Belgium

The recommendation states as its basis

The audit team noted, according to data in TRACES-NT for 2024, that in the vast ma- jority (over 90%) of cases of consignments in transit, confirmation of arrival and compli- ance of consignments had been completed in part III of the relevant CHEDs at either the BCPs of exit or the approved warehouses. However, at the warehouse visited, the audit team observed that the identity check on arrival of consignments at this warehouse was mainly based on information provided by the operator rather than the performance of an identity check, which was not in line with Article 26(4)(a) and (b) of Delegated Regula- tion (EU) 2019/2124 nor has the FASFC exempted consignments from those checks or updated its procedures to allow the derogation provided in Article 27(3) of the same Regulation.

For consignments of goods of animal origin in transit to United States' army bases locat- ed in the EU, the staff at one BCP allow the identity checks to be carried out based in part by information provided by the terminal operator on such consignments. This prac- tice is not in line with Article 49(1) of the OCR and Article 3(1) and (2) of Implementing Regulation (EU) 2019/2130.

Regarding the evaluated cases of consignments of goods in transit to vessels located in ports in other Member States, the audit team noted that an official certificate in accord- ance with the model laid down in Part I of the Annex to Commission Implementing Reg- ulation (EU) 2019/2128 had been issued in each case. The certificates, however, were not always completed in line with the requirements set out in Article 5 and Part 2 of the An- nex to Implementing Regulation (EU) 2019/2128.

At one BCP, the arrival of the consignments of goods in transit to vessels had not been confirmed for the 25 certificates issued in 2024 and follow-up measures were not ap- plied, which is not in line with Articles 30 and 31(5) of Delegated Regulation (EU) 2019/2124, although BCP staff had sent several reminders to the warehouse operator.

The audit team further noted that the FASFC did not ensure that the warehouse operator did submit a CHED in TRACES-NT for consignments transported from the warehouse to exit BCPs to be delivered to supply vessels in ports in third countries, and consequently failed to authorise the movement by finalising the CHEDs which must accompany con- signments. This is not in line with Article 28(a) and (b) of Delegated Regulation (EU) 2019/2124. The competent authorities instead issued an official certificate in accordance with the model laid down in Part I in the Annex to Implementing Regulation (EU) 2019/2128. 5.2.4 Documentary, identity and physical checks of consignments 5.2.4.1 Checks on consignments of animals

The FASFC stated that, with the exception mentioned in finding 30, identity checks are full checks or limited to a check on the seals on containers or means of transport in line with Article 3(1) and (2) of Implementing Regulation (EU) 2019/2130.

The official controls on animals and goods entering the EU through BCPs in Belgium are generally carried out in line with relevant EU legislation, documented procedures and planned arrangements. However, some shortcomings were noted in the performance of official controls on consignments of goods of animal origin in transit, which potentially weaken the guarantee that only compliant goods enter the Union.

The recommendation states as its basis

The audit team noted that seven inspection centres visited as part of the BCPs Antwerp Port, Brussels airport and Zeebrugge Port, of which three inspection centres were also designated as control points, were not compliant with certain minimum requirements for BCPs laid down in Articles 53(1)(a) and Article 64(3) of the OCR, and Articles 3, 4 and 8(2) of Implementing Regulation (EU) 2019/1014, for the categories of goods for which they had been designated.

The audit team noted the following non-compliances at these seven inspection centres, which, with one exception, remained undetected or were not recorded in the FASFC con- trol reports: · there was no room for storage of frozen goods of non-animal origin at the inspection centre Keurpunt at the BCP Antwerp Port, which is not in line with Article 3(1)(c) of Implementing Regulation (EU) 2019/1014. · there was no room for storage of frozen goods of non-animal origin at the inspection centre I.D.P. at the BCP Antwerp Port, part of the walls in the storage area for ambi- ent goods was not easy to clean and disinfect and part of the storage equipment (racking) was rusty, which is not in line with Articles 53(1)(a) and 64(3)(h) of the OCR and Article 3(1)(c) and (2) of Implementing Regulation (EU) 2019/1014. · at the inspection centre Luiknatie at the BCP Antwerp Port, the inspection area for controls on goods of non-animal origin was not kept clean, which is not in line with Article 64(3)(h) and (i) of the OCR. · the unloading area for containerised goods at the inspection centre Flanders Cold Centre 2/BNFW at the BCP Zeebrugge Port, is not covered with a roof, containers are unloaded at about 12 meters from the facilities, the walls of the facilities are not 14 easy to clean and disinfect, part of the walls were not maintained, and inspection equipment was not kept clean, which is not in line with Articles 53(1)(a) and 64(3)(h) of the OCR and Article 3(1)(a) and (c), and (2) of Implementing Regulation (EU) 2019/1014. · the facilities for unloading and storage of goods of animal origin not intended for human consumption at the inspection centre NHC-dnata Belgium at the BCP Brus- sels Airport were not easy to clean and disinfect and were not kept clean, which is not in line with Article 64(3)(h) of the OCR and Article 3(1)(c) of Implementing Regulation (EU) 2019/1014. · the size of the facilities at the inspection centre Worldwide Flight Service Belgium nv at the BCP Brussels Airport was not suitable for the volume of goods of animal origin handled at this inspection centre, which is not in line with Article 64(3)(b) of the OCR. The BCP staff informed the audit team that this issue was identified during its verification visits, resulting in three administrative sanctions. The staff stated that a subsequent verification visit with findings of non-compliance may lead to the sus- pension of activities of this inspection centre for this category of goods. · the BCP staff provided the audit team with reports of recent verification visits in which it reported non-compliances identified, along with corrective actions taken, at the inspection centre Eurofruitports at the BCP Antwerp Port. The audit team, how- ever, identified the following additional findings regarding operational hygiene and maintenance of the facilities, which are not in line with Articles 53(1)(a) and 64(3)(h) and (i) of the OCR and Articles 3(3) and 4(2)(a) of Implementing Regula- tion (EU) 2019/1014: o The unloading, inspection and storage areas were poorly maintained and not clean or easy to clean o The inspection area was not equipped with a table with a smooth washable surface easy to clean and disinfect. o The inspection area contained a storage cabinet with equipment both of which were dirty.

The audit team visited one control point designated by the competent authority for the performance of identity and physical checks on consignments of plants and noted that it was not compliant with the minimum requirements for BCPs, which is not in line with Articles 53(1)(a) and 64(3)(h) and (i) of the OCR, and Article 3(1)(b), (2) and (3) of Im- plementing Regulation (EU) 2019/1014 for the following reasons: · A container used for storage of quarantined goods, and the area surrounding it, were not maintained and kept clean. · Part of the fittings (racking) in a storage area for detained consignments were rusty and therefore not easy to clean. · One of the two inspection areas was not clean or maintained and easy to clean and did not have a supply of hot and cold running water. The competent authorities stat- 15 ed that it did not allow use of the exemption laid down in Article 3(6)(a) of Imple- menting Regulation (EU) 2019/1014. Conclusions on the compliance of border control posts with minimum requirements

The BCPs, including inspection centres thereof, and the control points visited were, with two exceptions, not compliant with certain minimum requirements for BCPs for the cate- gories of goods for which they had been designated. Consequently, the Belgian authorities cannot guarantee that compliant facilities are in place for the proper handling of goods and the prevention of risks which may result from cross-contamination.

The recommendation states as its basis

The audit team scrutinised documentation of FeBOs on manufacturing medicated feeds in all visited establishments. In general, prescriptions, recipes and labels of medicated feeds were available. The audit team randomly assessed prescriptions of different medicated feeds and in all cases, the prescriptions did not contain information on percentage of medicated feed in the daily ration or quantity of medicated feed per animal per day, and warnings necessary to ensure the proper use. This is not in line with the requirements of points 11 and 13 of Annex V to Regulation (EU) 2019/4. These were overlooked during previous official controls.

The audit team randomly assessed labels or accompanying documents of different medicated feeds and in several cases, labels did not contain information on contra- indications, instructions for use in line with the veterinary prescription and the withdrawal periods. This is not in line with the requirements of points 4, 5 and 8 of Annex III to Regulation (EU) 2019/4.

In general, the inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcoming in the competent authority's assessment of completeness of prescriptions and labels of medicated feed. 7 5.2.2 Sampling 5.2.2.1 Planning of official sampling

The recommendation states as its basis

FPS-HFCSE organises an annual meeting with the CAs of Flanders and Wallonia to review implementation of the previous year's seed monitoring programme and to develop the programme for the following year. FPS-HFCSE stated that it was agreed at the most recent such meeting that inspectors would seek out the highest risk seeds lots (i.e. those of non-EU origin) and seeds lots from the most recent growing season when taking samples for GM analysis. However, this methodology had not been documented in the revised control plan agreed by the three parties dated 26 June to ensure the effectiveness and appropriateness of official controls as required by Article 5(1)(a) of Regulation (EU) 2017/625, with the result that inspectors do not routinely adopt the revised methodology as described in finding 36.

The clear allocation of responsibilities among CAs, combined with their quality control procedures, provide a sound basis for ensuring the consistent implementation of legislation on GMOs, except in the seed area where documented procedures are not updated as required with the result that the highest risk seed lots are not consistently chosen for sampling and analysis.

The recommendation states as its basis

Official controls provide a reasonable level of assurance that conventional seeds of maize, oilseed rape, sugar beet and soya marketed in Belgium do not contain GMOs, but these controls are weakened by the failure to designate laboratories and to clearly define the range of analysis required.

The recommendation states as its basis

Belgian legislation (Royal decrees of 5 May 2008 and of 20 May 2022) requires mandatory registration of: i. all commercial poultry establishments regardless of the number of birds kept, ii. all poultry traders, iii. all "hobby keepers" with more than 200 hobby poultry, 4 iv. and all "hobby keepers" who wish to participate in or trade hobby poultry through public events such as a local weekly market. So called "hobby keepers" with less than 200 birds can attend competitions or exhibitions without having to register, and can sell directly to other hobby keepers, but if they supply the food chain or are involved in any commercial activities they must also be registered. In the event of participating in a public gathering, their identity details must be recorded by the event organiser.

"Hobby poultry" is defined in a guidance document for the public as the most common poultry species, including chicken, ducks, turkeys etc that are not intended for the food chain or for restocking supplies of game; they are then considered to be "captive birds". This definition, and the national provisions applied, are not entirely in line with the Animal Health Law (AHL), which defines poultry as birds kept or reared in captivity for production (of eggs, meat or other products). Furthermore, Articles 84 and 85 of Regulation (EU) 2016/429 and Article 3 of Commission Implementing Regulation 2022/1345, which provides for exceptions for registration of establishments, require among other that the kept terrestrial animals, germinal products or products of animal origin on the establishments, are not intended to be moved out of the establishment.

In Belgium there are several wildlife rehabilitation centres (around 25) which shelter injured or abandoned animals until they can be released into the wild again. The audit team interviewed a manager of one of these centres, located near the coast. The capacity of that centre could reach up to of approximately 5,000 birds annually. In some cases, the centre can keep birds for up to few months, especially when dealing with young birds, before they can be released in the wild again. These centres are currently not registered with veterinary authorities, despite keeping birds for an extended period and 5 therefore falling under the definition of an establishment according to Article 4 (27) of the AHL. Risk assessment

The recommendation states as its basis

When a farm veterinarian notifies the suspicion, authorities instruct the private veterinarian to take samples and to carry out the clinical assessment of the birds present at the establishment. The audit team noted a case, when the private veterinarian had a suspicion during his animal health check visit, and therefore took samples based on a general instruction document (available at the FASFC website) and sent them to a regional laboratory for further dispatch to the NRL. The practitioner then informed the LCU of the suspicion by email, including a clinical assessment of the animals present, as requested by Article 6 (2) of Delegated Regulation 2020/687. During the audit, the competent authority could not state clearly whether they reserve these tasks for an official veterinarian or they are officially delegated to private veterinarians according to Article 28 of the Regulation (EU) 2017/625.

LCUs contact registered establishments in the restricted zones, asking them to do an inventory of birds kept and to send it back, in the protection zone within 24 hours and in the surveillance zone within 48 hours. They also contact mayors asking them to forward publish information on restriction measures on local channels, to ensure that hobby keepers that are not registered receive information. All commercial establishments within the protection zone are visited by their private veterinarians within 24 hours. During these visits the veterinarians perform clinical examinations, checking health and production parameters' records, and taking samples for laboratory analysis as necessary. 17

The restriction zones established following an outbreak of HPAI are lifted as follows: i. The protection zone is lifted 21 days after it is established, provided hat clinical examinations on commercial holdings within the zone--conducted every four days--show no signs of concern. Once lifted, the area becomes part of the surveillance zone. ii. The surveillance zone is lifted 30 days after it is established, provided that no new outbreaks have been detected and all registered poultry establishments have undergone clinical examinations by a farm veterinarian and sampling as per FASFC instructions. The zone is lifted once all samples collected have been favourably tested using PCR testing by DGZ or Sciensano.

The recommendation states as its basis

However, the audit team noted that the Royal Decree (RD) of 30 November 2015 on the hygiene of foodstuffs of animal origin states that Food Business Operators (FBOs) of slaughterhouses of domestic ungulates should take their own-check carcass samples "at the end of the slaughter line or in the chiller but in any case, within two to four hours after slaughter".

As a result, the audit team noted in the four domestic ungulates' large capacity slaughterhouses visited that FBOs took these samples within two to four hours after slaughter when the carcasses already underwent blast-chilling. This is not in line with the provisions of Chapter II of Annex I to Regulation (EC) No 2073/2005 which requires that such samples should be taken after dressing but before chilling. Article 5(5) of the mentioned Regulation allows that FBOs may use other sampling and testing procedures, if they can demonstrate to the satisfaction of the CA that these procedures provide at least equivalent guarantees. The FASFC confirmed to the audit team that no such study had been carried out so far in order to provide the required guarantees.

National legislation and guidelines, necessary to ensure implementation and/or enforcement of the EU requirements applicable to the meat sector, are in place and they largely ensure compliance with EU legislation, except for some provisions regarding the own-check sampling of carcasses.

The audit team noted that the analytical method used by the FBOs are not consistently verified during official controls. In some cases, it was neither clear from the FBOs procedures nor from the analytical results whether the reference method or an alternative method was used by the FBO. Moreover, some of the LCU inspectors informed the audit team that they do not verify if the analytical method used by the FBO was in line with the requirements of points 1 and 5 of Article 5 of Regulation (EC) No 2073/2005 and/or were not aware of the availability of the list of the validated methods on the CA`s website. They were satisfied with the fact that the laboratory performed the analyses was accredited.

The official control system in place also includes taking official samples for microbiological analyses in order to guarantee the safety of red meat and poultry meat. However, the effectiveness of the system is weakened by the inconsistencies noted by the audit team in relation to CA` verification of FBOs` compliance with microbiological criteria.

The recommendation states as its basis

Although the audit team was provided with evidence of VOAs` training in all slaughterhouses visited and noted that procedures are available which describe the palpations and incisions that must be made during the PMI, non-compliances with Articles 19, 20 and 23 of Regulation (EU) 2019/627 were noted by the audit team in the slaughterhouses of domestic ungulates visited (see more under paragraph 65).

The mechanisms in place (such as documented procedures, training, and several IT applications) give the CAs a reasonable level of assurance that controls are carried out uniformly and consistently. However, the staff knowledge in relation to implementation of PMI requirements, which suggest a need for further training, does not ensure that the PMI requirements are apply fully in line with the EU requirements.

Although training and guidance documents are available to the VOAs performing PMI, the audit team noted some deficiencies in relation to the implementation of PMI in most of the slaughterhouses for ungulates visited: · pig testicles were not subject to visual inspection as required by point 1(h) of Article 23 of Regulation (EU) 2019/627, · masseters of adult bovines were not systematically incised (only one incision in the external masseter instead of the required two) as required by point 1(a) of Article 19 of Regulation (EU) 2019/627, · the lymph nodes (i.e. retropharyngeal, bronchial, and mediastinal) of adult bovines were not systematically incised as required by points 1(a) and 1(b) of Article 19 of Regulation (EU) 2019/627, · the bovine udder was not inspected as required by point 1(k) of Regulation (EU) 2019/627 · These shortcomings were not detected by the AR-VOA or the LCU inspector (in a small capacity slaughterhouse visited, a LCU inspector was not familiar with the details of the required PMI procedure).

In addition, in a small slaughterhouse implementing the derogation on the timing of PMI, the PMI of the gastro-intestinal tract was not carried out properly as the VOA carried out such inspection in small buckets/bins that did not allow a proper inspection (only a small surface of the tract was visible).

In general, AMI both for domestic ungulates and poultry and PMI of poultry are organised in line with the relevant EU requirements. However, the implementation of PMI has some systemic shortcomings, in particular, related to the obligatory incisions to be made during PMI of bovine animals (see also paragraph 48).

The recommendation states as its basis

The CCA informed the audit team that follow up of non-compliances detected during inspections where the result is "favourable with remarks" is carried out during the next planned inspection visit by the LCU inspector. In these cases, no deadline for correction is given to the FBO and the non-compliances are expected to be corrected by the following CA visit (which can be in 3 or 6 months depending on the planned inspection frequency). Although the VOAs are permanently present at the slaughterhouses, the FASFC procedure does not require them to perform such follow up controls.

The audit team also noted some inconsistencies regarding the deadlines given to rectify non-compliances which could have been eliminated by an immediate action, in order to comply with the requirements of Article 137(1) of Regulation (EU) 2017/625. In two slaughterhouses visited the deadlines given to the FBO to remedy the issues related to knife sterilisers (insufficient contact time with the disinfectant used to sterilize knives) was around two months (in one of the cases the deadline was extended). In other slaughterhouses an immediate action was requested by the LCU inspector in similar situations.

The system in place provides official staff with legal powers for the performance of 9 official controls and the enforcement of legal requirements. However, the enforcement system is weakened by the fact that some non-compliances are not always followed up in a manner which ensures swift corrective action by the FBO.

Member state response

ce Sampling is carried out without prior notice given to the operator. There are a few exceptional cases that allow our controllers/inspectors to notify the operator regarding the date of an inspection. The service note "CONT/2011/45/1486184 ­ Announced inspections" lists those cases. The content of the above mentioned service note shall be reminded to the inspectors and controllers during the next staff meeting. These meetings are organised in each Local Control Unit. The next meeting shall take place in September 2023. A summary of the conclusions and recommendations of the draft report was presented to the heads of the Local Control Unit during a meeting that took place on the 4th of May 2023. Please refer to the document "Staff meeting_04052023" for the list of attendance and the agenda of the above mentioned meeting.

The recommendation states as its basis

The use of c-section is generalised in farms with Belgian Blue cows. C-section protects cow and calf from suffering associated to calving difficulties caused by the selection of the breeding animals. However, official controls do not cover breeding procedures and Appendix B of the recommendation concerning cattle of the Convention requires that breeding should be carefully selected to reduce calving difficulties and c-section shall not be a routine measure.

The access of the involved authorities to information for the official controls is incomplete reducing the effectiveness and efficiency of the system: (i) The database containing the result of the planned animal welfare checks is kept by FASFC. Regions can access the checklist of individual inspections and receive regular automatic notification of identified non-compliances, but their access does not facilitate the data analysis (verification of compliance with established inspection frequencies, reports containing officials' comments, points marked as not applicable). (ii) FASFC cannot access enforcement data kept by the Regions and there is no alternative system for informing FASFC officials of the enforcement background and non- compliances identified by the Regions from sources other than the FASFC. This prevents FASFC officials conducting the checks to fully consider the compliance history for guiding inspections, or to identify recurrence during inspections particularly when non-compliance had been identified through notifications to the Regions. (iii) Regions can access data of individual farms in the cattle register database, but their access does not facilitate the use of data for analysis and planning (e.g. filtering farms by size, cattle breed, cattle age profile or mortality). (iv) Regions cannot access the results of the ante-mortem and 7 Lack of training post-mortem inspections of slaughterhouse and the rendering program on database. This does not facilitate the use of that data for the verification of controls (adequate reporting to the Regions of animal welfare finding at slaughterhouse indicating potential animal welfare controls at farm issues at farm) and the identification of potential animal compromises the welfare issues at farm (such as elevated mortality). effectiveness and the consistency of Training of officials on performing controls the controls. 13. Regions have not established training programmes for the officials performing official controls on animal welfare at farm and the applicable Shortcomings of legislation. Although FASFC officials have experience in conducting control official controls at farm (food safety, animal identification, animal health) and, being veterinarians, have knowledge on animal welfare, they verification have not received specific training on the performance of animal welfare procedures reduce controls at farm since, at least, the transfer of responsibilities to the Regions. This lack of training, particularly when the inspections the assurance instructions and guidance for interpretation of legal requirements are provided by the limited, compromises the consistence and effectiveness of the controls (see Section 7 of this audit report). Furthermore, this is not in line with controls and the management contract between the Regions and FASFC stating that hampers the Regions provide training for FASFC officials on the tasks they carry out improvement of in the context of animal welfare and with the Article 5(4) of the OCR. the system. Control verification procedures . 14. The Regions lack control verification procedures, other than audits, which is not in line with Article 12(2) of the OCR. FASFC has control verification procedures and an internal audits programme, however they do not cover animal welfare which is responsibility of the Regions. This lack of control verification procedures for animal welfare controls hinders their capability for ensuring those controls are consistent and effective. It also reduces the likelihood of identifying shortcomings requiring corrective actions or update of the documented procedures as per Article 12(3) of the OCR. 15. According to the management contract between the Regions and FASFC, the official controls on animal welfare performed by the FASFC may be subjected to audits by the Regions. Regions have not audited FASFC controls although two Regions have arrangements for the auditing of their animal welfare controls by external bodies

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The recommendation states as its basis

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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.

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The recommendation states as its basis

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

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 recommendation states as its basis

The CA performs controls of WPM listed under Commission Implementing Regulation (EU) 2021/127, which is inspected at the BCPs at a rate of 15%, in line with the requirements of this Regulation. The CA stated that the wood packing material (WPM) monitoring plan is based on two pillars. Firstly, controls of WPM present in consignments subject to official control by FASFC at the BCP. Secondly, the CAs conduct checks on operators selected by the number of imported consignments of WPM imported from a list of combined nomenclature codes, when imported from; Canada, China, Democratic Republic of Korea, India, Japan, Mexico, Republic of Korea, Taiwan, USA and Vietnam, where the presence of Bursaphelenchus xylophilus and Anoplophora glabripennis is known. These checks are performed by the LCUs and target the WPM present at the operator during the visit, contrary to the requirements of Article 4(2) of Commission Delegated Regulation (EU) 2019/2125, which requires that these physical checks shall be carried out on consignments selected in accordance with the provisions of Article 4(1) of the same Regulation.

The monitoring plan for WPM identified as high risk by the CA, does not select specific consignments for inspection and as a result, may not effectively prevent the introduction of pests into the EU on these products.

Member state response

ion subject to amendment of legislation: Part of the WPM monitoring plan focuses on importers of risk material. These importers are selected on the basis of a customs lists of imported risk material. Imported consignments are usually delivered quickly at their destination. Directing these checks to imported consignments can only be put in place if their arrival is notified by a CHED-PP. Imposing such an obligation at national level would quickly result in a relocation of these imports to other Member States. Therefore, we propose to amend Commission Delegated Regulation (EU) 2019/2125 in such a way that monitoring of imported consignments is harmonised at EU level. Since the import requirements for WPM are harmonised at EU level, it would be logic that at all EU border control post product-origin combinations have the same chance to be checked.

The current monitoring plan of WPM of roducts not falling under the direct control of the Agency uses post-factum inspections at importers of risk material (e.g. WPM of construction materials, tiles...). In order to meet the recommendation, new additional checks on WPM of recently imported consignments of risk materials will be carried out at importers premises (place of destination). These recently imported consignments will be selected on the basis of monthly customs lists of imported consignments of risk material.

The recommendation states as its basis

The CAs stated that an internal report of non-compliances found by Customs in relation to passengers' luggage, postal and courier packages is issued internally, although not reported in IMSOC, contrary to the requirements of Articles 40(4) and 41(4) of Regulation (EU) 2016/2031. Conclusions on actions in case of non-compliance

The actions taken in event of a non-compliance are generally in line with the EU requirements. However, interceptions on imports by private individuals are not reported as required. This means other MS are not able to take account of information regarding non-compliant goods coming into the EU when planning their controls. .

