Malta

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In particular, the Food Safety Act is essential in the scope of the audit. Subsidiary legislation 449.31 of 1 July 2003 explicitly lays down that the scope of assuring food hygiene at, and applicable to, all stages of the food chains after primary production. The production of sprouts, that is considered primary production, is therefore also excluded (see paragraphs 23 and 24). This is not in line with Article 1(2)(a) of Regulation (EU) 2017/625, which states that official controls in the area food and food safety, integrity and wholesomeness must be performed at any stage of production, processing and distribution of food, including primary production.

Primary production of FNAO (including sprouts production) is not included in the legal scope of official controls as required by Article 1(2)(a) of Regulation (EU) 2017/625. This compromises the capacity of the CA to implement the necessary controls to verify compliance with the relevant EU rules. 3

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Directorate of Food Standards (DFS): The Ministry for Agriculture, Fisheries and Animal Rights (MAFA) is in the process of publishing the "Primary Production of Food of Non-Animal Origin (FNAO) (including sprouts production) Regulations, 2024" under the Agriculture Act, Chapter 639 of the Laws of Malta. Copy of the approved regulation is being attached (Annex 1). These Regulations shall come into force within two months from their publication in the Government Gazette of Malta by end of 2024. Once published the Director of the Agriculture Directorate will delegate the powers of enforcement to the DFS within MAFA.

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However, EHD is not designated to cover the stages of primary production (before, during and after harvest on farm level and the production of sprouts). EHD covers the stages after harvest at retail and processing stages. EHD stated that there is no other authority designated to cover primary production stages regarding microbiological risks.

The CA is not designated for all stages of FNAO production and for sprout-producing establishments. Official controls at primary production, as required by Article 1(2)(a) of Regulation (EU) 2017/625, are not covered. This limits the basis for the implementation of official controls.

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Agriculture Directorate delegated the task to prepare a plan of implementation to the DFS which is to be made as per provisions ed in Article 1(2)(a) of Regulation (EU) 2017/625, for the controls at primary production level for FNAO. The European Commission will be informed of this plan upon finalisation together with a copy of such plan by end of 2024.

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The planning of official controls is based on Article 9 of Regulation (EU) 2017/625. The annual plans are based on an up-to-date database of registered FBOs containing the results of the last risk categorisation of the FBO from the previous calendar year. However, in the case of FNAO, contrary to Article 9(1)(a) and (d) of Regulation (EU) 2017/625, risks associated with the goods and third-party controls are not taken into account in establishing the frequency of official controls.

For defining the frequency of official controls at processing plants, indicators such as hygiene of premises, personal hygiene, water etc. are considered. The risks regarding the different types of produce are not considered. For vegetables and/or cut fruit and vegetables, official checks are carried out once or twice a year, depending on the outcome of this risk evaluation. 5.3.3 Implementation of official controls Legal requirements Articles 9(1)(d), 14 and 44(1) of Regulation (EU) 2017/625; Articles 4 to 8, and Annexes I and II of Regulation (EC) No 852/2004; Article 18 of Regulation (EC) No 178/2002; Article 3 of Regulation (EU) No 208/2013; Regulation (EU) 2020/2235; Article 1 and Annex I of Regulation (EC) No 2073/2005. 7 Findings Processors (cut fruits and vegetables)

Contrary to Article 9(1)(a) and (d) of Regulation (EU) 2017/625, risks associated with the goods and third-party controls are not taken into account to establish the frequency of official controls.

Several inspectors' knowledge and expertise on how to verify FBOs' management of L. monocytogenes risk was limited, and this could lead to an underestimation of this risk.

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Environmental Health Directorate (EHD): n 44: With regards to third party controls in areas of EHD remit, such controls will be taken in consideration and included in the checklists of the new Inspection Online Solution (IOS) so that the frequency of inspection will be in line with Regulation (EU) Page: 1 ref. DG(SANTE) 2024-8039 of the audit carried out from 15 January 2024 g to microbial safety of food of non-animal origin on Proposed by the competent authority and deadline by h it will be completed /25. It is targeted that this will be implemented by end of . lusion 46: aining seminar on Listeria was held for all Environmental th Officers (EHOs) and Public Health Laboratory (PHL) ntific personnel on the 26th and 29th April 2024. Please find ched agenda for this seminar (Annex 2). Ongoing training in area will be included in training programmes. controls on the primary production of food of non-animal in including sprout production are going to be included in the P, and results of such controls will be communicated on an al basis via the MANCP annual report. The DFS has initiated process to recruit inspectors. In the meantime, the Directorate iated drafting the procedures, checkl

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At the time of the audit, there were no sprout-producing establishments. A standard operating procedure (SOP) and a checklist have been prepared and will be used for the evaluation of applications for packing or distribution of sprouts. These are in the final stages of being approved and internally published.

There is no system in place for the approval of sprout-producing establishments, which is not in line with Article 2 of Commission Regulation (EU) No 210/2013.

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DFS: DFS has started drafting Standard Operating Procedures s) and checklists for sprout producing establishments by end 024. Page: 2 ref. DG(SANTE) 2024-8039 of the audit carried out from 15 January 2024 g to microbial safety of food of non-animal origin Action Proposed by the competent authority and deadline by which it will be completed An SOP has been drafted and is being reviewed in this regard by the EHD for the certification of sprout packing establishments (Annex 3) including the checklist on sprout packaging plants (Annex 4).

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For official controls of processing plants there is a generic checklist. The instructions provide a list of the main areas of inspection, without detailing specific points of control. Inspection reports can be viewed by the respective higher environmental health practitioner through the health inspectorate computer system. In cases of repeated non- conformities, or where a serious risk to health is identified, environmental health officers have legal powers to seize food and issue prohibition orders.

Regarding sampling of Listeria monocytogenes (L. monocytogenes) at surfaces level, a SOP was not available. The CA informed the auditor that not all the inspectors have thorough expertise regarding L. monocytogenes, in particular, concerning the obligation of CAs to verify compliance of FBOs with Article 5(2) of Regulation (EC) No 2073/2005 (2). However, during the audit, the CA drafted an SOP on sampling and on measures to take in case of positive L. monocytogenes results to rectify this shortcoming.

The auditor observed inspections being carried out of the high care areas and, in part, the non-high care cutting areas at both FBOs. Several non-compliances were detected by the inspectors, such as too high chlorate concentration of the washing water, damaged floor etc. However, the inspectors did not notice condensation water on the ceiling over a conveyer belt with unprotected produce, poor reaction of staff regarding food components falling on the desk during assembling a mixed salad, and a cobweb over a conveyer belt with unprotected produce. Other control systems

The lack of detailed checklists and clear instructions for inspectors on how to carry out and to document what has been subject to controls, questions the effectiveness and adequacy of official controls, thereby weakening the entire system.

Several inspectors' knowledge and expertise on how to verify FBOs' management of L. monocytogenes risk was limited, and this could lead to an underestimation of this risk.

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l EHD: in Conclusion 45: As mentioned, the old Health Inspectorate System (HIS) checklist is being phased out and the new IOS checklist is more comprehensive and detailed. It is expected that this process should be finalised by the end of 2024. Conclusion 46: As indicated above (recommendation 3), a training seminar on Listeria was held for all EHOs and PHL scientific personnel on the 26th and 29th April 2024. DFS: Once the recruitment is initiated, the inspectors will be provided training.

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Regarding sampling of Listeria monocytogenes (L. monocytogenes) at surfaces level, a SOP was not available. The CA informed the auditor that not all the inspectors have thorough expertise regarding L. monocytogenes, in particular, concerning the obligation of CAs to verify compliance of FBOs with Article 5(2) of Regulation (EC) No 2073/2005 (2). However, during the audit, the CA drafted an SOP on sampling and on measures to take in case of positive L. monocytogenes results to rectify this shortcoming.

Several inspectors' knowledge and expertise on how to verify FBOs' management of L. monocytogenes risk was limited, and this could lead to an underestimation of this risk.

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EHD: onclusion 46: s indicated above (recommendation 3), a training seminar on Listeria was held for all EHOs and PHL scientific personnel on the 26th and 29th April 2024.

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This audit framework covers all areas of consumer health protection. All specialist areas, within EHD remit, are audited over a period of 5 years. Audits covering topics related to microbial safety are incorporated in various vertical audits related to food safety. However, the area of microbiological risks in FNAO, in the scope of this audit, has not yet been covered. 4 Conclusions on competent authorities

Nonetheless, the CA activities, to verify the effectiveness of the official controls performed, are limited.

For official controls of processing plants there is a generic checklist. The instructions provide a list of the main areas of inspection, without detailing specific points of control. Inspection reports can be viewed by the respective higher environmental health practitioner through the health inspectorate computer system. In cases of repeated non- conformities, or where a serious risk to health is identified, environmental health officers have legal powers to seize food and issue prohibition orders.

EHD informed the auditor that inspectors have been provided with tablets with access to their IT system, to be used during official controls, and findings and recommendations should also be registered in the IT system. However, details on the inspected points at the premises are rarely registered and are often not traceable.

Regarding sampling of Listeria monocytogenes (L. monocytogenes) at surfaces level, a SOP was not available. The CA informed the auditor that not all the inspectors have thorough expertise regarding L. monocytogenes, in particular, concerning the obligation of CAs to verify compliance of FBOs with Article 5(2) of Regulation (EC) No 2073/2005 (2). However, during the audit, the CA drafted an SOP on sampling and on measures to take in case of positive L. monocytogenes results to rectify this shortcoming.

The auditor observed inspections being carried out of the high care areas and, in part, the non-high care cutting areas at both FBOs. Several non-compliances were detected by the inspectors, such as too high chlorate concentration of the washing water, damaged floor etc. However, the inspectors did not notice condensation water on the ceiling over a conveyer belt with unprotected produce, poor reaction of staff regarding food components falling on the desk during assembling a mixed salad, and a cobweb over a conveyer belt with unprotected produce. Other control systems

The lack of detailed checklists and clear instructions for inspectors on how to carry out and to document what has been subject to controls, questions the effectiveness and adequacy of official controls, thereby weakening the entire system.

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EHD: Page: 3 ref. DG(SANTE) 2024-8039 of the audit carried out from 15 January 2024 g to microbial safety of food of non-animal origin Action Proposed by the competent authority and deadline by which it will be completed of Conclusion 17 (finding 15): The EHD has audited areas within the FNAO area such as Sampling, Rapid Alert System for Food and Feed (RASFF), food borne illness but not specific for on microbial risks in FNAO. Audits in Microbial risks in FNAO will be included in the 2023- 2027 audit universe. Conclusion 45 (findings 28, 34, 37 and 40): As mentioned above (item 5), the old HIS checklist is being phased out and the new IOS checklist is more comprehensive and detailed. It is expected that this process is finalised by the end of 2024. The new IOS system has the facility to add comments for every non-compliance. Such comments include the inspection point where the non-compliance was noted. As indicated above (recommendation 3), a training seminar was held on the 26th and 29th April 2024 for all EHOs and PHL scientific personnel. Furthermore, the draft SOP on "Sampling of Food, Water intended for human consumption, Environmental Swabs and Food Contact Material" presente

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The Public Health Laboratory (PHL) consists of two main sections, namely chemistry and microbiology laboratories located at the Evans Buildings in Valletta. The plan to move the laboratory to new, more suitable premises will be finalised in 2024. This laboratory performs official food, feed and hygiene testing, investigation of suspected food poisoning and food poisoning outbreaks, food and environmental (3) EFSA ­ SCIENTIFIC OPINION on the risk posed by pathogens in food of non-animal origin. Part 1 (outbreak data analysis and risk ranking of food/pathogen combinations). EFSA Journal 2013;11(1):3025; EFSA ­ SCIENTIFIC OPINION on the risk posed by pathogens in food of non-animal origin. Part 2 (Salmonella and Norovirus in berries). EFSA Journal 2014;12(6):3706. EFSA ­ SCIENTIFIC REPORT. Tracing of food items in connection to the multinational hepatitis A virus outbreak in Europe. EFSA Journal 2014; 12(9); 3821; Food-borne diseases associated with frozen berries consumption: a historical perspective, European Union, 1983 to 2013. Euro Surveill. 2015; 20(29); Foodborne viruses: Detection, risk assessment, and control options in food processing. International Journal of Food Microbiology 285 (2018) 110 ­ 128. 10 surveillance/monitoring programmes and food authenticity investigations. The PHL is also the national reference laboratory for biological parameters like Salmonella, Campylobacter, L. monocytogenes, Coagulase Positive Staphylococci, Vero Toxigenic E. coli and Legionella.

The PHL operates a quality management system in compliance with ISO 17025 requirements. However, its accreditation was suspended in 2021 due to structural deficiencies, which has led to the decision to move the laboratory. This is not in line with Article 37(4)(e) of Regulation (EU) 2017/625 which sets out that only accredited laboratories can be designated, and Article 39(2)(a) of Regulation (EU) 2017/625 requiring the withdrawal of designation in case of failing to comply with the requirements.

The accreditation of the designated official PHL according to standard ISO 17025 is currently suspended. However, it is a requirement of Article 37(4)(e) of Regulation (EU) 2017/625 that PHL should be accredited, in order to ensure sound and reliable results.

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EHD: perintendent of Public Health (SPH) and the EHD are g in parallel on how accreditation can be attained within rrent PHL and on the outline of the new PHL which is ed to move to a new location. expected that: by end Q3 of 2024 an outline of requirements to regain accreditation by PHL in the existing premises is available and by end 2024, a plan for the new PHL will be outlined. meantime, PHL-EHD is also working to seek a proxy entative for the National Reference Laboratory (NRL) ties in this regard until the laboratory is again accredited. date ­ end of 2024.

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Malta is progressing in strengthening its laboratory capacity; it uses the services of different laboratories throughout Europe for many routine and/or confirmatory testing procedures. However, these laboratories are not officially designated as required by Article 37 of Regulation (EU) 2017/625.

External laboratories are not officially designated as required by Article 37 of Regulation (EU) 2017/625.

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D has already started communication with other Member to identify appropriate accredited laboratories. date ­ end of 2024. Page: 5

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While the initial NRCP for 2023 was submitted to the European Commission in March 2023, three other versions of the plan were internally circulated between Au- gust and December 2023, to the units in charge of implementation. A fourth version was presented during the audit by the NVL. None of the versions circulated after March 2023 fulfilled the minimum sample numbers as required by EU legisla- tion (17) nor did they cover all of the commodities and substance groups (18).

The 2023 NRCP sampling started only in September 2023 contrary to the require- ments of EU legislation (19) that the sampling is to be evenly spread throughout the year or the relevant production period for the commodity in question. (9) Internal Procedure PI 076 ­ Sampling Procedure to Collect Samples for Veterinary Residues excluding Contaminants and Pesticides. (10) Until 2022, the NVL was entirely part of the VRD. Since 2022, it has been a self-standing institution. A Memorandum of Understanding was signed between the VRD and the NVL and was last updated on 09/02/2024. (11) Commission Regulation (EU) 2022/1644, Commission Regulation (EU) 2022/1646. (12) Article 5(1)(a) of Regulation (EU) 2017/625. (13) Annex III to Commission Regulation (EU) 2022/1644. (14) Article 5(4)(c) of Regulation (EU) 2017/625. (15) Article 9(4) of Regulation (EU) 2017/625. (16) Points 5 and 6 of Annex II to Regulation (EU) 2021/808. (17) Annex I, II and III to Commission Regulation (EU) 2022/1646. (18) Annex II and IV to Commission Regulation (EU) 2022/1644. (19) Point 1. of Annex III to Commission Regulation (EU) 2022/1644. 6

Out of the 482 samples planned for 2023, 170 were taken in 2023. In addition, at the time of the audit, 95 of the 170 remained to be analysed. For eight substance group/matrix combinations indicated in the 2023 NRCP, no laboratory had been identified and contracted to do this work at the time of the audit ­ the samples were already taken and stored at the NVL. The competent authority claimed that the de- lays in testing and the under-implementation of sampling were related to difficulties in contracting laboratories and in procurement procedures.

In 2023, out of the 11 samples planned (minimum frequency 10 samples (22)), six were taken in the last two months of the year and none had been analysed at the time of the audit. 5.3. Implementation of the national risk-based control plan for residues of pharmaco- logically active substances in food of animal origin entering the Union from third countries

While the number of incoming consignments was stable over the past three years, only one sample was taken in 2023 (out of 64 planned). It was chosen taking into account the most common incoming consignments. The criteria for the selection of substance groups and commodity groups (23) were not applied.

The VRD sampling for contaminants (other than retail samples) in 2023 was imple- mented to 67-100%, depending on the number of samples planned for the different analyte groups to be tested for. Between 6 and 50% of the samples taken in 2023 had been analysed by the time of the audit. For three analyte groups (polycyclic aromatic hydrocarbons, dioxins and mycotoxins) out of a total of seven analyte groups, no samples had been analysed to date.

Notwithstanding that sampling of animal products at retail level for residues of pes- ticides and contaminants was performed in line with planned arrangements and EU requirements, there was significant under-implementation of the control plans for pharmacologically active substances in animals and animal products and for con- taminants in animal products sampled by the VRD. Combined with the absence of appropriate training, these shortcomings compromise the effectiveness of the con- trol system for residues and substantially weaken competent authority assurances that agri-food of Maltese origin complies with EU rules on residues. (35) Regulation (EU) 2022/931. (36) Article 12(1) of Regulation (EU) 2017/625. (37) Guideline No. F014 on Sampling, Sampling Procedures and ancillary issues, Revision Date: 28/04/21 (ongoing revision during the audit). (38) Article 3(6) of Regulation (EU) 2017/625. 9

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The Maltese Authorities have established a way forward for the ) in preparation and implementation of the National Residue Control Plan (NRCP), which includes the three residue control plans for pharmacologically active substances, and the Contaminants Control Plan (CCP). Such plans are being prepared and implemented in line with Commission Regulation (EU) 2022/1644, and Commission Regulation (EU) 2022/1646. The arrangements that are to be affected in the control plans for residues of pharmacologically active substances and the CCP include: · a risk-based sampling strategy; · detailed instructions for all officers involved in the drafting and implementation of the three residue control plans; and · monthly reports on samples taken for monitoring progression of sampling plans. The detailed instructions for risk-based sampling for the NRCP and the CCP are included in the guidelines document (Annex1). These guidelines include a description of responsibilities within the Veterinary Regulation Directorate (VRD), updated instructions on risk-based sampling, updated sampling forms, as well as criteria for risk assessment at all levels, and for different parameters. Furthermore, in respons

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BACKGROUND 4.1. Legal framework for controls on residues in animals and food of animal origin Member States are legally obliged to implement control plans for residues of pharmacologically active substances in animals and animal products (2). These (1) https://op.europa.eu/en/publication-detail/-/publication/ea42629a-8f3d-11ee-8aa6-01aa75ed71a1/language- en (2) Commission Delegated Regulation (EU) 2022/1644 and Commission Implementing Regulation (EU) 2022/1646. 4 comprise three plans: a national risk-based control plan for production in the Member States, a national randomised surveillance plan for production in the Member States and a national risk-based control plan for third-country imports into the EU. All of these plans are subject to annual Commission evaluation (3). Member States must establish multiannual national control programmes for pesticide residues (4) in food and feed of both animal and non-animal origin and they must also participate in the multiannual Union control programme in accordance with Article 29 of Regulation (EC) No 396/2005. Member States must control the presence of certain contaminants in food of both animal and non-animal origin. The foodstuffs of animal origin to be tested and the categories of contaminants to be tested are specified (5) as is the sampling frequency (6). This control plan is also subject to annual Commission evaluation (7). The scope of this report is limited to the competent authorities' implementation of control plans for residues of pharmacologically active substances, pesticides and contaminants in animals and animal products. It does not cover the controls on residues in food and feed of non-animal origin.

