France

The recommendation states as its basis

A) Official controls: 7 The current "Livestock inspection campaign" runs from 2024 to 2027 and provides for annual inspections to be carried out on registered poultry and captive bird establishments at the following rates by all DDPPs as follows: - One inspection every 4 years (25% annual target) for "authorised establishments", i.e. establishments with a "health charter/trade approval/official hygiene and health control for palmipeds". - 6% annual target for inspections to be carried out on poultry or captive bird rearing sites which are neither members of the Health Charter nor approved for trade in poultry or hatching eggs or registered for official hygiene and health control. This 6% target does not vary between high-risk Departments and low-risk ones (see map showing zones in finding 75).

There is a comprehensive national technical instruction with a template inspection report form for conducting these biosecurity inspections. (i.e. DGAL/SDSBEA/2024-74). Annex 2 of the national instruction specifies the annual number of inspections to be carried out by each Department from 2024 to 2027. The planned number of annual inspections for each Department is provided by the central authority and the DDPPs decide which establishments to inspect, using the risk criteria in the national instruction, e.g. establishments located in wetlands or areas with high stocking density, unsatisfactory results of previous inspections and establishments not inspected in previous years.

In the event of major biosecurity non-compliance, the services ask the farmers by formal notice to request the support of their technical or veterinary health management in order to establish an action plan and a precise timetable for compliance. There is a system in place to follow-up identified non-compliances with re-inspections and sanctions when deemed appropriate. Results for these inspections over recent years demonstrate a continuously improving situation, e.g. 22% of inspections scored C (insufficient) or D (very insufficient) in 2024 compared to 32% for the same categories in the combined period 2022 and 2023. The audit team reviewed reports of such inspections which appear appropriate.

The competent authority provided the following data related to 2024: Table 3 Number and percentage of establishments planned to be inspected and inspected in 2024 No of registered No of No of % of planned 8 poultry and establishments establishments inspections captive bird planned to be actually implemented establishments inspected inspected during 2024 during 2024 National 35 444 2 517 (7.1%) 2 200 (6.2%) 87% Pays de la 4 908 478 (9.7%) 376 (7.6%) 79% Loire 5 305 397 (7.5%) 227 (4.3%) 57% Nouvelle- Aquitaine The above data is a combination of the establishments with an annual target inspection rate of 25% and 6%. Data provided at national level showed that: - Of the 2 517 establishments planned to be inspected during 2024: o 1 018 related to authorised establishments o 1 499 related to non-authorised establishments. - Of the 2 200 establishments inspected during 2024: o 1 070 related to authorised establishments (= 105% of planned target) o 1 130 related to non-authorised establishments (= 75% of planned target) - 1 018 planned inspections of authorised establishments in 2024 = about 4,072 authorised establishments in total (based on an inspection rate of 25% per annum - This would mean that there were about 17 178 non "authorised establishments" poultry establishments in 2024 (21 250 ­ 4 072 based on data in finding No 2) - There are 14 194 registered establishments keeping captive birds - 14 194 + 17 178 = 31 372 total number of establishments included in the 6% annual target inspection rate. o 1 499 planned inspections for 31 372 = 4.7% o 1 130 completed inspections for 31 372 = 3.6%

The Regional Directorate for Pays de la Loire provided a breakdown of the official controls of poultry establishments during 2024. Based on the numbers provided and after excluding the authorised establishments with a 25% target for annual inspections, only 3.4% of non-authorised establishments may have had an official control related to biosecurity during 2024. Of the overall inspections, 9.5% scored C or D in 2024. (further detail provided in Appendix I below).

The current approach of planning official controls to check compliance with biosecurity measures does not comply with Article 9.1 of Regulation (EU) 2017/625 which requires that "Competent authorities shall perform official controls on all operators regularly, on a risk basis and with appropriate frequency, taking account of: (a) identified risks associated with: (i) animals ...; (iii) the location of the activities ...;

B) Inspections by private sector: 9 The Order of 29 September 2021 requires an annual evaluation of the biosecurity of all commercial poultry establishments by a third-party body. If the inspection is satisfactory, then the inspection can be carried out every second year. Many poultry establishments also receive an annual on-site "Animal Health Check" inspection by their veterinary practice which amongst other things allows a veterinarian to prescribe medication without visiting the establishment between inspections. The inspection includes biosecurity measures, but the competent authority could not say what percentage of poultry establishment these inspections are carried out on. On the establishments visited during the audit, the audit team saw inspection reports related to both these types of inspections and confirmed that they included biosecurity related questions. There is no national template for the inspection reports and the competent authority is not informed on the outcome of the inspections, but the reports must be available for viewing during official controls. Therefore, although both these inspections help improve the overall biosecurity standards on poultry establishments, the competent authority does not monitor their results or the extent to which they are implemented1.

The recommendation states as its basis

Enhanced passive surveillance: when preparing the instruction in section 5.1 of the post- vaccination surveillance protocol (DGAL/SDSBEA/2024-546), the competent authority followed the approach set out by the EU Reference Laboratory. This instruction requires farmers to collect tracheal or oropharyngeal swabs from up to five dead vaccinated birds each week. If fewer than five dead birds are found, they must collect additional samples 3 Section 5.2 of DGAL/SDSBEA/2024-546 allows "a period of ± 10 days is allowed compared to the regulatory frequency of 30 days.") 13 from sick birds to reach five. If there are no sick birds either, they must use apparently healthy birds to complete the sample set. The audit team observed: · DGAL/SDSBEA/2024-546 defines the "representative sample" mentioned in Annex XIII, point 2.2 of Regulation 2023/361 as five samples per vaccinated establishment, regardless of flock size. · In November 2024, following advice from the HPAI vaccination steering committee (Copil), the central authority informed stakeholders that they could collect samples from sick or healthy birds when five dead birds were not available. This was initially presented as a recommendation. It became a formal requirement when the instruction was amended on 26 March 2025. · Collected samples undergo virological testing.

On the three vaccinated establishments visited, the audit team discussed the implementation of enhanced passive surveillance. In all three, farmers took samples up to a maximum of three days per week and regularly from morbid or live birds when there were not five dead birds: · Establishment 1 (around 7 000 ducks on site). The keeper stated he collected samples over three days every week (Monday to Wednesday). The keeper often sampled morbid or live ducks when fewer than five dead birds were available over the three days and occasionally sent less than five samples. · Establishment 2 (around 21 000 broiler ducks on site) and 3 (around 9 000 ducks raised for foie gras). The respective keepers stated they collected samples once a week and took samples from morbid or live ducks when there were less than five dead birds on the day of collection.

During their 30-day visits to collect active surveillance samples, the supervising veterinarian must check that farmers implement enhanced passive surveillance. The active surveillance sample submission form includes the question "is the farmer implementing enhanced passive surveillance - Yes / No". In the visited establishments, the audit team was informed by the supervising veterinarians that if the farmer answers "yes", that they do not verify it further. Supervising veterinarians have access to laboratory results and can see how many and how often farmers submit samples but cannot see if the samples came from dead, morbid or healthy live birds.

None of the three establishments visited were implementing enhanced passive surveillance in accordance with the EU requirements in point 2.1 of Part 5 of Annex XIII of Regulation 2023/361 in that: - they are collecting samples from morbid and live ducks which is not in accordance with Regulation 2023/361 which only refers to "testing of a representative sample of dead birds" - the national instruction requests that samples are collected preferentially from dead then morbid and then healthy live until 5 samples are taken during the week / seven days. No farmer collected samples from dead birds over the seven days. The procedures in place to verify the correct implementation of enhanced passive surveillance are not effective and therefore do not comply with the requirements of Article

The recommendation states as its basis

"Enhanced passive surveillance" in vaccinated establishments is an "animal health requirement" under point 2.1 of Part 5 of Annex XIII of Regulation 2023/361 and is therefore an "official activity', as defined in Art 2.2 of Regulation 2017/625. Competent authorities can delegate official activities to "natural persons" based on Article 31 of the OCR. This delegation is subject to compliance with the delegated conditions laid down in Article 30, (applied mutatis mutandis), being fulfilled. Within the HPAI vaccination campaign in France, farmers perform enhanced passive surveillance. They receive training for this from the supervising veterinarians, but the competent authority has not formalised a delegation of this official activity in line with the requirements of Articles 30 and 31. This constitutes a non-compliance with Regulation (EU) 2017/625.

The competent authority disagreed with the audit team and indicated that it does not consider enhanced passive surveillance to be an official activity. It stated that, under Article 10 of Regulation 2016/429, post-vaccination passive surveillance falls under the farmer's responsibility.

The recommendation states as its basis

French authorities carry out the controls at port effectively. French authorities have five staff trained on welfare issues who have also gathered some technical knowledge to ensure that vessels are constructed and equipped to transport animals without causing injury or undue suffering. There are still weaknesses as regards updating and completing the documentation of procedures and methodologies.

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

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

The recommendation states as its basis

The system is non-compliant as regards the composition of the team of inspectors and the required on-board official controls during the first voyage following approval. The team of inspectors carrying out approval and pre-loading inspections does not systematically include the required official veterinarian and maritime expert. It only includes official veterinary auxiliaries who have acquired knowledge from maritime safety experts. In addition, there is no provision for an official veterinarian to carry out official controls on board the vessel during the first voyage.

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

Despite having approved ten vessels since 1 January 2024, French authorities have not implemented the requirement for an official veterinarian to carry out on-board official controls during the first voyage with animals after the approval (see finding 21). Moreover, the team of inspectors does not include a maritime expert, nor an official veterinarian (see finding 14). These two are contrary to Articles 9 and 10(1) of Regulation (EU) 2023/372.

DGAL district has approved ten livestock vessels since Regulation (EU) 2023/372 entered into force (6). The team of inspectors for these approval inspections included veterinary auxiliaries but not systematically a maritime expert nor an official veterinarian, contrary to Article 9 of Regulation (EU) 2023/372. The approval itself is signed by the official veterinarian heading the team but participation of the official veterinarian in actual inspections is sporadic due to their wider responsibilities (which also include the controls over fisheries, bivalves, export certifications and as border control post).

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

The recommendation states as its basis

The system is non-compliant as regards the composition of the team of inspectors and the required on-board official controls during the first voyage following approval. The team of inspectors carrying out approval and pre-loading inspections does not systematically include the required official veterinarian and maritime expert. It only includes official veterinary auxiliaries who have acquired knowledge from maritime safety experts. In addition, there is no provision for an official veterinarian to carry out official controls on board the vessel during the first voyage.

Despite having approved ten vessels since 1 January 2024, French authorities have not implemented the requirement for an official veterinarian to carry out on-board official controls during the first voyage with animals after the approval (see finding 21). Moreover, the team of inspectors does not include a maritime expert, nor an official veterinarian (see finding 14). These two are contrary to Articles 9 and 10(1) of Regulation (EU) 2023/372.

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

The recommendation states as its basis

The audit team noted, in four establishments out of 13 visited, discrepancies in the approval procedures: 8 · maximal production capacities were annotated in previous approvals, but not in the most recent ones. Such capacities were indicated by the FBO itself and accepted by the CA, without a real verification of their feasibility. In two establishments visited, the capacities indicated in the PMS were not realistic in relation to the working area, equipment and staff available; · in one establishment, the conditional approval for additional buildings had been granted for premises still under construction and without the necessary equipment; · the activity of re-packing of meat products manufactured by another FBO was not included in the approval; · enlargement of buildings and equipment (consisting in adding a new drying room and another chiller was completed and put in operation without informing the CA. This was identified by the CA at the time of the next planned inspection, without imposing any sanction to the FBO. Conclusions on approval of establishments

Although the approval procedures are in line with the requirements of Article 148 of the Regulation (EU) 2017/625, they are not always consistently applied, thus resulting in some establishments operating without fulfilling all necessary conditions.

The recommendation states as its basis

In one of eight CAs visited, staff shortage was critical, with an impact on the number of inspections carried out. In this particular case the inspectors had also been poorly trained (see point 29), with an impact on the quality of official controls.

DGAL does not have adequate tools to identify similar issues in the other 94 CAs in Metropolitan France. The statistics provided by the CCA show that nationwide 85% of the planned inspections have been effectively carried out. Some activities like export certification, official activities in slaughterhouses, alerts' follow-up, approval activities and official sampling are prioritised, explaining the above completion rate. 5.2.2 Supervision of CA staff and audits

The CCA has no adequate tools to identify staff shortages and underperformance of official controls at département (CA) level. This results in a lack of overview that could impact on the overall performance of official controls as the CCA is not able to implement the appropriate corrective measures.

The recommendation states as its basis

At establishment level, FBOs with global assessments B are issued a written warning for which they are not obliged to present an action plan. Only the global assessments C or D for establishments trigger enforcement measures: · FBOs with global assessment C are issued with a severe warning ("mise en demeure") with specific deadlines for implementation of corrective action; · FBOs with a global assessment D may be at risk of suspension of one or more activities. 14 In cases where one or more items in a report are categorized as B (minor non-compliance) or C (medium non-compliance), the entire report can still be globally categorised by the inspector as A. This A categorisation signifies that no immediate follow-up is necessary, which may allow deviations to persist until the next scheduled inspection, which can be up to three years later. This practice is not in line with the requirements outlined in Article 138 of Regulation 2017/625, as it may allow for prolonged non-compliance by FBOs. This issue was identified in audit report 2018-6450, which included a specific recommendation (recommendation 6, see section 5.5) to address this discrepancy.

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

The recommendation states as its basis

The DGAL issued a technical instruction containing detailed procedures regarding the registration of professional operators, their authorisation to issue plant passports, the visual examination of plants, the issuance of plant passports and the official controls on professional operators as required by Article 12(1) of Regulation (EU) 2017/625. The instruction contains guidance on how to practically implement the requirements, and examples of major and minor non-compliances. The instruction is directly used by the SRALs and the CTIFL. The FAM has developed its own procedures based on the DGAL technical instruction. The SEMAE has developed its own instructions based on international control and inspection standards (ISO 17065 and ISO 17020) and on Regulations (EU) 2017/625 and (EU) 2016/2031. Inspectors of each CA use checklists to verify if professional operators comply with the requirements listed in Article 92(1) of Regulation (EU) 2016/2031. However, these procedures contain some differences from the applicable EU requirements. 4 · The CAs sometimes grant provisional authorisation to issue plant passports as permitted under the DGAL technical instruction. In this case, they only verify whether operators possess the necessary knowledge concerning the signs, symptoms, and the means to prevent the spread of regulated pests, and to carry out the examinations as required by Article 89(1)(a) of Regulation (EU) 2016/2031 after granting authorisation to issue plant passports (see also finding 14). · In line with the DGAL technical instruction, inspectors may accept as demonstration of knowledge required by EU law when the operator knows the websites to consult regarding regulated pests or has printed documents about some of these pests. However, this does not mean that the operator possesses the necessary knowledge and is able to carry out examinations, as required by Article 89(1)(a) of Regulation (EU) 2016/2031. · Hand-written entries on plant passports are permitted in France. These plant passports do not comply with Article 83(1) of Regulation (EU) 2016/2031 which requires plant passports to be clearly legible, and the information on them to be unchangeable and durable (see also finding 30).

The roles and responsibilities of the different CAs are clearly regulated, with detailed procedures to assist inspectors providing a good basis for the effective implementation of EU legislation. However, minor differences in the application of some plant passport requirements and the insufficient training for inspectors mean that the CAs do not ensure that the plant passport system is implemented in a consistent manner and fully in line with EU requirements.

However, in a small number of cases, and in line with the technical instruction issued by the DGAL (see also finding 4), the SRALs grant provisional authorisation. In these cases, there is no on-site official control and documents regarding the traceability system and the format of plant passports intended to be issued are verified remotely. Operators which receive provisional authorisation are allowed to issue plant passports until the first on-site official control, after which the final authorisation can be granted. In these cases, the SRALs do not verify whether operators possess the necessary knowledge concerning the signs, symptoms, and the means to prevent the spread of regulated pests, and to carry out the examinations before granting authorisation to issue plant passports as required by Article 89(1)(a) of Regulation (EU) 2016/2031. The CAs could not quantify the number of provisional authorisations granted or their typical duration. 5.3.2 Official supervision of professional operators and verification of their actions

During the official controls observed by the audit team, the inspectors used checklists containing all relevant elements of the technical instruction issued by the DGAL to verify whether authorised operators comply with Article 92(1) of Regulation (EU) 2016/2031. These controls were broadly effective. However, the audit team noted the following: · All inspectors verified the content, format and attachment of issued and received plant passports. This was done correctly in all cases and resulted in inspectors finding non-compliant plant passports. Non-compliant plant passports were issued by two visited authorised operators and were present in the garden centre (see also finding 29). · Inspectors verified the traceability of several purchased and sold lots. The lots were chosen based on a risk analysis, and inspectors considered host plants of priority pests to be the highest risk. These controls were done correctly in all cases except in the case of an imported consignment where the inspector did not know what documents are required to accompany such consignments (see also finding 3). · Inspectors correctly verified the records of examinations of plants carried out by authorised operators or contracted professional service providers in all cases. · Inspectors verified whether authorised operators possess the necessary knowledge to carry out the examination required by EU legislation. · All inspectors except one correctly verified if authorised operators identify and monitor the points of their production process and the points concerning the movement of plants, plant products and other objects, which are critical as regards compliance with the EU requirements and if they keep records concerning the identification and monitoring of those points for at least three years, as required by Article 90(1) of Regulation (EU) 2016/2031. The FAM inspector observed by the audit team did not verify whether authorised operators comply with these requirements. The particular operator did not keep such records. · All inspectors observed by the audit team verified the corrective actions taken to address non-compliances recorded during the previous official control. When inspectors find any non-compliance with EU requirements, operators are requested to provide a written plan containing actions they would take to correct such non-compliances. When the CA considers that there are only minor non- 8 compliances, the corrective actions might be verified only during the following official control. However, in one case from 2023, the SRAL had found plants for planting infected by fig mosaic virus in a nursery visited by the audit team. The operator had not provided a written action plan to the CA and the CA had not verified whether any corrective actions had been taken, with the result that at the time of the audit some of the infected plants had been sold. Contrary to the first paragraph of Article 92(2) of Regulation (EU) 2016/2031, the CA failed to ensure that plants infected by fig mosaic virus, and therefore non-compliant with provisions concerning that Union regulated non-quarantine pest, were not moved within the EU. Conclusions on authorisation and supervision of professional operators for issuing plant passports

Certain weaknesses in the authorisation procedure and the annual official controls weaken the level of assurance that authorised operators fully meet the requirements for issuing plant passports.

Authorised operators are required to keep all plant passport related records for at least three years. The plant passports provided to the audit team were generally compliant with EU requirements. However, the following examples did not comply with the requirements of Article 83(2) and (4) of Regulation (EU) 2016/2031 since they did not contain some required elements or contained additional information. · Plant passports contained references to traceability information outside of the plant passport, but on the same substrate, instead of having the traceability code on the plant passport itself. · Plant passports with a hole on the label which removed part of the botanical name. · After the country of origin code, plant passports containing the registry number of the operator that produced the plants as additional data. · A PZ plant passport was notified by another MS where the scientific name or code of the pest and the code of the country in front of the operator's registry number were missing. Additional data, other than the variety, were present after the botanical name of the plant species (see also section 4.2).

Furthermore, the CAs tolerate some forms of non-compliant plant passports: · The use of pre-printed plant passports with hand-written amendments is tolerated by the SRALs. In general, such plant passports often do not comply with Article 83(1) of Regulation (EU) 2016/2031 based on which the plant passports must be clearly legible, and the information on them must be unchangeable and durable. However, the CAs verify if plant passports available at the time of the official control and containing hand-written entries are legible, unchangeable and visible. · Contrary to the Annex of Commission Implementing Regulation (EU) 2017/2313 ­ which provides that the required flag of the Union may be printed in colour (yellow stars on blue background), or in black and white, either with white stars on a black background, or vice versa ­ the colour of the substrate is tolerated as a background to the EU flag. 5.5.3 Plant passports combined with certification labels

Plant passports are attached to the trade units, replaced or invalidated by the authorised operators. However, the SRALs accept that the plant passport is only an accompanying document and is not attached to the trade units in the case of logs and plants moved in bulk, which is not in line with Article 88 of Regulation (EU) 2016/2031. 5.5.5 Application of the exemptions provided for in EU law

Authorised operators issue plant passports under official supervision generally in line with provisions of the EU regulations. However, the use of some non-compliant plant passports compromises the reliability of the system developed for issuing plant passports in France.

National legislation provides a legal basis for enforcement actions in case of non- compliances with plant health requirements. When such non-compliances are detected, operators are ordered to take corrective actions. If the necessary corrective actions are not taken, the CA issues a formal notice containing the possibility of withdrawal or suspension of the authorisation for issuing plant passports. When appropriate actions are still not taken, the CA withdraws or suspends the authorisation to issue plant passports and may apply financial penalties. In 2022 and 2023, about 160 professional operators had their authorisation to issue plant passports suspended until the operator took appropriate corrective actions. However, the audit team noted that the implementation of the corrective actions is not consistently verified (see also finding 16). 14 Conclusions on enforcement actions

In most but not all cases, sanctions applied by the CAs are effective, proportionate and dissuasive thereby helping to ensure that professional operators comply with their legal obligations.

Member state response

1. [D'après le rapport d'audit, cette recommandation 1.1 concerne torité compétente DGAL.] Dans le vademecum concernant les contrôles des autorisations à délivrer les passeports phytosanitaires (vademecum utilisé à la fois par la DGAL et le CTIFL), la partie concernant l'évaluation des connaissances de l'opérateur professionnel sur les organismes nuisibles règlementés (ONR) sera mise à jour en 2024 (pour une application en 2025). Lors du contrôle annuel de l'autorisation à délivrer les passeports phytosanitaires, outre la vérification que le professionnel ait accès aux informations sur les organismes nuisibles règlementés à surveiller, une série de questions précises devra systématiquement être posée par l'inspecteur à l'opérateur professionnel (ou le cas échéant au responsable du personnel en

The recommendation states as its basis

According to DGAL, from the 6 736 vessels of the French fishing fleet (mainland and overseas departments) 4 052 were in mainland France. The staff interviewed stated that fishing vessels are considered low risk and, due to the current pressure on staff numbers 8 and workload, the minimum frequencies are not met. The audit team saw several control reports for primary vessels with corrective measures applied. The inspection reports covered all relevant hygiene points. Facilities handling fishery products

The official control system in place covers the production chain of fishery products and is, in general, implemented as planned. However, some defined control procedures were not followed, like the inspection frequencies for primary production vessels, or were not effective in providing operators' compliance with EU rules regarding correct temperature limits in cold stores and the presence of temperature recording devices and the incorrect use of predictive tools in shelf-life studies. 5.3.2 Official controls of fishery products Legal requirements Council Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EU) 2023/915. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Implementing Regulation (EU) 2019/627. Findings

The recommendation states as its basis

Official staff followed adequately the procedures and appropriate follow-up, and enforcement measures were taken, where necessary. In general, the establishments were in good condition regarding structure and hygiene. During the visits, the following relevant deficiencies were noted by the audit team: a. In two establishments processing fresh fish, good hygiene practices were not respected. This included, among others, unsuitable routing of products, possible cross contamination of ice and the presence of wooden pallets when processing fish. b. One operator applied brine freezing to pelagic fish, packed it and moved it to the adjacent cold store. The temperature of the brine was minus 17.7 °C and the packaged fish was minus 17.5 °C. The HACCP system required a brine temperature of minus 20°C. The temperature limit for the cold store was set at minus 15 °C instead of minus 18 °C as written in the HACCP system. The critical control points were not defined by a decision tree. The HACCP plan had not been updated since 2019. Another establishment had applied the same temperature limit of minus 15 °C in its cold store. c. At one establishment, there was no continuous temperature recording device present. d. At several establishments a processing step called "stiffening" was applied. Smoked fish is stored between 0 °C and minus 9 °C before slicing. The EU legal requirement for this processing step is that it lasts at most, 96 hours. One operator stated that products exceeding this duration would be frozen to minus 18 °C and be labelled and sold as frozen product. This opinion was shared by the local official inspector. The CCA stated, that this is not in line with the national rules, which requires the product to be classified as unfit for human consumption. e. Regarding the prediction of shelf life of ready to eat products, an operator used a temperature/duration combination which was not in line with the European Reference Laboratory's Technical Guidance Document on challenge tests and durability studies for assessing shelf-life if ready-to-eat foods related in Listeria monocytogenes (10). (10) Available at: https://food.ec.europa.eu/system/files/2021-07/biosafety_fh_mc_tech-guide-doc_listeria-in-rte- foods_en_0.pdf. 9 f. At one establishment producing smoked fishery products, these were packed and palletised and put in the cold store for freezing. It took up to 72 hours for the product to reach minus 18 °C.

The official control system in place covers the production chain of fishery products and is, in general, implemented as planned. However, some defined control procedures were not followed, like the inspection frequencies for primary production vessels, or were not effective in providing operators' compliance with EU rules regarding correct temperature limits in cold stores and the presence of temperature recording devices and the incorrect use of predictive tools in shelf-life studies. 5.3.2 Official controls of fishery products Legal requirements Council Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EU) 2023/915. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Implementing Regulation (EU) 2019/627. Findings

The recommendation states as its basis

Official staff followed adequately the procedures and appropriate follow-up, and enforcement measures were taken, where necessary. In general, the establishments were in good condition regarding structure and hygiene. During the visits, the following relevant deficiencies were noted by the audit team: a. In two establishments processing fresh fish, good hygiene practices were not respected. This included, among others, unsuitable routing of products, possible cross contamination of ice and the presence of wooden pallets when processing fish. b. One operator applied brine freezing to pelagic fish, packed it and moved it to the adjacent cold store. The temperature of the brine was minus 17.7 °C and the packaged fish was minus 17.5 °C. The HACCP system required a brine temperature of minus 20°C. The temperature limit for the cold store was set at minus 15 °C instead of minus 18 °C as written in the HACCP system. The critical control points were not defined by a decision tree. The HACCP plan had not been updated since 2019. Another establishment had applied the same temperature limit of minus 15 °C in its cold store. c. At one establishment, there was no continuous temperature recording device present. d. At several establishments a processing step called "stiffening" was applied. Smoked fish is stored between 0 °C and minus 9 °C before slicing. The EU legal requirement for this processing step is that it lasts at most, 96 hours. One operator stated that products exceeding this duration would be frozen to minus 18 °C and be labelled and sold as frozen product. This opinion was shared by the local official inspector. The CCA stated, that this is not in line with the national rules, which requires the product to be classified as unfit for human consumption. e. Regarding the prediction of shelf life of ready to eat products, an operator used a temperature/duration combination which was not in line with the European Reference Laboratory's Technical Guidance Document on challenge tests and durability studies for assessing shelf-life if ready-to-eat foods related in Listeria monocytogenes (10). (10) Available at: https://food.ec.europa.eu/system/files/2021-07/biosafety_fh_mc_tech-guide-doc_listeria-in-rte- foods_en_0.pdf. 9 f. At one establishment producing smoked fishery products, these were packed and palletised and put in the cold store for freezing. It took up to 72 hours for the product to reach minus 18 °C.

The official control system in place covers the production chain of fishery products and is, in general, implemented as planned. However, some defined control procedures were not followed, like the inspection frequencies for primary production vessels, or were not effective in providing operators' compliance with EU rules regarding correct temperature limits in cold stores and the presence of temperature recording devices and the incorrect use of predictive tools in shelf-life studies. 5.3.2 Official controls of fishery products Legal requirements Council Regulation (EC) No 2406/96. Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EU) 2023/915. Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I and II of Annex VI to Implementing Regulation (EU) 2019/627. Findings

The recommendation states as its basis

Verification procedures do not cover the official controls on transport of unweaned calves. This, coupled with the prolonged omission of this area in the audit program, results in missed opportunities for the competent authority to identify shortcomings in the official controls, to get insights for improvement and to provide stakeholders with assurances of compliance with animal welfare legislation. 6 FINDINGS ON FRAMEWORK FOR OFFICIAL CONTROLS AND OTHER OFFICIAL ACTIVITIES The key strengths of the official control system were the instructions and guidance which enable the consistent and effective implementation of most requirements, the measures taken on non-compliance (suspension/withdraw of control posts approvals) and the bilateral cooperation with another Member State. However, the procedures present a few weaknesses. These mostly relate to controls on vehicles (i.e., the approval does not unequivocally reflect the suitability for transporting unweaned calves and there is not consistent verification of the suitability of the watering devices for unweaned calves), training and supervision of staff at control posts and on practices on handling of animals.

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

The departmental services of DGAL approve the control posts after having checked and issued an approval number to each control post. The approval is limited to species and categories establishing which control posts are approved for handling unweaned calves. The instructions for approval do not contain specific provisions other than the general requirements and an adaptation to the categories of kept animals.

In some cases, DGAL departmental services plan their controls considering risk factors, for example, past compliance records of the operators, notifications from other competent authorities, activities under the control of operator (e.g., involvement in intracommunity trade), weather conditions (extreme heat) and species (e.g., bovine animals). In other cases, the departments conduct official controls on ad hoc basis, for example following up on complaints relating to animal welfare. Although some departmental have targeted the transport of unweaned claves in planning their controls, the planning procedure and its implementation have not consistently considered risks associated to the transport of vulnerable animals (unweaned calves) over long journeys. 6 This has resulted in verification gaps which reduce the assurances provided by the system. A similar discrepancy has been described in DG(SANTE) 2023-7746 audit report on animal welfare of cattle kept for beef production (recommendation 3).

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

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

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

The recommendation states as its basis

In line with Article 12(1) of the OCR, the competent authority has made available a guide (vademecum) for the inspections of animal welfare in cattle farms. The vademecum contains instructions for the checks, legal references and how to apply them and occasionally refers to the Recommendation of the Council of Europe concerning cattle. The inspectors use the vademecum and report on a generic checklist template. The competent authority intends to make available to the inspectors in 2023 a detailed checklist, specific to animal welfare of cattle. The vademecum does not include, for example, how to evaluate the isolation of sick or injured animals in suitable accommodation and comfortable bedding, how to evaluate the access to a suitable water supply (pond 5 A good practice: water volume and quality, number of drinkers), or how to evaluate Stakeholders dehorning. These gaps resulted (described below in several findings), in support the official controls that are not always appropriate and consistent, contrary to the requirements of Article 5 (1) (a) and (b) of the OCR. work of the local authorities to 7. Technical instruction DGAL/SDSPA/2017-734 published in 2017 set out the establishment of operational units at DDPPs to address animal abuse. address animal Those units aim at detecting farmers in difficulty. Various stakeholders welfare cases (chambers of agriculture, health protection groups, veterinary services, related to the agricultural social security service, etc.) meet regularly to discuss and farmers that decide on the follow up of farmers in difficulty. These preventive meetings are steered by the local agricultural professional bodies, which face difficulties decide on measures to be taken to help the farmer in the first instance. In the event of persistent difficulties, a DDPP emergency unit intervenes to The competent address the issue. This may include removal of all or part of the animals authority provides from the farm in question. appropriate 8. Technical instruction DGAL/SDSPA/2015-593 recommends a flexible training to staff approach to address animal abuse at first stage. Proposed methods include for example measures to achieve more prompt actions to protect members the animals (e.g., it is faster that the farmer sells some of his animals than drafting an administrative or criminal procedure). If this first step is not Gaps in the risk- effective, then the entire methodology of administrative and criminal based proceedings is detailed and follows. prioritisation of 9. In line with Article 5(4) of the OCR, the competent authority provides official controls regular training to keep staff up to date in their area of competence. This and insufficient includes initial training before taking up duties and, continuous training implementation of to qualify for the responsibilities of the assigned post. Relating to the protection of animals, this includes sessions on animal welfare as well as on the management of abuse. In addition, there is a continuous approach to exchange knowledge and practices within the competent authority staff. In addition, the animal abuse network (within the office for animal welfare) provides specialised training, guidance and legal support to staff in the DDPPs for handling cases of animal abuse. 10. The competent authorities have put in place arrangements to plan and deliver official controls based on risk, in line with the requirements of Article 9 (1) of the OCR. As a result, there is a methodology on how to develop a plan of official controls, on a risk basis. The methodology allows each DDPP to select the criteria based on various sources of information. Generally, the DDPPs consider the criteria listed in Article 9 of the OCR as well as other factors, for example mortality issues, notified complaints etc. The methodology and its application in the DDPPs evaluated during the audit showed a lack of consideration of the activities under the control of the operators and of the use of proc

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

remédier aux anomalies de chaque point relevé dans les constats, il est proposé de compléter le vade- um, notamment sur les points suivants, au regard s connaissances scientifiques actuelles et des la réglementation : - Le référent bien-être animal ; - L'abreuvement, notamment la qualité de l'eau ; - L'accès aux aliments ; - La maintenance des auges et des cornadis ; - L'espace disponible pour les animaux ; - La température ; - Les conditions extérieures et la protection contre les intempéries ; - La prise en charge de la douleur lors des pratiques douloureuses (écornage, ébourgeonnage, castration, etc.) ; - Les conditions d'isolement des animaux malades ou blessés ; - Les bâtiments à inspecter. De plus, le vade-mecum sera également mis à jour afin de clarifier la notation des items et la notation générale du rapport. Parallèlement, une instruction générale sur les suites de contrôles officiels est en cours de révision, elle permettra d'accentuer l'efficacité des contrôles. Sa parution est prévue pour le début de l'année 2024.

The recommendation states as its basis

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

Member state response

, les constats d'audits internes font l'objet synthèses thématiques. Une synthèse des s d'audits a été réalisée dans le domaine de la nté et de la protection des animaux de rente, afin de onstats des audits réalisés lors du cycle 6-2021. Elle a été communiquée à l'ensemble de auté de travail par instruction technique. , Elle présente les principaux enseignements de ces sés par thématique, relatifs au processus inspection et aux dispositions techniques spécifiques de la filière. Une liste exhaustive des constats, anonymisée, est également annexée. Par ailleurs, le réseau d'animation qualité national travaille actuellement à l'amélioration du suivi des audits internes, à travers : - La mise en place d'un suivi systématique des plans d'actions que les structures mettent en 1 ion Proposed by the competent authority place pour pallier aux non-conformités et points sensibles relevés lors des audits. Une méthodologie est en cours d'élaboration pour préciser la façon dont ces non-conformités doivent être clôturées, à travers une vérification de l'efficacité des actions mises en place (visite sur site, envoi de documents, etc). - Cette clôture des constats sera vérifiée grâce à un nouvel in

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.

Member state response

est proposé d'une part, de modifier l'instruction ionale de programmation des contrôles pour mettre à toutes les DDPP de disposer d'un outil ir d'appui à l'analyse de risque. programmation sera ainsi basée sur plusieurs tères incontournables : 'outil OMAR, es anomalies d'identification, es anomalies de prophylaxie, es absences de cotisation à l'équarrissage, es signalements. te instruction devra également renforcer le nombre nspections inopinées prévues par an. parution est prévue en fin d'année 2024. 1

Member state response

le de la distribution et de l'utilisation des produits phytopharmaceutiques (PPP), la DGAl, la DGCCRF et l'Anses d'habilitations à contrôler les mêmes manquements et les mêmes infractions aux dispositions du Code Rural et de la (Chapitres III et IV du titre V du Livre II). Le plan national de contrôles officiels pluriannuel (PNCOPA) prévoit une définition du périmètre des contrôles comme suit : - La DGAL assure le contrôle des utilisateurs agricoles (exclusivement) et le contrôle des utilisateurs non agricoles, les applicateurs professionnels de PPP, ainsi que des contrôles à la distribution, - La DGCCRF assure le contrôle des sites de fabrication et de la mise sur le marché des PPP aux utilisateurs amateurs et professionnels, y compris la vente en ligne des PPP, ainsi que le contrôle des utilisateurs non agricoles, - L'Anses assure le contrôle de la fabrication, notamment la formulation des PPP. En raison de la juxtaposition des périmètres de contrôle, certains opérateurs peuvent faire l'objet de contrôles à une fréquence aléatoire. De plus, le protocole de coopération entre les autorités compétentes concernées n'a pas été renouvelé à son échéance en 2019. Ses dispositions restaie

Member state response

définir les contrôles des utilisateurs agricoles et des responsables de la 1ère mise sur le marché (RPMM), des critères de risque été établis et une fréquence basée sur l'analyse de risques a été définie afin de programmer les contrôles de ces opérateurs. lle démarche n'est pas mise en oeuvre pour les distributeurs, les applicateurs et les utilisateurs non agricoles. Toutefois, e relevé par les auditeurs, les distributeurs et les applicateurs sont soumis à l'obtention préalable d'un avis favorable d'un anisme certificateur, condition nécessaire à l'obtention de l'agrément provisoire pour débuter l'exercice de l'activité, qui assure forme de contrôle préalable au démarrage de l'activité. tiquement, l'analyse de risque est effectuée au niveau régional et départemental, essentiellement sur la base des risques ociés aux produits contrôlés, aux activités et aux antécédents des opérateurs du secteur ainsi que de toute information tinente collectée sur les produits et les opérateurs, c'est-à-dire sur les critères de l'article 9 du règlement OCR. Une formalisation une harmonisation sont toutefois nécessaires. ions proposées : autorités compétentes proposent d'établir une grille harmonisée

Member state response

e 9 du règlement (EU) n°2017/625 prévoit que : Les contrôles officiels sont effectués sans préavis, sauf si le préavis est nécessaire et dûment justifié pour les contrôles iciels à effectuer. En ce qui concerne les contrôles officiels demandés par l'opérateur, l'autorité compétente peut décider s'ils ont lieu avec ou sans préavis. Les contrôles officiels effectués avec préavis n'excluent pas les contrôles officiels sans préavis. . Les contrôles officiels sont, dans la mesure du possible, effectués de manière telle que les contraintes administratives et la erturbation des processus de production pour les opérateurs sont réduites au minimum nécessaire, sans toutefois nuire à la qualité trôles. les contrôles officiels des exploitants agricoles bénéficiaires des aides PAC sont effectués de manière concomitante avec trôles de la conditionnalité des aides PAC. L'information préalable étant prévue par les dispositions communautaires relatives C, cette catégorie d'exploitants est par voie de conséquence prévenue d'un contrôle officiel, généralement 48H en amont, passer 14 jours calendaires. Dans le cadre d'une approche harmonisée, cette mesure de prévenance est également ée pour les exploi

The recommendation states as its basis

The audit team reviewed a number of files, which showed an overall good communication between the regional and central INAO, DGCCRF, DGDDI and the CBs. However, the results of the controls on PDO/PGI wines are not included in the annual reports submitted to the Commission. This is not in line with Art. 113(1) of Regulation (EU) 2017/625, which requires the Commission to be informed of the outcome of all official controls carried out by the CAs, including those done by the CBs under its MANCP. Conclusion on competent authorities

Member state response

ités françaises considèrent que la recommandation n'est pas fondée. Le règlement (UE) 2017/625 concernant les contrôles officiels et les res activités officielles servant à assurer le respect de la législation alimentaire et de la législation relative aux aliments pour animaux ainsi ègles relatives à la santé et au bien-être des animaux, à la santé des végétaux et aux produits phytopharmaceutiques ne soumet pas le dispositif de contrôle des AOP et IGP viticoles aux règles substantielles et procédurale qu'il établit. L'article 1.4, le règlement (UE) 2017/625 soustrait de son champ d'application, les contrôles effectués pour vérifier le respect du règlement (UE) n° 1308/2013, à l'exception des contrôles réalisés en relation avec les normes de commercialisation identifiant d'éventuelles pratiques frauduleuses ou trompeuses aux règles de mise sur le marché des produits. Comme le précise le considérant 22 du règlement (UE) 2017/625, un système de contrôle spécifique et bien établi étant déjà en place pour le contrôle des règles relatives à l'organisation commune des marchés, ce règlement (UE) 2017/625 n'a pas lieu de s'appliquer pour les produits agricoles concernés. Les articles 109 et

We consider that the La Commission européenne considére que les contrôles menés par les recommendation is unfounded. Etats membres relatifs aux vins AOP et IGP doivent se conformer aux Regulation (EU) 2017/625 on dispositions du règlement N° 2017/625. of official controls and other official activities performed to ensure the Elle s'appuie plus précisément sur son article 1.4a) qui dispose que « le application of food and feed law, présent règlement ne s'applique pas aux contrôles officiels effectués rules on animal health and welfare, pour vérifier le respect du règlement n° 1308/2013 ; toutefois le présent plant health and plant protection règlement s'applique aux contrôles effectués en application de l'article products does not make the control 89 du règlement n° 1306/2013, lorsque ces contrôles identifient arrangements for wine PDOs and d'éventuelles pratiques frauduleuses ou trompeuses en ce qui concerne PGIs subject to the substantive and les normes de commercialisation visées aux articles 73 à 91 du procedural rules it lays down. règlement n° 1308/2013 ». Article 1 (4) of Regulation (EU) 2017/625 excludes from its scope En premier lieu, les autorités françaises tiennent à sou

The recommendation states as its basis

Representatives of the CBs met by the audit team stated that for PGI wine products, only documentary checks are carried out. This is done based on the data declared by operators in the CVI database. Inspectors do not verify the compliance with the other conditions set out in the product specifications with official on-site checks at the premises of operators (see also paragraph 43 above). This includes vineyards where the cultivation method and the vine varieties used are verified only by internal controls carried out by the ODGs. This is not in line with points 1(c), 3(a) and 4 of Article 19 of Regulation (EU) 2019/34, which provide that the annual verification of PGI wines shall consist of on-site checks at the premises of operators to verify that the conditions listed in the product specification are met.

INAO stated that the specifications of a PGI wine product under the competence of CB2 do not contain specific requirements to be met and verified on-site. However, for the specific PGI wine product examined by the audit team, the verification of compliance with the conditions set out in the product specifications could not be based exclusively on documentary checks. CB2 stated that, in general, on-site checks are carried out in case of non-compliances identified during the documentary checks or at the request of an operator who appeals an unfavourable result of the organoleptic testing. This non-compliance identified by the audit team is somewhat mitigated by the intensive, but non-official, on-site checks by ODGs and the provision of a "wine passport". This document is issued by the ODGs and serves as a proof that the ODG ­ after carrying out organoleptic and, if necessary, analytical testing ­ verifies the PGI wine specifications.

Member state response

Les autorités françaises considèrent que la recommandation n'est pas ondée. En effet, ces contrôles sur place sont d'ores et déjà opérés par la DGDDI qui, en respect de l'article 31 du RUE 2018/274, réalisent des contrôles terrain destinés à fiabiliser les données inscrites dans le sier viticole informatisé dont certaines recoupent justement des ts tirés des cahiers des charges. Etant précisé que le contrôle ainsi effectué l'est annuellement à l `égard d'au moins 5% de l'ensemble des viticulteurs. Les vérifications portent notamment sur la véracité de la localisation géographique des parcelles et l'encépagement. Page: 2 ns received 29/6/2023 mendations of report ref. DG(SANTE) 2022-7385 of the audit carried out from 14 November stem related to Protected Designation of Origin (PDO) and Protected Geographical Indication Proposed by the competent authority ns la très grande majorité des cahiers des charges des vins IGP, nditions de production s'en tiennent précisément à la délimitation zone géographique et à la liste des cépages utilisables. Il n'est as nécessaire de compléter les contrôles faits par la DGDDI au du CVI par des contrôles complémentaires qui poursuivraient le bjet et fe

consider that the ecommendation is unfounded. hese on-the-spot checks have lready been carried out by the DGDDI, which, in accordance with rticle 31 of Regulation (EC) No he 2018/274, carry out on-the-spot as checks designed to make the data entered in the computerised of vineyard register more reliable, ome of which overlap precisely ith information taken from the pecifications. The checks thus arried out are carried out annually n respect of at least 5 % of all winegrowers. hecks shall include checks on the eracity of the geographical ocation of the parcels and the vine arieties. Page: 3 to the report's recommendations (updated) received 21/02/2024 t of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2022-7385 of November 2022 to 28 November 2022 in order to evaluate the control system related to Protected Designation of Origin (PDO) ication (PGI) for wine sector products Proposed by the competent Updated Action Proposed by the competent authority ty , in the vast majority of the specifications for PGI the production conditions fined precisely to the tion of the geographical d the list of suitable grape es. It is therefore not

Member state response

ce qui concerne le fait que les contrôles officiels soient fondés sur les risques, les autorités françaises rappellent que la fréquence des contrôles peut être déterminée à deux niveaux : - une fréquence peut être fixée au niveau national par catégorie d'opérateurs d'une filière en tenant compte des risques de non conformité par catégorie d'opérateurs ; - lors de l'approbation des plans de contrôle, la fixation des fréquences peut aussi être faite en tenant compte des risques. Ainsi, des plans de contrôle, prévoient des fréquences différenciées de contrôles officiels en fonction du volume produit, ou la possibilité d'augmenter la pression Page: 4 ns received 29/6/2023 mendations of report ref. DG(SANTE) 2022-7385 of the audit carried out from 14 November stem related to Protected Designation of Origin (PDO) and Protected Geographical Indication Action Proposed by the competent authority de contrôles sur la base des résultats des contrôles des années antérieures et des informations fournies par les groupes de producteurs dans le cadre des contrôles internes. A ce titre, les autorités françaises estiment que les contrôles sont le plus souvent fondés sur les risques. Cependant, afin d

As regards the fact that official Les travaux pour approuver les plans de contrôle AOP viticole au ontrols are risk-based, we would nouveau format se poursuivent. oint out that the frequency of ontrols can be determined at two evels: -- a frequency may be set at ational level for each category of operators in a sector, taking into red account the risks of non- d compliance per category of perators; - when approving control plans, requencies may also be set taking nto account the risks. For example, ontrol plans provide for ifferentiated frequencies of official ontrols according to the volume roduced, or the possibility of ncreasing control pressure on the asis of the results of controls in revious years and the information rovided by producer groups in the ontext of internal controls. Page: 6 to the report's recommendations (updated) received 21/02/2024 t of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2022-7385 of November 2022 to 28 November 2022 in order to evaluate the control system related to Protected Designation of Origin (PDO) ication (PGI) for wine sector products Proposed by the competent Updated Action Proposed by

The recommendation states as its basis

Representatives of CB2 stated that the ODGs carry out internal checks, which include organoleptic and if necessary, analytical testing of all batches of PDO/PGI wines prior to packaging, whilst official external checks take place only after their packaging by organoleptic testing of all wine batches of circa 5% of operators. Representatives of CB3 stated that internal checks of PDO wines are carried out by the ODGs at 100% of wine batches prior to their marketing in bulk, where samples are taken for organoleptic and, if necessary, analytical testing. The same procedure is followed when different batches of PDO wines are destined for blending.

For CB1 and CB2, the official organoleptic and analytical testing is triggered by declarations of packaging and carried out only on wine that has already been packaged (bottled or bag in box). Either no official testing is carried out by these CBs on wines prior to their marketing in bulk or it is carried out only upon request of the operator, e.g. if he disagrees with non-compliances identified by the ODGs. INAO stated that the official organoleptic and analytical testing of the PDO/PGI wines is carried out after packaging to be as close as possible to the final product sold.

However, as the operators may continue their routine activities during official inspections carried out by the CBs, these batches can potentially already be on the market using the PDO/PGI designation, without having been blocked until the results of the official testing confirm that they comply with the conditions in the specification and possess all the appropriate characteristics of the PDO/PGI designation. This is not in line with point 4(a) of Article 19 of Regulation 2019/34, which requires that a product cannot use the PDO/PGI designation relating to it unless the results of the official organoleptic and analytical testing prove that the product in question complies with the conditions in the product specification and possesses all the appropriate characteristics of the PDO/PGI designation concerned.

