019/624. DAFM has not yet assigned OVs for this task, and LA veterinarians are not legally authorised to access farms. If the AMI is favourable, the private veterinarian or slaughterhouse staff holding the required certificate of competence, performs the emergency slaughter. 18

The official certificate for emergency slaughter used nationally differs from the model set out in Chapter 5 of Annex IV \ to Implementing Regulation (EU) 2020/2235, as do the arrangements in place. For example, the signing veterinarian is not an OV, and is neither required to declare the date and time of slaughter, nor that the slaughter and bleeding were carried out correctly. Other official controls at slaughterhouse level

The procedures for slaughter of cattle on-farm were not aligned with the applicable EU legislation, resulting in OV duties being performed by private veterinarians and certain EU requirements not being implemented nor certified in line with these requirements.

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e- 1. DAFM are appointing TVIs as OVs (as outlined above) for: i) Ante-mortem inspection ii) Post-mortem inspection iii) On-farm emergency slaughter iv) Ante-mortem inspection at holding of provenance 2. TVI training for on-farm emergency slaughter has been provided on the TVI training moodle. ng On Farm Emergency Slaughter training.pdf 3. Official Certificates for on-farm emergency slaughter and for AMI at holding of provenance have been made available on the public facing website: https://www.gov.ie/en/publication/4e0ea-food-safety-public-health-consumer-issues/#model- animal-health-certificates-for-tvis LA Response: 1. Review and amend existing LA standard operating procedures (SOPs) to ensure that the correct certificate signed by an appropriately appointed OV, accompanies the animal to the Page: 3 land to the recommendations of report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 December e the food safety control systems in place governing the production and placing on the market of bovine meat, Action Proposed by the competent authority abattoir. This review process is being facilitated by the LA SOP Working Group, which last discussed this matter at its meeting

sure that TVIs of the LA SOP D.29. Examples of the appointment letters are provided. With the service contract and the updated SOP it is now expected that all written OV appointments, new entrant LA TVIs sufficiently trained to meet relevant requirements and TVIs appointed Page: 3 authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 valuate the food safety control systems in place governing the production and placing on the market of ) Ante-mortem inspection as Ovs for AM/PM inspections, i) Post-mortem inspection will be completed by 31.10.2024. ii) Ante-mortem inspection at holding of provenance. The FSAI launched a new learning portal to inspectors in February 2024, which has many eLearning modules available to support and broaden LAVI knowledge on official controls performed by LAVIs in accordance with the legislation listed in Schedule 1 of the Service Contract. FSAI Response: AFM Response: The FSAI confirms that as of 23.03.2024 a service contract is now in place with the LAs until the 31.10.2024. AFM have put in place a Conflict of Interest protocol for Link to agreed service contracts. VIs in DAFM approved slaughter plant. Th

A answer of 15 December 2023 DAFM Response: Completed 19 Feb- ruary 2024 AFM are appointing TVIs as The two embedded documents are provided as evi- (as outlined above) for: i) dence that the Model Animal Health Certificate in e-mortem inspection ii) Post- the Case of Emergency Slaughter Outside the em inspection iii) On-farm Slaughterhouse is being used in DAFM supervised gency slaughter iv) Ante- slaughterhouses. em inspection at holding of enance 2. TVI training for rm emergency slaughter has provided on the TVI training A copy of the communication to TVIs instructing them le. See attachment "On farm to only use the new model certificate is embedded be- gency slaughter training" 3. low. cial Certificates for on-farm gency slaughter and for AMI olding of provenance have made available on the public FSAI Response: ng website: Implementation of LA controls on animals subject s://www.gov.ie/en/publica- to emergency slaughter/slaughtered on farm is evi- /4e0ea-food-safety-public- denced through the use of model animal health th-consumer-issues/#model- certificates, as illustrated below: al-health-certificates-for-tvis Page: 10 e action plan submitted by the competent authorities of Ir

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The overall operational control framework in LA does not match that of DAFM, either in terms of available resources, training of staff (while performing equivalent (OV) duties), arrangements to avoid/address possible conflict of interest, or supervision of the performance of controls. The considerable differences between the two CAs in respect of the above are detrimental to ensuring consistent official controls over, and enforcement in, the same type of establishments, including of comparable sizes. This results in diverging outcomes of DAFM and LA controls over equally applicable EU requirements, and inadequacies in the LA controls of such establishments.

In DAFM plants, TAOs perform certain tasks that, according to Article 3 of Regulation (EU) 2019/624 are tasks of an OA. For example, verification of FCI, identification checks, and some welfare checks. They inform the TVI/VI of their findings. Nonetheless, contrary to the requirements of the same Article; · the OV does not regularly verify that TAOs carry out their practical tasks properly. TAOs' work is supervised by SAOs. DAFM does not consider TAOs to be OAs for the purpose of AMI; · TAOs perform the practical tasks for all bovine animals (e.g. including those from herds that have not been declared officially free of tuberculosis).

The DAFM TVIs and VIs interviewed were aware of the relevant requirements for AMI and PMI of bovine animals and of the decisions to be taken, including for findings that are more frequently seen in cull cows. In two of the LA plants, the LA TVIs were not available to be interviewed by the audit team. The reports of the DAFM visits in one of these plants noted, amongst other, inadequate arrangements to conduct AMI, due to difficult access to the limited sized lairage pens, with the FBO reading the animal tags in the trailers. The LAVI had repeatedly highlighted inadequate lairage facilities for AMI as 15 an issue, which is also mentioned in the FSAI-LA reports and corrective action requests. Nonetheless, and despite the issue not having been addressed, slaughter continued.

LA procedures describe the identification requirements and checks that are to be carried out by the TVI/VI. Animals must be accompanied by the movement permission issued by AIM (ER 106 form). Carcases are not health-marked if this form is missing. TVIs check whether ear tags match the ER 106 form, in 5% of the animals. TVIs have no access to the database, although LA staff may have. There is no LA procedure for TVIs/LAVIs to deal with identification issues.

In DAFM plants, TAOs check the FCI and record the results on the AMI record used by the TVI. In LA plants, TVIs carry out FCI checks. The report of a DAFM visit in one of the LA plants mentions that the FBO was not aware of her/his role in checking the FCI prior to presentation of the animals for AMI. This (longstanding) non-compliance had not been previously identified by the LAs.

DAFM has procedures in place to arrange for sampling for residues when AMI and/or PMI findings lead TVI to suspect breaches of legislation on chemical residues or contaminants. This did not happen in the LA examined by the audit team, as the LA TVIs are not authorised to take samples and the LAVI, authorised to take samples, may not be available to do so. AMI procedures for poultry

The TVI may contact the LAVI to carry out controls and sample detained carcases (e.g. for Bovine spongiform encephalopathy (BSE) testing, detection of tuberculosis lesions); some exchanges in this regard were presented to the audit team. However, as regards residues sampling, this did not happen in one of the LA interviewed, and which attributed this to the LAVI not being present (TVIs are not authorised to take samples for residues). Under the circumstance, the LA did not fully apply the requirements of Article 14(1) of Regulation (EU) 2019/627 on laboratory testing for reaching a definitive diagnosis of a suspected hazard or detecting the presence of chemical residues.

That enforcement action, initiated in 2020, was not fully effective: the report of a visit by DAFM in the same plant in 2021 still identified issues preventing PMI to be performed correctly (final carcase inspection in congested chiller without access to higher parts, livers discarded and gastro-intestinal tract removed before being presented for PMI). 17

In another LA plant, the DAFM report also noted, amongst others, "very significant concerns" linked to PMI: unsatisfactory facilities for inspection of offal - no dedicated inspection point on red offal rail, not all red offal presented for inspection, no knife steriliser for the TVI; TVI attempting to conduct inspection under conditions giving rise to health and safety concerns.

The LAVIs for these plants clarified that in the first plant the DAFM findings had been addressed, while in the second the LAVI considered that, notwithstanding the challenging conditions, all aspects of PMI were compliant. The FBO of this plant had presented plans for construction (halted due to COVID-19 restrictions) with a view to, amongst others, increase space for red and green offal handling and inspection. PMI procedures for poultry

The AMI and PMI at slaughterhouse level are organised to cover the relevant elements for bovine slaughter (including of cull cows) and poultry. Some long-term arrangements that do not allow adequate performance of AMI and PMI had been accepted by the LAs, with divergent DAFM and LA assessments of the same arrangements.

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A Response: Both TVIs/LAVIs have direct access to DAFM AIMs Division personnel to resolve ID issues via le the use of NBAS forms to assist with the resolution of any ID issues arising at ante-mortem ection. 1. DAFM AIMS team will prepare a report to identify FBOs still using paper to confirm slaughter. This report will be used by the LA and DAFM for a targeted approach to online sign up of FBOs on AIMS. Timeline: End of Q1 2024 subject to a new Service Contract being put in place with the appropriate supports provided. 2. DAFM AIMS team and the FSAI have planned to organise a meeting in Q1 2024 where all LAVI and some of the bigger abattoirs who are still using paper notifications could attend to discuss ongoing issues. Timeline: End of Q1 2024 subject to a new Service Contract being put in place with the appropriate supports provided.

Division personnel to resolve ID issues via the use of The TVIs are now appointed as NBAS forms to assist with the resolution of any ID issues OVs and in signing the AIM check arising at ante-mortem inspection. sheet, they are verifying the animal identity, FCI and welfare status as 1.DAFM AIMS team will prepare a report to identify an OV. The technical staff presents FBOs still using paper to confirm slaughter. This report a weekly summary of the results of will be used by the LA and DAFM for a targeted approach the inspections performed by the to online sign up of FBOs on AIMS. TAOs and SAOs in that week to the OV. This gives the OV oversight of Timeline: End of Q1 2024 subject to a new Service the official controls performed by Contract being put in place with the appropriate supports the TAOs and SAOs. It highlights provided. unresolved non-compliances and recurrent non-compliances and this facilitates the OV in carrying out effective and appropriate enforcement actions. A copy of the check sheet summary report is provided below. 2.DAFM AIMS team and the FSAI have planned to organise a meeting in Q1 2024 where all LAVI and some of the bigger abattoirs who are still using paper

swer of 15 December 2023 DAFM Response: 30/11/2024 esponse: Both TVIs/LAVIs DAFM technical staff will be appointed as OAs direct access to DAFM when the training is completed. The training is Division personnel to re- scheduled to be completed at the end of Novem- e ID issues via the use of ber. To clarify how verification of the OAs tasks forms to assist with the performed (only) by TAO/SAO is organised, the embedded document below demonstrates how the Page: 15 e action plan submitted by the competent authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of r 2021 to 17 December 2021 in order to evaluate the food safety control systems in place governing the production and including traceability solution of any ID issues arising SAO makes a weekly report to the slaughterhouse ante-mortem inspection. 1. OV, detailing all the inspections carried out by the FM AIMS team will prepare a technical staff (OAs) in that week. port to identify FBOs still using Emphasis is put on non-compliances, unresolved per to confirm slaughter. This non-compliances and recurrent non-compliances. port will be used by the LA and With the appointment of TVIs as OVs, technical FM for a targe

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Both DAFM VIs and LAVIs are required to keep the approval of establishments under review. Examples of addition or removal of approved activities from the list following CA controls were made available to the audit team. However, the two medium size bovine slaughterhouses under the supervision of the LAs and reviewed by the audit team received DAFM visits in the context of (possible) transfer of official controls requested by the LAs based on their increasing throughput: · The DAFM report, following the visit in one of these establishments, raised very significant concerns in relation to the plant's capacity (slaughter line inadequate for current throughput, see paragraph 98). This was also the main root cause indicated by the LA for the non-compliances subject to repeated enforcement in the other slaughterhouse; · In the second establishment, the LAVS re-issued the approval to reflect the S.I. 22/2020 provisions and included limits in the throughput justified by the chiller's capacity. Following the DAFM visit which identified serious, long-standing animal welfare breaches amongst other non-compliances, the LA suspended the (recently re-issued) approval.

There is a system in place aimed at granting approval to establishments in line with the EU requirements. Although both CAs follow the procedures in place, there are significant differences in the outcomes of DAFM and LAVS assessments of compliance with the approval conditions, in the same establishments. This highlights a lack of consistency between DAFM and LA controls but also, and taken together with the FSAI's own findings, that the LA cannot consistently ensure that the approval of establishments is adequately kept under review. In one case reviewed, this resulted in an establishment continuing to operate under LA supervision for years although deemed non-compliant by DAFM, and under whose remit it should fall.

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LA Response: Establishments under LA supervision are risk assessed and audited annually to ensure that the approval certificate accurately reflects the activities currently undertaken in the establishment in line with the recommendation made under SOP D3. Page: 4 land to the recommendations of report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 December e the food safety control systems in place governing the production and placing on the market of bovine meat, Action Proposed by the competent authority The DAFM audits of LA approved premises were reviewed by the LAs and immediate corrective actions were taken to address non-compliances identified. In one plant all non-compliances have been addressed and a transfer to DAFM has been completed. In the other plants where, non- compliances were identified work programs to address non-compliances are in progress with a future transfer to DAFM anticipated. 1. Official control staffing levels (TVIs), in plants subject to this audit, have been increased to levels comparable to those available to carry out official controls in similar sized plants under DAFM supervision. Timeline: Staffing needs in all LA premises will be asses

Response: through normal service contract Page: 11 authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 valuate the food safety control systems in place governing the production and placing on the market of stablishments under LA supervision are risk assessed routes to review and amend nd audited annually to ensure that the approval certificate approvals of food businesses. The ccurately reflects the activities currently undertaken in extended service contracts include a he establishment in line with the recommendation made strengthened requirement for the nder SOP D3. LAs to review the compliance of the food establishments with their he DAFM audits of LA approved premises were approval. It is anticipated that work eviewed by the LAs and immediate corrective actions on approvals will be completed by ere taken to address non-compliances identified. In one 31.10.2024. lant all non-compliances have been addressed and a ransfer to DAFM has been completed. In the other plants Work on a cross agency FSAI here, non-compliances were identified work programs to guidance note on approvals, which ddress non-compliances are in progress with a f

nswer of 15 December 2023 FSAI Response: Response: Establishments un- The IE competent authority welcome the Commis- The actions propro- r LA supervision are risk as- sion services assessment that the actions proposed posed will continue ssed and audited annually to en- may provide intermediate solutions until DAFM to be progressed re that the approval certificate controls come into place. over the term of the curately reflects the activities Service Contract rrently undertaken in the estab- The following initiative and their associated im- with LAs. shment in line with the recom- provements have been outlined below. ndation made under SOP D3. e DAFM audits of LA ap- All LA's have confirmed that they reviewed the oved premises were reviewed individual FBO activities against the approval the LAs and immediate correc- conditions at least on an annual basis as part of their service contracts. ve actions were taken to address The cross agency FSAI guidance note on approv- n-compliances identified. In als is now at proof reading stage. A meeting of the e plant all non-compliances cross agency working group is planned to take ve been addressed and a trans- place on 20 September to conduc

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At central level, in brief: · The FSAI delivers its overall responsibility for the enforcement of food safety legislation on the production chain of bovine meat (after primary production), through service contracts with DAFM and LAs. It is also responsible for co-ordinating control activities between DAFM and LAs, and for ensuring consistent performance of controls; · DAFM is responsible for developing policy and legislation, as well as implementing EU rules in national law. It is also responsible for official controls in medium and large bovine and poultry slaughterhouses, delivered through its regional and local staff; · FSAI responsibilities do not cover animal health and animal welfare controls, as that legislation is not deemed "food legislation" under the FSAI Act. DAFM, as a CCA for animal health and welfare, does not have contractual arrangements with the LAs for the controls over and enforcement of the rules that fall outside FSAI's remit. See paragraph 44.

There is no regional or central structure for LAs. Some LAVS perform official controls in more than one county. In most cases, one person per county/group of counties is in 5 charge of the official controls as the CA (see also paragraph 42). Official controls in bovine and poultry slaughterhouses are implemented by 24 LAVS, under service contracts with FSAI. The Local Authority Veterinary Inspectors (LAVIs), employed to perform OV duties, are not required to be present during slaughter. They carry out audits and inspections of the FBO as well as oversight over TVIs. The TVIs carry out the AMI and PMI.

At the time of the audit, discussions on points i. to iii. remained inconclusive and, as a result, outstanding issues related to these points had not been addressed. 5.2.2 Impartiality, freedom from conflict of interest

The audit found that differences in the staffing levels of DAFM compared to LAs are maintained when plants under LA supervision grow to sizes comparable to those of plants under DAFM supervision. In two comparable facilities, DAFM availed of a permanently present VI, three TVIs, a TAO and visiting SAO and RSVI, while the LA employed two TVIs and a visiting LAVI. The last internal audit (see paragraph 37) of this LA identified a lack of sufficient manpower to carry out all necessary official controls.

The same LA audit report highlighted that controls, other than AMI, PMI and sampling, were carried out on a reactive rather than a proactive basis, and concluded that, due to the lack of a strategic approach and sufficient manpower, controls in line with the requirements were not necessarily ensured. At the time of the current audit, one LAVI continued to carry out all the veterinary controls in the LA, except AMI and PMI.

Although the CAs mentioned resource constraints linked to Brexit and the COVID-19 pandemic, the overall figures for controls in establishments in the scope of this audit suggest that the planned controls were largely implemented in the past 2 years; sometimes, additional controls were carried out. LAs reviewed by the audit team attributed the current audit's findings on the lack of consistency and in some cases of the effectiveness of controls, to resource issues. 7

The official control staff interviewed during this audit indicated an overall adequate understanding of their responsibilities, according to the procedures in place, and of the legal requirements on the topics on which they were questioned. Nonetheless, reports following FSAI and DAFM visits in LA plants indicate that certain non-compliances went undetected or that certain requirements were not adequately enforced (see paragraphs 72, 77, 87, 88, 97 to 100 and 109 to 112). 5.2.5 Supervision and Audits

The work of LAVIs is not routinely supervised. LAs' internal audits by another LA - meant to cover all areas of activity under the OCR within a five-year cycle - are peer- review exercises, given that each LA is considered a CA. There are significant differences between the reports produced by different LAs, which suggests that the approach is not standardised. The FSAI highlighted that there is ongoing work to harmonise the approach of the internal audits performed by LAVS.

The FSAI carries out audits of the official controls carried out by DAFM and LAs, as well as targeted audits on selected topics. The overview of FSAI audits of LAs' official controls indicates that, on average, LAs received one official control audit in the past 10 years, with some receiving 2 audits, and some none. In addition, some LAs participated in joint compliance reviews with FSAI, and/or received targeted audits.

FSAI's most recent audits on topics relevant for the scope of this audit were: on traceability and controls thereof (in 2016 and 2017); on LAs' controls over FBOs' implementation of Commission Regulation (EC) No 2073/2005 (in 2019, 2016 and 2015); on DAFM controls of approved poultry slaughterhouses, and on 2 LAs' controls over on- farm emergency slaughter (2013).

The FSAI, based on the outcome of its own audits, FSAI joint compliance reviews, LA inspections, as well as DG Health and Food Safety audits, raised concerns about the consistency and effectiveness of official controls at some LAVS-supervised establishments with the County and City Management Association (representing the Chief Executives of the LAs) in 2019.

It highlighted instances of: a) incorrect application of approval procedures (establishments being approved which should not be); b) non-compliances not being detected; c) regulatory responses being insufficient to secure compliance; d) official controls not in line with the SOPs developed by the LAVS with FSAI support, nor with the requirements of the service contracts or EU legislation on official controls. 9

In 2020, FSAI suggested that structural changes to the system could be key to improving the service, and to render it more robust and consistent in its enforcement activity. It also identified other actions, including changes to the service contract. In 2021, FSAI made a submission on LAVS reforms that it deems necessary, highlighting limitations in the efficiency/effectiveness of LAs oversight of slaughterhouses and cutting plants: · no LA veterinary technical supervision of the work of LAVI in most cases, affecting the LA's ability to verify correct and effective delivery of the controls (illustrated by examples of non-compliances gone undetected or not met with an adequate response, and of non-adherence to SOPs); · new VIs joining the service with little or no prior food law enforcement experience; in the absence of a technical hierarchy, there is no structured veterinary induction; · many LAs employing a single VI results in FBOs being regulated by the same individual for a long period of time; · many of the FBOs under LA supervision are small and micro-businesses with limited internal technical expertise; and · inconsistent alignment between required activity levels, and available VI resource.

At the time of this audit, no definitive policy decisions on the future delivery of official controls by LAs or the proposals made by the FSAI had yet been taken.

FSAI audits and support mechanisms do not cover animal welfare or animal health. DAFM established a Liaison Committee with the LAVS to discuss animal welfare and animal health control aspects, but its activities do not ensure supervision of the LA controls over animal health and welfare. DAFM controls in LA plants and one of the two LA internal audit reports reviewed by the audit team found ineffective welfare controls (see paragraphs 109-112). 5.2.6 Actions in case of non-compliance

Both DAFM and LAs interviewed by the audit team provided examples of different enforcement actions taken in case of non-compliances. Nonetheless, when DAFM visited slaughterhouses under LA supervision - in the context of possible transfer of control responsibilities from LA to DAFM - the outcome was significantly different (see paragraph 56). The non-compliances identified by DAFM had either not been previously identified by LAs, or their correction not effectively enforced to prevent their reoccurrence (see paragraphs 5, 72, 77, 87, 88, 97-100 and 109-112). While the LAs acted upon most of the non-compliances identified by DAFM, they did not fully agree with all DAFM findings. 10 Conclusions on competent authorities

DAFM has the overall organisation, resources, overall training of staff, as well supervision mechanisms in place to ensure that official controls in establishments under its remit are carried out consistently and in line with EU legislation, and that corrective actions are taken when needed. Nonetheless, DAFM does not supervise the animal welfare controls in establishments under LA supervision, which undermines its ability to perform effectively its task of ensuring consistency and effectiveness of animal welfare controls. In respect of ensuring absence of conflict of interest on the part of TVI, the arrangements are more robust in poultry and certain export establishments, than in other establishments under its remit.

The overall operational control framework in LA does not match that of DAFM, either in terms of available resources, training of staff (while performing equivalent (OV) duties), arrangements to avoid/address possible conflict of interest, or supervision of the performance of controls. The considerable differences between the two CAs in respect of the above are detrimental to ensuring consistent official controls over, and enforcement in, the same type of establishments, including of comparable sizes. This results in diverging outcomes of DAFM and LA controls over equally applicable EU requirements, and inadequacies in the LA controls of such establishments.

The delays in effectively using the existing FSAI coordination mechanisms and in CAs decision-making undermine the (effective) implementation of a number of horizontal EU requirements notably at LA level, such as the designation for certain official tasks and related derogation conditions, training requirements for staff involved in official controls, and safeguarding conflict of interest, which are of particular relevance for LA controls and the associated findings of this audit.

A number of the above issues have been identified and recognised by the FSAI, which has made proposals aimed at addressing the challenges at LA level and the future delivery of LA controls. The absence of decisions in this respect at the time of the audit impacts on the country's ability to arrive at, and ensure, consistency between DAFM and LA official controls and enforcement of the same legal framework.

Both DAFM VIs and LAVIs are required to keep the approval of establishments under review. Examples of addition or removal of approved activities from the list following CA controls were made available to the audit team. However, the two medium size bovine slaughterhouses under the supervision of the LAs and reviewed by the audit team received DAFM visits in the context of (possible) transfer of official controls requested by the LAs based on their increasing throughput: · The DAFM report, following the visit in one of these establishments, raised very significant concerns in relation to the plant's capacity (slaughter line inadequate for current throughput, see paragraph 98). This was also the main root cause indicated by the LA for the non-compliances subject to repeated enforcement in the other slaughterhouse; · In the second establishment, the LAVS re-issued the approval to reflect the S.I. 22/2020 provisions and included limits in the throughput justified by the chiller's capacity. Following the DAFM visit which identified serious, long-standing animal welfare breaches amongst other non-compliances, the LA suspended the (recently re-issued) approval.

DAFM visits concluded that one of these establishments did not comply with DAFM standards, and that the other one did not comply with the approval conditions under S.I. 22/2020. 12

DAFM explained its policy of requiring that non-compliances have been addressed at the time of approval, and prior to it taking over the official controls. Consequently, a transfer to DAFM may take as long as it takes for DAFM to deem an establishment to meet the approval standards: in one establishment, the transfer had not yet taken place despite repeated LA requests, since 2015. FSAI intends to address the transfer to DAFM of LA establishments exceeding the throughputs for which they were originally approved, in a Guidance Note.