FINDINGS AND CONCLUSIONS 5.1. Implementation of the national risk-based control plan for residues of pharmaco- logically active substances 1. The Veterinary Regulation Directorate (VRD) within the Ministry for Agriculture, Fisheries and Animal Rights (MAFA) is the competent authority responsible for planning and implementation of the national control plans for residues of pharmaco- logically active substances (NRCPs). 2. Within the VRD, in 2023 a coordinator for the NRCP was appointed, to: a. develop the NRCP and after validation by the director, email it to the units of the VRD in charge of its implementation; b. supervise the implementation of the NRCP; c. coordinate investigations and follow-up action related to non-compliant cas- es. (3) Article 8 of Commission Implementing Regulation (EU) 2022/1646. (4) Article 1 of Commission Implementing Regulation (EU) 2021/1355. (5) Point 1 of Annex I to Commission Delegated Regulation (EU) 2022/931. (6) Point 1 of Annex I to Commission Implementing Regulation (EU) 2022/932. (7) Article 7 of Commission Implementing Regulation (EU) 2022/932. (8) https://ec.europa.eu/food/audits-analysis/audit-report/details/4072 5 3. NRCP samples are taken by VRD officials under the supervision of the Principal Veterinary Officers (PVOs) in each VRD unit. Samples at farm level are taken by the Animal Health Unit and samples at slaughter and processing levels are taken by the Safety of the Food Chain Unit. 4. The sampling instruction (9) was drafted and approved in 2018 by the staff of the National Veterinary Laboratory (NVL) (10). The instruction was updated on 19 Janu- ary 2024 with the introduction of parts of the current EU legal requirements on resi- due controls for pharmacologically active substances (11). Notwithstanding this re- cent addition, the sampling officers were not aware of its existence and there were no other such instructions in place, resulting in random instead of targeted sampling and in inappropriate sample and matrix selections. This is not in line with EU legis- lation (12). 5. Whilst the VRD staff interviewed were competent in general sampling procedures, they did not receive any specific training on residues sampling, and they were not aware of the concepts of targeted sampling (all sampling was random) and the crite- ria for the selection of the appropriate matrices as laid down in EU law (13). This is not in line with EU legal requirements (14).

The general BCP sampling instruction seen by the audit team did not include any mention of requirements (24) which are pertinent for controls on residues (see finding 15) and thus the effectiveness and appropriateness of such controls can't be guaran- teed, as required by EU legislation (25). (26) (20) Article 6 of Regulation (EU) 2017/625. (21) Point 1. of Annex V to Commission Regulation (EU) 2022/1644. (22) Annex II to Commission Regulation (EU) 2022/1646. (23) Annex VI and VII to Commission Regulation (EU) 2022/1644. (24) Commission Regulation (EU) 2022/1644 and Commission Regulation (EU) 2022/1646. (25) Article 5(1)(a) of Regulation (EU) 2017/625. 7 5.4. Implementation of the multiannual control programme for pesticide residues and the Union-wide coordinated multiannual programme

Notwithstanding that sampling of animal products at retail level for residues of pes- ticides and contaminants was performed in line with planned arrangements and EU requirements, there was significant under-implementation of the control plans for pharmacologically active substances in animals and animal products and for con- taminants in animal products sampled by the VRD. Combined with the absence of appropriate training, these shortcomings compromise the effectiveness of the con- trol system for residues and substantially weaken competent authority assurances that agri-food of Maltese origin complies with EU rules on residues. (35) Regulation (EU) 2022/931. (36) Article 12(1) of Regulation (EU) 2017/625. (37) Guideline No. F014 on Sampling, Sampling Procedures and ancillary issues, Revision Date: 28/04/21 (ongoing revision during the audit). (38) Article 3(6) of Regulation (EU) 2017/625. 9

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A training course has been organised by the VRD officer who had followed through the EFSA courses and related meetings. This training course is to be carried out by the end of May for all officers involved in the implementation of the NRCP and the CCP. The objective of this training course is to: Page: 2 report ref. DG(SANTE) 2024-8082 of the audit carried out from 05 February 2024 ologically active substances, pesticides and contaminants in animals and animal Action Proposed by the competent authority and deadline by which it will be completed · Highlight the changes to the NRCP and the CCP, vis-a- vis the risk-based strategy to be adopted in line with the change in legislation. · Provide specific training on residues sampling, especially targeted sampling in line with Article 5(4)(c) of Regulation (EU) 2017/625. · Provide refresher training on follow-up procedures. The Border Control Post (BCP) Standard Operation Procedure (SOP) on the sampling procedure for residues and contaminants has been updated to include the requirements for a risk-based approach in line with Article 5(1)(a) Regulation (EU) 2017/625. (Annex 3)

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At the time of the audit, none of the laboratories for pharmacologically active sub- stances and for contaminants (non-retail samples) were appropriately designated as official laboratories by the VRD, contrary to EU requirements (50). Furthermore, some of the analytical methods used are not included in the laboratories' scope of accreditation as required by EU legislation (51). (52)

The NVL receives all samples taken by the VRD for testing for residues of pharma- cologically active substances and contaminants (with the exception of samples taken in the retail sector). It performs mixing and homogenisation of certain samples, stores samples and transfers them to the sub-contracted foreign laboratories.

The capability and performance of the laboratory network used for both pesticides and contaminants is fit for purpose. This is not the case for the sub-contracted la- boratories testing for residues of pharmacologically active substances. None were appropriately designated and some of the methods used were not included in their respective scopes of accreditation. Furthermore, some did not comply with the legal provisions for interpreting non-compliant results. There was an absence of data on the stability of analytes in matrix and substantial delays in the dispatch of stored samples from the NVL to the sub-contracted laboratories. Collectively these ele- ments substantially weaken the reliability of the results generated. (58) With the reply to the draft audit report, the competent authority provided updated information on sample storage and temperature management, aligned with EU legal requirements. (59) Point 19.2 of Codex CAC/GL 71-2009 Revision 2012, 2014 and point 7.8.3.1c of ISO/IEC 17025:2017. (60) Article 5(1) of Regulation (EU) 2021/808. (61) Regulation (EC) No 333/2007, Regulation (EC) No 401/2006 and Regulation (EU) 2017/644. 13

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The testing laboratories are appropriately designated as per Articles 37 and 39(1) of Regulation (EU) 2017/625 (Annex 4 a, b, c, d). Furthermore, almost all the analytical methods are included in the scope of accreditation of the designated laboratories as required by EU legislation. Those not yet included will be validated and added to the flexible scope on receipt of sample/s. Weekly sample dispatch from the National Veterinary Laboratory (NVL) to the designated laboratories will safeguard the stability of the analyte. Page: 3 report ref. DG(SANTE) 2024-8082 of the audit carried out from 05 February 2024 ologically active substances, pesticides and contaminants in animals and animal ion Proposed by the competent authority and deadline by ch it will be completed

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The audit team checked the sample acceptance/rejection system, including the exist- ing procedure (54), for incoming samples in the NVL. No criteria were specified with regard to determining whether the samples were suitable for testing (55). (56)

For the storage of the samples in the NVL, there is continuous monitoring of the ac- tual temperature in fridges and freezers used for NRCP samples. However, for fro- zen samples, the target temperature registered in the system and indicated in the ap- plication used for the surveillance of the freezers, was noted and considered `fit for purpose' at -10°C. Considering the fact that sometimes two to four months elapsed before the samples were sent to the sub-contracted laboratory for analysis, this may pose a problem since some analytes are not stable at that temperature for extended storage periods. The NVL could not demonstrate that the storage (and transport) conditions were adequate to ensure analyte stability in matrix (57) and thus the va- (50) Articles 37 and 39(1) of Regulation (EU) 2017/625. (51) Article 37 (4e) of Regulation (EU) 2017/625 and chapter 2 of Regulation (EU) 2021/808. (52) With the reply to the draft audit report, the competent authority provided signed copies of four designation letters addressed to official laboratories in other Member States. The letters were signed on 30/04/2024 and are in line with the requirements of Articles 37 and 39 of Regulation (EU) 2017/625. (53) Article 37 (4e) of Regulation (EU) 2017/625. (54) Process Instruction PI033 - Receipt and Handling of Samples, Revision 04, 06/05/2020. (55) Article 34(5) of Regulation (EU) 2017/625 (56) With the reply to the draft audit report, the competent authority provided a copy of the updated Process Instruction PI 033 - Receipt and Handling of Samples, Revision 05, 17/05/2024. The new version of the in- struction includes sample acceptance/rejection criteria. (57) Part 7 of Annex II to Regulation (EU) 2021/808. 12 lidity of results, considering that many samples are stored for prolonged periods pri- or to analysis. (58)

The capability and performance of the laboratory network used for both pesticides and contaminants is fit for purpose. This is not the case for the sub-contracted la- boratories testing for residues of pharmacologically active substances. None were appropriately designated and some of the methods used were not included in their respective scopes of accreditation. Furthermore, some did not comply with the legal provisions for interpreting non-compliant results. There was an absence of data on the stability of analytes in matrix and substantial delays in the dispatch of stored samples from the NVL to the sub-contracted laboratories. Collectively these ele- ments substantially weaken the reliability of the results generated. (58) With the reply to the draft audit report, the competent authority provided updated information on sample storage and temperature management, aligned with EU legal requirements. (59) Point 19.2 of Codex CAC/GL 71-2009 Revision 2012, 2014 and point 7.8.3.1c of ISO/IEC 17025:2017. (60) Article 5(1) of Regulation (EU) 2021/808. (61) Regulation (EC) No 333/2007, Regulation (EC) No 401/2006 and Regulation (EU) 2017/644. 13

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matrix 4.1(i) ntegrity The Competent Authority has compiled detailed instructions for officers responsible for sampling from the VRD regarding the nsport and storage of the samples from the sampling point to NVL. The criteria for the relevant conditions such as the perature and time have been described in the detailed sampling tructions. (ii) negotiated procedure (Ref: CT5000/2024) with four Member te official laboratories, has been approved for the provision of lytical services for residues of pharmacologically active stances, contaminants, and pesticides. The contract covering t of the analysis has been signed by both parties and receipt of h is acknowledged by the subcontracted lab (Refer to Annex The other contract is in the process of being signed. All ples received to date have been subcontracted under the on- ng short contracts for service open with the same official oratories. (iii) NVL sample submission form has been amended to include criteria and traceability of the conditions of incoming samples. fer to Annex 6: Form 3.1 ­ Chemical Analysis Sample mission Form rev.08 and Annex 7: Process Instruction PI033 eceipt and handling of Samples rev. 05 17/05/2024 (revised to lec

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There were issues with the sampling plans, for the first 2 years of AMR monitoring under the EU Decision: i. The VRD only issued and distributed its standard operating procedure (SOP) for sampling 22 months after the monitoring was due to start (October 2022). ii. The SOP refers to a fixed number of 150 caecal samples based on the derogation applicable when there is low or unknown prevalence of certain bacterial species combined with low annual production. However, when prevalence is above 30%, another derogation requiring a minimum number of isolates is applicable. The SOP does not reflect this possibility and does not state that sampling needs to be done at 3 all BCPs (see point 15iv). This is not fully in line with points 3(1)(b), 3(3) and point 4(1) of part A of the Annex to the EU Decision. iii. The HIS' annual memo was issued late in 2021 (only in September) but the situation improved in 2022 (memo issued in February). For these 2 years the sampling design was not proportionately distributed between the population of the two geographical regions (see point 14ii) due to resource issues.

The responsible competent authorities are clearly designated and have the necessary powers to implement the monitoring of AMR. However, issues of capacity (mostly Covid-19 related) and coordination affected the development and implementation of annual planning in 2021 and 2022.

In 2021 and to some extent in 2022, issues with the development and implementation of the AMR monitoring plan (such as lack of resources and sampling procedures) affected the ability to achieve the minimum number of required samples and representativeness of retail meat samples. This resulted in a lower availability of isolates for some of the relevant combinations of bacteria and animal species. Nonetheless, most issues are not likely to persist in the coming years if the changes planned for 2023 are implemented.

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The methods used by the PHL for fresh meat samples are not aligned with the EURL protocols. In particular, the deviations below are contrary to the requirements of points 4, 5 and 7 of Part A of the Annex to the EU Decision and affect the reliability of results: i. The selective isolation of CP-producing E. coli was not carried out in 2021 and 2022. Instead, the absence of meropenem resistance in isolates cultured on the Mac Conkey-CTX plates was used to establish the presence of presumptive CP-producing E. coli, which is not in line with the EURL recommended methods. As such there was no specific monitoring of CP-producing E. coli in place. ii. In relation to the method for isolation of ESBL-, AmpC- and CP-producing E. coli, the TBX plate was used as the identification step and source of isolates for storage and AST. However, this plate should only be used for selection and storage of isolates should be done from a non-selective plate.

The methods used by the NVL largely follow the relevant international standards. However, the audit team noted a few deviations which are not fully in line with points 4, 5 and 7 of part A of the Annex to the EU Decision and in some cases may affect the reliability of results, as follows: i. Carbapenem plates were not available for selective isolation of CP-producing E. coli, instead only OXA-48 plates were used in 2021 and 2022. This deviation from the recommended method decreases the sensitivity of the method. To correct this issue the Carbapenem plate has recently been introduced for specific monitoring for 2023. ii. The method used - Hippurate only - was insufficient to distinguish Campylobacter coli from Campylobacter lari. In the 2021 Campylobacter AST proficiency test, identification of Campylobacter jejuni was missed and the investigation was not documented (the NVL stated that this was due to the cause being known). Validation or proficiency tests have not been run for Campylobacter isolation due to the lack of a commercially available proficiency test in a suitable matrix.

Currently Malta's NRL for AMR is not accredited and does not perform all the required tasks of an NRL. This, coupled with deviations from the EURL recommended methods, storage of isolates and the lack of validation weakens the ability of Malta's official laboratories to correctly carry out testing and therefore diminishes the overall reliability of the data reported.

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Currently all NVL and PHL isolates are stored in calibrated freezers with a set point of ­ 75°C +/- 5°C (with an observed range of ­ 72.2 to ­ 78.3°C) instead of the required ­ 80°C as in point 7 of part A of the Annex to the EU Decision. Additionally, prior to March, NVL isolates were stored in a freezer at ­ 35°C. In both laboratories, there was no documented justification or testing to support the deviations in storage temperature.

Currently Malta's NRL for AMR is not accredited and does not perform all the required tasks of an NRL. This, coupled with deviations from the EURL recommended methods, storage of isolates and the lack of validation weakens the ability of Malta's official laboratories to correctly carry out testing and therefore diminishes the overall reliability of the data reported.

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In Malta there are two laboratories carrying out AST: i. The PHL, designated as the National Reference Laboratory (NRL) for AMR in 2008, is responsible for the analysis of retail samples. However, since its accreditation was withdrawn in 2022 (see also point 21), isolates are sent to the NVL for AST testing. ii. The NVL is designated for AMR monitoring and is responsible for isolation and AST for Salmonella spp., Campylobacter coli and Campylobacter jejuni, indicator commensal E. coli and ESBL-, AmpC- and CP-producing E. coli in caecal samples and BCP samples. Since late 2021 the NVL has subcontracted the serotyping of Salmonella cultures to the Instituto Zooprofilattaico Sperimentale dele Venezia, designated as the NRL for Salmonellosis by the Italian Ministry of Health. Coordination activities

Currently Malta's NRL for AMR is not accredited and does not perform all the required tasks of an NRL. This, coupled with deviations from the EURL recommended methods, storage of isolates and the lack of validation weakens the ability of Malta's official laboratories to correctly carry out testing and therefore diminishes the overall reliability of the data reported.

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In the 2021 report, there was no information on retail sampling in the text forms and the EHD was not aware of this requirement. This led to the absence of relevant information such as deviations in the sample design (see point 14) and on specific monitoring of presumptive CP-producing E. coli in retail meat samples (see point 24). The EHD committed to providing information to the VRD for the 2022 reporting.

The audit team noted that the scientific data validation of phenotypes as per the Manual for reporting 2021 antimicrobial resistance data within the framework of Directive 2003/99/EC and EU Decision 2020/1729/EU was not routinely done. EFSA requested several corrections of the 2021 AMR data on E. coli and Campylobacter spp. isolates; the isolates were re-tested, and the reported data was corrected.

Although the basic guidelines described in EFSA's reporting manual and data dictionaries are followed when reporting data, some gaps and the absence of routine scientific data validation of phenotypes hamper the ability to provide harmonised and comparable data on AMR.

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For 2022-2023, the VRD adopted a new horizontal approach for inspecting all feed and animal by-products operators aiming to get a comprehensive picture of the overall situation in the feed/animal by-product sectors. The outcome of this exercise will feed into the development of a risk assessment system, based on relevant scoring, by the end of 2023. Therefore, the audit team noted that, at the time of the audit, there was no risk-based approach in the planning of inspections, which is not in line with the requirements of Article 9(1) of Regulation (EU) 2017/625. 5.2.1.2 Implementation of inspections

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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he Competent Authority will develop a risk assessment by the end of October 2023 and will also implement a risk-based control plan in line with the provisions laid down in Regulation (EU) 2017/625 starting from January 2024. This will be done following the completion of the current official controls based on the horizontal approach.

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In all of the establishments visited, the audit team scrutinised the most recent inspection reports and interviewed the inspectors on their assessment of the operators' HACCP plans. The audit team noted that the inspectors' assessments of the hazard identification part of the HACCP plan were deficient in several establishments. In general, the hazard identification part of the operators' HACCP plans was incorrect (certain relevant hazards were not mentioned, although these were relevant for the different feed materials used and/or for additives/premixtures) or they were very generic without the level of detail necessary for a proper hazard identification (as required by Article 6(2)(a) of Regulation (EC) No 183/2005) and consequent risk assessment. Comprehensive descriptions of these non-compliances were not reflected in the 4 inspection reports seen. The audit team noted however that during the interviews, inspectors correctly identified several additional details of these non-compliances.

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The Competent Authority has requested corrective actions from four of the establishments visited by the auditors, specifically for e the review of their HACCP plan which must include the proper identification of all the possible hazards (ANNEX I a, b, c, d,). Furthermore, deadlines were given to complete the corrective action requests (i.e. end of September 2023 and mid-November 2023). The Competent Authority will assess the action taken after the given deadline and communicate the results to the auditors accordingly. The reference to Article 6 of Regulation (EC) No 183/2005 was included in the new version of the Animal Feeds inspection checklist under the section "HACCP", sub-section "HACCP framework", point 25 "Risk analysis" and point 28 "Detailed description of critical control points (if any)". Additionally, in the section "Compound feed Producer" there is a new sub-section "HACCP" (points 79-83) (ANNEX II). These additions will be reflected in the standardised control checklist. Furthermore, the inspection report template now contains a dedicated section for the HACCP (point 4) where the officers will report as applicable under the new sub-heading on findings in the template

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Verification of establishments' tests on cross-contamination, required by part 2(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. In both compound feed manufacturers visited (both using coccidiostats in production lines where feed for non-target species was also produced), the audit team scrutinised operators' documentation on the related testing and interviewed inspectors who usually control those establishments. In both establishments, the operators carried out cross-contamination tests twice per year. In one compound feed producer manufacturing medicated feed, the operator carried out cross-contamination test on active substances twice per year. In one establishment, the feed inspectors met satisfactorily assessed the results of the cross-contamination tests but experienced difficulties in assessing the appropriateness of the sampling method adopted by the operator. In the other establishment, neither the results nor the methods of the cross-contamination tests were adequate, and both points were overlooked during official inspections.

