Netherlands

The recommendation states as its basis

The competent authorities declared their view that the marketing authorisations for certain old antimicrobials are no longer in line with the most recent scientific knowledge, in that they often indicate doses that are too low and are administered for periods that are too long.

For old antimicrobials and for specific cases laid down in the prescription guidelines for the veterinary profession, the competent authorities allow veterinarians to deviate, the dose and duration of the treatment, from the terms of the corresponding marketing authorisations. The competent authorities declared that their goal is that when decisions for such a deviation are taken by veterinarians, these are based on scientific knowledge, and always follow a consistent approach. In order to do that, the guidelines detail the extent of deviation allowed for each condition, antimicrobial and animal species. It follows that there are not official controls to verify that these old antimicrobials are used in accordance with the terms of their marketing authorisations, as laid down in Article 106(1) of the VMPR.

The planning and implementation of veterinary controls that the NVWA carries out is appropriate to verify compliance with most of the requirements of the VMPR under the scope of this audit, and therefore largely contributes to a more prudent use of antimicrobials. However, the NVWA allow veterinarians to use old antimicrobials outside of the terms of their marketing authorisation.

The recommendation states as its basis

Regarding sampling at BCPs: i. Seven BCPs are designated for products of animal origin although approximately 90% of fresh meat arrives via Rotterdam port. Schiphol, and to a lesser extent, Eemshaven are the only other BCPs that have received imported fresh meat over the past four years. ii. The selection of eligible consignments for sampling is done by the Veterinary Border Control system based on: · the list of CN codes for fresh meat, as discussed during the drafting of the EU Decision, and · the list of BCPs and origins included in the TRACES data from year -2 and first half of year -1 (data used for preparing the sampling plan). iii. The audit team identified consignments from a few origins that were not sampled in 2021. The competent authority confirmed that the current system only flags consignments from origins and/or BCPs identified in the sampling plan instead of all CN codes for all origins and all BCPs approved for fresh meat. This means that some consignments may not be identified for sampling, which is not in line with point 3.3(a) of Part A of the Annex to the EU Decision. iv. The correct sampling rates were used, except for consignments mentioned in point iii above. Isolates recovered in 2021 and 2022 were subjected to antimicrobial susceptibility testing (AST) and reported to EFSA. Consignments sampled are identified in TRACES as being sampled and all results are marked as satisfactory (no further action required for monitoring results). 6 Conclusions on sampling

However, the gap in the system to detect eligible consignments results in some meat origins and potentially some consignments not being identified at BCPs, which affects the representativeness of sampling at this level.

The recommendation states as its basis

The NVWA has documented procedures for official controls for the animals transporter authorisation, checks prior to departure and during the arrive. journey, and for retrospective documentary checks. However, there are no documented procedures for welfare checks after arrival at the farm of The NVWA destination, contrary to Article 12(1) of the OCR. Official controls at this requires that stage are particularly relevant due to the predominant role of the Netherlands as Member State of destination for unweaned calves over unweaned long journeys. calves are transported on 15. The NVWA's documented procedures provide clarity in interpreting road vehicles some legal requirements in Council Regulation (EC) No 1/2005. equipped with Examples, relevant for the transport of unweaned calves, are: drinking systems having rubber · defining an "unweaned calf" as a bovine animal up to two months old; teats. · clarification on the acceptability of vehicles' drinking equipment for unweaned calves (Point 2.2 of Chapter VI, Annex I to Council Regulation (EC) No 1/2005). The NVWA requires rubber nipples as an acceptable system for providing water to the calves in the vehicle and a minimum of two in each vehicle compartment.

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

During the on-the-spot part of the audit, the RDW inspectors RDW inspectors demonstrated an inspection of a road vehicle for the approval to transport verify the unweaned calves.: functionality of · The RDW has satisfactory facilities for inspecting road vehicles. temperature Concerning ventilation systems, the RDW inspectors indicated that if a ventilator is blocked by the floor of a deck, it is not taken into warning systems account when verifying compliance with the minimum airflow although they required by Point 3.2 of Chapter VI to Council Regulation (EC) No 1/2005. may not always test them at both · The RDW inspectors are experienced and competent. They inspected the vehicle and found it to comply with the requirements laid down in high and low Chapters II and VI of Annex I to Council Regulation (EC) No 1/2005 temperature and with the RDW's documented procedures. However, the competent authority's interpretation of the RDW's documented extremes. . procedures allowed the verification of the functioning of the temperature sensors and the warning system in cases of either high or Approval low temperaturesRDW inspectors indicated that the check on high certificates of temperatures is not always done due to the time required to heat the temperature sensors beyond the warning limit7. means of transport 31. The RDW makes the list of approved means of transport publicly identify the available on its' website. The majority of road vehicles are approved for types of animals five years and in very few cases the duration of the approval was less, in the vehicle can line with Article 18(2) of Council Regulation (EC) No 1/2005. transport.

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

In two of the three farms visited, the drivers have not left copies of the relevant sections of the journey log listed in Point 5 of Annex II to Council Regulation (EC) No 1/2005: · This malpractice appears to be quite common, as confirmed by one of the two Dutch transporters met during the on-the-spot part of the audit. · Contrary to what was described during the remote part of the audit, 15 inconsistency the inspectors did not ask for the journey logs and therefore did not between the detect this non-compliance. They indicated that the check on the journey plan to verify that the organiser had planned the journey to procedures for comply with travelling and resting times is done using the version official controls uploaded in Traces-NT. There may however be differences between the version of the journey plan uploaded in Traces-NT and its at the place of authentic paper version. destination, as · Point 5 of Annex II to Council Regulation (EC) No 1/2005 requires described by that keepers at place of destination keep (copies of) all sections of the some official journey log, except for Section 4, for a minimum of three years. Not veterinarians, being able to access these sections of the journey log when visiting the farm of destination prevents the NVWA from conducting and their verification checks on the journey (e.g. verifying the farmer's implementation. statements of dead or unfit animals on arrival with the information that should be recorded in Section 3) and identifying potential needs There is a of requesting or notifying data, information, or assistance from or to thorough and other Member States.

Member state response

4. The absence of documented procedures - Finding 14: documented procedures for welfare checks after arrival at the farm of destination Although learning on the job is important for NVWA inspectors, Intervision-like team meetings ensure high quality and uniformity in the implementation of the inspections, a protocol for this has been drawn up and implemented (Annex K-LP-BEST-01) - Finding 24: At this moment the quality and consistency of official controls on the protection of unweaned calves during transport, is assessed by peer to peer supervision by the senior livestock veterinarian in each team. To enhance uniformity between the inspections and to fulfill the requirements for accreditation, this supervision will be placed with an external group of observers. These observers are currently being trained and will join an official control to assess how this task is being performed by the NVWA inspector. It is envisaged that every official control task will be observed in this way at least once every three years. The results of these observations will flow back to the team leaders, who will decide if extra training or guidance is needed for the official NVWA inspector. All details fr

The recommendation states as its basis

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

The NVWA also indicated that the lack of response over the years from some Member States' national contact points had led to discontinuing notifications in some cases.

In not notifying non-compliances concerning other Member States through the liaison bodies, the NVWA is not using the Commission's iRASFF system, contrary to Article 15(1) of Commission Implementing Regulation (EU) 2019/1715. iRASFF has been developed by the Commission to cater for, amongst others, notifications to other Member States for: assistance on request (e.g. in investigations as part of official controls); and assistance without request in the event of non- compliances. These two types of assistance are regulated by Articles 104 and 105 of the OCR which require the notified Member States to reply to 11 The NVWA the notifying Member State. Using iRASFF should therefore bring an follows-up on increase in the response rate to the NVWA's notifications of non- notifications of compliances, including from those Member States which generally do not reply through the national contact points. non- compliances and 23. During the remote part of the audit, the NVWA discussed with the audit team several cases of notifications of non-compliances received from suspicions of other Member States between 2020 and 2022. In all cases, the NVWA non- investigated or followed-up the notifications, took appropriate measures when relevant, in line with Articles 137 and 138 of the OCR), and compliances informed the notifying Member State of the results of their notified by other investigations. Member States.

Member state response

er 2022, the Netherlands consistently reported violations of Regulation (EC) 2005 via email to the National Contact Points (as per Article 24(2) of Council n (EC) No 1/2005). As of this date, the European Commission has not published a on bodies in accordance with Article 103(4) of Regulation (EU) 2017/625. the Netherlands Food and Consumer Product Safety Authority (NVWA) employ the same procedure, utilizing the old list of National Contact Points. As a email address (NVWA pb National Contact Point Animal Welfare and Animal -ah@nvwa.nl) has not yet been updated. Inspectors and/or official from the NVWA can send information about infringements to the National , which subsequently communicates these to the relevant member states. During was discovered that not all inspectors within the inspection division share bout infringements with the National Contact Point due to past unsatisfactory e.g., no response from member states or no action taken by a member state). Page: 2 ns of report ref. DG(SANTE) 2023-7736 of the audit carried out from 19 June long journeys n to ensure that all infringements l Contact Point. of pets have been received via tion (EC) No. 1/2005, as outlined d by email

The recommendation states as its basis

The NVWA has issued documented procedures for performing official controls on consignments of animals and goods of animal and non-animal origin entering the EU through Dutch BCPs, which include an import inspection manual (Werkhandboek Importkeuring) and instructions on the use of the electronic national veterinary border control system of the NVWA (Veterinaire Grens Controle Systeem ­ VGC system). The audit team noted that procedures are incomplete or are not in line with relevant EU requirements regarding transit (see section 5.2.3), internal audits, control verification procedures (see section 5.1.6) and identity checks on consignments of bulk liquid oils and fats (see section 5.2.4.2), which is not in line with Article 12(1) and (3) of the OCR. The manual and the majority of the documented procedures are publicly available. The 6 NVWA also maintains an online information system (Import Veterinair Online) for use by both NVWA staff and operators on the specific requirements for animals and goods of animal and non-animal origin entering the EU.

The audit team noted that the procedure for the performance of documentary checks on goods of non-animal origin (K-IK-INV-PR03) was not in line with the requirements of Article 2 of Commission Implementing Regulation (EU) 2019/2130. The procedure provides that, for products listed in Annex I to Commission Implementing Regulation (EU) 2019/1793, the documentary check (see also sections 5.1.5 and 5.2.4) is solely for the verification of the completeness of part I of the Common Health Entry Document (CHED-D); there is no cross-check to see if the information in the CHED-D corresponds with that provided in official certificates, official attestations or other documents accompanying the consignment. In addition, the procedure provides that for products listed in Annex II to that Regulation, the documentary checks are performed on copies of official certificates and not on the originals (see also sections 5.1.5 and 5.2.4). The audit team further noted that there are no arrangements to take corrective actions if the mandatory frequencies specified in EU law for identity and physical checks on food of non-animal origin are not met (see also section 5.2.4).

The Commission audit team noted that during the ABB audits of compliance of the inspection centres and control points with minimum requirements, and the ABB verification controls at BCPs, the ABB auditors had not identified several of the non- compliances identified by the Commission team, some of which were significant (see finding 68). The ABB reports evaluated by the Commission team neither contained deadlines by which non-compliances were to be remedied nor requests for action plans to be submitted.

Furthermore, the Commission audit team noted that the findings in the ABB reports had been poorly communicated to the import control team and there was little evidence that the shortcomings identified had been followed-up by the import control team. The Commission audit team also observed that most of the non-compliances were repeatedly found in subsequent audit or verification control reports. Most of the NVWA staff interviewed stated that they were unaware of the reported non-compliances and had no access to the ABB reports recorded in the NVWA database.

The audit team found that the failure by the NVWA to take appropriate measures in the light of the results of its internal audits or corrective actions in all cases where its control verification procedures identified shortcomings was not in line with Article 6(1) and 12(3) of the OCR respectively.

Whilst official controls on animals and goods entering the EU are conducted by appropriately trained staff and underpinned by documented procedures and comprehensive information technology systems, verification of consistent application of controls and compliance of facilities is weak. This is compounded by an ineffective internal audit and control verification system which either did not identify shortcomings or, if they were identified, did not follow-up on the timely rectification of these shortcomings. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

The audit team identified that for three consignments of animal origin which were split during transit, the traceability of those consignments was not ensured: · For one non-conforming consignment of over 100 000 kg fish, the CHED issued on arrival at the BCP indicated that the consignment arrived in bulk by vessel. Before the consignment was transported to a free warehouse, a second CHED had been issued at the BCP indicating that the consignment had arrived at the BCP in one container with a fictitious container number and 12 seals. The NVWA clarified that the consignment was transported from the BCP to the free warehouse in 12 road trips. The original consignment in transit was therefore split before it reached its destination, which is not in line with Article 19(e) of Regulation (EU) 2019/2124. In addition, traceability of this non-conforming consignment could not be guaranteed. · A second consignment was split into several consignments after storage in a customs warehouse. However, the sum of quantities declared in the split CHEDs exceeded the quantities in the original CHED, which is not in line with Article 28(b)(ii) of Regulation (EU) 2019/2124. Consequently, the competent authority did not ensure through its verification that the traceability system in place at the warehouse was effective, which is not in line with Article 26(2) of said Regulation. · A third consignment, according to the health certificate, originated from two establishments in a third country. The original CHED and subsequent split CHEDs issued after storage indicated one establishment of origin only. The overall quantity in the split CHEDs for one establishment of origin exceeded the quantities mentioned on the health certificate, which is not in line with Article 28(b)(ii) of Regulation (EU) 2019/2124. Consequently, the competent authority did not ensure through its verification that the traceability system in place at this warehouse was effective, which is not in line with Article 26(2) of said Regulation. 5.2.4 Documentary, identity and physical checks of consignments

The audit team noted that the identity checks on consignments of bulk liquid oils arriving in vessels were performed either (a) on the basis of a seal check in the absence of an (14) https://ec.europa.eu/food/audits-analysis/audit-report/details/3853 13 official seal, which is not in line with Article 3(2) of Regulation (EU) 2019/2130, or (b) a full identity check. The NVWA stated that it does not verify the quantity of bulk liquid oils when performing identity checks. This is not in line with Article 3(1) of Regulation (EU) 2019/2130. The audit team also observed that in this respect, the NVWA's procedures do not require verification of the quantity of consignments of bulk liquids. 5.2.4.3 Checks on consignments of goods of non-animal origin

The NVWA stated that documentary checks on consignments of goods of non-animal origin, when not selected by the VGC system for identity and physical checks, are performed automatically by the VGC system based on the completeness of the information contained in part I of the CHED-D, and without taking into account the information contained in official certificates, attestations or other documents accompanying the consignment. This is not in line with Article 2(3) of Regulation (EU) 2019/2130.

The NVWA further confirmed that documentary checks on consignments of goods of non-animal origin which are selected for identity and physical checks are performed on scanned copies of official certificates, attestations or other documents accompanying the consignment rather than on the original documents. This is also not in line with Article 2 of Regulation (EU) 2019/2130.

Consequently, the previous recommendation made in audit report DG(SANTE) 2017- 6054 regarding the performance of documentary checks on consignments of goods of non-animal origin remains unaddressed.

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The audit team found that two of the 14 inspection centres visited were compliant with the minimum requirements for BCPs. The other 12 inspection centres and the two control points visited were not compliant with the requirements laid down in Articles 64(3) and 53(1)(a) of the OCR respectively and Articles 3, 4, 5, 6 and 8 of Regulation (EU) 2019/1014. Many of the shortcomings identified by the audit team (and listed in findings 69 and 70) had not been identified by the ABB in its internal audit and control verification activities (see finding 31).

The recommendation states as its basis

There is, however, poor cooperation and communication within the NVWA as regards internal audits, control verification procedures and the follow-up of non-compliances identified by NVWA staff during the performance of those audits and verifications (see also section 5.1.6 below). 5.1.3 Training of staff

The Commission audit team noted that during the ABB audits of compliance of the inspection centres and control points with minimum requirements, and the ABB verification controls at BCPs, the ABB auditors had not identified several of the non- compliances identified by the Commission team, some of which were significant (see finding 68). The ABB reports evaluated by the Commission team neither contained deadlines by which non-compliances were to be remedied nor requests for action plans to be submitted.

Furthermore, the Commission audit team noted that the findings in the ABB reports had been poorly communicated to the import control team and there was little evidence that the shortcomings identified had been followed-up by the import control team. The Commission audit team also observed that most of the non-compliances were repeatedly found in subsequent audit or verification control reports. Most of the NVWA staff interviewed stated that they were unaware of the reported non-compliances and had no access to the ABB reports recorded in the NVWA database.

The audit team found that the failure by the NVWA to take appropriate measures in the light of the results of its internal audits or corrective actions in all cases where its control verification procedures identified shortcomings was not in line with Article 6(1) and 12(3) of the OCR respectively.

Whilst official controls on animals and goods entering the EU are conducted by appropriately trained staff and underpinned by documented procedures and comprehensive information technology systems, verification of consistent application of controls and compliance of facilities is weak. This is compounded by an ineffective internal audit and control verification system which either did not identify shortcomings or, if they were identified, did not follow-up on the timely rectification of these shortcomings. 5.2 IMPLEMENTATION OF OFFICIAL CONTROLS ON ANIMALS AND GOODS ENTERING THE EU

The audit team found that two of the 14 inspection centres visited were compliant with the minimum requirements for BCPs. The other 12 inspection centres and the two control points visited were not compliant with the requirements laid down in Articles 64(3) and 53(1)(a) of the OCR respectively and Articles 3, 4, 5, 6 and 8 of Regulation (EU) 2019/1014. Many of the shortcomings identified by the audit team (and listed in findings 69 and 70) had not been identified by the ABB in its internal audit and control verification activities (see finding 31).

The fact that the majority of BCPs, including their inspection centres, and control points visited were not compliant with the minimum requirements for BCPs for the categories of animals and goods of animal and non-animal origin for which they had been designated demonstrates a systematic failure in the competent authority's internal audit and control verification system and compromises the ability of the competent authority to provide assurances that animals and goods of animal and non-animal origin entering the EU through Dutch BCPs are appropriately handled, processed and stored and that only compliant animals and goods enter the EU.

The recommendation states as its basis

The NVWA confirmed that identity checks are not being performed on consignments of goods of animal origin in transit that exit the EU through BCPs in the Netherlands, which is not in line with Article 33 of Regulation (EU) 2019/2124. Consequently, the recommendation made in audit report DG(SANTE) 2013-6759 (13) remains unaddressed.

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The NVWA also stated that it does not perform official controls on consignments of animals and goods of animal origin from other EU Member States which have transited through a third country and re-enter the EU through a BCP in the Netherlands. This is not in line with Article 37(3) of Regulation (EU) 2019/2124.

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The audit team identified that for three consignments of animal origin which were split during transit, the traceability of those consignments was not ensured: · For one non-conforming consignment of over 100 000 kg fish, the CHED issued on arrival at the BCP indicated that the consignment arrived in bulk by vessel. Before the consignment was transported to a free warehouse, a second CHED had been issued at the BCP indicating that the consignment had arrived at the BCP in one container with a fictitious container number and 12 seals. The NVWA clarified that the consignment was transported from the BCP to the free warehouse in 12 road trips. The original consignment in transit was therefore split before it reached its destination, which is not in line with Article 19(e) of Regulation (EU) 2019/2124. In addition, traceability of this non-conforming consignment could not be guaranteed. · A second consignment was split into several consignments after storage in a customs warehouse. However, the sum of quantities declared in the split CHEDs exceeded the quantities in the original CHED, which is not in line with Article 28(b)(ii) of Regulation (EU) 2019/2124. Consequently, the competent authority did not ensure through its verification that the traceability system in place at the warehouse was effective, which is not in line with Article 26(2) of said Regulation. · A third consignment, according to the health certificate, originated from two establishments in a third country. The original CHED and subsequent split CHEDs issued after storage indicated one establishment of origin only. The overall quantity in the split CHEDs for one establishment of origin exceeded the quantities mentioned on the health certificate, which is not in line with Article 28(b)(ii) of Regulation (EU) 2019/2124. Consequently, the competent authority did not ensure through its verification that the traceability system in place at this warehouse was effective, which is not in line with Article 26(2) of said Regulation. 5.2.4 Documentary, identity and physical checks of consignments

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The NVWA stated that documentary checks on consignments of goods of animal and non-animal origin are performed upon arrival of the consignment at the BCP of entry in two out of seven designated BCPs in the Netherlands. Regarding the consignments 12 destined for the remaining five BCPs, these checks are performed at locations other than the BCP of entry which is not in line with Article 49(1) of the OCR.

A previous recommendation made in audit report DG(SANTE) 2017-6054 (14) regarding the performance of documentary checks on consignments of goods of non-animal origin, concerning the location where those checks are performed, remains unaddressed. Furthermore, this non-compliance now also relates to documentary checks on goods of animal origin. 5.2.4.1 Checks on consignments of animals

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The NVWA stated that documentary checks on consignments of goods of non-animal origin, when not selected by the VGC system for identity and physical checks, are performed automatically by the VGC system based on the completeness of the information contained in part I of the CHED-D, and without taking into account the information contained in official certificates, attestations or other documents accompanying the consignment. This is not in line with Article 2(3) of Regulation (EU) 2019/2130.

The NVWA further confirmed that documentary checks on consignments of goods of non-animal origin which are selected for identity and physical checks are performed on scanned copies of official certificates, attestations or other documents accompanying the consignment rather than on the original documents. This is also not in line with Article 2 of Regulation (EU) 2019/2130.

Consequently, the previous recommendation made in audit report DG(SANTE) 2017- 6054 regarding the performance of documentary checks on consignments of goods of non-animal origin remains unaddressed.

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The NVWA provided the audit team with an overview for the first six months of 2022 which showed that the frequency rates for identity and physical checks on consignments of food and feed of non-animal origin were largely in line with the minimum frequencies set out in the Annexes to Regulation (EU) 2019/1793. This was however not the case for sampling of goods of non-animal origin for ethylene oxide.

Whilst consignments of animals and goods of animal origin entering the EU are presented for official controls, and said controls are carried out in line with documented arrangements, some are not performed in line with EU rules (e.g. documentary checks are not performed at the BCP of entry in all cases) and a long-standing shortcoming concerning controls on consignments of goods of animal origin in transit remains. Regarding goods of non-animal origin, systematic, and in some cases long-standing shortcomings in the implementation of those controls remain, notably concerning the performance of documentary checks, the locations at which those checks are performed and the frequencies at which identity and physical checks are performed. The fact that the competent authorities have not ensured the implementation of official controls in line with EU rules undermines assurances that goods of non-animal origin entering the EU through Dutch BCPs comply with applicable requirements.

The recommendation states as its basis

The audit team found that the list made available by the NVWA on the internet for the three BCPs and two control points designated for goods of non-animal origin is not in the format set out in Annex I to Regulation (EU) 2019/1014 and does not contain the abbreviations and the specifications set out in Annex II to that Regulation. This is not in line with Article 7 of said Regulation.

The audit team found that two of the 14 inspection centres visited were compliant with the minimum requirements for BCPs. The other 12 inspection centres and the two control points visited were not compliant with the requirements laid down in Articles 64(3) and 53(1)(a) of the OCR respectively and Articles 3, 4, 5, 6 and 8 of Regulation (EU) 2019/1014. Many of the shortcomings identified by the audit team (and listed in findings 69 and 70) had not been identified by the ABB in its internal audit and control verification activities (see finding 31).

The fact that the majority of BCPs, including their inspection centres, and control points visited were not compliant with the minimum requirements for BCPs for the categories of animals and goods of animal and non-animal origin for which they had been designated demonstrates a systematic failure in the competent authority's internal audit and control verification system and compromises the ability of the competent authority to provide assurances that animals and goods of animal and non-animal origin entering the EU through Dutch BCPs are appropriately handled, processed and stored and that only compliant animals and goods enter the EU.

The recommendation states as its basis

Up to 50% of the work of this staff is to handle and follow up incidents and notifications (8 424 notifications in 2021). This activity comprises of notifications of the EU Commission's Rapid Alert System for Food and Feed (iRASFF), consumer complaints and company notifications, following the obligation for FBO to inform the authorities of possible food safety concerns, as set out in Article 19 of Regulation (EC) 178/2002.

The CAs responsible for the official control system over the production of fishery products are designated and their structure and organisation is suitable to perform their tasks. However, the significant shortage of staff and the limited risk criteria prevents the controls to be fully effective.

Controls at approved establishments are implemented and cover all applicable EU requirements. The stipulated frequencies, however, cannot be met due to the low staff numbers, which compromises the outcome of the risk-based assessment which the CA had carried out to determine an adequate frequency of controls, in line with Art. 9 of Regulation (EU) 2017/625.

Member state response

In December 2021 the Dutch Government agreed to an extra funding for the NVWA for eliminating the imbalance between tasks and resources and strengthening the position of the NVWA. A part of these additional fundings will result in the increase of staff of the NVWA, both inspectors on the field and supporting staff at the main office, including extra resources for controls within the fishery sector.

The recommendation states as its basis

There are two risk criteria used to determine the frequency of inspections: · the compliance record of a FBO and · the presence of a private certified food safety assurance system.

Controls at approved establishments are implemented and cover all applicable EU requirements. The stipulated frequencies, however, cannot be met due to the low staff numbers, which compromises the outcome of the risk-based assessment which the CA had carried out to determine an adequate frequency of controls, in line with Art. 9 of Regulation (EU) 2017/625.

Member state response

9 We believe that this recommendation should be based on point 63 of the draft report, ot point 62 as pointed out in this document (see yellow marked text). The proposed action hereunder is based on recommendation 63. Since 2021 a multidisciplinary working group has been developing a new model for a risk-based classification of FBO's and prioritization of the inspection tasks. This model, in line with the relevant criteria described in article 9, point 1 of Reg. 2017/625, uses the following criteria for the categorization of the risk: - Compliance history - Intrinsic product/sector risk - Certification (as a mitigation factor) In November and December 2022 a successful pilot has been conducted to test the applicability of this model. The new risk-based model has been introduced in March 2022, and further implementation will continue in 2022 and 2023.

The recommendation states as its basis

The NVWA stated that this procedure is no longer followed systematically. This is not in line with Article 10 of Regulation (EU) 2017/625. The CCA stated that, if non- compliances related to food safety would be obvious and found during sustainability checks, these would be noted in the inspection reports. Aquaculture farms

There are around 50 aquaculture farms (freshwater and saltwater). The inspection and sampling history regarding two farms for eel and one for trout was assessed. The farms were inspected at least once every one to three years depending on the risk category. The inspection reports did not contain food safety elements but mainly covered animal health, sustainability and residues. The CCA stated that food safety topics are not included within the scope of the controls on this type of operator. This is not in line with Article 10 of Regulation (EU) 2017/625.

Vessels intending to land fish need to notify the authorities in advance for sustainability controls.. Inspections at the auction halls, including discharge of fishing vessels, are registered in the IT-systems of the NVWA. 5.3.1.4 Facilities handling fishery products

The official control system covers the production chain of fishery products with the exception of primary production vessels, some landing sites and aquaculture premises. This prevents the CA from verifying that FBOs in primary production provide compliant products to the food chain, which is not in line with Article 10 of Regulation (EU) 2017/625.

Member state response

The number of inspection activities, especially within the primary sector, have been tion reduced in the last years due to the limited resources available. Until 2022 no specific projects have been launched aimed to control compliance with the legal requirements in annex I of Reg. 852/2004 on board of fishing vessels and within the aquaculture sector. The annual plan 2023 and further will include controls on annex I of Reg. 852/2004 within the primary sector. Additional trainings for inspectors that will conduct these controls (both new and experienced inspectors) are being developed and implemented. Page: 1 of report ref. DG(SANTE) 2022-7453 of the audit carried out from 07 February 2022 to 18 rning the production and placing on the market of fishery products

The recommendation states as its basis

Corrective actions to address the shortcomings regarding the uses of additives in brown shrimps to prevent the limit of benzoic acid in shrimps from being exceeded, are not effectively enforced. 5.3.2 Official controls of fishery products Legal requirements Regulation (EC) No 2406/96 Article 1 and Annex I to Regulation (EC) No 2073/2005. Regulation (EC) No 1333/2008. Commission Regulation (EC) No 1881/2006. Article 18 and 35 of Regulation (EU) 2017/625. 12 Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

e omission has been recognized, and enforcement actions have already been nducted as part of, or in combination with dedicated projects in 2020 and 2022. e 2007 National Guide for good practices at shrimp fishing vessels is under vision and will pay attention to the use of additives. e HACCP-procedures of the FBO's involved have been reviewed to ensure that e operators are in control of the use of additives. forcement in 2021 and 2022, mainly focused on the auctions where the dosage of nzoic acid takes place, have already led to a reduction of the number of non- mpliances detected. Page: 2

The recommendation states as its basis

For audits, if the FBO has a Private Quality Assurance Scheme (PQS) certified according to BRC, IFS, FSSC 22000, the frequency of audits could be reduced. Audits do not apply to primary production and having a PQS is not taken into account for reducing the frequency of official controls at this stage. Details are in the following table. Table: Official Controls frequency over FBOs in the scope of this audit. FNAO FBOs AUDIT'S FREQUENCY INSPECTION'S FREQUENCY PQS PRIMARY PRODUCTION Not established N/A Carried out by Projects SPROUT-PRODUCING ESTABLISHMENT PROCESSOR 1 every 1 every 1 every Freezing and/or Cutting Plants 3 years 6 years year Fruit and Vegetables 1 every To be Not yet fixed 5 years established Based on the CAs capacity

In primary production, controls are in the form of special projects, that take place with the aim of obtaining information on the whole sector regarding microbiological risks of produce.