Member state response

s autorités françaises tiennent en premier lieu à rappeler que le non- m respect d'une condition de production n'entraine pas systématiquement le retrait de bénéfice du signe pour le lot concerné. effet, les répertoires de traitement des manquements prévoient des gradations de la mesure de traitement des manquements (avertissement, contrôle supplémentaire, ...) en fonction de la gravité du manquement et d'une éventuelle récidive de l'opérateur. Ainsi un organoleptique ou analytique dans un vin n'entraine pas forcément le retrait de bénéfice de l'AOP ou de l'IGP pour ce vin. L'article 19, 4, a), vise à garantir qu'un produit ne puisse pas être porteur d'un SIQO si les résultats des vérifications devaient aboutir au elevé d'une non-conformité entrainant un retrait de bénéfice du SQO à l'égard du cahier des charges concerné. Mais le règlement (UE) 019/34 n'impose pas le blocage des lots. Lorsqu'un lot, après ustation par une commission d'examen organoleptique ou analyse, doit faire l'objet d'un retrait de bénéfice du signe (AOP ou IGP), le lot Page: 6 ns received 29/6/2023 mendations of report ref. DG(SANTE) 2022-7385 of the audit carried out from 14 November stem related to Protected

First of all, the French authorities Compte tenu des explications apportées par les autorités françaises sur would point out that failure to les conclusions de la recommandation 5, les autorités françaises comply with a production condition n'envisagent pas de modifier le système existant en France. does not systematically lead to the withdrawal of the benefit of the Les autorités françaises tiennent à souligner que les mesures à prendre t sign for the consignment lors des contrôles doivent être proportionnées aux risques et au contexte concerned. The registers for dealing économique. he with non-compliances provide for gradations in the action taken to Ainsi, les autorités françaises considèrent que le blocage des lots aurait deal with non-compliances un effet économique disproportionné par rapport aux avantages (warning, additional checks, etc.) théoriques qu'il apporterait sur la conformité des vins, d'autant qu'un according to the seriousness of the Page: 8 to the report's recommendations (updated) received 21/02/2024 t of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2022-7385 of November 2022 to 28 November 2022 in order

The recommendation states as its basis

The DGCCRF controls carried out by the regional BEVS on PDO/PGI wines during the 2020-2021 vinification periods revealed that the average level of non-compliant operators found was circa 30%. Of the 205 samples tested in 2020 and the 295 samples tested in 2021, 61 (or 30% in 2020) and 119 (or 41% in 2021) were found to be non- compliant. The regional BEVS met by the audit team stated that the main reasons for non-compliance are labelling problems, no indication of batch number, excessive sugar and sulphites content, rate of volatile acidity or enrichment higher than the maximum allowed for the PDO/PGI designation. The audit team noted that the frequency of non- compliance found by the CBs earlier in the production chain was much lower (see also paragraph 67 above). Although the regional BEVS results are not fully representative of the entire control system, since the sampling is based on risk analysis and notifications of non-compliances or fraud suspicion, the audit team considered that the high rates of non-compliance identified by the BEVS indicate that there may be shortcomings upstream in the control system. Performance of official controls of PDO/PGI wines in the market

The DGCCRF controls carried out by the regional BEVS at wine distributors (see also paragraph 49) during the 2020-2021 vinification periods revealed high non-compliance levels similar to those referred to in paragraph 70 above. Thus, the average level of non-compliances found was circa 35%. PDO/PGI wines are also sampled by DGCCRF for official organoleptic and analytical testing during the marketing of wines. Of the 83 samples tested in 2020 and the 75 samples tested in 2021, circa 45% were found on average to be non-compliant.

Member state response

Les autorités françaises considèrent que la recommandation n'est pas fondée. En effet, les taux de non-conformité ne sont pas comparables tre les contrôles réalisés par les organismes de contrôles sur légation de l'INAO et les contrôles réalisés par la DGCCRF. En effet : - Les contrôles DGCCRF portent notamment sur des éléments qui ne sont pas dans le périmètre du contrôle INAO comme les règles d'étiquetages, les pratiques commerciales trompeuses ou la falsification ; - Les contrôles DGCCRF sont déclenchés suite à des enquêtes de traçabilité approfondie sur les opérateurs suspectés de fraudes et sont donc des contrôles basés uniquement sur un ciblage très précis des opérateurs à contrôler. Au contraire, les Page: 7 ns received 29/6/2023 mendations of report ref. DG(SANTE) 2022-7385 of the audit carried out from 14 November stem related to Protected Designation of Origin (PDO) and Protected Geographical Indication Action Proposed by the competent authority contrôles effectués sur délégation de l'INAO ne sont pas uniquement fondés sur le risque de fraude et ont un caractère davantage systématique ; - La volumétrie de contrôle n'est pas la même, la conclusion 67 dénombrant plus de 60

We consider that the Les autorités françaises maintiennent leur analyse sur le fait que la recommendation is unfounded. The recommandation n'est pas fondée. rates of non-compliance are not comparable between the checks En effet, la finalité des contrôles réalisés par la DGCCRF ou sous la carried out by the INAO's responsabilité de l'INAO n'est pas la même et ne peuvent en aucun cas elegated inspection bodies and the être comparée. Page: 10 to the report's recommendations (updated) received 21/02/2024 t of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2022-7385 of November 2022 to 28 November 2022 in order to evaluate the control system related to Protected Designation of Origin (PDO) ication (PGI) for wine sector products Action Proposed by the competent Updated Action Proposed by the competent authority authority hecks carried out by the Les contrôles organoleptiques avant la mise sur le marché visent à GCCRF. Indeed: s'assurer notamment que le vin possède bien les caractéristiques de l'AO - DGCCRF controls include ou de l'IG. Ces contrôles sont effectués chez la grande majorité des ting elements which are not within the opér

The recommendation states as its basis

The ANSES-LSV is the National Reference Laboratory (NRL) for Xf. It coordinates and supervises the activities of the laboratories, which are designated for testing official plant and insect vector samples for Xf. The NRL confirms positive test results of the designated laboratories and identifies the Xf subspecies. ANSES-LSV is accredited to ISO/EN 17025, the scope includes analysis of a range of harmful pests with molecular methods.

An appropriate laboratory network supports the official controls. However, some tests are not carried out with methods listed in Annex IV to Regulation (EU) 2020/1201, and the scope of ISO/EN 17025 accreditation of some laboratories does not include the applied methods, which may compromise the appropriateness of the tests.

Member state response

s The French competent authorities have repeatedly pointed out to the Commission the Les autorités compétentes françaises difficulties that the accreditation requirement transmettent dans le tableau A en annexe referred to in Article 37 (4) (e) of Regulation la mise à jour des accréditations des (EU) 2017/625 poses in the phytosanitary laboratoires officiels impliqués dans le field due to the large number of harmful diagnostic de Xylella fastidiosa et de ses organisms and consequently the methods to vecteurs. Certains laboratoires ont pu s'accréditer et dans un cas, l'audit est be applied. Therefore, Delegated Regulation programmé. (EU) 2021/1353 on derogations from accreditation in particular for plant health is now implemented. However, an adjustment Les autorités compétentes françaises period is needed for official laboratories and difficulties remain for NRLs that will be re- informent la Commission que la reported to the Commission. méthode PCR temps réel tetraplex Dupas et al. 2019 a été intégrée dans le protocole OEPP PM 7/24 (5) Xylella fastidiosa. Real-time PCR tetraplex Dupas et al. 2019 has been used by the NRL for subspecies determination since spring 2022, after intern

The recommendation states as its basis

The audit team noted that: The planning of the RIBESS+ surveys was in line with requirements of Regulation (EU) 2020/1201; The central identification of the squares to be inspected does not consider the risk factors which are known or identified regionally (e.g., patterns in the spread of the disease, presence and dominance of sensitive plants); In many cases, the entire territory of the square cannot be accessed for inspection (e.g., private properties in urban areas, mountainous terrain, impenetrable natural or semi natural vegetation) which compromises the assessment of the plant health status and sampling; The inspection and sampling were carried out according to DGAL technical instructions. Symptomatic plants were prioritised for sampling and their geo-coordinates were sufficiently recorded for any possible follow-up. 5.5.3 Annual surveys of plants in the infected zones

The positives detected during the risk-based surveys carried out in the vicinity of the DAs in 2021 and 2022 indicate that the current DAs do no not reflect the full extent of Xf presence in the region. Therefore, the continuation of the delimiting surveys is essential.

During the 2021 BZ surveys, 81 samples tested positive, i.e., 5.5% of the totals. The positive rate was particularly high in Zone B and relatively low in Zone C. 80% of the positives were collected from the 400m parts of the BZs, while 70% of the positives originated from urban 20 epidemiological units. Table III summarises the result. In addition to the RIBESS+ findings 16 positives were detected in the BZs during the follow up actions of notifications from the public. Table III. Statistical surveys of the BZ in the Region PACA in 2021 Squares inspected Zone A Zone B Zone C Plant samples taken Positive samples 182 301 203 Samples with undetermined test result 368 620 462 Share of positive samples 24 51 6 Source: FREDON PACA 0 2 1 6.5% 8.0% 1.3%

Although the statistical surveys in the DAs were designed in line with the EU requirements, not all relevant risk factors were taken into consideration during their implementation, which may have resulted in not detecting all positives present at the selected survey sites.

Member state response

The planning of surveillance in the emarcated areas will take into account as an additional risk factor the proximity to an infected area detected in the previous year. In addition, we will ensure that the quadrats to be inspected are evenly distributed across all areas.

The recommendation states as its basis

In relation to the plant removals in the Region Occitanie, the SRAL stated that: The works are generally completed with steps in the following order: delimitation of the IZ, identification and notification of the owner of the positive plant, removal of the positive plant, prioritisation of the IZs for the removal of specified plants according to the identified risk (e.g. nurseries, sensitive agricultural crops in the proximity) and due to practical issues, inventory for specified plants, identification and notification of the owners of plants to be removed, completion of the removals; As much as possible, until they are removed, the positive tested plants are covered with insect-proof nets; For plant removals, a two-step approach was introduced, as any positive tested plant means a proven plant health risk. The identification and notification of the owner and the plant removal can be arranged more quickly than for all the other plants in the IZ subject to felling; The land register in the region contains up-to-date information about the owners; most of them can be readily identified and notified quickly; After the inventory of an IZ for specified plants is completed, the owners (typically 5 to 20) need to be identified and notified, which means a significant administrative burden; The owners have 10 days to submit their observations, after which the company awarded the public contract may intervene for private individuals. For communities and farm owners, a time limit of the order of one month is assigned for the destruction of plants; There were few appeals against the notifications, mainly due to the incorrect addressee in the documents. Thanks to the awareness raising activities of the municipalities and the CAs, the landowners generally accept the necessity of the measures; The plant parts removed by the company awarded the public contract are either incinerated at a safe site close to the IZ or shredded on-site, which is the common practice in natural and semi-natural areas; The large diversity in the accessibility of the sites and environmental concerns hindered the completion of the plant removals. If the number of positives increases, some additional measures are planned (e.g., automatic issuance of the notifications). After the outbreak is completely delimited, the IZs closest to the outer limit of the DAs are intended to be prioritised for plant removals.

The removal of plants was carried out with substantial delays in most of the IZs as the necessary capacities were established recently, which caused favourable conditions for the spread of the disease. The eradication impact of plant removals by shredding is strongly compromised by the massive aftergrowth in the semi natural and natural areas.

Although there were notable improvements since the 2021 audit in the number of IZs with completed eradication activities, the removal of plants including the positive tested and the potentially infected ones was carried out with substantial delays in most of the IZs, facilitating the spread of the disease.

Member state response

to In Provence-Alpes-Côte d'Azur region: Les autorités françaises transmettent à la Commission dans le tableau B joint les -- All contaminated plants found until 2021 tableaux mis à jour permettant d'évaluer have been treated and removed. les délais d'enlèvement des végétaux spécifiés dans les zones infectées des -- In 2022, 117 outbreaks were detected régions PACA et Occitanie. following surveillance of the infected zones En juin 2023, la majorité des végétaux and buffer zones. The new public trouvés contaminés en 2022 ont été procurement contract activated at the end of enlevés (85% en PACA et 96% en July 2022 provides for the treatment and Occitanie). Compte-tenu des conclusions removal of contaminated plants. It was de l'audit et de la recommendation 5, les implemented to reduce very significantly the travaux d'arrachage des végétaux time previously linked to the fact that the spécifiés à l'article 7(1) (b) à (e) du treatment and removal of contaminated plants règlement d'exécution (UE) 2020/1201 was the responsibility of the owners of the ont été priorisés dans les zones proches property concerned. de la limite de la zone infestée et dans les nouvelles zones trouvées For Occit

The recommendation states as its basis

For the 2021 surveillance of the BZs, the RIBESS+ model was applied with the minimum criteria set by Article 10 of Regulation (EU) 2020/1201 (level of confidence ­ 90%, design (target) prevalence ­ 1% and the first 400m surrounding the IZ considered as higher risk). Seven epidemiological units (urban, semi-natural, fruit trees, extensive agriculture, alfalfa, vines, other) were established for the DAs. The entire territory of the BZs was divided into 100m x 100m squares. Each square was attributed to an epidemiological unit, based on the registered land use data. The two-step approach, in line with the relevant guidance document of the European Food Safety Authority (EFSA), was used for the determination of the sample numbers for the epidemiological units. The size of the host plant population was established 13 based on the agricultural production statistics, but also comprehensive botanical inventories carried out at the end of 2020 in the demarcated areas. Epidemiological estimations were made for the non-agricultural areas.

Although the surveys in the DAs were designed in line with EU requirements, not all relevant risk factors were taken into consideration during their implementation, which may have resulted in not detecting all positives present at the selected survey sites.

The high number of IZs, the proportion of positives in the samples from the BZs and the presence of insect vectors carrying the bacterium indicate that Xf is present in all epidemiological units of the BZs. Consequently, the extent of the infection in the BZs cannot be comprehensively identified with the applied statistical methods, and the established IZs only partially reflect the current spread.

Member state response

delimitation methodology implemented Les autorités françaises communiqueront ces détails dans les délais définis à in 2022 in the Aude will be extended in 2023 l'article 35 du Règlement d'exécution to characterise the phytosanitary status of (UE) 2020/1201. areas which have not yet been surveyed.

The recommendation states as its basis

For the 2021 surveillance of the BZs, the RIBESS+ model was applied with the minimum criteria set by Article 10 of Regulation (EU) 2020/1201 (level of confidence ­ 90%, design (target) prevalence ­ 1% and the first 400m surrounding the IZ considered as higher risk). Seven epidemiological units (urban, semi-natural, fruit trees, extensive agriculture, alfalfa, vines, other) were established for the DAs. The entire territory of the BZs was divided into 100m x 100m squares. Each square was attributed to an epidemiological unit, based on the registered land use data. The two-step approach, in line with the relevant guidance document of the European Food Safety Authority (EFSA), was used for the determination of the sample numbers for the epidemiological units. The size of the host plant population was established 13 based on the agricultural production statistics, but also comprehensive botanical inventories carried out at the end of 2020 in the demarcated areas. Epidemiological estimations were made for the non-agricultural areas.

The high number of IZs, the proportion of positives in the samples from the BZs and the presence of insect vectors carrying the bacterium indicate that Xf is present in all epidemiological units of the BZs. Consequently, the extent of the infection in the BZs cannot be comprehensively identified with the applied statistical methods, and the established IZs only partially reflect the current spread.

The high number of IZs, the proportion of positives in the samples from the BZs and the presence of insect vectors carrying the bacterium indicate that Xf is present in all epidemiological units of the BZs. Consequently, the established IZs only partially reflect the current spread and the extent of the infection in the BZs cannot be comprehensively identified with the applied statistical methods.

Member state response

e proportionality of measures to control Xylella fastidiosa subsp. multiplex in areas where it can no longer be eradicated could be reviewed in the light of its impact. At this stage, the damage caused by multiplex in the demarcated areas in France is limited, but there are uncertainties about the behaviour of the bacterium which justify maintaining the control measures. ion Proposed by the competent authority Updated Action Proposed by the Competent Authority this context, in order to prevent the spread the bacterium in the European Union and guarantee the quality of the Community erial exported, the French authorities wish maintain a high level of control over plant erial intended for planting (nurseries and den centres) both for intra-EU movements for third countries. French authorities will consider the ommendation to develop the control ategy for the subspecies multiplex in the arcated area of Aude and in the arcated areas of Côte d'Azur as from the 3 monitoring campaign. However, ustments will be needed in the current opean legislation (Regulation (EU) 0/1201) to take account of the specific uation in these areas (continental location, species multiplex with a wide range of t

The recommendation states as its basis

The felling of specified plants within a radius of 100 m around the infested plants was not complete. Felling of four taxa (Acer spp., Corylus spp., Citrus spp., Rosa spp.) out of the 20 specified by Article 1(a) of Decision (EU) 2012/138 has been ordered by the CA. The CA explained the reason for selecting these taxa was that only maple and hazelnut plants 8 had been found infested, citrus plants are the main hosts of the pest, and the inspection of roses is very difficult. The CA justifies the reduction of felled taxa with the general heritage status of the district, however this differs from the AVAP Decision No 19.130 which specifies the individual trees and plantations of protected trees (see also finding 26). There was no official assessment and written conclusion by the CA on record that the felling of any specified plant was inappropriate. At the time of the audit, 685 specified plants were located within 100 m from the infested plants and almost 500 of them were on private premises. The list of these plants contains the explanation that the difficulties related to felling are due to the change of owners of properties and the lack of access to private premises. The audit team noted the presence of a Prunus laurocerasus bush right beside the initially infested plant and a short Lagerstroemia plant close to the infested hazelnut.

The incomplete felling of specified plants within a radius of 100 m around infested trees does not comply with Annex II section 3 (1)(a) of Decision (EU) 2012/138, which allows the CA not to perform such felling only in exceptional cases, where the responsible official body concludes that it is inappropriate. 5.5.3 Destruction of plants

The CA carries out intensive monitoring within the DA focusing on the first 500 m zone around the infested plants to detect the occurrence of any additional infestation, however, issues with access to private properties, felling of specified plants, and the potential movement of green waste out of the DA decrease the effectiveness of the eradication measures.

Member state response

es autorités compétentes françaises ont noté la nécessité de dans un document écrit les motivations et l'analyse ayant conduit à la décision que l'abattage de la é des espèces spécifiées n'était pas indiqué, comme prévu à l'annexe II section 3(1)(b) de la Decision (UE) 2012/138. Un tel document formalisant l'évaluation conduite et ses conclusions sera rédigé à l'avenir.

n The competent French authorities have En région Nouvelle Aquitaine le d the need to set down in writing in choix de ne pas abattre toutes les document the justifications and risk essences spécifiées comme prévu analysis that led to the decision that à l'annexe II, section 3(1)(b) de la ing all the specified species was not décision (UE) 2012/138, repose , as laid down in Annex II, sur : section 3(1)(b) of Decision (EU) 2012/138. In future, such a document - la volonté locale de préserver le setting out in writing the assessment quartier historique de Pontaillac ed out and its conclusions will be épargné par les bombardements drafted. de 1945 qui est considéré comme un poumon vert et un secteur patrimonial sous boisement mais aussi de respecter la sensibilité des habitants envers leur environnement végétal. - le résultat des investigations faites dans le quartier de Pontaillac révélant une infestation récente du capricorne asiatique, datant de moins de deux ans. Des analyses génétiques officielles ont confirmé l'hypothèse d'une seule introduction avec une ponte unique à l'été 2018 sur Acer negundo et un noisetier voisin. La région Nouvelle-Aquitaine a donc opté pour la mise en oeu

The recommendation states as its basis

National and regional legal acts ensure that officials have access to private premises. However, in case of non-cooperation, the CA needs the decision of the Liberty and Detention Judge (Juge des libertés et de la detention), on a case-by-case basis, to oblige owners to give access to their premises. To avoid this procedure, the CA focuses on information sharing to increase public acceptance of these measures (see also section 5.8). However, the CAs informed the audit team that there are cases when the monitoring of specified plants in private premises was not possible because of access issues. This issue was also noted in the 2022 autumn report on the detection dog survey. Although, beyond the first 500 m of the BZ, private premises for monitoring are chosen randomly, with those where specified plants are visible from the street being preferred. 5.5.2 Removal of plants

The felling of infested plants and specified ones within 100 m around them largely depends on the cooperation of the municipality and the citizens. The regional action plan identifies the issues regarding access to private properties and contains a statement that 9 the municipality would not support the felling of any asymptomatic plants. In spite of this, the CA did not take any measures to address such complication that could reasonably be expected to prevent, hinder or delay eradication, in particular those related to the accessibility, contrary to Annex II section 3 (1)(j) of Decision (EU) 2012/138. Conclusions on the eradication measures against A. chinensis

The CA carries out intensive monitoring within the DA focusing on the first 500 m zone around the infested plants to detect the occurrence of any additional infestation, however, issues with access to private properties, felling of specified plants, and the potential movement of green waste out of the DA decrease the effectiveness of the eradication measures.

Member state response

esures spécifiques suivantes seront mises en oeuvre en uvelle-Aquitaine : men individuel détaillé de tous les végétaux spécifiés non destinés à l'abattage qui se trouvent dans le rayon de 100 m tel que prévu à l'annexe II section 3(1)(b) sera réalisé et étendu dans un rayon de 500m. Il sera complété par un deuxième passage annuel de la brigade cynophile sur toute la zone de 500m ; - pour pallier aux difficultés liées à l'accessibilité aux propriétés privées, les prospections seront réalisées lors des vacances scolaires et en septembre lorsque de nombreuses propriétés sont encore habitées (résidences secondaires). Une communication via la mairie sera réalisée sur les dates de prospection prévues et des courriers seront laissés dans les boites aux lettres avec numéro à rappeler en cas d'absence des propriétaires lors du passage ; 2023 by the competent authority - s'agissant de la gestion des déchets verts, les actions décrites en réponse à la recommandation n°4 du tableau seront appliquées.

The recommendation states as its basis

The DAs for A. chinensis and A. glabripennis were established and amended in line with the EU legislation, allowing the application of the eradication and control measures. However, the designation of the BZ under intensive monitoring in Centre- Val de Loire is not in line with EU requirements, which may decrease the effectiveness of the monitoring for the presence of A. glabripennis.

Member state response

rêté préfectoral établissant la délimitation de la zone du Gien en Centre-Val de Loire a été mis à jour et publié 23 (voir Annexe 3, document A).

The recommendation states as its basis

Although the order of the prefect specifies that transport of plants and plant material of the specified plants from the DA is prohibited, compliance with this requirement is not ensured. The municipal green waste disposal site, where the public can bring pruned material or any green waste, is located outside the DA. The movement of such material is not controlled, which does not comply with Annex II section 3 (1)(d) of Decision (EU) 2012/138. 5.5.4 Tracing activity

The CA carries out intensive monitoring within the DA focusing on the first 500 m zone around the infested plants to detect the occurrence of any additional infestation, however, issues with access to private properties, felling of specified plants, and the potential movement of green waste out of the DA decrease the effectiveness of the eradication measures.

The municipality of Gien provided a site within the DA where the felled plants could be deposited, and they carried out the incineration. The order of the prefect lays down that transport of plants and plant material of the specified plants is prohibited from the DA. However, the municipal green waste disposal site, where the public can bring pruned material or any green waste, is located outside the DA, and movement of such material is not controlled. In addition, the CA stated that seasonal workers arrive to the city every year and offer cheap gardening, including pruning, and they carry away the plant material. Illegal dumping of this green waste within and outside the DA is a significant problem. 11 The CA of Centre-Val de Loire cannot prevent the movement of potentially infested material out of the DA, as required by Annex III section 3(2)(c) of Decision (EU) 2015/893.

The intensive monitoring activity of the regional CAs within the DAs is suitable to detect the occurrence of any additional infested plants. Although the change to containment strategy was not in line with EU requirements, the measures implemented by the regional phytosanitary services are generally in line with the provisions of the EU legislation regarding containment. However, issues with the potential movement of green waste out of the DA in Centre-Val de Loire could decrease the effectiveness of the official measures.

Member state response

ouvelle-Aquitaine, pour éviter tout risque lié au ent de matériel végétal potentiellement infesté hors de a zone délimitée, les mesures suivantes seront appliquées : x prospections annuelles par la brigade cynophile de l'ensemble des espèces spécifiées dans les 500 mètres autour des foyers seront réalisées pour s'assurer qu'elles ne sont pas infestées ; - un rappel sera réalisé aux collectivités territoriales concernées sur les mesures liées à la dérogation accordée pour la sortie des déchets verts de la zone délimitée, à savoir : o une sensibilisation du personnel collectant en porte à porte ou travaillant en déchetterie ; o le transport vers la plate-forme de broyage des collectes en porte à porte dans des camions-bennes étanches avec compactage à chaque introduction dans la benne et des bennes de la déchetterie de Royan sous filet à maille de 1 mm ; o le broyage avec une grille de 150 mm des déchets verts issus de la collecte ou de l'apport à la déchetterie de Royan dans les 48h00 maximum ; 2023 competent authority o la récupération du broyat dans une benne couverte par un filet à maille de 1mm pendant une durée équivalente à une nuit ; o un contrôle visuel des bennes avant broy

The recommendation states as its basis

The intensive monitoring activity of the regional CAs within the DAs is suitable to detect the occurrence of any additional infested plants. Although the change to containment strategy was not in line with EU requirements, the measures implemented by the regional phytosanitary services are generally in line with the provisions of the EU legislation regarding containment. However, issues with the potential movement of green waste out of the DA in Centre-Val de Loire could decrease the effectiveness of the official measures.

Member state response

utorités françaises partagent la conclusion No 49, ication des foyers semble réaliste en raison du faible bre de végétaux infestés et de l'absence de nouvelles tion au cours des dernières années. Le d'A. glabripennis à partir de la ZD est s françaises vont considérer la évoluer la stratégie de lutte vis-à-vis 2023 ion e iées ges yer et r ion la

The recommendation states as its basis

Currently, green offal and udders are not inspected as part of PMI. This is not in line with the requirements of Article 19 of Implementing Regulation (EU) 2019/627. The audit team was informed that the CCA is in the process of drafting a guideline clarifying the regulatory requirements, but noted that the requirements in question were already contained in EU legislation well preceding the above Regulation (i.e. in repealed Regulation (EC) No 854/2004 of the European Parliament and of the Council). Red offal including kidneys are examined during PMI, as required.

The delivery of official controls is adequate in preventing bovine animals unfit for (slaughter for) human consumption from entering the food chain. Nonetheless, the continued performance of AMI and PMI by OA without the presence of the OV in the slaughterhouse is contrary to EU requirements (except for PMI in low throughput slaughterhouses). The same applies to the absence of visual inspection of udders and its lymph nodes and the visual inspection of the gastro-intestinal tract and palpation of the gastric and mesenteric lymph nodes. It is necessary that the official controls verify that operators follow their existing procedures on dirty animals and carcases and that those are fit for purpose especially in the steps preceding PMI.

Member state response

l est à noter que ce constat ne concerne pas l'ensemble des abattoirs visités mais certains d'entre eux, notamment les plus anciens. La majorité des abattoirs d'animaux de boucherie en France dispose d'une chaîne et d'un poste de contrôle dédié aux abats. Lorsque ce n'est pas le cas, des accords existent entre services d'inspection et opérateurs de l'abattoir afin que ces derniers préviennent les inspecteurs fficiels si les abats présentent un aspect anormal. Conscient cependant que ce fonctionnement doit être amélioré, un recensement précis des sites d'abattage où cette inspection est problématique sera réalisé d'ici la fin d'année. Il est à noter que les abattoirs construits récemment disposent d'installations adaptées pour un contrôle des abats blancs tel que prévu dans la règlementation. Concernant les mamelles, le process d'abattage ne permet pas son contrôle de façon aisée (la mamelle est retirée de la carcasse très en amont, avant même la dépouille, comme pourrait l'être également le pénis). La mamelle n'est jamais valorisée en consommation humaine, il s'agit d'un sous-produit de catégorie 3. Par ailleurs, les principales lésions concernant la mamelle (mammite, nécrose, ...)

The recommendation states as its basis

Surveillance for wild birds is regularly adapted according to the perceived risk of introduction of HPAI, and is enhanced in all territories where the level of risk increases, and in restricted zones around outbreaks. This resulted in a significantly higher number of samples taken from wild birds once the first outbreaks were confirmed, as that was considered a period with increased risk. However, at the time when the first few index outbreaks were detected in poultry in 2020, 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.

The inability of the surveillance to detect promptly the virus in wild birds contrasts with the fact that the authorities considered circulation of the virus in them as the main cause for most of the initial outbreaks in the region. The NRL confirmed this a posteriori by virus phylogenetic studies. That sub-optimal effectiveness of the early warning system in wild birds cannot be considered in line with provisions laid down in Articles 26(2) and (4) and 27 of Regulation (EU) 2016/429, on the need to design and apply surveillance in a way that is appropriate and proportionate to the objectives pursued and to the risk factors involved in order to ensure the timely detection of the presence of the targeted disease. In doing that, the competent authority shall as well comply with EU requirements establishing the Union surveillance programme for HPAI, as laid down in Articles 3(1)(a) and (b)(i), 4(1)(b)(i) and 10(2) of, and Annex II to Delegated Regulation (EU) 2020/689.

ANSES experts pointed out that passive surveillance alone had been sometimes ineffective to detect some of the outbreaks, due to a longer incubation period with excretion of virus for several days prior to the clinical stage of the disease. In areas with 9 a high density of poultry, this probably led to fast undetected spread of infection and an immediate overflow of cases that surpassed the disease management and control capacity.

Although the authorities have made efforts to increase the sensitivity of surveillance for HPAI in both wild birds and domestic poultry, neither component was effective as an early warning system to better prevent the evolution of both epizootics. The authorities are aware of it and, in particular for domestic poultry, they are working on further strengthening that surveillance.

The recommendation states as its basis

The audit team reviewed files related to HPAI suspicions. In most cases, business operators and private veterinarians had notified quickly to the authority abnormal mortality rates and clinical signs. However, the audit team noted on two visited establishments, unnecessary delays, of three and one day, respectively. In second instance, although the establishment immediately notified a suspicion to a private veterinarian, he suspected bacteriological infection and only on following day he took correct decision to notify the suspicion to the authority. This delay occurred in the area with a high density of poultry during ongoing epizootic. That is not in line with requirements laid down in Article 18(1)(a) and (c) of Regulation (EU) 2016/429.

Despite raised and maintained public awareness, the delayed notification of suspect cases by certain operators, as noted on the establishments visited by the audit team, likely contributed to the spread of the disease in areas with a high density of poultry.

The recommendation states as its basis

It was only in September 2021 when the DGAL defined high-risk areas for the likely dissemination of HPAI after introduction of the disease by wild birds (areas at risk of virus spread), taking into account the density of poultry establishments and some other risk factors, mainly related to the presence of domestic waterfowl (see map 5 in Annex 2). In those areas, additional enhanced biosecurity and surveillance measures apply in instances of moderate and high risk of HPAI introduction. The delayed definition of those areas was not in line with Article 3 of Commission implementing Decision (EU) 2018/1136, that was adopted in August 2018 and applicable until 20 April 2021.

Despite plenty of evidence on the inappropriate application of, and insufficient compliance with national requirements on biosecurity in poultry establishments in the areas affected by both HPAI epizootics, the competent authorities failed to correct those shortcomings (already noted in the previous report) and enforce those requirements before they started. This played a major role in facilitating the introduction of the disease and its further spread. The authorities only recently linked 14 the payment of compensation to compliance with biosecurity requirements, acknowledging that before the recent epizootics they had lost an opportunity to incentivise that compliance and to make HPAI preventive measures more effective

The recently published ANSES analysis of the epidemiological information obtained from the recent HPAI epizootics helps the authorities to understand the main risk factors present in the affected areas that contributed to the introduction and spread of the disease. The authorities have now sufficient information to tailor more effective risk-mitigating practices to better prevent the occurrence of HPAI epizootics in the future.

The authorities allowed repopulation of establishments affected by outbreaks of HPAI only after verifying properly that there was no risk of residual infection. This contributed to prevent the resurgence of the disease in those establishments. However, as regards compliance with biosecurity measures to prevent reoccurrence of the disease, the authorities did not verify that lower biosecurity levels, often identified in epidemiological enquires as the most likely source of introduction and spread of the infection, were adequately addressed and strengthened.

The authorities have repeatedly underlined the significant risk that the very high density of poultry represents for the areas affected by the two recent HPAI epizootics, but they have not acted accordingly to reduce it. This, coupled with the sub-optimal application of biosecurity measures to mitigate the prevailing risks of HPAI introduction and spread, raises concerns about their capability to prevent and control new HPAI epizootics.

The recommendation states as its basis

Similar to what happened in previous HPAI epizootics, due to the sudden increase in the number of outbreaks, the departmental authorities were able to carry out complete epidemiological enquires, mostly, only at the beginning of the two recent epizootics. The audit team estimated that in 70-80% of the cases, they did not carry out an in-depth 11 enquiry. In the most affected département in the south-west region (Landes), the departmental authorities conducted complete enquires for the first eight outbreaks. Later on, they carried out enquires on some additional outbreaks, adding up to 20 in total (there were 341 confirmed outbreaks in this area). A similar situation was noted in the Pays de la Loire region (département Vendée), where the departmental authorities performed a limited number of in-depth enquiries only at the beginning of the 2021/22 HPAI epizootic.

During the two recent HPAI epizootics, the low number of epidemiological investigations and their varying quality precluded the authorities from obtaining fundamental information to understand the likely spread of the disease and to identify contact establishments. Hence, they could not take the right decisions to rapidly contain the spread of the disease.

Despite the efforts of the disease control centres established during the epizootics at national and regional level to coordinate the application of the main control measures in the affected areas, they lacked adequate timely expertise, epidemiological analytical capacity and up-to-date knowledge about available resources, to take certain important decisions at critical times. Thus, they could not provide adequate and rapid advice to the departmental authorities in those areas so that they could prioritise their actions to contain and prevent the spread of HPAI effectively.

The recommendation states as its basis

During both recent epizootics, as the number of new outbreaks sharply increased, the resources available for killing and disposal of carcasses were quickly depleted. Some establishments could only be culled three to four days after confirmation, even up to seven days at some stages in 2022 during the 2021/22 epizootic (see chart 4 in Annex 2). For example, in one of the establishments visited by the audit team, a prolonged keeping of live infected animals potentially shedding the virus, facilitated infection spread and caused some secondary outbreaks. In addition, due to high mortality and delays in killing, when killing started many birds had already died. These shortcomings are not in compliance with EU requirements laid down in Article 61(1)(b) and (c) of Regulation 13 (EU) 2016/429 and Article 12(1) of Delegated Regulation (EU) 2020/687.

The significant delays in the killing and disposal of animals and of other products that could be contaminated with the HPAI virus undermined the effectiveness of other containment measures and likely contributed to the further spread of the disease during the worst of both epizootics. 5.1.2 Diagnosis of HPAI

However, in both epizootics, a large proportion of the flocks subject to pre-emptive culling were already infected, indicating that this culling arrived late. In the most affected département (Landes), during the 2020/21 HPAI epizootic, out of 160 depopulated establishments, 70 were already positive for HPAI.

The exponential increase in the number of outbreaks in the 2021/22 HPAI epizootic, and the subsequent overflow of carcasses to be disposed of, exceeded the available 17 processing capacity and made preventive killing no longer feasible, as noted in the most affected département in the Pays de la Loire region (Vendée).

The shortcomings mentioned in the previous points did not allow the competent authorities to accelerate the killing of susceptible poultry within the restricted zone when the epidemiological situation so required. The actions were not in line with provisions of Article 61(1)(b) of Regulation (EU) 2016/429 and Article 22(2) of Regulation (EU) 2020/687.

The shortage of capacity to depopulate (including for preventive killing) animals, to dispose of their carcases and to quickly visit establishments within restricted zones, undermined the effectiveness of the control measures to contain the disease.

However, due to the rapid increase in the number of affected establishments and poultry in the Pays de la Loire region, the capacity of rendering plants in the area was quickly exceeded. This slowed down the killing process and postponed some of the activities until the accumulated amount of killed animals could be disposed of safely. To cope with the lack of capacity and to prevent further delays in killing of poultry, the authorities opted for burial on site of carcasses, which they did at purposely-made landfills in some of the establishments affected. They also stored ABP temporarily in some affected establishments and other designated sites. Representatives of the authorities met conceded that they should have explored those alternatives in peacetime, to know their limitations beforehand and to negotiate feasible arrangements for their use.

At the time of the audit the departmental contingency plans had not yet been updated to anticipate and deal with such exceptional situations. They had not included details and pre-arrangements on the alternative methods of disposal of carcasses that can be used locally, e.g., a list of sites selected and authorised for storage or burial on site of carcasses.

The shortcomings highlighted in the previous points are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429, on the responsibilities of the competent authorities to have access to adequate facilities to take the necessary disease control measures, including disposal of animals that may contribute to the spread of the disease, in the event of an animal health crisis. Conclusions on animal depopulation for the purpose of disease control

Since the previous Commission audit in 2019 the authorities had not taken adequate steps and had not made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases in establishments where the presence of HPAI was confirmed or as a preventive measure in areas affected by the disease. This caused significant delays in the depopulation of establishments and accumulation of carcases, which significantly undermined the effectiveness of other measures to contain the spread of the disease. 5.1.5 Cleaning and disinfection

In general, the departmental Plans for Sanitary Emergencies contain the necessary instructions and ready-to-use documentation for the authorities to act promptly in the event of a HPAI outbreak, in particular to handle the many administrative tasks involved in those situations. However, as demonstrated in the two recent HPAI epizootics, the authorities found challenging to apply some control measures effectively due to inadequate emergency preparedness. In this context some of the components of those plans were still either missing, not detailed enough or simply not guaranteeing a prompt and effective response (e.g., missing and/or inadequate quality of epidemiological enquires, inadequate establishment of some restricted zones, and ineffective pre- arrangements to kill poultry and dispose of carcasses during large outbreaks). Therefore, those plans cannot be considered fully in line with EU requirements laid down in Article 43(2) of Regulation (EU) 2016/429 on the matters that contingency plans should at least cover.

The authorities did not fulfil the undertakings given in response to the previous audit to update and complete the national contingency plan for HPAI, to adequately reinforce the most important components of the emergency preparedness system for the high-risk areas affected by previous HPAI epizootics, and to assess, and improve if necessary, the level of preparedness of the departmental authorities to cope with an epizootic. Hence, they could not avail of sufficiently qualified and trained human resources with access to all necessary operational tools to succeed with the rapid and effective containment of the disease.

The recommendation states as its basis

During the 2020/21 HPAI epizootic, the authorities established restricted zones based on the minimum radius required by EU legislation, i.e., a 3 km protection zone and a 10 km surveillance zone, taking also into consideration relevant municipal boundaries (e.g., a zone could be slightly expanded to cover the territory of a municipality until one of those boundaries). However, the authorities did not take into account other important factors, e.g., the disease profile (e.g., whether it was more or less virulent and transmissible depending on the species and production stage affected), the high density of poultry and the network of contacts, to determine if the boundaries and size of the restricted zones were adequate to contain the spread of the disease. In addition, the audit team saw examples where due to the reduced number of epidemiological enquiries, or to have access to only partial information from them, the authorities did not have enough evidence to establish the adequate size or shape of some restricted zones.

Although the authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, they defined their size and shape without having enough information on the likely spread of the disease and without considering important criteria for doing that. In addition, they did not take full consideration of all appropriate epidemiological criteria for establishing further restricted zones and when they did establish them they did so late. Therefore, those restricted zones were not effective to stop the spread of the disease before it reached epizootic proportions and expanded far beyond the initially affected areas.

The slow start and the difficulty to apply preventive killing at early stages as planned, limited the contribution of that measure to reduce quickly the poultry population in high-risk areas. In some instances, the authorities eventually implemented preventive killing and in the end it contributed to reduce the number of birds and regain control of 20 the situation in some areas heavily affected by HPAI. However, the delayed testing of flocks moved to slaughterhouses meant that many of them were already infected, thus increasing the risk of spreading the infection during critical periods of the epizootics.

The competent authorities granted thousands of derogations to move animals and products of animal origin from restricted zones. Derogations granted for emergency slaughter contributed significantly to the reduction of susceptible animals in restricted areas. However, non-compliances with movement requirements, such as not taking certain risk-mitigating measures and not respecting certain procedural conditions before granting those derogations, compromised the health status of the areas of destination of those commodities. 5.1.4 Animal depopulation for the purpose of disease control 5.1.4.1 Animal welfare considerations

The authorities did not fulfil the undertakings given in response to the previous audit to update and complete the national contingency plan for HPAI, to adequately reinforce the most important components of the emergency preparedness system for the high-risk areas affected by previous HPAI epizootics, and to assess, and improve if necessary, the level of preparedness of the departmental authorities to cope with an epizootic. Hence, they could not avail of sufficiently qualified and trained human resources with access to all necessary operational tools to succeed with the rapid and effective containment of the disease.

The recommendation states as its basis

As explained in section 5.1.3.1, during the 2021/22 HPAI epizootic, the central authority introduced a new strategy to immediately establish in the event of an outbreak further restricted zones in areas considered of high-risk for the introduction and spread of HPAI. When applied, this measure strengthened the application of control measures. Based on the epidemiological situation and the expected fast spread of infection, the departmental authorities, in coordination with the DGAL, established those further restricted zones even in some areas not defined as high-risk areas.

However, as mentioned in 5.1.3.1, those zones were not always applied as instructed. For example, the fast evolution of the epizootic in the Pays de la Loire region confirmed that the authorities did not properly consider the epidemiological situation when they defined the restricted zones and did not establish a further restricted zone immediately. This is not in accordance with Article 64(2)(b) of Regulation (EU) 2016/429 and Article 21(1)(c) of Delegated Regulation (EU) 2020/687. 5.1.3.4 Derogations to measures applied in protection and surveillance zones

Although the authorities established restricted zones rapidly once they confirmed the presence of HPAI in poultry establishments, they defined their size and shape without having enough information on the likely spread of the disease and without considering important criteria for doing that. In addition, they did not take full consideration of all appropriate epidemiological criteria for establishing further restricted zones and when they did establish them they did so late. Therefore, those restricted zones were not effective to stop the spread of the disease before it reached epizootic proportions and expanded far beyond the initially affected areas.

The recommendation states as its basis

The authorities do not consider the databases fully updated. Notification of data to the BD Avicole database became obligatory only in 2021. The data kept in there, in particular for independent farmers and those collected from censuses in recent epizootics, show that not all commercial establishments are registered yet and, as confirmed by the 26 audit team in the départements visited, data in the database was not fully updated. For example, up to 5% of establishments registered in the database had ceased their operation, while that information had not been updated in the database. That complicates planning of official activities such as visits to establishments located in restricted zones as well as regular inspections. 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, on the respective obligations of operators to register establishments and of competent authorities to keep certain information on them in their registers.

The shortcomings above had an impact on the application of control measures laid down in Regulation (EU) 2016/429 (Article 64(1) and (2)) and Delegated Regulation (EU) 2020/687 (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.

The presence of unregistered commercial establishments in restricted zones, alongside the lack of up-to-date information on the poultry population in the official databases used by the authorities to handle the HPAI outbreaks, increased the volume of control activities necessary to determine the census of poultry present in those zones at the expense of delaying other tasks that were more important to prevent the spread of the disease.

The recommendation states as its basis

The shortcomings highlighted in the previous points are not in line with requirements of Articles 13(1)(a), 43(2)(c)(i) and (iii), and 61(1)(b) of Regulation (EU) 2016/429, on the responsibilities of the competent authorities to have access to adequate facilities to take the necessary disease control measures, including disposal of animals that may contribute to the spread of the disease, in the event of an animal health crisis. Conclusions on animal depopulation for the purpose of disease control

Since the previous Commission audit in 2019 the authorities had not taken adequate steps and had not made the necessary logistical arrangements to ensure sufficient capacity to collect and dispose safely of the carcases in establishments where the presence of HPAI was confirmed or as a preventive measure in areas affected by the disease. This caused significant delays in the depopulation of establishments and accumulation of carcases, which significantly undermined the effectiveness of other measures to contain the spread of the disease. 5.1.5 Cleaning and disinfection

In general, the departmental Plans for Sanitary Emergencies contain the necessary instructions and ready-to-use documentation for the authorities to act promptly in the event of a HPAI outbreak, in particular to handle the many administrative tasks involved in those situations. However, as demonstrated in the two recent HPAI epizootics, the authorities found challenging to apply some control measures effectively due to inadequate emergency preparedness. In this context some of the components of those plans were still either missing, not detailed enough or simply not guaranteeing a prompt and effective response (e.g., missing and/or inadequate quality of epidemiological enquires, inadequate establishment of some restricted zones, and ineffective pre- arrangements to kill poultry and dispose of carcasses during large outbreaks). Therefore, those plans cannot be considered fully in line with EU requirements laid down in Article 43(2) of Regulation (EU) 2016/429 on the matters that contingency plans should at least cover.

However, it took the DGAL several years until this initiative resulted in an instruction and a published self-assessment tool, as they were available only since February 2021. The benchmarks included in the instruction should help the departmental authorities to better assess their preparedness for animal health emergencies, in particular regarding availability of material and human resources, and maintenance of the necessary technical and administrative skills. However, according to representatives of the authorities met, the presence of the HPAI epizootics in recent years precluded any analysis of the progress achieved with those self-assessment tools.

The DGAL presented to the audit team the main pillars of the new strategy they intend to follow in 2022, an action plan to tackle the shortcomings identified during the recent HPAI epizootics. They added that it will be the basis for updating their instructions, including the contingency plan to combat the disease.

The authorities did not fulfil the undertakings given in response to the previous audit to update and complete the national contingency plan for HPAI, to adequately reinforce the most important components of the emergency preparedness system for the high-risk areas affected by previous HPAI epizootics, and to assess, and improve if necessary, the level of preparedness of the departmental authorities to cope with an epizootic. Hence, they could not avail of sufficiently qualified and trained human resources with access to all necessary operational tools to succeed with the rapid and effective containment of the disease.

The recommendation states as its basis

The authorities used information management tools that included planning and recording of the activities performed on a daily basis by the departmental disease control centres. They shared data retrieved from these centres which with experts of the ANSES and of some veterinary schools. However, during the 2020/21 HPAI epizootic they experienced difficulties to obtain and share some of the data with those experts. During the 2021/22 HPAI epizootic, although the sharing of data with experts improved, the fact that many data were fragmented in several databases and formats made still difficult their analysis, for those experts to contribute rapidly and effectively to the decision-making process to manage the crisis situations. The DGAL is aware of this and has started to make improvements in that respect.

However, despite the improvements noted in this regard since the previous audit, the human resources available were not sufficient to perform timely 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 on responsibilities of the competent authorities to have qualified personnel and an effective organisation to apply disease control measures effectively, and on application of the 29 contingency plan for HPAI. 5.2.5 Availability of equipment and materials

The authorities did not fulfil the undertakings given in response to the previous audit to update and complete the national contingency plan for HPAI, to adequately reinforce the most important components of the emergency preparedness system for the high-risk areas affected by previous HPAI epizootics, and to assess, and improve if necessary, the level of preparedness of the departmental authorities to cope with an epizootic. Hence, they could not avail of sufficiently qualified and trained human resources with access to all necessary operational tools to succeed with the rapid and effective containment of the disease.

Despite the efforts of the disease control centres established during the epizootics at national and regional level to coordinate the application of the main control measures in the affected areas, they lacked adequate timely expertise, epidemiological analytical capacity and up-to-date knowledge about available resources, to take certain important decisions at critical times. Thus, they could not provide adequate and rapid advice to the departmental authorities in those areas so that they could prioritise their actions to contain and prevent the spread of HPAI effectively.