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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ss The Competent Authority has requested corrective actions from two of the establishments visited by the auditors, specifically for the review of the method and results of the carry over test II (minimisation of cross-contamination) and the inclusion in the HACCP of the procedures used (ANNEX IV a, b). One of the two operators sent a correct sampling method (ANNEX V a) while the second operator needed some clarifications from the Competent Authority (ANNEX V b ). Furthermore, the Competent Authority requested the operators to ensure that their laboratory test reports include uncertainty and recovery rate of the method used. Since these reports were not yet available by the given deadline (beginning of August ­ results pending), the Competent Authority could not close the corrective actions requested from the operators (ANNEX IV a, b). Evaluation of results for undesirable substances (coccidiostats in non-target feeds) will be made in accordance with Part C 6 of Annex II of Regulation (EC) No 152/2009. The checklist for animal feed was updated to include specific inputs on this aspect. This is done to ensure the appropriate checks of the effectiveness of minimisation of cross-conta

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Routine inspections include a verification of operators' traceability systems, including the operators' obligation to take samples of ingredients and from each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities, using a procedure pre-established by the manufacturer (hereinafter `retained samples'). This is required in part 4 of the section" Quality control" of Annex II to Regulation (EC) No 183/2005. The audit team scrutinised the operators' documentation on collection, packaging, labelling and storage of retained samples, interviewed the feed inspectors who usually control those establishments and made the following observations: · in two establishments, retained samples were not collected (and stored) from feed additives (amino acids); · in two establishments, retained samples were not adequately sealed; · in two establishments, FeBOs collected samples from incoming feed materials. These samples were used in their own laboratories to analyse different quality parameters and 5 the rest was kept as retained samples. Thus, the material was subject to diverse manipulations prior to being kept as retained samples; · in two feed material producers, the FeBOs consistently did not collect retained samples from each batch of produced feed material. These observations are not in line with the legal requirements established in part 4 of the section "Quality control" of Annex II to Regulation (EC) No 183/2005 and were not identified in any of the inspection reports seen.

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The Competent Authority has requested corrective actions from four of the establishments visited by the auditors on the appropriateness of retained samples specifically with regard to: - Collection of samples from each batch of feed materials and final products; - Collection of samples from amino acids and premixtures; - Sealing of samples; - Collection and storage of two different samples i.e. one to be retained and one for in-house laboratory analyses; - Storage time of retained samples until the end of shelf life. Various deadlines (beginning and middle of August 2023) were given to these establishments to enable them to implement the new procedure. Three operators implemented the corrective action requested by the given deadline (ANNEX VI a, b, c) while one operator is still in the process of procuring the necessary sampling items. The Competent Authority has assessed the progress and sampling method of this operator that commenced on the 28th of August 2023 and will update the Commission accordingly (ANNEX VI d, e). The checklist was updated to include specific inputs on this aspect to ensure that the retained samples are appropriate. These inputs include: - Section "Feed Mate

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Verification that operators meet legislative labelling requirements is included in the routine inspections. At all operators visited, the audit team scrutinised operators' labels and other relevant documents, interviewed inspectors normally controlling those establishments and made the following observations: · in one establishment, where complete feed contained several feed additives, the identification numbers of those additives were not on the label. This is not in line with the requirements laid down in Chapter I of Annex VI to Regulation (EC) No 767/2009; · in two establishments, on labels of complete feed for fattening pigs, the declared concentration of vitamin A was higher than the maximum limit allowed by Regulation (EU) 2015/724; · in several instances, labels of complementary feed containing feed additives with established maximum limits did not contain instructions for proper use, which is not in line with the requirements laid down in Article 17(1)(b) of Regulation (EC) No 767/2009; · labels of medicated feed seen did not contain information required by points 3, 4, 8 and 10 of Annex III to Regulation (EU) 2019/4. These deficiencies and non-compliances were not identified in any of the recent inspection reports seen.

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The Competent Authority has requested corrective actions from 6 establishments visited by the auditors, specifically for the nence of feed labelling (ANNEX VII a, b, c, d, e, f): - Specification of identification numbers of feed additives; - Correct concentration of Vitamin A (and/or other vitamins with established limits); - Declaration of the concentration of magnesium for ruminant's feed (if required) and of methionine for pig's feed; - Inclusion of dosage instruction for additives with established maximum limits; - Instruction for use in complementary feed; - Specification of the best before date in bulk feed; - Inclusion of the mandatory information for medicated feed as required by Annex III of Regulation (EU) No 2019/4. Various deadlines (on different dates in August, September and October) were given to the operators to implement the labelling requirement. At present, only one operator has implemented the corrective action requested (ANNEX VII d). The Veterinary Regulation Directorate (VRD) reviewed the animal feeds checklist and added a specific section for the pertinence of feed labelling. These include: - Section "Labelling ­ General", in particular point 37. Page: 4 ort

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The audit team visited FeBOs manufacturing medicated feed and/or placing it on the market and scrutinised operators' relevant procedures. It was noted that prescriptions, recipes, and labels of medicated feed were available. However, several prescriptions did not contain the information required by points 4, 5, 8 and 10 of Annex V to Regulation (EU) 2019/4. This non- compliance was overlooked during official controls.

While a project is underway to establish risk-based planning of official inspections, and official inspections are well documented, the effectiveness of these controls is weakened by several shortcomings in inspectors' assessment of (i) feed business operators' hazard identifications and cross-contamination tests within their hazard analyses and critical control point systems, (ii) operators' traceability systems (in particular collection and storage of retained samples), (iii) operators' compliance with labelling requirements, and (iv) prescriptions of medicated feed. 6 5.2.2 Sampling and analysis 5.2.2.1 Planning of official sampling

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The Competent Authority had issued a corrective action request to nts. phase out the hard copies of the prescriptions for medicated feeds which have the missing particulars mentioned in Annex V of Regulation (EU) 2019/4. The medicated feed prescriptions in use are now in electronic form only and they fully comply with Annex V. If one or more of the mandatory fields in the electronic prescriptions are not filled in, it cannot be finalised. Therefore, the feed mill will not produce any medicated feed. The operator will not accept veterinary prescriptions that do not comply with Annex V of Regulation (EU) 2019/4 (ANNEX VIII).

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BACKGROUND Member States' competent authorities have an obligation to carry out regular risk-based official controls throughout the feed chain to verify operators' compliance with legislative requirements pertaining to feed safety. The controls should cover various specific topics, for example, HACCP systems, operators' own-check programmes, traceability, labelling, etc. The Commission is obliged to perform controls to verify the application of relevant European Union (EU) legislation by each Member State and the functioning of national control systems. According to the VRD, in Malta, as of May 2023, there were: Type of feed business operators Number of establishments Feed material(s) manufacturers 5 Compound feed manufacturers 4 Medicated feed producers 1 Producers of feed additives/premixtures 0 Feed distributors 3 Feed importers 6 Feed transporters 8 Feed traders 1

The audit team observed official sampling in one compound feed manufacturer visited (the matrix and parameter to be controlled was suggested by the audit team; sampling for an analyte with non-uniform distribution was proposed). The audit team noted that the calculation of the number of incremental samples by the inspector was not in line with the requirements of parts 5.1 and 5.2 of Annex I to Regulation (EC) No 152/2009. During the preparation of the final samples, the inspector did not use (and did not have access to) a divider, as required by part 9.4 of Annex I to Regulation (EC) No 152/2009.

The audit team reviewed several sampling protocols and observed that those did not contain information on the sampled portion as required in part 10 of Annex I to Regulation (EC) No 152/2009. 7 5.2.2.3 Testing of official feed samples

Notwithstanding that a largely adequate risk-based approach is adopted for the planning of official sampling and that the contracted laboratories used for testing are appropriately accredited and all of the methods are included in their respective scopes of accreditation, shortcomings in the implementation of the official sampling procedure and in the designation of the laboratories, combined with the absence of reporting analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. 8 5.2.3 Actions taken on non-compliances

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es The SOP/SFC_AF/001/2017 was reviewed according to Annex I of Regulation (EC) No 152/2009, in particular regarding the calculation of incremental samples, as per point 8.1 and the preparation of final samples in case of contaminant non-uniform distribution, as per point 8.2, of the revised SOP (ANNEX IX). The request for purchase of a feed sampling divider is being processed by the Competent Authority (to be finalised possibly by end of 2023). The Feed Sample Submission form FS.1 was reviewed according to part 10 of Annex I of Regulation (EC) No 152/2009 with the addition of matrix (feed material, complementary feed, compound feed, medicated feed and premix), sample portion, and analyte occurrence (uniformly distributed, non-uniformly distributed and carry over) (ANNEX X). Page: 5 ort ref. DG(SANTE) 2023-7698 of the audit carried out from 08 May 2023 to feed hygiene

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The VRD is responsible for the designation of official laboratories. The audit team scrutinised the designation documentation for all three laboratories and saw that, despite that the designation was in writing, the content and arrangements were not in line with the requirements laid down in Article 37(2)(3) of Regulation (EU) 2017/625 (e.g., there were no evidence that the contracted laboratories had been already designated as an official laboratory by the competent authorities of the Member States on whose territories they were located; the documentation seen did not include any description of the laboratory tasks; etc.).

The audit team noted that, at the time of the audit, there were no arrangements in place to ensure compliance with the requirements laid down in Article 39 of Regulation (EU) 2017/625.

Notwithstanding that a largely adequate risk-based approach is adopted for the planning of official sampling and that the contracted laboratories used for testing are appropriately accredited and all of the methods are included in their respective scopes of accreditation, shortcomings in the implementation of the official sampling procedure and in the designation of the laboratories, combined with the absence of reporting analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. 8 5.2.3 Actions taken on non-compliances

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d as On the 08/08/2023, the contracted feed testing laboratories have and been officially designated as official laboratories through an official communication from the VRD to the National Veterinary Laboratory (NVL) informing of the two designated laboratories, and put in place suitable control arrangements, in accordance with Articles 37 and 39 of Regulation (EU) 2017/625 (ANNEX XI). The agreements with the new contracted feed testing laboratories are being processed. The competent authority selects laboratories in line with the requirements of Article 37(2b) & (4) of Regulation (EU) 2017/625. In the agreements, the competent authority will include the requirement to receive the audit / inspection reports of the relevant competent authority in that Member State, performed in accordance with Article 39(1) of Regulation (EU) 2017/625. The agreements will be forwarded as soon as these are finalised as evidence to the above. The conditions of the agreements will also include that the test reports are to be issued with the necessary details of uncertainty and recovery.

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The interpretation of the analytical results of official feed samples is the responsibility of FSAN officials based on the laboratory reports provided by testing laboratories. The FSAN officials send the test report and its assessment to the relevant FeBOs. The audit team noted that the inspectors experienced significant difficulties in interpreting the laboratory test reports, in particular in taking into account the mandatory parameters (e.g., recalculation to feed with 12% moisture content, correction for recovery), required by point 6 of Annex II to Regulation (EC) No 152/2009, to determine compliance. 5.2.2.2 Implementation of official sampling

The audit team noted that, based on the documentation provided, none of the contracted laboratories had been requested to provide the analytical results, related to undesirable substances within the meaning of Directive 2002/32/EC, (i) recalculated to a feed with a moisture content of 12%, (ii) with expanded measurement uncertainty, and (iii) corrected for recovery, all of which are mandatory parameters to assess compliance as per the requirements laid down in part C.6. of Annex II to Regulation (EC) No 152/2009. Moreover, the audit team observed one non-compliant decision made on the basis of testing where correction for recovery was missing thus weakening the technical and legal validity of the decision made. Conclusion on the planning and implementation of official sampling, and testing of official feed samples

Notwithstanding that a largely adequate risk-based approach is adopted for the planning of official sampling and that the contracted laboratories used for testing are appropriately accredited and all of the methods are included in their respective scopes of accreditation, shortcomings in the implementation of the official sampling procedure and in the designation of the laboratories, combined with the absence of reporting analytical recovery (and use thereof for decision making) undermine the legal and technical validity of the samples and the reliability of decisions made on the basis of the results. 8 5.2.3 Actions taken on non-compliances

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nces The Competent Authority has requested corrective actions from 2 establishments visited by the auditors, specifically for the sis inclusion in their laboratory reports of tests for undesirable substances, the uncertainty of analytical method and recovery rate as foreseen by the part C.6. of Annex II to Regulation (EC) No 152/2009 (ANNEX IV a, b and ANNEX V b). Also, ANNEX XI shows that the designation of official laboratories bears the request for the uncertainty and recovery values to be included in the test reports for undesirable substances. Page: 6

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There are no up-to-date list(s) at the disposal of TRD of all possible professional users of PPP, contrary to what is required by Article 10(2) of the Regulation (EU) 2017/625. Given the high number of farmers/land owners in Malta (approximately 11 400 in 2005 audit report DG(SANCO)/7671/2005), the CA acknowledge during the audit that it is possible 6 that a significant proportion of professional users of PPPs are not known to the TRD, are not trained and certified as professional users, and are not subject to official controls. This is not in line with Article 9(1) of the Regulation (EU) 2017/625.

The CAs consider most of the relevant risks and have defined control frequencies for controls on the marketing and use of PPPs. However, the absence of up to date list(s) of all professional users of PPPs and the lack of control at some users, such as service providers for the application of PPPs in non-agricultural use areas, reduces the efficiency of controls on the use of PPPs.

Due to the absence of an up to date list of all professional users of PPPs and consequent lack of official controls at those users not claiming CAP payments, the CAs cannot ensure the overall effectiveness of the official controls on the use of PPPs.

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f The Competent Authority has engaged with the Ministry responsible for Agriculture, and the Agriculture and Rural Payments Agency (ARPA), regarding the provision and use of information already available as well as of list/s developed for other purposes, in line with Article 10(2) of Regulation (EU) 2017/625. The Competent Authority will continue to seek up-to-date information through periodic requests, so as to use the data in line with Article 10(2) of Regulation (EU) 2017/625.

information already available as well as of list/s developed for other purposes, in line with Article 10(2) of Regulation (EU) Planned Actions 2017/625. The CA will continue collaborating with ARPA to have access to the lists of CAP beneficiaries and registered farmers with ARPA not The Competent Authority will continue to seek up-to-date claiming under CAP schemes. In this regards, the MOU between the information through periodic requests, so as to use the data in line CA and ARPA will be updated to include a requirement for the with Article 10(2) of Regulation (EU) 2017/625. provision of annual revised lists. Also, the CA will be reviewing and, if necessary, updating the list of service providers for the application of plant protection products in non-agricultural areas through a market research exercise, at least annually. Status Update Malta has invested heavily to establish a comprehensive system for Since completion of the audit, the CA has included in its plan service the coordination of targeted inspections which supports a providers for the application of PPPs in non-agricultural areas. transparent and effective approach towards enforcement. Such Planned Actions investment

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The CA stated that these service providers are currently not covered by any official controls unless they are also CAP beneficiaries. This is not in line with Article 9(1) of the Regulation (EU) 2017/625 which requires that official controls have to be performed at all operators regularly, on a risk basis and with appropriate frequency.

The CAs consider most of the relevant risks and have defined control frequencies for controls on the marketing and use of PPPs. However, the absence of up to date list(s) of all professional users of PPPs and the lack of control at some users, such as service providers for the application of PPPs in non-agricultural use areas, reduces the efficiency of controls on the use of PPPs.

Due to the absence of an up to date list of all professional users of PPPs and consequent lack of official controls at those users not claiming CAP payments, the CAs cannot ensure the overall effectiveness of the official controls on the use of PPPs.

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Malta has invested heavily to establish a comprehensive system for the coordination of targeted inspections which supports a transparent and effective approach towards enforcement. Such investments included the creation of a digital system to allow collection, analysis and appropriate follow-up action. Moreover, standardised checklists were created, and a comprehensive training programme was implemented. The Competent Authority will continue to work with stakeholders to strengthen the control on all operators, particularly service providers for the application of PPPs in non-agricultural areas.

standardised checklists were created, and a comprehensive training Q3 2022, and plans to extend risk-based official controls on all programme was implemented. categories of operators, including service providers for the application The Competent Authority will continue to work with stakeholders of PPPs in non-agricultural areas on the basis of the list compiled as to strengthen the control on all operators, particularly service per the clarification provided in response to Recommendation N° 1, providers for the application of PPPs in non-agricultural areas. by Q1 2023. TRD and ARPA have over the years established good cooperation with a view to foster cooperative working relations to facilitate coordination, where possible, simplify procedures for ensuring implementation and compliance to the relevant legislation. Note on the Requested Evidence Provisions have been planned with regards to the exchange of The most recent communication of cross-compliance checks information on the results of the cross-compliance controls carried performed by ARPA and forwarded to TRD for official control is

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The audit team noted that TRD does not communicate the results of official controls on PPP residues in domestic food and feed to ARPA to facilitate their planning of controls at user level. This is not in line with the Article 4(2) of the Regulation (EU) 2017/625, which requires to ensure efficient and effective coordination between all authorities involved. In 2020, some 10% of samples taken from domestically grown products had exceedances of maximum residue limits (MRLs), while in 2019, the exceedance rate was almost 15%. According to the European Food Safety Authority report "The 2019 European Union report on pesticide residues in food" (https://www.efsa.europa.eu/en/efsajournal/pub/6491) the average level of MRL exceedances in the EU for products of EU origin was 2.7%. The CA informed the audit team that information on MRL exceedances is not communicated to ARPA because court decisions are required to confirm these breaches and define penalties. The court proceedings are pending in most of the cases, with some dating back to 2016. There is no investigation undertaken by TRD of the root cause of the MRL exceedances at users of PPPs.

The lack of exchange of some official control data between TRD and ARPA further reduces the effectiveness and efficiency of the official control.

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TRD and ARPA have over the years established good cooperation with a view to foster cooperative working relations to facilitate ) coordination, where possible, simplify procedures for ensuring implementation and compliance to the relevant legislation. Provisions have been planned with regards to the exchange of information on the results of the cross-compliance controls carried Page: 1 arch 2022 ort ref. DG(SANTE) 2021-7299 of the audit carried out from 06 September use of plant protection products t by ARPA on a sample of CAP beneficiaries, as stipulated in e Memorandum of Understanding signed between the entities in 20. D and ARPA are committed to implement all the requirements the MOU to ensure fulfilment of the obligations. An exchange information on the results of the cross- compliance controls rried out by ARPA has now taken place.

out by ARPA on a sample of CAP beneficiaries, as stipulated in the Memorandum of Understanding signed between the entities in 2020. enclosed. TRD and ARPA are committed to implement all the requirements of the MOU to ensure fulfilment of the obligations. An exchange of information on the results of the cross- compliance controls carried out by ARPA has now taken place. Malta has complementary schemes related to monitoring formulations, residue levels in commodities, product labelling and inspections to enforce compliance with Regulation (EC) No. 1107/2009. Status Update The Competent Authority has issued two procurement cycles The CA is currently in communication with another competent during 2021 to identify adequate laboratory capacity for analysis, authority in the EU and is seeking to reach an agreement in respect of testing and diagnosis for formulation analysis of plant protection the necessary formulation analysis of PPPs.

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There is no laboratory for formulation analysis for PPPs designated by the CA in Malta, and no samples for formulation analysis have been taken at least since the last European Commission audit in 2005. This is not in line with the Article 5(1)(d) of Regulation (EU) 2017/625 requiring CAs to have access to adequate laboratory capacity for analysis, testing and diagnosis.

The absence of a designated laboratory for PPP formulation analyses limits the scope of official controls. Consequently, the CA cannot confirm that PPPs placed on the market are compliant with the authorisation requirements.