For these "special projects", each year, a crop category is identified and a limited number of FBOs is randomly selected (see table in paragraph 61) for microbiological inspections. Regardless of the outcome of the project, a different category is chosen for the following year, without continuity and without having a plan of when the FBO / category will be inspected further (see table in paragraph 54).

The prioritisation of these projects and controls is mainly based on the risks associated with pesticides and, to a minor extent, the risks of microbial contamination (i.e. EFSA opinion regarding crops posing particular risks).

The inspectors interviewed stated that a better balance between chemical and microbiological risks in prioritising official controls is advisable and it should be reflected in the official control risk-based plan. The inspectors informed the audit team that controls over hygiene at primary production is still a relatively new task.

The CCA informed the audit team that the approach in place aims to optimise the resources available. However, the team leader of the primary production area acknowledged that, based on the current state of implementation of projects, it is more likely to identify systematic deficiencies and to improve the sector for pesticides, whereas this is not possible for microbiological risks. Table: FNAO Primary producers (PP) in the scope of this audit Year No of FNAO Projects / No of Inspection Planned No of Inspection PP Performed 2017 2,074 Strawberries and Lettuce ­ Open ground / 30 24 (a*) 91 (b*) 2018 1,938 Soft fruits and Vegetables ­ Greenhouses /150 69 (c*) 0 (d*) 2019 2,102 RTE Crops ­ Open ground /100 2020 2,136 Soft-fruits and Leafy Green Vegetables / 40 * See point 62 below. 13

The CCA informed the audit team that: a) in 2017, for this project, 80% of implementation. Half of the inspected PP were PQS certified and there were no significant differences in the outcome of the inspections; b) in 2018, implementation stopped at 60% mainly due to other priorities related to official controls and difficulties in having the selected FBO with the targeted crop at the time of the inspection; c) in 2019, only 19 crops posing particular risks out of 69 inspected fell within the scope of this audit (implementation drop to 19%), mainly due to difficulties in having the selected FBO with the targeted crop at the time of the inspection; d) in 2020, no inspections were carried out due to the Covid-19 pandemic.

In primary production, the system of official controls covers both chemical (PPP) and microbiological risks, with greater attention being given to the former. As a result, the likelihood of detecting non-compliances with microbiological requirements is lower. In addition, non-compliances detected during the controls are not considered for future planning. This could lead to associated food safety risks being underestimated, weakening the system of official controls and thus the enforcement of EU legislation in this area. 5.2.4 Implementation of official controls over FBO obligations Legal requirements Articles 9(1)(d), 14 and 44(1) of Regulation (EU) 2017/625. Articles 4 to 8, and Annexes I and II to Regulation (EC) No 852/2004, Article 18 of Regulation (EC) No 178/2002, Article 3 of Commission Implementing Regulation (EU) No 208/2013, Commission Implementing Regulation (EU) 2019/628, Article 1 and Annex I to Commission Regulation (EC) No 2073/2005. Findings

The inspectors interviewed confirmed to the audit team that official controls are implemented at the primary producers in the scope of the specific project. However, the driving force to perform inspections is still pesticides residues; microbiological risks could also be part of the inspections.

Inspectors informed the audit team that due to time constraints the specific checklist (see paragraph 63) is not used systematically. The assessments of hygiene requirements can also differ, depending on the experience and on the knowledge that an inspector may have of an FBO. Thus, official controls are not systematically carried out in a coherent and uniform way, so are not effectively targeting microbiological risks.

When non-compliances were identified, corrective actions were systematically required but evidence of follow-up was not systematically available. Moreover, inspectors confirmed that non-compliances are not yet taken into account for future planning.

Generally, checklists were not part of the reports and were not stored / archived. Therefore, the traceability of the official controls depended on what was noted in the report, where usually, only non-compliances were recorded. Aspects related to PPP were well described and supported by solid evidence in the reports, which was not the case for microbiological risks related issues. Sprout-producing establishments

Regarding primary production, official controls are not consistently implemented. When implemented, the official controls partially targeted microbiological risks and are focusing mainly on chemical risks (PPP). This is not in line with Article 9(1) of Regulation (EU) 2017/625.

In addition, the specific checklist for microbiological inspections at primary production is not systematically used and when used not always documented, thus official controls are not carried out in a coherent and uniform way and are not effectively targeting microbiological risks.

Member state response

number of inspections on management of microbiological risks at primary production sites will be performed, most of them aimed at production of soft berries that are intended to be eaten raw. A small number of inspection will be focused on other products intended to be eaten raw like lettuce. For all inspections a separated checklist will be used. Enforcement will take place as prescribed in the specific enforcement guide line. The inspections will have as second focus chemical risks, for this subject a different checklist will be used, neral the NVWA is evaluating the way prioritizing of inspections on microbiological risks at grower is organized at the moment. An analysis to be discussed at management level is foreseen to be ning 2022. This may lead to better implementation of inspections in this field. Apart from that the scientific department of the NVWA is preparing a food safety risk assessment of food crops, the scope will also include products intended to be eaten raw. Publication is foreseen in 2022. The outcome of this assessment will be used to improve surveillance and enforcement where necessary following the publication f the Netherlands to the recommendations of repor

The recommendation states as its basis

Guideline 85 contains provisions for "small" sprout-producing establishments (with a production of less than 50 tonnes per year). In this case, and contrary to the establish requirements the guideline allows FBOs to reduce by half the minimum sampling frequency established in Chapter 3, Section 3.3, Part A of Regulation (EC) No 2073/2005. Conclusions on relevant national legislation and guidelines

However, NVWA Guideline 85 allows the reduction of the final product sampling frequency in sprout-producing establishments classified as small and therefore the minimum sampling frequency established in Regulation (EC) No 2073/2005 is not ensured.

An inspector informed the audit team that they are in the process of evaluating, according to NVWA Guideline 85, the request of a small sprout-producing establishment for a frequency reduction in the final product analyses.

The CCA informed the audit team that based on NVWA Guideline 85, they have already granted the permission to 1 out of the 8 sprout producers, to reduce the frequency of sampling final products. Processing Plants

A reduction in the sampling frequency on the final product in sprout-producing establishments has been granted by the CCA to FBOs in accordance with their Guideline 85. This is not in line with EU legislation.

Member state response

deline 85 will be changed according to the recommendation (i.e. retract possibility to use lowered g frequency) at the next revision in 2021. Food businesses involved will be notified of this Page: 2 f the Netherlands to the recommendations of report ref. DG(SANTE) 2021-7176 of the audit carried out from 2 to 11 tem of official controls relating to microbial safety of food of non-animal origin

The recommendation states as its basis

Regarding controls at sprout-producing establishments, the checklists used were the same as those used for processors of FNAO (which are also the same as those used for food of animal origin). Not all elements related to the specific legislation for sprouts were included 17 (i.e. import certificate requirements are not indicated). The inspectors confirmed that such a generic checklist could not provide guidance to inspectors during official controls at sprout-producing establishments.

In the reports examined by the audit team, as well as in the summary of non-compliances provided by the CCA, there was no evidence of non-compliances having been identified during official controls related to import certificates of seeds for sprouting.

When reviewing the outcome of official controls of sprout-producing establishments, the audit team noted that evidence of what was checked during official controls, regarding import certificates of seeds for sprouting imported from third countries, was rarely traceable.

The inspectors confirmed that the generic checklist that was in use up until the end of 2020, made it difficult to provide evidence of official controls over import certificates of seeds for sprouting controls.

The inspectors confirmed to the audit team that a specific checklist is now in place (since the start of 2021), which includes all of the specific requirements of the EU legislation for sprouts and seeds for sprouting. This checklist was assessed as satisfactory by the audit team.

However, shortcomings in the use of this new checklist were observed, mainly related to the fact that inspectors limited the assessment of compliance to the import certificates requirement based on the statement of FBOs, instead of seeking evidence (i.e. presence of the import certificate).

In one case, the audit team observed that the import certificate requirements for mung bean had been assessed as satisfactory without having had the certificate available. The team leader inspector (CA) informed the audit team that this was his usual method, but in the 18 future he will ensure to check for the physical presence of the certificate and its compliance with EU legislation.

Furthermore, at the request of the audit team, the CA requested the certificate from the operator. The operator was unable to provide it by the end of this audit.

Whilst the official controls relating to sprout-producing establishments identify regularly non compliances and did not adequately cover the legal requirements of import certificate for seeds from third countries, which could result in contaminated product being placed on the market.

The CA has procedures, instructions and checklists that enable the CAs to perform official controls of FNAO establishments and for establishments seeking approval, in a uniform fashion. However, the generic checklists in use up until the end of 2020 for sprout-producing establishments, in conjunction with the fact that in primary production the checklist was not systematically used, prevent inspectors from carrying out official controls in a consistent manner.

Member state response

As stated in findings 67 and 94 since 2021 a new checklist is in place which includes all of the specific irements for sprouts and seeds for sprouting. This checklist will be amended for inspections arting January 2022 onwards to ascertain that the inspectors has seen the presence of the import tificate. age: 3 f the Netherlands to the recommendations of report ref. DG(SANTE) 2021-7176 of the audit carried out from 2 to 11 tem of official controls relating to microbial safety of food of non-animal origin

The recommendation states as its basis

The CCA informed the audit team that supervision activities of inspectors, including on- the-spot visit of FBOs, could be carried out yearly by a senior inspector (team leader) if the capacity allows. However, there are no procedures or instructions in place for these supervisory activities. In addition, no records are kept of these activities so there is no evidence available of whether results are taken into account or how they are used in order to improve the system of official controls.

The CCA acknowledge that an effective system of verification on-the-spot of the implementation of training, procedures, instructions and use of checklists could improve the entire system of official controls. For example, if such a mechanism of supervision was in place, the CCA could have identified deficiencies in the controls of import 8 certificate requirements (see paragraphs 88, 93, 95 and 96) and consistency in the use of specific checklists during official controls on primary production (see paragraph 84), and could have corrected them in a timely manner.

The fact that the system of supervision in place does not include documented on-site verifications of inspectors affects the CAs' capability to assess the appropriateness and consistency of inspections, and to identify any shortcomings in their performance. 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 Registration of primary producers of FNAO

However, shortcomings in the use of checklists at primary production and at sprout- producing establishments were observed by the audit team. These deficiencies were identified by the audit team and brought to the attention of the CCA which acknowledged 23 that the current procedures in place for supervision (overseeing of inspections), which are based only on desk studies and training activities, do not allow for the identification of such shortcomings (see paragraphs 29, 30, 31, 32 and 34).

There are no mechanisms in place that can effectively identify, and correct, shortcomings of the official control system, in a timely manner. This affects the CAs' capability to assess the effectiveness and appropriateness of inspections, and to identify any shortcomings in their performance.

Member state response

the Netherlands there are several mechanisms in place to ensure that inspections at primary roduction sites are performed in an uniform way. In these mechanisms different roles for different ctors within the NVWA and their interactions are defined. In the case of the inspectors, the `domain pecialist `have a pivotal role. They are the ones that instruct their colleagues in a certain field if ecessary and they are consulted by them in the case of legal interpretation matters. If necessary the omain specialists will coach the other inspectors real time and accompany them on to field nspections. In the near future the domain specialist will also do random quality checks on inspections rmed by their colleagues. The implementation has already been started in parts of the rganization and will be completed for the whole organization end of 2021 he expertise department is amongst other things responsible for designing the inspection checklist and he instructions that inspectors work with. It will also design the yearly inspection program. There is a our weekly meeting between the expertise inspectors and the domain specialists where they discuss atters like upcoming projects and the way th

The recommendation states as its basis

The sampling carried out as part of the sampling projects at retail level, is carried out anonymously, thus preventing the FBO from exercising her/his right to a counter sample 20 for the purposes of obtaining a second expert opinion. In the case of positive results, the CA requires the FBO to take measures to ensure food safety.

The anonymous sampling procedure in cases of sampling projects, does not fully respect the right of the FBO to a second expert opinion, which is not in line with Article 35 of Regulation (EU) 2017/625. 5.2.6 Laboratory performance Legal requirements Articles 5(1)(d), 34 to 42, 100 and 101 of Regulation (EU) 2017/625. 21 Findings

Member state response

ymous sampling was introduced for sampling at retail level as a result of an agreement with sector representatives to limit the frequency of official controls, i.e. limit the time burden for each additional sampling at a single retail store/format. This has not resulted in opposition by food businesses as in many cases a second sample will yield a different result (the presence of harmful micro-organisms is in most cases not evenly distributed), and therefore the outcome of expected actions will not differ if there is a difference in result between samples taken by the competent authority or taken/analyzed by the food business operator. This exception is also taken up in consideration #48 of Regulation (EU) 17/625: "Operators ... have the right to ... a second analysis ... unless any such second analysis, test or diagnosis is ... irrelevant. Such would be the case, in particular, where the prevalence of the hazard cularly low in the animal or good or its distribution particularly sparse or irregular for the purpose of assessing the presence of quarantine organisms or, as the case may be, for performing a microbiological analysis.". We conclude the exception applies here. However, g

The recommendation states as its basis

The CAs responsible for the official control system over the production of milk and dairy products are clearly designated and their structure and organisation are adequate for the performance of their tasks. An exception, requiring legislative amendments, is the delegation given to private veterinarians to perform official controls in dairy holdings related to hygiene, for whom no provisions are in place to exclude potential conflicts of interest.

Member state response

In the designation Decree that the Ministry of Health, Welfare and Sport had initially published in December 2019, the veterinarians were designated for the provisions of Article 49 of Commission Implementing Regulation (EU) 2019/627. Paragraph 4 of that article states the checks in the field of hygiene measures during, among other things, refrigerated storage, transport and processing. These are tasks that COKZ performs. The auditors therefore rightly concluded that there was an overlap between the tasks of the designated veterinarian and the COKZ and, moreover, that the private veterinarians are also not qualified for these checks. This omission has since been remedied because the Ministry of Health, Welfare and Sport has officially published a revised designation Decree in the Staatscourant of 12 November, 2021. In this revised designation Decree, the veterinarians are only designated for the activities under Article 49, paragraphs 1 and 3. Link to designation Decree: https://zoek.officielebekendmakingen.nl/stcrt-2021- 46139.html

The recommendation states as its basis

Following an application for approval, the COKZ registers the undertaking and starts the approval procedure. An initial on-site assessment is performed by COKZ personnel, 8 following which a conditional approval may be granted for 3 months; an extension of the conditional approval for further 3 months may be considered if significant progress has been made in meeting the requirements, but shortcomings have still been identified. The decision on approval is made by COKZ on behalf of the Minister of the VWS. In some cases (i.e. registered processors seeking approval, when processes and documentation are already well established) a final approval can be granted immediately. Approved FBOs are entered in the Synergy database, managed by COKZ, which contains contact details and other basic information of FBOs; only the FBOs inspected by COKZ are identified as such in Synergy. COKZ updates these lists around every three months. The CCA stated that at least twice a year there is a NVWA-COKZ consultation/meeting regarding the update of these lists. However, not all FBOs are inspected annually, and not all items relevant for verifying compliance with regulatory requirements are checked during an inspection. This shortcoming was also identified by NVWA audits of COKZ in 2018 and 2020 (see paragraph 105).

The approvals are granted for generic dairy processing activity. The lack of additional information on the type of products manufactured and processing makes the CAs verification of possible changes that may have occurred, regarding e.g. the equipment and production lines, challenging, although such changes might require approval by the CA (see paragraph 29). And while COKZ stated that inspection reports identify processes and products manufactured, these were not always clearly identified in the reports seen by the audit team: the inspection reports and Sinergy record activities and product groups.

COKZ stated that in case of changes in location or ownership, as well as when major changes in structures, equipment and products occur, the approval must be revised and possibly amended. When reviewing some approval files, the audit team noted that this systematic approach had not been consistently adhered to. Several FBOs had not timely informed COKZ about relevant changes, either planned or implemented. These changes were only assessed at the time of the following routine inspection. In such cases, no supporting documentation was available in order to demonstrate that the approval file had been scrutinised before granting the approval (i.e. updated blueprints, descriptions of modified equipment, production lines, procedures, etc.).

Nearly all raw milk in the country is collected by 36 operators, which were all registered by the COKZ until 2020. In 2020, the COKZ requested such operators with storage facilities to apply for approval as milk collection centres, in line with the requirements of Regulation (EC) No 853/2004. Four FBOs applied, of which one was approved in 2020, one received a conditional approval in September 2021 and one is still active without an approval. The fourth contacted operator did not need a specific approval because it is using the storage facilities of another operator.

One of the milk collection centres moved to new premises in 2021 and had applied for an approval, which was granted one month after the inspection by the COKZ official as a final approval. No information was collected by COKZ to ascertain that no activities related to storage of milk had been carried out in the interim period, taking into account the same activity carried out by the FBO at its previous location (collection and storage of raw milk to deliver milk in specific quantities and quality according to client specifications).

The audit team noted that the validity of conditional approval is generally extended to the maximum of 6 months without a follow-up inspection being carried out at the end of the first 3-month period, as required by Article 148(4) of Regulation (EU) 2017/625. In some cases, the conditional approval of the FBO was retained for more than 6 months (in one case for 18 months).

Visits by COKZ inspectors on FBOs seeking approval were documented. However, the inspection reports did not mention this specific scope of the inspection, nor the final assessment of the inspector in relation to the approval.

The implementation of the system in place for approval of FBOs does not provide guarantees that all food businesses eligible for/requiring approval are provided with a valid approval, that the activities carried out are correctly covered by the approval, nor 10 that FBOs comply in full with regulatory requirements. In addition, no documented evidence was available as proof of a regular review of approvals.

Member state response

KZ will review the procedure (INS-003, Process description assessment of dairy ings in context of the Hygiene package and animal by-products) with regard to provals in accordance with Article 148 of Regulation (EU) 2017/625. The adjustment of this procedure has already been started, with an end date foreseen in ptember 2022. In addition, COKZ will develop an assurance system to ensure timely assessment in case of a conditional approval. This system will also include holdings that did not receive Page: 1 ted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2021- October 2021 in order to evaluate the official controls related to the safety of milk and dairy uthority tion activities take place as mentioned in Regulation hnical adjustment of the systems that is intended to be f 2022. /06/2022 (ref. Ares(2022)4109255): 03, Process description assessment of dairy package and animal by-products) with regard to le 148 of Regulation (EU) 2017/625. The reviewed tached in which the changes can be found in article granting conditional approval, has also been amended rk instruction will be written which will specifically and withdrawal of approvals. Associate

The recommendation states as its basis

In case of non-compliances graded C, a warning is issued, referring to the deadlines for their correction as indicated in the inspection report. The audit team noted that the cover letters accompanying the written warnings and inspection reports delivered to the FBOs were sometimes issued up to 3 months following the inspection, when the deadlines agreed with the FBO at the time of the inspection for corrective actions had already elapsed. Follow-up on-site verifications were generally carried out at the time of the next planned inspection, without taking into account the deadlines previously agreed. No documentation on corrective actions planned or implemented by the FBOs was requested by the inspectors to enable an administrative/documentary follow-up, in cases where it was not possible to carry out an on-the-spot verification. This has been a systemic deficiency in the COKZ control system, which was also detected at the time of the NVWA audits in 2018 and 2020 (see paragraph 105).

The audit team noted that the inspectors used mostly D categorisation of non-compliances (minor shortcomings), although in some cases seen the shortcomings should have been categorised as C. For instance, in one case the FBO did not have a procedure in place to verify the effectiveness of the heat treatment and did not carry out any testing for alkaline phosphatase or microbiology in final products; this was considered as a D non- compliance. As a consequence of this categorisation, no follow-up visit was carried out 17 within the next 3 months to ensure the shortcoming had been rectified. In another case, a shortcoming was categorised twice as C (serious), however it should have already been escalated as it was a repeated non-compliance.

The audit team screened the reports of several FBOs and noted delays, sometimes significant and up to 3 months from the date of the inspection, in the delivery of reports and written warnings. This shortcoming had also been noted at the time of the NVWA audit on COKZ in 2018, and led to a specific recommendation (see paragraph 105). 5.6.2 Official controls at establishment level

The system of official controls covers the entire dairy sector and is based on procedures and instructions aimed at ensuring consistency and uniformity of official controls. However, the assurance that that operators comply with national and EU provisions, and that non-compliances are timely corrected and appropriately followed-up is undermined by the delays in their implementation.

Member state response

COKZ will adjust the relevant procedure (INS-003, Process description assessment of dairy holdings in context of the Hygiene package and animal by-products). A re- inspection must be performed within three months after the original inspection. Shortcomings must be communicated immediately at the end of the inspection. Inspectors will be instructed about this before September 2022. In order to be able to monitor timely performance of the re-inspections, the assurance system will be further developed. The adjustment of the mentioned procedure has already been started, with an end date set at September 2022. By that time the assurance system will also be ready to monitor the relevant processes. In addition to the procedure and monitoring of timely execution of reassessments, this recommendation is also related to the availability of sufficient staff capacity. COKZ will pay attention to this issue. Page: 6 ted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2021- October 2021 in order to evaluate the official controls related to the safety of milk and dairy uthority ion to the correct application of the official th non-conformities. /06/2022 (ref. A

The recommendation states as its basis

Following an application for approval, the COKZ registers the undertaking and starts the approval procedure. An initial on-site assessment is performed by COKZ personnel, 8 following which a conditional approval may be granted for 3 months; an extension of the conditional approval for further 3 months may be considered if significant progress has been made in meeting the requirements, but shortcomings have still been identified. The decision on approval is made by COKZ on behalf of the Minister of the VWS. In some cases (i.e. registered processors seeking approval, when processes and documentation are already well established) a final approval can be granted immediately. Approved FBOs are entered in the Synergy database, managed by COKZ, which contains contact details and other basic information of FBOs; only the FBOs inspected by COKZ are identified as such in Synergy. COKZ updates these lists around every three months. The CCA stated that at least twice a year there is a NVWA-COKZ consultation/meeting regarding the update of these lists. However, not all FBOs are inspected annually, and not all items relevant for verifying compliance with regulatory requirements are checked during an inspection. This shortcoming was also identified by NVWA audits of COKZ in 2018 and 2020 (see paragraph 105).

The approvals are granted for generic dairy processing activity. The lack of additional information on the type of products manufactured and processing makes the CAs verification of possible changes that may have occurred, regarding e.g. the equipment and production lines, challenging, although such changes might require approval by the CA (see paragraph 29). And while COKZ stated that inspection reports identify processes and products manufactured, these were not always clearly identified in the reports seen by the audit team: the inspection reports and Sinergy record activities and product groups.

COKZ stated that in case of changes in location or ownership, as well as when major changes in structures, equipment and products occur, the approval must be revised and possibly amended. When reviewing some approval files, the audit team noted that this systematic approach had not been consistently adhered to. Several FBOs had not timely informed COKZ about relevant changes, either planned or implemented. These changes were only assessed at the time of the following routine inspection. In such cases, no supporting documentation was available in order to demonstrate that the approval file had been scrutinised before granting the approval (i.e. updated blueprints, descriptions of modified equipment, production lines, procedures, etc.).

Nearly all raw milk in the country is collected by 36 operators, which were all registered by the COKZ until 2020. In 2020, the COKZ requested such operators with storage facilities to apply for approval as milk collection centres, in line with the requirements of Regulation (EC) No 853/2004. Four FBOs applied, of which one was approved in 2020, one received a conditional approval in September 2021 and one is still active without an approval. The fourth contacted operator did not need a specific approval because it is using the storage facilities of another operator.

One of the milk collection centres moved to new premises in 2021 and had applied for an approval, which was granted one month after the inspection by the COKZ official as a final approval. No information was collected by COKZ to ascertain that no activities related to storage of milk had been carried out in the interim period, taking into account the same activity carried out by the FBO at its previous location (collection and storage of raw milk to deliver milk in specific quantities and quality according to client specifications).

The audit team noted that the validity of conditional approval is generally extended to the maximum of 6 months without a follow-up inspection being carried out at the end of the first 3-month period, as required by Article 148(4) of Regulation (EU) 2017/625. In some cases, the conditional approval of the FBO was retained for more than 6 months (in one case for 18 months).

Visits by COKZ inspectors on FBOs seeking approval were documented. However, the inspection reports did not mention this specific scope of the inspection, nor the final assessment of the inspector in relation to the approval.

The implementation of the system in place for approval of FBOs does not provide guarantees that all food businesses eligible for/requiring approval are provided with a valid approval, that the activities carried out are correctly covered by the approval, nor 10 that FBOs comply in full with regulatory requirements. In addition, no documented evidence was available as proof of a regular review of approvals.

In case of non-compliances graded C, a warning is issued, referring to the deadlines for their correction as indicated in the inspection report. The audit team noted that the cover letters accompanying the written warnings and inspection reports delivered to the FBOs were sometimes issued up to 3 months following the inspection, when the deadlines agreed with the FBO at the time of the inspection for corrective actions had already elapsed. Follow-up on-site verifications were generally carried out at the time of the next planned inspection, without taking into account the deadlines previously agreed. No documentation on corrective actions planned or implemented by the FBOs was requested by the inspectors to enable an administrative/documentary follow-up, in cases where it was not possible to carry out an on-the-spot verification. This has been a systemic deficiency in the COKZ control system, which was also detected at the time of the NVWA audits in 2018 and 2020 (see paragraph 105).

The audit team noted that the inspectors used mostly D categorisation of non-compliances (minor shortcomings), although in some cases seen the shortcomings should have been categorised as C. For instance, in one case the FBO did not have a procedure in place to verify the effectiveness of the heat treatment and did not carry out any testing for alkaline phosphatase or microbiology in final products; this was considered as a D non- compliance. As a consequence of this categorisation, no follow-up visit was carried out 17 within the next 3 months to ensure the shortcoming had been rectified. In another case, a shortcoming was categorised twice as C (serious), however it should have already been escalated as it was a repeated non-compliance.

The audit team screened the reports of several FBOs and noted delays, sometimes significant and up to 3 months from the date of the inspection, in the delivery of reports and written warnings. This shortcoming had also been noted at the time of the NVWA audit on COKZ in 2018, and led to a specific recommendation (see paragraph 105). 5.6.2 Official controls at establishment level

The system of official controls covers the entire dairy sector and is based on procedures and instructions aimed at ensuring consistency and uniformity of official controls. However, the assurance that that operators comply with national and EU provisions, and that non-compliances are timely corrected and appropriately followed-up is undermined by the delays in their implementation.

Member state response

This recommendation consists of two aspects. First, it concerns measures to be taken to ensure all tasks delegated to COKZ are performed properly. This concerns a proper overview of delegated activities and associated working agreements but also a systematic approach of NVWA audits. Secondly, NVWA must take measures with regard to the follow-up by COKZ on shortcomings identified during NVWA audits. For the latter aspect, reference is made to Recommendation 6. , The NVWA and COKZ plan activities on the basis of a formal Cooperation Agreement, annual target letter from NVWA and annual work programme from COKZ. In addition, a set of ongoing working agreements has been made. In 2022, the system in which the activities and working agreements are organized, as well as current projects for improvement and development, will be evaluated and improved. The NVWA performs annual audits of COKZ to test the performance of the delegated tasks, in line with the requirements of Article 33(a) of the OCR; this is also laid down in the Working Agreement between NVWA and COKZ. To assure a complete coverage of all tasks delegated to COKZ in the NVWA audits, NVWA will set up a multi-year audit program wh

The recommendation states as its basis

The CAs responsible for the official control system over the production of milk and dairy products are clearly designated and their structure and organisation are adequate for the performance of their tasks. An exception, requiring legislative amendments, is the delegation given to private veterinarians to perform official controls in dairy holdings related to hygiene, for whom no provisions are in place to exclude potential conflicts of interest.