There is a system in place aimed at granting approval to establishments in line with the EU requirements. Although both CAs follow the procedures in place, there are significant differences in the outcomes of DAFM and LAVS assessments of compliance with the approval conditions, in the same establishments. This highlights a lack of consistency between DAFM and LA controls but also, and taken together with the FSAI's own findings, that the LA cannot consistently ensure that the approval of establishments is adequately kept under review. In one case reviewed, this resulted in an establishment continuing to operate under LA supervision for years although deemed non-compliant by DAFM, and under whose remit it should fall.

Although the outcome of follow-up visits by the LAVI following the enforcement actions was considered satisfactory, a DAFM visit which took place some months later identified, amongst others, certain similar hygiene issues as well as inadequate handling of specified risk material. This suggests that, at least for some of the breaches, the corrective actions were not sufficiently effective, although deemed satisfactory by the LAVI.

In the other LA plant, the DAFM report identified issues which it deemed to be of very significant concern, amongst others in relation to/stemming from the daily numbers permitted by the LA for slaughter, for which the slaughter line and associated ancillary areas were not designed. The FBO had presented plans for extending the slaughter-line cutting capacity but, pending their completion, throughputs had not been affected.

The DAFM report also identified shortcomings not previously noted by the LAs, e.g. contamination of green offal (used for petfood - Category 3 ABP) with washings from the carcases splitting saw (Category 1 ABP); lack of changing facilities, and use of mobile toilets at the external perimeter of the premises for staff use, without adjacent hand- washing facilities.

The LAVIs reported to have taken the required action and that most of the findings reported by DAFM had been solved, including in relation to the procedures for dealing with ABP. Nonetheless, the gravity of some of these findings and their recurring character suggest that LA controls and enforcement in these plants had not been sufficiently effective.

DAFM started to enforce welfare during transport directly with the transporter at slaughterhouse level in 2019, but the VIs' approach was not yet uniform. One of the VIs interviewed and his RSVI were not aware of this DAFM approach and raised welfare 20 issues related to transport with the slaughterhouse operator, while the VI in another DAFM plant initiated enforcement action against the transporter. However, DAFM did not check whether the same transporter had been associated with non-compliances identified in other slaughterhouses when deciding whether a non-compliance was not repeated.

While in DAFM plants official controls staff may be present at the time of unloading and are present at the time of slaughter, this is not a requirement in most LAs. In practice, the TVIs may come to perform AMI, leave for other private tasks and return to perform delayed PMI. LAs did not report any animal welfare issues in the last 2 years. In the two LAs under review, the LAVI last notified DAFM in 2018 regarding an animal welfare incident during transport.

In one of the two LA slaughterhouses for which animal welfare controls were assessed, the LAVI had used the animal welfare checklists on an annual basis and, although certain non-compliances (e.g. no FBO checks of absence of life before dressing) were identified, the outcome of these controls was considered satisfactory. Nonetheless, when DAFM visited the same establishment, it identified animal welfare breaches which it deemed to warrant suspension of the FBOs' licence to slaughter. The LA acted upon these findings, took enforcement action and followed up the measures put in place by the FBO.

Following this incident, the LA requested DAFM to perform a dedicated animal welfare audit in the same establishment. The DAFM visit found, amongst other deficiencies, no evidence of monitoring/verification of the process of sticking/bleeding; a continued, considerable risk that head removal would commence before the animal's death (as noted in the previous DAFM visit); that the Animal Welfare Officer did not hold a certificate of competence; that the SOPs on animal intake and welfare from unloading to death did not adequately describe the process; and that the kill box and race were not fit for purpose.

Following the DAFM audit, the LA issued an improvement notice, followed by a suspension of the approval to slaughter given the FBO's inadequate progress. Nonetheless, in this case the LA's ability to identify and/or adequately assess the gravity of welfare non-compliances and to effectively enforce the relevant animal welfare requirements, was seriously called into question.

In the other slaughterhouse under LA supervision, the last report of an internal LA audit identified "significant weaknesses in the operating procedures of the slaughterhouse, particularly with regard to the requirements of Regulation (EC) No 1099/2009" which had not been detected by the controls. The VI acted upon these findings. Conclusions on organisation and implementation of official controls

Animal welfare requirements at slaughter and during transport are enforced, but to a lesser extent in slaughterhouses under LA supervision. There is a lack of consistency between the DAFM and LA controls (and between controls in LAs) over animal welfare, and a lack of supervision by DAFM over these controls at LA level, but also in respect of FBOs' compliance with hygiene and ABP rules. The effectiveness of LA controls had not been adequately ensured in the LAs under review, as highlighted by the shortcomings identified in the organisation and operation of LA controls both during this audit and by the FSAI.

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. DAFM is the Central Competent Authority (CCA) for animal welfare requirements. In relation by to the consistency and effectiveness of controls in animal welfare requirements, DAFM is e reviewing the current arrangements to consider options to allow DAFM act as the CCA for e animal welfare in local authority plants. Timeline: 31/03/2024 2. DAFM has established a cross divisional working group on Cross Divisional Animal Welfare Reporting System (CDAWR). The terms of reference include reviewing animal welfare at transport and issues raised in this audit. LA Response: Page: 5 land to the recommendations of report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 December e the food safety control systems in place governing the production and placing on the market of bovine meat, e competent authority an SOP D7 on the control of handling, storage and transport of ABP including owed and implemented by the LA in the FBOs that they supervise and inspect. t agreements with the FSAI, and in line with current food legislation, the LAs rious functional areas, hygiene inspections of premises and equipment used in anufacture, processing, disposal, transport and storage of food. In that

aspects of the ToR. 2.DAFM has established a cross divisional working group The intention is that the on Cross Divisional Animal Welfare Reporting System recommendations will take account (CDAWR). The terms of reference include reviewing of the need for an effective system animal welfare at transport and issues raised in this audit. for cross-reporting welfare issues detected in Local Authority slaughter plants and the need to See attachment Email re AW WG ensure information on the compliance history of relevant operators can be taken into account Page: 13 authorities of Ireland in response to Report ref. DG(SANTE) 2021-7188 of the audit carried out from 01 valuate the food safety control systems in place governing the production and placing on the market of when deciding on any enforcement action. ntrol of ncluding SRM. A collaboration agreement has been the LA in the signed between DAFM and the County and City Managers Association (CCMA), which represents the local authorities. he FSAI, and in The agreement covers training and LAs carry out in the exchange of information to inspections of enhance the consistency of official n with the controls in relation to animal port and stora

swer of 15 December 2023 FSAI Response: The actions propro- The issues were raised during the SOP working posed will continue DAFM is the Central Compe- group and SOP No. D7 is currently being re- to be progressed uthority (CCA) for animal viewed. over the term of the elfare requirements. In relation DAFM and FSAI Response: Service Contract o the consistency and effective- with LAs ess of controls in animal welfare From the date of transfer the procedures applied in . equirements, DAFM is reviewing all slaughterhouses will be the responsibility of a he current arrangements to con- single competent authority (DAFM). ider options to allow DAFM act DAFM Response 18.9.24: s the CCA for animal welfare in Regarding the working group on Cross-Divisional ocal authority plants. Timeline: Animal-Welfare Reports (CDAWR); The final 1/03/2024 2. DAFM has estab- recommendations of the group were made availa- ished a cross divisional working ble in May 2024 and takes account of the need for roup on Cross Divisional Animal an effective system for cross-reporting welfare is- elfare Reporting System sues detected in Local Authority slaughter plants CDAWR). The terms of refer- as well as the need to

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According to sampling procedures and additional information provided by the competent authorities, official sampling is in the most cases unannounced and unexpected as required by EU legislation (10). However, random sampling is (6) Annex IV to Directive 96/23/EC and Commission Decision 97/747/EC. (7) http://www.hpra.ie/homepage/veterinary/veterinary-medicines-information (8) Reference to their use, under exceptional circumstances and in line with Commission implementing Regulation (EU) 2018/470 of 21 March 2018 on detailed rules on the maximum residue limit to be considered for control purposes for foodstuffs derived from animals which have been treated in the EU under Article 11 of Directive 2001/82/EC. (9) Article 12 of Regulation (EU) 2017/625, Annex II to Regulation (EU) 2021/808. (10) Article 9(4) of Regulation (EU) 2017/625 and Point 1 of Annex III to Directive 96/23/EC. 4 performed in a certain number of cases, due to other existing practical arrangements. In these cases, the sampling officers did not plan dedicated residue sampling events, but took advantage of other control activities planned for the same establishment (unrelated to residue monitoring and undertaken pursuant to a separate risk assessment) to take residues samples during these visits. (11)

Contrary to the requirements laid down in EU legislation (12), the auditors noted that, in many cases on aquaculture farms (13) and sometimes in slaughterhouses (horses, pigs), multiple sampling, i.e. from the same producer and animal category and for the same substances to be tested for, was performed on the same day.

For several samples taken at slaughterhouses, one sampling officer did not follow the existing procedures and guidelines regarding the selection of animals for sampling. E.g., samples for hormone testing were taken from male animals while only females should have been sampled according to the plan. The non-respect of the clear guidelines available to the sampling officer had not been identified by supervision or other verification procedures.

For bovine sampling at slaughterhouse level, targeted sampling was not always implemented. The sampling inspector interviewed had no access to information on the outcome of official controls (e.g. previous non-compliant results) or background information about the producer and the farming system. The outcome of the ante mortem inspection (e.g. sex and age of the animal, secondary sexual characteristics, behavioural changes, signs of disease or chronic disorders, different health status of specific animals within a group) was also not considered in the choice of the animal to target for sampling and not in line with the applicable legal requirements (14). Nevertheless, suspect samples were taken occasionally after all findings of veterinary ante mortem checks had been carefully considered when deciding whether stock could proceed for slaughter and whether or not laboratory testing was required to ensure the safety of the food being produced.

With regard to aquaculture sea farming, fish at smolt stage are sampled at farm level. The sampling of adult fish has been implemented only for farms harvesting during the year and selected for sampling of animals ready to be placed on the market for consumption. These animals were sampled at processing level only. Therefore, the requirement to sample fish for Group A substances at all stages of production (15) was not met.

The residue monitoring plan is generally implemented in accordance with legal requirements and planned arrangements. However, targeted sampling was not consistently ensured and the sampling strategies applied for several commodities were not adequate. In addition, the evident lack of supervision or other verification procedures, in relation to sampling officers not following the detailed instructions, contributes to the persistence of sampling errors and weakens the effectiveness of the residue monitoring. 5.1.4. Other residue monitoring programmes Findings

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For one of the steroid samples the sex of the animal was not indicated in the sampling report. In another case the wrong animal sex was sampled, which was not in line with existing sampling instructions. As the sample was not discarded and still analysed by the laboratory, it led to a result for which no interpretation (as to whether illegal treatment had occurred or not) was possible.

The first follow-up step performed in relation to non-compliant results was in all cases a desk-based evaluation, called `herd profile', initiated in most of these cases within days following receipt of the non-compliant result. Furthermore, in seven of the ten files, on-farm visits were planned. For two of these the competent authority could not present any evidence that the visits had taken place (22).

Following the detection of ivermectin in bulk milk (this substance is not authorised for use in milk-producing animals in the EU), and despite the partial absence of records noted during the on-farm control and a parallel detection, below the Maximum Residue Limit (MRL), of another antiparasitic agent (closantel), the competent authority could not present during the audit any evidence that additional investigations (23) were performed. The creamery was informed by email of the (22) In their response to the draft report, the competent authority clarified that the planned visits were cancelled after having discussed these cases with the EURLs, and amendment of the initial evaluation, which took into consideration the possibility of the existence of endogenously formed hormones and the difficulties to distinguish between endogenously formed and administered hormones. (23) In their response to the draft report, the competent authority noted that additional investigations were performed and included a visit to the herd owners' veterinary practice and visits to local anthelmintic supplier outlets. 8 non-compliant result and advised that it was free to carry out further sampling of milk from this producer in the context of its own-control programme.

The legal framework for investigating non-compliant residue results is in line with the EU requirements. In most of the cases, the competent authority undertook investigations promptly when non-compliant residue results were received, and sanctions were imposed. However, in some cases follow-up actions were incomplete or non-exhaustive, and in other cases not well documented, militating against the identification of the cause of the non-compliance and thus preventing recurrence. (24) In their response to the draft report, the competent authority stated that it had requested that samples be taken next time that the herd owner presented animals for slaughter. (25) In their response to the draft report, the competent authorities stated that farm investigations were carried out. 9

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The audit team noted that the designation of the official laboratories in line with EU legislation (26) was, at the time of the audit, still ongoing and not finalised for any of the laboratories involved in the residue monitoring plan. The FSAI demonstrated a template Letter of Designation, which had been drafted in line with the requirements laid down in EU legislation (27). For the laboratories located in other EU Member States, efforts were made to ensure, in particular, that such laboratories are designated as official laboratories by the competent authority of the laboratory's home country in line with these requirements.

The fact that all laboratories are accredited, that the analytical methods used are included in their respective scopes of accreditation, that adequate internal quality controls are in place and that the laboratories have satisfactorily performed in proficiency tests, provide assurances to the competent authority on the reliability of results generated. Notwithstanding these positive aspects, the absence of formal designation of some of the laboratories and certain technical deficiencies in method validation, in particular in establishing decision limits, undermine the effectiveness of the overall residue control system.

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With regard to the validation of the confirmatory methods checked by the audit team, all relevant species/tissues were included in the validation. However, in one case (confirmatory method for tetracyclines and 4-epimers in muscle), studies on recovery, repeatability and reproducibility, based on the validation file submitted, were carried out only in bovine muscle while the method is used also for testing muscle of ovine, porcine, avian, cervine and equine animals. In two other cases (confirmatory methods for (i) anthelmintics, and (ii) dyes ­ both in aquaculture), the validation was carried out on wild salmon matrix and, partially, for prawns while the method is applied to other finfish, e.g. trout. The laboratory representative explained that the practical experience had demonstrated that the differences in the matrices were negligible, however, no documentary evidence of such comparison was presented by the laboratory. Such an approach is not fully in line with the requirements of EU legislation (31).

The fact that all laboratories are accredited, that the analytical methods used are included in their respective scopes of accreditation, that adequate internal quality controls are in place and that the laboratories have satisfactorily performed in proficiency tests, provide assurances to the competent authority on the reliability of results generated. Notwithstanding these positive aspects, the absence of formal designation of some of the laboratories and certain technical deficiencies in method validation, in particular in establishing decision limits, undermine the effectiveness of the overall residue control system.

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The audit team noted that, in the majority of the validation files scrutinised, some of the recovery values were outside the ranges set by EU legislation (32). Such outliers were noted and adequately analysed in a documented traceable manner in one of the validation files (33).

In two validation files (confirmatory methods for (i) thyrostats in urine, and (ii) anticoccidials in eggs and avian muscle), for some concentrations, contrary to the requirements of EU legislation (34), repeatability was greater than reproducibility. These events were not noted/analysed in the validation reports thus no assessment was done whether these occurrences could affect the method's fitness for its intended use.

In the vast majority of the validation files for unauthorised or prohibited pharmacologically active substances, the audit team noted that the calculation of CC had not been made either in line with EU requirements valid at the time of the validation or in line with the legal provisions valid at the time of the audit (35). (30) 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. (31) Part 4.3. of Annex I to Regulation (EU) 2021/808. (32) Part 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (33) In their response to the draft report, the competent authority noted that validation reports have been improved to include sections for acceptability criteria and status ­ where the acceptability criteria are not satisfied, such outliers are considered and documented in a traceable manner. (34) Part 1.2.2.2. of Annex I to (EU) 2021/808. (35) Part 2.6.1. of Annex I to Regulation (EU) 2021/808. 11 Representatives of all four laboratories interviewed explained that an alternative approach had been pursued due to the difficulty to confirm the calculated CC values experimentally. However, only one laboratory could provide documentary evidence of such experiments. The principal approach used in laboratories was to adopt the lowest calibrated level as CC, which is not fully in line with the rules laid down in EU legislation (36) During the audit, one laboratory committed to follow method 3 for the calculation of CC in the future. (37)

In two validation files (for anticoccidials (group B2b) in eggs and avian muscle, and for diflubenzuron and teflubenzuron (group B2f) in aquaculture), the CC values were calculated for obsolete MLs/MRL (38), i.e. for maduramicin, CC was 2.33 µg/kg while the ML in eggs is 12 µg/kg); for nicarbazin CC was 104.10 µg/kg while the ML in eggs is 300 µg/kg, and for diflubenzuron CC was 1161 µg/kg while the MRL in Salmonidae is 10 µg/kg (39)). Consequently, the methods for those substances were not appropriate for the purposes of residue monitoring and determining compliance with applicable limits. During the audit, the DAFM stated that it would request each laboratory to sign up for notifications to amendments of pertinent EU legislation so that such errors would not re-occur. In addition, the DAFM would also monitor amendments to the same legislation and notify laboratories accordingly. (40)

In one laboratory, the audit team noted that ruggedness was not formally checked as part of the validation protocol. The laboratory documentation stated in general that other procedures in place could demonstrate method performance and fitness of purpose. However, no summary/conclusion of relevant studies carried out was presented in the validation files seen in that laboratory. Such an approach is not in line with pertinent EU requirements (41).

With regard to all four laboratories, the audit team noted that stability of analyte(s) in solution was in general properly addressed. However, in a number of methods scrutinised, the analyte(s) stability assessment in matrix was missing, which is not in line with EU requirements (42). Combined with the absence of any temperature check of the incoming samples (see finding 47), 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 determined again by the concerned laboratory (43). (36) Part 2.6.1 of Annex I to Regulation (EU) 2021/808. (37) In their response to the draft report, the competent authority noted that after the audit, the laboratory included CC verification in its procedures where in case of unauthorised or prohibited pharmacologically active substances method 1 as laid down in point 2.6 of Annex I to Regulation (EU) 2021/808 was applied or would alternatively use method 3. (38) Annex to Regulation (EC) No 124/2009; Table 1 of the Annex to Regulation (EU) No 37/2010. (39) Table 1 of the Annex to Regulation (EU) No 37/2010. (40) In their response to the draft report, the competent authority noted that the laboratory had its own system for keeping abreast of MRL and legislation changes, had been aware of the MRL changes, and that the methods would be fully validated in accordance with Regulation (EU) 2021/808 to the current MRLs. (41) Part 2.4. of Annex I to Regulation (EU) 2021/808. (42) Part 2.5. of Annex I to Regulation (EU) 2021/808. (43) Part 2.1. of Annex I to Regulation (EU) 2021/808. 12

The fact that all laboratories are accredited, that the analytical methods used are included in their respective scopes of accreditation, that adequate internal quality controls are in place and that the laboratories have satisfactorily performed in proficiency tests, provide assurances to the competent authority on the reliability of results generated. Notwithstanding these positive aspects, the absence of formal designation of some of the laboratories and certain technical deficiencies in method validation, in particular in establishing decision limits, undermine the effectiveness of the overall residue control system.

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In line with the requirements of Articles 109 (1) and 110 (1) of Regulation (EU) 2017/625, the thesis for animal welfare is at the heart of the DAFM's strategy, the MANCP. The (2018-2022) MANCP, section 1.2, includes the National strategic objectives with two of these objectives being relevant for animal welfare: Objective 2: The enforcement of food and feed law, animal health and animal welfare rules and plant health rules. Objective 4: The co-ordination of official controls, to ensure effective and efficient implementation at national, regional and local level official controls are carried out regularly, on a risk basis and with appropriate frequency, impartiality, quality and consistency of official controls In addition, in section 4.1, it describes the specific objectives for animal welfare: Ensure compliance with EU and national legislative requirements Improve the health status of farmed animals Ensure the welfare of animals on farm 3 There is no further description of how to achieve those objectives (by means of breaking them down to operational objectives) and how to demonstrate the extent of meeting those objectives. The authorities have not set baselines to measure the outcomes for animal welfare objectives in the MANCP. It also does not detail how the prioritisation of official controls and allocation of resources reflect those objectives contrary to the requirement of Article 110 (2) of Regulation (EU) 2017/625.

DAFM has not translated its objectives into operational objectives and there is no indication on how the prioritisation of official controls and allocation of resources reflect those objectives. With this, DAFM misses the opportunity to demonstrate the level of compliance with AW legislation ensured, whether they are meeting their objectives and achieving demonstrable animal welfare improvements at farm level.

The FPD Programme for broilers uses slaughter plant data since 2017 and is designed as follows: Each incidence over 50% FPD in a slaughter cohort triggers a welfare notification that is received centrally. Previously, the cut-off point was 70% but it was amended reflecting improvement of the recorded performance. This notification is collated in a database to generate a league table of flocks or houses, At RVO level, they choose the flocks or houses at the top of the league- i.e. the ones with more problems. The officials open a FPD "Case" for the flock/house identified. The Case is followed with a regulatory visit and either the farm takes effective measures to address the welfare deficits identified or the officials close the house until the operator submits an action plan dealing with the outstanding welfare deficits. Following an FPD visit, the farmer is informed of the observations made and the welfare deficits identified. If the officials raise observations on three visits then 4 http://www1.clermont.inra.fr/wq/index.php?id=protocol&prod 10 they identify the flock house as non-compliant. In this way, the number of houses that are persistently associated with FPD will decrease over time. Thus, a baseline of FPD incidence has been established. The current target is to achieve the elimination of 5-10 flock houses each year from the top of the league table. The described methodology is not formalised in a procedure nor is FPD referred to in the MANCP or linked to a strategic objective.

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and allocation of As detailed in the final audit report (Finding 3), DAFM has an established ves of the methodology for setting out detailed objectives and performance indicators in its quired in Divisional Annual Business Plans. The Annual Business Plan for the Animal Welfare Division (Division responsible for implementation of animal welfare controls) for 2021, sets out operational objectives relating to animal welfare and aligns them to the strategic objectives in DAFM's Statement of Strategy and, where relevant, the Programme for Government. Operational objectives are also devised to ensure the very high-level objectives for animal welfare included in the MANCP are also addressed. The business plan also includes performance indicators which are used to measure the extent to which operational objectives have been achieved at the end of the year. As discussed during the audit, the Animal Welfare Division is in the process of developing a new approach to animal welfare controls to take account of developments around the use of animal-based indicators for assessing animal welfare in particular. Welfare assessments for broilers and pigs are already well developed and the priority fo

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DAFM introduced a new checklist for broiler inspections that focusses on legal requirements related to footpad dermatitis (FPD). Whilst this is very comprehensive for FPD, it does not cover all the legal requirements of Council Directive 2007/43/EC e.g. mortality. This means that it cannot fully serve as the tool to ensure compliance by checking and identifying different animal welfare issues at broiler farms. In addition, there is currently no instruction/procedure in place for the performance of official controls on broiler welfare at the farms. The available material for inspectors is a training presentation dating back to 2012, which means that apart from this not being a procedure, several essential points are outdated or missing contrary to the requirements of Articles 5 and 12 of Regulation (EU) 2017/625.

DAFM introduced a new checklist for pig farm inspections that focusses on legal requirements related to tail docking. This too does not cover all the legal requirements of Council Directive 2008/120/EC and therefore cannot serve as a tool to ensure compliance with animal welfare requirements. 4

The competent authorities (central and regional level) supervise the performance of official controls. To date, none of the audits or supervision activities (or other means of verification e.g. analysis) have assessed the system for setting objectives and indicators (measurement system) and its performance. The supervision activities lack a control verification procedure, contrary to the requirement of Article 12 (2) of Regulation (EU) 2017/625. A draft procedure for the verification of effectiveness of official controls is currently under internal consultation. DAFM officials described a challenge in ensuring consistency of official controls with a meaningful example: finding many non- compliances might mean a more thorough inspection, and/or a problematic farm. On that, each inspection report must be reviewed and signed off by the supervising officer. In addition to the provision of training, veterinary inspectors from the Central Competent Authority will on occasion accompany RVO inspectors during welfare inspections in order to verify the correct implementation of inspections. There have been numerous on-site training/verification sessions for these inspections, the Pig Tails Pilot, Dairy Herds, FPD Visits and pre-registration of pig holdings inspections, to ensure consistency in application of new regulatory methods.