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Malta has complementary schemes related to monitoring rmulations, residue levels in commodities, product labelling and spections to enforce compliance with Regulation (EC) No. 07/2009. e Competent Authority has issued two procurement cycles ring 2021 to identify adequate laboratory capacity for analysis, sting and diagnosis for formulation analysis of plant protection oducts as required by Article 5(1)(d) of Regulation (EU) 17/625. It is noted that there were no submissions meeting all e technical requirements as established by Regulation (EU) 17/625, Article 37(4). lta continues to be committed to identify suitable laboratory pacity and will explore different avenues to identify a provider. e Competent Authority would also welcome a coordinated proach by the European Commission to source a suitable boratory, in line with the approach taken in other areas.

products as required by Article 5(1)(d) of Regulation (EU) Planned Action 2017/625. It is noted that there were no submissions meeting all CA exchanges with another EU-MS CA have so far been positive and the technical requirements as established by Regulation (EU) anticipates to be in a position to designate a laboratory for 2017/625, Article 37(4). formulation analysis by Q3 2022. Following this, the CA aims to carry Malta continues to be committed to identify suitable laboratory out its first formulation analysis by the end of 2022. capacity and will explore different avenues to identify a provider. The Competent Authority would also welcome a coordinated approach by the European Commission to source a suitable laboratory, in line with the approach taken in other areas. Malta has established certification systems and designated the Status Update Competent Authority responsible for their implementation to Since completion of the audit, the CA has collaborated with The ensure evidence of sufficient knowledge of the subjects listed in Malta College of Arts, Science & Technology's Curriculum Annex I of the Directive (EC) 2009/128. Department, which has now approved the training progr

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As far as compliance with the requirements of Article 6(1) of the SUD on the certification off the staff of distributors is concerned, according to the data provided to the audit team by the CA, at the time of the audit only 24% of the 67 distributors selling products for professional users of PPP were compliant.

The low level of compliance with the requirements of Articles 5 and 6 of SUD raises concerns over the level of competency and training of the staff involved in the distribution of PPPs in Malta.

According to the information provided to the audit team, the main non-compliances detected in 2020 were related to the lack of valid certificates under Article 5(2) of the SUD (43% of operators selected in 2020, 57% in 2019), deficiencies with regard to IPM implementation, non-compliant use of authorised PPPs, inappropriate storage conditions and lack of up to date records on the application of PPPs.

The low level of compliance with the requirements of Articles 5 and 6 of SUD raises concerns over the competencies and training of the staff purchasing and using PPPs in Malta.

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lta has established certification systems and designated the ctive Competent Authority responsible for their implementation to sure evidence of sufficient knowledge of the subjects listed in nex I of the Directive (EC) 2009/128. Page: 2 arch 2022 ort ref. DG(SANTE) 2021-7299 of the audit carried out from 06 September use of plant protection products The Competent Authority will continue liaison with trainers and is working with an accredited educational institution, namely The Malta College of Arts, Science & Technology, to facilitate the provision of additional training programmes. Malta will continue to promote the importance of such training programmes through the development of a targeted communication campaign to complement the inspection framework already in place. Furthermore, implementation of Recommendation N° 6 will continue supporting the achievement of this action.

provision of additional training programmes. Planned Actions During 2022, the CA will be initiating a process for the performance Malta will continue to promote the importance of such training of documentary cross-checks of operators' lists to ensure that all programmes through the development of a targeted distributors and professional users of PPPs have sufficient staff communication campaign to complement the inspection holding a certificate under Article 5(2) of the Directive (EC) framework already in place. Furthermore, implementation of 2009/128 in line with the Article 6 of the Directive (EC) 2009/128. Recommendation N° 6 will continue supporting the achievement The reviewed process, as per the planned action for Recommendation of this action. N° 6, will be adopted in case of established non-compliances. Status Update Since completion of the audit, the CA has hired a Professional Officer Malta has established a comprehensive system for the coordination (Legal), who has been allocated to a central pool of legal advisors of inspections which supports a transparent and effective approach supporting all entities within the MCCAA. Also, the CA has allocated towards enforcement. a

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The audit team noted that TRD does not communicate the results of official controls on PPP residues in domestic food and feed to ARPA to facilitate their planning of controls at user level. This is not in line with the Article 4(2) of the Regulation (EU) 2017/625, which requires to ensure efficient and effective coordination between all authorities involved. In 2020, some 10% of samples taken from domestically grown products had exceedances of maximum residue limits (MRLs), while in 2019, the exceedance rate was almost 15%. According to the European Food Safety Authority report "The 2019 European Union report on pesticide residues in food" (https://www.efsa.europa.eu/en/efsajournal/pub/6491) the average level of MRL exceedances in the EU for products of EU origin was 2.7%. The CA informed the audit team that information on MRL exceedances is not communicated to ARPA because court decisions are required to confirm these breaches and define penalties. The court proceedings are pending in most of the cases, with some dating back to 2016. There is no investigation undertaken by TRD of the root cause of the MRL exceedances at users of PPPs.

The audit team noted the following: 11 · the checklist used by inspectors did not include provisions to verify if retailers keep records of the PPPs they store or place on the market for at least five years, contrary to the requirement of Article 67(1) of Regulation (EC) No 1107/2009; · the verification of whether products are sold to certified professional users only is based exclusively on the word of the operator. No documentary check is conducted such as checking invoices to verify the identity/certification status of buyers. Formulation Analysis

According to the data provided by the CA, non-compliances were identified in some 60% of the distributors of PPPs inspected in 2019. There was a major improvement in 2020, with non-compliances identified in some 27% of distributors inspected. Nevertheless, the level of distributors with non-compliances identified is still high.

According to the data provided by the CA, the level of non-compliances on the sale of unauthorised products remains very high (47% and 43% of the products randomly checked in 2019 and 2020 respectively).

The audit team noted that despite the high level of non-compliances identified during the inspections of the marketing of PPPs, the CA has never proposed that financial penalties be applied through their court system in Malta. In addition, no other sanctions such as withdrawal of certificates issued have ever been imposed. This is not in line with the Article 138(1)(b), that requires CA to ensure that the operators concerned remedy the non- compliances and prevent further occurrences of such non-compliances. The CA could not provide the audit team with a clear explanation why the abovementioned sanctions have never been applied. Conclusions on controls on the marketing of plant protection products

When detecting non-compliances, the CA fails in taking appropriate measure to ensure that the operators concerned remedy the non-compliances and prevent further occurrences of such non-compliances. 13 5.2.2. Controls on the use of PPPs Legal Requirements Articles 11 to 14 and 138 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67 (1) of Regulation (EC) No 1107/2009 on the proper use of PPPs Article 5 of Directive 2009/128/EC Article 67(1) of Regulation (EC) No 1107/2009, Article 4(1) of Regulation (EC) No 852/2004 of the European Parliament and of the Council, and Annex I, Part A.III to the same Regulation on keeping records of the PPP use Findings

As highlighted under paragraph 61, no additional sanctions such as withdrawal of certificates or additional financial penalties, have ever been applied by the TRD. 15 Conclusions on controls on the use of plant protection products

The high level of non-compliances identified during official controls indicate the need for more effective enforcement actions to ensure that the operators concerned remedy the non-compliances and that these do not recur.

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Malta has established a comprehensive system for the coordination of inspections which supports a transparent and effective approach towards enforcement. ) During Q4 2021, the Competent Authority has strengthened its capacity to take appropriate enforcement action in line with the relevant legislation by allocating further resources. Page: 3

During Q4 2021, the Competent Authority has strengthened its capacity to take appropriate enforcement action in line with the Planned Action relevant legislation by allocating further resources. Through the increased resource capacity, the CA will be completing a review of the process for determining appropriate enforcement measures to take in case of established non-compliances, in line with Article 138(1)(b) of the Regulation (EU) 2017/625, by 2022.

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In relation to HACCP-based procedures, a comprehensive HACCP- and pre-requisite plan must now be in place from the time of conditional approval, as foreseen in an 11 updated SOP (SOP/LI/SFC/01/2017, Issue No. 2 updated 15/05/2020), relevant for all food establishments. The CA acknowledge that the HACCP audits and follow up scheduled for 2020 (as identified in an overview table provided to the audit team) have yet to take place. Conclusions on recommendation 6 of audit report DG(SANTE) 2019-6665

The CA acknowledged that while these targeted inspections have addressed general hygiene requirements, they have not yet initiated the HACCP audits foreseen for 2020.

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2020, audits on HACCP appertaining to Approved Fishery Product establishments and fishing vessels have been carried out attached in Appendix 1a. A total of 14 audits on HACCP have een completed in 2020, and enforcement actions have been carried out on the subject of HACCP, or related issues.

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All levels of the CA are affected by staff shortages, as several officials are either on unpaid leave or maternity leave, whilst all but one of the Heads of the VRD Units posts are vacant, as well as the post of CVO. As a result, several officials cover and share the tasks from the colleagues above mentioned between different Units and services, while completing their workload, without having been provided with specific training for those tasks.

Field services of the EHD are also understaffed, which impacts on the number and on the extent of their inspections over retailers' activities.

The CCA stated that the last two competitions for recruiting OVs resulted in only one suitable candidate being selected; this person is in the process of being recruited and will take up the position in April 2020. Six Maltese veterinarians will be graduating from a University in Europe, and the CCA is expecting that at least some of these new graduates may be interested in participating in the forthcoming competitions for the recruitment of new staff. The CCA explained that the reasons for such low interest might either be because of the level of salary that is offered to junior OVs, or the requirement of knowledge of the Maltese language in order to qualify for the post. It is planned to modify this latter requirement for candidates originating from abroad, in order to make the competitions more attractive; newly recruited staff not fluent in the Maltese language will be granted one year to attend intensive language courses and undergo consequent proficiency tests.

The shortage of staff impacts on the effectiveness of official controls performed: the frequency of official controls in approved establishments, set by the CA on the basis of the specific criteria laid down by Article 9(1) of OCR, is not followed. The audits carried out by central level do not cover all requirements, and some administrative tasks (e.g. updating approval and inspection files) are not completed. A similar issue was brought to the attention of the audit team by representatives of the EHD: due to staff shortage, inspections in retail shops like butchers are performed at a much lower frequency than planned, and does not always cover all items present in the inspection checklists.

The VRD has a post dealing with policy and internal audit: however, this post (shared with the Policy and Enforcement Unit) is currently not operational as the relevant official is on unpaid leave. The programme for internal audits for 2018-2020 has not been implemented: the follow-up audit on animal identification and the registration system, scheduled for 2018, was not carried out.

Staff shortages have an important negative impact, at all levels of the CAs, on the overall delivery of the official control system, in particular on frequency of inspections on FBOs.

The audit team visited a poultry slaughterhouse to collect information on procedures implemented for ante-mortem inspection. The four approved poultry slaughterhouses carry out their operations daily at the same time: due to staff shortages, ante-mortem inspections are solely performed by a roving OV; four VSOs (one per slaughterhouse) and one senior VSO also provide support in inspection activities (mainly for post- mortem inspections and administrative tasks). The ante-mortem inspection includes an evaluation of the FCI documents accompanying the animals. The audit team noted that certain mandatory information were not indicated on such documents (e.g. number of animals included in the load, their age, indication that no medical treatments had been administered, etc.); these non-compliances were not identified, and thus not investigated, by the OV, who could not justify this conduct. 12 Post-mortem inspection

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Another call for applications was issued in March 2020, and 2 ndidates were successful. ( Annex 1 i) One VO will be hired at the end of July, and one declined the post. Further vacancies that are to be filled within VRD, are summarised as attached (Annex 1 ii). Vacancies include Veterinary Support Officers (VSOs) who will perform official controls in line with those described for auxiliaries in EU Regulation (EC) No. 625/2017 on official controls. Candidates may be successful for the Post of Trainee Junior Veterinary Officer, or, depending on past experience, directly as Veterinary Officer, In both cases, these will be put on an obligatory probationary period of one year to ensure supervised training. One Veterinary Officer (VO) was hired on the 6/04/2020 to perform OV duties on the slaughter-line of the Public Abattoir since the Audit, and his commencement date was anticipated to the first week of April (Annex 1 iii)

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Specific training for junior OVs was not always delivered; in one slaughterhouse, the recently recruited OV was not aware of (and did not verify) the requirements concerning microbiological testing of cattle carcases (see paragraphs 31 and 77); this same OV's knowledge of the criteria for the assessment of animal welfare at slaughter was also not sufficient (see paragraph 69). Some OVs have participated in different sessions of the 5 Commission's Better Training for Safer Food initiative. The audit team had been provided with documentation on the training for some official staff that was planned and carried out in 2019.

Training was not provided to official staff that had moved to another position and were carrying out new tasks. For instance, an OV was recently moved from the Trade Unit (dealing with border controls) to the SFCU at poultry slaughterhouses (see paragraph 53) with no training having been provided on the specific elements of these new responsibilities.

Not all officials performing the controls have sufficient knowledge/experience to perform them adequately, and no specific training arrangements are in place when staff is given new responsibilities or has to cover tasks from other colleagues or vacant posts. Given the number of incidents where staff were found to lack appropriate training to enable them undertake their duties competently, there is clear evidence of non-compliance with Art 5(4) (a) of the OCR.

In the second slaughterhouse visited, no slaughter activities were being carried out at the time of the audit, but the audit team's discussion with the OV highlighted its insufficient knowledge of animal welfare indicators in relation to slaughter activities (e.g. 15 seconds considered by the OV as a satisfactory stun-to-stick interval, not taking into account that, as general practice, the time needed to stun the animal, to unload it from the stunning box and to hoist it before sticking is usually between 45 and 60 seconds). 5.4.5 General and specific hygiene requirements Legal requirements Article 4 of Regulation (EC) No 852/2004. Article 3 of Regulation (EC) No 853/2004. Articles 35 and 46 of Regulation (EU) 2019/627. Findings

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Trainee Junior veterinary officer and Veterinary Officer has undergo one year of probation period, prior to being confirmed post of Veterinary Officer. This year is intended for training purposes, and the officer will be supervised by his superior. Following the DG SANTE audit, the following training and re- training has been organised: - New VO on Slaughter line : induction training done (Annex 2 i), Page: 1 t ref. DG(SANTE) 2020-6927 of the audit carried out from 24 February 2020 e production and placing on the market of bovine meat, including traceability - Poultry Slaughterhouse VSOs ; training carried out on various related duties.(Annex 2 ii) controls ), elated cond al ls lems n ad to be done , online osed Page: 2 t ref. DG(SANTE) 2020-6927 of the audit carried out from 24 February 2020 e production and placing on the market of bovine meat, including traceability

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The VRD has a post dealing with policy and internal audit: however, this post (shared with the Policy and Enforcement Unit) is currently not operational as the relevant official is on unpaid leave. The programme for internal audits for 2018-2020 has not been implemented: the follow-up audit on animal identification and the registration system, scheduled for 2018, was not carried out.

No mechanisms for the supervision of OVs are in place to give the CA a reasonable level of assurance that controls are carried out uniformly, correctly and consistently, and to allow it to take corrective actions if needed. Supervision tools currently in place include an interview with the staff to agree on their annual self-assessment and to evaluate their working records. As a consequence, no support for OVs is provided as no particular lack of knowledge is identified.

Some CARs have been documented for non-compliances related to hygiene of foodstuffs of animal origin. However, not all deficiencies detected by the audit team during the visits to the establishments (notably, those related to contamination of carcases, traceability of meat and sampling of carcases) were identified by the OVs and/or by the audits from the upper level of the CA. As a consequence, not all regulatory requirements have been effectively enforced. Conclusions on competent authorities

Supervision of the OVs and VSOs performance is carried out by evaluation of self- assessments and by some checks on the working documentation. The staff's management verification carried out on the ground is rare or inexistent: consequently, a reasonable level of assurance that controls are carried out uniformly, correctly and consistently, allowing the CA to take corrective actions if needed, cannot be ensured.

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upervision, control and verification procedures are being in reviewed to target specific sections of VRD using a risk-based approach. In addition to the Appraisal system, there is the gramme of internal audits that will not change from the one (b) provided. The duties of the Internal Auditor have been assigned to year and this been changed to the role of ill delegate the actual task of internal cific experience in the field. Internal rt in third quarter 2020. Sections within each Unit will consist of upplemented, where necessary, by field ication. The frequency will vary from a risk-based approach. Outcome of this recorded and, where necessary, used for sessment during the mentioned ividual officers. Audits programmed for 2020, there will focus on the Slaughterhouse Section to etent authority ls are taking place as per regulatory Page: 3 t ref. DG(SANTE) 2020-6927 of the audit carried out from 24 February 2020 e production and placing on the market of bovine meat, including traceability

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The shortage of staff impacts on the effectiveness of official controls performed: the frequency of official controls in approved establishments, set by the CA on the basis of the specific criteria laid down by Article 9(1) of OCR, is not followed. The audits carried out by central level do not cover all requirements, and some administrative tasks (e.g. updating approval and inspection files) are not completed. A similar issue was brought to the attention of the audit team by representatives of the EHD: due to staff shortage, inspections in retail shops like butchers are performed at a much lower frequency than planned, and does not always cover all items present in the inspection checklists.

Staff shortages have an important negative impact, at all levels of the CAs, on the overall delivery of the official control system, in particular on frequency of inspections on FBOs.

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d As of 06 April 2020 a new officer has been employed specifically y out OV duties in the Public Abattoir , which allows the enior Head of Section to focus on other official controls apart Official Controls on other approved ontinue in accordance with the Risk Categorisation of Food he red meat and poultry slaughterhouses are s frequency may change in 2021 in assessment as described in the Risk ove. f the planned audits had to be postponed due introduced by the Superintendent of Public a two-tier system was put in place: level 1 eferred to as `full lockdown') and level 2 iority was given to essential controls. as always to keep official controls in the hese were deemed essential in both levels.

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The audit team reviewed the approval files of the visited establishments, when available (in few cases no documentation was included in the files), and compared the available information with the results of the physical inspection of the premises: a. In one slaughterhouse (and in the CCA office) the approval file did not include any document. The same situation was found at the time of the 2007, 2009 and 2013 DG Health and Food Safety audits. The FBO later provided a letter issued by the CA on 20 December 2019, stating that the operator was "hereby being approved to run an abattoir"; a copy of such document was not included in the approval file kept in the CCA office, and both the FBO and the CA were unable to demonstrate that this letter was issued following an application. The slaughterhouse had undergone extensive refurbishments and changes in equipment (including the building of a new facility for emergency slaughter) since the last DG Health and Food Safety audit in 2013, which had identified relevant structural and hygienic non-conformities. However, the absence of a blueprint on file makes impossible to identify which parts have been refurbished and which areas and equipment are covered by the approval. Moreover, being a multispecies slaughterhouse, no maximum capacity or slaughter line speed have been set for the different animal species slaughtered in order to ensure appropriate hygienic slaughter practices. b. The cutting premises that were built later within the vicinity of the slaughterhouse described above were first conditionally approved and definitely approved in 2016: documentation related to the inspections that were carried out during the approval process was available on file. However, the blue print was not on file, making the evaluation of structures, equipment, and flow of carcases-final products-personnel difficult to evaluate. The approval did not indicate maximum capacities for cutting, nor did it set any restriction for middlemen who were still allowed to enter the premises with their own equipment and operate on the carcases. c. The cutting premises that were built later in the vicinity of the second slaughterhouse visited, were first conditionally approved and definitely approved in 2017: however, also in this case, no blueprint of the premises and equipment, nor maximum capacity allowed for cutting were documented. The attached slaughterhouse had been granted a flexibility measure in May 2017 related to the frequency of carcases testing for aerobic bacteria, Salmonella and Enterobacteriaceae counts. The FBO had been allowed to carry out such tests fortnightly on cattle and swine carcases, but not on small ruminants carcases. However, Article 5(3) of Regulation (EC) No 2073/2005 only allows FBOs to benefit from such flexibility when they are able to demonstrate implementation of effective HACCP-based procedures supported by good results from several sampling sessions. Neither the two OVs, who were in charge of official tasks at the premises since 2017, nor the senior OV responsible for their supervision had enforced these preconditions. In fact, the FBO had never tested carcases against the microbiological criteria set in the Regulation: such non-compliance was only detected on 22 November 2019 during an audit carried out by the CCA (the first 8 within a three years period). To date, the requirement is not yet enforced; the FBO could only demonstrate having received a quotation from an accredited laboratory for a suitable testing scheme. d. The last establishment visited was definitively approved as a cold store, and has been conditionally approved since December 2019 for re-packing activities and for producing meat cuts, meat preparations and minced meat. The audit team revised the file and the documents available, and compared them with the findings of the physical visit of the premises and of the activities carried out at the time of the audit. The establishment was still under construction in o

The procedure in place for conditional approval/approval of food producing establishments was not always followed by the CA when conditionally approving the premises; in the case seen, a conditional approval was granted although not all structures had been completed, and with pre-requisites and HACCP-based procedures largely incomplete.

