Hungary

The recommendation states as its basis

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 (3). These 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. These plans are subject to annual Commission evaluation (4). Member States must establish multiannual national control programmes for pesticides residues (5) in food and feed of both animal and non-animal origin and they must also participate in the Union-wide coordinated multiannual programme (6). Member States must control the presence of certain contaminants in food of both animal and non-animal origin ((i) in food placed on the Union market, and (ii) in food of animal origin entering the Union). The foodstuffs of animal origin to be tested and the categories of contaminants to be tested are specified (7) as is the sampling frequency (8). These control plans are also subject to annual Commission evaluation (9). 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.

As was the case for the NRCP samples in finding 4, the implementation of the NRSP plan did not fully meet the requirements (37) with respect to the minimum sampling frequencies in 2023 and 2024, with 58% and 77% taken respectively of the total minimum requirement of 165 samples. The audit team noted that samples for the NRSP were taken across the calendar year, however with similar reductions in certain months to that seen for the NRCP in finding 2. 5.3. Implementation of the multiannual national control programme for pesticide residues and the Union-wide coordinated multiannual programme

In 2023, 425 samples were planned, and 304 samples were tested giving an overall achievement rate of 72% (43). In 2024, 510 samples were planned and 396 were tested, giving an overall achievement rate of 78%.

In the 2023 contaminants plans, 373 of the 421 samples planned for all commodities, excluding processed products of animal origin, were tested giving an achievement rate of 89%. For processed products of animal origin in 2023, 40 samples were planned and 293 were tested (43). In 2024, 599 of 752 samples planned were tested across all commodities, an overall achievement rate of 80%.

Achievement rates for the controls on contaminants in food of animal origin in 2023 and 2024 did not meet the minimum requirements for sample numbers analysed (49) for certain commodities, as summarised in the table below. Commodity 2023 2023 2024 2024 Planned Tested Planned Tested (EU min) (EU min) Unprocessed bovine meat* 22 (22) 14 21 (20) 16 Unprocessed ovine and Caprine meat* 2 (2) 1 3 (2) 1 Unprocessed porcine meat* 139 (139) 128 142 (141) 122 Unprocessed poultry meat* 159 (158) 142 227 (223) 180 Fresh hen eggs and other eggs 41 (41) 36 25 (24) 17 Honey 39 (39) 36 45 (44) 36 * Including edible offal. EU min = minimum samples required as per EU regulations (49). Conclusion on the implementation of official controls

While the basis for the operation of control and surveillance plans is in place for residues of pharmacologically active substances, pesticides and contaminants, incomplete implementation of the sampling plans in 2023 and 2024, in addition to shortcomings in the supervision of implementation of sampling, undermine the overall effectiveness of the residue control plans.

The recommendation states as its basis

The national procedure allows that if a product has already been manufactured from non-compliant raw material, the competent authority "can decide on the fate of the manufactured product on the basis of a risk assessment, taking into account the test results", which contradicts pertinent EU requirements (51).

The OV is to evaluate the results and decide on the measure(s) to be taken in case of non-compliant result(s). The OVs interviewed by the audit team stated that they had not received any training on the topic and experienced difficulties to refer to applicable EU requirements, including on measures in case of suspected or confirmed illegal treatment (52), and when residues were identified at concentrations below the maximum residue limits for pharmacologically active substances authorised in veterinary medicinal products or as feed additives but where the presence of those residues was inconsistent with the food chain information (53).

The audit team scrutinised the follow-up of four non-compliant results for pharmacologically active substances and one for pesticides, and observed the following: · In one case (where illegal treatment was established), the competent authority did not take samples from all relevant batches belonging to the farm, and no (50) Articles 3, 4 and 5 of Commission Delegated Regulation (EU) 2019/2090. (51) Bullet point 1 of Article 5(1) of Delegated Regulation (EU) 2019/2090. (52) Article 6 of Delegated Regulation (EU) 2019/2090. (53) Article 4(2) of Delegated Regulation (EU) 2019/2090. 14 regular additional official controls were performed, which is not in line with relevant legal requirements (54). · In another example, a non-compliant result, due to interpretation error, was identified 10 months after the issuing of the analysis report. Furthermore, the NFCSO, while being informed by the laboratory of the non-compliant result at the time of issuing the analysis report, did not notice that the investigation report had not been received within the 30 days required by the national procedure (55). · For another non-compliant sample reviewed, the auditors noted that the analysis result was reported 3 months after the sampling took place (target turnaround time being 30 days), thus impacting the effectiveness of the measures taken. Conclusion on follow-up and enforcement

While there is a system in place to deal with non-compliant results, the actions taken are not fully aligned with pertinent EU legal requirements which undermines the overall effectiveness of the residue control system. 5.6. Laboratories, methods of analysis, method validation, and quality control 39. During 2023-2024, the laboratory network consisted of four national laboratories, all of which were within the NFCSO organisation. The audit team visited two laboratories, one with predominant responsibility for testing of the plans relating to pharmacologically active substances and some contaminants and the other with responsibility for testing of the plans relating to pesticides and contaminants.

The recommendation states as its basis

NÉBIH relies on the clause in the cooperation agreements that the companies `shall ensure the availability of personnel with the necessary qualifications and appropriate 5 experience'. It is not aware of and does not verify the qualifications and competence of the experts used by the companies for the evaluations.

An accredited company will only be involved in the evaluation of PPP authorisations if the applicant requests it in the application and specifies which of the two companies he has selected. If the competent authority accepts the request, the applicant will then enter into a contractual agreement with the company for the work and pay for it. Thus, it is not the competent authority that contracts the actual evaluation work or pays for it; in the cooperation agreement with NÉBIH, it is specifically stated that `the evaluation body shall carry out its evaluation activities in accordance with this cooperation agreement with NÉBIH without any financial compensation'. NÉBIH is not privy to the contract or the financial arrangements between the applicant and the company.

The competent authority has the final say in the evaluations and remains the authority for the subsequent authorisation. Nevertheless, the audit team considered that the arrangement of a direct financial agreement between the applicant and the evaluating company is not transparent. Article 74(2) of Regulation (EC) No 1107/2009 requires that fees or charges are established in a transparent manner. Furthermore, the arrangement does not protect against potential influence on the outcome of the evaluation due to the payment made and to the lack of an effective mechanism against possible conflict of interest, even if there are examples in practice of the evaluating company making negative proposals. Article 36(1) of Regulation (EC) No 1107/2009 requires that assessments are independent, objective and transparent, and Article 29(b)(iii) of Regulation (EU) 2017/625 requires that delegated bodies are impartial and free from any conflict of interest. General authorisation procedure

There is a procedure for authorisation of PPPs to ensure proper handling of applications. However, for a number of the authorisations, the evaluation is outsourced to private companies in a way that is not in line with EU legislation. The financial arrangements and the lack of an effective mechanism for managing conflicts of interest do not protect against potential influence on the outcome of the evaluation. In spite of this outsourcing of work, there are still significant delays in the authorisation process, which are a non- compliance.

The recommendation states as its basis

Since 2017, the annual number of emergency authorisations granted in Hungary has been in the range of 20-30. Each year, there have been several authorisations for the same 7 active substance, but for different commercial products. On the other hand, some authorisations were for a wide range of crops and pests, such as the one for a PPP containing the active substance kasugamycin mentioned in paragraph 24 below, which is not in line with Article 53(1) of Regulation (EC) 1107/2009, which stipulates that an emergency authorisation is for `a danger', i.e. not a broad range of different dangers. Furthermore, while each notification to the EU database indicated no more than the maximum of 120 days allowed, the actual granted period of use, across the range of crops could be longer. For example, the audit team noted that for several diquat products, the authorisations and product labels stated first use (e.g. for winter oilseed rape) 26 May 2025 and last use (e.g. for sunflower) 31 October 2025, resulting in a total period of use of 158 days. Another example is the 2025 kasugamycin product authorisation, which across the various crops covers a period from 30 April to 28 September, i.e. a period of 151 days. The audit team also noted that most of the emergency authorisations were not reported to the EU database before they entered into force, but with a delay of up to a couple of months. Thus, relevant requirements in Article 53(1) of Regulation (EC) 1107/2009 are not complied with. Furthermore, not all details were provided in the reporting, e.g. no indication was made when it was a repeated authorisation, and no information generally provided under the fields `8. Area permitted to be treated', `9. Area actually treated' or `10. Further limitations'.

For several active substances, PPP emergency authorisations have been issued repeatedly for 6, 7 or 8 years. The audit team noted that at least some of these applications, where the active substances are approved in the EU, would be more correctly accommodated, at least over time, within the conventional authorisation framework maintaining the system's integrity as referred to in `Commission Staff Working Document on emergency situations according to Article 53 of Regulation (EC) No 1107/2009'. Penoxulam (a herbicide) is the approved active substance with the most repeated PPP emergency authorisations (8 years in a row). The authorisations have included use in sorghum and rice. NÉBIH noted that an extension to minor use in sorghum was made. There are furthermore alternative authorised PPPs available for rice. There may therefore no longer be a need for emergency authorisations for PPPs with that active substance in those crops.

The audit team also noted that for 7 years in a row, an emergency authorisation was given for a PPP containing the active substance kasugamycin (an antibiotic) for use in pome fruit against fire blight (Erwinia amylovora) and in vegetable crops for various other bacterial diseases in outdoor and indoor production. NÉBIH stated that a risk assessment for antimicrobial resistance had been carried out. Nevertheless, the audit team had concerns about these authorisations from a one-health policy point of view. The EU withdrew the approval of this active substance in 2005, and according to the EU database, no other Member State has authorised its use in the last 10 years. Conclusions on authorisation of PPPs 8

Emergency authorisations are overall granted in line with documented procedures. However, they are often granted for wide groups of crops and pests and for longer periods than 120 days, which is not in line with Article 53 of Regulation No (EC) 1107/2009.

The emergency authorisations often also involve approved active substances. The dangers which these authorisations are addressing could therefore, at least over time, be contained by obtaining PPP authorisations as per Articles 33, 40, or 51 of Regulation (EC) No 1107/2009. Using emergency authorisations repeatedly instead, waters down the integrity of the authorisation system.

Most emergency authorisations are not communicated immediately to the Commission and other Member States, and many are notified incorrectly or incompletely. In view of the risk of creating antimicrobial resistance, the audit team had some concerns about the repeated authorisations of kasugamycin.

The recommendation states as its basis

For planning the controls, the results of the programmes for the monitoring of water status are not taken into account, which is not in line with Article 24(2)(a) of Regulation (EU) 2017/625. But the results of the pesticide monitoring programme, which is implemented by NÉBIH itself, is taken into account in the way that non-compliances found regarding maximum residue levels or unauthorised PPPs are followed up by inspections. E.g., an exceedance of the pesticide maximum residue level was identified in the monitoring programme at the vegetable grower visited by the audit team (see paragraph 80 below). This had been followed up in a previous inspection.

The recommendation states as its basis

Laboratory's PPP formulation analysis focuses on the active substances and on the physical properties. Its scope does not extend to unacceptable co-formulants or regulated impurities. This is not in line with Article 24(1) of Regulation (EU) 2017/625. Conclusions on laboratories used for formulation analysis of PPPs

The laboratory testing does not include analysis for unacceptable co-formulants and regulated impurities, which reduces the value of the sampling programme.

The recommendation states as its basis

Although the inspections observed were overall effective and carried out competently, some flaws were noted by the audit team: · At the retailer, packets with a PPP containing acetamiprid had an outdated label. Next to them on the shelf was a pile of papers with the updated label text, so that for each 15 sale, the customer would be given a copy of the updated text together with the wrongly labelled PPP. This was considered acceptable in the inspection, even if the authorisation for the product stipulates that an additional, self-adhesive label must be placed on the package. · For PPPs destined for other Member States at the manufacturer and the packer, Customs controls do provide some guarantees that those PPPs leave Hungary and are not marketed there. However, there were no checks that those PPPs were authorised in the Member State of destination. This does not ensure full compliance with Article 28(2)(c) of Regulation (EC) No 1107/2009. Import controls

Customs identify consignments of PPPs from the tariff codes and refer them to the plant health inspectors, who then carry out documentary and physical checks. This is done for 100% of the PPP consignments. The checks include verification that the active substance is approved in the EU. PPP or active substance imports do not require prior notification from the importer or pre-approval from the CA. Nevertheless, the integrity of each import is checked by verifying the batch numbers with the authorisation holder. For that purpose, the border control post has a list of contacts that are available 24 hours a day. This procedure is also followed for PPPs destined for or in transit to other Member States. However, it is not verified that the PPP is authorised in the receiving Member State. This does not ensure full compliance with Article 28(1) and (2)(c) of Regulation (EC) No 1107/2009. Furthermore, notification is not made to the receiving Member State if a consignment, customs cleared in Hungary, is on the way, which limits the possibilities of that Member State to ensure that the mentioned Articles are complied with.

Official controls at production and marketing level are comprehensive and overall carried out well. However, for manufacturers and packers, it is not verified that PPPs destined for other Member States are authorised there.

Import controls of PPPs intended for use in Hungary and other Member States are in place and largely carried out satisfactorily. However, for imports destined for other Member States, it is not verified that the PPPs are authorised there.

The recommendation states as its basis

The audit team noted the following shortcomings regarding approval and registration: a. One FBO that also stored and traded, in small quantities, chilled dairy products and some other foodstuffs obtained in other establishments2; b. Another FBO had received consignments of raw milk from another milk processing establishment. The FBO was not able to explain if the consignment came directly from milk producing holdings, or from an intermediate storage of the other milk processing establishment. In the latter case the establishment sending the raw milk is required to have the activity of collection centre included in its approval, in line with Article 4 of Regulation (EC) No 853/2004 and Article 148 of the OCR. The CAs committed to investigate the situation and report the outcome to the audit team; c. Transport companies delivering foodstuffs (including raw milk) must be registered. The control checklists seen by the audit team did not have a specific section for verification of the means of transport, indicating that official controls do not cover transport means. In one case, the audit team could verify that the registration of the transport company in the specific register/database (FELIR) was not requested by the processing dairy when signing the contract with the transport company. The FELIR registration number of that company could not be retrieved for the audit team. Conclusions on registration and approval of food business establishments 2 In their reply to the draft report, the CCA stated that immediate measures were taken to cease the practice; dairy products produced in another establishment will no longer enter the establishment. 7

No documented evidence of official controls on means of transport used for the transport of raw milk was provided to the audit team, to ensure that they meet the relevant EU requirements.

Some dairy establishments had not been approved for all activities, requiring approval, that they were carrying out.

The recommendation states as its basis

The audit team noted the following shortcomings regarding approval and registration: a. One FBO that also stored and traded, in small quantities, chilled dairy products and some other foodstuffs obtained in other establishments2; b. Another FBO had received consignments of raw milk from another milk processing establishment. The FBO was not able to explain if the consignment came directly from milk producing holdings, or from an intermediate storage of the other milk processing establishment. In the latter case the establishment sending the raw milk is required to have the activity of collection centre included in its approval, in line with Article 4 of Regulation (EC) No 853/2004 and Article 148 of the OCR. The CAs committed to investigate the situation and report the outcome to the audit team; c. Transport companies delivering foodstuffs (including raw milk) must be registered. The control checklists seen by the audit team did not have a specific section for verification of the means of transport, indicating that official controls do not cover transport means. In one case, the audit team could verify that the registration of the transport company in the specific register/database (FELIR) was not requested by the processing dairy when signing the contract with the transport company. The FELIR registration number of that company could not be retrieved for the audit team. Conclusions on registration and approval of food business establishments 2 In their reply to the draft report, the CCA stated that immediate measures were taken to cease the practice; dairy products produced in another establishment will no longer enter the establishment. 7

No documented evidence of official controls on means of transport used for the transport of raw milk was provided to the audit team, to ensure that they meet the relevant EU requirements.

The recommendation states as its basis

Joint MA-Ministry of Social and Labour Affairs Decree No 16/2008 on the testing of raw milk regulates the requirements for laboratory testing and control procedures for the placing on the market of raw milk of all animal species. However, the audit team noted that the Decree allows milk collection centres (MCCs) to test raw bulk milk for raw milk quality criteria instead of testing milk samples received from single dairy holdings, as required by Chapter I.3 of Section IX of Annex III to Regulation (EC) No 853/2004.

National legislation and administrative measures covering the dairy sector have been enacted and are in line with relevant EU legislation, except for sampling and testing provisions in relation to the quality criteria of raw milk in collection centres. 3

In the MCC visited the FBO followed the requirements of Decree 16/2008 to test bulk milk in the MCC for PC/SCC and not milk of individual holdings. However, on the FBO's own initiative (and for the purpose of payment of raw milk based on quality) milk from individual holdings (delivering a quantity of raw milk ranging from 16 to 300 litres per day) was tested monthly for SCC (but not for PC).

The raw milk quality control system in place for SCC, PC and inhibitory substances is well established and enforced by the dairy industry and controlled adequately by the CAs, except for the sampling and testing of raw milk at MCC instead of at individual dairy holdings. This is not in line with the requirement of Chapter I.3 of Section IX, Annex III to Regulation (EC) No 853/2004.

The recommendation states as its basis

No specific training for the dairy sector has been provided in recent years as there have been no legislative changes in this sector. However, the findings regarding dairy inspectors' knowledge on HACCP-based procedures indicates there is a need for specific training on this topic (see paragraph 62).

Some weaknesses in relation to the technical knowledge of the CA staff were noted by the audit team during the official controls of the milk processing establishments, in particular 6 regarding the control over the FBOs' procedures in relation to pasteurisation of milk (see paragraphs 62, 65 and 66). Conclusions on competent authorities

The general training system in place, aimed at ensuring that official staff carry out their tasks adequately, does not include specific training on official controls in the dairy sector. No such training has been carried out in recent years. The official staff met was not fully knowledgeable in the technical matters pertaining to the dairy sector.

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

The insufficient competence/technical knowledge of official staff undermines the effectiveness of official controls.

The recommendation states as its basis

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

However, in one medium-sized establishment, the FBOs did not carry out sampling of five sampling units, as required by Article 5(1) of Regulation (EC) No 2073/2005. The 13 CGO officials responsible for the annual inspection stated that this deficiency had been noted and notified to the FBO. However, this was not in the inspection report and no evidence of any derogation granted to the FBO in this regard was presented to the audit team. 66. 66. Environmental samples taken by the FBOs to detect the possible presence of Listeria monocytogenes (L. monocytogenes) did not follow the European Union Reference Laboratory (EURL) Guidelines on sampling the food processing area and equipment for the detection of L. monocytogenes: working surfaces in contact with products had been sampled, but drains had not. This had not been detected by the CAs controls.

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

The official controls did not cover FBOs compliance with procedures, based on HACCP principles, with sufficient depth and did not identify all relevant shortcomings.

The recommendation states as its basis

No audits were carried out in 2022 and 2023 to assess the effectiveness of official controls in the dairy sector.

Supervision of DGO official staff performance is the responsibility of the CGOs. However, the audit team noted that there is no established procedure for such supervision: in some CGOs this is limited to the evaluation of the percentage of completion of the control plan (without investigating their effectiveness), whilst, in others, some either observe inspections or carry out follow-up inspections to evaluate the performance of DGO and/or CGO staff. The results of these supervisory exercises, however, were not recorded. Conclusions on system of supervision and internal audits

Internal audits are carried out as planned. However, the performance of official controls in the dairy sector has not been targeted in these audits and supervisory mechanisms to evaluate staff performance are not standardised and are seldom recorded.

The recommendation states as its basis

According to the data provided by the CCA, of the approximately 430 red meat approved slaughterhouses in the country, there are 18 establishments that apply the derogation of the timing of post-mortem inspection (PMI) and 96 where PMI is carried out under the responsibility of the official veterinarian (OV). During the preparation for the audit, the CCA identified that some of those establishments were not in compliance with EU legislation as their annual throughput was above the permitted threshold for these derogations. Some CAs took immediate action and, as consequence, some establishments have now reverted to PMI with the presence of an OV on-site fulltime. The CCA is considering next steps which might include the increase of the throughput threshold for low-capacity slaughterhouses and inform the Commission and Member States. Conclusions on legislation and implementing measures.

A number of establishments make use of the derogation of PMI under the responsibility of the OV that are above the legally permitted throughput threshold. 3

Member state response

The central competent authority will determine the extent of the y increase of the capacity threshold based on the Article 7 of gulation (EU) 2019/624, and this will be notified in accordance ith the relevant legislation. The central competent authority will o issue a guidance on the conditions and requirements for rogation. Deadline: 31.08.2024.

The recommendation states as its basis

Background The 2021­2022 HPAI epidemic season was the largest observed in Europe, with a total of 2,467 outbreaks in poultry, 47.7 million birds culled in the affected establishments, 187 outbreaks in captive birds, and 3,573 HPAI virus detections in wild birds to an unprecedented geographical extent reaching from Svalbard islands to South Portugal and Ukraine, affecting 37 European countries (EFSA overview, 2023). An unprecedented number of HPAI virus detections were reported in wild and domestic birds in Europe from June to September 2022. The persistence of the virus in wild birds indicated that it may have become endemic in the wild bird populations in Europe. Up to May 2023, the number of HPAI outbreaks in poultry during the season 2022-2023 has decreased in Europe in comparison with the previous year (2021-2022). Since November 2021 until beginning of the audit Hungary notified 73 outbreaks in wild birds and 464 outbreaks in poultry. In 2021, the authorities reported 98 outbreaks in domestic poultry (six in backyards and the rest in commercial establishments). In 2022 the number of reported outbreaks in poultry went up to 280, seven in backyard poultry and the rest in commercial establishments (vast majority in waterfowl). In 2023, the country reported additional 79 outbreaks in poultry (up to 28 July), again majority (67) in waterfowl (mainly foie-gras production) (for more see Table 1 in Annex 2). Geographically, the outbreaks in this period were mostly clustered in the South of Hungary. Furthermore, from November 2021 to February 2022, the authorities detected four outbreaks in captive birds and two additional ones in January/March 2023. 2 4. Main findings and conclusions Registration 1. The authorities register poultry establishments including their location and size in the national holding registration system (TIR). The system also provides information on the type of establishment, species kept, start and any cessation of its operation. 2. According to the national legislation all flocks with 2,000 broilers or more and those with 500 adult birds or more must be registered. In addition, the registration is required for all commercial establishments, notwithstanding the number of birds they keep. 3. The authorities exempted from the registration requirement non-commercial (backyard) poultry establishments as they consider them compliant with criteria laid down in Article 3 of Regulation 2022/1345. The authority also considers the risk of those establishments insignificant, since in their view those establishments have limited, respectively no direct or indirect contacts with other poultry, insignificant epidemiological role in recent HPAI epidemics, and they were relatively rarely infected (4 % of all outbreaks).

The authorities assert that backyard flocks are unlikely to contribute significantly to the spread of the virus. However, this assertion lacks strong support from epidemiological enquiries due to inherent limitations (as detailed in finding 65) and an incomplete epidemiological analysis (see also finding 56). The authorities had not consistently performed census within protection or surveillance zones around the outbreaks, and they could not demonstrate that those establishments were included in the screening activities, except for one instance in May 2023. Furthermore, five out of twelve infected non- registered establishments kept more than 100 birds (up to 235), prompting doubts about whether they played a similar epidemiological role as much smaller ones. These factors had not been considered in any formalised risk assessments. The absence of sufficient evidence supporting the insignificance of the risk of non-commercial establishments in HPAI epidemics is not in line with Article 85 of Regulation (EU) 2016/429.

The TIR system does not contain information on the number of birds at each location. County authorities stated that many small-scale establishments registered in TIR had been inactive due to underreporting of a cessation of their activities. This is not in line with the provisions laid down in Articles 84, 93(a) and 101(1)(a) of Regulation (EU) 2016/429, and in Article 18 of Delegated Regulation (EU) 2019/2035.

The local authorities organise their activities mainly based on the information provided by bird keepers prior each repopulation/re-stocking of establishments and the information provided by private veterinarians. However, these arrangements resulted in unnecessary delays of some official actions e.g., more than one week delay in a census of establishments located in the surveillance zone.

The shortcomings above had an impact on the application of control measures laid down in Regulation (EU) 2016/429 (Article 65) and Delegated Regulation (EU) 2020/687 3 (Chapters I and II of Part II) requiring the availability of accurate and updated inventories of poultry establishments in the event of suspicion and confirmation of HPAI to establish restricted zones, apply and regularly adapt those measures, and grant derogations therefrom.

Weaknesses in the registration of poultry establishments and the insufficient reliability of data prevent the authorities from having a properly updated information on the poultry establishments. The oversight of non-registered establishments raises concerns about the potential underreporting of suspicions in those flocks and their real role in the recent HPAI epidemics. This hinders the capacity of the competent authority to ensure the efficient application of the disease prevention, surveillance and control measures.

Member state response

the All flocks that pose a significant risk of avian influenza are registered in our system. Only backyard flocks kept for own onsumption are not registered. Although these flocks are at risk of disease emergence, as there is minimal or no animal, person and vehicle movement in these flocks, they do not play a role in disease spread. In recent years, around 5% of outbreaks have been detected in backyard flocks. In the recent epidemic started in autumn 2023, we have seen that in the settlements where the virus has appeared in backyard flocks, it has not appeared in commercial flocks. In addition, in those settlements where it appeared in both commercial and backyard flocks, in all cases it appeared in backyard flocks after the outbreak in commercial flocks; but in no case the appearance in backyard flocks resulted in a commercial outbreak. It is also clear that HPAI has not spread from a backyard outbreak to other flocks. Only one backyard flock was affected in each affected municipality. In no case was it confirmed that the disease had spread from the backyard flock. Therefore, it is still our opinion that the backyard flocks do not play a role in the spread of the disease and can

The recommendation states as its basis

A model to estimate the risk of virus introduction in different areas of the country was completed by 31 March 2023. However, at the time of the audit, the experts that developed this model have not obtained yet complete population data for wild birds, nor the location of resting sites and migration1. Therefore, they were predicting new cases using a model that takes into account only the poultry population data, data on type of land/coverage, meteorological data and the previous outbreaks of poultry and wild birds. In addition, the authority and experts have plans to work on risk assessment for spreading of the infection between establishments, but the work has not started yet. The data that has not been incorporated into the risk assessment and the assessment that is still pending for the spread of the infection weakens the authority's endeavour to thoroughly effort to adequately identify all high risk-areas in the country.

The authorities named the main challenges they faced during recent epizootics: areas with high density of birds and poultry establishments, multiple birds movements (in particular waterfowl), airborne transmission of the virus, and inadequate biosecurity measures in establishments (e.g., inadequate disinfection of people and vehicles visiting establishments, sharing of staff and mechanisms). They have been trying to address some of those issues, (e.g., role of bird's catchers or vehicles from rendering plants, feed mills) 6 in spreading the disease by strengthening the measures applied to them. They also plan to introduce a wider monitoring of daily biosecurity operation on establishments by using live video feed, in particular during epidemics.

The fact that operators of many infected establishments did not comply with biosecurity rules is not in line with requirements laid down in Articles 10(1)(a)(iii), (b) and (c), (4)(b) and 11(1)(b) of Regulation (EU) 2016/429, on their responsibilities regarding disease prevention and knowledge and application of biosecurity measures. Completeness and updates of the Contingency plan

Risk assessment and identification of high-risk areas has allowed the competent authority to implement additional prevention, surveillance and control measures but this have not been sufficient to prevent the recurrence of epidemics waves. The inability of the authorities to reduce poultry density in areas proved problematic for epidemics will continue to challenge the veterinary service's capacity to deal timely with outbreaks.

The non-compliances on biosecurity, in particular in daily operational practices, contribute to an increased risk of the virus being introduced to poultry farms and would make it challenging to contain and control the spread of HPAI. The new compensation scheme for losses due to infection and wider engagement of poultry industry in biosecurity on commercial poultry establishments should contribute to improve compliance with biosecurity requirements.

Epidemiological investigations were generally done at the time of sampling or one or two days after. In the majority of instances, the local authority performed both the initial and final investigation. They used standardised form. In the initial inquiry they collected information on movements on and off suspected establishments during the incubation period (birds, vehicles, and personnel). However, in some cases, the official veterinarians did not include in the investigation report the likely origin of the infection or the full list of all contacts or had not followed these epidemiological links adequately due to lack of resources (e.g., links related to feed truck routes or establishments visited by the same team of birds catchers in incubation period). This is not in line with Articles 55(1)(g), 57 and 62 Regulation (EU) 2016/429 and Article 8(3) and (4), of Delegated Regulation (EU) 2020/687. In their analysis the authority confirmed that such contacts contributed to spread of infection in the previous two epidemics (see also tables 3 and 4 in Annex II).

Member state response

Our central regulations on biosecurity and the requirements beyond legislation are professionally sound, so we do not see the need for major changes as they are still adequate. Some of ill our measures are transitional and some are specific to a articular area or time period. These are imposed, extended, atory modified or withdrawn according to the epidemiological situation. Our aim is not to formulate new disease control ion standards or principles, but to continuously review, refine and update our existing measures and encourage farmers to comply with these. . We will achieve this by: - Further tightening the compensation regulation to force farmers to comply with disease control rules. The technical discussions on the amendment of the legislation have been completed and are currently being negotiated between the ministries. - The central authority wants to reinforce the support and supervision it already provides to and over the regional authorities. In this context, it has concluded and is concluding contracts with specialised veterinarians with extensive epidemiological experience, who will carry out their duties both during epidemics and peacetime. They will be responsible fo

The recommendation states as its basis

The simulation drills held aimed only at certain aspects of dealing with outbreaks and did not cover other essential components of emergency response (e.g., collection of 7 epidemiological data during epidemics, including enquiries, census and visits to establishments in the restricted areas). The authority had not verified the local authorities' preparedness for these tasks, or the ability to launch a rapid response. They missed an opportunity to share the experience gained in these areas during the previous period2. This is not in line with Article 44 of Regulation (EU) 2016/429.

The fact that veterinarians are frequently dealing with HPAI epizootics might justify the lack of exercises but does not excuse the authorities of incorporating lessons learnt and measures to correct deficiencies which have been already identified during the previous two Commission audits. Currently, the authorities face the risk of continuing making the same mistakes in future epidemics unless they introduce the appropriate changes in their contingency plan, and unless they appropriate train the staff to follow the contingency plan. Early detection

The training and simulation exercises enhanced the knowledge of local authorities. But their limited scope prevented authorities to address some weaknesses identified in the recent HPAI epidemics.

Member state response

f The central authority reviewed the contingency plans of all counties. Please find enclosed a table with the results of the review. We will ensure that the contingency plans are properly implemented by the following: - audits of government offices organised by the central authority: in 2024, target audits in the counties of Bács- Kiskun and Csongrád-Csanád, and comprehensive audits in the counties of Gyr-Moson-Sopron and Hajdú-Bihar, - quarterly NDCC-LDCC meetings, - meetings held by the national Chief Veterinary Officer for the chief veterinary officers of the counties, - presentations on avian influenza at professional conferences, - avian influenza simulation exercise, - one of the tasks of our experts is to review the effectiveness and feasibility of our existing measures and propose possible modifications.

The recommendation states as its basis

In 2021 and 2022 not all counties reached their targets for sampling of wild birds. A lower number of samples were noted also in two heavily affected counties in the South (which took less than 40% of their targets).

Since 2021 the authorities detected 73 outbreaks of HPAI in wild birds. However, 20 outbreaks were laboratory confirmed with more than one-week delay: in five instances with more than two weeks delay. At the time when the first few index outbreaks were detected in poultry, for which the authorities determined that introduction of the HPAI virus by wildlife was the most likely cause, the circulation of that HPAI virus had not yet been detected in wild birds in the affected areas. This undermines the effectiveness of the surveillance in wild birds and its role as early warning system and demonstrates inadequacy of the number and location of samples taken. That sub-optimal effectiveness of the early warning system in wild birds is not in line with provisions laid down in 2 In their response to the draft report the competent authority noted that although the gained experiences were not shared during the simulation exercises, the authority did this on other professional fora, like NDCC-LDCC and other meetings. 3 In their response to the draft report the competent authority noted that from 2020 an organization called "BirdLife Hungary" (the leading non-profit, apolitical, and charitable, nature conservation organisation in Hungary) and Hungarian National Parks are involved in the passive and ­ in the case of the former ­ also active surveillance of wild birds. This means that oropharyngeal/tracheal or cloacal swab samples are collected from live wild birds during bird-ringing. 8 Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429 and Articles 3(1)(a) and (b)(i), 4(1)(b)(i) and 10(2) of, and Annex II to Delegated Regulation (EU) 2020/689.

