Slovenia

The recommendation states as its basis

The AFSVSPP has no schedule of audits or inspections on delegated bodies as required by Article 33(a) of Regulation (EU) 2017/625. However, in 2024, for the first time, it inspected four delegated bodies to verify if they were conducting surveys in line with the Survey Guidelines. These controls identified a range of weaknesses common to all four bodies. These weaknesses included failing to consider all relevant risks in choosing surveys sites and incorrectly entering survey data into the UVH-apl/ISI database. The AFSVSPP subsequently organised specific training in 2025 to help address these weaknesses.

While the CA has started to supervise delegated bodies, the limited activity completed to date indicates that these bodies don't consistently adhere to the guidance on surveys, which impacts negatively on the quality and consistency of surveys.

The recommendation states as its basis

In 2024, adult P. japonica beetles were captured in traps at two motorway service stations/lorry rest areas along the A1 highway coming from Italy (there are outbreaks of P. japonica in Italy, including one in the autonomous region of Friuli-Venezia Giulia, which borders Slovenia). At the first site (Lukovica), six beetles were found in the same trap over five separate dates in July and August. Following the first detection, a total of eight extra traps were placed at this site in 2024, but there were no findings in any of these additional traps. At the second site (Barje), one beetle was found in a trap on 17 July and one on 5 September. The PHPRMD explained that these service stations are about 8-10 hours drive from the outbreaks in Italy, and that lorry drivers are required to rest for an extended period after 8-10 hours driving, thereby giving any beetles hitchhiking on the lorry an opportunity to fly off the lorry into the surrounding environment.

Slovenia did not establish demarcated areas in response to these findings. The PHPRMD explained that it took this approach because all findings were in traps and visual inspections in a 1km radius showed no evidence of pest damage to host plants. On this basis, it concluded that the pest had not multiplied and that these were isolated findings, so it could avail of the derogation to avoid establishing demarcated areas as permitted under Article 6(1) of Implementing Regulation (EU) 2023/1584. 12

The PHPRMD implements the measures required under Article 6(2) of the same Regulation (i.e. for MS availing of the derogation to establish demarcated areas), with one exception. It immediately intensified the number of traps and the frequency with which the traps were checked in a 1km radius of findings. It also intensified visual examination for the presence of adults and raised public awareness of the pest in the local areas. However, it does not inspect grassland and soil for the presence of larvae as required by Article 6(2)(c). It explained that as no beetles have ever been found outside traps, it sees no scientific reason to meet this requirement. This breach is significant, because it means that the source of the trap findings may be beetles emerging from soil close to the traps, (particularly at the Lukovica site, where all beetles were found in the same trap), rather than hitchhikers. If this is the case, Slovenia would be required to establish demarcated areas in line with Article 5 of Implementing Regulation (EU) 2023/1584.

The failure to inspect grassland and soil for the presence of P. japonica larvae in the vicinity of trap findings, means that the CA cannot satisfactorily demonstrate that the source of the trap findings are isolated findings of hitchhikers, rather than beetles emerging from soil (indicating that the pest has established), in which case Slovenia should have established demarcated areas around the trap findings.

The recommendation states as its basis

Slovenia does not comply with Article 26(1) of Regulation (EU) 2016/2031 which requires MS to carry out simulation exercises concerning the implementation of all contingency plans within a reasonable period of time, except in cases where the MS concerned has recently taken measures for the eradication of the pest or pests concerned. Slovenia has undertaken just one formal simulation exercise, a field-based exercise conducted by the FIS and the SFS in 2020 focusing on A. planipennis. The PHPRMD added that it has gained valuable experience through dealing with a suspected case of A. chinensis in 2022 and the trap findings of P. japonica in 2024. The PHPRMD has no schedule of planned simulation exercise but stated that it planned to conduct an exercise by the end of 20252. It explained that in recent years, it had allocated any additional capacity to deal with Grapevine flavescence dorée phytoplasma outbreaks, with the result that it was unable to conduct simulation exercises.

The PHPRMD, in discussions with the audit team, expressed confidence that its planned response to pest outbreaks, as outlined in its contingency plans, means that it is sufficiently prepared for relatively small pest outbreaks. However, it acknowledged that by not conducting simulation exercises, in particular for larger outbreaks, to test the robustness of these plans, there is a risk that it may not be able to access sufficient laboratories, equipment, personnel, external expertise and resources necessary for the rapid and effective eradication or, where appropriate, containment of larger outbreaks of priority pests, as required by Article 25(2)(c) of Regulation (EU) 2016/2031. Conclusions on contingency plans

The failure to conduct simulation exercises to test the robustness of contingency plans means that the CA cannot demonstrate that it will be able to access the necessary resources to ensure the rapid and effective eradication or, where appropriate, containment of any larger outbreaks of priority pests, if and when these are detected.