The approval of establishments is not kept under review by the CA, contrary to what is required by Article 148(5) of Regulation (EU) 2017/625, since the CA does not always have the relevant information to assess if changes have been introduced after the initial approval was granted.

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nternal audit and increased official controls based on ocumentary and file checks as mentioned in point 3 and 4 above, ensure Approval Procedures are in place. CA has formally requested the FBO to provide the missing . The FBO has complied and provided the e competent authority Page: 4 t ref. DG(SANTE) 2020-6927 of the audit carried out from 24 February 2020 e production and placing on the market of bovine meat, including traceability which was placed in the relevant file, documentation. (Annex 5 i) The CA has explanation of the Blueprint and is June 2020. equested the maximum capacity of tting Establishment. These are as placed in the abattoir file:- The rent slaughter lines are set eing slaughtered. With regards to cies of interest for the audit in d is set at 20 heads per hour. ughtering speed maxima are set at 90 ut 20 heads per hour for swine ( boars er hour for small ruminants. oning plant, processing maxima depend , and the species. The plant is split into rocessing of bovines and a part for the regards to swine, the maximum heads per hour. With regards to Bovines, head per hour for deboning and three in relation to the second abattoir has tached. (Annex 5ii) These include t

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The EHD stated that due to a lack of staff, documentary checks for consignments of food of non-animal origin or kitchenware are carried out at the central office of the EHD, and not at the BCP, which for goods referred to in Article 47(1)(d) and (e) of the OCR, is not in line with Article 49(1) of that Regulation.

A number of shortcomings were noted with respect to the implementation of official controls, in particular the late notification of arrival of consignments and the performance of documentary checks for food of non-animal origin, other than upon arrival of the consignment at a designated BCP, which undermine the effectiveness and appropriateness of official controls and their overall compliance with Union legislation. 14

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The VRD informed the audit team that no guidelines or documented procedures had been issued at the time of the audit for performing import controls on feed of non- animal origin and hay and straw. Prior to the UK's withdrawal from the EU such goods were not imported. The VRD confirmed at the closing meeting (see section 8 below) that documented procedures for the control of feed of non-animal origin, hay and straw would be in place by 31 May 2021. As a result of that action, the VRD will have by that date, documented procedures in place that include the relevant subjects 7 specified in Chapter II of Annex II to the OCR, and which have been updated as appropriate, in line with Article 12(3)(b) of the same Regulation. The EHD has issued two guidelines relevant to import controls: the Guideline on Designated Points of Entry, and Guidelines on the internal procedures to be adopted for certain imports, which includes all food of non-animal origin subject to reinforced checks and special measures, including food contact materials. The audit team noted that the EHD guidelines include the relevant subjects specified in Chapter II of Annex II to the OCR, however they had not been updated as appropriate, in line with Article 12(3)(b) of the same Regulation.

However, the lack of documented procedures and necessary arrangements, updated as appropriate, and delays in finalising and implementing the monitoring plan, have an adverse impact on both the effectiveness of the organisation of official controls on imports of animals and goods, and its compliance with Union legislation. The lack of recent internal audits or verification checks of the official controls for such imports, represent possible missed opportunities to identify and address those issues.

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At the time of the audit there were 11 unfilled posts for veterinary officers at the VRD, and to manage the workload, several officers had taken on additional duties, working only half time for their original job description without having been provided with specific training for their new tasks. The ABP Section has undergone frequent staff changes in recent years and two of the three officers in the ABP Section (one is on long term leave) are dividing their working time between controls on feedingstuffs and ABP.

The VRD has staff shortages in several of its Units, including the FSCU and its ABP Section. This has resulted in a higher workload for the ABP Section and failure to meet the annual targets for control frequencies. The situation is impaired by frequent staff turnover in the ABP Section, lack of specific procedures for some ABP control areas and lack of training on ABP organised in the last five years. The numerous weaknesses noted during the audit related to the approval of ABP plants (see section 5.2.) and the shortcomings noted at practically all of the sites visited by the audit team (see section 5.3.3.) indicate that the staff of the ABP Section have insufficient knowledge of the specific requirements for ABP and DP laid down in the EU legislation and thus compromises their ability to carry out effective official controls, in particular regarding requirements for incinerators and biogas plants.

The audit team noted significant shortcomings regarding the registration, approval and listing of ABP plants, establishments and operators. The interviewed staff of the ABP Section stated that these problems were due to frequent staff turnover, prioritisation of other tasks, a lack of resources and the absence of handover procedures of the respective files for approval, registration and listing. With regard to the approval and registration of ABP plants and operators: a) Whilst the biogas plant visited by the audit team has had an operation permit from the Malta Environment and Planning Authority (MEPA) since 2015, it has not been subject to an on-site visit before commencement of its activities as required by Article 44(1) of Regulation (EC) No 1069/2009 and has been operating without an approval contrary to the requirement of Article 24(g) of the same Regulation. It also does not have a pasteurisation/hygienisation unit as required in point 1, Section 1, 10 Chapter 1 of Annex V to Regulation (EU) No 142/2011 and the plant operator had not provided the competent authority with the guarantees that would allow a derogation to be made (point 2 of the above Section 1) from this requirement. b) According to the VRD statement there are four temporary storage points collecting liquid slurry. A part of the slurry is delivered from these points to the biogas plant, the rest is going into the sewage. The VRD has neither registered, nor approved, these facilities as ABP storage plants. c) One of the ABP incinerators visited had a valid environmental operation permit from the MEPA and was equipped with two lines for thermal treatment of ABP (one line for Category 3 material and one for mixture of the Category 1 and 2 material). The operator stated that an initial plan was to trade the derived fats and meat and bone meal produced on these lines, but so far the derived fats and meat and bone meal derived after the thermal treatment were all incinerated without being permanently marked. This is not in line with point 3(d) of Chapter V of Annex VIII to Regulation (EU) No 142/2011 which allows for derogating from marking the products only if these are moved from the processing plant for direct incineration by a closed conveyer system, which may not be by-passed, and that such a system has been authorised by the competent authority. The above examples are not in line with Article 24 of Regulation (EC) No 1069/2009, which requires that the competent authority approves all ABP plants and operators that are in operation.

The ABP Section has conducted very few official controls in ABP plants and establishments in recent years and the planned frequency of controls has not been met. The ABP Section staff stated that this was due to staff shortages and other work priorities. The audit team noted that: a) The biogas plant has never been inspected and the main and only large-scale incinerator plant was last inspected in 2016. 12 b) There was no evidence that ABP transporters have ever been included in the annual work plans. c) An approved storage plant handling raw hides, was last inspected in December 2019, the previous inspection had taken place nine years earlier. d) The environmental health officers responsible for the controls of the butcher's shop visited stated that they do not cover ABP in their controls. All of the above is not in line with the requirement to carry out official controls on operators regularly and with appropriate frequency provided for in Article 9(1) of Regulation (EU) 2017/625 and the requirement to carry out official controls and supervision of the handling of ABP and DP, as provided for in Article 45(1) of Regulation (EC) 1069/2009.

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There is a rolling call for applications for OVs (official veterinarians). Another call for applications was issued in March 2020, and 2 candidates were successful.(Annex 1 i) One VO will be hired at the end of July, and one declined the post. Further vacancies that are to be filled within VRD are summarised as attached (Annex 1 ii). Vacancies include Veterinary Support Officers (VSOs) who will perform official controls in line with those described for auxiliaries in EU Regulation (EC) No. 625/2017 on official controls. Another call for applications for VSOs was issued on Friday 3rd July 2020. Furthermore, one Veterinary Officer on unpaid leave with previous experience in ABP has returned to work at VRD, and has been assigned to the ABP Section as from 23/06/2020. Candidates may be successful for the Post of Trainee Junior Veterinary Officer, or, depending on past experience, directly as Veterinary Officers. In both cases, an obligatory probationary period of one year ensures there is supervised training.

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At the time of the audit there were 11 unfilled posts for veterinary officers at the VRD, and to manage the workload, several officers had taken on additional duties, working only half time for their original job description without having been provided with specific training for their new tasks. The ABP Section has undergone frequent staff changes in recent years and two of the three officers in the ABP Section (one is on long term leave) are dividing their working time between controls on feedingstuffs and ABP.

Neither AHWD nor VDR have provided training on controls over ABP and DP to any of the staff involved in the controls in the last five years: The last time the head of ABP Section attended training on ABP controls was in 2011 (participation in a Better Training for Safer Food (BTSF) training session). The VRD stated that some of its officials who are working in other areas had participated in BTSF training sessions in 2015 and that one officer in the ABP sector was nominated to participate in the BTSF training session on ABP in March 2020. However, this session was cancelled because of COVID-19. No training is provided to staff that move within the VRD to other departments in relation to their new field of responsibilities.

The audit team considered that the absence of training and lack of audits and supervision (see finding 14) were likely to be significant factors contributing to the adverse findings made concerning approval of plants (see finding 20) and the implementation of official controls on operators (see section 5.3.3.). 5.1.3 Legislation, procedures and instructions

The VRD has staff shortages in several of its Units, including the FSCU and its ABP Section. This has resulted in a higher workload for the ABP Section and failure to meet the annual targets for control frequencies. The situation is impaired by frequent staff turnover in the ABP Section, lack of specific procedures for some ABP control areas and lack of training on ABP organised in the last five years. The numerous weaknesses noted during the audit related to the approval of ABP plants (see section 5.2.) and the shortcomings noted at practically all of the sites visited by the audit team (see section 5.3.3.) indicate that the staff of the ABP Section have insufficient knowledge of the specific requirements for ABP and DP laid down in the EU legislation and thus compromises their ability to carry out effective official controls, in particular regarding requirements for incinerators and biogas plants.

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Every Trainee Junior veterinary officer and Veterinary Officer has to undergo one year of probation prior to being confirmed in the post of Veterinary Officer. This year is intended for training Page: 1 of report ref. DG(SANTE) 2020-7008 of the audit carried out from 24 February 2020 ontrols on hygiene, traceability and channelling of animal by-products (ABP) and Action Proposed by the competent authority purposes, and the officer will be supervised by his superior. BTSF: We planned on attending a scheduled course for a BTSF on Animal By-Products and TSEs, but this was cancelled due to Covid-19. At the moment there are no on-line courses (see BTSF Academy: https://btsfacademy.eu/training/mod/page/view.php? id=132) for this field VRD has engaged a Food Control Consultant on ABP- related matters who will provide on-site training in Malta (Annex 2 i). The training was postponed due to the Covid- 19 measures and currently the dates for the course are being discussed. The Expert shall perform professional services related to Animal by-Products and legal obligations and official controls related to Animal by-Products. The duties covered are: · Training the veterinarians on official contr

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Whilst the VRD has allocated responsibility for policy and internal audit to one official, the post holder is currently on long term leave and the programme for internal audits for 2018-2020 has not been implemented. Furthermore, the VRD has not carried out any internal or external audits in relation to official controls on ABP or DP. The situation is not in line with Article 6 of Regulation (EU) 2017/625.

The arrangements in place for (internal) audits, official control procedures and instructions, are not fit for purpose and do not support the implementation of effective official controls along the entire chain of collection, transport, use and disposal of ABP and DP. 5.2 Registration, approval and listing of ABP plants, establishments and operators

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Supervision, control and verification procedures are being reviewed to target specific sections of VRD using a risk-based approach. In addition to the Appraisal system, there is the programme of internal as audits that will not change from the one provided. A year ago, the duties of Internal Auditor were assigned to an officer. This position has changed to one of Coordinator. The latter will delegate the actual task of internal audit to officials with specific experience in the field. The internal Audit is due in the second semester. The internal audits for the sections within each unit will consist of document and file audits, supplemented, where necessary, by field visits for additional verification. The frequency will vary using a risk-based approach. Outcome of this verification level will be recorded and, where necessary, used for follow-up action and for assessment during the mentioned Appraisal procedures of individual officers.

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The audit team noted significant shortcomings regarding the registration, approval and listing of ABP plants, establishments and operators. The interviewed staff of the ABP Section stated that these problems were due to frequent staff turnover, prioritisation of other tasks, a lack of resources and the absence of handover procedures of the respective files for approval, registration and listing. With regard to the approval and registration of ABP plants and operators: a) Whilst the biogas plant visited by the audit team has had an operation permit from the Malta Environment and Planning Authority (MEPA) since 2015, it has not been subject to an on-site visit before commencement of its activities as required by Article 44(1) of Regulation (EC) No 1069/2009 and has been operating without an approval contrary to the requirement of Article 24(g) of the same Regulation. It also does not have a pasteurisation/hygienisation unit as required in point 1, Section 1, 10 Chapter 1 of Annex V to Regulation (EU) No 142/2011 and the plant operator had not provided the competent authority with the guarantees that would allow a derogation to be made (point 2 of the above Section 1) from this requirement. b) According to the VRD statement there are four temporary storage points collecting liquid slurry. A part of the slurry is delivered from these points to the biogas plant, the rest is going into the sewage. The VRD has neither registered, nor approved, these facilities as ABP storage plants. c) One of the ABP incinerators visited had a valid environmental operation permit from the MEPA and was equipped with two lines for thermal treatment of ABP (one line for Category 3 material and one for mixture of the Category 1 and 2 material). The operator stated that an initial plan was to trade the derived fats and meat and bone meal produced on these lines, but so far the derived fats and meat and bone meal derived after the thermal treatment were all incinerated without being permanently marked. This is not in line with point 3(d) of Chapter V of Annex VIII to Regulation (EU) No 142/2011 which allows for derogating from marking the products only if these are moved from the processing plant for direct incineration by a closed conveyer system, which may not be by-passed, and that such a system has been authorised by the competent authority. The above examples are not in line with Article 24 of Regulation (EC) No 1069/2009, which requires that the competent authority approves all ABP plants and operators that are in operation.

Whilst information on registration and approval is available for ABP operators, the list of approved ABP plants, establishments and operators on the web page of MAFA is unreliable as it is incomplete and not kept up-to-date. Furthermore, the competent authority has not enforced the respective EU rules as some operators are operating without the required competent authority approval or without having fulfilled all relevant requirements.

Medlemsstatens svar

An SOP for the approval of an ABP establishment has been created (pursuant to article 44 of EU n Regulation 1069/2009 with addenda; see attached Annex 4 i. Page: 3 of report ref. DG(SANTE) 2020-7008 of the audit carried out from 24 February 2020 ontrols on hygiene, traceability and channelling of animal by-products (ABP) and Action Proposed by the competent authority

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The audit team noted significant shortcomings regarding the registration, approval and listing of ABP plants, establishments and operators. The interviewed staff of the ABP Section stated that these problems were due to frequent staff turnover, prioritisation of other tasks, a lack of resources and the absence of handover procedures of the respective files for approval, registration and listing. With regard to the approval and registration of ABP plants and operators: a) Whilst the biogas plant visited by the audit team has had an operation permit from the Malta Environment and Planning Authority (MEPA) since 2015, it has not been subject to an on-site visit before commencement of its activities as required by Article 44(1) of Regulation (EC) No 1069/2009 and has been operating without an approval contrary to the requirement of Article 24(g) of the same Regulation. It also does not have a pasteurisation/hygienisation unit as required in point 1, Section 1, 10 Chapter 1 of Annex V to Regulation (EU) No 142/2011 and the plant operator had not provided the competent authority with the guarantees that would allow a derogation to be made (point 2 of the above Section 1) from this requirement. b) According to the VRD statement there are four temporary storage points collecting liquid slurry. A part of the slurry is delivered from these points to the biogas plant, the rest is going into the sewage. The VRD has neither registered, nor approved, these facilities as ABP storage plants. c) One of the ABP incinerators visited had a valid environmental operation permit from the MEPA and was equipped with two lines for thermal treatment of ABP (one line for Category 3 material and one for mixture of the Category 1 and 2 material). The operator stated that an initial plan was to trade the derived fats and meat and bone meal produced on these lines, but so far the derived fats and meat and bone meal derived after the thermal treatment were all incinerated without being permanently marked. This is not in line with point 3(d) of Chapter V of Annex VIII to Regulation (EU) No 142/2011 which allows for derogating from marking the products only if these are moved from the processing plant for direct incineration by a closed conveyer system, which may not be by-passed, and that such a system has been authorised by the competent authority. The above examples are not in line with Article 24 of Regulation (EC) No 1069/2009, which requires that the competent authority approves all ABP plants and operators that are in operation.

The audit team noted the following regarding listing: a) Several ABP plants and operators are not listed on MAFA's web page: a plant for storage of Category 1 material that was approved in December 2019 as a result of the actions taken regarding a complaint (see finding 15), operators transporting ABP (including vessels that were recently registered by the competent authority for transport of Category 1 and Category 3 materials between Member States (cooking oil from international catering waste)) and the fully operational (but not approved) biogas plant. b) The ABP Section has "inherited" several files on ABP operators from their predecessors and the staff have no oversight as to whether these operators are still active (and should be listed) or have ceased operation. c) The environmental permit to operate one low-scale incinerator seen by the audit team had expired in 2009. The plant was still on the list of approved ABP plants (listed as suspended) although the equipment was in a derelict state. The above shortcomings are not in line with Article 47(1) of Regulation (EC) No 1069/2009 requiring Member States to keep the lists of approved or registered establishments, plants and operators up-to-date. 11 Conclusion on the registration, approval and listing of ABP plants, establishments and operators

Whilst information on registration and approval is available for ABP operators, the list of approved ABP plants, establishments and operators on the web page of MAFA is unreliable as it is incomplete and not kept up-to-date. Furthermore, the competent authority has not enforced the respective EU rules as some operators are operating without the required competent authority approval or without having fulfilled all relevant requirements.

As the list of approved ABP operators, plants and establishments is not kept up-to-date (see finding 21), it cannot reliably support the planning and implementation of inspections. 5.3.2 Planning of official sampling and testing programmes

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The list of approved ABP establishments has already been updated and placed on the VRD official website: https://agrifish.gov.mt/en/vrd/Documents/abpSectio n/abp.pdf) The register is uploaded to the MAFA website (https://agrifish.gov.mt/en/Pages/Index.aspx) on the same page where the register of approved ABP establishments is located (https://agrifish.gov.mt/en/vrd/Pages/abp.aspx Work has begun on an updated register of ABP transporters. To ensure the accuracy of the database of ABP transporters, the Section is in the process of contacting all of them one by one to get updated (accurate) information. Enforcement action has been taken to address the shortcomings found at the Thermal Treatment Facility. An official communication (post-visit covering letter and a corrective action request or CAR) has been sent to the CEO of Wasteserv with the various shortcomings to be rectified and deadlines were given. The communication refers to the Autoclave/incinerator in Marsa and the Biogas plant in Maghtab (see attached covering Page: 4 of report ref. DG(SANTE) 2020-7008 of the audit carried out from 24 February 2020 ontrols on hygiene, traceability and channelling of animal by-products (ABP)

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The VRD has incorporated controls on ABP in its multi-annual national control plan (MANCP) of 2017-2021. The ABP Section is responsible for establishing annual work plans on the sector which includes targets for the number of inspections. No such plans were presented to the audit team regarding controls on ABP for the years 2017-2020. The head of the ABP Section stated that the target is to inspect the ABP plants and establishments at least once a year, regardless of the risk and type of the establishment or plant. However, no evidence was provided to the audit team that ABP transporters are controlled. This is not in line with Article 4(3) of Regulation (EC) No 1069/2009 and Article 32 of Regulation (EU) No 142/2011.