The recommendation states as its basis

The DGAL informed the audit team that BCP staff have access to guidance documents and instructions via its quality assurance intranet websites. The documents include three vade mecums respectively for import controls on animals, goods of animal origin and feed of non-animal origin. The DGAL staff also have access to the IMPADON database for further information to support documentary checks. With the exception of the vade mecum for live animals, the guidance documents and instructions have yet to be updated in order to take account of EU legislation which entered in force as of 14 December 2019.

The DGAL "guide d'inspection" contains general instructions for the performance of official controls at BCPs by its staff. It includes measures to be taken in the case of non- compliant consignments, in particular, destruction, redispatch and special treatment. This guide has also yet to be updated to take account of the measures provided for in Articles 65, 66 and 67 of the OCR.

The DGAL stated that the reasons for not having updated these instructions were due the prioritisation of staff resources in the preparations for the withdrawal of United Kingdom from the EU and the management of business continuity during the Covid-19 pandemic. The DGAL confirmed they would update the documented procedures in the period 2022-2023.

The competent authorities have documented procedures and guidance for the performance of official controls on consignments of animals and goods entering the EU, 8 in line with Article 12(1) of the OCR. However these have not been updated as appropriate, which is not in line with Article 12(3)(b) of that Regulation.

However, the lack of recent internal audits of the system of official controls on imports of animals and goods, including verification of compliance of the BCPs with minimum requirements, has had an adverse impact on the effectiveness of implementation of official import controls, and on the competent authorities' obligation to ensure the availability of suitable border control facilities (see section 5.3.), in particular for checks on goods of animal origin and feed of non-animal origin. This is, in part, further aggravated by the lack of updated documented procedures. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTS/TRANSITS OF ANIMALS AND GOODS

Member state response

mise à jour des « vademecum » POA (HC/NHC) et alimentation animale d'origine non animale et du guide d'inspection sera mise en oeuvre début 2023. Un réseau d'expertise est en cours de mise en place, il sera composé d'agents expérimentés dont une des missions sera de participer à la mise à jour des vademecum et du guide d'inspection. Les appels à candidature ont été lancés en avril et en juillet 2022 et le réseau sera constitué au dernier trimestre 2022. Les documents mis à jour seront accessibles sur l'intranet de la DGAL dès leur validation.

CA response received on 24 October 2022. the The update of the POA Vademecum (HC/NHC) and feed of non-animal origin and the inspection guide will be implemented in early 2023. ls are A network of expertise is being set up and will be composed of experienced officials, one of whose tasks will be to take part in updating the vademecum and the inspection guide. ticle tion The calls for applications were launched in April and July 2022 and the network will be set up in the last quarter of 2022. The updated documents will be accessible on DGAL intranet as soon as they are validated. 0, 21,

The recommendation states as its basis

The audit team noted that, for consignments of animals and goods of animal origin intended for transhipment within the transhipment period, the DGAL stated that it requires TRACES-NT to be used for the notification of such consignments, in line with Article 16(1) of Regulation (EU) 2019/2124. The DGAL further stated that each BCP must set up a local procedure to monitor the notified information before the transhipment period expires. The DGAL informed the audit team however that, in practice, the BCPs do not have systematic access to customs declarations or manifest data (other than roll- on roll-off ferry manifests). As a consequence, the BCP staff can only rely on operators' notifications (see section 5.2.2).

However, the lack of recent internal audits of the system of official controls on imports of animals and goods, including verification of compliance of the BCPs with minimum requirements, has had an adverse impact on the effectiveness of implementation of official import controls, and on the competent authorities' obligation to ensure the availability of suitable border control facilities (see section 5.3.), in particular for checks on goods of animal origin and feed of non-animal origin. This is, in part, further aggravated by the lack of updated documented procedures. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTS/TRANSITS OF ANIMALS AND GOODS

The audit team evaluated one CHED-P authorised for transhipment at a port BCP. For this consignment, there was a five-month delay in notification of the arrival. The CHED- P for this consignment was, following a documentary check only, finalised as a transhipment to a third country. In reality, this consignment was stored for at least five months at the terminal. The competent authority, although having a transhipment procedure in place, was not aware of this consignment until its notification in TRACES.

All consignments notified at an airport BCP were subjected to at least a documentary check and an identity check, even in cases where the transhipment period was not exceeded. However, for 19 of these consignments, no date of departure was indicated in part I of the CHED-P, thus not allowing calculation of the transhipment period. In 17 of 21 cases where a physical check was not done, it was stated that the reason for not performing the physical check was `reduced checks'. For three of the five consignments 14 on which physical checks were performed, the transhipment period had not been exceeded.

The DGAL technical instruction for transhipped consignments does not require any pre- notification or checks other than in cases where the transhipment period has been exceeded. In such cases, those consignments should be subject to a documentary check, and with an identity and physical check only in cases of suspicion of non-compliance.

The DGAL could not provide evidence that the BCPs of transhipment acted in line with their instruction. In addition, as noted in section 5.1.5, BCPs do not have systematic access to customs declarations or manifest data, and as a consequence, BCPs only rely on the operator's notification of transhipment.

The audit team noted that the procedure in place does not ensure that, in the event that a transhipment takes place, it is done in line with Articles 13 and 16 of Commission Delegated Regulation (EU) 2019/2124. 5.2.3 Transit and ship supply procedures

However, a number of shortcomings were noted in the implementation of official controls. They concerned, for example, prior notification of arrival of consignments, documentary checks, transhipment and transit, and decisions on consignments and, in addition, the performance of documentary checks for food of non-animal origin other than upon arrival of the consignment at designated BCPs. These shortcomings collectively undermine the effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the Union.

Member state response

c Des travaux seront engagés courant 2022 avec la douane et les gestionnaires de CCS afin d'automatiser la gestion des transbordements. L'objectif sera d'automatiser un signal adressé aux PCF, leur permettant de bloquer l'envoi si le délai nécessitant des contrôles SPS est dépassé. L'instruction interne (IT 2020-798) sera modifiée en conséquence et complètera ce dispositif.

CA response received on 24 October 2022. in Work will be started in 2022 with Customs and CCS managers to automate the management of transhipments. The aim ent will be to automate a signal sent to BCPs, allowing them to block the consignment if the deadline requiring SPS checks for is exceeded. ls on The internal instruction (IT 2020-798) will be amended accordingly and will complement this mechanism. Compléments DGAL avril 2023: - Nous mettrons à jour l'IT 2020-798 au plus tard au 1er semestre 2023 (incluant la nécessité de vérifier les durées de transbordement). 16 - TRACES NT sera systématiquement utilisé pour enregistrer tout transbordement. Page: 1 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s with Union requirements Action Proposed by the competent authority EU) - Un avis aux opérateurs rappelant l'obligation de notifier dans TRACES tout transbordement sera émis au 1er semestre 2023. - Un travail sera conduit en parallèle avec la douane,

The recommendation states as its basis

During the current audit cycle, five audits were planned in 2017, whereas six were carried out, and in 2018, three out of six planned audits were carried out. No audits took place between 2019 and 2021, with none planned for the remainder of 2021. The DGAL explained that during this period, audits could not be carried out for resource reasons, activities related to the preparedness for the withdrawal of United Kingdom from the EU and the COVID-19 pandemic.

The audits are concluded with individual audit reports, detailing the objectives, scope, findings and conclusions, and recommendations if applicable. Follow-up of previous audit recommendations is carried out by desk-based assessment or during the subsequent on-the-spot audit. As no audits have taken place since 2018 for above-mentioned reasons, follow-up on the 2018 audits is still outstanding.

The General Inspectorate of Services of the DGCCRF also carries out internal audits and verification checks. The prioritisation of these internal audits is based on an analysis of risk factors which leads to the establishment of a multi-year program for 2016-2020. The audit of official controls on imports of food of non-animal origin and food contact materials, which was scheduled for 2020, did not take place. The DGCCRF stated that this was due in part to the COVID-19 pandemic and the transfer of responsibilities to the DGDDI).

The DGCCRF stated that the multiannual audit programme is currently being revised, but that there are no plans to integrate import control audits in view of the transfer (see section 5.1.1). The DGDDI stated that it did not yet plan any audits for the same reason.

The audit team noted that the competent authorities have procedures in place to verify the effectiveness of their controls and carry out internal audits in line with Articles 5(1)(a), 6(1) and 12(2) of the OCR. However, there has been a shortfall in its implementation as no such internal audits have been carried since 2018, prior to the entry into force of the OCR. Conclusions on the organisation of official controls on imports/transits of animals and goods

However, the lack of recent internal audits of the system of official controls on imports of animals and goods, including verification of compliance of the BCPs with minimum requirements, has had an adverse impact on the effectiveness of implementation of official import controls, and on the competent authorities' obligation to ensure the availability of suitable border control facilities (see section 5.3.), in particular for checks on goods of animal origin and feed of non-animal origin. This is, in part, further aggravated by the lack of updated documented procedures. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTS/TRANSITS OF ANIMALS AND GOODS

Member state response

- L'Instruction Technique « programmation des audits en PCF », en lien avec la Procédure Nationale audit détaille la programmation nationale des audits des PCF entre 2022 et 2026. Elle est basée sur une analyse de risque et inclut les suites des audits et le suivi, qui sera réalisé par les équipes d'audits et le SIVEP central, grâce à l'outil QUALISHARE, développé par le BQPPS. Le projet en cours de finalisation est en pièce jointe. 1 f. DG(SANTE) 2021-7216 of the audit carried out from 01 October 2021 of animals and goods and verification of compliance of border control Proposed by the competent authority udits ont repris en avril 2022, un courrier du Responsable National adressé aux correspondants régionaux assurance (CRAQ) et relayé aux PCF a été adressé fin janvier 2022. d'assurer la réalisation des audits, nous recrutons et allons fier des auditeurs « import » et des sachants techniques ort » : el à candidature pour le recrutement d'auditeurs et nts techniques « import » a été publié (IT 2022-118 du /22), et relayé par mail (23/02/22) ormation auditeurs import (formation initiale et tique « audit en PCF ») s'est tenue les 15 au 17 mai 2022 et 10 juin 2022 (programmes de format

CA response received on 24 October 2022. and -- The technical instruction `programming of BCP audits', in conjunction with the national audit procedure, details the e national planning of BCP audits between 2022 and 2026. It is based on risk analysis and includes audit follow-up and follow-up, which will be carried out by the audit teams and the central SIVEP, using the QUALISHARE tool sults developed by BQPPS. The draft being finalised is attached. . ticle -- the audits resumed in April 2022, a letter from the National Quality Officer sent to the regional quality assurance ion correspondents (CRAQ) and forwarded to the BCPs was sent at the end of January 2022. - In order to ensure that the audits are carried out, we recruit and describe import auditors and technical experts: - The call for applications for the recruitment of `import' auditors and technical experts was published (IT 2022- 118 of 03/02/22) and relayed by email (23/02/22). 6, 49, - Import auditors training (initial and thematic training "BCP audit") took place on 15-17 May 2022 and 09-10 June 2022 (attached training programmes). The recommendations of this audit were presented to future internal auditors on that occa

The recommendation states as its basis

However, the audit team further noted that 140 out of the 1,974 transiting consignments are recorded in TRACES-NT without confirmation of arrival at the exit BCP within 15 days from the date transit was authorised at the BCP of introduction. The audit team did not find evidence that the competent authorities of the BCP of introduction had followed- up on these consignments, which is not in line with Article 20 of Regulation (EU) 2019/2124. DGAL informed the audit team that it would take action to ensure that this requirement is followed up. 15

However, a number of shortcomings were noted in the implementation of official controls. They concerned, for example, prior notification of arrival of consignments, documentary checks, transhipment and transit, and decisions on consignments and, in addition, the performance of documentary checks for food of non-animal origin other than upon arrival of the consignment at designated BCPs. These shortcomings collectively undermine the effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the Union.

Member state response

éliorer le suivi des envois en transit pour lesquels la h France est le PCF d'entrée, nous avons adressé un rappel par mail e des PCF concernant le respect de l'instruction elative aux transits (le 05/01/22), concernant la e mettre en place un suivi des transits, afin de respecter tation. sera vérifié lors des audits internes des PCF s - Une demande d'ajout dans l'outil IMSOC d'une alerte automatique en cas de non complétude de la partie III du CHED 15 jours après sa validation par le PCF d'entrée, a été ès de l'équipe TRACES de la Commission. (mail du joint). oncernés ont indiqué avoir : sé leurs agents au respect de la réglementation en transit (en particulier, pas de validation du DSCE si ortie n'est pas indiqué en cas de transit direct) lace d'un suivi des transits leur permettant de une enquête dès le délai concernant la partie III 3 f. DG(SANTE) 2021-7216 of the audit carried out from 01 October 2021 of animals and goods and verification of compliance of border control ction Proposed by the competent authority - les particularités liées au transit ont été intégrées aux fiches d'inspection détaillées permettant un suivi de chaque envoi. Formation interne : le plan de formation

CA response received on 24 October 2023. low- -- In order to improve the monitoring of transit consignments for which France is the BCP of entry, we sent a reminder by email to all BCPs concerning compliance with the technical instruction on transits (05/01/22), concerning the need to monitor transits in order to comply with the rules. ch no the -- This point will be checked during internal audits of BCPs. the -- A request for an automatic alert to be added to the IMSOC tool if part III of the CHED is not complete after 15 days ation after its validation by the BCP of entry has been submitted to the Commission's TRACES team. (email of 14/06/2021 attached). Page: 4 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s with Union requirements Action Proposed by the competent authority ticle -- The BCPs concerned stated that they had: n made their officials aware of compliance with transit regulations (in particular, no validation of the CHED if an - exit

The recommendation states as its basis

The audit team noted discrepancies in the relevant boxes of part I of the CHED-As evaluated, which were either not fully or correctly completed. Examination of the documentary checks showed that the discrepancies in part I were either not detected or corrected, and that the outcome of those checks had been recorded as satisfactory. These CHEDs had subsequently been validated and the corresponding consignments accepted for entry into the EU, which is not in line with Article 2(3) of Regulation (EU) 2019/2130.

All but three consignments of goods of animal origin intended for import, evaluated by the audit team, were subject to documentary checks and identity checks. Identity checks were either full identity checks or checks on seals in accordance with Article 3 of Regulation (EU) 2019/2130. With the three exceptions (see section 5.2.5), the frequency 16 rate for identity checks was in line with the baseline frequency rate set out in Article 5 and Annex I to Commission Implementing Regulation (EU) 2019/2129.

The audit team noted discrepancies in the relevant parts of the CHED-Ps evaluated, which were either not fully or correctly completed, and that the information included in part I of the evaluated CHED-Ps did not match the information in the accompanying certificates or attestations in 10 out of 28 CHED-Ps verified, which is not in line with Article 2(3) of Regulation (EU) 2019/2130. However, the CHED-Ps were subsequently finalised and the corresponding consignments accepted for entry into the EU, which is not in line with Article 55 of the OCR.

For one consignment re-imported, the DGAL did not provide evidence that the consignment was accompanied by an official declaration of the competent authority or of public authorities as regards handling, unloading storage and reloading of the consignment in the third country, which is not in line with the requirements laid down in Article 3(2)(b) of Regulation (EU) 2019/2074. However the other requirements of Article 3 of said Regulation were met, including the monitoring of the transport and arrival at the place of destination.

However, a number of shortcomings were noted in the implementation of official controls. They concerned, for example, prior notification of arrival of consignments, documentary checks, transhipment and transit, and decisions on consignments and, in addition, the performance of documentary checks for food of non-animal origin other than upon arrival of the consignment at designated BCPs. These shortcomings collectively undermine the effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the Union.

Member state response

Mise à jour des Vademecum : voir recommandation n° 1 Un mail sera adressé à l'ensemble des PCF une fois le rapport udit validé. Ce message récapitulera l'ensemble des non onformités relevées lors de l'audit de la Commission. Formation interne : le plan de formation 2022/2023, intègrera un ocus sur les points suivants : réglementation transit, concordance entre le DSCE, le certificat sanitaire et les autres ocuments, gestion des transits ; le type de contrôle réalisé (documentaire, identité et physique et pour les animaux vivants, l'examen clinique et l'incidence u transport), 4 f. DG(SANTE) 2021-7216 of the audit carried out from 01 October 2021 of animals and goods and verification of compliance of border control Action Proposed by the competent authority - le résultat de ces contrôles - les décisions prises suite aux contrôles officiels en accord avec la section III du règlement OCR. - la gestion des réimportations Voir également recommandations 4 et 7

CA response received on 24 October 2022. ied Update of the Vademecum: see recommendation 1 ce ules -- Once the audit report has been validated, an email will be sent to all BCPs. This message will summarise all non- ance compliances identified during the Commission's audit. in egards Internal training: the 2022/2023 training plan will focus on the following points: of th - transit regulations, - correspondence between the CHED, the health certificate and the other documents, it transits management; the - - the type of check carried out (documentary, identity and physical and for live animals, clinical examination and icates, the impact of transport), ation - the results of these checks decisions taken following official controls in accordance with Section III of the OCR Regulation. e - management of re-imports ticle - ion See also recommendations 4 and 7 Compléments DGAL avril 2023 : 7, 78 Page: 6 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s w

The recommendation states as its basis

The DGCCRD informed the audit team that documentary checks on consignments of food of non-animal origin are not performed upon arrival of the consignment at the BCP in the case of 5 out of 11 designated BCPs, which is not in line with Article 49(1) of the OCR.

However, a number of shortcomings were noted in the implementation of official controls. They concerned, for example, prior notification of arrival of consignments, documentary checks, transhipment and transit, and decisions on consignments and, in addition, the performance of documentary checks for food of non-animal origin other than upon arrival of the consignment at designated BCPs. These shortcomings collectively undermine the effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the Union.

The DGCCRF confirmed that the documentary check is not, for all BCPs, carried out at the BCPs of entry, but is done in administrative offices at department level. This is not in line with Article 49(1) of the OCR (see also Section 5.2.4.3). The DGAL also confirmed that for four small BCPs (La Rochelle, Rouen, Chateauroux-Deols and Vatry), documentary checks were also not always performed at the BCP.

Member state response

mmission a considéré que l'organisation de la DGCCRF dans certains PCF était contraire aux exigences figurant à l'article 49 (1) du règlement sur les contrôles officiels. Pour les auditeurs, les contrôles documentaires réalisés dans certaines DDPP ne pouvaient pas être considérés comme étant réalisés au poste de contrôle frontalier. Cette problématique doit trouver sa solution dans le transfert de missions des contrôles à l'importation vers les douanes. s Pour ce qui concerne le respect des délais de pré-notification par les opérateurs, les agents de contrôle de la DGCCRF ont été informés de la nécessité de s'assurer du respect de cette exigence par les opérateurs. Une information similaire sera transmise à la DGDDI.

CA response received 24 October 2022. Page: 7 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s with Union requirements Action Proposed by the competent authority mal The Commission considered that the organisation of the DGCCRF in some BCPs was contrary to the requirements of Article 49 (1) of the Official Controls Regulation. For the auditors, the documentary checks carried out in some DDPP ls could not be considered to be carried out at the border control post. ied This problem must be resolved by transferring tasks from import controls to customs. As regards the operators' compliance with the pre-notification deadlines, the DGCCRF control officers were informed the of the need to ensure that operators complied with this requirement. Similar information will be sent to the DGDDI. ticle and Compléments DGDDI avril 2023 : Les contrôles documentaires sont effectués au poste de contrôle frontalier. L'organisation de la DGDDI est la suivante : tion l

The recommendation states as its basis

The audit team evaluated four CHED-Ps authorised for transit. Two of the four consignments concerned imports rather than transit, including one with a destination in Switzerland.

Out of the eight CHEDs verified, there were two cases of animals being introduced followed by a quarantine period; however the details of the controlled destination (quarantine) were not completed in part II of the CHED for both cases. The DGAL clarified that for both cases, this decision was made in error.

The audit team noted that in two cases, details on the total number of animals checked were either not completed, or indicated that no animals were checked, in part II of the CHED-A. This did not enable verification that a clinical examination had been carried out on the animals concerned in line with Article 4(3) and paragraphs 2, 5 and 6, as applicable, of Part II of Annex I to Regulation (EU) 2019/2130.

The audit team noted discrepancies in the relevant boxes of part I of the CHED-As evaluated, which were either not fully or correctly completed. Examination of the documentary checks showed that the discrepancies in part I were either not detected or corrected, and that the outcome of those checks had been recorded as satisfactory. These CHEDs had subsequently been validated and the corresponding consignments accepted for entry into the EU, which is not in line with Article 2(3) of Regulation (EU) 2019/2130.

In addition in four out of the eight CHED-As evaluated, the impact of the transport on animals was not completed in part II, which is not in line with Article 56(3)(b) of the OCR and Article 40(2) of Commission Implementing Regulation (EU) 2019/1715.

All but three consignments of goods of animal origin intended for import, evaluated by the audit team, were subject to documentary checks and identity checks. Identity checks were either full identity checks or checks on seals in accordance with Article 3 of Regulation (EU) 2019/2130. With the three exceptions (see section 5.2.5), the frequency 16 rate for identity checks was in line with the baseline frequency rate set out in Article 5 and Annex I to Commission Implementing Regulation (EU) 2019/2129.

The audit team noted discrepancies in the relevant parts of the CHED-Ps evaluated, which were either not fully or correctly completed, and that the information included in part I of the evaluated CHED-Ps did not match the information in the accompanying certificates or attestations in 10 out of 28 CHED-Ps verified, which is not in line with Article 2(3) of Regulation (EU) 2019/2130. However, the CHED-Ps were subsequently finalised and the corresponding consignments accepted for entry into the EU, which is not in line with Article 55 of the OCR.

Following their evaluation of examples of imports of consignments of food of non- animal origin subject to a temporary increase of official controls or emergency measures, the audit team noted that the laboratory results had been delivered in a timely manner in line with Article 37(4)(d) of the OCR. The audit team noted however that, in three out of six cases, the inspector's conclusion of the laboratory tests was not recorded in TRACES-NT, which is not in line with Article 56(3)(b) of the OCR and Article 40(2)(b) of Commission Implementing Regulation (EU) 2019/1715. In the remaining cases, the details of the analyses, such as for example, the test method and detailed results, were not fully completed. The DGCCRF explained that, in accordance with its instructions, it does not require BCP staff to enter such results. 17 5.2.5 Decisions on consignments and follow-up

The audit team found that, in the case of a consignment of fishery products where the cold chain was not maintained, the competent authority at the BCP permitted the operator to subject the consignment to special treatment to alter the best before date of the goods by reducing it by six months to 18 months. This neither ensured compliance with the rules referred to in Article 1(2) of the OCR, nor was in line with the DGAL procedures.

The audit team noted, that a consignment of meat products, which was notified by the operator at the BCP of entry, was refused for reasons of a missing health certificate without being subjected to a documentary, identity or physical check. The health certificate was, however, uploaded in TRACES-NT. At the same BCP, but without being sent to the dedicated inspection centre used for controls of fishery products, the inspectors at this centre refused for similar reasons two consignments of fishery products without subjecting them to mandatory controls. The DGAL explained that the three consignments formed part of a `groupage' load. The operator did not present a health certificate for two consignments of composite products which also formed part of the load and following this finding the BCP staff also rejected all other consignments of animal origin previously mentioned which formed part of the load.

The audit team found that the decisions on these three consignments were not taken following the performance of official controls, including documentary checks and, where necessary, identity checks and physical checks, indicating whether the consignment is in compliance with the rules referred to in Article 1(2) of the OCR, which 18 is not in line with Article 55 of the said Regulation. The DGAL informed the team that it had since taken corrective action to ensure that consignments are only refused following the performance of official controls which indicate that the consignment is not in compliance with the applicable rules.

The audit team found that decisions on consignments were not always taken in line with Article 55 of the OCR. Conclusions on the implementation of official controls on imports/transits of animals and goods

However, a number of shortcomings were noted in the implementation of official controls. They concerned, for example, prior notification of arrival of consignments, documentary checks, transhipment and transit, and decisions on consignments and, in addition, the performance of documentary checks for food of non-animal origin other than upon arrival of the consignment at designated BCPs. These shortcomings collectively undermine the effectiveness and appropriateness of official controls to ensure that only compliant consignments of animals and goods enter the Union.

Member state response

Mise à jour des Vademecum : voir recommandation n° 1 La prochaine évolution du VM animaux vivant insistera sur 'enregistrement des contrôles réalisés et de leur conclusion. Vademecum POA HC intègrera les remarques concernant le traitement spécial, et la conduite à tenir. - Formation interne : le plan de formation 2022/2023, intègrera un focus sur les points suivants : - réglementation transit, 5 f. DG(SANTE) 2021-7216 of the audit carried out from 01 October 2021 of animals and goods and verification of compliance of border control ction Proposed by the competent authority concordance entre le DSCE, le certificat sanitaire et les autres ocuments, gestion des transits ; e - le type de contrôle réalisé (documentaire, identité et physique t pour les animaux vivants, l'examen clinique et l'incidence u transport), le résultat de ces contrôles les décisions prises suite aux contrôles officiels en accord avec a section III du règlement OCR. la gestion des réimportations oir également recommandations 4 et 5 Point d'attention lors des audits internes (voir aussi ecommandation n°3): lors de l'évaluation des CHED sélectionnés Concernant les décisions prises avant contrôle officiel, comme il é

CA response received on 24 October 2022. aken Update of the Vademecum: see recommendation 1 ds The next development of live animals will insist on recording the controls carried out and their conclusion. The POA HC Vademecum will incorporate the comments on the special treatment and the action to be taken. ls Internal training: the 2022/2023 training plan will focus on the following points: Page: 8 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s with Union requirements Action Proposed by the competent authority - transit regulations, re correspondence between the CHED, the health certificate and the other documents, tity - ical transits management; ing - in - the type of check carried out (documentary, identity and physical and for live animals, clinical examination and the the impact of transport), s. the results of these checks ticle - 1(2) decisions taken following official controls in accordance with Section III of the OCR Regulation. EU) - m

The recommendation states as its basis

However, the lack of recent internal audits of the system of official controls on imports of animals and goods, including verification of compliance of the BCPs with minimum requirements, has had an adverse impact on the effectiveness of implementation of official import controls, and on the competent authorities' obligation to ensure the availability of suitable border control facilities (see section 5.3.), in particular for checks on goods of animal origin and feed of non-animal origin. This is, in part, further aggravated by the lack of updated documented procedures. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON IMPORTS/TRANSITS OF ANIMALS AND GOODS

The audit team found that none of the evaluated BCPs met the minimum and detailed rules on minimum requirements for BCPs laid down in article 64 of the OCR and Commission Implementing Regulation (EU) 2019/1014.

In the case of the selected BCPs which are designated for products of non-animal origin, categories PNAO-HC(food) and PNAO-NHC(feed), none had the pre-requisite areas or rooms for unloading, inspection or storage of goods, which is not in line with Article 3(1) of Regulation (EU) 2019/1014.

However, the audit team found that the proposed commercial storage facility did not meet the minimum requirements for BCPs, which is not in line with Article 3(1) of Regulation (EU) 2019/1014. The audit team made the following main observations: a. the flow of goods did not facilitate their proper handling and prevention of risks which may result from cross contamination; 20 b. the dedicated inspection areas did not have a supply of hot and cold running water or facilities for washing and drying of hands, which is not in line with Article 3(1)(b) of Regulation (EU) 2019/1014; and c. the ambient storage facilities were not appropriate to the categories of food of non- animal origin for which the BCPs were designated, i.e. the scope of designation was not limited to goods for which no temperature requirements apply.

Regarding the BCP Nantes Saint-Nazaire designated for goods of animal origin, the audit team found, inter alia, that appropriate arrangements were not in place for the proper handling of packed and unpacked goods and to prevent risks which may result from cross contamination. This is not in line with Article 64(3)(h) of the OCR and Article 3(9)(b) of Regulation (EU) 2019/1014.

The audit team found that, inter alia, in respect of the inspection centre Fécamp at BCP Le Havre which is listed for liquid fish oils and fats only, there was no procedure in place for cleaning and disinfection of the special pipes used for the unloading of bulk liquids of animal origin. This is not in line with Article 64(3)(h) and (i) of the OCR. In addition, the specification in the list of BCPs did not limit the use of this inspection centre for liquid in bulk only, despite the inspection centre availing of derogations laid down in Article 3(5) and 6(4) of Regulation (EU) 2019/1014 for such goods.

Regarding the selected airport BCP for live animals (categories LA-E, LA-U and LA- O), the audit team observed that the changing room with shower facilities, unloading, inspection and housing facilities for other live animals, category LA-O, do not constitute one integrated and whole working unit, which is not in line with the minimum requirement laid down in Article 5(3) of Regulation (EU) 2019/1014.

In addition, the audit team found that the facilities for categories LA-E and LA-U do not have restraining equipment in place for equidae, and that the restraining equipment for ungulates other than equidae are stored in a separate room to the inspection area, which is not in line with Article 5(1)(f) of Regulation (EU) 2019/1014.

For BCPs Port de Saint-Nazaire Montoire, Nantes Saint-Nazaire and inspection centre Fécamp, the DGAL and the DGCCRF did not provide information on suitable 21 arrangements in place at all of the BCPs to ensure the smooth operation of official controls and to apply measures as provided for by Articles 65, 66 and 67 of the OCR, which is not in line with Article 64(3)(e) of that Regulation. Conclusions on minimum requirements for border control posts

None of the BCPs evaluated are fully compliant with the minimum requirements for BCPs for the categories of animals and goods for which they have been designated. Consequently the French authorities cannot guarantee the appropriate handling of animals and goods, the proper verification of compliance of those animals and goods and the prevention of the risk of cross contamination in these facilities. However, the competent authority has already initiated corrective actions in the BCPs concerned during this audit which, when completed, should go some way to achieving compliance in these BCPs.

Member state response

ne Instruction Technique portant sur la désignation est en cours rédaction (projet joint). Elle détaille, sur la base du tableau d'évaluation des PCF/PC de la Commission, les exigences pplicables, et inclut la demande que les responsables de PCF et PC réalisent une évaluation de leurs infrastructures et ipements, selon ce tableau, et fassent part des difficultés au EP central. Les suites données y sont également détaillées. es audits internes qui sont mis en place dès cette année (voir ommandation n°3) permettront de vérifier ce point et d'assurer suivi des points sensibles et non conformités via le plan d'action PCF et des gestionnaires. us trouverez ci-joint la réponse à votre courrier de février 2021 la désignation des PCF. a grande majorité des contrôles de PNOA destinés à limentation animale ne relève pas des contrôles renforcés vus par la réglementation européenne. La désignation des PCF a revue au regard de l'inactivité et de l'absence de contrôles, me prévu dans le projet de l'IT « désignation ». 7 f. DG(SANTE) 2021-7216 of the audit carried out from 01 October 2021 of animals and goods and verification of compliance of border control if au PCF aéroportuaire ption en versio

the CA response received on 24 October 2022. er -- a technical instruction on designation is being drafted (attached draft). It details, on the basis of the Commission's BCP/CP evaluation table, the applicable requirements, and includes the request that BCP and CP managers carry out an r posts Page: 10 received on 17 May 2023 submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7216 of the audit carried out from 01 November 2021 in order to evaluate the system of official controls on imports of animals and goods and verification of compliance of s with Union requirements Action Proposed by the competent authority the assessment of their infrastructure and equipment, according to this table, and report difficulties to the central SIVEP. The follow-up is also detailed. ds ost -- the internal audits set up this year (see recommendation 3) will make it possible to verify this point and to ensure that sensitive and non-compliant points are followed up via the BCP and managers' action plan. ticle -- Please find attached the reply to your letter of February 2021 on the designation of BCPs. tion nd -- The vast majority of checks on PNOA intended for an

The recommendation states as its basis

According to their reports, officials seem well able to identify existing non- compliances. Regarding their follow-up of deficiencies, the picture is mixed. The audit team saw examples of excellent follow-up (e.g. in one poultry slaughterhouse, the official veterinarian carried out all inspections according to the established frequency, systematically requested an action plan to the operator, consistently sent written warnings for non-compliances, additional timely follow-up visits, initiated an infringement procedure for repeated non-compliance, managed to bring the slaughterhouse in compliance with Annex 2 to the Regulation). There were also many cases with repeated reporting of non-compliances over several years, just in the inspection report without further measures taken, relying on a "good cooperation" with the operator, and therefore several cases of year-long delays in operators taking appropriate corrective actions. Conclusions on official controls

The inconsistent follow up of non-compliances leads to some deficiencies remaining for unacceptably long periods in the establishments that competent authorities are not addressing in an effective, dissuasive and proportionate manner. This undermines the purposes of the official controls to ensure compliance and spare any avoidable pain, distress or suffering to the animals at the time of killing. 7

The official reports identified problems related to restraining and requested an action plan to solve them. In many cases where addressing the issue would require changes to structures or equipment (e.g. slippery floor before stunning chamber for pigs, unsuitable V-restrainer for sheep), these non-compliances have been persisting for a number of years (see also paragraph 18). 5.4.2 Stunning methods and checks on stunning

Member state response

non-conformité, certaines lacunes persistent pendant des périodes excessivement longues dans les établissements et les autorités compétentes n'y remédient pas de manière efficace, dissuasive et proportionnée ». Le ministre de l'agriculture a annoncé le 5 juillet 2021 1un « plan abattoirs » qui comporte plusieurs volets, dont les deux volets détaillés ci-après qui visent précisément à renforcer l'action des services du ministère de l'agriculture en charge du contrôle de la protection animale dans les abattoirs, dans le but de prendre des mesures coercitives efficaces et harmonisées à l'échelle nationale. Renforcer les contrôles Mise en place des « inspections coordonnées » dans l'ensemble des abattoirs Les inspections coordonnées consistent en la réalisation de l'évaluation d'un point précis du process d'abattage, simultanément dans tous les abattoirs français, au moyen d'un référentiel harmonisé et fermé, décrit dans des instructions techniques 2spécifiques pour chaque session de contrôle. Ce type d'inspection doit permettre d'identifier les établissements qui présentent des anomalies graves et/ou rédhibitoires pour la bonne maîtrise du process, notamment en matière de protection a

The recommendation states as its basis

The authorities included a note in the relevant vademecums and in the slaughterhouse newsletter to remind official staff of the deadline (December 2019) for the transitional period for requirements on layout, construction and equipment in slaughterhouses that were in operation before 1 January 2013. They did not issue dedicated information or reminders about the deadline to operators and there was no evidence of any coordinated official pressure on the operators to meet the deadline.

The audit team found evidence that the authorities only identified and communicated non-compliances in the establishments after the transitional period expired. They did not ensure that operators used the transitional period to bring their establishments in compliance with relevant requirements of Annex 2 to the Regulation. Therefore, when the transitional period finished, there were non-compliant establishments with regards to structure (e.g. passage ways which shall be designed to allow the animals to move freely; design of entry pathways/entry into gas stunning equipment) and equipment 8 (e.g. no installed device in the stunning equipment to continuously record stunning parameters, no alarms).

The actions of the authorities increased the awareness of official staff about structural requirements, but failed to ensure compliance of existing slaughterhouses by the end of the transitional period. The remaining structural non-compliances will create animal welfare risks until their correction and the absence of stunning equipment without recording will make it difficult for the authorities to audit operator's compliance that animals were stunned effectively in a continuous way.

Member state response

Page: 1 rity s SVI (services vétérinaires d'inspection) de suites hension et leur acceptation par les professionnels ; autorité compétente locale et son accompagnement par ité d'anomalies anciennes, récurrentes et graves en rte ; abattoirs français sur les volets sanitaires et de la t vocation à s'enchaîner en alternant des points de ité sanitaire et de la protection animale. La première ntrôle des conditions d'amenée des animaux au poste a seconde portera également sur le respect de la protection ment traiter des modes opératoires normalisés. réalisé, afin de garantir la mise en conformité rapide et Par ailleurs, les bénéfices de cette méthode d'inspection s feront l'objet d'une évaluation. nationale pour les abattoirs (FINA3) ix) ont été recrutés et seront prêts dès le mois d'octobre 2021 sur le territoire pour la gestion des cas les plus difficiles en réfets ou de la DGAL. Cette première force d'inspection our d'expérience. uillet 2021 un courrier à l'ensemble des Préfets 4pour nimale en abattoir et leur demander d'agir avec fermeté Page: 2 oposed by the competent authority a situation l'impose. Depuis juillet 2020, l'activité a été suspendue pour 6 abattoirs. t repris une activ

The recommendation states as its basis

However, in particular in the two mainland regions of France with outbreaks and in the vicinity of DAs, the surveys do not take into consideration all relevant factors of the Xf spread by natural and human assisted means to non-agricultural areas. As the survey results may not reflect the actual presence of Xf in these areas, the eradication efforts could be compromised.

Member state response

as are L'objectif de la SORE (Surveillance des Organismes Réglementés et e with Emergents) est de détecter le plus précocement possible l'ensemble des sous-espèces de Xylella fastidiosa sur l'ensemble du territoire national. Ce dispositif est mis en oeuvre depuis la campagne 2020 et est en amélioration continue. Une part de l'échantillonnage concerne la filière vigne, filière d'importance économique majeure en France et qui fait l'objet d'une forte attente de la part la profession agricole, compte tenu de la présence de la sous-espèce fastidiosa sur vigne aux Baléares. La surveillance renforcée en JEVI en PACA en 2020 sur la zone littorale à l'ouest de l'aire de contamination A et entre les aires A et B1 a permis de valider la délimitation existante (un seul foyer détecté à La Seyne sur Mer, à proximité de la zone délimitée). Cela valide donc la SORE JEVI mise en place. Afin de renforcer la surveillance vis-à-vis du risque que représente la sous- espèce Xf multiplex, plusieurs actions sont prises dès la campagne de surveillance 2022 : - Au niveau national en 2022, 400 examens visuels et 400 prélèvements asymptomatiques sont à réaliser en JEVI et dans les zones naturelles et semi-na

The recommendation states as its basis

Although the latest update of the national contingency plan takes into account the provisions of Regulation (EU) 2020/1201, it does not include comprehensive details about the minimum resources to be made available and about the procedures for ensuring the swift provision of additional resources in case of the confirmed presence of Xf, contrary to Article 3.2(a) of Regulation (EU) 2020/1201. The provision for additional resources are generally regulated by the Technical Instruction DGAL/SDPRAT/2019-712 of 15/10/2019 concerning programming, delegating powers and introduction of the measures. SRALs may request specific appropriations for covering unforeseen expenditures following outbreaks. Consequently, and in particular in Occitanie, there were significant delays in making available the necessary resources (see section 5.5.2). The required staff and technical resources were not made available at the time of the audit. 10 Conclusions on the contingency plans for Xf

Member state response

ces La mise à disposition de ressources est prévue de façon générique dans he l'Instruction technique DGAL/SDPRAT/2019-712 du 15/10/2019 relatif aux odalités de programmation, de délégation et de gestion des crédits du cle 3(2)(a) programme 206, hors titre 2. dits dits « spécifiques » visent à couvrir les dépenses imprévues es à la détection de foyers d'organismes nuisibles aux végétaux. t sollicités par les SRAL et couvrent les dépenses nécessaires à la place d'une surveillance renforcée, de prospections et d'enquêtes mesures de lutte. ion sur le long terme d'un foyer repose sur : crédits généraux qui couvrent les dépenses prévisibles es à la gestion des risques pour la santé des végétaux, assation de marchés publics (pour la réalisation des ges et traitements phytosanitaires) selon les procédures exigées code de la commande publique. 2 s received received 28 June 2022 Action Proposed by the competent authority Afin de fluidifier ces actions, une fiche technique sur ce sujet sera rédigée d'ici fin 2022 dans le cadre du PNISU Santé des végétaux ­ Principes généraux (Instruction technique du DGAL/MUS/2022-329 du 10-06-2022).

The recommendation states as its basis

In both Occitanie and PACA regions, procedures are in place for removal of plants specified in Article 7(1) of Regulation (EU) 2020/1201. At the time of the audit, all plants which tested positive in 2020/2021 had been removed, albeit with a delay of up to 5 months after sampling.

The substantial delays in the removal of positive tested and other specified plants in the IZs and the shortcomings in controlling the insect vector population raise serious doubts, whether the eradication of Xf can be achieved.

Member state response

ticle 7(1) of Les actions suivantes ont été mises en place : h le marché public relatif aux prestations de traitement phytosanitaire et d'élimination des végétaux dans le cadre de la lutte contre la bactérie Xylella fastidiosa en région Occitanie a été notifié le 12/07/2021 et est évalué à 1 444 000 pour 2021 ; - la région PACA a ajusté le processus pour limiter les délais d'arrachage en gérant de façon continue des zones infectées tout au long de l'année. Par ailleurs, une réorganisation est en cours avec un pilotage centralisé de la gestion des foyers de la région depuis l'antenne du SRAL à Nice et un renforcement des ressources humaines associées, ce qui va permettre de gagner en efficacité. Des délais sont incompressibles, notamment l'identification et la notification des propriétaires ainsi que la procédure contradictoire, qui permet de s'assurer de la bonne acceptabilité des mesures.

The recommendation states as its basis

The substantial delays in the removal of positive tested and other specified plants in the IZs and the shortcomings in controlling the insect vector population raise serious doubts, whether the eradication of Xf can be achieved.

Member state response

e contrôle des vecteurs est réalisé avant et après l'arrachage des végétaux en zone infectée. 8(2) En PACA, la zone délimitée se situe en quasi-totalité en milieu urbain, ce qui rend impossible la mise en oeuvre de traitements phytosanitaires compte-tenu de la réglementation en vigueur et pour des questions d'acceptabilité des mesures de lutte. 3 s received received 28 June 2022 Action Proposed by the competent authority En Occitanie, la zone délimitée se trouve majoritairement en zone agricole et en milieu semi-naturel voire naturel. Dans le département viticole de l'Aude, les agriculteurs réalisent des traitements pour lutter contre la cicadelle de la flavescence dorée, qui sont également efficaces contre les vecteurs de Xf. Compte tenu du plan d'actions national pour réduire l'usage des produits phytosanitaires, un programme de recherche a été lancé en 2019 pour trois années ciblant la définition de bonnes pratiques de gestion de Xylella et de ses vecteurs dans différents compartiments des écosystèmes (forêts de chênes, bandes enherbées et différents agroécosystèmes dont les vignes). Elles permettront d'améliorer la résilience des agro-écosystèmes et d'identifier les modalités d

The recommendation states as its basis

The measures implemented by the CA at professional operators, who trade or plant specified plants, help to control the movement of infected plants. However, the current restrictions on Xf host plants entering Corsica are not in line with requirements of Article 36 of Regulation (EU) 2020/1201.

Member state response

ect Comme indiqué lors de l'audit, le préfet de Corse s'est engagé à abroger 36 of cet arrêté d'ici le 1er janvier 2023. elated the

The recommendation states as its basis

The authorities in PACA have performed movement controls at ports and roads. In 2020, such controls took place on 14 occasions in the ports of Toulon and Nice, and on 11 occasions at roadside control points in cooperation with the customs authorities. The movement controls at ports were restricted to boats leaving for Corsica, but did not include boats leaving to destinations in Italy and Spain. This is not in line with Article 32 of Regulation (EU) 2020/1201, as the controls are not systematic in relation to all destinations. DGAL stated that they plan to extend the ferry checks to destinations in Italy and Spain.

In Occitanie, no movement controls at roads had been carried out by the time of the audit as the CAs focused on surveys, plant removals and controls in nurseries. Conclusions on the official checks on movement of specified plants and host plants within the EU

However, the movement checks on roads, airports and ports in PACA and Occitanie do not adequately address the risk that infected plants could be carried to other destinations, including other Member States. 17

Member state response

being En PACA, dès 2022, les contrôles routiers vers l'Italie vont être renforcés en collaboration avec les douanes. Par ailleurs, le SRAL PACA a pris de contact avec la compagnie de ferries réalisant des trajets entre la région PACA et les autres Etats-membres (Sardaigne et îles Baléares) pour le 32 procéder à des contrôles et sensibiliser les voyageurs. 4 ports s received received 28 June 2022 Proposed by the competent authority tory. En Occitanie, la découverte récente des foyers n'a pas permis de prioriser ce paramètre. Les mesures destinées à prévenir les déplacements de x spécifiés hors de la zone délimitée (sont déployés en 2022. Il que les établissements concernés vendent essentiellement à des liers locaux. Les établissements identifiés en ZD vont tous faire d'une inspection en 2022. Une campagne de communication est e vers les opérateurs professionnels (établissements de ion/revente ; agriculteurs...), les communes, les particuliers... en nt ce point. Des contrôles routiers pourraient intervenir dès 2023. 5

The recommendation states as its basis

There are national provisions that are not in line with EU legislation. These are related to the procedure for approval of CBs, the granting of certain exceptional production rules (derogations) and the exchange of information between the CBs and the CAs in case of non-compliances (See relevant sections of this report). Conclusions on relevant national legislation and provisions

The INAO is responsible for the suspension/withdrawal of approval of CBs. The approval procedure is described in INAO-DIR-CAC-5-Rev. 4. CBs are approved by the INAO before they are formally accredited, on the condition that accreditation to ISO/IEC 17065:2012 is obtained within one year. This does require that the INAO receives from the COFRAC the operational admissibility of the CB's files, which is issued after the COFRAC has carried out a documentary check of all documents in the accreditation file. To obtain such operational admissibility from the COFRAC, the CB must have a control plan approved by the INAO. The COFRAC explained to the audit team that for them it is not acceptable to grant accreditation to a CB that has no real activity and for which it cannot be checked how inspections are carried out in practice. Nevertheless, once the CBs are approved by the INAO and have some real activities, COFRAC can grant accreditation if CB activities are carried out in line with ISO 17065. This practice is not in line with Article 29(b)(iv) of Regulation (EU) 2017/625 and Article 27(5)(c) of Regulation (EC) No 834/2007, as the CBs are approved before being accredited.

Member state response

recommandation identique avait été faite par la DG Santé lors de l'audit mené en France en 2013 : « Recommandation 2013-6880-1 : "Garantir que les organismes de contrôle soient par l'Institut national de l'origine et de la qualité et que des tâches ne leur soient déléguées que lorsqu'ils bénéficient d'une accréditation selon la norme EN 45011 ou le guide ISO 65, comme exigé par l'article 27, paragraphe 5, point c), du règlement (CE) nº 834/2007 et par l'article 5, paragraphe 2, point c), du règlement (CE) nº 882/2004." A l'issue de la dernière réponse apportée par les autorités françaises, la recommandation a été clôturée sur la base des actions prises par la France, comme cela est indiqué dans le profil pays de juillet 2017 (Ref. Ares(2017)3784993 - 27/07/2017 ­ pièce jointe). Les autorités françaises confirment les réponses apportées dans le cadre des audits de suivi généraux ainsi que lors de l'audit de mars 2021. Les OC sont agréés par l'INAO préalablement à toute certification d'un opérateur. Les procédures du Cofrac précisent que la décision d'accréditer un OC ne peut être prise sur le simple fondement d'une évaluation sur dossier des procédures dudit OC; l'OC candidat doit d

are DG SANTE made an identical recommendation following their audit in France in 2013: `Recommendation 2013-6880-1: `Ensure that control bodies are approved by the National Institute of Origin and Quality and tasks are delegated to them only when accredited according to EN 45011 or ISO Guide 65, as required by Article 27(5)(c) of Regulation (EC) No 834/2007 and by Article 5(2)(c) of Regulation (EC) of No 882/2004.' Following the last reply from the French authorities, the recommendation was closed on the basis of the action taken by France, as indicated in the Country Profile of July 2017 (Ref. Ares(2017)3784993 - f 27/07/2017 ­ attached). The French authorities confirm their earlier replies in connection with the general follow-up audits and the audit of March 2021. The CBs are approved by the INAO before any operator is certified. Under the COFRAC procedures, the decision to accredit a CB cannot be taken solely on the basis of a desk evaluation of its procedures. The applicant CB must have certified operators in the sector for which it is seeking ccreditation. Under Standard NF EN ISO/CEI 17011 (for accreditation bodies accrediting conformity assessment bodies) COFRAC is, in fact

The recommendation states as its basis

The INAO provided to the audit team the most recent supervision reports for four CBs. The team noted that the instructions and the provisions in place for supervision of CBs were followed. In all cases, the report template was used. However, in two of the reports reviewed, there was no evidence that the inspectors had checked that the risk-based selection of operators for sampling was properly carried out by the CBs. As mentioned in chapter 5.2.4 below, the audit team found for the two CBs involved in the audit that the selection of operators for sampling and additional visits was not fully in line with the EU organic regulations, including for one of them that the risk assessment did not take into account the volume of production (see chapter 5.2.4 below). This had not been detected and recorded in the supervision reports. In addition, in the case of one CB, the supervision report did not make any reference to the number of samples planned for 2020, the treatment of positive results, the number and outcome of investigations, etc.