Member state response

The veterinarians affiliated to SGD play a key role in ensuring that only milk from healthy animals is supplied. The independence of veterinarians is an important point of attention in the law and official regulations and in the other regulations by which the activities of veterinarians are safeguarded in practice. Assurance that veterinarians act free of conflict of interest in the performance of their official duties is therefore guaranteed by a combination of measures: 1. A veterinarian may only practice veterinary medicine if he/she is registered in the veterinary medicine register (Article 4.3 of the Animals Act). Independence of these veterinarians is guaranteed by the fact that they have a duty of care as included in Animals Act. Veterinarians can be held liable for non-compliance with this duty of care by way of disciplinary law. 2. Affiliation of veterinarians to an independent private assurance system, like SGD, also contributes to their independent position. Affiliation to such a system is an important Page: 13 ted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2021- October 2021 in order to evaluate the official controls related to

The recommendation states as its basis

The NVWA performs annual audits at COKZ to test the performance of the delegated tasks, in line with the requirements of Article 33(a) of the OCR; this is also laid down in the Working Agreement between NVWA and COKZ. Three NVWA audits to COKZ were carried out in the period 2018-2020: the audits in 2018 and 2019 have been completed, whilst the 2020 audit was performed as a remote assessment of the follow-up of audit recommendations made in the 2018 and 2019 reports, due to the restrictions caused by the COVID-19 pandemic. The report of 2018 made 16 recommendations to COKZ, among which the following are considered relevant for the sector being audited: · re-inspections to be timely carried out in cases of non-compliances; · in case of serious infringements, identification of the correct legal basis should be included in the inspection report. The 2019 report followed-up the recommendations and guidance of the 2018 audit, and concluded that several recommendations had not been adequately addressed (including those mentioned above), and made the following additional recommendations: 24 · documentation on traceability to be checked during inspections; · sampling procedures to be brought in line with those of the national legislation, with inspectors being trained on these procedures; · temperature monitoring equipment for transport being checked for operation, use and maintenance. The 2020 report concluded that 25 out of the 27 recommendations of the 2019 report were addressed satisfactorily, with the exception of the following two: · recommendations from the NVWA audit report should be adequately addressed within reasonable deadlines; · to extend sampling to cases of non-compliances in accordance with existing procedures.

The audit team noted that the conclusions of the follow-up of the previous NVWA audits were in contrast with the finding of the DG Health and Food Safety audit as the recommendations of the previous NVWA audits were although the effectiveness of the measures adopted by COKZ had not been fully comprehensive. Moreover, serious non- compliances with regard to approval procedures were not taken into account.

Audits on delegated authorities are performed regularly, although not sufficiently in identifying all relevant shortcomings and enforcing the correction of the ones identified, as the recommendations of the audit reports had not or not comprehensively been addressed and followed-up.

Member state response

ring the last NVWA audit of COKZ, conducted in November 2021 (shortly after the HFAA audit in the Netherlands in October), an improved method was already applied. Since the 2021 audit, actions needed to remedy shortcomings must be submitted by COKZ within a maximum of 3 months (or earlier in the case of serious shortcomings). When assessing improvement measures, the NVWA explicitly checks whether a cause analysis has been performed, the extent of the shortcoming has been established, and whether the measures taken are appropriate and have been carried out or are planned Page: 15 ted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2021- October 2021 in order to evaluate the official controls related to the safety of milk and dairy uthority . The audit report is only closed once the measures e NVWA auditors assessed the progress of the to recommendations from the 2019 audit as well ns from the 2018 audit. The NVWA concluded s and improvement measures were implemented, which ent in the reported shortcomings. All audits have thus been followed up, assessed /06/2022 (ref. Ares(2022)4109255): 1, is still ongoing and is carried out within the agreed se

The recommendation states as its basis

The Control Body delivering egg marketing inspection has systematically verified and enforced the labelling of eggs with the correct farming system providing high confidence in the controls of the only compulsory EU-wide labelling scheme for animal welfare.

The NVWA has not assessed the effectiveness and appropriateness of their official controls at some stages of production (i.e. breeders, pullets, day-old chicks) and has not conducted any internal audits of the official controls on laying hens. They do not know whether the current controls are effective (i.e. they achieve results) to ensure compliance with animal welfare requirements nor whether they are suitable for this.

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

The MANCP categorizes laying hen establishments among the high risk group for non-compliance, identifying overcrowding and the failure to provide the necessary facilities as the most likely non-compliances. The project delivered in 2017 addressed this risk, as did the project undertaken by the COKZ to set official capacity limits for each laying hen establishment. The NVWA has not subsequently carried out regular and proactive controls to verify compliance with stocking levels and the availability of suitable facilities on these establishments. This is not in line with Article 110(1) read in conjunction with Article 9 of the OCR and with the rules provided for in Articles 18 to 27.16

The SKAL carries out annual inspections of organic farms. While the scope of these inspections does not specifically include animal welfare requirements, they do cover the assessment of stocking density, maximum 17In the response to the draft report the Competent Authority commented that COKZ also checks stocking density and may impose a penalty if the provisions of Annex II to Regulation (EC) 589/2008 (in conjunction with Directive 1999/74/EC and any additional national legislation) are not being complied with. 12 number of hens per house, provision of furniture and litter, verification of the beak trimming ban and access to open-air runs. On the other hand, organic farms are not subject to the comprehensive and systematic measurements completed by the COKZ. Implementation of the Official Control Plan The NVWA has 25. The verification of compliance with welfare rules on laying hens farms is performed a low organized in projects conducted every 5 years or so (the last was completed in 2017 and the next is due in 2022). The project completed in 2017 did number of not allow the drawing of conclusions on the compliance of the sector as a welfare whole and excluded pullets, breeders and day-old chicks. inspections, 26. The NVWA did not plan in advance the number and distribution of controls which do not at farms operating different farming systems. It has performed a very low cover all the number of inspections between projects (22 in 2018, 7 in 2019 and 1 in relevant stages 2020), mainly in response to notifications. The few proactive inspections of production do not cover hatcheries or rearing and breeding establishments and they are and farming not conducted regularly in some farming systems (e.g. cage and organic). systems. The verification 27. Where the NVWA identifies non-compliances, it takes action to determine procedures have the origin and extent of the non-compliance and, if necessary, imposes measures on the party concerned. overlooked the need for 28. There are no defined objectives/targets in relation to the number of proactive inspections. The verification of the implementation of the amending the controls relies on the adequacy of the instructions and the delivery of the controls. Although the COKZ instructions states that the wintergarden may be included in the determination of the usable area if it is permanent accessible, it added that, in practice, this means through the daylight period. As the open-air runs requires continuous daylight access, this 13 instructions for imply that verandas would be considered usable area by defect as reflected inspections. in the COKZ checklist. This interpretation may lead to overstocking situations at night. The verification of the 29. The verification of the effectiveness of the enforcement strategy mainly relies on the projects performed every 5 years. The most recent project effectiveness of (2017) identified non-compliances in around the 5% of the inspected the control plan establishments. The characteristics of the sample (i.e. 45 inspections randomly selected) were insufficient for drawing conclusions for the whole is limited. sector. The cross-compliance checks provide a moderate supplementation to that verification. Animal welfare indicators in laying hens are not used for the verification of the effectiveness of the controls. Analysis of results and internal audits The use of the 30. The low number of official controls delivered on the welfare of the laying analysis of the hens has not allowed the NVWA to take account of their outcome for the results from the review of the MANCP. The NVWA has scheduled a project for assessing official controls the level of compliance in the sector for 2022. for improving those controls is 31. The NVWA has not carried out internal audits covering the official controls in the scope of this audit. In 2020, the NVWA conducted a study on fraud limited and in eggs, which included recommendations for strengthening the labelling internal audi

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

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

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

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

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

The recommendation states as its basis

The Control Body delivering egg marketing inspection has systematically verified and enforced the labelling of eggs with the correct farming system providing high confidence in the controls of the only compulsory EU-wide labelling scheme for animal welfare.

The NVWA has not carried out or planned any inspection to check the the OCR. welfare of day-old chicks, pullets or layer breeders. The Article 21(1) of the Official Controls Regulation (OCR) requires official controls to verify The NVWA the welfare requirements for animals at all relevant stages of production verified and while the NVWA's inspections at approved hatcheries, rearing and enforced the breeding establishments do not cover the verification of compliance with the welfare legislation (specifically, the requirements established in ban on Directive 98/58/EC)13. unenriched

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

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

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

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

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

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

The recommendation states as its basis

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

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

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

The 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

In 2019, a turkey holding that had a positive test result in one house had tested twice more all houses, prior to sending them to slaughter, with those subsequent tests giving negative results. The operator informed that: All the Salmonella test results were sent to the slaughterhouse; and that the turkeys from the house with the initial positive result had been correctly registered as Salmonella positive in the food chain information form, even with two subsequent negative results.

The gap in the NVWA certification system concerning the Salmonella status of a flock had little to no impact in the possible spread of Salmonella. This due to the very low number of incorrect certificates and the correct reporting in the food chain information.

Member state response

From July 2021, the official veterinarians who issue health ertificates for Intra-Community trade will check the Salmonella ols status of a flock, based on the Salmonella monitoring test results with that are registered in the database KIPnet. This check ensures that the information of the official Salmonella controls is used when issuing certificates, in compliance with Article 88, 3 (C) of Regulation (EU) 2017/625. After summer another check will be added to ensure that the accurate Salmonella monitoring test results are used for the certification. During the pre-screening of the export applications, the Salmonella monitoring test results of the flock will be directly consulted in the database KIPnet. On the day of certification the official veterinarians will do a second check on the accurate Salmonella status of the flocks, based on the Salmonella monitoring test results.

The recommendation states as its basis

The audit team saw documented evidence of both NVWA and COKZ activities demonstrating that those are in line with EU requirements with two exceptions: 15 The national legislation and SNCP related instructions only require the NVWA to impose restrictive measures (in particular a ban on marketing of eggs) after confirmation of targeted Salmonella serovars. Therefore, a ban on the marketing of eggs is not imposed during the period when the positive Salmonella spp. results are already available and the flock should be considered suspect of being infected. This is not in line with Part D 2. of Annex II to Regulation 2160/2003. The timeframe between date of sampling and the date of reception of positive result for a targeted Salmonella serovar can range from 4-5 to 14 days which, depending on the size of the infected flock(s), can correspond to a few thousand eggs or as much as several hundred thousand; which is compounded by the fact that COKZ imposes restrictive measures on the eggs at holdings from the date of the test result of the targeted Salmonella serovar instead of from the date of the sampling. This meant that any eggs laid after the date of sampling and until the date of the test result were not blocked, nor recalled, from the market and could be sold as Class A eggs. This is not in line with Part D 2. of Annex II to Regulation 2160/2003.

The system in place provides guarantees that correct measures are taken when a laying hen flock is positive for a targeted Salmonella serovar. Measures taken on eggs after positive results are in general acceptable, but adopted with unnecessary delay (after serotyping). Additionally, the lack of clarity in one aspect of the delegation of control tasks to COKZ meant that there are no restrictions to placing on the market possibly contaminated eggs produced between the date of sampling and the date of reception of positive results, nor is recalling imposed. Therefore, the risk of Salmonella being spread from eggs to consumers is not fully mitigated. 17

Member state response

re Poultry farmers and laboratories will be obliged to report the detection of Salmonella spp. by automatic alert in the database KIPnet shortly. In the meantime notification will be done by email to the NVWA. In response the flock is declared suspected from the moment the samples were taken and all eggs produced thereafter, including those at the packing station, are blocked. If no target serotype is found, there is no longer a suspicion as mentioned in Part D (2), Annex II to Regulation (EC) No 2160/2003 and the restrictions will be lifted. If a target serotype is found, the flock is declared infected and measures will be applied in line with Part D (2 and 3), Annex II to Regulation (EC) No 2160/2003. Page: 1 y 2021 ations of report ref. DG(SANTE) 2021-7320 of the audit carried out from 15 Control programmes in particular poultry populations Action Proposed by the competent authority

The recommendation states as its basis

The audit team saw documented evidence of both NVWA and COKZ activities demonstrating that those are in line with EU requirements with two exceptions: 15 The national legislation and SNCP related instructions only require the NVWA to impose restrictive measures (in particular a ban on marketing of eggs) after confirmation of targeted Salmonella serovars. Therefore, a ban on the marketing of eggs is not imposed during the period when the positive Salmonella spp. results are already available and the flock should be considered suspect of being infected. This is not in line with Part D 2. of Annex II to Regulation 2160/2003. The timeframe between date of sampling and the date of reception of positive result for a targeted Salmonella serovar can range from 4-5 to 14 days which, depending on the size of the infected flock(s), can correspond to a few thousand eggs or as much as several hundred thousand; which is compounded by the fact that COKZ imposes restrictive measures on the eggs at holdings from the date of the test result of the targeted Salmonella serovar instead of from the date of the sampling. This meant that any eggs laid after the date of sampling and until the date of the test result were not blocked, nor recalled, from the market and could be sold as Class A eggs. This is not in line with Part D 2. of Annex II to Regulation 2160/2003.

The system in place provides guarantees that correct measures are taken when a laying hen flock is positive for a targeted Salmonella serovar. Measures taken on eggs after positive results are in general acceptable, but adopted with unnecessary delay (after serotyping). Additionally, the lack of clarity in one aspect of the delegation of control tasks to COKZ meant that there are no restrictions to placing on the market possibly contaminated eggs produced between the date of sampling and the date of reception of positive results, nor is recalling imposed. Therefore, the risk of Salmonella being spread from eggs to consumers is not fully mitigated. 17

Member state response

The NVWA has given clear instruction to the COKZ in f conformity with Regulation (EU) 2017/625, regarding the ion moment of imposing restriction. The COKZ is now imposing restrictive measures on the eggs at the holdings from the date of sampling. See also the action proposed under recommendation no. 2. Besides, NVWA is tightening the co-operation with COKZ by updating working procedures and quarterly meetings with COKZ to reflect on the performances with regard to the delegated tasks.

The recommendation states as its basis

From 2017 to 2019, the NVWA performed annual audits on COZK controls over laying hen holdings, and establishments further along in the egg production and marketing chain. The audits included accompanying a few COKZ inspections on the spot at each of those establishments. None of the audits detected deficiencies with COKZ performance in relation to the tasks delegated by the NVWA. 19

The NVWA audits did not look into how COKZ performed the egg channelling after the imposition of restriction measures in laying hen holdings. NVWA did not detect that COKZ was imposing restrictions on the eggs, and/or recalling those eggs, only from the date of the positive test result instead of from the date of the sampling for that test. Conclusions on official controls, verification and audits

The NVWA controls on delegated bodies have effectively ensured compliance from C-Mark. It did not detect that COKZ has been imposing restrictions on egg marketing later than required which indicates weaknesses in the effectiveness of NVWA controls over this body.

Member state response

cle The NVWA will perform an audit, as mentioned in Article 33(a) of Regulation (EU) 2017/625, on COKZ in September 2021. In this upcoming audit the process of imposing restriction on eggs and/or recalling eggs will be verified. Especially the findings from the audit by DG(SANTE) will be subject of investigation. Page: 2

The recommendation states as its basis

The CA informed the audit team that there is an internal procedure in place that foresees that the same private veterinary practitioner cannot certify the emergency slaughter and also perform the PMI of the same animal. Should a private veterinarian find themselves in this position they must report this to his/her supervisor and ask to be replaced. There are no safeguard measures in place to ensure that conflict of interest is avoided or to be able to verify that the above procedure is strictly followed.

In the case where the CA identifies that a private veterinarian is not acting in line with their entrusted official duties, then he/she can be excluded from future official assignments and a note is introduced in the Register. The CA also informed the audit team that they have requested private veterinarians to perform, if possible, their official duties in areas located outside the areas where they normally carry out their own private work. The CA does not verify if this request is followed. 5.2.3. Staffing and equipment

There are certain procedures in place ensuring that the OVs involved in private veterinary practice are impartial and free of conflict of interest. Nonetheless, there are no safeguard mechanisms or measures in place to verify that those procedures are adhered to.

The recommendation states as its basis

The CA indicated to the audit team that in certain cases OAs can carry out AMI of poultry under the responsibility of the OV without meeting the requirements of Article 3(2) of Regulation (EU) 2019/624. This Article specifies, among other requirements, that for the above to take place the AMI must be carried out previously by an OV in the holding of provenance.

Regarding the poultry slaughterhouses, the official controls, appear in line with the newly introduced EU requirements. Nonetheless, a number of OAs are allowed to carry out AMI under the responsibility of the OVs without meeting the conditions set in Article 3(2) of Regulation (EU) 2019/624.

The recommendation states as its basis

Project protocols seen (see finding 11) contained adequate instructions for controls of retained samples (i.e. those to be taken and kept by FeBOs from ingredients and final products manufactured). The inspection reports assessed by the auditor contained satisfactory information on official controls of retained samples in FeBOs. Local feed inspectors interviewed demonstrated good knowledge on the practical implementation of such controls. However, the auditor noted, that in three out of five relevant establishments assessed this control was not adequately implemented, even though required by internal instructions. In the food-producing establishment, the feed inspector controlled the traceability of the produced feed materials. Checks on implementation of point 4 of Annex II "Quality Control" to Regulation (EC) No 183/2005 on collection and storage of retained samples was part of the project protocol, but it was overlooked during official control. Compliance of the operator with this legal requirement was also not checked by the food inspector.

The auditor assessed the report of the official control on the sole approved primary producer of feed. The feed inspector stated that requirements of Annex II to Regulation (EC) No 183/2005 were checked, but findings were not recorded in official reports. The auditor requested additional evidence (operator`s documentation on collection and storage of retained samples, results of tests of mixing homogeneity, and procedure on calibration of measuring devices) and the assessment of these documents from the local inspector. The competent authority provided adequate evidence; the assessment of the calibration of the measuring devices and test on homogeneity of mixing were satisfactory. The competent authority did not provide the operator`s documentation on collection and storage of retained samples. The collected retained 6 samples were clearly labelled and stored by the operator under conditions, which prevented adulteration. However, the samples were not sealed which contradicts the requirements of point 4 of Annex II "Quality Control" to Regulation (EC) No 183/2005.

Inspections are planned in the form of risk-based project inspections and system audits, ensuring that the official controls are carried on a risk-basis. The inspectors' assessment of FeBOs' hazard analysis, results of tests on mixing homogeneity and carry-over, verification of implementation of traceability requirements were largely adequate. However, the effectiveness of feed inspections is weakened by shortcomings in officials' verification of the correctness of feed labelling and inconsistent verification of collection and storage of retained samples. 7 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

The recommendation states as its basis

In general, verification of whether operators meet the legislative labelling requirements is part of the system audits (see finding 12). In addition, one specific project was also carried out on labelling (see finding 11). During the interviews, the auditor reviewed with the local inspectors several labels of the FeBOs included in the programme. While the inspectors interviewed demonstrated in general good knowledge of the subject, in several cases the inspectors did not identify certain inaccuracies/non-compliances: The identification codes of feed additives were missing on labels of feed additives, contrary to Article 16(1)(f) of Regulation (EC) No 1831/2003. Technological feed additives with maximum limits were not labelled on premixtures which is a legal requirement in Article 16(1)(a) and (f) of, and Annex III to, Regulation (EC) No 1831/2003. Absence of declaration of feed materials on the label, contrary to Article 16(1)(b) of Regulation (EC) No 767/2009. Based on a dosage instruction of a complementary feed, the daily intake of a feed additive was lower than the minimum required in the authorisation of the additive by Regulation (EC) No 885/2010. Declarations on type of feed (complete, complementary, etc.) were not in line with the legal requirements of Article 15(a) of Regulation (EC) No 767/2009. Dosage instruction for complementary feed (dairy cow) was not on the label, contrary to Article 17(b) and point 4 of Annex II to Regulation (EC) No 767/2009.

Inspections are planned in the form of risk-based project inspections and system audits, ensuring that the official controls are carried on a risk-basis. The inspectors' assessment of FeBOs' hazard analysis, results of tests on mixing homogeneity and carry-over, verification of implementation of traceability requirements were largely adequate. However, the effectiveness of feed inspections is weakened by shortcomings in officials' verification of the correctness of feed labelling and inconsistent verification of collection and storage of retained samples. 7 5.2.2 Sampling 5.2.2.1 PLANNING OF OFFICIAL SAMPLING

Member state response

Nederland komt dit jaar met een herzien Nationaal Actieplan In een brief aan de Europese Commissie van 28 maart 2019 is aangegeven dat gewacht zou worden met deze herziening totdat de PBL Tussenevaluatie van de Nota `Gezonde Groei, Duurzame Oogst en de totstandkoming van de Toekomstvisie Gewasbescherming 2030 zou zijn afgerond. De doelen en acties van het in september 2020 vastgestelde Uitvoeringsprogramma Toekomstvisie Gewasbescherming 2030 zijn leidend voor de herziening van het NAP. Het streven is om het herzien NAP rond de zomer van 2021 vast te stellen en zal in het voorjaar van 2026 worden geactualiseerd voor de periode 2026 ­ 2030. De looptijd van het NAP wordt daarmee in lijn gebracht met de looptijd van het Uitvoeringsprogramma Toekomstvisie Gewasbescherming 2030. Voor het actualiseren van het herziene NAP in 2026 zal gebruik worden gemaakt van het monitoringsprogramma dat in het kader van het Uitvoeringsprogramma wordt vastgesteld. In dat monitoringsprogramma zal de voortgang van het doelbereik aan de hand van nog vast te stellen indicatoren worden gevolgd.

Member state response

Deze aanbeveling zal worden uitgewerkt in de hiervoor genoemde herziening van het NAP. Hierbij zal onder meer worden aangesloten bij de monitoring van werkzame stoffen die leiden tot normoverschrijdingen van waterkwaliteitsnormen.

The recommendation states as its basis

ToBRFV was first found in the Netherlands in a tomato fruit producing crop in October 2019. The production site was checked during the annual survey. Samples of symptomatic plants were tested positive with the ELISA method and were later confirmed by RT-PCR and next generation sequencing methods. Up to the time of the audit, the presence of the virus was identified in tomato fruit crops at 27 production sites.

The current practice of reporting the outbreaks is not in line with the requirements of the EU legislation. Any delayed reporting may have prevented a full overview of the current state of play of outbreaks in the Netherlands. It could prevent MS from assessing any indirect risk for them and so could negatively influence the related controls.

Member state response

uit See also comments para 4.2 (p.3). More notification reports have een issued into Europhyt-outbreaks than reflected in the audit report. NL action plan The NL recognizes that more frequent reporting could have provided a more up-to-date overview of the pest situation in the Netherlands. The NL will aim at updating pest reports on ToBRFV every half year and in duly justified cases where new facts become available or the pest status of the Netherlands changes. Legal reservation However from a principle point of view the NL disagrees with the legal interpretation, in particular the presumption that each individual find should be reported whereas the pest status for the area does not change. Also reports were issued within the deadlines described in 2019/1715. The Netherlands has duly communicated the presence of the pest in the Netherlands in line with article 11 (a) of Regulation (EU) 2016/2031: "the presence in its territory of a (non-listed) Union Quarantine pest not known to be present there". Also updates have been provided of new relevant information in line with art. 32.4 of EU Regulation 2019/1715. A first pest report was issued in October 2019 within 8 days following the f

NL new action plan (20210628) ne 2021 all individual findings of ToBRFV have been duly reported in Europhyt outbreaks. All subsequent new findings or relevant changes for each individual find of ToBRFV will be duly reported in Europhyt outbreaks as of 10 June 2021.

The recommendation states as its basis

For the authorisation of the movement of specified seeds, the CAs accept the negative results of the tests carried out by the NAL laboratories. The CAs stated that the NALs are obliged to take samples and test them in line with the provisions of Regulation (EU) 2020/1191 (see chapter 5.1.4.2).

Currently there is no obligation for the seed companies to report to the CAs the number of samples and the methods used for the tests they carried out on seed lots and batches in stock. Each NAL is obliged to keep detailed records on the samples and tests they carried out. The CAs only have comprehensive information about whether seed lots in stock had been sampled in line with the provisions of the Annex of Regulation (EU) 2020/1191 for NAL laboratories and whether the test results represent the plant health status of each specified seed lot in store. 5.5.4 Official controls on plant passport issuance

Naktuinbouw has a system for the controls and verification of the sampling and tests carried out by the seed companies with NAL. However, this is not the case for other seed companies. Therefore the relation between the tests and the seed lots to be marketed is not always officially established, which is not in line with provisions of Article 7(2) of Regulation (EU) 2020/1191. 18 Conclusions on controls on movement of specified seeds within the EU

A considerable part of the specified seed lots which were in storage prior to 15 August 2020 were not tested with the molecular method. Although many lots have been tested with ELISA method, the potential plant health risk is only partially addressed due to the lower sensitivity of those tests.

The supervision of the ToBRFV tests carried out by the seed companies by annual audits provides a level of guarantee. However, the sampling for those tests is not supervised adequately in all cases and therefore the associated plant health risk is not addressed. In addition, the CAs do not have comprehensive information about whether the test results reflect the plant health status of each specified seed lot. 5.6 CONTROLS ON THE INTRODUCTION INTO THE EU OF SPECIFIED PLANTS FOR PLANTING Legal requirements Article 8 of Regulation (EU) 2020/1191. Findings

Member state response

n of the For EU internal movement it is foremost the responsibility of the operator to ensure compliance with EU plantpassport wn requirements including the necessary checks (including testing), within as well as traceability of movements to other operators as well as and to other locations of the same company (art 69 and 70 PHR). companies are subject to official supervision of the g of seeds of Solanum lycopersicum and Capsicum sp. c NAL rules are described in annex 17 to the nnaire (NAL conditions 2020). Included for ease of ce. The sampling procedures are part of the NAL audits out by Naktuinbouw. more Naktuinbouw carries out annual checks in line with of Regulation 2016/2031 of al seed companies. This is flected in the response to the questionnaire (15): ition, there is an annual administrative check. During this random checks are made to see whether seed batches are Page: 3 31 March 2021 dations of report ref. DG(SANTE) 2020-7085 of the audit carried out from 09 controls for the tomato brown rugose fruit virus Action Proposed by the competent authority traceable and whether the plant passport is correct, whether the seed batch meets all requirements and is correctly applied."

NL new action plan (20210628) course of 2021 a new procedure will be set up and implemented from 1 September 2021 onwards for official supervision of sampling by companies which are not recorded as part of NAL. See new timeline: instead of implementation in 2022, this has been modified to September 2021. Page: 1 dations (updated), received 30 June 2021 itted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2020- 30 November 2020 in order to evaluate the situation and controls for the tomato brown rugose fruit thority most the nsure y checks ceability of l as to (art 69 ficial s of p. The NAL annual lation s is also estionnaire: ministrative ecks are e sport is Page: 2 dations (updated), received 30 June 2021 itted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2020- 30 November 2020 in order to evaluate the situation and controls for the tomato brown rugose fruit Action Proposed by the competent authority correct, whether the seed batch meets all requirements and is correctly applied."

The recommendation states as its basis

The NVWA stated that coated tomato and pepper seeds are excluded from the sampling regime as coating may affect the tests. In particular, chemicals in the coating could influence the RNA extraction or inhibit the PCR process. Currently there are no validated laboratory protocols for coated seeds. The majority of the seeds are imported as minimally processed. The growers use chemicals during the extraction and dry the seeds before the dispatch.

Consignments or seed lots of Capsicum spp., for which the AD on the PC certifies that the variety is resistant, are accepted for import. NVWA stated that there are uncertainties about which genes ensure the resistance. During their monitoring activity for ToBRFV the NVWA tested positive pepper seed lots, which had been declared to be ToBRFV resistant. Resistance of a variety could be linked to only one of the two parental lines. Hence, a contamination of the hybrid seed may only be related to the parents whereas the seed itself is still resistant.