DAFM has not translated its objectives into operational objectives and there is no indication on how the prioritisation of official controls and allocation of resources reflect those objectives. With this, DAFM misses the opportunity to demonstrate the level of compliance with AW legislation ensured, whether they are meeting their objectives and achieving demonstrable animal welfare improvements at farm level.

In this respect, the system follows the use of an evidence-based approach by making use of the existing statistics, administrative data and the proposed monitoring framework. Reporting of welfare issues found in the broiler slaughterhouses provides an informational basis for the RVOs that receive it. However, to be effective, this aspect requires clear guidance and an appropriate follow-up mechanism so that in certain cases farms that present a certain degree of animal welfare deficiencies undergo closer monitoring and if needed inspections and further enforcement. The lack of arrangements in this respect and the non-binding nature of the reports forwarded from slaughterhouses means that DAFM does not take corrective actions based on these reports. This is not in line with the requirements for follow-up described in Annex III to Directive 2007/43/EC and reduces the impact of the official controls.

DAFM has put in place a range of tools and developed methodologies in order to gather information and report the results of the official controls internally and to the stakeholders, including the EU Commission. Reporting does not fully support the development and use of indicators, which means that DAFM misses the opportunity to integrate the available data and tools in order to reflect the overall status of animal welfare at farms and improve it.

The inadequate enforcement of certain legal requirements (pig stocking densities, routine tail docking in pigs) and the lack of arrangements to ensure that actions are taken as a follow-up to monitoring at the slaughterhouse (broiler sector) reduce the effectiveness of the official controls. 9

The FPD Programme for broilers uses slaughter plant data since 2017 and is designed as follows: Each incidence over 50% FPD in a slaughter cohort triggers a welfare notification that is received centrally. Previously, the cut-off point was 70% but it was amended reflecting improvement of the recorded performance. This notification is collated in a database to generate a league table of flocks or houses, At RVO level, they choose the flocks or houses at the top of the league- i.e. the ones with more problems. The officials open a FPD "Case" for the flock/house identified. The Case is followed with a regulatory visit and either the farm takes effective measures to address the welfare deficits identified or the officials close the house until the operator submits an action plan dealing with the outstanding welfare deficits. Following an FPD visit, the farmer is informed of the observations made and the welfare deficits identified. If the officials raise observations on three visits then 4 http://www1.clermont.inra.fr/wq/index.php?id=protocol&prod 10 they identify the flock house as non-compliant. In this way, the number of houses that are persistently associated with FPD will decrease over time. Thus, a baseline of FPD incidence has been established. The current target is to achieve the elimination of 5-10 flock houses each year from the top of the league table. The described methodology is not formalised in a procedure nor is FPD referred to in the MANCP or linked to a strategic objective.

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ments of DAFM has developed a written procedure to provide guidance to DAFM staff on U) 2017/625, the cross-cutting issue of control verification procedures. The document, which was presented in Draft format during the audit ("Control Verification Procedures") has been finalised. It presents a documented procedure on the actions necessary l controls and to ensure the effectiveness and consistency of all official controls including a requirement for data collection and analysis in order to monitor the extent to which operational targets have been met. The procedure also requires Divisions ntrols and to review and interpret the results of official controls and to report on the extent to which the controls were effective and whether the objectives set out in the Divisional Business Plan were met. The report will identify any shortcomings or Page: 2 received 30 April 2021 to the recommendations of report ref. DG(SANTE) 2020-6961 of the audit carried out from 23 November e use of quality controls and indicators for animal welfare Action Proposed by the competent authority 27, 28 potential for further improvement. The report may also include recommendations to be addressed in the context

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The competent authority has put in place a methodology to base its controls on risk. The planning process differentiates between species and it prioritises based on risks deployed by the competent authority. The central level issues lists of flocks/herds for targeted welfare inspections to DAFM's Regional Veterinary Offices (RVOs) on an annual basis. The majority are selected on a risk basis. The parameters they use to assess risk include for example: Herd/flock size; Movement/birth/mortality rates; A Cross Divisional Animal Welfare Report for that herd/flock (a system identifying a herd/flock at an animal market, slaughter plant, assembly centre, etc. as a welfare risk and reporting the flock to the relevant RVO for follow up); Local knowledge and compliance history; Presence of a specific welfare indicator e.g. tail docking in pigs, FPD in broilers. Identifying farms with a heightened risk of non-compliance and determining the reasons behind the deficiencies at farms is an evidence-based process. The available information reflects the picture at the farms and can support informed decisions on planning of official controls. However, the risk prioritisation of controls does not consider all relevant factors described in Article 9(1) of Regulation (EU) 2017/625 for risk basis of official controls. In addition, DAFM has not defined what the regular and appropriate frequency of controls is.

The evidence and risk-based prioritisation system for official controls is systematic and focussed but it does not consider all necessary factors and has not defined the regularity and appropriate frequency of the official controls. Therefore, they might use wrong or incomplete assumptions when selecting the farms to control.

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controls DAFM will review its system for selecting herds/flocks for risk based controls in ar and relation to all species. This review will take account of the risk factors listed in ne with Article Article 9(1) of Regulation 625/2017. As part of this review DAFM has already opened discussions with external groups, including operators of private quality assurance schemes, to put in place a mechanism whereby data on animal welfare risks can be shared and included in the decision making process of selecting herds/flocks for risk based inspections. As detailed in the audit report (finding 11) there is a system in place whereby DAFM staff carrying out cross compliance controls can report animal welfare issues to staff with primary responsibility for animal welfare and vice versa. However there is scope for more collaboration between the relevant sections on Page: 3 received 30 April 2021 to the recommendations of report ref. DG(SANTE) 2020-6961 of the audit carried out from 23 November e use of quality controls and indicators for animal welfare tion Proposed by the competent authority imal welfare and this will be further explored by the Animal welfare Division ring 2021. ecifically in

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In this respect, the system follows the use of an evidence-based approach by making use of the existing statistics, administrative data and the proposed monitoring framework. Reporting of welfare issues found in the broiler slaughterhouses provides an informational basis for the RVOs that receive it. However, to be effective, this aspect requires clear guidance and an appropriate follow-up mechanism so that in certain cases farms that present a certain degree of animal welfare deficiencies undergo closer monitoring and if needed inspections and further enforcement. The lack of arrangements in this respect and the non-binding nature of the reports forwarded from slaughterhouses means that DAFM does not take corrective actions based on these reports. This is not in line with the requirements for follow-up described in Annex III to Directive 2007/43/EC and reduces the impact of the official controls.

The inadequate enforcement of certain legal requirements (pig stocking densities, routine tail docking in pigs) and the lack of arrangements to ensure that actions are taken as a follow-up to monitoring at the slaughterhouse (broiler sector) reduce the effectiveness of the official controls. 9

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ler welfare at A Standard Operating Procedure for carrying out controls in broiler flocks relating rm level, in to Footpad Dermatitis (FPD) is currently being finalised. It includes a step by step ocedure for carrying out FPD inspections including the follow up actions quired in the event of welfare deficits being identified, ultimately ending in legal nctions if the deficits are not addressed by the keeper. It it envisaged that the itten procedure will finalised within the next month. e of the operational objectives for DAFM during 2021 is to carry out a number targeted inspections on broiler flocks relating to FPD. Flocks have already been lected based on the frequency of FPD detection at slaughter (in other words om the top of the FPD league table) and have been issued to DAFM's Area nagement Teams for implementation. Inspections will be carried out by ecifically trained Official Veterinarians in line with the standard operating ocedures mentioned above, in order to ensure a consistent approach to the spections and the follow up actions taken. the FPD inspections described above do not address all aspects of Directive 07/43/EC, a number of additional inspections will be carried

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Similar to the broiler sector (finding 23), DAFM does not always ensure that pig holdings comply with the requirement laid down on Article 3(1) of Council Directive 2008/120/EC on stocking densities, as, on the basis of the data presented, there is strong evidence of overstocking on pig farms

Most recently introduced (November 2020), the Intact Tails Programme aims to address the issue of routine tail docking in Irish pig farms. Nearly all commercial herds in Ireland rear pigs with docked tails contrary to the requirements of Directive 8 2008/120/EC. A new ante mortem/post mortem system will provide data for herds presenting pigs with docked tails for slaughter. DAFM envisage that in the future, these data will inform the risk-based approach applied to regulatory visits. At the moment, since the number of commercial pig herds in Ireland is not large, a randomised, area- based approach is used for selecting herds for Intact Tails visits.

The inadequate enforcement of certain legal requirements (pig stocking densities, routine tail docking in pigs) and the lack of arrangements to ensure that actions are taken as a follow-up to monitoring at the slaughterhouse (broiler sector) reduce the effectiveness of the official controls. 9

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oldings comply DAFM has developed a programme of pig welfare controls namely the Intact Tails ouncil Programme, in order to address the issue of routine tail docking on Irish pig farms. th the The inspections, which are carried out by specifically trained Official Veterinarians, on of look to identify the specific welfare deficits associated with tail biting in a weaner and fattener pen in each pig farm visited. After each inspection the keeper is notified of the deficits identified and instructed to take actions to address each one. The programme is collaborative and aims to give keepers the opportunity to comply with the regulations before legal sanctions are initiated. The programme involves a series of up to four visits at 6 monthly intervals which ensures that progress on each pig farm can be closely monitored. The final Standard Operating Procedure for the programme is included with this submission. Implementation of the programme commenced in November 2020. During 2021 the programme will be extended to include at least one third of all commercial pig herds. Lists of herds for inspections under the programme have already been issued to DAFM's Area Management Teams for impleme

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Relevant guidance documents (see finding 16) contain instructions on controls of retained samples (i.e. those to be taken and kept by FeBOs from ingredients and final 6 products manufactured). The audit team checked some of these samples randomly, and all of these had been appropriately taken, labelled and kept under control in dedicated storage places. These retained samples from feed additives and premixtures were kept at least for six months or until the end of the shelf-life of the products produced with these ingredients. Retained samples of compound feeds were kept at least for three months or until the end of the shelf-life of the produced products. The samples had not been sealed properly except at one FeBO visited. In two compound feed producers visited, retained samples were not taken from amino acids used for production. This is not in line with the requirements of point 4 of Annex II "QUALITY CONTROL" to Regulation (EC) No 183/2005. Previous inspection reports in these establishments did not mention this non- compliance. 5.2.1.4 Labelling

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. The effectiveness of the inspections is weakened by incomplete verification of the appropriateness of retained samples in compound feed manufacturers and observed shortcomings in officials' verification of the correctness of labelling of feed additives and premixtures particular in relation to products originating from outside of Ireland. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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ess - Feed Business Operators will be informed by way of Trader Notice of the requirement to retain samples of additives used in the manufacture of compound feed and of the requirement for all retained samples (ingredients and manufactured product) to be adequately sealed. - Inspection guidance documents and inspection report forms will be updated as necessary to enable verification of compliance - Training will be provided to staff on updated guidance and inspection documents and procedures - Deadline for completion ­ 30/11/19

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The audit team also checked documentation/labelling of imported feed additives and noted that generally these products fulfilled the relevant authorisation requirements laid down by Article 3 of Regulation (EC) No 1831/2003. Some exceptions were identified relating to amino acids (no information on the bacterial strain used). The competent authority had overlooked these non-compliances during previous official inspections.

The audit team noted that, at the FeBOs visited, the labelling control focused on the final products but not on feed additives, premixtures used during the production. At the time of the audit, the audit team identified numerous shortcomings relating to labelling of feed additives/premixtures used as ingredients for production and some shortcomings relating to the labelling of premixtures and complementary feeds produced in the majority of the establishments visited. Most labelling shortcomings related to products originating from outside Ireland and these had been overlooked during previous inspections. Examples of non-compliances included: 7 The functional group of feed additives were missing on the labels of feed additives, which is a legal requirement of Article 16(1)(a) of Regulation (EC) No 1831/2003. Safety recommendations regarding the use and/or specific requirements mentioned in the authorisation of the feed additive were not labelled which is a legal requirement of Article 16(1)(e) of Regulation (EC) No 1831/2003. Name or business name and address of business/person responsible for the production/import/trade of feed additive was not on the label which is a legal requirement of Article 16(1)(b) of Regulation (EC) No 1831/2003. The use of certain premixtures containing vitamin A in accordance with the labelled instruction would lead to the established maximum levels of vitamin A in complete feed for fattening pigs being exceeded, which is contrary to the requirements laid down in Commission Implementing Regulation (EU) No 2015/724. Labelling of mixture of feed additives did not contain the approval number of the importer/trader company which is a legal requirement of Article 16(1)(d) of Regulation (EC) No 1831/2003 and the word premixture which is a legal requirement of Article 16(4) of Regulation (EC) No 1831/2003. Based on a dosage instruction of a complementary feed the daily intake of a feed additive was lower than the minimum required in the authorisation of the additive in Commission Regulation (EC) No 537/2007. Conclusion on the planning and implementation of inspections

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. The effectiveness of the inspections is weakened by incomplete verification of the appropriateness of retained samples in compound feed manufacturers and observed shortcomings in officials' verification of the correctness of labelling of feed additives and premixtures particular in relation to products originating from outside of Ireland. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

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ess - Feed Business Operators will be informed by way of Trader (b) Notice to have appropriate control systems in place to ensure that all feed additives and premixtures under their control (including feed additives and premixtures imported from third countries and other MSs) are labelled in accordance with Regulation (EC) 1831/2003 - Inspection guidance documents and report forms will be updated to: (i) incorporate an increased frequency of checks to verify compliance of feed additives and premixtures with labelling requirements under Article 16 of Regulation (EC) No 1831/2003 and (ii) to enable the verification that the conditions for use of additives as set out in Regulation 1831/2003 and in the authorisation of the specific additives are met - Training will be provided to staff on updated guidance and inspection documents and procedures - Deadline for completion ­ 30/11/19 Page: 1 port ref. DG(SANTE)/2019-6630-MR of the audit carried out from 25 March s, their ingredients and traceability Action Proposed by the competent authority

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Local inspectors met had a good knowledge of official sampling requirements laid down in Regulation (EC) No 152/2009 including the concept of 'sampled portion' and calculation of incremental samples. Local inspectors use a sampling protocol for official sampling. This protocol contains information ­ among others ­ on the type of product, the target species, the total quantity of the product and the size of the sampled portion, which is in line with the requirements of points 10 of Annex 1 to Regulation (EC) No 152/2009. Local inspectors have to specify if the sample was taken for detection of Salmonella and/or for other specific analyses (e.g. priority analyses). The audit team noted that since normally the feed headquarters decides on the substances to be checked for (see finding 33); the samplers are not always in position to decide whether to follow the procedure for heterogeneous or homogeneous distribution of substance(s). Conclusion on the planning and implementation of sampling

The system in place for planning of official sampling is effective and risk-based. However, while the competent authorities are in principle capable of ensuring the representativeness of the samples, the policy of the headquarters deciding on the substance to be tested for, the samplers do not know in advance which procedure they should apply and thus, sampling may not always be representative for the substance in question. 5.2.3 Actions taken on non-compliances

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- To take account of the heterogeneous or homogeneous distribution of the substance(s) being checked for, sampling procedures will be updated to ensure that samplers are aware of what procedure to apply (for either heterogeneously or homogeneously distributed substances) for each sample to be taken. - Sampling procedures will also be updated so that the sampling report forms will include details of the sampling procedure undertaken (heterogeneous or homogeneous distribution) and details on the number of incremental samples. - Training will be provided to staff on updated sampling procedures and report forms - Deadline for completion ­ 30/11/19

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The audit team encountered one instance where a non-EU authorised mixture of feed additives was exported to a number of countries. The FeBO demonstrated that one importing country`s competent authority had listed the product, thus the requirements of Article 12 of Regulation (EC) No 178/2002 were met. However, the FeBO could not demonstrate that this was the case for other importing countries. The Irish competent authority could not provide additional information on this issue because previous official controls had not included verification of implementation of this obligation. This is not in line with the requirements of Article 12 of Regulation (EC) No 178/2002. Conclusion on establishments producing/trading non-authorised (in the EU) feed additives but are exporting or re-exporting them from the EU to a non-EU country

In one instance seen, official controls did not identify that the competent authorities of the relevant non-EU countries had not expressly agreed to the placing on their territory of non-authorised (in the EU) mixture of feed additives. 11

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- Feed Business Operators involved in the export of feed additives/premixtures to third countries will be informed by way of Trader Notice of the requirements under Article 12 of Regulation (EC) No 178/2002 including the requirement that the export of non-authorised feed additives can only take place if the competent authority of the country of destination has expressly agreed to the placing on the market of such products on their territory - Inspection guidance documents and report forms will be updated to enable DAFM verify compliance of Feed Business Operators with this requirement - Training will be provided to staff on updated guidance and inspection documents - Deadline for completion ­ 30/11/19 nts ­ who are inspectorate staff of the feed headquarters of the DAFM ­ are f FeBOs'. For the purposes of clarification, District Superintendents are not part announced audits are carried out by Feedingstuff Inspectorate staff. The role of carried out by Supervisory Agricultural Officers (local inspectors). Page: 2

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DAFM is finalising an information leaflet to assist keepers with implementation of equine legislation. The leaflet is designed to outline the requirements of identification, medicinal treatments, eligibility for slaughter, updating of passport information, return of passports on death of an equine and change of ownership. The information leaflet will be freely available on the of Department's website in Q1 in 2020 and in Regional Veterinary Offices. The leaflet will be distributed to: each registered equine premises; approved PIOs for inclusion with each new passport issued to keepers from a given date; and a wide range of equine stakeholders, for circulation to clients, members and members of the public, in early 2020. The list of equine stakeholders includes - Auction Houses and Marts Equine Retail Outlets Equine Transporters Farm Organisations Irish Equine Centre Irish Horseracing Regulatory Board Irish Racehorse Trainers Association Irish Thoroughbred Marketing Irish Thoroughbred Breeding Association Horse Fair Organisers Page: 1 eport ref. DG(SANTE)/2019-6669-MR of the audit carried out from 07 May ng the production of horse meat including traceability Action Proposed by the c

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In case of change of ownership national legislation requires the purchaser to notify the issuing PIO of the new owner's details. In this regard the CAs and PIOs visited stated that the change of ownership is very seldom transmitted to the PIOs for endorsement and therefore updated in the passports. One of the PIOs visited stated that cases occurred where up to ten different owners have been keeping horses before ownership was finally updated in the passport and in the PIO's database. As a consequence of this omission, the PIO database and the AIM are not recording updated data.

The procedure for the handling of the passports is as follows: a. Passports of dead or slaughtered horses have to be returned to the issuing PIO or to the AIMs offices respectively. In case of dead animals, it is the keepers' responsibility to inform and send the passport to the issuing PIO. b. For slaughtered animals: passports have to be made invalid by stamping or cut by VI and then returned to the AIM (which in turn may destroy or return them to the issuing PIO, in accordance with specific procedures agreed with each PIO). c. For animals dead or euthanized in other locations (e.g. farms, race courses, veterinary clinics, etc.): if the passport is available it should accompany the dead animal to the knackery, however the Irish Horse racing Regulatory board might send it directly to the PIOs. 12

The fact that a number of horses are not yet identified, together with the late identification of horses after the compulsory period of time (12 months) highlight that the owners/keepers do not consistently meet their obligations on horse identification and recording of changes in ownership. Nonetheless, the automatic exclusion from the food chain of horses which were registered late of for which duplicate or replacement passports were issued, mitigates potential risks in the production of horse meat.

A database for containing data about the registration and identification of horses is kept at central level and is updated with information from the PIOs and the slaughterhouses. Even if the database provides for the recording of all the information required under EU rules. The information contained is not sufficiently sanitary requirements on intra-EU trade and importation of animals, semen and embryo, food, feed and plants. https://ec.europa.eu/food/animals/traces_en 17 accurate/reliable as relevant provisions (notably Artt. 12, 27 and 35) of Regulation (EU) No 2015/262 are not consistently adhered to, thus jeopardising the controls on horse identification and movements. Conclusions on official controls on horse identification and movement controls cont.

Rules are in place for keeping track of movements of horses; however, due to the unreported changes of ownership(s), to the frequent movements within the country, the free movements for different reasons and under certain rules (TPA) and, in some cases, for a temporary period of time, the CA is not in a position to ascertain reliably their movements.

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Checks will be carried out at veterinary practices as part of the rall checks on medicines usage. There are a small number of quine only practices and a number of these will be targeted for f inspection in 2020. The attached documents will be finalised for are use in these inspections. The inspections will be carried out by the AMTs. he Additional form to accompany On Farm Equine Medicines Inspection Report.doc Page: 2 eport ref. DG(SANTE)/2019-6669-MR of the audit carried out from 07 May ng the production of horse meat including traceability posed by the competent authority eds Insp itional info for Practice inspections.doc edicines ints One Pager.docx under Point. No. 1, information on the use of medicinal ill be included in the DAFM leaflet, clearly setting out sibilities on the treating veterinarian and keepers in o the proper protocol for recording of medications. so reviewing the derogation under Article 37(5) of o 2015/262 with a view to determining if it can be o facilitate compliance with the relevant legislation. e enforcement action will be taken on foot of findings pliance.

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The CCA and CAs met explained that even if there are legal basis and procedures for applying sanctions, it is sometimes challenging to enforce the requirements of the legislation in the sector audited, mainly due to difficulties in carrying out official controls for detecting some non-compliances and gathering the proof to support them. Moreover, in cases of alleged fraud it is difficult to prove intent, responsibility and risk for public health. For instance, in their view the following obligations are difficult to enforce: The registration of medical treatments in the passports (see also paragraphs 34, 110 and 136.a); The change of ownership must be communicated by the new owners to the PIO and registered (see also paragraph 45); The passport accompanying the body of dead animals, e.g. to knackeries, often animals are received without passports (see also paragraphs 46.b and 47.b) The notification of the movement of horses leaving the territory or when dead (see also paragraph 60). 8 Conclusions on competent authorities

Both horse slaughterhouses visited have a register on the premises where the keeper verifies the identification of the horse(s), by cross-checking the transponder, the passport and querying the central DAFM database, prior to the formal introduction in the slaughterhouse. Horses that are found not compliant during this pre-screening must wait until their documents are corrected by the last owner, or are rejected and may leave the holding. In some cases the horses can remain in this holding for several days. In practice it operates as a marshalling centre; however, the CAs do not consider them as such and not posing a higher risk.3 The operators of the holding had neither a holding register nor records of medical treatments (see also chapter 5.4.3.1).

Exclusion of horses as food producing animals occurs in the following situations: a. According to the CAs, the FBOs and the racing authorities met, more than half of the horses in Ireland are in the passport declared irreversibly excluded from the food chain by the owner, the keeper or the PVP in case veterinary medicines not permitted in horses for human consumption have been administered to the animal. In this regard a trainer stated that he systematically excludes the horses when accepting an animal for training as this reduces the administrative burden for recording medical treatments, and that this is becoming quite a common practice. At the trainer premises and the knackery visited, the audit team could confirm this. b. The PIO must exclude the horse from the food chain when late registration (> 12 months old) occurs and in case a passport is duplicated. The PIO registers the exclusion in the passport and in the Central Equine Database (CED). 5.4.1.2 Identification verification (transponder)

A database for containing data about the registration and identification of horses is kept at central level and is updated with information from the PIOs and the slaughterhouses. Even if the database provides for the recording of all the information required under EU rules. The information contained is not sufficiently sanitary requirements on intra-EU trade and importation of animals, semen and embryo, food, feed and plants. https://ec.europa.eu/food/animals/traces_en 17 accurate/reliable as relevant provisions (notably Artt. 12, 27 and 35) of Regulation (EU) No 2015/262 are not consistently adhered to, thus jeopardising the controls on horse identification and movements. Conclusions on official controls on horse identification and movement controls cont.

In one of the slaughterhouses visited, Part 1 of the FCI is completed and signed by the keeper of the equine animal, Part 2 is completed and signed by the haulier and Part 3 is completed and signed by the FBO. In the other slaughterhouses visited, the FCI was always completed and signed by the FBO responsible for the holding adjacent to the 23 slaughterhouse. It was noted that the FCI never indicates the use of medicines and there was no indication that this information had been requested from the previous owner of the animal. The keeper met at one slaughterhouse explained that he relies on the oral statement and the information reported in the passports. None of the passports checked by the audit team contained a record of any medical treatment. Possible treatments at holdings of traders are not recorded. As a consequence, the reliability of the FCI cannot be properly verified. 5.4.3.2 Animal welfare

All PVP registered by the Veterinary Council are allowed to use veterinary medicines, including in cascade use, and they are the solely authorised persons to perform the identification by inserting the transponder and the verification of the markings. The CAs stated that it is PVPs' responsibility to prescribe the medical treatment and record it in the horse passport.