The INAO did not take into account COFRAC's accreditation reports when supervising the CBs, which is not in line with Article 92c (1) of Regulation (EC) 889/2008. Conclusions on approval, supervision and withdrawal of CBs

Member state response

Prise en compte par l'INAO des rapports d'accréditation pour les OC agréés En plus de l'échange systématique sur les résultats des évaluations du Cofrac (cas de suspension d'accréditation notamment) déjà prévu, la convention entre l'INAO et le Cofrac du 17 janvier 2018 va être modifiée pour prévoir l'envoi systématique s résultats des rapports d'évaluation établis par le Cofrac à l'INAO, pour les organismes agréés par l'INAO. Page: 3 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit carried out from 08 March 2021 r organic production and labelling of organic products Action Proposed by the competent authority Par ailleurs, en application de l'article 43(5) 1 du règlement (UE) 2018/848, les résultats des évaluations techniques réalisées par l'INAO seront également envoyés au Cofrac. Echéance de réalisation : 31 mars 2022 2 En parallèle, l'instruction de service (INAO-IS-2009-16 : guide de réalisation d'une évaluation technique d'organisme de contrôle) sera mise à jour pour intégrer la revue et la prise en compte par les évaluateurs techniques de l'INAO des résultats des rapports d'accréditation de l'OC au moment de sa supervision (notamment les écarts

INAO to take into account the accreditation reports for the approved CBs In addition to the systematic exchange on the results of COFRAC's assessments (in particular suspensions of accreditation) already envisaged, the agreement of 17 January 2018 between INAO and COFRAC will be in amended to provide for the results of COFRAC's assessment reports for bodies approved by the INAO to be systematically sent to the INAO. o In application of Article 43(5) of Regulation (EU) 2018/848, the results of technical assessments carried out rts by the INAO will also be sent to COFRAC. Implementation deadline: 31 March 2022 th Page: 3 y's response to the report's recommendations (updated, received 20/9/2022) s' assessment of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7301 of out from 08 March 2021 to 23 March 2021 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Additional information Septembre 2022 : La convention entre l'INAO et le Cofrac est en cours de modification pour prévoir l'échange d'information sur le résultat des évaluations techniq

The recommendation states as its basis

The audit team noted that the documentary evidence that CBs issue in line with Article 29(1) of Regulation (EC) No 834/2007 was not available for some operators on the published list of operators. The CA stated that the CBs do not issue documentary evidence for operators in their first year of conversion. For these operators an attestation of conversion was granted stating that the operator is engaged in organic production but it is not allowed to market products with an organic reference. This attestation is not published, which is not in line with Article 92(b) of Regulation (EC) No 889/2008. In addition, this document is not in line with Article 29(1) of Regulation (EC) No 834/2007 and Article 68(1) of Regulation (EC) No 889/2008, as it does not indicate that the operator meets the requirements of the regulations, it does not refer to any period of validity or indicate the type or range of products.

Member state response

Etablissement de documents justificatifs pour tous les opérateurs qui se conforment au Règlement Bio, y compris les opérateurs en conversion ce jour, les OC en France n'émettent pas de documents justificatifs aux opérateurs qui sont en première année de conversion et qui ne peuvent pas mettre sur le marché des produits avec des références à la production biologique. Les opérateurs en 1ère année de conversion peuvent recevoir des attestations de début de conversion. Avec l'entrée en application du R. (UE) 2018/848, les modalités de délivrance des certificats biologiques, pour les opérateurs en 1ère année de conversion ont été clarifiées par la Commission européenne. A compter du 1er janvier 2022, les OC délivreront des certificats à l'ensemble des opérateurs engagés, contrôlés et qui respectent les dispositions prévues dans le R. (UE) 2018/848, même lorsqu'ils sont en 1ere année de conversion. u Echéance de réalisation : 1er janvier 2022 Mise en ligne des documents justificatifs de l'ensemble des opérateurs qui sont contrôlés et sont conformes au règlement relatif à l'agriculture biologique. Page: 6 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit ca

Documentary evidence for all operators complying with the `Organic' Regulation, including operators in conversion to At the moment, France does not issue supporting documents to operators in the first year of conversion, who r are not able to make reference to organic production when placing their products on the market. Operators in the first year of conversion can be issued with certificates confirming that conversion has started. of With the entry into application of Regulation (EU) 2018/848, the European Commission has clarified the procedures for issuing organic certificates, including those for operators in the first year of conversion. From 1 January 2022, the CBs will issue certificates to all operators engaged in organic production and subject to supervision who comply with Regulation (EU) 2018/848, even if they are in their first year of conversion. it ne Implementation deadline: 1 January 2022 f Septembre 2022 : Depuis le 1er janvier 2022, tous les OC agréés par l'INAO pour la certification du mode de production biologique doivent appliquer les Dispositions de contrôle communes, INAO-DEC-CONT-AB-4. Cette décision indique à la page 8 : « Pour commercialiser des produits e

The recommendation states as its basis

When operators move CB, the relevant elements of their file and the reports referred to in the second subparagraph of Article 63(2) of Regulation (EC) No 889/2008 must be transferred from the previous CB to the new CB. The audit team reviewed several cases of transfer of operators. However, while the relevant elements of the operator's files are transferred, the reports referred to in Article 63(2) are not transferred. This is not fully in line with Article 92(2) of Regulation (EC) No 889/2008. Conclusions on registration of operators

Member state response

Echanges d'informations adéquats entre les OC Les autorités françaises considèrent que les dispositions déjà mises en place en rance répondent aux dispositions réglementaires visées dans la recommandation et us qu'en conséquence la recommandation n'a pas lieu d'être. En effet, en cas de changement d'OC, l'ancien OC doit transmettre au nouvel OC plusieurs documents listés à l'Annexe 3, paragraphe 3 de la circulaire délégation de tâches (INAO-CIRC-2009-01 jointe à cet envoi) y compris les rapports des contrôles précédents, les mesures prises ou en cours par l'ancien OC, comme les auditeurs ont pu le constater avec les nombreux exemples de transmissions de dossiers entre OC qui ont été fournis lors de l'audit. és Extrait de la circulaire délégation de tâches (INAO-CIRC-2009-01) : « Conformément aux dispositions du paragraphe 2 de l'article 92 du Règlement (CE) n° 889/2008, l'ancien organisme de contrôle transmet au nouvel organisme de contrôle l'ensemble des informations et des documents pertinents relatifs à cet opérateur ou aux activités de celui-ci, à l'exception des informations ou des documents qui n'ont pas d'incidence sur le fonctionnement du système de contrôle. Les éléments à

Exchange of adequate information between CBs The French authorities consider that the provisions already in place in France meet the regulatory requirements referred to in the recommendation and that, therefore, the recommendation has no basis. Where there is a change of CB, the previous CB has to send the new CB various documents listed in the e third paragraph of Annex 3 to the circular on task delegation (INAO-CIRC-2009-01, attached), including the o in reports on previous checks and measures taken or in progress by the previous CB. This was confirmed by the auditors with numerous examples of files transferred between CBs, provided during the audit. Extract from the circular on task delegation (INAO-CIRC-2009-01): `In accordance with Article 92(2) of Regulation (EC) No 889/2008, the previous control body shall transfer to the new control body all relevant information and documents relating to the operator or its activities, except for information or documents that have no bearing on the functioning of the supervisory system. The items to be transferred are: - certification status (current, suspended, withdrawn, terminated), - the number and nature of checks carried out from 1 Ja

The recommendation states as its basis

In addition, the two CBs visited have risk analysis procedures in place to select operators for additional visits. The CBs have a mixed risk assessment based on quantitative and qualitative factors. However, one CB did not have the volume of production as a risk factor in its procedure, which is not in line with Article 65(4) of Regulation (EC) No 889/2008 and the INAO Directive.

The two CBs also have procedures for sampling based on risk. The audit team noted that even if most of the operators selected for sampling are based on risk there is also an important number of operators that are randomly selected by the inspectors. Therefore, it 10 is very difficult for the CBs to have an overview to ensure that operators selected for sampling in the end are those posing the highest risk. In one CB, around 30 % and 40% operators classified as low risk were selected for sampling in 2019 and 2020 respectively. This is not in line with Article 65(2) of Regulation (EC) No 889/2008.

Member state response

OC doivent prendre en compte dans leur analyse de risque la quantité de oduits produits/distribués/transformés etc. par l'opérateur. La directive DIR-CAC-3 prévoit que le critère quantité de production soit pris en ns les analyses de risque des OC. Lors des évaluations techniques de 2022, une attention particulière sera portée sur le respect des critères à prendre en compte dans l'analyse de risque. Avec l'entrée en application du R. (UE) 2018/848, les critères de risque à prendre en compte par les OC sont établis dans les dispositions de contrôle communes aux OC français, DCC AB (INAO-DEC-CONT-AB-3). Dans le cadre de la transition vers le nouveau règlement relatif à l'agriculture biologique (R. (UE) 2018/848), l'INAO a demandé aux OC de lui présenter leurs nouvelles procédures d'analyse de risque répondant aux nouvelles dispositions, pour instruction et validation. Page: 9 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit carried out from 08 March 2021 r organic production and labelling of organic products by the competent authority s services s'assureront ainsi que les OC tiennent compte du critère de risque duits, dans les procédures présentées. l

The CBs must take into account in their risk analysis the quantity of products produced/distributed/processed, etc. by the operator. t Guideline DIR-CAC-3 provides that the production quantity criterion is to be applied in the CBs' risk analyses. The 2022 technical assessments will focus particular attention on compliance with the criteria to be t taken into account in the risk analysis. With the entry into application of Regulation (EU) 2018/848, the risk criteria to be taken into account by the CBs have been included in the common control provisions for the French CBs, DCC AB ((INAO-DEC- er CONT-AB-3). As part of the transition to the new Organic Regulation (Regulation (EU) 2018/848), the d in INAO has asked the CBs to present their new risk analysis procedures meeting the new standards, so that they can be examined and validated. This will also entail checking that the CBs are taking into account production quantity as a risk criterion in the procedures presented. Implementation deadline: 31 January 2022 for the validation of the risk analysis procedures. Septembre 2022 : Les procédures d'analyse de risque des deux OC visités au cours de l'audit sont jointes, et s prennent bien

The recommendation states as its basis

At the beginning of the year, inspectors are given an indicative annual plan of inspections with the operators to inspect and, in the CB's database, inspectors have online access to all necessary information concerning previous controls of the operators, and any pending non-compliances. However, the two CBs could not provide evidence that inspectors have the information the operator must submit to the CB when engaged in organic production in line with Article 63 of Regulation (EC) No 889/2008 (a full description of the unit and of the precautionary measures).

The reports issued by the CB inspectors lack detail on how verification takes place, with no objective evidence attached to the reports. The reports consist of a template where inspectors tick off the aspects verified with little or no further description of, or references made, to the documents or records checked or any explanation to provide evidence that the item checked was in line with requirements.

For example, the audit team reviewed a report of an inspection carried out at an operator who has plant and livestock production. The inspector stated that the density of animals was in line with the requirements as were the records of veterinarian medicines and the 12 consumption of feed. The inspector also stated that the purchase and use of inputs and the quantity of feed produced and used was in line with requirements. However, these statements were not supported by evidence as the reports lack details on how the checks had been made. This lack of detail prevents effective supervision, as there is no evidence that can be objectively assessed. Nevertheless, in some instances, for example, when inspectors carry out an exercise to verify the balance between input and output, they attach to the report the sheet with all data collected, including references to the batches, processing sheet, invoices of purchases and sales and all quantities involved.

Member state response

by Les rapports de contrôle rédigés par les OC doivent fournir les informations adéquates (y compris les exercices de traçabilité), sur le type de vérification effectuée, et sur l'existence ou absence de pièces justificative. Les autorités françaises soulignent que les OC font l'objet d'évaluations techniques g régulières au cours desquelles des observations d'activité sont réalisées. Ces évaluations techniques, et particulièrement les observations d'activité, permettent de s'assurer de l'efficacité des contrôles des OC et répondent à la recommandation émise. OC Cependant, afin de mieux clarifier les obligations des OC, la Circulaire INAO- u CIRC-2009-01 va être modifiée pour l'année 2022 pour inclure la précision suivante : « L'organisme de contrôle doit rédiger à l'issue de ses contrôles des rapports de contrôle exhaustifs, reprenant l'intégralité des points soumis aux contrôles, Page: 11 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit carried out from 08 March 2021 r organic production and labelling of organic products ction Proposed by the competent authority r les matérialisant les points effectivement contrôlés, les motifs recevables pour les

Control reports drawn up by CBs must provide adequate information (including traceability exercises), on he the type of verification carried out, and on the existence or absence of supporting documents. ut The French authorities stress that the CBs are subject to regular technical assessments, which include e observation of activity. These technical assessments, in particular the observation of activity, enable the effectiveness of the CBs' controls to be ensured and respond to the recommendation. Page: 11 y's response to the report's recommendations (updated, received 20/9/2022) s' assessment of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7301 of out from 08 March 2021 to 23 March 2021 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Additional information Nevertheless, in order to further clarify the CBs' obligations, Circular INAO-CIRC-2009-01 will be he amended for 2022 to include the following: `Once it has completed its checks, the control body shall draw up a comprehensive control report covering ll the points subject to c

The recommendation states as its basis

The audit team noted that the sampling form used does not provide the detailed information about the circumstances under which the samples were taken necessary for the CB to interpret results in case of presence of non-authorised substances. For example, to distinguish whether the presence of the substance is due to contamination from conventional neighbours or to the use of the substance by the operators themselves.

Member state response

Les formulaires d'échantillonnage utilisés par les OC doivent contenir les nformations adéquates sur les circonstances du prélèvement afin de leur ermettre d'évaluer les résultats d'analyse obtenus. a décision de la Directrice INAO-DEC-CONT-AB-1, devant être appliquée par les C agréés depuis le 1er janvier 2020, indique au point 4.1.2 que la fiche de rélèvement utilisée par les OC doit contenir a minima les informations suivantes : -la nature et l'origine du lot l'opérateur susceptible d'être notifié en cas de non-conformité, le cas échéant, le ou les fournisseurs du produit prélevé, la date et lieu du prélèvement, Page: 12 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit carried out from 08 March 2021 r organic production and labelling of organic products Proposed by the competent authority s conditions de la réalisation (en cas d'impossibilité de respecter les modalités quises de prélèvement). cas d'un prélèvement au champ, la fiche de prélèvement devra indiquer dans schéma ou dans une description écrite, les lieux de prélèvement des sous- llons (ou échantillons primaires) et les risques observés (cultures voisines et bio/non bio ». leurs, au poin

The sampling forms used by the CBs have to contain adequate information on the circumstances of sample e collection to enable them to assess the analysis results. of Point 4.1.2 of Director's Decision INAO-DEC-CONT-AB-1, to be applied by approved CBs since 1 January 2020, states that the sampling form used by the CBs must contain at least the following information: ` -nature and origin of the batch, - the operator to be notified in the event of non-compliance, - where applicable, the supplier(s) of the product sampled, n - the date and place of sampling, - the sampling conditions (if the normal sampling requirements cannot be met). In the case of field sampling, the sampling form must include a diagram or written description of the ocations at which the sub-samples (or primary samples) are taken, and the risks observed (neighbouring crops and organic/non-organic status)'. Point 4.2 of the above Decision further states that: ults `the sampling methods must be adapted to the situation. The CB must use a sampling procedure that allows it to evaluate the result obtained.' Specific examples have also been included: `Below are some examples of situations for which the sampling procedure

Member state response

Une recommandation identique avait été formulée par la DG Santé lors de l'audit mené en France en 2013. Recommandation 2013-6880-2 : Veiller à ce que les tâches relatives à la reconnaissance rétroactive des périodes de conversion, à l'attache des bovins dans les exploitations de petite taille et à l'utilisation d'animaux non biologiques ne soient pas déléguées aux organismes de contrôle, mais demeurent sous la responsabilité de l'autorité compétente, comme établi par l'article 36, paragraphe 2 et les articles 39 et 42, du règlement (CE) n° 889/2008, et que les critères de définition des exploitations de petite taille dans lesquelles l'attache des bovins est autorisée soient e 2 clairement établis.". ) Lors des échanges sur la mise à jour du Profil pays et du suivi des recommandations de 2015, les autorités françaises ont fourni une analyse juridique des dispositions relatives aux dérogations. De cette analyse, il résulte que l'article 27.7 du règlement (CE) n° 834/2007 prévoit que : « Les autorités compétentes ne peuvent pas déléguer les tâches suivantes aux organismes de contrôle :a) la supervision et l'audit des organismes de contrôle ; b) la compétence en matière d'octroi de dér

DG SANTE made an identical recommendation following their audit in France in 2013. the Recommendation 2013-6880-2: `Ensure that the tasks related to the retroactive recognition of conversion periods, tethering of cattle in small holdings, use of non-organic animals are not delegated to the Control Bodies, but are the responsibility of the Competent Authority, as prescribed by Articles 36(2), 39 and 42 of Regulation (EC) No 889/2008, and that criteria for small holdings in which tethering of cattle is allowed are clearly defined.' During the discussions on updating the Country Profile and the follow-up to the 2015 recommendations, the French authorities provided a legal analysis of the provisions on exceptions. According to this analysis, Article 27(7) of Regulation (EC) No 834/2007 states: `The competent authorities may not delegate the following tasks to the control bodies: (a) the supervision and audit of other control bodies; (b) the competence to grant exceptions, as referred to in Article 22 (of Regulation (EC) No 834/2007), unless this is provided for in the specific conditions (...).' This means that, conversely, all other tasks entrusted to the competent authorities under t

The recommendation states as its basis

There are national provisions that are not in line with EU legislation. These are related to the procedure for approval of CBs, the granting of certain exceptional production rules (derogations) and the exchange of information between the CBs and the CAs in case of non-compliances (See relevant sections of this report). Conclusions on relevant national legislation and provisions

Laboratories used are designated by the CA and accredited to ISO 17025. The analytical scope of the laboratories used by CBs is adequate. 5.2.8 Exceptional production rules and other derogations. Legal Requirements Article 29, Sections 2 to 4 of Chapter 6 of Title II, and Annex IX of Commission Regulation (EC) No 889/2008 Article 22(2) of Council Regulation (EC) No 834/2007 Findings

Member state response

n ce qui concerne la définition des exploitations de petite taille, à la différence de ce qui a été indiqué lors de l'audit, il doit être précisé qu'il existe bien une définition des exploitations de petite taille : est considérée en France comme exploitation de petite taille toute exploitation ayant moins de 2 millions d'euros de chiffre d'affaires or ou ayant moins de 10 salariés. Il convient d'observer que le règlement (UE) 2018/848 qui entrera en application au 1er janvier 2022 harmonise ce point en explicitant la définition d'exploitation de petite taille, à moins de 50 bovins (hors jeunes animaux). La définition actuellement en vigueur en France sera donc supprimée et remplacée par la définition européenne à cette date. s Les opérations de gestion des animaux, comme l'écornage, sont bien autorisées au ticle cas par cas, par exploitation, par catégorie d'animal (âge, sexe...) et par nature opération (écornage, ébourgeonnage). S'agissant de dérogations qui ne sont pas ie des dérogations exceptionnelles au sens de l'article 22 du règlement (CE) n° 834/2007, elles peuvent avoir une attribution annuelle, à l'instar par exemple de ce se passe pour la dérogation mixité cultures pére

s As regards the definition of small holdings, such a definition does exist, contrary to the audit finding. In of France, a `small holding' means any holding with a turnover of less than EUR 2 million or fewer than 10 employees. ely Page: 15 y's response to the report's recommendations (updated, received 20/9/2022) s' assessment of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7301 of out from 08 March 2021 to 23 March 2021 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Additional information a We would observe that Regulation (EU) 2018/848, which will become applicable on 1 January 2022, as harmonises this point by clarifying the definition of a small holding, referring to a maximum of 50 bovine animals (excluding young stock). The definition currently used in France will, therefore, be deleted and replaced by the European definition on that date. Animal management operations, such as dehorning, are indeed authorised on a case-by-case basis, by a holding, animal category (age, sex, etc.) and nature of the operation (dehorning, d

The recommendation states as its basis

Physical checks were not carried out of all consignments from countries from where the EU has special guidelines for controls. From the data in TRACES, the audit team noted that a significant proportion of certain products from China and Ukraine in 2019 and 2020 were not subject to the sampling required by the Commission Guidelines on official controls of such products. For example, in 2019, 34 consignments out of 94 were cleared without laboratory tests. Representatives from DGCCRF confirmed the figures and explained that in 2019, it was not possible to carry physical checks in the port of Marseille, due to infrastructure issues so consignments from these countries were not sampled. The DGCCRF informed the audit team that this issue has been solved and now these controls can be carried out in all French ports. 19 Conclusions on imports of organic products

Member state response

Les instructions concernant le contrôle physique systématique des produits et pays d visés par les lignes directrices sont détaillées dans l'instruction annuelle générale the relative aux contrôles à l'importation des produits biologiques (TN) Cette obligation a fait l'objet d'un rappel à la réunion réseau des contrôles à l'importation en avril 2021 et chaque modification relative aux lignes directrices est adressée aux PCF en temps réel (A titre d'exemple: le dernier message transmis aux PCF le 29 juin 2021 concernait les dispositions pour les produits originaires d'Inde). En complément, un suivi dans Traces va être effectué pour s'assurer de la bonne application de ces lignes directrices. s

The instructions concerning systematic physical checks on products and countries covered by the guidelines are set out in the annual general instruction on import controls on organic products. A reminder of this instruction was given at the meeting of the import controls network in April 2021, and ng each amendment of the guidelines is addressed to the BCPs in real time (for example: the last message sent to the BCPs on 29 June 2021 concerned the provisions for products originating in India). ed There will, in addition, be a follow-up in TRACES to ensure that the guidelines are being applied correctly se s Page: 17 y's response to the report's recommendations (updated, received 20/9/2022) s' assessment of the action plan submitted by the competent authorities of France in response to Report ref. DG(SANTE) 2021-7301 of out from 08 March 2021 to 23 March 2021 in order to evaluate the control systems for organic production and labelling of organic products Action Proposed by the competent authority Additional information l ts

The recommendation states as its basis

The audit team reviewed several files related to detection of non-authorised substances at the two CBs involved in the audit. Both CBs initiate an investigation when there is a detection of non-authorised product or substance. However, the investigation is actually a form completed by the operators concerned and none of them declared any wrongdoing on their part in any of the cases examined by the audit team. The interpretation of the analytical report by one CB was not in line with the INAO decision. The CB only carries out an investigation and blocks the product when the laboratory analytical report indicated that the substance is detected above 0.02 mg/kg. If the quantity detected is below 0.02mg/kg no actions are taken and the product is considered organic. Furthermore, this CB has established thresholds above 0.02mg/kg for specific substances and applied concentration factors for some processing products like dried products. This is not in line with the organic rules (see paragraph 101 below).

The audit team reviewed several cases of non-compliances identified at operator level by the CBs visited and notified to the CAs. In all cases, the CB imposed sanctions on the operators in line with the catalogue of measures. However, deadlines for the investigation are not defined so it could take up to several months from the identification of the irregularity to resolve the case. The CB only notified the CAs of the irregularities at the end of the process when the CB certification committee has taken a formal decision. This is not in line with Articles 27(5)(d) and 30(2) of Regulation (EC) No 834/2007 and Article 20 92(4) of Regulation (EC) 889/2008 which require immediate notification of irregularities or the likely occurrence of irregularities.

In one particular case of Ethylene oxide contamination in sesame seeds originating in India, the CB only decided to take measures after a substantial delay even though the level of contamination was far above the maximum residue level. In addition, the CB informed the INAO about the case around 40 days after the detection of the substance. This constitutes significant misconduct on the part of the CB given there is an ongoing alert about Ethylene oxide contamination of sesame seeds and other products from India and there should be immediate exchange of information between the CBs and the CAs in order to enable the CAs to notify the Commission and other Member States through OFIS.

The audit team reviewed four cases related to OFIS notifications. There is a procedure to deal with notifications in OFIS. In the four cases investigated, the INAO and the CBs carried out investigations to identify the source of contamination. The CBs involved carried out inspection visits to the relevant operators and took samples. Other CBs involved were also informed. In two of the cases, the CB concluded that the contamination was accidental without providing robust evidence of that. The INAO provided information in OFIS respecting the established deadlines. Conclusions on measures in cases of irregularities and infringements

Member state response

Les OC mènent des enquêtes appropriées et prennent des mesures immédiates en cas de présence de produits non autorisés décision INAO-DEC-CONT-AB-1 portant Dispositions de contrôle communes relatives à la stratégie analytique à mettre en oeuvre dans le cadre du contrôle des ) opérateurs de la production biologique prévoit plusieurs dispositions relatives aux actions à mener par les OC, dont celle prévoyant que chaque résultat d'analyse qui révèle la présence de produit(s) ou substance(s) interdit(s) en agriculture biologique cle (AB) soit évalué par l'organisme certificateur avec la participation de l'opérateur et 'une enquête soit menée par l'OC. Page: 19 ns received 17/9/2021 mendations of report ref. DG (SANTE) 2021-7301 of the audit carried out from 08 March 2021 r organic production and labelling of organic products Action Proposed by the competent authority La décision visée ci-dessus va être modifiée dans le courant de l'année 2022, pour apporter plus de précisions sur les obligations à respecter par les OC en prenant en compte les dispositions des textes européens entrant en application au 1er janvier article 1 et 2 du R. (UE) 2021/279 et article 29(1) du R. (UE) 2018/848).

The CBs carry out adequate investigations and take immediate action if unauthorised products are found. Decision INAO-DEC-CONT-AB-1 laying down common control provisions on the analysis strategy to be s implemented for the supervision of operators in organic production contains a number of provisions on the c action to be taken by the CBs, including a requirement for any analysis result revealing the presence of non- r authorised product(s) or substance(s) in organic production to be evaluated by the certifying body with the participation of the operator, and for the CB to carry out an investigation. The above Decision will be amended in 2022 to provide more details on the CBs' obligations in the light of the provisions of EU legislation to be applied from 1 January 2022 (Articles 1 and 2 of Regulation (EU) s 2021/279 and Article 29(1) of Regulation (EU) 2018/848). Septembre 2022 : Un rappel va être prochainement fait aux OC Bio concernant l'obligation de bloquer les produits concernés par un soupçon de manquement à la Règlementation Bio et de mener une enquête s officielle. le Une attention particulière sur ce point sera portée par l'INAO lors des prochaines évaluations techniques

The recommendation states as its basis

The CVI can be signed by the private veterinarian who also provides services to the farm. There are no safeguard measures in place to ensure that the same private veterinarian attesting the suitability of an injured bovine animal to be transferred to the slaughterhouse or for on-farm slaughter, is excluded from performing the AMI/PMI of the same animal as a private veterinarian under contract.

The veterinarian's fees and travel expenses for the initial examination of the animal outside a slaughterhouse and for the completion of the part of the CVI relating to the private veterinarian are borne by the applicant for the visit and are paid directly to veterinarian. 5.2.3. Staffing and equipment

There are procedures in place ensuring that private veterinarians when carrying out official tasks under contract are impartial and free of conflict of interest. Nonetheless, there are no safeguard mechanisms or measures in place to mitigate such risks when a CVI is issued. As a consequence, it is possible that the same private veterinarian can attest the fitness of transport or on-farm slaughter of a bovine animal under his/her care and subsequently carry out the AMI/PMI of the same animal when assigned to perform official control tasks. 14

Member state response

Le mode opératoire relatif à la maîtrise de l'impartialité ("OPE Impartialité" du 18 septembre 2020 transmis en cours d'audit) définit les responsabilités et les modalités de gestion des risques liés aux conflits d'intérêt et à la perte ble d'impartialité dans toutes les activités de l'organisme GAL. Il s'applique à l'ensemble des agents de l'organisme DGAL, y compris les vétérinaires privés agissant en qualité de vétérinaire officiel. Il prévoit notamment l'identification, à tout moment, des sques de conflit d'intérêt, par l'agent ou par un supérieur hiérarchique, ainsi que des modalités de prévention : - échange dans le cadre de l'entretien initial, pouvant être tracé par la rédaction d'une charte d'éthique et de déontologie (un modèle est proposé en annexe du mode opératoire) ; - identification et traçage des risques de perte d'impartialité lors de la planification de l'activité de l'agent et lors de l'entretien annuel ; - modalités de traitement des conflits d'intérêt ; - bilan annuel des situations rencontrées à l'échelle de la structure et prise de mesures appropriées le cas échéant. Les risques liés aux actions et fonctions exercées par ailleurs, dont l'activité de vétérinai

The recommendation states as its basis

In the second slaughterhouse reviewed, also slaughtering over 1000 LVU per year it was explained that it is possible that on certain days, the OV is not permanently present throughout the day. Therefore, it is possible that the OA can carry out the AMI of bovine animals which do not present any abnormalities and those animals to be slaughtered. This is not in line with Article 3 of Regulation (EU) 2019/624 which requires that this task must be carried out under the supervision of the OV (that is, with the OV present in the premises). Animals presenting abnormalities are detained by the OA and undergo a second-level AMI, performed by the OV. This issue regarding the absence of the OV during AMI was identified during the 2019 internal audits, but no recommendations were made to address it.

It was also explained by the CAs that in the specific case where an animal is obviously in distress when the OV is not present at the premises, the OA informs the OV as quickly as possible and directly makes an appropriate decision, which may be: the immediate slaughter of the animals fit for human consumption (for example, an animal which has just been injured either in the lairage or during transport and is obviously in distress), retaining the carcase and offal for inspection by the OV. This practice is not in line is with Article 3 of Regulation (EU) 2019/624; the emergency killing of the animals unfit for human consumption (for example, a sick animal in obvious distress).

The audit team was informed that at local level, the local organisation and the priorities defined by the departmental authority may explain why the AMI might be carried out by 19 an OA under the responsibility and not under the supervision of the OV as required by Article 3(1) of Regulation 2019/624.

Based on the information provided by the CCA for bovine slaughterhouses, the staff of the VIS is systematically present during slaughter. The OV is present for decisions linked to the PMI and systematically validates this decision by signing the slaughterhouse seizure certificates. If the OV needs to be absent, including in slaughterhouses slaughtering over 1000 LVU per year, carcasses suspected of presenting abnormalities during the PMI are detained by the OA to be inspected at a later stage by the OV (see paragraph 87).

One OV in charge of a slaughterhouse slaughtering over 1000 LVU per year stated that it is possible that the OV might not be present at all times during slaughter since he/she might be assigned to other tasks elsewhere, during this period the OV can be reached by phone if needed. This is not in line with the requirements of Article 7 of Regulation (EU) 2019/624 that requires that PMI must be carried out under the supervision of the OV in slaughterhouses slaughtering over 1000 LVU.

The OV can carry out the PMI of slaughtered animals or entrust part of this task to one or more OAs under his supervision. If it is not the OV who directly performs the PMI, the OA performs the PMI of the animals after slaughter (first level of PMI). The OA sorts the animals depending on whether or not they present abnormalities. Animals presenting abnormalities are retained. The abnormalities might be pathological lesions, abnormalities requiring further investigations or inspection (e.g. identification or FCI issues, known health risks etc.) by the OV either on the same day or early the next day. 21 Due to the lack of continued presence of the OV highlighted in the paragraph above this procedure does not always ensure, in slaughterhouses slaughtering over 1000 LVU, that the PMI is carried out under the supervision of the OV as required by Article 7 of Regulation (EU) 2019/624. The issue regarding the absence of the OV during PMI was also identified during the 2019 internal audits.

The VIS perform various controls regarding bovine identification, checks on the FCI and on hygiene requirements during slaughter, including AMI/PMI and record their findings in the CA's information systems. Regarding the AMI of bovine animals, the implementation of the central level instructions does not ensure the required (supervisory) presence of OV in the slaughterhouses at all times required by EU legislation. Similarly, the PMI of bovine animals is not performed at all times under the OV supervision in slaughterhouses slaughtering more than 1000 LVU per year.

Member state response

L'effectif des agents d'inspection en abattoir d'animaux de boucherie est de 1489 agents (dont 363 vétérinaires officiels et 1126 auxiliaires officiels) pour 1289 équivalent temps plein (chiffres 2020). Les besoins en effectifs sont revus chaque année à ccasion du dialogue de gestion entre nistration centrale et les services déconcentrés. Pour chaque abattoir, un algorithme rmet de définir un effectif alloué pour le service d'inspection, en fonction du tonnage, des espèces abattues et de l'amplitude d'abattage. of

The recommendation states as its basis

The following are (non-exhaustive) examples of animals considered unfit for transport: serious open wound; animal suffering from a severe prolapse; animal unable to move by itself without suffering (example: dairy cow with spread legs); newborn whose navel has not healed; calves less than 10 days old, transported over 100 km; pregnant female ready to give birth (more than 90% gestation)/or having given birth less than a week before transport.

It was evident from the documentation reviewed by the audit team that bovine animals that had suffered an accident (including a non-open fracture) or had a non-serious prolapse were transported to the slaughterhouses accompanied by a CVI document signed by a private veterinarian, provided that they were able to move independently/unassisted. In the CVI the private veterinarian attested their capability of transfer, the fulfilment of the requirements of Council Regulation (EC) No 1/2005 and indicated which additional measures should be taken in order to ensure that no additional suffering is caused during transport. This practice is permissible under DGAL's relevant guidance document contrary to point 2(a) of Chapter I of Annex I to Regulation (EC) 1/2005 which lays down that animals unable to move independently without pain or to 20 walk unassisted shall not be considered fit for transport. This has already been identified in a previous DG Health and Food Safety audit (ref. DG(SANTE) 2015-7427).

There are procedures and guidelines in place for official staff for the relevant controls, which provide guidance on how to act in different scenarios regarding the handling of cull cows (i.e. emergency slaughter, identification of unfit animals for transport and/or slaughter). The controls system identifies relevant non-compliances, which are followed up satisfactorily. Yet, as already identified in a previous DG Health and Food Safety audit, bovine animals that have suffered an accident are transported to the slaughterhouses accompanied by a CVI, without all EU requirements being met.

Member state response

lan d'action a été développé pour répondre à la recommandation 2015-7427-8 demandant aux rités françaises de prendre les mesures pour s'assurer que seuls les animaux aptes au transport soient transportés vers l'abattoir : un groupe de travail français a été constitué en 2016 pour favoriser 4 ion Proposed by the competent authority battage d'urgence à la ferme et améliorer les structions données pour le transport de bovins identés sous CVI. Des formations ont été mises place pour les vétérinaires amenés à évaluer ptitude au transport des bovins accidentés en vue tablir un CVI. En 2019, 24 formations ont été loyées pour 283 vétérinaires formés. En 2020, 15 mations ont été déployées pour 74 vétérinaires més, et ce malgré la survenue de la crise sanitaire e au SARS-CoV-2. Mesures de prévention des accidents en élevage bovin volet agricole du plan France Relance comprend actions spécifiques pour les filières animales, r accompagner leur modernisation. La mesure acte biosécurité et bien-être animal », dotée de millions d'euros, s'adresse aux exploitations icoles et vise à améliorer les conditions d'élevage regard du bien-être animal. Dans la liste des estissements éligibles au financemen

The recommendation states as its basis

Similarly to domestic ungulates, there are no provisions in place to carry out AMI for poultry at the holding of provenance, therefore the AMI must be carried out at the slaughterhouse by or under the supervision of the OV, in line with Article 18(2) of Regulation (EU) 2017/625. The requirement that the OV is present during slaughter activities is implemented only in those poultry slaughterhouses slaughtering more than 15,000 tonnes per year (34 out of 914 slaughterhouses covering 70% of production).

In 17 slaughterhouses with an annual throughput between 10,000 and 15,000 tonnes the procedures in place require the permanent presence of at least one member of official staff (OV/OA) during slaughter activities with a daily supervisory visit by the OV in case not permanently present. In the remaining 78 slaughterhouses (with a capacity ranging from 300 to 10,000 tonnes per year), at least one member of official staff (OV/OA) is present for certain days each week. These arrangements in place do always ensure that the AMI/PMI is carried out under the supervision of the OV. Article 7(1)(a)(ii) of Regulation (EU) 2019/624 requires that PMI can only be performed by an OA under the responsibility of the OV in slaughterhouses slaughtering less than 150,000 poultry per year.

In the low-capacity slaughterhouses, the VIS is not present throughout the slaughter activities and only visits the slaughterhouses with a minimum frequency of two visits per year while the slaughterhouse is in operation. Besides the AMI issue highlighted in paragraph 95 the current arrangements are not in line with Article 18(3)(c) of Regulation (EU) 2017/625 which allows slaughterhouse staff to assist in the performance of official control tasks in poultry and lagomorphs slaughterhouses when the task is carried out in the presence of the OV or the OA and following their instructions.

When permanently present at the slaughterhouse or during visits/inspections, the OV or OA carries out a PMI, which includes an inspection of the viscera and body cavities of a representative sample of each flock and an inspection of the poultry declared unfit for consumption by the slaughterhouse staff. The latter is not in line with Article 25(1)(a) of Regulation (EU) 2019/627 according to which the OV/OA shall inspect the viscera and body cavities of a representative sample of each flock, on a daily basis. In France, the derogation of Article 25(2) of Regulation (EU) 2019/627 has not been applied to date.

The number of available official staff and the procedures in place for their deployment while on operation do not ensure in 880 poultry slaughterhouses (30 % of total national production) compliance with the requirements of Article 18(3) of Regulation (EU) 2019/627 regarding the presence of official staff, of Article 25(1) of Regulation (EU) 2019/627 regarding the practical arrangements of the PMI of poultry and the supervision requirements of Article 18(2) of Regulation (EU) 2017/625 and of Articles 3(2) and 7(1)(a)(ii) of Regulation (EU) 2019/624.

Member state response

L'effectif des agents d'inspection en abattoir de volaille et lagomorphe est de 136 agents (dont 34 vétérinaires officiels et 102 auxiliaires officiels) pour 125 équivalent temps plein (chiffres 2020). Les besoins en effectifs sont revus chaque année à asion du dialogue de gestion entre l'administration centrale et les services déconcentrés. Pour chaque abattoir, un algorithme permet de définir effectif alloué pour le service d'inspection, en tion du tonnage. La présence des agents spection dans les abattoirs de volaille et gomorphe est encadrée par une instruction onale (DGAL/SDSSA/2015-17) dont l'application est vérifiée à l'occasion des audits internes réalisés en abattoir. 7

The recommendation states as its basis

For many of the specific technical requirements, included under Section 1 of Chapter IV of Annex I to the Regulation, to be checked when approving a vessel and which are not of a veterinary nature the Vade Mecum: in some instances (ventilation air exchanges and backup water pumping system) indicates that only "the classification society referred to in Chapter IV, Section 1, Point 1 of the Regulation, is competent to" test/verify/certify the requirements, thus implying that the competent authority officials working at the port of exit (hereafter "port inspectors") do not have the skills to verify these requirements; in other instances (fire-fighting and power supply systems, all monitoring and alarm systems) indicates that is not the responsibility of the port inspectors, but must be certified in the ship's safety certificates issued by a classification society; does not provide sufficient instructions on how to verify the suitability of the drainage system including its tanks and pumping and backup pumping systems; instructs the port inspectors to verify these requirements by checking certificates issued by a classification society. According to Section F2102 of the Vade Mecum, checks on these certificates consist in a verification that they are still valid. The DGAL acknowledged that certificates issued by classification societies do not certify compliance with the technical animal welfare requirements listed in Section 1 of Chapter IV of Annex I to the Regulation.

In addition, for pre-loading controls, the Vade Mecum only indicates that the presence of the equipment listed in Section 1 of Chapter IV of Annex I to the Regulation must be checked but not that these are in good working order (water and drainage pumps and backup pumps, alarm systems, firefighting equipment and power generation devices). This is not in accordance with Article 20(1)(c) of the Regulation.

Due to the nature of the audit, it was not possible to attend a physical inspection of a livestock vessel. Concerning an inspection for approval: the Vade Mecum does not explain how to verify compliance with the specific technical requirements of the vessel (see also paragraph 3); port inspectors indicated they check ventilation systems by asking the operator to turn them on and verifying that air is exiting the vents, as instructed by the Vade Mecum. This type of check however does not confirm that the ventilation systems are providing the minimum required air changes per hour on each deck (Point 2 of Section 1 of Chapter IV of Annex I to the Regulation). According to the Vade Mecum, only a classification society can verify this (see also paragraph 32). according to the Vade Mecum, port inspectors should verify compliance with the requirement for alarm systems only by consulting classification society certificates, as it is not their competence to verify the presence of such devices. The port inspectors however indicated that they ask the ship's captain to run a mock emergency to check the alarm systems. According to inspection reports examined by the audit team, the port inspectors were requesting this mock test already in 2017, although not for all the alarm systems included in Point 8 of Section 1 of Chapter IV of Annex I to the Regulation. port inspectors were capable of explaining the layout of a vessel's drainage system from its plan. In the example used, drainage would be flowing in the corridors before reaching the drains leading to the pumps in the lower floors. Feed is given to the animals on these same corridors, meaning that it will be contaminated during the journey, contrarily to the requirement of Point 1.3 of Chapter VI of Annex I to the Regulation.

In the pre-loading checklists, port inspectors confirm that the equipment listed in Section 1 of Chapter IV of Annex I to the Regulation was present. There is no indication that they verify that this equipment is in good working order, although this is required by Article 20 of the Regulation (see also paragraph 4).

Documented procedures do not provide the necessary instructions for port inspectors on how to verify all the relevant legal requirements as part of a practical official control of a livestock vessel. In particular, these instructions are generally inadequate to support the port inspectors in verifying compliance with the specific technical requirements of the Regulation during official controls for approval of livestock vessels.

The effectiveness of controls of livestock vessels is dependent on the experience of the port inspectors. For some of the requirements, the port inspectors go beyond what the procedures indicate. Nonetheless, official controls are not adequately verifying all the requirements, and this could have implications for animal welfare during sea journeys. Controls carried out on vessels loading in France and during the French approval procedure for livestock vessels are inadequate to minimise the animal welfare risks linked to most specific technical equipment on board.

The recommendation states as its basis

For many of the specific technical requirements, included under Section 1 of Chapter IV of Annex I to the Regulation, to be checked when approving a vessel and which are not of a veterinary nature the Vade Mecum: in some instances (ventilation air exchanges and backup water pumping system) indicates that only "the classification society referred to in Chapter IV, Section 1, Point 1 of the Regulation, is competent to" test/verify/certify the requirements, thus implying that the competent authority officials working at the port of exit (hereafter "port inspectors") do not have the skills to verify these requirements; in other instances (fire-fighting and power supply systems, all monitoring and alarm systems) indicates that is not the responsibility of the port inspectors, but must be certified in the ship's safety certificates issued by a classification society; does not provide sufficient instructions on how to verify the suitability of the drainage system including its tanks and pumping and backup pumping systems; instructs the port inspectors to verify these requirements by checking certificates issued by a classification society. According to Section F2102 of the Vade Mecum, checks on these certificates consist in a verification that they are still valid. The DGAL acknowledged that certificates issued by classification societies do not certify compliance with the technical animal welfare requirements listed in Section 1 of Chapter IV of Annex I to the Regulation.

Port inspectors are responsible for inspecting and approving livestock vessels (Article 19 of the Regulation) but they do not have the technical knowledge to verify compliance with the specific technical requirements of Section 1 Chapter IV Annex I of the Regulation (Article 5(1)(e) of Regulation (EU) 2017/625).

Documents submitted with the application include classification society certificates, deck plans and a contingency plan: The application files reviewed by the audit team had these supporting documents. The deck plans illustrate the layout of the livestock area, and watering, drainage, ventilation, lighting and fire-fighting systems. According to the Vade Mecum, when carrying out the physical inspection, the port inspectors must verify that these systems are laid out according to the plans. The port inspectors are accepting certificates issued by any classification society as proof of compliance with most of the technical requirements found in Section 1 of Chapter IV of Annex I to the Regulation (see also paragraph 3). Verification of these technical requirements is an official control task, and can therefore only be performed by a competent authority or a person or body to which this task has been delegated (Article 2(1) of Regulation (EU) 2017/625). The port inspectors also indicated that, apart from the validity, there was nothing else they could check in the classification society certificates. Contingency plans provide instructions to care for sick or injured animals during the sea journey. They do not provide guidance for other possible emergencies that may arise at sea, such as fire outbreaks or engine failures leaving the vessel adrift at sea. 9

Due to the nature of the audit, it was not possible to attend a physical inspection of a livestock vessel. Concerning an inspection for approval: the Vade Mecum does not explain how to verify compliance with the specific technical requirements of the vessel (see also paragraph 3); port inspectors indicated they check ventilation systems by asking the operator to turn them on and verifying that air is exiting the vents, as instructed by the Vade Mecum. This type of check however does not confirm that the ventilation systems are providing the minimum required air changes per hour on each deck (Point 2 of Section 1 of Chapter IV of Annex I to the Regulation). According to the Vade Mecum, only a classification society can verify this (see also paragraph 32). according to the Vade Mecum, port inspectors should verify compliance with the requirement for alarm systems only by consulting classification society certificates, as it is not their competence to verify the presence of such devices. The port inspectors however indicated that they ask the ship's captain to run a mock emergency to check the alarm systems. According to inspection reports examined by the audit team, the port inspectors were requesting this mock test already in 2017, although not for all the alarm systems included in Point 8 of Section 1 of Chapter IV of Annex I to the Regulation. port inspectors were capable of explaining the layout of a vessel's drainage system from its plan. In the example used, drainage would be flowing in the corridors before reaching the drains leading to the pumps in the lower floors. Feed is given to the animals on these same corridors, meaning that it will be contaminated during the journey, contrarily to the requirement of Point 1.3 of Chapter VI of Annex I to the Regulation.

In the pre-loading checklists, port inspectors confirm that the equipment listed in Section 1 of Chapter IV of Annex I to the Regulation was present. There is no indication that they verify that this equipment is in good working order, although this is required by Article 20 of the Regulation (see also paragraph 4).

This, together with the absence of suitably qualified staff for assessing specific technical requirements for livestock vessels translates into a poor evaluation of these requirements (such as air changes per hour on each deck of a livestock vessel, and the equipment used for watering and drainage systems on board a livestock vessel) during the approval and pre-loading inspections.

The recommendation states as its basis

The relatively high levels of lesions detected during a survey in two slaughterhouses indicate serious animal welfare problems in a significant number of French farms and a need for an enforcement strategy aiming at improved compliance with minimum requirements as well as serious improvement measures to reduce the incidence of tail biting.

The sector has started to record evidence of tail/ear biting lesions. However, procedures for the assessment of lesions are incomplete. Farm risk assessment tools are still being developed and there is no robust framework in the Action Plan for improvement measures or when farms should transition to rearing pigs with intact tails. These last three components need to be put in place quickly in order to start making tangible progress to improve compliance with the Directive. In addition, the extended CA deadlines (end 2022 to 2024) mean that without a focus on shortening deadlines and sufficient priority, full compliance with legal requirements will not be reached within the next four years.