At the time of the audit, the inspection bodies selected consignments for sampling randomly, without taking into consideration the existing risk such as countries, exporters and varieties with ToBRFV interception history. The NVWA is of the opinion that ToBRFV is much wider distributed in the world than officially recorded. Therefore, 21 third countries were evenly targeted, to avoid overlooking potential risky pathways. The audit team considers that a non-targeted sampling reduces the effectiveness of the test in preventing the entry of infected seed lots to the EU territory. In addition, the audit team noted that the IT system run by the two inspection bodies does not enable the NVWA to check real-time, whether the mandatory sampling rate set by Regulation (EU) 2020/1191 is observed. The CAs stated that the ongoing upgrade of the IT system and the database in which the import inspections are registered would enable the inspectors to take into consideration risk criteria for the selection of consignments for sampling. The upgraded system is expected to be operational in the course of 2021.

The controls of imported seeds are generally in line with EU requirements. However, the selection of consignments for laboratory tests does not take into consideration all known risk factors and no measures are implemented to prevent the free circulation of imported seeds before the laboratory analysis is completed. These issues compromise the effectiveness of EU measures to protect against the introduction of ToBRFV in seeds.

Member state response

NL action plan 1191 Following the outcome of seed testing at import during the quired by course of 2021, an updated risk profile of all seed imports and ToBRFV interceptions will be made to enhance the level of import testing for specific origins, where relevant. For interceptions of ToBRFV on Capsicum varieties this will depend on any findings in crops exhibiting clear symptoms. Capsicum varieties carrying the L3/L4 ­ gene/allele are considered to be resistant. It concerns hybrid seeds and positive testing for ToBRFV may be explained by the mother plant not carrying resistance genes or by contamination during seed extraction/cleaning. NL info on risk approach for import testing 2020 and 2021 The worldwide distribution of ToBRFV is highly uncertain and there is, at present, no strong evidence on higher risk as related to specific origins. Initially a random approach is chosen, to allow targeting all third countries. Seeds are imported from approximately 40 countries. For some third countries the numbers of imported consignments is very low. To get more information on all relevant third countries a random approach is chosen for selecting imported consignments, Page: 4 31 March 2021

NL new action plan (20210628) rom 2 August 2021 onwards the testing % , of seeds of specified plants will be set at 30% of the consignments from Peru, China and Israel, in relation with the high interception records for these countries. Following the outcome of seed testing at import during the course of 2021, an updated risk profile of all seed imports and ToBRFV interceptions will be made to enhance the level of import testing for specific origins, where relevant. For interceptions of ToBRFV on Capsicum varieties this will depend on any findings in crops exhibiting clear symptoms. Capsicum varieties carrying the L3/L4 ­ gene/allele are considered to be resistant. It concerns hybrid seeds and positive testing for ToBRFV may be explained by the mother plant not carrying resistance genes or by Page: 3 dations (updated), received 30 June 2021 itted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2020- 30 November 2020 in order to evaluate the situation and controls for the tomato brown rugose fruit thority testing V is resent, no elated to m approach hird e third re ountries a ting east each included in ceptions of el. from Page: 4 dations (update

The recommendation states as its basis

If the consignment was sampled, the importer receives a notification about the sampled lot. The company is then informed about the test results in writing. The audit team noted that at the time of the audit no official measures were applied to block the consignment until the laboratory test was completed, although Article 10 of Regulation (EU) 2020/1191 requires laboratory tests due to the existing plant health risk. Therefore, the exemption provided by Article 4(9) of Regulation (EU) 2019/2130 does not apply and the consignments cannot be released for free circulation before the test results are available. The approach followed by the CAs meant that some seed lots were placed on the market before the laboratory analysis was completed, including at least one documented case, where the sample tested positive for ToBRFV. The NVWA stated that the relevant instructions will be amended and the consignments will be blocked until the tests are finalised. The new rules will be implemented in January 2021. 22 Conclusions on the controls on the introduction into the EU of specified seeds

The controls of imported seeds are generally in line with EU requirements. However, the selection of consignments for laboratory tests does not take into consideration all known risk factors and no measures are implemented to prevent the free circulation of imported seeds before the laboratory analysis is completed. These issues compromise the effectiveness of EU measures to protect against the introduction of ToBRFV in seeds.

Member state response

pled NL action plan 1, are Import consignments of seeds falling under 2020/1191 will be the test systematically blocked as part of compulsory testing of these seeds. This was also clarified in our letter of 17 November 2020. * Background information As explained in (14) of the questionnaire, the Netherlands already started at the beginning of July with testing at import as Page: 5 31 March 2021 dations of report ref. DG(SANTE) 2020-7085 of the audit carried out from 09 controls for the tomato brown rugose fruit virus monitoring ignments are is ruction to protect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality

NL New action plan (20210628) The imported consignments subjected to nal sampling for ToBRFV are systematically line blocked until the (negative) test result is U) available, starting 1 January 2021 as part of compulsory testing of these seeds. New response information (20210628) Page: 5 dations (updated), received 30 June 2021 itted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2020- 30 November 2020 in order to evaluate the situation and controls for the tomato brown rugose fruit e competent authority : ds in the Netherlands ly 2020 as a monitoring al enactment of 2020/1191 rce on 15 August 2020. ng as part of monitoring, blocked if there is no ne pests. eed consignments) has erroneously, the ectors were not amended one based on the new s. ns starting on 1 January for inspectors that each and tested for ToBRFV il the (negative) test n e pre-audit therlands already started uly with testing at import ng program. As part of g without a suspicion for t, consignments are not Page: 6 dations (updated), received 30 June 2021 itted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE) 2020- 30 November 2020 in order to

The recommendation states as its basis

The objectives for animal welfare in the 2015-2018 Multi-Annual National Control Plan (MANCP) include: a. To increase compliance, with a target of 80% compliance or better from the result of inspections. b. To include a random selection of farms for comparison of their compliance results with the risk chosen farms.

The report on the implementation of the MANCP in 2017 indicates that: a. For pigs, 350 production sites were inspected with an overall compliance rate of 70%. For calves the compliance rate was 60%, and the report concluded that this level of compliance was "moderate". For broilers, the compliance rate was 45% and the report concluded that this was unsatisfactory. b. The results do not give a representative picture of compliance within the sector as the inspections were conducted with other controls: for the purpose of cross compliance; for a project; in response to a notification from a third party. The report does not provide any indication of how the results from the inspections of the randomly selected farms compare with the results from the farms chosen on the basis of risk. 4 The MANCP network reference document "Developing Objectives and Indicators" states that the underlying principle behind these requirements and guidelines is that we cannot manage our control systems without setting clear objectives and monitoring progress towards those objectives. A strategic objective is a long- term objective, setting out what an official control system and its priorities intend to achieve. Strategic objectives usually relate to outcomes and impacts. Objectives should be Specific, Measurable, Attainable, Relevant, and Time-bound (SMART). 3

The NVWA does not measure whether the objective to increase compliance to 80% or better has been met(6). The reports on the implementation of the MANCP acknowledges that risk based checks increase the probability of finding non-compliant farms and results therefore do not demonstrate the overall level of compliance. The NVWA has not analysed the results from randomly selected farms to conclude whether this objective was met or not, or adjusted the objective so that it matches better to risk based controls.

The recommendation states as its basis

In the broiler sector, Directive 2007/43/EC point 1(c) Annex V requires that in at least seven consecutive subsequently checked flocks from a house the cumulative daily mortality rate is below 1 % + 0,06 % multiplied by the slaughter age of the flock in days. However, NVWA guidance requires the cumulative daily mortality rate to be below 5%, which is higher than allowed by the Directive, e.g. for a flock with a slaughter age of 42 days the limit is 3.52%9. 8 http://www1.clermont.inra.fr/wq/index.php?id=protocol&prod 7

Animal based indicators are well established in the broiler sector, where the data is collected at slaughterhouses and used to select the highest risk farms for inspection. Although this is a robust system of control it does not make use of certain indicators which are required by EU legislation, i.e. verification of daily mortality rates and the limit for cumulative daily mortality rates for broiler flocks operating at the higher stocking densities.

The recommendation states as its basis

The audit team noted that, contrary to the requirements of Article 48 of Regulation (EC) No 1069/2009, the NVWA does not systematically confirm the arrival of consignment of PAP to competent authorities of the Member State of origin by means of TRACES. The system of checks in place is based on random selection of certain consignments in TRACES and a cross-check of these data on the spot. Only 10% of required confirmations took place in recent years. The frequency of confirmation to the place of origin did however increase to 20% in 2019 (see also finding 20).

Inadequate implementation of EU requirements concerning transmission of information to the competent authority of the Member State of origin or destination via TRACES relating to intra-EU trade of PAP undermines the reliability of information on the intra- EU trade of such products.

Member state response

The NVWA prepares a new procedure to ensure that information about the arrival of consignments of processed animal proteins is fied to the Member State of origin, by means of TRACES, including extra employees for these (administrative) tasks.

The recommendation states as its basis

The competent authority stated that trade of consignments of OF/SI containing PAP and/or MBM is not notified in TRACES. This is not in line with Article 48(3) of Regulation (EC) No 1069/2009. 5.2.3 Exports and imports of PAP

Inadequate implementation of EU requirements concerning transmission of information to the competent authority of the Member State of origin or destination via TRACES relating to intra-EU trade of PAP undermines the reliability of information on the intra- EU trade of such products.

Member state response

The Dutch authorities disagrees with the finding and mmendation to notify OF/SI containing PAP consignments in intracommunity trade. We do not see any legal requirement in the ABP regulation to substantiate this recommendation. The wording of the article 48.3 of Regulation (EU) no. 1069/2009 clearly states that "PAP derived from category 3 material" needs a notification via TRACES by the MS of origin. There is no mention of "and products containing PAP" as is done in other parts of the Regulation when it is the intention of the legislator to include not 100% pure products. This interpretation is supported by the majority of MS as confirmed during the working group on ABP of 15 October 2018.

The recommendation states as its basis

Checks on exports of consignments of ruminant PAP via the port of Rotterdam are is carried out in accordance with the internal instructions of the NVWA. The competent authority stated that there are two types of official controls on exported consignments from the Netherlands, namely administrative and physical controls. Administrative checks on consignments with the origin in the Netherlands are carried out in the processing plants, including check of data in TRACES. Following the pre-notification via e-mail the local inspectors can carry out a random check of the containers at the point of exit. However, the audit team noted that the pre-notification via e-mail from the operator to the competent authority does not comply with the instruction from the NVWA as regards the content of such pre- notification. The audit team also noted that such checks do not ensure the check required at the point of exit as required in point 1 of section E of Chapter V of Annex IV to Regulation (EC) No 999/2001.

Physical controls (seal checks) are carried out at an inspection centre of the BIP Rotterdam approved for import of liquid fats, oils and fish oils at Maastank B.V. No seal checks are carried out on consignments with origin in other Member States (Belgium, United Kingdom). This is not in line with point 1 of section E of Chapter V of Annex IV to Regulation (EC) No 999/2001. As regards consignments from Ireland, the competent authority stated that these consignments are only being transhipped in the port of Rotterdam.

The NVWA inspectors who do not have access to TRACES carry out seal checks on a certain proportion of consignments intended for export. There is no procedure in place to require that the competent authority responsible for the exit point (border inspection 10 post) informs via TRACES the competent authorities of the processing plants about the arrival of the consignment at the exit point and such notifications are not made by the inspectors. This is not in line with point (c) of section E of Chapter 5 of Annex IV to Regulation (EC) No 999/2001.

The lack of an adequate control mechanism in place to verify at the point of exit that all consignments of ruminant PAP exported from the Netherlands and other EU Member States have actually left the EU territory undermines the effectiveness of official controls in place.

Member state response

NVWA and Customs plan to have an agreement for the risk he based verification of the seals and containernumbers at the point exit from the EU by Customs officials. Discussions are ongoing. In the meantime we will also continue with the cross- hecks with the Customs data. Page: 1 of report ref. DG(SANTE)/2019-6644-MR of the audit carried out from 10 hygiene, traceability and trade requirements of processed animal proteins, petent authority

The recommendation states as its basis

Three processing plants visited during the audit use processing method 7, which had been authorised by the competent authority. In one processing plant, during the 30 day validation period microbiological samples had been taken (Salmonella, Enterobacteriaceae, Clostridium perfringens) by the operator. The audit team noted that the sampling frequency and laboratory results were in compliance with EU legislation.

In another processing plant visited, the validation report provided by the operator to the competent authority at the time of validation did not contain all of the processing 8 parameters required by point G 2, Chapter III, of Annex IV to Regulation (EU) 142/2011. The competent authority had not noticed this shortcoming.

However, problems identified regarding operators' validation of method 7 in the 11 processing plants and the official assessments thereof, undermine confidence in the reliability of the results of official controls on this aspect of PAP production.

Member state response

ew validation for method 7 will be carried out at the processing plant in which the place of sampling for Salmonella, Enterobacteriaceae) during od was not in line. r approval will be completed and n for method 7, the data relevant for this OS. Page: 2

Member state response

Zie het commentaar op bevindingen nrs. 13 en 16. zien hierover tijdens de audit van 2014 geen kingen zijn gemaakt terwijl deze situatie sindsdien ongewijzigd is gebleven, ging LNV er vanuit dat het toezicht op Skal in lijn is met de geldende Europese regelgeving ten aanzien van het toezicht op controlerende autoriteiten. Gezien uw aanbeveling zal LNV Skal verzoeken om interne audits uit te voeren of audits bij zichzelf te laten uitvoeren en op basis van de resultaten daarvan passende maatregelen te nemen, overeenkomstig artikel 6 van Verordening EG nr. 2017/625 en hierover LNV te informeren.

Zie het commentaar op bevindingen nrs. 13 en 16. zien hierover tijdens de audit van 2014 geen kingen zijn gemaakt terwijl deze situatie sindsdien ongewijzigd is gebleven, ging LNV er vanuit dat het toezicht op Skal in lijn is met de geldende Europese regelgeving ten aanzien van het toezicht op controlerende autoriteiten. LNV zal in de eerste helft van 2021 een transitiedocument opstellen voor de door Raad voor Accreditatie uit te voeren transitiebeoordeling -van Verordening (EG) 834/2007 naar Verordening (EG) 2018/848- van Skal. Skal gaat met ingang van 1-1-2022 werken volgens de nieuwe Verordening, de transitiebeoordeling kan derhalve in het eerste kwartaal van 2022 worden afgerond.

Member state response

entaar op bevindingen nrs. 9 en 19, en de conclusies nrs. 25 en 103. singen en decertificering, zijn te beschouwen als 4, ernstige onregelmatigheden en deze worden onmiddellijk oor Skal aan LNV gemeld. VO in kennis stellen van tijdens invoercontroles ontdekte niet conforme producten, zodat die informatie aan aten en de Europese Commissie kan worden . Dit wordt vastgelegd in een werkinstructie van Skal. Realisatiedatum: 1 september 2020. Page: 1 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority De informatie uitwisseling tussen NVWA en SKAL vindt reeds plaats op basis van de hernieuwde samenwerkingsovereenkomst die aan het auditteam is verstrekt. ie 92 e 19

st dat het geleverde commentaar op bevindingen nrs. 9 en 19, en de conclusies nrs. 25 en 103 cept verslag van de audit niet tot andere usies hebben geleid, derhalve zullen we opvolging 4, geven aan uw aanbevelingen. We hebben zowel uw aanbeveling onder 1) als uw g onder de eerste bullit van aanbeveling 2) opnieuw bezien en komen daarbij tot de conclusie dat de rol autoriteit in het controlesysteem zoals bedoeld ning (EG nr. 882/2004) onvoldoende invulling heeft gekregen en kan worden verbeterd. We zullen de rol Page: 1 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority van bevoegde autoriteit in brede zin evalueren, bezien in de context van Verordening EG nr. 2017/625 en de invulling in de nationale wetgeving (Kaderwet zelfstandige bestuursorganen en Wet Naleving Europese regelgeving publieke entiteiten). Op basis hiervan zullen we tot herziene ie invulling van de rol van bevoegde autoriteit komen. Deze evaluatie zal starten in de eerste helft van 2021 en in 2021 worden afgerond. 92 Skal zal RVO in kennis stellen van tijdens invoercontroles ontdekte niet conforme producten, zo

Member state response

Naar aanleiding van uw bevindingen tijdens de audit en uw aanbeveling heeft Skal een aanpak opgesteld om te voldoen aan de genoemde vereisten uit Verordening (EG) 834/2007. in 2020 is Skal gestart met een inventarisatie van de doelgroep en een actief communicatietraject om bij de s doelgroep de regels te benadrukken zoals deze zijn vereist Page: 2 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority op grond van artikel 28, lid 1, van Verordening (EG) nr. 834/2007. Gedurende een periode van twee maanden kunnen de n die zich alsnog willen laten certificeren zich aanmelden bij Skal; de bedrijven die in aanmerking willen n voor de vrijstellingsvoorwaarden zoals beschreven in artikel 28, lid 1, van Verordening (EG) nr. 834/2007, wordt een redelijke termijn geboden om te stoppen met bereidingsactiviteiten. Na deze termijn en uiterlijk begin november 2020 zal Skal de toelatingsonderzoeken en inspecties opstarten voor de bedrijven die zich hebben gemeld voor certificering. De bedrijven die zich laten certificeren zullen een nieuw certificaat krijgen, dan wel zal deze activiteit op een bestaand

Naar aanleiding van uw bevindingen tijdens de audit en uw aanbeveling heeft Skal een aanpak opgesteld om te voldoen aan de genoemde vereisten uit Verordening (EG) 834/2007. in 2020 is Skal gestart met een inventarisatie van de doelgroep en een actief communicatietraject om bij de s doelgroep de regels te benadrukken zoals deze zijn vereist Page: 2 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. tion Proposed by the competent authority grond van artikel 28, lid 1, van Verordening (EG) nr. 4/2007. durende een periode van twee maanden kunnen de rijven die zich alsnog willen laten certificeren zich nmelden bij Skal; de bedrijven die in aanmerking willen komen voor de vrijstellingsvoorwaarden zoals beschreven in tikel 28, lid 1, van Verordening (EG) nr. 834/2007, wordt n redelijke termijn geboden om te stoppen met reidingsactiviteiten. deze termijn en uiterlijk in het eerste kwartaal van 2021 l Skal de toelatingsonderzoeken en inspecties opstarten or de bedrijven die zich hebben gemeld voor certificering. bedrijven die zich laten certificeren zullen een nieuw rtificaat krijgen, dan wel zal deze activiteit op een staand c

Member state response

1-1-2021 zal Skal het model van bijlage XII bij Verordening (EG) nr. 889/2009 volgen, er van uitgaande dat deze verordening nog zal gelden tot 1-1-2022. Page: 3 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority nbeveling om alle activiteiten van de marktdeelnemers certificaat op te nemen is reeds bestaande praktijk, in l van supermarkten zal dit gaan gebeuren (zie de reactie anbeveling 3). Skal heeft de controle van niet-geregistreerde marktdeelnemers inmiddels aangescherpt in samenspraak met de NVWA. Verder verwijzen we u voor de acties richting supermarkten naar de reactie op aanbeveling 3. Page: 4 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority

1-1-2021 zal Skal het model van bijlage XII bij rordening (EG) nr. 889/2009 volgen, er van uitgaande dat ze verordening nog zal gelden tot 1-1-2022. De aanbeveling om alle activiteiten van de marktdeelnemers t in het certificaat op te nemen is reeds bestaande praktijk, in Page: 3 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority l van supermarkten zal dit gaan gebeuren (zie de reactie op aanbeveling 3). Skal heeft de controle van niet-geregistreerde marktdeelnemers inmiddels aangescherpt in samenspraak met de NVWA. Verder verwijzen we u voor de acties richting supermarkten naar de reactie op aanbeveling 3.

Member state response

Zie het commentaar op bevindingen nrs. 41, 42, 43, 44, 45, 47, en de conclusies nr. 50. e NL is van mening dat de werkwijze van Skal in een drie jarige cyclus waarbij na twee jaar het uitvoeren van een basis inspectie het derde jaar wordt afgesloten met een nspectie her certificering in lijn is met de vereisten op nd van artikel 2, lid 7, van Verordening (EG) nr. 882/2004 en artikel 27, lid 3, van Verordening (EG) nr. 834/2007. LNV zal Skal verzoeken marktdeelnemers voor aanvullende ontroles te selecteren reeds op grond van hun risicoprofiel, zoals vereist op grond van artikel 92 quater, lid 2, onder b), van Verordening (EG) nr. 889/2008. Zie verder de reactie op beveling 9. sis De laatste aanbeveling sluit aan bij de reeds bestaande n praktijk; bij de totstandkoming van de risicoprofielen van de ist op bedrijven wordt door Skal al rekening gehouden met de , lid hoeveelheden product, zoals vereist op grond van artikel 65, g lid 4 van Verordening (EG) nr. 889/2008 door middel van de combinatie van de omzet in euro's en het aantal productspecificaties dat een bedrijf op het certificaat voert. Page: 5 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labellin

NL stelt vast het geleverde commentaar op bevindingen nrs. 41, 42, 43, 44, 45, 46 en 47, en de conclusies nr. 50. van het concept verslag van de audit niet tot andere conclusies hebben geleid van het auditteam, dit heeft grote Page: 4 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority pact voor het gehele controlesysteem. LNV zal derhalve uw aanbevelingen nader gaan onderzoeken en uitwerken tot een bijgestelde werkwijze, waarbij we tevens aanbeveling 7 kken. LNV zal bij dit onderzoek de verschillende actoren in het huidige controlesysteem betrekken en nader analyseren hoe de vereisten uit de door u genoemde Verordeningen vertaald nen worden in een aangepaste werkwijze voor de uit te n inspecties. Dit onderzoek start begin 2021. De eerste resultaten van dit onderzoek legt LNV graag medio 2021 ter reking aan u voor, waarna we in de tweede helft van resultaten verder zullen uitwerken in een epaste werkwijze. In 2022 kan de nieuwe werkwijze gens worden geïmplementeerd. op LNV zal Skal verzoeken marktdeelnemers voor aanvullende d controles te selecteren reeds op grond van hun risic

Member state response

Ter voorbereiding van de inspecties heeft Skal in het ICT e systeem (ACM) diverse informatie beschikbaar voor de e inspecteur om de inspectie voor te bereiden. Hieronder valt onder andere het laatste inspectierapport plus bijlage, ijkingen brieven, klachten en bezwaar procedures. arnaast is alle e-mail correspondentie met het bedrijf in ACM vast gelegd. Bovendien worden daar indien nodig extra bijzonderheden aan toegevoegd vanuit gegevens die a toezicht over het bedrijf verzameld zijn. Dit vormt de basis voor de voorbereiding van de inspecteur op de fysieke inspectie van het bedrijf. In relatie tot de specifieke punten die door het audit team zijn aangedragen: Informatie in verband met de volledige beschrijving van de eenheden van een bedrijf zoals is vereist op grond van artikel 63 van Verordening (EG) nr. 889/2008, en in het bijzonder met betrekking tot het tijdstip waarop de verwerking van de biologische producten plaatsvindt, moet een bedrijf vastleggen in documentatie die aan Skal beschikbaar gesteld moet worden. Op dit moment wordt dat beoordeeld n tijdens de fysieke inspectie. Skal is de uitvoering van de strategische ICT gestart op 1 januari 2020; dit omvangrijke traject om

voorbereiding van de inspecties heeft Skal in het ICT steem (ACM) diverse informatie beschikbaar voor de e inspecteur om de inspectie voor te bereiden. Hieronder valt nder andere het laatste inspectierapport plus bijlage, ngen brieven, klachten en bezwaar procedures. aarnaast is alle e-mail correspondentie met het bedrijf in CM vast gelegd. Bovendien worden daar indien nodig xtra bijzonderheden aan toegevoegd vanuit gegevens die ezicht over het bedrijf verzameld zijn. Dit vormt de asis voor de voorbereiding van de inspecteur op de fysieke nspectie van het bedrijf. n relatie tot de specifieke punten die door het audit team ijn aangedragen: Informatie in verband met de volledige beschrijving van de eenheden van een bedrijf zoals is vereist op grond van artikel 63 van Verordening (EG) nr. 889/2008, en in het bijzonder met betrekking tot het tijdstip waarop de verwerking van de biologische producten plaatsvindt, moet een bedrijf vastleggen in documentatie die aan Skal beschikbaar gesteld moet worden. Op dit moment wordt dat beoordeeld tijdens de fysieke inspectie. Skal is de uitvoering van de strategische ICT gestart op 1 januari 2020; dit omvangrijke traject omvat de gefaseerde implem

Member state response

Het inspectieproces van Skal is vastgelegd in het workflow ogramma ACM. Dit programma is zo ontworpen dat de inspecties volledig zijn met betrekking tot alle productiestappen en activiteiten van het bedrijf. De interne d van traceerbaarheid wordt steekproefsgewijs op basis van de ) beoordeling van de inspecteur uitgevoerd. Indien het bedrijf schillende productiestappen op verschillende locaties eeft verspreid, dan worden er cross compliance controles uitgevoerd over de locaties. Dit gebeurt niet altijd binnen het tijdbestek van één specifieke inspectie. Wel is het daarbij een vereiste dat de locatie een eigenstandige certificering voert en ook als zodanig onder toezicht staat van Skal. Op deze wijze borgt Skal de verificatie van de traceerbaarheid van producten in alle stadia van de productie, de verwerking distributie, zoals is vereist op grond van artikels 24, lid 4, artikel 66, leden 1 en 2 en artikel 72 van Verordening (EG) nr. 889/2008. Tijdens de inspectie worden alle relevante registers opgevraagd bij de marktdeelnemers. Het is de inspecteur die de inschatting maakt welke registers relevant zijn. Deze rden tijdens de inspectie beoordeeld door de inspecteur. het inspectierapp

inspectieproces van Skal is vastgelegd in het workflow ogramma ACM. Dit programma is zo ontworpen dat de pecties volledig zijn met betrekking tot alle ductiestappen en activiteiten van het bedrijf. De interne aceerbaarheid wordt steekproefsgewijs op basis van de deling van de inspecteur uitgevoerd. Indien het bedrijf nde productiestappen op verschillende locaties spreid, dan worden er cross compliance controles gevoerd over de locaties. Dit gebeurt niet altijd binnen het ek van één specifieke inspectie. Wel is het daarbij dat de locatie een eigenstandige certificering ook als zodanig onder toezicht staat van Skal. Op e wijze borgt Skal de verificatie van de traceerbaarheid cten in alle stadia van de productie, de verwerking utie, zoals is vereist op grond van artikels 24, lid 4, 66, leden 1 en 2 en artikel 72 van Verordening (EG) 889/2008. Page: 8 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. ction Proposed by the competent authority e inspectie worden alle relevante registers pgevraagd bij de marktdeelnemers. Het is de inspecteur die e inschatting maakt welke registers relevant zijn. Deze orden tijdens de inspect

Member state response

De juistheid van de op producten aangebrachte etiketten conform artikel 24 van Verordening (EG) nr. 834/2007 vindt plaats tijdens de jaarlijkse inspecties voor de producten die in NL worden geproduceerd en verwerkt. Deze controle indt altijd plaats op basis van een op basis van een risico inschatting gerichte steekproef. Ook bij verkoop van te consumenten producten vindt regelmatig via proeven controle plaats van de juistheid van de en, zoals bijvoorbeeld in het onderzoek bij supermarkten in 2018. Onder aanbeveling 3 staan de acties benoemd die inmiddels door Skal zijn opgestart om de controle op de ppunten aan de consument aan te scherpen, de controle van de etiketten maakt hier onderdeel van uit. Daarnaast is de NVWA belast met het toezicht op de (algemene) etiketteringsplicht op grond van Verordening 1107/2009. Hieronder vallen ook de biologische producten. Page: 9 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority Conform de samenwerkingsovereenkomst tussen Skal en NVWA worden de door NVWA aangetroffen afwijkingen bij Skal gemeld.

e juistheid van de op producten aangebrachte etiketten onform artikel 24 van Verordening (EG) nr. 834/2007 vindt laats tijdens de jaarlijkse inspecties voor de producten die n NL worden geproduceerd en verwerkt. Deze controle indt altijd plaats op basis van een op basis van een risico nschatting gerichte steekproef. Ook bij verkoop van verpakte consumenten producten vindt regelmatig via steekproeven controle plaats van de juistheid van de Page: 9 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. sed by the competent authority en, zoals bijvoorbeeld in het onderzoek bij in 2018. eling 3 staan de acties benoemd die inmiddels jn opgestart om de controle op de ppunten aan de consument aan te scherpen, de de etiketten maakt hier onderdeel van uit. van etiketten is een onderdeel van de standaard voor inspecties bij bedrijven die verpakken en groothandels en consument. De specifieke etiketten bij retailers is voor het laatst in 2019 In het toezichtsplan van 2021 op de retail is de etiketten meegenomen. De uitvoering van dit n start in het eerste kwartaal van 2021. van het toezicht op de retail heeft Skal extra paciteit nodig

Member state response

Zie de reactie op bevinding nr. 66, en conclusie 72. n voor In reactie op de aanbeveling het volgende. NL is van mening dat de huidige thematische benadering voor bemonstering in beginsel adequaat is. Aangezien Skal verder gaat dan uitsluitend te bemonsteren op basis van de risico indeling op bedrijfsniveau, is de aanpak doelgericht en doeltreffend. Echter zal, in overeenstemming met artikel 65, lid 2, van Verordening (EG), om die reden Skal worden rzocht een aanpak op te stellen zodat de bemonstering edig overeenkomstig artikel 65, lid 2, plaatsvindt, en die evens recht doet aan de specifieke risico's van bedrijven in NL. Waarbij 1 januari 2021 wordt aangehouden als sdatum van de gewijzigde aanpak. sturing van de analyse van de monsters gebeurt op van een inhoudelijke beoordeling met betrekking tot de risico's op potentiële besmettingen op basis van het type product en land van herkomst. Deze analyse bestaat nimaal uit een multi residumethoden, aangevuld met single residumethoden (zoals bijv. fosetylaluminium) indien aartoe aanleiding is. LNV heeft de aanwijzing van de laboratoria voor officiële controles van biologische producten belegd bij de NVWA. Tussen Skal en de NVWA zijn de

Zie de reactie op bevinding nr. 66, en conclusie 72. oor In reactie op de aanbeveling het volgende. NL is van mening dat de huidige thematische benadering voor bemonstering in beginsel adequaat is. Aangezien Skal verder gaat dan uitsluitend te bemonsteren op basis van de risico indeling op bedrijfsniveau, is de aanpak doelgericht en doeltreffend. Echter zal, in overeenstemming met artikel 65, lid 2, van Verordening (EG), om die reden Skal worden cht een aanpak op te stellen zodat de bemonstering g overeenkomstig artikel 65, lid 2, plaatsvindt, en die ns recht doet aan de specifieke risico's van bedrijven in NL. Waarbij 1 januari 2021 wordt aangehouden als tum van de gewijzigde aanpak. ring van de analyse van de monsters gebeurt op een inhoudelijke beoordeling met betrekking tot de risico's op potentiële besmettingen op basis van het type product en land van herkomst. Deze analyse bestaat aal uit een multi residumethoden, aangevuld met single residumethoden (zoals bijv. fosetylaluminium) indien toe aanleiding is. LNV heeft de aanwijzing van de laboratoria voor officiële controles van biologische producten belegd bij de NVWA. Tussen Skal en de NVWA zijn de gegevens uitgewisseld op ba

Member state response

De bevoegdheid om een ontheffing te verlenen voor onthoornen ligt bij Skal. Skal heeft de werkwijze voor het erlenen van deze ontheffing reeds aangepast en verleent deze op ad hoc basis, zoals is vereist op grond van artikel 18, lid 1, van Verordening (EG) nr. 889/2008. Dit wordt formeel vastgelegd door wijziging van het Skal Reglement nr.23, welke door het bestuur van Skal zal den vastgesteld op 12-6-2020, en in werking treedt met ingang van 1-7-2020. Inspecteurs controleren stelselmatig of dergelijk ingrepen in overeenstemming met het voornoemde artikel plaatsvinden. Dit wordt gewaarborgd doordat dit standaard onderdeel van de vragenlijst van de inspecteurs is.

