Luxembourg

The recommendation states as its basis

A list of approved food business establishments is made available on the ALVA website on a "Fiche Informative". This list does not adequately follow the technical specifications of issued by DG Health and Food Safety (5) as required by Article 45(2) of Implementing Regulation (EU) 2019/1715. Establishments are categorised in the above list according to their main commercial activity with additional activities (and potentially those of a higher risk from a food safety perspective) presented in a separate column. It is the operator who decides on the category when registering the establishment in the "MyGuichet.lu" web platform.

ALVA does not maintain and keep in TRACES an up-to-date list of approved fishery products establishments contrary to the requirement of Article 45(1)(a) of Implementing Regulation (EU) 2019/1715. ALVA indicated that staff had not been assigned for this purpose.

Contrary to the EU rules, ALVA is not providing the Commission services with information necessary for the functioning of TRACES, in particular, it has not provided the lists of food business establishments approved in accordance with Regulation (EC) No 852/2004 in the fishery products sector.

The recommendation states as its basis

The control plan does not cover organoleptic examinations, testing for parasites and controls on poisonous fishery products as laid down in Article 70(a), (f) and (g) of Commission Implementing Regulation (EU) 2019/627 and following the practical arrangements laid down in Chapter I(A), (F) and (G) of Annex VI to the same Regulation. 9 Conclusions on official controls of fishery products

ALVA does not respect the specific requirements of official controls with respect of fishery products set in the EU rules due to the absence of organoleptic examinations, testing for parasites and controls on poisonous fish species.

The recommendation states as its basis

The law of 28 July 2018 on the system of controls and of sanctions regarding foodstuffs, is the main law governing controls applicable to the establishments within the scope of this audit. This national legislation does not provide the possibility for the CA to impose administrative fines. This is a longstanding issue, already identified in previous Commission audits including DG(SANCO) 2011-8856 and DG(SANCO) 2014-7219. The CA explained that a solution to this has been in preparation for a number of years and that a draft bill was currently being studied. 1 EU legal texts quoted in this document refer to the last amended version 2

The lack of legal instruments for the CA to impose economic sanctions limits the efficiency of official controls.

The Law of 28 July 2018 established a control system and sanctions relating to foodstuffs, covering all steps of the production chain. As previously explained, this legal 5 instrument does not give the possibility to the CA to impose economic penalties to FBOs other than through a penal process2. Conclusions on competent authorities

Furthermore, when FBO fails to take corrective action, the lack of an option to impose economic sanctions (other than through penal courts) reduces the ability of the CCA to ensure that the FBO remedies the situation.

Member state response

In the actual legislation there is the possibility to fix taxes for re- control after detection of non-compliances but this hasn't been applied until now for the sake of harmonisation. The procedures and checklists of the new administration will be adapted so that taxes could be applied more efficiently and easier. The new law proposal (in legislative procedure) foresees administrative sanctions (sanctions for all the legislations which could be applied following the first official control).

We'll have the possibility to give a fine to the FBO in the case of non-compliances as soon as our new checklists for the inspections of approved establishments will be finalized (1st semester 2024). Our new national bill of law (revision of the law from 2018) with new possibilities for the use of administrative fines that are more effective is right now in its legal consultation phase at the Council of State, Our legal service estimates that the new law will be finalized in approximately 6-9 months.

The recommendation states as its basis

There were shortcomings in the CA identifying non-compliances and/or taking appropriate measures to ensure that the operator resolved and prevented the recurrence of those non-compliances.

Member state response

Concerning finding n° 25, could you please provide us with examples? We actually consider that the root cause analysis has n done. We remember we discussed , for example the bad cleaning of the slaughterhouse, we informed the direction of the SH about this, following that they convened the responsible of the cleaning society and the cleaning improved after that, for us, in that case the root cause analysis had been made.

We developed a new checklist for the per operational check during slaughter and modified the pre operational and the animal fare checklist. All checklists need to be signed by the FBO. On all the checklists there is a folder dedicated to the follow-up which has to be made by the FBO. Under this folder is another folder where a follow-up from the FBO needs to be written. This system permits to ensure that the FBO looks at the problem and resolves the root cause of any deficiency. If the OV estimates that the root cause of the deficiency has been clearly identified and that the deficiency has been corrected he will validate the feedback of the FBO. Every month a meeting is organized between the OVs of the slaughterhouse and the FBO to discuss recurrent problems. Please see the three attached checklists.

The recommendation states as its basis

FBO staff regularly presented carcases with visible contamination for PMI, which created extra work for the vacataires, some of which were busy removing the contamination during PMI.

The audit team did not observe, in any of the two establishments, any FBO staff checking on carcase contamination and taking suitable corrective action (i.e. immediately removing all visible contamination, before presenting those carcases for PMI). The official staff had taken up the task of removing the contamination before declaring the carcases fit for human consumption. HACCP Legal requirements Article 5 of Regulation (EC) No 852/2004. Findings

The FBOs food safety management systems checked by the audit team included sufficient controls on animal identification, FCI and on the cleanliness and the state of health of the livestock. In relation to carcase monitoring for the presence of contamination, the FBOs had decided to set a frequency of two checks per week.

The CA accepted this frequency of controls over FBO monitoring of carcass contamination as sufficient. At the time of the visits, especially during cattle production, the OVs and vacataires were seen to be busy removing visible faecal contamination from 9 a significant number of carcases. No monitoring by the FBO on the carcases presented for PMI was observed, nor any action to avoid or to eliminate the contamination on those carcases. Microbiological criteria Legal requirements Articles 35 and 36 of Regulation (EU) 2019/627. Commission Regulation (EC) No 2073/2005. Findings

The shortcomings identified in how the OVs deal with contamination on carcases, with lack of enforcement to ensure that FBOs monitor the hygiene of operations and take suitable and timely action before carcases are presented for PMI with visible contamination.

Member state response

A procedure will be put in place by the FBO to ensure that the carcasses won't present faecal contamination when they are resented for the PMI. During the per-operational hygiene check, special attention will be put on faecal contamination of carcasses. If needed, the quality management service of the slaughterhouse will be informed and forced to take immediately corrective measures. Page: 1 of report ref. DG(SANTE) 2023-7724 of the audit carried out from 02 May ning slaughter hygiene and meat inspection requirements Action Proposed by the competent authority A procedure will be put in place by the FBO to ensure that the risk of faecal contamination of carcasses caused by dirty livestock will be minimised.

The FBO has written a procedure on this topic (please see attached document). Page: 1 of report ref. DG(SANTE) 2023-7724 of the audit carried out from 02 May ning slaughter hygiene and meat inspection requirements ion Proposed by the competent authority competent authority has written a procedure on the agement of dirty livestock. er operational checklist about hygiene during slaughter, taining a control point about fecal contamination is used and led in every week in the slaughterhouse since the 25/10/2023. ase see the documents attached.

The recommendation states as its basis

There are several official checklists that the CCA have created and are used during the day-to-day activities at the establishments and also during yearly audits. The daily checklist includes pre-operational checks and animal welfare checks. There are no checklists, nor documented procedures in place for other official controls, including operational hygiene related activities. For those cases, the system relies on verbal instructions and guidance and support from central office staff.

Occasionally different officers gave very different deadlines to similar non-compliances. This was evident when comparing several yearly audit reports. As explained by the CA, this has improved as a result to recent changes in the official controls team, with the current team providing more realistic and suitable enforcement.

The lack of documented procedures or guidance affects the effectiveness of delivery of official controls and results in some controls not fully carried out or not carried out in a consistent manner.

Despite these daily checks, in some instances, the OVs didn't manage to identify some problems concerning lack of cleanliness that were later identified during the yearly audit carried out by central office staff.

There are no dedicated checklists or written guidance to aid the OVs when monitoring the hygiene standards during the slaughter operation.

In relation to the operational hygiene requirements, the OV controls did not identify a number of generalised and recurrent unhygienic practices (see p.20) which were observed during the audit.

According to the records checked and discussions with CA staff, the establishment OVs had not identified any problems in relation to FBO's own sampling. However, the audit team found that the sampling programmes were not fully in line with legislation. Issues including the fact that FBOs do not take the samples randomly during production but tend to sample batches or the use of alternative sampling arrangements without demonstration of equivalence (i.e. chicken tested before chilling or beef tested during chilling).

Member state response

g A check-list for the control of per-operational hygiene during slaughtering has been developed and will be available and used trols on a regularly basis by the OVs. with A written procedure to detect faecal contamination during the slaughtering process will be put in place, on behalf of this procedure the vacataires will be involved in the detection of faecal contamination. A procedure with new measures concerning dirty livestock will also be written and made available for the OVs. Concerning ante-mortem inspection (AMI) a written procedure will be developed to identify the animals which have been submitted to AMI, a document to fill in an a daily basis will be available and used by the OVs. The trainings of the OVs on site will be enhanced concerning the hygiene during slaughter. An evaluation of the performance of the trainings of the OVs will be organized on a regularly basis. Concerning FBO's own sampling, the quality management service of the slaughterhouse will change the sampling programme, it will be randomized and in case of use of alternative methods, they should have been validated by the CCA before. Page: 2 of report ref. DG(SANTE) 2023-7724 of the audit carried out f

. A checklist for the control of per operational hygiene during ughtering is in place since the 25/10/23 and used on a daily ls basis by the OVs. th 2. A written procedure to detect faecal contamination during the ughtering process is in place (date :30/11/2023 ) (see attached ument) Two procedures with new measures concerning dirty livestock in place , one from the FBO and one from the competent hority (see 2 attached documents) (date : 04/2023 + 11/2023) A procedure to identify animals which have been submitted to e-mortem inspection (AMI) has been developed and is in ce (date :30/11/2023 ) (see attached document) Concerning the trainings of the OVs, a training on animal fare & hygiene at slaughter will be organized by the CCA tumn 2024). ervisions of the OVs will be organized on site by the OV ad of service), at least one supervision/year will be done with h OV working in the slaughterhouse. The 3 checklists (animal fare, pre operational and per operational) will be used to form the supervision. Concerning FBO's own sampling a new sampling procedure been written by the FBO (see attached document) Page: 2 of report ref. DG(SANTE) 2023-7724 of the audit carried out from 02 May nin

The recommendation states as its basis

The post-mortem inspection arrangements in the slaughterhouse that makes use of the time of inspection derogation is not in line with EU law which requires correlation of carcases and offal irrespective of the delay in PMI.