An error in the interpretation of legal requirements in official guidance and inspection checklists means that the legal requirement for all categories of pigs to have access to enrichment materials is not being enforced.

There are no specific programmes in France for animal welfare measures on pig farms currently financed or co-financed by the European Union Fund for Rural Development (EUFRD).

Official controls have not yet started to enforce compliance criteria for legislative requirements related to risks for tail biting though this is planned for 2020 once guidance is revised. Whilst the premises visited complied with the existing vademecum, they did not comply with existing legislative requirements on enrichment material and the requirements prohibiting routine tail docking.

Mistakes in the interpretation of legal requirements for enrichment material and interpretation of requirements on mutilations mean that animal welfare and cross compliance inspections massively underreport the high rates of non-compliance for these two items with serious implications for cross compliance payments.

The provision of water through liquid feeding systems does not ensure that all pigs over two weeks of age have permanent access to a sufficient quantity of fresh water.

It is unlikely that corridors can provide suitable accommodation for sick and injured pigs in most building and management scenarios. Blanket acceptance of the use of corridors by the CA without strict conditions and a case-by-case assessment intended to ensure that these areas are suitable for all the objectives specified in the relevant legislation is not in accordance with these legal requirements.

Member state response

conformité clairs sur chacun des points réglementaires relatifs à des facteurs de risque de la caudophagie. Le vade-mecum d'inspection protection animale en élevage de porcins est ainsi modifié en décembre 2019 sur les sous-items suivants : aire de couchage (ligne A0205L01), qualité de l'air (sous-item A0301), température et humidité de l'air ambiant (sous-item A0401), compétition alimentaire et en matière d'abreuvement (sous-item B0102), mesures préventives et curatives en lien avec la caudectomie (ligne D0103L02), local d'isolement (sous-itemD0203), matériaux manipulables (ligne D0303 L01), matériaux de nidification (ligne D00304L01) et fréquence de l'abreuvement (ligne E02). Des seuils ont été définis chaque fois que possible, en l'occurrence pour les matériaux manipulables, l'abreuvement, la compétition alimentaire et la qualité de l'air (NH3). Il sera publié sur le site internet du MAA d'ici fin 2019. voir document joint 2019-6603_rec1-1 Concernant les matériaux manipulables, des exigences sont imposées pour les porcs en groupe et pour les porcs en case individuelle, selon un calendrier clairement défini. Au-delà du nombre de matériaux en fonction du nombre de porcs par case,

The recommendation states as its basis

The central competent authority estimates that the incidence of tail docking in France is over 99%. This is routine tail docking. The CA does not yet enforce the legal requirements in Point 8 of Chapter I, Annex I, of the Pig Directive to take measures to prevent tail-biting and other vices by improving inadequate environmental conditions or management systems.

DGAL and INAPORC have funded a French version of the German SchwIP tail-biting intervention programme (Schwanzbeiß Interventions Programm) which will be available to veterinarians and technicians by end 2019. The programme is not intended for routine use on farms but to help identify risks for tail-biting in problematic farms. It is not clear how the tool will be utilised: by whom (5), and at what frequency, nor how farms are defined as "problematic" or by whom. The sector wish to collate data on the outcomes to gain an overview of the common problems/solutions found. Recording of ear/tail lesions on farm

The pig sector distributed in May 2019 a sheet for recording evidence of tail and ear lesions on farms which requires farmers to record incidence and severity of bites in one house for each category of pigs throughout the rearing period. It includes space to record any changes to environmental conditions on farm. Whilst this is progress, registering data from only one house in farms that have two or more houses would not provide an overview of the farm situation in relation to evidence of tail biting. This would not satisfy the requirement for evidence described in paragraph two of Point 8 of Chapter I, Annex I, of the Pig Directive. Monitoring sheets can be easily integrated into basic farm management procedures as every house already has a management/health monitoring sheet. This would give a representative picture of the situation on holdings, where biting problems may vary from location, or type of housing/ climate, over the whole premises within the different categories. Actions involving private veterinarians

There are CA proposals to fund health visits in 2022 to 2023 by veterinary practitioners to review implementation of training, risk factors and monitoring tools and by 2024 that individual farm plans will be used by the CA in the context of official controls. However, there are at present no proposals in the Action Plan for farmers to implement the legal requirement of paragraph 2 Point 8 of Chapter I of Annex I to the Pig Directive relating to improvement measures in a coherent and consistent way. Enforcement through official controls See section on official controls. Additional findings on the Action Plan

There are no intervention levels for tail biting defined to establish when farmers should/can start trials on keeping pigs with intact tails. It is notable that some Member States have already set intervention levels for when these should start. The only mention of rearing small groups of pigs with intact tails as "control groups" within existing premises is one sentence in the fiche for recording evidence of tail/ear biting which states: "If few bites have been observed for six months, have you thought of contacting your technician or veterinarian in order to set up a `whole tail' trial?". As there is no definition of what is "few bites" and no threshold has been set for any move to rearing pigs with intact tails, this will at present only be on a voluntary basis whereas the legal requirements of paragraph 2 Point 8 of Chapter I of Annex I to the Pig Directive clearly state that routine tail docking is prohibited. The staff working document accompanying Commission Recommendation (EU) 336/2016 also states in Point 9 that "When tail-biting has stopped, then some batches (1-2 litters) of undocked tails should be trialled ­ with a view to stopping the docking of tails."

There are no proposals for dealing with the trade in tail docked pigs, including from other Member States. Some Member States are working together to draft proposals to deal with this issue which will require close cooperation to ensure the provisions of the Directive are complied with.

DGAL has worked with stakeholders to implement an Action Plan on tail docking as part of the overall animal welfare strategy. It has taken actions to develop criteria for certain legal requirements that are related to tail biting risk factors on tail docking of pigs to enable inspectors and farmers to make a judgement on whether individual farms comply with EU requirements but these have not yet been implemented. Tail docking is still routinely carried out and the CA is not yet enforcing the corresponding legal requirements.

The relatively high levels of lesions detected during a survey in two slaughterhouses indicate serious animal welfare problems in a significant number of French farms and a need for an enforcement strategy aiming at improved compliance with minimum requirements as well as serious improvement measures to reduce the incidence of tail biting.

The sector has started to record evidence of tail/ear biting lesions. However, procedures for the assessment of lesions are incomplete. Farm risk assessment tools are still being developed and there is no robust framework in the Action Plan for improvement measures or when farms should transition to rearing pigs with intact tails. These last three components need to be put in place quickly in order to start making tangible progress to improve compliance with the Directive. In addition, the extended CA deadlines (end 2022 to 2024) mean that without a focus on shortening deadlines and sufficient priority, full compliance with legal requirements will not be reached within the next four years.

Docked pigs received from other farms may present a challenge for the competent authorities to change management practices on the farms receiving these animals which is not addressed in the Action Plan. 8

The planning, execution and follow up of official controls were carried out according to the existing procedures in place. However: DGAL and the local CA acknowledge that the existing guidance for legal requirements relating to risks for tail biting to official veterinarians (OVs) to carry out and report the results of inspections consistently is not fully satisfactory but is a work in progress. In addition there has been no training on the implementation of the new guidance and 10 checklists given to official veterinarians at District level although all those met were aware of the Action Plan and the ongoing developments related to it; Article 3 (2) of Regulation (EC) No 882/2004 requires that official controls should be unannounced. Official controls on pig farms are not routinely unannounced in all regions of France; Existing procedures do not include: defined criteria for certain legal requirements relating to tail biting risks to enable inspectors to assess farmers' compliance; nor do they contain any framework or instructions for assessing the evidence of tail/ear lesions and improvement measures in farms that rear docked pigs; The vademecum cites Council Directive 91/630/EEC as the main legal base for inspection requirements. This directive has been amended a number of times and superseded by the Pig Directive; The legal requirements on the prohibition of tail docking are being incorrectly assessed by inspectors as compliant: even when routine tail docking is practised on almost all farms, the recording of evidence of tail/ear injuries has only recently started, and farms are not required to put in place improvement measures to improve environmental conditions in order to prevent tail biting; There are serious implications for cross compliance payments as the question on mutilations (PB 3 of the cross compliance inspection form) is being interpreted only in relation to whether tail docking itself was performed in a satisfactory way, and not whether it was legally justified to tail dock on the farm. A non-compliance rate averaging 4% was recorded during 2014 to 2018 when the true situation is actually nearer to 100% according to DGAL and the pig sector. Due to a mistake in interpretation of the Pig Directive, point D0303 of the inspection vademecum and the related animal welfare inspection checklist report (Protection animale en élevage grill d'inspection l'élevage de porcs) only require the provision of enrichment material to pigs in groups, and sows and gilts in groups of more than 10 animals. Point PB7 of the cross compliance checklist indicates that the requirements for enrichment material are not applicable to sows and gilts in stalls.

DGAL intends to: Intensify official controls on pig farms at the end of 2019 once the inspection vademecum has been updated, including increasing unannounced inspections and incorporating improved enforcement and follow up procedures trialled in the largest pig producing area to improve the consistency of controls and their impact in 2020; Hold specific animal welfare training in 2020 for official vets dealing with pigs, including on the updated inspection vademecum and in the Districts to organise trainings for farmer groups based on non-compliances detected in local farms; Work on incorporating/using the results of risk assessment tools in the framework of their controls; Take phased enforcement measures to rectify the mistakes in the transposition of requirements for all pigs to receive enrichment material. DGAL informed the sector that 11 in June 2019 that all pigs must receive enrichment materials not only those kept in groups. However, there is no timeframe for these actions defined and until this issue is addressed the sector will not be in compliance with the requirements of point 4 of Chapter I, Annex I of the Pig Directive.

Member state response

d'inspection, les autorités françaises ont prévu de concentrer désormais leurs efforts sur les 2 autres facteurs de risque faisant l'objet de recommandations spécifiques, à savoir (1) l'isolement des animaux et (2) les mesures préventives et curatives pour mettre fin à la caudectomie en routine. Il est demandé par instruction du DGAL aux services vétérinaires d'appliquer le vade mecum d'inspection actualisé dès 2020, avec des suites renforcées et harmonisées. Afin de faciliter l'appropriation de ces changements de pratique d'inspection, des formations seront proposées aux inspecteurs à partir de 2020. Un arrêté ministériel est par ailleurs en cours de rédaction sur l'obligation de moyens pour l'abreuvement et les seuils susmentionnés. Enfin, un courrier aux préfets rappelle les obligations en matière de contrôles inopinés et d'harmonisation des suites. Voir documents joints 2019-6603_rec1-2 à 2019-6603_rec1-4 Sur l'ensemble de ces facteurs de risque, les autorités françaises ont travaillé en étroite concertation notamment avec la profession porcine, les instances vétérinaires et les services vétérinaires locaux. Les professionnels ont par exemple réalisé des fiches à destination de

Member state response

fourniture d'eau par l'intermédiaire de systèmes d'alimentation liquide ne garantissant pas le respect de la réglementation, une obligation de moyens est ésormais imposée y compris en système soupe. La profession porcine a pris note cette décision et de nombreux groupements se sont saisis de cette question et ent leurs éleveurs à s'équiper. instruction du DGAL précise les suites à donner sur ce facteur de risque important matière de caudophagie. Pour les systèmes d'alimentation liquide (soupe) : en l'absence d'eau dans tout ou partie des auges, l'éleveur sera mis en demeure de mettre en conformité (suite administrative), il pourra faire l'objet d'un procès rbal (suite judiciaire) et les aides soumises à conditionnalité seront réduites selon barème défini par la DGPE. en l'absence d'abreuvoirs spécifiques, l'éleveur sera averti dès 2020 (suite ministrative) et sanctionné dès 2021. En effet, au vu du coût des investissements, ge: 3 report ref. DG(SANTE)/2019-6603-MR of the audit carried out from 17 June nt tail-biting and avoid routine tail-docking of pigs n Proposed by the competent authority nvient d'encourager pendant l'année qui vient la dynamique favorable sée par la plupart des

The recommendation states as its basis

The audit team noted that in the vast majority of the cases observed, a warning had been given to the FeBOs (2-14 days in advance) on the visits by the authorities (both from the DGAL and the DGCCRF side). Both authorities confirmed this practice and explained that prior notification was given to ensure the availability of the necessary staff and access to relevant documentation. The audit team pointed out that while such an approach can be justified in rare cases (remote locations, irregular working hours, etc.), providing the FeBOs with prior notice is not in line with the requirements laid down by Article 3(2) of Regulation (EC) No 882/2004.

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. Verification of the correctness of labelling is adequate to ensure that labelling requirements have been met by the operators. The effectiveness of the inspections is however weakened by several elements including the giving of prior notice to establishments prior the inspections, deficient assessment of operators' HACCP-plans, and incomplete verification of the appropriateness of the operators' retained samples. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The recommendation states as its basis

In every establishment visited, the audit team checked the DGAL feed inspectors' assessment of the operators' hazard analysis and critical control points (HACCP) plans. In many cases, the inspectors' assessment was sufficient. However, in 5 of the 11 establishments visited, the audit team noted shortcomings in relation to the adequacy of the risk assessment for some ingredients used for the production of feed additives, and for some of the feed additives themselves (predominantly contaminants of chemical origin, e.g., heavy metals, dioxins/polychlorinated biphenyls (PCBs), etc.). The failure of the operators to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was neither spotted by the inspectors met during the audit nor had been identified in any of the previous inspection reports. In one case, there was no adequate HACCP plan in place at the time of the visit.

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. Verification of the correctness of labelling is adequate to ensure that labelling requirements have been met by the operators. The effectiveness of the inspections is however weakened by several elements including the giving of prior notice to establishments prior the inspections, deficient assessment of operators' HACCP-plans, and incomplete verification of the appropriateness of the operators' retained samples. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The recommendation states as its basis

A systemic shortcoming was noted by the audit team in terms of the preparation of final samples from the aggregate ones for control of substances where non-uniform distribution of the analyte/substance is presumed. The inspectors would normally use simple manual mixing to ensure appropriate homogenisation rather than special equipment (e.g. mechanical or automatic dividers) which is required by part 9(4) of Annex I to Regulation (EC) No 152/2009. For substances with a non-uniform 4 In their response to the draft report the competent authority noted that composition analyses to verify the correctness of declarations on the additives present and the concentrations thereof are also carried out at the request of investigators on feed sampled under the monitoring and control plan concerning undesirable and prohibited substances. 9 distribution, simple manual mixing alone cannot ensure complete homogenisation of the aggregate sample. Only in one case the inspector stated that there was one mechanical divider available. Conclusion on the planning and implementation of official sampling

The system in place for planning of official sampling is effective and risk-based. However, the effectiveness of the sampling is weakened by the fact that the representativeness of the sampling, and thus the samples' legal and analytical validity, is not ensured for controls on substances with a non-uniform distribution. 5.2.3 Actions taken on non-compliances

The recommendation states as its basis

As for the operators' obligation to take samples of ingredients and of each batch of products manufactured and placed on the market, or of each specific portion of production (in the case of continuous production) in sufficient quantities using a procedure pre-established by the manufacturer (hereinafter: retained samples), the audit team checked several samples in all of the establishments visited. In the vast majority of cases they could not be considered as adequate due to the absence of a pre-established written procedure (on taking of retained samples) by the operators, absence of sealing, and/or insufficient quantity. This is not in line with the requirements laid down in the section "Quality control"(4) of Annex II to Regulation (EC) No 183/2005. The audit team noted that the absence of sealing had not been identified as a non-compliance in the available inspection reports.

The system of planning of inspections is based on appropriate risk-related factors and thus ensures that the official controls are carried out regularly, on a risk-basis and with appropriate frequency. Verification of the correctness of labelling is adequate to ensure that labelling requirements have been met by the operators. The effectiveness of the inspections is however weakened by several elements including the giving of prior notice to establishments prior the inspections, deficient assessment of operators' HACCP-plans, and incomplete verification of the appropriateness of the operators' retained samples. 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The recommendation states as its basis

The audit team examined two RASFF notifications (one originated from France and one was sent to France due to the distribution of the affected product) and the actions taken by the relevant competent authorities (mainly by the DGCCRF through its Alert Unit). Whilst the immediate actions taken to ensure withdrawal of the products affected from the market were sufficient and timely, in one of the two notifications the return of the affected product to the country of origin was not verified and documented by the competent authority. This situation could not thus be considered as completely remedied as required by Article 54 of Regulation (EC) No 882/2004.

In every establishment visited, the audit team studied non-compliances from previous inspections (if any had been identified). Examples included deficient labelling, HACCP- related deficiencies, etc.). The audit team noted that in many cases the inspection reports and communication with the FeBOs did not contain an unambiguous request for corrective action and consequently no timeframe was specified for the FeBO to remedy the deficiency(ies). Dedicated and comprehensive follow-ups were very rarely carried out. The inspectors met clarified that such follow-up(s) would be done during the next planned inspection. However, the audit team pointed out that in the vast majority of the cases the next planned inspection would be in four-five years' time and thus the timeliness and effectiveness of the corrective actions, if any, would not be verified within a reasonable period of time. The situation observed is not in line with the requirements laid down by Article 54 of Regulation (EC) No 882/2004.

The fact that the competent authority does not specify timelines to operators to remedy non-compliances identified during official controls and it may be between 4 and 5 years before corrective actions are verified, weakens the effectiveness of the overall control system. 5.2.4 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

The recommendation states as its basis

The audit team noted that provision of information on activities related to production for/trade with third countries of non-EU authorised feed additives/premixtures was not 3 Available at: http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=FR 3 mandatory in the application form for registration/approval. This does not allow building knowledge on such activities and operators involved (see finding 51). The competent authorities clarified that the application forms and the registration process were being revised to better identify the precise activities of the FeBO.

There is a well-established system in place for the registration and approval of operators, which supports the planning of official controls. However, absence of verifiable information on production and trade of non-EU authorised feed additives/premixtures weakens the organisation of official controls on relevant establishments.

The audit team observed that neither the DGAL nor the DGCRF possessed any list of the relevant establishments though they had a note from an industry association clearly identifying the number of non-EU authorised feed additives/preparations/premixtures and the trade of those with third countries by French operators.6 The competent authorities explained that they were experiencing difficulty in collating information on relevant activities and establishments since reporting of such activities was not compulsory, although strongly recommended. As a result, the relevant activities could be discovered only during an inspection. Under these circumstances it is clear that no official controls can be planned and carried out with the aim to verify that relevant FeBOs meet the requirements laid down by Article 12 of Regulation (EC) No 178/2002. The competent authorities informed the audit team that the current revision of the application forms and the registration process would rectify this issue (see finding 7). However, no information on the completion of that revision could be given.

The absence of information on relevant operators' activities precludes the organisation of official controls on establishments producing non-EU-authorised feed additives/preparations/premixtures and trading these with third countries. be taken on a case-by-case basis, since the measures will depend on the findings made in the case in question. 6 In their response to the draft report the competent authority noted that the information had been requested from the industry association, but the relevant authorities have not yet received it. The competent authorities explained to the audit team that the association had raised the issue of the identification of such products. 11

The recommendation states as its basis

The audit team noted that two of the operators visited had received approval for using processing method 7 in a continuous system, however: a. One operator, despite being approved for processing in a continuous system, had carried out validation for the processing method in a batch system with single loads of material ranging from 80 to 120 kg while the targeted operational capacity of the system was up to two tonnes per hour. This way of processing was neither reflected in the operators HACCP-based procedures nor in the approval document issued by the authority; b. Neither of the two operators explained in the validation file the way they measured the feeding rate to demonstrate the minimum transit time inside the entire relevant part of the continuous system to ensure sufficient exposure of the processed material to desirable processing parameters. Moreover, there were no critical control points (CCPs) established for the parameter(s) relevant for the continuous process, such as: (i) feed screw revolutions per minute, (ii) the electric power, (iii) the evaporation/condensation rate, or (iv) the number of pump strokes, if relevant, that would allow a correlation to be made between the exposure to processing parameters and the transit time; c. HACCP-based procedures, attached by both operators to the validation file, determined critical limits (values) in relation to temperature and processing time. 6 One operator, in its HACCP-based procedures had established a 30% tolerance for these limits. This would allow the processing of material below the critical limits though the audit team did not see any evidence that such a situation had arisen. The above points are not in compliance with the requirements laid down in points 1, 3(b) and 4 of Section 2 of Chapter I of Annex XVI to Regulation (EC) No 142/2011. They had not been detected or objected by the competent authority during the approval process.

The process for granting approval ensures that insect PAP placed on the market complies with microbiological safety criteria, but was insufficiently robust as regards the assessment of the validation of the processing method and of the HACCP-based procedures; this however did not affect the safety of the product.

Member state response

La filière de la transformation des sous-produits animaux de catégorie 3 a proposé aux autorités françaises une mise à jour de leur Guide de Bonnes Pratiques d'Hygiène et d'application des principes de l'HACCP le 27/06/2019. A cette occasion, les autorités françaises vont demander d'inclure une description de la nature des paramètres mesurables pour un système continu ou discontinu pour valider les méthodes de transformation utilisées. Ce document pourra être utilisé par les professionnels et les inspecteurs. Parallèlement une réunion sera organisée au printemps 2020 avec les inspecteurs suivant des usines de transformation utilisant une méthode 7 afin de partager les modalités de validation de cette méthode et les paramètres à suivre. Dans l'attente de la conduite de cette réunion, un appui par l'experte nationale sur les sous-produits animaux pourra être apporté aux inspecteurs en tant que de besoin. Ce point fera, également, l'objet d'un focus particulier dans le cadre de la prochaine session de formation à l'HACCP en lien avec les SPA en 2020.

The recommendation states as its basis

The DGAL website contains the link to the lists of ABP-approved and registered establishments and personnel responsible for official controls have access to these lists. The audit team noted that the link restricts external access and therefore, neither the public nor operators can access the lists. Moreover, the list for Category 3 ABP processing plants (relevant for this audit) held by the authority was outdated (October 2018) and, as a consequence, did not contain information on one of the two approved operators visited. This is not in line with Article 47 of Regulation (EC) No 1069/2009 requiring that Member States shall keep up-to-date lists of approved or registered establishments, plants and operators and make them available to other Member States and to the public (3).

Whilst an arrangement for listing and maintaining the list of approved ABP operators is in place, it is not publicly available and is not updated promptly. This limits the possibility of the public, authorities from other Member States and other operators to verify if a given operator placing its products on the market is approved or not.

Member state response

Les services en charge de la publication sur le site internet ministère de l'agriculture et de l'alimentation (MAA) ivent corriger les anomalies afin que les listes soient de nouveau accessibles au public extérieur au MAA au plus tard le 15 novembre 2019. La prochaine mise à jour sera faite pour le 15 novembre 2019, à partie de la nouvelle base de données mise en place en 2019. Page: 1

The recommendation states as its basis

Risk classification is determined by DGAL by the application of a formula which comprises the outcome of the last inspection and the volume, type and target of production; the reliability of the FBOs, in performing their own-checks and informing the CAs of any real or potential risk, is not weighted appropriately in this formula. It is noted that the highest risk class IV does not necessarily include insufficiently performing FBOs; FBOs with high volumes of production, or targeting highly sensible consumers, may also be included in this class. On the other hand, a very negative notation of one of the elements of the formula does not necessarily lead to an increase in the risk classification of the FBO. Consequently, the risk classification of establishments might not exactly reflect the situation seen by the DG Health and Food Safety audit team during visits to premises (see paragraph 63). Local CAs stated that they may update the risk classification given at central level (only up or down by one class), but this is rarely done.

After each inspection a report with the findings is created and signed by the official. The FBO receives the report with an accompanying letter containing the final decision, signed at Department level. The findings are recorded in the RESYTAL database and are scored, according to their seriousness, within the formula used for the risk classification of FBOs for the following year (see paragraph 43).

Official controls are planned on the basis of the risk categorisation of FBOs, which does not give the necessary weight to the key elements supporting the categorisation. As a consequence, the frequency of controls and follow-up of previously detected non- conformities may be not appropriate.

The recommendation states as its basis

There is a supervision system in place allowing different competent authorities involved in the implementation of surveillance and control programmes (including the AMR monitoring one) to monitor their progress. However, this system is not able to detect gaps in how the AMR monitoring sampling plan is being regularly implemented. The audit team saw examples of such (undetected) gaps, including not taking any of the scheduled Salmonella samples in one of the slaughterhouses visited or grouping all the annual samples from March to May in another slaughterhouse. This does not allow competent authorities to ensure that the monitoring is carried out in accordance with the 1 http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=FR 3 relevant requirements of Part A of the Annex to Decision 652/2013/EU and is therefore not in line with Article 2 of the same Decision. Conclusions on the competent authority

The competent authorities responsible for the monitoring of AMR are clearly designated and have, in general, the necessary powers and resources to develop and implement this programme. However, two issues affect their ability to ensure its effective implementation, namely the staffing constraints related to the reporting arrangements in 2016 and the gaps in the supervision system.

Member state response

rangements are effectively 1. L'absence de détection de la non réalisation des échantillons pour nts set out by Article 2 of Salmonella chez les bovins est en partie due à la présentation de l'instruction technique. Par conséquent, l'instruction technique sera modifiée pour la réalisation en 2019. Deadline : nov. 2018 2. SIGAL ne permet pas de présenter le taux de réalisation par plan par département par mois. Par exemple, il est aujourd'hui impossible d'accéder directement à l'information suivante : taux de réalisation des prélèvements de caeca de volailles dans le département XX en mars 2018 et comparaison avec la programmation. En revanche il est possible d'accéder aux données en pièce jointe confidentielle (DOC_1 présente une extraction réalisée semaine 15 pour les prélèvements de caeca) et de les mettre en forme pour suivre l'avancée du plan par département. L'autorité compétente surveillera régulièrement l'avancée de la réalisation de chaque plan, afin de pouvoir prévenir au besoin les régions où un retard est observé. Fréquence des Action Plan received from the competent authority on 16 May 2018 Action Proposed by the competent authority vérifications prévue : tous les 2 moi

1. The failure to detect the fact that samples for testing for Salmonella have not been taken from Un système de tableau de bord cattle is partly due to the presentation of the présentant la réalisation par abattoir technical instructions. Amendments will therefore et par mois va être développé. Une be made to the technical instructions for the extraction de SIGAL sera sampling in 2019. Deadline: November 2018 automatiquement réalisée chaque semaine. Les abattoirs concernés 2. The French Information System for the apparaîtront en rouge s'ils n'ont fait Directorate-General for Food (Système l'objet d'aucun prélèvement. Une d'information de la Direction Générale de consultation régulière de ce tableau l'Alimentation - SIGAL) does not allow the rate of par les coordinateurs PSPC en sampling to be shown for each plan, department and services départementaux leur month. For example, direct access to the following permettra d'identifier les abattoirs information is currently impossible: rate of qui n'ont pas fait l'objet de sampling of poultry caeca in department XX in prélèvements et d'alerter les agents March 2018 and comparison with the programming. des services d'inspection de ces It

The recommendation states as its basis

Contrary to the requirements of point 2.3.2 of part A of the Annex to Decision 2013/652/EU, less than 170 of isolates from the SNCP were subject to AST in 2014 and 2016. In addition, the NRL could not establish whether all the available isolates were subject to AST or not. Representatives from the Salmonella NRL declared that a number of reasons contributed to this: In a given year the NRL does not know the total number of isolates obtained in the département laboratories. This is mainly because the NRL has no access to the electronic database where this information is available, namely the Information System for the Directorate-General for Food (Système d'information de la Direction Général d'Alimentation - SIGAL). Some initially available isolates could not be subject to AST or reported because they were either contaminated or lacked basic epidemiological information, respectively. 5 Salmonella isolates from carcass samples collected at slaughter

Representatives from DGAL declared that only isolates derived from samples taken under the official control plan mentioned above were subject to AST. For broilers and turkeys, 170 Salmonella isolates were obtained in 2014; for 2016, 168 and 123 respectively. For pigs and bovines under 1 year of age, 117 and 43 isolates were obtained respectively in 2015. According to DGAL, the lower number of isolates from pigs and, in particular, from bovines, are explained by the low prevalence of Salmonella on the carcasses of these 2 species (10 % and 1 % respectively). The audit team noted that in the turkey and pork slaughterhouses visited several isolates were obtained from the sampling carried out by the operators. Contrary to the requirements of point 2.3.2 of part A of the Annex to Decision 2013/652/EU, these isolates were not subject to AST or reported. Isolates gathered from caecal samples collected at slaughter

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in Decision 2013/652/EU. This implementation is largely satisfactory. However, shortcomings were noted that reduce the representativeness of data obtained, in particular the lack of randomisation to select samples and their lack of distribution over the whole year. In addition, the measures in place to gather Salmonella isolates and to subject them to susceptibility testing were not always sufficient to achieve the objectives of the legislation. 5.2.2 OFFICIAL LABORATORIES Requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

Member state response

isolates are subject to Pour l'année 2019, les autorités françaises sont en attente d'un avis de the minimum required number l'Anses pour l'organisation du plan à l'abattoir pour la filière bovine. required by point 2.2 of Part A L'instruction technique sera rédigée en tenant compte de cet avis de l'Anses en fin d'année 2018.

he French authorities are awaiting an Les actions a/ et b/ ne sont pas ion from the French Agency for Food, envisageables pour les autorités vironmental and Occupational Health and Safety françaises. Lorsqu'on compare d'un e nationale de sécurité sanitaire de côté le gain pour la santé publique ation, de l'environnement et du travail - et le consommateur européen et de NSES) for organising the plan at slaughterhouses l'autre les efforts humains et beef/veal sector. The technical instructions budgétaires à fournir, l'intérêt be drafted on the basis of the ANSES opinion d'explorer la piste consistant à 018. collecter les souches de Salmonelles isolées lors d'autocontrôles est très faible. Il paraitrait plus pertinent que soit fixé au plan européen un objectif plus adapté à la très faible prévalence des Salmonelles chez les bovins dans chaque État membre, sous la forme d'un nombre minimal de prélèvements fonction du tonnage national et non plus un objectif en nombre d'isolats. Cela permettrait d'une part de surveiller la prévalence des Salmonelles chez les bovins, et d'autre part de continuer à suivre les profils d'antibiorésistance chez les souches isolées. Les autorités françaises o

The recommendation states as its basis

In contrast to the requirements laid down in point 2.3 of Decision 2013/652/EU, the collection of samples at the slaughterhouses was not representative enough due to the following: A lack of randomisation in the collection of samples. The work instructions drafted by DGAL for the years 2015-2017 stated that samples should preferably be taken on Mondays Tuesdays or Wednesdays. This is to allow the laboratories to complete their processing within the 5 working days of the week. In the slaughterhouses visited samples were mainly taken on Mondays and Tuesdays and in some cases only on Mondays. In addition, the batches to be sampled in the 6 slaughterhouse were not always chosen randomly. Different factors affected the choice of batch, such as the personnel available at the slaughterhouse or the size of the batch. The caecal samples gathered were not evenly distributed over each month of the year. Sampling started always either in February or March and finished occasionally in November. Furthermore, in some cases, samples were not taken in July or August due to staff taking leave over this period of time. According to officials met during the audit, the late start was mainly due to the drafting of the work instructions for a given year that were finalised late the previous year. Isolates from meat samples collected at retail

The competent authority has documented procedures in place to support the implementation of most of the provisions laid down in Decision 2013/652/EU. This implementation is largely satisfactory. However, shortcomings were noted that reduce the representativeness of data obtained, in particular the lack of randomisation to select samples and their lack of distribution over the whole year. In addition, the measures in place to gather Salmonella isolates and to subject them to susceptibility testing were not always sufficient to achieve the objectives of the legislation. 5.2.2 OFFICIAL LABORATORIES Requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

Member state response

es is representative, as required 1. Un mail a été envoyé aux DD(CS)PP et DRAAF en mars 2018 afin de the Annex to Decision leur rappeler la possibilité (DOC_2 confidentiel), pour la recherche de s over each month of the BLSE, d'analyser les échantillons de viandes et caeca dans un délai de 96H ys and slaughtering batches. comme mentionné dans les instructions techniques. Il leur a été également rappelé la nécessité de ventiler l'ensemble des prélèvements du lundi au vendredi et à défaut du lundi au jeudi. Action Plan received from the competent authority on 16 May 2018 Action Proposed by the competent authority 2. En mars 2018, il a été décidé de revoir le calendrier de publication des instructions techniques afin de permettre aux régions et aux départements de débuter plus vite les prélèvements. L'objectif sera de publier les instructions techniques relatives aux plans 2019 dès novembre 2018. 3. Il a été décidé d'organiser des demi-journées d'information et d'échange avec les préleveurs dans chaque région afin de les sensibiliser à la nécessité de respecter la ventilation des prélèvements. L'objectif sera également de connaître leurs difficultés. Deadline : début prévu pour le sec

as sent to the French Departmental ctorates for (Social Cohesion and) Protection of Population (Direction départementale de (la n sociale et) la protection des populations ­ PP) and the Regional Directorates for Food, lture and Forestry (Direction Régionale de ntation, de l'Agriculture et de la Forêt ­ March 2018 reminding them of the dential DOC_2), for the detection d-spectrum -lactamases (ESBL), of mples of meat and caeca within 96 hours, ed in the technical instructions. They were ded of the need to present a breakdown samples from Monday to Friday or, failing Monday to Thursday. h 2018, it was decided to revise the or publishing the technical instructions to regions and departments to start sampling ly. The aim will be to publish the instructions relating to the 2019 plans as r 2018. Page: 4 Plan received from the competent authority on 3 August 2018 ion Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2018-6307-MR of the audit ruary 2018 in order to evaluate the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria in and food by the competent authority Updated Action proposed by the competent authori

The recommendation states as its basis

With the exception of the information to be conveyed in the narrative part of the reports, the results of the monitoring programme were reported largely in line with the requirements of the data dictionary provided by EFSA in 2014 and 2015. However, and contrary to the requirements set out in point 2 of Part B of the Annex to Decision 2013/652/EU, in 2016, no information on either the available Campylobacter isolates or on the Salmonella isolates from carcasses of broilers were reported to EFSA within the required timeline. According to the person responsible for reporting, staffing and technical issues are the reasons for this shortcoming. It was explained that the lack of IT specialists capable of summarising the MIC data in a quick and manageable format resulted in one person having to do these operations manually. Representatives from DGAL undertook to correct this problem and declared that the situation has already improved for the reporting of the MIC results from 2017. Conclusions on assessment and reporting of AMR

Although the main reporting requirements were met in 2104 and 2015, the problems experienced in 2016 resulted in the reported obligations not being met for that year. This hampered the ability of the competent authority to provide harmonised and comparable data on AMR. 9

Member state response

e available isolates is timely Une nouvelle organisation a été mise en place à l'Anses depuis l'audit pour rity, as required by point 2 pouvoir respecter le calendrier de transmission des données AMR à l'EFSA : 2/EU. - les 2 laboratoires de l'Anses participant à la production des données de sensibilité aux antibiotiques utilisent (ou sont en cours de paramétrage avec une mise en production effective pour les données 2018) un LIMS pour l'enregistrement des données épidémiologiques et la sensibilité des isolats. Des règles de cohérence ont été élaborées pour s'assurer de la qualité des om the competent authority on 16 May 2018 Action Proposed by the competent authority données à l'enregistrement. - en fin de campagne, selon un calendrier défini au sein de l'Anses, les données sorties du LIMS sont analysées avec un script R pour vérifier leur complétude et leur cohérence par rapport aux descripteurs demandés par l'EFSA - si le rapport R est satisfaisant, les données sont ensuite transférées à l'EFSA, sinon, les données sont modifiées jusqu'à ce qu'elles soient conformes Ces étapes sont résumées dans un SOP qui a été transmis à l'EFSA fin mars 2018. Ce SOP décrit les différentes étapes

nce the audit, ANSES has been reorganised to to abide by the timetable for sending icrobial resistance (AMR) data to the ean Food Safety Authority (EFSA): ANSES laboratories participating in the ntibiotic susceptibility data use a tion Management System rding epidemiological data and the isolates, or are in the process of h a system with a view to using it to r 2018. Rules for ensuring e been developed to guarantee the data being recorded; the marketing year, following a own in ANSES, the data from the ed with an R script to check for d consistency with the descriptors SA; Page: 5 received from the competent authority on 3 August 2018 ion Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2018-6307-MR of the audit ruary 2018 in order to evaluate the monitoring and reporting of antimicrobial resistance in zoonotic and commensal bacteria in and food he competent authority Updated Action proposed by the competent authority satisfactory, the data are then otherwise, they are amended marised in a standard (SOP) which was forwarded to arch 2018. This SOP s stages needed to guarantee the transmitted, the stakeholders fferent stages, the documents or

The recommendation states as its basis

The implementation rate of the scheduled inspections of approved ABP operators was 62% in 2016 and 58% in 2017 (174 out of 298 scheduled controls was actually carried out). The competent authority explained this low implementation rate by the fact that there had been an increase in the request for approval of composting plants and biogas producers, due to a national programme in this sector, and therefore, 215 approval visits had to be carried out in 2017. As these approval visits have to be prioritised and are time-consuming, scheduled official controls often have to be postponed to the following year. As inspections of registered operators will have to be considered in the future planning, a further decline in the rate of implemented regular inspections is very likely to be expected (see also finding 15). 5.2.1 Hygiene requirements

The competent authority was unable to meet its planned targets for official controls in the ABP sector in 2016 and 2017 due to a spike in unscheduled approval visits and the limited time available to inspectors to carry out official controls. This indicates a weakness in the official control system given the resources available are insufficient to carry out the number of planned inspections and there is no built-in contingency to be able to absorb ad-hoc requests such as new establishment approvals. As official controls on registered operators will also have to be factored in from 2018 on, the implementation rate of inspections will almost certainly decrease further, weakening the system overall.

The recommendation states as its basis

The audit team visited a storage plant which stored PAP on behalf of two processing plants. The establishment had been approved for the storage of PAP in big bags in 2016 and has never been inspected since. The audit team noted that the establishment has not been well maintained and at the time of the visit did not comply with legal requirements laid down in Section 1 of Chapter III, Annex IX to Regulation (EU) No 142/2011 anymore. The operator declared that they are currently planning a comprehensive refurbishment of the storage premises. Moreover, in addition to the storage of PAP in big bags for which it was approved, the establishment is storing also a liquid product (poultry fat) in tanks; however, this activity is not included in its approval document. The audit team reviewed several commercial documents for the consignments together with the inspector and found that several of them were incomplete and contained inaccuracies. 12

In general, checks on commercial documents accompanying consignments of derived products were regularly carried out during inspections and these checks were recorded in the relevant points of the checklist. The officials met were largely familiar with relevant requirements; however, some of them mentioned difficulties in assessing commercial documents as they were not familiar with the model for intra-EU trade. In France, for national trade, there is no specific form required, but any document is accepted which includes the relevant information, in line with point (4a), Chapter III, Annex VIII to Regulation (EU) No 142/2011. In all premises visited during the audit, the audit team checked a random sample of these documents and in most cases, these documents were not fully in line with the legal requirements (form, data missing such as approval/registration number, wrong place of loading, no indication of species etc.). Some of these non-compliances had already been spotted by inspectors during official controls, but the operators had not rectified these shortcomings (see finding 39). These shortcomings might also limit the ability of the competent authorities to ensure that certain ABP and PAP are eligible to be used in the production of feed for aquaculture.

The OF/SI manufacturer visited traded an amount of around 800 tonnes (3% of his production) in 2018 to other Member States, including consignments consisting of 100% PAP and/or MBM mix. Contrary to Article 48(3) of Regulation (EC) No 1069/2009, TRACES notifications relating to intra-EU trade were not made for these products. The competent authority stated that such notification is not required by the relevant internal instruction (see finding 21). The operator had not issued commercial documents for these consignments either, which had not been spotted during official controls. During an official control in 2017, the inspector had identified non-compliances as regards the accompanying commercial documents for the trade within France and had asked for an amendment, but the operator had yet to react up to the time of the audit. 13 5.2.3 Exports and imports of PAP

Routine official controls still need to be strengthened as they did not detect a number of shortcomings, in particular with regards to the issuing of commercial documents. Inaccuracies and information gaps in commercial documents used for domestic trade weaken the competent authority's ability to verify the traceability of certain ABP and PAP and to verify whether they are used in accordance with their intended purpose. The implementation of official controls in relation to hygiene requirements was in general satisfactory.

The recommendation states as its basis

In 2017, DGAL prepared two service notes (590 and 790) on the requirements of the national and intra-EU trade of ABPs and derived products, including PAP and MBM. The audit team reviewed the notes and determined that there is a detailed description of how the French competent authority has to notify the competent authority of origin via the Trade Control and Expert System (TRACES) about the arrival of the consignments as required by Article 48 of Regulation (EC) No 1069/2009. In particular, note 590 is very detailed and includes also a comprehensive annex with a list of specific cases. However, OF/SI containing PAP and/or MBM are not listed as requiring notification. 8 This is not in line with the requirement of Article 48(3) of Regulation (EC) No 1069/2009. Note 790 also provides for the possibility to delegate the required TRACES messages to the operator under certain conditions, where more than 30 consignments per year are dispatched or received. The competent authority has to verify annually a defined sample of TRACES notifications to see whether the operator is fulfilling the conditions for this derogation. This arrangement, however, has not had a notable impact on the rate of notifications of the arrival of PAP consignments (see finding 37).

The audit team noted that, although training and instructions had been provided (see findings 5, 7, 21), in the vast majority of cases arrivals of consignments of PAP were not confirmed by the French competent authorities to the competent authorities of the Member States of origin by means of TRACES, contrary to Article 48(3) of Regulation (EC) No 1069/2009. In 2017, according to figures of the competent authorities, arrival of only 7.37% of such consignments was confirmed, and in 2018, 4.45%.

The audit team identified several shortcomings relating to TRACES notifications of intra-EU trade of PAP and OF/SI. For OF/SI, the competent authority had omitted to include a requirement for the operator to issue a TRACES notification, thereby undermining the traceability of the consignments. The percentage of PAP consignments arriving to France from other Member States which are notified back to the competent authorities in the Member State of origin is still wholly inadequate (approximately 4%), impacting on the fulfilment of traceability requirements in intra-EU trade.

The recommendation states as its basis

The audit team identified several shortcomings relating to TRACES notifications of intra-EU trade of PAP and OF/SI. For OF/SI, the competent authority had omitted to include a requirement for the operator to issue a TRACES notification, thereby undermining the traceability of the consignments. The percentage of PAP consignments arriving to France from other Member States which are notified back to the competent authorities in the Member State of origin is still wholly inadequate (approximately 4%), impacting on the fulfilment of traceability requirements in intra-EU trade.

The recommendation states as its basis

When, following the amendment of Regulation (EC) No 999/2001, exports of consignments of PAP derived from ruminants started in July 2017, the BIPs in France implemented the instruction communicated by SIVEP (see finding 22). In the BIP visited, the procedure for export checks established by the BIP included a verification of the arrival of the consignment in the port via an extract of the tracking application "AP+" including the seal number, which the operator has to provide as the BIP only has limited access to this application. In addition, a second extract from the application is required when the container has been loaded and the ship has left the port, which usually is sent seven days after the departure of the vessel. In order to record this check in TRACES, BIP staff entered the name of the official in charge and the port as the place of the official control in the control tab, but no box of a check carried out was ticked. 1

In this way, the BIP visited by the audit team verified the exit of all 24 consignments of PAP containing ruminant protein in 2017 and 43 in 2018 notified to them via TRACES, until the exit of consignments via this port stopped in February 2018. Since the SIVEP procedure TI 240 was issued only in March 2018 (see finding 23), no seal check was ever carried out at this BIP.

According to the evidence provided by the competent authority, in another BIP, through which the majority of consignments were exported from France, the information that the consignment actually left the EU was received in relation to around 99% of consignments in 2017 and around 94% in 2018 up to the time of the audit (for 2018: 1049 out of 1139 valid commercial documents). Around 70 consignments were still under verification at the time of the audit, as the departure of these containers had not yet been confirmed via the extract of the tracking application. Evidence was received after the audit that these 70 consignments had exited the EU. In some cases, the operators had created the commercial documents but not notified the BIP of the exit of the consignments. The BIP only verified the exit after the audit, in a few cases several months after the consignments had exited, despite the fact that the internal procedure sets a deadline of 15 days to react to non-confirmation of exit. The audit team was not provided with evidence of competent authority follow-up in cases where the operator had failed to notify the BIP of the arrival of the consignment at the port or indeed its exit from the EU. For 11 consignments, the BIP stated that they received a notification in TRACES much later than the creation of the commercial document, and in four cases, no notification was received at all, despite the creation of the commercial document in 1 In its response to the draft report, the competent authority noted that to demonstrate that the consignment of PAP has left the EU, an operator may be requested by a BIP, in addition to submitting information in the AP + software and in the commercial documents, to provide a delivery note for the consignment in question. Such requests may be ad hoc or systematic depending on the outcome of controls carried out in exporting establishments. If a BIP does not have access to the AP + software, it should put in place a procedure to verify the exit of the consignment from the territory of the EU. In such cases, the BIP may request that the operator provides a delivery note on a systematic basis. The competent authority stated that to date only the BIPs of Le Havre and Marseille-Fos are concerned by the export checks of PAP and these two border posts have access to the AP + software. 14 TRACES, which should have triggered such a notification. After the official instruction was issued by SIVEP in March 2018, around 2% of seal checks were carried out at this BIP, whereas 3% were required.

In another BIP however, no verification of whether the containers had exited, either following the procedure TI 240 (see finding 23) or their own procedure, was ever carried out; containers were neither tracked nor a seal check performed. This was the case for 270 consignments which were notified by operators via commercial documents in TRACES in 2017 and 653 consignments in 2018 up to the time of the audit. This is not in line with point 1(c), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001. Following the audit, the BIP confirmed the exit of the 653 consignments in 2018 by providing extracts of the tracking application "AP+". The audit team verified a random sample of these consignments in TRACES and found that in general, the basic data matched the data provided in the commercial documents although in several cases, the destination of the consignment according to the tracking was different (another non- EU country) from the destination stated in the commercial document.

All processing plants visited exported PAP to non-EU countries via the last mentioned port as the exiting point. The audit team noted that in several cases different points of exit were selected in the corresponding box in TRACES (the BIP, but also the port as designated point of entry for phytosanitary controls). Neither the operator, nor the competent authority could provide evidence that the seals of these export consignments had been checked at any BIP, contrary to the requirements of point 1(c), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001. At one operator, the audit team noted when reviewing a random sample of commercial documents for exported PAP consignments that for two consignments no TRACES notification had been sent to the BIP. The competent authorities had not identified this omission during previous official controls, although it is required by point 1(d), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001. In one case, the operator had asked for a visit in 2017 in order to prepare for the export of some consignments. The local competent authority had explained the procedure and also contacted the relevant BIP, but had never verified whether the consignments had been sent to the BIP and whether they had exited the EU.

The reduction of seal checks of consignments of PAP containing ruminant protein exiting the EU from 100% of all consignments to just 3% chosen on a random basis is not implemented in accordance with the procedure developed for this purpose. The BIPs do not receive documents confirming the exit for all consignments which have been notified to them, the target of 3% seal checks of consignments is not being met and the competent authority is not consistently reacting to failures of the operators to confirm the arrival of the consignments at the port and their ultimate departure from the EU. Taken together with the fact that not all BIPs have access to the tracking 16 application that would enable them to verify the whereabouts of these consignments for themselves, undermines the effectiveness of the export checks carried out in relation to the consignments of PAP containing ruminant protein 5.2.6 Follow-up of relevant recommendations on ABP made in previous audit reports (DG SANTE 2014/7042) The table below summarises the follow-up to a part of the relevant recommendation made in report DG SANTE 2014/7042-MR final No Recommendation (extract of the relevant part) Finding 2 To take account of the risk of diversion or misuse of Largely addressed as regards the ABP/DP in the organisation and implementation of registration of traders and official controls on the traceability of ABP/DP, transporters and the planning of including at the level of traders and transporters, as official controls of these laid down by Article 3 of Regulation (EC) No operators (see findings 12 and 882/2004. 15); not addressed yet as regards the implementation of official controls (see findings 36 and 37). See recommendation No 1 of the current audit report. 4 To carry out the necessary checks to ensure that the Addressed as regards the sourcing and the transport of ABP and PAP for the registration, authorisation and manufacturing of feed for aquaculture take place listing of operators along the under the conditions laid down by Article 7 and chain of production of feed for Annex IV to Regulation (EC) No 999/2001. aquaculture (see finding 10). Further requirements concerning official controls at aquaculture feed manufacturers were not assessed during the audit.