The ABP Section has conducted very few official controls in ABP plants and establishments in recent years and the planned frequency of controls has not been met. The ABP Section staff stated that this was due to staff shortages and other work priorities. The audit team noted that: a) The biogas plant has never been inspected and the main and only large-scale incinerator plant was last inspected in 2016. 12 b) There was no evidence that ABP transporters have ever been included in the annual work plans. c) An approved storage plant handling raw hides, was last inspected in December 2019, the previous inspection had taken place nine years earlier. d) The environmental health officers responsible for the controls of the butcher's shop visited stated that they do not cover ABP in their controls. All of the above is not in line with the requirement to carry out official controls on operators regularly and with appropriate frequency provided for in Article 9(1) of Regulation (EU) 2017/625 and the requirement to carry out official controls and supervision of the handling of ABP and DP, as provided for in Article 45(1) of Regulation (EC) 1069/2009.

Concerning the official controls on the effective implementation of the permanent written procedures based on the Hazard Analysis and Critical Control Points (HACCP) principles, including operators' own checks and the standards of the products after processing, the audit team noted that the operator of the biogas plant had not established any own checks to monitor compliance with Regulation (EC) No 1069/2009 or procedures, contrary to the requirements of Articles 29 and 28 of the above Regulation. 13 Furthermore, the operator of the biogas plant did not have any sampling and testing regime for digestion residues as part of the operators' own checks, which is contrary to the requirement laid down in Section 3, Chapter I of Annex VI to Regulation (EU) No 142/2011. This plant had never been inspected (see finding 27.a). 5.3.3.2 Official controls in other establishments handling ABP

The Maltese competent authorities have neglected the conduct of official controls on ABP and DP in recent years and the evidence seen on the spot in the establishments visited by the audit team suggests that recent official controls are not effective in detecting and preventing inappropriate processing, handling and use of ABP and DP. Considering the numerous shortcomings in relation to the registration/approval and listing of ABP plants, establishments and operators, the overall picture is not consistent with a well-functioning system of official controls. 16

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An inspection work plan that covers all the links in the ABP chain has been created (Annex 6 i) The work plan for the inspections of ABP transporters has been included. A yearly inspection of 1% of the total which at the moment means 16 transporters, more or less, will be carried out, whereas approved ABP establishments will be inspected with a risk- based frequency on a yearly basis. Furthermore, the following SOPs have been updated:- - SOP_GQ_003_2010 (Procedures necessary for collection of dead animals-issue3.pdf (see attached Annex 6 ii) - SOP_ABP_001_2016 (SOP for the transport permit of ABP); (see attached Annex 6 iii) Page: 5 of report ref. DG(SANTE) 2020-7008 of the audit carried out from 24 February 2020 ontrols on hygiene, traceability and channelling of animal by-products (ABP) and Action Proposed by the competent authority With respect to finding 27, VRD has communicated with the Environmental Health Directorate(EHD), asking for the latest work policy on how EHD officers assess how ABPs are being handled at the retail level (e.g. butcher shops); (see attached Annex 6 iv) They replied that this is part of their ongoing checks as per checklist attached. (Annex 6v) With re

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The few written records of official controls available for the establishments and plants visited at the end of 2019 or beginning of 2020 were very short and overall superficial - a number of non-compliances identified by the audit team had not been detected during the competent authority's controls in 2019 and 2020. 5.3.3.1 Official controls in the ABP plants

The official controls on ABP plants had not noted any serious shortcomings in relation to general hygiene conditions, operation and maintenance. However, the audit team still noted some shortcomings in the high-capacity incineration plant visited: a) The solid components of wastewater (Category 1 material) were pumped out to an approved site instead of disposing it using the methods allowed for this material under Article 12 of Regulation (EC) No 1069/2009. If this shortcoming existed at the time of the previous inspection in 2016, it was not recorded in the report of said inspection. b) The meat and bone meal resulting from the thermal treatment preceding incineration was stored in large open vats with birds feeding from them. Furthermore there were many plastic containers in the yard without any identification. The operator stated that these contained rendered fats stored for incineration. The above is contrary to the requirement of points 3 and 5, Section 1, Chapter I of Annex III to Regulation (EU) No 142/2011 which require that animals must not have access to ABP that are awaiting for incineration and that these ABP must be covered, and correctly identified, respectively. If these shortcomings existed at the time of the previous inspection in 2016, they were not recorded in the report of said inspection.

Regarding controls on requirements on general hygiene, the audit team noted some shortcomings that had not been picked up during previous official controls: a) In the poultry slaughterhouse, blood was collected in vats to be disposed of in the high-capacity incinerator plant. However, blood ended up also in the drain of the slaughter hall and some of it was leaking out from the floor to the slaughterhouse surroundings. This is contrary to requirements laid in point 6 of Section 2 of Chapter I of Annex IV to Regulation (EU) No 142/2011, which prohibits disposal of blood through the waste stream. This had not been recorded as a shortcoming in the two annual control reports seen, the latest of November 2019 and was restricted to identification, traceability and transport of ABP. b) In the same slaughterhouse, the mechanical removal of SRM was not always complete. This shortcoming had been recorded in a 2018 inspection report which recommended the operator to take care of this shortcoming. However, no deadline was set by which this should have been corrected and there was no evidence of follow-up by the competent authority to verify that this had happened.

In the dairy establishment visited the permanent procedures based on the HACCP principles regarding ABP disposal included disposal of separator sludge and white wash water into the drains, instead of applying the methods provided for in Article 14 of Regulation (EC) No 1069/2009. This had not been noted as a shortcoming in the report of an inspection carried out in 2019.

The official controls on ABP covered identification of ABP. The ABP storage plants and food business operators had arrangements in place to collect and identify ABP. Nonetheless, the audit team noted the following shortcomings in relation to identification of ABP which had not been identified in the records of official controls: a) Some of the containers designated and vehicles registered for transport of ABP to the high-capacity incinerator plant were not correctly identified and labelled; and b) In one of the cutting plants visited, ABP was collected in containers that were not correctly identified and labelled. 14 All the above are not in line with point 2 of Chapter II of Annex VIII to Regulation (EU) No 142/2011, requiring proper identification of handled ABP.

The audit team noted that the official controls in some of the establishments visited have not included the checks on records or, when they covered record keeping, did not detect a number of non-compliances related to the traceability requirements laid down in Article 22 of Regulation (EC) No 1069/2009 and the relevant requirements of Chapter III of Annex VIII to Regulation (EU) No 142/2011. For example, in the dairy establishment visited, no commercial documents were available for the former foodstuffs and other ABP sent to landfill, which is contrary to the requirement of Article 21(2) and Article 22(1) of Regulation (EC) No 1069/2009. There was no evidence that the official controls had identified this shortcoming.

The visited ABP storage plant for fallen stock had an adequate register in place which ensured traceability of the fallen stock. However, copies of commercial documents were not available for some consignments that had arrived (e.g. for spent hens) and in an ABP plant approved for storage of Category 3 hides the operator had commenced issuing commercial documents only in December 2019.

Several containers designated for transport of ABP seen by the audit team at the sites visited were not identified and labelled in line with the requirements of point 2 of Chapter II of Annex VIII to Regulation (EU) No 142/2011. This shortcoming was not noted in any of the inspection reports seen by the audit team, some of which were recent (official controls carried out at the end of 2019 or in January 2020). 15 5.3.4 Implementation of official sampling and testing programmes

The Maltese competent authorities have neglected the conduct of official controls on ABP and DP in recent years and the evidence seen on the spot in the establishments visited by the audit team suggests that recent official controls are not effective in detecting and preventing inappropriate processing, handling and use of ABP and DP. Considering the numerous shortcomings in relation to the registration/approval and listing of ABP plants, establishments and operators, the overall picture is not consistent with a well-functioning system of official controls. 16

Medlemsstatens svar

Enforcement action has been taken addressing the ABP-related shortcomings found at the Public Abattoir and cutting establishment. Official communication (post-visit covering letter and CAR) has been sent to the manager of the Public Abattoir regarding the various shortcomings noted during the audit; Deadlines were given. (see Annex 7i attached) Two CARs have been concluded and are included in this same annex. Enforcement action had been taken addressing the ABP-related shortcomings found at the Malta Dairy Producers (MDP). Official communication (post- visit covering letter and CAR) has been sent to the manager of MDF regarding the various Page: 6 of report ref. DG(SANTE) 2020-7008 of the audit carried out from 24 February 2020 ontrols on hygiene, traceability and channelling of animal by-products (ABP) and ee attached orters e to a vehicle f the means of abelling of the s of transport gory of ABP ansport

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in The procedure for the approval of new establishments will be strictly usiness followed. No permanent approvals will be issued to Operators who will not nce with fulfil all recommendations made by VRD by the end of the conditional 2004. period.

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The audit team noted that the full approval of the auction hall was not given after the expiry of the second three-month period of conditional approval. VRD indicated that full approval had not been granted because the establishment failed to implement the corrective actions requested after controls, these were to include a microbiological analyses plan (on water and swabs of surfaces), and the hazards that had not been identified adequately in the HACCP plan. Nonetheless, the auction hall remained in operation for a further year without any approval until the full approval was granted. This is not compliant with VRD documented procedure for approval or EU legislation. During this time, VRD was assessing the progress being made to implement the corrective actions requested in the inspection/audit reports.

The vessels that are registered under the FDA are eligible to obtain the approval to operate as a freezer or factory vessel. After receiving the application for approval, VRD will carry out an inspection on board of the vessel. The official will assess compliance with the EU requirements1. HACCP manual, layout, sampling and analyses results must be available during the audit. A full approval may be granted or conditional approval for a period of three/six months. A freezer vessel visited by the audit team, had initially 1 Regulation (EC) No 852/2004 of the European Parliament and of the Council and Regulation (EC) No 853/2004 of the European Parliament and of the Council. 7 been approved in 2005. A new full approval had been issued in December 2013 (including a new approval number) for the production of frozen packaged whole gutted fish (the vessel was in fact dedicated to catching deep sea red shrimp). Auditors noted that the new approval had been granted without the vessel having a HACCP plan or a VRD inspection taken place. A draft HACCP plan was dated February 2019.

The procedures for approval of land-based establishments and freezer, factory and reefer vessels are in line with EU requirements. Nonetheless, the implementation of such procedures presented shortcomings that allowed FBOs to operate without being approved (auction hall) or without compliance with the requirements for approval (freezer vessel).

Furthermore, the lack of knowledge of VRD concerning the precise number of freezer and factory vessels that VRD must approve, impedes compliance with Article 3(2) of Regulation (EC) No 854/2004 and subsequently compliance with Article 7 of Regulation (EC) No 854/2004. The lack of approval of all freezer vessels registered in Malta results in the list, which is publicly available, not being maintained and kept up-to-date, which is not in compliance with Article 31(2)(f) of Regulation (EC) No 882/2004. This and paragraph 42 underline the lack of cooperation between the two relevant CAs (see also paragraph 32).

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f An official request has been addressed through the Food Safety Commission to acting DG DFA by VRD in order to have access to the list of the registered lready fresh fishing vessels. An official letter was also sent to acting DG DFA in of order to obtain all the necessary information about all landings of frozen No fishery products. ist of As soon as the information is provided, VRD will start the approval procedure nd factory for the freezer vessels indicated and the list will be kept updated. In the es and to meantime, VRD has started contacting approximately 300 operators to set up lation (EC) a procedure to verify if such vessels require just registration.

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Recommendation 2 of the 2011 report requested the competent authority to ensure that the length of time between sampling and laboratory results would be sufficiently short to allow for effective follow-up in case of non-compliant results 16. In 2017 the tendering procedure to contract an external laboratory failed and, as a result, half of the samples taken in 2017 had not been analysed at the time of the audit, remaining in the freezers of the NVL waiting for new arrangements to be put in place with subcontracting laboratories. Conclusions on implementation of residue monitoring

Whilst sampling in 2017 was implemented as planned, the inordinate delay in laboratory testing of samples taken in 2017 has substantially weakened the effectiveness of the residue monitoring plan for that year. Even if those samples are eventually analysed, there is a possibility that time-dependent analyte instability will invalidate the results (i.e. samples which were truly non-compliant at the time of sampling will test as false-compliant) and, in the event that non-compliant results would be found, the delay between sampling and analysis will militate against identification of the cause of the residue and effective follow-up investigations. 5.1.3. Other residue monitoring programmes Legal Requirements Article 11 of Directive 96/23/EC Findings 11 Article 5 of Directive 96/23/EC 12 Article 11 of Directive 96/23/EC 13 Article 24 of Directive 96/23/EC 14 Article 9 of Directive 96/23/EC 15 Article 24 of Directive 96/23/EC 16 Council Directive 96/23/EC 6

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Although the BIP staff interviewed demonstrated good knowledge of Union legislative requirements for imports and transhipment of goods (with the exception of some aspects pertaining to non-harmonised species), other VRD staff have occasion to work in the BIPs after normal working hours and, for them, the absence of adequate instructions for conduct of checks and taking decisions on consignments militates against consistency in approach.

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The MCCAA audit system achieved ISO 9001 certification in 2004 (by an accredited certification body) and is subject to certification assessment every year. The audit team discussed with the competent authorities the extent to which this assessment covers the internal audit activities. Whilst this assessment is independent and covers inter alia the internal audit activities, it is limited to the requirements of the ISO 9001 standard and does not focus on the aspects of the audit process (such as programme development, independence etc.). This means that the certification assessment does not provide information on whether the audit process is achieving its objectives therefore does not serve as an independent scrutiny of the audit process.

VRD and EHD have no arrangements in place to perform independent scrutiny of the audit process contrary to the requirement of Article 4(6) of Regulation (EC) No 882/2004. 9 Conclusions on independent scrutiny

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

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ent scrutiny as The Food Safety Commission and the Standards and Metrology Institute (Certification Services) have signed a Service Agreement to carry out an Independent scrutiny of the Food Safety Commission and of the Internal Audits of its members as per Article 4(6) of Regulation (EC) No 882/2004 (national audit system). This Service Agreement was carried out on the 3rd February 2016 between the Food Safety Commission, referred to in the attached document as the "Client", and the Standards and Metrology Institute, referred to in the same document as the "Authority". The Standards and Metrology Institute is a separate entity from the Technical Regulations Division as per Article 7(3) of the Malta Competition and Consumer Affairs Authority Act , which states that; "The responsibilities vested in each entity shall be exercised by the Director General heading the respective entity and in doing so each Director General shall act independently and autonomously, free from the direction or control of any person or authority without prejudice to article 12:" The Act is also being attached.

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The competent authorities have put in place systematic arrangements to ensure that appropriate corrective actions are proposed and implemented and that these actions have been effective at ensuring deficiencies are addressed. However, the lack of a procedure to systematically "escalate" cases where audit recommendations are not addressed means that deficiencies in the performance of the official controls may remain outstanding/reoccur for a long period of time contrary to the objectives of Article 4 (6) of Regulation 882/2004. 5.2.7 Transparency Legal requirements and other audit criteria Article 4(6) of Regulation (EC) No 882/2004 requires, inter alia, that "audits ........shall be carried out in a transparent manner". Section 5.2 of the Annex to Decision 2006/677 provides guidance on transparency, including the following: "In order to demonstrate the audit process is transparent, documented procedures should, in particular, include a clearly defined audit planning process, audit criteria and audit report approval and distribution mechanisms. Management and implementation of the audit process should be transparent to all relevant stakeholders. In particular, there should be full transparency between the audit body and the auditee. Ensuring the audit process is transparent in the eyes of other stakeholders will assist in the dissemination of information, and in particular in the sharing of best practice within and between competent authorities. The Member States should adopt the appropriate measures to ensure their audit systems are transparent, taking national legal and other requirements into account. To that end, the 20 Member States should consider encouraging practices that improve the transparency of the process." Findings

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measures in the The following changes to the internal audit procedures have been required by Article agreed upon by the Environmental Health Directorate (EHD) : Page: 1 dations of report ref. DG(SANTE)/2016-8833-MR of the audit carried out from 22 February n place to implement article 4(6) of Regulation (EC) No 882/2004 (national audit system) report is issued following a meeting ditors, the Director for Environmental auditees to discuss the root causes of issues the proposed corrective actions. These o be minuted. e is opened after each and every audit audit report, requests for corrective actions material. The file is only closed once all the s have been addressed. If the corrective cannot be closed due to a failure in shortcomings, the file is referred to the is attention. lation Department (VRD)guidelines for the em have a specific chapter on "Action plan" d) which states that a meeting shall be rector of VRD with the senior staff of the Unit discuss and endorse the action plan established es to the internal audit procedures have been tion plan" will be amended as follows rector shall organize a meeting with the ff of the units audited within 1 month after the rt or follow up r

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Finding 10 of report 2014-7003 described how checks on manifests had stopped in March 2014 according to the competent authority due to a lack of human resources. The 4 situation remains the same and this activity is not systematically performed contrary to the requirements of Articles 6 and 7 of Regulation (EC) No 136/2004 and Articles 5 and 6 of Regulation (EC) No 282/2004. The audit team noted that, however, manifests checks would still be necessary because the INTERTRACE application works with complete Customs nomenclature (CN) codes to identify consignments subject to checks, and Customs do not require a CN-code in their pre-notifications. In cases where CN- code information is absent or not provided in a specific format, the information is not processed by INTERTRACE, which means that some consignments that should be subject to veterinary checks might escape controls. This is also the problem for consignments notified with two digit CN-codes, mis-declared, or for consolidated consignments. In addition, 30% of notifications to Customs are still provided to the INTERTRACE in a format not readable by the system (finding 11 of report 2014-7003). The competent authority still does not foresee any actions to address this shortcoming which also affects the controls on the transhipped consignments system (finding 11 of report 2014-7003). 5.2.1.2 Transhipped consignments

The competent authority does not carry out manifests checks. Those controls are still essential because of the limitations of the INTERTRACE in using the data provided by Customs, and consignments intended for import or for transhipment can move undetected when they should undergo controls.

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gible In order to ensure that eligible consignments are subject to veterinary achieve the checks, in accordance with Articles 6 and 7 of Regulation (EC) No 136/2004 o 136/2004 and and Articles 5 and 6 of Regulation (EC) No 282/2004, Veterinary and Phytosanitary Regulation Department (VPRD) through the Trade Unit has resumed carrying out checks on Manifests. The checks of manifest received in PDF format is being carried out in accordance with the procedure set out in 04/BIP/SOP/2013 (attached). A specific INTERTRACE functionality has been developed and is now in place, to carry out an automatic and regular control check of the consignments listed on the manifests. The system automatically checks all the records transmitted by the Customs department and included in the manifests to produce a list of consignments with CN (Combined nomenclature) codes of veterinary interest, including consignments with incomplete CN codes that have not been notified to BIPs (Border Inspection Posts). Furthermore, a new function will be implemented by mid-December 2016in order to process all consignments that do not have a CN code. These will automatically be processed by the system and records selected

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An internal audit performed at the Maltese BIPs in September 2015 recommended putting in place verification activities on the official controls at BIPs. The competent authority started conducting supervisions after this internal audit with the aim of verifying the effectiveness of the official controls in line with Article 8(3)(a) of Regulation (EC) No 882/2004. The supervisions included the assessment of documentary checks, correctness of CVEDs and correct use of TRACES. The audit team noted that these activities were not based on a written procedure and were discontinued. The competent authority stated this was due to the increased workload put on the official inspectors at the BIPs.

The deficiencies identified during this audit (e.g. limitations of INTERTRACE, poor enforcement measures, incomplete pre-notifications) were not identified by the verification activities. The lack of effective verification procedures in Malta has been highlighted in several reports of the Directorate General for Health and Food Safety. 10 Conclusions on the verification activities

The lack of corrective actions following the internal audits, combined with a lack of documented procedures to perform specific supervision activities does not allow the competent authority to identify gaps in the system for controls and opportunities for improvement, in particular as regards transhipments by using the features of INTERTRACE.