Member state response

the A procedure will be put in place, which assures that all carcasses and offal will be submitted to a post-mortem inspection (PMI ) n the official veterinarian. Offal will be collected in red food boxes and will be made available in this way to be checked by the official veterinarian. To be sure that the offal could be linked to the carcasses (Slaughterhouse without slaughter line for offal), batches of offal will be made (for examples one batch will contain 10 chickens), these batches will be identified and associated to the same batch of chickens. A checklist for the per-operational hygiene check will be available for the OV and used on a regularly basis. Page: 3

e A written procedure about the post-mortem procedure for poultry is in place. Please see the attached document. Page: 3

The recommendation states as its basis

LEGAL BASIS FOR THE AUDIT The audit was carried out under the general provisions of EU legislation and in particular, Articles 116, 117 and 119 of Regulation (EU) 2017/625.

Nevertheless, the failure to ensure that designated laboratories have appropriate validated, accredited confirmatory methods for certain analyte/matrix combinations undermines the competent authority's ability to legally establish non-compliance and thus to ensure timely follow-up of non-compliance. 5.1.3. Implementation of the residue monitoring plan Findings

The ASV provided the audit team with a number of analytical reports issued by all of the three contracted laboratories and the audit team noted that in most cases the results were reported as compliant or non-compliant without providing information necessary for correct interpretation in line with legal requirements (5), namely numerical value of the analyte's level, if identified, and decision limit (CC) and/or detection capability (CC). The competent authority stated that they accepted (19) Article 100 of Regulation (EU) 2017/625. (20) Article 37(1) and 37(3) of Regulation (EU) 2017/625. (21) Article 37(2)(b) of Regulation (EU) 2017/625. (22) Article 37(5)(a) of Regulation (EU) 2017/625. (23) Article 37(4)(e) and 37(5) of Regulation (EU) 2017/625 and section 1.2 of the Annex to Decision 98/179/EC. (24) Article 38 of Regulation (EU) 2017/625 and Article 5 of Decision 2002/657/EC. 8 laboratories' assessment without further verification although the numerical values could be reported via email correspondence, of which two examples (from one and same contracted laboratory) were demonstrated. In one of the emails, the laboratory stated that the method used had been "non-quantitative" thus unlikely been a confirmatory method. The legal provisions (5) require use of confirmatory methods to make a legally valid decision on non-compliance.

The recommendation states as its basis

For honey, there are two different means of sampling. Approximately half of the producers are members of a national quality scheme, which involves controls by ASTA and submission by the producers to ASTA of a number of samples, which ASTA analyses to examine quality parameters. ASTA provides the remaining part of the samples to ASV. Thus the samples used for this part of the residues monitoring plan are not actually official samples, but rather samples provided by the producer, which is not in line with EU requirements (17). For the remaining honey producers, ASV staff sample honey at retail level during the appointed sampling week. Samples consist of pots of honey that can be traced back to the producer.

Sampling arrangements for some honey samples do not meet EU requirements, which risks reducing the likelihood of detecting residues in this commodity. 5.1.4. Other residue monitoring programmes Findings

The recommendation states as its basis

In line with EU legislation (20), all of the laboratories have been designated as official laboratories by the ASV in writing and their respective tasks and conditions under which these tasks are carried out, are described in relevant designations. However, and contrary to legal provisions (21), there are no formal provisions in the contracts that the laboratory is already designated as an official laboratory by the competent authorities of the member state on whose territory it is located. In addition, the audit team noted that some methods were stated (on the analytical reports seen) as not included in the scope of the accreditation by the contracted laboratories which contradicts pertinent legal requirement (22) and the contractual obligations.

Laboratories are accredited to EN ISO/IEC 17025:2017, the methods used are largely included in their respective scopes of accreditation and the laboratories' performance in proficiency tests has been generally satisfactory, providing assurance on the reliability of results. However, the absence of formal verification of certain designation criteria for official laboratories, the partial absence of information essential for interpretation of the analytical results and the erroneous approach by one contracted laboratory to interpret certain analytical data undermine the effectiveness of the residue control system.

The recommendation states as its basis

The ASV provided the audit team with a number of analytical reports issued by all of the three contracted laboratories and the audit team noted that in most cases the results were reported as compliant or non-compliant without providing information necessary for correct interpretation in line with legal requirements (5), namely numerical value of the analyte's level, if identified, and decision limit (CC) and/or detection capability (CC). The competent authority stated that they accepted (19) Article 100 of Regulation (EU) 2017/625. (20) Article 37(1) and 37(3) of Regulation (EU) 2017/625. (21) Article 37(2)(b) of Regulation (EU) 2017/625. (22) Article 37(5)(a) of Regulation (EU) 2017/625. (23) Article 37(4)(e) and 37(5) of Regulation (EU) 2017/625 and section 1.2 of the Annex to Decision 98/179/EC. (24) Article 38 of Regulation (EU) 2017/625 and Article 5 of Decision 2002/657/EC. 8 laboratories' assessment without further verification although the numerical values could be reported via email correspondence, of which two examples (from one and same contracted laboratory) were demonstrated. In one of the emails, the laboratory stated that the method used had been "non-quantitative" thus unlikely been a confirmatory method. The legal provisions (5) require use of confirmatory methods to make a legally valid decision on non-compliance.

The audit team noted one case where in a PT one contracted laboratory detected level of a group A6 substance above CC but below minimum required performance level (MRPL) and consequently reported that result as "compliant". That assessment was not accepted by the PT provider, however, the laboratory stated that they would continue with the approach chosen. Such interpretation of analytical results for analytes with established MRPL is not in line with pertinent legal provisions (5) and may, in absence of CC in the analytical report, effectively disallow the competent authority from initiating an investigation as required by legislation (25).

The audit team was informed by the competent authority that the contracted laboratories normally provided most of CC/CC as separate files. However, such a file provided by one contracted laboratory contained solely maximum residue limits (MRLs) and a statement that CC was at half of MRL, which is incompatible with the procedure to establish CC (26). Absence of correctly established CC/CC effectively leaves the competent authority unable to interpret, or verify interpretation, of the analytical results provided by that laboratory.

Laboratories are accredited to EN ISO/IEC 17025:2017, the methods used are largely included in their respective scopes of accreditation and the laboratories' performance in proficiency tests has been generally satisfactory, providing assurance on the reliability of results. However, the absence of formal verification of certain designation criteria for official laboratories, the partial absence of information essential for interpretation of the analytical results and the erroneous approach by one contracted laboratory to interpret certain analytical data undermine the effectiveness of the residue control system.

The recommendation states as its basis

The auditor noted that official feed samples are analysed by different laboratories. One of these laboratories, at the time of the audit, was not accredited to ISO/IEC 17025 which is not in line with the requirements laid down by Article 37(4) of Regulation (EU) 2017/625. The competent authority clarified that the accreditation procedure had been launched at the beginning of 2020 but could not be progressed due to COVID-19-related travel restrictions in place since March 2020. 5.2.2.2 IMPLEMENTATION OF OFFICIAL SAMPLING

The system in place for planning of official sampling is effective and risk-based. Its implementation is generally adequate, however the lack of laboratory accreditation and incomplete sampling records weaken the reliability and legal validity of official samples taken. 5.2.3 Actions taken on non-compliances

Member state response

Le laboratoire ASTA désigné pour l'analyse des métaux lourds concernés par cette recommandation n'est pas accrédité pour l'analyse des métaux lourds dans les aliments pour animaux mais présente quand même une grande expérience dans l'accréditation selon l'ISO17025. Le même laboratoire est notamment accrédité pour l'analyse des aflatoxines, des vitamines A et E de l'analyses des éléments Ca, Mg, Na, P, Cu, Fe, Mn, Zn sur aliments pour animaux. L'accréditation des métaux lourds est en cours et un audit technique OLAS en vue de l'accréditation est prévue en octobre 2021.

Le laboratoire ASTA désigné pour l'analyse des métaux lourds concernés par cette recommandation n'est pas accrédité pour l'analyse des métaux lourds dans les aliments pour animaux mais présente quand même une grande expérience dans l'accréditation selon l'ISO17025. Le même laboratoire est notamment accrédité pour l'analyse des aflatoxines, des vitamines A et E de l'analyses des éléments Ca, Mg, Na, P, Cu, Fe, Mn, Zn sur aliments pour animaux. L'accréditation des métaux lourds est en cours et un audit technique OLAS en vue de l'accréditation est prévue en octobre 2021.