Member state response

La France a fait le choix de désigner, comme premier levier de la réduction des risques et des effets des pesticides sur la nté humaine, la réduction du recours au produits phytopharmaceutiques. Cela s'inscrit dans l'article 4 de la directive, agraphe 3, qui mentionne la réduction de l'utilisation des pesticides comme un moyen pouvant être approprié pour btenir une réduction du risque. C'est en effet la seule voie qui puisse conduire à un réel changement des pratiques gricoles à la hauteur des enjeux de santé et des enjeux environnementaux. Cette approche a été définie politiquement n 2008 suite à la concertation organisée dans le cadre du Grenelle de l'environnement. La concertation très large engagée lors des Etats Généraux de l'Alimentation, qui se sont tenus en France en 2017, a permis de confirmer le caractère consensuel de cette approche qui a donc été réaffirmée en avril 2018 par le gouvernement. La France s'est dotée d'objectifs quantifiés et de cibles en ce sens. L'indicateur utilisé pour mesurer les résultats au regard de cet objectif est le NODU (nombre de doses unité). Il prend en compte, au-delà des quantités de substance active, les doses homologuées, définies sur la

La France a fait le choix de désigner, comme premier levier de la réduction des risques et des effets des pesticides sur la humaine, la réduction du recours au produits phytopharmaceutiques. Cela s'inscrit dans l'article 4 de la directive, aphe 3, qui mentionne la réduction de l'utilisation des pesticides comme un moyen pouvant être approprié pour nir une réduction du risque. C'est en effet la seule voie qui puisse conduire à un réel changement des pratiques coles à la hauteur des enjeux de santé et des enjeux environnementaux. Cette approche a été définie politiquement 008 suite à la concertation organisée dans le cadre du Grenelle de l'environnement. La concertation très large engagée lors des Etats Généraux de l'Alimentation, qui se sont tenus en France en 2017, a permis de confirmer le caractère consensuel de cette approche qui a donc été réaffirmée en avril 2018 par le gouvernement. La France s'est dotée d'objectifs quantifiés et de cibles en ce sens. L'indicateur utilisé pour mesurer les résultats au regard de cet objectif est le NODU (nombre de doses unité). Il prend en compte, au-delà des quantités de substance active, les doses homologuées, définies sur la base du pouvoir

The recommendation states as its basis

In the first case, during the approval procedure, the authorities approved as a single establishment and assigned a unique approval number to a set of four individual facilities located adjacently or near to each other. During the visit the audit team identified two different units (buildings adjacent and with a direct communication between them being considered one unit) physically separated, with independent entrances, different operational staff and, in one of them, performing different operations. These two units are located in a public common area which cannot be considered as a unique area under the full control of the food business operator. The authorities informed the audit team that in this particular case the food business operator registered the activity and the sites (geographically very close) under the same business registration and Siret number. Because the approval procedure is bound to the registration of the business activity and to the Siret number, the authorities had no other possibility than to grant a global approval for all units and assigning a unique approval number.

Therefore, the approval procedure implemented by the French authorities allows the existence of exceptional cases in which Article 2(1)(c) of Regulation (EC) No 852/2004 is not respected. As a result the requirements of Article 31 of Regulation (EC) No 882/2004 and Article 6(1) to (3) of Regulation (EC) No 852/2004 are not met.

In most of the cases, the approval procedures implemented, which commence after food business operators are registered with the National Institute of Statistics and Economic Studies (Siret number), are fit for purpose and in line with the EU rules.

However, there are exceptional circumstances where different units of a same business operator can have the same unique approval number. This is not in line with the requirements of Article 2(1)(c) of Regulation (EC) No 852/2004 which leads to the requirements of Article 31 of Regulation (EC) No 882/2004 and Article 6(2) of Regulation (EC) No 852/2004 not being met.

Member state response

autorités françaises utilisent le numéro SIRET (unité géographique) comme entifiant d'un établissement. Un numéro SIRET est attribué à tout établissement principal ou secondaire au sens de l'article R.123-40 du Code de commerce, à savoir n « tout établissement permanent, distinct du siège social ou de l'établissement principal t dirigé par la personne tenue à l'immatriculation, un préposé ou une personne ayant voir de lier des rapports juridiques avec les tiers ». Cette notion de rapport e juridique avec des tiers, qui inclut les contrats de vente de denrées alimentaires, est cohérente avec la notion de mise sur le marché évoquée au point 1 de l'article 4 du règlement (CE) n°853/2004. Dans le cas décrit, il n'y a qu'un seul établissement. De plus, la définition d'un établissement posée par l'article 2 du règlement (CE) n°852/2004 vise une « unité », c'est-à-dire une « structure organisée, cohérente au sein d'un ensemble plus vaste » (dictionnaire Larousse), et non un simple bâtiment ou installation au sein d'un complexe industriel. Dans le cas décrit, l'établissement est constitué de différentes installations situées à proximité immédiate les unes des autres et communicantes deux p

The recommendation states as its basis

With regard to the 15 tuna freezer vessels controlled by the department visited during the audit the audit team noted that all of them had been approved after an on-the-spot inspection and that after the approval several control visits were made. Using the period 2010 to 2017 as reference, the audit team noted that the defined minimum frequency for (8) Two approved facilities located within a wholesale market were visited during the audit. However, those visits did not cover the wholesale market as an approved facility. 11 the inspections under the SRN (once every two years ­ for freezer vessels considered as risk class I) was not achieved (see table below). (Number of vessels) Within Within Within Within Within 2 years 3 years 4 years 5 years 7 years SRN inspection after approval 5 2 1 4 1 Last SRN inspection 6 3 3 1 - Vessels approved last year 2 Vessels not inspected regularly 13 every two years (as per SRN) Table - Summary of inspections to freezer vessels

The audit team visited two freezer vessels outside metropolitan France and noted that they had been inspected by the relevant departments in accordance with the set procedures, although the minimum frequency of once every two years has not been followed.

The audit team visited eight processing establishments in five French departments and the authorities of those departments provided detailed information concerning the inspections of the approved establishments. During the visits the audit team noted that, with regard to the DGAL controls, the defined inspection frequencies (based on the risk category) were not respected in two out of six establishments (the remaining two establishments have been recently approved). These two establishments were located in two different departments. The audit team also noted that the frequencies for the inspections within the scope of DGCCRF were respected in the establishments visited.

The authorities of the two departments where the frequencies were not respected informed the audit team that another establishment also had not been inspected within the set frequencies. They attributed this to staff shortage (sick leave and transfer of staff), additional tasks acquired that were not initially foreseen (new approval, follow- ups, investigations of alerts) and increased export certification tasks.

The official control system in place covers completely the production chain of tuna fishery products and is globally implemented as planned. However, the audit team noted instances where the defined procedures were not adhered to, e.g. inspection frequencies for establishments on land and freezer vessels, and completion of the inspection within the defined timeframe.

Member state response

our Le non-respect des fréquences d'inspection définies pour chacun des navires ongélateurs dans certains départements est dû à la difficulté de les organiser en 'éloignement des navires qui restent à proximité de leurs zones de pêche et nt jamais dans leur département d'immatriculation. Par conséquent, les gélateurs seront sortis du champ du calcul d'une note de risque pour 2020 uence minimale d'inspection d'une fois tous les 5 ans sera fixée dans le charges pour la prescription 2020. L'instruction technique 2018-656 relative és de réalisation des contrôles officiels sera modifiée sur ce point. de l'inspection des établissements à terre, l'instruction technique 2018-656 l'inspection de ces établissements relève de la programmation nce régulière nationale » sur la base d'une note de risque. Il sera rappelé ification de l'instruction technique, prévue ci-dessus, l'importance de inspection de ces établissements. ification de l'instruction technique : fin 2019, pour une application en osed by the competent authority

The recommendation states as its basis

One of the vessels was a brine freezer while the other was a brine freezer with a second step of blast freezer (for fish not intended for canning).

In general the operations carried out by the operators were broadly in line with the EU rules with the exception of the freezing process in one establishment on land ("static freezing") and in one freezer vessel (double step freezing). The authorities deem these processes as in accordance with the EU requirements, which the audit team finds as not respecting the conditions set in Chapter I(I)(C)(1) of Section VIII of Annex III to Regulation (EC) No 853/2004. 14 5.3.2 Official control of the products Legal requirements Article 17(2) of Regulation (EC) No 178/2002, Articles 4 and 7 of Regulation (EC) No 854/2004, Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

Member state response

es Le navire congélateur inspecté lors de l'audit utilise une première étape de congélation e en saumure (maximum autorisé de 45 à 65 heures) puis une deuxième étape de ation à air soufflé (20 heures). Ce procédé de congélation en deux temps, avec .C, précisément ces mêmes durées, a été reconnu conforme à la réglementation re par la Commission européenne (Ref. Ares(2015)378844 du , sous réserve qu'il n'y ait aucune remontée de température durant le congélation, point qui n'est pas relevé dans les constats. Par conséquent, és françaises considèrent que le procédé utilisé par ce navire congélateur est la réglementation. s, le règlement (CE) n°853/2004 n'objective pas la durée correspondant à « rapidement [d']une température ne dépassant pas -18°C ». on technique 2015-807 relative à la congélation des denrées animales ou nimale indique que « la zone de température de cristallisation maximale au mique du produit (différente selon les produits mais comprise en général et -5°C) doit être franchie le plus rapidement possible ». Pour les poissons, la de -5°C correspond à un stade où environ 75 à 80 % de l'eau est congelée oduits. s utilisées par les navires congélateurs font l'objet d'une

The recommendation states as its basis

However, in one establishment the audit team noted that the competent authorities approved a freezing process that is not in accordance with the EU requirements. The audit team noted that a part of a cold storage room had been dedicated to freeze fishery products and the duration of the freezing process was set at 72 hours. The audit team checked the relevant production records and noted that, at the start of the freezing process the products were at 2°C, after 48 hours were at -11.5°C and after 72 hours were at -18°C.

The competent authorities informed the audit team that this type of freezing, "static freezing", is allowed in France and is documented in the Technical Instruction DGAL/SDSSA/2015-807 of 12/11/2015 and provided the audit team with a copy. The audit team informed the French authorities that the practice and the instruction do not respect the EU rules, namely the requirements of Chapter I(I)(C)(1) of Section VIII of Annex III to Regulation (EC) No 853/2004.

In general the operations carried out by the operators were broadly in line with the EU rules with the exception of the freezing process in one establishment on land ("static freezing") and in one freezer vessel (double step freezing). The authorities deem these processes as in accordance with the EU requirements, which the audit team finds as not respecting the conditions set in Chapter I(I)(C)(1) of Section VIII of Annex III to Regulation (EC) No 853/2004. 14 5.3.2 Official control of the products Legal requirements Article 17(2) of Regulation (EC) No 178/2002, Articles 4 and 7 of Regulation (EC) No 854/2004, Chapters II and III of Annex III to Regulation (EC) No 854/2004. Findings

Member state response

Le règlement (CE) n°853/2004 n'interdit pas la congélation statique et prévoit que « les Action Proposed by the competent authority établissements terrestres où sont congelés des produits de la pêche doivent disposer ion d'équipements répondant aux exigences fixées pour les navires congélateurs ». Or, les navires congélateurs doivent eux-mêmes « disposer d'un équipement de congélation d'une puissance suffisante pour que le coeur des produits atteigne rapidement une température ne dépassant pas -18°C ». L'instruction technique 2015-807 relative à la congélation des denrées animales ou d'origine animale ne donne aucune obligation en termes d'équipement, notamment de tunnel de congélation, conformément aux principes du « Paquet hygiène » (obligations de résultats et non de moyens). Cependant, elle indique que la zone de température de cristallisation maximale (comprise en général entre -1°C et -5 °C selon les produits) doit être franchie le plus rapidement possible. Les méthodes utilisées par les établissements à terre pratiquant la congélation des produits font l'objet d'une approbation par les services de contrôle. Les autorités françaises considèrent donc que les conditions énoncée

The recommendation states as its basis

The official controls of tuna fishery products are broadly carried out adequately and in line with the requirements of Regulation (EC) No 854/2004.

In addition, the official controls plans for fishery products (including tuna) do not contain sampling to verify the levels of inorganic tin as required by Chapter II(D) of Annex III to Regulation (EC) No 854/2004.

Member state response

aux L'étain inorganique est un sujet qui est suivi par les autorités françaises. Un plan de eillance des résidus d'étain inorganique est régulièrement mené sur les denrées tain végétales. De plus, une enquête a été effectuée en 2012 sur l'aptitude au contact D, alimentaire des aciers, notamment revêtus d'étain. En revanche, il n'y a pas actuellement de plan de surveillance de l'étain inorganique sur les produits de la pêche en conserve. Par conséquent, un plan de surveillance de l'étain inorganique dans les conserves de thon et sardine sera mené en 2020. Date de parution de l'instruction technique : décembre 2019

The recommendation states as its basis

The plans mentioned above generally cover the requirements of Regulation (EC) No 854/2004 in relation to environmental contaminants and parasites. However, they do not include testing of relevant fishery products for tin. Additionally, sampling for histamine carried out for product in the internal market, which only covers the retail level, is not implemented as required by Chapter II(C) of Annex III to Regulation (EC) No 854/2004 and by Chapter 1(1.26) of Annex I to Regulation (EC) No 2073/2005 ­ random testing, which if it is carried out outside retail would require nine sample units.

DGCCRF also samples fishery products in the framework of its national tasks (see paragraphs 36 and 37). In 2017 fishery products were sampled (one sample unit and usually at retail level) to determine the levels of additives and in 2018 two specific tasks targeting tuna were executed. One (TN 273 KA) focused on the use of vegetable extracts and the other (TN 273 KH) on tuna loins (chilled/fresh). According to the authorities 64 samples were taken in tuna loins and 24 of these showed abnormal results for ascorbic acid (22 samples with values ranging 351 mg/kg to 3 500 mg/kg) and nitrates/nitrites (two confirmed cases with nitrosylated pigments). Non-conform results for histamine were not detected. Following the non-compliant results the authorities issued warning letters and, in some cases, administrative sanctions.

The official controls of tuna fishery products are broadly carried out adequately and in line with the requirements of Regulation (EC) No 854/2004.

However, those controls are not fully in line with Chapter II(C) of Annex III to Regulation (EC) No 854/2004 and Chapter 1(1.26) of Annex I to Regulation (EC) no 2073/2005 because samples are only taken at retail level (not random).

Member state response

'histamine Les autorités françaises justifient la mise en oeuvre de leur plan de contrôle officiel Action Proposed by the competent authority , relatif à l'histamine au niveau de la distribution par leur objectif d'évaluer le niveau d'exposition des consommateurs à ce risque. 1.26, Les autorités françaises considèrent ce ciblage de la distribution pour la surveillance de l'histamine conforme à la réglementation. Le chapitre II du règlement (CE) n°854/2004 ne précise pas pour l'histamine (partie C, alinéa 1) que les analyses doivent être réalisées de la production à la distribution, contrairement à ce qui est précisé pour l'évaluation organoleptique (partie A, alinéa 1 et 2). De plus, le règlement (CE) nº n°2073/2005 prévoit un critère sur l'histamine dans les produits de la pêche uniquement au stade des produits mis sur le marché pendant leur durée de conservation. Le plan de surveillance annuel de l'histamine dans les produits de la pêche est complété par les autocontrôles réalisés par les professionnels sur l'ensemble de la chaîne, de la production à la distribution. Le nombre conséquent de ces autocontrôles (85.000 analyses en 2017), dont les résultats sont inspectés de façon ap

The recommendation states as its basis

Both administrations have systems to ensure officials have access to training, amongst other, on relevant RTE topics. a. DGAL training includes food technology, inspection of food safety management systems, HACCP based procedures, microbiological criteria, alerts and outbreaks management and auditing. In this regard the audit team noted that while the training for most of the above technical topics was delivered to a large number of officials, this was not the case for audit training, although national control procedures require local CAs to carry out audits or to use auditing techniques routinely in their controls in RTE producing establishments. b. DGCCRF training includes Hygiene Package provisions, HACCP and alert management. According to the local officials, HACCP is covered to a limited extent in the induction training provided. In recent years more HACCP training started to be offered by DGCCRF and 35 of the 543 officials involved in the official controls have participated to it. No DGCCRF staff in the DD(CS)PP visited by the audit team participated to it. Training on microbiological criteria/Regulation (EC) No 2073/2005 or specific to RTE sector is not available to DGCCRF officials. This does not support them in the related official controls (see paragraphs 58 to 61, 63, 68 and 69). 5 In their comments to the draft report the CA noted that DGCCRF is unsure what constitutes `high risk' and, in the absence of a definition, believes that there is no need to differentiate between `ready-to-eat food' and `high-risk ready-to-eat food'. 7

Both DGAL and DGCCRF staff have access to the "Better Training for Safer Food" (BTSF) initiative and the "resource persons" met participated in BTSF sessions. The official control staff met was in general experienced and knowledgeable for their work. Some support/training needs were identified during the audit, mainly in relation to: a. CAs' assessments and audits of good hygiene practices and HACCP, grading of non-compliances and enforcement and follow-up action (see paragraphs 11, 58-62 and 88 - 93). b. approval of establishments and keeping it under review (see paragraphs 25 to 28) linked mainly to the staff understanding of the rules. c. CA's controls over sampling and testing procedures linked to a lack of understanding of some of the applicable requirements (see paragraphs 11b, 63 to 69).

This suggests that the official control staff is not adequately kept up-to date in their area of competence as required by Article 6(b) of Regulation (EC) No 882/2004 for the areas highlighted above. The audit team did not note any problems related to facilities and equipment for the performance of official controls.

The challenges identified, mainly in relation to aspects of training, may have an impact on the controls over the production of RTE food, if not adequately addressed.

DGAL's had recently updated the approval procedures. The general inspection handbook instructs inspectors to check that the activities carried out by the establishment correspond to those covered by the approval. The FBOs visited by the audit team were in most cases approved for the activities they carried out. However, the audit team noted in four of the six approved establishments visited instances on non-compliance with the provisions of Article 31(2) of Regulation (EC) No 882/2004 and/or the national procedures explained by the CCA as local staff's apparent lack of awareness of the rules.

The comprehensive approval procedure supports official control staff in their work and several elements of it are implemented satisfactorily. Nevertheless, staff's lack of correct understanding of certain provisions thereof as well as the less strict national rules do not ensure that compliance with the EU legislation is routinely achieved.

The differences in the development of the control systems for the different sectors suggest a missed opportunity for sharing good practices and exploiting synergies within and between DGCCRF and DGAL with a view to providing comparable support for staff carrying out controls in establishments with similar risks, further strengthening the control systems and their consistencies as well as ensuring a uniform control approach towards all FBOs. 4.4.3 Challenges encountered by the CA in the organisation and performance of controls over the production of RTE foods

The recommendation states as its basis

All FBOs are required to register with the Business Formalities Centres to enable the company to be created and be assigned a SIREN (business) number and a SIRET6 number. The FBO declares the main activity performed in accordance with the French Administrative Nomenclature (NAF) codes drawn up by the National Institute of Statistics and Economic Studies (INSEE). The Business Formalities Centres are obliged 6 In their comments to the draft report, the CAs noted that a SIRET number is assigned to any primary or secondary establishment within the meaning of Article R123-40 of the Commercial Code, i.e. `any permanent establishment, distinct from the registered office or principal establishment and headed by the person required to be registered, an official or a person with the power to enter into legal relationships with third parties'. 9 to inform INSEE of any business creation, modification or cessation (Decree of 18 March 1981). The DGAL and DGCCRF databases are automatically updated through a link to this INSEE data.

Both CAs have procedures in place for registration of RTE producing establishments and in the case of DGAL also for approval. However, the registration system does not favour the correct identification of production activities, including ready-to-eat, for all types of establishments. This has an impact in the DGCCRF's ability to organise the related risk based official controls.

Each CA has put in place a system of routine risk based official controls over production of RTE foods, supported by comprehensive procedures and covering relevant aspects of the legislation. The procedures for organisation of controls are currently under review for further fine-tuning the risk determination for the RTE sector. While some of the national provisions and procedures provide clarification for aspects that go beyond the EU requirements, other are less strict and if applied as such may potentially provide a lower level of safety than the EU requirements, in particular as regards Listeria, Coagulase-positive Staphylococci and controls for parasites in fishery products.

The recommendation states as its basis

In addition, there are different national rules addressed to CAs and FBOs that support a harmonised national approach for the RTE sector: a. National legislation applicable at retail, in particular for storage and transport temperatures for food of animal and non-animal origin. See also paragraphs 45, 46, 102 for additional support for the RTE sector and related controls available in ANSES opinions, guides, instructions and working procedures. The national federation for trade and distribution also adopted guidance on microbiological criteria applicable at retail. b. Industry guidance endorsed by the three administrations (DGAL, DGCCRF, DGS) which applies also to RTE meat products, dairy products and raw vegetables ready to be used have been issued and supports FBOs and CAs in their controls. This is not the case for the composite products sector or for raw products (e.g. tartare, carpaccio, sushi), highly popular according to ANSES (see last paragraph of chapter 3.1). Both FBOs and CAs met highlighted different challenges, in particular for the composite products sector (see paragraph 101). Support needs for the official controls in this sector were identified by the audit team (see paragraph 13, 14, 58 to 61) c. Pasteurisation of meat products is described in the industry guidance endorsed by DGAL and the related Fiche Technique of the Vademecum for DGAL official controls. Depending on the production method, type of meat products and validation outcome, a minimum core temperature of 55°C for more than 40 minutes may be efficient to destroy non-sporulated pathogen flora and reduce the total flora. The examples seen on the spot involved temperature of above 65°C for more than 50 minutes. d. Arrêté of 19 October 2006 on the use of processing aids in the production of foodstuffs allows washing with chlorine solution in a concentration of maximum 80 ppm, followed by rinsing, as decontamination method for fruits, vegetables and mushrooms ready to use under national rules. The same legal act allows the use of acetic acid solution with pH below 2.8, followed by rinsing, as processing aid for unprocessed trout and salmon to flocculate the surface mucus.

The lack of clarification on what constitutes RTE which takes account of national consumption habits and FBOs' approaches as well as the lack of guidance for the composite products RTE sector do not support the related official controls and uniformity thereof.

An array of sector specific support mechanisms and access to several technical training, aid the CAs in their controls on production of RTE food, but to lesser extent for composite products.

The controls on Hygiene Package requirements in establishments producing food of animal origin are well developed. This was noted to a lesser extent for establishments producing composite products in particular in the case of DGCCRF, with an unknown percentage of registered establishments not subject to such controls on a scheduled basis.

The controls cover satisfactorily a range of aspects of the Hygiene Package, with some areas for improvement in relation to FBO's measures for prevention of cross- contamination and sampling and testing procedures. The CAs' ability for detection of the 23 non-compliances and assessment of the impact thereof is sometimes hindered by the current system for targeting controls and the limited use of systematic reviews.

The differences in the development of the control systems for the different sectors suggest a missed opportunity for sharing good practices and exploiting synergies within and between DGCCRF and DGAL with a view to providing comparable support for staff carrying out controls in establishments with similar risks, further strengthening the control systems and their consistencies as well as ensuring a uniform control approach towards all FBOs. 4.4.3 Challenges encountered by the CA in the organisation and performance of controls over the production of RTE foods

The recommendation states as its basis

The official controls over FBOs compliance with the microbiological sampling and testing requirements of Regulation (EC) No 2073/2005 are limited. CAs are not 17 required to verify FBOs' sampling methods. In the case of alerts, CAs verify the testing method indicated in the laboratory test results. Nonetheless, official control decisions are taken on the basis of FBOs' test results. The CCA clarified that CAs have the option of taking official samples from time to time to provide clarification to the inspector, guide his/her work and determine the measures taken following the inspection.

The controls cover satisfactorily a range of aspects of the Hygiene Package, with some areas for improvement in relation to FBO's measures for prevention of cross- contamination and sampling and testing procedures. The CAs' ability for detection of the 23 non-compliances and assessment of the impact thereof is sometimes hindered by the current system for targeting controls and the limited use of systematic reviews.

The recommendation states as its basis

The procedures also establish deadlines for finalising the controls, reporting and following-up of non-compliances. Within the current establishment rating system, these deadlines do not support swift FBO action to address non-compliances when such non 7 In their comments to draft report, the CCA noted that the threshold of 1 000 cfu/g was set instead of 10 000 cfu/g for the other products to be consumed cooked, in order to take into account the risk of minced or thinly sliced products being insufficiently cooked through. In some cases, products labelled as `to be cooked' have been considered `ready-to-eat', either because the instructions on the label were not specific enough for the consumer, or because, given eating habits, the product could be consumed without first being cooked or reheated. 15 compliances do not impact on the overall rating for the establishment.

The effectiveness of the control and enforcement system is also weakened by the fact that some long-standing deficiencies detected and classified by the CAs as medium or major ones are not adequately followed­up and enforced by the CAs to ensure the FBOs swiftly remedy the situation.

The recommendation states as its basis

Between 2013 and 2017 DGAL took 2167 RTE samples. From 2013 to 2016 the sampled matrixes only included unpasteurised dairy products and sausages while in 19 2017 sliced pig meat products were targeted. During this period the testing focussed on Salmonella and Listeria testing (STEC in 2014). Sampling of RTE for microbiological criteria does not take place every year at production level. The non-compliance rates identified range from zero in 2017 for Listeria in sliced meat products to 2.25% in 2016 for Listeria in unpasteurised dairy.

Official sampling and testing of RTE food is in place. Official laboratories are accredited and subject to NRL coordination. The organisation of the official sampling for RTE food of animal origin prepacked by the producers, with a view to testing for Listeria, suggests a discriminatory approach focusing more on RTE food produced in other countries, including other MS.

The recommendation states as its basis

In Corsica, Decree No 15-580 of 30 April 2015 of the Préfet (as amended), allowing import of specified plants from non-EU countries and entry from EU territory outside the DAs to Corsica only by professionals and only following a detailed request, is still in force. The competent authorities of Corsica do not authorise any entry of Xf host plants from infected EU Member States, such as Italy and from the Alicante Province of Spain to the island. The audit team noted that the restrictions implemented by the Decree of the Préfet are not in line with Article 19 of the Decision which requires Member States to repeal or amend measures they have adopted to protect themselves against the introduction and spread of Xf. 5.1.3 Service notes, work instructions

A centralised institutional structure with clear division of responsibilities is in place to deal with Xf outbreaks. National and regional legislation, DGAL service notes and work instructions ensure and facilitate the direct application of provision of the Decision. However, Decree No 15-580 of 30 April 2015 of the Préfet is not in line with Article 19 of the Decision as it implements additional protection measures and trade restrictions which are not justified by the existing plant health risk.

Member state response

Conformément à l'article 5.2) de la décision d'exécution 2015/789/UE, la plantation des végétaux hôtes en zone infectée est soumise à autorisation. té préfectoral n°15-580 du 30 avril 2015 prévoit une interdiction d'entrée de ces végétaux en Corse avec toutefois une possibilité de dérogation à cette interdiction d'entrée de ces végétaux sur l'île. L'ensemble de la Corse est situé en zone infectée. Les végétaux dont l'entrée est admise en Corse sont destinés à être plantés en Corse donc en zone infectée. Aussi l'objectif de cet arrêté est similaire à celui de l'obligation posée par l'article 5.2) susmentionné.

The recommendation states as its basis

In the PACA region, in the period April-October 2018, FREDON carried out monitoring in the circles of 5km radius around the established IZs according to the DGAL work instructions (see blue circles in Figure IV). In line with provisions of Article 6(7) of the Decision a grid split into 100m x 100m squares within a zone of a width of 1 km surrounding the IZs and a grid split into 1km x 1km squares within the 1-5 km part of the BZs was applied. However, no surveillance was carried out beyond 5km radius in the remaining territory of the 44 municipalities, declared as BZ (see chapter 5.3.1). Therefore the presence of Xf was not checked in some parts of the BZs, which is not in line with Article 6(7) of the Decision.

The audit team was informed that the monitoring protocol requires the pre-definition of two observation points in each grid square from which the presence of symptomatic specified plants needs to be checked visually. Each identified symptomatic specified plant must be sampled for laboratory tests.

The audit team observed a monitoring, carried out by FREDON in a BZ, and noted that the agents: Carried out the grid-based monitoring in line with DGAL work instructions; Were well trained and experienced and possessed all necessary equipment for the visual surveys and sampling; Selected two observation points in each square then located those points with the help of maps, aerial photos and a GPS device; Carried out a 360o visual check from each observation point, checked the vicinity for the presence of specified plants with visible or suspicious symptoms and took samples only from symptomatic plants; The exact GPS position of each sampled plant was recorded and the plants were labelled. The packing, labelling and mailing method ensured the full traceability and conservation of the samples; After each inspection, a standard report was prepared electronically, which was uploaded to the central database after the field inspection was finished.

The audit team noted that: The applied practice of visual checks from two observation points, in particular for the grids squares of 1km x 1km, and in the grids of 100m x 100m in urban/semi- urban areas with scattered vegetation and restricted view, does not ensure that specified plants present in the grid are visually inspected taking into account the available technical evidence. Consequently symptomatic specified plants could be overlooked and not sampled. This is not in line with Article 6(7) of the Decision; In the BZs laboratory samples are taken only from the symptomatic plants, while Article 6(7) of the Decision also requires sampling of asymptomatic plants in the vicinity of the symptomatic ones.

The 2018 annual monitoring in the BZs was partly in line with provisions of Article 6(7) of the Decision as certain parts of of the BZs were not checked and the applied system of two observation points does not ensure that specified plants present in each grid are visually inspected. Therefore symptomatic plants could be overlooked and not sampled. Consequently the monitoring cannot fully confirm the status of Xf in those areas.

Member state response

En région Provence-Alpes-Côte d'Azur, la surveillance des zones tampons est réalisée conformément aux dispositions prévues à l'article 6.7) de la décision d'exécution 2015/789/UE. 100% des quadrats de 100 mètres de côté et 94% des quadrats de 1 ètre de côté ont été inspectés. Cela représentait 21 434 inspections et 10 717 quadrats inspectés. Le budget dédié à la surveillance des zones tampons en PACA s'élevait en 2018 à 367 000 (hors analyses), soit deux tiers du budget total alloué à Xylella dans la région. Pour la campagne 2019, le budget dédié à la surveillance des zones tampons a été revalorisé, passant à 443 000 . La surveillance est conduite à raison de deux inspections par quadrat ce qui est en ligne avec les dispositions de la décision qui précisent que l'État membre procède « à des inspections visuelles de végétaux spécifiés [...]». Les agents effectuent des contrôles visuels à 360 degrés à chaque point d'inspection. À aucun moment, la décision ne fournit d'information supplémentaire concernant Page: 1 ons, received 30 April 2019 eport ref. DG(SANTE)/2018-6483-MR of the audit carried out from 19 ficial controls for Xylella fastidiosa tion Proposed by the competent authorit

The recommendation states as its basis

The competent authorities stated that they carried out the eradication activities in the IZs in the PACA region according to established priorities as follows: Priority I is the removal of the positive tested plants. The intention is to complete the removal as soon as possible, taking into consideration the time necessary to identify the owner and issue the felling order. In the majority of cases the removal can be completed before the monitoring of the IZ for host and symptomatic plants is finished; Priority II is the removal from the entire territory of the IZ of plants of those species, which have been identified as hosts of Xf subspecies multiplex in the PACA region; Priority III is the removal from the entire territory of the IZ of plants of those species, which have been identified as hosts of Xf subspecies multiplex in outbreaks elsewhere in the EU territory. Table V. summarises the state of play of the eradication activities at the time of the audit. Table V. Eradication activities in the IZs of the PACA region IZs with IZs with Plants Positive Host Host plants tested plants plants removed Zone* IZs completed host completed positive removed identified A inventory clear-cut 17 6 6 23 10 3,280 1,247 B 91 57 34 130 122 51,793 23,857 C 2 2 2 4 4 407 308 PACA 110 45 42 157 136 55,480 25,412 Source: DGAL/DRAAF * see figure IV. and Table II.

In the IZs established for Xf subspecies multiplex there were delays in the removal of certain host plants in the 100m radius around positive tested plants and France does not consider to remove a range of other host plants in the same areas as a priority. In addition in the IZ for Xf subspecies pauca the physical protection of olive trees was discontinued. Therefore provisions of Article 6(2) of the Decision were not entirely implemented. Consequently there is a risk that infected plants remained in the IZs, serving for a further spread of the disease.

Member state response

séminaire de l'EFSA « European conference on Xylella fastidiosa : finding swers to a global problem » qui s'est tenu à Majorque du 13 au 15 novembre 17 concluait ainsi : « Control of X. fastidiosa is complex and needs to be ilored for each case (region) by understanding the specific pathosystem volved (pathogen, vectors, host, environment). One size does not fit all. » nsi, il n'y a pas d'approche unique et efficace dans la lutte contre Xylella car s agents pathogènes, les vecteurs, les plantes hôtes et l'environnement sont fférents sur l'ensemble du territoire de l'UE. Cette conclusion justifie une proche plus adaptée à la diversité des situations rencontrées en Europe. r ailleurs, en PACA, bien que faisant l'objet d'une surveillance intensive puis plusieurs années, nombre d'espèces hôtes n'ont jamais été trouvées ntaminées dans cette région ; c'est le cas par exemple de l'olivier (Olea ropaea), du laurier-rose (Nerium oleander) ou encore du romarin osmarinus officinalis). Les autorités françaises ont officiellement saisi Page: 2 ons, received 30 April 2019 eport ref. DG(SANTE)/2018-6483-MR of the audit carried out from 19 ficial controls for Xylella fastidiosa ction Proposed by t

The recommendation states as its basis

In Corsica, at the time of the audit no controls were carried out on the implementation of Article 5 of the Decision concerning the prohibition of planting host plants in the IZ. The competent authorities informed the audit team that there is replanting activity; however they do not have detailed information about it. The working group, referred to by paragraph 65 above, intends to develop a proposal for the new authorisation system in line with provisions of Article 5(2) of the Decision. 20 Conclusions on planting of host plants in the IZs

The ban on planting host plants in the IZs, requested by Article 5(2) of the Decision, is not observed in Corsica, which may compromise the containment measures.

Member state response

onformément aux recommandations du rapport CGAAER/CGEDD Xylella astidiosa en Corse : connaissances, risques afférents à sa présence pour la égétation cultivée ou naturelle, et stratégies d'enrayement, un groupe de travail nimé par les services de l'Etat évalue les impacts potentiels de la plantation de égétaux d'espèces hôtes sur chacune des filières agricoles d'intérêt en Corse. l'issue de ce travail, les modalités de mises en oeuvre de l'article 5.2. de la écision 2015/789 seront déterminées avant fin 2019.

The recommendation states as its basis

There are many nurseries in the DAs, especially in the Department Alpes-Maritimes. FREDON agents are responsible for controlling the movement of specified plants within and out of the DAs. The audit team was informed that the nurseries are inspected generally twice annually during the vegetation period. One of the visits is the annual 21 plant passport control. Besides the producer and trader nurseries, inspections are carried out at the markets of national interest (MIN), at florists and at hyper- and supermarkets dealing with plants.

The authorisation of movement of vine bud-wood produced in Corsica for thermotherapy in mainland France is not in line with provisions of Article 9 of the Decision.

The frequency of official controls in the nurseries together with the limited information about the final destination of the plants do not ensure that specified plants, which have been grown for at least part of their life in a DA, do not move out of those areas. In particular in the DAs of the PACA region there is a risk that specified plants leave the DA which could contribute to the spread of Xf.

Member state response

n France, aucune dérogation au titre de l'article 9.2) n'a été délivrée. , une étude de faisabilité est en cours, associant les acteurs de la filière t devrait aboutir d'ici fin 2019. La mise en service de la station nterviendra en 2020. n PACA, les professionnels du végétal sont bien identifiés et informés égulièrement par les services phytosanitaires de la région. La fréquence 'inspections officielles dans les pépinières et jardineries a doublé entre 2017 et Page: 3 ons, received 30 April 2019 eport ref. DG(SANTE)/2018-6483-MR of the audit carried out from 19 ficial controls for Xylella fastidiosa ction Proposed by the competent authority 018 suite aux recommandations du rapport d'audit de 2017, passant d'une à eux inspections par an. Cette fréquence étant à nouveau jugée insuffisante, elle st augmentée en 2019 à raison de trois inspections par an dans chacun des tablissements situés en zones délimitées. Ainsi, le budget annuel dédié à la urveillance et aux prélèvements dans les pépinières s'élèvera à partir de 2019 à 17 000 . Des contrôles mensuels, en partenariat avec les douanes et les ervices de la chambre de commerce et de l'industrie, seront mis en place dans es ports de Ni

The recommendation states as its basis

In 2018 the SRAL of the PACA region placed signs at some petrol stations of a retail chain located inside the DAs. The signs provide information about Xf and the associated plant health risk in a visually attractive form. The audit team noted that the signs are not placed at the border of the DA. Although the format attracts attention, it is difficult for the bypassing drivers and passengers to read the entire text. The CAs consider that the current signs provide information for a broader range of recipients and can be better protected from vandalism than any sign erected at the border of the DA.

Recommendation No 3 of the 2017 audit report requested France to ensure that road signs are set up, indicating the borders of the DAs as required by Article 6(8) of the Decision. As the signs are not placed at the borders of the DAs, they do not indicate the limits of those areas; therefore the recommendation is partially addressed. 5.6.4 Road controls, controls at seaports, airports 5.6.4.1 In the PACA region

Although road signs provide certain indication about the Xf risk, they cannot inform the public effectively about the delimitation of the DAs.

Member state response

e format des panneaux sera adapté afin de rendre le message plus lisible. Les anneaux seront apposés sur les limites des zones délimitées, au niveau des outes et autoroutes, avec le concours des services compétents au sein du inistère chargé des transports.

The recommendation states as its basis

There are no Xf related physical controls on passengers or on the outgoing commercial traffic in Nice port, Nice airport and Toulon port which are situated in DAs.

Recommendation No 5 of the 2017 audit report requested France to ensure that road checks are carried out on specified plants being moved out of the DAs in the PACA region as required by Article 11(1) of the Decision. As the frequency of the controls are limited and at the current control points the plants originating from the DAs cannot be sufficiently targeted the recommendation is partially addressed. 5.6.4.2 In Corsica

Due to their location and frequency the road controls in the PACA region cannot have a significant mitigating or deterring effect on movements of specified plants.

Member state response

es contrôles routiers mis en place en 2018 seront poursuivis en 2019, otamment avec l'ouverture d'une troisième zone de contrôles dans le épartement du Var. Page: 4

The recommendation states as its basis

Although the procedures and instructions provide the necessary support for effective checks on journey planning, the fact that districts do not implement some of the requirements mean that the approved planning to provide feed, water and rest to the animals is not assured. For exports going into Turkey by road, this absence of assurance together with the lack of awareness of the operating hours of the Turkish border controls and of the time needed to go through at district level, create a risk for unnecessary suffering to animals.

The recommendation states as its basis

The DGAL procedure covering all the checks related to the journey logs (see also paragraph 9) also refers to checks at time of loading during which the handling of the animals and vehicle conditions could be verified in line with requirements (Article 15(1) and Annex I, Chapters III and VI of Reg. 1/2005). However, it does not require the performance of checks at time of loading. In this regard: 6 DGAL informed the audit team that checks at the moment of loading is something that is under study as there are difficulties with having official staff available to perform them; For 2016 two of the districts met had not planned nor performed any such check and were the departure point for a total of 69 export consignments; Another district, departure point for 55 export consignments, programmed and performed one check at time of loading in 2016. This check was of a multi-vehicle consignment and reported compliance of vehicles and of handling of the animals but detected that the journey time that had been indicated by the organiser in the journey plan was underestimated. This occurred because after loading the first vehicle the driver waited for the other vehicles to also load, in order to travel together, and these loading and waiting times had not been included in the journey planning. The consignment left with the journey plans, submitted to and already stamped by the district, unchanged, contrary to the requirements of Art. 14(1)(b) of Reg. 1/2005. The district sent a formal notification to the transporter informing them about the results of the check and indicating corrective action required for future journeys.

The absence of checks at the moment of loading prevent the competent authorities from having adequate confirmation of the handling at loading and maintenance conditions of vehicles leaving from France for export.

Regarding retrospective checks to verify the travelling and resting times to provide water, feed and rest to the animals (Art. 15 of Reg. 1/2005): Two of the districts met informed the audit team that they had performed the required 5% minimum retrospective checks of journey logs but could not provide the corresponding records. The other district informed that because of lack of human resources it had been unable to carry out these checks in due time; The three districts stated that it was difficult to obtain the return of journey logs from the transporters and that up to 2016 no system was in place to attempt to ensure this return. For 2017 a system to obtain the journey logs was being designed and would be implemented; Two districts informed the audit team that when attempting in 2017 (in preparation for this audit) to obtain satellite navigation data and temperature registers for consignments exported to Turkey during 2016 almost none had been received. One district stated that it received one set of satellite navigation for a consignment but that the data provided was impossible to analyse; In 2016 one animal died during the journey in each of four consignments leaving from France for export. None of the districts from which the consignments originated had targeted these as journey logs to be investigated; Until October 2017 two of districts met had not yet implemented a system with identified criteria to select the journeys to be targeted for retrospective checks and the other district was in the initial stages of implementing such a system.

Although the procedures indicate the type and frequency of checks on planning of journeys and on returned journey logs they do not include any reference to checks of journeys' satellite navigation data. DGAL stated that the checks on satellite navigation data are planned to be included as part of the revision and update of the extensive 2011 procedure (see also paragraph 9).

The districts met had not implemented some requirements from DGAL procedures that had already been in place for between one to six years. Namely: Journey planning to be provided to district authorities two working days prior to the intended departure date (Annex II, (3)(b) of Reg. 1/2005); Checks on contingency plans (Articles 14(1) and 11(1)(b)(iv) of Reg. 1/2005); Proof of reservations at control post(s) to unload and rest the animals; 9 Put in place a system to ensure transporters return the completed journey logs (Annex II, (8) of Reg. 1/2005); Perform at least 5% retrospective checks of journey logs and keep the corresponding records.

Although the procedures and instructions provide the necessary support for effective checks on journey planning, the fact that districts do not implement some of the requirements mean that the approved planning to provide feed, water and rest to the animals is not assured. For exports going into Turkey by road, this absence of assurance together with the lack of awareness of the operating hours of the Turkish border controls and of the time needed to go through at district level, create a risk for unnecessary suffering to animals.

The system of retrospective checks does not provide satisfactory assurances for detecting if journey times were realistic and for its compliance with legal requirements.

The recommendation states as its basis

The districts met had not implemented some requirements from DGAL procedures that had already been in place for between one to six years. Namely: Journey planning to be provided to district authorities two working days prior to the intended departure date (Annex II, (3)(b) of Reg. 1/2005); Checks on contingency plans (Articles 14(1) and 11(1)(b)(iv) of Reg. 1/2005); Proof of reservations at control post(s) to unload and rest the animals; 9 Put in place a system to ensure transporters return the completed journey logs (Annex II, (8) of Reg. 1/2005); Perform at least 5% retrospective checks of journey logs and keep the corresponding records.

Most of these shortcomings had not been detected by the system for supervision and verification of official controls. However, when preparing for this audit the districts met reviewed their performances in this area detected some of them and are taking steps to address these (see also the 2nd and 5th bullets of paragraph 23).

France had a higher percentage of cattle consignments exported in 2016 with animal welfare non-compliances (12.6%) than the EU average for that same period (8.3%). Conclusions on resting

The fact that different levels of supervision fail to detect existing shortcomings and the higher percentage of animal welfare non-compliances in consignments leaving from France indicate that the current system of supervision is not achieving its objectives of ensuring correct performance of tasks in the area of animal welfare during transport.

The recommendation states as its basis

As the prescribed check on contingency plans are not properly implemented, there is no assurance that in the eventuality of unexpected long delays at the border the needs of animals blocked at the border can be met, and that these animals are not caused unnecessary suffering. 11

The recommendation states as its basis

In 2016, the surveillance in the BZs started in August and the activity was carried out according to a protocol, developed by DGAL. The audit team noted that: There were over 300 BZs in Corsica, the majority of which consisted of natural scrubland and/or mountainous area with difficult access; The 20 BZs in PACA were mainly situated in urban areas with numerous private properties and not always easily accessible. Taking into consideration these and the available resources France applied a specific system in 2016 as follows. In PACA a survey grid of 100m x 100m was used in the inner 1 km part of each BZ, while in the 1km ­ 10km part a grid of 1km x 1km was applied; In Corsica a grid of 1km x 1km was used in the BZs situated in the northern part of the island (17 outbreaks). In South Corsica, until August 2016, the 324, largely overlapping BZs were surveyed based on a 5km x 5km grid. Thereafter, in the light of a possible establishment of a BZ between a future eradication zone in the northern part of the island and a containment zone in the southern part, the CA started surveying the outer parts of the BZs in South Corsica, based on a 1km x 1km grid.

In each grid square, two observation points were designated. The surveillance team checked the vicinity of the observation point for the presence of specified plants and took samples in the case of the presence of symptoms or any suspicion. The plants were sampled individually, composite samples were not collected. The CA informed the audit team that for better coverage of the areas, in the future new observation points will be selected each year. Table III and Table IV summarises the results of the surveys in the BZs in 2016. Table III. Surveys in the BZs in Corsica in 2016 Total Total Number Number of Number of Number of Positive number number of of 1km x 1 5km x 5 km inspections samples results of 100m x km grids 1km x 1 inspected grids (2/grid) 2,260 20 100m km grids inspected grids 1,525 South Corsica 360,000 3,600 782 97 North Corsica 94,900 949 449 0 898 824 1 Total 454,900 4,549 1,231 97 2,423 3,084 21 Source: DGAL 14 Table IV. Surveys in the BZs in PACA in 2016 Total Total Number Total Number of Number of Number Positive number of number of of 100m number of 1km x 1 km inspections of results 100m x 100m x 100m grids (100m- 100m x 1km x 1 grids (2/grid) samples 3 100m grids grids km grids inspected (1- 10km) (100m-1km) inspected (1-10 km) 10 km) 1,016 1,073 111,769 4,469 515 3,062 276 Source: DGAL

The audit team noted that in 2016 only a proportion of the grids, identified by France were actually checked. The proportion varied in the different BZ. The audit team observed surveys, carried out by FREDON agents in the BZs of PACA and Corsica and noted that the agents: Were well trained and experienced and were fully familiar with the details of the DGAL and FREDON inspection and sampling protocols; Possessed all necessary equipment for the visual surveys and sampling, including the recording of the outcome; Located the pre-defined observation points with the help of maps, aerial photos and GPS devices. As the observation points were selected based on spatial information, it was necessary to adjust them to the actual conditions (visibility, accessibility) of the site; Did a 360o visual survey at each point and searched for specified plants with visible or suspicious symptoms and tried to link these to the possible bacterial infection (as opposed to mechanical damage); It was also noted that only plants in the close vicinity (maximum 50m) of the observation point were checked. The survey protocol did not require agents to search a larger area and in many cases, access was very difficult; Individual samples were taken from symptomatic and suspicious specified plants. These were packed, duly labelled, transferred, in cool boxes and sent to the laboratory by express mail, ensuring the arrival the following day. The exact GPS position of each individual plant was recorded and the plants were clearly labelled for future identification in the field; After each inspection, a standard report was prepared using a computer tablet. After each working day these reports were uploaded to the central database.