Although there is no evidence that the significant delays in confirming the infection in wild birds had a negative effect on the early detection of poultry outbreaks, these delays undermine the investigation of transmission pathways in poultry during the epidemics. 10

Member state response

The number of wild birds tested under passive and active rning surveillance is increasing year by year. While in 2020, 964 ry. wild birds were surveyed, in 2021 the number was 3245, in 2022 3682 and in 2023 5690. We have continued to confirm positive wild bird outbreaks during the peacetime of last year. Between May and August 2023, we detected the HPAI subtype H5N1 in 150 wild birds. We also found the virus in wild birds in October 2023, before it appeared on poultry farms, and ordered the mandatory confinement of poultry in high-risk areas. Page: 4 4 port ref. DG(SANTE) 2023-7752 of the audit carried out from 13 to 28 l of highly pathogenic avian influenza Action Proposed by the competent authority and deadline by which it will be completed In the case of mass wild bird mortality, as was the case among cranes in our country during autumn of 2023, it is easier to find carcasses and positive cases than to find a single dead wild bird. In the case of individual wild bird mortalities, carcasses disappear quickly in the wild due to predation, which can cause sampling difficulties. The BirdLife Hungary and the national parks will continue to be actively involved in wild bird sampling.

The recommendation states as its basis

Since 2021 the authorities detected 73 outbreaks of HPAI in wild birds. However, 20 outbreaks were laboratory confirmed with more than one-week delay: in five instances with more than two weeks delay. At the time when the first few index outbreaks were detected in poultry, for which the authorities determined that introduction of the HPAI virus by wildlife was the most likely cause, the circulation of that HPAI virus had not yet been detected in wild birds in the affected areas. This undermines the effectiveness of the surveillance in wild birds and its role as early warning system and demonstrates inadequacy of the number and location of samples taken. That sub-optimal effectiveness of the early warning system in wild birds is not in line with provisions laid down in 2 In their response to the draft report the competent authority noted that although the gained experiences were not shared during the simulation exercises, the authority did this on other professional fora, like NDCC-LDCC and other meetings. 3 In their response to the draft report the competent authority noted that from 2020 an organization called "BirdLife Hungary" (the leading non-profit, apolitical, and charitable, nature conservation organisation in Hungary) and Hungarian National Parks are involved in the passive and ­ in the case of the former ­ also active surveillance of wild birds. This means that oropharyngeal/tracheal or cloacal swab samples are collected from live wild birds during bird-ringing. 8 Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429 and Articles 3(1)(a) and (b)(i), 4(1)(b)(i) and 10(2) of, and Annex II to Delegated Regulation (EU) 2020/689.

In two establishments visited in high-risk counties, the audit team noted unnecessary delays in sampling (up to three days) for the laboratory confirmation of the disease. In one case, the private veterinarian decided to sample only for bacterial infection where symptoms compatible with HPAI were present. He only notified the suspicion for HPAI to the local authority once he got negative results for bacterial infection from the private laboratory. In the second case, the local authority had a positive laboratory result to a test made before authorising a movement. However, they decide to doubt the result since at that time, the birds did not show clinical signs; thus, they repeated sampling. This is not in line with Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429 to ensure the timely detection of HPAI. Laboratory capacity- Diagnostics used for general early detection.

The laboratories are responsible for the transport of samples from the field to the laboratory in less than 24 hours. The audit team noted in the counties visited, that sometimes this deadline was not met and resulted in delays (for more see finding 64).

Although there is no evidence that the significant delays in confirming the infection in wild birds had a negative effect on the early detection of poultry outbreaks, these delays undermine the investigation of transmission pathways in poultry during the epidemics. 10

Unnecessary delays in the confirmation of outbreaks in domestic poultry through laboratory results resulted in delays in establishing control measures. This likely increased the risk of further spread of the disease and resulted in a higher number of infected establishments.

Since 2021, there were delays in providing laboratory results. On average, the turnaround time from suspicion to laboratory confirmation was two days. Out of 470 outbreaks detected since 2021, the official laboratories confirmed 173 outbreaks within one day. 193outbreaks (41%) were confirmed two days after suspicion and the laboratories needed three to seven days to confirm 104 outbreaks (22%). Delays in laboratory confirmation were noted also during the previous Commission audit and despite the commitments of 12 the authority to address them they failed to do it. In 26 outbreaks the authorities waited for laboratory confirmation before proceeding with culling. For the rest, the authorities started immediately with arrangements for the necessary control and eradication measures (e.g., depopulation and disposal); thus, they minimized a negative effect of these delays. In some other instances, those delays relate to preventive killing when the laboratory results were available only after depopulation.

Delays in confirmation of the disease, incomplete epidemiological enquiries, poor follow up of contacts with outbreaks, and inadequate screening and surveillance activities in restricted zones increased the risk of further uncontrolled spread of the infection. The authority partially mitigated these with the additional actions they applied, such as the extension of surveillance zones around the outbreaks and the strict actions applied on contact establishments.

Member state response

n Meetings for the NDCC and LDCCs are held quarterly, where it is highlighted that the local authorities shall organise meetings with the participation of private veterinarians. All 29. LDCCs shall report on the measures, meetings and trainings carried out since the latest meeting. The Hungarian Veterinary Chamber is always informed about the important epidemiological events. The private veterinarians are all members of the Chamber, which notifies them, so that they are aware if HPAI occurs on their service area. Moreover, we are working on a procedure that will achieve the direct notification of the private veterinarians by the NFCSO. We continue the training of animal keepers in 2024, together with the sector. Information documents on avian influenza are available on the thematic website. Avian influenza diagnostics has been introduced at the premises in Debrecen of the NFCSO VDD in order to increase the laboratory capacity and to provide examination closer to Page: 5 4 port ref. DG(SANTE) 2023-7752 of the audit carried out from 13 to 28 l of highly pathogenic avian influenza Action Proposed by the competent authority and deadline by which it will be completed the site of samplin

The recommendation states as its basis

Epidemiological investigations were generally done at the time of sampling or one or two days after. In the majority of instances, the local authority performed both the initial and final investigation. They used standardised form. In the initial inquiry they collected information on movements on and off suspected establishments during the incubation period (birds, vehicles, and personnel). However, in some cases, the official veterinarians did not include in the investigation report the likely origin of the infection or the full list of all contacts or had not followed these epidemiological links adequately due to lack of resources (e.g., links related to feed truck routes or establishments visited by the same team of birds catchers in incubation period). This is not in line with Articles 55(1)(g), 57 and 62 Regulation (EU) 2016/429 and Article 8(3) and (4), of Delegated Regulation (EU) 2020/687. In their analysis the authority confirmed that such contacts contributed to spread of infection in the previous two epidemics (see also tables 3 and 4 in Annex II).

Delays in confirmation of the disease, incomplete epidemiological enquiries, poor follow up of contacts with outbreaks, and inadequate screening and surveillance activities in restricted zones increased the risk of further uncontrolled spread of the infection. The authority partially mitigated these with the additional actions they applied, such as the extension of surveillance zones around the outbreaks and the strict actions applied on contact establishments.

Member state response

central authority supported the work of the local authority he by seconding experts from the centre and from other counties. Their main role was to carry out epidemiological investigation, and to reveal epidemiological contacts. We plan to use these kind of secondment in case of future epidemics as well. This is supported by the work of highly experienced epidemiological experts contracted by the central authority as described in points above. Their task is detailed in point 2. Besides the data collected by them and the analysis of those, our improved risk analysis system is the basis of our measures to be taken and the review of the existing ones.

The recommendation states as its basis

The authorities assert that backyard flocks are unlikely to contribute significantly to the spread of the virus. However, this assertion lacks strong support from epidemiological enquiries due to inherent limitations (as detailed in finding 65) and an incomplete epidemiological analysis (see also finding 56). The authorities had not consistently performed census within protection or surveillance zones around the outbreaks, and they could not demonstrate that those establishments were included in the screening activities, except for one instance in May 2023. Furthermore, five out of twelve infected non- registered establishments kept more than 100 birds (up to 235), prompting doubts about whether they played a similar epidemiological role as much smaller ones. These factors had not been considered in any formalised risk assessments. The absence of sufficient evidence supporting the insignificance of the risk of non-commercial establishments in HPAI epidemics is not in line with Article 85 of Regulation (EU) 2016/429.

During the epidemics, the central authority collected daily reports from the LDCCs which included updated information on outbreaks, e.g., epidemiological enquiries, depopulation, disposal of carcasses, compensation. Although the Department of Animal Health within the NFCSO includes trained epidemiologists, the epidemiological data available, e.g., incomplete epidemiological enquiries, had not allowed comprehensive analyses of the epidemiological situation, and thus, the NDCC could not appropriately use it to take informed and effective decisions. This is not in line with Article 43(2)(a), (c)(iii)(iv)(vi) and (d) of Regulation (EU) 2016/429.

The experts from the NDCC visited the infected areas. During their on-site visits, they analysed the epidemiological situation and advised additional measures and modulation of actions, which were implemented. In doing so, they addressed, to some extent, the lack of sufficient crisis management tools that would enable them to conduct timely and more effective analyses. This deficiency in adequate tools had been previously identified in a Commission audit, but the authority has failed to address it.

At central level, the authority works on improvement of their mapping tool to make it fitter for epidemiological analysis and on finalising an IT tool (EPIDEMIR) that should serve for collecting epidemiological data from affected counties.

The county authorities pointed out that a mapping tool would help them to draw epidemiological maps during epidemics, to better understand the dynamics of the epidemic and to quickly collect and analyse the information available (e.g., on all 4 In their response to the draft report the competent authority noted that the introduced methods are now accredited and have the certificate of compliance for proficiency test organised by the NRL. 11 registered poultry establishments located in restricted zones). Currently, they use a commercial product which is not customised for that purpose.

The local authorities were short of human resources, in particular during the peak of epidemics, for all task they needed to carry out. They prioritised some tasks, such as stamping out of outbreaks and granting movement derogations to reduce poultry density in the areas affected. They strengthened the LDCC in the most affected counties with additional staff coming from not affected areas. Due to their limited experience working with poultry and infections like HPAI, the seconded officials often conducted only certain tasks. The authorities did not carry out timely all activities they should have, and they did not implement quickly all the control measures necessary to contain the disease rapidly (e.g., depopulation of affected establishments and pre-emptive killing, official visits to poultry establishments in the restricted zones, completion of epidemiological enquiries). That was not in line with requirements laid down in Articles 13(1)(a) and 43(2)(c)(iv) of Regulation (EU) 2016/429. The previous Commission audit detected similar deficiency for which the authority provided commitments to address it. However, their failed to implement them fully, which prevent those measures to work as expected in preventing recurrence of the disease.

The avian influenza expert group set up by the Chief Veterinary Officer held a full formal expert meeting in January 2019. Since then, there were regular meetings with some members of the expert group. The national avian influenza expert group was not adequately involved during the epidemics to support the competent authority in assessing all relevant measures for the control or eradication of the disease. This is not in line with Articles 43 of Regulation (EU) 2016/429 and 66 of the Commission Delegated Regulation (EU) 2020/687. Dealing with suspect and confirmation cases. Restricted areas

The authorities did not identify and collect information of all non-commercial (backyard) poultry establishments within the restriction zones. This is not in line with Article 65(1)(a) 13 and (b) of Regulation (EU) 2016/429 and Articles 26 and 41 of the Commission Delegated Regulation (EU) 2020/687. The authorities confirmed that not all commercial establishments located in protection zone were inspected by official veterinarians. Instead of clinical inspections, they relied on passive surveillance and visited only those establishments that requested derogation for bird movements.

In the recent epidemics the authorities granted a total of 3,234 derogations for bird movements within and from restricted zones. The great majority (2,732) were direct movements from farms to slaughter. The remaining movements were granted for day-old chicks from hatcheries, in vast majority outside the restricted zone, and some movements of ready-to-lay poultry from or within restricted zones. The authorities did not grant any permission for introduction of birds from free area into restricted zones; instead, they accelerated the reduction of the population density in the restricted area.

The animal movements were carried out in line with most of the requirements, including clinical inspections, prior-movement testing for presence of HPAI virus, in sealed vehicles, on best available routes to avoid cross contamination, and they were all under official supervision. However, before granting a derogation from the measures applicable in a restricted zone, the authority did not take into account the local epidemiological situation, results of visits and their risk assessment was not sufficiently informative to ensure that the derogations would not endanger disease control. The competent authorities had mitigated this risk with compulsory prior-movement testing in which they detected additional 50 outbreaks. But the risk had not been negligible since some outbreaks were detected on establishments initially tested negative in prior-movement sampling but with HPAI virus detected in following days, i.e., some birds moved out been likely already infected. This is not in line with Article 28(1)(5)(c) and 43(1)(5)(c) of the Commission Delegated Regulation (EU) 2020/687. The authority only partially addressed the recommendation from the previous audit despite commitments and actions they provided to the Commission. Depopulation

Since the previous audit, the local authorities started to document their plans for killing birds during outbreaks, but those documents have been limited to essential information, e.g., number of birds to be killed, days for killing, order to transport company to provide vehicles for transport of carcasses and order to process carcasses in the rendering plant. The plans did not include certain details, e.g., staff available for activities related to killing, practical arrangements to ensure efficiency during killing, and further measures/actions to mitigate a risk of spreading of infection and prevent any unnecessary suffering of animals.

In one high-risk county, the authorities confirmed that no plans been prepared. Instead, the authorities relied on their experience from previous epidemics and their knowledge of the requirements. But as demonstrated on some outbreaks, the lack of detailed plan for killing resulted in unnecessary delays. The authority failed to satisfactory address identical deficiencies from the previous Commission audit despite the commitments provided. 14

The routine method of killing for large-scale establishments was sublimed dry ice. The authorities did not monitor the main parameters, i.e., temperature and carbon dioxide concentrations. The application of the method did not prevent directs contact of the animals with dry ice, which resulted in frostbites of unprotected bird's parts. Furthermore, the veterinarian met during the audit stated that in some instance the animals were rather dying from suffocation that due to CO2 effect. This is not in compliance with paragraphs 1 and 2 of Article 18 of Regulation (EC) No 1099/2009.

During recent epidemics, 41% of the outbreaks detected were depopulated three or more days after suspicion was reported; 22% at four or more days, 11% at five or more days and 5% more than 6 days up to two weeks. This delays, mainly due to lack of resources (personnel) occurred during the peak of epizootics, in particular around the holidays (Eastern, Christmas and New Year). This is not in line with Article 61(1)(b) of Regulation (EU) 2016/429 and Articles 12(1)(a) and 22(2) of Delegated Regulation (EU) 2020/687. Despite the commitments given to the Commission the authority had not satisfactory addressed the similar recommendation from the previous audit. Disposal and Cleaning and disinfection

The shortage of adequately trained staff, the lack of crisis management tools and the unreliability of data in existing databases undermine the effectiveness and efficiency of the actions taken to prevent and control the spread of HPAI, causing delays and requiring additional resources that could be otherwise assigned to other tasks.

The authority had not used the avian influenza expert group. This prevented the authority of getting expert advice, missing opportunities for improving their response strategy, improve their post-epidemic analysis and strengthen the prevention measures against HPAI recurrence.

Delays in confirmation of the disease, incomplete epidemiological enquiries, poor follow up of contacts with outbreaks, and inadequate screening and surveillance activities in restricted zones increased the risk of further uncontrolled spread of the infection. The authority partially mitigated these with the additional actions they applied, such as the extension of surveillance zones around the outbreaks and the strict actions applied on contact establishments.

The derogations granted for moving birds out of the restricted zones reduced the density of the poultry population and help to accelerate the eradication of the disease from those areas. However, the authorities did not adequately analyse the risk arising from these movements. The compulsory testing before animals were moved showed that some animals which were going to be moved were infected. Some although negative in testing originated from establishments with animals already in incubation period of the disease. 16 Thus, the movements might have contributed to spread the disease and make its control more challenging.

The authorities continued using dry ice as the main killing method during HPAI epidemics. The authorities did not address the deficiencies noted in the previous audit and the absence of appropriate procedures means that they do not safeguard the welfare of the animals and they inflict unnecessary suffering to them during killing.

The authority satisfactory addressed a shortage of disposal capacity noted in the previous audit, which helped to decrease the risk of spreading the disease after depopulation of establishments. However, the persistent delays in depopulating establishments resulted in an extended period keeping live infected animals, potentially shedding the virus. This situation facilitated the spread of the infection and led to some secondary outbreaks. The risk was only partially mitigated through preventive killing, as its application was also delayed due to resource constrains.

Member state response

In general, in order to improve the availability of human resources, the CA has proposed a legislative package isk which is currently under consultation within the government. This legislative proposal would provide for the delegation of various official control tasks in accordance with the OCR (2017/625). Within this framework the system of approved veterinarians would be renewed and expanded. Page: 6 4 port ref. DG(SANTE) 2023-7752 of the audit carried out from 13 to 28 l of highly pathogenic avian influenza Action Proposed by the competent authority and deadline by which it will be completed At the meeting between the NDCC and LDCCs, and also in writing, counties were reminded that every county needs to 65(1)(a) have an action plan with deadlines about the implementation of measures prescribed in legislation, i.e. census during epidemics. The census of registered commercial holdings is ensured. Counties will have to implement the census of backyard flocks kept for the keeper's own consumption, but , they will have to deliver this task based on their own resources. The NDCC will pay particular attention to the implementation through its report system. In case of non- delivery, th

The recommendation states as its basis

In May 2023, the authorities implemented targeted surveillance before lifting the restriction zones. This surveillance included sampling of some commercial and non- 15 commercial establishments. However, lack of adequate surveillance prior lifting of the measures in other instances (see findings 4 and 69) is not in line with articles 39 and 55 of Regulation 2020/687 and the conditions set up in the Annex X and XI, of the same Regulation.

On some occasions, the authorities lifted the restrictions before the final cleaning and disinfection was carried out in the restricted establishments. Nevertheless, the final cleaning and disinfection was carried out in all cases before the authorities allowed the repopulation of such establishments.

Delays in confirmation of the disease, incomplete epidemiological enquiries, poor follow up of contacts with outbreaks, and inadequate screening and surveillance activities in restricted zones increased the risk of further uncontrolled spread of the infection. The authority partially mitigated these with the additional actions they applied, such as the extension of surveillance zones around the outbreaks and the strict actions applied on contact establishments.

Member state response

In the surveillance zone, derogations are only authorised after a visit by official veterinarians. As holdings cannot be stocked in the restricted area while disease control measures are in vide place, only an insignificant number of non-empty holdings n remain in the surveillance zone. Before lifting measures, a census is performed on holdings that have not been visited by official veterinarians, and if justified, inspection and possibly sampling is ordered.

The recommendation states as its basis

The Central and regional authorities do not carry out internal audits or have audits carried out on their animal health control systems. They rely on contacts with local authorities and daily reports provided. The Commission audit identifies several persistent deficiencies and weaknesses in the official control system and its application, not all the been detected and addressed by the authorities. This is not in line with Article 6 of said Regulation (EU) 2017/625.

Verification activities and analyses failed to identify some gaps and weaknesses in the system that play significant epidemiological role in recurrence and fast spread of the disease. In addition, the authority had not effectively addressed many persistent deficiencies detected in their verification activities or the Commission audits.

Member state response

The central competent authority will held a comprehensive nd audit in Gyr-Moson-Sopron and Hajdú-Bihar counties in ols 2024. An HPAI targeted audit will be held in Bács-Kiskun and Csongrád-Csanád counties. Audits conducted at government offices by the central competent authority has to be notified to the Ministry of Public Administration and Regional Development (former Prime Ministers Office) a year before. Only small changes can be introduced to this pre-notified audit plan. From 2024 on, every year, the National Disease Control Centre will plan an HPAI targeted inspection in two counties in addition to the two comprehensive inspections in the two counties designated by the Ministry of Public Administration and Regional Development. Page: 8 4 port ref. DG(SANTE) 2023-7752 of the audit carried out from 13 to 28 l of highly pathogenic avian influenza Action Proposed by the competent authority and deadline by which it will be completed As explained under previous points, in addition to the experts seconded from NFCSO, the main task of contracted epidemiological experts is to control the appropriate implementation, effectiveness and feasibility of measures. Their experience and data

The recommendation states as its basis

Initial validation data for screening of stilbenes and steroids were revised by the laboratory in response to the findings made in the 2020 audit report (see finding 32 of that report) to eliminate most of the obvious discrepancies. However, some data at the lowest calibration levels still showed that the performance characteristics (e.g., identical repeatability and reproducibility values for methylboldenone and 17- clostebol chlorandrostenedione) were not in line with legal requirements (8). These shortcomings in the method performance characteristics were neither spotted nor evaluated by the laboratory. In addition, the calculation of CC was not in line with legal provisions (9).

In the method validation file for confirmation of thyrostats, a number of recoveries were outside the acceptable range laid down in EU legislation (10). This was not noticed by the laboratory and thus no assessment of the possible influence of that phenomenon on the suitability of the method had been carried out. The linearity of the calibration curve for propylthiouracil was below the criteria set by the laboratory ­ however, this was not reflected and concluded on in the validation documentation. The laboratory representative informed the audit team that the revalidation of the method was planned for 2025.

In the validation documentation for the screening and confirmatory method for beta- agonists, there was inadequate assessment of several method performance characteristics (e.g., recoveries outside the established range (10), reproducibilities identical to repeatabilities (8)).

At the time of the audit, the screening and confirmatory method for chloramphenicol, thiamphenicol and florfenicol was under validation. Consequently, no properly validated method was available in the laboratory for monitoring residues of these analytes.

The validation of the screening method for antibacterial substances was stated to be finalised just prior to the audit. The available documentation included only data on specificity and results of measurements at one fortification level for each analyte/matrix combination. This level was assumed as the CC with no justification for that decision. This is not in line with legal requirements (11). Since the validation did not address all of the performance characteristics required for quantitative screening methods (12), the method could not be considered as properly validated.

The validation report for the coccidiostats confirmatory method dated from 2014 and contained implausibly identical values for repeatabilities and reproducibilities (8) and numerous recoveries outside the established range (10). These observations were not commented on in the validation documentation. Moreover, during the routine application of the method, the analyst met stated that "no CC were used due to erroneous values obtained during the validation". Thus, at the time of the audit, there (8) Part 2.3.2.2. of Annex I to Decision 2002/657/EC and part 1.2.2.2. of Annex I to Regulation (EU) 2021/808. (9) Part 3.1.2.6. of Annex I to Decision 2002/657/EC and part 2.7.(1) of Annex I to Regulation (EU) 2021/808. (10) Part 2.3.2.1. of Annex I to Decision 2002/657/EC and part 1.2.2.1. of Annex I to Regulation (EU) 2021/808. (11) Part 2.7.(2) of Annex I to Regulation (EU) 2021/808. (12) Part 2.1. of Annex I to Regulation (EU) 2021/808. 4 was no properly validated method in this laboratory for coccidiostats. The laboratory representative informed the audit team that a new validation was planned for 2022.

Validation data from 2014 for confirmation of sedatives were reassessed by the laboratory in response to the 2020 audit report. However, a number of recoveries were still outside the required range established in the EU (10). Again, these shortcomings were not noted in the most recent validation documentation (e.g., for chlorpromazine and propionilpromazine). Furthermore, the fortification levels used for azaperone and carazolol were lower than the relevant maximum residue limits (MRLs) established in EU (13) and thus no correct determination of CC was possible in these circumstances (14).

The validation data from 2016 for the screening and confirmatory method for NSAIDs were reassessed by the laboratory in response to the 2020 audit report. As a result, the laboratory found the method unsuitable for a number of analytes and a new validation was planned for May 2022. However, the unsuitable method was still in use for routine testing of residue monitoring samples.

For all of the methods scrutinised, the laboratory had no practice to analyse and evaluate data obtained during the method validation experiments and consequently no conclusions on any of these methods' fitness for their intended use were made.

During the validations, analyte stability and ruggedness had not been assessed at all though required (15) and this had already been brought to the attention of the laboratory staff during the 2020 audit (see finding 29 of the 2020 audit report). Only for the beta-agonists method had the laboratory presented data on analyte stability in matrix which had been compiled by the relevant European Union Reference Laboratory (EURL). However, the conditions cited by the EURL were not identical with those in the laboratory and thus the data cannot be used solely as evidence of adequate assessment of the analyte stability (16). During the routine use of the thyrostat method, there was no consideration of instability of the analytes during freezing/thawing cycles and during storage in a freezer (17) which may affect the analytical validity of such samples. The lack of information about analyte stability, in combination with lengthy turnaround times (e.g., up to four months for antimicrobials) can undermine the analytical validity of the results (i.e. truly non- compliant samples may not be detected).

Overall, the actions taken by the laboratory to rectify method validation deficiencies identified during the 2020 audit, were neither sufficiently effective nor comprehensive enough to satisfactorily address Recommendation 5 of the 2020 audit report. (18) 5.2.2. Quality control

The actions taken to rectify deficiencies identified during the 2020 audit concerning method validation and internal quality control at the FTNRL were insufficient to satisfactorily address the relevant recommendations. Whilst outsourcing of laboratory testing is planned, the absence of appropriate designation of those facilities potentially weakens the effectiveness of this measure.

Member state response

The methods of A1 and A3 substances is screening method use S, while the confirmation method is GC/MSMS. The value of CC is compliant according to Regulation 657/2002, and also Regulation 808/2021. The compliance of the relevant methods with EU requirements is ensured and is supported by a request for a position paper from the EURL (2022-7480_Action plan_Annex_I ). 8. We will validate this method before end of 2022. Page: 1 e 9. The laboratory has no screening method for beta-agonists, only a confirmation method. Validation of this method was done in line with 657/2002/EK in 2015. In this document, recoveries of tulobuterol are still not adequate in case of the said matrices. The method is planned to be revalidated by 2025 in line with Regulation 808/2021. If a sample is suspected to be positive for this compound, our Laboratory will send it to the appropriate foreign, accredited laboratory for confirmation in every case. g 10. The ELISA screening method for chloramphenicol is properly Page: 2 validated and is even verified for the upcoming RPA of 0,15 ppb. Furthermore, our proper confirmation method from 2009 for these three substances is still in use. For now, even the CC of 0,25

The recommendation states as its basis

The audit team scrutinised the internal quality control system in place and its implementation for the methods in the scope of the audit and observed the following: (13) Table 1 of the Annex to Regulation (EU) No 37/2010. (14) Part 3.1.2.5. of Annex I to Decision 2002/657/EC and part 2.6.(2) of Annex I to Regulation (EU) 2021/808. (15) Parts 3, 3.1.1.3. and 3.1.1.4. of Annex I to Decision 2002/657/EC, and parts 2.1, 2.4 and 2.5 of Annex I to Regulation (EU) 2021/808. (16) Part 3.1.1.4. of Annex I to Decision 2002/657/EC and part 2.5. of Annex I to Regulation (EU) 2021/808. (17) EURL Refection paper 2014: Natural growth promoting substances in biological samples, Chapter 2, paragraph 2.2. (18) In its response to the draft report, the competent authority provided a short list of completed and mostly ongoing actions in relation to Recommendation 5 of the 2020 audit report. 5 a. there was no practice to include a compliant control sample (blank matrix) in each batch of the analyses performed to collect data for the ongoing method performance verification. The laboratory representative explained that such samples would be included in analytical runs only in case of confirmatory analysis. This is not in line with legal requirements (19); b. there were a number of cases where the calculation of results had been made well outside the working range of the calibration curve without any justification given in the quality control documentation (e.g., calculation of nicarbazin levels). In addition, on numerous occasions, the results for one matrix were calculated on the basis of a calibration curve based on another, not equivalent matrix (e.g., calibration curves created on the basis of chicken muscle were routinely used to calculate results for pig kidney) despite the fact that such an approach was questioned during the 2020 audit (see finding 34 in the 2020 audit report); c. acceptability ranges for the calibration curve parameters were largely well described which is in line with legal requirements (20). However, the audit team noted three occasions where the coefficient of determination (R2) was below the set criterion without any documented action in the quality control documentation (e.g., 4-aminoantipyrine and N-formyl-4-aminoantipyrine in milk); d. quality control charts were seen for all of the methods scrutinised and were based on recovery of fortified samples. Control charts were updated with up to three months delay (due to a high workload as explained by the analysts met). There was no routine assessment of quality control results. The audit team saw a number of cases where the recovery levels were outside the acceptability range without any note/action in the quality control documentation (e.g., control charts for nicarbazin and N-methyl-4-aminoantipyrine). The audit team also saw an adequate quality control procedure which included relevant criteria of the control charts' assessment, however it was not implemented for the methods scrutinised during the audit. These findings indicate that the actions taken by the laboratory with regard to the internal quality control deficiencies identified during the 2020 audit were not in line with legal requirements and Recommendation 6 of the 2020 audit report has not been satisfactorily addressed. 5.2.3. Equipment, subcontracting and laboratory designation

The actions taken to rectify deficiencies identified during the 2020 audit concerning method validation and internal quality control at the FTNRL were insufficient to satisfactorily address the relevant recommendations. Whilst outsourcing of laboratory testing is planned, the absence of appropriate designation of those facilities potentially weakens the effectiveness of this measure.

Member state response

he internal quality its n the scope of the ude a compliant 18/a. Every sequence contains a reagent blank, blank matrix, rmed to collect data standard, calibrations and a fortified control point. This is boratory in line with Regulation ch 808/2021. lytical runs only th legal requirements used for 18/b. Part 2.8. of Annex I to on four Regulation (EU) 2021/808 Page: 8 not applies to validation, where 5- point calibration is used. culation During the screening analyses, we use 3-point calibration bration which is adequate, and for the confirmation methods we use 5 or more points. We consulted the EURL about this. us Regarding the calculation of results in different matrices: alibration We usually calculate the results of kidney samples s created based on a calibration curve of muscle samples, but we sults for include fortified control points both for kidney and muscle in g the each sequence. Since the recoveries of these fortified points are similar (±20%, based on Regulation 808/2021), we consider the analytes to behave in the same way in both matrices, so it is justified to calculate one with the calibration of the other one. n curve c. Non-compliant data will be investigated as des

The recommendation states as its basis

The system in place for the control of ASF in wild boar is effective. The constant reduction in wild boar density over the last three years should help the authorities to slow down the spread of the disease. The effective passive surveillance, the good testing and correct disposal of carcases helps preventing the spread of the disease from wild animals.

The authorities use unclear risk criteria to decide how many and which establishments the counties should target for their biosecurity inspections. Their control plan is poorly implemented and the authorities do not inspect the vast majority of small commercial establishments and non-commercial ones. Therefore, for these sectors, the authorities are not aware of level of compliance with basic 8 requirements, the degree of preparation to avoid the entry and spread of ASF and the awareness of operators regarding the disease. This is a major risk to prevent the disease entering such establishments and to detect the disease promptly if this happened.

The competent authority maintains that there are no "outdoor" pig establishments in Hungary as defined in the EU strategy for ASF, although they keep a list of "outdoor" pig establishments and there are establishments allowing pig access to outdoor pens. The absence of legal definition of "outdoor establishments" creates different interpretations between officials2. All this creates some uncertainty when evaluating the risk of introduction of ASF.

The contingency plans at county level are still incomplete, as they lack guidance for depopulation, information regarding availability of equipment and materials necessary for the effective control of the disease and provisions to dispose of the carcases safely and quickly. This compromises the readiness of Hungary to deal effectively with outbreaks in the event that ASF is confirmed in domestic pigs.