Member state response

Action subject to amendment of TRACES-NT: In case of a f non-compliance for passenger luggage or in small postal and courier consignments for private persons, a CHED-PP needs to be created manually by the FASFC, in order to be able to notify the interception via TRACES NT. It is also difficult to fill out all the boxes of the CHED-PP (e.g. personal data of the consignor & consignee (conflict with General Data Protection Regulation), no border control post in case of passenger luggage, ...). This creates an enormous administrative burden and a disproportionate workload for the FASFC. Page: 1 0 August 2022 f report ref. DG(SANTE) 2022-7394 of the audit carried out from 23 March 2022 lant health by the competent authority ns, the FASCF will only be in a position to report nces in passenger luggage if TRACES-NT d in such a way that reporting could be done per per passenger). courier consignments, the FASFC is elaborating ation with Customs, a methodology for carrying ntrols. Notification of interceptions of plants, plant her material will be included in his methodology. icable as from 01/01/2024.

Action subject to amendment of TRACES- NT: In case of a non-compliance for passenger luggage or in small postal and courier consignments for private persons, a CHED-PP needs to be created manually by the FASFC, in order to be able to notify the interception via TRACES NT. It is also difficult to fill out all the boxes of the CHED- PP (e.g. personal data of the consignor & Page: 1 ndations (updated) received 26/10/2022 mitted by the competent authorities of Belgium in response to Report ref. DG(SANTE) 2022-7394 of 022 in order to evaluate the system of import controls for plant health Action Proposed by the competent authority consignee (conflict with General Data Protection Regulation), no border control post in case of passenger luggage, ...). This creates an enormous administrative burden and a disproportionate workload for the FASFC. For those reasons, the FASCF will only be in a position to report the non-compliances in passenger luggage if TRACES-NT would be adapted in such a way that reporting could be done per flight (and not per passenger). For postal and courier consignments, the FASFC is elaborating in close cooperation with Customs, a methodology for carrying out officia

The recommendation states as its basis

Belgium is using TRACES for import of plants, plant products and other objects at all BCPs and CPs. FASFC staff, as well at LCUs as at BCPs, have reading and writing access to the system, while those posted working at the Regions have read-only access for CHED-PP parts I and II, and writing access for part III. Customs has reading access to TRACES. The system is also used to report non-compliant consignments. The CAs stated that although full implementation of the electronic signature is expected for the near future, it has not been fully implemented yet, contrary to the requirements of Article 39(1)(b)(c) and (d) of Commission Implementing Regulation (EU) 2019/1715. 5.2.2Documented Control Procedures

Belgium has adopted IMSOC systems into their procedures for controls on imported regulated plants and plant products in line with EU requirements, ensuring a harmonised approach to the management of controls within the EU. Harmonisation of the system will be completed when the electronic signature is fully implemented.

Member state response

e with Action implemented since 1st of May 2022: To our understanding, art. 39 is related to electronic certificates for the Union and the use of electronic signature and . tronic CHED-PP is described in art. 41. To be onic CHED-PP, the CHED-PP should carry the ature of the certifying officer and the electronic petent authority. We don't see a legal obligation onic CHED-PP. Nevertheless, since 1st of May c CHED-PP with electronic signature and have been fully implemented in Belgium. Page: 2

c Action implemented since 1st of May 2022: (d) To our understanding, art. 39 is related to electronic certificates for goods entering the Page: 2 ndations (updated) received 26/10/2022 mitted by the competent authorities of Belgium in response to Report ref. DG(SANTE) 2022-7394 of 022 in order to evaluate the system of import controls for plant health the competent authority f electronic signature and ic CHED-PP is described alid as electronic CHED- uld carry the electronic rtifying officer and the the competent authority. We bligation to issue electronic ss, since 1st of May ED-PP with electronic ronic seal have been fully ium. Page: 3

The recommendation states as its basis

There are official laboratories with adequate capabilities for the ToBRFV tests. However, the practice used for the confirmation of positive or undefined sample of imported specified seeds is in not line with the EU legislation and the proficiency of the laboratory test was not verified, there is a risk of false results, which may compromise the controls.

Member state response

it virus are As in the ILVO laboratory, where the vast majority of samples for the were analysed and the initial and confirmatory tests were carried the Annex to out in full compliance with the legislation, the decision was immediately made to have the confirmation test carried out at ILVO, in case there was a positive result in CRA-W. In the meantime the confirmation method is being developed (and on the date of writing this action plan, this development is almost finalised) in accordance with paragraph 3 of the Annex to Regulation (EU) 2020/1191 at CRA-W. In the near future, the result for seed samples detected positive with the ISF method will be confirmed at CRA-W by a second RT-PCR (using primers and probe of Menzel et al.).

The recommendation states as its basis

In 2020 and 2021, the FASFC carried out annual surveys for the detection of ToBRFV, which were planned after a risk assessment, as required by Article 5(2) of Regulation (EU) 2020/1191. Only tomato fruit growers were targeted. Growers of Capsicum sp. were included in the 2020 and 2021 survey programmes, but sampling was not carried out, on the assumption that pepper producers generally cultivate resistant varieties. Concerning the surveys on the market the FASFC stated that growers comply with the marketing standards, i.e., sort out of symptomatic fruits. Therefore, it is difficult to find symptomatic fruits on the market.

The annual surveys for ToBRFV concentrated on high-risk production sites, related to outbreaks and to the follow-up of contaminated seed lots. As the planned number of random surveys at tomato producers was not achieved, and pepper growers were not checked, the actual outbreak situation may not be entirely known, which could compromise the eradication efforts.

Member state response

e based on In 2022 the calculated number of companies will be fully assigned in Belgium, to the random survey. Control services will actively look for non-resistant Capsicum varieties. However, there are no guarantees that these will be found during random checks as the varieties traded in Belgium are largely resistant, which was confirmed by the auctions.

The recommendation states as its basis

The audit team noted that the inspection and sampling procedure of the production of specified plants for planting is in line with provisions of Article 6(1)(a) of Regulation (EU) 2020/1191. However, the inspections which are carried out once a year per production site cannot cover those specified plants for planting which are not present during the official visit. For sites with continuous production of multiple crops with various sowing times, a single inspection may not be considered as appropriate to obtain comprehensive information about the status of the production site. Conclusions on the controls of the movement of specified plants for planting within the EU

The controls at the places of production of specified plants for planting are in line with EU requirements and aimed at reducing the risk of introduction of the virus to fruit production establishments. As the timing of the inspections is not appropriate for each lot at sites with various growth periods, there is a risk of not detecting some infections.

Member state response

fied plants for Knowing that there is always a chance of spreading the virus ed by of Article when inspectors go through the planting material, which may then affect several fruit growers at a later stage, and knowing that the chance of detecting symptoms is also very low in young plants, the FASFC is of the opinion that to carry out multiple inspections is suboptimal and not legally required. One inspection at the most appropriate time is in line with the legislation and minimizes the risk of spreading the virus. (See comments document for a more elaborate argumentation) Page: 1 eived 21 June 2022 tions of report ref. DG(SANTE) 2022-7399 of the audit carried out from 02 February ntrols for Tomato brown rugose fruit virus Action Proposed by the competent authority

The recommendation states as its basis

The audit team noted that: · The sampling rates of the consignments were in line or above the minimum set by the EU legislation; · The sampling rate was significantly lower in 2021 than in 2020, but still in line with provisions of the EU legislation; · The selection for sampling was generally based on the size of the consignment and the number of lots in it. Other risk factors, such as countries of origin (other than China and Israel, specially requested by the EU legislation), exporters and varieties with EU level interception history were not taken into consideration. This is not in line with requirements of Article 9(1) of Regulation (EU) 2017/625. 18 Conclusions on the controls on the introduction into the EU of specified seeds

The controls on imported specified seeds are generally in line with EU requirements. However, the selection of consignments for sampling does not take into consideration all relevant risk factors and therefore cannot be considered fully risk based as required by Article 9(1) of the Regulation (EU) 2017/625. This compromises the effectiveness of EU measures to protect against the introduction of ToBRFV by specified seeds.

Member state response

e sampled in FASFC will at least take into consideration interceptions of 2020/1191 specified seeds from certain countries and exporters when ealth risk, as selecting consignments for sampling, because this information can be retrieved via Qlikview in TRACES NT. As long as it is not obligatory to mention other risk factors such as varieties and production sites on the CHED-PP, these risk factor cannot, systematically, be taken into account. Page: 2

The recommendation states as its basis

The audit team noted that, if the overall assessment is "Favourable" or "Favourable with comments", no corrective action is requested or enforced for identified non-compliance. This is only triggered if the inspections are "Unfavourable", which means that lower grade (less severe) non-compliances are up to the operators' discretion to address. This is not in line with Article 138(1)(b) of the OCR.

According to the CA, a new checklist has been developed designed to allow for the follow up of identified non-compliances, in order to prevent these being neglected and perpetuated. The audit team noted that the above-mentioned checklist does not necessarily improve enforcement, in particular for less severe non-compliances, as: a) the system does not apply to BMO inspections. This means that non-compliances identified from BMOs are not subject to follow up if their inspections are assessed as "Favourable" or "Favourable with comments". b) The checklist deals with non-compliances assigned three or more points; those with one point are not followed up, irrespective of their total number.

The triggering of enforcement measures only above a certain threshold of non- compliances or the severity-grading thereof, is detrimental to operators taking actions aimed at correcting possibly multiple and/or minor non-compliances or preventing their re-occurrence. 7

Member state response

ijdens de revisie van de controlemethodologie werd e oorspronkelijk voorzien om ook de niet-conforme items met weging 3 op te volgen tijdens een volgende inspectie aan de hand van de checklist Basisscope (op heden opgenomen in de CL Basisscope in DIS en in de CL PRI-TRA 3709 Opvolging corrigerende acties van de operator). Na implementatie bleek het niet haalbaar met de beschikbare middelen in de sector Distributie om deze opvolging voor alle niet-conformiteiten met weging 3 te doen. Er werd daarom beslist om enkel een opvolginspectie uit te voeren van inspecties met ongunstig resultaat voor minstens 1 checklist. Om redenen van uniformiteit werd deze manier van werken voor de sector Distributie uitgebreid naar de sectoren Transformatie en Primaire Productie. In 2023 wordt een evaluatie van de nieuwe controlemethodologie in de sector Distributie voorzien, waarbij ook deze opvolging van de niet-conformiteiten met weging 3 voor de 3 sectoren (PRI, TRA, DIS) in beschouwing zullen worden genomen. Bij deze evaluatie zal de opvolging van niet-conformiteiten met weging 1 echter niet herbekeken worden. De wegingen werden toegekend door de Technische Overleg Comités (TOC's) en een weging 1 be

The recommendation states as its basis

In response to queries from the audit team in respect of the operation of the various official controls over operators working "under the approval" of an approval owner (option b(ii) above), the CA indicated these cases to be known, and fully within the scope of official controls: a) an applicant operator who plans to work with others in an "under the approval" arrangement, should indicate this on the floor plan with the approval application. b) All operators involved should be registered and have a registration number with an address of the establishment where the activity will take place. c) Operators that will work "under the approval" should apply to the LCU for approval using the application form, and in which they indicate whether they apply for approval or whether they intend to work "under the approval". d) The approval owner takes responsibility for the operators that work "under the approval" and will be subject to legal measures in case of non-compliance. (S)he is responsible both for the HACCP implementation, which the other operators must have access to and implement, as well as traceability. Concerning the latter, the records are kept either by the approval owner, or together with the other operators, but they must make arrangements for this. e) Legal measures can be taken against the approval owner if the activities of other operators working "under the approval" are not notified to the LCU. f) During an inspection, the CA will become aware of operators working "under the approval" and not complying with the requirements above.

The audit team noted that: a) Question 45 of the "Frequently asked questions" in the section on approvals on the CA website is only explicit in terms of time/space separation of activities and products for cases of individual approval of all operators involved. It is therefore unclear why a prospective approval owner would need to indicate the intention to operate a working "under the approval" arrangement on the floor plan. Moreover, such an arrangement may be entered into at any time, even after the approval. 9 b) Although the approval application requires operators to indicate their intent to work "under the approval", it does not require an attestation or acknowledgement from the approval owner as regards the obligations arising from this arrangement. c) According to the CA, legal measures against operators not complying with the requirements can only be taken if these operators are present and produce, during an official control (4).

The audit team noted a case of an approved establishment known to the CA to have four operators working "under the approval" arrangements, and of which the CA had sought the withdrawal of the approval. The official control reports drafted did not include references to non-compliances identified in relation to the activities of these four operators, but do not clarify whether this was because they were compliant, or because they were not present and active during the official controls. Upon request by the audit team, the CA performed an official control in order to verify whether progress has been made towards compliance of the operator, during which two additional operators were identified on site, working "under the approval", and which were not known to the CA, as neither had submitted the required application to the LCU. Therefore, the CA was also not aware how long these operators had been active under this arrangement.

The provision to allow operators to produce in approved establishments "under the approval" of another operator, and the way this is implemented, has a negative impact on ability of the control system to verify and ensure compliance with the legal requirements of all operators involved and, consequently, on the safety, hygiene and traceability of fishery products produced by those operators under such an arrangement.

Member state response

In de nieuwe module AER (erkenning/toelating/registratie) is voorzien dat wanneer een operator een activiteit aanvraagt onder lace de erkenning of toelating van een andere operator, beide to operatoren een brief zullen ontvangen wanneer deze activiteit bij ed het FAVV geregistreerd wordt. (EU) In de procedure `Beheer van operatoren en hun gegevens' en de FAQ erkenningen zal opgenomen worden dat een schriftelijk akkoord nodig is van de operator met de erkenning/toelating alvorens de activiteit van een andere operator zal kunnen geregistreerd worden onder deze erkenning/toelating. In de CL AER zal een item toegevoegd worden zodat de C/I telkens hij deze checklist invult, zal nagaan of er andere operatoren werken onder de erkenning/toelating. Planning van de controles Er zal worden onderzocht op welke manier de activiteiten van de operatoren die werken onder erkenning/toelating van een andere operator gericht kunnen worden gecontroleerd. Hiervoor zal een werkgroep opgericht worden met experten van DG Controlebeleid, DG Controle hoofdbestuur en de LCE's. De timing om deze oefening af te ronden is eind 2023.

The recommendation states as its basis

The most recent Multi-Annual National Control Plan (MANCP) for 2018-2020 has a section, which describes official controls for PDO/PGI/TSG products and GI spirit drinks and contains a list and detailed description of the competent authorities in all regions of Belgium. The FASFC submitted annual reports to the Commission on the implementation of the MANCP in 2018 and 2019. However, both reports include only the results of inspections carried out annually to producers of PDO/PGI/TSG products and GI spirit drinks in Flanders. The results of the controls carried out in Wallonia are not presented. This is not in line with Article 40 of Regulation (EU) 1151/2012 and Article 40 of Regulation (EU) 2019/787. Wallonia Region

CAs are designated for the official controls of PDO/PGI/TSG products and GI spirit drinks and the distribution of tasks is clearly defined. Training is provided to official staff. In the annual reports of the MANCP, the CAs systematically report the control activities of PDO/PGI/TSG products and GI spirit drinks carried out at producers/operators and at retailers in the market. However, the controls carried out in Wallonia region are not included. 5.2.2 Control Bodies Legal requirements Articles 28, 29 and 31 to 33 of Regulation (EU) 2017/625. Article 37(1) and (3) of Regulation (EU) No 1151/2012. Article 38(2), (4) and (6) of Regulation (EU) 2019/787. Findings

Member state response

Le prochain rapport MANCP sera communiqué via le système OC. Les régions se chargeront de l'encodage et de la the validation des données selon une répartition des tâches établie. Cette nouvelle méthode de travail permettra l'exhaustivité du rapport.

The recommendation states as its basis

The DQAW is also meant to assess the quality of controls through administrative checks of inspection reports at the CB headquarters and on-the-spot checks of operators. However, at the time of the audit, the DQAW was not carrying out these tasks. This is not in line with Article 79 of the Decree of the Walloon Government of 14 July 2016 and Article 33(a) of Regulation (EU) 2017/625. The DQAW stated that checks will commence during 2021, with at least one operator for each PDO/PGI product to be selected for inspection. The selection of operators will be based on the analysis of risk factors such as previous warnings, operator history and volume of certified production, described in the draft guidelines, mentioned in paragraph 25 above. Conclusions on Control Bodies

The CA monitors the accreditation of the CB provided by BELAC. However, the CA does not ensure that the conditions for delegating official controls tasks to the CB are fully satisfied and does not adequately supervise the CB. This could undermine the quality and reliability of inspections carried out. 5.2.3 Verification of Compliance Prior to Placing on the Market Legal requirements Article 37(1) of Regulation (EU) No 1151/2012. Article 38(2) of Regulation (EU) 2019/787. Article 24 of Regulation (EC) No 110/2008. Findings Wallonia Region 9

The audit team noted that most severe non-compliances were followed up well. However, some findings, mostly concerning non-compliant labelling, which had already been reported at the same producers the previous year, were not upgraded to "major". No corrective action had been taken either by the operators or by the CB, whilst no further follow up of the situation was carried out by the DQAW. The CB does not systematically submit the inspection reports of non-compliant PDO/PGI operators to the DQAW. The DQAW stated that the CB is obliged to do this only where they have taken decision for withdrawing the certification.

Official controls are undertaken at producers/processors of PDO/PGI/TSG products and, for the case of Flanders, also GI spirit drinks. Most shortcomings identified by the CB at operators of PDO/PGI products in Wallonia were systematically followed up by corrective action plans and severe shortcomings may lead to suspension of certification. However, the supervision of the CB is not fully adequate as in certain cases the CB does not follow the procedure for classification of non-compliances.

Member state response

onclusion n° 29. Un contrôle administratif au siège de l'OCI et un contrôle sur place chez un opérateur aura lieu chaque année pour un tiers des dénominations enregistrées. L'objectif est de vérifier la qualité du travail de l'OCI au moins une fois tous les 3 ans pour chaque dénomination enregistrée. Cette fréquence, revue à la baisse par rapport à ce qui a été dit lors de l'audit, semble largement suffisante pour assurer un suivi efficace de l'OCI tout en n'exerçant pas une pression excessive sur l'OCI et les opérateurs. La sélection des dossiers s'effectuera sur base d'une analyse de risque, comme annoncé. Tout cela est formalisé dans une instruction de contrôle toujours actuellement en cours de validation. Conclusion n° 69. Les non-conformités relatives à l'étiquetage sont maintenues en non-conformités B ou « mineures » tant qu'un accord ne sera pas intervenu entre l'AC et les opérateurs sur une clarification de la législation wallonne relative à l'étiquetage des IG (arrêté ministériel du 14 juillet 2016 relatif aux systèmes de qualité européens et aux mentions de qualité facultatives régionales, art. Page: 1 8 June 2021 f report ref. DG(SANTE) 2021-7304 of the audit carried out

The recommendation states as its basis

The DQAW stated that the same principles as those of PDO/PGI/TSG products have been established for GI spirit drinks. However, at the time of the audit, these were not yet applicable in Wallonia and no controls of GI spirit drinks were carried out. This is not in line with Article 38 of Regulation (EU) 2019/787.

Annual inspections of all operators of PDO/PGI/TSG products are carried out in Wallonia and Flanders with an appropriate inspection frequency required for checking the product specifications. For GI spirit drinks, however, this is only the case in Flanders.

Member state response

s of Un contrôle du respect des cahiers des charges des boissons ticle spiritueuses sous indications géographiques produites en EU) Wallonie sera mis en place pour fin 2021.

The recommendation states as its basis

The FPS-e is the central competent authority for controlling PDO/PGI/TSG products and GI spirit drinks on the market and their labelling in the entire country. Within the FPS-e, the Directorate-General for Economic Inspection (DGEI) is designated for this 5 purpose. However, the controls carried out are not systematic or risk based (see also section 5.2.5).

DGEI inspectors of FPS-e are responsible for carrying out labelling and traceability checks at retailers and distribution centres of products under all national quality schemes including PDO/PGI/TSG products and GI spirit drinks. The results of controls at retailer level are systematically reported to FPS-e. Non-compliances trigger further checks at producers or importers of PDO/PGI/TSG products and GI spirit drinks. Controls are also done of direct sales from producers. However, the market controls are not based on a national inspection plan or analysis of the associated risk of non-compliance or to the amounts of non-domestic PDO/PGI/TSG products and GI spirit drinks on the market. The vast majority are in response to complaints received, mainly concerning non- domestic products. Only a small part are carried out occasionally at randomly selected local markets and retailers. This is not in line with Article 36 of Regulation (EC) No 1151/2012, Article 24 of Regulation (EC) No 110/2008 and Article 9 of Regulation (EU) 2017/625.

There is no coordination or planning of risk-based inspections of PDO/PGI/TSG products on the market, or for these products to be selected whilst carrying out general labelling checks. If no complaints are received the market checks carried out are of rather limited scope. 13 5.2.5 Procedures and Performance of Official Control Activities Legal Requirements Articles 12, 13(1), 23, 24(1), 36(3), 44 and 46(1) of Regulation (EU) No 1151/2012. Regulation (EU) No 664/2014, in particular Article 1. Regulation (EU) No 668/2014, in particular Article 4. Article 18 of Regulation (EC) No 178/2002. Article 5(1)(h), Articles 12 to 14 of Regulation (EU) 2017/625. Article 26 of Regulation (EU) No 1169/2011. Articles 38 and 39 of Regulation (EU) 2019/787. Findings Procedures for Performance and Reporting of Control Activities

As also mentioned in paragraph 49 above, the audit team noted that in most cases, the controls were based on complaints received from third parties. Inspectors carried out cross checks to verify the traceability of the products. However, no written instructions or inspection manual have been elaborated for carrying out market checks; controls are mainly based on the expertise of inspectors. Communication with other MSs to confirm that non-Belgian products are produced by authorised operators is only done occasionally, limiting the ability of the FPS-e to identify potential fraudulent/illegal use of the relevant EU logos. Official controls on the market of spirit drinks undertaken by the CA

The controls for the use of the registered names for PDO/PGI/TSG products and GI spirit drinks on the market are not based on documented procedures. Therefore, it cannot be ensured that they are overall adequate. Moreover, inspections are not designed to detect misuse of protected names for products originating from other MSs and non-EU countries. 5.2.6 Enforcement Measures Legal Requirements Article 13(3) of Regulation (EU) No 1151/2012. Article 105(1) and Articles 138 and 139 of Regulation (EU) 2017/625. Article 39 of Regulation (EU) 2019/787. Article 24 of Regulation (EC) No 110/2008. Findings

Member state response

names A global risk analysis has been initiated in the framework of the ance of internal and external audit of the Belgian federal supervisory tion authority, the Economic Inspection. A specific risk analysis of the controls on PDO/PGI/TSG will be initiated shortly. Page: 2

The recommendation states as its basis

However, the audit team noted that the FNAO inspectors were not aware of the European guidance to verify how FBOs correctly take environmental samples to detect Listeria monocytogenes in their establishments. Supervision

However, staff was not aware of specific guidance regarding the FBO's methods for environmental sampling to detect Listeria monocytogenes, which therefore cannot be verified effectively by official controls. 5.2.2 Registration/approval of food establishments Legal requirements Article 6 of Regulation (EC) No 852/2004, Article 2 of Regulation (EU) No 210/2013 of the European Parliament and of the Council and Articles 10(2), 138(1), 138(2)(c)-(j), 138(3), 138(4) and 148 of Regulation (EU) 2017/625. Findings

The audit team noted that FNAO inspectors check if FBOs have environmental sampling in place to detect Listeria monocytogenes. However, the inspectors asked by the audit team did not witness how these own-control samples are taken in situ.