The recommendation states as its basis

The sampling protocols seen generally contained information on the total size of the sampled batch. When the whole batch was not accessible, the sampling protocol contained a note on that but the size of the sampled portion was not described in the sampling protocols. This is not in line with the requirements of point 10 of Annex I to Regulation (EC) No 152/2009.

The system in place for planning of official sampling is effective and risk-based. Its implementation is generally adequate, however the lack of laboratory accreditation and incomplete sampling records weaken the reliability and legal validity of official samples taken. 5.2.3 Actions taken on non-compliances

Member state response

e of La procédure d'échantillonnage a été corrigée suite à l'audit pour respecter cette exigence légale. Dorénavant les inspecteurs indiquent sur la fiche de prélèvement la taille de la portion échantillonnée, lorsque ce n'est pas le lot entier d'aliments pour animaux qui est échantillonné. Voici le texte modifié dans la procédure CAA-PT9-échantillons- prélèvement_et_transport : « L'échantillon sera prélevé sur le lot entier ou sur une partie du lot, en fonction de l'accessibilité et de l'aspect/odeur des parties du lot présent ; ceci sera indiqué sur la fiche de prélèvement en précisant la quantité de la partie du lot échantillonné. Si aucune indication n'est faite, le lot entier a été échantillonné. » Page: 1

e of La procédure d'échantillonnage a été corrigée suite à l'audit pour respecter cette exigence légale. Dorénavant les inspecteurs indiquent sur la fiche de prélèvement la taille de la portion échantillonnée, lorsque ce n'est pas le lot entier d'aliments pour animaux qui est échantillonné. Voici le texte modifié dans la procédure CAA-PT9-échantillons- prélèvement_et_transport : « L'échantillon sera prélevé sur le lot entier ou sur une partie du lot, en fonction de l'accessibilité et de l'aspect/odeur des parties du lot présent ; ceci sera indiqué sur la fiche de prélèvement en précisant la quantité de la partie du lot échantillonné. Si aucune indication n'est faite, le lot entier a été échantillonné. » Page: 1

The recommendation states as its basis

In relation to controls under the remit of ASTA, the audit team noted that: · the allocation of responsibilities between ASTA and ADA regarding official controls at distributors (for both PPPs for professional and non-professional use) has been clearly defined, and a standard checklist and written instructions for inspectors have been developed by ASTA. However, detailed labelling checks have not been initiated yet. These are planned to be performed as part of official controls at PPP distributors in 2021 (from mid May onwards, because inspections at distributors usually take place during the high season). · A standard checklist for official controls at landscapers and seed treatment facilities has been developed. The first inspections at these operators by ASTA staff were initially planned for 2020, but due to the COVID pandemic, these were postponed until 2021. At the time of the audit, these had not yet started. With regard to seed treatment facilities, there is only one such operator in Luxembourg, and it would not be subject to inspection in 2021. 9 · There are about 160 small-scale professional farmers who are not subject to official controls. There are no plans for these to be covered by the control system. Representatives from the SPV stated that this is due to the limited extent of the land used, although this approach was not justified through a documented risk assessment. This is not in line with Article 9(1) of Regulation (EU) 2017/625. · In the case of non-compliances identified during official controls at PPP distributors and professional users, there are no penalties imposed on the operators by ASTA. In general, the measures taken consist of verbal or written warnings. Representatives from the SPV stated that the current PPPA only contains penal sanctions, which is a limitation for ASTA to enforce provisions laid down in the SUD and Regulation (EC) No 1107/2009. This is not in line Article 17 of the SUD, which requires that effective, dissuasive and proportionate penalties be applied in the case of infringements. · Representatives from the SPV stated that an amendment of the PPPA is in preparation, and that this would include administrative sanctions, which would allow ASTA officials to take actions at non-compliant operators more easily. Conclusions on the organisation of official controls on the sustainable use of pesticides

A significant number of small-scale growers are not subject to official controls and inadequate penalties are applied to professional operators under the remit of SPV controls. This undermines the overall effectiveness of official controls on the sustainable use of pesticides.

Member state response

A partir de 2021, le SPV effectuera des contrôles auprès des opérateurs non couverts par les contrôles de l'UNICO. La sélection des opérateurs à contrôler se fera dans un deuxième temps sur une analyse des risques sur base de l'expérience acquise dans les premières campagnes de contrôles.

of 2021, the Plant Protection Service (SPV) will conduct checks at the premises of operators not covered by checks by the Control Unit (UNICO). Operators to undergo checks will be selected subsequently following a risk analysis based on the experience gained from the initial inspection campaigns.

The recommendation states as its basis

In relation to controls under the remit of ASTA, the audit team noted that: · the allocation of responsibilities between ASTA and ADA regarding official controls at distributors (for both PPPs for professional and non-professional use) has been clearly defined, and a standard checklist and written instructions for inspectors have been developed by ASTA. However, detailed labelling checks have not been initiated yet. These are planned to be performed as part of official controls at PPP distributors in 2021 (from mid May onwards, because inspections at distributors usually take place during the high season). · A standard checklist for official controls at landscapers and seed treatment facilities has been developed. The first inspections at these operators by ASTA staff were initially planned for 2020, but due to the COVID pandemic, these were postponed until 2021. At the time of the audit, these had not yet started. With regard to seed treatment facilities, there is only one such operator in Luxembourg, and it would not be subject to inspection in 2021. 9 · There are about 160 small-scale professional farmers who are not subject to official controls. There are no plans for these to be covered by the control system. Representatives from the SPV stated that this is due to the limited extent of the land used, although this approach was not justified through a documented risk assessment. This is not in line with Article 9(1) of Regulation (EU) 2017/625. · In the case of non-compliances identified during official controls at PPP distributors and professional users, there are no penalties imposed on the operators by ASTA. In general, the measures taken consist of verbal or written warnings. Representatives from the SPV stated that the current PPPA only contains penal sanctions, which is a limitation for ASTA to enforce provisions laid down in the SUD and Regulation (EC) No 1107/2009. This is not in line Article 17 of the SUD, which requires that effective, dissuasive and proportionate penalties be applied in the case of infringements. · Representatives from the SPV stated that an amendment of the PPPA is in preparation, and that this would include administrative sanctions, which would allow ASTA officials to take actions at non-compliant operators more easily. Conclusions on the organisation of official controls on the sustainable use of pesticides

A significant number of small-scale growers are not subject to official controls and inadequate penalties are applied to professional operators under the remit of SPV controls. This undermines the overall effectiveness of official controls on the sustainable use of pesticides.

Member state response

modifiée du 19 décembre 2014 relative aux produits harmaceutiques sera modifiée afin d'introduire la possibilité d'appliquer de telles sanctions. Délai pour la modification de la loi : 31.12.2023

The amended Act of 19 December 2014 on plant protection products will be amended in order to introduce the possibility of applying penalties of this kind. Deadline for the amendment of the Act: 31.12.2023 Ajout du 07.02.2022 suite à la lettre Ares(2022)559650 du 25.01.2022 : Le délai pour la modification de la loi est porté au 31.12.2022 Page: 1 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the Action Proposed by the competent authority

The recommendation states as its basis

The audit team noted the following: · There are only two key quantitative objectives specified in the NAP. The first is the reduction of `big movers' by 30% by 2025, and the second is the reduction of the use of PPP by 50% by 2030. However, the baseline period is not specified in either case. · The definition and the listing of AS called `big movers' is a measure under the NAP, and has been achieved by the publication of an official list of such AS2. However, the NAP does not contain any description of the indicators to monitor the progress of the reduction target. The same applies to the second objective (50% reduction in the use of PPPs). This is not in line with Article 4(1) of the SUD. · Although the NAP contains two measures aimed at reducing the use of PPPs containing AS of particular concern, at the time of the audit, these were not yet formally identified. Moreover, the NAP does not include indicators to monitor the use of active substances of particular concern. This is not in line with Article 4(1) of the SUD. Conclusions on the National Action Plan

The revised NAP, in force since December 2017, contains objectives, detailed measures and actions to achieve a general reduction in the use and risk of PPPs. Although two key quantitative objectives have been defined, the lack of baselines and indicators does not allow to monitor the progress, and limits the possibility to define and achieve adequate targets for reduction of PPP use and risks, arising thereof.

Member state response

données statistiques servant d'indicateurs en terme de substances actives utilisés sont accessibles au site web https://agriculture.public.lu/de/agrarstatistik/landwirtschaft- t/verbrauch-psm.html. La liste des « big movers » comprend les substances actives jugées particulièrement préoccupantes. L'année de référence est celle de l'adoption du plan d'action national (2017). Suite au prochain réexamen du plan d'action, il sera décidé si celui-ci sera modifié. Dans ce cas les indicateurs et valeurs de référence y seront inclus. Page: 1 0/2021 f report ref. DG(SANTE) 2021-7297 of the audit lementation of measures to achieve the sustainable cts Action Proposed by the competent authority

The statistical data which serve as indicators for active substances used may be accessed ks on the following website: https://agriculture.public.lu/de/agrarstatistik/l andwirtschaft-umwelt/verbrauch-psm.html , The list of `big movers' comprises those active substances which are considered of particular concern. The reference year is the year in which the national action plan was adopted (2017). Following the next re-examination of the action plan, it will be decided whether it should be amended. If this is the case, the reference indicators and values will be included in it.

The recommendation states as its basis

The audit team noted that the certification system does not include provisions for the withdrawal of certificates. This is an administrative sanction, which is not yet included in the national legislation (see also finding 12). This is not in line with Article 5(2) of the SUD. 13

There is a system in place to provide the necessary training and certification to PPP operators. However, the process to build the system started only from late 2017 and certification was only mandatory since January 2021. As a result, it is estimated that a significant number of PPP professional users have not yet been duly trained and certified. This means that PPPs are being sold and used by operators, who do not have the necessary knowledge on the proper use of PPPs and the associated risks for the human health and the environment.