From the minutes of the meetings of the Equine Liaison Group of 2016 and 2017 it emerges that there are some concerns around the use of medication in the horse industry. Key areas needing particular attention were: a. Record keeping/recording of medicines administered in the passport and the non- availability of passports when animals are being treated, leading to the passport not being endorsed with medical treatments, as required; b. Accurate administration of medicines, particularly relating to the use of medicines (such as phenylbutazone) which can be mixed in with feed, leading to some of the treatments accidentally transferred to other horses for which it was not intended; c. Scarcity of approved medicines for horses, leading to the use of unauthorised/exceptional medicines, usually (but not necessarily) used via cascade rules and prescribed by PVPs.

The CA in the slaughterhouses carries out the verification of the eligibility of horses for slaughter for human consumption in a meticulous way, allowing the detection non- compliances and irregularities. The system ensures that only horses with correct identification and clearance for slaughter enter the food chain. However, the virtually complete absence of records of the medical treatments in the passports, together with the scarce verification of compliance with the requirements on prescription and correct recording of the applied treatments in the horse passports, reduces the confidence that only horses which are eligible for human consumption are presented for slaughter.

The official controls pay limited attention to the fate of the quite large amount of horses which are not eligible for slaughter for human consumption, and of the veracity of the information in passports concerning medical treatments. This diminishes the effect of the otherwise robust controls in the slaughterhouses. 29

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In one plant where there was an issue there was an immediate corrective action undertaken by DAFM as outlined in this letter: er plant a system was immediately put in place to ensure act and lungs cannot be placed in Cat 3 containers until Post Mortem Vet. n ongoing assessment of post-mortem by VI personnel er plants, and this serves to ensure compliance with 854/2004, and prevent recurrence of the findings Page: 3 eport ref. DG(SANTE)/2019-6669-MR of the audit carried out from 07 May ng the production of horse meat including traceability Action Proposed by the competent authority In addition, there has been training of new incoming personnel who will be undertaking post-mortem inspection and training of existing personnel is being planned to commence in 2020.

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The audit team noted that while the MANCP and annual reports include elements on official controls for PDO/PGI/TSG, no elements are included on the planning and performance of the official controls of GI spirit drinks.

The non-compliances considered as minor or directly addressed by the operators (under the supervision and follow-up of the competent CA) and not leading to formal sanctions or prosecution are not reported to DAFM. Therefore the annual report transmitted by DAFM to the European Commission services does not include all the non-compliances found. This is not in line with Article 40.2 of Regulation (EU) No 1151/2012. 6 Conclusions on Competent Authorities

The CAs' control activities and results are not all included in the annual report and in the MANCP submitted by Ireland to the European Commission. 5.2.2. Verification of compliance prior to placing on the market Legal requirements Article 37(1) of Regulation (EU) No 1151/2012 Articles 22(1) and 24 of Regulation (EC) No 110/2008 Findings

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Competent Authority (CA) Response: DAFM Reporting will be carried out in line with the requirements of Regulation 2017/625, with a particular focus on the requirements specified under Article 11 and Article 113 and the reporting in the Multi-annual national control plans (MANCP) and annual reports. (Completion Date ­ Q1 2020) DAFM CAs to record and report all non-compliances (including non- compliances considered as minor or directly addressed by the operators). (Completion Date ­ Q1 2020) HSE When requested, the HSE will report on the required data from completed official controls in respect of these reporting requirements. Revenue Revenue will provide, information on 'planning and performance of the official controls of GI Spirit Drinks' to the relevant CA's. CAs (DAFM, Revenue, HSE and FSAI): A meeting has been scheduled in Q1 2020, with the Competent Authorities (CAs) responsible for GI official controls (i.e. for both Spirit Drinks and Agricultural Products and Foodstuffs), in Page: 1 January 2020 of report ref. DG(SANTE) 2019-6703 of the audit carried out from 02 September ed to Protected Designation of Origin (PDO), Protected Geographical Indications ducts and foodstuffs and

nd DAFM (a) DAFM Reporting will be carried out in line Work Completed: DAFM have d with the requirements of Regulation included non compliances as part with a particular focus of the 2019 MANCP (filed in Q1 on the requirements specified under 2020) Article 11 and Article 113 and the o 7 Pre-Market reporting in the Multi-annual o 12 On the Market national control plans (MANCP) nnual reports. (Completion Date ­ Q1 2020) DAFM (b) DAFM CAs to record and report all non- Work Completed: Irelands 2019 compliances (including non- reporting return included non compliances considered as minor or compliances in return under directly addressed by the Section 10 of the Annual Report operators). submitted in 2020. (Completion Date ­ Q1 2020) FSAI HSE Progress on-going: When requested, the HSE will report on the required data from Due to COVID-19 a Cross-agency completed official controls in meeting planned in 2020 to discuss Page: 1 e recommendations (Updated) received 20 November 2020 nt authorities of Ireland in response to Report ref. DG(SANTE) 2019-6703 of the audit carried out from 02 September 2019 to te the control systems related to Protected Designation of Origin (PDO), Protected Geogra

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In the same Category 3 processing plant visited, a production line for Category 3 poultry blood has been in operation since November 2017. According to the business operator and from what was described in the relevant part of the operator's HACCP plan, the resulting poultry bloodmeal (a type of PAP) was being dispatched to another Member State to be used for the manufacturing of pet food and feed for aquaculture. However, the audit team noted that the competent authority had not yet given the relevant authorisation for the production of PAP to be used in aquaculture, which is necessary when a processing plant also processes ABP of ruminant origin, as laid down in Article 5 7 in conjunction with point (c) of Section D, Chapter IV of Annex IV to Regulation (EC) No 999/2001.

With the exception of (the very few) traders, the system of official controls covering producers, storage facilities and transporters of PAP is characterised by a relatively high frequency of inspections, is based on risk criteria, and supported by a comprehensive set 7 of procedures. A relatively high number of samples are also planned to verify that PAP to be used in feed are in line with relevant microbiological criteria and are free from non-authorised proteins of animal origin. However, insufficient attention has been paid to ensuring that processing plants producing PAP to be used in aquaculture and also processing ABP of ruminant origin on the same site are authorised by the competent authorities and inaccuracies identified in the certificates of approval and registration of some ABP plants and operators (also reflected in the relevant publicly available list) could undermine the overall reliability of relevant information available.

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By 31st August 2018, the Department of Agriculture Food and Marine will ensure that processing plants producing PAP for lture (which are not dedicated exclusively to processing non- ruminant ABP), will comply with the relevant conditions set out in Section D (c), Chapter IV of Annex IV to Regulation (EC) No 999/2001. By 31st October 2018, DAFM will authorise processing plants producing aquaculture, provided the relevant conditions are satisfied. By 31st October 2018, DAFM will publish on its website, an up-to - date list of approved processing plants producing aquaculture, in accordance with requirements of Section A(d), Chapter 5 of Annex V to Regulation 999/2001.

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However, in some cases, the audit team noted that the approval and registration certificates issued by DAFM did not reflect the actual products manufactured or handled, contrary to what is required by Article 47 of Regulation (EC) No 1069/2009 and did not follow the technical specifications as required by Article 32(5) in conjunction with point (3), Chapter II of Annex XVI to Commission Regulation (EU) No 142/2011. In particular, in a Category 3 processing plant visited, several processing lines were in operation. One was producing poultry PAP and another, mammalian PAP (containing also protein of ruminant origin). In the approval document, the list of products manufactured included only "poultry PAP", whereas mammalian PAP was described as "mixed offal meal". Moreover, in the aforementioned list, the wording "blood products" was used instead of "bloodmeal". The same inaccurate details were included in the relevant list of ABP plants. In another case, the registration certificate of a haulier visited, carrying only Category 3 PAP, referred to "meat and bone meal (MBM)" instead of PAP.

With the exception of (the very few) traders, the system of official controls covering producers, storage facilities and transporters of PAP is characterised by a relatively high frequency of inspections, is based on risk criteria, and supported by a comprehensive set 7 of procedures. A relatively high number of samples are also planned to verify that PAP to be used in feed are in line with relevant microbiological criteria and are free from non-authorised proteins of animal origin. However, insufficient attention has been paid to ensuring that processing plants producing PAP to be used in aquaculture and also processing ABP of ruminant origin on the same site are authorised by the competent authorities and inaccuracies identified in the certificates of approval and registration of some ABP plants and operators (also reflected in the relevant publicly available list) could undermine the overall reliability of relevant information available.

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By 31st August 2018, DAFM will review, and update as required, the val and registration of ABP premises and operators to ensure that the approval and registration certificates accurately reflect that the products manufactured and processes utilised as required by Article 47 of Regulation (EC) No 1069/2009 and Chapter II of Annex XVI to Commission Regulation (EU) No 142/2011 By 31st August 2018, DAFM will publish on its website an up-to-date list of registered and approved ABP plants and operators Page: 1 port ref. DG(SANTE)/2018-6334-MR of the audit carried out from 12 February traceability and trade requirements of processed animal proteins, including oposed by the competent authority

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In one Category 3 processing plant visited, a production line processing Category 3 poultry blood by using Method 7, was added in 2017 (see findings 10 and 11). The business operator had a largely comprehensive HACCP plan where relevant critical control points were described, and the operator had carried out a validation which included microbiological analyses of daily samples of finished product for one month, as required. This validation was considered satisfactory and subsequently authorised by DAFM following an inspection carried out after the validation period. However, the audit team noted the following: a) all analytical results for Clostridium perfringens were reported as "<10 c.f.u./g", which is different to the relevant provision laid down by Article 8 and point G(1), Chapter III of Annex IV to Commission Regulation (EC) No 142/2011, which requires "Absence in 1 g of product", and b) there were no records of the processing conditions when the samples were taken in either the validation file or in the inspection report, contrary to the provision laid down by point G(2), Chapter III of Annex IV to the same Regulation above. 8

Moreover, during a meeting in another RVO, the audit team noted that the validation of the processing Method 7 used by another Category 3 processing plant, where multi- species ABP (including ruminant ABP) were used as raw material, had been favourably assessed and authorised by DAFM on the basis of analytical results reported as "<10 c.f.u./g" as well. However, this PAP containing proteins of ruminant origin had been dispatched directly to pet food plants in Ireland, as required by Section I, Chapter II of Annex X to Commission Regulation (EC) No 142/2011.

Official controls on hygiene requirements during the production and trade of PAP are carried out largely as planned and followed-up as required. However, the competent authority has not paid sufficient attention to ensure that only eligible Category 3 ABP are used to produce PAP as feed material and there were weaknesses in the way in which the validation of operators' processing Method 7 was evaluated by the competent authorities. These shortcomings were partially mitigated by the operators' generally comprehensive HACCP plans for ABP and by the absence of issues, to date, resulting from monthly official samples of PAP tested for microbiological criteria.

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1st August 2018, DAFM will review the operations of ABP g plants using Method 7 to ensure they have complied with onditions laid down by Article 8 and point G, Chapter III of Annex mission Regulation (EC) No 142/2011, and will take te action as required, by 31st October 2018. 2004 method was used for elucidating Clostridium ns. All analytical results for Clostridium perfringens were as "<10 c.f.u./g", rather than negative in 1 g, because the aboratories diluted 1g sample in 1.10 solution, and test 1 ml ilution with a negative result. In future, before issuing an tion for a Method 7 processing method, DAFM will ensure siness operator will have demonstrated "Clostridium ns absent in 1 g of the products" over a 30 day sampling s required by the legislation.

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carried out the following actions: mmediately issued legally binding Compliance Notices od Business Operators (FBOs that were found to be Category 2 digestive tract material with Category 3 -Product (ABP). ssued a Trader Notice (TN 2/2018) to all slaughter plant ness Operators (FBOs) on the correct categorisation of tract content as Category 2 Animal By-Product (ABP). _correct ation of Digestive Tract Content as cat 2 ABP.pdf er Notice clearly points out to FBOs that digestive tract Page: 2 port ref. DG(SANTE)/2018-6334-MR of the audit carried out from 12 February traceability and trade requirements of processed animal proteins, including ty uct and cannot be included ce also points out that Service (VPHIS) staff will tegory 2 digestive tract content BP. tice (VPN 5/2018) to all ABPs ility in correctly g of each appropriately. The staff and the official must use to verify ticularly the classification plants. nsible for verifying that s are correctly implemented notice on the category ve contents was observed in om these plants was ry 1 processing plant. ce (TN02/2018) to y category 3 ABP may be ants, and that the intake or 2 ABP, including digestive ring plant is prohibited, and is

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All CAs reported a shortage of resources over recent years, which according to the CAs and the internal audit reports seen led to not achieving the target for planned controls and occasionally to reducing the official samples for process hygiene criteria (limited staff at laboratory level as well). All CAs reported progress in hiring new staff after the ban on recruitment of public servants in Ireland was lifted. Currently, most CAs achieve targets above 90% of the planned controls with efforts being made to ensure a swift handover and training of new staff.

In contrast, certain difficulties in this respect are still encountered in SFPA. Figures emanating from the new quantification system (see paragraph 20) indicate that SFPA achieved 71% of the overall planned official controls, and 60% of the controls in high risk RTE food producing FBOs. The figures indicate that the two regions with the 7 highest number of FBOs have the lowest rate of implementation of controls (43% and 57%).

The same quantification system highlights that the FBOs producing high risk RTE fishery products have amongst the lowest rates of implementation of SFPA controls (between 29% and 39%) compared to other types of FBOs in the regions with the highest number of FBOs. The highest rate of implementation of controls concerned FBOs producing low risk non-RTE foods, which was explained by the lower number of scheduled controls. In most cases, FBOs had been subject to controls at a minimum of once per year in 2017, with only a small number of RTE food producing establishments receiving no official controls in 2017

The SFPA resource challenge had been identified by FSAI in a 2016 audit and work has been done to quantify it through the new quantification system, resulting in the data provided in paragraphs 10 and 11, but the corrective action is outstanding. SFPA attributed this to a lack of staff, difficulties in recruiting also due to budgetary constraints as well as the fact that SFPA is undergoing a management reorganisation.

Challenges were identified in particular in relation to the availability of personnel resources, aspects of training and verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings which identified some of these issues, may and sometimes do impact on the controls over the production of RTE foods, to a greater extent for SFPA.

The controls are largely implemented by the CAs as planned, with the risk based frequency, mainly without prior warning. However, in the case of SFPA, while the planned frequency of controls in establishments producing high risk RTE fishery products is three times per year, the implemented frequency in 2017 was approximately once per year - the same as for establishments producing low risk RTE - in the regions with the highest numbers of FBOs.

The similar level of implemented controls for all types of FBOs in these two regions, despite having been assigned different inspection frequencies on the basis of identified risks, together with the limited attention given to new approvals in another region (see also paragraph 30) suggest that SPFA, in the face of dealing with limited resource and with multiple tasks may have to look again at the prioritisation process to ensure resource for higher risk facilities within and between regions. 4.4.1.2 Procedures for official controls

SFPA highlighted that the joint controls between SFPA official controls staff support the identification of shortcomings and gave an example of one region where 80% of the inspections are joint inspections. However, in one of the regions with the highest number of FBOs, 1% of the inspections were explained by the CA to be joint inspections. The CA highlighted a constant increase in the number of fishery establishments in the busy regions.

No official control officer was assigned to one of the fishery establishments visited by the audit team. No official controls had been carried out in this establishment in the past year, although three were planned. Several non-compliances were noted on the day of the audit team visit, including some long standing ones.

Each CA has put in place a system of risk based official controls over production of RTE foods, supported by procedures and covering relevant aspects of the legislation. Most establishments producing RTE products are placed in the "high risk" category, reflected in a higher frequency of controls which is largely achieved by the CAs, except SFPA.

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SFPA - Since the audit, the SFPA has recruited 13 additional Sea- Fisheries Protection Officers (SFPOs). These SFPOs are currently undergoing training and will be deployed to regional port offices in early 2019. This will see SFPO staff numbers in the two regions visited as part of the DG (Sante) audit increase from 7 to 11 (3 new SFPOs assigned and one SFPO reassigned from a different region) and from 5 to 10 (5 new SFPOs assigned), respectively. Trainee SFPOs come from diverse backgrounds and have worked in areas such as fisheries, veterinary medicine, farm quality standard auditing, environmental protection and food production. See the SFPA response to Recommendation No. 2 for details of training. There are plans to recruit and train more SFPOs in 2019. FSAI FSAI will monitor close out of this finding through the service contract liaison process with SFPA. SANTÉ F close-outs (as well as other audit items) are a standing item on the agenda of these meetings with SFPA.

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While the official control staff met were experienced and in general trained and knowledgeable for their field of work within the scope of this audit, some individual points for guidance/support or training were identified during the audit (see paragraph 15), mainly in relation to: a. approval of establishments and keeping it under review (see paragraphs 30, 47 and 82c). b. the focus and depth of the controls in fishery establishments, establishments where non-compliances were found at official testing, as well for assessing the flexibility options implemented by FBOs (see paragraphs 43, 45, 46, 47, 50, 51, 54 and 76). c. sampling and testing requirements (see paragraphs 53 to 59 and 82 f). d. the need for training and support in relation to food additives and flavourings was highlighted by some CA staff met, especially for the meat and dairy sectors (see also paragraph 52, 82 points b and g). For the fishery sector the CAs highlighted also the need for training on sampling to avoid contestations from FBOs, 8 especially when FBOs apply the absence in 25 g criteria and detection of Listeria might lead to burdensome recalls.

Challenges were identified in particular in relation to the availability of personnel resources, aspects of training and verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings which identified some of these issues, may and sometimes do impact on the controls over the production of RTE foods, to a greater extent for SFPA.

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l DAFM - DAFM Dairy Controls and Certification Division to of review guidance, training and support for relevant items identified in the audit. e SFPA - The SFPA strives to ensure that all staff receives adequate training. Since the DG (Sante) audit, a review of training records has been undertaken. A number of Sea-Fisheries Protection Officers (SFPOs) have been identified for additional training. This will be undertaken in 2019. Page: 1 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April n of ready-to-eat food ction Proposed by the competent authority he SFPA implements a comprehensive 6 month food safety and isheries control training programme for new SFPOs involving lassroom work, appropriate online courses, on the job mentoring y experienced staff. SAI ­ FSAI Training and Compliance team will facilitate a cross gency training working group to address the training needs dentified during this mission. range of compliance and training solutions will be provided to fficial agencies in the meat and dairy sectors including areas such s additives and flavourings in 2019 and 2020.

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The CAs have procedures in place for approval of food business establishments supporting them in ensuring compliance with the provisions of Article 31, paragraph 2 of Regulation (EC) No 882/2004. Examples of CAs following the procedures were presented to the audit team. The FBOs visited during the audit were in most cases approved for the activities they carried out. However, during the visits on the spot the audit team noted that not all CAs ensure systematic compliance with the provisions of the points (c), (d) and (e) of the above mentioned paragraph: a. Contrary to the provisions of point (d), paragraph 2, Article 31 of Regulation (EC) No 882/2004: i. local SFPA staff granted full approval to one of the two fishery establishments visited by the audit team based on their first on-site visit carried out when the establishment was not in operation. The CA explained that full approval was granted based on compliance with infrastructure and equipment requirements and on confidence with the implementation of FBOs food safety management system in the previous FBO premises. SFPA central level accepted the approach due to resources limitations. The CA saw the establishment in operation only one year later as a result of local prioritisation of tasks at busy times and with limited resources. ii. in one of the two recent cases reviewed by the audit team where SFPA used conditional approval for new FBOs, the establishment operated on conditional approval for longer than the maximum of six months allowed by Regulation (EC) No 882/2004. SFPA at central level highlights to the local inspectors when the approval visits are due, but it does not follow-up by highlighting when the establishments are no longer covered by the conditional approval. b. Contrary to the provisions of points (c) and (e), paragraph 2, Article 31 of Regulation (EC) No 882/2004, i. some of the issues identified in the establishment under LA official control, for example in relation to infrastructure and operational procedures, could have been addressed when the establishment was approved. The LA welcomed FSAI expert support at the time of approval of establishments subject to flexibility rules. FSAI confirmed to be in the position to provide this support. ii. difficulties with staff uniform understanding of the use of approval categories resulted in establishments being approved also for activities they did not carry out and missing an activity carried out. "Drying and salting for consumption" was listed in the approved activities of one 12 establishment under SFPA supervision, where salting was only a step in the production of smoked fish. Production of shrimp cocktail which, according to the CCA, should be within the approved activities was omitted in the approval of the same establishment performing this activity. Despite the lack of availability of cooking equipment in one fishery establishment "Cooking and breaded products" was specified among the approved activities by SFPA as in the past the FBO made trials for such production. iii. Another fishery establishment was approved as a coldstore where the chillers on-site were only used for own production. This establishment was also approved for chowder production which did not take place, because the wider approval category included chowder production. iv. One meat product establishment under DAFM supervision was also approved for minced meat, although mincing was only an intermediary step in the production of meat products for several years. The recent CA approval visit concerned only extension of premises and did not identify that the current approval was not up to date. The approval certificate was amended during this audit to reflect the current activities, but similar findings had been identified also in report of audit DG(SANTE)/2013- 6693 which suggest that the measures put in place following the above mentioned audit had not been fully effective in preventing reoccurrence.

Each CA has a system for registration and approval of establishments producing RTE foods and strives to support compliance within own organisation. The CAs apply the related procedures which for several aspects are supportive of achieving compliance. In some cases, the implementation of the approval procedures does not ensure full compliance with the provisions of Article 31 of Regulation (EC) No 882/2004 (SFPA, VPHIS, LA), partially due to training and staffing issues. There is scope for further exploiting synergies and sharing practices through coordination between CAs in order to further strengthen the current procedures.

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- The approval procedures have been recently reviewed and here are plans to implement updated procedures from January 019. These changes include a country wide review of the current pproval certificates with a new certificate being issued to each BO to reflect the processes and activities that are approved. The lication system has been developed to include timelines for the ifferent stages of the approval process. ith regard to the point on granting full approval in a premises ot under operational conditions, see SFPA comment 4.3 Finding 0 a i above. SAI SAI will issue a memo (attached) to competent authorities equesting them to review their approval procedures and to ensure rt. 31 requirements of Regulation 882/2004 are implemented Page: 2 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April n of ready-to-eat food Action Proposed by the competent authority whilst also addressing the specific points, i.e. that conditional approval does not exceed six months, that full approval is not granted before an inspection of the premises under operational conditions, with satisfactory result, and that the approval of establishments is kept under review and FBOs are approve

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The national guidance issued by FSAI for flexibility within the provisions of the Hygiene Package addresses RTE food production to a very limited extent, and only for the local authorities (LA)s. The other CAs (see paragraph 7) do not benefit from national measures on flexibility. An ad-hoc approach is used by CAs in most-cases.

The visits on the spot demonstrated that implementation of official controls in relation to FBOs flexibility measures in small establishments proves still challenging. The CAs indicated that they would welcome further national support in order to avoid that non- compliances are accepted as flexibility (see paragraphs 47, 54 and 82 g). Conclusions on national measures

There is scope for further exploring the flexibility options allowed by the EU legislation for the RTE sector in the national measures to support a harmonised and correct implementation thereof by the FBO and related official controls.

Coordination and cooperation mechanisms within and between CAs are in place and functioned as expected for the outbreak investigation and food incidents cases evaluated by the audit team. Nevertheless, some of the different approaches taken by CAs, as described under the different chapters of this report, each with strengths and sometimes weaknesses, suggest that sharing the good practices for strengthening each other's systems through coordination is not fully exploited.