Member state response

ral authority has developed the parameters to comply a active pig holdings. These parameters include the ent of pigs to/from the holding in the last 3 years and . This way, inactive keepers, holdings that keep pigs temporarily or holdings where the pig keeping activity has to be ed for some reason (e.g. subsidies, where pig keeping has to be notified before the subsidy has been granted in order to were filtered out. From now on, the risk-based yearly establishment control plan will be based on these data. As a next step, the central authority will clean the database fromholdings that were inactive for more than 3 years (no pig movement). Deadline: 30. 11. 2022. The central authority already has a database containing the geographical coordinates of all pig keeping establishments. A map can be generated in the TÉRADATTÁRHÁZ (TT) database that was presented during the audit. THe training of the local authority and giving out access rights is already ongoing, and by 31. 12. 2022, all local animal health units will have access to this database. Attachments to point 1: 2 screenshots (TT coordinates.png; TT holding data.png)

The recommendation states as its basis

The competent authority is incorrectly certifying consignments of live pigs as compliant with the ASF Regulation, as they originate from establishments without approved biosecurity plans. Therefore, there is an unknown proportion of live pigs moving out of restricted zone II without complying with the requirements and their meat being placed on the intra-Union market. The risk of disease spread due to these shortcomings is partially mitigated by the systematic pre-movement testing.

Member state response

's ASF eradication plan prescribes the following during taking census on the infected and high risk areas s 2.3.3.1.1 és 3.3.1.1): "The information given shall include the obligation for keepers to notify the local competent veterinary authority of any change in the keeping of pigs (cessation, suspension, Page: 1 ref. DG(SANTE) 2022-7498 of the audit carried out from 25 January controls in relation to African swine fever ion Proposed by the competent authority tarting, change of location, etc.)." the second half of 2022, a national census will be carried where it has not yet been carried out this year yet. above information shall be provided to keepers during census in a documented form throughout the country, h the content set out in Article 84(2a-b) of Regulation 6/429, and shall be published in the form of a press ease. dline: 30 November 2022. ion: Point 3 of and Annex 4 to the circular letter of the ef Veterinary Officer No. ÉFHÁT/153/2022 (hereinafter erred to as the Circular).

The recommendation states as its basis

The absence of verification activities over county authorities and approved veterinarians jeopardises the continuous improvement of the official control system and favours the persistence of non-compliances.

The low number of suspected ASF cases reported from establishments (i.e. pigs with clinical symptoms compatible with ASF) put in question the effectiveness of the awareness campaigns or the willingness of key stakeholders to notify. This might jeopardise early detection of ASF in domestic pigs.

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

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

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

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

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

Member state response

ase see point 1. ual monitoring control plan based on risk assessment will based on the list described under point 1 from 2023 onwards. risk-based design will take into account the ommendations of the Bioinformatics Department of the versity of Veterinary Sciences, Budapest.

The recommendation states as its basis

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

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

Member state response

central authority will revise and update the national tingency plan in line with the recommendations (deadline: 7.2022). Based on the updated national contingency plan, we will order the revision of the county contingency plans, which be verified by the central authority by 01.08.2023. e: 2 ref. DG(SANTE) 2022-7498 of the audit carried out from 25 January controls in relation to African swine fever tion Proposed by the competent authority

The recommendation states as its basis

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

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

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

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

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

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

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

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

Member state response

tion: Issue of the Circular letter of the Chief Veterinary ficer (Circular) No. ÉFHÁT/153/2022 (15.06.2022) nex 2, point 1(i) of Circular No. ÉFHÁT/121/2021, in cordance with Annex II, point 2(i) of Commission plementing Regulation 2021/605 (hereinafter the gulation), details the requirements that must be included the profile-appropriate biosecurity plan of establishments cated in the infected area, that intends to dispatch oducts from the infected area and exporting live pigs om a high risk area. e biosecurity plan (re-issued with Annex 1 to the rcular) which complies with the above requirements st be approved by the District Chief Veterinarian by ans of an official Decision (point 1 of the Circular). ring official visits carried out in accordance with point I Circular No. ÉFHÁT/121/2021, in accordance with ticle 16(1) of the Regulation, it must be ascertained that e biosecurity plan has been implemented. In the event of n-compliance, the Decision on approval must be thdrawn and, until it is corrected and a new decision is sued, pigs and their products may be marketed only in ngary from the holding in question (point 2 of the rcular). adline: immediately, continuously e district o

The recommendation states as its basis

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

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

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

Member state response

see the answer for point 5.

The recommendation states as its basis

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

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

Member state response

tion: points 4-5 of the Circular he Central Authority reiterates its call to the attention of he county authorities to fully comply with the provisions f Circular 6200/1884-1/2019 (point 4 of the Circular) y 30 June 2022, the county veterinary authorities must end to the central authority (NDCC) the number (list) of pproved and service-providing veterinarians involved in SF control and the number of inspections carried out in ccordance with the above circular, the results of such nspections, the number of appointments withdrawn and he reasons for such withdrawals. he above report shall thereafter be sent to the Central uthority every six months. If the central authority finds a age: 5 ref. DG(SANTE) 2022-7498 of the audit carried out from 25 January controls in relation to African swine fever Action Proposed by the competent authority shortfall (min. 30%) in the number of reviews, it must request the territorial body to make up the shortfall within one month. From 2023, the central authority should propose a full audit of two counties per year for ASF in the audit plan of the Prime Minister's Office. In addition, the central authority should carry out target audits of two counties

The recommendation states as its basis

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

Member state response

22.07.06 Válasz terv: On 1 December 2016, the National African Swine Fever and Classical Swine Fever Expert Group issued guidance for service providers and official veterinarians on the suspicion of African Swine Fever (attached). This guidance, in a revised form, is Annex 4 to the National Contingency Plan. The annex must be sent by the central authority to the county authorities together with the contingency plan, but also in a separate document, with specific instructions that the annex must be distributed to all veterinarians and pig farmers. Deadline 31 August 2022. Thereafter, any lesion in accordance with the guidelines shall be considered as a suspicion of African swine fever and shall be treated accordingly. Page: 6

The recommendation states as its basis

In the regions visited, the audit team interviewed the county officials responsible for granting approvals, examined a number of approval files and documents presented by operators of ABP plants visited and noted numerous and repetitive inconsistencies related to the approval process. Thus, approvals had been granted without: a. proper assessment of the reliability of the operators' own checks, b. official controls on operators' validation (including on processing method 7), c. proper assessment of operators' HACCP-based procedures, and d. an on-site visit, to verify if the plant complied with all of the legal requirements, and in particular, those related to (i) the prevention of cross-contamination between ABP of different categories and (ii) the equipment required for the processing method notified for approval. The above findings are not in line with requirements of Articles 44 of Regulation (EC) No 1069/2009, and Section 2 of Annex XVI and Letter G in Chapter III of Annex IV to Regulation (EU) No 142/2011. The CGO and NFCSO representatives met explained that these inconsistencies in the approval process resulted from misinterpretation of the applicable approval requirements by the officials concerned.

Whilst the legal basis for the registration, approval and listing of ABP plants is in line with EU requirements, implementation of the approval process was deficient resulting in unwarranted approvals being granted by the NFCSO and operators who did not meet all of the legal requirements, commencing their operations, thus undermining confidence in the proper functioning of the ABP chain. 5.2.2 Planning of official controls

In audited regions, the audit team reassessed documents held by operators, observed the operators' on-site activities, compared these with records from the most recent official controls (including for the purpose of the approval/re-approval process), and noted that official controls either overlooked and/or misinterpreted a number of requirements. For example, there was a lack of proper: a. Verification of the information entered by operators in the documents accompanying the ABP consignments (commercial documents) which otherwise would have allowed the officials to identify that additional activities were taking place for which operators did not have the required approval/authorisation; b. Assessment of operators' HACCP-based procedures related to processing methods used, in particular, to the processing parameters and their critical limits; 10 c. Checks on the processing plants' validation demonstrating the effectiveness of processing method 7; d. Assessment of the reliability of the operators' own checks related to sampling, in particular, on microbiological standards (Salmonella, Enterobacteriaceae and E.coli) and on the content of glyceroltriheptanoate used for marking of DP of the Category 1 and 2 material; e. Official sampling (see finding 28c) and the performance checks related to glyceroltriheptanoate. 5.2.3.3 Actions taken in the event of non-compliance and follow-up

The recommendation states as its basis

The audit team analysed documents related to the planning of official controls and noted that in 2020 and 2021, the NFSCO did not use the above-stated algorithm for planning controls but rather adjusted its inspection programmes manually. Consequently, in these years the NFCSO selected operators, establishments and plants with the following four activities: 1) operators handling animal by-products inside the European Union and in third countries: (https://ec.europa.eu/food/system/files/2021-09/animal-products_approved-establishments_abp_tech- specs.pdf) 7 transport of ABP, 2) collection of ABP, 3) processing of ABP, and 4) using ABP for special feeding purposes.

The NFSCO representatives explained that in 2019, the rules of domestic legislation resulted in/triggered complete migration of data on the ABP operators to the electronic IT-based risk assessment system. Prior to the migration, information on some operators was available only in a paper form at the county and district levels. Thus, the list of ABP operators in the IT- based risk assessment system for planning official controls was inaccurate ­ lacking a significant number of operators. Therefore, the manual adjustment was necessary to establish if all registered and/or approved ABP/DP operators, establishments and plants remained active at the time of the migration. Due to the high number of operators covered, the NFCSO extended its controls from 2020 to 2021 stressing that the manual selection was temporary and that district inspectors could carry out additional controls also on other types of operators aside from those planned, for example when ordered to do so by the NFCSO or where there was a public complaint or a case of suspicion.

With respect to the above, the audit team noted that: a. In none of the regions visited had the district inspectors met carried out any additional controls or focussed their inspections on the ABP plants/operators representing the above-mentioned four types of activities. b. In one region visited, there were numerous incinerators and, at least from 2017, the district inspectors had not carried out an ABP inspection on any of them. The above is not in line with requirements of Article 4(3) of Regulation (EC) No 1069/2009. The CGO and the DGO representatives met explained that the overall number of controls planned in all areas for which the district officials are responsible is so high that, with the current resources, the district inspectors do not plan any additional controls. Conclusion on planning of official controls

As designed, the system for planning official controls, in principle, takes into account the relevant risk criteria. However, this is undermined by the fact that the information on at least two of the planning criteria is unreliable (the result of the last inspections and reliability of operators' own checks). Furthermore, the fact that several types of operators have been excluded from the planning process, weakens assurances that the entire ABP/DP chain is adequately controlled. 5.2.3 Implementation of official controls

The recommendation states as its basis

The NFCSO has in place training arrangements for its staff covering general aspects of administrative and official controls rules and a sector-specific development. Trainings vary in form and range from those with personal participation (mostly pre-COVID pandemic) to on- line courses (during the COVID pandemic). The audit team examined evidence of training, interviewed ABP inspectors met and noted that: a. The CGOs' and DGOs do not specialise in selected types controls but multitask, covering many different controls, e.g. on animal health and welfare, food and feed hygiene, ABP, etc. 4 b. Prior to the COVID-pandemic, the authority regularly organised on-site, training courses inviting the staff from the county and district offices. During the COVID- pandemic, trainings were delivered by e-learning. The training courses usually covered various control-related topics, including some aspects related specifically to ABP. c. Officials' awareness of ABP requirements was inconsistent, with many misinterpretations of requirements and/or overlooking of various requirements applicable both to official controls and to ABP operators, establishments and plants and, in particular, the approval process for operators, the assessment of operators' HACCP-based procedures and the assessment of operators' own checks and ABP- related sampling requirements (see Section 5.2). The above training arrangement, in principle, complies with requirement of Article 5(4) of Regulation (EU) 2017/625, except for point (a) of the said Article.

The constituent parts of the official control system are in place, vis-á-vis legal framework, designation of competent authorities, provision of adequate and appropriate laboratory capacity and an internal audit system capable of identifying problems in the implementation of official controls in this sector. Nevertheless and in spite of the training programme provided for control staff, fundamental misinterpretations of various ABP requirements as evidenced by interview of control staff and examination of official control records in parallel with operators' documentation (see conclusion 35), indicate that this key requirement of the control system is not functioning effectively. (3) Keresési eredmények - Állategészségügy lakossági - Nébih (gov.hu) 5

The audit team examined presented inspection reports with checklists and noted that these did include checks on the reliability and results of own controls that had been performed by the operators. Nevertheless, following further interviews with several county and district inspectors met, examination of inspection records in the operators visited, including cross- checking these with the documents kept by operators, the audit team noted that the inspection reports properly reflected only a fraction of the inspectors' findings. The inspectors' assessments of their remaining findings were inappropriate due to misinterpretations of the applicable requirements and/or the overlooking of these (see Section 5.2.3). For example, as regards operators' own checks, the inspection reports recorded these as having been assessed as satisfactory, when in fact this was not the case as seen by the audit team.

As designed, the system for planning official controls, in principle, takes into account the relevant risk criteria. However, this is undermined by the fact that the information on at least two of the planning criteria is unreliable (the result of the last inspections and reliability of operators' own checks). Furthermore, the fact that several types of operators have been excluded from the planning process, weakens assurances that the entire ABP/DP chain is adequately controlled. 5.2.3 Implementation of official controls

In the 3 audited regions, the official control records contained evidence that officials had verified the traceability requirements for collection, transport and dispatch of ABP and DP. The audit team re-examined these inspection reports alongside the source documents held by the operators and observed the operators on-site activities. The audit team noted that official control reports either overlooked and/or misinterpreted the following: a. Inappropriate operator practices for the categorisation and collection of ABP in slaughterhouses, resulting in the comingling and dispatch of Category 2 and Category 3 material as Category 3. b. Inappropriate information in documents accompanying ABP consignments, resulting in incorrect statements on the category of ABP and the destination. c. The limitation of controls on ABP/DP consignments only to those arriving from intra- Union trade and from third countries and neglecting such consignments originating in Hungary. 5.2.3.2 Official controls in ABP plants

In audited regions, the audit team reassessed documents held by operators, observed the operators' on-site activities, compared these with records from the most recent official controls (including for the purpose of the approval/re-approval process), and noted that official controls either overlooked and/or misinterpreted a number of requirements. For example, there was a lack of proper: a. Verification of the information entered by operators in the documents accompanying the ABP consignments (commercial documents) which otherwise would have allowed the officials to identify that additional activities were taking place for which operators did not have the required approval/authorisation; b. Assessment of operators' HACCP-based procedures related to processing methods used, in particular, to the processing parameters and their critical limits; 10 c. Checks on the processing plants' validation demonstrating the effectiveness of processing method 7; d. Assessment of the reliability of the operators' own checks related to sampling, in particular, on microbiological standards (Salmonella, Enterobacteriaceae and E.coli) and on the content of glyceroltriheptanoate used for marking of DP of the Category 1 and 2 material; e. Official sampling (see finding 28c) and the performance checks related to glyceroltriheptanoate. 5.2.3.3 Actions taken in the event of non-compliance and follow-up

Whilst official controls are performed on the ABP chain, their effectiveness and appropriateness is substantially undermined by a fundamental misinterpretation of the requirements applicable to operators as evidenced by the numerous deficiencies and discrepancies between the content of the official control records and the operators' records, observed by the audit team. Whilst the absence of monitoring/supervision in relation to ABP controls is also an issue, overall, the controls, as currently applied are not fit for their intended purpose and provide little in the way of assurances that the ABP/DP production and distribution chain in Hungary functions in line with EU requirements.

The recommendation states as its basis

Notwithstanding finding 13, the audit team noted that for some of the plants and operators visited during the audit, the published lists contained inaccurate information on the operators' associated operations, the processing method used and/or the category of ABP material handled (see Section 5.2.3.2). Conclusion on registration, approval and listing of ABP plants, establishments and operators

Whilst the legal basis for the registration, approval and listing of ABP plants is in line with EU requirements, implementation of the approval process was deficient resulting in unwarranted approvals being granted by the NFCSO and operators who did not meet all of the legal requirements, commencing their operations, thus undermining confidence in the proper functioning of the ABP chain. 5.2.2 Planning of official controls

In audited regions, the audit team reassessed documents held by operators, observed the operators' on-site activities, compared these with records from the most recent official controls (including for the purpose of the approval/re-approval process), and noted that official controls either overlooked and/or misinterpreted a number of requirements. For example, there was a lack of proper: a. Verification of the information entered by operators in the documents accompanying the ABP consignments (commercial documents) which otherwise would have allowed the officials to identify that additional activities were taking place for which operators did not have the required approval/authorisation; b. Assessment of operators' HACCP-based procedures related to processing methods used, in particular, to the processing parameters and their critical limits; 10 c. Checks on the processing plants' validation demonstrating the effectiveness of processing method 7; d. Assessment of the reliability of the operators' own checks related to sampling, in particular, on microbiological standards (Salmonella, Enterobacteriaceae and E.coli) and on the content of glyceroltriheptanoate used for marking of DP of the Category 1 and 2 material; e. Official sampling (see finding 28c) and the performance checks related to glyceroltriheptanoate. 5.2.3.3 Actions taken in the event of non-compliance and follow-up

Whilst official controls are performed on the ABP chain, their effectiveness and appropriateness is substantially undermined by a fundamental misinterpretation of the requirements applicable to operators as evidenced by the numerous deficiencies and discrepancies between the content of the official control records and the operators' records, observed by the audit team. Whilst the absence of monitoring/supervision in relation to ABP controls is also an issue, overall, the controls, as currently applied are not fit for their intended purpose and provide little in the way of assurances that the ABP/DP production and distribution chain in Hungary functions in line with EU requirements.

The recommendation states as its basis

The CGO inspectors collecting official samples from ABP plants stated that, in 2019 and 2020, they collected all of the samples planned. The audit team could not compare if the number of planned ABP samples matched the number collected as this information was not available. Nonetheless, in the audited regions the audit team checked a number of the laboratory examination results from the collected samples and noted the following: a. The CGO feed inspectors collected official samples in ABP processing plants producing processed animal proteins destined for manufacturing feed and/or pet food. In none of the regions did the CGO or DGO inspectors collect official samples from other types of ABP establishments although such ABP sites existed. b. The examination scope covered microbiological standards such as Salmonella and Enterobacteriaceae. Verification of the glyceroltriheptanoate content was not tested for, despite the fact that some of the plants used/handled DP derived from the Category 1 and 2 material. c. For microbiological standards, from a batch of a final product, inspectors collected a single sample instead of the five samples required. The above are not in line with requirements of Point 1(a)(ii) and (b) in Section 1 of Chapter I in Annex XVI to Regulation (EU) No 142/2011 and Chapter I of Annex X in the said Regulation.

Whilst official controls are performed on the ABP chain, their effectiveness and appropriateness is substantially undermined by a fundamental misinterpretation of the requirements applicable to operators as evidenced by the numerous deficiencies and discrepancies between the content of the official control records and the operators' records, observed by the audit team. Whilst the absence of monitoring/supervision in relation to ABP controls is also an issue, overall, the controls, as currently applied are not fit for their intended purpose and provide little in the way of assurances that the ABP/DP production and distribution chain in Hungary functions in line with EU requirements.

The recommendation states as its basis

The NFCSO has in place training arrangements for its staff covering general aspects of administrative and official controls rules and a sector-specific development. Trainings vary in form and range from those with personal participation (mostly pre-COVID pandemic) to on- line courses (during the COVID pandemic). The audit team examined evidence of training, interviewed ABP inspectors met and noted that: a. The CGOs' and DGOs do not specialise in selected types controls but multitask, covering many different controls, e.g. on animal health and welfare, food and feed hygiene, ABP, etc. 4 b. Prior to the COVID-pandemic, the authority regularly organised on-site, training courses inviting the staff from the county and district offices. During the COVID- pandemic, trainings were delivered by e-learning. The training courses usually covered various control-related topics, including some aspects related specifically to ABP. c. Officials' awareness of ABP requirements was inconsistent, with many misinterpretations of requirements and/or overlooking of various requirements applicable both to official controls and to ABP operators, establishments and plants and, in particular, the approval process for operators, the assessment of operators' HACCP-based procedures and the assessment of operators' own checks and ABP- related sampling requirements (see Section 5.2). The above training arrangement, in principle, complies with requirement of Article 5(4) of Regulation (EU) 2017/625, except for point (a) of the said Article.

The constituent parts of the official control system are in place, vis-á-vis legal framework, designation of competent authorities, provision of adequate and appropriate laboratory capacity and an internal audit system capable of identifying problems in the implementation of official controls in this sector. Nevertheless and in spite of the training programme provided for control staff, fundamental misinterpretations of various ABP requirements as evidenced by interview of control staff and examination of official control records in parallel with operators' documentation (see conclusion 35), indicate that this key requirement of the control system is not functioning effectively. (3) Keresési eredmények - Állategészségügy lakossági - Nébih (gov.hu) 5

As designed, the system for planning official controls, in principle, takes into account the relevant risk criteria. However, this is undermined by the fact that the information on at least two of the planning criteria is unreliable (the result of the last inspections and reliability of operators' own checks). Furthermore, the fact that several types of operators have been excluded from the planning process, weakens assurances that the entire ABP/DP chain is adequately controlled. 5.2.3 Implementation of official controls

Whilst official controls are performed on the ABP chain, their effectiveness and appropriateness is substantially undermined by a fundamental misinterpretation of the requirements applicable to operators as evidenced by the numerous deficiencies and discrepancies between the content of the official control records and the operators' records, observed by the audit team. Whilst the absence of monitoring/supervision in relation to ABP controls is also an issue, overall, the controls, as currently applied are not fit for their intended purpose and provide little in the way of assurances that the ABP/DP production and distribution chain in Hungary functions in line with EU requirements.

The recommendation states as its basis

The NFCSO-DPPSCA has issued two specific documented procedures for the official controls on imports of consignments of food of non-animal origin for the presence of aflatoxins and unauthorised genetically modified organisms in rice products originating in China. No documented procedures or instructions for performing official controls on imports of other food of non-animal origin had been issued at the time of the audit, which is not in line with Article 12(1) of the OCR.

The NFCSO-DPPSCA informed the audit team that it was in the process of updating its Authority's Guide, which is aimed at controls on food of non-animal origin in the Single Market, to include guidance on performing official controls on imports of such products listed in Annexes I and II.1 to Regulation (EU) 2019/1793. The NFCSO-DPPSCA stated that the update was due to be completed by January 2022.

However, the lack of documented procedures for the performance of official controls on food of non-animal origin, has the potential to undermine assurances that such controls are sufficient to minimise, as far as possible, the introduction of non-compliant consignments into the Union. 11 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTS/TRANSITS OF ANIMALS AND GOODS

The recommendation states as its basis

BACKGROUND Controls on residues and contaminants and the use of veterinary medicinal products in Hungary were previously audited by the Commission in 2012 (2) and the 2012 report concluded that the system of residue monitoring was in compliance with EU legislation. However, the overall effectiveness of the residue monitoring plan was compromised by weaknesses in laboratory performance and, in particular, by deficiencies in implementation and a lack of effective supervision thereof. All five audit report recommendations were satisfactorily addressed.

FINDINGS AND CONCLUSIONS EU legal acts quoted in this report are provided in Annex I and refer, where applicable, to the last amended version. Relevant provisions of the EU legal acts cited in Annex I are referred to in the individual findings.

The risk-based distribution of samples to the 19 counties is based on production volumes for the most commodities and animal species but not for all, which is not fully in line with EU requirements (11). In case of honey, all sampling under the 2018 and 2019 plans was allocated to nine counties representing 77% of national honey production, no samples were assigned for collection in the remaining 10 counties although honey is also produced in the most of them. NFCSO staff stated that they plan in future to fully allocate the sample number for equine and ovine animals and for honey according to the production volume of the respective counties. (4) Articles 9 and 12 of Regulation (EU) 2017/625. (5) Ministerial decree No 10/2002 and instructions to plan and implement the residue monitoring plan (A reziduum-toxikológiai monitoring ellenrzési tervben szerepl laboratóriumi vizsgálatokra és az azt követ hatósági intézkedésekre vonatkozó eljárásrend). (6) Available at: https://atiportal.nebih.gov.hu/moengallatgykesz.html (7) Article 9(1a) and 9(1e) of Regulation (EU) 2017/625. (similar requirements existed also in Article 3 of Regulation 882/2004). (8) Annexes I-IV to Directive 96/23/EC. (9) Annexes I, II and IV to Directive 96/23/EC, Annex to Decision 97/747/EC. (10) Annexes I-IV to Directive 96/23/EC, Commission Decision 97/747/EC, Commission Implementing Regulation (EU) No 2018/555. (11) Article 9(1a) of Regulation (EU) 2017/625. (Similar requirements existed also in Article 3 of Regulation 882/2004). 3

For aquaculture finfish, sample plan distribution to the counties did not take the counties` aquaculture production volume into account, or cover all of the commercially produced species like trout, catfish, carp and sturgeon. The latter is not in line with EU requirements (12). Furthermore, none of the aquaculture samples to be analysed for Group A substances, is planned to be taken at farm level, which is not in line with EU requirements (13). Staff from the NFCSO informed the audit team, that they intend to use in future production data from the Hungarian Fish Institute to allocate species- specific sample numbers to the counties. Conclusion on planning of residue monitoring

Planning of residue monitoring is, with some exceptions (absence of testing of caprine animals and some species of farmed fish and no on-farm sampling of farmed fish), largely in line with EU requirements. 5.1.3. Implementation of the residue monitoring plan

Member state response

e national residue monitoring plan (NRCP) issued in 2021 the farmed fish category has been divided into the followings: African catfish Trout Carp Other fish (not carp, trout or African catfish). The sampling points have been modified and clearly described in the 2021's NRCP. Samples will be taken at the farms and in the slaughterhouses as well. In relation to caprine animals' goat milk is analyzed. In addition, 1 goat muscle sample for CAP (Group A6) has been included.

The recommendation states as its basis

The 2018 national residue monitoring plan was largely implemented as foreseen with the exception of eggs and caprine/ovine milk. For eggs 75% of planned samples were taken and for ovine milk 80% (60% in 2019). For caprine milk 70% and 20% of planned samples were taken in 2018 and 2019 respectively, which is not in line with EU law (17).

There is currently no mechanism in place to identify and thus allow either the counties or the central competent authority to prevent multiple sampling from the same operator, as required by EU law (19). The Hadju Bihar county staff stated that under the current system they do not receive copies of the sampling reports sent by the district veterinarians to the testing laboratories. Therefore they cannot verify if multiple sampling from the same operator takes place. Similarly staff from the NFCSO confirmed that they did not supervise and verify if this requirement had been respected by the counties. Thus the actions foreseen to address recommendation No 2 of the 2012 audit report with regards to ensuring that no multiple sampling from the same operator takes place, were not effective.

However, the audit team received a copy of a letter sent during the time of the audit from the Secretary of State to all counties asking staff to pay attention to the fact that samples should not be taken from the same establishments and rather to sample as many establishments and animal holdings as possible. The competent authority further expressed its intention to create a supervision mechanism to avoid multiple sampling from the same operator.

Both the national and Baranya county sampling data indicate that samples from honey were frequently taken at retail level. Sampling blended honey decreases the chances of identifying non-compliant results (due to dilution) and, even if non- compliant results were identified, tracing back to the offending producer, as required by EU legislation (20), would be difficult.

The absence of supervision of implementation has contributed to weaknesses such as multiple sampling of the same producer, under-sampling of certain commodities and sampling strategies (in the case of honey) which militate against detection of residues and compromise traceability in the event of non-compliant results being detected. 5.1.4. Follow-up of non-compliant results

Member state response

19. icial guide for residual toxicity sampling has been further ed. The modified system prevents taking multiple samples from the same producer. The amendment will also ensure, that the origin of the honey ples taken can be traced back to the producer. Deadline: April 2021. Page: 1 port ref. DG(SANTE) 2020-6989 of the audit carried out from 15 October taminants in live animals and animal products including controls on veterinary

The recommendation states as its basis

Staff from the NFCSO informed the audit team that they verify the implementation of the residue monitoring plan at the end of the sampling year (31 March) but not periodically during the sampling year identify and correct any potential under- implementation like the one described above for eggs and caprine/ovine milk. This is not in line with national (5) and EU requirements (18). Thus the actions taken to (12) Article 9(1)(a) of Regulation (EU) 2017/625 (13) Chapter 3 of Annex IV to Directive 96/23/EC. (14) Article 1 and Point 2.1 of the Annex to Commission Decision 98/179/EC. (15) Point 1 of the Annex III to Directive 96/23/EC. (16) Article 34(5) of Regulation (EU) 2017/625, Article 1 and point 2.6 of the Annex to Decision 98/179/EC. (17) Article 2 and Chapter 1 and 2 (only if eggs are still in the text) of the Annex to Commission Decision 97/747/EC. (18) Article 12 (2 and 3) of Regulation (EU) 2017/625. (Similar requirements existed also in Article 8 of 4 address recommendation No 3 of the 2012 audit report have not been fully effective. NFCSO staff met during the audit stated that one reason for this is a lack of an IT system to compare the data on the samples taken, available in the laboratory IT system, with the national or county residue monitoring plan data. They stated further that such system is currently in development and is forecasted to be in place until the end of 2021.

There is currently no mechanism in place to identify and thus allow either the counties or the central competent authority to prevent multiple sampling from the same operator, as required by EU law (19). The Hadju Bihar county staff stated that under the current system they do not receive copies of the sampling reports sent by the district veterinarians to the testing laboratories. Therefore they cannot verify if multiple sampling from the same operator takes place. Similarly staff from the NFCSO confirmed that they did not supervise and verify if this requirement had been respected by the counties. Thus the actions foreseen to address recommendation No 2 of the 2012 audit report with regards to ensuring that no multiple sampling from the same operator takes place, were not effective.

The absence of supervision of implementation has contributed to weaknesses such as multiple sampling of the same producer, under-sampling of certain commodities and sampling strategies (in the case of honey) which militate against detection of residues and compromise traceability in the event of non-compliant results being detected. 5.1.4. Follow-up of non-compliant results

Member state response

er to ensure that the required number of samples are planned for all commodities, a new IT system is under ent. It will support the horizontal tasks of planning eability and will provide up-to-date information for the concerned. elopment will be finalized in 6 months, the training for s is planned for the summer of 2021. help of this IT tool NFCSO will be able to supervise the tation of the NRCP in the counties/districts during the o, as the new IT system will link the Laboratory IT ith the NRCP. Page: 2 port ref. DG(SANTE) 2020-6989 of the audit carried out from 15 October taminants in live animals and animal products including controls on veterinary

The recommendation states as its basis

The audit team evaluated the follow-up investigations for the six cases, all of which concerned antimicrobials in pigs, poultry and cattle. - in one case (oxytetracycline and doxycycline in porcine tissue) the applicable follow-up procedures were followed, the cause of the non-compliance was identified and a deterrent fine imposed in line with EU legislation (24). - In five of the six cases, evidence was provided that affected product was traced and if still present, destroyed to safeguard public health, which is in line with EU law (27). - In three cases, written records of the follow-up investigation did not include a description of the control methods applied at farm level or the outcome of such official control. This is not in line with EU legislation (25). Due to this it could not be established if the cause of the non-compliances had been identified or not, or what measure had been taken at the farm to bring the operator back into compliance. - In four cases, contrary to national instructions (5), the farm involved was not included in intensified controls for six months and no follow-up samples were taken at slaughterhouses when receiving further animals from these farms. Representatives of the central competent authority agreed with the audit team that in these cases it would have been appropriate to have taken follow-up samples as foreseen in EU law (26). The audit team was informed that a letter had been sent during the audit from the Secretary of State to all counties asking them to take such follow-up samples and to note these accordingly in the respective sampling report. - representatives from the NFCSO informed the audit team, that they intend to implement a procedure for verification of the effectiveness and appropriateness of follow-up investigations and corrected measures taken. Conclusions on follow-up of non-compliant results

Whilst the competent authority has drawn up comprehensive instructions for investigating non-compliant results, these were not followed consistently, resulting in follow-up which was not as effective as it should have been. (23) Commission Delegated Regulation (EU) 2019/2090. (Similar requirements existed also in Directive 96/23/EC). (24) Articles 138 and 139 of Regulation (EU) 2017/625. (Similar requirements existed also in Articles 54 and 55 of Regulation 882/2004). (25) Article 13 of Regulation (EU) 2017/625 (Similar requirements existed also in Article 9 of Regulation 882/2004). (26) Article 5 of Commission Delegated Regulation (EU) 2019/2090. (Similar requirements existed also in Article 18 of Directive 96/23/EC). 6 5.1.5. Laboratories

Member state response

vestigating the unsatisfactory test result, the county d chain safety authority must submit the following nts to NFCSO: he notification (e-mail) for the county food chain safety y of the relevant district and the request for ation ase the origin of the live animal is not from the county, the tion (e-mail) for the competent county food chain safety y and the report containing the results of the ation from the competent county food chain safety y nts accompanying the animals concerned (food chain ion, veterinary certificate, Unified Registration and cation System, Poultry Information System, TRACES for originated from another country) -spot inspections in the slaughterhouse (emphasis on summary statement at the end of the recorded report ng and performing a re-test, attaching sampling reports, ling report must indicate the re-test and refer to the f the tests reporting an unsatisfactory result ation on the holding, report on the use of medicinal , medical treatments, deliveries and places of delivery als of similar age, findings of feedback, date of possible ions, direction of examination, results listed g a summary report to NFCSO in addition to the above s. Page: 3 port ref. DG(SAN

The recommendation states as its basis

The audit team scrutinised the FTNRL's general procedure "Validation, verification and evaluation of test methods" and concluded that it did not prescribe the determination of CC/CC or include the study of analyte stability in solution and in matrix, contrary to the requirements of EU legislation (30). In the validation files seen by the audit team, data on specificity were found only in one file (amphenicols) and ruggedness was addressed only partly (different species and operators). CC/CC were available (although the software calculation was not shown).