The audit team noted that the use of grids larger than 100m x 100m, in combination with the applied survey method, which does not include entering private gardens and natural areas difficult to access, was not suitable to obtain comprehensive information about the infection status of the area. The visual checks in the randomly selected observation points provided information only about a small part of a grid which was not representative and the vast majority of the area remained unchecked. Such surveillance is also not in compliance with the requirements of the Decision, which requires, in the BZ, that the surveyed area be based on a grid split into 100m x 100m squares.

Recommendation No 1 of the 2016 audit report recommends France to ensure that the monitoring in the BZs is implemented in line with Article 6(7) of the Decision. This recommendation has not been addressed. 15

Recommendation No 4 of the 2016 audit report recommended France to ensure that surveys in the DAs take into consideration the presence and biology of the specified plants, and in particular the accessibility of hosts in private gardens and in remote areas. The audit team noted that due to climatic conditions and composition of the flora in the BZs in Corsica and PACA, the survey period of August-December 2016 was suitable as practically all host plants of Xf subspecies multiplex and the vast majority of specified plants could be visually checked (being in full vegetation with leaves) and duly sampled. However, as it is explained above (see paragraph no. 45) there were no attempts made to access host plants in private gardens and remote areas. Therefore, recommendation No. 4 of the 2016 audit report remains only partly addressed. 5.2.3 Surveys in the Infected Zones

The survey system, applied by France in the BZs is not in line with the provisions of the Decision. It does not provide the required level of meticulousness and territorial coverage and therefore, the information collected about the infection status of BZs is inadequate and unreliable.

Member state response

En PACA, tous les quadrats ont été inspectés en 2017 conformément aux modalités prévues dans le plan national d'intervention sanitaire d'urgence de Xylella fastidiosa (DGAL/SDQSPV/2017-39) Dès 2017, l'ensemble des zones tampons en PACA sera inspecté par quadrat de 100 x 100 m, avec une priorisation centrifuge autour de chaque foyer. En région Corse, la mise en oeuvre de la surveillance des zones tampons (près de 4000km²) telle que demandée par la décision d'exécution 2015/789/UE n'est pas envisageable. Une demande de passage à une stratégie d'enrayement et de modification de la décision d'exécution a été transmise à la Commission européenne le 21 mars 2017. Une surveillance spécifique du territoire corse est mise en oeuvre sur la base d'une analyse de risque. Cette surveillance concerne prioritairement: les végétaux spécifiés introduits en Corse en 2015 et 2016 ; certains foyers et leur environnement : présence de cultures sensibles à proximité ou en expansion, présence d'activité vectorielle ; les abords des ports, lieux d'introduction des végétaux ; les zones agricoles avec des cultures sensibles (oliviers, Prunus, agrumes, vigne) ; les secteurs hors des zones délimitées actuelle

In PACA, all grids were inspected in Les actions programmées en Corse 2017 in accordance with the national en 2018 sont conformes aux operational plan for sanitary dispositions de la décision emergencies for Xylella fastidiosa d'exécution 2015/789 modifiée par (DGAL/SDQSPV/2017-39). la décision 2017/2352 du 14 décembre 2017. From 2017 on, all buffer zones in PACA will be inspected in grids of 100 x 100 m, with priority given to the areas ately surrounding each outbreak. In Corsica, the monitoring of buffer zones (almost 4 000 km²), as instructed by implementing Decision 2015/789/EU, is not feasible. A request was sent to the European Commission on 21 March 2017 asking to switch to a containment strategy and to amend the implementing decision. Targeted monitoring is implemented in Corsica on the basis of risk analysis. It prioritises: - specific plants that arrived into Page: 1 eport recommendations (updated) received 29 December 2017 e Action Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2017-6141-MR h 2017 to 31 March 2017 in order to evaluate the situation and official controls for Xylella fastidiosa n Proposed by the competent CA's fi

The recommendation states as its basis

The outbreak in Menton was treated as a special case for the DRAAF/SRAL for the following reasons: The first laboratory tests in 2015 identified the presence of Xf subspecies multiplex on some Polygala myrtifolia plants, which were removed and destroyed already in 2015; EU host plants of the subspecies multiplex known at that time, were also removed and destroyed; During the first laboratory test, a PCR method (Hernandez-Martinez et al., 2006) was used which could not detect Xf subspecies pauca; After the recent version of the EPPO Xf diagnostic protocol was published, the DNA extract of the positive sample was re-tested with a different method (Pooler and Hartung, 1995) and found positive for Xf subspecies pauca; After the new test result was confirmed, DRAAF/SRAL inspectors revisited the IZ and carried out an inventory to identify the presence of plants, which were hosts of the subspecies pauca in the EU; The Xf subspecies pauca hosts and other specified plants in the close vicinity of the Polygala myrtifolia plants, removed in 2015 were sampled and tested again, individually. All results were negative; The newly identified hosts (Dodonaea viscosa, Laurus nobilis, Nerium oleander, Olea europea, Westringia fruticosa) were then marked, treated and removed in line with the provisions of the Decision; 18 However, the CA decided against the removal of sixteen 300-400 year old Olea europea (olive) trees. These plants did not show any symptoms and repeatedly tested negative during 2016-2017; DRAAF/SRAL decided to protect these olive trees with insect-proof nets. The plants were heavily pruned and the upper part of the trunk and remaining branches of the canopy were wrapped with these net. The audit team noted that protecting the trees with netting is not in line with the Decision and its efficacy against the further spread of the pest is not yet established.

The audit team noted that eradication measures in PACA, in particular the removal of host plants in the IZ, were generally in line with the provisions of the Decision, except for: Delays in removal and destruction of the host plants due to problems with identification and notification of the land owners and The non-removal of olive trees in the Menton IZ.

In Corsica, eradication measures, fully in line with provisions of the Decision were implemented only in the case of the first outbreaks, identified in 2015. The audit team noted: The number of outbreaks is very high; 237 were identified until February 2016 and a further 104 in the period February 2016 ­ March 2017; The number of host species, found positive increased rapidly and at the time of the audit there were 36; A part of the IZs are located in areas with difficult access where the removal of any plant is sometimes very difficult; A considerable part of the IZs cover natural land or abandoned agricultural land, where, after the removal of the hosts, no agricultural activity is expected. Therefore the CA has concerns regarding possible soil erosion. The CA also fears that the areas where the host plants were removed will be recolonised by invasive plants species from the surrounding areas, which may change the flora substantially.

Due to the above mentioned concerns and due to the limited accessibility, in newly established IZs in Corsica removal and destruction of all host plants is not carried out. The following plants present in the IZ are removed and destroyed: Until May 2016: plants which were tested positive or showing symptoms and all the Polygala myrtifolia plants, regardless of their health; Since May 2016 in addition all plants of the species, which tested positive, are also eradicated.

The audit team was informed by the CA that although numerous new host species were identified in Corsica in 2016, only about 25% of the IZs, established in 2015 and about 75 % of the IZs established in 2016 were revisited. During these inspections over 1,000 samples were taken and about 0.6% of these tested positive.

The CA stated that the immediate removal and destruction of the host plants in Corsica was not possible due to the large number of outbreaks, in particular in South Corsica. 19

On the basis of the above the audit team noted that in Corsica, the eradication measures were not in line with the Decision and therefore there is a continuous presence of the bacterium in the IZs.

The audit team furthermore noted that although there is no comprehensive information available about the range of vectors and their transmission potential, related to Xf subspecies multiplex, results of insect collections showed the continuous and high presence of cicadas in the IZs of Corsica.

The eradication measures in PACA are largely in line with the provisions of the Decision. However, some delays in removal of the host plants in certain IZs and the non-removal of olive trees in the case of the Menton IZ compromise their efficiency. The use of protective netting is not in line with the Decision.

The eradication measures in Corsica are not in line with the provisions of the Decision and do not ensure the elimination of the bacterium from the IZs. 20

Member state response

En PACA : Page: 1 ort ref. DG(SANTE)/2017-6141-MR of the audit carried out from 20 March s for Xylella fastidiosa Action Proposed by the competent authority - tous les végétaux infectés et tous les végétaux hôtes dans les zones infectées du département du Var ont été arrachés et détruits ; - dans les Alpes-Maritimes, la totalité des végétaux infectés et une grande majorité des végétaux hôtes ont été arrachés. L'arrachage du reste des végétaux hôtes est retardé pour diverses raisons : contentieux, absence provisoire du détenteur de végétaux. De plus, les actions suivantes sont mises en oeuvre en 2017 : 1 - Mise en oeuvre de la procédure d'exécution d'office, procédure prévue par le Code Rural et de la Pêche Maritime. 2 -Réduction du délai de gestion des foyers : les DRAAF/SRAL veilleront à l'arrachage sans délai des végétaux contaminés qui seraient découverts. L'arrachage des végétaux hôtes est mis en oeuvre conformément au plan national d'intervention d'urgence de Xylella fastidiosa (DGAL/SDQSPV/2017-39).

CA: Les actions programmées en Corse en 2018 sont conformes aux nfected plants and all host plants in dispositions de la décision nfected areas of the département of d'exécution 2015/789 modifiée par ere removed and destroyed; la décision 2017/2352 du 14 décembre 2017. Alpes-Maritimes, all infected plants ost host plants were removed. The al of the remaining host plants has Page: 2 eport recommendations (updated) received 29 December 2017 e Action Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2017-6141-MR h 2017 to 31 March 2017 in order to evaluate the situation and official controls for Xylella fastidiosa Proposed by the competent CA's final Action Plan ty layed for various reasons: , temporary absence of the owner plants. tion, the following measures were n 2017: mentation of the enforcement ure provided for by the Rural and e Fishing Code. uction of the time taken to outbreaks: the DRAAF/SRAL sure that any contaminated plants ied will be removed as quickly as e. The removal of host plants is out in accordance with the l operational plan for sanitary cies for Xylella fastidiosa DQSPV/2017-39).

The recommendation states as its basis

The CA informed the audit team that the DAs, established after the first outbreaks, detected in 2015 or early 2016 in Corsica were signposted. However, after the number of DAs increased exponentially, it was technically not possible to indicate the border of each. In PACA there are no road signs either. The majority of the DAs are located in highly populated urban areas, with numerous exiting roads. Therefore the CA informed the audit team that they considered that it was not feasible to apply road signs. The audit team noted that the current practice is not in line with Article 6(8) of the Decision. Notwithstanding the difficulty in applying road signs in urban areas the audit team is of opinion that the compliance with this provision of the Decision is necessary to facilitate controls of specified plants moving out of the DAs. 5.4.2 Movement ban of specified plants

Contrary to the requirements of the Decision, there are no road signs at the borders of the DAs. This reduces the level of general public awareness about the DAs and increases the risk of unintentional movement of specified plants out of them.

Member state response

Une carte détaillée des zones délimitées est disponible à la sultation du public sur les sites internet des DRAAF Corse et PACA, à une échelle minimale du 1/25.000ème. Dès 2017 les actions suivantes vont être mises en oeuvre en PACA : 1 - Recenser toutes les routes (autoroutes, départementales, chemin communaux) qui permettent de sortir de la zone délimitée, identification des axes prioritaires devant faire l'objet de signalisation. 2 - Mise en place de panneaux de signalisation sur les axes prioritaires, en concertation avec les autorités de gestion des routes. Page: 2 ort ref. DG(SANTE)/2017-6141-MR of the audit carried out from 20 March s for Xylella fastidiosa Action Proposed by the competent authority

tailed map of the demarcated areas 200 panneaux de signalisation ont ilable on the websites of the été commandés et seront livrés en nd PACA DRAAF, at a janvier 2018. Ces panneaux comporteront le message suivant : « Risque Xylella fastidiosa - Page: 3 eport recommendations (updated) received 29 December 2017 e Action Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2017-6141-MR h 2017 to 31 March 2017 in order to evaluate the situation and official controls for Xylella fastidiosa ion Proposed by the competent CA's final Action Plan hority imal scale of 1/25 000. Mesures adoptées et limites de la zone délimitée disponibles sur le n 2017, the following measures site internet de la DRAAF PACA ». l be implemented in PACA: Les panneaux seront implantés en limites et à l'intérieur des zones Listing all roads (motorways, délimitées : principalement sur les sidiary roads, minor roads) leading aires de l'autoroute A8 et dans les of the demarcated area and stations services des zones ntifying priority points where road délimitées. ns must be set up. Setting up road signs at the priority nts, in collaboration with the road agement authorities.

The recommendation states as its basis

The audit team visited several nurseries, both producers and traders with outlets in the BZs and noted that: The majority of the sales take place during the spring (February-May) and autumn (October-December) period. The retailers receive their stocks in containers or pots generally from outside the DAs. The plants are usually sold quickly, spending no more than 3-4 weeks at the premises. However, the ligneous plants could be kept for longer periods if not sold; The producer nurseries apply regular insect controls, however the retailers generally do not use any pesticides due to environmental and health protection reasons. The premises are not isolated and are usually surrounded by areas, where the insect vector of the bacterium is present; The audit team found evidence that one production nursery sells specified plants (young vegetable and herbaceous ornamental plants) outside the DA to professional clients and the CA did not apply any measure to stop this; The nurseries are generally cooperating with the CAs; 21 The nurseries are strongly concerned with the current economic impact of the control measures and in particular about the future as the possible extension of the Xf host range may affect other important plant species they produce or trade with; The nurseries often question the necessity of the measures and request the application of tailor-made actions based on the assessment of the risk related to their activity in the BZ; The nurseries are generally aware of the requirements; in particular they are familiar with the list of specified plants. They keep appropriate records on their production, incoming stocks and sales to professional clients regarding specified plants. The records include the name and address of the supplier/client, date, plant species, varieties and quantities; In the shops, usually at the cash registers, posters or information sheets are available about the specific measures introduced in the DAs, including the list of specified plants and maps showing the DA border; A MAAF note requires nurseries in the DAs to keep records of their private clients. The nurseries usually keep records of the sales of specified plants to private clients, but it is not integrated into their IT system Each nursery and shop visited asked for the postal code of the private client. In addition in Corsica the name and phone number of the buyer and destination address of the plants are requested; Due to legal reasons (personal rights, data protection) the information is only collected if the client agrees to provide it. The nurseries are not entitled to refuse the sales, if the postal code is outside the DA. It cannot be controlled either, whether the private clients actually plant or use the plants within or outside the DA.

The audit team found that the current system of official controls, as described in paragraphs 76-78, in particular in PACA, allows for the possibility that specified plants, which have been grown for at least part of their life in a DAs, move out of those areas, mainly through sale to private clients. Thus the provisions of Article 9(1) of the Decision are not implemented. 5.4.3 Application of the derogation provided by Article 9(2) of the Decision

The current system of movement controls cannot guarantee that specified plants, which have spent a part of their life in the DAs, do not leave those areas. Therefore a risk exists for Xf spread with human assistance.

Member state response

ts En PACA : Aucune dérogation pour la sortie des végétaux only spécifiés hors des zones délimitées n'a été accordée. En Corse, la sortie de végétaux spécifiés de Corse ne concerne que : - des établissements en zone indemne. - le déplacement de végétaux dormants de vigne destinés à la plantation, réalisé conformément aux dispositions prévues à l'article 9, paragraphe 4 bis, de la décision d'exécution 2015/789/UE. En PACA, pour renforcer la surveillance de la circulation des végétaux spécifiés à l'intérieur des zones tampons, autorisée au sens de l'article 9, le plan d'action suivant est prévu: 1 - Engagement du particulier client d'une jardinerie située en zone délimitée, par signature sur le double du bon de caisse gardé par l'établissement vendeur, que le lieu de plantation du végétal ne se situe pas hors de zone délimitée. 2 ­ Augmentation du nombre d'inspections PPE dans la zone délimitée (établissements de production et de revente) : deux inspections par an dans les établissements concernés. 3 - Inspections en grandes et moyennes surfaces en périphérie de zones délimitées : 2 campagnes de contrôles par an. 4 - Inspections sur le MIN de NICE et des marchés : inspections réguliè

o exemptions were granted En complément des inspections ovement of specified plants out programmées à l'intérieur et en the demarcated areas. périphérie des zones tampons (pépinières, jardineries, Corsica, the movement of specified supermarchés, marchés, MIN de nts off the island only concerns: Nice), une enquête de traçabilité aval des végétaux spécifiés vendus stablishments in the disease-free area. dans la zone tampon sera conduite en 2018. Par l'étude des registres he movement of dormant vines des commerçants, nos services ended for planting and moved in vérifieront que les végétaux vendus ordance with the provisions of n'ont pas quitté la zone autorisée. Page: 4 eport recommendations (updated) received 29 December 2017 e Action Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2017-6141-MR h 2017 to 31 March 2017 in order to evaluate the situation and official controls for Xylella fastidiosa by the competent CA's final Action Plan f implementing Decision r to increase the e movement of specified ffer zones, authorised the following action afted: nts purchasing from a cated in a demarcated m, by signing a copy of e kept by the garden pla

The recommendation states as its basis

The current system of movement controls cannot guarantee that specified plants, which have spent a part of their life in the DAs, do not leave those areas. Therefore a risk exists for Xf spread with human assistance.

Member state response

d En PACA, il est prévu que soient réalisés des contrôles routiers conjoints avec le Service des douanes en zone délimitée. Ces contrôles pourront être réalisés à l'occasion des contrôles aux péages, conjointement avec les services compétents.

, road checks will be carried En Provence-Alpes Côte d'Azur, tly with the customs authorities les contrôles routiers ont été mis en emarcated area. These checks place dans un premier temps au arried out as part of checks at péage de la Turbie sur l'autoroute dges in cooperation with the A8, qui est un axe principal de t authorities. circulation des Alpes Maritimes, dans le sens France- Italie puis dans le sens Italie ­ France. Dans ce departement, les inspections ont été conduites le 9 octobre, le 27 novembre et le 7 décembre 2017. Dans le Var, des inspections ont été conduites le 20 novembre 2017. Ces inspections seront poursuivies Page: 6 eport recommendations (updated) received 29 December 2017 e Action Plan submitted by the competent authorities of France in response to Report ref. DG(SANTE)/2017-6141-MR h 2017 to 31 March 2017 in order to evaluate the situation and official controls for Xylella fastidiosa Proposed by the competent CA's final Action Plan ity en 2018.

The recommendation states as its basis

The ongoing lack of capability to identify the subspecies in each relevant case may compromise the application of the eradication measures laid down in the Decision.

Member state response

f Des travaux sont en cours en France et en Europe pour optimiser se et valider un nouveau protocole MLST pour l'assignation des sous-espèces de X. fastidiosa. Le LNR a d'ores et déjà initié ces travaux et les résultats de validation seront partagés (a minima via la base « Diagnostic OEPP »). Les experts bactériologistes des pays membres de l'OEPP se réuniront le 12 septembre 2017 pour en discuter et examiner si ces résultats justifient une révision de la norme OEPP PM7/24 de septembre 2016 relative aux analyses de Xylella fastidiosa. Page: 4

s being carried out in France and ope in an effort to optimise and te a new MLST protocol for the fication of subspecies of X. iosa. The National Reference tory has already commenced n this and the validation results e shared (at least via the EPPO stic database). Leading iologists from EPPO member ies will meet on 12 September o discuss this matter and examine r the results justify amending tandard PM7/24 of September oncerning analyses of Xylella iosa. Page: 7

The recommendation states as its basis

The effectiveness of checks carried out at the PECs visited is reduced however, by the lack of facilities to ensure that the sample taken from containerised consignments is representative, as required by EU legislation.

Member state response

La Commission sera informée des lieux au sein des PEC de Marseille et Fos ­ Port Saint Louis ou les conteneurs peuvent être vidés afin de garantir la représentativité des échantillons prélevés par les inspecteurs pour examen visuel des envois. Une instruction locale sera rédigée par ces PEC pour qu'un pourcentage de conteneurs soit ainsi vidé pour examen visuel. Date : 31 décembre 2017 The Commission will be informed of the locations inside the Point of entry of Marseille and Fos-Port Saint Louis, where the containers can be emptied in order to guarantee that the sample taken by inspectors for visual examination are representative. A local instruction will be drafted by these points of entry in order that a percentage of containers is emptied for visual examination.

The recommendation states as its basis

The audit team observed documentary checks being carried out at the PECs at Roissy and Marseille and noted that: The inspectors had a good knowledge of the documentary requirements, and in particular, were familiar with the additional declaration requirements of the consignments received at the PEC; checks were sufficient to ensure that the phytosanitary certificates complied with the conditions in Articles 13(1)(ii) and 13a(3) and (4) of Directive 2000/29/EC, including for additional declarations; In the event of a non-compliance, the phytosanitary certificates had been cancelled and endorsed with a red triangle stamp in line with points (a), (b) and (c) of Article 13c(7) of Directive 2000/29/EC; However the phytosanitary certificates were not endorsed with an entry stamp, with at least the name of the service and the date of entry, as required by Article 13c(3) of the same Directive. The audit team noted though, that the original documents are stored securely, together with their accompanying documents, at the PEC. 5.4.3 Identity checks

The phytosanitary certificates are not endorsed with an entry stamp as required by EU legislation, however the risks arising from this are mitigated by the secure storage of the original documents, which effectively prevents their misuse.

Member state response

, Le SIVEP demandera par instruction aux PEC d'apposer un visa d by comprenant le nom du service et la date sur les certificats phytosanitaires à l'issue de la procédure d'inspection phytosanitaire. Date : 31 décembre 2017 SIVEP will request by instruction to the points of entry that phytosanitary certificates are endorsed with an entry stamp, with at least the name of the service and the date of entry.

The recommendation states as its basis

The BIP has a sufficiently large changing room and washbasin with cold and hot water at the disposal of staff responsible for carrying out veterinary checks of live animals. However, a shower is not available in the BIP facilities for live animals contrary to the requirements of point 4 of Annex A to Directive 91/496/EEC. 3

The unloading area is adequate for the animal species expected, as required by point 2 of Annex A to Directive 91/496/EEC. Horses are transported to the BIP in boxes which are placed on the platforms pulled by the airport trailer. The equipment for the unloading (step-down) of horses from the above-mentioned platforms onto the rubber floor was not available, and needs to be procured. The airport operator provided assurances that the unloading equipment will be provided within the month after the audit.

The inspection area is suitable for carrying out the checks required. However, it is not fully equipped with the necessary tools that would allow staff to perform identity and physical checks (e.g. equipment to restrain, thermometer), contrary to the requirements laid down in Articles 3 and 4, and Annex II (parts I and II) to Decision 97/794/EC. The microchip reader was available during the audit. The competent authority informed that sampling for registered horses will be carried out only in suspicious cases following the derogation foreseen in Annex II (part III.1) to Decision 97/794/EC.

The animals' housing and isolation facilities are easy to clean and disinfect. However, the walls in the isolation facilities had gaps in them allowing communication with the outside that impedes the correct isolation of animals, when necessary.

In general the BIP facilities are ready for receiving and checking consignments of live animals. However, the facilities proposed do not fully ensure the standards for animal welfare during unloading and for isolation, whenever such need arises. In addition, a shower for the BIP staff should be made available.

Member state response

s Finding 11 La douche sera installée avant le 30 juin 2017. Elle sera positionnée à l'intérieur du grand vestiaire. Finding 12 L'équipement de déchargement est désormais à disposition au PIF de Lyon. Finding 13 L'équipement nécessaire au contrôle d'identité et contrôle physique (« tord-nez », thermomètre) a été acheté le 15 janvier 2017 et est désormais disponible au PIF de Lyon. Finding 14 Les espaces dans les cloisons ont été couverts, et l'espace de consigne est désormais isolé. Finding 15 Les fissures ont été réparées. Un joint a été posé entre les nouvelles plinthes et le sol. De fait le nettoyage et la désinfection sont à nouveau possibles, tout comme la protection contre les rongeurs nuisibles. Ainsi, il n'est plus nécessaire d'échanger la destination des locaux, comme cela avait été envisagé et validé lors de l'audit. La disposition originale des pièces est donc conservée. Page: 1

The recommendation states as its basis

The audit team noted that due to sampling and laboratory capacity problems, especially immediately after the first outbreaks, it was not possible to sample and analyse all the specified plants in the 100m area around the IZ. Instead, the area of 15m around each IZ was prioritised. In this area the specified plants were sampled and tested in line with provisions of the Decision.

In PACA the majority of the outbreaks were discovered in the last months of 2015 or in 2016, therefore no surveys had been carried out in the BZs at the time of the audit, which is not in line with the provisions of the Decision. In Corsica, due to the numerous recent outbreaks, the CA stated that it was not in a position to carry out surveys in line with the provisions of the Decision (i.e. visual inspections and sampling of plants with 18 symptoms based on a 100m x 100m grid). At the time of the audit, the entire BZ area was 380,100 ha; therefore the same number of visual inspections would be required annually to fulfil the requirements of the Decision.

The audit team was informed that visual inspections were and will be carried out in the BZs based on a grid split into 1km x 1km squares. The CAs noted that the proper implementation of the plan could be hindered by the inaccessibility of some areas. 5.3.4 Tracing back and forward of infection sources

No surveys were carried out in 2015 in the BZs in PACA. In Corsica the intensity of the surveys in the BZs is lower than that required by Article 6(7) of Decision 2015/789/EU. As a result there is no comprehensive information available about the infection status of the BZs.

The sampling and testing practice within a radius of 100m around the infected plants is not in line with the provisions of Article 6(3) of Decision 2015/789/EU. Therefore, the real extent of the spread of infection is not known in each outbreak site.

The recommendation states as its basis

In the case of the first three outbreaks in Corsica it was assumed that the infection was caused by Xf subsp. pauca, therefore in the 100m area around the IZ, hosts plants of that subspecies and all symptomatic plants of other species were removed. Later, based on the assumption that Pm was the prominent source of infection, each plant of this species was removed. The audit team noted that due to capacity problems, Corsica SRAL could not return to all the outbreak sites where removal had been completed, to check for the presence and order the removal of plants of newly identified host species. For all outbreaks in PACA, immediate removal of host plants (known to be hosts at the time that the infected plants were detected) was ordered in the 100m zone and this had been implemented at the time of audit. 5.3.3 Surveys for Xf in the DAs

The audit team visited nurseries in the DAs in Corsica and PACA, to whom derogation B had been granted and noted: They keep records on entries and sales. In the case of private clients the name, address and telephone number is recorded; Plants are treated with pesticides at least once a month; They are inspected by the SRAL regularly; In the nursery in Corsica, host plants (Lavandula sp.) were present, although this species was not considered as a host plant at the time of the demarcation. SRAL informed the audit team that the lot was put on hold and sampled, and that destruction was planned in the case of positive results; 5.3.6 Other measures to prevent the spread of Xf

The measures taken in the DAs show the commitment of the French CAs to eradicating Xf, in order to protect major crops and environmentally and economically important areas. Specific efforts were made to implement appropriate measures. The demarcation of the affected areas, the eradication of infected plants and hosts (known at the time of detection) in the 100m radius and the trace back and forward of the infections was carried out in line with the provisions of Decision 2015/789/EU. However, as outbreak sites where eradication activity had been completed were not revisited after new hosts were identified, there is a risk that infected plants remain in those areas.

The recommendation states as its basis

DGAL stated that it interprets the provisions of Article 9 of Decision 2015/789/EU as providing the possibility to grant three different types of derogations to nurseries in the DAs. SRAL authorises the movement of host and specified plants within and outside of the DAs according to the scheme outlined in paragraphs 72-75 below. In general, the applicable derogation depends on the type of plants and the length of time they spend in the DA. Derogation A is applied to nurseries who deal with marketing of plants which are in pots or containers and the premises are not considered as growing fields (i.e. plants are not multiplied and kept on solid surface). It is granted for non-host specified plants which were in stock in the nursery at the time of demarcation; Derogation B is applied for the same type of nurseries as derogation A. It is granted for non-host specified plants, which enter the nursery from outside the DAs after demarcation and which do not spend more than one vegetation period at the premises; Derogation C is applied to nurseries which deal with host plants or propagate and/or keep stocks of specified plants at the premises, in containers or on the open field longer than one vegetation period.

Derogation A is granted if the nursery Carries out an inventory on the stocks; Carries out permanent insecticide treatment of the plants against insect vectors; Keeps a record on sales and keeps a register of observations any disease symptoms; Receives prior authorisation of the stocks from SRAL; Subscribes for the BSV and follows training on Xf organised by an expert body.

Derogation B is granted if the nursery Keeps a record on entries (date, supplier, quantities) per plant species; Carries out permanent insecticide treatment of the plants against insect vectors and keeps a record of the treatments; 20 Keeps a record on sales (date, client, quantities) per plant species and keeps a register of observations of any disease symptoms; Subscribes for the BSV and follows training on Xf organised by an expert body.

The audit team noted that derogations A and B are not in line with provisions of Decision 2015/789/EU. However, DGAL stated that based on the French language version of the Decision, it interprets that the movement ban of Article 9 refers to plants which have been cultivated in the DAs and does not include those that are kept on premises for wholesale and retail purposes only. The CA considers that the measures, linked to derogation A and B provide the necessary guarantees of not distributing the pest through sales of planting material. The CA has also emphasised that the approach was developed based on the need to allow trade of planting material without pronounced risk while taking efforts to prevent the spread of Xf.

The audit team visited nurseries in the DAs in Corsica and PACA, to whom derogation B had been granted and noted: They keep records on entries and sales. In the case of private clients the name, address and telephone number is recorded; Plants are treated with pesticides at least once a month; They are inspected by the SRAL regularly; In the nursery in Corsica, host plants (Lavandula sp.) were present, although this species was not considered as a host plant at the time of the demarcation. SRAL informed the audit team that the lot was put on hold and sampled, and that destruction was planned in the case of positive results; 5.3.6 Other measures to prevent the spread of Xf

Nurseries located in DAs are allowed to move non-host specified plants outside their DA without fulfilling all requirements of Article 9(2) of Decision 2015/789/EU. It creates a potentially high risk as the plants spend time in the nursery, surrounded by potentially infected plants without any protection against transmission by vectors.

The recommendation states as its basis

Outside the DAs, surveys in the two regions targeted nurseries and public places, where there were reports about the presence of Pm plants or symptomatic plants. The audit team was informed that in both regions, there are numerous private properties where Pm and other host plants are present. Accessing these properties for surveillance purposes is very difficult. In Corsica many private properties are second homes of residents in continental France and the owners are not present for much of the year. Therefore in many cases it is difficult to obtain the consent of the owner/tenant for the survey.

In some areas, especially in Corsica, Pm has become part of the wild flora and is commonly found in scrublands (in French - maqui). The audit team was informed that there are signs that some of these wild plants exhibit symptoms of Xf. However, the majority of these plants are located in sites that are difficult to access in order to take samples and practically inaccessible for the implementation of eradication measures, if necessary. SRAL Corsica surveyed some scrublands with a drone and confirmed the presence of symptomatic Pm plants. SRAL intends to contact the National Botanical Conservatory of Corsica, who are involved in flora mapping of wild areas, in order to collect information about the spread of Pm and to involve them as appropriate in surveillance activity. 14

In 2015 France carried out a comprehensive and risk based Xf national survey as required by EU legislation. The surveys outside the DAs in Corsica took into consideration the new risk elements identified as a result of the outbreaks. In PACA, as the outbreaks were detected recently, there was no time for comprehensive surveys outside the DAs. In both regions, the limited accessibility of private properties, scrublands or other natural sites compromise the surveys. The lack of movement controls of specified plants beyond the controls related to the implementation of the plant passport system outside the DAs does not increase the risk of spread substantially as there is limited trade of plants outside those areas.

The audit team was informed that visual inspections were and will be carried out in the BZs based on a grid split into 1km x 1km squares. The CAs noted that the proper implementation of the plan could be hindered by the inaccessibility of some areas. 5.3.4 Tracing back and forward of infection sources

The recommendation states as its basis

For DGCCRF, even if some potential mechanisms exist (the Ministerial Audit Committee) that could be suitable to undertake independent scrutiny of the audit processes, these mechanisms are not being used for this purpose at present.

At the time of the DG SANTE audit, no decisions had been taken as to when and how independent scrutiny of the DGCCRF internal audit processes would be achieved. Conclusions

For DGCCRF, independent scrutiny of the current audit processes has not yet been carried out. This is contrary to the requirements of Article 4(6) of Regulation (EC) No 882/2004. 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: -- generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, 14 -- specific technical knowledge and skills, -- personal attributes, -- education, -- work experience, -- auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

Member state response

Une partie de l'audit interne de la DGCCRF est déjà soumise à un examen formel par le comité d'audit Interne (CAI) via la mission d'audit interne (MAI). ffet, l'IGS-CCRF est d'ores et déjà tenue de communiquer son projet de programme annuel au chef de la mission d'audit interne du ministère de l'économie et des finances (MAI), pilotée par l'Inspection générale des finances, qui le transmet ensuite pour approbation au CAI. L'IGS-CCRF doit également informer le CAI de l'état d'avancement de l'ensemble des missions inscrites à son programme d'audit interne. Enfin, l'IGS tient le CAI informé de la mise en oeuvre du suivi des recommandations selon les modalités prescrites par ce dernier. Pour répondre précisément à la recommandation formulée par les auditeurs de la DG SANTE visant à la mise en place d'un examen indépendant sur le système d'audit interne de la DGCCRF, il est envisagé d'en confier la réalisation dès 2017 à la Mission d'audit interne du ministère de l'économie et des finances (MAI). Celle-ci est chargée d'élaborer et de mettre en oeuvre, sur la base d'une analyse fondée sur les risques, le programme d'audit interne approuvé par le Comité d'audit interne des ministères (CAI

The recommendation states as its basis

In relation to the handling of samples: a. In Le Havre and Marseille BIPs, officials used tamper-proof seals and the samples were transported under the responsibility of the competent authority. This was different in BIP Roissy-CDG, where the bags for the samples were not closed with a tamper-proof seal5. This was already noted during the previous audit DG(SANCO) 2010-8554. 4 In their comments to the draft report, the competent authorities noted that, after satisfactory documentary checks, the second consignment was released. 5 Immediately after the audit, the SIVEP informed the audit team of the corrective actions implemented to eliminate this shortcoming: the "Inspection Guide" has been amended requiring, amongst others, the use of tamper-proof bags individually identified and sufficient communication to the laboratory so that the integrity of the sample can be verified at arrival. The expected date for implementation was end of May 2016. 9 b. DGCCRF closes the samples with commercial adhesive tape and attaches the sampling document with an aluminium seal. This procedure does not render the sample tamper-proof. In addition, the operator is responsible for the transport of the sample to the laboratory. The practice of using non tamper-proof samples coupled with the circumstance that the operator himself transports the sample for analysis does not guarantee the legal validity of the sample required by Article 11(7) of Regulation (EC) No 882/2004.

Enhanced controls are implemented when necessary on the consignments presented at the borders. Sampling procedures are correctly implemented by the two sanitary authorities. The sealing and handling of samples, when the competent authority does not maintain the chain of custody, cannot ensure their legal and analytical validity for laboratory testing. 10 5.3.2 Decision on the consignments and enforcement measures Legal requirements Article 5 of Directive 97/78/EC. Article 8(3) of Regulation No 885/2014. Article 8(2)(a) of and Annex I to Regulation (EC) No 669/2009 Article 9(6) of Regulation (EC) No 884/2014. Article 12 of Commission Implementing Regulation (EU) No 322/2014. Articles 19(2) and 24 of Regulation (EC) No 882/2004. Findings

The recommendation states as its basis

DGAL uses BIP facilities for the controls under their responsibility (products of animal origin and feed). For the controls on food of non-animal origin, identity and physical checks are implemented in interim storage facilities operating under Customs supervision. The importers propose on a case-by-case basis the storage facility, chosen amongst any operator (not necessarily food or feed operator) functioning in the area2. The competent authority underlined that this practice is not a use of the derogation provided under Article 19 of Regulation (EC) 669/2009. They also stated that they are satisfied with the guarantees provided by the current arrangements.

The system described in the previous paragraph does not ensure that the facilities used for identity and physical checks are hygienically adequate to store food. The registration as food operators of these interim storages is not a pre-requisite, so operators are not necessarily subject to the obligations laid down in Regulation (EC) No 852/2004. Verification of the hygiene conditions is done when the officials go on-the-spot to implement the import controls. This arrangement does not ensure that products are always handled hygienically (which is required by Article 16(3) of Regulation (EC) No 882/2004). 5.1.3 Fees

Controls on food of non-animal origin, under the responsibility of DGCCRF, are performed in temporary storage facilities where hygiene conditions are only verified after the goods arrive. This arrangement does not ensure that goods are handled hygienically.

The recommendation states as its basis

In response to the recommendation of the audit DG(SANCO) 2010-8596 on the fees borne by the operators, DGCCRF introduced the Statutory Order of 16 August 2013, 2 In their response to the draft report, the competent authority noted that currently there is no specific registration system for bonded warehouses where food of non-animal origin can be presented for checks and stored while awaiting the result of the testing. If the premises have a food storage activity, they are registered in the food sector and subject as such to hygiene rules. There is currently no link between the enhanced import controls and the hygiene controls in these establishments. 5 setting the amounts of the fee for import checks on the food of non-animal origin referred to in Annex I to Regulation (EC) No 669/2009.

Regarding emergency measures taken under Article 53 of Regulation (EC) No 178/2002, the French authorities amended the Customs Code in 2014 to provide a national legal basis for charging operators the costs of import controls. Nevertheless, the implementing decree has not been drafted yet, and the requirements of Article 14 of Regulation (EC) No 884/2014, Article 13 of Regulation (EC) No 885/2014 and Article 13 of Regulation (EC) No 2015/175 are not complied with (all costs resulting from the official controls including sampling, analysis, storage and any measures taken following non- compliance, shall be borne by the feed or food business operators). Conclusions on the general requirements regarding the official controls system

In compliance with the EU legal requirements, staff are appropriately qualified to perform their job, and instructions are available. The communication between and within the competent authorities functions well, which contributes to the effectiveness of the controls.

The recommendation states as its basis

At the BIP Roissy-CDG, staff from SIVEP explained that manifest checks have not been carried out since 2013. The competent authority explained that (a) the resources required for manifest checks are disproportionate to the number of undeclared consignments detected, (b) the non-declared consignment ­ if any ­ would have left the airport by the time staff has time to check the manifests, and (c) data in the manifests are often difficult to interpret. This position does not comply with the requirements laid down in Article 6(b) of Regulation (EC) No 136/2004, to gather all pertinent intelligence for the purpose of detecting consignments not presented for controls3.

The cooperation between Customs and the two sanitary authorities ensures that the relevant consignments are presented for sanitary controls. For products of animal origin, the lack of manifest checks at the BIP Roissy-CDG opens the possibility that mis- declared or non-declared consignments enter the Union without the prescribed controls.

The recommendation states as its basis

CBs may grant authorisation to new operators joining the production scheme without an inspection visit being carried out by the relevant CB to verify compliance with the product specification.

Member state response

avant la mise sur le marché (INAO) : ôles officiels menés en France couvrent les nouveaux opérateurs. En effet, en application des dispositions point 1 du III de la directive INAO-DIR-CAC 1 de , relative à la mise en oeuvre des contrôles et au traitement des manquements : « Le plan de contrôle précise : - la nature des contrôles à effectuer permettant de s'assurer que l'opérateur est en mesure de les satisfaire aux exigences du cahier des charges. Ce contrôle réalisé sur place, sauf exception dûment justifiée, est effectué par l'organisme de le cas échéant, l'ODG peut y contribuer ». L'habilitation d'un nouvel opérateur est toujours prononcée par l'OC, soit : - après un contrôle comprenant un contrôle physique de l'opérateur par l'OC ; - après un contrôle documentaire réalisé par l'OC, lorsque le contrôle physique n'est pas jugé nécessaire, notamment lorsque le cahier des charges ne prévoit pas d'exigence structurelle spécifique (par exemple, nécessité pour l'opérateur de disposer d'un équipement spécifique) pour la catégorie d'opérateurs, ou lorsque cette exigence peut être contrôlée de manière sécurisée par un contrôle documentaire ; - après un contrôle documentaire effectué par

The recommendation states as its basis

Official controls for verification of compliance with the product specification prior to placing on the market of PDO/PGI/TSG products are not always adequately planned and implemented as required by Article 3 of Regulation (EC) No 882/2004. In particular, the selection of operators to be visited is not always based on risk assessment and the frequency of visits does not always ensure that all operators are regularly inspected. Moreover, inspections are not always carried out without prior warning.

Member state response

avant la mise sur le marché (INAO) : orités françaises considèrent que les contrôles officiels sont réalisés de manière ulière.

The recommendation states as its basis

Most aspects of official controls are adequately undertaken at producers/processors of PDO/PGI/TSG to verify compliance with the product specification. Market controls are adequate overall. However, there are no documented procedures to ensure that the requirements of Article 1 of Regulation (EU) No 664/2014 and Article 4 of Regulation (EU) No 668/2014 (which had not yet been included in all relevant control plans) are verified during inspections at PDO/PGI/TSG operators. 5.2.5 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings

Member state response

r les auditeurs au point 31 du rapport ne peut être considéré comme sentatif ; en effet, pour d'autres produits vus par les auditeurs, les fréquences de ficiels chez les producteurs peuvent aller jusqu'à 50 % par an. e qui concerne le fait que les contrôles officiels soient fondés sur les risques, les autorités rappellent que la fréquence des contrôles peut être déterminée à deux niveaux : e fréquence peut être fixée au niveau national par catégorie d'opérateurs d'une filière en nt compte des risques de non conformité par catégorie d'opérateurs ; rs de l'approbation des plans de contrôle, la fixation des fréquences peut aussi être faite en mpte des risques. Ainsi, des plans de contrôle, dont certains examinés par les voient des fréquences différenciées de contrôles officiels en fonction du volume ou la possibilité d'augmenter la pression de contrôles sur la base des résultats des ôles des années antérieures et des informations fournies par les groupes de producteurs cadre des contrôles internes. itre, les autorités françaises estiment que les contrôles sont le plus souvent fondés sur s risques. Elles estiment néanmoins que la prise en compte des risques pourrait être iorée. Dans ce

Member state response

e aux démarches réalisées par la DGAL auprès des présentants des éleveurs d'animaux à fourrure, ceux-ci ont fait appel à un organisme de formation qui a déposé une demande itation. Celle-ci est en cours d'étude, afin que les certificats de compétence puissent être émis fin 2015.

ite aux démarches réalisées par la DGAL auprès des ésentants des éleveurs d'animaux à fourrure, ceux-ci ont it appel à un organisme de formation qui a déposé une ande d'habilitation. Celle-ci est en cours d'étude, afin que tificats de compétence puissent être émis fin 2015.

Member state response

thodes d'inspection seront enrichies, dès que possible, d'éléments complémentaires relatifs aux modes opératoires ormalisés, procédures de contrôles des exploitants, et registre ent. Ces éléments seront diffusés aux inspecteurs officiels au travers des vade mecum, formations nationales et échanges de pratique.

Les méthodes d'inspection seront enrichies, dès que possible, d'éléments complémentaires relatifs aux modes opératoires normalisés, procédures de contrôles des ploitants, et registre notamment. Ces éléments seront diffusés aux inspecteurs officiels au travers des vade mecum, formations nationales et échanges de pratique. vade-mecum protection animale en abattoir de boucherie a été mis à jour le 10 septembre 2015 (cf. Document joint SSA2-PAAbB_VM_cle8919fc). Le vademecum protection animale en abattoir de volaille sera mis à jour avant la fin du premier trimestre 2016.

Member state response

struction déclinant la politique des suites dans les établissements agro-alimentaires est en cours de rédaction. Celle- ci établira les lignes directrices à suivre pour les suites administratives et pénales en fonction de l'évaluation des inspections. llèle, dans le cadre de la démarche de pilotage de la performance de la DGAL visant à renforcer l'efficacité de l'action des services déconcentrés, un indicateur relatif aux suites données aux inspections non-conformes pour le domaine va être mise en oeuvre pour 2016. Enfin, ces attendus seront intégrés aux formations nationales destinées aux agents des services vétérinaires d'inspection dès 2015. Page: 1 ort ref. DG(SANTE)/2015-7427-MR of the Audit carried out from 08 April ce at slaughter and during related operations

Une instruction déclinant la politique des suites dans les établissements d'abattage est en rs de rédaction. Celle-ci Page: 1 an submitted by the Competent Authorities of France to the recommendations of Report ref. d out from 08 April 2015 to 17 April 2015 in order to evaluate the animal welfare controls in place at er 2015 tablira les lignes directrices à suivre pour les suites administratives et pénales en fonction de 'évaluation des inspections. Cette instruction devrait paraître avant mars 2016. n parallèle, dans le cadre de la démarche de pilotage de la performance de la DGAL visant à enforcer l'efficacité de l'action des services déconcentrés, un indicateur relatif aux suites onnées aux inspections non-conformes pour le domaine va être mise en oeuvre pour 2016. nfin, ces attendus seront intégrés aux formations nationales destinées aux agents des services étérinaires d'inspection dès 2015.

Member state response

usion des guides de bonnes pratiques, lorsqu'ils seront lidés, devraient permettre cette sensibilisation des responsables tion animale. illeurs, la formation des responsables protection animale dans dre du renouvellement de leur certificat de compétence sera orientée sur ces problématiques.

iffusion des guides de bonnes pratiques, lorsqu'ils seront validés, devraient permettre cette bilisation des responsables protection animale. ar ailleurs, la formation des responsables protection animale dans le cadre du renouvellement de eur certificat de compétence sera orientée sur ces problématiques.

Member state response

L'instruction relative à l'agrément est en cours de modification afin notamment d'y ajouter ces éléments.

'instruction relative à l'agrément est en cours de modification afin notamment d'y ajouter ces léments. elle-ci devrait paraître avant mars 2016. Page: 2 an submitted by the Competent Authorities of France to the recommendations of Report ref. d out from 08 April 2015 to 17 April 2015 in order to evaluate the animal welfare controls in place at er 2015

Member state response

émarches sont poursuivies auprès des fabricants pour leur er les exigences règlementaires. Par ailleurs, un plan d'action relatif aux contrôles des équipementiers va être défini avec l'autorité compétente de ceux-ci ).

s démarches sont poursuivies auprès des fabricants pour leur rappeler les exigences réglementaires. ar ailleurs, un plan d'action relatif aux contrôles des équipementiers va être défini avec 'autorité compétente de ceux-ci (DGCCRF) . es contrôles locaux ont d'ores et déjà eu lieu ponctuellement. En complément la méthodologie es contrôles sera complétée avec la DGCCRF pour mars 2016.

Member state response

méthodes d'inspection seront enrichies d'éléments complémentaires relatifs aux modes opératoires normalisés, s de contrôles des exploitants, et registre notamment. Ces éléments seront diffusés par les vade mecum, les formations et nges de pratique.

s méthodes d'inspection seront enrichies d'éléments omplémentaires relatifs aux modes opératoires normalisés, rocédures de contrôles des exploitants, et registre notamment. e vade-mecum protection animale en abattoir de oucherie a été mis à jour le 10 septembre 2015 (cf. ocument joint SSA2-PAAbB_VM_cle8919fc). e vademecum protection animale en abattoir de volaille era mis à jour avant la fin du premier trimestre 2016. léments seront également diffusés par les formations et es échanges de pratique. Page: 3 an submitted by the Competent Authorities of France to the recommendations of Report ref. d out from 08 April 2015 to 17 April 2015 in order to evaluate the animal welfare controls in place at er 2015

The recommendation states as its basis

In France, official lists of approved and registered establishments are managed at regional level and are publicly available. Each region is responsible for updating their official lists on the basis of information provided by each relevant Département by using the national database of business operators (SIGAL). In 2012 an instruction was issued by DGAL highlighting the need to change the previous codification of establishments handling ABP/DP in order to bring it in line with the EU technical specifications for establishments and plants handling ABP. However, the audit team noted that a number of operators included in the SIGAL database did not appear in the official regional lists. This was also the case of a trader visited during the audit (see paragraph 20). According to representatives from DGAL this is due to the fact that the code-updating phase of registered and approved establishments is not completed yet. Moreover, an official in charge of updating the official lists stated not having time to do this task (see also paragraph 6). This is not in line with requirements laid down by Article 47(1) of Regulation (EC) No 1069/2009.