The CAs have procedures in place for approval of food business establishments supporting them in ensuring compliance with the provisions of Article 31, paragraph 2 of Regulation (EC) No 882/2004. Examples of CAs following the procedures were presented to the audit team. The FBOs visited during the audit were in most cases approved for the activities they carried out. However, during the visits on the spot the audit team noted that not all CAs ensure systematic compliance with the provisions of the points (c), (d) and (e) of the above mentioned paragraph: a. Contrary to the provisions of point (d), paragraph 2, Article 31 of Regulation (EC) No 882/2004: i. local SFPA staff granted full approval to one of the two fishery establishments visited by the audit team based on their first on-site visit carried out when the establishment was not in operation. The CA explained that full approval was granted based on compliance with infrastructure and equipment requirements and on confidence with the implementation of FBOs food safety management system in the previous FBO premises. SFPA central level accepted the approach due to resources limitations. The CA saw the establishment in operation only one year later as a result of local prioritisation of tasks at busy times and with limited resources. ii. in one of the two recent cases reviewed by the audit team where SFPA used conditional approval for new FBOs, the establishment operated on conditional approval for longer than the maximum of six months allowed by Regulation (EC) No 882/2004. SFPA at central level highlights to the local inspectors when the approval visits are due, but it does not follow-up by highlighting when the establishments are no longer covered by the conditional approval. b. Contrary to the provisions of points (c) and (e), paragraph 2, Article 31 of Regulation (EC) No 882/2004, i. some of the issues identified in the establishment under LA official control, for example in relation to infrastructure and operational procedures, could have been addressed when the establishment was approved. The LA welcomed FSAI expert support at the time of approval of establishments subject to flexibility rules. FSAI confirmed to be in the position to provide this support. ii. difficulties with staff uniform understanding of the use of approval categories resulted in establishments being approved also for activities they did not carry out and missing an activity carried out. "Drying and salting for consumption" was listed in the approved activities of one 12 establishment under SFPA supervision, where salting was only a step in the production of smoked fish. Production of shrimp cocktail which, according to the CCA, should be within the approved activities was omitted in the approval of the same establishment performing this activity. Despite the lack of availability of cooking equipment in one fishery establishment "Cooking and breaded products" was specified among the approved activities by SFPA as in the past the FBO made trials for such production. iii. Another fishery establishment was approved as a coldstore where the chillers on-site were only used for own production. This establishment was also approved for chowder production which did not take place, because the wider approval category included chowder production. iv. One meat product establishment under DAFM supervision was also approved for minced meat, although mincing was only an intermediary step in the production of meat products for several years. The recent CA approval visit concerned only extension of premises and did not identify that the current approval was not up to date. The approval certificate was amended during this audit to reflect the current activities, but similar findings had been identified also in report of audit DG(SANTE)/2013- 6693 which suggest that the measures put in place following the above mentioned audit had not been fully effective in preventing reoccurrence.

Most CAs have laid down criteria of what constitute "significant change in activities" (under Article 6, paragraph 2 of Regulation (EC) No 852/2004) that FBOs are required to notify to ensure CAs have up-to-date information on the establishments. This information supports CAs in early detection of changes that impact the approval/registration conditions as well as early detection of non-compliances. However, as each CA developed own criteria, exploiting the potential for synergies between CA through coordination and sharing of practices within and between Agencies, may further enhance the individual approaches. Some examples are presented below: a. Within DAFM, VPHIS requires meat establishments to notify the CAs of major structural changes. This is not the case for Dairy Inspectorate which requires dairy establishments to notify of additions of new processes or new products only. The dairy inspectors enquire with the FBOs if structural changes took place since their last official control and their possible impact on the approval conditions, but this will take place during the visits on the spot when changes may be already in place. b. Some CAs link the approval with the infrastructure capacity of the establishment that ensures adequate operation under hygienic conditions. Others only deal with the non-compliances related to lack of space due to increased production volumes when they are identified at the time of the routine controls. HSE links the approval 13 with a maximum capacity only for activities subject to approval, not for all foods produced in the same establishment. c. In a multi-activities establishment under HSE supervision, the increased volume of work for the production of composite products that did not require approval, led to production in rooms not initially intended for this purpose or not at the capacity noted at the time of the audit and to some unhygienic practices that impacted all types of production (e.g. inefficient cleaning and verification thereof for some fixtures and equipment, unhygienic storage of exposed food contact materials - see also paragraph 76 - and of exposed ingredients on low racks next to the chiller door due to lack of space). Conclusions on registration and approval of food business operators

Each CA has a system for registration and approval of establishments producing RTE foods and strives to support compliance within own organisation. The CAs apply the related procedures which for several aspects are supportive of achieving compliance. In some cases, the implementation of the approval procedures does not ensure full compliance with the provisions of Article 31 of Regulation (EC) No 882/2004 (SFPA, VPHIS, LA), partially due to training and staffing issues. There is scope for further exploiting synergies and sharing practices through coordination between CAs in order to further strengthen the current procedures.

The audit team noted different approaches between and in some cases within the CAs in connection to the fact that each has its own procedures. Some of the procedures are more supportive of swiftly achieving compliance than others- for example in relation to approval of establishments, audits of FBOs procedures and practices, the deadlines used for similar type of non-compliances and verification of effectiveness of controls (see paragraphs 40 to 43 and 75 to 77).

All CAs use their enforcement powers when they identify non-compliances, but some of the differences between CAs in assessing the gravity of findings, in the deadlines given for rectifying shortcomings as well as in their procedures for official controls and 23 verifying the effectiveness of these controls, suggest a missed opportunity for exploiting synergies and ensuring a level playing field through coordination, in particular for FBOs of the same sector or with the same risk categorisation.

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FSAI ­ FSAI will continue to work with the official agencies (CAs) to further strengthen co-ordination of official controls, as recommended. FSAI will write in Q1 2019 (letter attached) to the senior management of the CAs, to propose an approach to develop and implement measures to improve the official controls via an ting cross-agency group during 2019. The measures will be implemented as appropriate in individual agencies, e.g. through updating procedures, with the aim of maximising the content that is common to all agencies. Page: 3 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April n of ready-to-eat food Action Proposed by the competent authority FSAI Letter to Official Agencies.pdf On the specific examples cited: With regards to the assessment of `significant changes' in FBO activities, FSAI will address these through the cross- agency actions proposed under Recommendation 3. FSAI has commenced (Q4 2018) a process of undertaking joint inspections of certain establishments supervised by LAs to advise on the application of flexibility provisions and improve the verification of official controls and. A revision of FSAI's Guidance Note 11 on official controls

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Challenges were identified in particular in relation to the availability of personnel resources, aspects of training and verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings which identified some of these issues, may and sometimes do impact on the controls over the production of RTE foods, to a greater extent for SFPA.

Some CAs aim to cover compliance with all legal requirements within two to three years (with two visits per year), while others aim to achieve the same in one year with a range between two to twelve visits per year, depending on the CA. The depth and thoroughness of the controls vary between CAs. The DAFM checklists for HACCP tend to focus on the main activity and due to the infrequency of the marginal activities the related controls focussed on the main production in the small dairy establishments visited. Marginal activities are subject to official sampling and the food safety management system that manages all activities is subject to audit (see also paragraph 47e).

The official controls over FBOs compliance with the EU food hygiene requirements are largely satisfactory, in particular in large establishments subject to DAFM controls. The unsatisfactory elements concern mainly the controls over FBOs compliance with Regulation (EC) No 852/2004 (a.in particular for the use of flexibility options and avoidance of cross-contamination in small establishments (LA and Dairy Certification), establishments with multiple activities (HSE) and establishments subject to SFPA control; b. for the use of food additives and flavourings, including smoke flavourings in their production), as well the controls over FBOs sampling and testing methods.

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I - le FSAI will work with the official agencies to progress this mmendation during 2019. This will be partly addressed ugh the training proposed for Recommendation 2. FSAI will ude the issue in the letter to the agencies in Q1 2019, (letter tached) the proposed response to Recommendation 4, requesting that measures are taken to strengthen official controls on these cts (control of hazards and additives). Letter to Official cies.pdf revision of Guidance Note 11 on HACCP during 2019 (in onse to Recommendation 4) will also address the official rols on FBOs' procedures to control hazards, including obiological and chemical hazards. will also review official food sampling plans and ensure that e incorporate as appropriate checks on compliance for food tives and smoke flavourings. - Dairy Controls and Certification Division to review and ngthen as necessary the official controls over FBO's liance with Regulation (EC) N. 852/2004 based on lusions of the audit. - These recommendations will be addressed in training and review of the SFPA's Approved Establishment Inspection klist. This will be conducted in 2019. Page: 5 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April

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In some of the establishments visited (producing fishery, dairy and meat products able to support the growth of Listeria), CAs accepted that FBOs do not carry out sampling for the detection of Listeria in the processing area and equipment during processing, but only after cleaning and disinfection, to assess its efficiency. This does not take into account the EURL Guidance on sampling the food processing area and equipment for the detection of Listeria monocytogenes which recommends sampling during processing. Sampling only after cleaning and disinfection makes the detection of the pathogen difficult and can lead to a false sense of security.

The official controls over FBOs compliance with the EU food hygiene requirements are largely satisfactory, in particular in large establishments subject to DAFM controls. The unsatisfactory elements concern mainly the controls over FBOs compliance with Regulation (EC) No 852/2004 (a.in particular for the use of flexibility options and avoidance of cross-contamination in small establishments (LA and Dairy Certification), establishments with multiple activities (HSE) and establishments subject to SFPA control; b. for the use of food additives and flavourings, including smoke flavourings in their production), as well the controls over FBOs sampling and testing methods.

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SAI ­ SAI will issue a memo in Q1 2019 (letter attached), to all fficial Agencies requesting them to remind their inspectors to ake into account in the official controls over FBOs' sampling rocedures the provisions of the EURL "Guidelines on sampling he food processing area and equipment for the detection of isteria monocytogenes". FSAI Letter to Official Agencies.pdf n Q4 of 2018 FSAI finalised a second eLearning module on egulation 2073/2005. It was made available to official agencies hrough our intranet and to FBOs via our public website. This ew module deals with sampling, testing, interpretation of results nd trend analysis. The first module deals with identifying elevant criteria and determining when a food is ready-to-eat. ince Module 2 was made available in October, 291 official gency staff have completed module 2 and 225 have completed odule 1. urther training on Regulation 2073/2005 is planned with DAFM or early in 2019. Participation with be contingent on attendees aving completely the two eLearning modules above. SAI will produce guidance on environmental sampling for isteria monocytogenes by Q4 of 2019. The aim is to highlight he key elements of the EU guide on environ

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FSAI and each of the CAs have audit structures in place to verify the effectiveness of CAs controls. The reports of all FSAI audits are published on their website. The focus given to controls over RTE food production varies between CAs and sometimes it is limited, although the CAs associate the RTE food sector with a higher risk. a. FSAI carried out horizontal scope audits of CAs that included aspects relevant also for the RTE sector. The first and only FSAI audit specifically targeting the official controls over RTE food production took place in 2016. This audit concerned DAFM controls in meat establishments and covered relevant aspects of the performance of these controls. DAFM put in place several corrective actions for the identified weaknesses. b. DAFM latest audits covering this topic had been in 2010 and 2011 and targeted the controls in the dairy sector. The audits focussed on the controls and procedures for assessing FBO compliance with the HACCP requirements and the microbiological criteria as set out in Regulation (EC) No. 2073/2005. Both audits had largely positive outcomes. c. FSAI informed the audit team that specific audits of the official controls exerted in the RTE sector had been carried out in five LAs during 2015 and 2016. The two 9 reports made available to the audit team concluded that the controls were effective in facilities producing RTE meat products. d. HSE and SFPA, organisations with more recent internal audit arrangements, had not carried out internal audits focussing specifically on official controls related to production of RTE foods.

Challenges were identified in particular in relation to the availability of personnel resources, aspects of training and verification of effectiveness of controls. These challenges, together with delays in effectively addressing audit findings which identified some of these issues, may and sometimes do impact on the controls over the production of RTE foods, to a greater extent for SFPA.

All CAs use their enforcement powers when they identify non-compliances, but some of the differences between CAs in assessing the gravity of findings, in the deadlines given for rectifying shortcomings as well as in their procedures for official controls and 23 verifying the effectiveness of these controls, suggest a missed opportunity for exploiting synergies and ensuring a level playing field through coordination, in particular for FBOs of the same sector or with the same risk categorisation.

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ols FSAI ­ will address this Recommendation with each CA. FSAI will to the agencies in Q1 2019 (letter attached), to request that nal audit programmes are strengthened, to give a particular to the detection of non-compliances with food legislation fficient follow-up. As well as this action for the individual ies, FSAI will progress through a cross-agency group the er improvement of consistent approaches to dealing with non- iances (this is the same group referenced in mendations 4 and 5). Page: 7 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April n of ready-to-eat food tion Proposed by the competent authority AI considers that the work required to develop official controls comply with Regulation (EU) 2017/625 will also be relevant in is regard. AI Letter to Official Agencies.pdf PA - The SFPA has a system on internal audits which includes e verification of the effectiveness of the official controls. Since e DG(Sante) RTE audit, the SFPA has assigned a "Subject tter Expert" to participate in each internal audit. addition, in the 2019 Food Safety Control Plan, full audits will quire the presence of two officers, where possible. E - The HSE EHS position paper on e

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SFPA does not use official laboratories a required by article 12 (1) of Regulation (EC) No 882/2004 for testing official samples of RTE food for Listeria and Salmonella, only private accredited laboratories. This CA informed the audit team of its own system in place to check yearly on the accreditation scope and the methods used.

The NRL for Listeria and Salmonella explained that this lack of designation does not allow them to adequately fulfil the NRL obligations under Article 33 of Regulation (EC) No 882/2004 in relation to the laboratories used by SFPA to test official samples for these pathogens. The NRL disseminates to all laboratories carrying out official testing the information received from the EURL, but it can review the activities only of official laboratories used by the other Agencies (not SFPA), including on their participation to proficiency testing and follow up of non-compliant results. 4.4.2 Measures in case of non-compliance Legal requirements Article 54 and Article 55 of Regulation (EC) No 882/2004, Article 50 of Regulation (EC) No 178/2002, Articles 2, 3, 4, 6 and 7 of Regulation (EU) No 16/2011 Findings

Comprehensive official sampling and testing of RTE food is in place with a largely satisfactory outcome, in particular at production level. CAs take action when non- compliances are identified. Official laboratories are accredited and subject to NRL coordination. The laboratories used by SFPA to test official samples for Listeria and Salmonella are not designated as official laboratories and do not benefit from NRL's coordination. 4.4.3 Challenges encountered by the CA in the organisation and performance of controls over the production of RTE foods

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AI ­ review of the SFPA system for microbiological testing of RTE oducts has taken place in conjunction with FSAI. Consequently is now proposed, to transfer this microbiological analysis (including Listeria and Salmonella testing) to the official control s laboratory network (i.e. HSE Official Food Microbiology boratories (OFMLs) and the LA Cork veterinary laboratory) ere existing designations are already in place, and where this sting is already subject to DAFM NRL oversight. rvice level agreements (SLAs) are being developed between PA and the HSE OFMLs and the LA veterinary Laboratory, to Page: 8 port ref. DG(SANTE)/2018-6437-MR of the audit carried out from 23 April n of ready-to-eat food o be in place, ignated confirming

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Appropriate facilities are available for observing animal health and welfare requirements for equidae. The facilities at BIP Shannon airport are not appropriate for handling and housing ungulates.

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M has developed detailed checklists for verification of FBOs legal requirements as part of the performance of official controls. Although training has already been provided for all DAFM inspectors involved in official controls of FBOs producing sprouts, further training, in follow up to the Mission Report findings, is now planned. This will cover verification of FBOs' legal requirements in relation to sampling and testing, the traceability/certification requirements for imported seeds. Inspection procedures will be further reviewed to be more specific in terms of these requirements. In addition two meetings have already been held with staff (28/04/2016 and 24/05/2016), by way of follow up to the mission and in order to discuss and fully address the audit findings. The above verification requirements, will also be confirmed, during DAFM's own internal supervisory checks of official controls performed (as per SOP 005).

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DAFM did take adequate actions in relation to cases of non- compliances identified at the sprout producers, in accordance with the requirements of Article 54 of Regulation (EC) No 882/2004. In relation to the FBOs visited as part of the audit, FBOs were verbally informed of the non-compliances during the mission. Compliance Notices were also formally issued by DAFM (i.e. on 7th March 2016 to one FBO and on 10th March to the other FBOs)- directing them to rectify the non compliances identified during the Page: 1 port ref. DG(SANTE)/2016-8734-MR of the audit carried out from 23 February lating to microbial safety of primary production of food of non-animal origin audit. Evidence of the enforcement actions taken by DAFM in accordance with Art. 54 of Regulation 882/2004, can be found in the copies of the Compliance Notices issued to FBOs, forwarded to the Mission team. Follow up inspections have also taken place at the FBOs visited during the mission, by DAFM, confirming that these non- compliances have now been satisfactorily addressed by the FBOs. Subsequent inspections have also confirmed that there has been no reoccurrence of these non compliances. Note: According to the draft CAP

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There are six administrative staff in the Organic Unit assisted by two inspectors and one technical officer charged with, inter alia, organic controls of organic production. In addition, there are 30 technical officers who undertake controls at local markets and retailers. All DAFM staff met by the audit team were experienced in the area of organic production and were found to be knowledgeable for the tasks assigned. DAFM staff attend regular training on organic production and meetings, including the Committee on Organic Production held in Brussels. However, DAFM informed the audit team, that due to the limited resources, no dedicated staff member is allocated to supervisory activities in the area of processing.

A system of controls is in place in accordance with Article 27(4) of Regulation (EC) No 834/2007. CAs responsible for controls in organic production are designated with a clear distribution of tasks and responsibilities among the CAs and the delegated CBs. There is good communication and co-operation between the different CAs, and regular meetings are held between DAFM and the CBs. However, due to limited staff resources, the CA does not adequately supervise CBs controls in the area of processing which reduces the effectiveness of the system in place (see also conclusion no 23). 5.2.1.1 Control Bodies: Approval, Supervision and Withdrawal Legal Requirements Articles 5(2) and (3) of Commission Regulation (EC) No 882/2004. Articles 27(5) to (9) and (14) of Council Regulation (EC) No 834/2007. Article 92(c) of Commission Regulation (EC) No 889/2008. Findings

Furthermore, as these CBs do not have a branch office in Ireland, the office audits are carried out at the home of the CBs´ inspectors, where all information necessary for supervision might not be available. Moreover, DAFM does not notify the result of the supervision to the CB headquarters, but only to the inspector. Therefore it cannot be ensured that the management of the CB is aware of any non-compliance and that effective corrective measures are taken as necessary.

In addition to office audits, DAFM carries out witness audits to observe the performance of the CBs´ inspectors. According to the information provided to the audit team, eight witness audits were carried out in 2015 at farm level. No witness audits were carried out to observe the performance of controls at processors. The inspections at processors by CBs observed by the audit team were overall superficial and not all relevant requirements were checked by inspectors (see finding 54). The failures in the performance of CBs were not identified by DAFM inspections described in paragraph

The audit team reviewed a number of reports issued by DAFM following witness audits and re-inspections. Several shortcomings were identified and the overall performance of inspectors was evaluated. The shortcomings were notified to the CBs concerned with a delay of several months. This delay in the communication of the results of supervision undermines its effectiveness, as it does not ensure that corrective action is taken by CBs in a reasonable time.

Moreover, corrective measures proposed consisted only in re-inspecting the operator where the supervision had taken place. No corrective measures were proposed by DAFM to or required from CBs to avoid the repetition of the shortcomings related to the performance of the inspectors. Some of the shortcomings described in the reports issued by DAFM were repeated during the inspections observed by the audit team (e.g. no identification of individual animals present on the fields, no measurements of stables in every inspection). The lack of corrective action to address the root cause of the problem detected does not fully ensure the effectiveness of the controls carried out by CBs. This is not in line with Article 27(9)(b) of Regulation (EC) No 834/2007. Conclusions on Approval, Supervision and Withdrawal of Control Bodies

There is a system of approval, annual supervision and withdrawal of CBs in place in Ireland, which includes the withdrawal of the CB's approval by the CA in case a CB fails to fulfil its obligations. Regular coordination and communication between CAs and CBs is established aiming at harmonising organic controls. The effectiveness of the CA's supervision of CBs is however reduced because the CA does not effectively supervise CBs' controls in the area of processing (due to staff shortage). The system is further weakened by the fact that the CA does not take all relevant information into account when supervising CBs located outside Ireland and that several systematic shortcomings in the performance of CBs related to the planning of controls and the enforcement of organic rules were overlooked by the CA during supervision of CBs. Inappropriate communication of such shortcomings by the CA to the CBs hampers timely implementation of appropriate corrective actions. 5.2.2 Registration of operators Legal Requirements Articles 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Articles 92(2) and 92(b) of Commission Regulation (EC) No 889/2008. Findings 7

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On foot of the audit findings and recommendations we are currently reviewing our controls of the sector and will, where necessary, implement change to address all the issues raised. We have also undertaken a comprehensive overhaul of the existing e Service Agreement, which has now been substantially rewritten and expanded to provide additional contractual security between the CA and the CBs in all areas of control, performance and ommunication. A copy of the current version of the revised o Service Agreement is attached. A comprehensive Catalogue of Infringements has also been prepared which provides detailed idance to CBs in carrying out their controls (also attached). In our 2017 Organic Workplan we will undertake witnessed audits of CB's inspectors control work to ensure that controls are effective. We will also carry out independent CA audits of those operators (especially processors) who, through risk analysis, are deemed to present most risk. 8 AES professional staff of AES Division are responsible for CB oversight and controls in the organic sector. Their main responsibilities include the supervision of CBs' inspections to ensure that controls are effective. The organic cont

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According to DAFM, Ireland requires the registration of operators as indicated in Article 28(1) of Regulation (EC) No 834/2007. Any operator who produces, prepares, stores, places organic products on the market or import/export from/to non-EU countries shall submit his undertaking to the control system. Subcontracted operators are also subject to the control system. The audit team reviewed the agreements for the delegation of tasks signed between DAFM and the CBs and noted that the requirement regarding operators who place products on the market was not explicitly included. The audit team noted that wholesalers dealing only with pre-packed and labelled feed were not subject to the control system. In addition, CBs did not adequately verify the activities carried out by traders dealing with pre-packed and labelled food, who were found by the audit team to trade products not included in the scope of their registration certification (see finding 64). This is not in line with the abovementioned Article 28(1).

Since 2012, the Horticulture and Plant Health Division is responsible for inspections at retailers (which were previously inspected by technical staff of the Agricultural Environment and Structure Division). The fulfilment of conditions for the exemption of retailers from official controls is usually checked during these inspections. However, the audit team noted that the scope of these inspections focus on plant production only, and do not cover products of animal origin, providing information to the CA which is insufficient to satisfactorily assess whether retailers exempted under Article 28(2) of Regulation (EC) No 834/2007 (continue to) fulfil conditions for exemption.

The system however does not ensure that all operators, in particular wholesalers, are registered. Moreover, the fact that the list of operators does not include all required information and is not regularly updated, reduces the tool's functions for effective verification of the status of organic operators.

Although the CA conducts inspections at retailers to verify fulfilment of conditions for exemptions of retailers from organic controls, the limitation of the inspection scope to plant products only, fails to ensure that all relevant retailers are covered by the CA inspections. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Articles 3, 41 and 92f of Regulation (EC) No 882/2004 of the European Parliament and of the 9 Council. Article 27(3) of Council Regulation (EC) No 834/2007. Articles 65(1), (4) and 92(c)(2) of Commission Regulation (EC) No 889/2008. Findings

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DAFM will include in the organic retail operator inspections a gs Procedure and Check List to vet the retailer activities against the regulatory criteria for CA exemption from the control system. Training will be provided to relevant technical staff. We will maintain updated registers of exempted and non - exempted retailers. These procedures will be introduced in 2017 and operational immediately after introduction. In relation to operators selling feed (as distinct from food) which was an issue raised during the audit, our review of the legislation leads us to believe that such operators may also be exempt under the terms of Article 28(2) where definition of `products' includes feed, and where a `user' as distinct from a `consumer' is also clearly envisaged. Page: 2 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of organic products

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However, the list does not contain updated documentary evidence issued by CBs using the model set up in Annex XII to Regulation (EC) No 889/2008, including at least the range or types of products certified. In addition, although the DAFM register is updated to reflect changes in the organic status of operators, the changes are not necessarily fed into the list kept on the website. This lack of complete information is not in line with Article 92(b) of Regulation (EC) No 889/2008.

The system however does not ensure that all operators, in particular wholesalers, are registered. Moreover, the fact that the list of operators does not include all required information and is not regularly updated, reduces the tool's functions for effective verification of the status of organic operators.