All of the validation files consisted of summary reports produced by a commercial software used for the evaluation of raw data. The laboratory representative stated that the software algorithm, according to the vendor, was based on pertinent requirements of EU law (30). For all of the methods there was no conclusion in the validation file on the methods' fitness for purpose.

With regard to method validation, the audit team made further the following observations: i. Group A1 ­ stilbenes (Gas Only blood and urine of bovine animals, pig, Chromatography ­ Tandem Mass sheep, and poultry tissues were included in the Spectrometry (GC-MS/MS) validation experiments while urine of horses method), and muscle of aquaculture, farmed game, and rabbit are also routinely tested with the same ii. Group A3 ­ steroids (GC-MS/MS (27) Article 37(1) and (3) of Regulation (EU) 2017/625. (28) Article 37(4)(e) and 37(5) of Regulation (EU) 2017/625 and point 1.2 of the Annex to Decision 98/179/EC. (29) Article 1 and point 2.5 of the Annex to Decision 98/179/EC. (30) Part 3 of Commission Decision 2002/657/EC. 7 method) methods. iii. Group A6 ­ amphenicols (Liquid CC for chloramphenicol in honey and urine Chromatography ­ Tandem Mass exceeded the minimum required performance Spectrometry (LC-MS/MS) limit established by EU law (31). method) iv. Group A1 ­ stilbenes, and Group Repeatability and reproducibility data were A3 ­ steroids (GC-MS/MS either identical or very close to each other methods), (contrary to what is expected (32)) without investigating the reason(s) for that v. Group A6 ­ nitrofurans ((LC- phenomenon. MS/MS method) vi. Group B1 ­ macrolides and Calculation of CC was not in line with EU lincosamides (LC-MS/MS method) law (33) leading to unjustifiably high values that might have an impact on possible decision-making when the level found is below the laboratory's CC but above the CC that would have been obtained with the approach established by EU law. vii. Group A6 ­ amphenicols (LC- - No clear indication of what species were MS/MS method), included in the validation experiments; viii. Group B1 ­ macrolides and - Some recovery values were outside the lincosamides (LC-MS/MS ranges established by EU law (34) without method) spotting/evaluating that phenomenon. ix. Group A1 ­ stilbenes, and Group A considerable number (up to 50 and 26 %, A3 ­ steroids (GC-MS/MS respectively) of statistically outlying data was methods), identified by the software without investigating the reason(s) for that x. Group B2a ­ avermectins (High phenomenon. Performance Liquid Chromatography with Fluorescence Detection (HPLC- FL) method) xi. All methods scrutinised - Recovery, repeatability and reproducibility data were not assessed as foreseen in EU law (35); - Not all matrices routinely tested were included in the validations. Instead, results obtained for some matrices are extrapolated to other matrices (e.g., "poultry tissues are analytically similar to aquaculture") without verifying the validity of such extrapolation.

With regard to the FTNRL, the audit team noted that, contrary to EU requirements (36) , no verification of screening analytical methods (seen for chloramphenicol, nitrofurans and sulphonamides) had been carried out. In conjunction with findings (31) Annex II to Commission Decision 2002/657/EC. (32) Part 2.3.2.2 of Commission Decision 2002/657/EC. (33) Part 3.1.2.5 of Commission Decision 2002/657/EC. (34) Part 2.3.2.1 of Commission Decision 2002/657/EC. (35) Part 2.3.2 of Commission Decision 2002/657/EC. (36) Part 2.2 of Commission Decision 2002/657/EC; Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer), Community Reference Laboratories (CRLs) Residues 20/1/2010. 8 Nos 30 and 32, the audit team could consequently conclude that the actions taken to address recommendation No 5 of the 2012 audit report had been ineffective.

The audit team scrutinised the internal FTNRL quality control data related to testing results of six samples (randomly chosen by the audit team) in which concentrations of pharmacologically active substances (primarily antibiotics) exceeded relevant CC values. In all six cases the quality control samples were run in matrices different to the tested samples. Consequently, the results' legal and technical validity was compromised in the absence of any comparison on the suitability of the quality control matrices. This is aggravated by the fact that not all matrices routinely tested were included in the relevant validation studies (see also finding 33). Thus, the audit team concludes that the actions taken to address recommendation No 4 of the 2012 audit report had been ineffective.

Notwithstanding the fact that all of the laboratories are accredited to ISO 17025, that methods are included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of (37) Article 38 of Regulation (EU) 2017/625 and in Article 5 of Commission Decision 2002/657/EC. (38) Part 2.9 of Commission Decision 98/179/EC. (39) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. 9 internal quality control procedures substantially undermine confidence in the reliability of analytical results and thus the effectiveness of the residue control system, an issue which has been identified during previous Commission audits. 5.2. Official controls on farms and in slaughterhouse regarding the use of veterinary medicinal products 5.2.1. Competent authorities

The recommendation states as its basis

The audit team scrutinised the internal FTNRL quality control data related to testing results of six samples (randomly chosen by the audit team) in which concentrations of pharmacologically active substances (primarily antibiotics) exceeded relevant CC values. In all six cases the quality control samples were run in matrices different to the tested samples. Consequently, the results' legal and technical validity was compromised in the absence of any comparison on the suitability of the quality control matrices. This is aggravated by the fact that not all matrices routinely tested were included in the relevant validation studies (see also finding 33). Thus, the audit team concludes that the actions taken to address recommendation No 4 of the 2012 audit report had been ineffective.

Monitoring of methods' performance (internal quality control) is carried out by including fortified samples in each analytical batch and plotting the obtained absolute recovery values on control charts; there are in general clear criteria on the assessment of those data. However, there is no check against the ranges established by EU law (33). The audit team noted numerous cases with recoveries outside the established ranges which had not been spotted/assessed on the control charts.

Notwithstanding the fact that all of the laboratories are accredited to ISO 17025, that methods are included in their respective scopes of accreditation and that the laboratories' performance in proficiency tests has been generally satisfactory, deficiencies in the validation of analytical methods and in the implementation of (37) Article 38 of Regulation (EU) 2017/625 and in Article 5 of Commission Decision 2002/657/EC. (38) Part 2.9 of Commission Decision 98/179/EC. (39) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrices, September 2020. 9 internal quality control procedures substantially undermine confidence in the reliability of analytical results and thus the effectiveness of the residue control system, an issue which has been identified during previous Commission audits. 5.2. Official controls on farms and in slaughterhouse regarding the use of veterinary medicinal products 5.2.1. Competent authorities

Member state response

In addition to the Poultry Information System (BIR) used by the authority, there is a poultry registration system for members of the ltry Product Board (BTT). The system has been already started, hough further development is ongoing. Information on the location and size of poultry farms can be obtained from it, and it is also possible to display maps. In the middle of May, some of the GIS developments were plemented, through which the domestic poultry farms of the BTT members can be displayed by species and capacity. Subsequently, in early the system will start to be supplemented with an epidemiological module, in line with the provisions of the amended Decree on Compensation. A link with the BIR is planned at a later stage of development. A database containing real-time data (current poultry population per farm) is also planned, but this will require longer consultation between the central authority and the BTT and it requires significant financial resources. No specific deadline has yet been set.

dition to the Poultry Information System (BIR) used by the authority, there is a poultry registration system for members of the Poultry Product Board (BTT). The system has been already started, although further development is ongoing. Information on the location and size of poultry farms can be obtained from it, and it is also possible to display maps. In the middle of May, some of the GIS developments were implemented, through which the domestic poultry farms of the BTT members can be displayed by species and capacity. equently, in early June, the system will start to be supplemented with an epidemiological module, in line with the provisions of the amended Decree on tion. A link with the BIR is planned at a later stage of development. A database containing real-time data (current poultry population per farm) is also planned, but this will require longer consultation between the central authority and the BTT and it requires significant financial resources. No specific deadline has yet been set. Update October 2021: The registration of establishments that are obliged to be registered according to the legislation, including poultry holdings, is ensured. The current system is already

The recommendation states as its basis

The competent authority could not provide the evidence requested by the audit team to confirm that the NFCSO had carried out any recent assessment to identify specific risk factors regarding the introduction in, and the transmission within and between poultry holdings of HPAI. Representatives of the NFCSO indicated that they consider the entire country to be a high-risk area. However, the epidemiological evidence from the previous epizootic, indicates that there are risk factors associated with specific geographical locations that experienced HPAI outbreaks in Hungary in the past. Those factors include the areas with a high density of domestic waterfowl. Although the audit team found evidence that the competent authorities did not have up-to-date information in relation to the number, location, size and density of all commercial and non-commercial holdings in those areas (see finding 36), the high density of birds in those areas is a well-known reality. In addition, poultry in those areas are often in open-air holdings and the frequency of movements between holdings is very high. These are areas through which migratory birds travel or have some of their resting areas. This is not in line with requirements laid down in Article 3(1) of Commission Implementing Decision (EU) 2018/1136, which requires that Member States identify the areas of their territory that are at particular risk for the introduction of HPAI viruses into poultry holdings.

The NFCSO did not update the risk profile of those areas taking into account the epidemiological evidence of an increasing threat posed by the detection of HPAI. They did 7 not update the profile after confirmation of the first outbreaks in Hungary in January, and despite the presence of HPAI infection in migratory wild birds in neighbouring Member States. This is not in line with requirements laid down in Article 3(3) of Decision (EU) 2018/1136. Nevertheless, the competent authorities took some actions to reinforce the application of generic risk mitigation and biosecurity measures in the whole country (see the next points).

Member state response

The deadline for carrying out the risk assessment is the 30th of September, 2021. The deadline for the development of a specific plan to mitigate the risks and strengthen the prevention and early detection of HPAI, using the results of the risk assessment is the 31st of December, 2021. Page: 1 1 ort ref. DG(SANTE) 2020-7110 of the audit carried out from 19 October he prevention and control of avian influenza on proposed by the competent authority

eadline for carrying out the risk assessment is the 30th of September, 2021. he deadline for the development of a specific plan to mitigate the risks and strengthen the prevention and early detection of HPAI, using the results of the risk assessment is the 31st of December, 2021. Update October 2021: The avian influenza monitoring programme was published on 5th July. At the selection of holdings to be sampled the risk factors listed in Section 5 and 6 of Annex II of Commission Delegated regulation 2020/689 must be taken into account. The 10 km wide zones around the * sites are at extreme risk for AI, therefore all the county offices received a list of poultry holdings belong to these zones via email. When selecting farms to be sampled, an effort should be made to sample them where possible. It must be indicated on the form that the samples originate from this zone. The risk assessment mentioned in our previous reply was carried out as follows: We classified the 19 counties of the country into three risk categories, distinguishing low, medium and high risk areas. The following criteria were taken into account when carrying out the risk assessment: - area of * sites in relation to co

The recommendation states as its basis

After confirmation of the first outbreaks in January 2020, the NFCSO issued CVO Decision 1/2020, ordering the enclosed housing of poultry in the territory of the whole country. This is in line with requirements on risk mitigation of HPAI laid down in Article 4.4(b) of Decision (EU) 2018/1136. CVO Decision 03/2017 had already established that keepers of commercial poultry holdings throughout the country should apply certain biosecurity requirements, and that the county and district veterinary services should regularly check and enforce them. CVO Decision 03/2017 also establishes specific requirements on stocking levels of poultry. It provides that stocking of poultry cannot be authorised if the holdings do not meet the other biosecurity requirements. However, the competent authority could not provide the evidence requested by the audit team to confirm that the competent authorities had carried out official controls to ensure the implementation and enforce the risk mitigation and biosecurity measures laid down in those Decisions, in particular in the potential high-risk areas mentioned previously. This is not in line with requirements of Article 10(1) of Decision (EU) 2018/1136.

The competent authorities assessed the official controls carried out in 2018 to verify compliance with CVO Decision 03/2017. They concluded that there had been some improvements in the implementation of biosecurity standards, when compared with 2016/17. They have not carried out similar assessments since 2018, and the competent authority could not provide the evidence requested by the audit team to confirm that they had enforced CVO Decision 3/2017 during the first months of 2020. This is not in line with Article 10(1) of Decision (EU) 2018/1136.

The competent authorities decided that the absence of wild bird cases was a reason for not implementing further mitigating measures in high-risk areas after the first outbreaks detected in January 2020. Despite the temporary exception mentioned above for Bács-Kiskun County, The competent authority could not provide the evidence requested by the audit team to confirm implementation of the increased surveillance of wild bird populations or the further monitoring for dead or sick wild birds since the first cases of HPAI were detected in January. This is not in line with Article 4(1)(b) of Directive 2005/94/EC, which requires Member States to carry out surveillance in wild birds to contribute, on the basis of a regularly updated risk assessment, to the knowledge of the threats posed by wild birds. This is not in line either with Article 8 of Decision (EU) 2018/1136, which requires Member States to carry out increased surveillance in wild bird populations.

Member state response

The national avian influenza contingency plan was updated in December, . county contingency plans for all diseases were requested by the O from the CGOs offices, the plans were received, and the lidation process has begun. The validation process is expected to be leted by the end of the year for all diseases. During this period, the dation of avian influenza plans will be a priority, ending by 30 ember. year and next, we will organize on-site / online trainings for local orities centrally, in the framework of which we will also describe the tical application of the provisions of the contingency plan with the of simulation exercises.

years ago, the Commission stopped co-funding the sending of wild bird samples m the field, this step questions the importance of wild bird monitoring for the protection poultry populations. Despite this, we still carry out both passive and active monitoring of wild birds. The ission of samples is funded from the national budget. The Hungarian Ornithological ety carries out the sampling of wild bird carcasses found along migration routes/wetlands and the sampling of healthy wild birds during ringing, as part of the active participation obligation imposed by the NDCC. In the framework of the wild bird monitoring programme, 500 samples have been scheduled onally. For wild birds, efforts should also be made to collect samples from the 10 km wide zone around * sites. bird samples to be collected are set higher in those counties where high-density waterfowl populations are kept. influenza surveillance programme was submitted to the European Commission this year in accordance with the AHL and related legislation.

The recommendation states as its basis

Regardless of which form the competent authorities used, the investigation forms that the audit team examined rarely reached conclusions on the likely length of time during which avian influenza may have been present on the holding or on the possible sources of the infection, as required by Article 6(2) of Directive 2005/94/EC. The approach taken to carry out the epidemiological investigations was not standardised or consistent along the epizootic, and there was a persistent lack of quality and completeness of the data obtained. This, in many cases, did not allow the competent authorities to investigate all the elements contained in points (a) to (d) of Article 6(2) of Directive 2005/94/EC.

The shortcomings described in the previous points precluded the NDCC from taking fully into account the results of the epidemiological inquiries to take well-informed decisions to: a) apply and adapt additional disease control measures, as necessary for each outbreak or affected area, and b) grant derogations to the restrictions applied as a result of the outbreaks. This is not in line with the requirements of Article 6(3) of Directive 2005/94/EC. 5.1.1.3 Handling of confirmation ­ Derogations

The audit team confirmed that when they established the protection and surveillance zones in response to confirmed HPAI outbreaks, the LDCCs did not carry out the poultry censuses of all holdings in the protection zone, as required by Article 18 of Directive 2005/94/EC, and of all commercial poultry holdings in the surveillance zones, as required by Article 30 of Directive 2005/94/EC. The NDCC and the LDCCs relied exclusively on the national holding registration system (TIR system) to identify the holdings, to monitor and inform them about 14 the restrictions in those zones. The TIR system is not updated regularly, which prevents the competent authorities from having a properly updated contingency plan giving an indication of the number, location, size and density of commercial holdings, as required by Article 62(2) of, and points 10 and 12 of Annex X to Directive 2005/94/EC. It does not include either information on non-commercial farms. The competent authority could not provide the evidence requested by the audit team the total number of non-commercial farms in the protection or surveillance zones. This is not in line with Article 16(3)(c) of Directive 2005/94/EC. They also could not provide information requested by the audit team to demonstrate whether all farms, in particular those in the protection zones, were included in the screening and surveillance activities required by EU legislation for the control of the infection. This is not in line with requirements in that respect laid down in Articles 18(b) and 29(1) of Directive 2005/94/EC. 5.1.3.2 Further restricted zones

To address recommendation 7 made in the report of the previous audit, the revised national contingency plan requires the competent authorities to plan depopulation activities in line with the requirements of Article 18 of Regulation (EC) No 1099/2009, in order to avoid potential animal welfare problems. A specific form is included in the contingency plan for this purpose. However, the competent authority could not provide the evidence requested by the audit team that the local competent authorities prepared depopulation plans and, consequently, that they had carried out that activity in accordance with those plans. Instead, they relied on their experience from previous epizootics and their knowledge of the requirements. This is not in compliance with paragraphs 1 and 2 of the Article mentioned above. 18

The routine method of killing used was sublimed dry ice (the solid form of carbon dioxide, which usually sublimes at around ­78.5ºC) within closed containers. The local veterinarians did not report any difficulties killing waterfowl using this method, but one of the more experienced veterinarians highlighted the difficulty of preventing contact between the birds and the sublimed dry ice. The officials did not fully monitor the temperature and carbon dioxide concentrations to render safely the birds insensible. Therefore, despite the guarantees provided by the competent authorities to address recommendation 7 of the previous audit, they have not applied the measures undertaken to do that in a satisfactory manner. This does not comply with Article 4(1) of Regulation (EC) No 1099/2009 as it is not one of the methods listed for killing domestic waterfowl in Chapter I of Annex I to Regulation (EC) No 1099/2009. Moreover, the use of that killing method is not in line with requirements laid down in Chapter II of that Annex (point 8) and Article 18(2) of the said Regulation. 5.1.4.2 Disposal of carcases

During the epizootic, there were also important delays on the depopulation of other outbreaks (see also finding 21), taking up to more than 14 days in some cases (e.g. ADNS reference 2020-251). Therefore, despite the guarantees provided by the competent authorities to address recommendation 8 of the previous audit report, they have not applied the measures undertaken to do that in a satisfactory manner. This does not comply with Article 11(2) of Directive 2005/94/EC, as downstream delays in disposal of carcases resulted in upstream delays in slaughtering poultry on holdings where outbreaks were confirmed. It is not in line either with requirements of Annex X (point 5) to the said Directive, as the competent authorities did not ensure that the necessary equipment and materials were available for the disposal of carcasses, a fundamental measure for the effective control of HPAI. Conclusions on animal depopulation with the purpose of disease control

The NFCSO updated the national contingency plan following the recommendation 1 of the previous audit. However, the competent authorities did not implement some of these updates (e.g., categorisation of areas at risk, use of guidance for depopulation, quick carcass disposal and census of holdings in restricted areas). This is not in line with Article 5(1)(i) of Regulation (EU) 2017/625 which requires that Member States be prepared to operate their contingency plans in the event of an emergency.

Each county is obliged to develop and keep updated its own contingency plan, based on the national model, but including information and guidance tailored to the specific needs of the county. The audit team checked as an example the contingency plan in Bács-Kiskun County and found that it does not include important information for the rapid control of the epizootic 21 in that county and that it had not been updated since the last epizootic. The missing information includes, for instance, a list of stakeholders' contacts, indication of the availability of equipment and materials necessary for the effective control of the disease, and information on the skills and responsibilities of staff. This does not comply with the requirements laid down in Article 62(1) and (2) of, and Annex X (paragraphs 3, 4 and 5) to Directive 2005/94/EC. The central competent authorities have not verified and corrected appropriately the contingency plans of the counties affected by the 2020 HPAI epizootic. Taking into account that national arrangements on contingency planning require that the national plan is completed and updated with its adaptation to each county's specific conditions, that incompleteness and lack of verification is not in compliance with Articles 5(1)(i) and 12(2) of Regulation (EU) 2017/625. 5.2.2 Registration of poultry holdings ­ Areas with high density of poultry

Despite CVO Decision 03/2017 establishing the requirement to inform and obtain official approval for the introduction of poultry, the TIR system is not fully up to date and does not have records of non-commercial holdings. The TIR system includes many holdings that are not active (3,000 holdings are registered, of which approximately 50% keep birds at a point in time). As explained in previous sections, that shortcoming has compromised the quality of the epidemiological investigations, caused delays in identifying all holdings within the restricted zones and contact and at-risk holdings, and precluded that the competent authorities could analyse the epidemiological situation in order to consider whether there was a need to avail of the additional measures provided by Articles 10(1) and (2), and 15(2) of Directive 2005/94/EC. This, together with the absence of a comprehensive on-site census in protection and surveillance zones during the epizootic (see finding 36), is not in line with requirements laid down in Articles 6(2), 16(3)(c) and 62(2) of, and with Annex X (points 10 and 12) to Directive 2005/94/EC.

Despite the information included in point 76 above, the situations described in the previous points were caused by the limited availability of suitably qualified and experienced staff ­ many of them natural persons who had been delegated some official control tasks and other official activities ­ who had not received appropriate training to perform their duties competently in the context of this animal health emergency. This is not in compliance with requirements laid down in Articles 5(1)(e) and (4), 30(b)(i) and (ii) and 31(2)(b) of Regulation (EU) 2017/625 and in Annex X (point 7) to Directive 2005/94/EC. In addition, the lack of arrangements put in place and actions performed by the NFCSO for the purpose of ensuring that the level of preparedness of the counties affected by the 2020 HPAI epizootic was adequate to control the disease effectively does not comply with requirements in respect of control verification procedures laid down in Article 12(2) of the said Regulation. 5.2.5 Diagnostic capacity in case of an emergency

Member state response

do not see the significance of measures based solely on the detection he M gene under the NRL protocol. If a sample is submitted for avian uenza testing but the disease is not suspected on the basis of the ical and pathological signs, only the PCR test for the M gene shall be performed by the laboratory. However, if avian influenza is suspected on basis of the clinical and pathologial signs or the epidemiological ation, a differentiating PCR test will be performed in parallel with the detecting the M gene and both will give results within 5 to 6 hours, hat no time is gained for the M gene alone. NRL informed NDCC and the county about the results of the stigations without delay, and on the basis of the results, the restricted s were identified and the measures were ordered without delay. few late reporting results during the epidemic were mainly due to the to repeat the test because of a sample of inadequate quality or tful results. In most cases the depopulation performed was based on icion, therefore the affected holdings were already depopulated re the confirmation of HPAI. Accordingly the few late confirmation ed no role in the spreading of the disease. Page: 2 1 ort ref. DG(SAN

ional avian influenza contingency plan was updated in December, 2020. county contingency plans for all diseases were requested by the NFCSO from the Os offices, the plans were received, and the validation process has begun. The validation Page: 3 s, updated 20 October 2021 ted by the competent authorities of Hungary in response to Report ref. DG(SANTE) 2020-7110 of 2020 in order to evaluate the application of measures for the prevention and control of avian Action Proposed by the competent authority process is expected to be completed by the end of the year for all diseases. During this period, the validation of avian influenza plans will be a priority, ending by 30 September. This year and next, we will organize on-site / online trainings for local authorities centrally, in the framework of which we will also describe the practical application of the provisions of the contingency plan with the help of simulation exercises. Update October 2021: 1. The updates of 20 December to the national contingency plan are highlighted in yellow in Attachment 2. These are: legislative background; NDCC-related parts due to NDCC becoming a separate directorate; EURL change; insertion of link to cu

Member state response

nce the HPAI epidemic 2016-2017 the rendering capacity has been eloped, the number of the by-product collection containers increased n 2020 with 63 containers. In April 2020 the capacity of the plant in dmezvásárhely increased from the previous 1 100 tons/week to 1 900 ns/week. This plant can change disposal from Category 3 to Category 2 case of increased demand, therefore during an epidemic by-products n be disposed in this plant too. In 2020 this change lasted from 15 April 11 May. The information flow between the epidemiologist of NDCC d the colleagues of the rendering plant is continuous in peacetime too. our opinion, the few cases of shortage of disposal capacity were mporary and all resolved, and did not play a significant role in the read of the epidemic. e County Government Offices have been facing lack of human sources for years. Therefore in the event of an epidemic the reallocation human resources from other counties has been ordered by NDCC.

We do not see the significance of measures based solely on the detection of the M gene under the NRL protocol. If a sample is submitted for avian influenza testing but the disease is not suspected on the basis of the clinical and pathological signs, only the PCR test for the M gene shall be performed by the laboratory. However, if avian influenza is suspected on the basis of the clinical and pathologial signs or the epidemiological situation, a differentiating PCR test will be performed in parallel with the PCR detecting the M gene and both will give results within 5 to 6 hours, so that no time is gained for the M gene e. The NRL informed NDCC and the county about the results of the investigations without nd on the basis of the results, the restricted areas were identified and the measures ordered without delay. The few late reporting results during the epidemic were mainly due to the need to repeat the test because of a sample of inadequate quality or doubtful results. In most cases the depopulation performed was based on suspicion, therefore the affected holdings were already depopulated before the confirmation of HPAI. Accordingly the few late confirmation played no role in the

The recommendation states as its basis

In March 2020, the NDCC ordered the prompt depopulation of all poultry present on the first affected holdings and on the holdings within the protection zones established in Bács-Kiskun and Csongrád Counties. Taking into account the fast evolution of the disease and the high 11 density of poultry present in the area, after those first cases, the competent authorities decided in accordance with Article 10(1) and (3) of Directive 2005/94/EC, to apply the measures provided for in Article 11 to holdings where outbreaks were suspected. However, the limited transport and carcase disposal capacity caused important delays in many of those cases. As a result, 78% of the outbreaks detected after March were depopulated three or more days after suspicion was reported; 49% at four or more days and 33% at five or more days and up to more than two weeks (e.g. ADNS reference 2020-121). Therefore, the competent authorities did not apply the intended measures in line with Article 11(1) to (3) of Directive 2005/94/EC. Those limitations delayed as well the application of preventive slaughtering and killing of poultry from contact holdings and from non-affected holdings within the protection zones in accordance with the options provided by Articles 15(2) and 17(3) of the said Directive.

The previous audit reported delays in the disposal of carcases due to limited rendering capacity. The competent authorities addressed this problem in their action plan, ensuring an increase in rendering capacity for a maximum of six weeks in case of an emergency. On 28 May, in the communication to the Commission mentioned in section 5.1.3.3 (point 43), they indicated that the required rendering capacity had been available throughout the epizootic and that the rendering plants were working in longer shifts and during weekends. However, during this audit, they confirmed that, due to initial low rendering capacity, there were delays in depopulation of outbreaks and of preventive culling in the protection zone set on 26 March. The competent authorities used burial sites only for a few carcases because of technical difficulties with site selection.

During the epizootic, there were also important delays on the depopulation of other outbreaks (see also finding 21), taking up to more than 14 days in some cases (e.g. ADNS reference 2020-251). Therefore, despite the guarantees provided by the competent authorities to address recommendation 8 of the previous audit report, they have not applied the measures undertaken to do that in a satisfactory manner. This does not comply with Article 11(2) of Directive 2005/94/EC, as downstream delays in disposal of carcases resulted in upstream delays in slaughtering poultry on holdings where outbreaks were confirmed. It is not in line either with requirements of Annex X (point 5) to the said Directive, as the competent authorities did not ensure that the necessary equipment and materials were available for the disposal of carcasses, a fundamental measure for the effective control of HPAI. Conclusions on animal depopulation with the purpose of disease control

Member state response

the epidemiological environment where the epidemic has occurred, the ost important thing is to eradicate the affected stocks as quickly as possible. all cases, the killings and evacuations took place on the basis of the iminary report and proposal of the LDCCs, which was approved by e NDCC in all cases before the implementation. is and the following year, we will organize central trainings for local thorities on the proper documentation of depopulation, its idemiological and animal welfare aspects.

Since the HPAI epidemic 2016-2017 the rendering capacity has been developed, the number of the by-product collection containers increased in 2020 with 63 containers. In April 2020 the capacity of the plant in Hodmezovasarhely increased from the previous 1 100 tons/week. This plant can change disposal from Category 3 to Category 2 in case of increased demand, therefore during an epidemic by-products can be disposed in this plant too. In 2020 this change lasted from 15 April to 11 May. The information flow between the epidemiologist of NDCC and the colleagues of the rendering plant is continuous in cetime too. In our opinion, the few cases of shortage of disposal capacity were temporary and all , and did not play a significant role in the spread of the epidemic. The County Government Offices have been facing lack of human resources for years. Therefore in the event of an epidemic the reallocation of human resources from other counties has been ordered by NDCC. Update October 2021: The following action plan is in place to address and prevent the temporary shortage of transport and disposal capacity: - continuous liaison between the NDCC and the representative of the plant, with clear

Member state response

e deadline for drawing up the procedure is the 31st of December, 2021. Page: 3 1 ort ref. DG(SANTE) 2020-7110 of the audit carried out from 19 October he prevention and control of avian influenza ction proposed by the competent authority

epidemiological environment where the epidemic has occurred, the most important thing is to eradicate the affected stocks as quickly as possible. all cases, the killings and evacuations took place on the basis of the preliminary report and proposal of the LDCCs, which was approved by the NDCC in all cases before the implementation. This and the following year, we will organize central trainings for local authorities on the proper documentation of depopulation, its epidemiological and animal welfare aspects. Update October 2021: The central authority prepared a guide for the preparation of an epidemiological depopulation plan for livestock holdings. The guide is attached (Attachment 12). The contingency plan has already included measures for culling and its documentation. For November, we will organise an online training for the colleagues working in the field involved in evacuations with the following agenda items: - practical application of the contingency plan - practical application of the attached depopulation guide, organising and documenting depopulations, - documentation of the culls, - recording and reporting protocol for depopulation and killing.

The recommendation states as its basis

In response to recommendation 6 from the previous audit, the NFCSO introduced new arrangements to assess the epidemiological risks before granting derogations from the measures applicable in restricted zones as required by Article 33(1) of Directive 2005/94/EC. That includes using a risk assessment form, which forms part of the revised national contingency plan (Annex VII-paragraph 18a). Most of the assessments reviewed by the audit team did not cover all relevant risks and it was not clear whether they took account of the local epidemiological situation and were sufficiently informative for the competent authorities to ensure, before granting the derogations, that they would not endanger HPAI 15 control (see next points for examples in that respect). This is not fully in line with Article 33(5) of Directive 2005/94/EC, which provides that derogations shall only be granted if they do not endanger disease control.