De bevoegdheid om een ontheffing te verlenen voor onthoornen ligt bij Skal. Skal heeft de werkwijze voor het erlenen van deze ontheffing reeds aangepast en verleent deze op ad hoc basis, zoals is vereist op grond van artikel 18, lid 1, van Verordening (EG) nr. 889/2008. Dit wordt formeel vastgelegd door wijziging van het Skal ke Reglement nr.23, welke door het bestuur van Skal zal worden vastgesteld op 12-6-2020, en in werking treedt met ingang van 1-7-2020. Inspecteurs controleren stelselmatig of dergelijk ingrepen in overeenstemming met het voornoemde artikel plaatsvinden. Dit wordt gewaarborgd doordat dit standaard onderdeel van de vragenlijst van de inspecteurs is.

Member state response

in Zoals bekend heeft Nederland te maken met grote hoeveelheden importen die via Nederland de Europese Unie binnen komen. Om dit logistiek in goede banen te leiden, heeft NL een afwijkende inrichting voor de importcontroles. Tijdens de audit van 2014 is dit aan de auditors toegelicht en deze afwijkende werkwijze akkoord bevonden. NL stelt vast dat dit auditteam tot een andere conclusie komt en zal opvolging geven aan de gemaakte aanbevelingen. zien de impact op de logistieke processen van Douane, importeurs en Skal is enige tijd benodigd om een nieuw proces in te richten en de logistiek hierop aan te passen. Page: 11 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority estreefd wordt dit te realiseren in eerste kwartaal 2021, maar niet later dan 1 juli 2021. Een belangrijke randvoorwaarde om de aanbevelingen te kunnen realiseren is dat Skal toegang krijgt tot Traces om de resultaten van de invoercontroles op te slaan. l heeft reeds opvolging gegeven aan de aanbeveling om werkwijze inzake aanvullende officiële controles en onsters in lijn te brengen met artikel 2, lid 3, van Verordening

in Zoals bekend heeft Nederland te maken met grote hoeveelheden importen die via Nederland de Europese Unie et binnen komen. Om dit logistiek in goede banen te leiden, heeft NL een afwijkende inrichting voor de importcontroles. Tijdens de audit van 2014 is dit aan de auditors toegelicht en is deze afwijkende werkwijze akkoord bevonden. NL stelt vast dat dit auditteam tot een andere conclusie komt en zal opvolging geven aan de gemaakte aanbevelingen. Gezien de impact op de logistieke processen van Douane, importeurs en Skal is enige tijd benodigd om een nieuw proces in te richten en de logistiek hierop aan te passen. Gestreefd wordt dit te realiseren in eerste kwartaal 2021, n maar niet later dan 1 juli 2021. Page: 12 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. tion Proposed by the competent authority n belangrijke randvoorwaarde om de aanbevelingen te nnen realiseren is dat Skal toegang krijgt tot Traces om de sultaten van de invoercontroles op te slaan. eeds opvolging gegeven aan de aanbeveling om e inzake aanvullende officiële controles en n lijn te brengen met artikel 2, lid 3, van ng (EG) nr.1235/2008. Vanaf

Member state response

Page: 12 20 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority worden toegepast. Hier ligt een belangrijke kverantwoordelijkheid bij Skal. LNV is zich bewust van de eventuele juridische kwetsbaarheid van Skal en ziet tevens de mogelijke financiële risico's. In dit kader zijn LNV en Skal voornemens om, op basis van een nadere analyse in 2020, afspraken over het verdelen van risico's c.q. aansprakelijkheden te maken. Dit in het licht van de ontwikkelingen in de omgeving en het werkveld van Skal. k breder binnen LNV wordt nagedacht over dergelijke risicoregelingen en/of mogelijke garantstellingen bij ortgelijke verbonden partijen. Tevens zal LNV Skal verzoeken nog in 2020 een nadere analyse uit te voeren naar de beperkingen die Skal ervaart op algemene bestuursrechtelijke beginselen door Skal in relatie tot de vereisten uit de Verordening (EG) nr. 2017/625 (heeft per 14 december 2019, de 882/2004 vervangen) en Verordening (EG) nr. 889/2008. Op basis daarvan zal zo nodig nadere uitwerking door Skal moeten volgen ten einde 1, te waarborgen dat bedoelde handhavingsmaatregelen . worden uitgevoe

vindt het van groot belang dat bedoelde ndhavingsmaatregelen worden uitgevoerd en dat enredige en afschrikkende handhavingsmaatregelen past. Om dit te kunnen waarborgen is nader derzoek nodig naar organisatorische inbedding van het ntrolesysteem, bij Skal maar ook bij de overige betrokken Page: 13 17/12/2020 f report ref. DG(SANTE) 2019-6712 of the audit carried out from 19 to 27 labelling of organic products. Action Proposed by the competent authority diensten als Douane, RVO en NVWA. Waarbij beschikbare handhavingsmaatregelen worden bezien in de juridische t. LNV start dit onderzoek begin 2021, en zal het zoek in 2021 afronden. Hierbij zou het dienstig kunnen wanneer hierin gebruik kan worden gemaakt van de ennis en ervaring van andere lidstaten / beschikbare best tices. Naar aanleiding van uw concept verslag zijn reeds de volgende acties door LNV, in overleg met Skal, in gang gezet ter extra borging van de autoriteit en onafhankelijkheid van Skal. Er is met ingang van 2020 een structurele financieringsstroom van LNV naar Skal gerealiseerd voor de afhandeling van OFIS meldingen alsmede de eventueel daaruit voortvloeiende beroeps- en bezwaarzaken. In overleg met Skal zal in 2021 n

Member state response

The relevant instructions and checklists were clarified so that inspectors have clearer information (see Annex, in Dutch). These adjusted documents were discussed with the local inspectors during the regular training meeting of 13th of December 2018.

The recommendation states as its basis

On the basis of the information provided by the operator of the second plant, although the main final product was dried larvae of Black Soldier Fly, the intention was to place on the market insect PAP. The audit team noted that the full approval had been granted recently (July 2018) without the testing of the final product over a period of 30 production days being completed, as this period only started on 1 November 2018. This decision is not in line with the provisions laid down by Article 44 of Regulation (EC) No 1069/2009 and the specific provisions laid down in Point G, Chapter III of Annex IV to Regulation (EU) No 142/2011. Conclusions on registration, approval and listing of operators producing insects and insect PAP as feed

Operators producing insects or insect PAP for animal feed are subject to official controls which, inter alia, provide a basis for their registration, approval and listing. In one of the two plants visited by the audit team, there was sufficient evidence to support the approval. This was not the case for the second plant where approval had prematurely been granted without relevant EU requirements being fulfilled, indicating that the approval process is not consistently applied by the competent authority.

Member state response

e Inspectors must stick to the applicable instructions and quality procedure, e.g. "BUI101 - inspection from start to finish" and the ral and specific enforcement policy and instructions on ABP /feed. This procedures describes the method to be followed, necessary for carrying out all aspects of an inspection, incl. the recording of non-compliances. These instructions and procedures are periodically discussed within the involved inspection-teams during the regular team meetings. Within the new system for the recording of inspection-findings, INSPECT, the inspectors are given the opportunity to digitally record the findings and communication with the operators within this system. Page: 1

The recommendation states as its basis

In response to findings of the previous audit regarding enforcement of additional declarations, the NVWA prepared a detailed guidance document, which provides a flow chart and sector specific tables on individual genera or species of plants to determine the additional declaration requirements. This document is published in English on the NVWA website7. The audit team identified a minor shortcoming with this guidance document, in that it omits the requirement for certain additional declarations, that the area or place of production established as free must be stated in the declaration. The audit team observed two documentary checks where such declarations were relevant, and in neither case was the absence of the area or place of production identified as a non-compliance. The NVWA undertook to correct this.

The system now also includes enforcement of additional declaration requirements for phytosanitary certificates, for which there is a comprehensive guidance document to assist inspectors. However, the omission in the guidance, although quite minor, means that some EU requirements are not enforced in the Netherlands, and not implemented by the many exporting countries which use this document as guidance.

Member state response

from Erroneously this element was not incorporated in the NL overview of additional declarations (see website: https://english.nvwa.nl/topics/import-regulations-of-the- netherlands-on-plant-health/documents/import/fytosanitair/nvwa- import-fytosanitair/documents/overzicht-bijschrijvingen-alle- sectoren). This database also serves as tool for inspectors to verify the additional declaration as part of import documentary checks. Follow-up will be considered together with implementation of the upcoming (and last) amendment of the annexes of 2000/29/EC, at the end of 2019. Amendment of the database and instructions at an earlier stage will lead to unnecessary admin burdens for inspectors and possible logistic delays. The specification of the `registration number of the place of production' as part of the additional declaration is ambiguous, for the following reasons: a) not clear what type of `code' or description is added to the ad by third countries. b) there are `various' codes requested from third countries, such as the `traceability code' and sometimes the PUC. c) Communication is required by the European Commission to third countries on this specific issue, prior to enactment (of

Erroneously this element was not incorporated in the NL overview of additional New response: 20190226 declarations (see website: See word revision left column. https://english.nvwa.nl/topics/import- regulations-of-the-netherlands-on-plant- health/documents/import/fytosanitair/nvwa- import-fytosanitair/documents/overzicht- bijschrijvingen-alle-sectoren). This database also serves as tool for inspectors to verify the additional declaration as part of import documentary checks. Follow-up will be considered together with implementation of the upcoming (and last) amendment of the annexes of 2000/29/EC, at the end of 2019. Amendment of the database and instructions at an earlier stage will lead to unnecessary admin burdens for inspectors and possible logistic delays. Page: 1 ns, received 28 February 2019 tted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE)/2018- to 18 September 2018 in order to evaluate the system of import controls for plant health authority New Response ation number rt of the us, for the or description ries. ested from ceability code' he tries on ctment (of the ered for ons in our ts .1 and 32.1, incorporated name (or of Page: 2 ns,

The recommendation states as its basis

The work instructions include detailed provisions concerning the size of samples to be taken from lots of plants and plant products. The NVWA stated that the sampling methodology had been reviewed in light of recommendation 3 made in the previous audit report. The instructions for sampling of the main imported commodity types are summarised in Tables 2 to 4 below. Table 2: Extract of sampling instructions for plant health checks of cut flowers (source: NVWA, work instruction of 13-09-2017) Lot size (stems) Minimum sample size Unit of (number of units) per lot inspection <100 50% 400 ­ 10 000 200 10 001 ­ 25 000 300 25 001 ­ 40 000 400 40 001 ­ 55 000 500 50 001 ­ 70 000 600 Stems 70 001 ­ 85 000 700 85 001 ­ 100 000 800 100 001 ­ 125 000 900 125 001 ­ 150 000 1 000 150 001 ­ 200 000 1 100 >200 000 1 200 NOTE: the sample units must be collected from a minimum of two packages, and no more than 200 units can be collected from any single package Table 3: Extract of sampling instructions for plant health checks of fruits and vegetables (source: NVWA, work instruction of 13-09-2017) Lot size (packages) Minimum sample size Unit of (number of units) per lot inspection <100 2 100 ­ 300 3 301 - 500 3 501 ­ 1000 4 1001 ­ 2000 Packages 5 2001 ­ 3000 7 3001 ­ 4000 9 4001 - 5000 11 8 5001 ­ 6000 13 >6000 15 Table 4: Extract of sampling instructions for cuttings (source: NVWA, work instruction of 13- 09-2017) Lot size (pieces/genus) Minimum sample size Unit of (number of units) per lot inspection 1 - 200 50% 201 ­ 10 000 100 Pieces For each 10 000, or part thereof, additionally 100 Maximum 1 000 NOTE: No minimum number of packages is specified from which to select the sample units

Notwithstanding the size of the sample (in terms of the number of sample units), the audit team found that the number of packages from which samples are collected can be small in proportion to the total number of packages in a lot. The audit team observed inspections of fruits, cut flowers and cuttings, which were all sampled in line with the work instructions, and noted that: for seven lots of citrus, which contained between 1 500 and 1 780 packages, the sample was taken from five packages (since this is the unit of sampling); for one lot containing 110 packages of cut flowers of Solidago sp. the sample was collected from three packages; and for one lot containing 240 packages of cuttings of Euphorbia pulcherrima, the sample was taken from five packages.

Possible infestation in a lot or consignment may be unevenly distributed, whereby only the plants in an individual package are affected. Therefore, the small number of packages from which samples are taken, may not be sufficient in all cases to ensure that the sample can be considered representative of the lot, which is not in line with Article 13a(1)(b)(iii) of Directive 2000/29/EC.

For cuttings, the sampling methodology has been revised since the previous audit, so that every genus in a consignment is considered as a separate lot and is subject to the same level of sampling (previously, for consignments containing more than one genus, up to six genera were subject to a standard intensity of sampling, and a lower intensity of sampling was applied to every other genus). In most cases, the sampling methodology provides an adequate level of statistical reliability, according to ISPM 31. However, for small lots (<10 000 pieces), the sampling methodology generally provides less than a 90% level of confidence of detecting a 2% level of infestation, according to ISPM 31.

In some cases, the sampling methodology provided in the official work instructions may not fully ensure that samples are representative with respect to their size or selection 9 Source: NVWA Annual phytosanitary report 2017 (https://www.nvwa.nl/documenten/plant/fytosanitair/fytosanitair/inspectieresultaten/rapport-fytosanitaire- signaleringen-2017) 11 from the lot or consignment. This limits the statistical reliability of the plant health checks carried out.

Member state response

es This recommendation coincides with the ongoing EU )(iii) of harmonisation efforts as part of a new implementing act falling the under the new Official Control Regulation (art. 52). ine Therefore the Netherlands will await the outcome of this implementing act before addressing this recommendation.

recommendation coincides with the ongoing EU harmonisation efforts as part of a of new implementing act falling under the new Official Control Regulation (art. 52). Therefore the Netherlands will await the outcome of this implementing act before addressing this recommendation.

The recommendation states as its basis

The audit team noted that, with respect to sampling: Inspectors selected the sample for inspection themselves and were free from interference from third parties; Inspectors had access to the entire consignment and samples were collected from packages selected at random from different points of the consignment; The size of samples taken for inspection was in line with the work instructions (see section 5.1.4 above); The audit team observed four inspections of citrus fruits from South Africa. For one lot of Citrus paradisi, two boxes were selected for visual checks, each 20 containing 20 fruit and all the fruit in the boxes (40 in total) were inspected; for another lot of Citrus sinensis, five boxes were selected, two contained 56 fruit and three contained 22 fruit, all the fruit (178 in total) were inspected. Consequently, the inspections of these lots were not based on at least 200 fruit, which is not in line with Article 6 of Decision 2016/715. For each of the other two lots, 280 fruit were inspected in total from five boxes.

However, in line with the work instructions, inspections of citrus fruit covered by EU emergency measures against citrus black spot, are sometimes carried out on significantly fewer fruit than is required.

Member state response

rgentina, Erroneously this element was not incorporated into the s of instructions whereby for some smaller trades with bigger fruits rticle 6 (pomelos, grapefruits) the threshold of 200 fruits is not reached. These checks will be implemented starting mid January 2019, whereby instructions will specify a minimum sample size for visual inspection of at least 200 fruits of each batch of 30 tonnes, in line with the provisions of Commission Decision 2016/715. Attached is an amendment of the instructions. 20181120_06 13 Steekproefgrootte bij import_3.19.docx

rroneously this element was not incorporated into the instructions whereby for some smaller trades with bigger fruits t (pomelos, grapefruits) the threshold of 200 fruits is not reached. These checks will be implemented starting mid January 2019, whereby instructions will specify a minimum sample size for visual inspection of at least 200 fruits of each batch of 30 tonnes, in line with the provisions of Commission Decision 2016/715. Page: 3 ns, received 28 February 2019 tted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE)/2018- to 18 September 2018 in order to evaluate the system of import controls for plant health Action Proposed by the competent authority New Response Attached is an amendment of the instructions.

The recommendation states as its basis

The audit team noted that, with respect to the implementation of the checks: Inspectors had a good knowledge of the different harmful organisms which the commodities they were inspecting were most likely to host; The audit team observed three inspections of pomelo (Citrus maxima) from China, each fruit was individually wrapped in both clear plastic wrapping and red plastic netting. The inspector removed the wrapping from half of the fruit and carried out a thorough visual inspection of each fruit, cutting any fruit with suspect symptoms. The remaining fruit were not unwrapped, and the inspector carried out a visual inspection of the visible parts of the surface of the fruit. The inspection of the wrapped fruit could not be considered meticulous since much of the surface of the fruit was obscured by the wrapping materials. The inspector cited the section in the official work instructions which provided for the practice of only unwrapping 50% of the sampled units. The KCB stated that this practice was only common in the case of pomelo fruits from China, and less frequently for some consignments of blueberries (Vaccinium sp.) from South America; The audit team also observed inspections of bare root cuttings of Chrysanthemum indicum by inspectors from the Naktuinbouw, and of bare root cuttings of Euphorbia pulcherrima by inspectors of the KCB. Both checks were carried out consistently and in both cases inspectors identified whiteflies and leaf miners as harmful organisms of particular concern. The inspectors did not look at each stem (the sample unit) individually but rather looked at 50 cuttings simultaneously, checking all visible sides of the bunch of cuttings and making some effort to spread them out but not such that each cutting was separated and substantially visible; The checks of individually packaged fruit and cuttings were not considered by the audit team to be meticulous, which is not in line with Article 13a(1)(a) of Directive 2000/29/EC. A similar point (recommendation No. 2), was also made in the previous audit report. All other checks observed were considered meticulous.

Plant health checks of cuttings and individually packaged fruit cannot be considered meticulous, and this reduces the efficacy of detecting any harmful organisms which may be present.

Member state response

f The following action plan will be applied as of mid January 2019. ative Instructions will be amended for fruits which are selected as part 9/EC, of the sample size for visual examination. All possible wrapping th and other obstructions will be removed to allow proper Page: 2 2018 tions of report ref. DG(SANTE)/2018-6481-MR of the audit carried out from 11 ort controls for plant health Action Proposed by the competent authority . examination of the bare fruit (see also attachment under 3). However no follow-up will be given to the finding concerning `cuttings'. The current instructions allow for a meticulous inspection of individual cuttings. Notably they are spread out in such a way that each individual cutting can be examined for both sides. Only if an anomaly is seen on an individual cutting would this lead to picking out this cutting for further examination.

The following action plan will be applied as of mid January 2019. Instructions will be amended for fruits which are selected as part of the sample size for visual examination. All possible wrapping and other obstructions will be removed to allow proper examination of the bare fruit (see also attachment under 3). However no follow-up will be given to the finding concerning `cuttings'. The current instructions allow for a meticulous inspection of individual cuttings. Notably they are spread out in such a way that each individual cutting can be examined for both sides. Only if an anomaly is seen on an individual cutting would this lead to picking out this cutting for further examination. Additional comments: The Netherlands will incorporate inspection of cuttings as part of the annual import EU inspectors' workshop to be conducted in 2020 Page: 4 ns, received 28 February 2019 tted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE)/2018- to 18 September 2018 in order to evaluate the system of import controls for plant health tion Proposed by the competent authority New Response the Netherlands and which is also attended F3. other follow-up action is fo

The recommendation states as its basis

The audit team noted that the notification procedures laid down in Commission Directive 94/3/EC are generally complied with. However, the NVWA do not notify interceptions related to passengers' baggage, postal or courier imports (see sections 5.3.5 and 5.3.4 above respectively), which is not in line with the requirements of Article 2 of Directive 94/3/EC.

Interceptions involving passengers' baggage, postal and courier imports are not notified to the Commission and other Member States, including those involving the presence of harmful organisms or prohibited articles. This does not enable the Commission and other Member States to evaluate and potentially mitigate the risk posed by such imports.

Member state response

ssion Legally there is currently no strict requirement that such nt interceptions of passengers' baggage or packages are notified, st or except where it would concern explicitly `consignments' (see art. 1 of Directive 94/3/EC). Consignments are currently defined (art. 2-1. (p) of 2000/29/EC) as `a quantity of goods being covered by a single document required for customs formalities or for other formalities, such as a single phytosanitary certificate'. A similar definition is included in the OCR (see art. 3 (37) of EU Regulation 2017/625). Moreover the current notification model of 94/3/EC is not suitable for interceptions of passengers' baggage or packages shipped by individuals. Especially for small quantities exempted from the requirement to be accompanied by a phytosanitary certificate this is problematic as key data is missing (such as `consignor', `consignee', `type of document'), and it is very cumbersome to file such information for each individual passenger. In almost all cases the confiscated plant material is not identified at genus level, if intercepted by customs officers. It would be helpful if first a harmonised model is developed specifically geared towards notifying

all cases whereby specific harmful anisms are intercepted the NL envisages t to incorporate such interceptions in Europhyt. ' herwise, legally there is currently no strict quirement that such interceptions of ssengers' baggage or packages are notified, cept where it would concern explicitly onsignments' (see art. 1 of Directive /3/EC). nsignments are currently defined (art. 2-1. ) of 2000/29/EC) as `a quantity of goods ing covered by a single document required r customs formalities or for other rmalities, such as a single phytosanitary rtificate'. A similar definition is included in Page: 5 ns, received 28 February 2019 tted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE)/2018- to 18 September 2018 in order to evaluate the system of import controls for plant health authority New Response gulation model of ceptions of hipped by xempted from by a problematic as signor', and it is rmation for ost all cases not identified customs rmonised eared gage (for coming flight nd for rier service. ry-into-force Page: 6 ns, received 28 February 2019 tted by the competent authorities of the Netherlands in response to Report ref. DG(SANTE)/2018- to 18 September

Member state response

bevoegde autoriteit erkent de bij deze aanbeveling horende bevindingen en conclusie. Het opvolgen van de aanbeveling heeft een ienlijke impact en dient daarom goed onderzocht te worden. Er zal een impactanalyse worden gemaakt om in overleg met het erantwoordelijke Ministerie te bepalen hoe de aanbeveling opgevolgd zal worden en op welke termijn dit gerealiseerd kan worden. Gezien de beperkte bezetting in de zomerperiode is het nog niet mogelijk om concrete acties te formuleren. Zodra hierover meer duidelijkheid kan worden gegeven wordt DG SANTE hierover geïnformeerd."

The recommendation states as its basis

No documentary checks are carried out for the products covered by Commission Regulation (EC) No 669/2009. The importers submit data in the Client-VGC and the computerised system checks automatically that all necessary boxes have been filled in. After this, consignments are selected randomly for identity and physical checks or released. The data in the Client-VGC is not verified against any certificates (e.g. phytosanitary) or commercial documents accompanying the consignment, which is not in line with Article 8(1)(a) of Commission Regulation (EC) No 669/2009 and the definition of documentary checks in Article 2(17) of Regulation (EC) No 882/2004.

For consignments covered under Commission Implementing Regulation (EU) No 884/2014 and Commission Implementing Regulation (EU) No 885/2014, the persons responsible for the load do not have to provide Customs with the original health certificate. It is sufficient to email a scanned copy of the certificate to Customs. This does not make it possible to ascertain the authenticity of the health certificates contrary to the requirements of Article 9(2) of Commission Implementing Regulation (EU) No 884/2014 and Article 8(1) of Commission Implementing Regulation (EU) No 885/2014.

Documentary checks for products of non-animal origin are not implemented in line with EU requirements; therefore such checks cannot ascertain if, where relevant, consignments are accompanied with authentic or appropriate health certificates, results of analyses performed and other relevant documents. 8

Member state response

e De vastgestelde omissies zullen worden opgelost in overleg met de eigenaren van de betreffende GIP-faciliteiten. Streefdatum: 1 oktober 2017 Page: 1

The recommendation states as its basis

Drivers' certificates of competence are issued by the Dutch Driving Test Organisation (Centraal Bureau Rijvaardigheidsbewijzen ­ CBR).

Regarding the vehicle's conditions: the full range of checks carried out by the RDW for a new vehicle approval is also performed when renewing the 5-year approval (Article 18 of Regulation (EC) No 1/2005); the Dutch certificates of approval currently do not distinguish which vehicles are appropriate for weaned and which are appropriate for unweaned animals, contrarily to what is required by Chapter IV Annex III of Regulation (EC) No 1/2005. This implies that unweaned animals may be transported on vehicles that are inadequate for this category of animals with the biggest risk being the inability to access liquids due to unsuitable drinking devices (Point 2.2 of Chapter VI, Annex I of Regulation (EC) No 1/2005). The NVWA indicated that it intends to split the vehicle approval on this basis: one approval for "calves younger than 2 months" and another for "calves over 2 months" (similarly, one for "lambs and kids younger than 6 weeks" and another for "lambs and kids over 6 weeks). This was supposed to start after 1 January 2017, but has been delayed; the new start date is 1 July 2017; the stocking density (Point 2.1 Chapter III, Annex I of Regulation (EC) No 1/2005) is checked during loading; the presence of an official at 100% of loadings also allows the NVWA to check: o maintenance conditions of the vehicle and space above the animals (Points 1.1. and 1.2 of Chapter II, Annex I of Regulation (EC) No 1/2005); o appropriate bedding for the animals and suitability of the vehicle's drinking devices for the species and categories of animals that are to be transported (Points 1.2 and 2.2 of Chapter VI, Annex I of Regulation (EC) No 1/2005).