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contains The finding is accepted. We are looking at best practice internationally. The BioC system, which is used in other countries, appears to the best option. This model is currently under consideration by the Irish CA as the model for Ireland and the means of meeting our regulatory requirement.

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However, the information submitted is not always complete or not adequately verified by CBs. The audit team noted that at two farmers, not all CB inspectors observed were aware of all the activities carried out and of precautionary measures taken by the operators. This was not checked in previous inspections. At one grower, the CB inspector did not pay attention to the processing steps which took place on the farm (drying of cereals) and the subcontracting activity (transport of organic feed in bulk, traceability and records of cleaning of the vehicles). At another grower, the CB3 10 inspector had never checked the transport of the product to costumers, which was a subcontracted activity. This indicates that the CBs did not adequately verify the information submitted by operators which is not in line with Article 63(2) of Regulation (EC) No 889/2008.

However, the audit team noted during visits to processors that these procedures were not followed by one CB. The CB did not inspect and authorise new products /production lines before the production start. The failure of operators to notify such new activities to in advance of the production start to the CB was not considered a non-compliance by the CB, contrary to its procedure. The verification of such a scope extension was only done later, during the next inspection visit, with the risk that potentially non-compliant products might have already been placed on the market by the time of this inspection (see finding 53).

Incomplete operator files and the fact that CBs do generally not require operators to notify changes in their activities hamper the effective planning of controls as well as verification of relevant requirements on-the-spot. Moreover, CBs do not necessarily carry out prior inspections when notified by an operator of a new activity.

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for CBs The finding is accepted and has been discussed with all CBs, both individually and collectively. Procedures will be reviewed on an ongoing basis at the Organic Forum. The procedures are in place for notification of major changes by operators to CBs however a time, re-iteration of the obligations will be communicated to all tial operators. y of

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However, the time allocated to inspections at processor level is very limited, even in the case of processors handling large quantities of organic and conventional products. As observed by the audit team during the inspections, not all relevant requirements were checked by inspectors and not all premises were fully inspected, which is not in line with the procedures of the CBs (see finding 54). In addition, CB2's procedures require inspectors to observe the production lines during the production of an organic product once every three years, which means that inspections are not always scheduled to allow verification of conditions under which processing of organic products takes place. This is not in line with Article 92c(2)(a) of Regulation (EC) No 889/2008, which requires that results of the risk analysis must provide the basis for the planning of announced and unannounced inspections.

However, CB1 does not take into account for the risk analysis, the quantities produced by operators, which is a compulsory criterion according to Article 65(4) of Regulation (EC) No 889/2008. In addition, the results of the risk analysis carried out by CB1 and CB2 do not serve in practice as an adequate basis for the planning of annual and unannounced inspections (less than 10% of operators are differentiated by this method). In the case of CB1, the majority of operators were classified in the lowest risk category, while only 2.5% of operators were classified by CB2 as high risk operators. This is not in line with Article 92c(2)(a) of Regulation (EC) No 889/2008.

The audit team reviewed the list of operators selected by CB1 and CB2 for additional controls, and noted that only a small number of operators visited were selected based on their risk category. CB1 and CB2 carried out most of the additional inspections to new 11 operators and also to follow-up on non-compliances detected during the previous annual inspection. This is not in line with Article 92c(2) (b) and (d) of Regulation (EC) No 889/2008. Conclusions on Planning and Prioritisation of Controls

Generally, CBs plan and prioritise controls of operators at a sufficient frequency, including unannounced inspections. However, the effectiveness of the system is reduced as CBs do not consider the quantity of products handled per operator in their risk evaluation and high risk operators are not necessarily subject to additional controls.

While inspections at farm level are generally allocated with sufficient inspection time, there is a risk for inspections at processors to remain rather ineffective as allocated inspection time per operator is too short to allow adequate verification of relevant requirements and / or inspections are not always conducted when organic products are processed. 5.2.4 Controls of operators Legal Requirements Articles 8 and 9 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Titles II and III of Council Regulation (EC) No 834/2007. Titles II and IV and Article 65 of Commission Regulation (EC) No 889/2008. Findings

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the We have discussed this issue with CBs during the 2016 annual al office audits and outlined actions to correct the issues highlighted on in the audit report. DAFM will give assistance, guidance and direction to CBs in the risk of application of risk to their operators. The risk assessment will identify those operators for announced and unannounced inspections for the compulsory annual audits and those operators for additional unannounced visits and targeted sampling and 08; analysis . This selection process will be operational for the 2017 s is inspection campaign. d (d) of DAFM will issue guidelines to CBs on the time that we consider should be allocated to processor controls. This duration will be proportionate to the risk assessment carried out on operators. This task is currently underway. Page: 3 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of organic products

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However, the checklists used are not sufficiently detailed and do not include some relevant requirements of EU Regulations. This lack of detailed documented procedures is not in line with Article 27(6)(a) of Regulation (EC) No 834/2007. During the inspections observed, the audit team noted that inspectors did not check certain requirements that were not included in the checklists, in particular: CBs do not require operators to keep records on the results of verification on reception of organic products as required by Article 66(2) of Regulation (EC) No 889/2008 and do not adequately check records. The audit team noted that the records kept by both processors visited were not designed to verify the organic status of the products purchased, as they lacked relevant information on the labels and delivery notes or invoices (see finding 62). It was noted during the inspection that a processor had been using an ingredient not labelled as organic for the production of an organic product, as no verification had been made on reception by the operator. CB3 does not physically inspect and carry out documentary checks of all sites where aquaculture animals are kept, in particular, records relating to animals kept and quantities of feed used. This is not in line with Articles 67(1)(a) and 79(b) of Regulation (EC) No 889/2009; CB1 and CB2 do not require operators to record the conditions under which operations such as disbudding, dehorning and castration of animals are carried out 13 (see finding 76). The audit team noted that farmers carried out these operations at the most appropriate age, but without applying any anaesthesia or analgesia, which is not in line with Article 18 of Regulation (EC) No 889/2008.

The effectiveness of controls at operators was however reduced as checklists used were incomplete and relevant requirements sometimes incorrectly and/or superficially verified by CB inspectors. This concerned in particular inspections at processors where relevant premises were not always fully checked by CB inspectors and stock and financial records not sufficiently verified when performing the calculation of the input/output balance. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 18 of Regulation (EC) No 178/2002 of the European Parliament and of the Council. Articles 23, 24 and 27(13) of Council Regulation (EC) No 834/2007. Title III of Commission Regulation (EC) No 889/2008. Findings

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DAFM will ensure that documented procedures used by CBs are sufficiently detailed and include procedures for verifying operators' records of the results of verification of reception of on organic products. DAFM will direct CBs to visit all aquaculture production sites of each operator and that the prescribed records are maintained by operator and checked by the CB. These issues will be verified by id the CA during o-t-s controls. For terrestrial animal production, the operator records must be maintained and include the recording of: the prescribed procedures carried out on the animals, the conditions under which they were undertaken and all other regulatory requirements. These records will be checked at annual audit by the CB. To facilitate effective CA oversight, DAFM will harmonise checklists used by CBs.

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Inspections witnessed by the audit team at processors were overall superficial with no in-depth verification of all information provided by operators The following aspects were not adequately checked by inspectors: not all premises were checked by inspectors, even though the CB´s procedures indicates that all premises of an operator must be inspected. The lack of adequate verification of premises is not in line with Article 67(1)(a) of Regulation (EC) No 889/2008. CBs did not systematically verify the results of operators´ own quality assurance programs referred to in Article 67(1)(c) of Regulation (EC) No 889/2008. Although the checklist used by CB2 included a specific question on the checks carried out by operators themselves, the inspector did not check any record but simply asked the question to the operator in order to fill in the checklist. The CBs did not provide any evidence to the audit team that this verification has been done in previous inspections. Without this check, CBs cannot verify operators´ compliance with Article 91(1) of Regulation (EC) No 889/2008, which requires operators to notify CBs of any non-compliant product that they may have produced or received from third parties. inspectors verified a number of labels in the office of the operators but they did not verify the labels applied to the final products stored in the premises. Moreover, inspectors do not cross-check whether the labels used by operators are still the ones which were approved by CBs . when checking the balance between input and output required by Article 66(2) of Regulation (EC) No 889/2008, the CBs did not check a representative number of invoices to verify the accuracy of the records kept by operators. In addition, inspectors checked the internal records corresponding to one day of production only, although the CBs´ procedures require inspectors to check the balance input/output of at least one week of production. No other checks were carried out by CBs on stock or financial records kept by operators to verify the nature and quantities of products purchased, produced, stored or sold by operators, which is not in line with Articles 66(1)(a) to (d) of Regulation (EC) No 889/2008. No other documentary checks are carried out during the year, as CBs do not require operators to regularly submit information on their activities. 14 Conclusions on Controls at Operators

The effectiveness of controls at operators was however reduced as checklists used were incomplete and relevant requirements sometimes incorrectly and/or superficially verified by CB inspectors. This concerned in particular inspections at processors where relevant premises were not always fully checked by CB inspectors and stock and financial records not sufficiently verified when performing the calculation of the input/output balance. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 18 of Regulation (EC) No 178/2002 of the European Parliament and of the Council. Articles 23, 24 and 27(13) of Council Regulation (EC) No 834/2007. Title III of Commission Regulation (EC) No 889/2008. Findings

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These audit findings were discussed with individual CBs at 2016 Annual Office audits and outline was provided of remedial actions n required. CBs have been specifically directed to fully follow their own procedures. DAFM will ensure the effectiveness of processor inspections by providing direction to CBs as to what the CA considers should be checked and verified during an o-t-s inspection. These will include the specific issues highlighted in the audit report finding. , Page: 4 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of organic products )(a) The CBs' current procedures will be vetted against these directions and, where necessary, those procedures will be e amended. These directions will address, in particular but not exclusively, those processor inspection deficiencies advised during the audit. Process underway and will be completed by mid 2017. As indicated in response to Recommendation 1 - DAFM inspectors will be given detailed professional training on carrying out effective audits of processing operations and CBs' inspectors control work.

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According to the CBs´ standards, operators must ensure that products are clearly and accurately labelled in order to comply with all relevant requirements. However, labelling checks at processors carried out by CBs are not effective (see finding 54). As a result, CB1 did not note the use by a processor of a label which had not been approved by the CB. The label used indicated the use of a non-organic ingredient of agricultural origin while in the approved label it was indicated as organic. Furthermore, according to the recipe, the ingredient used was 6.7% of the weight of the product, which is not in line with EU Regulations.

In addition, the audit team noted several non-compliances with Article 24 of Regulation (EC) No 834/2007 concerning the labels (e.g. small size or no presence of the EU logo, ingredients of agricultural origin not indicated as organic, non-use of the code of the CB or of the operator who carried out the last operation on the product, etc.). These non- compliances had not been noted by CBs during controls. 15

Moreover, CBs do not adequately follow-up on the use of non-compliant labels. For example, DAFM notified CB1 of a complaint received from a client regarding a label where the main ingredient was not indicated as organic. CB1 informed DAFM on 12 August 2016 that the operator had been asked to change the label. However, the CB did not require the operator to stop using the non-compliant label. The audit team noted that the label was still used for the production of the same product on 18 August 2016. In addition, the CB did not require the operator to demonstrate the organic origin of the ingredient. There was also no request to evaluate if other products in the range could also be subject to the same labelling problem (which was found to be the case by the audit team during the audit).

However, the audit team noted that the organic nature or the lot number of products supplied was not indicated on all accompanying documents. This lack of relevant information did not permit the linking of raw materials supplied with the accounts of the supplier, who also handled similar conventional products. The lack of this information is not in line with Articles 31(1)(b) and (d) of Regulation (EC) No 889/2008. Moreover, in the case of the chicken breast, the documents provided by CB2 were not sufficiently detailed to trace the product throughout all the processing steps (slaughter, cutting, packaging and distribution) and therefore it was not possible to track the product back to the farmer, as claimed on the product package. This is not in line with Articles 23(1) and (2) of Regulation (EC) No 834/2007, as it could not be demonstrated that the products and ingredients advertised as organic had been obtained in accordance with the rules of the Regulation.

In addition, the information on the labels was not supported by the documents kept by operators. In the two multi-ingredient products, the information concerning the place where the agricultural ingredients had been farmed (EU/non-EU agriculture) did not match with the information on the documents provided by suppliers. CBs permit processors to always use the reference to EU/non EU agriculture, regardless of where the agricultural products have been farmed, which is not in line with Article 24(1)(c) of Regulation (EC) No 834/2007.

Moreover, the trader who distributed two of the products was not registered for products of animal origin and CB1 had failed to detect this shortcoming. This also indicates that controls carried out by DAFM at retail level do not ensure that operators verify the documentary evidence of suppliers, which is not in line with Article 29(2) of Regulation (EC) No 834/2007. 16 Conclusions on Labelling and Traceability

The system in place provides for a regular verification of labelling of organic products and their traceability by CBs and the CA. However, the system has so far failed to effectively rectify recurrent non-compliances with regard to compulsory labelling requirements, including the list of ingredients. 5.2.6 Sampling and laboratory analysis Legal Requirements Article 12 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Article 65(2) of Commission Regulation (EC) No 889/2008. Findings

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and CBs have been advised of these specific audit findings and that their procedures must embrace all regulatory requirements and in the particular those identified deficiencies in their operator oversight rticles of organic processor operators. they Particular attention must be paid to verifying supporting n documentation to ensure the integrity of the organic processed products and that the labelling is fully compliant with the e regulations. Checks must include, inter alia, that the labels applied to the final product are those approved by the CB. ; DAFM is reviewing their procedures for controlling labelling and as traceability requirements. Amendments to our procedures will . include direction to our control staff on checks to be undertaken to ensure full traceability of organic products and that labelling meets the regulatory requirements. Training will be provided to control staff. Relevant modules of recent round of BTSF training workshops will also be delivered to our control staff. This review is ongoing and will be completed by middle of 2017. Page: 5 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of or

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However, the sampling procedure used by CB1 is not in line with horizontal and national requirements. The audit team noted that the CB, in accordance with an "informal" procedure, had taken samples, but not provided for counter samples, which prevents the taking of any enforcement measures against the operator concerned in case of dispute. "Formal" samples are only taken when a first positive result is found or when a suspicion exists. This shortcoming, which is not in line with Articles 12(1) and (2) of statutory instrument 112/2004, had not been noted by DAFM supervision.

DAFM has not designated any laboratory for the testing of organic samples which is not in line with Article 12(1) of Regulation (EC) No 882/2004. The audit team noted that analytical reports from the main laboratory used by one CB did not indicate whether results presented in the reports related to the limits of detection or the limits of quantification, which is an important quality requirement. This shortcoming had been raised by INAB during the previous audit carried out to the CB, but DAFM did not request the CB the correct this shortcoming.

CBs sampling policy ensure that the required minimum samples are taken based on an appropriate risk assessment of operators as well as provide for sampling in cases of suspicion. Although CBs use accredited laboratories for the testing of organic products, these laboratories are not designated by the CA with the risk that relevant requirements and rules are not defined and hence laboratories results inadequate to provide the basis for the enforcement of organic rules. CB sampling procedures are not always adequate, which could reduce the validity of the testing results. Moreover, CBs do not always take appropriate measures in case of positive samples to identify the reason for contamination, nor do CBs always notify the CA of such cases (see chapter 5.2.9). 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 22(2) of Council Regulation (EC) No 834/2007. Article 29 of Commission Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Commission Regulation (EC) No 889/2008. Findings

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d, in DAFM have advised CBs of audit findings and is drawing up list designated laboratories and associated specifications which will e circulated to CBs with directions to implement immediately. will ensure that the analytical results of the samples taken are reliable by introducing standardised sampling and analytical chniques in compliance with the relevant regulations/directives d national laws. targeted Workshop on Sampling procedures, Interpretation of alytical results, follow up action, reporting, etc will be ganised by DAFM for CBs. FVO experts will be invited to rticipate &/or observe. rkshop will be held before middle of 2017. Page: 6 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of organic products

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DAFM issued guidance according to which operations such as dehorning of young animals, attaching elastic bands, tail docking of bovine animals and cutting of teeth are carried out routinely, which is not in line with Article 18(1) of Regulation (EC) No 889/2008. CBs do not check conditions under which these operations are carried out by the operators. During inspections observed, all farmers explained that no anaesthesia or analgesia was used, even for the castration of animals, which is not in line with Articles 18(1) and (2) of Regulation (EC) No 889/2008. Conclusions on Exceptional Production Rules and Other Derogations

The system in place generally ensures that derogations are granted by DFMA and CBs based on a thorough evaluation of the operators request. There is good cooperation between CA and CBs and appropriate procedures are in place. However, the fact that dehorning and similar operations do not require prior-approval by the CA and conditions under which they are carried are not verified by CB inspectors during on the spot controls constitutes a major weakness of the system in place. 5.2.8 Imports of Products from Organic Production Legal Requirements Article 33 of Regulation (EC) No 834/2007. Chapter 3 of Title III of Regulation (EC) No 1235/2008. Annexes II, III, V and VI of Regulation (EC) No 1235/2008. Findings

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DAFM implementing procedure to fully address the findings and 08 meet all of the regulatory requirements. Detailed directions will be n a given to the CBs on the logistics of granting, under DAFM direction exceptions. CBs will include in their procedures the by implementation of these directions and operators will be informed of the requirements. DAFM will produce a Guidance Documents for CBs and livestock producers; all the conditions of Article 18 will be included. This Guidance Document will be circulated by DAFM to all terrestrial based organic livestock producers. It will address inter alia, those specific deficiencies highlighted by the auditors and will address the requirement of obtaining prior approval to carry out the prescribed procedures, the competence of the operator, the application of anaesthetic and/or analgesia, record keeping and the keeping of records which will be checked by the operator's CB during the annual inspection. Please see also our separate note on this issue. Under DAFM direction, TEAGASC, the national agriculture education service are currently amending their Animal Health and Welfare Module to highlight and outline the specific organic regulatory r

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Import controls consist of the verification of the Certificate of Inspection accompanying the consignments. So far, no physical checks on consignments have been carried out by DAFM before they are imported. However, no risk assessment was ever made by the DAFM to justify the absence of physical checks which is not in line with Article 27(3) of Regulation (EC) No 834/2007. DAFM informed the audit team that new procedures in co-operation with the Customs are being developed, which will require importers to notify DAFM 10 days in advance of the arrival of a consignment and the performance of risk-based physical checks by the Organic Unit.

CBs do not require importers to notify in due time the arrival of consignments to be imported, contrary to Article 84 of Regulation (EC) No 889/2008. Visits and sampling at importers is planned based on risk by CBs, but, as indicated in findings 53 and 54, CBs do not systematically check how importers verify consignments at arrival. Therefore, CBs are not necessarily aware of any non-compliant product received by importers. Moreover, CBs do not always inform DAFM of non-compliances detected at importers, in particular when the operator concerned is not directly responsible for the non- compliance (see finding 85). This information can therefore not been taken into account for the planning of import controls by DAFM. Conclusion on Imports of Products from Organic Production

An import control system is in place in Ireland, consisting of documentary checks adequately carried out by the CA. However, the decision on the nature of controls, in particular to carry out physical checks on imported products, is not based on an assessment of the risk of occurrence of irregularities and infringements. The effectiveness of the system is further reduced due to the fact that importers are not required to notify the arrival of consignments to CBs in due time and non- compliances identified at operators by CBs are not notified to the CA to be taken into account for the CA's planning of import controls. 5.2.9 Measures in cases of irregularities and infringements Legal Requirements Articles 54 and 55(1) of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Articles 27(5)(d) and 30 of Council Regulation (EC) No 834/2007. Articles 91, 92, 92a and 92(d) of Commission Regulation (EC) No 889/2008. Findings

According to the agreement between CBs and DAFM, when CBs detect severe irregularities, they must inform DAFM immediately. However, the audit team noted that not all severe irregularities are notified by CBs, but only the ones classified as "manifest infringements", which need the agreement of DAFM for suspending the license of the operator concerned. Generally, non-compliances are only notified to DAFM after the procedure of appeal has finished and the certification decision has been confirmed by the CB which is not in line with Article 30(2) of Regulation (EC) No 834/2007 requiring immediately notification of such non-compliances. Moreover, analytical results showing the presence of unauthorised substances are not notified to DAFM unless the use of unauthorised substances is confirmed which is contrary to Article 27(5)(d) of Regulation (EC) No 834/2007 requiring immediate notification even in the likelihood of a non- compliance. When non-compliances are notified, this is often made with a significant delay, which undermines the effectiveness of the measures taken by DAFM. 21

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s DAFM's own review earlier in 2015 had identified this as an area where controls should be strengthened and we accept the finding. U Revised procedures were in place before the audit and are working well. One of the outcomes of this is a detailed record of all with imports into the country which will now form the basis for a risk ) No assessment procedure to inform the physical inspection regime (inc sampling). time, The requirement to notify OCBs regarding arrival of consignments has been re-iterated to operators. CBs have been 2) reminded of requirement to immediately share information.

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According to the CBs procedures, actions are taken by CBs in all cases where analytical results show the presence of unauthorised substances. CBs visited confirmed during the office audits that the likelihood of a non-compliance (i.e. detection of a traces of unauthorized plant protection product) is not notified, and even if the non-compliance is confirmed, it is not always notified to DAFM (see finding 85). Conclusions on Sampling

CBs sampling policy ensure that the required minimum samples are taken based on an appropriate risk assessment of operators as well as provide for sampling in cases of suspicion. Although CBs use accredited laboratories for the testing of organic products, these laboratories are not designated by the CA with the risk that relevant requirements and rules are not defined and hence laboratories results inadequate to provide the basis for the enforcement of organic rules. CB sampling procedures are not always adequate, which could reduce the validity of the testing results. Moreover, CBs do not always take appropriate measures in case of positive samples to identify the reason for contamination, nor do CBs always notify the CA of such cases (see chapter 5.2.9). 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 22(2) of Council Regulation (EC) No 834/2007. Article 29 of Commission Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Commission Regulation (EC) No 889/2008. Findings

At the time of the present audit, DAFM had not adopted a catalogue of measures as required by Article 92(d) of Regulation (EC) No 889/2008. At the opening meeting, DAFM presented the audit team with a draft statutory instrument for DAFM to apply 20 sanctions to operators in cases where they are found to commit an offence against the organic regulations. However, this legal act has to do with the role of DAFM regarding monetary sanctions applied to operators, and not with the measures to be applied by CBs.

The Organic Food and Farming Standards classify non-compliances in three categories according to the severity of the non-compliance and the certification decision to be taken (corrective action for deviations not affecting the organic status of the products, de- certification of product for irregularities affecting the organic status of the product and suspension of the operator´s licence for severe infringements or with a prolonged effect). However, the classification is not pre-defined for specific requirements of EU Regulations. In addition, no other measures are pre-defined either by CBs for particular cases of non-compliance. As a result, both CBs decide on a case-by-case basis, which does not ensure consistency in the implementation of the measures taken by individual CBs and among CBs. The audit team noted a number of cases which demonstrated the inconsistency and inadequacy of the measures: CB1 detected at a processor one raw material not labelled as organic, which had been used for the processing of an organic product. Despite this being a non- compliance which may affect the organic status of the product, the inspector reported it as a deviation. In fact, the vast majority of the non-compliances found by CB1 were reported as "deviations", even when the organic status of the product was affected. CB2 reported an irregularity as a severe non-compliance with a prolonged effect which should have been notified as a "manifest infringement" according to the description in the CB procedure. However, no suspension of the licence of the operator was proposed by the CB to DAFM. CB2 required one operator to provide evidence that a non-compliant product had not been sold as organic. However, in other cases CB1 and CB2 did not follow the same approach and they only verify the use of non-compliant products at the next inspection.

According to the agreement between CBs and DAFM, when CBs detect severe irregularities, they must inform DAFM immediately. However, the audit team noted that not all severe irregularities are notified by CBs, but only the ones classified as "manifest infringements", which need the agreement of DAFM for suspending the license of the operator concerned. Generally, non-compliances are only notified to DAFM after the procedure of appeal has finished and the certification decision has been confirmed by the CB which is not in line with Article 30(2) of Regulation (EC) No 834/2007 requiring immediately notification of such non-compliances. Moreover, analytical results showing the presence of unauthorised substances are not notified to DAFM unless the use of unauthorised substances is confirmed which is contrary to Article 27(5)(d) of Regulation (EC) No 834/2007 requiring immediate notification even in the likelihood of a non- compliance. When non-compliances are notified, this is often made with a significant delay, which undermines the effectiveness of the measures taken by DAFM. 21

The system in place does not ensure that adequate and harmonised measures are taken in cases of irregularities and infringements. Although OFIS notifications were timely followed up, there was no evaluation by the CA of the actions taken by the CBs. Moreover, CBs do not always and immediately notify the CAs of irregularities, which is, in particular with regard to severe irregularities, undermining the effectiveness of the actions taken by the CA.