As regards registration of transporters and traders, a Ministerial Decree was issued in 2011 highlighting the obligation for these business operators to notify their activities to the departmental authorities and, in 2013, another instruction was issued to remind the local competent authorities to update the lists of establishment handling ABP/DP with registered transporters and traders. Moreover, according to representatives from DGAL, a meeting with various associations of business operators was held in 2011 where, among other things, this obligation was clarified. However, the audit team noted that in many cases, transporters and traders did not appear in the official regional lists or their number was very limited. Representatives from DGAL and business operators met by the audit team confirmed this is very likely an underestimation of the real situation. As a result, this is not fully in line with Articles 23 of Regulation (EC) No 1069/2009. 5.2.3 Organisation and planning of official controls Findings

The system of official controls for the traceability of ABP/DP is negatively affected by an early stage of registration process of transporters of ABP/DP and by the unreliability of the relevant official lists of plants, establishments and operators involved in the chain of ABP/DP.

Member state response

DGAL : of Une ordonnance modifiant le code rural et de la pêche maritime ors (partie législative), publiée le 5 juin 2015 (ordonnance n°2015-616 icle du 4 juin 2015 en annexe), officialise la nécessité pour tous les opérateurs de la filière sous-produits animaux d'être enregistrés au titre du règlement (CE) 1069/2009 (art 23). Des sanctions sont prévues par cette loi en cas de défaut d'enregistrement. La liste issue de la base de données nationale (SIGAL) a été mise en ligne le 2 juin 2015 sur le site internet du Ministère en charge de l'agriculture, conformément à l'article 47 du règlement suscité. La mise à jour de cette liste nationale est désormais automatique et quotidienne, sur la base des saisies effectuées par les services en charge des ateliers dans la base de données nationale (Sigal, pour établissements enregistrés, autorisés et agréés). Les listes sont disponibles à partir du lien suivant : http://agriculture.gouv.fr/IMG/pdf/ListeOfficielleEtablissementsSP AN_cle8726ab.pdf Dans le cadre du PNI 2016-2019, l'instruction prévoiera d'insister sur le contrôle de la traçabilité et sur les autorisations nécessaires aux opérateurs de la filière. La grille d'inspection à utilise

The recommendation states as its basis

As indicated in the National Inspection Programme, the frequency of inspections of business operators handling ABP/DP is risk-based. It is determined by applying a formula which, among other things, takes into account the theoretical risk of the plant (on the basis of the nature of the activities and the products handled), the volume of the product placed in the market and the performance of the business operator (determined by the inspector in charge of the official controls). The resulting frequency of inspections may vary from once per year to once every four years. In the Départements visited, the audit team noted that Category 3 processing plants were inspected generally every three years and that the usual duration of an inspection is 2-3 hours. This level of official control does not allow to adequately take into account the risk of diversion or misuse of PAP (see also paragraph 13), therefore, this is not fully in line with Article 3 of Regulation (EC) No 882/2004.

In the Départements visited, inspections were carried out at the planned frequencies and were largely in line with the frequency-criteria established by the National Inspection Programme. However, the audit team noted that the National Inspection Programme does 5 not include some registered business operators, namely transporters and traders handling ABP/DP, without any solid risk-based justifications being provided by the competent authorities and, as a result, these business operators are not subject to planned official controls (see also paragraph 20). This is not in line with requirements laid down by Article 3(3) of Regulation (EC) No 882/2004.

A standard checklist is available for officials to carry out inspections in ABP plants. This checklist consists of a list of generic items applicable to all processing plants. In addition to that, a guide released in 2009 provides further details and legal clarifications. According to the competent authorities the checklist and the guide are going to be updated soon to take into account, among other things, the relevant changes in the legislation. The audit team noted that, although the current checklist (and the draft of the new one) is largely comprehensive, it contains only two-three generic items related to the traceability of ABP/DP. As a result, officials are only required to confirm, or not, if commercial documents and a traceability procedure are present (see paragraph 22) and this could lead to an oversight of the risk of misuse or diversion of ABP/DP. This is not fully in line with Article 3 of Regulation (EC) No 882/2004.

The system of official controls covers a number of operators dealing with ABP/DP, however its effectiveness is negatively affected by the following: a) traders and transporters which are not subject to official controls without a risk based justification and, b) organisation of official controls which only allows superficial checks that cannot ensure enough attention to the risk of diversion or misuse of ABP/DP. 6

In a trader importing fishmeal visited, the audit team reviewed the documentation of three imported consignments of fishmeal in bulk and noted that for one of them no analysis showing the absence of unauthorised constituents of animal origin accompanied the consignment as required by Article 7 of Regulation (EC) No 999/2001 and set out in Section C, Chapter III of its Annex IV. The competent authorities stated that for such consignments of fishmeal, which had been released for free circulation, no analysis was available. The audit team noted that the competent authorities did not know this deficiency because the operator had never been inspected (see paragraph 12). 7 5.3.2 Operator obligations regarding identification, transport and traceability Findings

However, it was noted the following: a) the points related to the origin and the traceability of ABP/DP were not checked in a regular manner or, when checked, it was done in a superficial way. In particular, no checks were carried out which could identify discrepancies between the amounts of materials received and dispatched (e.g. checks on the patterns and congruence of incoming and outgoing material) and only one or two commercial documents were reviewed per inspection. Relevant inspectors stated this was mainly due to lack of time since the inspections usually last 2-3 hours (see paragraph 6); and furthermore in all establishments visited inspectors did not pay attention to the registration of the transporters, partly due to the lack of reliable lists of such business operators (see paragraph 10).

Official controls on ABP/DP are carried out in accordance with the national plan and using a standard checklist but, the fact that there is a very limited confirmation of arrival of consignments of ABP/DP traded from other Member States and that checks on traceability requirements are often carried out in a superficial manner or not at all, negatively affects the ability of the competent authorities to detect any diversion or misuse of ABP/DP (see conclusion 16).

Member state response

DGAL : Pour 2016, et sur la base de la liste nationale publiée, une ls évaluation des risques sera établie concernant les établissements enregistrés et tenant compte des opérateurs susceptibles de and favoriser les usages fautifs ou délictueux de sous-produits animaux icle ou de produits qui en sont dérivés. Selon les moyens disponibles et alloués, une instruction établira un programme national d'inspection qui inclura en particulier les transporteurs et les négociants. 20

The recommendation states as its basis

The audit team noted that, according to data extracted from TRACES, the percentages of consignments with notification of arrival in 2013 and 2014 were the following: Controlled(*) consignments into France Controlled(*) consignments from France Number (% Categories Number (% of Categories of the total) the total) C1: 158 (97.0% of total C1) C1: 383 (16.0% of total C1) 2013 318 (9.5%) C2: 129 (69.0% of total C2) 1020 (13.9%) C2: 49 (37.1% of total C2) C3: 31 (1.0% of total C3) C3: 591 (12.3% of total C3) 2014 - C1: 155 (52.5% of total C1) C1: 314 (30.0% of total C1) C2: 14 (13.0% of total C2) 1st 254 (11.6%) C2: 38 (31.6% of total C2) 809 (18.9%) C3: 481 (27.0% of total C3) semester C3: 61 (3.4% of total C3) (*) consignments with notification of arrival

In all establishments visited, which were receiving consignments of PAP from other Member States, inspectors declared that they do not usually check or require any confirmation of the arrival of consignments from the business operators. The only controls carried out are during a routine inspection (see section 5.2.3) when a number of consignments may be checked. As confirmed by representatives from DGAL, the situation seen in the Départements visited is very likely typical of the whole country. As a result, the current level of notification of consignments of Category 1 and 2 ABP/DP and PAP, traded into or from France, is not in line with Article 48(3) of Regulation (EC) No 1069/2009.

Official controls on ABP/DP are carried out in accordance with the national plan and using a standard checklist but, the fact that there is a very limited confirmation of arrival of consignments of ABP/DP traded from other Member States and that checks on traceability requirements are often carried out in a superficial manner or not at all, negatively affects the ability of the competent authorities to detect any diversion or misuse of ABP/DP (see conclusion 16).

Member state response

GAL : L'instruction datant de 2011 (LDL 01008 du 17/08/2011 modifiée he en 2013) va être reprise en totalité afin de tenir compte des recommandations des audits de 2013 et 2014 en vue d'être en cohérence avec l'article 48 (3) du règlement (CE) 1069/2009. Elle prévoira entre autres une procédure entre les opérateurs recevant les marchandises et les autorités locales afin de faciliter ces contrôles à destination. Elle sera mise en oeuvre en 2016 au plus tard et sera associée à une formation nationale prévue en décembre 2015. Page: 2 petent authority on 3 July 2015 the recommendations of Report ref. DG(SANTE)/2014-7042-MR of the Audit evaluate the traceability of animal by-products (ABP) and derived products and ins of animal origin in feed for aquaculture animals

The recommendation states as its basis

However, the audit team noted that official controls paid limited attention to ensure the actual implementation and effectiveness of the business operator's control systems (see paragraph 22) and transporters and traders of ABP/DP are not subject to planned official controls (see paragraph 10). As an example, one Category 3 processing plant visited consisted of two units, including one handling multi-species ABP (comprising ruminants) which had been authorised in 2012 by the local competent authority to produce bloodmeal for aquaculture. It was noted that in 2012 an inspection took place but during this inspection no specific checks were carried out regarding the traceability, the handling of the products and the risk of cross-contamination, as the plant was not operating at the time and, afterwards, no further inspections were carried out, apart from an official sample to detect the presence of ruminant DNA, taken a few weeks before the audit. This is not in line with the conditions laid down by Article 7 and Annex IV to Regulation (EC) No 999/2001. 5.6.2 Use of PAP for producing compound feed Findings

However, although the inspectors explained that the new requirements for the use of PAP for aquaculture are indirectly taken into account in the context of the review of the Hazard Analysis and Critical Control Points (HACCP) plan, the checklists used do not contain specific points on these provisions (see also paragraph 36). In particular, the audit team noted that these checklists do not contain specific items on transport and were not regularly checked despite this being identified as a potentially important issue in the follow-up of non-compliances (see paragraph 51). As an example, in one feed manufacturer, the audit team noted that one of the previous loads of a lorry carrying PAP in bulk from another Member State consisted of PAP of ruminant origin (lamb). After this load, a cleaning operation was recorded but the inspector in charge was not in a position to confirm neither if this cleaning was based on a documented procedure that had been given prior authorisation by a competent authority nor whether this cleaning would be accepted on the basis of the fact that France does not avail of derogations for transporters (see paragraph 34). This is not fully in line with the conditions laid down by Article 7 and Section B, Chapter V of Annex IV to Regulation (EC) No 999/2001.

Although the restricted scale of production and use of PAP for the production of feed for aquaculture animals (which is mainly traded to other Member States) and the good own- control systems of business operators lower the risk of diversion or misuse of PAP containing proteins of ruminant origin, during inspections, officials generally pay limited attention to the measures implemented by the business operators, in particular in relation to the sourcing of ABP/PAP and their transport. This limits the capability of the competent authorities to ensure that PAP destined to aquaculture does not contain proteins of ruminant origin.

Member state response

to DGAL : 1. action sur la grille d'inspection en sous-produits animaux / produits dérivés (SPAN/PrD) : des items spécifiques relatifs aux éventuelles autorisations (en particulier celles prévues par le règlement 999/2001) ont été créés et le référentiel insiste sur le contrôle des documents d'accompagnement commercial (DAC). 2. action en formation initiale SPAN/PrD : insistera dès de la session de 2015 (novembre) sur le lien entre SPAN/C3 et R 999/2001, et sur la traçabilité des matières (exercices sur les DAC existants seront renforcés) 3. dans le cadre de l'instruction prévue en réponse à la recommandation 3, un point sera prévu pour les usines destinataires fabricant d'aliments pour animaux d'aquaculture utilisant ces protéines animales transformées (PAT). 4. la note de service relative au règlement (UE) n°56/2013 sera modifiée en intégrant les points à contrôler (avec des renvois aux items des grilles, pour que ça serve de vademcum). 5. La base de données SIGAL sera complétée par des éléments (descripteurs, autorisation) permettant l'élaboration des listes d'établissements prévues par le Page: 3 petent authority on 3 July 2015 the recommendations of Report ref. DG(SANTE)/2014-

Member state response

To ensure that the movement of Les structures de production de plants d'actinidia visitées et susceptible plants is in line with inscrites comme appartenant à « un site de production Article 3 of Commission exempt de l'organisme spécifié, [...] dont le niveau Decision 2012/756/EU. In d'isolement et de protection par rapport à l'environnement particular, that the propagation extérieur est tel qu'il exclut effectivement toute présence de material and places satisfy the l'organisme spécifié » étaient en phase d'installation. De fait, requirements for their elles faisaient encore l'objet d'une surveillance et auraient production in points 2 and 3 of fait le cas échéant de mesures de gestion dans leur Annex II to that Decision. environnement des 4500 m. Les autorités françaises reconnaissent que ces structures, auraient dû pour le moment être décrites dans le rapport 2013 comme de simples « lieux de production exempt [...] entourés d'une zone environnante de 500 m et [...] entourée d'une zone de 4 km [...] ». Néanmoins, outre les aspects relatifs à la mise en place tardive des analyses asymptomatiques du fait de la finalisation du développement de la méthode d'analyse asymptomatique, ce

Member state response

To ensure that the sampling for L'ANSES avait d'ores et déjà amorcé courant 2013 un travail the detection of the presence of d'évaluation des tests asymptomatiques en vue de leur asymptomatic infection by déploiement dans le cadre du passeport phytosanitaire Pseudomonas syringae pv européen. Ainsi courant 2013 des analyses asymptomatiques actinidiae is carried out, and avaient d'ores et déjà été réalisées dans le cadre d'un projet that this takes into account the pilote en région Midi-Pyrénées. Comme discuté lors de known technical constraints, in l'audit, il a été annoncé en date du 26/02/2014 que particular, that the samples are l'évaluation de ces tests pour des analyses sur échantillons collected at the optimum time asymptomatiques présentaient dorénavant des résultats and are handled appropriately, convenables (méthode interne ANSES). La méthode est ainsi in order to ensure that the dorénavant considérée comme utilisable pour la réalisation conditions of points 2(e) and 3 d'analyses officielles afin de se conformer à la décision of Annex II to Decision 2012/756/UE. Ces tests ont donc été initiés courant 2014 en 2012/756/EU are complied cohérence avec la note de service en vigu

Member state response

I. - Plan d'actions proposé par la DGCCRF - Au niveau de la région Aquitaine, une journée technique régionale sur le thème « contaminants/HACCP/contrôle des responsables de la première mise sur le marché des denrées alimentaires alimentaires » a été organisée le 18 avril 2013. Le programme et la liste des participants (21 agents) sont joints (PJ n°1). A l'issue de cette journée, il a été convenu de mettre en place une grille méthodologique pragmatique pour l'évaluation des procédures basées sur l'HACCP. La grille ci-jointe (PJ n°2) sera d'abord testée au niveau régional avant d'être généralisée au niveau national. - Au niveau national : une note de service sur le contrôle et l'évaluation de la mise en place et de l'application par les exploitants du secteur alimentaire de procédures fondées sur les principes HACCP telles que prévues à l'article 5 du règlement (CE) n°852/2004 relatif à l'hygiène des denrées alimentaires a été rédigée (PJ n°3). La note est en cours de signature. la grille nationale de cotation des risques utilisée dans le cadre de la procédure CPMM sera précisée pour permettre aux enquêteurs de mieux connaître le type de contaminants à contrôler dans les différentes

Member state response

GAL (I'ACC) a modifié depuis peu son système de collecte des données départementales nécessaires à ation au plan national de l'exécution des différents PNCS et à leur éventuelle adaptation. L'utilisation lusive du système SIGAL depuis 2012 permet une intégration des données de tous les départements au il de l'eau, donc potentiellement plus réactive. Depuis 2012, des extractions sont réalisés au moins deux fois par an sur SIGAL afin de vérifier par filière la conformité des programmes de dépistage (notamment la complétude des PNCS dans chaque département en fin d'année) et pour évaluer les résultats obtenus (en particulier le nombre de contaminations, en décroissance régulière au plan national, et particulièrement dans certains départements de forte production, depuis plusieurs années en filière ponte et stable aux étages reproducteurs de la filière chair). Parallèlement, les contrôles officiels peuvent aussi faire l'objet d'un suivi spécifique par les DDPP dans la base de données SIGAL à partir des interventions prévisionnelles (IP) dont ils sont l'objet. SIGAL permet effectivement de contrôler à tout moment le taux de réalisation des ÌP effectuées pour chaque contrôle officiel pro

Member state response

écution des PNCS est suivie en première intention et dans le détail (suivi par bâtiment et par troupeau n place) au plan départemental par les DDPP (les AC). Ce suivi est effectué de façon continue dans la où les troupeaux sont mis en place tout au long de l'année. suivi réalisé par les DDPP au plan départemental porte sur les dépistages obligatoires effectués par les ofessionnels d'une part et sur les contrôles officiels d'autre part. Les contrôles officiels sont en effet planifiés le cadre de la programmation effectuée chaque année par les chefs de service en DDPP et obligatoire tre de l'assurance-qualité. 'en 2011, les DDPP disposaient de leurs propres outils de suivi sous forme de tableaux spécifiques. s 2012 le suivi est assuré via SIGAL, qui nécessite encore des adaptations de façon à répondre ement aux besoins des départements (DDPP). A cette fin, un tableau de bord à l'échelle de l'exploitation, tait en cours de production au moment de l'audit, a été livré depuis et est en phase de déploiement s des DDPP. illeurs, grâce à l'assurance-qualité, une programmation des inspections est effectuée en début d'année. alisation de cette programmation, qui inclut évidemment les contrôl

Member state response

ction annuelle prévue dans le cadre de la directive 2009/158/CE est rendue obligatoire au plan ional par l'arrêté du 11 octobre 2011 relatif aux conditions de police sanitaire régissant les échanges de les et d'oeufs à couver au sein de l'Union européenne. nes DDPP rencontrent des difficultés pour réaliser l'ensemble de ces inspections. Pour y palier, l'ACC ge d'utiliser la possibilité offerte par la directive 2009/158/CE de confier ces inspections à des inaires habilités au sens de la directive (vétérinaire mandaté au sens de la réglementation française). tion implique l'adoption d'un décret en conseil d'État, de textes d'application et le déploiement de rmations spécifiques. La durée de ces travaux est estimée à 2 ans.

Member state response

: échanges intra-communautaires et contrôles revenant aux ESA r compte de la recommandation, il est proposé d'imposer par voie réglementaire la réalisation de vements tous les quinze jours en bâtiment pour les établissements échangeant régulièrement. Ce stage serait composé de deux échantillons par prélèvement et serait complété par un prélèvement tous nze jours au couvoir, comme déjà effectué actuelement. L'ACC considère en effet que l'alternance de ge en élevage et au couvoir présente un bon compromis entre réactivité du dépistage et meilleure ssements n'échangeant que de façon sporadique, il est proposé de maintenir un rythme de rélèvements de toutes les huit semaines en bâtiment et de tous les quinze jours au couvoir, et d'imposer en églementairement la réalisation d'un dépistage en bâtiment tous les quinze jours. Ce dépistage renforcé ous les quinze jours serait composé d'un prélèvement de deux échantilllons et serait obligatoire au ins un mois avant l'échange. Il est proposé de soumettre ces dispositions à une évaluation de l'Anses. int 2 : réalisation des prélèvements de confirmation est prévu de modifier les arrêtés de lutte contre les salmonelles dans les filières ponte, G

Member state response

identique aux points 1 et 2 en ce qui concerne les objectifs relatifs à l'échantillonnage officiel. de la pratique de l'échantillonnage de confirmation en routine, l'arrêté lutte vrier 2008 relatif à la filière ponte d'oeufs de consommation prévoit la prise d'un APDI direct, sans ts de confirmation, dans le cas où il a été mis en évidence un lien épidémiologique entre exploitation présentant une positivit et une TIAC. Action Proposed by the Competent Authority dentique aux points 1 et 2 en ce qui concerne les objectifs relatifs à l'échantillonnage officiel. table, la fréquence des contrôles officiels visant les cheptels reproducteurs de dindes a changé en passant de seulement 10 % des troupeaux à contrôler à la totalité (100 %). Cette importante ification a entraîné des difficultés pour les quelques DDPP où sont concentrés les élevages de dindes oductrices. onformément à l'évaluation des moyens nécessaires à la réalisation des PNCS, effectuée par les DDPP (AC) en concertation avec la DGAL (ACC), les départements rencontrant ces difficultés ont signalé l'impossibilité de répondre au PNCS visant les dindes reproductrices en transmettant une FROS au cours de l'année 2013 comme indiqué

Member state response

DGCCRF : La DGGCRF tient tout d'abord à souligner que les délais observés par l'OAV correspondent aux délais globaux nécessaires à la réalisation de l'ensemble des analyses effectuées sur un échantillon (jusqu'à 10 analyses sont possibles pour un échantillon). Le délai final correspond au délai nécessaire à l'analyse la plus longue. Ces analyses concernent à la fois la vérification de la loyauté de l'aliment pour animaux (composition du produit) et celle de sa sécurité. Afin d'améliorer les délais sur les analyses relatives à la sécurité, quatre pistes d'amélioration vont être poursuivies : Une réorganisation et un renforcement de l'équipe du laboratoire de Rennes : création d'un pôle « broyage » transversal pour réduire les délais sur cette opération Renforcement du pôle « revue de demandes et édition des rapports d'essais » grâce à l'implication des responsables des sections analytiques concernées. Renforcement de la section « additifs », qui présente les délais les plus longs, et qui se verra affectée 2 agents supplémentaires courant 2014. Regroupement des sections « Analyses de base » et « Analyses minérales » Une adaptation des méthodes d'analyses pour privilégier les méthodes

Member state response

DGCCRF : Une note de service détaillant les spécificités des trôles officiels sur les dispositions relatives à l'alimentation animale pour les coproduits des établissements n'exerçant pas une activité principale en alimentation animale sera rédigée. La note de service « Contrôle et évaluation de la mise en place et de l'application, par les exploitants du secteur alimentaire, de procédures fondées sur les principes HACCP telles que prévues à l'article 5 du règlement (CE) n°852/2004 relatif à l'hygiène des denrées alimentaires » (actuelle NS 2013-18) sera également modifiée afin de faire référence aux contrôles relatifs aux coproduits destinés à l'alimentation animale. DGAL : La note de service « Procédure d'agrément et composition du dossier d'agrément pour les établissements manipulant et préparant des denrées alimentaires d'origine animale » du 12 juin 2012 (annexe 1) inclut, dans le paragraphe relatif à la description des activités de l'entreprise, le contrôle de la destination, au sens des règlement (CE) n°183/2005 et (CE) n°1069/2009, des sous- produits générés et/ou des denrées alimentaires retirées de la consommation. Le contrôle spécifique de ces activités sera modifié dans

Member state response

Comme indiqué dans la note envoyée à la Commission le 14 mars n 2014 (LRP 162-14 annexe 2), les autorités françaises rappellent tout d'abord que selon leur interprétation, l'obligation Page: 3 nts published in a separate annex can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3270 eport ref. DG(SANCO)/2013-6750 -MR of a/an audit carried out from 14 the identification of hazards and management of risks along the feed chain ale aire animale nts rs ou à médiaires lle de la faciliter les ité r de ous une en idé pour t faciliter de renforcer entes. n d'action sionnels eurs trement eurs elé aux égionaux nts published in a separate annex can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3270 eport ref. DG(SANCO)/2013-6750 -MR of a/an audit carried out from 14 the identification of hazards and management of risks along the feed chain lors des formations des inspecteurs relatives à la sécurité itaire des aliments.

Member state response

r Les autorités françaises rappellent tout d'abord qu'à leur sens, 'obligation de se fournir auprès d'établissements enregistrés ne cerne que les fabricants d'aliments composés et les éleveurs, et pas nécessairement les producteurs de matières premières. CRF : Un courrier de rappel sur l'obligation de se fournir en ments pour animaux auprès de fournisseurs enregistrés a été oyé le 12 mars (annexe 3) aux syndicats professionnels des ricants d'aliments composés (SNIA, Coop de France Nutrition male, AFCA-CIAL et FACCO). nécessité de contrôler ce point sera rappelée aux agents de la CRF via une note de service. Il a d'ores et déjà été demandé enquêteurs de contrôler le respect de cette obligation lors des ns de prélèvement ou des enquêtes ciblées programmées pour 4 (cf. TN 32 GD en annexe 4 ou TN 31 GP en annexe 5 par mple) et de mettre en oeuvre les suites pénales et inistratives appropriées en cas de non-respect de cette position. L : Un courrier de rappel sur l'obligation d'enregistrement a envoyé aux organisations professionnelles des éleveurs afin leur rappeler leurs obligations de se fournir auprès tablissements du secteur de l'alimentation animale dûment egistrés voire agréés. L

Member state response

formation continue en alimentation animale, réalisée de e: 5 nts published in a separate annex can be found at: http://ec.europa.eu/food/fvo/rep_details_en.cfm?rep_id=3270 eport ref. DG(SANCO)/2013-6750 -MR of a/an audit carried out from 14 the identification of hazards and management of risks along the feed chain anière conjointe par la DGCCRF et la DGAL, comportera une ession sur le contrôle du plan HACCP auprès des opérateurs ettant sur le marché des coproduits à destination de 'alimentation animale (cf. plan de formation en annexe 6). es autorités françaises souhaiteraient par ailleurs que les ormations sur l'HACCP en alimentation humaine dans le cadre es BTSF (better training for safer food) comportent un module ur les particularités du contrôle de l'adéquation du plan HACCP ux cas des coproduits destinés à l'alimentation animale. GCCRF : ne enquête ciblée a été programmée en 2014 sur le contrôle ACCP des opérateurs de l'alimentation animale « industriels » dont l'activité principale n'appartient pas au secteur de l'agro- limentaire) (TN 31 GP en annexe 5). e contrôle des coproduits de l'industrie agro-alimentaire destinés l'alimentation animale sera effectué à l'occasion des

Member state response

ion de l'OAV concerne les contrôles officiels à e à la destruction par vandalisme d'un essai au champ. ons officielles transmises aux services régionaux en charge e ces essais contiennent déjà toutes les dispositions la mise en oeuvre des contrôles requis par l'article 4.5 de la 1/18/CE, y compris en cas de destruction des essais par d'une mise en oeuvre complète de ces instructions, cas de destruction des essais par vandalisme, a été rappelée des 7 et 8 août 2012 aux services régionaux concernés.

Member state response

e 2001/18/CE relative à la dissémination volontaire mes génétiquement modifiés (OGM) dans l'environnement on article 21.2, le principe de seuils d'exemption d'étiquetage sence fortuite d'OGM dans des produits conventionnels. A aleur de ce seuil n'est connue que pour les OGM destinés à ent transformés : la valeur de 0,9% (à l'instar des filières de n humaine et animale, a en effet été retenue). En revanche, 'est fixé pour la filière « semences » bien que ce point de discussions communautaires depuis 2001. françaises ont, à plusieurs reprises, rappelé le caractère e la définition au niveau européen de seuils de présence les semences. ns du Conseil du 4 décembre 2008, sous Présidence ppelaient la nécessité de fixer de tels seuils et invitaient la Page: 1 ef. DG(SANCO)/2012-6318-MR of an audit carried out modified organisms, in particular with regards to seeds Commission européenne à définir ces seuils de présence fortuite le plus rapidement possible. En effet, faute de seuil réglementaire, il semble difficile d'exiger l'étiquetage des semences en tant que semences génétiquement modifiées lorsque des traces d'OGM sont détectées à un niveau inférieur à 0,1% dans la mesure où, d'une part

Member state response

par l'OAV, le champs du contrôle des semences mises été étendu aux lots de semences génétiquement a campagne 2012-2013 en cours, la TN envoyée par la PP et DDCSPP impliquées dans ces contrôles prévoit a conformité de l'étiquetage et de la traçabilité des lots de u regard de l'article 21 de la directive 2001/18/CE et de age: 2 ef. DG(SANCO)/2012-6318-MR of an audit carried out modified organisms, in particular with regards to seeds u réglement (CE) n°1830/2003. La DGCCRF tient cette TN à e l'OAV. formation sur ce point a été dispensée aux inspecteurs seau "Semences-OGM" à l'occasion de la réunion du est tenue les 5 et 6 juin 2012. Le compte-rendu de la réunion léments de cette formation.

Member state response

ndé par l'OAV, une analyse de risques a été réalisée en juin te des résultats des contrôles antérieurs ainsi que des iques et économiques du secteur des semences. de risques prend en compte les trois paramètres suivants : production ; s et variétés de semences ; des semences. de risques est développée dans la TN envoyée par la PP et DDCSPP impliquées dans le contrôle des lots de la campagne 2012-2013 en cours. Elle sera reconduite pour orienter les contrôles. La DGCCRF tient cette TN à e l'OAV. oint a été abordé avec les inspecteurs du réseau "Semences- la réunion qui s'est tenue à Rodez les 5 et 6 juin 2012.

Member state response

SCL de Strasbourg va demander à intégrer la matrice portée flexible, lors de son prochain audit de t COFRAC (Comité français d'accréditation) de janvier campagne 2012-2013, les analyses visant à mettre en résence éventuelle de semences GM dans les lots de olza seront accréditées. Page: 3 ef. DG(SANCO)/2012-6318-MR of an audit carried out modified organisms, in particular with regards to seeds Le laboratoire BioGEVES est disposé à inclure toutes les méthodes utilisées pour les analyses officielles dans le champ de son accréditation. Il propose d'inclure les 13 méthodes manquantes à l'occasion de son prochain audit de renouvellement. Cet audit devrait être planifié par le COFRAC en 2014. Par ailleurs, bien que tous les laboratoires nationaux de référence français pour les OGM disposent d'une accréditation selon la norme ISO 17 025 pour le champ des OGM, la multiplicité des analytes, matrices et méthodes et de leurs combinaisons rend difficile l'accréditation pour l'ensemble des cas possibles. La révision du règlement (CE) n° 882/2004 en cours a permis de réexaminer les exigences de l'article 12 et la Commission a bien identifié la nécessité de prévoir une période de désignation trans

Member state response

énérale de l'alimentation veillera à ce que la procédure de prévue par le Manuel qualité national soit appliquée ent aux essais d'OGM, à savoir l'envoi d'une fiche de nterne par la DGAL au SRAL lorsqu'un écart entre une t le travail réalisé est constaté. Les instructions officielles essais d'OGM au champ ont été modifiées en ce sens par la ce du 9 août 2012. Page: 5

Member state response

L'audit de l'OAV 2012-6633 portant sur l'efficience de notre organisation a conclu au respect des riptions du règlement (CE) N°/882/2004. L'accréditation à la norme ISO 17020 attribuée par le COFRAC garantit le respect de ce même règlement ainsi que celui de la Décision du nseil 2006/677 en matière de dispositif d'audit interne. Lors des groupes de travail Audit Network organisés par la Commission, il a été acté qu'un dispositif croisé d'audit, horizontaux et verticaux, permettait de satisfaire à cette obligation. Extrait du CR du groupe Audit Network animé par *(please note that it has been necessary to delete this text in order to respect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality) : "Full coverage during a 5-year cycle can be achieved by using a combination of horizontal and vertical audits combined with annual review of negligible risk areas. On the basis of the output of the risk-based planning process, the areas identified as high-risk should be covered using both horizontal and vertical audits, while low-risk areas can be covered by a lower frequency of horizontal audits. Negligible risk audit areas can be considered as being covered, when

Member state response

Actuellement, pour le contrôle des paramètres environnementaux, les vademecum concernant la protection animale fournissent aux inspecteurs une procédure documentée pour réaliser une évaluation sensorielle à laquelle s'ajoute une observation des animaux et un examen du registre d'élevage. (Cf P.J. Rec. 4.0) L'équipement nécessaire à la réalisation des contrôles officiels est une préoccupation importante de la DGAl et du bureau de la protection animale, notamment depuis l'accréditation de nos services au titre de la norme ISO 17020. Dans ce contexte, la mesure des paramètres environnementaux requière des procédures particulières liées à la qualité de la mesure. La exion sur ce sujet s'inscrit dans la définition globale de la politique de métrologie de la DGAL. En 2011, conformément aux engagements pris suite à l'audit 2010-8390, deux agents de l'AC ont été formés à la métrologie. Le bureau de la protection animale a rencontré différents professionnels (techniciens d'élevage, spécialistes de la mesure, fabricants de matériels), et a testé divers matériels. Enfin, le recensement des besoins en matériel relatif à la protection animale a été effectué, comme le montre la note jointe en an

Member state response

sence d'aire de picotage-grattage et l'absence de litière dans les cages aménagées est relevée les inspecteurs comme une non conformité. Cependant, les éleveurs disent rencontrer une impossibilité technique à satisfaire à cette obligation. En effet, les observations effectuées dans les élevages équipées montrent l'accumulation de fientes sur cette aire, une tendance des poules à y pondre en dehors du nid. Les oeufs produits sont sales ce qui peut entrainer des problèmes sanitaires, l'infestation de poux est supérieure et le gaspillage d'aliments est augmenté ce qui est moralement et économiquement inacceptable. Les autorités compétentes prévoient une saisine de l'ANSES au second trimestre 2013 afin d'évaluer les dispositifs actuels et de définir les dispositifs utilisables en élevage au vu des contraintes pratiques et sanitaires.

Member state response

qui concerne les procédures relatives au point 6 de l'annexe I et au point 3 de l'annexe II la directive 2007/43/CE sur la protection des poulets destinés à la production de viande, le cum « inspection PA d'un élevage de Gallus gallus (arrêté ministériel du 28/06/2012) » fournit des indications méthodologiques pour effectuer des mesures "sensorielles" ou vérifier enregistrement d'hygrométrie de l'éleveur. L'approche sensorielle donne un avis global prenant compte les critères requis mais ne permet pas d'obtenir la comparaison au référentiel chiffré préconisée par la réglementation. Le vademecum prévoit le recours éventuel à une mesure appareillée, renvoyant à un vademecum général sur les mesures en protection animale qui iste pas à ce jour. (PJ Rec. 4). Le choix de l'achat de matériel et les procédures documentées qui s'y référeront sont dépendantes de l'avancée du dossier concernant la métrologie, exposé au at point 2 de ce document. En ce qui concerne la délivrance des dérogations pour l'élevage à des densités élevées correlées au calcul de divers taux de mortalité, l'autorité compétente prévoit une évolution des indications 4/7 Action Proposed by the Competent Authority du vadem

Member state response

L'instruction relative au contrôle d'un véhicule en vue de la délivrance de l'agrément pour les s de plus de 8 heures (article 7.1 du règlement (CE) n°1/2005), est finalisée. Les orientations y sont données aux inspecteurs pour l'évaluation du respect de chacune des exigences de l'annexe I chapitre II (moyens de transport) et chapitre VI (dispositions particulières pour les voyages de longues durées) du règlement (CE) n°1/2005, parmi lesquelles les points 2,3 et 3,2 du chapitre VI (PJ Rec.5.1). L'ensemble des dispositions réglementaires concernées sont listées dans une grille de synthèse réglementaire (évaluation de conformité, ou non, à chacun de ces points) : (PJ Rec.5.2.)

Member state response

Une instruction particulière (PJ Rec.6.1) a été envoyée aux autorités compétentes locales des r départements concernés pour rappeler les obligations de l'article 5h du règlement (CE) 255/97 (notification de l'information visée à l'annexe I point C7), et notamment le contenu complet de cette information prévu au point C7 de l'annexe I, dont certains éléments font défaut dans certains postes de contrôle. Un modèle de document de notification, associé à un modèle de registre y sont joints. Toutefois, les autorités françaises sont confrontés à un problème juridique : le point C7 exige la mention de l'adresse des convoyeurs, mais cette mention n'est pas prévue sur les modèles de certificat de compétence dont la présentation est obligatoire en cours de transport. Or les services 5/7 roposed by the Competent Authority ires français n'ont pas compétence juridique (et les responsables des postes de contrôle oins) à exiger d'autres documents sur lesquels figureraient cette information lle. En conséquence, seules les informations figurant sur le certificat de compétence être notée sur le registre des postes de contrôle, à savoir les nom/prénom des urs et les numéros de leurs certificats de co

Member state response

ux procédures alternatives au passage devant un juge peuvent être envisagées pour accélérer le traitement pénal des constats d'infraction et permettre une application plus effective des sanctions : l'amende forfaitaire recouvrable sur place moyennant une minoration du montant théorique re qui peut être très efficace dans le cadre des contrôles sur route, car immédiatement le), transaction pénale permettant à l'administration de soumettre une proposition de sanction au procureur sans passer devant un juge (cette procédure permet d'envisager des peines ntaires qui peuvent se révéler plus dissuasives qu'une simple amende minorée). r une nature d'infraction donnée, ces deux procédures sont exclusives l'une de l'autre : urquoi une re-définition des infractions notamment aux dispositions des règlements (CE) et (CE) n°1255/97 est en cours, afin de bien déterminer la procédure la plus judicieuse nvient de prévoir pour chacun des manquements possibles aux dispositions de ces ts. dispositifs nécessaires à la mise en oeuvre de transaction pénale sont en place : bases instructions aux services, dispositif de formation. Néanmoins, cette procédure représente 6/7 etent Authority vailler pour les

Member state response

le port (FR MRS 1) ­ Hangar 14 e préciser que les circuits d'eaux usées des zones import et export pendants, le PIF disposant d'une fosse de rétention qui lui est 'atteste la procédure de gestion ci-jointe (cf. gestion des maritime de Marseille (GPMM) a confirmé par écrit sa volonté de nouveau centre d'inspection pour les animaux vivants avant l'été rier du GPMM). , le règlement d'exploitation du Hangar 14 sera modifié afin de éparation dans le temps des flux import et export des équidés, la systématiquement donnée aux activités du PIF. La modification du finalisée au cours du 1er semestre 2013. ue (FR DKK 1) maritime de Dunkerque (GPMD) a réagi promptement à la suite n OAV. Dès le 9 octobre 2012, une 1re réunion a été organisée en e CABAU-WOEHREL, présidente du directoire du GPMD, et chef du PIF. Elle a été suivie de 6 autres réunions, la t prévue le 16 janvier 2013. Le GPMD s'est engagé à présenter restructuration finalisé avant le 1er février 2013. roux-Déols (FR CHR 4) aéroportuaires de Châteauroux se sont engagées à présenter, vril 2013, un projet de nouvel agencement des locaux afin de Page: 1 Action Plan received from CA on 15 January 2013 (SANCO)/2012-6511-MR of an audit ca

le port (FR MRS 1) ­ Hangar 14 e préciser que les circuits d'eaux usées des zones import et export pendants, le PIF disposant d'une fosse de rétention qui lui est 'atteste la procédure de gestion ci-jointe (cf. gestion des maritime de Marseille (GPMM) a confirmé par écrit sa volonté de nouveau centre d'inspection pour les animaux vivants avant l'été rier du GPMM). , le règlement d'exploitation du Hangar 14 sera modifié afin de éparation dans le temps des flux import et export des équidés, la systématiquement donnée aux activités du PIF. La modification du finalisée au cours du 1er semestre 2013. ue (FR DKK 1) maritime de Dunkerque (GPMD) a réagi promptement à la suite n OAV. Dès le 9 octobre 2012, une 1re réunion a été organisée en e CABAU-WOEHREL, présidente du directoire du GPMD, et chef du PIF. Elle a été suivie de 6 autres réunions, la t prévue le 16 janvier 2013. Le GPMD s'est engagé à présenter restructuration finalisé avant le 1er février 2013. roux-Déols (FR CHR 4) aéroportuaires de Châteauroux se sont engagées à présenter, vril 2013, un projet de nouvel agencement des locaux afin de Page: 1 rding PIF de Chateauroux-Déols (FR CHR 4) .europa.eu/food/fvo/rep_details_en.cfm?re

Member state response

'agrément des CR Les dispositions réglementaires ont été réactualisées notamment par l'arrêté du e l'Union 16 décembre 2011 pour répondre à l'ensemble des objectifs fixés par la sur cet agrément, législation communautaire notamment la séparation des flux d'animaux anière suffisante le destinés au commerce national de ceux destinés à l'expédition vers un autre ons et exigences Etat membre et le respect des procédures de nettoyage et désinfection. Pour les centres de rassemblement se destinant au commerce d'animaux vers les autres Etats membres, la fréquence des contrôles de l'agrément par la DD(CS)PP devrait être a minima annuelle. La vérification des conditions d'agrément sera complétée d'une part par un vétérinaire désigné à cet effet (voir réponse à la recommandation 6) et d'autre part lors de la supervision du vétérinaire certificateur par la DD(CS)PP dans le centre de rassemblement ou par le biais des certificats émis.

Member state response

es à l'article Le code rural et de la pêche maritime a été récemment modifié et répond à cette es procédures recommandation. ux articles 54 et L'article R. 233-3-7 prévoit que lorsque la DD(CS)PP constate un manquement à l'application des dispositions relatives au centre de rassemblement, ou aux dispositions communautaires et nationales applicables aux maladies contagieuses, à l'identification et à la tenue du registre d'élevage, aux notifications des mouvements des animaux, à la protection animale, ou aux conditions de circulation des animaux, il rédige un rapport et le transmet au préfet, qui peut suspendre ou retirer l'agrément. Le préfet met en demeure le responsable du centre de rassemblement de se conformer aux exigences qu'il lui prescrit dans un délai qui n'excède pas trois mois. Pendant ce délai, le préfet peut prononcer la suspension de l'agrément. A l'issue de ce délai et en l'absence de mise en conformité, le préfet prononce le retrait de l'agrément. page: 1 dations du rapport de mission réf. DG(SANCO)/2011-6043 réalisée du 20 au 29 septembre sanitaire dans le cadre des échanges de bovins à l'intérieur de l'Union européenne Action Proposed by the Competent Authority En

Member state response

ne faisant l'objet La première étape de la réponse consiste à s'assurer que les élevages sont llement indemnes effectivement suspendus lorsque cela est prévu par la réglementation. Pour cela l'article 6, trois actions sont prévues, qui seront définies dans une note de service prévue ve 64/432/CEE. pour mars 2012 : a. Former les vétérinaires et sensibiliser les éleveurs sur la réalisation des tests, la détection et la déclaration des suspicions. Cette action avait commencé avant l'audit et se poursuivra durant 2012 et 2013. b. Poursuivre ou développer la supervision des vétérinaires de différentes façon: d'une part en faisant le suivi statistique du nombre de résultats non négatifs obtenus par élevage afín de cibler des contrôles de supervision là où la faible proportion de résultats non négatifs est suspecte, effectuer des contrôles sur place par la DD(CS)PP pour vérifier la bonne exécution des dépistage et organiser en cas de doute le contrôle de certains animaux par le test interferon gamma. c. Rappeler aux DD(CS)PP les circonstances de suspension de qualification et les modalités de leurs notifications. La deuxième étape de la réponse consiste à limiter le risque que des bovins

Member state response

ent et conservent Une note de service sera publiée en mars 2012 pour les points 1 à 3 suivants : bovine dans le 1. Rappeler aux DD(CS)PP les conditions d'allégement des prophylaxies et d'âge e la directive au dépistage et augmenter l'intensité de dépistage lorsque cela s'avère toire français dans nécessaire, y compris en imposant des contrôles de vente sur les animaux tuberculination ou destinés à l'élevage. fectue pas à un font l'objet d'une 2. Simplifier et réviser les modalités de gestion des suspicions pour tous les sont soumises à un départements. age de la Préciser que lors d'IDS ou d'IDC non négatives, la qualification doit être tive dont on suspecte une réaction non né) doivent soit être testés 6 semaines plus diagnostique. Si l'interprétation du test est et l'animal doit être abattu et la levée de ntervenir qu'à la suite d'un contrôle de plus de 6 semaines, 42 jours après circonstances où un microbisme trôle de tous les animaux par dosage de de l'IDC. é en première intention, si dans un cheptel bservées et qu'il n'y a pas eu de cas page: 3 dations du rapport de mission réf. DG(SANCO)/2011-6043 réalisée du 20 au 29 septembre sanitaire dans le cadre des échanges de bovins à

Member state response

nitaire des Une note de service est prévue pour mars 2012 pour les points 1 et 2 ectués sur les 1. Modifier l'instruction relative à la réalisation des intradermotuberculinations. dispositions visées Insister sur le fait que la lecture des IDS et des IDC au cutimètre doit être la règle générale et que les résultats des mesures doivent être conservés. Préciser que lorsque la mesure au cutimètre n'est pas possible pour des raisons liées aux conditions de manipulation des animaux et qu'une lecture papalpation est faite, il convient de le noter et de tracer l'information. Dans ce cas, si une réaction page: 4 dations du rapport de mission réf. DG(SANCO)/2011-6043 réalisée du 20 au 29 septembre sanitaire dans le cadre des échanges de bovins à l'intérieur de l'Union européenne ority thode alternative impliquant deux mesures site d'injection, l'autre sur une site de de l'encolure), les résultats doivent être fs enregistrés dans SIGAI. Continuer les ur évaluer la variabilité des mesures de esquelles la méthode de mesure au jour de négative est considérée comme non t en cours de détermination, cette est enregistrée dans SIGAI et que les s du reste du troupeau. de l'interféron gamma. été modi

Member state response

L'annexe III de l'arrêté du 18 mai 2009 fixe la liste des Points d'entrée communautaires (PEC). Une copie de la dernière version de cet arrêté, date du 25 janvier 2012, sera transmise sans délai aux services de la Commission.

Member state response

Des instructions officielles seront rédigées afin qu'un visa d'entrée soit apposé par le service compétent sur l'original du certificat phytosanitaire, certificat phytosanitaire de re-export, indiquant le nom du service et la date de soumission du document. (Echéance 30 juin 2012).

Member state response

Des instructions officielles seront rédigées afin que l'original du ificat phytosanitaire soit annulé par le service compétent par l'apposition d'un triangle rouge indiquant le nom du service et la date du . (Echéance 30 juin 2012).

Member state response

torités compétentes poursuivront leur efforts en vue de réduire les s de notification par l'intermédiaire d'Europhyt, particulièrement dès qu'un organisme nuisible a été détecté et identifié.

Member state response

vision complète du dispositif d'agrément des structures au titre de ective 2008/61/CE est en cours. Elle prévoit notamment d'inclure édure de suivi des structures agréées pendant la durée de leur de confinement. (Echéance 31 décembre 2012).

Member state response

rités compétentes veilleront désormais à informer via Europhyt s Membres par lesquels des lots de produits figurant dans V-B de la Directive 2000/29/EC ont été introduits sans contrôle re. (Echéance 30 juin 2012).

Member state response

s compétentes souhaitent que la nécessité de cette dation soit revue à la lumière des commentaires joints au e rapport. Pour clarifier complètement la situation, les autorités ntes proposeront par écrit aux services de la Commission ription dans l'Annexe V-B de la Directive 2000/29/EC de certains actuellement non réglementés provenant de certains pays.