The current system for certification of approved vehicles does not sufficiently distinguish the types of vehicle appropriate for weaned and unweaned animals. As a result unweaned animals may not have access to liquid and be if necessary fed during long distance journeys. The risk of unweaned animals being transported in these unsuitable vehicles is sufficiently mitigated in the Netherlands by systematic controls at the moment of loading. However, this shortcoming may negatively impact journeys starting from another Member State, where the suitability of the vehicles may not be systematically verified at the moment of loading as in the Netherlands.

The recommendation states as its basis

Contingency plans, set up by transporters as required by Regulation (EC) No 1/2005, do not include measures to provide bedding, feed and water to the animals in the eventuality of unexpected long delays at the EU border. There are therefore inadequate assurances that the needs of animals blocked at the border can be met and that these animals are not caused unnecessary suffering.

Member state response

he Besluit Houders van Dieren is revised, the text will be brought into line with that of the translation of Directive 2008/120/EC. The procedure for doing this started recently. When it will be completed depends on the progress made, but it may be by the end of 2018.

Member state response

On the basis of the Declaration of Dalfsen, the Tails Steering Committee, which includes representatives from sectoral organisations, the research community (Wageningen University and Research (WUR)), animal welfare organisations and the Government, has included this in its road map. A risk assessment protocol is being prepared which is in line with the principles on which the guidance in Commission Recommendation (EU) 2016/336 of 8 March 2016 is based, and/or other appropriate best practice. It is planned that the broad outlines of the risk assessment protocol should be in place by the end of 2017, and that it will in the first instance be applied in holdings participating in the practical network. It will be elaborated further in 2018, with a view to introducing it nationwide in 2019. The Tails Steering Committee is responsible for this, and the Government will monitor progress and assess whether the risk assessment protocol is in line with the principles of the Recommendation. In 2018 instructions and guidance will be drawn up for NVWA inspectors, so that they are able to assess whether pig holdings comply with the provisions on the prevention of tail-biting and avoidance of rou

Member state response

t, too, has been included in the road map, as referred to under commendation 2. It is planned that the current brochure (from 2007) should be vised in the first half of 2018. The revised version will be based on the guidance t out in Commission Recommendation (EU) 2016/336 and/or other suitable best actice. The Tails Steering Committee is responsible for this, and the vernment will monitor progress and assess whether the instructions and idance are adequate. A communication campaign is to be conducted first, in der to bring the new guidance to the attention of pig farmers. 2018 instructions and guidance will be drawn up for NVWA inspectors, so that ey are able to assess whether pig holdings comply with the provisions on the evention of tail-biting and avoidance of routine tail-docking, and to enforce em. Enforcement will start in 2019. Risk-based compliance assessment will be lled out, as part of the strategy to move the pig sector towards phasing out of utine tail-docking in pigs.

The recommendation states as its basis

NVWA responded promptly and in general appropriately to the outbreak of Rsr1 in roses. NVWA elaborated hygiene protocols for places of production of Rosa whilst Naktuinbouw, in collaboration with producers, developed advanced quality standards for the production of propagating material. However, for cut flowers the risk of further Rsr1 spread was not fully addressed.

Member state response

a The NVWA will follow up this recommendation. If there will be a finding in a crop at a Rosa cut flower producer, and this crop is suspected to be contaminated, this crop is blocked and it is no longer allowed that cut he flowers are sold during confirmation of the .1 contamination. In the case, the suspicion is confirmed, the crop st be destroyed and delivery of this crop is not allowed. Figure 2 will be amended in the NVWA documents (see below), and Naktuinbouw and the stakeholders will be informed. Page: 1 ations received 14 February 2018 ands to the recommendations of report ref. 25 September 2017 to 29 September 2017 in stonia solanacearum in Rosa CUT FLOWER GROWERS water sample NO NEGATIVE pending plus / contaminated1) Delivery no delivery of material for allowed propagation to propagating company Official measures (T1) ar delivery to end consumers is not allowed NEGATIVE official release (T4) (Freedom to operate) delivery from this lot allowed official Release Page: 2 (T5) ations received 14 February 2018 ands to the recommendations of report ref. 25 September 2017 to 29 September 2017 in stonia solanacearum in Rosa ter basin, which may contain many harmless bacteria,offici

The recommendation states as its basis

Nevertheless, the methods used to allocate responsibilities to the different competent authorities and laboratories involved, and the information available to the laboratories and reporting officers, did not allow the gathering and identification of the relevant Salmonella isolates for the populations required by point 1(a) of Part A of the Annex to Decision 2013/652/EU. As a consequence, the available Salmonella isolates were not tested and/or reported (see points 22 and 25) in order to achieve the minimum number required. 1 http://ec.europa.eu/food/audits-analysis/country_profiles/details.cfm?co_id=NL 3 Conclusions on the competent authority

The competent authorities responsible for the monitoring of AMR are clearly designated, adequately organised and have the necessary powers for the implementation of the harmonised monitoring of AMR. Nevertheless, there are gaps in the allocation of tasks and in the information available to the different authorities involved in the gathering, selection and testing of Salmonella isolates. These gaps had a negative impact on achieving the Decision 2013/652/EU targets for these bacteria.

In 2014, the competent authority did not report any Salmonella isolates obtained at farm level for the three categories requested by Decision 2013/652/EU (broilers, laying hens and turkeys), despite their availability. The competent authority stated that some of the reported isolates may have originated from samples taken in the context of the SNCP but the flow of information does not allow distinguishing them from isolates from other origins.

Data on the isolates provided by the RIVM do not include information regarding the sampling programme/context, which does not allow the NRL for AMR to ensure that an adequate selection of isolates is subject to AST. As a consequence, all the reported Salmonella isolates were identified as obtained from caeca at slaughterhouses while their origin was unknown.

The RIVM is responsible for the selection of isolates that are submitted to the NRL for AMR for AST. However, the RIVM only gathers a small amount of isolates obtained under the SNCP. This is not in accordance with the technical requirements of point 2.3.2 of Part A of the Annex to Decision 2013/652/EU as, if available, Salmonella isolates obtained in the framework of the national control programmes shall be collected to achieve the minimum number required.

The Agriculture and Nature division of the NVWA oversights the SNCP. The official samples taken within the SNCP are tested in the Animal Health laboratory. The isolates obtained have not been subject to AST so far, since the NVWA staff with responsibilities over the SNCP were not aware, before this audit, of the provisions of Decision 2013/652/EU that requires subjecting these isolates to AST. 2 http://ec.europa.eu/food/audits-analysis/audit_reports/details.cfm?rep_id=3245 6

The Salmonella isolates obtained from the official samples taken in the context of testing and verification of compliance with Regulation (EC) No 2073/2005 were gathered and subject to AST but the results were not reported to EFSA, as required by points 1 (a) and 2.2 of Part A of the Annex to Decision 2013/652/EU. The NVWA stated that the AST results for these Salmonella isolates were excluded from reporting to EFSA because the isolate information available in the database to the reporting officers was insufficient to allow, for example, the exclusion of repeated epidemiological units.

In the three slaughterhouses visited the audit team noted that the food business operator's private laboratories regularly obtained Salmonella isolates. Contrary to point 2.2 of Part A of the Annex to Decision 2013/652/EU, these isolates were not gathered by the competent authority despite the fact that the official isolates available were not sufficient to achieve the minimum required (see point 11). Isolates gathered from caecal samples collected at slaughter

Nevertheless, and due to deficiencies in the organisation, including the information flow of the Salmonella isolates gathering by the competent authority, the minimum numbers required were not achieved and reported accurately.

Member state response

of isolates (Salmonella isolates from SNCP, 2160/2003 /2005 controls) and required information was made mandatory private labs recently. tion on isolates and flocks tested (2160/2003) SNCP is in KIP data base, access and analysis of this data will be improved soon. Isolates obtained from Official sampling in scope of 2073/2005, "verification projects", will be supplied to the laboratory with required information to allow reporting.

ssion of isolates (Salmonella isolates from SNCP, 2160/2003 2073/2005 controls) and required information was made mandatory for private labs recently. formation on isolates and flocks tested (2160/2003) SNCP is in KIP data base, access and analysis of this data will available starting January 2018. Isolates obtained from Official sampling in scope of 2073/2005, "verification projects", will be supplied to the laboratory with required information to allow reporting starting January 2018.

The recommendation states as its basis

Nevertheless, and contrary to point 2.3 of Decision 2013/652/EU, the allocation was not made on the basis of the annual throughput of domestically produced meat. For example, in the poultry slaughterhouse visited the audit team was informed that over 60% of the broilers slaughtered originated from other Member States.

In accordance with the procedures in place, samples were generally taken on the same day of the week. This is contrary to point 2.3 of Decision 2013/652/EU that requires that the AMR monitoring programme should be randomised. The audit team noted that there was sufficient sample transport services available to allow a better sample randomisation.

The procedures in place did not ensure that, as requested by point 2.3.1 of Part A of the Annex to Decision 2013/652/EU, repeated epidemiological units were excluded from sampling. In two slaughterhouses visited the audit team noted that repeated epidemiological units were sampled. In the case of broilers the procedures in place did not ensure that the flock (which is according to the Decision the epidemiological unit for poultry) was the sampling epidemiological unit. Isolates from meat samples collected at retail

Weaknesses in the procedures in place ensuring a proportional sample allocation to slaughterhouses based on the throughput of domestically produced animals, sample randomisation design and avoidance of sampling repeated epidemiological units undermine the representativeness of the samples taken. 5.2.2 OFFICIAL LABORATORIES Legal requirements Article 10 of Directive 2003/99/EC; Article 4 and Annex Part A.5 of Decision 2013/652/EU. Article 33 of Regulation (EC) No 882/2004. Findings

Member state response

hasis on planning of sampling on domestic slaughter volumes. ratory working days and frequency of sample transport on some slaughter houses, is sampling on all weekdays not ut better randomisation will be discussed and implemented. Before reporting to EFSA all the farm numbers (UBN numbers) in the total file will be checked to assure every bacterial isolate origins from a unique epidemiological unit. Any sample originating from the same epidemiological unit will be excluded from the data.

e emphasis on planning of sampling on domestic slaughter volumes. laboratory working days and frequency of sample transport lity on some slaughter houses, is sampling on all weekdays not le. , but better randomisation will be discussed and implemented. Randomization and communication of flock identification was implemented for monitoring projects starting January 2017. See attached `projectprotocols' for pigs, veal and broilers (relevant sections are highlighted). The protocols do not fully prevent repeated sampling of the same epidemiological units, but allow for correction afterwards. Before reporting to EFSA all the farm numbers (UBN numbers) in the total file will be checked to assure every bacterial isolate origins from a unique epidemiological unit. Any sample originating from the same epidemiological unit will be excluded from the data.

The recommendation states as its basis

In both laboratories the procedures in place were generally in line with the relevant standards. However, the audit team noted the following: NVWA laboratory: o Despite the fact that the laboratory performed investigations of unusual results of MIC determination, the documented procedures in place did not detail these situations specifying the actions to be taken. o There were no procedures in place, in line with ISO 20776-1:2006 and Clinical and Laboratory Standards Institute (CLSI) M07-A10, to perform colony counts on inoculum suspensions in order to ensure that the required final inoculum concentration is routinely obtained and therefore the test wells contain an adequate number of cells. o In the cases of sulphonamides and trimethopin the MIC determination was not fully harmonised, following the ISO 20776:2006 standard, between different staff performing the determination. o Incubation time and temperatures for MIC determination were not performed fully according to ISO 20776:2006 and CLSI standards as required by point 3 of Part A of the Annex to Decision 2013/652/EU. In particular, the time/temperature defined for incubation of Campylobacter, Salmonella and E. coli included deviations, from the above standards, by up to 1ºC and 4 hours. These deviations might have an effect in the MIC values obtained. NRL for AMR o Contrary to point 4.1 of Part A of the Annex to Decision 2013/652/EU, the ESBL testing procedures were not fully in line with the EURL protocol for ESBL-, or AmpC- or carbapenemases-producing E. coli. Only one colony, instead of three, was subcultured in blood agar and not in MacConkey agar with cefotaxime as 11 required by this standard. In addition, the laboratory's acceptance protocols did not ensure, despite the notable improvement from 2015, that the test commenced always within 48 hours of taking the sample as requested by the EURL protocol. o Temperature requirements for Campylobacter MIC determination as specified in the laboratory procedures were aligned with the relevant CLSI standards, but the incubator used was set at 36 +/- 2ºC when the standard specifies that incubation should be carried out at 36-37ºC. The incubation time set in the procedures for Salmonella and E. coli MIC determination included deviations from ISO 20776:2006 up to 4 hours. These deviations might have an effect on the MIC values obtained.

Nevertheless, improving the laboratory procedures to ensure full alignment with the incubation times and temperatures set in the relevant standards, would further strengthen the quality of the results obtained.

Member state response

has implemented a quality check of the coecal samples by checking the period between the sampling and arrival at the laboratory. All samples arriving later than two days after sampling will be excluded from the monitoring programme. The NRL has modified the protocol for isolation of ESBL/AmpC- producing E. coli according to the EURL protocol by substituting the blood agar plate in the second sub-culture step by a MacConkey agar with 1 mg/L cefotaxime. This has been implemented from the start of 2017. Both the NRL and NVWA will review their laboratory procedures and bring the procedures in line with the ISO and CLSI standards. Specifically incubation times and temperatures for Campylobacter, Page: 1 ef. DG(SANTE)/2016-8919-MR of the audit carried out from 10 stance in zoonotic and commensal bacteria in certain food- apted. The amended incubation 2017. sis will be placed on recognition ng of the results of sensitivity analysis. ning of the personnel doing the actual

e NRL has implemented a quality check of the coecal samples by checking the period between the sampling and arrival at the laboratory. mples arriving later than two days after sampling will be excluded to from the monitoring programme. The NRL has modified the protocol for isolation of ESBL/AmpC- Page: 1 ly 2017 ort ref. DG(SANTE)/2016-8919-MR of the audit carried out from 10 resistance in zoonotic and commensal bacteria in certain food- to the EURL protocol by substituting the nd sub-culture step by a MacConkey agar has been implemented from the start of eview their laboratory procedures and with the ISO and CLSI standards. s and temperatures for Campylobacter, be adapted. The amended incubation ed in 2017. emphasis will be placed on recognition reading of the results of sensitivity analysis. training of the personnel doing the actual

The recommendation states as its basis

The veterinary and imports division of the NVWA is responsible for reporting AMR data under Decision 2013/652/EU to EFSA. The verification of the reported data, prior to their uploading, is minimal. As a consequence, the omission of some compulsory reporting areas, such as Salmonella isolates at farm level and in the context of Regulation (EC) No 2073/2005, was not noticed.

In the case of the Salmonella isolates reported in 2014 and 2015 the sampling stage and the matrix was reported incorrectly.

Also incorrect isolation dates were reported for the ESBL-producing E. coli isolates tested in 2015 by the NRL for AMR where different isolation dates were reported for the first and second panel testing of the same isolate.

The ESBL-producing E. coli identified in 2015 from bovine and pig meat retail samples were not reported. The competent authority stated that this was due to a mistake.

The competent authority could not exclude that isolates from repeated epidemiological units were reported, which is requested by point 2.3 Part A of the Annex to Decision 2013/652/EU.

The collection form used for reporting the `generic description of the implementation of the AMR monitoring' was not submitted to EFSA. Conclusions on assessment and reporting of AMR

The annual report includes all the mandatory information for each individual isolate reported under harmonised monitoring, and a significant amount of information reported on a voluntary basis which exceeds the current mandatory monitoring under EU legislation. There are though some weaknesses in the completeness and quality of information provided for some isolates and the lack of overall description of the implementation of AMR monitoring that have an influence on the harmonised reporting of AMR data. 13

Member state response

mphasis on the reporting process will be implemented in 2017. A eting, every 6 weeks, of people involved in data providing and ng is already implemented uncertainty about the exact meaning of the "isolation data" was 2016 data) rting of compulsory data. a is reported from NL, and some data on meat (ca. 40 isolates) did not make it ementation of the AMR monitoring, in ed in the reporting of 2016 data. e is a good description of the to fill the text forms.. Page: 2

ore emphasis on the reporting process will be implemented in 2017. A ar meeting, every 6 weeks, of people involved in data providing and porting is already implemented 2016 uncertainty about the exact meaning of the "isolation data" was 017 (2016 data) reporting of compulsory data. y data is reported from NL, and some data on m red meat (ca. 40 isolates) did not make it implementation of the AMR monitoring, in ncluded in the reporting of 2016 data. there is a good description of the used to fill the text forms. ompleted according to the EFSA manual of reporting Page: 2

The recommendation states as its basis

Specific checklists for controls on traceability and labelling are in use. However no checklists or sampling reports of meat products were available on the use of additives. The V&I checklist for traceability and labelling (effective from 15-02-2015) does not 4 contain detailed questions on internal traceability and quantitative traceability (mass balance). In-depth verification of traceability within establishments is rarely performed.

The CA did not have a special checklist or instructions for checking the use of additives. Evidence of official sampling was not available in the establishments visited.

The Dutch CA has clarified their position in a note to the DG Health & Food Safety dated 3 June 2015 concerning internal traceability, pointing out that neither Article 18 of Regulation (EC) No 178/2002 nor the Commission Guidance on the implementation of Regulation (EC) No 178/2002 European law imposes any obligations on FBOs to have an internal traceability system, and that, as a consequence, the NVWA cannot impose requirements in this regard. The only exception concerns the traceability of beef.

The requirement that FBOs must be able to demonstrate from whom products are received and to whom products are delivered is checked and enforced. However, if the mass balance (correlation of quantities received with output of final product, quantities in-storage and production losses) is not correct, or absent, no follow-up actions are taken and no sanctions can be imposed.

A control system is in place and developments to improve mechanisms for detection of fraud and traceability control are in progress. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. However, controls on traceability are not sufficiently thorough and controls on the use of additives are inadequate. Staff have not received effective training on the issues covered by this audit. 5.2.2. Implementation of official controls

The audit team verified the documentation of these 12 files. The outcome of this exercise was as follows: Qualitative tracing (one step backwards, one step forwards) was satisfactory in all cases. In 4 out of 12 cases, the correlation of quantities along the production chain was satisfactory. In the other eight, the CA did not verify the amount produced against the raw material intake, the product recipes, the technical specifications of the additives and spice mixtures used. The absence of reliable production sheets was noted. Many commercial documents were not fully compliant with the requirements set out in in Article 3 of Regulation (EU) No 931/2011. The CA did not verify that dispatch documents contained sufficient information (lot number, batch no., description) to reliably link the consignment with the documentation. 7 In one sample the tracing of the additives had not been possible due to the large number of additives.

The audit team selected five out of the twelve files for on-the-spot verification of the data provided by the CA. The outcome of this exercise was as follows: Qualitative tracing was satisfactory in three out of five cases. However correlation of quantities (received, used, in-stock, dispatched) was not conclusive in any of the five cases. When checked in detail, inconsistencies, which had not been identified by the CA, were found. In the five cases, the team confirmed the evaluation by the CA that the food labelling was not compliant. In addition the audit team identified that: A sample of meat was named "kogelbiefstuk" (topside), giving the impression that it was "fresh meat" however the label on the back indicated that it was a meat preparation due to the addition of additives to prolong shelf life and to correct the decolouration. Such a description is misleading to consumers. In addition the label on the product indicated the presence of stabiliser E415 however this additive only had a function in the marinade used. In one meat product (sample file verified on-the-spot), E412 was used without technical justification and was not mentioned on the label. The FBO stated that this additive will no longer be used for this product. During the tracing of one product, the CA had not identified that the same production code was used for products already produced and to be used in the future with the same intermediate product. In the freezer store, 200 kg of intermediate product was stored and was not included in the mass balance calculation. Conclusion on official controls on food processing chain

Impressive resources had been mobilised to facilitate this audit and to trace the 12 samples. However, the outcome of the traceability exercises conducted by the audit team within this audit demonstrates that controls are not sufficiently rigorous to detect some important deficiencies, in particular, in relation to accounting for all meat and ingredients used and to information on commercial documents and labelling. 5.2.2.2.Official controls on Food Business Operators' obligations Audit findings

Within planned CA visits, the time normally allocated for the CA comprehensive controls on the labelling and traceability is much shorter than the time used for the tracing of the 12 samples during this exercise. This could explain that, contrary to the findings during this audit, the results of most planned inspections did not indicate systemic non compliances regarding traceability, labelling and use of additives.

The audit team noted shortcomings in relation to follow-up of deficiencies in some of the establishments visited. In one establishment, in particular, the CA had noted significant shortcomings in relation to traceability and critical control points but these had not been addressed during follow-up visits.

In one establishment the audit team identified the presence of eight bags of dried blood without identification. The provider of dried blood had a procedure to remove all labels (including identification marks, process codes, use-by-date, etc.) from product supplied. The CA informed the DG Health & Food Safety that, while a warning had been issued to the provider of the dried blood, no further action had been taken. (see also paragraph 39 fourth sub indent).

Control of incoming goods: In three establishments visited, some meat and meat products had been accepted without the required health mark or identification mark. In one of them (a large distribution centre), in the reception area three consignments out of six were not compliant. In a cutting plant, the individual commercial documents of the incoming consignments from one supplier did not correspond with the content of the corresponding truck. A difference of 200 half pig carcasses was noted on three consignments. The FBO control at entry did not identify these discrepancies. A similar discrepancy (altering of commercial documentation to correct a significant weight difference) had been noted by the audit team in the file of one of the samples selected for the traceability exercise (see paragraph 27) where the same cutting plant was involved. In a cold store the procedure for control at reception for chilled and frozen products was not sufficiently thorough. A wrong batch number was attributed and, although it had been identified that a consignment had an elapsed use-by-date and was blocked in the system, other inaccuracies in the documentation were not noticed during entry control. 9 The FBO had accepted the dried blood (see paragraph 37) without any comments and stated that the procedure for the control of the incoming ingredients did not include the verification of the labelling. The CA informed the audit team that an inspection would be initiated the following week.

Traceability systems: In one establishment visited the FBO had no traceability procedures in place: products were registered but without any link to the individual consignment such as production dates or codes, batch numbers, the accompanying documents. Although during a previous inspection, the CA had identified that traceability was inadequate, no follow-up on this non-compliance had been carried out. During the visit the CA stated that a fine would be issued for this non-compliance. In several establishments, some products were unidentified and there were open packages without identification. In a number of cases, quantities of raw materials, product in stock, and product dispatched did not correlate. In other cases, the information available did not allow a reliable calculation: e.g. absence of internal traceability records; quantities based on estimates which did not take into account produce not meeting specification (sent for re-work); anomalies in calculation of use-by dates. In one cutting plant, an employee did not follow the FBO's own traceability procedures: the procedure for traceability of pig meat was used instead of that for bovine meat. The consequence was that a batch of beef meat exceeded more than one day's production, contrary to the requirements of Regulation (EC) No 1825/2000. In addition, the FBO's procedure for pig meat had not yet been adapted in line with the requirements of Regulation (EU) No 1337/2013. One operator used the same production code for products already produced and to be used in the future with the same intermediate product. This could lead to products with the same product codes and different use by dates. In one case, the FBO own procedures for determining shelf-life and use-by-dates was imprecise and, in any case, was not followed. In several establishments, old obsolete labels were still present on plastic crates, causing confusion on the origin of the products.

Use of additives: In one establishment, according to the recipe of one non-heat treated meat product, the content of nitrite to be used was above the legal limit set out in Regulation (EC) No 1333/2008. Specifications, on several additive pre-mixes seen, did not mention the content of the additives for which a maximum limit is established and consequently this does not allow calculation of the maximal amount to be used. Official controls do not include checks on the use of additives.

The significant non-compliances in one establishment raises question as to the efficacy of the official controls in this particular case. Concerning the many non-compliances relating to the incoming goods, while none of them can be considered as critical, their range and frequency indicate that, notwithstanding the official system in place, controls are superficial and unable to detect any systemic non- compliances regarding traceability (particularly with regard to quantities) and labelling. A contributing factor is the insufficient time allocated for checks on traceability during official controls. No systematic official controls are performed on the use of food additives by FBOs.

The absence of official controls on the flow of product through establishments undermines the effectiveness of the overall system of traceability.

The Dutch CA considers that for the production of MSM ("type 4") with reference to point 4 Chapter III, Section IV of Annex II of Regulation (EC) No 853/2004, there is no time limit between deboning and production of MSM. The FBO producer of MSM visited restricts the use of the poultry carcasses to five days after slaughter because they produce only "type 4", but has no indication if the three days between slaughter and cutting had been respected in all cases. In addition, the use by date (three days) of the 11 deboned poultry carcasses fixed by a German supplier was ignored by this FBO and had expired. The CA undertook to follow-up this issue.

The recommendation states as its basis

The CA did not have a special checklist or instructions for checking the use of additives. Evidence of official sampling was not available in the establishments visited.

A control system is in place and developments to improve mechanisms for detection of fraud and traceability control are in progress. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. However, controls on traceability are not sufficiently thorough and controls on the use of additives are inadequate. Staff have not received effective training on the issues covered by this audit. 5.2.2. Implementation of official controls

The audit team verified the documentation of these 12 files. The outcome of this exercise was as follows: Qualitative tracing (one step backwards, one step forwards) was satisfactory in all cases. In 4 out of 12 cases, the correlation of quantities along the production chain was satisfactory. In the other eight, the CA did not verify the amount produced against the raw material intake, the product recipes, the technical specifications of the additives and spice mixtures used. The absence of reliable production sheets was noted. Many commercial documents were not fully compliant with the requirements set out in in Article 3 of Regulation (EU) No 931/2011. The CA did not verify that dispatch documents contained sufficient information (lot number, batch no., description) to reliably link the consignment with the documentation. 7 In one sample the tracing of the additives had not been possible due to the large number of additives.

The audit team selected five out of the twelve files for on-the-spot verification of the data provided by the CA. The outcome of this exercise was as follows: Qualitative tracing was satisfactory in three out of five cases. However correlation of quantities (received, used, in-stock, dispatched) was not conclusive in any of the five cases. When checked in detail, inconsistencies, which had not been identified by the CA, were found. In the five cases, the team confirmed the evaluation by the CA that the food labelling was not compliant. In addition the audit team identified that: A sample of meat was named "kogelbiefstuk" (topside), giving the impression that it was "fresh meat" however the label on the back indicated that it was a meat preparation due to the addition of additives to prolong shelf life and to correct the decolouration. Such a description is misleading to consumers. In addition the label on the product indicated the presence of stabiliser E415 however this additive only had a function in the marinade used. In one meat product (sample file verified on-the-spot), E412 was used without technical justification and was not mentioned on the label. The FBO stated that this additive will no longer be used for this product. During the tracing of one product, the CA had not identified that the same production code was used for products already produced and to be used in the future with the same intermediate product. In the freezer store, 200 kg of intermediate product was stored and was not included in the mass balance calculation. Conclusion on official controls on food processing chain

Impressive resources had been mobilised to facilitate this audit and to trace the 12 samples. However, the outcome of the traceability exercises conducted by the audit team within this audit demonstrates that controls are not sufficiently rigorous to detect some important deficiencies, in particular, in relation to accounting for all meat and ingredients used and to information on commercial documents and labelling. 5.2.2.2.Official controls on Food Business Operators' obligations Audit findings

Within planned CA visits, the time normally allocated for the CA comprehensive controls on the labelling and traceability is much shorter than the time used for the tracing of the 12 samples during this exercise. This could explain that, contrary to the findings during this audit, the results of most planned inspections did not indicate systemic non compliances regarding traceability, labelling and use of additives.

Use of additives: In one establishment, according to the recipe of one non-heat treated meat product, the content of nitrite to be used was above the legal limit set out in Regulation (EC) No 1333/2008. Specifications, on several additive pre-mixes seen, did not mention the content of the additives for which a maximum limit is established and consequently this does not allow calculation of the maximal amount to be used. Official controls do not include checks on the use of additives.