Member state response

An e-learning tool concerning Regulation (EU) No 2073/2005 with emphasis on Listeria monocytogenes (L.m) will be made available to the control staff. This tool will contain following parts: criteria for L.m., importance of growth characteristics of Ready to eat (RTE)-products in relation to growth of L.m., shelf life studies in general, shelf life studies for L.m. (based on literature, modelling, challenge testing, durability studies), environmental monitoring, analytical methods (incl. pooling). The official control staff will be made aware of the EU technical guidance document for shelf life studies for Listeria monocytogenes and the EU guidance document for the environmental sampling for Listeria monocytogenes. These documents are however currently under revision. As these new versions need to be included in the e-learning tool, the timeline for its completion will depend on the publication of the new version of these guidance documents. (see also audit General Follow-up, Reference Nr. 2020_6970, Recommendation 2019-6676-3)

The recommendation states as its basis

The system is weakened by the fact that the information available about primary producers is insufficient to take into account higher risks of microbiological contamination of certain produce. This, and the fact that inspections regarding food hygiene do not comprise specific measures to prevent microbiological risks during the pre-harvest and harvest stages of production hamper the effectiveness of the official control system.

The LCU staff informed the audit team that official controls for primary producers focus on activities after harvest. Furthermore the LCU staff stated that the current registration system would not allow the inspectors to identify the size and the kind of crop produced at a farm. The only way to select farms with high risk crop would be by experience and former inspections carried out there.

Primary production requirements such as staff hygiene, use of fertilisers and facilities were addressed by the inspectors. However, controls staff hygiene like the presence and use of hand wash facilities and field toilets during harvest, and the protection of fields 10 from some external risks (e.g. no cultivation under electric lines to avoid droppings of birds, measures to prevent access of wild animals) are not foreseen by the control system and therefore not implemented by the inspectors even in the case of crops deemed as high risk.

Official controls are implemented as foreseen by the national control system. The official control system, however, is unable to identify and rectify shortcomings prior to and during harvesting of FNAO. 5.2.5 Official sampling Legal requirements 6 http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=4037 11 Articles 34 and 35 of Regulation (EU) 2017/625 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

Member state response

The items described in our checklists (PRI 3525) are based on the Regulation (EC) No. 852/2004. The FASFC does not agree that his control system does not include controls prior or during harvesting, only that no focus is given on controls at these stages and no specific items are foreseen for these stages, for the arguments given during the audit. However, a technical consultation committee will be organised to analyse if some items can be improved and/or specified, with respect to Regulation (EC) No.852/2004 and Regulation (EU) No. 2017/625 if these items are Page: 1 port ref. DG(SANTE) 2020-6921 of the audit carried out from 20 October relating to microbial safety of food of non-animal origin Action Proposed by the competent authority appropriate and as far as possible (e.g. prevention of the access of animals to open fields is deemed impossible by the FASFC). The FASFC, at present, still judges that no in dept official control is needed at the production stages prior and during harvest, due to the high level of certified self-checking systems and downstream official and own controls. In order to re-evaluate this judgement, the FASFC will evaluate the possibility of a one-time sp

The recommendation states as its basis

The FASFC registration for primary producers of FNAO distinguishes between arable crops, fruit and vegetables. There is not more information available about the volume and nature of the production like soft fruit or leafy vegetables for direct consumption. There is a separate registration procedure for sprout producers in place (see below). Authorisation of processing plants

Different risk levels for different products, as indicated by EFSA5 opinions, have not been taken into account in the risk assessment.

Leafy green vegetables and soft berries are in the same risk category as potatoes and other vegetables intended to be eaten after cooking.

Frozen berries and frozen vegetables are in the same risk category as potatoes and other vegetables intended to be eaten after cooking.

In addition, for the risk based plan within the same product group, factors such as size of the farm/establishment and production volume are not taken into account.

The system is weakened by the fact that the information available about primary producers is insufficient to take into account higher risks of microbiological contamination of certain produce. This, and the fact that inspections regarding food hygiene do not comprise specific measures to prevent microbiological risks during the pre-harvest and harvest stages of production hamper the effectiveness of the official control system.

The system of own-controls certified by a recognised third party certification body in place could mitigate the risk of the lack of official controls before and during harvest. For primary producer's such own control systems are voluntary, and about 50% have certified own control systems in place.

As a result, different risk levels for different products are not taken into account, contrary to the provisions of Article 9 of Regulation (EU) 2017/625.

The LCU staff informed the audit team that official controls for primary producers focus on activities after harvest. Furthermore the LCU staff stated that the current registration system would not allow the inspectors to identify the size and the kind of crop produced at a farm. The only way to select farms with high risk crop would be by experience and former inspections carried out there.

Official controls are implemented as foreseen by the national control system. The official control system, however, is unable to identify and rectify shortcomings prior to and during harvesting of FNAO. 5.2.5 Official sampling Legal requirements 6 http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=4037 11 Articles 34 and 35 of Regulation (EU) 2017/625 and Annex I, Chapter 1 of Regulation (EC) No 2073/2005. Findings

Member state response

ls for Apart from sprouts, there is at the moment in Belgium no as registration demanded for RTE risk products. This is in line with the legal registration requirements in EU legislation. The FASFC will evaluate (legal possibilities/procedure, availability auditors/certification bodies and identification tools for the targeted operators) whether it is possible to legally oblige high risk operators (such as producers of RTE) to validate their self- checking system. Page: 2

The recommendation states as its basis

Belgium's 2018-2020 Multi-annual national control plan (MANCP) describes the protocol signed between FASFC and the three regions on delegation of responsibilities on animal welfare, providing the general framework. The MANCP (Section 3.2.11.15.6) states that the competent regional authorities undertake to periodically provide a contribution to MANCP and to the MANCP annual progress report. The audit team noted that information on the planning regarding animal welfare checks was very general, and it did not include objectives for animal welfare for any of the three regions. The MANCP is available at: http://www.afsca.be/apropos/mancp/mancpbelge/default.asp.

The 2018-2020 MANCP is incomplete regarding official controls in the animal welfare area. The absence of animal welfare objectives together with the absence of information from regional authorities to the progress report make it impossible to 10 assess whether the authorities are directing their efforts effectively or efficiently.

Member state response

he Regions will provide information regarding the objectives onal and official controls for the animal welfare area. We planned to get a definitive text to include in the MANCP for June 2021.

The recommendation states as its basis

The Flemish competent authority explained that, as FASFC is under the Federal competent authorities, it is difficult to cooperate without updating and improving the protocol signed with them. The Walloon competent authority agreed with that view and added that the non-optimal sharing of information with FASFC is mainly due to the institutional set up and they always try to achieve a good direct communication with the slaughterhouse official veterinarians.

The audit team requested an overview of the results of one of the points in the FASFC checklist from the Flemish competent authority. The competent authority indicated that, since 2018 the FASFC had not been entering the checklists into their electronic system, but instead sent either hard paper copies or e-mailed scanned copies to the regions. This makes it difficult for the regions to provide an overview and for their Animal Welfare Inspection Units to assess the findings. For this reason, the regions stopped using the FASFC findings for prioritising which slaughterhouses they visit.

The Flemish competent authority indicated that its Animal Welfare Unit has prepared new checklists and procedures. This is to prepare for the start of a new system where the Animal Welfare Unit would appoint directly private veterinarians to carry out inspections on animal welfare in slaughterhouses, in addition to the official veterinarians of the FASFC. This revision will take into account the non-compliances detected by veterinarians working in the slaughterhouse and prioritise the less compliant establishments for visits by the Animal Welfare Unit. The appointed private veterinarians will start at the end of October 2020. They will daily check animal welfare in every slaughterhouse for a maximum of three hours and they will complete the new checklist once a week per slaughterhouse.

The Walloon competent authority indicated that the shortage of resources limits their activities and for the time being they depend on the FASFC checks in the slaughterhouses and informed the audit team that: Its new plan is that its Animal Welfare Unit will do three controls per year for large scale slaughterhouses and one for the others. They did not provide a starting date. It has recently produced a new checklist for their Animal Welfare Unit. In March 2020, based on the protocol signed with FASFC, it issued new instructions for the FASFC official veterinarians.

The responsibilities for animal welfare at slaughter are clear, but Belgium has not ensured efficient and effective coordination between all authorities involved. This translates into suboptimal cooperation and insufficient sharing of information between the federal and regional competent authorities. The high dependence on the federal checks in the slaughterhouses is more relevant for the Walloon region, where the shortage of resources limits their activities. The checklists filled in by federal official veterinarians do not add much value to the official system. They systematically miss existing non-compliances and create administrative burden for regional authorities due to the way they are transmitted.

Member state response

es Brussels region: A meeting took place with the local control unit or of the FASFC in Brussels on 11/10/2020. Following this meeting: the contact points have been clarified, animal welfare training took place for the veterinarians of the FASFC on 02/03/2021. A letter was sent to the veterinarian in charge of the EU) mission to remind them of the frequency of filling the checklist at the slaughterhouse in January. Flanders: there will be discussions with the FASFC and the other Regions in order to optimize the consistency and the effectiveness of the different inspections. For this the results of the study mentioned in the response to question 3 will also be taken into account. Wallonia: Thematic technical meetings will be organized in 2021 between the FASFC and the regions in order to improve the inspection system. A revision of the "contrat de gestion" of the protocol (between the FASFC and the regions concerning the control of animal welfare) will be proposed to the FASFC during the year 2021. This will aim to ensure better coordination between the authorities involved. Page: 1 of report ref. DG(SANTE) 2020-6953 of the audit carried out from 12 October at slaughter and during r

The recommendation states as its basis

In response to Recommendation 2 of audit report DG(SANTE) 2014-7057 - to take account of previous inspection results when establishing the risk basis for controls - the Belgian competent authorities provided in their action plan a summary of the system for controls in place after regionalisation, indicating that: Wallonia and Flanders analyse the reports of the FASFC official veterinarians to establish a benchmarking between slaughterhouses. That would allow the regions to prioritise certain slaughterhouses or specific items for their inspections.

The audit team noted that, for 2017, 2018 and 2019, there was no evidence that the analysis for benchmarking to prioritise between slaughterhouses had been carried out. The Flemish and Walloon authorities agreed that a systematic risk analysis had not been carried out in those years.

The slaughterhouse of Brussels-Capital region installed video cameras after the request from the regional competent authority following an animal welfare incident. The authority uses them (see paragraphs 26 to 28) to complement on-site inspections and to monitor critical points during slaughtering. The audit team noted that the regional competent authority officials have to review the recordings of the cameras on site. Due to the COVID-19 restrictions on on­site visits, they could not reach the frequency of video checks planned for the year. The animal welfare officer indicated that following the use of video footage, the staff performance, and the public image of the company have improved. 5.1.3 Controls on business operators' obligations Legal requirements Articles 5(1)(h), 12(1), 13, 14, 18(1), (2), (3), (4) of Regulation (EU) No 2017/625 Articles 4(1)(b), 11(3)(a), 24, 38, 39, 43(6), 44 and Annex I of Regulation (EU) No 2019/627 Articles 3(1)-(2), 4, 5(2)(c)(iv) and 5(3)(b), 7, 8(a), 13, 14 and Annex II Chapter I (3)(a) and (s), Chapter II (5) of Regulation (EU) No 2019/624 Articles 6 and 17 of Regulation (EC) No 1099/2009 8 Findings Brussels-Capital region

The absence of risk-based method for establishing the frequency for official controls does not allow the Flemish and Walloon competent authorities to set the frequency of their controls based on risk and to ensure the level of compliance expected in different situations. This decreases the efficiency of their official controls to target problematic establishments.

The measures that Brussels-Capital regional authority put in place in its red meat slaughterhouse paid off. They improved animal welfare, in particular during slaughter without stunning. The use of video surveillance by the operator and authorities proved useful to improve the welfare of animals and to enforce the legislation. The current arrangements where the officials can only review the video footage from the establishment is a lost opportunity for the authorities for e.g. keep their controls on the slaughterhouse during the Covid-19 restrictions.

Member state response

Brussels region: at the start of each year, dates have been set in nia the inspector's outlook calendar in order to respect the frequency ed ­ of inspections at the slaughterhouse. If the fixed date is not possible to respect, another date is chosen the week after. This was added in the procedure. Flanders: a study has been commissioned to evaluate the system and the inspections of the Flemish private veterinarians on animal welfare at slaughter. This study should also develop a method for carrying out a risk analysis of the slaughterhouses in order to determine the number of inspections. This method for risk analysis should take previous inspection results into account. The results of this study are expected for November 2021. Wallonia: A new legislation is in the process of being approved by the Walloon Government (the 2nd reading took place on March 11, 2021). This legislation implements the mandatory of video surveillance in slaughterhouses and introduces the possibility of hiring veterinarians by competent authorities. These veterinarians will carry out additional specific animal welfare checks in slaughterhouses at the request of Walloon authorities. This will make it possibl

The recommendation states as its basis

Since 1 July 2014, the government delegated to its three regions the responsibility to organise and perform official controls and other official activities for the requirements on the welfare of animals. Since 1 January 2015, Flemish, Walloon and Brussels- Capital Regional governments fully took on this responsibility in their territories and were given competence to adopt their own legislation. Each Region has a separate inspection unit dedicated to animal welfare - the Animal Welfare Unit.

The audit team verified the actions taken to address Recommendation 1 of audit report DG(SANTE) 2014-7059 - on improving the system for providing certificates of competence, by publishing the necessary legislation, targeting the animal welfare officer and covering tasks in slaughterhouses which present particular risks for animal welfare such as slaughter without stunning. The respective competent authorities stated that: In Flanders, the legislation approving the training programme has been published. The competent authority also indicated that although there is an examination module on slaughter without stunning available for cattle and for sheep and goats, the module on slaughter without stunning of sheep and goats has now lost its purpose, since there is a ban on this type of slaughter for both species (see also section 5.5.2 on slaughter without stunning). In Wallonia, the legislation in force to approve the training programme for animal welfare officers and for personnel of the slaughterhouses has not yet been adopted but there is a draft text at political level. The competent authority also indicated that as in this region there is now a ban on slaughter without stunning, the training on slaughter without stunning is no longer relevant. InBrussels-Capital region, legislation approving the training programme has been published and the competent authority also indicated that its module "slaughter without stunning" is in operation as slaughter without prior stunning is carried out in its slaughterhouse.

The Walloon competent authority has not yet fully addressed recommendation 1 of audit report DG(SANTE) 2014-7059, as it has not yet published the necessary legislation to approve the training programme, and it has therefore not fulfilled its responsibilities as designated competent authority.

Member state response

me Wallonia: A new legislation is in the process of being approved by the Walloon Government (the 2nd reading took place on March 11, 2021). lity nd Page: 2 of report ref. DG(SANTE) 2020-6953 of the audit carried out from 12 October at slaughter and during related operations Action Proposed by the competent authority rticle

The recommendation states as its basis

Recommendation 6 of audit report DG(SANTE) 2014-7059 requested the competent authorities to put in place a system for monitoring in the slaughterhouse the welfare of broilers in the farm of origin, in line with the requirements from Annex III to Council Directive 2007/43/EC.

The competent authorities with poultry slaughterhouses (Flanders and Wallonia) have not addressed recommendation 6 of audit report DG(SANTE) 2014-7059. The monitoring of welfare indicators in poultry slaughterhouses is insufficient to allow the competent authorities to take enforcement actions on farms when and where necessary. With the absence of data on daily mortality rates the veterinarians in the slaughterhouses lose a valuable tool to evaluate at what stage of the birds' life the animal welfare problems have occurred. 5.6.3 Criteria for the use of increased stocking density in broiler farms.

Member state response

Flanders: a study has been commissioned to develop a strategy by which Flanders could comply with these requirements. This to study is now in the final stages and describes the different animal e welfare indicators, the way they could be measured and which follow-up could be given. Also, a meeting has been held with the poultry sector on the 16th of March. Wallonia: A meeting with the sector will be organized in 2021 in order to take the necessary measures to enforce these obligations. The measures taken in Flanders will also be taken into account to achieve improvements in 2021.

The recommendation states as its basis

Audit report DG(SANTE) 2014-7059 recommended (Recommendation 7) setting up a procedure to ensure that the checks by a certifying body confirm that producers operating at the higher stocking densities comply with Directive 2007/43/EC.

In response to the pre-audit questionnaire for this audit, the competent authorities of the regions with broilers' farms (Flanders and Wallonia) indicated that they had signed a protocol with the certifying body. This protocol includes that this certifying body has to notify the Animal Welfare Units if it notices severe animal welfare infringements. The Animal Welfare Units will then follow up and carry out an inspection of its own.

The audit team noticed that: The certifying body provided a document of August 2020 with the items that they inspect and the way they carry out the inspections. In this document, the certifying body has grouped together, from the previous checklist, the animal welfare requirements laid down in Directive 2007/43/EC, to provide better information to the regional competent authorities and farmers. The two regional competent authorities have not yet analysed this document. The two regional competent authorities indicated that they do not have access to the database of the checklists completed by the certifying body and commented that if they had received the complete checklist, it would have been possible to see exactly which legislative requirements were not respected. The two regional competent authorities also informed the audit team that due to their heavy workload, the protocol with the certifying body has not been followed up properly and that they have not checked if the certifying body provides all the necessary data and that no analysis has been done. The last report that the certifying body sent to the regional competent authorities covered 2019. It includes all farms affiliated with the certifying body and the non- conformities the body found during its checks (mainly on stocking densities). The regional competent authorities' opinion is that the report provides insufficient information for them to carry out an analysis/assessment of compliance. There is no further guidance on what is considered "serious animal welfare 19 infringement". The certifying body has not issued any report of serious animal welfare deficiencies. Other items of the protocol signed with the certifying body were not implemented either, such as the yearly meetings to discuss follow up and the planned audits. All the above indicate there is little progress on setting up criteria for the use of increased stocking density and for the implementation of a procedure to ensure that the checks by a certifying body confirm that producers operating at the higher stocking densities comply with Annex V to Directive 2007/43/EC. Conclusions on criteria for the use of increased stocking density in broiler farms

The competent authorities have not addressed recommendation 7 of audit report DG (SANTE) 2014-7059. The absence of procedures to check compliance in producers operating at the higher stocking densities, together with the absence of monitoring signs of welfare problems at slaughterhouse level, leaves unmonitored the welfare of broilers from the farms presenting the greatest risks.

The protocol signed with the certifying body has not been implemented which leaves the regional competent authorities unaware of any possible shortcomings and welfare problems at farms. This impedes them to take effective action to solve existing issues.

The regional competent authorities cannot confirm compliance in the farms operating at the higher stocking densities. This creates the potential risk that broilers are kept at stocking densities under which the housing and management conditions are not able to ensure their welfare.

Member state response

es. This recommendation also is part of the study mentioned in the response to recommendation 5. Wallonia: A study on the impact of density on the animal welfare of broilers is currently being carried out by the Walloon Agronomic Research Center. The main objective of this study is to analyze the effects of the system applied in Wallonia to obtain the exemption allowing a stocking density higher than 33 Kg / m². The finality is to decide whether it is necessary to continue in this direction in a context for improving animal welfare. The results should be available before the end of 2021 and will help guide actions to address this recommendation. Page: 3

The recommendation states as its basis

The competent authorities successfully strengthened surveillance in both domestic pigs and wild boars, notably in ASF restricted areas. The early detection system is now more effective and they have improved the monitoring of the epidemiological situation in the ASF infected area. However, the early detection system in ASF free areas is slightly weakened, in particular by not testing road killed wild boars and some non-investigated delays in turnaround times for getting laboratory results (3).

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

The recommendation states as its basis

The authorities have not provided the additional guarantees required for meat derived from pigs originated in Part II and which is placed on the EU market (4); but until now, the associated risk has been limited. (2) In their response to the draft report the competent authority stated that the free areas are only permitted on condition that double fencing is installed for non-commercial pig farms. (3) In their response to the draft report the competent authority stated that the delays observed concern samples for which the veterinarian asks the first line laboratories DGZ and ARSIA for a certain diagnosis but without initially including ASF in the diseases to be analysed. After receipt of the analysis results, some veterinarians then request additional analyses on the same samples, sometimes including ASF in this additional demand. This is not in line with the competent authority instructions on increased surveillance for ASF, which require samples to be submitted to a first line laboratory for examination for ASF whenever treatment for a disease problem in a group of pigs is initiated. In the light of this finding the competent authority proposed actions to address the relevant recommendation (Rec no 1). (4) In their response to the draft report the competent authority stated that the practice of stamping the carcasses coming from part II with an oval EU health-mark, was already known prior the audit and an initiative was taken to change it - via a Royal Decree - and was already finalized. More of the modification of the Royal Decree of 19 March 2004 concerning the eradication of ASF, was modified on 5 December 2019 in order to provide the legislative basis for this national health mark. This practice has on this base immediately been stopped following the audit like foreseen. Since then, a special national health-mark has been used to stamp the carcasses of the few domestic pigs coming from part II. As before, these carcasses were only used for fresh meat sales in a supermarket in zone II (local distribution) and were not used for intracommunity trade. Currently, only a small number of domestic pigs destined solely for personal consumption of the pig keepers involved remain. 4

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 the facilities for animals ­ registered horses (category E), good hygiene conditions had not been maintained; however, these had not been used in five years. The surrounding area was not kept clean, there was no cover for the drain and the unloading/loading ramp was no longer fit for purpose due to disuse and exposure to bad weather. 15 Conclusions on suitability of facilities

With the exception of the facilities for live animals ­ category E (registered horses) in the BIP Oostende, the facilities, equipment and hygiene of both BIPs/DPEs were in general fit for purpose for undertaking import controls.

Member state response

border De uitbater heeft al enkele aanpassingen uitgevoerd (nieuw platform). Een brief met de te remediëren probleempunten zal verstuurd worden met het verzoek aan de uitbater om tegen 31/7/2019 een actieplan met concrete tijdslimieten voor deze punten in te sturen naar het FAVV. De GCP van Oostende zal de opvolging doen. Page: 1

The recommendation states as its basis

The CCA and CAs met explained that although there are legal bases and procedures in place for applying sanctions, it is sometimes challenging to enforce the requirements of the legislation in the sector audited, mainly due to difficulties in carrying out official controls for detecting certain non-compliances and for gathering the evidence to support them. For instance, it is their view that the following obligations are difficult to enforce: The verification of the registration of medical treatments in the passports by the treating veterinarian including the activities of the private veterinarian. 8 The verification that the change of keeper is communicated by the new keeper to CBC for registration; Verification of passports issued in other countries and the status of these horses in the central horses databases from the issuing countries, due to legibility issues (see also paragraphs 58, 61 and 79.a); Ensuring that the information flow requirements of Articles 34 and 35 of Regulation (EU) 2015/262 are complied with after the death of an equine animal, in the case of fallen stock, and that the corresponding passports are rendered invalid and are sent to the PIBs (see paragraph 88.b). Notification of the movement of horses leaving the territory or notification of the death of an animal (see also paragraph 63). Coordination and collaboration between CAs, PIBs and sport associations

The audit team noted the following concerning the procedure for the handling of passports and the transmission of the data to the CED: a. The passports of slaughtered animals were invalidated and returned to the CBC offices. In one slaughterhouse visited, the CED was updated on-line, whereas in the other slaughterhouse the passport was not always returned within the specified deadlines (5 working days after slaughter); the stamp used in one slaughterhouse did not explicitly invalidate the passports. b. The rendering company visited ­ the only such facility in Belgium - omits to read, record and transmit the number of transponders from fallen stock they collect to the CED, which is not in compliance with the Art. 44.1 of RD of 16 February 2016 (see paragraph 60). The name of the owner/keeper of the horses and the address of the collection point are recorded, in order to be able to send the invoice for rendering services. However, this data is not communicated to the CED, which as a result is unable to verify that owner/keepers are complying with their obligation to return the passport to the PIB. 15 c. The CA has not enforced the application of the requirements of the above- mentioned RD and, as a consequence, the numbers of the transponders of the horses rendered are not communicated to the CED (8). This is not in line with the requirements of Article 34 of Regulation (EU) 2015/262(9). d. In addition, there is no information available concerning the number of horses without identification. As a consequence, the CED is not reliable because many identifications of dead horses remain active in the CED. The fact that the identity of fallen stock is not recorded and that passports are not recuperated and destroyed jeopardises the credibility of the CED and leaves the door open to fraud.