Member state response

cates, La loi modifiée du 19 décembre 2014 relative aux produits phytopharmaceutiques sera modifiée afin de permettre explicitement le retrait des certificats. Délai pour la modification de la loi : 31.12.2023

The amended Act of 19 December 2014 on plant protection products will be amended in order explicitly to permit certificates to be withdrawn. Page: 2 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the Action Proposed by the competent authority Deadline for the amendment of the Act: 31.12.2023 Ajout du 07.02.2022 suite à la lettre Ares(2022)559650 du 25.01.2022 : Le délai pour la modification de la loi est porté au 31.12.2022

The recommendation states as its basis

As of the end of March 2021, 1,912 operators (covering all four categories of operators) were included in the ASTA database as certification holders. Nonetheless, based on a CA's estimation, in 2018, the potential number of agricultural professional users was around 4,400. In addition, representatives from the SPV stated that it is possible that professional users who do not regularly buy or use PPPs, in particular those who do not belong to the agricultural sector, are not all aware of the certification requirement. As a consequence, these non-certified users do not appear in the database until they submit a request to obtain a certificate. Therefore, the current number of certified professional users represents less than 50% of the total. This is not in line Article 5 of the SUD.

There is a system in place to provide the necessary training and certification to PPP operators. However, the process to build the system started only from late 2017 and certification was only mandatory since January 2021. As a result, it is estimated that a significant number of PPP professional users have not yet been duly trained and certified. This means that PPPs are being sold and used by operators, who do not have the necessary knowledge on the proper use of PPPs and the associated risks for the human health and the environment.

Member state response

ate, A partir de 2022, le SPV adaptera les contrôles afin de couvrir ding cet aspect. Ainsi, par contrôles aléatoires de factures auprès des ibuteurs, il sera vérifié si les acheteurs sont en possession du certificat requis.

s of 2022, the Plant Protection Service (SPV) will adapt checks so that this aspect is covered. Thus random checks of invoices will f be carried out at distributors in order to verify whether buyers have the requisite certificate

The recommendation states as its basis

The audit team noted that: · since the entry into force of Grand Ducal Regulation of 17 April 2016, ASTA has carried out only one physical inspection at a vineyard, at the time of application. In addition, they carried out a review of records and documents kept by all applicants, in 2019. · UNICO performs checks at CAP-growers, and aerial spraying was one of the risk criteria for selection of applicants to be inspected in 2020. With regard to aerial spraying, these controls included a verification of the grower PPP application logbook in order to prove that parcels, where aerial spraying has taken place, were the ones included in the map provided as part of the application package. However, the effectiveness of these checks is limited by the fact that, in the case of aerial spraying, PPP application records are kept by the contracted aerial spraying company, not by the grower. Moreover, in general, UNICO staff do not make use of the detailed information included in the Annexes of derogations granted.

According to national legal requirements, the service provider shall record and provide GPS data to the applicants. The applicants shall keep these records for a period of three years, and provide these to CAs upon request. ASTA and UNICO stated that they had experienced difficulties in getting the GPS data. In 2020, ASTA received these data, but they did not use these for more detailed checks or further analysis.

The evidence described in finding 49 and 50 demonstrates insufficient monitoring by CAs to ensure that the conditions established in the derogations granted have been complied with. This is not in line with the provisions of Article 9(5) of the SUD.

Although aerial spraying by airplanes and helicopters is prohibited, derogations are allowed under specific conditions established by the relevant CA only in viticulture, and for relatively small areas. The process for granting derogations, together with relevant mitigation measures is adequate. However, the measures put in place by the MAVDR for monitoring are not sufficiently robust. Moreover, the exclusion of drones 17 from the scope of the definition of aerial spraying is not in line with the relevant SUD provision. This may entail additional risks for human health and the environment.

Member state response

al A partir de 2022, le SPV adaptera les contrôles afin de couvrir g, cet aspect. Les contrôles prévus à cet effet sont : 1) contrôle sur place au site d'atterrissage 2) contrôle administratif des pièces à soumettre par le demandeur lors de la campagne de pulvérisation 3) contrôle du balisage et du tracé GPS de l'hélicoptère.

of 2022, the Plant Protection Service , (SPV) will adapt checks so that this aspect is covered. The checks planned for this purpose are the following: (1) on-the-spot check at the landing site, Page: 3 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the Action Proposed by the competent authority (2) administrative check of the documentation to be submitted by the applicant during the spraying campaign, (3) check of the markers and of the helicopter's GPS point.

The recommendation states as its basis

The CAs stated that according to their interpretation, drones are not considered aircraft under the definition laid down in Article 3(5) of the SUD. For this reason, they consider that there is no need for derogations to be granted when drones are used for PPP application. Moreover, the CAs consider that drones can be used in all crops, in all fields (not only on slopes), and that all PPPs authorised in Luxembourg can be applied by drones without any specific risk assessment. The CAs stated that they were not aware of the scale of use of drones for this purpose. The CA's interpretation of aerial spraying is not in line with Article 3(5), therefore, the use of drones for aerial spraying in Luxembourg is not in line with Article 9(1) of the SUD. Conclusions on aerial spraying

Although aerial spraying by airplanes and helicopters is prohibited, derogations are allowed under specific conditions established by the relevant CA only in viticulture, and for relatively small areas. The process for granting derogations, together with relevant mitigation measures is adequate. However, the measures put in place by the MAVDR for monitoring are not sufficiently robust. Moreover, the exclusion of drones 17 from the scope of the definition of aerial spraying is not in line with the relevant SUD provision. This may entail additional risks for human health and the environment.

Member state response

icle 3, point 5, de la directive 2009/128/CE, définit la ments pulvérisation aérienne comme l'application de pesticides par aéronef (avion ou hélicoptère), la définition étant reproduite à l'identique à l'article 1er, point 5, de la loi modifiée du 19 décembre 2014 relative aux produits phytopharmaceutiques. La parenthèse contenant les mots avion ou hélicoptère a pour fonction d'expliquer le mot aéronef qu'elle suit. L'absence de points de suspension ou de l'abréviation etc. montre le caractère exhaustif de l'énumération. La notion de drone, d'origine plus récente, a une signification propre qui ne permet pas de l'assimiler ni à un avion ni à un hélicoptère. Page: 2 0/2021 f report ref. DG(SANTE) 2021-7297 of the audit lementation of measures to achieve the sustainable cts Action Proposed by the competent authority Les drones ne sont donc pas visés par l'article 9 de la directive, imposant aux États membres d'interdire la pulvérisation aérienne

Article 3(5) of Directive 2009/128/EC defines aerial spraying as the application of pesticides from an aircraft (plane or helicopter), the definition being reproduced identically in Article 1(5) of the amended Act of 19 December 2014 on plant protection products. The parenthesis containing the words `plane or helicopter' serves to explain the preceding word `aircraft'. The absence of an ellipsis or of the abbreviation `etc.' shows that the list is exhaustive. The concept of a drone, which is more recent, has its own meaning and cannot be likened to a plane or helicopter. Drones are therefore not affected by Article 9 of the Directive, which requires the Member States to prohibit aerial spraying. Page: 4 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the Action Proposed by the competent authority Ajout du 07.02.2022 suite à la lettre Ares(2022)559650 du 25.01.2022 : Notre interprétation de l'article 3, point 5, de la directive 2009/128/CE reste inchangée.

The recommendation states as its basis

The audit team noted that in 2019 nearly 45% of agricultural land was in water protection zones participating in agri-environment schemes, with nearly two years remaining in which to achieve the aim to have 70% of land under these schemes as set out in the current NAP. Nonetheless, the action to develop a tool for advisors to help identify risks of water contamination was discontinued because of staffing issues. Moreover, while a 10 m buffer zone along SW, where the use of PPP is prohibited, came into force in 2018 through national legislation, this provision is not yet enforced during official controls.

With regard to prohibiting or restricting the use of certain PPPs in water protection zones, the CA has identified AS of particular concern, and has established risk mitigation measures for their use. The use of PPPs containing S-metolachlor is prohibited in Luxembourg, and the use of PPPs containing metazachlor is allowed only outside water protection zones. Nonetheless, PPPs containing these AS, are still authorised for placing on the market in Luxembourg. Representatives from the SPV explained that this measure took into account the fact that some Luxembourgish farmers are interested to buy the afore-mentioned PPPs in Luxembourg to use on land, which they own in neighbouring countries, where these PPPs are authorised for use. The audit team noted that the afore- mentioned measures have been in place since the adoption of Grand Ducal Regulation of 12 April 2015, and the results of the water monitoring in 2019 and 2020 show some good results with regard to the presence of the substances metazachlor and S- 18 metolachlor/metolachlor. Nonetheless, due to the still significant presence of their main metabolites (metazachlor-ESA and metolachlor-ESA) both in SW and GW, the effectiveness of these measures is still limited (see findings 59 and 63).

GW analytical results for 2019 show that, of the 489 samples taken, there were 312 exceedances3. Exceedances for metazachlor-ESA (a metazachlor metabolite) were found in 149 samples (30% of the samples) and for S-metolachlor-ESA in 110 samples (22% of the samples), whereas 23 samples (5% of total samples) saw exceedances for the sum of all PPPs. Results from 2020 show that, of the 355 samples taken, there were 223 exceedances3. Exceedances for metazachlor-ESA were found in 90 samples (25% of the samples) and for S-metolachlor-ESA (a metolochlor metabolite) in 68 samples (19% of the samples). Exceedances for the sum of all PPPs were found in 28 samples (8% of the samples).