The audit team confirmed that most of the criteria laid down in Annex IV to Directive 2005/94/EC, some of which the competent authorities had taken into account to decide on the application of preventive culling in accordance with Articles 15(2) and 17(3) of the said Directive, were applicable to the relevant restricted zones. Therefore, increasing the density of poultry in those high-risk zones ­ a derogation that should have been based on a risk assessment carried out in accordance with Article 33(1) of the said Directive ­ while applying those measures conducive to reduce quickly the density of susceptible poultry, was a contradiction that may have undermined the objective pursued with the application of the former two articles.

The competent authorities detected 24 outbreaks during pre-movement testing: 23 of them in movements granted for direct slaughter and one to force-feeding. The competent authority could not provide the evidence requested by the audit team on the risk assessments required by Article 33 of Directive 2005/94/EC that the competent authorities should have undertaken prior to these movements being authorised or on possible epidemiological links to previous outbreaks.

The impressive amount of PCR tests carried out during the epizootic, in excess of 30,000 (approximately 70% between 25 March and 8 June), used for testing some 130,000 swabs from live poultry and tissues from poultry carcasses, cast doubts on the alleged limited analytical capacity of the NRL in that respect. As indicated in the report of the previous audit, the numerous derogations granted to holdings in the restricted zones overstretch significantly the testing capacity of the NRL (i.e. in 2020, derogations required PCR testing of tens of thousands of samples). This is not in line with Annex X (point 8) to Directive 2005/94/EC. 25

Member state response

g the epidemic the information flow of epidemiological data was nuous between the LDCCs and NDCC. This was performed via ne and e-mail (daily and extraordinary reports) and with on-spot visits y NDCC. Therefore the epidemiological data were quickly and accurately available for NDCC in order to decide on measures for the tection against the epidemic. n addition NFCSO performs wide range of informatics developments and including the Epidemir. The development of the Epidemir system is onsecutive, and according to plan all epidemiological data will be vailable from this system. Current developments: the module for rding data related to compensation has been in use since January 021, the client application and its official interface for permitting the stablishment of livestock farms are awaiting handover. Preparations for gn of the census module have also begun. he Data Warehouse specialist system is also under development, and his system will be used for the mapping of epidemics in the future. he collection of epidemiological data and the system of information low (even during the IT developments) are continuous, there was no lack f information. ll positions in the NDCC and the AHAW ar

e deadline for drawing up the procedure is the 31st of December, 2021. Update October 2021: Contingency Plan Annex VII.18a: "Risk assessment for the issuing of a derogation decision" - Consistent and documented application at all times ission of this document by the LDCC to the NDCC together with the daily report, in addition to the mandatory elements of the daily reports Page: 8 s, updated 20 October 2021 ted by the competent authorities of Hungary in response to Report ref. DG(SANTE) 2020-7110 of 2020 in order to evaluate the application of measures for the prevention and control of avian Action Proposed by the competent authority

Member state response

DCC's operational activities will also be available from the Epidemir ystem. For example, the killing of animals module is being prepared. hile Epidemir is being developed, epidemiological data will be received rom the LDCC to the NDCC in daily reports, via e-mail. If urgent information is required, it is also possible to transmit information by Page: 4 1 ort ref. DG(SANTE) 2020-7110 of the audit carried out from 19 October he prevention and control of avian influenza Action proposed by the competent authority telephone. The development of the Laboratory system is also continuous, from January 2022 laboratory data related to avian influenza will be included in this system. The data will be transferred from the Laboratory System to the Data Warehouse (DWH), from where reports are going to be available

ring the epidemic the information flow of epidemiological data was continuous between the LDCCs and NDCC. This was performed via phone and e-mail (daily and extraordinary reports) and with on-spot visits by NDCC. Therefore the epidemiological data were quickly and accurately available for NDCC in order to decide on measures for the protection against the epidemic. In addition NFCSO performs wide range of informatics developments including the Epidemir. The development of the Epidemir system is consecutive, and according to plan all epidemiological data will be available from this system. Current developments: the module for recording data related to compensation has been in use since January 2021, the client application and its official interface for permitting the establishment of livestock farms are awaiting handover. Preparations for the design of the census module have also begun. The Data Warehouse specialist system is also under development, and this system will be used for the mapping of epidemics in the future. The collection of epidemiological data and the system of information flow (even during the IT developments) are continuous, there was no lack of information. All pos

The recommendation states as its basis

To ensure that all holdings comply with registration requirements, the central competent authority had requested a new census survey, in order to remove registered holdings where no pigs have been kept for the previous three years and to register all new pig holdings or holdings that were previously unregistered. The Ministry of Agriculture is implementing a number of supporting actions to further improve the effectiveness and impact of this latest census (e.g. no fees for registering holdings, information campaigns, and enhanced cooperation with municipalities). 4

There are official controls at pig holdings and they are effective. However, there are a significant number of un-registered backyard holdings and as demonstrated by the last ongoing census, counties do not apply a consistent classification of pig holdings and 9 there is outdoor access for pigs at small commercial and backyard holdings. This hinders the possibility to trace those animals, the likelihood to detect the disease at an early stage, and increases the risk of the infection entering into the herds.

The recommendation states as its basis

There is a regular feed training programme whereby the representatives of the NFCSO organise training for the county and district feed safety officers on different topics. In the last three years training was provided on traceability, evaluation of laboratory results, implementation of official inspections, assessment of labelling, and implementation of official sampling. In the period 2015-2018, the central competent authority organised seven training courses per year for county and district officials in different regions. The audit team interviewed officials who had participated in these training courses but their knowledge on certain topics (e.g. labelling and official sampling) was not sufficient (see findings 35 and 45).

Despite the fact that training had been provided on the legal requirements of feed labelling (see finding 4), county feed inspectors were generally unable to apply this knowledge during official inspections, and thus to undertake their duties competently, (see finding 33 and 34) which is not line with requirements of Article 6(a) of Regulation (EC) No 882/2004. Conclusion on the planning and implementation of inspections

Regular and thorough verification of the FeBOs' own control and traceability systems strengthens the effectiveness of the official controls. However, significant weaknesses were seen on the verification of labelling requirements during official controls. The training provided does not support the official control staff to undertake their duties competently. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The audit team noted that, in spite of the centrally-developed guidance document on the practical aspects of official sampling (see finding 42) and training provided (see finding 4) on the legal requirements of official sampling, county feed safety inspectors, as opposed to the performance of official sampling carried out by the Food and Feed Safety Directorate of the NFCSO, were not aware of the guidance document with the result of them failing to follow the requirements on official sampling laid down by Commission Regulation (EC) No 152/2009. This calls into question the appropriateness of the training provided under the requirements of Article 6(a) of Regulation (EC) No 882/2004.

The system in place for planning of official sampling is risk-based. However, the legal and analytical validity of official sampling is weakened by systematic deficiencies on the implementation of official sampling by county feed safety inspectors thus, severely undermining the effectiveness of the official sampling system. The training provided does not support county officials to undertake their duties competently. 5.2.3 Actions taken on non-compliances

Member state response

Characteristics of the system applied up until now for the training of feed inspectors: Training sessions were organized in seven centres of regions covering the whole territory of the country. 2. The number of participants in those sessions was approximately 30. The system applied up until now is updated as follows on the basis of the findings of the audit: 1. After theoretical presentations more time will be allocated to practical case studies. 2. The efficiency of practical case studies will be improved by forming groups of 6-8 inspectors for the purposes of the training. 3. The practical application of the theoretical knowledge will be tested at the end of the case study. 4. Areas will be repeated where a lack of knowledge will be found. 5. If typical lack of knowledge is identified, the training plan will be adapted accordingly. 6. As of September, 2018. the training sessions as updated will be initiated, until September, 2019. introduced in each of the regions, and held continuously as updated. Deadline for compliance: 30.09.2019

Characteristics of the system applied up until now for the training of feed inspectors: Training sessions were organized in seven centres of regions covering the whole territory of the country. 2. The number of participants in those sessions was approximately 30. The system applied up until now is updated as follows on the basis of the findings of the audit: 1. After theoretical presentations more time will be allocated to practical case studies. 2. The efficiency of practical case studies will be improved by forming groups of 6-8 inspectors for the purposes of the training. 3. The practical application of the theoretical knowledge will be tested at the end of the case study. 4. Areas will be repeated where a lack of knowledge will be found. 5. If typical lack of knowledge is identified, the training plan will be adapted accordingly. 6. As of September, 2018. the training sessions as updated will be initiated, until September, 2019. introduced in each of the regions, and held continuously as updated. Deadline for compliance: 30.09.2019

The recommendation states as its basis

The audit team noted that, in spite of the centrally-developed guidance document on the practical aspects of official sampling (see finding 42) and training provided (see finding 4) on the legal requirements of official sampling, county feed safety inspectors, as opposed to the performance of official sampling carried out by the Food and Feed Safety Directorate of the NFCSO, were not aware of the guidance document with the result of them failing to follow the requirements on official sampling laid down by Commission Regulation (EC) No 152/2009. This calls into question the appropriateness of the training provided under the requirements of Article 6(a) of Regulation (EC) No 882/2004.

The system in place for planning of official sampling is risk-based. However, the legal and analytical validity of official sampling is weakened by systematic deficiencies on the implementation of official sampling by county feed safety inspectors thus, severely undermining the effectiveness of the official sampling system. The training provided does not support county officials to undertake their duties competently. 5.2.3 Actions taken on non-compliances

Member state response

In addition to training sessions as updated according to the specifications described under recommendation I, this recommendation will be complied with in the form of simulation exercises organized in the premises of relevant establishments, using the appropriate sampling tools. Each inspector will be required to perform the calculation as shown in the legislation and to take the sample itself. The whole procedure will be controlled and corrected in case of need. Deadline for compliance: 30.09.2019 Page: 1 rt ref. DG(SANTE)/2018-6319-MR of the audit carried out from 20 to 28 gredients and traceability ction Proposed by the competent authority

In addition to training sessions as updated according to the specifications described under recommendation I, this recommendation will be complied with in the form of simulation exercises organized in the premises of relevant establishments, using the appropriate sampling tools. Each inspector will be required to perform the calculation as shown in the legislation and to take the sample itself. The whole procedure will be controlled and corrected in case of need. Deadline for compliance: 30.09.2019 Page: 1 port ref. DG(SANTE)/2018-6319-MR of the audit carried out from 20 to 28 gredients and traceability ction Proposed by the competent authority

The recommendation states as its basis

Whilst verification of labelling had been regularly carried out during previous county inspections, no non-compliances had been identified during such official controls. Despite this, the audit team was able to identify numerous and significant shortcomings on labelling at the majority of establishments visited. Examples of shortcomings were: 7 The identification number of several feed additives not being present on the label, which is a legal requirement of Article 16(1)(f) of Regulation (EC) No 1831/2003. Identification of feed materials used as a carrier for feed additives production was not included on the labelling as required by Article 16(1)(b) of Regulation (EC) No 767/2009. Feed material being labelled as feed additive, which is not in line with the requirements of Article 15(a) of Regulation (EC) No 767/2009. Labels were seen for various premixtures from different producers stating that "the premix contains additional vitamins and micro-elements (beyond those listed) based on the agreement with the buyer and defined in the technical specifications (with no such detailed technical specification available) ". This is not in line with the requirements of Article 16(1)(a)(c) of Regulation (EC) No 1831/2003.

Furthermore, in some cases county inspectors could not explain how to assess the laboratory results of official samples related to control of declared concentrations (e.g. coccidiostats in a premixture for broilers, vitamin A in a pre-mixture for fattening pigs).

Regular and thorough verification of the FeBOs' own control and traceability systems strengthens the effectiveness of the official controls. However, significant weaknesses were seen on the verification of labelling requirements during official controls. The training provided does not support the official control staff to undertake their duties competently. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Member state response

On the top of the update of the training system as specified under ommendation I a better compliance will be ensured through the ollowing elements: . The question concerning `correct labelling' within the hecklist will be thoroughly explained (most recent updates in the egislation, transitional periods, use of the register of feed dditives) in such a way that the controller can find the incorrect abelling with a higher efficacy. . Central and local monitoring procedures, which were reviously focused mainly on taking the samples, will be extended o cover the control of the labelling in detail. . FBOs' compliance with the labelling rules will be ncreased through not only online guidelines but also through resentations held for the stakeholders and their organisations. eadline for compliance: 30.09.2019

On the top of the update of the training system as specified under ommendation I a better compliance will be ensured through the ollowing elements: . The question concerning `correct labelling' within the hecklist will be thoroughly explained (most recent updates in the egislation, transitional periods, use of the register of feed dditives) in such a way that the controller can find the incorrect abelling with a higher efficacy. . Central and local monitoring procedures, which were reviously focused mainly on taking the samples, will be extended o cover the control of the labelling in detail. . FBOs' compliance with the labelling rules will be ncreased through not only online guidelines but also through resentations held for the stakeholders and their organisations. odified deadline for compliance: 31.03.2019

The recommendation states as its basis

The audit team visited two different FeBOs producing and exporting non-authorised (in the EU) feed additives and/or premixtures to non-EU countries. None of the two FeBOs could demonstrate that the competent authority of the receiving non-EU countries had been informed of the reason for which and the circumstances in which the feed concerned could not be placed on the EU market, and no evidence was available as to their agreement to the import of such products into their countries. The Hungarian central competent authority could neither provide the necessary assurances, as there is no procedure in place to verify compliance with the requirements of Article 12 of Regulation (EC) No 178/2002, as thus, officials had never carried out controls on this specific matter. Conclusion on establishments producing/trading non-authorised (in the EU) feed additives but are exporting or re-exporting them from the EU to a non-EU country

Official controls do not verify that, in case of export of non-authorised (in the EU) feed additives, the authorities of importing non-EU countries are informed of the reasons for which and the circumstances in which the feed concerned could not be placed on the EU market, nor that they had expressly agree to place such products into their countries.

Member state response

he fact that an operator exports to third countries additives (or ixes or compound feed containing those additives) not orised in the EU and the consequent obligation to comply ith Article 12 of the GFL will be specifically mentioned in the ecision issued by the CA when approving the operator's facility. iven the fact that this decision serves as a basis for the stablishment control, this provision will be specifically dealt with uring all the controls of those establishments (typically once per ear). eadline for compliance: 30.09.2019 Page: 2

he fact that an operator exports to third countries additives (or ixes or compound feed containing those additives) not orised in the EU and the consequent obligation to comply ith Article 12 of the GFL will be specifically mentioned in the ecision issued by the CA when approving the operator's facility. iven the fact that this decision serves as a basis for the stablishment control, this provision will be specifically dealt with uring all the controls of those establishments (typically once per ear). eadline for compliance: 30.09.2019 pproval: n Hungary, feed additives non-approved in the EU can only be roduced, placed on the market, stored or exported by FBO's pproved for the purpose. Approvals of currently active FBO's of his kind will be amended and approvals for FBO's which will Page: 2 port ref. DG(SANTE)/2018-6319-MR of the audit carried out from 20 to 28 gredients and traceability be issued in such ly mention the Regulation s specify if stores e conditions lso contains a with a full king this 2/EK is These targeted -authorised endment of the

Member state response

The revision of the National Action Plan is currently underway and we will take into account your comments. Following the revision, the NAP will be consulted publicly. The review will be completed by 30 June 2019, the outcome of which will be communicated to the Commission.

The revision of the National Action Plan is currently underway and we will take into account your comments. Following the revision, the NAP will be consulted publicly. The review will be completed by 30 June 2019, the outcome of which will be communicated to the Commission.

Member state response

To update the national contingency plan for avian influenza taking into account the lessons learnt from the analysis of the strengths and weaknesses identified with regard to the operation of the animal health emergency preparedness system during the recent epidemic of HPAI. Article 62 of, and Annex X to Directive 2005/94/EC; Article 18 of Regulation (EC) No 1099/2009. Based on conclusions (104) and (108), and associated findings (9), (60), (83), (85) and (99).

Member state response

The NFCSO introduces a new independent review procedure for the audit body to ensure that the management receives assurance that official ontrols meet the objectives of Regulation (EC) No 882/2004. Deadline for the preparation of the procedure: June 30, 2018 Page: 1

The recommendation states as its basis

The County offices provide training for district offices mainly on certification of animals but also on welfare issues. During 2016 NÉBIH required all counties to give training on animal welfare requirements to those district official veterinarians dispatching consignments for long journeys. NÉBIH supplied training materials (including the elements in paragraph 3 a-g above) and all officials were trained by December 2016.

Most officials at district level did not take into account the training or instructions regarding the time taken to cross the border at Turkey and the working hours of Turkish veterinary authorities there, in their verification of journey log planning (see paragraphs 26 to 28 below). This resulted in incorrect journey planning and animals subjected to routinely longer journey times.

Staff at district level generally did not know how to check certain requirements requested by NÉBIH, e.g. approving vehicle deck surface areas and suitability of drinkers or analysis of retrospective satellite navigation system or temperature records from long journeys (see paragraphs 10, 11, 12, 26 27 and 28 below). This is despite training and guidance from both central and county level. This lack of knowledge or competence in carrying out tasks at district level is not in compliance with Article 6 of Regulation 882/2004.

There has been inadequate progress in rectifying the deficiencies reported during the Commission audit to Hungary DG(SANCO) 2011/6045 on animal welfare during transport. Actions taken by the Hungarian authorities to rectify the deficiencies were ineffective as the same deficiencies were found at district level in 2017.

Official controls at district level do not ensure transporter's compliance. This together with the absence of verification in a number of key areas might cause unnecessary pain or suffering to animals during long distance transport by road to non-EU countries.

The recommendation states as its basis

Most officials at district level did not take into account the training or instructions regarding the time taken to cross the border at Turkey and the working hours of Turkish veterinary authorities there, in their verification of journey log planning (see paragraphs 26 to 28 below). This resulted in incorrect journey planning and animals subjected to routinely longer journey times.

Staff at district level generally did not know how to check certain requirements requested by NÉBIH, e.g. approving vehicle deck surface areas and suitability of drinkers or analysis of retrospective satellite navigation system or temperature records from long journeys (see paragraphs 10, 11, 12, 26 27 and 28 below). This is despite training and guidance from both central and county level. This lack of knowledge or competence in carrying out tasks at district level is not in compliance with Article 6 of Regulation 882/2004.

There is no verification of the district level work due to budgetary constraints, though a framework for doing so is in place. The district levels could not demonstrate adherence to documented procedures and this was not known to higher levels. This is not in compliance with Article 8 of Regulation 882/2004. District officials at times took decisions based on discussions with transporters rather than confirming themselves that requirements are met or following NÉBIH guidance. 4 Conclusions on Official Controls

There has been inadequate progress in rectifying the deficiencies reported during the Commission audit to Hungary DG(SANCO) 2011/6045 on animal welfare during transport. Actions taken by the Hungarian authorities to rectify the deficiencies were ineffective as the same deficiencies were found at district level in 2017.

Official controls at district level do not ensure transporter's compliance. This together with the absence of verification in a number of key areas might cause unnecessary pain or suffering to animals during long distance transport by road to non-EU countries.

The recommendation states as its basis

Vehicle approval renewals are subject to the same process as new vehicles. There is extensive written guidance available for consultation for district official veterinarians (OVs) who approve vehicles for long journeys. This includes specific guidance on suitability of drinkers but not on measuring vehicle space allowances. There is no systematic training for OVs, but some have taken part in Better Training for Safer Food courses and meetings between counties and districts allow dissemination of this information. A note from NÉBIH also draws attention to the need for accurate vehicle deck areas to calculate appropriate stocking densities and to verify the suitability of drinking devices for the species of animals being transported.

The audit team reviewed vehicle approval certificates. All but one of them were inaccurate with regard to the calculation of deck surface area: many listed only an overall area for multi-deck vehicles, or the same deck surface areas for multi-deck trucks, including those with goose-neck decks at the front. This is not in compliance with the requirements necessary to correctly issue the vehicle certificate in Article 18 of Regulation 1/2005 and the specifications required to be completed in the certificate listed in Annex III Chapter IV of Regulation 1/2005. District officials relied upon the figures provided by vehicle manufacturers' which were not always accurate.

Vehicle drinking devices were not physically verified at the time of approval by the district OVs. They assumed vehicle manufacturers' would fit suitable drinkers for the species that the vehicles was listed as being capable of transporting. This is not in compliance with Article 18 of Regulation 1/2005 or in line with NÉBIH guidance. Vehicles approval certificates were issued for different species and ages of animals which would require different non-compatible drinking systems e.g. horses, rabbits, 5 calves and pigs on one certificate and would lead to some animals being unable to drink during rest stops due to the unsuitability of drinkers.

The poor standard for approval leads to a risk of inadequate space allowances and unsuitable drinking devices, during long journeys and thus to welfare problems for the animals transported. The inadequate measuring of deck floor surface areas and assessment of drinking devices at the time of approving the vehicle leads to incorrect calculations on stocking densities ­ as they are based on the deck surface area indicated in the vehicle approval certificate. Therefore, reductions in stocking density indicated in most journey logs for summer consignments are often inaccurate.

The recommendation states as its basis

Officials at district level did not recognise the physical limitations imposed by vehicle design height restrictions and the carriage of two decks of average height large adult cattle. There was a recent instruction issued (see also paragraph 3c above) but no clear practical guidance (vehicle and animal schematics) from NÉBIH on this. Adequate headspace and therefore ventilation was not ensured when large adult cattle (over 500kg) were transported e.g. the guidance from NÉBIH for 20cm space requirement above the withers of large bulls on two decks (which must be stacked in some way) on conventional trucks would require a minimum2 vehicle height of over 4.8m. i.e. it is not possible to load large adult cattle on two decks in conventional livestock vehicles while providing adequate headspace. This is not in compliance with Annex I, Chapter II, point 1 (1.2) of Regulation 1/2005 and NÉBIH guidance. For the most-modern, modified two- deck vehicles, and for other smaller categories of cattle this was satisfactory.

The requirements for adequate headspace and therefore ventilation provision for large adult cattle in two-tier vehicles is not respected causing unnecessary suffering to these animals during long distance transport by road to non-EU countries. The actions 7 proposed in response to previous DG SANTE recommendations on these issues were not effective as they have not been properly implemented at district level.

The recommendation states as its basis

Competent authorities confirmed that the national database for animals does not contain a record of geographic co-ordinates for registered pig holdings as required by Article 1 (1) (d) to Commission Decision 2000/678/EC.

The reserved rendering capacity should allow Hungary to cope with depopulation in an outbreak situation. However, in the event of confirmation of ASF, due to limitations of the database performing a census of pigs will be more time consuming and demand increased resources to localise holdings in restricted areas. In addition, there is no verification of the availability of adequate county contingency plans by the CCA. This may delay containment of disease in an outbreak scenario.

Member state response

From 2016, all the eligible isolates collected in the frame of SNCP 2.2 from flocks of laying hens, gathered at slaughterhouses in the frame of official control or originating from food business operators own checks and sent for serotyping to NFCSO Food said Microbiological NRL in the context of Regulation (EC) No 2073/2005 will be subjected for AMR testing. Flocks, instead of holdings would be considered as epidemiological unit. Deadline: retrospectively even for 2016 isolates, as all these isolates are stored at NFCSO Food Microbiological NRL. For those categories, where the minimum number of isolates is supposed not to be achieved, competent authority considers the possibility to collect more (or all) isolates from private laboratories. Deadline: 1. April 2017

hen the minimum From 2016, all the eligible isolates National Food Chain Safety Office Food a isolates required to collected in the frame of SNCP from and Feed Safety Directorate has a icrobial susceptibility flocks of laying hens, gathered at database on laboratories that are 2 of Part A of the slaughterhouses in the frame of official authorized for testing samples in the 013/652/EU are not control or originating from food frame of food business operators' own able Salmonella isolates business operators own checks and checks. An official circular letter was bject to antimicrobial sent for serotyping to NFCSO Food prepared by the director of Food and ing, in order to comply Microbiological NRL in the context of Feed Safety Directorate to contact the ) of the said Decision. Regulation (EC) No 2073/2005 will be heads of food microbiological d on conclusion No subjected for AMR testing. Flocks, laboratories to collect the isolates in instead of holdings would be 2017 from carcass testing of pig for No 16, 21, 27 and 28. considered as epidemiological unit. Salmonella according Regulation (EC) Deadline: retrospectively even for No 2073/2005. These isolates should be 2016 isolates, as al

The recommendation states as its basis

During official controls at sprouts and packer establishments, the CAs can gather information about suppliers of seeds, in particular through verification of traceability. The audit team noted that following such checks, CGO DFCSAHU had identified a number of producers of seeds for sprouting (see paragraphs 60, 65, 70 and 71). Based on the statement that the responsible divisions of NFCSO DPPSC and CGO DFCSPPSC/DFCSA were not aware of the existence of such producers, the audit team noted that the information had not been shared between the various bodies concerned resulting in such producers not being subject to official controls. This limited cooperation does not fulfil the requirements of Article 4(5) of Regulation (EC) No 882/2004. Conclusion on Designation of CAs and Resources for Official Controls

The CAs in the context of this audit are designated at all stages of primary production as required by Article 4 of Regulation (EC) No 882/2004 and this gives a good basis for the implementation of official controls. However, limited coordination and cooperation between the government bodies involved results in some producers of seeds for sprouting not being subject to official controls. 6 5.2.2 Registration / Approval of Food Establishments Legal requirements Article 6 of Regulation (EC) No 852/204, Article 2 of Regulation (EU) No 210/2013 and Article 31 of Regulation (EC) No 882/2004 Findings Registration of Food Establishments

In this establishment a number of different seeds are sprouted. As part of the official control the inspector reviewed the label information for the different types of seeds held in storage. The inspector informed the audit team that in this FBO, all seeds for sprouting were of EU origin. Moreover, a variety of seeds for sprouting was from a Hungarian producer.

The audit team noted that evidence of seeds for sprouting produced in Hungary, although already outlined in the previous inspection report, did not result in appropriate actions from the CAs. 12

The inspector started the traceability verification from three 200g packs of seeds for sprouting: radish, sunflower and rape seeds labelled as "Agriculture EU". The inspector correctly asked for evidence of origin and for the declaration of "seeds for sprouting" on the invoice documentation. The sunflower seeds for sprouting were from a Hungarian producer.

The CCA confirmed that being not aware of any Hungarian producers of seeds for sprouting, these producers are not controlled as such (see paragraph 15 and 48).

Member state response

ithin the CCA, as The two Directorates together NFCSO FFSD and NFCSO No 882/2004, with a DPPSC, will draft a guidance note to cover the official uting in the scope of control of sprouting establishments and establishments packing and supplying seeds for sprouting. The guide will be a balance of information provided by CGO DFCSPPSC/DFCSA DIVISION FOR FOOD SAFETY, QUALITY AND CONTROL and CGO DFCSAHU and CGO DIVISION FOR PLANT PROTECTION AND SOIL CONSERVATION. Deadline: end of 2017

The recommendation states as its basis

The inspector verified the sampling plan of the FBO, specifically the results of the preliminary tests for seeds for sprouting and the tests of final products (sprouts). Seeds for sprouts are not tested before use (preliminary tests). The CAs allowed the FBO to use, instead of preliminary tests for seeds, the analytical reports on the seeds provided by the supplier. Moreover, the tests of the final products (sprouts) were available, but the frequency was not respected and samples were not analysed for STEC. In the previous reports there was no evidence of non-compliances regarding analytical frequency and parameters. The inspector informed the audit team that she was aware from previous inspections that the FBO did not comply with the requirements laid down by Annex I, Chapter 3.3 of the Regulation (EC) No 2073/2005. However, on the basis that this could have impacted the economic situation of the FBO, the inspector stated that no actions had been requested in order to resolve this non-compliance.

The CAs confirmed that this second sprout-producing establishment (not visited) complied with the frequency for preliminary tests on seeds for sprouting and final tests on sprouts. However, STEC was not tested as required by Annex I, Chapter 3.3 of the Regulation (EC) No 2073/2005.

The CAs informed the audit team that the inspector of this second facility was aware from previous inspections that also this FBO did not comply with the requirements laid down by Annex I, Chapter 3.3 of the Regulation (EC) No 2073/2005. However, the high price and the limited availability of STEC analyses was the reason for not requiring this.

The inspector verified the sampling plan of the FBO, specifically the results of the preliminary tests on seeds for sprouting and the tests on final products (sprouts). Seeds for sprouting were regularly tested according to Annex I, Chapter 3.3 of Regulation (EC) No 2073/2005 before growing. All the results were compliant. The tests of the final products (sprouts) were available and the frequency had been respected. However, samples of final product were not analysed for STEC. This non-compliance had been identified in previous inspection reports and a deadline (not yet expired at the time of the audit) had been given to the operator to address the situation.

Official controls at sprout-producing establishments, contrary to what is required by Article 1 of Regulation (EC) No 2073/2005, do not consistently enforce the requirements laid down in Annex I, Chapter 3.3 of the said Regulation (as regards preliminary testing of seeds intended for sprouting and sprouts). Enforcement of such requirements had only been initiated recently in the establishments visited.

Member state response

on (EC) No 2073/2005, NFCSO FFSD will develop a guide for the official control of the requirements laid sprouting establishments covering the requirements of art A.2 of the said Regulation (EC) 2073/2005. The guide will set out the f seeds intended for procedure to be followed by the official controllers recording how the FBOs meet the requirements of the regulation as preliminary testing of seeds intended for sprouting and sprouts. The guide will contain the procedure to be followed in the case of non-compliance. Deadline: end of 2017 Page: 1

The recommendation states as its basis

However, other aspects such as planning and preparation of inspections and control measures to be applied by CBs were not verified in this supervision. As no office audits had been carried out since 2011, the CCA had not verified whether both CBs had incorporated some relevant requirements of Regulation (EC) No 889/2008, as amended by Regulation (EC) No 392/2013, in force since 1 January 2014. The lack of adequate verification of the internal procedures used by CBs for the controls is not in line with Article 92c(1) of Regulation (EC) No 889/2008. The audit team identified several shortcomings in the office audits carried out to both CBs (e.g. inadequate selection of operators for additional visits, inconsistent and inadequate enforcement measures applied by CBs, inadequate notification of severe irregularities to the CAs) that had not been identified by the CCA.