The CCA stated that when a horse is slaughtered or dies in a different MS there is no uniformity in the way that feedback information is transmitted. The CCA has no means by which to evaluate if MS convey the information in all required cases. Sometimes: the CA of the other MS informs FASFC (who informs CBC); or they inform the PIB directly (who informs CBC); or no information is received. Exclusion of horses as food producing animals occurs in the following situations:

Belgian legislation requires notification to the CED of any changes regarding keepers and their contact details, yet such information is very rarely transmitted to the CBC for endorsement. 5.4.1.2 Identification verification (transponder) Dealers' premises and assembly centres

The evaluation of an animal's eligibility for slaughter is hindered by: a. The huge variety of model/templates of passports from different origins; b. The difficulties to consult foreign databases: e.g. the status of horses are not visible in certain databases (the Netherlands and Germany) c. The absence of information concerning the administration of essential substances and notification in the CED of changes in keepers as required by Belgian law. d. The absence of the date of identification in German passports, combined with the fact that the German database cannot be consulted. During transport

Any horse entering the country as part of intra-community trade is covered by a health certificate and is registered in TRACES. It must be registered in the CBC within 30 days and in any case before any change in keeper. Where no health certificate can be submitted to the CBC at the time of the registration request or where the health certificate is non-compliant, an approved veterinarian must perform a clinical examination of the animal and a blood sample is taken to test for the absence of specific diseases, such as Infectious anemia at the keeper's expense. In practice, very often the health certificate is kept by the first keeper (most commonly a dealer) and is not available to the owner requesting registration.

The content of the CED is not always up-to-date and its reliability is lessen due to various reasons, which also hinders its use for reconciliation and verification tasks. The CED contains 331,692 horses, but it is estimated by the CA that only 250,000 are still alive and present on the territory. The reasons for the discrepancies regarding information are: (11 ) In their response to the draft report, the CA noted that the CBC sends statistics on the evolution of data in Horse-ID to the FPS-HSFCE on a very regular basis (several times a year). The database is monitored indirectly: the FASFC inspection services regularly consult the data submitted. In the event of a problem, the information is sent to the FPS-HSFCE. This was the case before Horse-ID was introduced. Since the entry into force of this new programme, the tasks linked to the CBC have been carried out correctly. 20 a. Contrary to the provisions of Article 27 of Regulation (EU) 2015/262, there is delayed or absent notification of change of status by keepers, veterinarians and/or PIBs (horses that are excluded from the food chain, at a later stage, after registration, appear as eligible horses for the food chain in the database) and, contrary to Article 35 of the same Regulation, keepers are not returning the passports of dead horses to the PIBs. b. The CBC is not duly updated with information about fallen stock and for horses that have permanently left the country. As a consequence, a large number of dead horses are still active in the database (on average 10,000 dead horses are collected per annum by the rendering plant whereas the horse keepers do not return the passports back to the issuing bodies, contrary to what is required). Additionally there is no established flow of information from PIBs located in the other MS to where horses are permanently moved which, must transmit data updates to the central database of the MS where the animal was born/the passport was produced.

The different PIBs are not controlled by the CA and no checks are carried out to verify if the passports of dead animals are returned to the PIBs and if this information is included in the CED.

The CED records are based on the place of holding, not of the ownership. It records primarily identification information on horses that are kept in Belgium. There is an obligation for keepers to notify any change in contact details, end of holding period, place of holding if more than 90 days, permanent departure from the territory of Belgium, and exclusion from the food chain. However, keepers regularly omit to inform CED.

Under the provisions of the Memorandum of Agreement with the Netherlands, Luxembourg and France, registered horses may travel between these countries without being recorded in TRACES once they are accompanied by a passport, are microchipped and are fit and healthy to travel. If permanently resident in the new country, they must be registered at the CBC in the country of residence. However, communication of this new registration in other countries is seldom received by CED. Conclusions on horses identification, holdings/keepers registration and movement 21 controls

The fact that a number of horses are not yet identified, together with the late identification of horses after the compulsory period (12 months) highlight that the owners/keepers do not consistently meet their obligations on horse identification pursuant to Articles 11 and 12 of Regulation (EU) 2015/262. Nonetheless, the automatic exclusion from the food chain of horses which were registered late or for which duplicate or replacement passports were issued, mitigates potential risks in the production of horse meat.

The CED containing data of the registration and identification of horses is kept by the CBC at central level and is updated with information from the PIBs and the slaughterhouses. Even though the database allows for the recording of all the information required under EU rules, the information contained is not up to date, as relevant provisions (notably Articles 12, 27 and 35 of Regulation (EU) 2015/262) are not consistently adhered to.

The system in place does not provide reasonable assurance that the requirements laid down in Article 35 of Regulation (EU) 2015/262 are complied with and, in particular, concerning the obligation of the keeper of the deceased horses (excluding those slaughtered) to return the passport for invalidation by the PIBs.

Member state response

e CA will evaluate the procedure as part of the implementation of the AHL and the new VMPs regulation.

The recommendation states as its basis

All Category 3 processing plants visited were using processing method 7 which had been validated by the ABP operators and authorised by the OVAM. All analytical reports of the samples taken during the 30 days period of validation required by Article 8 and point G(1), Chapter III of Annex IV to Commission Regulation (EU) No 142/2011 were available. In one plant several cases were found by the audit team where samples for detection of Clostridium perfringens had not been taken directly after the treatment. This is not in line with the requirements of point G1(c)(i), Chapter III, Annex IV of Regulation (EU) No 142/2011. The audit team noted that in two of the three processing plants visited records of temperatures (which is a critical control point) used during the validation period were not available. The inspector explained that temperature diagrams were checked during the validation on the screen of the computer and that these records were not saved/maintained. This is not fully in line with the requirements of point G2, Chapter III, Annex IV of Regulation (EU) No 142/2011.2

Although official controls on ABPs and derived products fall under the responsibility of several Federal and/or Regional competent authorities, the system is well designed and the controls which are risk-based are underpinned by comprehensive establishment listing, well-managed cooperation and communication within and between the different Federal and Regional authorities and, with the exception of the use of TRACES, comprehensive instructions and guidance for inspectors. Shortcomings in record keeping and sampling in relation to official verification of operators` validation of processing method 7 questions the reliability of method performance.

Member state response

e OVAM procedure for validation for method 7 will foresee , that logged records and other data relevant for the validation process are stored in the OVAM files. The analysis reports of the approved laboratories for the 30 days validation tests already now contain a specific reference to the ABP regulation requirements to make sure they are complied with by the laboratory.

The recommendation states as its basis

The FASFC prepared a service note on the requirements of intra-union trade of PAP and MBM. The note which is applicable only to staff working under the responsibility of FASFC, contains a comprehensive description of the obligation of the Belgian competent authority to notify the competent authority of destination about the departure of the consignments and also on the obligation to notify the competent authority of origin about the arrival of the consignments through the TRAde Control and Expert System (TRACES), as required by Article 48 of Regulation (EC) No 1069/2009..

Although official controls on ABPs and derived products fall under the responsibility of several Federal and/or Regional competent authorities, the system is well designed and the controls which are risk-based are underpinned by comprehensive establishment listing, well-managed cooperation and communication within and between the different Federal and Regional authorities and, with the exception of the use of TRACES, comprehensive instructions and guidance for inspectors. Shortcomings in record keeping and sampling in relation to official verification of operators` validation of processing method 7 questions the reliability of method performance.

The audit team visited a storage plant which imported PAP from third countries. The company had a well-designed storage system to avoid mixing the PAP of different batches. The company traceability system was also clear and well-managed. The imported products were accompanied by a health certificate and the TRACES document. Some parts of the imported PAP were transported to other Member States for pet food production, but TRACES documents were never issued for these transports, which is not in line with the requirements of article 48 of Regulation (EC) No 1069/2009. The local inspector did not identify the lack of TRACES notifications during the official controls. 11

Nevertheless, checks on the implementation of requirements concerning preparation and confirmation of TRACES notifications of intra-Union trade of PAP and OF/SI are not adequate. This weakness partly undermines the reliability of the flow of information of the intra EU-trade of such products.

Member state response

A specific question to verify the required TRACES messages have en send by the operator will be taken up in the checklist of the FASFC for storage plants for derived products (including PAP), during the next revision. The concerned sector organizations will be reminded on these requirements during the next available platform of the Feed and ABP sector.

The recommendation states as its basis

The FASFC prepared a service note on the requirements of intra-union trade of PAP and MBM. The note which is applicable only to staff working under the responsibility of FASFC, contains a comprehensive description of the obligation of the Belgian competent authority to notify the competent authority of destination about the departure of the consignments and also on the obligation to notify the competent authority of origin about the arrival of the consignments through the TRAde Control and Expert System (TRACES), as required by Article 48 of Regulation (EC) No 1069/2009..

Although official controls on ABPs and derived products fall under the responsibility of several Federal and/or Regional competent authorities, the system is well designed and the controls which are risk-based are underpinned by comprehensive establishment listing, well-managed cooperation and communication within and between the different Federal and Regional authorities and, with the exception of the use of TRACES, comprehensive instructions and guidance for inspectors. Shortcomings in record keeping and sampling in relation to official verification of operators` validation of processing method 7 questions the reliability of method performance.

The audit team noted that, although training and instructions were provided (see findings 5 and 19), in several cases, arrivals of consignments of PAP were not confirmed by the Belgian competent authorities to the competent authorities of the Member State of origin through TRACES, contrary to Article 48(3) of Regulation (EC) No 1069/2009. In 2017 around 25% of such arrivals were not notified and this increased to 60% in 2018.3

Nevertheless, checks on the implementation of requirements concerning preparation and confirmation of TRACES notifications of intra-Union trade of PAP and OF/SI are not adequate. This weakness partly undermines the reliability of the flow of information of the intra EU-trade of such products.

Member state response

This recommendation concerns the FASFC as well as the Walloon and Flemish regional authorities. For PSW a new more stringent procedure is being drafted and will include timely and regular checks. For OVAM a single centralized responsible is in charge of the follow up on notification. A commitment for a more rigorous implementation of the already existing procedures is made. FASFC: since a minority of consignments for which the FASFC is competent are not notified of arrival, the local control units will be reminded of the service note and requirements regarding the Page: 1 eport ref. DG(SANTE)/2018-6335-MR of the audit carried out from 10 of hygiene, traceability and trade requirements of processed animal proteins, tion Proposed by the competent authority tification of arrival during the next sectoral consultation atform (consultation headquarters/local control units). gular reminders of this duty on notification for arrival will be heduled on the agenda of the Belgian Commission Animal By- oducts.

The recommendation states as its basis

The FASFC issued a circular letter relating to OF/SI containing PAP and/or MBM. The letter contained detailed information about the necessity of TRACES notification. If the OF/SI is going to intra-Union trade, TRACES notification is only necessary if it is pure (100%) PAP and/or MBM. This is not fully in line with the requirement of Article 48 of Regulation (EC) No 1069/2009. The FASFC stated, that export of OF/SI with ruminant PAP is not allowed according to national legislation. Based on chapter 5 of the farm control checklist, if OF/SI were used in the 21 days prior to the date of the control, the inspector has to check on-the-spot that the exact parcel of land - where the OF/SI was used - fulfils the legal requirements of Chapter II, Annex XI of Regulation (EU) No 142/2011 (see finding 29). Such controls are carried out generally every 8 years.

Although official controls on ABPs and derived products fall under the responsibility of several Federal and/or Regional competent authorities, the system is well designed and the controls which are risk-based are underpinned by comprehensive establishment listing, well-managed cooperation and communication within and between the different Federal and Regional authorities and, with the exception of the use of TRACES, comprehensive instructions and guidance for inspectors. Shortcomings in record keeping and sampling in relation to official verification of operators` validation of processing method 7 questions the reliability of method performance.

One OF/SI manufacturer visited produced OF/SI from PAP and MBM. The commercial packaging of these products was small bags (less than 50kg) and big bags (less than 1000 kg). The company exported only small bags to third countries which contain PAP from non-ruminant and the concentration is up to 75%. The company traded with other Member States small bags containing up to 90% of MBM and big bags containing up to 50% of PAP and/or MBM. There were no TRACES notifications relating to these consignments (see finding 23). Belgium did not use the possibility described in point 3, 10 Section 1, Chapter II, Annex XI of Regulation (EU) No 142/2011 to authorise a component which makes big bags of OF/SI unpalatable. The competent authority stated that the guarantees requested by national legislation fulfil the requirements of point 4(b) Section 1, Chapter II, Annex XI of Regulation (EU) No 142/2011. These guarantees are: big bags are labelled with the obligatory labelling requirements described in point 2(b)(xi), Chapter II, Annex VIII of Regulation (EU) No 142/2011, additional labelling requirements such as "not destined for land to which farmed animals have access, store in place physically separated from livestock", sealing at the top and the bottom of the big bags, regular official controls on farms using OF/SI (see finding 23).

The audit team noted that, as a general policy in Belgium, intra-Union trade of consignments OF/SI containing not pure (100%) PAP and/or MBM (see findings 23) are not notified in TRACES, contrary to Article 48(3) of Regulation (EC) No 1069/2009. This was confirmed during visit of an OF/SI manufacturer (see finding 29). 5.2.3 Exports and imports of PAP

Nevertheless, checks on the implementation of requirements concerning preparation and confirmation of TRACES notifications of intra-Union trade of PAP and OF/SI are not adequate. This weakness partly undermines the reliability of the flow of information of the intra EU-trade of such products.

Member state response

The FASFC disagrees with the finding and recommendation to tify OF/SI containing PAP consignments in intracommunity ade. do not see any legal requirement in the ABP regulation to to bstantiate this recommendation. The wording of the article 48 of gulation 1069/2009 clearly states that "PAP derived from tegory 3 material" needs a notification via TRACES of the MS destination. There is no mention of "and products containing P" as is done in other parts of the regulation when it is the tention of the legislator to include not 100% pure products. is interpretation is supported by the majority of MS as nfirmed during the working group on ABP of 15 October 2018.

The recommendation states as its basis

The FASFC prepared a comprehensive procedure on export of PAP-containing ruminant protein. The procedure provides detailed instructions on the control of seals at the BIP. There are also detailed instructions on recording the outcome of the control in TRACES (fulfil relevant parts of the control page). The audit team found that there was no instruction on the obligation for the competent authority responsible for the establishment of origin to carry out regular controls to verify the correct application of seals and verify that confirmation from the point of exit on the identity (seal) control, had been received through TRACES. Such confirmation is required by point 1.(d), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001.

In one processing plant visited in 2018 (up until the end of August), 467 consignments of PAP containing ruminant protein were sent to third countries (the total number of export consignments containing ruminant PAP from Belgium in that period was 2100). In 2018, the point of exit was different on the transport documents and TRACES documents in around 30 cases (e.g. transport document Antwerp and Rotterdam, TRACES only Antwerp). The representative of the BIP mentioned in the TRACES document confirmed that these consignments had never arrived at the point of exit. The consequence is that seal checks had not been carried out at the BIP declared in 3 In its response to the draft report the competent authority noted that detailed analysis of the data used by the audit team showed that the share of the FASFC in these percentages of non-notification was limited. In 2017 only a very limited number of consignments were not notified. However in 2018 (Jan. ­ Sept.) indeed a substantial part of the consignments were not notified, largely due to work overload by a food crisis in the first half of 2018 and a temporarily backlog due to the holiday season just before the audit. 4 In its response to the draft report the competent authority agreed with the finding that in some cases only 20% of the imported PAP consignment in bulk had been sampled and not the first 6 consignments. There is however a service note of the FASFC which clearly describes the requirements of Annex XIV, section 2, point 2 of Regulation (EU) no 142/2011, including the requirement to sample the first 6 consecutive consignments from each third country after which the sampling is reduced to a sampling of 20% of the consignments. The finding is the result of an individual mistake of the inspector, misunderstanding the information in the service note regarding the 20% reduced sampling after 6 consecutive, compliant consignments. This procedure has been reminded and clarified during the mentioned training on import of ABP. 12 TRACES. In a few cases the same point of exit was specified on the transport documents and in TRACES (Antwerp), however, there was no evidence that these consignments had arrived at this BIP. 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 1.(c), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001. The competent authority had not identified during previous official controls that the confirmation of sealing at BIP was not received through TRACES, although it is required by point 1.(d), Section E, Chapter V, Annex IV of Regulation (EC) No 999/2001 (see finding 20) . 5.2.4 Follow-up of non-compliances Legal requirements Article 46 and 53 of Regulation (EC) No 1069/2009. Articles 54 and 55 of Regulation (EC) No 882/2004. Findings

The lack of a control mechanism in PAP processing plants to verify that confirmation of the identity (seal) controls at the point of exit had been received through TRACES and the improper implementation of sampling requirements on imported PAP undermine the effectiveness of official controls on export and import of PAP. 13

Member state response

present 4 category 3 processing use this regime for export of f ruminant PAP or PAP including ruminant PAP. We are convinced majority of the found shortcomings originate in the novelty of e procedure and operators not being fully familiar with this red procedure. ring the audit mission the sectoral organisation and the ncerned operators were already reminded on these quirements. Page: 2 eport ref. DG(SANTE)/2018-6335-MR of the audit carried out from 10 of hygiene, traceability and trade requirements of processed animal proteins, on Proposed by the competent authority ng the next export platform of ABP and derived products that FASFC organises with all relevant sector organisations; the edure will be reminded. competent authority for the verification of the implementation he export procedure at category 3 rendering plants has still to etermined in Belgium. Discussions are ongoing.

The recommendation states as its basis

The FASFC has prepared guidance on sampling requirements for imported PAP. Samples for microbiology have to be taken from the first 6 consecutive bulk consignments of PAP from each third country. The audit team identified that in some cases only 20% of the imported PAP consignments in bulk had been sampled without any evidence that analyses on the first 6 consignments had been carried out as required by point 2, Section 2 of Annex XIV to Regulation (EU) No 142/2011.4

The lack of a control mechanism in PAP processing plants to verify that confirmation of the identity (seal) controls at the point of exit had been received through TRACES and the improper implementation of sampling requirements on imported PAP undermine the effectiveness of official controls on export and import of PAP. 13

Member state response

The service note of the FASFC describes the requirements of x XIV, section 2, point 2 of Regulation (EC) no 142/2011, uding the requirement to sample the first 6 consecutive ignments from each third country after which the sampling is ced to a sampling of 20% of the consignments. e finding 36 is the result of an individual mistake of an ector, misunderstanding the information in the service note rding the 20% reduced sampling after 6 consecutive, liant consignments only a focused action was needed. specific legal requirement regarding sampling for onella/Enterobacteriaceae during import controls of PAP explained during the 5 training sessions on import of ABP n to BIP inspectors in September ­ November 2018. Page: 3

Member state response

Controle: Verordening 1924/2006 en de controles daarop in het najaar 2018, Verordening 1169/2011 en de controles daarop in het voorjaar van 2019. - De Checklists Etikettering worden gewijzigd: Momenteel zijn de volgende punten opgenomen: " De ingrediëntenlijst is aanwezig en bevat de noodzakelijke elementen" met daarbij in de commentaren als eerste punt " Ingrediëntenlijst vergelijken met de receptuur ! " " De stoffen en producten die allergieën of intoleranties veroorzaken, zijn vermeld in de ingrediëntenlijst" met in de commentaren "de overeenkomst verifiëren tussen de receptuur en de ingrediëntenlijst vermeld in de etikettering van het product" Dit gaat gewijzigd worden zodat de vermelding over het vergelijken van de receptuur met het etiket niet meer in de commentaar staat maar concreet in de vraag zelf vermeld wordt, zodanig dat zelfs in het geval enkel de versie van de CL zonder commentaren zichtbaar zou zijn, er toch duidelijk aangegeven wordt dat die vergelijking moet gebeuren. Dit zal ook nog aan bod komen tijdens de opleidingen. - Er werd nooit gesteld dat het nakijken van een etiket binnen een bepaalde tijdsframe moest afgewerkt worden en dat daardoor bepaalde onderdelen

Member state response

d Les démarches suivantes seront faites : ons -détailler davantage les prochains plans d'action ,assortis d'analyses de risques encore plus affinés et basés sur une approche stratégique englobant objectivement tous les maillons de . la chaîne. -associer partiellement les contrôleurs régionaux dont dispose l'Inspection économique en leur faisant exécuter les contrôles de routine. Libérer ainsi dans le chef des inspecteurs spécialisés le temps nécessaire pour effectuer des contrôles en amont, là où c'est nécessaire. -utilisation maximale de la nouvelle compétence prévue par le Code de droit économique qui permet d'exiger de la part des acteurs économiques concernées des analyses/vérifications par des laboratoires indépendantes. - améliorer les scénarios du point de contact que l'Inspection économique a déjà mis en place afin que les différents acteurs du marché puissent au mieux faire part de dysfonctionnements et que ces signaux soient mieux reçus et puissent être traités rapidement. Page: 2

The recommendation states as its basis

The current control system in place does not compel control staff to check, during inspections at FBOs whether the use of FIAs in foodstuffs fully complies with the relevant EU legislation. The pool of inspectors that should carry out second line inspections, is not in place yet7.

There is a system in place for the official controls of FIAs, including import, marketing and their use that is overall fit for purpose, and includes appropriate action in case of non-compliance. However, checks of compliance with the FIAs legislation are only carried out now and then since 2016, at the initiative of individual inspectors. Therefore the production, marketing and use of FIAs are not systematically subject to verification and enforcement where necessary, as regards the FIAs legislation. 8

Member state response

ensure " Een team van gespecialiseerde medewerkers in de materie van voedselverbeteraars zal een scenario uitwerken en opleiding voorzien voor de organisatie van doelgerichte acties ter controle van het gebruik van voedselverbeteraars. Gradueel en aan de hand van `lessons learned' zal geëvalueerd worden hoe het systeem van controleren verder kan geoptimaliseerd worden." Timing : opstart in 2019 Page: 1

The recommendation states as its basis

Some requirements in the regional legislations and / or their implementation are not in line with EU rules. This mainly relates to exceptional production rules (see chapter 5.2.7), conditions for the grazing of cattle (paragraph 40) as well as the exemption and control of retailers (see paragraph 27 and 30). Conclusions on National Legislation and Provisions

Regional provisions are in place to implement legally binding Union acts. However, some of these provisions and / or their implementation are not in line with requirements of the EU organic regulations.

All three Regions made use of Article 28(2) of Regulation (EC) No 834/2007 and exempted retailers selling pre-packed products to the final consumer. According to Article 4.2 and 4.3 of the Decree of Wallonia and Article 4.2 and 4.3 of the Decree of Bruxelles-Capital the exemption from official controls is limited to retailers with an annual turnover of less than 5,000 Euros (of sales of organic products) in these two Regions provided conditions laid down in Article 28(2) of the above mentioned regulation are fulfilled.However, CAs confirmed that no controls are undertaken to verify whether exempted retailers fulfil conditions for exemption from official controls provided for in Article 28(2) of Regulation (EC) No 834/2007. Conclusions on Registration of Operators

The system in place generally ensures that operators are registered and that key information about their organic activity is made publicly accessible by CAs. However, there is no system in place to verify whether exempted retailers fulfil conditions for 6 exemption. Moreover, documentary evidences issued by CB do not necessarily follow the model provided for in the EU regulation. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Articles 3 and 41 of Regulation (EC) No 882/2004 Article 27(3) and 28(2) of Regulation (EC) No 834/2007 Articles 65(4) and 92c(2) of Commission Regulation (EC) No 889/2008 Findings

All operators certified by the CBs visited receive at least one annual control. However, Article 17 of the Decree of the Flemish Government referred to in paragraph 2 provides for partial annual checks on retailers provided that controls cover all aspects during a period of three years. This is not in line with Article 27(3) of Regulation (EC) No 834/2007 which requires that operators, with the exception of wholesalers and operators selling to the final consumer or user as described in Article 28(2) of the same regulation, must be subject to a verification of compliance once a year.