SW analytical results for 2019 show that, of the 602 samples taken, there were 43 analyses in which AS were detected at levels exceeding the respective environmental quality standard, and 776 analyses in which AS exceeded the DW regulatory standard of 0.1µg/l. Results from 2020 show that, of the 700 samples taken, AS levels exceeding the respective environmental quality standard were detected in 71 analyses and the DW regulatory standard of 0.1µg/l was exceeded in 767 of the analyses. For both years, the DW limit breaches were largely accounted for by detections of metazachlor-ESA (36% of samples in 2019 and 20% in 2020) and S-metolachlor-ESA (5% of samples in 2019 and 9% in 2020), glyphosate (11% of samples in 2019 and 9% in 2020) and its metabolite AMPA (41% of samples in 2019 and 42% in 2020). The CA indicated that the majority of samples analysed have some level of contamination present.

In the monitoring programme of 2019, 192 samples were analysed with 15 of them found to exceed the DW regulatory limit. In 2020, 150 samples were taken, and the DW regulatory limit was exceeded in nine samples. The contamination in both years was caused in all cases except one, by the metabolites of metazachlor and S-metolachlor. Conclusions on water protection

The NAP includes a number of measures to protect water bodies from the impact of PPPs. Some of them have been put in place by the CAs, or are in progress, in particular the ban on the use of certain substances of particular concern and the increase of agricultural land, subject to agri-environment schemes in water protection zones. Others have been discontinued, or are not enforced yet as is the case for the 10 m buffer zone to protect SW. In the context where the results of water monitoring reflect a worrying 4 As laid down by Directive 2013/39/EU of the European Parliament and of the Council of 12 August 2013. 20 situation and recent data do not indicate significant improvements, the full implementation and enforcement of all planned measures is necessary.

Member state response

A partir de l'année culturelle 2021, des contrôles ponctuels seront vues de manière plus systématique. Vu l'importance de la pression sur la qualité des eaux de surface et souterraines, les sibilités de sanctions devront être revues une mise en relation des dispositions sur l'utilisation des substances phytosanitaires issue de la législation environnementale avec celles de la législation sur la mise sur le marché et de l'utilisation de ces produits. Une obligation des utilisateurs de tenir un registre détaillé des applications contrôlable par les autorités agricoles et environnementales devra également être mise en place.

As of the crop year 2021, spot checks will be provided for in a more systematic manner. Considering the importance of the pressure on the quality of surface and ground water, the possibilities of sanctions will have to be reviewed by linking the provisions on the use of plant protection products resulting from environmental legislation with those on the placing on the market and use of these products. An obligation will also have to be imposed on users to keep a detailed register of applications which may be checked by the agricultural and environmental authorities.

The recommendation states as its basis

Verification of the implementation of IPM principles by professional users is not part of any dedicated controls by the CAs, although the implementation of certain aspects of the IPM principles are verified by UNICO in the framework of controls under agri- environment measures. This is not in line with Article 14 of Directive 2009/128/EC on IPM, and Article 55 of Regulation (EC) No 1107/2009.

There are various initiatives and measures to promote low pesticide-input pest management and these include advanced and widely used pest monitoring and forecasting systems, in particular, for viticulture and the cereal crops sector, as well as an ambitious NAP for organic agriculture. However, there are no crop specific IPM Guidelines, and IPM implementation is not enforced, apart from a few IPM aspects in 5 https://agriculture.public.lu/de/publications/weinbau/Rebschutz/2021/rebschutzhinweise_2021.html 25 the case of official controls under the framework of the CAP Agri-environmental measures. As a result, no guarantees can be provided that all PPP professional users implement IPM general principles at farm level, and in particular that PPP are used as a last resort.

Member state response

e 2022, le SPV fera remplir la liste de contrôle « lutte » par tous les opérateurs concernés à chaque contrôle.

f 2022, the Plant Protection Service (SPV) will have the `integrated pest Page: 5 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the Action Proposed by the competent authority nagement' checklist completed by all the operators involved in each check. Ajout du 07.02.2022 suite à la lettre Ares(2022)559650 du 25.01.2022 : La mission de l'UNICO n'inclut pas le contrôle de l'application des principes de la lutte intégrée. Le SPV effectuera lui-même ce type de contrôle auprès des utilisateurs professionnels du domaine agricole, en employant la liste de contrôle « lutte intégrée ».

The recommendation states as its basis

ASTA has not formally identified trends in the use of certain AS, priority items or good practices, contrary to what required by Article 15(2)(b) and (c) of the SUD. Consequently, it could not communicated the results of such an assessment to the Commission and other MSs, and to make this information available to the public, contrary to what is required by Article 15(3) of the SUD.

Although the CA has not carried out the required evaluation of the sales data underlying HRI 1, the positive downward trend in HRI 1, which is faster than the EU average, and the declining sales of PPPs containing more hazardous active substances, indicate that Luxembourg is making good progress towards achieving the target in the Farm to Fork strategy.

Member state response

Veuillez vous référer à la réponse à la lettre Ares(2021)4385661. Les données sur lesquelles reposent les IRH 1 et 2 ont été e conclusion y relative est accessible en ligne: https://agriculture.public.lu/de/agrarstatistik/landwirtschaft- umwelt/harmonisierte-risikoindikatoren.html Page: 3

Please refer to the reply to letter Ares(2021)4385661. The data on which HRI 1 and 2 are based have been analysed and a conclusion on this is available online: https://agriculture.public.lu/de/agrarstatistik/l Page: 6 ations (updated) received 8 February 2022 es of Luxembourg in response to Report ref. DG(SANTE) 2021-7297 of the audit carried out from implementation of measures to achieve the sustainable use of pesticides and aspects of the hority Page: 7

The recommendation states as its basis

The audit team noted that the facilities and equipment used for official controls of animals and goods of animal origin meet the minimum requirements with the exception of the facilities for porcine animals at the live animal inspection centre. The audit team noted that the quarantine and housing facilities have in parts, walls constructed with rough concrete blocks, which together with the wall/ceiling junction, are not easy to clean, in line with Article 3(2) of Regulation (EU) 2019/1014. The ASV informed the audit team that this non-conformity had been identified before the facilities became operational, but that no changes had been made by the operator at the time of the audit.

The audit team noted that the inspection and storage areas for products of non-animal origin were not in fully in-line with the requirements of Articles 3(1)(c) and 4(2) of Regulation (EU) 2019/1014. SECULIM provided detailed floorplans and photographs of a new facility `Inspection zone 3 FNAO' which was planned to be operational by early 2021. The audit team noted that the proposed facilities would, if completed as planned, be compliant with the above requirements. Conclusions on minimum requirements for border control posts

The BCP meets the minimum requirements for BCPs, including inspection centres for live animals and products of animal origin, for the categories for which it was designated, with the exception of the facilities for porcine animals at the live animal inspection centre where the walls are not easy to clean and disinfect, and the facilities in place for controls of products of non-animal origin, which the competent authority has initiated action to address.

The recommendation states as its basis

All pigs are imported from authorised third countries, territories or part thereof and listed approved bodies in line with Article 3a(1) of Commission Regulation (EU) 206/2010 and are moved to an approved body, institute or centre in Luxembourg. The ASV stated that the pigs are subject to 15 days quarantine on arrival, and that based on a risk-assessment, it was concluded that the risk of introducing a disease from such (9) Groups A, B(1), B(2) and B(3) in Annex I to Directive 96/23/EC. (10) dangerous to humans, animals or the environment. (11) hazardous to humans, animals or the environment. 8 imports is very low. In light of that assessment, and concerns regarding the impact of taking blood samples on the welfare of the imported animals, it had been decided not to take blood samples, to confirm the absence of risk and validity of the risk assessment. The audit team noted that such an approach is not in-line with Article 4(3) and point 1(a) of Section III of Annex III of Regulation (EU) 2019/2130. The ASV noted that all necessary equipment is available and that blood samples would be taken in future, if required to do so.

The evaluation of the implementation of official controls on imports/transits of consignments of animals and goods was based on valid Common Veterinary Entry Documents (CVEDs) and CHEDs recorded in TRACES that were selected by the audit team. The implementation of official controls on imported consignments of products of non-animal origin was based on valid Common Entry Documents (CEDs), selected by the competent authority. 11 5.2.1 Prior notification of arrival of consignments and systems to ensure they are presented for import controls

The recommendation states as its basis

The audit team noted that one rejected consignment of products of animal origin was re- dispatched to the country of origin within 60 days of rejection, via an airport other than the one (BCP) of entry. The consignment was moved between airports under a customs procedure without SVA approval. Customs and the SVA subsequently confirmed that a consignment landed at one airport may be transported by road to another airport (destination) without the need for a customs transit document (T1) under a road-feeder service (`Luftfrachtersatzverkehr'). The air transport document (Air Waybill) indicates the airport of destination. The audit team noted that the procedure was not in line with the requirements laid down in Article 17(2)(a) of Directive 97/78/EC, which was applicable at the time that the re-dispatch concerned occurred, and neither does it satisfy the conditions for re-dispatch laid down in Article 72(1) of the OCR, since 14 December 2019, in particular with respect to the prior agreement and exchange of information on the intended destination of the consignment. Conclusions on the implementation of official controls on imports/transits of animals and goods

Shortcomings were noted in the implementation of certain documentary and physical checks, and in the procedures for the re-dispatch of non-compliant consignments, which take place without the required prior agreement of the competent authorities and thereby, without the assurance that any potential risks to the Union or the third country of destination arising from the non-compliant consignment, have been addressed.