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ctiveness of official In order to verify the effectiveness of the official controls carried out at the n (EC) No Maltese Border Inspection Posts, a system of verification has been developed and the procedure set out in 02/BIP/SOP/2016 (attached). The first level of verification is carried out by the Senior Officer (Head of the BIP) who will verify on a quarterly basis the effectiveness of official controls as part of the performance assessment of BIP veterinary officers. In these ns it assesses the following activities: mplementation of internal procedures; ss of the Common Veterinary Entry Documents (CVED); se of Traces and INTERTRACE systems; of identified cases of non-compliances and; e actions taken. ior Officer carries out these verifications using "QlikView" tool in system, hard copies of the CVEDs and the INTERTRACE system for t consignments. nt Authority has also foreseen a second level of checks to be by the Traces administrator in order to verify on a yearly basis the carried out at BIPs. This verification combines the information the quarterly reports by the Head of the BIP and the data n the "QlikView" tool in the Traces system. attached the above mentioned procedure 02

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The pre-notification is done via INTERTRACE (table 1). The shipping agents provide most of the data required in part I of the CVEDs, but the next BIP of destination is not required by the competent authority and is not provided by the shipping agents, contrary to the requirement of Article 1 of Decision No 2011/215/EC. This repeated non- compliance was already identified in report 2014-7003 (findings 13 and 14) and still remains to be addressed as the competent authority has not foreseen actions to enforce this requirement. Month of pre- Consignments notification pre-notified Jan-15 1824 Feb-15 1899 Mar-15 1717 Apr-15 2169 May-15 2116 Jun-15 1436 Jul-15 1870 Aug-15 1385 Sep-15 1622 Oct-15 1450 Nov-15 1241 Dec-15 1097 Jan-16 1070 Feb-16 1535 Table 1 Data from INTERTRACE

INTERTRACE also generates email reminders when the consignments stay for more than seven days and are not notified in TRACES and are not presented for veterinary checks contrary to the requirements of Articles 2, 3 and 4 of Decision No 2011/215/EU. These reminders inform the shipping agent of the non-compliance with import legislation, warning them about the administrative fine applicable. The audit team noted that a significant number of containers stayed in the port for more than seven days and left the port without been checked despite the repeated daily emails sent to the operators by the competent authority. Based on the information provided by the competent authority there were approximately 30 such containers in January 2016 (table 3). In addition, the audit team assessed two such emails sent to the operators on 23 and 25 February 2016 and found that on 25 February one container had been in the port for 24 days, 10 containers for 11 days, three containers for 10 days and 14 containers for 9 days. None of these containers had been presented for the required veterinary checks. While, in the above-mentioned cases, the competent authority had identified repeated non-compliances, aside from the routine emails reminders (that had failed to ensure that the operators remedied the situation), it did not take any additional actions. This is not in line with the requirements of Article 54 of Regulation (EC) No 882/2004. The competent authority stated that since May 2015 there has been a remarkable improvement in the pre-notification rates of transhipments and compliance with the requirements, therefore imposing fines is considered a burden and not an effective means to further improve compliance. 5.2.2 Veterinary checks Legal Requirements Annex II to Regulation (EC) No 136/2004, Articles 4(1) and 5 of Directive 97/78/EC, Decision 2001/812/EC. Findings 5.2.2.1 Imported consignments

Import controls are generally implemented in line with the legal requirements. For consignments in transhipment, since May 2015 the competent authority has used the data from Customs, the agents responsible for the consignments and the port operator to identify and control consignments where required. Some deficiencies still exist i.e. the competent authority: does not use the available data if consignments are pre-notified with two digit CN-codes or no CN code, or when the format of the documents from Customs is not compatible with INTERTRACE. does not enforce the requirement for operators to provide information on the next BIP of destination when transhipments are destined to be imported in other EU Member States, which increases the risk of consignments introduced later into the Union without being subject to official controls. does not apply effective enforcement measures when the operator ignores the 9 request from the competent authority to bring the consignment to the BIP for controls, and the consignment leaves the port. does not ensure that the monitoring plan for microbiological hazards is based upon the nature of the products and the risk they represent.

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iance the As per Recommendation no.1, consignments with no CN code and with two icle 54 of the digit codes have been included on the list of consignments that are regularly the Officers in accordance to 04/BIP/SOP/2013. nt Authority is in the final stage of modifying the INTERTRACE rder to comply with requirements set out in Article 1(b) of the Implementing Decision 215/2011. The port of destination will be the "prenotification" information that is provided by the erators. The feature is expected to be in place by mid of 16. nt Authority has initiated an enforcement procedure against mic Operators who failed, to declare on the Traces system as from 016 consignments that stayed in the port for more than 7 days.

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Finding 19 of report 2014-7003 described that the monitoring plan did not include microbiological hazards and that the risk assessment was not documented. The audit team noted that risk-based planning for microbiological testing is still not documented and the decision on hazards/commodities to be tested or to be excluded from testing is not justified.

Import controls are generally implemented in line with the legal requirements. For consignments in transhipment, since May 2015 the competent authority has used the data from Customs, the agents responsible for the consignments and the port operator to identify and control consignments where required. Some deficiencies still exist i.e. the competent authority: does not use the available data if consignments are pre-notified with two digit CN-codes or no CN code, or when the format of the documents from Customs is not compatible with INTERTRACE. does not enforce the requirement for operators to provide information on the next BIP of destination when transhipments are destined to be imported in other EU Member States, which increases the risk of consignments introduced later into the Union without being subject to official controls. does not apply effective enforcement measures when the operator ignores the 9 request from the competent authority to bring the consignment to the BIP for controls, and the consignment leaves the port. does not ensure that the monitoring plan for microbiological hazards is based upon the nature of the products and the risk they represent.

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the nature of The Competent Authority is developing a Monitoring Plan for microbiological ed by point 1 of hazards based on a documented on risk assessment that will be ready by the 16 in order to be fully implemented as of January 2017.

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Under the SNCPs, FBO compliance with biosecurity conditions has to be checked annually by officials and when a farm is found positive for relevant Salmonella serotypes. According to the CA the frequency has been determined on the basis of a risk analysis which takes into account the data obtained through the SNCPs implemented the preceding year. A standard checklist was introduced by the CA in 2011 for verification of the biosecurity measures applied on-farm to prevent the introduction of Salmonella. The audit team noted that this annual frequency is not always respected in the cases reviewed and in one Salmonella positive farm visited biosecurity checks had not been 5 performed after relevant Salmonella positive results. A shortcoming concerning frequency of official controls had been noted during the previous FVO audit. The audit team noted in the farms visited some deficiencies concerning biosecurity measures, such as no pest-proof doors, high grass and vegetation such as trees around the poultry houses and storage of redundant material in some instances against the walls of the premises which could potentially attracts rodents. As noted by the audit team and confirmed by the CA, these shortcomings had not been identified/recorded by official staff. In other cases, some shortcomings which had been recorded by officials during consecutive official controls were still present at the time of the FVO visits, i.e. the absence of FBO pest control records was a recurrent problem recorded in the relevant checklist during official controls over the past few years with no action taken by the CA to rectify the situation. Shortcomings concerning biosecurity measures had been noted during the previous FVO audit.

As regards biosecurity standards, the CA does not ensure that official controls on biosecurity measures applied in the poultry holdings are carried out at the established frequency based on risk analysis in accordance with Article 3.1 of Regulation (EC) No 882/2004 and in line with the SNCPs.

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s of The National Veterinary Laboratory (NVL) has since achieved accreditation in accordance with ISO/IEC 17025 on the 29th April and Salmonella analysis is within the accreditation scope. Attached ISO accreditation certificate -NAB016 (Annex I).

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Under the SNCPs, FBO compliance with biosecurity conditions has to be checked annually by officials and when a farm is found positive for relevant Salmonella serotypes. According to the CA the frequency has been determined on the basis of a risk analysis which takes into account the data obtained through the SNCPs implemented the preceding year. A standard checklist was introduced by the CA in 2011 for verification of the biosecurity measures applied on-farm to prevent the introduction of Salmonella. The audit team noted that this annual frequency is not always respected in the cases reviewed and in one Salmonella positive farm visited biosecurity checks had not been 5 performed after relevant Salmonella positive results. A shortcoming concerning frequency of official controls had been noted during the previous FVO audit. The audit team noted in the farms visited some deficiencies concerning biosecurity measures, such as no pest-proof doors, high grass and vegetation such as trees around the poultry houses and storage of redundant material in some instances against the walls of the premises which could potentially attracts rodents. As noted by the audit team and confirmed by the CA, these shortcomings had not been identified/recorded by official staff. In other cases, some shortcomings which had been recorded by officials during consecutive official controls were still present at the time of the FVO visits, i.e. the absence of FBO pest control records was a recurrent problem recorded in the relevant checklist during official controls over the past few years with no action taken by the CA to rectify the situation. Shortcomings concerning biosecurity measures had been noted during the previous FVO audit.

In two out of three farms visited municipality water was used. The CA informed the audit team that when the supply of water is from private boreholes, analysis to ensure water quality is performed by the FBO on a voluntary basis. In one of the farms using well water, the audit team was informed by the CA that water analyses for some 6 parameters were performed by the FBO. However, analyses results were not available to the audit team. Cleaning and disinfection

Under the SNCPs and as required by national legislation, after depopulation of a positive flock an effective cleaning and disinfection should be carried out by the FBO. The audit team was informed by the CA that the effectiveness of such cleaning and disinfection must be verified by official environmental samples. Under national legislation, the CA can permit restocking only once no Salmonella spp. is isolated from these environmental samples. However, in two positive farms visited (broiler holdings) this procedure was not followed as permission for restocking was granted by the CA although such samples had not been taken. Epidemiological surveys in the framework of the SNCPs

The official controls in place do not guarantee FBO compliance with all the general hygiene provisions laid down in Regulation (EC) No 852/2004 for primary production, in particular concerning water quality and cleaning and disinfection practices. Therefore the CA does not fully ensure that appropriate measures are in place to prevent Salmonella contamination at farm level. 7

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The Official Veterinarian i/c of the Animal Health Unit ­ Poultry ency Section (AHUPS) has drafted a schedule regarding the frequency in of official controls to be carried out over a 12 month period on poultry holdings (broilers and layers) according to the risk analysis established (Annex II; the farms highlighted in red are those classified as the medium risk1 positive ST or SE in 5 years or 4 Salmonella spp. in the last 4 tests).

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In 2013 an internal audit was carried out by the VRD to verify the correctness of the implementation of the SNCPs. The majority of the shortcomings highlighted in the resulting audit report are similar to those detected by the FVO audit team during the course of this audit. The deadline set for the verification of the corrective actions required in the 2013 report was April 2014. The CA informed the audit team that the deficiencies found during the internal audit had not, at the time of the current FVO audit, been addressed or followed-up. The CA explained that the appointed auditor had left and is still to be replaced (see also Chapter 5.3). 4 Conclusions on competent authority

The CA have not yet ensured that appropriate corrective measures were taken in the light of the results of the internal audit carried out on the implementation of SNCPs.

All the data related to Salmonella sampling are adequately registered in a dedicated central database. Through this tool the CA is in the position to monitor the implementation of official and own-check sampling, and to review and evaluate the progress of the SNCPs. However the audit team noted that when deficiencies are identified during monitoring through the database as regards the correctness of sampling frequency and sampling procedures, effective corrective actions are not taken by the CA to remedy the situation. Examples of emails sent by the NVL to all the actors involved highlighting these problems were available to the audit team, however the review of the information entered in the database and the visit on-the-spot at farm level during the course of this audit confirmed that these deficiencies exist since the previous FVO audit in Malta carried out in 2010. In addition, problems on sampling frequency in the laying hen population were found during an internal audit (see Chapter 5.1- Audit) and the CA did not take any corrective action in this respect.

The CA has tools in place to facilitate monitoring the implementation of the SNCPs. However, when issues are detected corrective actions for remedying the situation are not taken. Therefore the CA does not ensure that all the activities contained in the SNCPs are implemented as described in the approved programmes, in particular concerning the sampling (insufficient number of samples and incorrect sampling). This is not in line with Article 15.1 (a) of Decision 2013/722/EU.

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all The Official Veterinarian i/c of the Poultry Section of Animal (f), Health Unit has amended the Bio-security check-list (Annex III) to include the type of water used (municipal or bore-hole) and a certificate of analysis is therefore being requested when there is use of wells or bore-holes. During any planned official control on the farm the competent authority, based on the report, issues enforcement actions if necessary in order to guarantee that farms are compliant with basic hygiene rules; with this regards, some corrective actions have been requested; follow up will be carried out with the appropriate time frame (Annex IV). To avoid that restocking is carried out prior to complete farm Page: 1 Ref. Ares(2015)2200752 - 27/05/2015 ort ref. DG(SANTE)/2015-7518-MR of the Audit carried out from 26 January Programmes in particular poultry populations (breeders, laying hens, broilers disinfection, the Veterinary Regulation Directorate is modifying the National Livestock Database (NLD). The modification entails that the purchasing forms are blocked until verification of the efficiency of cleaning and disinfection is provided to the poultry section by the National veterinary labora

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The competent authority has written job descriptions for the official veterinarians and the veterinary support staff. These include the general responsibilities of the personnel and they do not detail specific tasks and related responsibilities (finding 17) contrary to the requirement of Chapter II(4) of Annex II to Regulation (EC) No 882/2004. In this context, it was noted that auxiliary staff carry out controls and sign certificates when such activities have not been included in their responsibilities. This shortcoming was reported in the 2010 report and a recommendation (No 3) was consequently issued, which has not been addressed.

The competent authority complies with the requirements of communication, training and instructions (with the exception of instructions for control of transhipments and for sampling for microbiological testing) and resources to support the effective implementation of the controls. However, the system does not ensure veterinary checks and certification are only performed by authorised staff which may lead to imports of consignments that do not fulfil the legal requirements related to animal and/or public health.

Previous FVO audits identified that veterinary checks and issuing of certificates were not always done by authorised staff (see finding 4). After the 2010 FVO audit the competent authority hired an additional official veterinarian but the shortcoming had not been addressed at the time of the 2011 audit (see heading 5.2.1 of the 2011 report). The situation remains unchanged, auxiliary staff carrying out controls when official 6 veterinarians are not present in the BIPs and signing subsequent certificates (CVEDs) in TRACES.

The audit team noted that in the port BIP official controls and the signing/issuing of CVEDs was done by the official veterinarians. In the airport BIP the official veterinarian is present once per week and support staff performs more than 95% of the official import controls, including the signing/issuing of CVEDs. Official veterinarians are not involved in the performance of official controls to ensure that they are correctly implemented. This means that: Official controls are not performed under the responsibility of the official veterinarian contrary to the requirements of article 4(1) of Directive 97/78/EC; The signing of CVEDs, is done by support staff instead of the official veterinarians which is not in line with Article 5 of Directive 97/78/EC. Although this non- compliance was identified in the 2011 FVO report, the competent authority has not addressed it in order to have only official veterinarians signing the CVEDs.

Import controls are implemented but the systemic problems identified in previous FVO audits remain unaddressed: pre-notification of consignments does not include all the information required, the competent authority does not ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement, controls are not implemented by authorised staff (including the issuing of certificates), the monitoring plan has a limited scope. As regards transhipments, the competent authority has access to information (Customs information, manifests) but does not use it to identify the goods and the required controls on consignments transhipping in Malta are not implemented. The above undermine the capability of the system to prevent the introduction to the Union market of consignments that do not meet the requirements of the import legislation.

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The Veterinary Regulation Directorate has removed the auxiliary staff's TRACES individual accounts to prevent any abuse. Since the 2014 mission took place, these checks are solely carried out by Official Veterinarians (OVs). For this reason an ad hoc roster has been created to guarantee that releases are carried out by OVs also after normal working hours. Additionally, to strengthen controls at BIP, an OV has been added to the section. New individual job descriptions (ANNEX I) for all the officials within the Unit have been created by the Head of Unit and endorsed by the Chief Veterinary Officer (CVO). The outcome of their work is monitored and evaluated every three months using the Performance Management Plan review, which is the official tool used by the Maltese Public Service. The Competent Authority is already monitoring the activity carried out by the Official Veterinarians, also through the TRACES Administrator. OVs are obliged to send the complete Common Veterinary Entry Document (CVED) from their individual outlook account to the Competent Authority and this is being implemented. Non-compliances with such specific rules will be dealt in accordance with the Public Administra

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The 2011 report recommended (recommendation 3) ensuring that consignments requiring veterinary checks are notified to the BIP before their arrival in the EU and ensuring that actions are taken in case of non-compliance and sanctions imposed so that the operator remedies the non-compliance detected. The audit team noted that this recommendation has not been addressed (see findings 8 and 11).

Consignments intended for import are pre-notified electronically through TRACES in line with the requirements of Article 2(1) of Regulation (EC) No 136/2004 for consignments of products of animal origin and Article 1(1) of Regulation (EC) No 282/2004 for consignments of live animals. In this regard: Between January 2013 and March 2014 the competent authority implemented a procedure to screen ship manifests in order to identify consignments subject to veterinary control that were not pre-notified to the BIPs, in line with Articles 5 and 6 of Regulation 136/2004. In this period, the competent authority sent four letters to two shipping agents informing them of several cases of consignments not pre- notified and that sanctions would be applicable in the case of recurrence. The audit team noted that no sanctions were imposed. The competent authority stated that checks on manifests stopped due to a lack of resources. The absence of such cross-checks increases the possibility of consignments of veterinary interest (if not pre-notified to the BIPs and not identified by Customs) being introduced into the European Union without having been subjected to veterinary checks, which is not in compliance with the requirement of Article 4(1) of Directive 91/496/EEC and Article 3 of Directive 97/78/EC.

The 2011 report (heading 5.6.1) described the electronic database (INTERTRACE) developed by the competent authority to extract information on relevant consignments from the information received every day from Customs, so that consignments that had not been pre-notified would be identified. The report concluded that INTERTRACE did not provide useful data to the veterinary services. Currently, approximately 30% of the data sent by Customs is in a scanned format, not retrievable/usable by INTERTRACE to identify consignments of interest. The memorandum of understanding with Customs has no details on the availability/exchange of information/data between the two authorities although a 2012 internal audit had recommended that this issue should be addressed (finding 23).

Information in the Customs database related to transhipped consignments, either with two digit CN (Customs nomenclature) codes or no CN code (this includes consolidated consignments), need to be retrieved manually in order to provide information/reports to the competent authority on all the consignments of veterinary interest. 5.2.2 Veterinary checks Legal Requirements Annex II to Regulation (EC) No 136/2004, Articles 4(1) and 5 of Directive 97/78/EC, Decision 2001/812/EC. Findings

Import controls are implemented but the systemic problems identified in previous FVO audits remain unaddressed: pre-notification of consignments does not include all the information required, the competent authority does not ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement, controls are not implemented by authorised staff (including the issuing of certificates), the monitoring plan has a limited scope. As regards transhipments, the competent authority has access to information (Customs information, manifests) but does not use it to identify the goods and the required controls on consignments transhipping in Malta are not implemented. The above undermine the capability of the system to prevent the introduction to the Union market of consignments that do not meet the requirements of the import legislation.

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ll Economic Operators' (EOs), including those who never pre notified were identified and ted to a training session that took place on 8 June 2015 (ANNEX II vide e-mail pre- notification). During this session they were reminded of their obligation to choose between using TRACES to carry out all notification procedures or to use INTERTRACE for pre notification and TRACES for transit and transhipments staying over 7 days. The monitoring of EOs compliance has been assigned to the support staff (also as part of Page: 1 competent authority on 22 July 2015 of Report ref. DG(SANTE)/2014-7003-MR of the Audit carried out from 25 rol system for live animals (LA) and products of animal origin (POAO) ritten duties) who are supervised by the Head of Unit. (ANNEX Ia-d) pliance level has increased and TRACES certificates for transit and transhipments ng produced every day. The compliance rate has improved due to the support the ff is providing to the EOs. This support includes individual training and retraining s. expecting to reach compliance by Autumn as this is the minimum time needed to valuate if all stakeholders are compliant. The enforcement actions will follow if liance is detected.