CBs' control plans are based on an assessment of the risk which is generally adequate and efforts are made to increase the effectiveness of controls by improving the planning of visits to processors. CBs conduct a high number of controls which potentially compensate the risk related to the fact that not all CBs directly consider production quantities in their risk evaluation of operators. Some key information is not yet reported in the framework of the MANCP. 5.2.4 Controls of operators Legal Requirements Articles 8 and 9 of Regulation (EC) No 882/2004 Titles II and III of Regulation (EC) No 834/2007 Title II and IV of Regulation (EC) No 889/2008 Article 65 of Commission Regulation (EC) No 889/2008 Findings

At a dairy farm, the audit team noted that the CB accepts that operators may keep animals permanently indoors up to an age of six months, even during the grazing period. The responsible CA confirmed that the CB follows relevant instructions adopted by the advisory committee referred to in paragraph 22. This is not in line with Article 14(2)(b)(ii) of Regulation (EC) No 834/2007 and Article 14(2) of Regulation (EC) No 889/2008 which stipulates that herbivores shall have access to pastures for grazing whenever conditions allow. Conclusions on Controls at Operators

Controls at operators were overall effective although some shortcomings were observed with regard to the control of labelling of organic products, the calculation of input/output and the records of the verification of the organic status of products when received by operators. The implementation of some production rules is not in line with EU organic regulation. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 and 24 of Regulation (EC) No 834/2007 Title III of Commission Regulation (EC) No 889/2008 9 Findings

As regards dehorning of animals, derogations granted by CAs to individual operators are valid for one year and for an estimated number of animals. In the case of CB1 applications by farmers are accepted before animals are born. This is not in line with 11 Article 18 of Regulation (EC) No 889/2008 which does not provide for routine dehorning, but requires a case-by-case assessment before derogation can be granted. The CB assesses the case and forwards a proposal for decision to the CA. However, no documents are provided to the CA to support the CB proposal.

CB1 stated that dehorning has to be done within seven days of birth of the animal. In the case of CB2, the audit team noted that derogations were granted for the dehorning of animals of up to 6 months of age and more. During inspections observed, it was not verified whether animals when dehorned were of appropriate age and subject to application of appropriate anaesthesia/analgesia as required by Article 18(2) of Regulation (EC) No 889/2008.

During witness audits, it was noted that a conversion period of three months was granted to an operator who produces vegetables in glasshouses. The CB stated that it followed relevant instructions provided by the CA (Flanders) on its website. This was confirmed by the relevant CA. The CA further stated that pesticides which were not authorised for organic production were previously used on production in hydroculture and that the soil, at that time, was covered with plastic film which prevented contamination. This was confirmed by a soil sample (no residues) before the three months conversion period was granted to the operator. This is not in line with Article 36(2)(b) of Regulation (EC) No 889/2008 which stipulates that the parcels for which the conversion period is reduced were natural or agricultural areas which were not treated with non-authorised products over a period of three years before such derogation can be granted.

Regional legislations (see paragraph 2) allow for the tethering of animals in holdings having less than 50 animals. However, no evidence was provided to the audit team demonstrating that all other specific conditions laid down in Article 39 of Regulation (EC) No 889/2008 are verified by CAs before the derogation is granted. Conclusions on Exceptional Production Rules and Other Derogations

Some of the regional provisions for exceptional production rules and other derogations, as well as their implementation, are not in line with EU rules. 5.2.8 Imports of Products from Organic Production Legal Requirements Articles 32 and 33 of Regulation (EC) No 834/2007 Chapter 3 of Title III and Annexes II, III, V and VI of Commission Regulation (EC) No 1235/2008 Findings

Member state response

The regional legislations will be adjusted where needed: The mutilation of animals: the recognised control bodies will be reminded that in accordance with the provisions of Art. 18 of Reg. 889/2008 any suffering to the animals shall be reduced to a minimum by carrying out the operation only at the most appropriate age. The requirements on the applications, granting and control of mutilation of animals will be reinforced The shortening of conversion period: BE is of the opinion that the requirements regarding the shortening of the conversion period are implemented correctly. The grazing of animals: (i) the reference to Article 14(2)(b)(ii) of Regulation (EC) No 834/2007 is invalid (ii) in accordance with Article 14(1)(b)(ii) of Regulation (EC) No 834/2007 "husbandry practices, including [...] housing conditions shall ensure that the developmental, physiological and ethological needs of animals are met"; BE considers the latter article must be taken into account when deciding whether or not it is found appropriate to keep calves under six months inside the buildings. Tethering of animals: BE is of the opinion that the requirements regarding the tethering of animals in small holdings

The recommendation states as its basis

Customs is responsible for general import controls. There is however no CA responsible for import controls of organic goods and the implementation of relevant EU requirements. This is not in line with Article 27(1) of Regulation (EC) No 834/2007 which requires EU MSs to designate one or more competent authorities responsible for controls in respect of the obligations established in the EU organic regulations (see also chapter 5.2.8)

The regional CAs stated that a protocol is being developed between the Regions and Customs for the implementation of the electronic certification via the Trade Control and Expert System New Technology (TRACES NT) applicable as of October 2017. However, neither a draft nor a deadline for finalization of such a document could be provided by the regional CAs or Customs to the audit team. This, together with the fact that no CA is currently responsible for import controls, puts at risk the timely implementation of the electronic certification system.

Files reviewed confirmed that good communication is in place between the regional CAs and the paying agencies concerning irregularities relating to EU organic rules and the exchange of other relevant information such as the list of land parcels managed by an organic farmer. However, irregularities related to imported goods are not shared in a systematic manner by the regional CAs with Customs (see paragraph 62). Conclusions Competent Authorities and Control Bodies

The control system for organic production is only partially in place. Although competencies and related obligations are well defined at regional level, no CA is responsible for import controls of organic goods (see also chapter 5.2.8). 5.2.1.1 Control Bodies: Approval, Supervision and Withdrawal 4 Legal Requirements Articles 5(2) and (3) of Regulation (EC) No 882/2004 Articles 27(5) to (9) and 27(14) of Regulation (EC) No 834/2007 Articles 92c and 92e of Commission Regulation (EC) No 889/2008 Findings

There is no CA designed for import controls of organic products in Belgium, contrary to Article 27(1) of Regulation (EC) No 834/2007. 12

Provisions of Regulation (EC) No 1235/2008 in relation to the EU import of organic products such as the risk assessment to determine the frequency of physical checks or the sampling of consignments of organic products before they are released for free circulation into the EU by Customs are not implemented.

Customs may receive, on an ad-hoc basis, information from regional CAs as regards organic consignments entering into the EU via Belgium. The audit team was presented some examples showing that organic consignments from Ukraine, Russia and Kazakhstan were sampled. However, the CAs could neither present an overview nor could they provide evidence to confirm that all organic consignments from Ukraine, Russia and Kazakhstan had been subject to the reinforced control measures adopted by the EU.

In a case reviewed by the audit team, an organic consignment was imported into Belgium without a Certificate of Inspection. This was discovered by the CB during control at the importer who had imported this consignment. The CB notified the regional CA, but the irregularity was not shared with Customs. Conclusions on Imports of Products from Organic Productions

Import controls may take place on an ad-hoc basis in Belgium. However there is no CA responsible for import controls and it is currently not ensured that relevant control requirements are implemented. 5.2.9 Measures in cases of irregularities and infringements Legal Requirements Articles 54, 55(1) of Regulation (EC) No 882/2004 Article 27(5)(d) and 30 of Regulation (EC) No 834/2007 Articles 91, 92, 92(a) and (d) of Commission Regulation (EC) No 889/2008 Findings

Member state response

he regional CAs are responsible for the management of TRACES and for controls on import. The necessary provisions to fulfill the requirements and to ensure an effective and efficient control system on import are already own being implemented. The Belgian Regional authorities foresee that procedures and a working agreement with the Custom services will be adopted by the end of 2018. A first coordination meeting gathering the regional CAs, the Customs and the Food safety agency took place on 17 Nov 2017.

The recommendation states as its basis

In Brussels-Capital, no supervision of CBs has been carried out since 2012. During the office audit at CB1, it was confirmed that the CA of Wallonia had not conducted any office audits or witness audit in 2016. This is not in line with Article 92e of Regulation (EC) No 889/2008 according to which CAs have to organise an annual inspection of CBs that have been delegated control tasks under the EU organic regulations.

Supervision of CBs by regional CAs is only partially implemented. Good coordination and communication is in place with regard to certain aspects, although there are shortcomings regarding the communication of irregularities by CBs to the CAs (see also chapter 5.2.9). 5.2.2 Registration of operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007 Article 92b of Commission Regulation (EC) No 889/2008 Findings

Member state response

ing 20 and conclusion 24 to be corrected, see our comment. Actually all the CBs get annual supervision by two out of the three regional CAs. The third CA will also set up and implement a procedure for annual supervision, in line with Art 92 of R (EC) N°889/2008 by July 2019.

The recommendation states as its basis

Lists of operators are published on the webpages of the CAs of the three Regions. On these webpages links are provided to relevant CB webpages where updated documentary evidences of operators can be accessed. Evidence of monthly communication of updated lists of operators by CBs to regional CAs was furnished to the audit team. However, the documentary evidence issued by one of the three CBs to operators does not follow the model provided for in annex XII of Regulation (EC) No 889/2008. This is not in line with Article 92b of the same Regulation.

The system in place generally ensures that operators are registered and that key information about their organic activity is made publicly accessible by CAs. However, there is no system in place to verify whether exempted retailers fulfil conditions for 6 exemption. Moreover, documentary evidences issued by CB do not necessarily follow the model provided for in the EU regulation. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Articles 3 and 41 of Regulation (EC) No 882/2004 Article 27(3) and 28(2) of Regulation (EC) No 834/2007 Articles 65(4) and 92c(2) of Commission Regulation (EC) No 889/2008 Findings

Member state response

BE acknowledges that at least one type of documentary evidence Page: 2 8 t ref. DG(SANTE)/2017-6073-MR of the audit carried out from 19 organic production and labelling of organic products Action Proposed by the competent authority does not use properly the model laid down by annex XII of Regulation (EC) No 889/2008. Necessary adjustments will be made. This is foreseen by January 2019.

The recommendation states as its basis

All three Regions made use of Article 28(2) of Regulation (EC) No 834/2007 and exempted retailers selling pre-packed products to the final consumer. According to Article 4.2 and 4.3 of the Decree of Wallonia and Article 4.2 and 4.3 of the Decree of Bruxelles-Capital the exemption from official controls is limited to retailers with an annual turnover of less than 5,000 Euros (of sales of organic products) in these two Regions provided conditions laid down in Article 28(2) of the above mentioned regulation are fulfilled.However, CAs confirmed that no controls are undertaken to verify whether exempted retailers fulfil conditions for exemption from official controls provided for in Article 28(2) of Regulation (EC) No 834/2007. Conclusions on Registration of Operators

The system in place generally ensures that operators are registered and that key information about their organic activity is made publicly accessible by CAs. However, there is no system in place to verify whether exempted retailers fulfil conditions for 6 exemption. Moreover, documentary evidences issued by CB do not necessarily follow the model provided for in the EU regulation. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Articles 3 and 41 of Regulation (EC) No 882/2004 Article 27(3) and 28(2) of Regulation (EC) No 834/2007 Articles 65(4) and 92c(2) of Commission Regulation (EC) No 889/2008 Findings

Member state response

The system to verify the exemption of retailers will be set up and nforced through cooperation with the federal public service Economy. The necessary provisions to fulfill the requirements and to ensure an effective and efficient control system are being implemented. We foresee that procedures and a working agreement with the federal public service Economy will be adopted by July 2019

The recommendation states as its basis

The Multi-Annual Control Plan (MANCP) contains a section describing the control system for organic production in Belgium. However, it does not include information on some of the key aspects of the control system and its supervision, including procedures and resources, contrary to requirements laid down in Article 92f and Annex XIIIb of Regulation (EC) No 889/2008.

CBs' control plans are based on an assessment of the risk which is generally adequate and efforts are made to increase the effectiveness of controls by improving the planning of visits to processors. CBs conduct a high number of controls which potentially compensate the risk related to the fact that not all CBs directly consider production quantities in their risk evaluation of operators. Some key information is not yet reported in the framework of the MANCP. 5.2.4 Controls of operators Legal Requirements Articles 8 and 9 of Regulation (EC) No 882/2004 Titles II and III of Regulation (EC) No 834/2007 Title II and IV of Regulation (EC) No 889/2008 Article 65 of Commission Regulation (EC) No 889/2008 Findings

Member state response

the next MANCP-report BE will provide more elaborate information on the supervision activities.

The recommendation states as its basis

A calculation of the balance of input and output was conducted during all inspections observed. The exercise was mainly based on documentary checks and often did not include the verification of the real situation on the spot. At the egg producers visited, the input/output calculation focused on feed consumption per hen per day for a randomly selected hen house. The data related to an appropriate period, starting from the stocking day of the house with hens up to the inspection day. Inspectors took data from records such as the volume of feed in stock, but did not verify the real amount of the feed still in stock on the day of inspection. At a plant producer, the inspector verified invoices for sale but did not check plausibility of these quantities by comparing them with actual production data and estimated yields. At one of the processors visited, the inspector did not verify the accuracy of the records kept by the operator regarding quantities produced and sold, despite the fact that relevant invoices were available. This is not in line with Article 66 of Regulation (EC) No 889/2008 which requires that documentary accounts are used to verification operations performed by the operator.

At one of the processors visited, the internal checklist for reception of goods referred to food safety aspects only but not to verification of the organic status of a product. This had never been raised as non-compliant by the CBs in the past. The CBs visited confirmed that operators are not required to record the verification of the organic status of the goods at reception which is not in line with Article 66(2) of Regulation (EC) No 889/2008.

Controls at operators were overall effective although some shortcomings were observed with regard to the control of labelling of organic products, the calculation of input/output and the records of the verification of the organic status of products when received by operators. The implementation of some production rules is not in line with EU organic regulation. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 and 24 of Regulation (EC) No 834/2007 Title III of Commission Regulation (EC) No 889/2008 9 Findings

As regards the labelling, a number of labels on packaging of organic products were seen which included a reference to both, EU and non-EU agriculture, on the same label despite the fact that ingredients were of either EU or non-EU origin. The CAs stated that such reference, i.e. EU / non-EU on the same package, is considered acceptable mainly for practical reason, even if this reference does not always fully reflect the content of the product. This is not in line Article 24(1)(c) of Regulation (EC) No 834/2007. At another operator certified by CB1, the size of the EU logo on the label used did not meet the minimum dimensions set out in point 7 of Annex XI of Regulation (EC) No 889/2008. The labels were provided by the operator's producer association who market the operator's production to final consumers. The producer association is also certified by CB1. This issue has never been raised as non-compliant by the CB either during the inspection observed by the audit team or during previous inspections. At another operator (CB2), the packaging material used for the processed product did not show the CB code number as required by Article 24(1)(a) of Regulation (EC) No 834/2007. The CB has never requested the correction of this non-compliance although the operator has been using this type of packing material for several years. Conclusions on Labelling and Traceability

The system in place generally allows for traceability of organic products at all stages. However, controls of labels were superficial and the lack of obligatory information was overlooked with the risk that consumers are misled or that key information to ensure traceability of a product is not provided. 5.2.6 Sampling and laboratory analysis Legal Requirements Article 12 of Regulation (EC) No 882/2004 Article 65 (2) of Commission Regulation (EC) No 889/2008 Findings

Member state response

Although this was already a point of particular interest during recent supervision audits, we will stress the importance of the cited issues. Control bodies will be reminded thereof regularly. Page: 3 8 t ref. DG(SANTE)/2017-6073-MR of the audit carried out from 19 organic production and labelling of organic products Action Proposed by the competent authority

The recommendation states as its basis

The two CBs visited have a list of laboratories which are used for the testing of organic samples. These laboratories are accredited to ISO 17025, but they are not designated by the CAs for the testing of organic products as required by Article 12(1) of Regulation (EC) No 882/2004.

The CAs of Flanders and Wallonia stated that the scope of active substances tested by the laboratories in the case of organic samples is verified during supervision of CBs. However, the audit team noted that result of such verification was not reported by the CAs in the relevant supervisory reports.

The CBs visited, stated that, in relation to the scope of active substances analysed for, they relied on the fact that the laboratory was accredited. In their view, accreditation implied that the laboratory would be aware of the appropriate testing scope for organic samples. Nevertheless evidence was seen that CBs request single residue methods when required, for example when substances such as glyphosate have to be tested for.

The high number of samples annually taken by the CBs is based on an adequate risk assessment and laboratories used by CBs are accredited. However, laboratories are not designated by the CA as required by EU legislation. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 and sections 2 to 4 of Chapter 6 of Title II of Commission Regulation (EC) No 889/2008 Findings

Member state response

he Regional Competent authorities will explore the opportunities arding the designation of laboratories. In a first stage, the laboratories designated by de federal food safety agency will be taken into account. At a further stage and if deemed appropriate, specific "organic" laboratories will be designated by July 2019.

The recommendation states as its basis

The catalogues of measures are overall comprehensive and the files reviewed by the audit team confirmed that the CBs apply measures in line with the catalogues. However, 13 the majority of measures provided for in these catalogues consist only of light action such as "observation", "comment", "warning", "a request for improvement" and enhanced controls". Moreover, operators who use conventional seeds without prior approval receive a "warning" in Flanders and a "request for improvement" in Wallonia.

Files reviewed and inspections observed during the audit confirmed that measures imposed by CBs in particular in cases of severe and/or recurrent non-compliances were not sufficiently effective to ensure compliance with Article 30 of Regulation (EC) No 834/2007: An organic operator was only issued a "request for improvement" for the recurrent use of conventional seed without prior-derogation from the CB. The field in question was only declassified after the operator was found to have used conventional seeds without prior-approval for the fifth time. The inspection history of an operator visited showed recurrent non-compliances such as insufficient separation, incorrect calculation of the balance of input/output for several organic products, lack of notification of new products to the CB and the selling of several products labelled organic without certification. Despite these severe non-compliances with organic rules, the CB continued to certify the operator. Similar non-compliances were detected during the witness audit and the CB decided to suspend the certificate following this visit. In several cases, it was noted by the audit team that the CBs continued certifying operators before non-compliances with production rules, such as excessive stocking density, inadequate area for animals were corrected by the operators and verified by the CB. Moreover, the CBs visited confirmed that an irregularity noted at an operator is disregarded after a period of 24 months elapses and that, if then the same irregularity occurs, the softest measures suggested in the sanction catalogues would be applied.

The CBs visited apply a "soft" approach with regard to enforcement measures in particular in cases of severe and recurrent irregularities. This, together with the fact that not all irregularities are either reported to relevant CAs or fully investigated by CBs, reduces the effectiveness of the control system.

Member state response

gium was one of the first Member States to dispose of a national legally binding catalogue of measures. This catalogue has proven to be useful for years. Nevertheless Belgium acknowledges that there is room for improvement. We will take into account as much as possible the experiences and examples of good practices from other Member States (a project which is encouraged by the organic unit from DG AGRI) to improve our catalogue of measures. In accordance with the regional regulations, reviewing the catalogue of sanctions must be carried out in consultation with the sector, through discussion in the framework of the advisory committees. Taking account of the procedural steps to be followed and of the sensitivity of the issue at stake, BE foresees to adopt the necessary legal bases in 2019.

The recommendation states as its basis

Regional legislations require the investigation of irregularities irrespective of the level of residues of non-authorised products / pesticides found in an organic product.

However, files reviewed by the audit team confirmed that not all such cases were investigated in line with Article 91 of Regulation (EC) No 889/2008.

CB2 confirmed that in cases where samples taken from raw material not yet used by a processor show residues below the limit referred to above, the processor can use the material in question, as the processor in question is not guilty of the contamination, which must have occurred earlier in the food chain. The CB stated that it would not await the outcome of the investigation contrary to Article 91 of the above mentioned regulation. Moreover, the CB confirmed that the producer of the raw material would not necessarily be informed of the incidence, which is not in line with Article 92(4) of Regulation (EC) No 889/2008 requiring the CB to inform without delay the CB of the operator who had produced the product in question.

In another case, CB2 had taken two samples from a batch in order to investigate a 14 suspicion notified by the importer of the product (Cumin) in question. The CB sent one of the two samples taken to the laboratory. The sample tested positive for cypermethrin (0.015 mg/kg). The operator required the counter sample to be tested which did not show any residue of the insecticide. The CB accepted the result from the counter sample and the product was sold as organic. However, the audit team noted that 1) the counter sample was tested in a laboratory which was chosen by the operator but was not listed in the CB procedures and 2) that the sample taken by the operator prior to the sampling by the CB also contained residues of cypermethrin. The CB was aware of this and confirmed that, in cases where a counter sample has to be tested, the operator has the possibility to choose the laboratory. The CB also confirmed that in the case of contradictory laboratory results, the result of the counter sample would always overrule the result of the first sample and that such cases would not be further investigated to verify whether the operator had complied with the organic rules. This is not in line with Article 91 of Regulation (EC) No 889/2008 which requires that the product cannot be placed on the market with indications referring to the organic production method until it is satisfied, on the basis of the information received from the operator or from other sources, that the doubt has been eliminated.

The CBs visited apply a "soft" approach with regard to enforcement measures in particular in cases of severe and recurrent irregularities. This, together with the fact that not all irregularities are either reported to relevant CAs or fully investigated by CBs, reduces the effectiveness of the control system.

Member state response

CBs will be reminded of this point. The issue will be carefully assessed during the forthcoming supervision audits. Page: 4 8 t ref. DG(SANTE)/2017-6073-MR of the audit carried out from 19 organic production and labelling of organic products Action Proposed by the competent authority

The recommendation states as its basis

Files reviewed during the audit confirmed that, in line with regional requirements, CBs communicated to the regional CAs the lists of all operators on a monthly basis as well as 5 enforcement measures imposed by CBs twice per year. However, shortcomings have been identified with regard to the communication of irregularities and the likelihood of irregularities by CBs to the CAs (see chapter 5.2.9). Conclusions on Control Bodies: Approval, Supervision and Withdrawal

Supervision of CBs by regional CAs is only partially implemented. Good coordination and communication is in place with regard to certain aspects, although there are shortcomings regarding the communication of irregularities by CBs to the CAs (see also chapter 5.2.9). 5.2.2 Registration of operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007 Article 92b of Commission Regulation (EC) No 889/2008 Findings

CB2 confirmed that in cases where samples taken from raw material not yet used by a processor show residues below the limit referred to above, the processor can use the material in question, as the processor in question is not guilty of the contamination, which must have occurred earlier in the food chain. The CB stated that it would not await the outcome of the investigation contrary to Article 91 of the above mentioned regulation. Moreover, the CB confirmed that the producer of the raw material would not necessarily be informed of the incidence, which is not in line with Article 92(4) of Regulation (EC) No 889/2008 requiring the CB to inform without delay the CB of the operator who had produced the product in question.

Regional legislations require immediate notification of irregularities in cases (i) which involve operators controlled/certified by other CBs, and (ii) when products, plots, or operators are to be decertified by CAs. In Flanders, such notifications have to be done within three working days. In the other two regions, no deadline is imposed, which means that immediate notification is required according to the understanding of the two CAs concerned.

Both CBs confirmed that CAs are formally notified when irregularities involve operators in non-EU countries. This is not in line with Article 92(4) of Regulation (EC) No 889/2008 which requires that CBs, when identifying irregularities with regard to products under the control of other control bodies, shall inform those control bodies without delay. Nevertheless, CBs copy, on an ad-hoc basis, CAs into email communication by which operators are informed of irregularities. Moreover, CBs confirmed that the likelihood of irregularities are not required to be notified to CAs, which is not in line with Article 27(5)(d) of Regulation (EC) No 834/2007.

Files reviewed by the audit team confirmed that findings of residues of non-authorised pesticides below the limit established in the regional legislations are not notified by the CBs to the relevant CAs. Moreover, CB2 did not notify cases of samples which showed multiple residues of non-authorised pesticides, neither was a case notified to the CA where a feed sample showed pesticide residues beyond the above mentioned limit. The 15 CB stated the case was not notified because no feed was left to be decertified. Conclusions on Measures in case of Irregularities and Infringements

The CBs visited apply a "soft" approach with regard to enforcement measures in particular in cases of severe and recurrent irregularities. This, together with the fact that not all irregularities are either reported to relevant CAs or fully investigated by CBs, reduces the effectiveness of the control system.