Labelling: 10 In one establishment visited, MSM was not mentioned on the labels because the FBO stated that the official instruction will only be applicable from 1/1/2016 and many retailers have not yet amended their IT system (see paragraph 19). Cases were seen where additives used were incorrectly specified on the label; or additives were mentioned but not used; or additives were used but not mentioned (including ingredients such as smoke flavouring). In one establishment the presence of Category 3 animal by-products was not identified and labelled as such.

The significant non-compliances in one establishment raises question as to the efficacy of the official controls in this particular case. Concerning the many non-compliances relating to the incoming goods, while none of them can be considered as critical, their range and frequency indicate that, notwithstanding the official system in place, controls are superficial and unable to detect any systemic non- compliances regarding traceability (particularly with regard to quantities) and labelling. A contributing factor is the insufficient time allocated for checks on traceability during official controls. No systematic official controls are performed on the use of food additives by FBOs.

The recommendation states as its basis

A clarification on the labelling requirements for meat products which have incorporated MSM has been issued and is in force since 17 March 2015. The labels must include the use of MSM. The verification of the application will only start after 31 December 2015.

The audit team selected five out of the twelve files for on-the-spot verification of the data provided by the CA. The outcome of this exercise was as follows: Qualitative tracing was satisfactory in three out of five cases. However correlation of quantities (received, used, in-stock, dispatched) was not conclusive in any of the five cases. When checked in detail, inconsistencies, which had not been identified by the CA, were found. In the five cases, the team confirmed the evaluation by the CA that the food labelling was not compliant. In addition the audit team identified that: A sample of meat was named "kogelbiefstuk" (topside), giving the impression that it was "fresh meat" however the label on the back indicated that it was a meat preparation due to the addition of additives to prolong shelf life and to correct the decolouration. Such a description is misleading to consumers. In addition the label on the product indicated the presence of stabiliser E415 however this additive only had a function in the marinade used. In one meat product (sample file verified on-the-spot), E412 was used without technical justification and was not mentioned on the label. The FBO stated that this additive will no longer be used for this product. During the tracing of one product, the CA had not identified that the same production code was used for products already produced and to be used in the future with the same intermediate product. In the freezer store, 200 kg of intermediate product was stored and was not included in the mass balance calculation. Conclusion on official controls on food processing chain

Impressive resources had been mobilised to facilitate this audit and to trace the 12 samples. However, the outcome of the traceability exercises conducted by the audit team within this audit demonstrates that controls are not sufficiently rigorous to detect some important deficiencies, in particular, in relation to accounting for all meat and ingredients used and to information on commercial documents and labelling. 5.2.2.2.Official controls on Food Business Operators' obligations Audit findings

Within planned CA visits, the time normally allocated for the CA comprehensive controls on the labelling and traceability is much shorter than the time used for the tracing of the 12 samples during this exercise. This could explain that, contrary to the findings during this audit, the results of most planned inspections did not indicate systemic non compliances regarding traceability, labelling and use of additives.

Labelling: 10 In one establishment visited, MSM was not mentioned on the labels because the FBO stated that the official instruction will only be applicable from 1/1/2016 and many retailers have not yet amended their IT system (see paragraph 19). Cases were seen where additives used were incorrectly specified on the label; or additives were mentioned but not used; or additives were used but not mentioned (including ingredients such as smoke flavouring). In one establishment the presence of Category 3 animal by-products was not identified and labelled as such.

The significant non-compliances in one establishment raises question as to the efficacy of the official controls in this particular case. Concerning the many non-compliances relating to the incoming goods, while none of them can be considered as critical, their range and frequency indicate that, notwithstanding the official system in place, controls are superficial and unable to detect any systemic non- compliances regarding traceability (particularly with regard to quantities) and labelling. A contributing factor is the insufficient time allocated for checks on traceability during official controls. No systematic official controls are performed on the use of food additives by FBOs.

As stated in paragraph 19 above, labelling requirements for meat products which have incorporated MSM has been issued and are in force since 17 March 2015. The verification of the application of these requirements will start after 31 December 2015. Conclusion on Mechanically Separated Meat

The recommendation states as its basis

The officials met during the audit had not recently received specific training on traceability, labelling or additives. The CA informed the audit team that audit teams of the IAD received informal training. During a meeting the V&I had organised an exchange of views with their staff covering meat traceability and labelling (for example, on general labelling requirements and on health claims). At the beginning of 2015 (January and February), all C&V inspectors attended a training course on the requirements set out in Regulation (EU) No 1169/2011.

A control system is in place and developments to improve mechanisms for detection of fraud and traceability control are in progress. Within the scope of the audit, the official control plans are implemented as foreseen and official controls are carried out in accordance with documented procedures. However, controls on traceability are not sufficiently thorough and controls on the use of additives are inadequate. Staff have not received effective training on the issues covered by this audit. 5.2.2. Implementation of official controls

Member state response

De bevoegde autoriteit zal op basis van dit rapport van de Voedsel- en Veterinair Bureau (VVB) verder maatregelen treffen om op de ingezette werkwijze invulling te geven aan de voorschriften in artikel 6, onder a), van Richtlijn 2008/120/EG van de Raad. Hiervoor zal de bevoegde autoriteit in goed overleg blijven met de betrokken varkensorganisaties en kwaliteitsborgingsprogramma's om ervoor zorg te dragen dat de personen die dieren verzorgen voldoende geïnformeerd zijn. Vanuit de controlerende instantie van de bevoegde autoriteit zal de naleving op de Richtlijn 2008/120/EG gericht blijven op de controle op de leefomstandigheden van de varkens en de naleving van de eisen zoals opgenomen in het besluit Houders van Dieren waarin de eisen van de Richtlijn zijn geïmplementeerd in Nederland. Op de gebieden waarin we zien dat de naleving onvoldoende is zal er gewerkt worden aan passende communicatiestrategen om het kennisniveau van de vakbekwaamheid op een hoger peil te krijgen. Dit in vergelijking zoals dat nu ook wordt toegepast in kader Page: 1 of Report ref. DG(SANTE)/2015-7417-MR of the audit carried out from 07 animal welfare of activities promoting competence of animal handlers and

The recommendation states as its basis

The audit team noted that Customs officials perform the documentary checks using a database which contains up to date and relevant information on requirements for transit consignments. The models of transit/storage veterinary certificates uploaded in the above-mentioned database are correct and comply with the model established by EU legislation. However, the audit team noted that a number of these certificates additionally bear the footnotes referring to the draft document number provided during the Standing Committee on Plants, Animals, Food and Feed. This leads to discrepancies between the certificates accompanying the consignments and the model in the database. There is no documented procedure explaining either to Customs officers or to BIP staff how to handle the veterinary certificates issued by third countries which do not bear the above-mentioned footnotes, contrary to the requirements of Article 8 of Regulation (EC) No 882/2004. The BIP staff explained that Customs officers would contact the BIP staff if the information in the veterinary certificate was unclear or if deficiencies were detected.

BIP staff stated that, when officials detect errors in the certificates, explanatory letters from the third country competent authority were routinely requested. The NVWA 4 confirmed that replacement certificates are rarely requested. Despite the absence of EU legislation on this matter, the Guidelines for Design, Production, Issuance and Use of Generic Official Certificates (CAC/GL 38-2001), issued by the Codex Alimentarius Commission, indicate that, for certain administrative corrections or if the certificates are lost or damaged, replacement certificates are foreseen. This is also reflected in the Guidance on transit. The BIP operational procedures do not indicate when explanatory letters can be accepted and when replacement certificates should be requested instead.

The veterinary checks for transit consignments at the entry BIP are implemented ensuring that consignments in transit fulfil the necessary animal health guarantees. The fact that the NVWA accepts explanatory letters when discrepancies are found during documentary checks weakens the effectiveness of the documentary controls. 5.2.2 Controls at warehouses and ship suppliers 5.2.2.1 Approval and listing of the warehouses/ship suppliers and specially approved warehouses

The recommendation states as its basis

The warehouse operators identify each box of the consignment stored in the warehouse with a label with the reference number of the arriving CVED, in accordance with the requirement of Article 1(5) of Decision 2000/571/EC. In addition, the information on the consignments stored in the warehouse is recorded in the operators' databases, in accordance with the requirements of Article 3(1) of the same Decision. Nevertheless, the audit team noted discrepancies in the traceability of consignments stored (see finding 36).

The audit team conducted traceability exercises both to trace back and trace forward a randomly selected consignment stored in the warehouse. The audit team noted the following: In one warehouse, the warehouse operator incorrectly recorded the country of origin of the product stored in the warehouse (i.e. the country of origin of the product was Canada, but it was recorded in the operator's database as Argentina). In the other warehouse, the records were correct but the boxes stored displayed labels with an incorrect CVED number.

The official staff responsible for the official controls at the warehouses perform weekly verification of the consignments stored in the warehouse concerned. The audit team noted that during these verification visits the information on the selected consignments 8 is obtained from the warehouse operators' databases and it is cross-checked with the number of boxes stored in the warehouse. Official staff do not compare the data of the operator with official data available (e.g. amounts entering and exiting the warehouse). Therefore, the verification activities are not appropriate to identify the deficiencies described in finding 36, contrary to the requirements of Article 4(2)(a) of Regulation (EC) No 882/2004. 5.2.2.3 Movement from the free/customs warehouses to the exit border inspection post

There is a well-functioning system of official controls on consignments in transit upon entry or exit from warehouses and ship suppliers which ensures that if a consignment has been manipulated during transit or does not arrive at the warehouse, this will be detected. Consignments ready for dispatch are subject to official controls. The controls during the storage are limited and do not include reconciliation exercises, which may potentially compromise the overall system of official controls at the warehouses. 5.2.3 Controls at the exit border inspection post

The recommendation states as its basis

The Veterinary and Import Division and the Consumer and Safety Division of NVWA are responsible for the planning of the monitoring plan on imported food of animal origin. The NVWA described that both divisions meet after the drafting of the monitoring plan and agree on the implementation at the BIPs. The NVWA stated that for the preparation of the following year's monitoring plan it takes into account RASFF information, quantities of imports, requirements of Regulation (EC) No 2073/2005, general information on problematic products and advice of the Office for Risk Assessment within the NVWA. There is no evidence that non-compliances not recorded in RASFF (e.g. consignments rejected at the borders due to discrepancies found during documentary checks) are considered in the risk assessment. The meetings or other discussions covering the technical side of the monitoring plan (e.g. risk identification and assessment) are not documented (see finding 6).

The monitoring plan includes residues of veterinary medicines, contaminants and microbiological examination (mainly Salmonella). The NVWA could not demonstrate that its controls are risk-based and did not present any risk assessment or other rationale for the design of the plan (e.g. for testing Trichinella in horse meat, beta-agonists in chicken meat or for excluding from testing honey or egg products, for which the Netherlands is the main country of introduction into the EU). In the absence of any such assessment, the NVWA is not in position to ensure that official controls are carried out on a risk basis as required by Article 3 of Regulation (EC) No 882/2004 (see finding 1).

Whilst there is a monitoring plan in place, the absence of a risk-based rationale for the design and content of the plan does not ensure that the plan covers all relevant commodities and the related risks. 5.1.2 Implementation of the monitoring plan

Member state response

NP Residuen Het Nationaal Plan Residuen van Diergeneesmiddelen (NPR) wordt uitgevoerd op basis van Richtlijn van de Raad 96/23/EG. De productsoorten, de aantallen monsters in relatie tot de productieomvang en per productsoort de stofgroepen, liggen vast zoals in de Annex II en Annex IV bij de Richtlijn 96/23/EG en de gerelateerde Commissie Beschikking 97/747/EG is aangegeven. De monitoring van importproducten wordt op basis van de vereisten van de Richtlijn 96/23/EG uitgevoerd. Per productgroep worden de belangrijkste herkomstlanden geïdentificeerd en doelgericht bemonsterd. In de planning van het NPR wordt rekening gehouden met de gangbaar gebruikte diergeneesmiddelen op basis van het zogenaamde formularium dat in Nederland door dierenartsen wordt gebruikt om tot de keuze van een therapeuticum te komen. De risico-afweging is beperkt tot de keuze van het subject waarvan een monster wordt genomen. Conform de Richtlijn 96/23/EG richt die risico-afweging zich op de historie van de eigenaar/aanbieder en van de subjecten waarop de monitoring is gericht (targeted sampling). Voor importproducten is in de Richtlijn 96/23/EG geen minimum monsteraantal gedefinieerd. Nederland hanteert een be

The recommendation states as its basis

Samples under "special projects" (see finding 5) are taken during physical checks at the BIPs, but they are not recorded in TRACES. The NVWA informed the audit team that these samples give an overview for specific commodities, and there are no enforcement actions in case of non-compliances (e.g. rejections, recalls, RASFF notifications). The reason presented was the big delay between the sampling and testing and the limited possibility of the product still being present on the market. BIP staff are not made aware of the results of these tests or of the outcome of the project. This lack of information undermines the ability of the BIP staff to use the intelligence gathered to better inform their actions when assessing the risks associated with imported consignments. There is no evidence that the NVWA uses the results of these "special projects" to improve the following year's monitoring plan.

The procedures in place allow for the possibility of BIP staff to take actions in case of suspicion (including detention and sampling) in accordance with Article 20 of Directive 97/78/EC. However, in practice this is limited to the consignments which are subject to various EU safeguard decisions. These controls are correctly recorded as "Suspicion" in box 28 of the CVEDPs and consignments are detained until the laboratory test results are received.

There is a system in place which could allow BIP staff to take samples in case of suspicion. However, in practice, cases of suspicion where samples are taken are limited only to consignments which are already subject to EU safeguard decisions. The absence of sample collection in regard to any consignment other than the ones subject to EU safeguard decision, together with the limited scope of the monitoring plan, undermines the effectiveness of the official control system.

The instruction on re-enforced checks issued by the Veterinary and Import Division of the NVWA requires that BIP staff take samples following the requirements of re- enforced checks for the next ten consignments as required by Article 24 of Directive 97/78/EC and Article 30 of Council Directive 96/23/EC. The instruction explicitly excludes any further sampling of subsequent consignments (i.e. from the 11th to 30th consignment). This policy decision is contrary to the objective of Article 20 of Directive 97/78/EC which requires the competent authority to carry out any veterinary checks that it deems appropriate in order to confirm or rule out suspicion. 8

The competent authority's decision not to apply re-enforced checks on consignments falling between the 11th to 30th is not in line with the Guidance on re-enforced checks and does not fulfil the objective of the legislation to confirm or rule out suspicion. This approach also has an impact on the consistency of the controls at EU level, as consignments that would normally undergo detention, and possibly testing, in the rest of the Member States do not undergo these controls in the Dutch BIPs.

Member state response

De uitslagen van monsters die zijn genomen in het kader van speciale projecten zullen not aan het GIP-personeel beschikbaar worden gesteld en in TRACES worden eregistreerd. et GIP-personeel zal in de praktijk tevens maatregelen gaan nemen in het geval van moeden van niet-naleving (inclusief inbewaringneming en bemonstering) vereenkomstig artikel 20 van Richtlijn 97/78/EG. Het betreft hierbij andere zendingen an die welke aan Europese vrijwaringsmaatregelen worden onderworpen. e beslissing van de bevoegde autoriteit om geen verscherpte controles toe te passen op endingen tussen de 11e en 30e zending is heroverwogen. Het standpunt uit 2012 is erzien en er is besloten de richtsnoeren van de Commissie ook op dit punt te gaan olgen en de werkinstructies aan te passen. Vanwege de impact vraagt dit enige oorbereiding alsmede een overgangstermijn. treefdatum: 1 juni 2016. Page: 2

The recommendation states as its basis

The NVWA is an independent agency commissioned by the VWS and the MEA. It is under the administrative responsibility of the MEA but functions as an executive delivery body for both Ministries. The NVWA is subdivided into seven divisions. The Agriculture and Nature division is responsible for the official controls of FNAO relating 5 to plant protection products (PPPs). However, the official controls do not cover microbiological contamination at primary production of FNAO.

The CAs in the context of this audit are designated. 5.2.2 Registration/Approval of Establishments Legal Requirements Article 6 of Regulation (EC) No 852/2004, Article 2 of Commission Regulation (EU) No 210/2013, Article 31 of Regulation (EC) No 882/2004 Findings 5.2.2.1 Registration of Food Establishments

Member state response

The action plan for this recommendation consists of three tivities: Use of private quality systems As explained during the audit the NVWA wants to use the information from private quality systems. In order to decide if the quality systems are fit for this purpose the NVWA is reviewing and auditing the system at the moment. Foreseen is that every company will be audited in the framework of the private quality systems from 01-07-2016 onwards. Inspections primary production 2016 The private system approach clearly shows that only at 01-07- 2017 all primary production companies will be audited. For that reason the NVWA will carry out an inspection programme in 2016 focussing on the microbiological contamination and giving special attention to awareness of the producers. Chain approach concerning lab results This means further strengthening the co-operation within the NVWA when positive lab results are found at the level of retail or wholesale, follow up inspections are carried out at the level of the primary producer. This will be implemented 01-01-2016

Member state response

All activities of an FBO will be included in the assessment and approval of plants that produce liquid egg and egg products. The pproved activities will be listed in the approval letter in detail.

Member state response

1. Aanpassing van de surveillance plannen zal dit jaar ons of opgepakt worden. Voor de EIIC's die zijn aangesloten bij de NVD x C (Dutch Zoo Association) zal dat in overleg met de NVD verlopen. Bij de aanpassingen zal met name aandacht gevraagd worden voor 9), de huidige dierziekterisico's en de lijst A ziektes. Eind 2016 zullen bij alle EIIC's de surveillance plannen aangepast zijn op dit punt. 2. De jaarlijkse audits bij de EIIC's zullen worden verdiept door herziening van de vragen in auditlijst en intensievere controles van aangevoerde dieren, hun status en de quarantaine maatregelen van de EIIC. De NVWA streeft ernaar dat de aangepaste auditlijst vanaf juni beschikbaar is voor de dierenarts- bedrijfsbeheerders. 3. Er wordt jaarlijks een intervisie bijeenkomst georganiseerd met de dierenarts-bedrijfsbeheerders. 4. Erkenningsdocumenten zullen worden geactualiseerd bij aanpassingen en verbouwingen van de EIIC. Deze wijzigingen, inclusief een herziene plattegrond, zullen in de erkenningsdossiers voortaan worden opgenomen. 5. Op de NVWA website zal bij het overzicht van de EIIC's aanvullende voorwaarden (bv de afwezigheid quarantaine) zo spoedig mogelijk opgenomen worden. Verder za

Member state response

Hoewel de expertise van aangestelde dierenartsen bij de huidige quired EIIC's groot is (het zijn alle specialisten), zijn ze er niet aantoonbaar op getoetst. In de auditlijst zal de NVWA dit jaar daarom aan aantal vragen opnemen waarmee de kennis en vaardigheden van de dierenarts zoals bedoeld in bijlage C bij de Richtlijn wordt getoetst (zie ook aanbeveling 2 onder punt 2).

Member state response

B to NVWA-NVIC zal verdenkingen direct melden aan NVWA-TO levend vee én, afhankelijk van de ziekte, aan de Nederlandse f CVO. De CVO informeert vervolgens de Europese Commissie. De erkenning van de betreffende EIIC zal bij iedere verdenking van een lijst A of B ziekte van de Richtlijn worden geschorst door NVWA-TO levend vee. Pas als de verdenking is opgeheven c.q. het bedrijf weer helemaal vrij verklaard kan worden, wordt de schorsing weer opgeheven.

Member state response

imals T.a.v. de beperking van de export van primaten naar andere lidstaten (alleen mogelijk naar EIIC's) heeft de NVWA direct na de FVO audit de NVWA instructie aangepast en de NVWA dierenartsen geïnformeerd. Verder zal 3 en 4 van de bijlage C van de Richtlijn opgenomen worden in nationale regelgeving. Naar verwachting is dit eind 2016 geïmplementeerd in de Nederlandse regelgeving

Member state response

Zie aanbeveling 1 punt, naast de algemene gezondheidseisen zal in bij de toetsing van de surveillance plannen ook de controle op lijst oint 1 A en B ziekten beter opgenomen worden. Page: 2 6 dations of Report ref. DG(SANTE)/2015-7564-MR of the audit carried out from 09 control system in place for bodies, institutes or centres approved in accordance Naast de jaarlijkse goedkeuring van de plannen, zal gewaakt worden dat direct actualisatie van de plannen plaatsvindt bij dreiging dierziekten

Member state response

t De NVWA zal de andere lidstaten binnen 6 weken via de CVO informeren over de nationale diergezondheidseisen van de niet geharmoniseerde dieren. Er zijn in Nederland 3 typen certificaten voor niet geharmoniseerde dieren waarover de andere lidstaten geïnformeerd zullen worden: 1. niet zoogdieren 2. overige zoogdieren, behalve primaten 3. primaten Page: 3

The recommendation states as its basis

The NVWA is the competent authority responsible for coordination of the use of TRACES in accordance with the requirements of Article 1 of Decision 92/486/EEC. In 2012, the structure of the NVWA was changed, which has led to the removal of the local veterinary units (LVUs) and the regions. The information on the structural changes has not been provided to the Commission in order to amend Decision 2009/821/EC. This has an impact on the use of TRACES. Currently, the official veterinarians issuing INTRA-CERTs access TRACES as the central competent authority (not as local veterinary units listed in Decision 2009/821/EC) in order to reflect the existing structure of the NVWA. The audit team noted that all INTRA-CERTs in TRACES identify the non-existing local veterinary units. This is due to economic operators accessing the system using the postal code of the region in the Netherlands following the old structure of the local veterinary units. The NVWA expressed awareness of its obligation to provide updated information to the Commission on the amendment of Decision 2009/821/EC.

The set-up of the competent authority in TRACES does not correspond to the current structure where local veterinary units of the NVWA following regional division have been removed. Therefore, all INTRA-CERTs in TRACES identify the non-existent local veterinary units. The competent authority has suitably qualified and experienced staff for TRACES activities.

Member state response

Proposal for the new structure of the competent authority was submitted to DG SANTE / TRACES-Team on 3 April 2015 and was voted in SCOPAFF of 16/17 April 2015. Implementation will be realized in cooperation with the TRACES team.

The recommendation states as its basis

Repeated non-confirmation of exit of transit consignments was noted, even though the work instructions issued by the NVWA require the confirmation of the exit of transit consignments within 30 working days as required by Article 9 of Directive 91/496/EC and Articles 11 and 12(8) of Directive 97/78/EC. In the Rotterdam BIP visited, the transit consignments were followed-up using shipping companies' IT systems to check if they left the port and that information was recorded in TRACES. The Amsterdam BIP visited does not have a follow-up system to track exit transit consignments and does not record them in TRACES.

Commercial operators pre-notify consignments exiting the warehouse using hard copy CVEDs. After veterinary checks, consignments are accompanied using hard copy CVEDs completed and signed manually by official veterinarians. These CVEDs are entered manually into TRACES by correctly using the split function, when the veterinary officials are not overloaded with veterinary checks at the warehouses. This means that some consignments are notified to the BIPs in other Member States via TRACES with a delay. As a result, those consignments can leave the EU territory without the exit BIP being able to perform the controls. The risk is mitigated since the veterinary authorities communicate with other Member States and Dutch Customs in all cases when confirmation is not received.

National instructions issued by the NVWA require the confirmation of arrival for re- imported consignments in accordance with the requirements of Article 15 of Directive 97/78/EC. However, TRACES-NL does not identify those consignments for follow-up by the veterinary inspectors at the place of destination and it is not recorded in TRACES. Re-imported consignments might be higher risk, especially if they were rejected by the third countries because of bacterial or chemical contamination. The reasons of rejection by third countries of products of animal origin produced in the Netherlands might need to be investigated.

Consignments sent for destruction are not followed up by the veterinary inspectors at the place of destination due to the set-up of the risk module in TRACES-NL. TRACES-NL does not classify those consignments as high risk and does not require them to be followed up at the place of destination contrary to the requirements of Article 17(2b) of Directive 97/78/EC. 5.2.8 Signatures

In relation to the movement of live animals from other Member States: INTRA-CERTs and CVEDs are downloaded into TRACES-NL and are filtered for official controls if this foreseen by the national risk evaluation plan. Approximately 8 percent of consignments of live animals are physically controlled at the destination (except for some live animals from several Member States where controls are carried out on 100 percent of consignments) following the requirements of Article 5(a) of Directive 90/425/EC on non-discriminatory checks. Those controls are correctly recorded in TRACES. Official controls related to ante-mortem inspections are recorded in TRACES following the frequency of 8 percent identified by TRACES-NL. The competent authority stated that the reduction in controls is due to limited human and financial resources. Even though the controls are carried out at the abattoirs, they are not recorded in TRACES contrary to the requirements of Article 2(a) of Decision 2004/292/EC. The audit team followed several cases where staff of the Agriculture and Nature Division of the NVWA carried out animal welfare controls en route and at the place of destination. Those controls were routinely recorded in TRACES as required by Article 2(a) of Decision 2004/292/EC. 5.2.10 DOCOM module

The instructions mentioned in finding 41 describe requirements on the controls to be carried out at the place of destination when certain animal by-products arrive from other Member States. Those instructions require that the controls of certain animal by- products shall be carried out on an average of 10 percent of consignments contrary to the requirement of Article 48 of Regulation (EC) No 1069/2009. The competent authority stated that the reduction in controls is due to limited human and financial resources, and the high number of animal by-products arriving from other Member States.

The use of TRACES for routine activities for imports and for intra-Union movements of live animals leaving the Netherlands is in general correct. Lack of records in TRACES reflects lack of controls by the BIPs (e.g. exit of transit consignments) or by the NVWA offices (e.g. re-imported or consignments sent for destruction). In some cases these controls are done, but not recorded in TRACES. The arrival of a number of intra-Union consignments is not controlled at the place of destination (e.g. animal by- products) or the full range of controls are not recorded in TRACES (e.g. slaughter animals). Therefore, the traceability of consignments mentioned above and the communication between the competent authorities of Member States is undermined. 11

Member state response

e- In response to the finding 18: Controls on exit of transit consignments will be prepared and carried out for all BIP's. Work instructions will be amended if necessary. Follow up of the controls will be recorded in TRACES. Target date: 01 July 2015. In response to the finding 20: CVED's are immediately entered in TRACES to prevent delay. Action undertaken promptly after the mission. In response to the finding 36: Business rule will be activated in TRACES NL to check reimported consignments 100% at the place of destination. Target date: before 01 July 2015. In response to the finding 37: TRACES NL will be extended with the possibility to select consignments sent for destruction to check at the place of destination. Request for change is formulated and has been submitted to the IT-department. National instructions will be issued /amended to carry out checks at the place of destination and to record the result in TRACES. Target date to implement: 01 August 2015. In response to the finding 40: Official controls related to ante-mortem inspections will be carried out in accordance with EU-requirements. Results of controls will be recorded in TRACES, in line with Page: 1 s of Report ref

Member state response

Vanaf het jaar 2015 staan er voor alle slachthuizen systeeminspecties "doden" gepland. Deze inspecties zijn een goed hulpmiddel om de naleving van alle voorschriften van de Verordening te controleren en tegelijkertijd de officiële dierenartsen in hun eigen werkomgeving te trainen. (29, 31, 32, this 36, 38, 40, 43, 46, 48, 50). Elektrische apparatuur in de grote slachthuizen zal speciale aandacht krijgen (43), evenals de maximale capaciteit van de onderbrengvoorzieningen in alle slachthuizen (36). De werkvoorschriften worden per 1 mei 2015 aangepast: er zal een beschrijving worden opgenomen over de wijze waarop de welzijnsverificaties uitgevoerd moeten worden. Dit betreft ook taken en verplichtingen van de dierenwelzijnfunctionarissen en bedrijfsexploitanten (27, 48). Een aantal dierenwelzijnfunctionarissen zal in 2015 aanvullende trainingen moeten volgen zodat ze voldoen aan Artikel 17 lid 4 van de Verordening (31, 49). De gids voor goede praktijken voor kleine slachthuizen voor hoefdieren is eind 2014 in gebruik genomen. Hierin staan voldoende handvatten voor slachthuizen om hun standaardwerkwijzen op te stellen (32, 46) Bevindingen 41 en 47 zijn afgehandeld: de mechanische fixati

Member state response

rds Op het VKI formulier staat de mortaliteit in de eerste week en de gecumuleerde dagelijkse mortaliteit over de gehele mestperiode vermeld. Deze gegevens worden bekeken door de slachterij en de 1 ions of Report ref. DG(SANCO)/2014-7078 -MR of a/an audit carried out from are controls in place at slaughter and during related operations. zichthoudend dierenarts op deze slachterij en indien daartoe nwijzingen bestaan is het mogelijk om op het herkomstbedrijf de overige cijfers betreffende de mortaliteit op te vragen. De dagelijkse gegevens betreffende de mortaliteit over de gehele slachtperiode zijn dus wel inzichtelijk voor de dierenarts, maar worden niet mee gestuurd naar de slachterij.