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A comprehensive Catalogue of Infringements has been developed n and is attached here. This addresses all aspects of the finding cts and here, including instances where immediate notification to the CA cle is required. In addition, the new Statutory Instrument signed by the Minister last year provides legal certainty for infringements of ols the relevant EU regulations and for the further imposition of , as penalties by the CA as necessary. 07. .

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The cases reviewed demonstrated that there was good communication and co-operation between DAFM and CBs. While measures by CBs were generally appropriate to identify the origin of the contamination, there was no evaluation by DAFM of these CB actions before the documentation of the investigation was uploaded onto OFIS. In one case when an antibiotic was found on marketed frozen fish, the CB first suspended the licence of the operator and then lifted the suspension based on a second sample which tested negative for the presence of the antibiotic. DAFM accepted this decision without further enquiries to the CB on the origin of the non-compliance with is not in line with Article 92(a)(4) of Regulation (EC) No 889/2008. Conclusions on Measures in Cases of Irregularities and Infringements

The system in place does not ensure that adequate and harmonised measures are taken in cases of irregularities and infringements. Although OFIS notifications were timely followed up, there was no evaluation by the CA of the actions taken by the CBs. Moreover, CBs do not always and immediately notify the CAs of irregularities, which is, in particular with regard to severe irregularities, undermining the effectiveness of the actions taken by the CA.

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ons in DAFM are fully compliant with the regulatory requirements of OFIS. Page: 8 ary 2017 report ref. DG(SANTE)/2016-8746-MR of the audit carried out from 05 s for organic production and labelling of organic products

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At the time of the DG SANTE audit, Ireland had yet to establish a computerised seed database, and therefore did not fulfil the requirements of Articles 48 to 52 of Regulation (EC) No 889/2008. DAFM informed the audit team that the database will be operational in early October. Conclusions on Seed Data Base

A seed database has not yet been established in Ireland. 22

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e Organic Seed Database has been established. Expressions of 2 of interest from seed suppliers have been sought and the database is rrently being populated. AES will provide technical advice and put into the operation of the database as required. Page: 9

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National legislation on animal welfare is found under the Animal Health and Welfare Act of 2013 which prohibits persons from doing, or failing to do, anything or causing or permitting anything to be done to an animal that causes unnecessary pain, distress or suffering. The Statutory Instruments (S.I.s) regulating the welfare of cattle of dairy farms include: S.I. 311 of 2010 implementing Directives 98/58/EC and 2008/119/EC amongst others; S.I. 225 of 2014 on the prohibition of non-medical tail docking of cattle, as foreseen by Paragraph 19 of the Annex to Directive 98/58/EC; S.I. 107 of 2014 and 127 of 2014 regulating operations and procedures carried out on cattle, as foreseen by Paragraph 19 of the Annex to Directive 98/58/EC.

There were 101 general animal welfare inspections of cattle farms (dairy or beef) in 2013 and 117 in 2014 with, respectively, 81 (80%) and 79 (68%) farms reported in full compliance. In 2013 these inspections also reported mutilations as being the most frequent non-compliance (S.I. 225 of 2014), at approximately a third of the total (10 of 32), while for 2014 mutilation non-compliances were approximately 5% of the total (3 of 61). 16. 181 inspections on conditions for rearing calves were carried out in 2013 and 204 inspections in 2014 with, respectively, 137 (76%) and 133 (65%) farms in full compliance: For 2014 DAFM gave inspectors a specific instruction to continue to check if replacement heifers present at the same farm had been tail-docked; In both years the main non-compliances reported, 50% or more of the total, concerned 'Record keeping' together with 'Buildings and accommodation'; The report for 2014 submitted by DAFM to the Commission includes an analysis on the above non-compliances, as required by Article 8(2) of Decision 2006/788/EC, indicating that they respectively "concerned incomplete records of medicines administered" and "were related to cleansing and disinfection of housing, pens, equipment and utensils, the presence of sharp edges and protrusions likely to cause injury to calves and environmental conditions".

In 2015 there were approximately 1,350 cross compliance inspections (for all types of cattle and species other than cattle as well) that specifically included animal welfare (there are other cross compliance inspections that do not include animal welfare as one of the primary objectives but will include welfare if issues are noted during the controls). Cross compliance inspection detected 60 to 70 animal welfare non- compliances per year between 2012 and 2014. Within these the most frequently detected 6 Regulation (EC) No 1698/2005 (OJ L 277, 21.10.2005, p. 1­40) 11 in bovine animals is mutilation (specifically tail-docking, S.I. 225 of 2014) corresponding to approximately a third of the total. For a first time offence this usually results in a 5% deduction in the single farm payment. The number of mutilation non- compliances detected from 2012 to 2014 remained stable.

The audit team was informed by the CA that farmers performing tail-docking, which was detected during both cross-compliance inspections and the pilot of 2016, claimed that they had done it for hygiene reasons and because they were unaware of the prohibition on tail-docking. The CA informed the audit team that the prohibition on non- medical tail-docking of bovines in the national legislation (lastly S.I. No. 225 of 2014) has been in place since 2003. Conclusions on assurances from competent authority activities on farmer's compliance with legal requirements

The CA is actively involved in measures that improve the welfare of cattle on dairy farms. Official controls provide satisfactory assurances of compliance with animal welfare requirements for cattle in dairy farms. Awareness levels on national legislation prohibiting tail docking are not high and, despite some preventive measures, there is an apparently low but continuing level of the banned practice of mutilation (tail-docking) of dairy cows.

Information on official controls on tail docking is already reported in paragraphs 17 to 24. Bord Bia is the only other actor which uses tail docking as a welfare indicator. The low frequency of this non-compliance is also supported by the negative reaction of the farmer group met by the audit team who, when asked for their opinion, immediately condemned this practice. Conclusions on indicators of animal welfare

Improving trends are perceived in the majority of welfare indicators, particularly those which are being promoted by several actors from the industry. Actions for the management of mastitis, through the control of somatic cell count in milk, are strongest since most actors are addressing this issue. Actions addressing tail-docking are weakest, as they are being addressed by only one actor other than the CA. 15

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DAFM will write to all stakeholders notifying them of the legal requirement on tail docking and requesting their assistance and support in complying with this law. DAFM will use FAWAC offices to raise awareness and request stakeholder representatives to bring this information to the attention of their members. DAFM is currently updating FAWAC Dairy Welfare guidelines with additional information and advice for farmers regarding the necessity for compliance with the prohibition of tail docking. DAFM will use every avenue available to inform farmers of their legislative requirements e.g. Teagasc Open Days, the National Ploughing Championships etc. DAFM will be communicating to all marts reminding them that it is illegal for cows with docked tails to be sold at marts. It is a breach of SI 225/2014 for a person to have in his or her possession or under his or her control a bovine whose tail or part of whose tail has been removed of an animal with a docked tail. A successful prosecution has been taken by the CA and will continue to be taken if non-compliances are found. A meeting of the Area Management Teams (North & South Regions) held in May 2016 was attended by all the central, region

amongst all actors to avoid this · DAFM will write to all stakeholders notifying them of the legal requirement on tail docking ent causing unnecessary pain and requesting their assistance and support in complying with this law. ttle, as required by Article 3 of Recommendation based on · DAFM will use FAWAC offices to raise awareness and request stakeholder representatives 34. Associated finding: 12, 15, to bring this information to the attention of their members. · DAFM is currently updating FAWAC Dairy Welfare guidelines with additional information and advice for farmers regarding the necessity for compliance with the prohibition of tail docking. · DAFM will use every avenue available to inform farmers of their legislative requirements e.g. Teagasc Open Days, the National Ploughing Championships etc. · DAFM will be communicating to all marts reminding them that it is illegal for cows with docked tails to be sold at marts. It is a breach of SI 225/2014 for a person to have in his or her possession or under his or her control a bovine whose tail or part of whose tail has been removed of an animal with a docked tail. · A successful prosecution has been taken by the CA and will contin

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The representatives of the DAFM stated that screening analysis of samples are carried out routinely based on a contract with the FERA laboratory. They also stated that, mainly due to budget constraints, feed samples are not analysed for the presence of GM material for which an authorisation procedure is pending or the authorisation has expired, which is not in compliance with Commission Regulation (EU) No 619/2011. 11 The DAFM stated that a feed and seed GM laboratory is planned to be put in place within the DAFM in the near future and more testing including the low level presence is foreseen there.

Control in feed is equally appropriate, with the exception of checking of the presence of GM material for which an authorisation procedure is pending or the authorisation has expired which is not carried out. Because of this there is a potential risk that non- compliant feed is marketed. 5.3.4 Controls of specific import requirements Legal requirements Articles 3, 4 and 5 of Commission Implementing Decision 2011/884/EU. Findings

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ith A programme of sampling and testing for GM events that are covered under Regulation (EU) No 619/2011 will be put in place for 2016. Feed samples to be taken and tested in the 3rd and 4th quarters of 2016

A programme of sampling and testing for GM events that are covered under Regulation (EU) No 619/2011 will be put in place for 2016. Feed samples to be taken and tested in the 3rd and 4th quarters of 2016.

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As for specified processed food samples, the shortcoming identified might lead to biased sampling and unreliable results. 5.3.6 Laboratory performance Legal requirements Articles 12 and 33 of Regulation (EC) No 882/2004. Chapter V.2 of Commission Recommendation 2004/787/EC. Article 5 and Annex II of Commission Implementing Decision 2011/884/EU. Articles 4 and 5 of Commission Regulation (EU) No 619/2011. Findings

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Guidance for port health officers on sampling is being developed the EHS to ensure that food samples of rice products imported from China are taken in line with CEN/TS 15568:2007, in accordance with Annex II, 2 of Commission Implementing Decision 2011/884/EU. Training of port officers will completed in this new guidance. To be completed by 30/09/2016.

Guidance for port health officers on sampling ing developed by the EHS to ensure that food samples of rice products imported from China are taken in line with CEN/TS 15568:2007, in accordance with Annex II, 2 of Commission Implementing Decision 2011/884/EU. Training of port officers will completed in this new guidance. To be completed by 30/09/2016. received 24/08/2016

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An NRL has been designated, however, it's role concerning cooperation with GMO laboratory is not totally fulfilled. The impact of this shortcoming is mitigated by the participation of the GMO laboratory in proficiency tests and having good records on internal and external audits.

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FERA were contracted through competitive tender to provide an NRL-GMO to Ireland. The current contract was for the period 2013-2015, but was extended to 2016. A retendering process for the period 2016-2018, is currently underway. The Contract stipulates that the NRL will undertake duties as described in Article 33 of Regulation 882/2004 (EC). Actions taken by FERA in fulfilment of this contract are reviewed annually. An annual report is also issued by FERA (attached). Proposed Action DAFM as CA, will, following the completion of the current tender, request that the successful tenderer detail how it proposes to satisfy the requirements of Article 33 as they apply to ONL's and review these actions annually as part of the contract review referred to above. Page: 1 ly 2016 Report ref. DG(SANTE)/2016-8801-MR of the audit carried out from 25 January tically modified organisms, including their deliberate release into the environment final report 070116.docx

re contracted through competitive r to provide an NRL-GMO to Ireland. urrent contract was for the period 2013- but was extended to 2016. A dering process for the period 2016-2018, rrently underway. The Contract lates that the NRL will undertake duties e for the Tender was 12 noon 6th Successful and unsuccessful in the process of being notified.

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The PAL laboratory performs GMO analysis in accordance with international standards within their limitations. However, the lack of laboratory capacity and limited analytical scope pose a risk that some GM events which might be present in food are not detected.

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ed Cork Public Analyst's Laboratory and the Competent Authority (FSAI) will review the existing scope of analysis of food samples ew to extending the range of authorised and unauthorised equired in the legislation.

blic Analyst's Laboratory and the A proposal has been submitted by Cork etent Authority (FSAI) will review the Public Analyst Laboratory to HSE g scope of analysis of food samples management for funding to set up the view to extending the range of additional GMO analytical facilities in sed and unauthorised GMOs as Cork Public Analyst Laboratory. This is d in the legislation. currently being considered by HSE. Subject to funding the timeline for purchase of equipment, method development, validation and accreditation is estimated at approximately 2 years.

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Shortcomings in analytical procedures for testing of rice products imported from China might lead to unidentified GM rice being imported and placed on the market. 5.3.7 Enforcement measures Legal requirements Articles 4(5) and 33 of Directive 2001/18/EC. Articles 45 of Regulation (EC) No 1829/2003. Article 11 of Regulation (EC) No 1830/2003. Findings

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out Cork Public Analyst's Laboratory and the Competent Authority ll review the existing scope of analysis of Rice products from China with a view to satisfying the requirements of enting Decision 2011/884/EU. Page: 2

blic Analyst's Laboratory and the hority (FSAI) will review the e of analysis of Rice products China with a view to C U. A proposal has been submitted by Cork Public Analyst Laboratory to HSE management for funding to set up the additional GMO analytical facilities in Cork Public Analyst Laboratory. This is currently being considered by HSE. Subject to funding the timeline for purchase of equipment, method development, validation and accreditation is estimated at approximately 2 years.

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SFPA is in the process of reviewing the composition of its Internal Audit and Risk Committee with reference to its ability to provide independent scrutiny of technical audit findings relating to the rformance of SFPA official controls.

ponse from the SFPA received 3 March 2017: SFPA is in the process of reviewing the composition of its Internal Audit and Risk Committee with reference to its ability to provide independent scrutiny of technical audit findings relating to the performance of SFPA official controls. No action plan was received from DAFM SFPA expect that its Internal Audit and Risk Committee will be in a position to provide enhanced independent scrutiny of technical audit findings relating to the performance of SFPA official controls by the latter half of 2017 subject to the planned development of added technical competence in the Committee. Page: 1 ted by the competent authorities of Ireland in response to Report ref. DG(SANTE)/2016-8834-MR mber 2016 in order to evaluate the system put in place to implement article 4(6) of Regulation Action Proposed by the competent authority Commission services' assessment of the competent authority's response

SFPA received 3 March 2017: SFPA is in the process of reviewing the its Internal Audit and Risk Committee with reference to its ability to ndent scrutiny of technical audit findings relating to the performance of controls. was received from DAFM ments during 2017 to broaden the scope of independent scrutiny of the audit er to fully achieve the objectives of the legislation.

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In DAFM, the audit charters of both VIAU and IAU state that independent scrutiny shall be carried out by the Audit Monitoring Group. In practice, this group is one person: both VIAU and IAU have for a number of years used an external expert to scrutinise and provide feedback on their audit programmes, in particular to ensure that appropriate risks were considered. This same individual is a co-signatory of their audit charters.

While this process adds value to the audit programmes, it does not consider other aspects of the audit process and no particular feedback on these aspects has been received.

SFPA has recognised that some adjustments will be necessary to enable the committee to discharge this newer responsibility: The current audit committee membership was set up before the inclusion of audits conducted in accordance with Article 4(6) of Regulation (EC) No 882/2004 in its remit. As a result its membership was established with a focus on financial auditing and internal controls. The SFPA representative met by the DG SANTE audit team stated the reinforcement of the committee with additional external members with specific expertise relevant to the internal audit of fisheries control and food safety of fishery products was under discussion; The terms of reference for the committee include assisting the SFPA in fulfilling its responsibilities in relation to oversight of the audit process and advising the SFPA on whether an appropriate regime of internal control is in operation. The terms of reference do not include any reference to the objectives of Regulation (EC) No 882/2004 nor to the requirements of article 4(6) of that Regulation.

The charter states that its scrutiny should have a particular focus on ensuring that the audit process "is capable of producing objective results and meeting its obligations under Regulation (EC) No 882/2004". At the time of this DG SANTE audit, the terms of reference for the independent scrutiny had been drafted, based on the NAS Network document on Independence and Independent Scrutiny. A suitable individual to carry out independent scrutiny had just been identified and it was intended to finalise the terms of reference with this person over the following weeks.

While all competent authorities have taken steps to ensure independent scrutiny: in two competent authorities the arrangements had only very recently been put in place; in another two competent authorities the arrangements were insufficient to achieve the objectives of the process either because the whole audit process was not included in the scrutiny or because the arrangements for such scrutiny did not involve individuals with sufficient relevant experience in the field of audits conducted in accordance with Article 4(6) of Regulation (EC) No 882/2004.

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Conclusion no. 199 refers. SFPA has developed a central action tracker to capture all the actions that are on-going, enable a central point of oversight and assignment of responsibility and to allow for the monitoring and reporting of progress of those actions. This action tracker will incorporate audit findings relevant to Article 4(6) of Regulation (EC) No. 882/2004. SFPA continues to use the Technical Audit Review Group to review technical audit reports and contribute to the development of corrective action plans intended to address audit findings and enable the process of continuous improvement. This group also plays a role in the dissemination throughout the organisation of learning relating to the audit process. Page: 1

n SFPA has developed a central action tracker to capture all the actions that are on-going, enable a central point of oversight and es assignment of responsibility and to allow for the monitoring and reporting of progress of those actions. This action tracker will incorporate audit findings relevant to Article 4(6) of Regulation (EC) No. 882/2004. SFPA continues to use the Technical Audit SFPA continues to develop its monitoring Review Group to review technical audit and implementation capability in relation to reports and contribute to the development of progress on audit findings with a view to corrective action plans intended to address enabling continuous improvement in the audit findings and enable the process of execution of its official controls. It is continuous improvement. This group also expected that more detailed information plays a role in the dissemination throughout relating to the advancement of this process the organisation of learning relating to the will be available as audit finding close-out audit process. and escalation systems continue to be refined. Page: 2

ed a central action tracker to capture all the actions that are on-going, al point of oversight and assignment of responsibility and to allow for the reporting of progress of those actions. This action tracker will incorporate relevant to Article 4(6) of Regulation (EC) No. 882/2004. to use the Technical Audit Review Group to review technical audit reports to the development of corrective action plans intended to address audit nable the process of continuous improvement. This group also plays a role in ion throughout the organisation of learning relating to the audit process. Page: 1 ved from the Department of Agriculture, Food and the Marine on 17 May 2017 mmendations of report ref. DG(SANTE)/2016-8834-MR of the audit carried out from in place to implement article 4(6) of Regulation (EC) No 882/2004 (national

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Documentation on the amount of raw milk collected from reactor animals, storage of this milk, method, location and date of the disposal was not available on either holdings.

The CA has no documented procedure in place to verify appropriate disposal of milk from TB reactor animals. 5.2.6 Control of raw milk upon collection Legal requirements Article 8 of Regulation (EC) No 854/2004. Findings

On farm disposal of milk from TB reactor animals was not documented. In both cases the milk was spread on land. In one case the farmer stated that the field was not used for grazing, where the milk was disposed. In the other case the grazing was suspended on that particular field for six weeks after the disposal. Conclusion on animal by-products

An effective system for control of animal by-products is in place in milk processing plants but not in milk production holdings. 1 In their response to the draft report, the CA noted that in relation to TBCs, where supply has ceased for one month, the calculation of the geometric average includes the results from the month before the cessation of supply. The CA's view is that this gives a higher level of consumer protection. If results from consecutive months only were used, the calculation of the geometric average would be delayed for a further month. Accordingly, the competent CA would not propose to amend the method of calculation of the geometric average for TBCs. 14

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business operators are The Competent Authority has changed its procedures to require s put in place to control milk producers to keep records of the quantity of milk, location, s required in point III 7, date & method of disposal of milk from Tuberculosis reactor n particular, amount, animals and official controls are being put in place to verify f the disposal of raw compliance with the requirements in point III 7, Part A, Annex I on milk production to Regulation (EC) No 852/2004.

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The CAs carried out qualitative traceability checks, but did not carry out any quantitative controls (i.e. checks of quantities of raw materials received, used in production, remaining in storage, dispatched).

The official inspector did not carry out traceability control during the last audit cycle in one establishment visited.

The FVO audit team carried out traceability exercises in three establishments. In one case the qualitative traceability was satisfactory. In a second case a simple clerical error was detected. In the third case, the documentation available on-the-spot was incomplete but was subsequently supplied to the FVO audit team. Based on these documents the qualitative traceability was satisfactory. Conclusions on traceability, labelling and identification marking

The official control system on qualitative traceability is effective (though not always carried out).

Checks on quantitative traceability are not included in the official control system. 5.2.5 Control of milk production holdings Legal requirements Article 8 of Regulation (EC) No 854/2004. Findings

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ce compliance by The Competent Authority is currently monitoring/enforcing Article 18 of Regulation compliance with Art. 18 of Regulation 178/2002. Information uding the qualitative and concerning consignments of food of animal origin is made available to the food business operator to whom the food is supplied and, upon request, to the CA, as required under Article 3 of Reg. 931/2011. Clarification is sought on what additional controls would be necessary to comply with the requirements of this Article.

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In the case that there is an interruption of at least one month in the supply of milk from a holding (seasonal production), the calculation method for determining the geometric average for SCC differs from that used for TBC: calculation for SCC starts from re-commencement of supply, 13 calculation of the TBC average includes the results from the month before the cessation of supply. As consequence the months used in the calculation are not consecutive.1 Conclusions on control of raw milk upon collection

The calculation of the geometric averages for TBC is not always based on rolling geometric average over a two-month period. 5.2.7 Animal by-products Legal requirements Article 5 of Regulation (EC) No 854/2004. Regulation (EC) No 1069/2009, and in particular Articles 21 and 22 sets out the requirements for collection and transport of animal by products, including requirements for identification, records and the use of commercial documents. Findings

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alculation of geometric In relation to TBCs, where supply has ceased for one month, the in line with the calculation of the geometric average includes the results from the n IX of Regulation (EC) month before the cessation of supply. The CA's view is that this gives a higher level of consumer protection. If results from consecutive months only were used, the calculation of the geometric average would be delayed for a further month. Accordingly, the CA would not propose to amend the method of calculation of the geometric average for TBCs. Note: The above should probably go in as a comment at Finding No. 80 and Conclusion No. 82 and the words `See comment on Finding No. 80 and Conclusion No. 82' could go in here as our official response.

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In one processing establishment visited the geometric average for SCC of one supplier exceeded the limit over three consecutive months. The supplier was informed but was not suspended. The CA was not informed.

There is a system in place to control the safety and the quality requirements of the raw milk. Implementation of the system (i.e. suspension of collection when parameters exceed) is the responsibility of the FBOs. However the CA was not always kept fully informed.

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ctive system that The Competent Authority has an effective system in place to Page: 1 recommendations of Report ref. DG(SANTE)/2015-7595-MR of the audit carried out from 20 April n place for official controls related to the safety of food of animal origin, in particular milk and milk and 4, Chapter I Section ensure that when raw milk fails to comply with points III 3 and 4, aken to correct the Chapter I Section IX of Regulation (EC) No 853/2004, measures ter I Section IX of are taken to correct the situation. The CA had detected the non compliance detailed in finding No. 79 in the course of its own official controls and the non compliance had been closed out ahead of the FVO audit. Page: 2

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light of findings of the audit the CA issued notification to all ports to review vessel hygiene inspections completed (Q1-Q3) ith view to focusing activity on increasing number of inspections in Q4. By Q 4 2014 SFPA will review policy for fishing vessel inspections with view to setting more representative targets for 2015 taking into account seasonality, species availability and other risk factors.