Member state response

The legal provisions will be adjusted where needed. will be reminded of this point. The issue will be carefully assessed during the forthcoming supervision audits. Page: 5

The recommendation states as its basis

In 2014, responsibility for animal welfare was transferred from federal level to the three Belgian Regions (Flanders, Wallonia and Brussels Capital). At the time of the DG SANTE audit, protocols had been signed between FASFC and each of the Regions under which FASFC will perform animal welfare controls at slaughterhouses and on farms. Regions remain directly responsible for follow-up of non-compliance and any necessary enforcement action arising from the results of the controls carried out by FASFC. The management contracts defining the modalities of the controls were in the course of being finalised and signed. The IAU informed the DG SANTE audit team that the contracts include a provision for the Regions to audit, or have audits carried out on, the animal welfare controls performed by FASFC on their behalf. 5.1.2.2 Responsibility for audits of official controls

The DG SANTE audit team met with representatives from the Regions, responsible for controls on animal welfare. A representative of the regional internal audit service of the Flanders Region was also present. In the case of Flanders, the internal audit representative confirmed that his service was aware of the need to plan audits in relation to animal welfare controls to meet the requirements of Article 4(6) of Regulation (EC) No. 882/2004 and that while the planning for 2016 did not include its topic, audits were expected to take place in 2018. The modalities of these audits had not been confirmed. At the time of the DG SANTE audit, the representatives of the Walloon and Brussels Capital Regions could not confirm what audit arrangements would be put in place. Conclusions

Responsibility for auditing of official controls has also been clearly allocated, with the exception of controls on animal welfare falling under the scope of Regulation (EC) No. 882/2004, for which auditing arrangements have not yet been defined.

The recommendation states as its basis

The FASFC explained that BIPs do not have access to and have not carried out manifest checks since 2013. This is contrary to the requirements of Article 6 of Commission Regulation (EC) No 136/2004. The FASFC stated that the discussion on access to the relevant databases is ongoing. Meanwhile, the FASFC receives from Customs all data about consignments controlled by Customs during the previous month. This information is distributed to the BIPs. Antwerp BIP staff stated that this information is not used since it is time-consuming to review and does not allow staff to make proper searches for non-declared consignments.

There is adequate cooperation with Customs authorities ensuring that consignments requiring enhanced controls are presented for official controls. For products of animal origin, staff do not have access to information about arriving consignments contained in the databases of Customs or port/airport operators (except for Brussels-Zaventem BIP) which would enable them to verify that consignments are always presented for controls. Thus, the BIP staff are reliant on Customs for identifying consignments.

Member state response

rigin Mechanismen om elektronisch toegang te bekomen tot de manifesten zijn in ontwikkeling. In afwachting van dat deze sts, as mechanismen beschikbaar zullen zijn, zullen alternatieve systemen toegepast worden om de manifestgegevens steekproefsgewijs te controleren.

The recommendation states as its basis

The documented procedures and instructions in place are sufficient for BIP staff to perform the controls correctly and consistently once the consignments are notified. However, an internal procedure to ensure that consignments will be presented for veterinary checks is not in place, which increases the possibility of a consignment entering without veterinary checks.

Member state response

BSCA heeft een nieuwe beschrijving van de GIP en de procedures overgemaakt aan het FAVV waarin de importflux gedetailleerd is beschreven.

The recommendation states as its basis

The inspection room is suitable for different species of animals. However, it is not equipped with the necessary tools that would allow staff to perform identity and physical checks (e.g. refrigerator for storing samples, equipment to restrain, equipment to check their identification i.e. microchip readers), contrary to the requirements laid down in Articles 3 and 4 of Decision 97/794/EC.

The existing isolation spaces (kennels) to detain a typical consignment of the species expected are located outside the BIP facilities, near the tarmac. The distance between the kennels and the runaway of the airport is insufficient to mitigate adequately the noise levels. The kennels are not suitable for puppies, small dogs, cats or ferrets: they do not provide lighting, ventilation and/or temperature control. Overall, the isolation facilities proposed cannot ensure that the environmental conditions are adequate to avoid distress to the animals, contrary to the requirements of Regulation (EC) 1/2005.

Contracts and procedures are in place, as required by points 8 and 10 of Annex A to Directive 91/496/EEC, as follows: for cleaning and disinfection of the facilities of the BIP, laboratories where the samples have to be sent, disposal of carcasses/dead animals, and additional veterinary surgeon services. There is no contract for pest control in the area where the kennels are located, outside the building (see finding 16).

The facilities proposed cannot ensure that standards for animal welfare can be maintained for dogs, cats or ferrets, where there is a need for housing. The BIP facilities are adequate for receiving and checking consignments of insects.

Member state response

De erkenningsaanvraag wordt beperkt tot insecten, met als gevolg dat de aanbevelingen ten aanzien van honden/katten/fretten wegvallen. Dit gegeven werd, samen met een herwerkte erkenningsaanvraag, reeds overgemaakt aan de FVO. Page: 1

Member state response

- La nécessite d'ajuster les fréquences d'inspection sera évaluée sur base des résultats d'inspection et de la mise en oeuvre de l'autocontrôle (Fin 2016) - Le programme d'analyses des DAONA sera réévalué en concertation avec le comité scientifique (approche filières) (Fin 2017). - Les dispositions relatives au respect des conditions d'hygiène lors de la récolte des DAONA seront renforcées dans le guide sectoriel d'autocontrôle dans la production primaire (module A) (Fin 2017). Page: 1

Member state response

1. Utilisateurs de semences traitées : Une modification de la législation nationale est en cours afin de consolider la base légale pour le contrôle des utilisateurs de semences traitées. Cette consolidation est prévue pour 2017. 2. Utilisateurs de PPP pour semences : a. Le contrôle des utilisateurs de PPP pour semences sera intégré dans le protocole de collaboration entre l'AFSCA et le SPF-DG5 lors de sa prochaine révision. Délai de mise en oeuvre : 31 décembre 2017 b. Les opérateurs appliquant des PPP sur semences seront recherchés, identifiés et inspectés conformément aux fréquences de contrôle applicables. Délai de mise en oeuvre : 1er janvier 2017

Member state response

egistre officiel des produits a été adapté et reprend désormais tous les PPP pouvant être commercialisés et utilisés ainsi que tous les permis de commerce parallèle délivrés depuis l'entrée en vigueur du Règlement 1107/2009. Une étude coût/bénéfice sera effectuée afin de considérer le ge à une procédure d'autorisation des PPP avec changement éro d'autorisation et l'approbation des projets d'étiquette. Délai de mise en oeuvre : 1er juillet 2017 Page: 1 t ref. DG(SANTE)/2015-7470-MR of the Audit carried out from 21 April plant protection products

Member state response

FSCA note que la Commission EU n'a pas encore adopté le Règlement visé à l'article 68 du Règlement 1107/2009 qui établit 2 les dispositions applicables aux contrôles à réaliser en particulier sur la production, l'emballage, l'étiquetage, le stockage, le transport, la commercialisation, la formulation, le commerce parallèle et l'utilisation des produits phytopharmaceutiques. Les législations belge et européenne n'imposent actuellement pas de déclarer les méthodes d'analyse des co-formulants dans les dossiers d'autorisation des PPP. Par ailleurs, la liste des co- formulants interdits visée à l'article 27 du règlement (CE) N°1107/2009 n'a pas encore été élaborée par la Commission européenne. L'AFSCA a un programme d'analyse des PPP sur le marché Belge en place depuis de nombreuses années. Ce programme prévoit : - l'analyse des teneurs en substances actives, synergistes et phytoprotecteurs déclarés lors de l'autorisation des PPP; - l'analyse des principales propriétés physico-chimiques des PPP et leur respect aux spécifications de la FAO ; - l'analyse d'impuretés pertinentes. Le programme d'analyse 2015 prévoit l'analyse de 87 PPP dont 8 importations parallèles. Page: 2 t ref. DG(SANTE

Member state response

ôles du respect des conditions d'autorisation des PPP en Belgique et destinés au marché belge sera effectué inspections chez les fabricants de PPP. Il sera vérifié que ances actives, phytoprotecteurs, synegistes et co- s utilisés répondent aux conditions d'autorisation des mise en oeuvre : contrôles effectués en 2016

Member state response

CA note que la Commission EU n'a pas encore adopté le ent visé à l'article 68 du Règlement 1107/2009 qui établit sitions applicables aux contrôles à réaliser en particulier oduction, l'emballage, l'étiquetage, le stockage, le port, la commercialisation, la formulation, le commerce et l'utilisation des produits phytopharmaceutiques. de ce Règlement ainsi que d'une base de donnée e reprenant l'ensemble des autorisations valables en EU ontrôle des dispositions de l'article 28(2) (c) et (d) ent difficile. -list d'inspection de l'AFSCA seront adaptées afin de Page: 3 t ref. DG(SANTE)/2015-7470-MR of the Audit carried out from 21 April plant protection products réaliser le contrôle des produits destinés à l'exportation: 1. L'étiquetage des produits présents sera contrôlé. Dès qu'une base de donnée reprenant tous les PPP autorisés en EU sera disponible, la validité des autorisations des PPP destinés à un autre EM sera vérifiée par sondage lors des inspections. 2. Le registre de mise sur le marché des PPP sera contrôlé afin de garantir que les PPP destinés à l'exportation n'ont pas été utilisés en Belgique. Délai de mise en oeuvre : contrôles effectués en 2016

The recommendation states as its basis

In the FLVVG-LFSAG (Federal Laboratory for the Safety of the Food Chain Gentbrugge) laboratory visited the audit team saw that a number of honey and hair residue samples were received in the laboratory but two honey and one hair sample went missing before the analysis could be performed. In June 2014 it was reported that this was the second honey sample to go missing in this laboratory in the last eight months. An investigation was performed in the laboratory but the reason for the samples going missing was not identified1. The outcome of the investigation was communicated to DG Laboratories so that further action could be taken (e.g. taking replacement samples).

In two of the slaughterhouses visited, official residue samples were kept in unsecured fridges and freezers, either in storage rooms within the slaughterhouse's own laboratory area or in an unlocked fridge in a room with no access restriction for personnel. The temperature of one freezer was also not monitored. Such unsecured storage is not in line with the requirements of point 2.9 of the Annex to Decision 98/179/EC regarding suitable storage to ensure analyte stability and sample integrity or the requirements of Article 11(7) of Regulation (EC) No 882/2004 that samples must be handled in such a way as to guarantee both their legal and analytical validity.

Although samples are effectively sealed, such storage does not fully ensure that all samples remain under official control from the time of sampling through to analysis. If such samples were removed by a third party and this was noticed at the end of the day or the next day before samples were to be collected, although the animal carcase would likely still be available for sampling in the slaughterhouse, many of the original matrices which may have been subject to sampling would not be (e.g. 1 In their response to the draft report the competent authorities clarified that a human error seems to be the most plausible reason for the missing samples. On an annual basis, in 2014 this constituted 0.014% and in 2013 0.007% of all samples analysed by the laboratory involved. Since the last sample went missing in May 2014, no samples were lost in the laboratory. 4 liver, kidney, hair, urine, blood, cornea). The competent authority stated that they had not experienced official samples being removed from a slaughterhouse and that, if this happened, an investigation would take place and appropriate measures would be taken.

The residue monitoring plan is generally implemented effectively, notwithstanding some shortcomings in the secure storage of samples in slaughterhouses and the traceability of honey samples in one of the laboratories visited2. 2 In their response to the draft report the competent authorities provided a detailed root cause analysis and analysis of the extent of the issue of three samples being mislaid in the laboratory concerned. 5 5.1.4. Other residue monitoring programmes Legal Requirements Articles 9 and 11 of Directive 96/23/EC; Articles 8 and 10 of Regulation (EC) No 882/2004. Findings

Member state response

Laboratories orrective action taken: - Staff awareness was raised by tackling the subject during a section meeting of 19th June 2014 in the laboratory. - Since 9th of June 2015 (after announcement in the section meeting on 8th of June 2015), samples that have to be stored at room temperature are kept at a location (room 0.22) different from the place where the compliant samples are scanned out to be removed (room 0.25). - Since 9th of June 2015 (after announcement in the section meeting on 8th of June 2015), two persons are executing the scanning and removal of compliant samples together, instead of one person. 2. Evaluation of the effectiveness of the implemented corrective action: Special attention will be given to the item 'disposal of analyzed samples' during internal audits. DG Control Er zal naast de richtlijnen voor de AV-DMO betreffende de organisatie van de monsternemingen in het slachthuis ook een richtlijn uitgeschreven worden (waarschijnlijk in het lastenboek) omtrent de opslag van de monsters in een hiertoe geschikte en beveiligde locatie in het slachthuis. Dit zal gebeuren ten laatste op 31/12/2015 zodat dit bij het ondertekenen van de nieuwe uitvoeringsovereenkomsten

The recommendation states as its basis

The method for quinolones (in operation since 2006) has been validated in accordance with the requirements of Article 3 of Decision 2002/657/EC in bovine muscle. No other muscle matrices (for example pig, poultry, fish and rabbit) have been validated (though there were satisfactory results in proficiency tests for oxolinic acid and difloxacin in rabbit meat in 2009). There are no instructions on how to address possible matrix effects in the general SOP on method validation.

The LC-MS method for sulphonamides in muscle was recently validated at 20 µg/kg (screening) and MRL level (confirmation) in line with the requirements of Article 3 of Decision 2002/657/EC. While the screening method was validated in muscle of different animal species, confirmatory method validation was carried out only in pig muscle samples. No muscle of other animal species (e.g. cattle, fish, and rabbit) was included in the validation study. 9

Notwithstanding shortcomings with regard to verification of method performance in muscle samples of different animal species, the competent authority can have confidence in the reliability of analytical results produced by residue laboratories3.

Member state response

ive action taken and planned: Screening methods: For all screening methods the document "Guidelines for the validation of screening methods for residues of veterinary medicines (initial validation and transfer)" has to be followed, ensuring that during the initial validation of the matrix of concern, these animal species are involved which are foreseen to be provided for analysis. In case a sample from a species not included in the initial validation study has to be analysed, extra quality controls shall be included in the measurement series (e.g. by introduction of samples of the species of concern, both blanks and spikes at MRL, or standard addition to the sample to be analysed) or a limited validation to guarantee the method is suitable for the parameter/matrix/species combination. These data can be used to document the validation file. Confirmatory methods: A complete validation has to be performed for the most relevant species. These depend on the kind of substances to be analysed (e.g. for coccidiostats these will be poultry and bovine, for NSAIDS bovine and porcine, ...). For the other species, at least a secondary validation including blank samples and samples spiked at the

The recommendation states as its basis

As described in the 2009 FVO report, a special form called document d'administration ou de fourniture (DAF) is used to document veterinary treatments on holdings. Veterinary practitioners are obliged to record on DAFs both medicines personally administered by the veterinarian to animals on the farm during the risk period and those delivered from the veterinary depot to the farmer. The DAF forms seen by the audit team did not include the identification of specific/ individual animals to be treated4. Therefore the DAF form cannot be considered as equivalent to treatment records as required under Article 10 of Directive 96/23/EC and Article 69 of Directive 2001/82/EC. At all three farms visited (cattle, pig, laying hens) these DAF forms were available.

For recording treatments administered to food-producing animals by a farmer, a standardised form (administration/ supply record) is distributed by the Flemish association (Dierengezondheidszorg Vlanderen -DGZ) and the Walloon association (Association Régionale de Santé et d'Identification Animales -ARISA), with the provision that treatment records have to be maintained for each animal species separately (i.e. separate records for cattle, sheep etc.). As recording of withdrawal periods is not foreseen in this form, the content of the form is not fully in line with Article 10 of Directive 96/23/EC and Regulation 852/2004 (Annex I, Part A III, point 8(b))5. Although there is still no legal obligation to register treatments outside the so-called "risk period" (period before animal products are estimated to enter in the food chain, described in the 2009 FVO report), the form was used on cattle and pig farms visited. 4 In their response to the draft report the competent authorities noted that the DAF form includes a column for the identification of the animal or the group of animals treated or for which the medicinal product was supplied and that the column in question has to be filled out by the veterinarian. 5 In their response to the draft report the competent authorities noted that the medicinal products record for farmers does however include a column headed 'N° référence Médicament' [Medicinal product reference No]. This number is that of the DAF or the prescription for the medicine in question, and thanks to this reference it is possible to identify the DAF or the prescription in the IN register and thus to find the withdrawal time. 12

Actions to address the recommendation of the 2009 FVO report to ensure that all treatments applied to food-producing animals are recorded have not been finalised. The competent authority stated that consultations with stakeholders are on-going and that a task force to draft a new legislative act on veterinary medicines records on farms was formed with the target to have the Belgian legislation compliant with EU rules by 1 January 2016. Conclusions

Conditions governing the authorisation and distribution of veterinary medicinal products are in line with EU requirements. The availability of information required to verify the residues status of animal products entering the food chain is not ensured since treatments administered outside the "risk period" do not need to be recorded. 5.2.3. Official controls Legal Requirements Article 3, 4 and 8 of Regulation (EC) No 882/2004; Article 80 of Directive 2001/82/EC; Article 4(2) of Regulation (EC) No 854/2004. Findings 5.2.3.1. Controls at wholesale level, retail level and on veterinary practitioners

Member state response

re La législation nationale sera adaptée pour qu'elle soit pleinement en conformité avec la législation européenne. embre 2015, le projet sera envoyé à la Commission ns entreront en vigueur le

The recommendation states as its basis

Templates for food chain information are in place for all farmed species. However, in the case of cattle, the justification given by the competent authority being a reduction in the administrative burden on farmers, this food chain information has been simplified to a standard declaration on the rear of bovine passports: "Is there pertinent information to mention in the framework of food chain information?" The farmer ticks the box to indicate "yes" or "no" and signs and dates the statement. In the case of ticking "yes" the farmer is given the choice to tick one of two other standard statements: "The information is indicated on the form for this purpose submitted to the slaughterhouse" or "The information has already been transmitted to the slaughterhouse by electronic means".

Such simplified food chain information for bovines is not in line with the requirements of Regulation (EC) No 853/2004, which states in Annex II, Section III that "However, it is not necessary for the slaughterhouse operator to be provided with:....the information referred to in point 3(a), (b), (f) and (g), if the producer 8 In their response to the draft report the competent authorities noted that the frequency depends on the health status of the aquaculture farm and the species kept and is in line with the official minimum inspection frequencies laid down in Directive 2006/88/EC on animal health requirements for aquaculture animals. 14 declares that there is no relevant information to report." This provision does not cover point 3(c) for example: "veterinary medicinal products or other treatments, administered to the animals within a relevant period and with a withdrawal period greater than zero, together with their dates of administration and withdrawal periods."

The system in place for controls on the distribution and use of veterinary medicinal products is well designed, notwithstanding the fact that the simplified food chain information introduced for bovines in the form of a farmer declaration is not in line with EU requirements and weakens the effectiveness of said system as regards investigations of non-compliant results. As regards equidae, the system for the identification of horses is in place and controls on slaughtered horses are being effectively implemented.

Member state response

L'AFSCA prendra une action pour répondre à la remarque l'équipe d'audit. Page: 4

The recommendation states as its basis

The manual on phytosanitary import control has an attachment with 12 sampling tables for visual inspection for different types of commodities prepared on the basis of ISPM 31. These tables define the number of units for sampling e.g. fruits, sachets, bunches of flowers, to be selected for visual inspection. For each type of commodity, a sampling matrix at confidence level of 95% and 99% is set as per ISPM 31. In addition for each confidence level, two columns with sampling sizes for different detection levels varying from 1% to 5% are set. The sampling size i.e. the column to be used depends on the level of risk established for the lot or consignment. Default sampling rate for all types of commodities is low risk. However, the sampling size for large consignments which are qualified as low risk of fruit and vegetables was considered by the FVO team as not appropriate e.g. 60 pieces of fruit for a large consignment.

The FVO team witnessed plant health checks of fruit (pomelo and lime), vegetables (green chillies and bitter gourd) and cut flowers (gypsophila) and noted that: Inspectors had appropriate technical competence regarding the detection of HOs in commodities which they regularly inspected; Inspections witnessed were meticulous. Inspectors checking cut flowers were shaking bunches above a paper sheet for the detection of thrips. All the bunches were opened for additional examination of the leaves under the illuminated magnifying lens; The inspection of fruit consisted of random selection of the required number of fruit from different boxes to meticulously inspect them with a magnifying glass. 10% of fruits selected for visual inspection were peeled and cut to check for the presence of any larvae; For the inspection of vegetables, 10 boxes were selected and from each box 15 fruits were taken for visual examination as they determined as a high risk commodity. After visual inspection of the sample some suspicious fruits were brought to the BIP office for detailed examination under the binocular microscope. A thrip was detected there and a sample was taken for determination in the laboratory; Inspections were carried out in adequate conditions of lighting; The size of the sample taken for visual inspection was always in line with the FASFC guidelines.

The definition of the "unit" to be sampled for visual inspection in the FASFC guidelines is not appropriate for some commodities e.g. a single fruit of small green chilli counts as a unit. For a large consignment of chillies the sampling size would be 60 pieces for low risk or 150 pieces for high risk consignment. The sample size inspected for large consignments of fruit and vegetables is not in line with ISPM 31 and cannot be considered as a representative sample. This does not comply with Article 13a(1)(b)(iii) of Directive 2000/29/EC. In view of ISPM 31, the sample size should be big enough to result in a satisfactorily probability for finding pests. 13

Plant health checks are carried out meticulously, however the quantity of units inspected for some commodities is significantly below the recommended quantity and cannot be considered as representative. Therefore, recommendation (6) of the previous report has not been fully addressed.

Member state response

instructions in relation to the sampling units for fruit and vegetables will be adapted by 30/06/2016.

The recommendation states as its basis

There is not a procedure in place for monitoring of non-regulated products. They are checked only if presented in mixed consignments, in consignments of fruits and vegetables which are subject to marketing standards quality controls and in consignments of non-animal origin in case of suspicion of the presence of HOs. Products infested with regulated HO are intercepted. Samples taken for other type of controls are smaller than those for the plant health checks.

The FVO team noted that articles on the Alert list are considered as high risk for the inspection but there are no procedures in place to enable the inspection of high risk non-regulated products. The plant health inspectors did not monitor them, this is not in line with provisions of Article 16(2) second subparagraph of Council Directive 2000/29/EC.

The FASFC does not have a procedure for monitoring of non-regulated commodities, irrespective of risk. The instructions for inspections are not updated even when interceptions with regulated HOs have been reported, and the practice of plant health checks is not adapted accordingly. Therefore, recommendation (7) of the previous report has not been fully addressed.

Member state response

pections of non-regulated articles (whether or not in the EU Third Country Alert list) in mixed consignments (containing d and non-regulated articles) will be registered in the local databases by 30/06/2016. Customs will be contacted to organise from 2016 onwards, yearly one targeted action for phytosanitary checks on non-regulated articles.

The recommendation states as its basis

The FASFC explained that the reason for lower number of interceptions compared to the number of consignments was that for 20 ­ 30% of notified consignments, plant health checks are carried out in APIs in other Member States. In addition to that, Belgium extensively applies reduced frequency of checks (see also section 5.6.4). However, the FVO team notes, even taking into account the CAs explanation, that, as shown in table 2, page 6 when comparing interceptions made and number of inspections and trade volumes, Belgium still intercepts less harmful organisms on average for certain commodities (e.g. plants for planting and mangoes and guavas from West Africa) than other Member States do. 8 5.5.2. Facilities and equipment for inspection at or near the point of entry and other than at or near the point of entry Legal requirements Article 13c(2)(b) of Directive 2000/29/EC establishes that identity and plant health checks must (with certain specific exceptions) be made by the official body of point of entry in connection with the Customs formalities. The minimum conditions for carrying out plant health checks at such places are established by Directive 98/22/EC. Directive 2004/103/EC establishes the procedures and conditions for carrying out checks at a place other than the point of entry into the EU or a place close by. Findings

Overall interception and trade figures indicate that for certain commodities, the level of interceptions for HOs is out of proportion to the volume of trade and number of inspections performed. 9

As mentioned in paragraph 30, page 12, the overall interception figures indicate that for certain commodities, Belgium intercepts less harmful organisms than other Member States on average. Conclusions on plant health checks

According to EUROPHYT notifications, the number of interceptions of WPM at EU level was 2 330 in 2012, 2 142 in 2013 and 2 209 in 2014. As indicated in the section 4.3, figures for Belgium were respectively 15 (0.6% of EU interceptions), 24 (1.1%) and 37 (1.7%). The number of interceptions has increased, however it is still not in proportion to the volume of trade into Belgium. Conclusions on checks for wood packaging material

There is a system in place to inspect WPM as required by EU legislation, however in the light of absence of records the FVO team could not verify that the amount of checks is adequate. Therefore, recommendation (9) of the previous report has been partially addressed.

Member state response

ata on the number of phytosanitary checks carried out by States are not publicly available (customs data on imports in a Member State is not equal to number of phytosanitary checks carried out by that Member State), the review will be limited to national data. Each year (May), the number of interceptions will be set out against the number of phytosanitary import checks and compared to the data of the previous years.