The recommendation states as its basis

A recently developed procedure has been adopted to determine the main risk associated with each official control system, which identifies certain areas of the food chain (e.g. production, processing, transport etc.) where controls are carried out. This approach to risk-based planning is a starting point but does not reflect the diversity of official controls and sectoral requirements within each of the 21 official control areas. As the broader official control areas have not been subject to a more detailed breakdown, the risks relating to the different aspects have not been explicitly identified (e.g. product, process, establishment type etc.). Furthermore, there is no methodology in place to assign a risk ranking to each aspect. For example, in the case of food hygiene, OSQCA did not break this area down into official controls in different types of establishment (mobile food sellers, restaurants, primary production, processing plants, wholesalers, retailers, mass catering etc.), size of establishment/volume of production, production processes etc. OSQCA recognised that it would be useful to carry out more in-depth audits that cover sector-specific requirements based on risk but this is not possible given the current very limited resources and lack of access to technical experts. 12

The strategy for the current three-year cycle is to audit each control system at least once to gain an overview of the state of play of official controls. This means effectively that risk prioritisation is limited to the order in which the official control areas will be audited. The concept of 'adequate coverage of all relevant areas of activity' of point 5.1 of Decision 2006/677/EC was taken to mean 'audit' of all relevant areas, rather than risk- based consideration of all relevant areas. OSQCA stated that this would be considered for the next audit cycle and that it would also reflect on lengthening the audit cycle to five years to facilitate more in-depth audits.

Whilst OSQCA did not carry out audits for several years, it is now on track to audit the horizontal aspects of all 21 official control areas in the 2017-2019 cycle. However, given the scarce resources, the scope and depth of these audits is limited to evaluating compliance with the horizontal requirements of Regulation (EC) No 882/2004.

A procedure for determining the risks associated with each official control system has been recently developed but is not sufficiently detailed to identify risk-based priorities, nor does the planning cover the actual performance of official controls and diversity of sectoral requirements. The impact on the current audit cycle is limited, however, given that a) OSQCA's aim is to gain a quick overview of all official control systems after a long period without audits, and b) there are currently only resources available to audit horizontal requirements. 5.2.5 Implementation of the audit process 5.2.5.1 Legal requirements Article 2(6) of Regulation (EC) No 882/2004 states that "Audit" "means a systematic and independent examination to determine whether activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives." In section 5.1 of the Annex of Decision 2006/677/EC further guidance is provided to Member States on the `Systematic Approach', including: "A systematic approach should be applied to the planning, conduct, follow-up and management of audits. To that end, the audit process should: 13 ....... -- be supported by documented audit procedures and records to ensure consistency between auditors and to demonstrate that a systematic approach is followed, -- include procedures for generating audit findings, including the identification of evidence of compliance and noncompliance, as appropriate, and for preparing, approving and distributing audit reports, -- include procedures to review audit conclusions, in order to identify system-wide strengths and weaknesses in the control system, disseminate best practice and ensure the monitoring of corrective and preventive actions, -- be monitored and reviewed to ensure the audit programme's objectives have been met and to identify opportunities for improvement." Section 6.1 of the Annex of Commission Decision 2006/677 provides guidance on implementation of the Audit Process: "To comply with the requirements of Article 4(6) of Regulation (EC) No 882/2004, the audit system should cover the following three points set out in Article 2(6): (a) Verification of compliance with planned arrangements in order to provide assurances that official controls are carried out as intended and that any instructions or guidelines given to staff carrying out the controls are followed. This may largely be addressed by document review, but will also require on-site verification. The audit team will require good generic audit knowledge and skills to address this audit objective. (b) Verification of the effective implementation of planned arrangements. In order to assess effectiveness, that is the extent to which planned results are achieved, on-site operational implementation must be included. This should include an assessment of the quality and consistency of the controls and should involve on-site audit activities. The audit team will require the relevant technical expertise in order to address this audit objective. (c) The audit system should also seek to assess whether the planned arrangements are suitable to achieve the objectives of Regulation (EC) No 882/2004, and in particular the single integrated multi-annual national control plan. This should include assessing the suitability of official controls, with regard, for example, to their frequency and the methods applied, having regard to the structure of the production chain(s) and to production practices and volume. The audit team should have substantial knowledge and understanding of system auditing, together with relevant technical input to address this audit objective. In order to determine whether the planned arrangements are suitable to achieve the objectives set out in (c) above, the following should be considered: Audit criteria should include strategic objectives stemming from Regulations (EC) No 178/2002 and (EC) No 882/2004 (including the single

Member state response

Le programme d'audit actuel 2017-2019 reste en place pour que l'OSQCA puisse se faire un premier aperçu des 21 systèmes de contrôle officiel mentionnés dans le MANCP. Cependant dans l'élaboration du cycle d'audit prochain de 2020 ­ 2024, la programmation et l'analyse de risque est revue. Ceci est pris en compte dès à présent par l'élaboration de la procédure « cycle d'audit ». Pour atteindre cet objectif, l'OSQCA va prendre en considération des critères de risques plus poussés des différentes administrations compétentes ainsi qu'étudier et se baser sur la procédure existante d'autres Etats membres. (conclusion 32) L'OSQCA essaiera de combiner régulièrement des audits verticaux aux audits horizontaux programmés. (conclusion 31)

The recommendation states as its basis

Detailed documented procedures are in place to carry out the official controls and take samples correctly for live animals, products of animal origin and non-animal origin. The audit team noted one exception regarding the instruction for the controls of live animals, which does not require a check of the route plan for animals going on to travel long distances to ensure that proper resting times have been scheduled in order to respect animal welfare requirements during transportation (see findings 14 and 32). Conclusion on the organisation of the competent authorities and of official controls

The audit team noted several shortcomings in relation to the documentary checks of live animals: Several consignments of live animals were accepted when certificates did not comply with the detailed rules for documentary checks for live animals laid down in Annex I to Commission Decision 97/794/EC. In particular, several non- conformities were noted where the veterinary certificates were accepted without evidence that the certificate consisted of a single sheet or two or more pages that were part of a single and indivisible sheet of paper containing a sequence of numbered pages. The BIP staff accepted the route plans for breeding pigs which did not reflect the distance and resting times required during the long onward transportation to their destination in other EU Member States. This is contrary to the requirements of Article 21(2) of Council Regulation (EC) No 1/2005. The national instruction for the controls of live animals does not require staff to check the route plan for animals going on to travel long distances to ensure that proper resting times have been scheduled (see finding 5). Since Luxembourg BIP is one of the most important entries into the EU for breeding pigs (to Croatia, Czech Republic, France, Spain), this shortcoming significantly impacts animal welfare requirements during transportation. The CVEDA was incorrectly filled in in cases when dead/missing animals were detected during the identity and physical checks at the BIP, contrary to the requirements of Annex II of Commission Regulation (EC) No 282/2004.

The veterinary checks at the BIP are mostly carried out correctly and the decisions taken on the consignments are generally appropriate to satisfy the import control requirements. In some cases of live animals, BIP staff accepted consignments with inappropriate veterinary certificates and documentation related to the animal welfare of live animals which might lead to non-compliant consignments of live animals being accepted or animal welfare requirements not being respected.

Member state response

Les instructions pour les contrôles aux PIF ont été modifiées. A été ajouté dans la partie concernant le contrôle des animaux vivants, le contrôle du plan de route suivant l'article 21, paragraphe 2 du règlement 1/2005CE. Dans la partie concernant la rédaction du DVCEA une clarification a été apportée pour l'indication du nombre d'animaux introduits. Une formation pour les agents du PIF est prévue pour le mois de septembre 2017. Lors de celle-ci les modifications des instructions seront abordées ainsi que les non-conformités constatées au sujet de la conformité des certificats et surtout sur la complétude et l'indivisibilité des certificats. Annexe : - changement lignes directrices carnet de route - changement lignes directrices rédaction du DVCEA

Reply: The instructions for controls at BIPs have been of amended. A check of the route plan under Article 21(2) of Council Regulation (EC) No 1/2005 has been dded to the section concerning checks on live animals. In the section concerning the drafting of the CVEDA, the indication of the number of animals introduced has been clarified. Training for BIP staff is scheduled for September 2017. This will deal with amendments to instructions, non-conformities relating to the conformity of certificates and, especially, with the completeness and indivisibility of certificates.