However, the CCA only evaluates the topic covered by the supervision, and the overall performance of the inspectors is not evaluated. This is not in line with Article 27(9)(b) of Regulation (EC) No 834/2007. As a result, the supervision by the CCA did not identify the systematic shortcomings observed by the Commission audit team during the inspections witnessed. (see findings 54 and 55). 7

However, the report on the result of the supervision carried out in early September 2015 was submitted to CB1 only on 20 April 2016. At the time of the present audit, the report had not been submitted to CB2. As a consequence, both CBs had not yet implemented corrective actions to address the shortcomings identified by the supervision. Some of the shortcomings described in the CCA reports were again observed during the inspections observed by the audit team. This delay in the communication of the results of supervision undermines its effectiveness, as it does not ensure that corrective actions are taken by CBs in a timely manner. Conclusions on Control Bodies: Approval, Supervision and Withdrawal of approval

Member state response

The CCA modifies and completes the checklist ­ presented at the y audit ­ considering Article 92 point c) of Regulation (EC) No : 889/2008. Deadline: 31 of March 2017 The CCA regulates the preparation time of the audit report in the President's Statement No 3/2014 of the National Food Chain d Safety Office on the procedure and coordination of National Food Chain Safety Office concerning the tasks related to organic uction e Deadline: 30 of June 2017 (when setting the deadline we considered the present reorganisation of the structure and competence of the CCA)

The CCA modifies and completes the checklist ­ presented at the y audit ­ considering Article 92 point c) of Regulation (EC) No : 889/2008. Deadline: 31 of March 2017 The CCA regulates the preparation time of the audit report in the President's Statement No 3/2014 of the National Food Chain d Safety Office on the procedure and coordination of National Food Chain Safety Office concerning the tasks related to organic uction e Deadline: 30 of June 2017 (when setting the deadline we considered the present reorganisation of the structure and competence of the CCA)

The recommendation states as its basis

There were four transhipment consignments of products during 2015 which were destined for the Budapest-Liszt Ferenc BIP. This BIP had not detected the relevant TRACES notification sent from the first EU BIP although staff stated that TRACES notifications are checked twice per day. The competent authority contacted Customs who confirmed that all four consignments had been released for free circulation as they had CVEDs (see finding 10). A similar finding was reported in report DG(SANTE) 2014-7012 but corrective actions have not been implemented. Conclusions on the system to ensure presentation of consignments for veterinary checks

There is a system is in place to ensure that no consignment from a non-EU country is introduced into EU territory without being subjected to veterinary checks, although the system did not work for consignments transhipped via other Member States during 2015 at Budapest-Liszt Ferenc BIP. 5.3.2 Veterinary checks and the decision on the consignment Legal requirements Articles 4, 8, 15 and Annex III of Directive 97/78/EC, Article 4(1) of Directive 91/496/EEC, Article 27(2) of Commission Regulation 142/2011, 4(2)(d) of Commission Decision 2001/812/EC, Annex II of Commission Decision 97/794/EC and Commission Decision 94/360. Findings

Member state response

erring to 1st point of our letter which has been sent to the County Government Offices supervising the BIPs (in the following: Letter) , the following action was proposed by the central competent authority: TRACES system needs to be checked for this purpose on a daily basis by the BIP staff in a documented way the BIP veterinarians have to organise a training on the duly completion of a CVED and the transhipment consignments for the local Customs Office. A deadline for the local action plan for the recommendation was set (see attached the Letter in Hungarian language)

The recommendation states as its basis

In relation to the implementation of physical checks on consignments (products), the audit team noted that: Röszke BIP received 82% of consignments presented at Hungarian BIPs in 2014. Staff at Röszke BIP stated that physical checks are often carried out without unloading any of the consignment from the means of transport and can be based on only a visual examination of the boxes. This approach does not comply with the requirements of Section 3.4 of the BIP Manual. It also does not comply with Annex III of Directive 97/78/EC which describes the aim and types of physical checks to be conducted at BIPs. This also means that CVEDs do not reflect the reality of the controls done at the BIPs. Finding 22 from report DG SANCO/2014-7008 reported on the lack of unloading for physical checks at Röszke BIP and the situation has not changed. Contrary to the requirements of Decision 94/360/EC Röszke BIP does not implement the reduced physical checks regime. The excessive number of controls is not based on suspicion or a documented risk assessment. The BIP implemented physical checks in 905 out of 1,237 consignments destined for import during 2014.

In general, veterinary checks and decisions on consignments are correct but there are several issues which undermine the effectiveness of the system. The most significant of these is at Röszke BIP where the system to implement physical checks does not comply with national or EU requirements. Appropriate corrective action was not implemented in response to a related finding in report DG(SANCO) 2014-7008. This means that CVEDs do not reflect the reality of the controls done at the BIPs and the competent authority does not ensure that corrective action is taken when needed.

Member state response

The requirements for physical checks in Point 3.4 of the BIP al has been modified accordingly and the 2nd point of the Letter also includes some proposal on the practical implementing.

The recommendation states as its basis

In relation to the implementation of physical checks on consignments (products), the audit team noted that: Röszke BIP received 82% of consignments presented at Hungarian BIPs in 2014. Staff at Röszke BIP stated that physical checks are often carried out without unloading any of the consignment from the means of transport and can be based on only a visual examination of the boxes. This approach does not comply with the requirements of Section 3.4 of the BIP Manual. It also does not comply with Annex III of Directive 97/78/EC which describes the aim and types of physical checks to be conducted at BIPs. This also means that CVEDs do not reflect the reality of the controls done at the BIPs. Finding 22 from report DG SANCO/2014-7008 reported on the lack of unloading for physical checks at Röszke BIP and the situation has not changed. Contrary to the requirements of Decision 94/360/EC Röszke BIP does not implement the reduced physical checks regime. The excessive number of controls is not based on suspicion or a documented risk assessment. The BIP implemented physical checks in 905 out of 1,237 consignments destined for import during 2014.

Röszke BIP does not implement the reduced physical checks regime which leads to the incorrect application of the risk based approach established for import of certain goods in the EU. 5.3.3 Use of TRACES Legal requirements Article 3 of Decision 2004/292/EC. Findings

Member state response

BIP officer's attention has been drawn to the proper ntation of the reduced physical checks regime in point 4 of the Letter.

The recommendation states as its basis

Only Röszke BIP has received incoming transit consignments in recent years, e.g. 628 consignments during 2014. Details on non-confirmed consignments were sent about every two months to the central competent authority for further investigation. The audit team noted that the BIP did not consult with local Customs before consulting the central competent authority. This is not in line with internal procedures and causes unnecessary delays. It was clarified during the audit that the central office was not aware that Röszke BIP had not been contacting local Customs before it forwarded the list to them.

At Záhony BIP 20 out of 21 consignments were checked in 2014. In Röszke 4 out of 13 consignments were checked during 2014. Neither BIP followed-up the consignments not presented for checks.

There was one consignment in TRACES which indicated Eperjeske as the exit BIP (notified in December 2013). The BIP had not detected the notification via their daily screening and therefore had not informed Customs. The CVED indicated that the consignment was being transported by road. The competent authority confirmed that it had exited via BIP Záhony without being checked by the BIP. The same staff is responsible for import controls at the BIPs Eperjeske and Záhony, yet the consignment had not been detected. Transits of live animals

There were no entry transits and only four exit transits via Hungarian BIPs during 2014 and 2015. No Part IIIs of the CVEDs were completed by the exit BIPs in TRACES. One 11 consignment was discussed during the audit, i.e. a cat which entered via Budapest-Liszt Ferenc and with Röszke as the exit BIP. The animal was destined for Serbia and the CVED did not contain any details for the means of transport after the entry BIP and therefore the exit BIP could not detect it. Budapest-Liszt Ferenc did not receive any confirmation of exit via TRACES and did not follow this up with Customs. Controls on free and customs warehouses

Veterinary checks carried out at entry BIPs on consignments in transit comply with EU requirements and ensure that only eligible consignments are accepted. The system to promptly identify and follow-up consignments for which no confirmation of receipt at destination has been received by the entry BIP was not being implemented as planned, reducing the ability of the system to identify non-conforming consignments that have not left the Union as planned.

Member state response

The BIP officer's attention has been drawn to the procedure already described in the BIP Manual with point 9 of the Letter.

The recommendation states as its basis

Eperjeske BIP Facilities, equipment and hygiene conditions are compliant with the exception of: Facilities are shared for checks on consignments destined for human and non-human consumption but there is no documented risk assessment contrary to Article 4(5) of Decision 2001/812/EC. There is currently no system to ensure that equipment is calibrated as required. 12

Kelebia BIP Facilities and equipment were found to be sub-standard due to their poor maintenance (in addition to the main deficiencies identified in the other BIPs, at Kelebia, the most serious included broken doors preventing access to the unloading area) and hygiene conditions were poor.

Röszke BIP Facilities, equipment and hygiene conditions are compliant with the exception of: The storage room for frozen consignments destined for human consumption was being used to store paper files and office equipment at the time of the audit and was therefore unavailable for its intended use. The BIP staff stated that this situation had existed for about one year and no specific deadline for resolution was available. Although a written procedure exists to ensure appropriate cleaning and disinfection of the entire BIP, no records were available of its implementation. There is currently no effective system to ensure that equipment is calibrated as required.

Záhony BIP Facilities, equipment and hygiene conditions are compliant with the exception of: There is currently no system to ensure that relevant equipment is calibrated as required. Conclusions on the compliance of the facilities, equipment and hygiene conditions of the BIPs visited

BIPs have been constructed to an adequate standard but the lack of maintenance limits the possibility to use the facilities for their intended purposes and/or implement official controls correctly. Specifically in Kelebia BIP the facilities cannot be used for identity and physical checks.

Member state response

The requirement for a local supervision of cleaning/disinfection, calibration of devices, etc. have been set up in a new Annex in the BIP Manual (Annex XX). The BIP officer's attention has been drawn to this requirement in point 8 and 10 of the Letter. Page: 1 ort ref. DG(SANTE)/2015-7505-MR of the audit carried out from 25 trol system A central supervision check will be done at BIP Kelebia on 21 June 2016. (see attached Doc1) The possibility of suspension of the BIP Kelebia is petitioned to the responsible Secretary of State. (see attached Doc2)

Member state response

A Common Contingency Plan for all exotic diseases (requiring a contingency plan) will be drawn up latest by 31/12/2016. aim is to have better synergy between contingency plans of different mal diseases and to enhance unified and standardized emergency response in the country. A series of standardized operational and disease manuals will be drawn up in the future as well. This new system ensures, that new operation or disease manuals can be added to the existing ones. The deadlines for the completion of Operational Manuals: General Operation Manual on animal depopulation ­ 31/12/2016 General Operation Manual on disposal ­ 31/12/2016 General Operation Manual on biosecurity, cleansing and disinfection - 31/12/2016 The deadlines for updating and drawing up new Disease Manuals: - FMD ­ 31/12/2016 - ASF ­ 31/12/2016 endations received 18 July 2016 ted by the competent authorities of Hungary on 27 May 2016 in response to Report ref. eptember 2015 to 17 September 2015 in order to evaluate the implementation of contingency on the protection of animals during depopulation for disease control - CSF - 31/12/2016 - AI ­ 31/12/2016 - ND ­ 31/12/2016 - LSD, SVD, VS ­ 31/03/2017 - AHS ­ 31/06/2017

Member state response

ch emphasis will be given to standardisation in the operation manuals he exact role of county level contingency plans is being re-evaluated. fter the completion of the Common Contingency Plan, starting from 2017 ounty level contingency plans will be collected and reviewed by the central ompetent authority. Recommendations for amendments will be made where ecessary.

The recommendation states as its basis

There are no documented procedures containing information and instructions for officials carrying out inter alia controls on storage conditions, transport and handling of vaccine baits1. Such procedures are required under Article 8(1) of Regulation (EC) No 882/2004 and are aimed at ensuring the quality and consistency of official controls that is required under Article 4(4) of the Regulation. Conclusions on competent authorities

Although training on rabies eradication and surveillance takes place at all relevant levels, the lack of documented procedures for official controls by official veterinarians on the storage of oral rabies vaccine may lead to inconsistencies in the implementation of these controls.

Article 3(2) Regulation (EC) No 882/2004 states that official controls shall be carried out without prior warning. However, all controls on storage conditions, transport and distribution of the oral rabies vaccine carried out by the competent authorities are pre-announced to the operators. Before the start of each campaign Circular letters are sent from NFCSO to the Food Chain Safety and Animal Health Directorates of County Government Office, comprising inter alia the schedule and area of the campaign, information on vaccine storage/ distribution and instructions to carry out an official control at each airfield during the vaccine distribution. For the autumn campaign 2014 this circular letter was issued three weeks before the start of the campaign and indicated suitable days for visits by official veterinarians to each airfield and contact details for agreeing the date and time for the visit with the subcontractors. 8 Visits to each airfield by NFCSO-VMPD were pre-announced to the subcontractor and dates for these visits were indicated in the contractor's plan for the 2014 autumn campaign.

Once the 2014 vaccine batches had been accepted into the cold store the responsibility for maintaining the cold chain was delegated to the contractor/subcontractors and not closely verified by the competent authorities. The contractor for aerial bait distribution had delegated the responsibility for ensuring that the cold chain was maintained from acceptance of the vaccine batches at the cold store until the end of the vaccination campaign 3-4 weeks to several subcontractors. o In one airfield the subcontractor (flight operator) had the day-to-day responsibilities for correct storage of the vaccine consignment, transport of vaccine baits to the airfield, storage there, batch traceability, aerial distribution of baits and manual distribution to subcontractors. o Two other subcontractors were responsible for transporting the vaccine from the cold store and storage at all the other airfields in the refrigerated trucks used for the transport. o One subcontractor was responsible for manual distribution of vaccine baits. NFCSO-VMPD had planned to carry out one announced visit to each airfield during each distribution period. Records from the 2014 autumn campaign showed that such visits (by staff from central level) had been made to five of the six airfields. The NFCSO-VMPD visits were recorded on standardised check lists and had been made in the presence of the operator and sometimes the official veterinarian. The check list includes checks on records of vaccine stock, manually kept temperature records, storage temperature at the time of the visit, the functionality of planes and bait drop equipment, and the texture of vaccine baits. The NFCSO-VMPD visits did not include checks on flight route data or bait drop data at the airfield and neither the NFCSO nor the contractor could cross-check the manual temperature records against the built-in temperature recording devices in the transport/storage vehicles as they had no access to the readings of these during the campaign. In the Circular letter for the 2014 autumn campaign District Offices were instructed to carry out one announced inspection on each airfield during the distribution period. Records from the 2014 autumn campaign showed that four of the six airfields had not been inspected from District Offices.

The procedures agreed between the competent authority and the contractor for immediate reporting of non-compliant storage temperatures were not adhered to in 2014. The contractor for vaccine distribution does not carry out any checks on the activities of the subcontractors during the vaccine storage period or during vaccine distribution. However, the subcontractors are instructed to contact the contractor in case of problems. NFCSO-VMPD stated that it had been agreed with the contractor that such contacts should be made if the storage temperatures exceeded -15oC and records of such interventions should be provided in the final report from the campaign. Records in the final report from the 2014 autumn campaign showed no evidence of contacts between the subcontractor and the contractor when storage temperatures had exceeded -15oC for 4 days in two of the airfields. In the second of these airfields storage temperatures up to -5oC were recorded. Further checks showed that these problems had concerned one transport vehicle which, although a malfunctioning cooling unit had been identified by the flight subcontractor at one airfield, had subsequently been used by the transport subcontractor for storing vaccine at a second airfield. The contractor stated that 9 the subcontractor for vaccine transport and airfield storage would be requested not to use this vehicle in the next vaccination campaign. No deviating results in population immunity for 2014 were seen in in the areas serviced by the two airfields where non-compliant storage temperatures had been recorded however the monitoring results cover the whole year.

Once the vaccine has been accepted upon delivery to the cold store the responsibility for the implementation of an oral vaccination campaign rests with private operators (subcontractors) who are neither supervised by the main contractor nor subject to unannounced official controls by competent authorities during the campaign. This system is not effective as illustrated by the fact that deficiencies in the cold chain during 2014 had neither been corrected by the contractor nor reported at the time to the competent authorities.

Member state response

The official control of storage of the vaccines in the cold store before distribution is the task of the district official veterinarian. Additionally, as of 2015 spring campaign an un-announced control of storage conditions in the cold store performed by the CA has been introduced. The storage conditions during distribution are controlled at the airfields by the competent district official veterinarian. To harmonize these field controls, a check- list has been issued by the CA before 2015 spring campaign.

Member state response

and As of 2015 spring campaign for the first time QGIS 2.8.1. "Wien" ency of software was used for the assessment of the flight&dropping data collected by the flight companies (subcontractors) responsible for ed in bait distribution. These data were sent electronically on a daily ion basis to the central authority and to the contractor. With this method both the authority and the contractor receives timely d information of the work performed on the given day, and would have the opportunity to order corrective actions if necessary.

The recommendation states as its basis

The SMSD stated that various FVO audit reports recommendations in different departments higlighted the need to develop a new procedure for the verification of effectiveness and appropriateness of the official controls of different sectors in line with Articles 4(2)(a) and 8(3) of Regulation (EC) No 882/2004. The SMSD held a meeting with the sectors to provide guidance on the development of the new procedure, in January 2014. The SMSD sent an email providing guidance on the development of the procedure. This includes a SWOT analysis (analysis of strengths, weaknesses, opportunities and threats) of the official controls and the setting of measurable objectives and criteria related to them. The NFCSO departments should provide the results of this analysis to the SMSD by 14 March, 2014 and after that, a meeting would address any issues and finalise the procedure. Regarding the official import controls, at the time of the audit this development was in progress.

The certified system (finding 2) includes verification of effectiveness of the audit activities (which also include the central level supervision). After the ISO certification no verification according the new procedure (finding 2) has been followed on the official import controls.

No verification of effectiveness of the official import controls by following the new verification procedures was available at the time of the audit.

The competent authority is developing the activities for verification of effectiveness of the official import controls including objectives and indicators. The competent authority has not planned to implement such verification activities since 2012 leading to an absence of the evaluation of effectiveness and appropriateness of the official import controls and their compliance with EU legislation. 4

The competent authority has last audited in 2011, one of the BIPs' visited by the audit team. Both BIPs visited underwent their most recent supervision from the central level in 2010. Apart from these, the competent authority conducted a supervision on the approved warehouse under Article 12 of Directive 97/78/EC in 2010. All other BIPs last underwent a supervision either in 2010 or in 2012.

There is no head of the BIP in Budapest airport since 2011. No verification (central nor local) activities were followed on this BIP for this period of time. The competent authority issued a decision in March 2014 to have the former head of the BIP once per week to supervise the BIP activities.

No verification has been conducted on the activities of the official import controls sector at central level (LATSTD).

The competent authority does not conduct verification relating to official controls of consignments subject to veterinary inspection in customs warehouses (finding 6). However, the Customs have notified at least in two cases the competent authority regarding consignments subject to veterinary controls that had not been checked in a BIP, and which were found in customs warehouses during clearance procedure. The competent authority stated that those consignments were brought back to a BIP for veterinary inspection. 5.2.2 Veterinary checks

The head of the BIP Roszke stated that he conducts an informal supervision every two weeks on documentary checks, physical checks, sampling, facilities. Once per month he picks files of imported consignments and he assesses the correctness of the controls. He stated that he also checks TRACES on a weekly basis. The audit team noted that there is no written instruction for the supervision and the results of the supervison are not documented, which makes the statement not verifiable.

The head of the BIP Roszke conducts a monthly meeting with the inspectors in which among others, he stated that he is providing feedback on the errors he identifies in the official controls. The audit team assessed the notes and the agenda of three meetings selected by the head of the BIP and these had no information on deficiencies identified during supervision activities.

The verification activities were not implemented for the last two years, which means that the competent authority cannot ensure the effectiveness and appropriateness of the official import controls and their compliance with EU legislation.

An annual report follows the verification activities of the NFCSO. The SMSD and the management of NFCSO are using this report to set priorities and directions in the planning of the official controls and also the planning of the verification activities. However, as no verification activities were followed for the LATSTD since 2012, there was no input and impact of this reporting to the official import controls for the last two years.

The BIPs provide reports of the official import controls they conduct on a monthly, quarterly and annual basis to the central level. These include figures of imports. Currently the competent authority does not use this information to verify the effectiveness of the official import controls

The internal audit referred to in finding 14, identified some shortcomings and recommended to have available all relevant documented procedures and to keep staff up-to-date on their tasks. However, the audit report indicated that no action plan was required. There was no follow-up on the recommendations and no corrective actions were implemented contrary to the requirement of Article 8(3)(b) of Regulation (EC) No 882/2004.

The organisation of the verification activities foresees the use of the results of verification for planning and improving the official controls and also the future verification activities. However, in the area of the official import controls this has not been done for the last two years. Regarding verification activities conducted until 2012, improvements in the performance of the import controls were evident, however there were cases in which shortcomigns were not addressed meaning that the verification activities did not ensure the effectiveness and appropriateness of the official import controls and their compliance with EU legislation.

The recommendation states as its basis

There was one "technical audit"/central supervision carried by NFCSO-DAHAW-LATSTD in March 2014 on ABP legislation which included an assessment of the correct use of TRACES. The report was not available at the time of the FVO audit but preliminary feedback was that no 1 In their response to the draft report, the competent authority noted that CEDs must be issued via the use of TRACES in all DPEs (BIPs) within Hungary as from 1 September 2013. 10 significant issues were detected related to the use of TRACES at the one ABP establishment visited during the audit.

There is a system of local supervision by managers at the two BIPs and two LVUs visited which includes an evaluation of the use of TRACES. There are no instructions to cover local supervision and no specific reports are created. The head of one BIP visited stated that the results of the supervision are discussed during monthly meetings with staff although this is largely undocumented/recorded. The managers at both LVUs stated that they share the relevant outcomes of their supervision activity with appropriate colleagues but that this is largely undocumented/recorded (one LVU started supervision in January 2014). There was no local supervision at one of the two BIPs visited between 2011 to the time of the FVO audit due to the absence of the head of the BIP. According to the competent authority, there are plans to recommence local supervision at that BIP in the near future.

None of the issues identified by the FVO (findings 18 to 21, 24, 26 to 31, 36 and 37) had been identified by the various forms of verification being implemented by the competent authority with the exception of the rate of confirmation of receipt at destination for channelled consignments. Conclusion on verification and review

The system in place to assess the use of TRACES in BIPs and LVUs does not ensure that deficiencies are detected and corrective actions are implemented when required. As a consequence, (i) information in the database does not always reflect accurately the controls implemented and (ii) the system is not used to detect shortcomings in the implementation of controls (e.g. no controls at destination of consignments requiring them) and those remain inadequate.

The recommendation states as its basis

There is one customs warehouse in Hungary which is approved under Article 12(4) of Council Directive 97/78/EC which stores very small amounts of consignments of non-conforming goods. The last consignment entered into TRACES by the LVU responsible for this warehouse was in November 2012. The LVU has been granted Super LVUs (SLVU) status so that it can issue CVEDs for split consignments. The SLVU used such a collective account where the officials' names were not listed and therefore their names were not recorded individually when they issued CVEDs for consignments split at the warehouses (see finding 34).

Staff at BIPs and LVUs use TRACES correctly for routine activities. However, the receipt at destination of many consignments is not notified to BIPs or Member States of origin (e.g. slaughter animals, animal by-products), contrary to the legal requirements. This means that the traceability of such consignments is compromised and the arrival of the goods at the intended operator is not confirmed to origin.

Member state response

The modification of national regulations is in progress which

Member state response

to 11, 12: The CCA asked the training body to complete the training with a training material for the purposes of slaughter without stunning and with a training module for operators working in establishments killing fur animals. 13: According to the opinion of the CCA, Regulation (EC) 1099/2009 (henceforward: the egulation) does not lay down that the training shall include a practical part, however, we proposed the training body to include a practical part as well, if possible. If it is not possible, the CCA proposed the use of training videos concerning the different operations. e 14: Up to this day, the number of the certificates issued for the animal welfare officers: 163, and for the operators: 334. 7: In Hungary, certificates issued for animal welfare officers are valid for each category of animals and type of equipment ­ as the training for animal welfare officer is complete ch and covers all of these parts. According to paragraph (4) of Article 17 of the Regulation: " the animal welfare officer shall hold a certificate of competence (...) issued for all the operations taking place in the slaughterhouses for which he or she is responsible." 19: There are two types of trainings

Member state response

to Circulars will be issued to call the attention of the county CAs to of enhance the control of the fulfilment and frequency of sampling (both for own and official sampling).The deadline for action is 30 June 2014

Member state response

We will publish guides on the NFCSO's website both for official veterinarians and for FBOs on the number and frequency of mpling, and also a summary on the sampling methods of specific poultry populations. Deadline for action: 30 June 2014

Member state response

We will publish guides on the NFCSO's website for official of veterinarians and for FBOs on the number and frequency of sampling, and also a summary on the sampling methods of specific poultry populations. Regarding the antimicrobial testing bials and the eggs originating from flocks that are suspected of being infected with target Salmonella serotypes, a circular will be sent to the county CAs. The deadline for action is 30 June 2014

Member state response

We will publish guides on the NFCSO's website both for official of veterinarians and for FBOs on the number and frequency of g sampling, and also a summary on the sampling methods of specific poultry populations. Deadline for action: 30 June 2014

Member state response

The accreditation of the Veterinary Diagnostic Directorate of the NFCSO is in process. The NRL warned the unauthorized boratory situated abroad to apply for approval and to take part in the ring tests organized by the NRL. The deadline for action is 30 June 2014 Page: 1

Member state response

EDs will be completed with TRACES ning session was held on the use of the of the CED documents for all the raining was carried out jointly by the Animal Health and Animal Welfare f Plant Protection and Soil nloaded from the following link. /u/22454397/el%C5%91ad%C3%A1s st of attendance.

Member state response

ill be completed with TRACES ning session was held on the use of the of the CED documents for all the raining was carried out jointly by the Animal Health and Animal Welfare f Plant Protection and Soil nloaded from the following link. /u/22454397/el%C5%91ad%C3%A1s st of attendance. Page: 1 3-6639-MR of an audit carried Proposed by the Competent Authority

Member state response

een to be issued by the NFCSO with pletion of the CED. Based on this guideline, rontline customs staff is expected to be tive provisions of both the NFCSO Based on the coordination between seem to be substantial and satisfactory consignments to be released into free eted CED documents. National Food Chain Safety Office irectorate are invited to carry out a l Tax and Customs Authority. The also for them. loaded from the following link u/22454397/el%C5%91ad%C3%A1s 9g%C3%BCgyi%20elle %C3%A9ge%20%C3%A

Member state response

t was sent to the Commission on 17 July 2013. Page: 2 3-6639-MR of an audit carried by the Competent Authority

Member state response

easures to improve the equipment as ble tools will be purchased.

Member state response

tical samples are ground and homogenized in 006 a Retch ZM200 mill ensuring t will be delivered soon. Page: 3

Member state response

lmiszer-termelés, -elállítás és -értékesítés feltételeirl szóló VM rendeletre vonatkozó észrevétellel kapcsolatban rábbi álláspontunkat, amely szerint a rendelet nem állapít tartalmú szabályozást, amely indokolná a notifikációt. Az véleményét kérjük továbbá abban a tekintetben, hogy a . cikk (3) bekezdése szerinti felhatalmazás alapján intetében kell-e alkalmazni a 853/2004/EK rendelet 10. szerinti notifikációs kötelezettséget. almú baromfiipari létesítményekre vonatkozó eltéréseket ály notifikációjára vonatkozó észrevétellel edik a vágópontok mködésének részletes 2011. (VII. 29.) rendelet notifikációs eljárásának

Member state response

nc-biztonsági és állategészségügyi elnökhelyettese Page: 1 2013-6691-MR of an audit carried g the production and placing on the market y the Competent Authority 13. számú körlevelében azt az utasítást adta a megyei miszerlánc-biztonsági és állategészségügyi k, hogy a vágóhídon minden esetben a hatósági állatorvosnak n elvégeznie az élállatok vágás eltti vizsgálatát, mivel az i szállításának állategészségügyi szabályairól szóló 87/2012 ndelet alapján az állattartó telepen a vágóhídra történ n az állatorvosi bizonyítványt a szolgáltató állatorvos írja alá. A tartalmazza. entések alapján számos esetben csak a ortosításával tudták végrehajtani az utasítást.

Member state response

célzó javító intézkedésekre vonatkozó dokumentumok egy róértekezleten átadta a központi hatóság az FVO team részére ás túllépés megszüntetésére, 2. számú melléklet) tések alapján a hiányosságok egy részét már pótolták: s felújítási munkálatokat végeztek (fal, padozat, lábazat és áraképzdés megelzésére és a levágott testek a i elemeivel történ érintkezésének kiküszöbölésére, feletti elektromos vezetékek és fémcsövek burkolása et szereztek be (rekeszmosógép, központi fémdetektor, beléptet kapu, kézmosók számának növelése ásuk felülvizsgálata) Page: 2 2013-6691-MR of an audit carried g the production and placing on the market tent Authority dett várakoztató és az élállatszállító gépkocsik yben a ládák mosásának átalakítása folyamatban határid 2013. október 31. adalékanyagokra vonatkozó ajánlásokra ld. 10. és a 11. pontnál. létesítményekben ne forduljanak el hasonló óság meg fogja küldeni az FVO ellenrzésrl s jelentést a megyei igazgatóságok számára, romfi létesítmények felülvizsgálata során külön hogy elfordulnak-e hasonló hiányosságok, lan kijavítására és 2013 évvégi jelentés részeként ót. Határid: a központi hatóság számára a nyelv fordításának megérkezésétl számított 5 ágok számára

Member state response

az NÉBIH élelmiszerlánc-biztonsági és elnökhelyettese 02.4/00766/0041/2013. számú körlevelében ivatalok élelmiszerlánc-biztonsági és gait az engedélyezett létesítmények mködési ntetett és az országos listán szerepl adatok összevetésére és 2013. június 15-ig való megküldésére a NÉBIH ÉTbI kiterjed arra is, hogy a jövben a megyei igazgatóságok t legfeljebb 30 napon belül jelezni a NÉBIH ÉTbI Page: 3 2013-6691-MR of an audit carried g the production and placing on the market roposed by the Competent Authority tása érdekében. A megyei jelentések alapján az országos lista t. A körlevelet a 3. számú melléklet tartalmazza. sítményekben ­ ahol szükséges volt ­ megtörtént a osítása: a nem végzett tevékenységeket törölték, M"-et tüntettek fel valamint meghatározták az MSM darabolásra vonatkozó névleges maxmimális kapacitás

Member state response

program összeállításakor a NÉBIH ÉTbI kiemelten fogja llenrök szankciókra vonatkozó oktatását annak érdekében, egységesek, hatékonyak, arányosak és visszatartó 014. évi képzési program összeállításának határideje: NÉBIH ÉTbI 2011-ben kiadta a Hatósági Útmutatót, gyjteménye, folyamatosan bvül a hatósági ellenrzés ó új fejezetekkel és frissítése szükség szerint, de évente mal megtörténik, jelenleg az 5. kiadás hatályos. A fejezete magába foglalja a baromfi vágó,-darabolóüzemek e vonatkozó eljárásrendet (amely az FVO audit során llenrök részére), ennek 10. pontja tartalmazza a nem oganatosítandó hatósági intézkedéseket. A Hatósági ei is foglalkoznak a szankcionálással (pl.bírságok

Member state response

gelzen a központi hatóság az "oktatók oktatása" elve mányhivatalok élelmiszerlánc-biztonsági és Page: 4 2013-6691-MR of an audit carried g the production and placing on the market y the Competent Authority gyi igazgatóságai megyei higiénikusainak tartott oktatást egyei higiénikusok pedig "továbboktatták" a hatósági etékességi területükön. Az FVO ellenrzést követen a megváltoztatta a képzési módszert olyan módon, hogy ósági ellenrök számára tart oktatást 7 helyszínen, regionális épzés kötelez mindenki számára, aki élelmiszerlánc- ági ellenrzést végez. Az engedélyköteles létesítmények sére vonatkozó oktatási anyagot (amely magába foglalja a nyek hatósági ellenrzését is) elektronikus formában minden egkapja. Az eladásokat követen a hallgatóknak rdés felvetésére, konzultációra. A képzés végén a résztvevk adnak számot tudásukról. Az oktatás beleszámít a tzésbe mely szerint valamennyi közszolgálati ente részt kell vennie legalább egy szakmai továbbképzésén. it a NÉBIH viseli. zéséhez a NÉBIH ÉTbI megküldte a 854/2004/EK rendelet összeállított oktatási anyagot a megyei igazgatóságok számára. enleg a megyei igazgatóságok végzik.

Member state response

kon, amelyeket az FVO ellenrzés érintett és ez a tásra került, megtörtént a kábító berendezés, az állatok tának és az kábítással kapcsolatos üzemi dokumentáció A berendezéseket átalakították, beállították. A pulykavágóhídon ábító berendezés beszerzésére kerül sor, valamint a Page: 5 2013-6691-MR of an audit carried g the production and placing on the market e Competent Authority megtörténik oly módon, hogy a függesztés és a kábítás lerövidítik. más létesítményekben ne forduljanak el hasonló nti hatóság meg fogja küldeni az FVO ellenrzésrl végleges jelentést a megyei igazgatóságok számára, gy a baromfi létesítmények felülvizsgálata során külön arra, hogy elfordulnak-e hasonló hiányosságok, ladéktalan kijavítására és 2013 évvégi jelentés részeként efoglalót. Határid: a központi hatóság számára a magyar nyelv fordításának megérkezésétl számított 5 azgatóságok számára az évvégi jelentés megküldése.