The recommendation states as its basis

FASFC stated that according to national procedures, compliance of WPM is randomly checked during all official controls performed by them. In addition, in the framework of the national protocol, Customs officers have to check randomly that WPM is marked in accordance with ISPM 15. Plant health inspectors are informed about any non conformity and they take appropriate measures if necessary. These checks are not recorded in a local or national database, except in case of non conformity.

According to EUROPHYT notifications, the number of interceptions of WPM at EU level was 2 330 in 2012, 2 142 in 2013 and 2 209 in 2014. As indicated in the section 4.3, figures for Belgium were respectively 15 (0.6% of EU interceptions), 24 (1.1%) and 37 (1.7%). The number of interceptions has increased, however it is still not in proportion to the volume of trade into Belgium. Conclusions on checks for wood packaging material

There is a system in place to inspect WPM as required by EU legislation, however in the light of absence of records the FVO team could not verify that the amount of checks is adequate. Therefore, recommendation (9) of the previous report has been partially addressed.

Member state response

30/06/2016 the local databases will be adapted to register the d out on wood packaging material.

The recommendation states as its basis

The FASFC stated that the procedure applied when non-compliances are detected during an import check. Internal procedures require that inspectors have four days from the date of receipt of laboratory analysis to report interceptions to DG Control who is then in charge of validation and entering the interception in EUROPHYT within one day. The deadline set in the internal procedures for reporting interceptions is not in line with the requirement of Article 2 of Directive 94/3/EC.

EUROPHYT data shows that the average days elapsed between interception of HOs and notification was 10 days in 2014, 8 in 2013 and 13 in 2012. The average time for notification is not in accordance with Article 2 of Directive 94/3/EC, nevertheless it has improved since the previous audit and is comparable to the EU average (10 days in 2014, 9 in 2013 and 11 days in 2012). Conclusions on notification of interceptions and action taken

The internal deadline set for notifications is not in line with the EU legislation and although the average time actually achieved has improved since the previous audit, it continues to exceed the legal requirement. Therefore, recommendation (12) of the previous audit has only been partially addressed.

Member state response

y 31/12/2015 the notification procedure will be adapted in such a staff can directly enter data in Europhyt and that the eadquarter only validates it. This should help to further Page: 1 ref. DG(SANTE)/2015-7602-MR of the Audit carried out from 19 s for Plant Health reduce the notification time. Page: 2

The recommendation states as its basis

With the transfer of responsibility for animal welfare to the regions, from 1 January 2015 the regions' animal welfare departments are responsible for organising training and exams and awarding certificates of competence for the activities referred to in Article 7(2) of the Regulation, as envisaged by its Article 21.

Pending this change, national level training and exams were organised as follows: · There is a specific university-level course for AWOs. It was noted that all but one of the AWOs met by the audit team had attended this course. As there is not yet legal basis for this course, the CA are not checking that the AWOs have attended this course. · The other slaughterhouse personnel can undergo training organised by a training institute or in-house training organised by the AWO of the slaughterhouse. In the latter case there has to be an independent exam. For this an online exam programme has recently been created which can be accessed from a computer in the slaughterhouse. The exams have to be supervised, and the results validated, by an official veterinarian.

It was noted that certificates awarded to those who take the online exam do not differentiate between tasks. A CCA representative explained that the exam covers all activities as it was difficult to make this differentiation using the on line format used to develop the exam. Exam participants have to respond to pictures rather than plain written questions. On exam questions and topics set in Annex IV to the Regulation, it was noted that when an applicant worked in a slaughterhouse that practiced slaughter without stunning there were no precise questions/pictures regarding this practice, where both the practices and the monitoring of the risks for animal welfare are very different compared to slaughter with stunning. 4

The AWO responsible for one of the slaughterhouses visited that practised slaughter without stunning considered the training material inadequate for the practices in his slaughterhouse. There was no reference to checking for the absence of signs of life which is a key requirement where this type of slaughter is practised. Conclusions on framework for controls

The system for certificates of competence does provide for the required exam with a good emphasis of practical situations through its use of pictures in the assessment. BOs have used the good practice guides effectively, but both these and the exam are not adequately covering tasks in slaughterhouses which present particular risks for animal welfare such as slaughter without stunning.

Member state response

All Regions will publish the necessary legislation to approve the e, training programmes for the animal welfare officers and the personnel of the slaughterhouses. This legislation is at the moment in different stages at the different Regions: r's - Flanders: the draft still has to pass the Inspector of Finances and the Council of State. Publication is expected in September ­ October 2015. - Wallonia: The project will be submitted to the Minister for approval. - Brussels-Capital : The project will be initiated in the Brussels- Capital Region Concerning the training course for animal welfare officers, Belgium already goes beyond the requirements of the Regulation, demanding that this be a course on a university level, while the Regulation only requires a certificate of competence. Because of the number of participants it is not feasible to split up this course according to species, operations or type of equipment. However, at the start of this course, all participants are asked about their workplace and the species they work with and in relation to this information some parts of the course are more or less focused on. The examination for this course is an oral exam that is targeted s

The recommendation states as its basis

The results of the OVs' official controls were collated in the Foodnet database in such a way that they can be analysed. However, FAFSC has not yet used this data to evaluate and review the system of official checks to ensure that requirements are met and to better prioritise checks on such issues as broiler monitoring, problems reported from checklists and the effectiveness of enforcement in different provinces (see also sections 5.4, 5.5 and 5.6).

Every question on the OV electronic checklist is subject to a weighting factor reflecting the seriousness of non-compliance (see also sections 5.3 and 5.5). 5 · The weighting of the seriousness of non-compliance cases in the checklists triggers action when an individual case of non-compliance scores 10 or when more than 20 % of the items on the checklist are non-compliant. · For example, the lack of signs on lairage pens showing their capacity and the animals' time of arrival scores low in terms of the significance of the non-compliance as there were other ways that the CA checked overnight stays and overstocking.

The checklists for controls are well designed with a weighting factor reflecting the seriousness of non-compliance, however the data produced from the checks is not being adequately used to plan the subsequent controls on the basis of the business operators past records, or to analyse if the weighting factors for the various non- compliances were appropriate.

Centrally, FASFC is not using data such as Foodnet as effectively as it could to ensure requirements are met and to better prioritise checks. In general, analysis of the results of previous checks has not been carried out. In particular, the results of prioritising checks on slaughter without stunning were not available. 6

Member state response

risk Since the 1st of July 2014 the competency for animal welfare has become the responsibility of the Regions. A protocol will be signed between the Regions and the AFSCA in which the system Page: 1 f Report ref. DG(SANCO)/2014-7059-MR of an Audit carried out from 24 controls in place at slaughter and during related operations of private practitioners who work in an official manner for the ) AFSCA and who oversee the animal welfare in the slaughterhouses on a daily basis is maintained, but now they report directly to the Regions. This means that now all reports from the slaughterhouses are analysed centrally for each Region. This makes it easier to carry out a bench marking between slaughterhouses and this will allow to prioritize certain slaughterhouses or specific items for the inspections by the animal welfare inspectors of the Regions. If the veterinarians of the AFSCA would report a severe animal welfare problem in a slaughterhouse, an animal welfare inspector will inspect this slaughterhouse in short term. Other inspections by the animal welfare inspectors will be performed according to the risk analysis.

Member state response

ht The checklist used for the inspections in the slaughterhouses has e been adapted to clearly reflect that new equipment brought into operation after 1 January 2013 is also required to comply with the rules set out in Annex II.

Member state response

Action will be taken to ensure that official veterinarians Une communication sera adressée aux vétérinaires carry out the post-mortem inspection on the officiels pour leur rappeler que : slaughter line have a link between the carcass and the accompanying offal while the line is in operation. - un lien doit toujours pouvoir être maintenu entre les erators will be reminded of this obligation so that they carcasses et les viscères ; can adapt their line where necessary. Slaughterhouses will also be reminded of the need to - les installations doivent permettre une inspection de maintain traceability within the establishments. toutes les carcasses et de l'entièreté de chaque carcasse. With regard to small establishments where the post- Il sera également rappelé aux opérateurs et aux mortem inspection is carried out after the establishment's vétérinaires officiels que, là où un système de lot est activities, given the establishment's low output and the appliqué, si un problème est détecté aux niveau des fact that all carcasses are examined one at a time by the viscères et que ce problème pourrait affecter les official veterinarian, if one batch of offal is declared unfit carcasses, l'ens

Member state response

Working groups (technical consultation committees) are ponsible for incorporating the relevant parts of the egislation in the checklists. For all items on the checklists Ref. Ares(2016)2206698 - 11/05/2016 the Action Plan submitted by the competent authorities of Belgium in response to Report ref. DG(SANTE)/2014-7151- MR of ber 2014 to 21 November 2014 in order to evaluate the food safety control systems in place governing the production and at and products derived therefrom a "remarks" field is provided to allow inspectors/controllers to make more detailed observations. When those in charge of inspections in the processing sector held a meeting in March 2015, a reminder was given of the importance of reporting exhaustive information.

Member state response

The minor weightings 1 and 3 are for requirements for L'AC souhaite insister sur le fait que, quand des which isolated non- compliance is not considered to have problèmes/risques graves ou directs sont constatés, des a serious impact on the safety of the food chain. mesures systématiques et immédiates sont prises. Not all establishments achieve excellence (absence of any Tenant compte du considérant 41 du règlement 882/2004 minor non-compliance); a final outcome of "favorable (« Les infractions à la législation relative aux aliments with remarks" is quite acceptable and guarantees the pour animaux et aux denrées alimentaires et aux safety of the food chain. dispositions relatives à la santé animale et au bien-être des animaux peuvent constituer une menace pour la santé In any case, at the end of an inspection which is humaine, la santé animale et le bien-être des animaux. "favorable with remarks", there is a debriefing with the Par conséquent, ces infractions devraient faire l'objet de operator and all items on the checklist are reviewed, mesures effectives, dissuasives et proportionnées au including those related to any minor non-compliance. The niveau national dans l'ensemble de

Member state response

A microbiology training programme based on Regulation (EC) No 2073/2005 is currently being drawn up for spectors involved in the processing sector; specific questions related to durability testing and analysis of rends may be added to the checklists used. The amended checklists will be available at the end of 2015.

Member state response

A microbiology training programme based on Regulation (EC) No 2073/2005 is currently being drawn up for Ref. Ares(2016)2206698 - 11/05/2016 the Action Plan submitted by the competent authorities of Belgium in response to Report ref. DG(SANTE)/2014-7151- MR of ber 2014 to 21 November 2014 in order to evaluate the food safety control systems in place governing the production and at and products derived therefrom nspectors involved in the processing sector. here are already checklists for verifying that the operator omplies with the criteria and requirements set out in egulation (EC) No 2073/2005 and these generally nsure that the number of samples taken, the analytical ethod used, etc. are correct. However, the controllers nd inspectors responsible for controls in the processing ector will be made aware of the issue in meetings. If ecessary, further explanations will be added to the hecklists for the end of 2015.

Member state response

he competent authority believes that the exemption of L'évaluation des risques qui permet aux abattoirs de mall slaughterhouses complies with Regulation (EC) No faible capacité de déroger à la règle générale qui 073/2005 and is based on a risk analysis. prévaut pour les fréquences d'échantillonnage est décrite ee comments on the draft report. dans la circulaire PCCB/S3/823823. 2015_06_18_circ-ob 2015_06_12_Annex _FR_CHP_CSASalmoneel0la1v_oClairilcleusla_ivre2_-2C_HTPC__CcSoAmSpalelmt.opndefllavolailles_FR.pdf Trois critères sont pris en compte pour accorder la dérogation : - la capacité de l'abattoir, - l'historique des inspections - l'historique des analyses. Ref. Ares(2016)2206698 - 11/05/2016 the Action Plan submitted by the competent authorities of Belgium in response to Report ref. DG(SANTE)/2014-7151- MR of ber 2014 to 21 November 2014 in order to evaluate the food safety control systems in place governing the production and at and products derived therefrom Afin d'assurer une vérification systématique et régulière du respect de ces conditions par les abattoirs de faible capacité, un item sera ajouté à la check-list 2025 relative au contrôle des critères microbiologiques en a

Member state response

g A reminder of the need for better monitoring of the name en to MSM and to comply with the recent ruling of the Court of Justice of the European Union concerning this product was already given at a recent meeting of those in tent authority who are responsible for the ion of controls in the processing sector (SOC ng of 30 April 2015).

Member state response

Les organisme de contrôle Les organismes de contrôle DGZ et ARSIA sont agréés par Arrêté ministériel en tant qu'associations de lutte contre les maladies des animaux, conformément aux dispositions de l'Arrêté royal du 26/11/20061. Conséquemment, les associations sont chargées de participer à l'exécution des mesures de prévention et de lutte contre les maladies des animaux et d'exécuter les missions qui lui sont confiées par l'Agence dans ce cadre, ainsi que de se soumettre aux décisions du Ministre et à la surveillance et aux directives de l'Agence, du Service Public Fédéral Santé publique, Sécurité de la Chaîne alimentaire et Environnement et du CERVA De plus, les laboratoires de ces associations disposent d'un agrément conformément à l'Arrêté royal du 3 août 20122, remplaçant l'Arrêté royal du 15 avril 2005. Selon les dispositions de cet arrêté, le laboratoire, la personne ou les personnes sous la responsabilité de laquelle ou desquelles les analyses sont effectuées et les personnes mentionnées dans les statuts ne peuvent pas être intéressés à la production, la transformation, l'importation ou la vente des produits qui font l'objet des analyses ou catégories d'analyses pour lesqu

Member state response

boratoires qui effectuent des analyses en rapport avec la sécurité de la chaîne alimentaire ; Page: 1 ecommendations of Report ref. DG(SANCO)/2014-7152 -MR of a/an audit carried out from 09 the Salmonella National Control Programmes for particular poultry populations (breeders, laying Conformément à l'arrêté royal du 27 avril 20073, les autorités compétentes désignent, entre autres, ces 2 laboratoires pour l'échantillonnage dans le cadre de la lutte contre les salmonelles chez la volaille. L'AFSCA va s'assurer de garantir l'impartialité des 2 organismes auxquels elle a délégué les tâches de contrôle officiel et aussi de son personnel. De même, l'AFSCA va s'assurer de l'absence de conflits d'intérêts au sein de ces organismes. Dans ce contexte, DGZ et ARSIA seront invités à élaborer une politique sur les conflits d'intérêt et d'impartialité et un plan d'action pour mettre cette politique en pratique. L'AFSCA s'assurera que ce Plan d'action ARSIA/DGZ sera exécuté correctement. Le délai pour l'élaboration par les associations et la validation par l'AFSCA du plan d'action est prévu pour la fin de juillet 2015, pour la mise en pratique par les association pour la fin de 2015. Audit inte

Member state response

les salmonelles chez les volailles , ecommendations of Report ref. DG(SANCO)/2014-7152 -MR of a/an audit carried out from 09 the Salmonella National Control Programmes for particular poultry populations (breeders, laying aspect van belangenvermenging zeker mee opgenomen worden in de auditcriteria. r wordt een algemene opleiding gepland voor de controleurs/inspecteurs in 2015- waarin bioveiligheid aan bod zal komen. 2) Om de CL 2471 `landbouwbedrijf ­ infrastructuur, inrichting en hygiëne' adequater te gebruiken wordt een aanpassing voorzien tijdens een volgende TOC (Technisch Overleg Committee). De aangepaste CL zal ten laatste eind 2015 gebruikt worden. 3) De controle van de introductie en verspreiding van Salmonella via het veevoeder wordt uitgevoerd via de controles op diervoeders door de veevoederbedrijven in het kader van hun autocontrole (het FAVV ontvangt de notificaties van de veevoederbedrijven bij aanwezigheid van Salmonella). 4) De voorzorgsmaatregelen voor de introductie van Salmonella bij de opzet van nieuwe dieren worden genomen aan de hand van de ingangscontroles bij eendagskuikens en hanen. basisfrequentie voor de inspecties van pluimveebedrijven is risk-based. Volg

Member state response

FT PRI 519 (poulets de chair) et PRI 520 (dindes de chair) sont adaptées depuis le 12/2014. La ligne suivante est ajoutée : « Il faut vérifier l'absence de traitement imicrobiens dans le registre des médicaments avant d'échantillonner. ». 2) Une nouvelle version est publiée sur l'intranet de l'AFSCA le 16/03/2015 avec une Page: 3 ecommendations of Report ref. DG(SANCO)/2014-7152 -MR of a/an audit carried out from 09 the Salmonella National Control Programmes for particular poultry populations (breeders, laying marque supplémentaire pour les 2 FT: « Si traitement d'antibiotique en cours, revenir ns les 2 semaines avant l'abattage pour faire l'échantillonnage. »

Member state response

(EU) Nr. 200/2010, bijlage, punt 2.2.2.2.c) voorziet de mogelijkheid om in zonderingsgevallen een verificatiebemonstering uit te voeren indien de bevoegde toriteit reden heeft om te twijfelen aan de juistheid van het resultaat. Gezien de zware onomische en psychologische gevolgen voor een pluimveehouder wil de bevoegde erheid zekerheid dat het positieve staal een gevolg is van een infectie bij het pluimvee niet van externe contaminatie van het staal. De verificatiebemonstering die uitgevoerd rdt (conform artikel 5 van beschikking 2004/665/EG) is gevoeliger dan de orgeschreven minimale bemonstering. Er wordt steeds een onderzoek op het gebruik n antimicrobiële middelen uitgevoerd. De broeierijen voeren in het kader van hun mmercieel lastenboek een salmonellacontrole uit bij het uitkippen van elke batch. entuele positieve resultaten moeten verplicht gemeld worden aan de bevoegde erheid. Dit geeft een extra zekerheid dat tomen met negatief bevestigingsonderzoek en besmette eendagskuikens produceren. Tot op heden is het nog niet voorgekomen t een toom die negatief was bij bevestigingsonderzoek op een later tijdstip een te strijden serotype Salmonella kon gedetecteerd worden. Hier worde

Member state response

rordening (EG) nr. 2160/2003, bijlage II, D, punt 4b) voorziet de mogelijkheid om een vestigingsonderzoek uit te voeren. Het bevestigingsonderzoek dat uitgevoerd wordt in dit kader voldoet aan de technische specificaties in artikel 5 van beschikking 04/665/EG en er wordt systematisch een onderzoek op het gebruik van antimicrobiële ddelen uitgevoerd. Hier worden geen verdere acties noodzakelijk geacht. reeds geldende maatregelen voor tomen die besmet zijn met S. Enteritidis of S. phimurium zullen eveneens opgelegd worden als tijdelijke maatregelen van zodra lmonella spp. gedetecteerd wordt. Hiervoor wordt een wijziging van het KB van 27 ril 20074 voorzien. Het duurt minstens 18 maanden om een koninklijk besluit te jzigen. trijding van Salmonella bij pluimvee. Page: 4 ecommendations of Report ref. DG(SANCO)/2014-7152 -MR of a/an audit carried out from 09 the Salmonella National Control Programmes for particular poultry populations (breeders, laying

Member state response

a version 5 de la FT PRI 519 sera adaptée au plus tard à la fin d'avril 2015 en rajoutant le texte en bleu: « Annuellement, l'AFSCA prélève des échantillons dans 10% des exploitations comptant au moins 200 poulets de chair. Refaire en priorité les lots positifs des 12 derniers mois et le % de lots qui reste à échantillonné est sélectionné au hasard. ».

Member state response

a FT PRI 520 sera adaptée au plus tard à la fin d'avril 2015 en rajoutant le texte en bleu: « Annuellement, l'AFSCA prélève des échantillons dans 10% des exploitations comptant au moins 200 dindes de chair. Refaire en priorité les lots positifs des 12 derniers mois et le % de lots qui reste à échantillonné est sélectionné au hasard. ». Annuellement, l'AFSCA prélève des échantillons dans 10% des exploitations comptant au moins 200 dindes d'engraissement, y compris dans : Tous les autres lots présents si un lot a réagi positivement aux tests de dépistage de Salmonella Enteritidis ou Salmonella Typhimurium. L'ensemble des lots d'une exploitation où un lot précédent a réagi positivement aux test de dépistage de Salmonella Enteritidis ou Salmonella Typhimurium. Tous les lots dans les exploitations possédant plus de 200 dindes d'engraissement et non concernés par les points 1) et 2). Page: 5

Member state response

L'approche développée pour l'inspection des opérateurs du aid secteur des denrées fournissant leurs co-produits pour l'alimentation animale dans une entreprise du secteur des aliments pour animaux (TRA) est en cours d'implémentation. Les instructions pour l'implémentation du plan d'inspection sont en cours d'adaptation afin de pouvoir identifier les opérateurs du secteur des denrées alimentaires qui orientent leurs co-produits vers le secteur de l'alimentation animale en distinguant ceux qui les livrent aux exploitations agricoles (PRI) et ceux qui les livrent aux opérateurs du secteur des aliments pour animaux (TRA). Une nouvelle check-liste de l'agence concernant le contrôle des opérateurs du secteur des denrées fournissant leurs co-produits pour l'alimentation animale dans une entreprise du secteur des aliments pour animaux (TRA) sera rédigée (décembre 2014). La réalisation des contrôles au niveau des opérateurs du secteur des denrées fournissant leurs co-produits pour l'alimentation animale dans une entreprise du secteur des aliments pour animaux (TRA) est prévue pour début 2015. Le plan et les check-listes relatives aux inspections des opérateurs du secteur des denrées fournis

Member state response

Les opérateurs doivent être informés des risques liés au processus du séchage direct. Ce point sera évoqué lors d'une réunion avec les associations sectorielles qui supervisent les guides à la base Page: 1 014 rt ref. DG(SANCO)/2013-6748 -MR of a/an audit carried out from 18 e identification of hazards and management of risks along the feed chain plans HACCP dans le secteur de l'alimentation animale (mai 4). circulaire sur la problématique du séchage direct sera publiée illet 2014). fiches techniques de l'Agence concernant l'HACCP seront luées et le cas échéant modifiées afin de mieux contrôler ce nt. ailleurs, le programme de contrôle sera adapté de sorte que rigine (pays) des aliments séchés soit précisée lors du portage et étendu à d'autres opérateurs que les fabricants liments composés (juin 2014).

Member state response

Un rappel des règles en vigueur sera fait lors d'une réunion avec er les associations sectorielles. Celles-ci ont été invitées à répercuter on l'information auprès de leurs affiliés (mai 2014). fiches techniques de l'Agence concernant l'HACCP seront ifiées pour attirer l'attention des inspecteurs sur ce point et de ifier l'efficacité des mesures préventives prises par l'opérateur r éviter la contamination croisée (décembre 2014). Page: 2

Member state response

The system for determining the frequency of official controls in all types of establishments is risk based, also taking into account the feasibility of carrying out these official controls with the available resources and staff. d For the risk ranking of each individual FBO, the presence of a validated own check system, the inspection results and previous sanctions are taken into account. A refined calculation system for the contribution of ame the inspection results to the overall risk ranking of a FBO has been applied since the second half of 2013.

Member state response

All technical sheets related to the official sampling describe in detail the actions to be taken in case of non-compliant test results. The basis for the the technical sheets is the guidance document on action limits for n microbiological contaminants (new version since June 2013: http://www.favv-afsca.fgov.be/thematischepublicaties/actiegrenzenvoor microbiologischecontaminanteninlevensmiddelen.asp). The check-lists (CL's) concerning the scope "hygiene and infrastructure" will be extended with specific questions related to Regulation (EC) No 2073/2005 by 30/06/2014.

Member state response

infringements concerning Regulation (EC) No 2073/2005, a standard No table shall be drawn up by 1ste of October 2013. This table will contain are instructions in order to fix the amount of the administrative fine to be proposed in a harmonised way. This will enable equal and proportionate treatment of infringements of the same nature and related to the same Page: 1 the Competent Authority. The European Commission is not responsible for the maintenance of these links. July 2013 ns of Report ref. DG(SANCO)/2013-6861-MR of an audit carried out controls on food safety and process hygiene criteria (Commission d by the Competent Authority criteria will be taken into account in the standard table: and maximum amounts stipulated in the penalty s of the laws; f infringements; of the infringement; of the FBO (e.g. previous sanctions); ar elements (e.g. behavior of the FBO towards the tor); ce of the establishment concerned in the food chain (e.g. ze of the establishment, trade volume...); dence.