Member state response

De NVWA zal in de eerste helft van 2015 een meldingssysteem zetten. Echter, het mandaat voor het opzetten van dit meldpunt is nog niet in de Nederlandse regelgeving geregeld. Dit zal op z'n vroegst in de zomer van 2015 geregeld kunnen worden.

Member state response

ovenop de jaarlijkse controle kunnen bedrijven de volgende extra inspecties krijgen: Herinspectie (171 in 2014): wanneer blijkt dat een bedrijf op één of meerdere onderdelen niet voldoet. Gerichte inspectie (605 in 2014): wanneer tijdens een inspectie blijkt of wordt vermoed dat een bedrijf op één of meerdere onderdelen niet voldoet, bij een melding door derden over het bedrijf en in het kader van een handhavingsprotocol. Een handhavingsprotocol is een projectplan voor inspecties, inclusief eventuele monsternames, gericht op een specifiek risicogebied. Er zal een doorlopend handhavingsprotocol worden opgestart waarbij bedrijven met veel productspecificaties extra inspecties krijgen, specifiek gericht op controle van de productspecificaties. Naast deze inspecties zijn er ook extra acties: Wanneer een bedrijf dat in de risico-classificatie als "hoog risico" wordt aangemerkt dan volgen extra inspecties. Criteria die in de classificatie worden meegenomen zijn: afwijkingenhistorie, aard van de productie (alleen bio of bio en gangbaar), omzet en vrijwillige deelname aan een biologisch kwaliteitssysteem (BIOKAP, BQA) Datum gerealiseerd: 1 januari 2016

Member state response

In beginsel worden gerichte inspecties niet aangekondigd. In situaties waarbij een kwaliteitsmanager vereist is, wordt maximaal 24 uur van tevoren contact met het bedrijf gelegd. Dit gebeurt om te waarborgen dat de kwaliteitsmanager aanwezig is. Ook wordt daarmee voorkomen dat een inspecteur tevergeefs ver moet rijden en de inspectie niet kan uitvoeren omdat er niemand aanwezig is. Het leggen van dit contact is alleen bedoeld om na te Ref. Ares(2015)2274179 - 01/06/2015 of Report ref. DG(SANCO)/2014-7105-MR of an Audit carried out from

Member state response

organic production and labelling of organic products gaan of er iemand aanwezig is. Over de inhoud van de inspectie worden geen mededelingen gedaan. Datum gerealiseerd: 1 januari 2016 Tot op heden wordt één keer per drie jaar, tijdens een uitgebreide inspectie hercertificering, aan geregistreerden gevraagd een massabalans op te stellen. Voortaan wordt het opstellen van een massabalans voor elke jaarlijkse inspectie een verplichting. Datum gerealiseerd: 1 januari 2016

Member state response

Normaal gesproken lopen de inspecteurs door het gehele bedrijf heen en controleren op de scheiding tussen biologische en niet- iologische activiteiten. Echter, als het gaat om een bedrijf dat gesplitst is in twee verschillende eenheden met verschillende rechtspersonen dan kan een dergelijke rondgang niet plaatsvinden. De inspecteur heeft dan geen juridische bevoegdheid om op het gangbare bedrijf te komen. Wel wordt vanuit de biologische eenheid gecontroleerd of er een scheiding is aangebracht. Datum gerealiseerd: 1 januari 2016

Member state response

Momenteel vormt de basis voor de selectie waar monsters worden genomen: ed - Risico teelten - Bepalende weersomstandigheden - Schaarste in de markt - Meldingen door derden - Geconstateerde afwijkingen Extra actie: Bij een bedrijf dat in de risico-classificatie als "hoog risico" wordt aangemerkt zullen extra monsters worden genomen. Criteria die in de classificatie worden meegenomen zijn: afwijkingenhistorie, aard van de productie (alleen bio of bio en gangbaar), omzet en vrijwillige deelname aan een biologisch kwaliteitssysteem (BIOKAP, BQA) ef. Ares(2015)2274179 - 01/06/2015 of Report ref. DG(SANCO)/2014-7105-MR of an Audit carried out from organic production and labelling of organic products atum gerealiseerd: 1 januari 2016

Member state response

Momenteel wordt onderzocht wat de meest efficiënte en effectieve plossing is om er voor te zorgen dat laboratoriummonsters van erse producten, die bedoeld zijn om bestrijdingsmiddelen op te poren, tijdens het transport worden gekoeld. Deze oplossing ordt 1 januari 2016 geïmplementeerd. atum gerealiseerd: 1 januari 2016

Member state response

De douanemedewerkers kunnen Verordening 1235/2008 raadplegen via het Intranet van Douane (digitale boekwerken, e opgenomen in wetgeving VGEM). Een geconsolideerde versie is chter pas na enige tijd beschikbaar. Wijzigingen in relatie tot rtikel 13 lid 3 van deze verordening in verband met de controle unnen dus pas later worden geraadpleegd. m dit te verbeteren en op te lossen is gekozen om op het Intranet an Douane het van RVO.nl te ontvangen bestand, in de vorm van en Excel-model, te plaatsen. Dit is inmiddels gedaan met de aatste versie van juni 2015, waarin de wijzigingen als gevolg van ijvoorbeeld Verordening 2015/931 zijn verwerkt. et Intranet is door alle medewerkers snel en eenvoudig te enaderen. Afgesproken is dat de Douane van RVO.nl tijdig een pdate van het bestand ontvangt bij toekomstige wijzigingen en eze vervolgens op het Intranet kan plaatsen. ver deze nieuwe, aanvullende en efficiënte wijze van informatie inden, zijn de douanemedewerkers geïnformeerd. e tekstuele aanpassing in het Handboek in verband met deze ystematiek is in bewerking. atum gerealiseerd: reeds ingevoerd

Member state response

n de verordening worden geen maximum residugehalten enoemd. Daarom heeft Skal voor gebruik van niet-toegestane estrijdingsmiddelen een residubeleid opgesteld. Dit is vereenkomstig het later opgestelde EOCC-beleid. Als er sprake s van een residuwaarde onder de actiegrens (geen of Report ref. DG(SANCO)/2014-7105-MR of an Audit carried out from organic production and labelling of organic products

Member state response

2015 preparations will be made so that in the 2016 multi-annual national control plan, as established by article 40 (1) of Regulation (EU) No 1151/2012, the PDO / PGI / TSG business for products of animal and non-animal origin are in a separate section of the . In the 2015 national annual control report over 2014 we will realise this separate section already.

Member state response

Where new applications with new entrants are concerned the ederal Ministry of Economic Affairs advises the owner of the product dossier to inform the competent authority. Where new operators are concerned in relation to an existing GI or TSG, NVWA, KCB and COKZ are the competent authorities to verify these new operators. The Federal Ministry of Economic Affairs together with the competent authorities will review in 2015 how they will form this.

Member state response

g This will be arranged for 2015 in the annual projectplans of the hree competent authorities.

Member state response

the PGI product dossiers Gouda Holland and Edam Holland some requirements are laid down applicable for farm milk duction. These requirements are concerning: - hygiene (milk temperature; hygiene requirements) are inspected by the competent authority based on the EU hygiene package - milk sampling and analysis inspected by the competent authority based on the EU Hygiene package and based the Animal Act. In the inspection procedure for official control of PDO/PGI/TSG Page: 1 15 of Report ref. DG(SANCO)/2014-7109-MR of an Audit carried out from lated to Protected Designation of Origin (PDO), Protected Geographical products and foodstuffs these requirements will be incorporated. Further on will be checked that all requirements of the product dossiers are incorporated in the inspection lists on official control of PDO/PGI/TSG. If applicable additional inspection points will be incorporated. This also applies in the case/ checklists of products of non-animal origin. The origin of feed, established in Article 1 of Regulation (EU) No 664/2014; will be part of the review of NEW PDO-products of animal origin. For product dossiers from before Regulation 664/2014 came in force the requirement o

Member state response

ed Where it concerns the assessment of complaints in the retail chain action is taken by the competent authority. Official controls in the retail chain are included in the annual plan f the competent authority. Page: 2

Member state response

s A system of regular planed inspections of primary fishing vessels will be implemented as part of the official controls as described in o the inspection protocol "Official controls fish and fishproducts". The release of the new version of this inspection protocol is foreseen in January 2015.

Member state response

The CA agrees that the HACCP system of some visited companies showed certain shortcomings. But the CA is convinced however hat an efficient follow up of responsibilities as described in the Regulation 882/2004 and 854/2004 will take place. Working n- methods and protocols for HACCP and microbiological criteria are well described and applied in the daily practice. However in order to improve in 2014 feed back is foreseen to the inspectors. During the regular meetings special focus will be on the correct use of the protocols with specific attention to the storing conditions of fresh fish, company own checks and effective follow up of verifications done by the food business operators. The debriefing results will be brought under the attention of the inspectors in order to improve their work in accordance with the described working methods. In relation to the official control procedures for HACCP and the Regulation 2073/2005 as already exists, no further measures will be taken by the CA.

Member state response

On the short term (2014) regular meetings with the involved g inspectors are foreseen with a focus on the use of correct reference methods as described for histamine in the Regulation 2073/2005. The debriefing results will be brought under the attention of the inspectors in order to improve their work in accordance with the described working methods. Page: 1 ons of Report ref. DG(SANCO)/2014-7140 -MR of a/an audit carried out from

Member state response

systems in place governing the production and placing on the market of fishery the The official controls for PAH and histamine are already part of the (EC) official controls. These controls are, as part of an official ification, organized in the retail sector. However the official lyses of PAH and Histamine will be implemented for duction facilities and freezing vessels as well, complementary the official controls in the retail. This will be implemented next r in the work plan 2015 for official controls.

Member state response

cts The water testing policy is fully implemented in the control er system and guarantees the availability of potable water in all the ablishments . The existing water testing policy ensures the use safe water in all establishments according to Council Directive 83/EC. Municipal and county water companies are checking quality on a daily basis. The Environment and Transport pectorate (ILT) monitors the quality of drinking water. No ther measures are necessary. However a verification policy of quality of clean water used on primary fishing vessels for the duction of ice is not yet implemented by the owner of the sels and the CA. The CA will be resolve this in the inspection gram 2015.

Member state response

We will give specific focus on this aspect next year in the work n 2015 for official controls. Page: 2

Member state response

As of 1 January 2015 the official responsibility for the SNCP (Salmonella National Control Programme) will be transferred from the Product Board for Poultry and Eggs (current competent authority) to the NVWA (Netherlands Food and Consumer Product Safety Authority). As of that time the NVWA is the competent authority. The SNCP will therefore be reorganised with respect to tasks, responsibilities and competences as of now. If official controls will still be delegated after 1 January 2015, the organisations involved are required to be accredited, impartial and free from any conflict of interest, in accordance with Article 5(2)(b)(iii) and (c) of Regulation (EC) No 882/2004

Member state response

As of 1 January 2015 the NVWA is the competent authority. If they continue using delegated control bodies, they will carry out inspections or audits of these control bodies to which specific tasks are delegated. This in accordance with the requirements of Article 5(3) of Regulation (EC) No 882/2004. In advance of the transfer of tasks mentioned in 1, in 2014 the NVWA will start an entry-level audit of the organisations mentioned in point 1.

Member state response

During sampling a distinction will be made between official pling and own-check sampling. This distinction will be made in the database. See also recommendation 1 for the reassignment of official sample taking and analysis.

Member state response

tory sampling is carried out to demonstrate whether an infection is not only present in the livestock buildings but also in the animals. A similar verification method for laying hens is Page: 1 ns of Report ref. DG(SANCO)/2013-6696 -MR of a/an audit carried out from onal Control Programmes in particular poultry populations (breeders, laying permitted under Regulation (EU) No 517/2011. The results of this approach for the breeding flocks show that in 97.4 percent of cases a negative result for the confirmatory sampling of the animals is followed by a continued negative result for the standard controls which are subsequently carried out on the same flock. The approach followed by the Netherlands is therefore adequate and meets the objective of the Regulation. In the event of a positive screening test however, , restrictions will immediately be imposed regarding the trading of the animals and hatching eggs, pending the results of the confirmatory test sampling in animals.

Member state response

In the event of a positive result in one laying flock, the competent authorities will make sure that all other laying flocks on the same premises will be sampled according to the requirements of Regulations (EC) No 2160/2003 and (EU) No 517/2011) Page: 2

Member state response

trol NL De NVWA heeft een verbeterplan opgesteld om de kwaliteit van de werkzaamheden te vergroten. In het verlengde van dit verbeterplan, zal specifiek voor de VIP-teams (waar de diervoederteams onderdeel vanuit maken) een verbeterplan opgesteld worden, waarin de rapportage van de officiële controles in meegenomen wordt. EN The NVWA produced an improvement plan for the quality of the activities of the NVWA. In relation to this improvement plan, specifically for the VIP-inspectionteams (the Feed inspection teams are a part of the VIP-teams) an improvementplan will be set up. The reporting of official controls will be taken into account in this plan.

Member state response

De NVWA heeft een verbeterplan opgesteld om de kwaliteit van No de werkzaamheden te vergroten. In het verlengde van dit verbeterplan, zal specifiek voor de VIP-teams (waar de diervoederteams onderdeel vanuit maken) een verbeterplan opgesteld worden, waarin de verificatie van de officiële controles in meegenomen wordt. EN The NVWA produced an improvement plan for the quality of the activities of the NVWA. In relation to this improvement plan, specifically for the VIP-inspectionteams (the Feed inspection teams are a part of the VIP-teams) an improvementplan will be set up. The verification of official controls will be taken into account in this plan. Page: 1 on 27 February 2014 ns of Report ref. DG(SANCO)/2013-6753 -MR of a/an audit carried out from for the identification of hazards and management of risks along the feed

Member state response

NL Dit aandachtspunt is reeds onderkend. Bij de overdracht van taken van het Productschap diervoeder naar de NVWA, zal de registratie van diervoederbedrijven per 1 januari 2015 bij de NVWA zelf worden ondergebracht. Bij deze transitie zullen bedrijven de juiste activiteit(en) vermelden. EN This particular point is already recognized. Due to the transfer of tasks from the Productboard Animal Feed to the NVWA, the official registration of feed business operators will be accommodated by the NVWA from the 1st of January 2015. With the transition of the registration of the feed business operators, the activities will be registered in a proper way.

Member state response

y are NL of De juiste etikettering van voedermiddelen is onderdeel van de inspecties in 2014. EN The correct labeling of feed materials will be part of the controlprogram 2014.

Member state response

NL De reiniging en ontsmetting en vermijding van kruiscontaminatie by is onderdeel van de inspecties in 2014. N The cleaning of silos and avoiding of cross contamination will be part of the controlprogram 2014.

Member state response

NL De controle op de dioxinemonitoring bij mengvoederbedrijven is onderdeel van de inspecties in 2014. EN The control of the requirements of dioxinmonitoring for compoundfeed factories will be part of the controlprogram 2014. Page: 2 uary 2014 ns of Report ref. DG(SANCO)/2013-6753 -MR of a/an audit carried out from for the identification of hazards and management of risks along the feed Page: 3

Member state response

plementation of actions (sanctions) by the Competent Authority is currently being prepared with a view to their introduction if possible by 2015.

Member state response

Exit checks are carried out by using digital information on tracking & tracing sites and information from customs, which is compared to information in TRACES. Feed back information has been recorded in TRACES since 2010. There is no legal base to enforce containers being checked in at a certain location in the port for exit checks. Actually all consignments are loaded in or in the neighbourhood of the Rotterdam port area and are sealed by officials of the CA. The distance to the exit point is rather short. According to the CA the risk of manipulation is negligible. Performing checks on the containers at a certain location in the port will be of little value. The CCA will continue exit checks in this way.

Member state response

The relevant procedure is adapted. The requirement to perform n documentary checks for consignments being transhipped to third ountries, staying in a port more than seven and less than 20 days, is included Page: 1

Member state response

sure compliance of seed with the requirements 0/2003 and Directive 2001/18/EC. it is noted that the threshold applied in the authorised GM material in non-GM seed contravenes tive 2001/18/EC and Article 4 of Regulation (EC) No uld be read, as the threshold has never been applied, nsidered in the Netherlands for the authorised GM seed contravenes Article 21 of Directive cle 4 of Regulation (EC) No 1830/2003. In practice, r been applied as levels were always at or below the e threshold has never been applied. Therefore no repeatedly urged the Commission - during e meetings on 2001/18/EC and during the council ngs on the council conclusions on GMOs of 2008 - onized threshold level for the authorised GM material ands will continue to urge the Commission to re labeling thresholds for the adventitious presence of ial in conventional seeds at European level.

Member state response

rators are recently informed and instructed in Page: 1 SANCO)/2012-6312-MR of an audit modified organisms, including their deliberate the Competent Authority 3 and 5. ocuments (common entry document, health lytical report) take place at the moment of arrival, at ned in Article 3 of Decision 2011/884/EU. documentary control, Customs determines if the nd health certificate are present and if they are in Decision 2011/884/EU.

Member state response

Art. 4(2) of Decision 2011/884/EU has to be the documentary control, at the same stage as ical report and the health certificate. l verify if the declaration issued by the operator is entary control.

Member state response

e sampled and analysed according to the annual plan e in 2012. atory capacity is necessary to analyse the rice samples e border, in time. Also from the beginning of 2012, alysis is done by the RIKILT in order to generate A lab for routine GMO analysis Page: 2 SANCO)/2012-6312-MR of an audit modified organisms, including their deliberate Proposed by the Competent Authority es and the methods to be used for the detection of e in food/ feed products from China are directly enormous increase in the workload of the laboratory. nnecessary large amount of subsamples to be nt repeats of the analysis cause a lot of work. Despite ts to the commission on the methods to be used and prevent possible false positive results no response e proposed review of the decision that should have 2012, has not taken place yet. s recently given several proposals to improve the

Member state response

n up as set out in Article 9 of Regulation indicated during the mission. No action required. d out however that formally Regulation (EC) No licable to any controls with respect to Directive

Member state response

ies of the importteam, there were nt the backlog is no longer in place. A lot of been sent to Brussels earlier this year.. Page: 3

Member state response

ment the recommendation of the FVO on the e of resistance testing. The transfer of the resistance m two private laboratory owned by seed potato companies endent laboratory requires a careful transition. on facilities have to be made and knowledge has to be . The NPPO has set a deadline on November 1, 2013 for ories to present a detailed plan for the transition. uld like to emphasize that the NPPO has no doubt on of the resistance testing of both laboratories. Also in the no questions were raised on the reliability of these tests.

Member state response

plement the recommendation of the FVO concerning seed potatoes on a place of production in the year t outbreak. In the year after the finding of ring rot, the hinery and other facilities of the infested place of may only be used for ware potato production (after n). The current practice in the Netherlands will be

Member state response

s of the FVO on the definition of a field for PCN nores the essence of the approach. The essence of the odel is to sample always in small units and then defining to be declared free or ­in some cases- free and/or infested. oci model is based on very intensive sampling of real-life tions in field situations in the Netherlands, so the effect of ors for introducing and spreading of PCN factors are part d in) the foci-model. This approach is scientifically en substantiated and well documented in scientific articles. Page: 1 ref. DG(SANCO)/2012-6315-MR of an audit he potato sector Action Proposed by the Competent Authority ill start research to improve the model. Attention designate circumstances for which a more specific pplied. The approach for defining infested fields will e outcomes of the improved model.

Member state response

ch showed that potatoes grown as trap crop (full sted after 40 days, use of certified seed) can be reducing PCN populations. Only well developed brifolium are accepted by NPPO as a control ers are well aware of the success factors of trap ors are taken into account in the inspection crops. Nevertheless, the NPPO will evaluate the nd decide if and under which conditions they may 014.

Member state response

ity should ensure Due to re-organisation within the CA some Proposed actions are planned together with the ing out official controls, the backlogs have been developed regarding system annual audit or inspection. To this end all val conditions is accurate audits and inspections to verify EU approval establishments will have been visited within a action is taken when the conditions. The CA was aware of that fact and had year's cycle. The CA has no extra capacity not met, as required by already taken action to solve these backlogs. All available to perform these actions separately egulation (EC) No establishments with EU approvals will be visited from the annual audits and to shorten this for system-audits and -inspections in May 2014 at deadline. Procedures have been updated already the latest. During these visits all EU requirements on this point and inspectors are instructed. for approval will be checked. Specific approvals, under which activities no longer or never were carried out will be withdrawn.

Member state response

ity should ensure The listing of approved establishment will be Since this corrective measure is connected to the ng of approved establishments updated in line with the results of the action plan action in No 1 please see final comment No.1 date, as required by Article described under item 1. Furthermore the CA will regarding the deadline. Procedures to keep the ation (EC) No 882/2004. update the procedures to keep the list up-to-date list up-to- date have already been implemented. in the future.

Member state response

ity should ensure Regarding the effectiveness of these official Timeframe for the proposed actions: iveness of official controls as controls the CA will take the following actions icle 4(2)(a) of Regulation until: 1. evaluation of the intervention policy: 4 is improved, so that 1. The CA will evaluate the intervention policy Oct/Nov 2013, implementation Jan 2014 ncerning general hygiene (more dissuasive if necessary) and implement 2. evaluation of the inspection frequency: azard Analysis Critical based procedures and necessary changes ongoing and implemented in Annual Plan 2014 2. The CA will consider the increase of the 3. training: ongoing, every year several inspection frequency in areas were necessary (risk Page: 1 CA UPDATED RESPONSE 13/08/2013 ent Authorities of the Netherlands to the recommendations of Report ref. DG(SANCO)/2012-6367-MR of an audit vember to 05 December 2012 in order to evaluate the control system in place governing the production of mechanically Action Proposed by the Competent Authority Competent Authority Update ements for mechanically based approach). courses available production are detected. 3. The CA will consider additional training and/or 4. interna

Member state response

ith the European See 3. See 3. Timeframe nts, the Competent d ensure that deficiencies cted in the establishments not present in other ishments (Article 54 of No 882/2004).

Member state response

ity should ensure In general MSM should be labeled as MSM if the The CA will carry out additional inspections in ions of Directive product meets with all the 3 criteria from Reg. September 2013 in every MSM-producing erning the indication of 853/2004, totally in line with EU-Regulations: establishment. All items related to MSM - mechanically separated 1. the product obtained by removing meat from specially the labelling of MSM, will be checked er ingredients in meat flesh-bearing bones after boning or from poultry and if necessary enforced according meat preparations are carcasses, EU-leglslation. ll as the requirements 2. using mechanical means, All MSM has to be labelled "MSM". When a FBO can demonstrate that the MSM is lling of meat preparations 3. resulting in the loss or modification of the in compliance with point 3, Chapter 3. section 5. anically separated meat muscle fiber. ANNEX II of Reg (EC) no 853/2004, CA will apter IV, Section V, Annex In some cases these criteria (more specific point 3) are not quite clear. Page: 2 CA UPDATED RESPONSE 13/08/2013 ent Authorities of the Netherlands to the recommendations of Report ref. DG(SANCO)/2012-6367-MR of an audit vember to 05 De

Member state response

ity should ensure The CA will encourage the branche and trade The CA agrees on FVOs comment and will ly separated meat sold to organization to develop a guideline how to label enforce Regulation (EC) No 931/2011, not only ments is accompanied by the MSM and other mechanically separated meat that in MSM-producing establishments, but also in mation which allows food does not meet all the 3 criteria and to provide the the supply chain. ors to use it in meat correct information in the supply chain. The CA Starting September 2013. d meat products in will check this guideline. the requirements of points The CA will enforce in cases of non compliance considering the ongoing discussion mentioned in Section V, Annex III to No 853/2004, and to label recommendation no 5 and awaiting the results tined to the final consumer thereof. ith the requirements of 13/EC and of paragraph 2, ex III to Regulation (EC) Page: 3

Member state response

plants and operator is an ongoing business which started o speed this process in the chain of OF/SIplants and l be send to plants and traders. nsporters: the sector and the NVWA are currently working lder to inform transporters of registration and the rules to. This should be finished in oktober 2012. This folder than just ABP, and will also address Food and Feed be distributed to transport companies. Transporters which ts and on the road will be checked and

Member state response

mixing components will be istery and incorperated in national legislation. With the enforcement will be developed.

Member state response

transporters are registered a e based on risk based controls will be developed and will be performed.This is forseen in 2013. Page: 1

Member state response

gard to the provisions of article 3.1 of Regulation (EC) No 4 we want to stress that all official controls of NVWA are already d in a risk based way, however this is an ongoing process. In the years this risk based approach will lead to a further differentiation nd bad performing FBO's based on the provisions of sistent risk based approach between the Divisions of the he main challenge. Slight differences between Divisions ntrols for similar type of activities might exist. In 2012 we and if necessary repair these inconsistencies. the report is stated that the Industry Division does not ng for the verification of compliance with microbiological e establishment under its remit. This might suggest that ways necessary during verification of compliance, in which agree to this suggestion. n 2011 samples were actually taken by the Industry rtunately we were not able to show the relevant documents sion. Nevertheless, in 2012 Industry Division will start a ed) monitoring program (retail samples) and a sample meat product industry (per sector)

Member state response

to note, that, although the official auxiliaries had been appointed ion of the training, they had already received more training er the completion of the training, then necessary under Page: 1 ry 2012 Report ref. DG(SANCO)/2011-6019-MR of an audit taken by the competent authorities with regard to official d meat, meat preparations, meat products and casings Action Proposed by the Competent Authority 54/2004; , the training scheme for auxiliaries will be changed in such a y will have enough theoretical and practical hours before they d.

Member state response

t regard we want to note that the existing procedures for official arding approval conditions are correct and adequate. Due to oing major reorganization of the CA, the procedures have not been ectly. The management of NVWA has been informed and in will be taken in order to ensure that procedures will be rectly.

Member state response

es will be updated in line with the requirements/ possibilities Besides measures will be taken to achieve that procedures owed correctly and performance of P.M. inspection will be .

Member state response

to increase effectiveness of the official controls, active n between the independent audit team and the responsible r the different establishments will be enhanced. Also, the officials have to be informed about the results of the audits non-compliances). Follow-up and Intervention measures will oved..

Member state response

er on No 2. tion: The procedures regarding rework of carcasses, that are in Page: 2 ry 2012 Report ref. DG(SANCO)/2011-6019-MR of an audit taken by the competent authorities with regard to official d meat, meat preparations, meat products and casings Action Proposed by the Competent Authority isual inspection, will also be implemented for regular meat nitoring by the FBO will be performed after post mortem n including a verification of this monitoring by NVWA. This hat health marking is performed only when there are no grounds g meat unfit for human consumption.

Member state response

aining and in relevant communication platforms the relevant re issues will be discussed and particular attention will be ffective implementation of the existing procedures. In 2012 the on of Regulation 1099/2009 will be finalized.

Member state response

to stress that in fact all eligible carcasses have been sampled, the mission some discrepancies had been found in the tion of the number of slaughtered animals and the number of This was due to ambiguities in the sampling protocols of some ses. protocols have already been checked and adapted, where o discrepancies remain at present. to some minor deviations of the testing procedures as laid lation (EC) No 2075/2005 the laboratories have brought the ompletely in line with the legal requirements.

Member state response

ntion strategy of the NVWA is that minor deficiencies (no risk afety and/or animal welfare) are followed by oral intervention, iencies are followed by written intervention and major Page: 3 ry 2012 Report ref. DG(SANCO)/2011-6019-MR of an audit taken by the competent authorities with regard to official d meat, meat preparations, meat products and casings Action Proposed by the Competent Authority are followed by a (written) penalty and official measures as Article 54, part 2 of Regulation (EC) No 882/2004. In the s all these deficiencies (minor, medium and major) are d described. In 2012 the NVWA will pay special attention sting intervention strategy has to be followed correctly always. a system will be developed that medium and major are discussed with the food business operator and that the tions of the FBO are well documented.

Member state response

ention strategy of the NVWA is explained under No.9. In 2012 WA will pay special attention that the intervention strategy has to correctly at all times, including follow-up of ces. Page: 4