Member state response

c-biztonsági és állategészségügyi elnökhelyettese számú körlevelében azt az utasítást adta a megyei élelmiszerlánc-biztonsági és állategészségügyi a vágóhídon minden esetben a hatósági állatorvosnak kötelessége dokumentáltan elvégezni az élállat r is, ha ez a tevékenység a megszokott munkaidn kívül gi idszak). Az utasítás kiterjed arra, hogy hogy amíg a delkezik a 854/2004/EK rendeletben elírt sak a hatósági állatorvos folytonos felügyelete körlevelet az 1. számú melléklet tartalmazza. A megyei zett jelentések alapján számos esetben csak a hatósági tosításával tudták végrehajtani az utasítást. A hatósági való jelenlétével kapcsolatos kockázatbecslést a központi 2013-6691-MR of an audit carried g the production and placing on the market by the Competent Authority i. Határid: 2014. február 28.

Member state response

izsgálati ponton megállapított hiányosságokat már pótolták az nyekben. Megjegyzend, hogy az audit idpontjában az ályaszakasz üres volt, mivel itt tevékenységet nem ükör ezért nem volt a helyén. fogja vizsgálni a baromfi vágó,-darabolóüzemek hatósági lakított eljárásrendet abban tekintetben, hogy a késleltetett rán egyetlen post mortem vizsgálati pont elegend-e a fogyaszthatósági döntés meghozatalához, valamint szaksegédek felügyeletére ennek dokumentálása vonatkozásában. Határid: 2013.

Member state response

zerlánc-biztonsági és állategészségügyi elnökhelyettese Page: 7 2013-6691-MR of an audit carried g the production and placing on the market Action Proposed by the Competent Authority ámú körlevelében utasította a megyei szerlánc-biztonsági és állategészségügyi gy haladéktalanul intézkedjenek egyes vállalkozások an megtéveszt gyakorlatának megszüntetésére, mely lefejtett, intalanított, un. báderhúst darált húsként ék, valamint az MSM-et beleszámolják a ústartalmába. atóság határozatban kötelezte azt a vállalkozást a s megszüntetésére, ahol az FVO ellenrzés A vállalkozás megfellebbezte a határozatot, a NÉBIH els fokú döntést.

Member state response

ényekben, ahol az FVO ellenrzés megállapította a nem ok használatát, a termékek receptúrájából törölték ás létesítményekben ne forduljanak el hasonló i hatóság meg fogja küldeni az FVO ellenrzésrl gleges jelentést a megyei igazgatóságok számára, a baromfi létesítmények felülvizsgálata során külön rra, hogy elfordulnak-e hasonló hiányosságok, déktalan kijavítására és 2013 évvégi jelentés részeként oglalót. Határid: a központi hatóság számára a agyar nyelv fordításának megérkezésétl számított 5 gatóságok számára az évvégi jelentés megküldése. Page: 8 2013-6691-MR of an audit carried g the production and placing on the market Action Proposed by the Competent Authority a NÉBIH ÉTbI által kiadott Hatósági Útmutató I. fejezet mazza az élelmiszer adalékanyagok hatósági ellenrzésére endet. i program összeállításakor a NÉBIH ÉTbI kiemelten fogja ellenrök adalékanyagok felhasználásának hatósági kozó oktatását. A 2014. évi képzési program atárideje: 2014. február 28.

Member state response

kben, ahol az FVO ellenrzés hiányosságokat állapított rel kapcsolatban, már megtörtént azok pótlása. ogy más létesítményekben ne forduljanak el hasonló zponti hatóság meg fogja küldeni az FVO ellenrzésrl lv végleges jelentést a megyei igazgatóságok számára, hogy a baromfi létesítmények felülvizsgálata során külön nak arra, hogy elfordulnak-e hasonló hiányosságok, haladéktalan kijavítására és 2013 évvégi jelentés részeként sszefoglalót. Határid: a központi hatóság számára a tés magyar nyelv fordításának megérkezésétl számított 5 igazgatóságok számára az évvégi jelentés megküldése. a NÉBIH ÉTbI által kiadott Hatósági Útmutató I. fejezet lmazza a HACCP alapú eljárások hatósági ellenrzésére endet. követen a NÉBIH által kialakított új tipusú képzési i ellenrök oktatása során kiemelten foglakozunk az tesítmények HACCP alapú eljárásainak hatósági Page: 9 2013-6691-MR of an audit carried g the production and placing on the market sekkel. ÉBIH ÉTbI továbbra is P alapú eljárások hatósági pzési program

Member state response

- It has to be emphasised that the case found during the audit was individual, and the county directorate carried out the appropriate b) of measures in favour of meeting the requirements of Article 4(1)b) of Regulation (EC) 882/2004. The official veterinarian for the farm concerned has been changed. - A training course was held on 21 November 2013 by the head of h) unit of the NFCSO Animal Health and Animal Welfare irectorate on rules of movements and TRACES for the county official veterinarians (No of the invitation is 02.3/2530/2013). Requirements on aquatic animals were part of the lecture material, namely: - movements of aquatic animals, including INTRA certificates that were addressed by the FVO - control rules of aquatic animal consignments from other countries - guidelines on completing the animal health certificate part of the documents, by species, including fish Lecture material and guideline were sent to the participants by e- mail and were also uploaded on the internal website of NFCSO. Please, find attached the invitation, the list of participants and the guideline made for the training on the health certificates by species, including fish. A special training on aquacu

Member state response

isterial Decree No 113/2008 on the rules of notification of diseases lays down the requirements for listed fish diseases well. In accordance with its annexes, ISA and KHV are to be orted also on national level and to the EU. SVC is also listed in Annex 1 among diseases notifiable on national level, so the nty directorates are obliged to report these cases to the central petent authority. Page: 2 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. Art 26 of Decree No 127/2008 also lays down ­ in accordance with Art 27(b) of Directive 2006/88/EC ­ that the chief veterinary officer is to inform other member states and the Commission within 24 hours on listed non-exotic diseases if the country was declared free from that disease. This requirement is applicable for ISA and KHV in Hungary. Taking into account the above mentioned legal references, only notification of SVC on EU level is not transposed directly, but this obligation is laid down in a directly applicable Decision No 2010/221/EU. In our opinion, as SVC is not a listed disease anymore, the 24 hours obligation cannot be required under 27(b) of

Member state response

isterial Decree 127/2008 will to be amended accordingly to be rought in line with the rules of authorisation in Directive 2006/88/EC. s A new electronic database (FELIR) is under development for the registration of operators under Paragraph 47/B. of Act No XLVI of 2008 on the food chain and its official control, carrying out any activity that falls under the control of the food chain, including aquatic animal production businesses. Page: 3 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. l the finalization of the new system, a guideline for the stration form (questionnaire) of the aquaculture farms is lized and is available on the public website of NFCSO on the owing link: ://www.nebih.gov.hu/szakteruletek/szakteruletek/mgszh_aai/n atvanyok_aai the registration form itself for aquaculture establishments a completed example form for carp breeding farms can be d on the link above, in favour of unified interpretation of e documents. registration forms of the aquaculture farms which are lable now on the NFCSO website are going to be updated l 15th of April 2014.

Member state response

ee 127/2008 Article 4 paragraph (3) on aquaculture animal health already laid down the type of establishments that are to be . registered only, in accordance with Directive 2006/88/EC. rding the appropriate procedures of registration and approval, se, see answers to point 3. registration forms of the aquaculture farms which are lable now on the NFCSO website are going to be updated l 15th of April 2014. rding rules on small quantities, Ministerial Decree No 010. (IV. 30.) on the requirements of small quantity food Page: 4 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. production, preparation and sale lays down that under maximum 6000 kg of fish per year, a food production business is in accordance with Article 1(3)c) of Regulation 853/2004/EC. In accordance with the definition in the Decree, a small quantity producer provides small quantities of self-produced or collected/harvested primary product directly to the final consumer and to a retailer or catering operator within 40kms or the same region, within the territory of Hungary. These producers are registered by the district veterinary offic

Member state response

ision 2008/896/EC is indirectly implemented in Annex 2 of Decree 127/2008 that lays down the concerning main rules on risk egorisation of farms in accordance with Directive 2006/88/EC. Page: 6 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. When amending Decree 127/2008, a reference is to be inserted in to the directly applicable Decision 2008/896/EC to draw the attention to the detailed rules of risk categorisation. The guideline regarding the determination of the risk level of farms is going to be worked out until 28 February 2014 in the frame of the risk-based animal health surveillance schemes. NFCSO-DAHAW has worked out the official guideline to risk- based classification of fish farms, and has distributed to the county directorates on 12 March 2014. The guideline is publicly available on the following link of NFCSO website: https://www.nebih.gov.hu/szakteruletek/szakteruletek/aai/kozerde ku_aai/egyeb_informacio/utmutato.html

Member state response

The accreditation process of the laboratories of the NRL in apest is ongoing. The external audit of the National Accreditation Body is expected in first half of 2014.

Member state response

e development of the contingency plan is in progress and is intended to be submitted for approval in accordance with the procedure referred to in Article 62(2). The contingency plan is to be finalized until 1 May 2014.

Member state response

On 21 November 2013, a TRACES training was held by the competent head of unit of the NFCSO- Directorate of Animal Health and Animal Welfare to the county OVs, including the rules for the movement of fish. (please, see answer to point 1) ace In accordance with the training of 21 November 2013, circular letter No 0.2/1726/1/2013. of 13 December 2013 was released by the NFCSO to county directorates on the use of TRACES on Page: 7 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. ional level. the basis of the circular, all county directorates are obliged to ue the rules of procedure on the monitoring of consignments m other member states. The circular contains rules on data oading, error notification, planning of controls and uploading reof into TRACES. circular stresses the importance of the health certificate part the commercial documents, with examples concerning aquatic mal health. o a guideline was elaborated on the county rules of procedure the use of TRACES and on the handling of commodities from er member states in the TRACES system. The guideline vides risk assessment aspects that have to be

Member state response

in Rules of Regulation 1251/2008/EC is to be required for the ignments of susceptible species for breeding and further keeping regarding diseases that Hungary has a higher health status . checklist for farm controls was completed with the question fish consignments from or to other member or third countries the past one year, and also the conformity of consignment uments is to be ensured during the check, in favour of ceability. favour of the proper implementation and adequate control of movement rules, a circular and a guideline has been issued as cribed in point 8. the reinforcement of movement rules concerning SVC, a arate circular will be issued for the county Directorates and o for the stakeholders to draw the attention to the rules Page: 8 eport ref. DG(SANCO)/2013-6784 -MR of a/an audit carried out from 04 ontrols in place for live aquaculture animals and products thereof. originating from the higher health status of Hungary. The obligations concerning the certificates for live fish will be also highlighted. A guideline will be also prepared on this issue. In favour of the proper implementation of aquatic animal health rules, an expert meeting was held in the MRD on 3 Februa

Member state response

Milking farms will be registered by the District Office - large scale farms by the end of 2014 - others by the end of 2015 To ensure that the procedure and system for the calculation of the frequency of inspections at approved establishments and milk production holdings enables a risk based and appropriate frequency of official controls, taking into account the relevant risk parameters as required by Article 3.1 of Regulation (EC) No 882/2004. Answer of the competent authority: The risk ranking system of the official controls of the food-, feed- and animal health sector is based on the following data: -type of activity (animal farming, approved food production etc.) performed in the establishment -other risk factors related to activity (capacity, species kept etc.) -result of the last official control -time elapsed since last official control The risk ranking is IT based (OAIR system), the algorithm used results in a risk score. If the risk score exceeds the limit set, the establishment will be put automatically into the annual plan. Due to the high score given to type of activity each approved food processing establishment is loaded into the plan, but according to the system's str

Member state response

SD will hold a training for county food hygienist on 27 March 2014. One subject of the training will be the experiences d from FVO audit 2013-6889 especially about the shortcomings of t and about the actions to be taken to address the dations. This includes the introduction of the system to ata of establishments to central level. (Annex 1: letter of ning and its' annexes (Annex1_1; Annex 1_2; Annex 1_3) regional training for food and feed). Furthermore NFCSO ref. DG(SANCO)/2013-6889 -MR of a/an audit carried out from 18 by the competent authorities with regard to official controls related to ed an order (02.4/01677/0000/2014.) for the CGO DFCSAHs ubmit all the operation permits by 31 May 2014 in order to let CCA have an up-to-date view on the operations carried out by oved establishments. (Annex 2: letter 02.4/01677/0000/2014.) ation permits have to include the approved activities carried species by species.

Member state response

All Trichinella laboratories will be involved in the ring trials nised by the National Reference Laboratory for Parasites P) in the first half of 2014. Laboratories with unsatisfactory lts will also be involved in the training and validation system he NRLP. Following validation, a repeated proficiency test be organised for these laboratories in the second half of 2014.

Member state response

training on 27 March 2014 (see Annex1) and the seven regional trainings during the year will include the subject to give edback to the farms on the ante mortem and post mortem ection results carried out at the slaughterhouses. The cedures for the official control of red meat establishments" : 3 ref. DG(SANCO)/2013-6889 -MR of a/an audit carried out from 18 by the competent authorities with regard to official controls related to ll be issued by the end of 2014 as part of the Official Guide.

Member state response

tioned during the opening meeting, the trainings according Regulation No. (EC) 1099/2009 are continuously organized ng the year. Recently more than 50 animal welfare officer ld a certificate of competence as referred to in Article 21, and re than 100 persons involved in killing and related operations ok part on the necessary training, and have the certificate of mpetence.

Member state response

In the review program for 2014, approved on 17 December 2013 1.2/504-1/2013.), NFCSO FFSD named the topic of "the review ractice for the control of production, utilization and belling of MSM in approved food producing establishments". e inspections will take place in 4 counties (county/ID number: abolcs-Szatmár-Bereg/2014-24; Pest/2014-25; Bács- skun/2014-26; Jász-Nagykun-Szolnok/2014-27) (Annex 3: view program for 2014). e NFCSO FFSD will hold a training for county food hygienist ee Annex 1) which will include the topic of "review of the actice for production, utilization and labelling of MSM". The ry same topic will be included in the 7 regional trainings in 14 organized by the relevant department of NFCSO FFSD pproved Food Production Supervision Department). e "Procedures for the official control of red meat tablishments" will be issued by the end of 2014 as part of the Page: 4 ref. DG(SANCO)/2013-6889 -MR of a/an audit carried out from 18 by the competent authorities with regard to official controls related to the on and of inings

Member state response

V.23.) FVM rendelet 2012. május 9-én megjelent a 2009/128/EK irányelv átültetése a hazai szabályozásba selekvési terv kidolgozására vonatkozó 4. cikk kivételével ­

Member state response

vényvédelmi Cselekvési Terv jelenleg egyeztetés alatt áll, en meghatározott határidre megküldésre kerül a és a többi tagállamnak. . november 26.

Member state response

élyezett termékek tekintetében gyakorlatunk megfelel az k. Azonban számos olyan növényvédelmi probléma van, lomban lév, de az adott kultúrára még nem engedélyezett r használatával lehet megoldani, ezek többsége iterjesztés. A kiskultúráknál felmerül problémák re az eredeti engedélyek módosítására van szükség. . december 31.

Member state response

iztosításához az élelmiszerláncról és hatósági óló 2008. évi XLVI. törvény módosítására van szükség. december 31.

Member state response

elkülönített tárolását a növényvédelmi tevékenységrl szóló 23.) FVM rendelet módosításában kívánjuk elírni, a FAO megfelelen. . szeptember 30. Page: 1 f. DG(SANCO)/2012-6287-MR of an audit carried Action Proposed by the Competent Authority

Member state response

ényvédszer-analitkai Laboratórium modernizációja tekintetében folyamatban van. december 31.

Member state response

ódmezvásárhelyi Növényvédszermaradék- ratóriuma az EN ISO/IEC 17025:2005 szabványnak égzi tevékenységét. Akkreditációs minsítését 2012. en megkapja. tóriumok a SANCO/12495/2011 számú, az élelmiszerekben és nlév növényvédszer-maradékok vizsgálatára rvalidálási és minség-ellenrzési eljárásokkal ánymutatásban foglaltaknak megfelelen mködnek tevékenységet független minségbiztosítási felügyel zeresen. A rendszeres vezetségi átvizsgálás a ndeletnek és a SANCO minség szabványainak való s kiterjed. tt minden laboratórium részt vesz az illetékes európai dszermaradék-analitkai laboratóriumoknak szervezett méréseken.

Member state response

ezzük a történelmi növényvédszer hulladék ismételt jtési akciókból eddig kimaradt 14 megyében. Page: 2 f. DG(SANCO)/2012-6287-MR of an audit carried Action Proposed by the Competent Authority érés alapján becsült ártalmatlanítási költségekre 2013-ban, a ségvetés készítésekor a tárca javaslatot tesz a költségfedezet a történelmi növényvédszer hulladék begyjtésére és sára azokban a megyékben, ahol eddig nem történt meg. nyílik arra, hogy 2014-ben véglegesen megoldódjon a édszerek hulladékainak problémája.

Member state response

3. évi Élelmiszerlánc-felügyeleti Tervében a növényvéd delmének és felhasználásának ellenrzési programja án kerül kialakításra. április 1.

Member state response

d szerek kereskedelmének és felhasználásának hatósági meghatározó eljárásrendek jelenleg kidolgozás alatt állnak. end készül a kereskedelmi egységek, külön a termelknél elyi valamint a termhelyi ellenrzésre. Az eljárásrendek z ellenrzések végrehajtásakor jelenleg is alkalmazott rül. Az eljárásrendek az ellenrzési helyszínek z kockázatbecslési útmutatót is tartalmazni fognak. július 1.

Member state response

sztési Minisztérium és a Közigazizgatási és Igazságügyi illetékes államtitkárságai között, a szakmai és ai kérdések egyeztetése folyamatos.

Member state response

kiadott ajánlások nyomonkövetésére vonatkozó elírásokat Page: 3 f. DG(SANCO)/2012-6287-MR of an audit carried Action Proposed by the Competent Authority tok végrehajtására kiadott hatósági eljárásrend 10.5 fejezete eljárásrend mellékelten megküldve.)

Member state response

igazgatóságai szakterületi ellenrzéseket végeznek, k 2013-tól része lesz az ellenrzések hatékonyságának Page: 4

Member state response

lelmiszerekben elforduló szennyez anyagok, az elsdleges termelés szintjére vonatkozó sa folyamatban van. (Határid: 2013. július 31.)

AO-PPSCAD: The MGSZH-NTI: Amint azt korábban írtuk az eljárásrend kidolgozása procedures for the official folyamatban van, és az alábbi ütemezésben lesznek a feladatok végrahajtva: controls of food contaminants · 2012. december 31-ig Helyes Mezgazdasági Gyakorlat alapján at primary production level are útmutató kiadása termelknek; currently being developed. · 2013 els félévében az ellenrök oktatása (kockázatbecslés, (Deadline: 31 July 2012) mintavételi eljárásrend). (Deadline: 31 July 2013) Az illetékes hatóság (korábbi nevén MgSzH) jelenleg dolgozik egy átfogó az elsdleges termelk regisztrációját szolgáló elektronikus rendszeren. Ennek várható mködési idpontja 2014 els negyedéve. Az elektronikus rendszer mködésének beindulásáig az illetékes hatóság az ellenrzéseket az új eljárás szerint a meglev adatok alapján végzi.

Member state response

i monitoring tervben, az elsdleges növényi i megtervezésre kerültek; a 2012-es tervben már

AO-PPSCAD: The national MGSZH-NTI: A 2012-es monitoring tervben - az adatszerzés érdekében - itoring plan includes the mintavételi számokat már szerepeltettünk. A kapott adatok alapján 2013-as ber of samplings for monitoring terv már a megkövetelt dokumentációs eljárásnak is eleget fog ary plant products: they tenni a 12. pontban tervezett eljárásnak megfelelen. (Határid 2012. ready feature in the plan for december 31.) 2012.

Member state response

bI speciális képzést fog tartani az ben elforduló szennyez anyagok elemzését célzó hatósági rén a megyei kormányhivatalok élelmiszerlánc-biztonsági ügyi igazgatóságainak. A képzésen résztvevknek pedig gzottakat tovább kell adniuk a megyéknél és a kerületi gozó ellenröknek. (Határid: 2013. július 31.) SZH-NTI hatósági mintavétel terén megfelel seket fog tartani. (Határid: 2013. július 31.)

AO-FFSD: The AO-FFSD MGSZH-NTI: Az 1. pontban említett ütemezésnek megfelelen. (Határid: l provide specific training 2013. július 31.) in the official sampling of food for contaminants analysis for Page: 1 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority he staff of the county overnment offices of the ood Chain Safety and Animal ealth Directorates. The articipants in the training ust pass on the knowledge cquired in the training to the nspectors working in the ounties and the district ffices. Deadline: 31 July 2012) Deadline: 31 July 2013) O-PPSCAD: The AO- PSCAD will provide dequate regional training in he official sampling of food or contaminants analysis. Deadline: 31 July 2012) Deadline: 31 July 2013)

Member state response

lmiszerekben elforduló szennyez anyagok, zésének az elsdleges termelés szintjére vonatkozó lgozása folyamatban. (Határid: 2013. július 31.) Page: 1 DG(SANCO)/2012-6290-MR of an audit carried ed by the Competent Authority

he AO-PPSCAD: The procedures for the official MGSZH-NTI: Az említett eljárásrend határideje legkésbb 2013. július 31. ontrols of food contaminants f at primary production level are Page: 2 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority urrently being developed. Deadline: 31 July 2012) Deadline: 31 July 2013)

Member state response

H-ÉTbI egy részletes eljárási útmutatót fog lynek részét fogja képezni az élelmiszerekben elforduló agok megfelel mintavételi eljárásaira vonatkozó ási útmutató elektronikus úton is elérhet lesz a t végz ellenrök számára. (Határid: 2013. július iszerekben elforduló szennyez anyagok, nek az elsdleges termelés szintjére vonatkozó zása folyamatban van. (Határid: 2013. július 31.)

O-FFSD: The AO-FFSD l produce a detailed manual f of procedures including a guide to the procedures overning the sampling of ood for contaminants nalysis. The manual of rocedures will be available in lectronic format for the fficers performing official ampling. Deadline: 31 July 2012) Deadline: 31 July 2013) O-PPSCAD: The rocedures for the official ontrols of food contaminants t primary production level are urrently being developed. Deadline: 31 July 2012) Deadline: 31 July 2013) Page: 3 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority

Member state response

július 1-jei hatállyal igazgatói utasítás került amely alapján az EURL munkaértekezleteket követen az ntéseket az EURL által szolgáltatott információkkal és ütt iktatni kell, és azokat elektronikus úton meg nyezanyagok vizsgálatát végz valamennyi hatósági e. A munkaértekezletet követ laboratóriumvezeti t vev kolléga beszámolót tart a munkaértekezletrl, mentálni kell.

AO-FFSD: The Director ed an order taking effect n 1 July, under which llowing the EURL working sion the completed field eports must be submitted ogether with the information nd working papers provided y the EURL to all official aboratories involved in the esting of contaminants. The ttending fficial is required to give a resentation on the EURL orking session at the ubsequent laboratory meeting, hich is recorded in the inutes.

Member state response

udit idpontjában a Kecskeméti Regionális boratórium MSZ EN ISO/IEC 17025:2005 szabvány ditációjának megújítása folyamatban volt, a helyszíni anuár 11-én megtörtént. A Laboratórium az akkreditált ius 3-án megszerezte, amelynek tényét a NAT-1- Page: 2 DG(SANCO)/2012-6290-MR of an audit carried the Competent Authority ditálási okirat bizonyítja. ez akkreditációs felülvizsgálat alkalmával az akkreditációs okiratban a vizsgált növényi mátrix atnyilag növényi anyag szerepel).

n AO-FFSD: At the time of the MgSzH-ÉTbI: A nem akkreditált módszerek a validálás után legkorábban udit the renewal of the sorra kerül akkreditálási felülvizsgálat során területbvítésként kerülnek accreditation of the Kecskemét akkreditálásra. A validálás határideje a 9. ponthoz tartozó táblázatban egional Food Chain szerepelnek. Laboratory according to MgSzH-NTI: A laboratórium a MSZ EN ISO/IEC 17025:2005 szerint Page: 4 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority tandard MSZ EN ISO/IEC akkreditált. Az akkreditált terület a növényi anyagok nitrát meghatározására 7025:2005 was underway; an vonatkozik, amely egy szélesebb kiterjesztést takar, beleértve a zöldség-, nspection was performed on gyümölcsöket is. ite on 11 January 2012. The aboratory obtained its ccredited status on 3 March 012, as attested by ccreditation certificate No AT-1- 1306/2012. O-PPSCAD: The term examined plant material' urrently used will be changed o `examined plant matrix' in he next scheduled ccreditation review.

Member state response

MGSZH-ÉTbI egy részletes eljárási útmutatót fog elynek részét fogja képezni az élelmiszerekben elforduló elel mintavételi eljárásaira vonatkozó el mennyiség minta biztosítását. július 31.) izottsági rendelet I. Mellékletében illetve a II. ban elírt feltételek biztosítása érdekében az ÉT-NRL e helyezett egy nagy kapacitású RETSCH ZM-200 t, mely lehetvé teszi a nagy mennyiség egyesített ban történ feldolgozását. rilisban kiadott feladatterv már tartalmazza a csolatos hiányosságok kijavítását.

O-FFSD: The AO-FFSD l produce a detailed manual of procedures including a procedures governing ampling of food for ontaminants analysis, as well s a guide to providing an Page: 5 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority ate quantity of samples. Deadline: 31 July 2012) Deadline: 31 July 2013 n an effort to meet the equirements set out in Annex and point 2 of Annex II to ommission Regulation (EC) o 401/2006, the Food oxicological National eference Laboratory (FT- RL) has acquired a large- apacity RETSCH ZM-200- ype grinder enabling the aboratory processing of large uantities of homogenised amples. O-PPSCAD: The task list ssued in April 2012 already ncludes the task of addressing he shortcomings of sampling.

Member state response

z auditot követen az ÉT-NRL validásási ütemtervet validált vizsgálati módszerek validálására, mely yancsak megújításra került a validálásokat elsegít szerzdése. módszerek validálását a laboratóriumok 2012. Page: 3 DG(SANCO)/2012-6290-MR of an audit carried Action Proposed by the Competent Authority 31-re vállalták.

AO-FFSD: Following the udit, the FT-NRL issued a MgSzH-ÉTbI: Csatolt melléklet. chedule for validating the MGSZH-NTI: A nitrát meghatározás módszerének validálása a tervezett Page: 6 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority ethods that have not yet been adekvált eszközbeszerzés elhúzódása miatt késbbi idpontra tolódik. alidated. A copy of this Terveink szerint a validálás elemei a következk lesznek: alidation schedule is 1. specifikusság, vailable. Also, the licence 2. linearitás, greement for the Interval 3. torzítatlanság, oftware managing the 4. pontosság, alidations was renewed. 5. tartomány, O-PPSCAD: The 6. stabilitás meghatározása, aboratories have agreed to 7. kimutatási határ megállapítása. ave their analytical methods A validálást követen jártassági vizsgálaton való részvételt tervezünk. alidated by 31 December (Határideje: 2013. június 30.) 012.

Member state response

I: 2012. július 1-jei hatállyal igazgatói utasítás került k értelmében az MGSZH-ÉTbI valamennyi n a mérési eredményeket a 401/2006/K bizottsági et 4.4 pontja (mikotoxinok) illetve a 333/2007/EK delet D része (nehézfémek) alapján, a visszanyerések e vételével és a kiterjesztett mérési bizonytalanság közlésével dni. : A hibák kijavítására a korrekciós intézkedések tek.

orted AO-FFSD: The Director ued an order taking effect MGSZH-NTI: A módszer validálásakor a mérés bizonytalanságát is July 2012, under which meghatározzuk. nalytical results in all (Határid: 2013. június 30.) aboratories of the AO-FFSD re provided as required by t 4.4 of Annex II of ommission Regulation (EC) 2006 (mycotoxins) and art D of the Annex to ommission Regulation No Page: 7 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food ction Proposed by the Action Proposed by the Competent Authority ompetent Authority 33/2007 (heavy metals), with dequate information on ecovery and expanded easurement uncertainty. O-PPSCAD: Corrective easures have been taken to emedy the errors.

Member state response

MGSZH-NTI és az MGSZH-REFI: Már a 2012-es itoring tervezés során közös minotoring terv készült zanyagok vizsgálatára. ÉTbI és az MGSZH-NTI együttmködési dásában foglaltak folyamatosan felülvizsgálatra kerülnek a ényesebb és hatékonyabb együttmködés érdekében.

nd AO-FFSD, AO-PPSCAD and SMSD: A joint food ontaminants monitoring plan as developed for the year 2. he issues governed by the greement between the AO- FSD and the AO-PPSCAD re regularly reviewed in the nterest of successful and ffective cooperation.

Member state response

ntavételi tervezési eljárásrend kidolgozása és Határid: 2012. december 31.) Page: 4 DG(SANCO)/2012-6290-MR of an audit carried the Competent Authority

O-SMSD: Development and ntroduction of annual sampling planning procedures Deadline: 31 December 2012). Page: 8 Hungary to the recommendations of Report ref. DG(SANCO)/2012-6290-MR of an audit carried out from te controls for contaminants in food Action Proposed by the Action Proposed by the Competent Authority Competent Authority Page: 9

Member state response

és Takarmánybiztonsági Igazgatóság (ÉTbI): s takarmányok kapcsán kiadott útmutatót nlás értelmében ki fog terjedni a 0,9% alkalmazására armány kapcsán. ember 15.

Member state response

Takarmánybiztonsági Igazgatóság (ÉTbI): alidált vizsgáló módszerek száma az új GMO ének következtében folyamatosan növekszik. Az eti be ezeket az új módszereket, jelenleg 23 t. Az akkreditálás feltétele, hogy megfelel n az új módszer használatában (ez minimum 3 az akkreditálásra vonatkozó nemzeti jogszabály rek akkreditálásának adminisztratív folyamata a Testületnél minimum 6 hónap. A 2012. év végéig ben még nem akkreditált módszerek yamatban van. A még nem akkreditált módszerek t a vizsgálati jegyzkönyvben a laboratórium Page: 1 CO)/2012-6303-MR of an audit carried ically modified organisms including their Action Proposed by the Competent Authority

Member state response

Takarmánybiztonsági Igazgatóság (ÉTbI): gészítjük az illetékes hatósági személyzetnek szóló ak vonatkozásában, hogy azok a vállalkozások, ületen szabálysértést állapítottak meg, milyen edéseket foganatosítsanak. zeptember 15.

Member state response

rmánybiztonsági Igazgatóság (ÉTbI): gészítjük az illetékes hatósági személyzetnek szóló ak vonatkozásában, hogy ha az élelmiszerek területén szabálysértést állapítottak meg, milyen eljárást kell ágnak. zeptember 15. Page: 2

Member state response

re Emberi Erforrások Minisztériuma: A 92/52/EGK tanácsi irányelv elírásainak a magyar jogba történ átültetését megvalósító jogszabály-módosítást az Emberi Erforrások Minisztériumának 2012. II. félévi jogalkotási munkaterve tartalmazza.

uman Resources Human Resources' legislative schedule for the second ludes the legislative amendments necessary to transpose e 92/52/EEC into Hungarian law.