Member state response

g The guide to good practices on sprouted seeds and the audit tools eets, (check-list and guidance document) are under revision. The circular r letter on sprouted has been revised since 1/7/2013. ticle The inspection check-lists on sprouted seeds are in the process of nt revision to be compliant with the new provisions of the European ation and Regulation (EC) No 2073/2005. ted in point 2, the CL's concerning the scope "hygiene and " will be extended with specific questions related to ) No 2073/2005 by 30/06/2014. of the technical sheet 922 (own checks dairy sector) is e 01/04/2013 (cfr. observations FVO on p.8 of the report). Page: 2 the Competent Authority. The European Commission is not responsible for the maintenance of these links. July 2013 ns of Report ref. DG(SANCO)/2013-6861-MR of an audit carried out controls on food safety and process hygiene criteria (Commission Action Proposed by the Competent Authority

Member state response

ia set As already stated in point 2, the CL's concerning the scope "hygiene and s infrastructure" will be extended with specific questions related to Regulation (EC) No 2073/2005 by 30/06/2014.

Member state response

when This point will be put on the agenda of next bilateral meeting with the food industry (FEVIA) in the fourth trimester of 2013. At the next meeting between FASFC and the certification and inspection bodies in October 2013, this recommendation will be highlighted. During the FASFC audits of these certification and inspection bodies, the recommendation of the FVO will be taken into account. The guidance document on Listeria monocytogenes shelf-life studies for ready-to-eat foods (under Regulation (EC) No 2073/2005) and the technical guidance document on shelf-life studies for Listeria monocytogenes in ready-to-eat foods are available on the FASFC website http://www.favv-afsca.fgov.be/laboratoria/erkendelaboratoria/dienstnota s/ The approved guides to good practices and own checks and the auditing tools address this aspect in general terms. At the next revision of these guides for processing industry, this aspect will be further elaborated. Some guides and auditing tools (e.g. fishery products) already mention that shelf life studies shall take into account storage conditions in the commercial circuit and at the consumer's home. Guidance auditing tool Page: 3 the Competent Authori

Member state response

' A circular letter on pooling of samples was issued on 8/5/2013: r http://www.favv-afsca.fgov.be/levensmiddelen/omzendbrieven/_docume 3, 4, 5 nts/2013-04-24_omzendbriefmicrobiologiepoolingvanmonsters_NL.pdf on http://www.favv-afsca.fgov.be/denreesalimentaires/circulaires/_documen nalysis, ts/2013-04-24_omzendbriefmicrobiologiepoolingvanmonsters_FR.pdf food As already stated in point 2, the CL's concerning the scope "hygiene and infrastructure" will be extended with specific questions related to Regulation (EC) No 2073/2005 by 30/06/2014.

Member state response

by Follow-up of the inspection bodies is foreseen at different levels: - Accreditation (Belac) odies - Approval by FASFC afety - Annual meetings between FASFC and the inspection bodies - There's a system in place for the follow-up of complaints on inspection bodies - Auditing of certification and inspection bodies by FASFC. At the meeting between FASFC and the certification and inspection bodies in May 2013, the recommendation 8 was highlighted. During the FASFC audits (first audit foreseen in July 2013), the FASFC will take into account the recommendation of the FVO. Page: 4 the Competent Authority. The European Commission is not responsible for the maintenance of these links.

Member state response

s le nouveau système de calcul des fréquences d'inspection présenté lors de la réunion d'ouverture, les résultats des inspections de l'année précédente sont pris en compte. Ce système est d'application en 2014. o Pour l'implémentation du système dans les secteurs viande et poisson, il faudra passer par la modification de êté royal du 22 décembre 2005 fixant les fréquences des contrôles officiels nécessitant la présence d'un gent de l'Agence Fédérale pour la Sécurité de la Chaîne Alimentaire dans les établissements du secteur des viandes et du poisson dans le cadre du programme de contrôle de l'Agence car cette dernière sert de base légale pour attribuer le coût des inspections réalisées par les chargés de mission à l'opérateur. La modification de l'arrêté est prévue pour cette année et l'entrée en vigueur de l'arrêté aura lieu au plus tard en 2015, une fois l'arrêté paru au moniteur belge. Dans la conception du nouveau business plan qui sera mis en oeuvre à partir de 2015, la méthodologie d'établissement des fréquences d'inspection dans tous les secteurs d'activité sera révisée, en tenant compte des observations formulées par l'OAV.

Member state response

Dans la procédure d'agrément des organismes de certification et d'inspection dans le cadre de l'AR sur ocontrôle, au point 5.2.1.7.2., il est bien stipulé que l'OCI notifiera immédiatement à l'AFSCA toutes les C A1 (c.à.d. les non-conformités qui représentent un danger pour la santé des personnes, des animaux et des plantes). Il en va de même lorsque l'OCI constate que sont exercées par un opérateur des activités non onnues de l'Agence. Les suspensions et les retraits de certificats sont toujours communiqués immédiatement à l'AFSCA. Enfin dans les 3 jours ouvrables qui suivent la décision définitive concernant la validation d'un système d'autocontrôle, les résultats de l'audit positifs ou négatifs doivent être encodés dans l'application.

Member state response

alyses pour le dénombrement des germes totaux dans le lait cru des espèces autres que les vaches seront réalisées dès 2014 sur les échantillons déjà programmés et ce chaque année, dans le cadre du amme de contrôle officiel de l'AFSCA. La fiche technique relative aux critères microbiologiques dans le lait cru de toutes espèces reprend déjà ce critère microbiologique légal. Les mesures à prendre lors du dépassement d'un critère microbiologique sont quant à elles décrites dans le document limites d'action pour ontaminants microbiologiques dans les denrées alimentaires

Member state response

In het kader van het handelsverkeer van slachtdieren wordt via het Traces contactpunt aan de systeemontwikkelaars van Traces en verzocht om de mogelijkheid te onderzoeken de gegevens in Beltrace, die de controle van de binnengekomen dieren registreert in het slachthuis, over te brengen naar Traces. Dit vermijdt een dubbele encodering in het slachthuis en bijgevolg een verhoogde werklast. In het kader van het handelsverkeer van dierlijke bijproducten waarvoor in België verschillende federale en regionale overheden bevoegd zijn, wordt gevraagd om het systeem aan te passen of een specifieke tool te ontwikkelen om de Traces berichten beter te kunnen selecteren naar die verschillende overheden toe. Page: 1

In het kader van het handelsverkeer van slachtdieren wordt via het Traces contactpunt aan de systeemontwikkelaars van Traces en verzocht om de mogelijkheid te onderzoeken de gegevens in Beltrace, die de controle van de binnengekomen dieren registreert in het slachthuis, over te brengen naar Traces. Dit vermijdt een dubbele encodering in het slachthuis en bijgevolg een verhoogde werklast. In het kader van het handelsverkeer van dierlijke bijproducten waarvoor in België verschillende federale en regionale overheden bevoegd zijn, wordt gevraagd om het systeem aan te passen of een specifieke tool te ontwikkelen om de Traces berichten beter te kunnen selecteren naar die verschillende overheden toe. Updated response from CA received 10 June 2014 Contact a été pris entre les autorités compétentes belges et la Commission, en date du 4 juin. Question transmise par la Belgique : « Enregistrement dans TRACES des contrôles réalisés à destination, en particulier dans le cadre du commerce intracommunautaire : la question est posée de savoir si une solution technique serait envisageable du côté de TRACES de manière à ce que l'information déjà enregistrée dans Sanitel- Beltrace puisse être utilisé

Member state response

technical training on symptoms of harmful organisms in exotic fruit bles will be provided to the inspectors. ion under ISO 17020 will be extended to the Border Inspection Posts e audited by June 2013. Training is part of the ISO 17020 standard.

on symptoms of harmful organisms in exotic fruit d to the inspectors. will be extended to the Border Inspection Posts 13. Training is part of the ISO 17020 standard. At foreseen.

Member state response

technical audit on the equipment in Border Inspection Post for ary inspections will be taken up in the audit planning from 2013 delines for inspectors a topic on the use of equipment will be added.

s a topic on the use of equipment will be added. the equipment in Border Inspection Post for be taken up in the audit planning from 2013 dit is to verify compliance with Directive the Border Inspection Posts for phytosanitary

Member state response

ines for inspectors will be updated by the end of the year.

will be updated by the end of the year.

Member state response

for inspectors will be updated by the end of the year. Page: 1 ort ref. DG(SANCO)/2012-6304-MR of an audit carried out for plant health Action Proposed by the Competent Authority

be updated by the end of the year. Page: 1 012-6304-MR of an audit carried out etent Authority

Member state response

as taken place with the NPPO of New-Zealand. It has been New-Zealand will send copies of each certificate to our generic for consignments which enter the EU via a BIP in Belgium.

the NPPO of New-Zealand. It has been nd copies of each certificate to our generic which enter the EU via a BIP in Belgium.

Member state response

s for the inspectors will be updated and a training on sampling for pection will be provided by the end of the year.

will be updated and a training on sampling for ided by the end of the year.

Member state response

nalyses will be adapted at least every 6 months based on the n from the EUROPHYT database.

dapted at least every 6 months based on the YT database.

Member state response

l programme will be changed shortly as well as the technical datasheet g of plants for Anoplophora chinensis.

he technical datasheet on sampling of plants for be adapted by 1 November 2012.

Member state response

ction for risk material in collaboration with Customs will be set t the control plan at importers of wood packaging material is carried out.

ial in collaboration with Customs will be set that the control plan at importers of wood etely carried out. Page: 2 012-6304-MR of an audit carried out by the Competent Authority

Member state response

oratoria heeft een template gemaakt van een toraat-generaal Controle zal overgemaakt worden n trichinenlaboratorium non-conformiteiten een opvolging van de corrigerende maatregelen etrokken PCE en het directoraat-generaal s te stellen. D-suivi-visite-

Member state response

ontroles georganiseerd worden op de en waarvoor er in het slachthuis esteld worden m.b.t. de voedselketeninformatie. De effende informatie over de voedselketen in aangepast worden.

Member state response

trole start in mei 2012 met een reeds eerder uizen'. Het doel van dit actieplan is om de algemene de autocontrole in de Belgische slachthuizen te ge non-conformiteiten zal er ernstiger worden lging op lange termijn worden verzekerd zodat de Page: 1 ed to the end of this action plan 012-6332-MR of an audit carried out r and processing of fresh meat, in particular de ien. van de van deze l in de voor hygiène ns haute on. Les ture, e la viande e préparations k-lists. L'une viande, té 8 fois par an e Page: 2 e were extracted and have been added to the end of this action plan 012-6332-MR of an audit carried out r and processing of fresh meat, in particular e. t Page: 3 e were extracted and have been added to the end of this action plan Datum huis XXXXXX van Antwerpen kondigde) en opsporen in vers vlees het opsporen gebruikte eenstemming zijn Commissie van 5 r de officiële controles TG, DG Laboratoria erslag krijgt na (naam van het e betreffende de volksgezondheid van de PCE die van kunnen vergewissen eren corrigerende added to the end of this action plan Date 1 abattoir de XXXXXX cale d'Anvers prévoit aboratoires officiels raîche (fréquence tion et les conditions de u Règlement les règl

Member state response

ALL: during the platform on animal by-product of 21 June 2012, where 24 all relevant sector associations are represented sensitization of the OF/SI rs with the findings of the FVO mission was carried out (annex o submitted in due time to the FVO). oned in the remarks on the mission report, the the need to specifically register farmers that e registered and have the implicit activity of method is already acknowledged by the FVO 21 March, OVAM has informed the need for approval of their activities. Six an application for approval. OVAM will e sector of OF/SI in order to identify other t to registration or approval. The screening is 12 ­ beginning of 2013. ore specifically the OWD, will deliver an that has the value of an approval, to the plants he conditions and procedures that prevail for ent are exactly the ones that are defined by 009 and 142/2011. For this purpose, the OWD tors. OWD will perform a screening of the sector tify other companies that are subject to Page: 1 Action Plan received from CA 21 August 2012 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers Action Proposed by the Competent Authority on or approval.

ALL: during the platform on animal by-product of 21 June 2012, where 24 all relevant sector associations are represented sensitization of the OF/SI rs with the findings of the FVO mission was carried out (annex o submitted in due time to the FVO). oned in the remarks on the mission report, the the need to specifically register farmers that e registered and have the implicit activity of method is already acknowledged by the FVO 21 March, OVAM has informed the need for approval of their activities. Six an application for approval. OVAM will e sector of OF/SI in order to identify other t to registration or approval. The screening is 12 ­ beginning of 2013. ore specifically the OWD, will deliver an that has the value of an approval, to the plants he conditions and procedures that prevail for ent are exactly the ones that are defined by 009 and 142/2011. For this purpose, the OWD tors. OWD will perform a screening of the sector tify other companies that are subject to Page: 1 dations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority The screening is planned for the end of 2

Member state response

g the platform on animal by-product of 21 June 2012, where l relevant sector associations are represented sensitization of the OF/SI ors with the findings of the FVO mission was carried out (same annex entioned above under 1). checklist TRA 2069 (French version) which can be found at .favv-afsca.fgov.be/checklists- nts/FAVVChecklist-2069v3fr.pdf ,question 2.3 stipulates in t which information must be present on the commercial f incoming raw materials must be . ish region): verification of the commercial documents will ant item of consideration during company visits. This aspect tegrated in the check-list that is used for approval application. elements will also be taken on board in the administrative Page: 2 Action Plan received from CA 21 August 2012 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority f the requirements to be checked by the OWD 5). l region): not applicable

g the platform on animal by-product of 21 June 2012, where l relevant sector associations are represented sensitization of the OF/SI ors with the findings of the FVO mission was carried out (same annex entioned above under 1). checklist TRA 2069 (French version) which can be found at .favv-afsca.fgov.be/checklists- nts/FAVVChecklist-2069v3fr.pdf ,question 2.3 stipulates in t which information must be present on the commercial f incoming raw materials must be . ish region): verification of the commercial documents will ant item of consideration during company visits. This aspect tegrated in the check-list that is used for approval application. elements will also be taken on board in the administrative will be part of the requirements to be checked by the OWD DPC (see point 5). Brussels Capital region): not applicable Page: 4 dations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority ruary 2013 tions in check-lists been done. re referred to in the response provided to e adapted with the same deadlines that the n point 1 (here above).

Member state response

ALL: during the platform on animal by-product of 21 June 2012, where all relevant sector associations are represented sensitization of the OF/SI ectors with the findings of the FVO mission was carried out (same annex mentioned above under 1). rm level to check for compliance with the OF/SI enhanced/modified. The checklist on OF/SI rules /www.favv-afsca.fgov.be/checklists- st-2158v4fr.pdf (French version). This s from the 1st of June 2012. F/SI on ABP rules will be proposed for the first spectors. ween the central services and the PCU's where highlighted to the provincial services of ion. (annexes submitted in due time to the Page: 3 Action Plan received from CA 21 August 2012 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers Action Proposed by the Competent Authority

ALL: during the platform on animal by-product of 21 June 2012, where all relevant sector associations are represented sensitization of the OF/SI ectors with the findings of the FVO mission was carried out (same annex mentioned above under 1). rm level to check for compliance with the OF/SI enhanced/modified. The checklist on OF/SI rules /www.favv-afsca.fgov.be/checklists- st-2158v4fr.pdf (French version). This s from the 1st of June 2012. F/SI on ABP rules will be proposed for the first spectors. ween the central services and the PCU's Page: 5 commendations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers Action Proposed by the Competent Authority t issues of OF/SI where highlighted to the provincial services of C via a presentation. (annexes submitted in due time to the

Member state response

ish region: Additional attention is given to this specific point in the t the EID-inspectors use to carry out official controls in ng plants. This ensures future controls in processing plants will the GTH-requirements more deeply. Next to this, in both plants GTH-shortcomings were observed, the inspectors will start ent so the situation will be rectified ultimately by March 2013. r regions are not involved.

ish region: Additional attention is given to this specific point in the t the EID-inspectors use to carry out official controls in ng plants. This ensures future controls in processing plants will the GTH-requirements more deeply. Next to this, in both plants GTH-shortcomings were observed, the inspectors will start ent so the situation will be rectified ultimately by March 2013. r regions are not involved.

Member state response

S: will make use of the derogation which allows the production of OF/SI containing cat 2 meat-and-bone meal or processed animal protein without the mixing component when these are delivered in packages or big bags of more than 50 kg and less than 1000 kg. Deadline: 1/10/2012. The big bags will need to be closed and sealed. The following mentions will be obligatory (on the big bag and the accompanying document): "not destined for application to land to which farmed animals have access" and "store at a place which is physically separated from the animals". Traceability must be guaranteed by every producer and intermediary (register IN-OUT). TRACES registration will be required for import of these OF/SI without component in big bags. de of these products in big bags of more than 1000 kg or in bulk will only be possible if a producer proposes an appropriate Page: 4 Action Plan received from CA 21 August 2012 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers Action Proposed by the Competent Authority r approval of this component by the nnex: "Derogation `constituant' FR" ned measures in the national legislation mprovers. Dead

S: will make use of the derogation which allows the production of OF/SI containing cat 2 meat-and-bone meal or processed animal protein without the mixing component when these are delivered in packages or big bags of more than 50 kg and less than 1000 kg. Deadline: 1/10/2012. The big bags will need to be closed and sealed. The following mentions will be obligatory (on the big bag and the accompanying document): "not destined for application to land to which farmed animals have access" and "store at a place which is physically separated from the animals". Traceability must be guaranteed by every producer Page: 6 dations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers Action Proposed by the Competent Authority r IN-OUT). TRACES registration will be ese OF/SI without component in big bags. cts in big bags of more than 1000 kg or in e if a producer proposes an appropriate r approval of this component by the nnex: "Derogation `constituant' FR" ned measures in the national legislation il improvers. Deadline: 30/06/2013 anic agriculture (main users of these lation on OF/SI containing ABP.

Member state response

FASFC: odifications to the checklists and the system to control the requirements rm level will be adapted in order to increase the ns. the registration and the process of approving chain of OF/SI improves, an increasing number es will be added to the annual ABP-control plan. arried out in collaboration with the Department C), will take place when the plants have tive attests. The number of controls will be the human resources available within the e DPC and to the risk linked to the activities that torage plants. Page: 5 Action Plan received from CA 21 August 2012 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority l region): not applicable

FASFC: odifications to the checklists and the system to control the requirements rm level will be adapted in order to increase the ns. the registration and the process of approving chain of OF/SI improves, an increasing number es will be added to the annual ABP-control plan. arried out in collaboration with the Department C), will take place when the plants have tive attests. The number of controls will be Page: 7 dations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority the human resources available within the e DPC and to the risk linked to the activities that torage plants. l region): not applicable ruary 2013 ion checklist end march 2013. information we have obtained concerning the s that the number of plants that are concerned is r that will be sent (see point 1) will also have as e picture concerning these operators: at the time re such OF and SI ? issue does not have to be addressed with the at other issues in relation to the ABP Regulation f the human resources that are available and his very specific topic, 6 to 8 plants will be ring the period 01/05/2013 to 3

Member state response

FASFC is not agreeing with action point. Article 3 of regulation e 882/2004 states controls should be risk based with an appropriate uency. The danger that via fertilizers the feed ban could be breached ons and analysis. The inspections at farm level for crop farmers and horticulturalists (the hecklist for livestock farmers (feed used). collected at farm level for the detection of in the feed used (around 200-220 samples are ically at farm level). here are no indication that a higher frequency of or farmers using organic fertilizer. Therefore the farm level can be considered as risk based and ate. e FASFC will: ecklists (OF/SI labelling (already done point 3) and feedban controls on cross contamination and fraud)) in all risk assessments of feedban to the in the livestock sector. on campaign (coordinated action) by the on and coordination unit (NICU) in 2013 or Page: 6

FASFC is not agreeing with action point. Article 3 of regulation e 882/2004 states controls should be risk based with an appropriate uency. The danger that via fertilizers the feed ban could be breached ons and analysis. The inspections at farm level for crop farmers and horticulturalists (the hecklist for livestock farmers (feed used). collected at farm level for the detection of in the feed used (around 200-220 samples are ically at farm level). here are no indication that a higher frequency of or farmers using organic fertilizer. Therefore the farm level can be considered as risk based and ate. e FASFC will: ecklists (OF/SI labelling (already done point 3) and feedban controls on cross contamination and fraud)) in all risk assessments of feedban to the the livestock sector. on campaign (coordinated action) by the nd coordination unit (NICU) in 2013 or Page: 9 dations 1, 2, 6 and 7) on 20 February 2013 f Report ref. DG(SANCO)/2012-6476-MR of an audit carried out rements for organic fertilisers and soil improvers mpetent Authority ruary 2013 ee point 1) the FASFC will not register the use soil improvers containing derived products of farms. This does not jeopardize the effectivene

Member state response

om 2013 onwards, the competent control k (at an official inspection) each producer of a product s registered as a PDO/PGI/TSG at least once a year. mpetent control authority will carry out unannounced e basis of a risk analysis. This risk analysis will be ten instruction for the prioritization of those checks, ket level, a formal priority list will be drawn up in proach becomes more systematic. ucers of already registered names can only start initial control. ucers of a product for which a European registration e subject to a prior audit, in accordance with Article (EU) No 1151/2012, so that they comply with all roduct specification when the European registration 'AC s'engage à formaliser pour fin 2013 la à travers une instruction qui explicitera les n oeuvre des actions suivantes (déjà menées apport d'activité annuel de l'OC à l'AC ; uelle de l'AC au Comité consultatif de l'OC ; Page: 1 2-6811-MR of an audit carried out ns of Origin (PDO), Protected cts and foodstuffs Action Proposed by the Competent Authority tématique de l'AC aux audits de surveillance de ons et en plus de l'accréditation, l'AC wallonne orer la supervision de l'OC à vérifier elle-même s la qualité du travail de

Member state response

on between the competent authority and the uthority concerning infringements on the market, le improvement of controls is provided for at least 13, a first meeting was held on Thursday 14 March l meeting, the regions responsible for agriculture and eral Enforcement and Mediation (DGCM) of the s at least once a year on the Belgian dossiers and he registration process. In 2013, a meeting was held on ussels. age à conclure pour fin 2013 un accord avec la oration en matière de contrôle général de P/IGP/STG sur le marché, et sur les mesures à Page: 2 2-6811-MR of an audit carried out ns of Origin (PDO), Protected cts and foodstuffs Action Proposed by the Competent Authority étection d'une non-conformité.

Member state response

checklist for TSG products applies from the checklist of a PGI includes that the f raw materials is updated every year and that the mass ne réunion d'information réunissant les producteurs nisée pour exposer les exigences réglementaires en e. Un document précisant ces exigences sera établi es producteurs. Une instruction sera rédigée à Délai de mise en oeuvre : fin 2013. a en place une procédure de constatation et de tions en matière d'étiquetage des produits sous gées après leur mise sur le marché sur son territoire, es contrôles effectués par la DGCM. Délai de mise en Page: 3

Member state response

tweedaagse opleiding, gebaseerd op een lijst van orden aan de inspecteurs / controleurs werkzaam

Member state response

p het KB van 16 januari 2006 (tot vaststelling van de van de erkenningen, toelatingen en voorafgaande fgeleverd door het FAVV), zal in de loop van 2012 voor ondertekening r worden overgemaakt. n dat scheepsbevoorraders een erkenning moeten krijgen. ning worden de voorwaarden gekoppeld zoals artikel 13 van Richtlijn 97/78.

Member state response

rd opgemaakt om de voorwaarden van transit te de controles. De procedure zal in het eerste trimester van rd worden.

Member state response

e voorafgaande kennisgeving beschrijft en es voorziet, is gepubliceerd op de website van het Page: 1 y 2012 (SANCO)/2011-8920-MR of an audit carried out tent Authorities with regard to the import/transit Action Proposed by the Competent Authority e/invoerderdelanden/_documents/2011_12_05_invoer endbrief_NL.pdf de toepassing en handhaving van de regels ten aanzien atie in de GIP's zullen geïmplementeerd worden vanaf

Member state response

udit is uitgevoerd tussen 16/1 en 2/2/2012. gebeuren zoals voorheen door de NICE.