The recommendation states as its basis

In 2016, the SECUALIM and the ADA established a new system of controls of food of non-animal origin in the DPE (see finding 4). In particular, the person responsible for the load or the customs agent creates the CED using TRACES and provides scanned certificates to accompany the consignment (e.g. a phytosanitary certificate or health certificate required by EU legislation) using email for consignments which are required to be accompanied by CEDs. The DPE staff carry out the documentary controls based on scanned copies of the certificates and decide whether to proceed with the identity and physical checks or not. 6

The same procedure for the documentary controls (see finding 15) is used for consignments of non-animal origin from Japan where the specific declaration model is established in EU legislation. Similarly, the SECUALIM stated that this procedure would be applied to consignments of food of non-animal origin where the EU legislation requires a special model certificate and attestation of laboratory test results (e.g. Commission Implementing Regulation (EU) No 884/2014 and Commission Implementing Regulation (EC) No 885/2014). This does not make it possible to ascertain the authenticity of the health certificates, contrary to the requirements of Article 5(1) of Commission Implementing Regulation (EU) No 2016/6. 5.3.2.2 Identity and physical checks

There is a system in place to carry out controls of food of non-animal origin following the EU requirements at the DPE. However, the documentary checks cannot verify that consignments are accompanied with authentic and appropriate health certificates and results of laboratory analysis, where relevant. 9

Member state response

d Selon l'interprétation de l'OAV l'original de la déclaration doit être contrôlé par les autorités compétentes avant mise en libre pratique des denrées en provenance du Japon. Pour se conformer à cette exigence une note particulière est introduite dans le DOC 113 dès sa prochaine édition. Le DOC113 est publié et mise à disposition des importateurs sur le site internet. (http://www.securite-alimentaire.public.lu/professionnel/Denrees- alimentaires/Importation/DOC_113/index.html) Par ailleurs, le mode opératoire MO 40 sera adapté en son point 3.2.2. pour préciser que les inspecteurs de la SECUALIM doivent contrôler l'original des attestations éditées dans le cadre du règlement EU N° 2016/6. Pour cela, à l'avenir l'importateur devra présenter cet original au bureau Import de la SECUALIM au Cargocenter à l'inspecteur de la SECUALIM. Page: 1 Ref. Ares(2017)4355004 - 06/09/2017 s of report ref. DG(SANTE)/2017-6043-MR of the audit carried out from 02 system

According to the FVO's interpretation, the original of the declaration should be checked by the of competent authorities before the release for free circulation of foodstuffs from Page: 1 nt authorities of Luxembourg in response to Report ref. DG(SANTE)/2017- o evaluate the official import control system Action Proposed by the competent authority onclusion 35. Associated Japan. A particular note has been introduced into the next edition of DOC 113 to comply with this requirement. DOC 113 is published and made available to importers on the website (http://www.securite- alimentaire.public.lu/professionnel/Denrees- alimentaires/Importation/DOC 113/index.html). In addition, point 3.2.2 of the MO 40 procedure will be adapted to specify that SECUALIM inspectors must check the original of the certificates published under Regulation (EU) No 2016/6.

The recommendation states as its basis

The facilities for products of animal origin and live animals (except for ungulates) comply with EU requirements. The absence of housing facilities for ungulates (in particular for pigs) weakens the implementation of animal welfare requirements.

Member state response

L'autorité compétente et les agents du PIF sont en contact avec les exploitants de l'aéroport pour réaménager la station prévu au transfert des ongulés, et notamment des porcs. L'autorité compétente a demandé aux responsables de l'aéroport de fournir un plan d'action avec échéancier avant fin septembre 2017. Page: 2

to ensure that BIP facilities The competent authority and BIP staff are in nts set out in Article 6 and contact with the airport operators to refurbish the ive 91/496/EEC. facility intended for the transfer of ungulates, onclusion 47. Associated particularly pigs. The competent authority has asked the airport operators to provide an action plan and Page: 2 nt authorities of Luxembourg in response to Report ref. DG(SANTE)/2017- o evaluate the official import control system oposed by the competent authority before the end of September 2017 ction plan received on 11 December e clarification à la ation N° 3 du rapport DG 7-6043 on de « time-line » pour la réalisation de n porcine au CargoCenter bre 2017 : réception des plans à l'ASV. Discussion avec les les du Cargo-Center et proposition de changements. évisionnel accepté 15 décembre 2017 : 2ème version . Plans approuvés par ASV et ion à la 15 janvier 2018 : Avis de la a DG Santé. Si accord, blocage du budget e des autorisations de construction s ministères luxembourgeois concernés 15 février 2018 : Si réception isations nécessaires et si la météo le ébut des constructions. 2018 : Fin prévue des travaux Page: 3

The recommendation states as its basis

In addition to the responsibilities stated under paragraph 7, ASTA is the CA in charge of decision making with regard to compliance or non-compliance of pesticide wholesalers, as part of official controls on the marketing of PPPs. ASTA staff are also responsible for carrying out of ad-hoc inspections at small scale growers and landscapers (see paragraphs 36 and 74 below). ASTA stated, however, that their staff do not have the status of "judicial police officers" ("officier de police judiciaire" (OPJ)). In order for ASTA staff to take any of the measures under Article 54 (2) of Regulation (EC) No 882/2004, they have to be accompanied by police officers. Once the Regulation, listed under paragraph 2, has been adopted, ASTA staff will have the OPJ status allowing them to take enforcement measures in the case of irregularities identified. This is not fully in line with the requirements of Article 4 (2) (e) of Regulation (EC) No 882/2004.

Official controls on both marketing and use of PPPs are performed in accordance with written instruction, in a uniform manner, which ensures consistency and operation of PPP wholesalers and professional users to the same standards. However, the complications for ASTA staff to take enforcement measures under Article 54 (2) of Regulation (EC) No 882/2004 in the case of irregularities identified at pesticide distributors, small scale growers and landscapers could compromise the effectiveness of official controls.

ASTA staff do not have the OPJ status allowing them to take enforcement measures (see paragraph 8 above), unless accompanied by police officers. However, there are provisions in the PPPA, allowing the Minister of Agriculture to take a number of administrative measures, which correspond to some of these, laid down in Article 54 (2) of Regulation (EC) No 882/2004. According to information provided during the audit, in the case of irregularities identified and reported by ADA, ASTA staff could only recommend non- compliant operators as to what corrective measures to take in order to remedy the situation. There are no other follow-up actions by any of the CAs in order to verify that adequate action has been taken, as required by Article 54 (2) of Regulation (EC) No 882/2004.

According to information provided by ASTA, at the time of the audit, national legal provisions and rules regarding penalties applicable to infringements of Regulation (EC) No 1107/2009 and Directive 128/2009/EC were laid down in the PPPA. For the same reasons, as listed above (see paragraphs 8 and 70), ASTA staff are not allowed to impose penalties. At the time of the audit, imposition of penalties, as well as any further measures in the case of serious infringements, were the responsibility of the Court of Justice. Once the Regulation, listed under paragraph 2, has been adopted, ASTA staff will have the powers to enforce the imposition of the penalties referred to in the final bullet points of paragraphs 2 and 3. Controls on the use of PPPs

At grower level, in the case of ad-hoc inspections by ASTA, the situation with regard to enforcement measures is similar to that described under paragraph 70 above. The reason is the same; ASTA staff do not have the OPJ status to apply any of the measures under Article 54 (2) of Regulation (EC) No 882/2004, or to impose sanctions. Conclusions on Enforcement Measures

For official controls on the use of PPPs, a system is in place for decision making on compliance with national and EU legal requirements, including enforcement measures and sanctions. However, this is not the case for official controls on the marketing of PPPs and for professional users with no extensive use of PPPs (landscapers and small scale growers), where there is a risk that non-compliances are not remedied by infringing operators, as no corrective measures are recommended to non-compliant operators and due to the absence of verification by any of the CAs. The complications with regard to imposition of penalties is one further complication. As a result of all these, the effectiveness of official controls at the operators concerned could be compromised.

Member state response

e ASTA expects the regulation foreseen under Article 18 of the to be adopted by September 2017 and ASTA staff to be appointed as OPJ by the end of 2017.

Member state response

or On the 8th of September 2016 ASTA informed authorisation 3 of holders that the national procedure for the renewal of authorisations will be replaced by the renewal procedure provided for by Article 43 of Regulation (EC) No 1107/2009. ASTA referred to the Guidance Document on the Renewal of Authorisations according to Article 43 of Regulation (EC) No 1107/2009 (SANCO/2010/13170 rev. 13 ­ 14 July 2015). As of the 8th of September 2016 ASTA will only renew authorisations if Article 43 applies. Where necessary, authorisations will be prolonged until an Article 43 renewal is due. Authorisations of plant protection products containing active substances whose approval has been renewed after the 26th of September 2016 will only be renewed if the authorisation holders submitted the necessary information to ASTA. The competent IT-services have been tasked on the 7th of September 2016 with the adaption of ASTA's IT-system to provide for a better managing of Article 43 renewals. ASTA expects the adaptations to be done by January 2017.

Member state response

n Concernant les sanctions prévues au règlement (CE) n°882/2004, es un projet de loi a été déposé à la chambre des députés et 'avancement peut être suivi sur le site de la chambre des députés: En ce qui concerne le bien-être animal, un avant-projet de loi abrogeant la loi de 1983 est en voie d'élaboration par le Service Juridique du Ministère ( voir chapitre « contrôles et sanctions » en annexe).

Member state response

Formation sur le bien-être au transport et à l'abattage le 15/05/2014 par ..."Please note that it has been necessary to delete this text in order to respect the provisions of Article 339 of the Lisbon Treaty as regards confidentiality) pour les vétérinaires officiels et les praticiens. Une réunion d'information avec le secteur porcin est prévue pour le mois d'octobre 2014.

Member state response

te Un plan pour les transformations a été présenté, les demandes de de devis et d'autorisations sont en cours.

Member state response

L'Administration de la gestion de l'eau procédera à une refonte des programmes de contrôle avec les fournisseurs d'eau afin d'inclure la mesure du chlore libre lors des contrôles complets et l'information de la chloration. Page: 1

Member state response

several law proposals 6614 ; 6646 ; 6659 are being discussed in l the Parliament, furthermore the government is finalising an audit on the official control structures to better implement official controls of food safety.