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A.3 of Chapter II As a follow up to the FVO Mission on Live Bivalve Molluscs compliance with (LBM) in 2011 Ireland (IE) made changes to its classification VII of Annex III to system and subsequently for the 2012 Review of Classified and maintaining Bivalve Mollusc Production Areas in Ireland a tolerance limit of 1000MPN E.coli/100 grams was introduced in the 10% allowance for A classified areas. The change in system was presented at the recent FVO Mission in October 2013 and is highlighted in the draft report DG (SANCO)/2013-6674. The EU legal requirements in the area of shellfish microbiological classification are under review and there has been active discussion between the Commission and Member States (MS) on this issue. At the December 2013 meeting of the European Commission DG-Sanco Working Group on Live Bivalve Molluscs discussions continued between the Commission and MS on the basis for awarding A classifications. At this meeting the Commission presented draft revision text of Regulation 854/2004 which would give effect to a "codex over time" approach to awarding A classification to production areas whereby a 20% allowance would be allowed for monthly samples to exceed 230 M

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g sanitary surveys The objective of carrying out sanitary surveys in all classified n (EC) No 854/2004 areas remains a priority for the SFPA and work is ongoing in this cation of areas. In area to develop a programme of sanitary surveys. The legislation distribution of the refers to "classification" of areas (Point A.6. of Chapter II of the analysis are as Annex II to Regulation (EC) No 854/2004), when the CA decides to classify an area a sanitary survey will be carried out in accordance with the aforementioned legislation. In addition when the boundaries of a classified area are extended the SFPA undertakes to complete a sanitary survey. External resources will be employed (commencing in July 2014) by the SFPA to assist with this work. Completed sanitary surveys will ensure that monitoring points are as representative as possible of the production area. Completed sanitary surveys will form part of the annual classification review process. In addition as part of the classification review, maps of production areas and their associated sampling locations will be reviewed and amended as necessary to ensure that the sampling locations are as representative as possible (in accordance wi

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classified Following the FVO Mission in October 2013 a sampling working gs points in order to group was set up during Quarter 1 of 2014 with representatives ter II of Annex II to from FSAI, SFPA and the MI. The first meeting of the group was held in March 2014 and it looked at such topics as location of sampling points and verification official control samples. An outcome from the sampling working group will include 2

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or biotoxins positioning of sampling points. The relevant Codes of Practice on Microbiological and Biotoxin monitoring will also be amended as ne with Point B.5 of necessary. An instruction document will be developed (during Quarter 3 of 2014) for SFPA staff carrying out sampling of 4. classified production areas; one of the areas the document will give guidance on is sampling from designated sampling points to ensure compliance with the legislation (Point B.2 of Chapter II of Annex II to Regulation (EC) No 854/2004) and current best practices as reflected in both the 2012 Community Guide to Microbiological Classification and Monitoring of LBM Production Areas and the CEFAS CRL's Microbiological Monitoring of LBM Production Areas Guide to Good Practice. In addition a biotoxin sampling pack will be developed to provide guidance for industry samplers and their training reviewed. A series of information events for industry will also be organised during Quarter 2 of 2015 to update industry on relevant areas including sampling. The marine biotoxin monitoring programme has evolved in Ireland over 20 years with continuous updates in methodology specified by the EURL including various anim

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with EU legislation By Quarter 4 of 2014 the CAs will have carried out a review of for microbiological response and monitoring actions currently taken in the case of out ops are exceeded as of range classification results to ensure proportionate outcome, egulation (EC) No consistent implementation across all ports and continued public microbiological health protection (in the case of product from A classified ot placed on the production areas going directly on the market). The relevant lation (EC) No section (section 6.4) of the Code of Practice for the Mollusc Production Areas this review. s are enforcing the nnex III Section VII apter III, Annex II). If dy a restricted harvesting ked product of those parts regulatory limits for market. Regulation (EC) No relates to activities in shore are not harvested from lops harvested outside I of Annex II to Regulation oduct not meeting the of Section VII of Annex III to Regulation (EC) No 853/2004 is not permitted to be placed on the market.

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The CCA should ensure that an establishment is approved or maintains its approval only if the FBO has demonstrated that it complies with the relevant requirements of food law, in accordance with paragraph 2(c) of Article 31 of Regulation (EC) No 882/2004.

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The CCA should keep establishments' approval under review when carrying out official controls as required by Article 31(2) of Regulation (EC) No 882/2004 and in particular ensure that deficiencies found by the audit team are corrected in the establishments visited and are not present in other ones.

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ng) DAFM proposes to further expand risk analysis to take account of the n reliability of feed operators' own checks for activities when preparing the 2013 and subsequent Feedingstuffs Annual Inspection and Sampling Programmes.

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Official sampling instructions have been revised to ensure targeted sampling for the possible presence of residues of coccidiostats in feed for non-target species.

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) HQ staff will run regular reports to improve the verification of the t effectiveness of official controls to identify outstanding non-compliances trols, which require follow up action. DAFM has amended its procedures manual to ensure non-compliances found during audits are reported to feedingstuffs inspectors carrying out subsequent inspections. When the improvements to the feedingstuffs establishments/inspections database, which are ongoing are completed, a Pre Inspection Report will provide an up-to-date summary of FBO activities, inspection/audit history and active non-compliances.

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e The national lists of feed establishments will be expanded to provide greater h details of the activities. The revised lists will be made public on the DAFM website before the end of 2012.

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DAFM has amended its Procedures Manual for feedingstuffs inspectors and HQ staff requiring timely follow up to verify that operators remedy non- compliances identified and flagged to operators during inspections and audits. This includes cross reporting of non-compliances between HQ auditing staff and field inspectors HQ staff will run regular reports to improve the verification of the effectiveness of official controls to identify outstanding non-compliances which require follow up action. Page: 1 Action Plan received from CA 5 September 2012 ions of Report ref. DG(SANCO)/2012-6480-MR of an audit carried out from 21 to fication of hazards and management of risks along the feed chain Action Proposed by the Competent Authority

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FM has issued a Trader Notice to FBOs reminding them of their e obligation to source feed from registered or approved FBOs which is labeled in accordance with feed legislation. emo has issued to all HQ staff and field inspectors to verify during inspections and audits the measures taken by FBOs to comply with the Trader Notice. The Procedures Manual has been amended accordingly.

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AFM has issued a Trader Notice to feed operators reminding them of their igation to ensure the measures they have in place minimise cross- tamination. emo has issued to all HQ staff and field inspectors, inspections to focus get during inspections and audits on measures taken by FBOs to minimise cross contamination, in particular, concerning the presence of coccidiostats in feed for non-target species. The Procedures Manual has been amended accordingly.

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DAFM has issued a Trader Notice to feed operators reminding them of their ligation to ensure traceability of feed from intake, through production and dispatch. A memo has issued to all HQ staff and field inspectors, to focus during audits and inspections on FBOs' controls for traceability. The Procedures Manual has been amended accordingly.

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AFM has issued a Trader Notice to feed operators reminding them of their gation to (a) source feed from registered or approved FBOs and (b) have HACCP based procedures in place for risk assessing suppliers and ingredients. ts A memo has issued to all HQ staff and field inspectors to focus on FBOs' controls for the sourcing of safe feed during audits and inspections. The Procedures Manual has been amended accordingly. Page: 2

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m of DAFM has already put in place arrangements (Veterinary Procedure to act Notice No.6 of 2012 and a Traders Notice sent to FBOs) to ensure that any carcase sampled for the presence of residues can be linked to the flock of birth of the animal from which that carcase derived. As regards the on-farm aspect, in line with Council Regulation 21/2004 the National Sheep Identification System now operates on the basis of one identification for life from holding of origin. It is now possible for the FBO to link the animal to the Identification Code of the holding of origin.

put in place arrangements (Veterinary Procedure 2012 and a Traders Notice sent to FBOs) to ensure that or the presence of residues can be linked to the animal from which that carcase derived. aspect, in line with Council Regulation 21/2004 ntification System now operates on the basis of life from holding of origin. It is now possible for imal to the Identification Code of the holding of

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Official inspectors will be reminded by circular of official instructions in relation to the avoidance of multiple sampling from a single supplier. Checks carried out by supervisory veterinarians under Article 8 will focus compliance with this official instruction during 2012/13.

ll be reminded by circular of official instructions in nce of multiple sampling from a single supplier. supervisory veterinarians under Article 8 will this official instruction during 2012/13.

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Official veterinarians will be reminded by circular and during training of official instructions in relation to the full completion of the FCI ocument (Target date: 10/12). Checks carried out by supervisory to veterinarians under Article 8 of Reg. 882/2004 will focus on compliance with this official instruction during 2012/13. Page: 1 Action Plan received on 10 July 2012 s of Report ref. DG(SANCO)/2012-6529-MR of an audit carried out es and contaminants in live animals and animal products Action Proposed by the Competent Authority

is now in place for goats and will be for farmed ians will be reminded by circular and during training of in relation to the full completion of the FCI 10/12). Checks carried out by supervisory ticle 8 of Reg. 882/2004 will focus on compliance Page: 1 Updated action plan received 20 August 2012 NCO)/2012-6529-MR of an audit carried out live animals and animal products tion Proposed by the Competent Authority ruction during 2012/13.

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AFM will progressively enhance the dissemination of information to herdowners via a number of measures including placing of ticle posters/leaflets in public areas used by herdowners (e.g. livestock marts, airage/offices of slaughter plants, regional veterinary offices and eagasc farm advisory offices). SVIs will outline the requirements for aintaining the AR Records when the regional offices meet epresentatives of the farming organizations annually. In addition each erdowner, in the Spring of 2013 (in conjunction with the information re he national eradication schemes TB and Brucellosis), will be circulated ith information re the requirements for keeping AR Records. Checks n compliance will feature in ongoing on-farm inspections.

enhance the dissemination of information to er of measures including placing of in public areas used by herdowners (e.g. livestock marts, ghter plants, regional veterinary offices and ffices). SVIs will outline the requirements for rds when the regional offices meet farming organizations annually. In addition each g of 2013 (in conjunction with the information re n schemes TB and Brucellosis), will be circulated requirements for keeping AR Records. Checks ure in ongoing on-farm inspections.

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This complex scientific issues raised by this recommendation, arising in urn from implementation of Commission Decision 2002/657 and ssociated Guidance Documents, are under active examination to chieve resolution. As part of this process, the CA will, during Q3 2012, onduct a review of relevant procedures and processes across the aboratory network and, if necessary, will engage assistance from elevant CRLs.

ic issues raised by this recommendation, arising in n of Commission Decision 2002/657 and uments, are under active examination to , the CA will, during Q3 2012, conduct a review of processes across the laboratory network and, if assistance from relevant CRLs and the necessary ensure full compliance with Commission Page: 2 Updated action plan received 20 August 2012 NCO)/2012-6529-MR of an audit carried out live animals and animal products the Competent Authority

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o A meeting with FSAI and DAFM was held in May 2012. FSAI are ontinuing to progress the development of the FSAI guidance for sis National Reference Laboratories and Official Laboratories with the le, component authorities the NRLs and the official laboratories. This ve guidance outlines specific requirements for both NRLs and official labs o ensure that the standards and methods of analysis meet the Page: 2 Action Plan received on 10 July 2012 s of Report ref. DG(SANCO)/2012-6529-MR of an audit carried out es and contaminants in live animals and animal products mpetent Authority lation. Guidance to be finalized in Q4 of

and DAFM was held in May 2012. FSAI are development of the FSAI guidance for Laboratories and Official Laboratories with the ies the NRLs and the official laboratories. This pecific requirements for both NRLs and official labs ds and methods of analysis meet the t legislation. Guidance to be finalized in Q4 of

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re Since a number of observations have been made by the Irish authorities ons at on some aspects of the FVO analysis underpinning this recommendation, he action for this recommendation may need to be revised in light of the ility of methods will be included as a eetings of the Cross agency residue er service contract arrangements with ). Also, any outstanding issues ll be resolved to ensure that methods able to detect residues at concentrations in Commission regulation (EU) No ssistance of the relevant CRL (Q3/Q4

bservations have been made by the Irish authorities of the FVO analysis underpinning this recommendation, ommendation may need to be revised in light of the suitability of methods will be included as a uture meetings of the Cross agency residue ngs under service contract arrangements with 3/ 2012). Also, any outstanding issues hods will be resolved to ensure that methods nd suitable to detect residues at concentrations id down in Commission regulation (EU) No h the assistance of the relevant CRL (Q3/Q4

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national protocols that deal with the Approvals of Food review process for Approved Establishments is dealt with by the ation (EC) No 853/2004. be amended to rectify this. This will be completed by end of ic health inspectorate an instruction to staff to review aspects of plant approval that are Os and to take action where infrastructure, facilities or written me unsatisfactory. Completion date: 01/06/12 nspectorate tification Division will review its procedures and amend where e that the approval of establishments is kept under review when l controls as required by Article 31.2(e) of Regulation (EC) No ents. As the document is the intellectual property of the Competent Authority, the European ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately Page: 1

Email dated 5 March 2012 HSE The HSE has a set of national protocols that deal with the Approvals of Food Establishments. The review process for Approved Establishments is dealt with by the Protocols re;- Regulation (EC) No 853/2004. LA The relevant SOP to be amended to rectify this. This will be completed by end of Quarter 3 2012 DAFM Veterinary public health inspectorate VPHIS will introduce an instruction to staff to review aspects of plant approval that are not being used by FBOs and to take action where infrastructure, facilities or written procedures have become unsatisfactory. Completion date: 01/06/12 DAFM Dairy Produce Inspectorate Dairy Controls & Certification Division will review its procedures and amend where appropriate to ensure that the approval of establishments is kept under review when carrying out official controls as required by Article 31.2(e) of Regulation (EC) No 882/2004.

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unt the past record of compliance and the reliability of own s iterated in Guidance Note 1 (Revision 2) part 2.3.4 that viation from standard frequency of planned inspection. See link ancenoteno1guidanceforthehealthserviceexecutiveontheinspectio on2 e amended to rectify this. This will be completed by end of ectorate airy Controls & Certification Division as the risk analysis h the frequency of official controls already takes into account the pliance and the reliability of own checks as required by Article 882/2004.

Email dated 5 March 2012 No clarification required HSE The HSE takes into account the past record of 1 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts compliance and the reliability of own checks of a FBO. This is iterated in Guidance Note 1 (Revision 2) part 2.3.4 that expressly deals with deviation from standard frequency of planned inspection. See link to Guidance note http://www.fsai.ie/guidancenoteno1guidancefor thehealthserviceexecutiveontheinspectionoffood businessesrevision2 LA The relevant SOP will be amended to rectify This will be completed by end of Quarter 3 2102. DAFM Dairy Produce Inspectorate No action proposed by Dairy Controls & Certification Division as the risk analysis carried out to establish the frequency of official controls already takes into account the FBOs past record of compliance and the reliability of own checks as required by Article 3 of Regulation (EC) No 882/2004.

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ification Division have already documented procedures in place of 2012 will clarify in the procedures what requirements are proval of collection centres and milk purchasers' facilities ents. As the document is the intellectual property of the Competent Authority, thPeaEguero: p2ean ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately

Email dated 5 March 2012 DAFM Document provided which details the official controls required for DAFM Dairy approval of milk purchasers and collection centers and the activity for Dairy Controls & Certification Division have already which they are approved. documented procedures in place but by end of quarter 1 of 2012 will clarify in the procedures what requirements are applicable for the approval of collection centres and milk purchasers' facilities 2 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts

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l be amended to rectify this. This will be completed by end of h inspectorate o Trichinella sampling have been updated by VPN 18/2011 . See attached VPN. isfied that our methods are to the satisfaction of EU nce Laboratory and await the outcome of the FVOs s stated by the FVO in the cover letter to the draft report

Email dated 5 March 2012 or LA LA The relevant SOP will be amended to rectify this. This Amended LA SOP A5 provided to take account of wild boar will be completed by end of Quarter 3 2012. DAFM VPN 18/2011 will be revised to include sampling procedures for wild DAFM Veterinary public health inspectorate The boar. Revision to be completed by 1st August 2012. procedures in relation to Trichinella sampling have been updated by VPN 18/2011 issued on 22nd Ireland is awaiting documentary confirmation from the EURL in Rome December 2011. See attached VPN. that the testing method used here is equivalent to that in Regulation 2075/2005. This confirmation will be communicated as soon as it is VPHIS and VPHRL DAFM are satisfied that our received. methods are to the satisfaction of EU Trichinella Community Reference Laboratory

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h inspectorate ocedure in place which detail the actions to be taken ces. These procedures are continually under review. g a more audit based approach to official controls in increase the efficiency and effectiveness of addressing ate Dairy Controls & Certification Division will review and procedures to ensure that official controls are effective and in case of non-compliances, as required by Articles 4.2 and ) No 882/2004. ents. As the document is the intellectual property of the Competent Authority, thPeaEguero: p3ean ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately

Email dated 5 March 2012 HSE Guidance has been developed by FSAI and HSE on inspections and use of enforcement powers in line with the requirements of Regulation 882/2004 and national legislation. The national implementation of this guidance aims to ensure that official controls are effective and consistent 3 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts and that appropriate enforcement actions are taken when non compliances are found. This guidance includes: · FSAI Guidance Note 1 (Rev. 2) for the HSE on Inspection of Food Businesses. This guidance was revised in December 2011 and includes provisions for prioritising inspections in businesses where non compliance are identified and prioritizing these businesses for action - including where businesses have repeated non-compliances. There must be regular review by HSE management of the food businesses on the priority action list. This is outlined in Part 4 of the guidance. Link to Guidance note 1 provided · Enforcemen

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t of HACCP Compliance (revision 2) is used by the HACCP based systems are in place. See link to .ie/WorkArea/DownloadAsset.aspx?id=738 on auditing food safety management systems (HACCP ority Veterinary inspectors in Q2/Q3 2012. training to the Local Authority TVI's in Q4 2012. nspectorate /2008 provides for an evaluation of HACCP nd a HACCP check-list, no formal HACCP audit is ach to official controls will target the FBO's HACCP principles) and their implementation in . ded to all Veterinary Inspectors and roll out will coorespondance. tification Division process of continuing improvement, efresher training on procedures based on HACCP hat the HACCP based systems in milk processing Article 5 of Regulation (EC) No 852/2004. ents. As the document is the intellectual property of the Competent Authority, thPeaEguero: p4ean ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately . DG(SANCO)/2011-6017-MR of an audit carried out petent authorities with regard to official controls related Action Proposed by the Competent Authority

mail dated 5 March 2012 SE LA See FSAI comment below. SAI guidance note 11 Assessment of HACCP ompliance (revision 2) is used by the HSE to ensure hat appropriate HACCP based systems are in place. ee link to Guidance note - ttp://www.fsai.ie/WorkArea/DownloadAsset.a px?id=738 6 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts SAI FSAI he FSAI will deliver training on auditing food safety The FSAI training on auditing food safety management systems anagement systems (HACCP based procedures) to (HACCP based procedures) to Local Authority Veterinary inspectors

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t and Compliance division will carry out an audit of Official controls by TVI's in Local Authority supervised food business operations e April 2012. an instruction to all Local Authority County Managers advising e of recruitment for OV's they must have completed the necessary tionary training otherwise the County Council must look to aining. This instruction will be issued by end of Quarter 1 2012. public health inspectorate tly developing and commencing implementation of an updated ogramme which will ensure that newly recruited OVs will onary training of at least 200 hours duration. This training will of VPHIS activity. It is intended that this Mentoring system will ented by 31/12/12. ents. As the document is the intellectual property of the Competent Authority, the European ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately Page: 5 . DG(SANCO)/2011-6017-MR of an audit carried out petent authorities with regard to official controls related

ocal Authority Veterinary inspectors in Q2/Q3 2012. will commence at the beginning of October 2012. The feedback from t is planned to provide HACCP training to the this training will be used by the Local Authority SOP group who will ocal Authority TVI's in Q4 2012. schedule a meeting after this training (before end of 2012) to amend SOP D1/2008 to take account of the recommendation . AFM Veterinary public health inspectorate .1.6-`Although the DAFM SOP 06/2008 provides DAFM or an evaluation of HACCP prerequisites, the Every non-slaughter establishment considered high risk following an lant CCPs and a HACCP check-list, no formal annual risk assessment (either because of the nature of the food they ACCP audit is mentioned'. produce, e.g. ready to eat, or because of the level of non-compliances during the previous 12 months) will be audited once every 6 months. he new VPHIS audit based approach to official Other establishments will be audited once every 12 months ontrols will target the FBO's documented procedures based on HACCP principles) and their implementation n relevant approved food premises. raining has already been provided to all eterinary Inspectors and roll out will ommenc

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ures to be amended (by end of quarter 2 of 2012) to include sure that the requirements of Chapter I, Section IX, Annex III to (EC) 853/2004 in relation to the use of raw milk from animals not ith the requirements of points 1 to 3 of Chapter I, Section IX, o Regulation (EC) 853/2004, and, in particular, from any animals ositive reaction to the prophylactic test vis-à-vis TB, are met.

e Email dated 5 March 2012 DAFM VPHIS who monitor drinking milk plants will amend our Milk SOP by DAFM adding a section on Supplier Controls at Raw Milk Intake from TB Restricted Herds detailing the procedures and controls involved in DAFM procedures to be amended (by end of quarter 2 handling milk from TB Restricted herds. Additionally a communication of 2012) to include controls to ensure that the system is being established between ERAD and VPHIS to inform requirements of Chapter I, Section IX, Annex III to relevant VIs of relevant TB restricted herds Regulation (EC) 853/2004 in relation to the use of raw milk from animals not complying with the requirements Draft checklist provided amending current Dairy Controls & Certificate of points 1 to 3 of Chapter I, Section IX, Annex III to Regulation (EC) Division controls. Revised checklist and SOP to be issued by end of Q2. 8 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts 853/2004, and, in particular, from any animals s

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of communication between the relevant Divisions of DAFM ablished (by end of quarter 1 of 2012) in the cases of TB breakdowns, by Article 4(5) of Regulation (EC) No 882/2004.

Email dated 5 March 2012 DAFM DAFM circular provided - Notifying Milk Purchaser of herd restriction DAFM and de-restriction and new DAFM procedures ER 122A and ER 122B A formal system of communication between the relevant forms Divisions of DAFM will be established (by end of quarter 1 of 2012) in the cases of TB breakdowns, as uired by Article 4(5) of Regulation (EC) No 82/2004. 9 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts

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y public health inspectorate ill issue instruction to staff and FBOs that all `oval marks' must d when the packaging is opened. Completion date 1/06/12.

mail dated 5 March 2012 cation DAFM Veterinary public health inspectorate VPHIS DAFM will issue instruction to staff and FBOs that all `oval marks' must be destroyed when the packaging is opened. Completion date 1/6/12. LA FSAI issued instruction to all Local Authority Veterinary Inspectors on 21st June 2012. Instruction provided from FSAI. FSAI The Guidance will be completed by end of 2012 and circulated to all relevant official agencies forthwith.

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op guidance for all Official Agencies in order to ensure of compliance with the requirements. This will begin in Quarter 2 ents. As the document is the intellectual property of the Competent Authority, the European ere possible and where it did not violate Article 287 of the Treaty as regards confidentiality, the been added as annex and may be opened separately Page: 6

he Email dated 5 March 2012 The document will provide guidance to official agencies and relevant FBOs with respect to their requirements for an adequate supply of potable water as per Point 1(a), Chapter VII of Annex II to Regulation FSAI (EC) No 852/2004. The guidance will cover areas such as sampling FSAI will develop guidance for all Official requirements/volume, communication to all relevant parties in the event Agencies in order to ensure consistency of of out of specification test results, frequency of sampling, testing compliance with the requirements. This will begin parameters etc. The focus of the guidance will be food businesses using water as part of their food processing operations. Relevant SOPs in the agencies on the official control of the potable water requirement will be in Quarter 2 of 2012. amended as necessary. The focus of the guidance will be manufacturing establishments using 10 Updated CA response submitted on 22 June 2012 -MR of an audit carried out from 17 to 28 October 2011 in order to evaluate the follow-up action taken thorities with regard to official controls related to the safety of food of animal origin, in particular meat, ucts water as part of th

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lly designated following consultation and agreement with f Health and the FSAI. e responsible for coordinating this action point.

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ficer has participated in the workshop on `Better fer Food' since the mission. Further on-the-job training ed and records of such training will be maintained on an ongoing

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Procedures for 2012 is being revised to require the officer to check the results of `own checks' conducted by the ormation gathered will be factored into the control plan for the ng year as a part of the risk assessment.

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hods of analysis have been validated for processed cereal- ods and baby foods for infants and young children. When the ry has been officially designated, the number of samples will, at least, reflect the minimum number required by on Regulation (EC) No 915/2010, (see Recommendation 1).

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already drafted to address this recommendation whereby fines may be applied for minor infringements of the ion, such as unauthorised use which had no adverse effect on animals or the environment. Page: 1