Member state response

rm NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): Az anyatej-helyettesít és anyatej-kiegészít tápszerekre és bébiételekre vonatkozó speciális ellenrzési paraméterek teljes kör beépítése a 2013. ssing évre vonatkozó monitoring tervbe, hogy megvalósuljon a hatékony C) ellenrzés az elállítás, a feldolgozás és a forgalmazás minden szintjén. (Határid: 2013. március 31.) NÉBIH Növény-, Talaj- és Agrárkörnyezetvédelmi Igazgatóság (NTAI): A hatósági ellenrzések kiterjesztése az elsdleges mezgazdasági termelk szintjére a bébiételekre vonatkozó egyedi rendelkezések betartása érdekében a 2013. évre vonatkozó monitoring tervben (Határid: 2013. március 31.) Emberi Erforrások Minisztériuma: Az anyatej helyettesít és anyatej-kiegészít tápszerek ellenrzése laboratóriumi vizsgálatokkal kiegészítve az ÁNTSZ 2013. évre tervezett Page: 1 ed 7 September 2012 ns of Report ref. DG(SANCO)/2012-6365-MR of an audit carried n taken by the competent authorities with regard to official controls over ply chain Action Proposed by the Competent Authority kiemelt munkatervi feladatainak részét képezi. A bébiételek hatósági ellenrzése laboratóriumi vizsgálatokkal kiegészítve az ÁNTSZ 2012. év kiemelt

Safety Directorate of the National Food Chain Safety ure effective controls at all stages of production, and distribution, the special monitoring parameters for infant low-on formulae and baby foods will be incorporated in nto the 2013 monitoring plan (Deadline: 31 March 2013) lant Protection, Soil Conservation and Agri- he NFCSO official controls to include primary agricultural ill be incorporated into the 2013 monitoring plan in with the specific provisions on baby foods (Deadline: n Resources nt formulae and follow-on formulae, including , are among the priority tasks to be included in the Page: 1 . DG(SANCO)/2012-6365-MR of an audit carried ompetent authorities with regard to official controls over Action Proposed by the Competent Authority n for 2013. Official controls on baby food, including s, were a priority task under the NPHMOS 2012 work plan course of implementation.

Member state response

A NÉBIH és az ÁNTSZ közötti együttmködési megállapodás megkötése a hatáskörök egyértelm elhatárolása érdekében a hatósági ellenrzés minden szintjén, az elállítás, a feldolgozás és a forgalmazás on területén. (Határid: 2013. június 30.) Az erre a területre vonatkozó nemzeti jogszabály módosítással kapcsolatban is megtesszük a szükséges lépéseket.

cooperation agreement between the NFCSO and the iew to clearly delineating their respective official controls at all stages of production, processing ion. (Deadline: 30 June 2013). ing the necessary steps to amend the national legislation

Member state response

n a risk NÉBIH Rendszerszervezési és Felügyeleti Igazgatóság (REFI): A 1 (a) 2012-es évben ez már megvalósult. A Nemzeti Élelmiszerlánc- biztonsági Hivatal által kiadott 2012. évi Élelmiszerlánc-biztonsági és Állategészségügyi Létesítmény Ellenrzési Terv egy informatikai háttérrel támogatott kockázatbecslésen alapul. A kockázati modell a következ alapadatokból épül fel: - Létesítmény alapbesorolás (pl. engedélyezett élelmiszer elállítás, bejelentésköteles élelmiszer elállítás) - Létesítmény kockázati profil (pl. kapacitás, kiszállítási tevékenység) - Korábbi ellenrzés tapasztalatai - Elz ellenrzés óta eltelt id Az adatokat a rendszer egy elre megadott algoritmus alapján értékeli, és Page: 2 ed 7 September 2012 ns of Report ref. DG(SANCO)/2012-6365-MR of an audit carried n taken by the competent authorities with regard to official controls over ply chain Action Proposed by the Competent Authority apott érték szerint sorba rendezi a létesítményeket. Az egyes esítményekhez tartozó értékek alapján készíti el a NÉBIH REFI az uális évre szóló ellenrzési tervet. A tervben szerepl létesítmények enrzését az illetékes területi hatóság osztja ki a dolgozóknak, a rehajtott ellenrzéseket a webe

Management Unit within the NFCSO: This task was already in 2012. The NFCSO's Food Chain Safety and Animal hment Control Plan published in 2012 is based on an IT- assessment. was constructed according to the following basic data: ication of the establishment (e.g. authorised food otifiable food manufacturer) of the establishment (e.g. capacity, supply activities) revious inspections st inspection. yses the data according to a pre-defined algorithm and Page: 2 . DG(SANCO)/2012-6365-MR of an audit carried ompetent authorities with regard to official controls over the Competent Authority blishments according to the results. The NFCSO nit uses the results for the individual repare the current year's control plan. The competent for the various establishments included in the plan ction tasks among its workers, and completed orded in the web module. The NFCSO System responsible for supervising the controls, and reports an's implementation.

Member state response

ontrol NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): Az . NÉBIH ÉTbI speciális képzést fog tartani az anyatej-helyettesít és atej-kiegészít tápszerek és bébiételek hatósági ellenrzése terén a yei kormányhivatalok élelmiszerlánc-biztonsági és állategészségügyi zgatóságainak. A képzésen résztvevknek pedig a képzésen angzottakat tovább kell adniuk a többi ellenrnek. (Határid: 2013. ember 31.)

d and Feed Safety Directorate The NFCSO Food and Feed rate will provide specific training on controls on infant formulae and baby foods for the staff of the county of the food chain safety and animal health attending the training will pass on the content to the Deadline: 31 December 2013).

Member state response

-on NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): A IH ÉTbI egy részletes eljárási útmutatót fog készíteni az anyatej- helyettesít, az anyatej-kiegészít és a bébiételek ellenrzésére icle 8 vonatkozóan. Az eljárási útmutató elektronikus úton is elérhet lesz a ósági ellenrök számára. (Határid: 2013. december 31.) IH Növény-, Talaj- és Agrárkörnyezetvédelmi Igazgatóság Page: 3 ed 7 September 2012 ns of Report ref. DG(SANCO)/2012-6365-MR of an audit carried n taken by the competent authorities with regard to official controls over ply chain Action Proposed by the Competent Authority I): A NÉBIH NTAI a bébiételek alapanyagának az elsdleges elés szintjén való hatósági ellenrzésére vonatkozó eljárásrendet fog lgozni. (Határid: 2013. december 31.)

nd Feed Safety Directorate The NFCSO Food and Feed will prepare a detailed manual of procedures for ant formulae, follow-on formulae and baby foods. s will also be able to access the manual electronically. ber 2013). f Plant Protection, Soil Conservation and Agri- Page: 3 . DG(SANCO)/2012-6365-MR of an audit carried ompetent authorities with regard to official controls over he Competent Authority O Directorate of Plant Protection, Soil i-environment will develop a set of procedures for the primary production stage of baby food raw 31 December 2013).

Member state response

controls NÉBIH: Az egyes szakterületek hatósági ellenrzéseinek hatékonyságát az adott terület által végrehajtott szakterületi ellenrzések hivatottak télni. Minden szakterület maga állítja össze központi útmutatóit, ek megvalósításáról és a megvalósult ellenrzések hatékonyságáról lülvizsgálati programban tervezett szakterületi ellenrzések során tud yzdni. Szakterületi ellenrzéseket a NÉBIH központi illetékes gatóságai a megyéknél a 6. pontban jelzett eljárási útmutatók szülte után, azok betartásának ellenrzése céljából fognak tartani.

l Food Chain Safety Office ss of official controls in specific areas is assessed by the ed in the area concerned. Each area compiles its own and their implementation and the effectiveness of the verified during the specialised area controls planned gramme. The competent central directorates of the pecialised area controls in the counties after the s referred to in point 6 have been prepared, in order are being complied with.

Member state response

ory NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): rszágos mintavételi terv már kiegészült a vizsgáló laboratóriumok elölésével (2012. 06. 01-én), így mind a papír alapú dokumentációt náló mintavevk, mind a ­ korábban is létez informatikai ldást használó ­ elektronikus dokumentációt használó mintavevk rik a kijelölt akkreditált hatósági laboratóriumot. Amennyiben a avev olyan mátrix ­ paraméter kombináció vizsgálatát kéri, yre a hatósági laboratóriumi hálózat nem rendelkezik akkreditált zerrel, a NÉBIH-ÉTbI Koordinációs és Módszertani Laboratóriuma Page: 4 ed 7 September 2012 ns of Report ref. DG(SANCO)/2012-6365-MR of an audit carried n taken by the competent authorities with regard to official controls over ply chain Action Proposed by the Competent Authority veszi át a mintát és keres akkreditált szolgáltató laboratóriumot, amely megbízás alapján elvégzi a minta vizsgálatát.

nd Feed Safety Directorate ed testing laboratories has already been added to the an (on 01.06.2012), so those taking the samples, g with paper documentation or those using the who were using the existing computerised system ch are the designated accredited official analysis of a particular matrix/parameter d for which the official laboratory network does not Page: 4 . DG(SANCO)/2012-6365-MR of an audit carried ompetent authorities with regard to official controls over Action Proposed by the Competent Authority ited method, the NFCSO Food and Feed Safety Coordination and Methodology Laboratory takes over the tracts an appropriately accredited laboratory to perform

Member state response

cial NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): are A hatósági laboratóriumi rendszerben akkreditált laboratóriumok végzik a vizsgálatot. A módszerek akkreditáltságát áttekintjük, és területbvítéssel biztosítani fogjuk a hálózatban minden szükséges paraméterre a megfelel laboratóriumi hátteret (Határid: 2013. július ds 31.) Ameddig a hatósági laboratóriumi hálózat nem rendelkezik akkreditált y módszerrel, a NÉBIH ÉTbI Koordinációs és Módszertani Laboratóriuma szi át a mintát, és keres akkreditált szolgáltató laboratóriumot, amely gbízás alapján elvégzi a minta vizsgálatát. NÉBIH Növény-, Talaj- és Agrárkörnyezetvédelmi Igazgatóság (NTAI): A Bizottság 2006/125/EK és 2006/141/EK irányelveiben külön kiemelt növényvédszer hatóanyagokra elírt határértékeknek való maradéktalan megfelelést a vizsgáló laboratórium 2013-ban esedékes újra akkreditálása során megvalósítja.

and Feed Safety Directorate accredited under the official laboratory system perform the ill review the accreditation status of the available tend coverage to ensure that the network has the ratory capacity for all the parameters required (Deadline: . cial laboratory network does not have a suitable accredited CSO Food and Feed Safety Directorate's Coordination boratory takes over the sample and contracts an edited laboratory to perform the tests. ate of Plant Protection, Soil Conservation and Agri- boratory will check that the limits laid down in ectives 2006/125/EC and 2006/141/EC for the active specific pesticides are being fully complied with during accreditation due in 2013.

Member state response

NÉBIH Növény-, Talaj- és Agrárkörnyezetvédelmi Igazgatóság ant (NTAI): h A Bizottság 2006/125/EK és 2006/141/EK irányelveiben külön kiemelt Page: 5 ed 7 September 2012 ns of Report ref. DG(SANCO)/2012-6365-MR of an audit carried n taken by the competent authorities with regard to official controls over ply chain Action Proposed by the Competent Authority növényvédszer hatóanyagokra elírt határértékeknek való maradéktalan megfelelést és az Unió többéves ellenrzési programjának betartását a food vizsgáló laboratórium 2013-ban esedékes újra akkreditálása során megvalósítja.

ate of Plant Protection, Soil Conservation and Agri- Page: 5 . DG(SANCO)/2012-6365-MR of an audit carried ompetent authorities with regard to official controls over Action Proposed by the Competent Authority boratory will check full compliance with the limits laid ssion Directives 2006/125/EC and 2006/141/EC for the s of specific pesticides, and with the EU's multiannual ogramme, during renewal of its accreditation due in 2013.

Member state response

d NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): A NÉBIH ÉTbI egy részletes eljárási útmutatót fog készíteni az anyatej- helyettesít, az anyatej-kiegészít és a bébiételek ellenrzésére vonatkozóan, amely magába fogja foglalni, hogy a hatósági ellenrzéseknek hogyan és milyen módon kell kiterjednie az összetételre és a címkézésre vonatkozó követelményekkel kapcsolatos egyedi kritériumokra. Az eljárási útmutató elektronikus úton is elérhet lesz a hatósági ellenrök számára. (Határid: 2013. december 31.)

d Feed Safety Directorate d and Feed Safety Directorate will prepare a detailed cedures for controls on infant formulae, follow-on baby foods, which will include instructions on how and ethods the official controls are to cover the individual compositional criteria. The manual will also be available to electronic form. (Deadline: 31 December 2013).

Member state response

siness NÉBIH Élelmiszer- és Takarmánybiztonsági Igazgatóság (ÉTbI): tems A NÉBIH ÉTbI egy részletes ellenrzési listát fog készíteni az No élelmiszeripari vállalkozók által létrehozott és fenntartott HACCP rendszerekre vonatkozó hatósági ellenrzésekre. Az ellenrzési lista elektronikus úton is elérhet lesz a hatósági ellenrök számára. (Határid: 2013. július 31.) Page: 6

d and Feed Safety Directorate ood and Feed Safety Directorate will compile a detailed r official controls on the HACCP systems set up and food business operators. The checklist will also be inspectors in electronic form. (Deadline: 31 July 2013). Page: 6

Member state response

dered the AH-county in question accordingly with official to take the appropriate measures. The final AH-county is 1 June 2012 for register OF/SI approve them as OF/SI storage plants. Previously, national ABP training `register/approval' was intends to continue including this issue in the

dered the AH-county in question accordingly with official to take the appropriate measures. The final AH-county is 1 June 2012 for register OF/SI approve them as OF/SI storage plants. Previously, national ABP training `register/approval' was intends to continue including this issue in the he CA 24 July 2012 y one county. However, the registration/approval to all counties during 30 November 2011 gards OF/SI (see slide 35 of attached s, that must be still working on this ic, (local) trainings in certain counties, rather than er.E.g. first local training was hold on 3 July the effectiveness will be continuously checked checks carried out by CCA.

Member state response

of ABP plants was once updated accordingly to the audit AH-central on 21 March 2012. Last update was on 8 May 10/rev2 technical specification document for list have been also thoroughly considered during /szakteruletek/szakteruletek/mgszh_aai/kozerde antartott/1774_2002_EK_info.html ill only available in HU language for a while, EN unched) /szakteruletek/szakteruletek/mgszh_aai/kozerde antartott/1774 an be checked on or) are under liquidation or not. AH-central was Page: 1 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers ction Proposed by the Competent Authority e in March 2012, but this check must be done vising AH-counties. It is drawn to the attention, that changes in related activity is primarily the obligation of for every issued approval or register documents nce about this immediate report obligation. ral instruction 02.3/2262/2009/2009. on the report ctivity related to ABP plants is still live. AH-central ttention by the check of AH-counties, whether they on or liquidation activities or not. AH-central will also ue in latter ABP trainings (exact training date not yet

of ABP plants was once updated accordingly to the audit AH-central on 21 March 2012. Last update was on 8 May 10/rev2 technical specification document for list have been also thoroughly considered during /szakteruletek/szakteruletek/mgszh_aai/kozerde Page: 1 n Plan received from CA 24 July 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers rity 2002_EK_info.html ble in HU language for a while, EN szakteruletek/mgszh_aai/kozerde n iquidation or not. AH-central was this check must be done It is drawn to the attention, that ctivity is primarily the obligation of roval or register documents iate report obligation. /2262/2009/2009. on the report BP plants is still live. AH-central k of AH-counties, whether they tivities or not. AH-central will also inings (exact training date not yet ty and product type only in Page: 2 n Plan received from CA 24 July 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers ction Proposed by the Competent Authority sing plants), and not deleted the activity in Section been amended accordingly by deleting the plant from tion flow between counties and CCA: es approvals/

Member state response

dy ordered accordingly the AH-county in question er 02.3/343/4/2012. to answer the obvious findings of The corrective measures have been taken. The follow up ried out by AH-county on 13 March 2012, the fficial minutes was taken. The representative of o present in this follow up check. ircular letter on processing plants also answers this

dy ordered accordingly the AH-county in question er 02.3/343/4/2012. to answer the obvious findings of The corrective measures have been taken. The follow up ried out by AH-county on 13 March 2012, the fficial minutes was taken. The representative of o present in this follow up check. ircular letter on processing plants also answers this rom the CA 24 July 2012 y taken concerning municipal centers related to that isited, so it can be considered not a countrywide, but ective action. Page: 3 n Plan received from CA 24 July 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers Authority tional ABP implementing Decree 45/2012./V.8/VM of the Minister of to its paragraph 30, all the municipal t be revised within one year from the e.As it has been mentioned before CCA y, it includes a new dedicated Section ntre revision checks. In the new ction, questions raised about . It has been also mentioned that fill- re made, to check the ABP category on ed.

Member state response

structed AH counties in question in order to answer tion with official letters 02.3/343/3/2012. and he Category 1 and 2 processing plant has taken all the arding introducing GTH marking, proper labelling, Page: 2 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers Authority rcial document deficiencies, marking bays etc. Follow up check on this , the 0004504 numbered official also provided about the check). The as not yet introduced GTH marking as proper calibration documents, but the ed. The final deadline given by the 2. wo deadlines for taking corrective g up a closed pipeline system and for ecording devices and 7 July 2012 for n and its documentation.

structed AH counties in question in order to answer tion with official letters 02.3/343/3/2012. and he Category 1 and 2 processing plant has taken all the arding introducing GTH marking, proper labelling, rcial document deficiencies, marking bays etc. Follow up check on this , the 0004504 numbered official also provided about the check). The as not yet introduced GTH marking as proper calibration documents, but the ed. The final deadline given by the 2. wo deadlines for taking corrective Page: 4 n Plan received from CA 24 July 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers the Competent Authority a closed pipeline system and for ing devices and 7 July 2012 for its documentation.

Member state response

cted other MSs to gather relevant information and in heir experience. According to the received OF/SI mixing ment document on 20 March 2012, the competent can consider this MS's experience on the residental instruction on OF/SI will be for the modification is September cessing plant which have been visited ng activity. Their approval has been 1/959/1/2012. decision of the uct is not labelled as it would be sleading anymore, labelling is used I Annex VIII to 142/2011/EU Page: 3 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers the Competent Authority ular' Cat 2 MBM). All of their MBM derived orwarded to a composting plant, where it is mixed with

cted other MSs to gather relevant information and in heir experience. According to the received OF/SI mixing ment document on 20 March 2012, the competent can consider this MS's experience on the ental instruction on OF/SI will be the modification is September ng plant which have been visited tivity. Their approval has been /1/2012. decision of the s not labelled as it would be ing anymore, labelling is used ex VIII to 142/2011/EU ll of their MBM derived sting plant, where it is mixed with 012 ed attached. d8XbAhXrcDNWQxZHJHYlk Page: 5 n Plan received from CA 24 July 2012 G(SANCO)/2012-6477-MR of an audit carried rements for organic fertilisers and soil improvers the Competent Authority list update .com/open?id=0BwABd8XbAhXrVzdPMGllWUlvSXc lementing Decree .com/open?id=0BwABd8XbAhXrdHVYV3l<5VXBZOGs (slide 35) .com/open?id=0BwABd8XbAhXrMF9l<YVQ2OWxmTVU

Member state response

/7/2012. circular instruction, AH-central intends to draw l the AH-counties on the main and crucial elements of processing plants. ecklist have been also modified and clarified by AH- R' System (National Animal Health Information checklist part gives the opportunity to explain on raised in the `Remark' column. Furthermore, AH- ith this recommendation in future ABP trainings of ing date not yet known). AH-central also decided to future processing plant checks. Page: 4

/7/2012. circular instruction, AH-central intends to draw l the AH-counties on the main and crucial elements of processing plants. ecklist have been also modified and clarified by AH- R' System (National Animal Health Information checklist part gives the opportunity to explain on raised in the `Remark' column. Furthermore, AH- ith this recommendation in future ABP trainings of ing date not yet known). AH-central also decided to future processing plant checks. Page: 6

Member state response

ion of a written procedure for planning and ampling plans; (31/12/2012)

ion of a written procedure for planning and ampling plans; (31/12/2012)

Member state response

nal/local colleagues from the targeted sampling from the targeted sampling, underline the avoiding m the same sites and individual animals (no:

nal/local colleagues from the targeted sampling from the targeted sampling, underline the avoiding m the same sites and individual animals (no:

Member state response

l/local colleagues from the effective sidue monitoring plan (30/11/2012). om the supervision of implementation the NRP, from the regional authorities, including the samples and the result of the investigation of the .4/01422/0030/2012).

l/local colleagues from the effective sidue monitoring plan (30/11/2012). om the supervision of implementation the NRP, from the regional authorities, including the samples and the result of the investigation of the .4/01422/0030/2012). bruary 2013 on receipt of the samples increased monitoring -compliant samples. county offices quarterly on the number and amples and binds them to replace these missing Page: 1 ion Plan (on Recommendation 3) received on 19 February 2013 2012-6527-MR of an audit carried ve animals and animal products Action Proposed by the Competent Authority ised monitoring guidance has been created, the near future. This new guidance includes s regarding the sampling methods and the

Member state response

published (Annex nr. 1), which purpose is to the test results integrating the test methods procedures with the eligibility criteria of performance statement contains also the measures to be g or exceeding the warning or intervention limit l cards. A training has been performed on the Page: 1 erein I, 2 and 4 can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=2968 2012-6527-MR of an audit carried ve animals and animal products petent Authority l cards (Annex nr 2. ­ training material, Annex ).

published (Annex nr. 1), which purpose is to the test results integrating the test methods procedures with the eligibility criteria of performance statement contains also the measures to be or exceeding the warning or intervention limit cards. A training has been performed on the l cards (Annex nr 2. ­ training material, Annex ).

Member state response

n plan was drawn up concerning the reassessement distracting matrix effects in case of different r. 4). Page: 2

n plan was drawn up concerning the reassessement distracting matrix effects in case of different r. 4). Page: 2

Member state response

t. Discussion and highlighting during the next onference (19/12/2012), and circular. Deadline:

mendment of the checklist. Discussion and highlighting during the next ational animal welfare conference (19/12/2012), and circular. Deadline: 1/02/2012.

Member state response

ns questions on the subject. ring the next national animal welfare and circular. Deadline: 01/02/2012.

checklist already contains questions on the subject. ssion and emphasizing during the next national animal welfare conference (19/12/2012), and circular. Deadline: 01/02/2012. dditional information received on 21/02/2012: he need of manipulable materials on pig farms is going to be ighlighted also by given examples, which are good beside any slurry ystem.

Member state response

ion in the checklist, completing with the exact ng during the next national animal welfare , and circular. Deadline: 01/02/2012.

t of the question in the checklist, completing with the exact data. Discussion and emphasizing during the next national animal welfare onference (19/12/2012), and circular. Deadline: 01/02/2012.

Member state response

ce on transport. Data of mortality rates might accompanying the animals. izing during the next national animal welfare and circular.

of the guidance on transport. Data of mortality rates might be inserted in documents accompanying the animals. ch Discussion and emphasizing during the next national animal welfare conference (19/12/2012), and circular. eadline: 01/03/2012.

Member state response

order to ensure the financial resources.

ions started in order to ensure the financial resources. Page: 1 of Report ref. DG(SANCO)/2011-6045-MR of an audit carried of controls for animal welfare on farms and during transport 21 February 2012. tion Proposed by the Competent Authority Additional information received on 21/02/2012: Still in progress.

Member state response

No 32/1999 (III. 31.) FVM of the Minister of l Development on the rules for the protection of rposes. Deadline: 01/09/2012. Page: 1 /2011-6045-MR of an audit carried welfare on farms and during transport Competent Authority

Amendment of the Decree No 32/1999 (III. 31.) FVM of the Minister of the Agriculture and Rural Development on the rules for the protection of imals kept for farming purposes. Deadline: 01/09/2012.

Member state response

ee No 32/1999 (III. 31.) FVM of the Minister of Development on the rules for the protection of ng purposes. Deadline: 01/09/2012.

as Amendment of the Decree No 32/1999 (III. 31.) FVM of the Minister of culture and Rural Development on the rules for the protection of e animals kept for farming purposes. Deadline: 01/09/2012.

Member state response

ational action plan according to the requirements ent. Submitted to the European Commission.

in Hungary presented a national action plan according to the requirements of the gentleman agreement. Submitted to the European Commission.

Member state response

nce on transport: all transporters must be least once a year by the Competent Authority al. These controls must be carried out on the basis of on system and on the temperature recording journey times. Deadline: 01/03/2012.

Completion of the guidance on transport: all transporters must be controlled randomly at least once a year by the Competent Authority llite issuing the approval. These controls must be carried out on the basis of from the navigation system and on the temperature recording system, focusing on the journey times. Deadline: 01/03/2012.

Member state response

ce on transport: all transporters must be once a year by the Competent Authority e controls must be carried out on the basis of on system and on the temperature recording urney times. Deadline: 01/03/2012.

Completion of the guidance on transport: all transporters must be rolled randomly at least once a year by the Competent Authority Page: 2 of Report ref. DG(SANCO)/2011-6045-MR of an audit carried of controls for animal welfare on farms and during transport 21 February 2012. ion Proposed by the Competent Authority suing the approval. These controls must be carried out on the basis of d data from the navigation system and on the temperature recording stem, focusing on the journey times. Deadline: 01/03/2012.

Member state response

circular on internal height, supplementing the ex, which contains the relevant A and the relevant points of Reg. 1/2005, as er of the European Commission with Ref. No. Page: 2 /2011-6045-MR of an audit carried welfare on farms and during transport Action Proposed by the Competent Authority ) 862232.

Please find enclosed the circular on internal height, supplementing the guidance with a new annex, which contains the relevant commendations of EFSA and the relevant points of Reg. 1/2005, as n summarized by the letter of the European Commission with Ref. No. nt SANCO G3 AN/ap D(2011) 862232.

Member state response

elines on transport ­ instructions on the ingency plans. Deadline: 01/03/2012.

s, Amendment of the guidelines on transport ­ instructions on the uirements of the contingency plans. Deadline: 01/03/2012. Additional information received on 21/02/2012: The referred case was an export. Checklists for the approval of airlines and intra-Community air transport are going to be established. Deadline: 01/05/2012.

Member state response

ce on transport about the aspects of checking the ventilation system, if necessary.

Amendment of the guidance on transport about the aspects of checking he drinking devices and the ventilation system, if necessary. ex Deadline: 01/03/2012. Page: 3 of Report ref. DG(SANCO)/2011-6045-MR of an audit carried of controls for animal welfare on farms and during transport 21 February 2012. nce

Member state response

uter system which summarizes the data (filtering ison with the data of the previous years. Deadline: Page: 3

ols, Development of computer system which summarizes the data (filtering out the faults), comparison with the data of the previous years. Deadline: n. 01/07/2012. Page: 4

Member state response

t materials Vidékfejlesztési Minisztérium: Itt valamint az (5.1.) pontban került megjegyzésre, hogy az élelmiszerek forgalomba hozatalának, valamint elállításának engedélyezésérl, illetve bejelentésérl szóló 57/2010 (V. 7.) FVM számú rendeletben az élelmiszerekkel érintkezésbe kerül anyagok gyártói és forgalmazói helyett, a 9.§ (1) pontjában, csak az ,,élelmiszer-csomagolóanyag gyártással, forgalmazással" foglalkozó vállalkozásokra terjed ki a bejelentési kötelezettség. E rendelet módosításra kerül a következképpen: az élelmiszer- csomagolóanyag gyártók helyett az ,,élelmiszerekkel érintkezésbe kerül anyagok gyártói" kerülnek megnevezésre. A forgalmazók helyett, a nem magyarországi elállítás esetén, ,,az élelmiszerrel érintkezésbe kerül anyagok els magyarországi forgalomba hozóinak" kell bejelenteniük tevékenységüket. A módosítások lehetséget adnak az illetékes hatóság részére, az FCM területen mköd összes vállalkozás ellenrizésére. Határid: 2012. június 30. MgSzH ÉTbI: Az MgSzH ÉTbI felveszi a kapcsolatot a magyarországi élelmiszerrel érintkezésbe kerül anyagokat gyártókat tömörít szervezettel illetve közvetlenül az élelmiszer csomagolóanyag gyártó és forgalmazó vállalkozásokkal,

Member state response

e appropriate MgSzH ÉTbI: Az MgSzH ÉTbI speciális képzést fog tartani az l controls, as adalékanyagok (FA) és az élelmiszerrel érintkezésbe kerül anyagok No (FCM) területén a megyei kormányhivatalok élelmiszerlánc-biztonsági és állategészségügyi igazgatóságainak; a képzésen résztvevknek pedig a képzésen elhangzottakat tovább kell adniuk a megyéknél és a kerületi hivataloknál dolgozó ellenröknek (Határid: 2012. év vége).

Member state response

examination MgSzH ÉTbI: Az MgSzH ÉTbI egy részletes eljárási útmutatót fog cle 10(2)(e) készíteni az élelmiszer adalékanyagok (FA) és az élelmiszerrel mination of érintkezésbe kerül anyagok (FCM) ellenrzésére vonatkozóan, amely additives and magába fogja foglalni, hogy a hatósági ellenrzéseknek hogyan és milyen módon kell kiterjednie az élelmiszer adalékanyagok tisztasági követelményeit tartalmazó dokumentumok és az élelmiszerrel érintkezésbe anyagok megfelelségi nyilatkozatainak vizsgálatára (Határid: 2012. év vége).

Member state response

ment good MgSzH ÉTbI: Az MgSzH ÉTbI felveszi a kapcsolatot a magyarországi lation élelmiszerrel érintkezésbe kerül anyagokat gyártókat tömörít szervezettel illetve közvetlenül ezen vállalkozásokkal és tájékoztatja a Page: 2 mendations of Report ref. DG(SANCO)/2011-8999-MR of an audit carried al control systems in place for food additives and for food contact materials dation Action Proposed by the Competent Authority helyes gyártási gyakorlat betartására vonatkozó kötelezettségükrl, és felhívja a figyelmüket, hogy ezen kötelezettségük teljesülését a hatóság ellenrizni fogja (Határid: 2012. április vége).

Member state response

of good MgSzH ÉTbI: Az MgSzH ÉTbI egy részletes eljárási útmutatót fog lishments készíteni az élelmiszerrel érintkezésbe kerül anyagok (FCM) e 10(2)(d) ellenrzésére vonatkozóan, amely magába fogja foglalni, hogy a hatósági ellenrzéseknek hogyan és milyen módon kell kiterjednie az élelmiszerrel érintkezésbe anyagokat gyártók helyes gyártási gyakorlatának értékelésére. Ezen értékelések eredményeit is figyelembe kell venni az adott létesítmény ellenrzési gyakoriságának késbbi megállapításánál (Határid: 2012. év vége).

Member state response

s) are in MgSzH ÉTbI: Az MgSzH ÉTbI egy részletes eljárási útmutatót fog performing készíteni az élelmiszer adalékanyagok (FA) és az élelmiszerrel additives érintkezésbe kerül anyagok (FCM) ellenrzésére vonatkozóan, amely magába fogja foglalni az élelmiszer adalékanyagok és az élelmiszerrel érintkezésbe anyagok vizsgálatára vonatkozó ellenrzési listát, amely segíti az ellenröket a hatósági ellenrzés egyes lépéseiben (Határid: 2012. év vége).

Member state response

Vidékfejlesztési Minisztérium: Mint az a jelentés-tervezetbl is látható, tion (EC) az adatok begyjtésére és elemzésére, az intézményi háttér biztosított. Page: 3 mendations of Report ref. DG(SANCO)/2011-8999-MR of an audit carried al control systems in place for food additives and for food contact materials roposed by the Competent Authority éshez szükséges adatok elérhetsége biztosított, mivel ndelkezünk élelmiszerfogyasztási adatbázissal; élelmiszerekben ténylegesen felhasznált élelmiszer- adalékanyagok mennyiségérl információ gyjthet, a hazai vállalkozások adminisztrációs kötelezettségei alapján, illetve hatósági ellenrzéseken keresztül. Az illetékes hatóság az ellenrzési / monitoring tevékenysége során ezen adatokhoz hozzájut. at alapú rendszer felépítése / kidolgozása megkezddött. iszerláncról és hatósági felügyeletérl szóló 2008. évi XLVI. felhatalmazása alapján a vidékfejlesztési miniszter rendeletet ad elmiszer-adalékanyagokról szóló 1333/2008/EK rendelet 27. teljesülése céljából. 2012. szeptember 30. Page: 4