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Consignments intended for import are pre-notified electronically through TRACES in line with the requirements of Article 2(1) of Regulation (EC) No 136/2004 for consignments of products of animal origin and Article 1(1) of Regulation (EC) No 282/2004 for consignments of live animals. In this regard: Between January 2013 and March 2014 the competent authority implemented a procedure to screen ship manifests in order to identify consignments subject to veterinary control that were not pre-notified to the BIPs, in line with Articles 5 and 6 of Regulation 136/2004. In this period, the competent authority sent four letters to two shipping agents informing them of several cases of consignments not pre- notified and that sanctions would be applicable in the case of recurrence. The audit team noted that no sanctions were imposed. The competent authority stated that checks on manifests stopped due to a lack of resources. The absence of such cross-checks increases the possibility of consignments of veterinary interest (if not pre-notified to the BIPs and not identified by Customs) being introduced into the European Union without having been subjected to veterinary checks, which is not in compliance with the requirement of Article 4(1) of Directive 91/496/EEC and Article 3 of Directive 97/78/EC.

The 2011 report (heading 5.6.1) described the electronic database (INTERTRACE) developed by the competent authority to extract information on relevant consignments from the information received every day from Customs, so that consignments that had not been pre-notified would be identified. The report concluded that INTERTRACE did not provide useful data to the veterinary services. Currently, approximately 30% of the data sent by Customs is in a scanned format, not retrievable/usable by INTERTRACE to identify consignments of interest. The memorandum of understanding with Customs has no details on the availability/exchange of information/data between the two authorities although a 2012 internal audit had recommended that this issue should be addressed (finding 23).

In several examples reviewed during the audit, INTERTRACE provided wrong information. For example, EU consignments already introduced to Malta through the port, were still indicated as being in the port and identified as imports. INTERTRACE does not allow for recording of consignments exiting the port to the internal market as it focuses on the monitoring of transhipments by recording the arrival at the port, unloading and loading to another ship.

Import controls are implemented but the systemic problems identified in previous FVO audits remain unaddressed: pre-notification of consignments does not include all the information required, the competent authority does not ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement, controls are not implemented by authorised staff (including the issuing of certificates), the monitoring plan has a limited scope. As regards transhipments, the competent authority has access to information (Customs information, manifests) but does not use it to identify the goods and the required controls on consignments transhipping in Malta are not implemented. The above undermine the capability of the system to prevent the introduction to the Union market of consignments that do not meet the requirements of the import legislation.

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ides the action plan mentioned in point 2, VRD is again implementing cross checks the INTERTRACE reports. Manifests submitted by Customs are checked by the port staff as part of their daily written duties. In order to identify consignments subject rinary checks that were not pre notified to BIP, and this is done in accordance with ached SOP. (ANNEX III) resees that 50+1 of the manifests are screened; however VRD is planning to increase ber of manifest cross checks in view of the enhancements that are requested to the ACE plus developer; VRD foresees these developments to be completed by the the year. ERTRACE plus system is now generating warning letters to the EOs and these ompted EOs to comply even further with the legal requirements. A copy of such letters is being submitted with this reply and it also makes reference to the trative penalties imposed on EOs for failure to comply with such legal ments. (ANNEX IV) ing committee composed of the Ministry Chief Information Officer, his team as well cers of the Veterinary Regulation Directorate (VRD) is regularly meeting to discuss uired developments that are needed within the National Livestock Database that s the INTERTRACE plus modu

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Article 24 of Regulation (EC) No 882/2004 states that Customs shall not allow the entry or handling in free zones or free warehouses of consignments subject to veterinary checks without the agreement of the competent authority. This requirement is not included in the memorandum of understanding between the competent authority and Customs. There is no procedure for the enforcement of the requirement and the competent authority cannot ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement. This shortcoming was noted in previous FVO audits and as recommendation (No 1) in the 2011 report. The recommendation has not been addressed. 4

Import controls are implemented but the systemic problems identified in previous FVO audits remain unaddressed: pre-notification of consignments does not include all the information required, the competent authority does not ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement, controls are not implemented by authorised staff (including the issuing of certificates), the monitoring plan has a limited scope. As regards transhipments, the competent authority has access to information (Customs information, manifests) but does not use it to identify the goods and the required controls on consignments transhipping in Malta are not implemented. The above undermine the capability of the system to prevent the introduction to the Union market of consignments that do not meet the requirements of the import legislation.

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The MOU signed by Customs and VPRD is again being reviewed. It will contain references to address requirements of Art. 24 of Regulation (EC)882/2004 and also require Customs to provide VRD any notification related to any possible handling in Free Zones or Custom Warehouses of goods subject to veterinary checks. It is envisaged that such MOU will be finalised by September 2015. A change in the Multi Annual National Control Plan (MANCP) is going to be reported for 2015.This will entail a risk-based microbiological plan for several commodities and for this reason the Environmental Health Laboratory ISO 17205 accredited, is carrying out microbiological analysis and the results of such tests have already been inserted in TRACES. At this stage, the plan is based on commodities type and origin, taking into consideration also the Rapid Alert (RASSFF) notifications. At the end of the Year the plan is going to be reassessed and modified if necessary. In relation to the residue plan, the National Veterinary Laboratory, that has also been ISO 17025 accredited, is strengthening its capacity in order to guarantee correct monitoring for those tests being carried out abroad; these will be solely p

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Annex II to Regulation (EC) No 136/2004 requires that the monitoring plan reflects the nature of the imported consignments and the hazards that they represent. The monitoring plan for imports includes sampling for chemical hazards and it is implemented correctly at the BIPs. An average of 3% of the imported consignments is subject to testing. The plan does not cover microbiological hazards and does not include an assessment of microbiological risks that would justify their exclusion from the plan. As a consequence, imported products of animal origin have not been tested for microbial pathogens although relevant commodities have been imported (beef, poultry). These parameters for imported goods testing are not covered by market controls. TRACES data indicate that there was no sampling under suspicion for those parameters, either. There is no formal procedure for drafting the monitoring plan and the BIP staff is not involved.

Import controls are implemented but the systemic problems identified in previous FVO audits remain unaddressed: pre-notification of consignments does not include all the information required, the competent authority does not ensure that no entry or handling of veterinary consignments occurs in the free zone of the port without their agreement, controls are not implemented by authorised staff (including the issuing of certificates), the monitoring plan has a limited scope. As regards transhipments, the competent authority has access to information (Customs information, manifests) but does not use it to identify the goods and the required controls on consignments transhipping in Malta are not implemented. The above undermine the capability of the system to prevent the introduction to the Union market of consignments that do not meet the requirements of the import legislation.

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TRACES is not used for transhipped consignments. There are no controls on those movements contrary to the requirements of Article 11 of Council Directive 97/78/EC. The consignments could go on to a non-BIP EU port, where no checks would take place; or if they went to another EU BIP port, the port would not receive information about the transhipment via the TRACES inbox notifications as provided for in the General Guidance for consignments of live animals and animal products from third countries in transit or transhipment. 5.2.3 Veterinary checks

The port is a free zone and operates 24/7 with few exceptions. Imports of products of animal origin are allowed only during the presence of the official veterinarians, but transhipments can happen at any time. This means that those consignments could leave the port without TRACES documents intended for transhipment, which is not in line with Article 3 of the Commission Decision 292/2004/EC. 5

In the airport BIP, checking the arriving consignments and issuing and signing CVEDS in TRACES is normally done by auxiliary staff using a generic TRACES account. The implementation of veterinary checks by auxiliary staff is not in accordance with paragraph 2 of the Annex to Decision 2001/812/EC, Article 5(1) of Directive 97/78/EC and Article 4 of Directive 91/496/EEC.

Documentary and identity checks are recorded in TRACES. The audit team evaluated a sample of documents, and found a number of shortcomings, for example: at the airport several CVEDs indicated satisfactory documentary checks even though the data on the health certificate did not match with data declared on the first page of the CVED by the persons responsible for the load; the approval numbers of controlled destinations in the CVEDs were incorrect; many CVEDs are issued by auxiliary staff who sign using a generic password; consignments of live lobsters were certified with CVEDAs instead of the required CVEDPs. In the 2010 report a high number of errors in TRACES data were also reported.

Consignments sampled in 2013 and 2014 under the monitoring plans and subsequently released into free circulation appeared in TRACES as still pending results. The competent authorities confirmed that the tests have not been done yet. This means that in the case of a non-compliant result, it is too late to act ­ for example, no re-enforced check (REC) or Rapid Alert System for Food and Feed (RASFF) notification could be triggered. The significant delay of a year between sampling and testing was already highlighted in the 2010 report.

The results of the tests actually carried out were not entered in TRACES either. This is not in line with Annex III to Regulation (EC) No 136/2004. 5.2.4 INTRA module

TRACES is used for import-related activities. Inaccurate and/or incomplete data in TRACES is linked to shortcomings in the official controls (controls done by non- authorised staff, lack of testing of official samples or controls not implemented, specifically in transhipments), which undermines confidence in the official control system on the whole.

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The action plan mirrors the one proposed for the . recommendations presented in report 2014/7003. At the end of 2015 VRD is planning to carry out an internal Audit to receive evidence that controls have improved, and in particular, that the mistakes in CVEDs are not only reduced, but are tackled in the correct manner. Update received from the CA 4 September 2015 The following are the corrective actions which have been identified and properly been taken to solve the deficiencies that were identified during the previous audit missions: Only official veterinarians are now authorised to carry out veterinary checks in the border inspection posts and to enter the results in TRACES as required by Article 4(1) and Article 5(1) of Directive 97/87/EC; To date Approximately 100 official controls on transit and transhipment have been carried out and registered through TRACES since the mission took place; The monitoring of the pre-notification system of consignments has now come into effect, although the system needs further fine tuning; Microbiological tests have now become part of the monitoring plan and their results are being recorded in TRACES, even though risk assessment needs further imp

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ply was accepted. The Competent Authority will notify FVO once the Legal Notice is published; it is currently at public consultation stage.

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ply was accepted.

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Reply was accepted.

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ltese Authorities confirm that the original response to this ommendation should be construed as acceptance of the conclusion of the report. Page: 1

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continue to ensure recruitment of official staff. At present there are Officers within the Veterinary Regulation Directorate (VRD) and ng call throughout 2013. The first call has already been processed have been selected from the first call. These candidates will in the next weeks. Another call closed on 15 March 2013. lls are set to close on 14 June 2013; 13 September 2013; and . It is envisaged that the vacant positions for Official thin the VRD will be fulfilled by the end of processing of these for the Veterinary Support Officers. A call was issued on 13 d interviews were held on 12 and 13 February 2013. There applicants out of which 11 were successful during the of these successful candidates should be employed within the

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SOP on how to approve establishments that prepare food of s been prepared (a specific one is present for Fishing Vessels different requirements compared to establishments 1 7 May 2013 roposed by the Competent Authority of animal origin). Approval will be granted only if the ator (FBO) has fulfilled all conditions that have to be met dit or within the three plus three month period foreseen in the ed document "Procedure for approval of new applicant"

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tted the Risk Assessment on 20 December 2012 and this clearly eration past records and own checks. However, the frequency of not dictated by these two parameters. The VRD has already assessment of the plan of official controls by modifying the ing official controls in 853 approved establishments" as g the risk. Establishments will receive a score and according be reassessed on a yearly basis. ed a document entitled "Risk Categorisation of Food Frequency for Official Controls" which outlines the re- essment and frequencies.

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ating Procedures (SOPs) in line with Article 8 of Regulation continuously under development. The SOP "Performing in 853 Approved Establishments" has been modified in order onsistency and the efficacy of the official controls. ed version 2 of the above mentioned document entitled al Controls in CR853 Approved Establishments" 2 7 May 2013 Action Proposed by the Competent Authority 001/2012

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ement already exists entitled "Guidelines on Enforcement FC/001/2011; Issue No 1; Review Date 31/07/2013; Effective 08/2011. The Competent Authority will make sure that appropriate s taken in line with the SOP contents in all the approved establishments. ion to the Civil Abattoir, if required and as already carried out in the duction or suspension of activity will be enforced until the Competent y is satisfied by the remedies carried out by the Operator.

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ind attached a schedule of refurbishment works at the Civil Abattoir.

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oval process can take place only after 90 days from and after a proper HACCP and full traceability system for the cutting and g hall.

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s have been reminded once again about their obligations in relation to ber of samples and appropriate number of tests to be carried heir products. These recommendations refer also to the carrying out of fe studies. In particular a guidance document entitled "Listeria genes and Regulation (EC) No 2073/2005" has been prepared to assist Official Veterinarians in carrying out their Official Controls in 3 he Competent Authority ng attached. At least two Official raining on microbiological criteria in attending this same training during 2014. rforming the necessary tests required in

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r raw sheep and goats milk laid down in Section IX of Annex III 3/2004 are still under discussion with the Commission. sue as soon as discussions with the 4

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eterinary medicinal products available on the market have already been reviewed and the range of substances to be investigated has been updated in the 2012 National Residue Control Programme (NRCP) and is contained in Annex 1; those marked with an asterisk indicate the substances that have been included as per the FVO's recommendation. Annex 2 contains the list of antimicrobials covered by the six plate test

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ituation with regard to the list of commodities has been corrected immediately after the FVO mission. Fish samples were taken in November 2011. An officer within the Veterinary Regulation Directorate has been assigned the task of sampling from local fish farms. The total samples for fish in 2011 amounts to 27. For 2012, the samples are being spread out over the year as part of the revised MANCP. With regard to the long turnaround times the Competent Authority has taken action by adding an agreement in the tender document to receive results from the contracted laboratory within 28 days from the receipt of sample including Sundays and public holidays in the case of screening tests. Confirmatory tests and border inspection post samples are to be reported within 14 days from the receipt of sample including Sundays and public holidays. Once agreements are signed with the contracted laboratories, samples will be 1 he Maltese Competent Authorities to the recommendations of Report ref. -8859-MR of an audit carried out from 03 to 07 October 2011 in order ate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products 1

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el has been recruited (2 additional technical officers) and the validation -plate tests and TLC sulphonamides is estimated to be finalised in 6- s. ther recruitment call for 1 laboratory attendant and 2 Senior Laboratory icians have been approved and will be published in 2012.

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e were a few substances for which the contracted laboratory did not have lidation protocols according to Commission Regulations. In order to correct coming the NVL has changed the laboratory selecting one which uses ated methods for those substances.

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NS is going through with the re-evaluation of all registered MPs. These are being checked for their MRL status according to egulation (EU) 37/2010. The authorisation of unapproved products ill be revoked. during this re-evaluation it is found that a target species has been eleted the authorisation is amended, the holder of that authorisation s informed and advised to procure only that VMP with the latest 2 3 November 2012 Response of the Maltese Competent Authorities to the recommendations of Report ref. DG(SANCO)/2011-8859-MR of an audit carried out from 03 to 07 October 2011 in order to evaluate the monitoring of residues and contaminants in live animals and animal products, including controls on veterinary medicinal products 15 November 2012 Action Proposed by the Competent Authority

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Product Information. Applications for authorisation according to Article 7 of Directive 2001/82/EC will include, as part of the supporting documentation, the relevant extract from the table of allowed substances in Regulation (EU) 37/2010. Only the page where there is mention of that active substance(s) and its MRL is necessary. The 3 points above are also applicable to medicated pre-mixes. The electronic database and list of authorised VMPs on the Directorate's web page has been updated. The web page list includes all withdrawal periods of the VMPs. A circular addressed to all veterinarians has been issued providing clear instructions on the use of the cascade system stressing the importance of record keeping during its application, how treatment should be restricted to animals on a single holding and the requirement to specify an appropriate withdrawal period to the animal produce. A copy of this circular is contained in Annex 3. VMANS has prepared a leaflet intended to provide guidance on the application of the cascade system so as to minimise the risks associated with the "off-label use". This will be sent to all veterinarians, vet pharmacies, and farmers. The leaflet is contai

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outside Malta. For this reason they will have to apply for an import Licence at the VMANS. This import scheme will allow veterinarians to obtain one of two different licences. One for VMP imported from the EU and another from a third country. A sample application form is contained in Annex 5. The medicated feeding stuff manufacturers will be obliged to report half yearly the production quantity of medicated feed and consumption of medicated premixes to VMANS. A copy of the communication with the only authorised medicated feed mill in this regard is contained in Annex 6 Co-operation with AHWU and VMANS officers will be strengthened. AHWU will be asked to record all VMPs found in the farms during the official inspection and forward the list to VMANS. VMANS will allow access to the VMPs database to the AHWU. VMANS is reporting to officers within the AHWU and Safety of the Food Chain any irregularities detected during the official inspection of home mixers, for example, unauthorised on-farm mixing of medicated premix. A circular has been issued to all veterinarians urging them to increase their level of compliance with prescribing rules. A copy is contained in Annex 7. e Competent Auth

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e manual of Procedure is currently being revised by VMANS in order to include ad hoc SOPs and checklists related to the inspection of private veterinarians. Ps on the prescriptions received by VMANS will be vetted for their authorisation status and proper use. Prescriptions will be categorised according to farm origin. These will be reconciled with the standardised herd book (Treatment by VMPs pages) during official inspection of home mixers. Any irregularities detected in these pages will be reported to the AHWU and Safety of the Food Chain. e frequency of inspection and complexity of inspection will be based on the risk of the activity carried out by the establishment, that is, medicated feedstuff mills will be inspected more often than on- farm mixer but the latter will have to keep a `Book of Operation'. les will be established that outline the aspects of production and testing that can impact the quality of finished Medicated feeding stuff by end of December 2012 dicated feed mills are approved only after they are in full compliance with all the requirements of the legislation. At present there is only one approved medicated feed mill. addition to a planned annual official ins

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Equine Register has been modified to be in full accordance with ation (EC) 504/2008. A copy of the document of description is contained Annex 8. No horses have been slaughtered for human consumption as they e not fulfilled the requirements of Regulation (EC) 504/2008. The erinary Regulation Directorate has been registered with the UELN to be e to generate Unique Equine Life Numbers for equines. The UELN Code the Veterinary Regulation Directorate is 470003. The Malta Racing Club been registered as UELN with the Code 470001 for a couple of years. 6

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grading of the old agreement is being prepared.

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points noted by the audit team have been addressed and version 5 of the alta BIP Manual has been produced. A further modification and update to gh address further issues is currently underway. A number of new Standard Operating Procedures (SOPs) are being drafted.

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o Legal Letters with fines have been sent to the persons responsible for the load. of The two major operators have attended meetings with the Competent Authority d are supplying electronic files with the necessary data. The other shippers 1 Response of the Competent Authorities of Malta to the recommendations of Report ref. DG(SANCO)/2011-8963-MR of an audit carried out on 1-4 November 2011 in order to evaluate the follow-up action taken by the Competent Authorities with regard to the import/transit control system and border inspection posts and import controls not carried out at border inspection posts 3 February 2012 Action Proposed by the Competent Authority still need to reply to the legal letter.

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A complete self assessment of the Veterinary Regulation Directorate, within the Ministry for Resources and Rural Affairs, in line with the Tool for the Evaluation of Performance of Veterinary Services (PVS tool) is being discussed with the Internal Audit and Investigations Department, within the Office of the Prime Minister, during 2012. Depending on the position taken by the Food Safety Commission for internal audits, the Competent Authority will decide whether to seek external expertise to run an audit of import controls during 2012.

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The situation has been addressed and wording has been placed on the original certificate to this effect.

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k on the Marsaxlokk BIP have been finalised, work on the Luqa BIP will finalised by the second quarter of 2012. 2