Member state response

mal Concerning traceability of food of animal origin before the end of the first semester 2015 a training with all inspectors will focus on this item and taking in account the experience gained during the e FVO audit procedures will be adapted in accordance. ncerning animal waste we consider that no action is necessary because: -during the audit there was no evidence that traceability was not in accordance with Reg. CE 1069/2009 -Reg. CE 1069/2009 was not part of the scope of the audit -the finding mentioned in the report is worth to be considered from a theoretical point of view but was insignificant for a practical and appeared only because of the very detailed traceability system of the food business operator (FBO). Concerning additives and food ingredients a training was organised on 2nd April summarising the BTSF session on additives held in Athens in February 2015.

Member state response

Up to now the competent authority ensured that the FBOs were compliant to Art.18§2 of Reg.(EC) No178/2002 and to Art.18§3 of Reg.(EC) No178/2002 and no failings were identified during the audit concerning these points so no action is necessary for these issues. We agree with the auditors that in view of verifying the information provided on the labels as well as the use of additives the internal traceability has to be improved. After the training referred to in point2 above the competent authority will Page: 1 f Report ref. DG(SANTE)/2014-7232-MR of an Audit carried out from 25 cial controls over the post-slaughter traceability of meat, meat products and adapt the control checklist and focus more in detail to traceability including qualitative as well as quantitative aspects considering different specific factors of the enterprise as the type of activity, the size, workflow, short-or long-term production, numbers of persons interacting......during the third quarter of 2015. Furthermore at least once per year a traceability exercise will be organised and documented.

Member state response

rs Discussions are ongoing with SECUALIM to adapt the checklists, a working-group took place on 8/04/2015 an other one is foreseen for 18/05/2015 and checklists will be effective end of first semester or beginning of the second one.

Member state response

food The competent authority considers this point in relation with point3 above and will focus more in detail to the ingredients used during the production and the ingredients mentioned on the label.

Member state response

Concerning the finding in relation to the cold store where individual consumer packs arrived without identification mark, the cold store and the producing establishment had the same owner and are situated within a distance of 4km for that reason several years ago an inspector accorded this "flexibility". This is no longer tolerated, the establishment has stopped this practice. Page: 2

Member state response

s concernant les conditions dans lesquelles les animaux de compagnie peuvent être introduits ou réintroduits sur le territoire de l'UE ont été site web de l'ADA (http://www.do.etat.lu/voyages/index.htm) dans mise en place du site web de l'ASV qui est toujours en construction.

s concernant les conditions dans lesquelles les animaux de compagnie peuvent être introduits ou réintroduits sur le territoire de l'UE ont été site web de l'ADA (http://www.do.etat.lu/voyages/index.htm) dans mise en place du site web de l'ASV qui est toujours en construction.

Member state response

e en place un plan d'audit annuel pour vérifier l'application des i que les décisions prises par le personnel de l'ADA et du personnel du place d'un registre pour les contrôles effectués par les agents de l'ADA ouvements non commerciaux d'animaux de compagnie va faciliter la décisions relatives aux animaux contrôlés. Un rapport d'audit sera ier des inspections communes sur site avec les agents de l'ADA pour ution des contrôles documentaires et d'identité ainsi que les décisions s aux animaux. Un rapport concernant ces inspections communes sera n système d'audit sera mis en place pour la vérification des procédures s relatives aux colis personnels de produits d'origine animale. collecte et de l'élimination des déchets de cuisine et de table provenant ansport internationaux la visite d'inspection des infrastructures et des a complétée par un volet de vérification des procédures mises en place. s résultats de ces audits et vérifications des mesures correctives seront vement des recommandations seront adressées aux différents

e en place un plan d'audit annuel pour vérifier l'application des i que les décisions prises par le personnel de l'ADA et du personnel du place d'un registre pour les contrôles effectués par les agents de l'ADA ouvements non commerciaux d'animaux de compagnie va faciliter la décisions relatives aux animaux contrôlés. Un rapport d'audit sera ier des inspections communes sur site avec les agents de l'ADA pour ution des contrôles documentaires et d'identité ainsi que les décisions s aux animaux. Un rapport concernant ces inspections communes sera n système d'audit sera mis en place pour la vérification des procédures s relatives aux colis personnels de produits d'origine animale. collecte et de l'élimination des déchets de cuisine et de table provenant ansport internationaux la visite d'inspection des infrastructures et des a complétée par un volet de vérification des procédures mises en place. s résultats de ces audits et vérifications des mesures correctives seront vement des recommandations seront adressées aux différents pplémentaires : annuel pour vérifier l'application des procédures ainsi que les Page: 1 Updated Action Plan received from CA 1 October 2012 ef. DG(SANCO)/2012-649

Member state response

ions données au personnel du centre de tri de la poste concernant les POA poste seront complétées surtout en ce qui concerne les trophées de bi un traitement taxidermistecomplet. Page: 1 2012 ef. DG(SANCO)/2012-6496-MR of an audit ot carried out at border inspection posts and specific Action Proposed by the Competent Authority directrices fournies à l'ADA seront modifiées et complétées pour les ns concernant ce type de produits. A côté des contrôles relatifs aux règles de ersonnel du PIF devra être consulté dès lors que ces produits ne sont pas s d'un certificat attestant le traitement taxidermiste complet. ures à respecter et les contrôles à effectuer seront présentés lors des séances de formation du personnel de l'ADA pour les rendre familiers avec e produits.

ions données au personnel du centre de tri de la poste concernant les POA r la poste seront complétées surtout en ce qui concerne les trophées de nt subi un traitement taxidermiste complet. directrices fournies à l'ADA seront modifiées et complétées pour les ns concernant ce type de produits. A côté des contrôles relatifs aux règles de ersonnel du PIF devra être consulté dès lors que ces produits ne sont pas s d'un certificat attestant le traitement taxidermiste complet. ures à respecter et les contrôles à effectuer seront présentés lors des séances de formation du personnel de l'ADA pour les rendre familiers avec e produits. ns supplémentaires : ctions écrites données au personnel du centre de tri de la poste vues, complétées et modifiées en date du 10.07.2012 les trophées de chasse. les instructions à observer par les agents de l'ADA seront et commentées lors de la prochaine formation prévue au cours trimestre 2012. Page: 3 Updated Action Plan received from CA 1 October 2012 ef. DG(SANCO)/2012-6496-MR of an audit ot carried out at border inspection posts and specific Action Proposed by the Competent Authority

Member state response

i vient d'être rédigé par le service juridique du Ministère de l'agriculture ansposition des règlements (CE) N° 1069/2009 et (UE) N° 142/2011 en droit Cette loi donne aux autorités compétentes désignées les moyens de prendre les propriées tel que prévu à l'article 46 et des sanctions sont déterminées en cas on des dispositions de ces règlements conformément à l'article 53 du (CE) 1069/2009. u projet de loi est attaché en annexe. positions nationales d'adoption d'une loi et les délais prévus, la publication et oeuvre peuvent être attendu pour le deuxième semestre 2013. Page: 2

i vient d'être rédigé par le service juridique du Ministère de l'agriculture sition des règlements (CE) N° 1069/2009 et (UE) N° 142/2011 en droit loi donne aux autorités compétentes désignées les moyens de prendre les iées tel que prévu à l'article 46 et des sanctions sont déterminées en cas s dispositions de ces règlements conformément à l'article 53 du 1069/2009. jet de loi est attaché en annexe. ions nationales d'adoption d'une loi et les délais prévus, la publication et re peuvent être attendu pour le deuxième semestre 2013. Page: 4

Member state response

sidues to be sampled will be mentioned not only on the r the moment but also on the sampling list send in advance so icial veterinary has all information in advance to target ing will be provided.

Member state response

es will be updated before submitting the NRP for 2012.

Member state response

with LNS are ongoing for validation, if it won't be possible 35 concerned samples will be send to an other laboratories.

Member state response

avertir, mettre en garde les acteurs de la chaine de médicament vétérinaire, dresser procès-verbal au Parquet lettre circulaire (réf. 14.11 du 24.10.201) a été itulaires d'autorisations de mise sur le marché précisant légale de la mention du numéro d'autorisation dans du produit (voir annexe). Lettres à grossistes et pharmaciens

Member state response

ice de nos fonctions, priorité sera donnée aux missions i nous incombent par des textes législatifs Page: 1 ber 2011 DG(SANCO)/2011-8860-MR of an audit ontaminants in live animals and animal products, Action Proposed by the Competent Authority

Member state response

cice de nos fonctions, priorité sera donnée aux missions s incombent par des textes législatifs.

Member state response

indent ("according to GDR of 10.08.2009) it says "In "second identification" the animal status as intended for mption is suspended for six months after the issue of the t" however according to article 12 of GDR of 10.08.2009, port will be issued in this case, as the owner is still in of the passport. The issuing body only writes down the new D in the existing passport with a comment "second ion" ­ no new passport will be issued. The new microchip ID e recorded in the database of the issuing body. For food safety decided to exclude the animal from the food chain for six case of loss of microchip, evidence has to be given that the hes with the animal described in the existing passport (e.g. "outline diagram" in the passport). rial Decision of 17.01.2011 comprises rules for the issuance Page: 2 011 DG(SANCO)/2011-8860-MR of an audit ontaminants in live animals and animal products, ty for slaughter where the deadline xceeded. According to the audit as being not in line with the 008. Horses should be ntil the 31st of December of their considered) ­ however in practice not always done within the legal rg specific finding). As this case no 504/2008, a ministerial ise food safety. In order