The recommendation states as its basis

However, the analyses do not cover unacceptable co-formulants and have only once included a regulated impurity, which is subject to a maximum threshold. The CA is currently exploring options to expand the scope of formulation analysis to include these elements. 9 Conclusions on planning of official controls

Formulation analysis of PPPs is planned for active substances but checks for other important components of the composition of PPPs, such as regulated impurities and unacceptable co-formulants, are not included in the regular planning. 5.2.3. Delegation of certain tasks Findings

The Agricultural Institute of Slovenia (Kmetijski institut Slovenije) and Benaki Phytopathological Institute in Greece are the designated official laboratories to carry out formulation analysis of PPPs. The latter is the designated official laboratory for the same task in Greece. The combined list of accredited activities, in accordance with ISO/IEC 17025:2017, from both laboratories covers the requirements of formulation analyses with regard to active substances. Conclusions on laboratories used for formulation analysis of plant protection products as part of official controls.

The recommendation states as its basis

In the same year, one out of the two registered manufacturers and one out of the two registered re-packers were inspected. The audit team witnessed an inspection of a manufacturer and noted that phytosanitary inspectors reviewed the records of PPP production, raw materials, sales as well as disposal of obsolete, expired or out of specifications PPPs, and also inspected the warehouses. The records are retained for five years. However, the inspection did not verify that the producer of the active substances, safeners, and synergists was the one specified in the PPP authorisation, which is not fully in line with Article 14(e) of Regulation (EU) 2017/625. There are no inspection requirements in place to verify that PPPs intended for use in another EU Member State or a third country actually leave Slovenia.

Inspections of manufacturers, although thorough, fail to verify, for PPPs placed on the market in Slovenia, compliance with the authorisation specification regarding the source of production of active substances, safeners, and synergists, as well as the movement within Slovenia of PPPs intended for use in another EU Member State or a third country.

The recommendation states as its basis

The retailer visited during the audit was aware that PPPs for professional use are to be sold only to those holding a valid training certificate. However, the sales records he kept and made available to the inspectors did not include buyer details. Thus, it cannot be verified that all sales of PPPs for professional use are restricted to eligible buyers, which is not in line with Article 6(2) of Directive 2009/128/EC. The CA confirmed that keeping records without reference to buyers is in line with national requirements and mentioned that, in the past, inspectors may have secretly posed as buyers to monitor compliance with this obligation.

There are no methods or techniques to verify that sales of PPPs authorised for professional use only are restricted to persons holding a valid training certificate . 5.3.2. Controls on the use of plant protection products Legal Requirements Articles 11 to 14 and 137 to 139 of Regulation (EU) 2017/625 Articles 28, 31, 55 (first and second sentences) and 67(1) of Regulation (EC) No 1107/2009 Articles 5 and 6 of Directive 2009/128/EC Regulation (EU) No 547/2011 Findings

The recommendation states as its basis

The ASFVSPP issued detailed procedures for its phytosanitary inspectors regarding the registration of professional operators, their authorisation to issue plant passports, the visual examination of plants, the issuance of plant passports and the official controls on professional operators as required by Article 12(1) of Regulation (EU) 2017/625. The procedures contain guidance on how to practically implement the requirements, and instructions for official measures in case of non-compliances. Similar procedures for the other CAs are being prepared and expected to be issued at the end of 2024. The own procedures of the other CAs contain limited plant passport related instructions for their staff. Each CA uses checklists to verify if professional operators comply with the requirements listed in Article 92(1) of Regulation (EU) 2016/2031. However, these procedures contain some differences from the applicable EU requirements. · In line with the ASFVSPP procedures, during official controls inspectors verify that authorised operators have the certificate confirming that they passed the official knowledge test. However, passing the test years before an official control does not mean that the operator still possesses the necessary knowledge and is able to carry out examinations, as required by Article 89(1)(a) of Regulation (EU) 2016/2031 (see also finding 16). · The checklists do not contain the obligation of authorised operators to provide appropriate training, when necessary, to their personnel involved in the examinations, as required by Article 90(2) of Regulation (EU) 2016/2031. Consequently, inspectors did not consistently verify the compliance with this requirement (see also finding 16).

The roles and responsibilities of the different CAs are clearly regulated, with detailed procedures to assist inspectors providing a good basis for the effective implementation of EU legislation. Minor differences in the application of some plant passport requirements mean that Slovenia does not implement all the rules in line with the requirements established by EU legislation.

During the official controls observed by the audit team, the inspectors used checklists to verify whether authorised operators comply with Article 92(1) of Regulation (EU) 2016/2031. These controls were broadly effective. However, the audit team noted the following: · All inspectors verified the content, format and attachment of plant passports issued and received. However, in the case of forest plants for planting the CA tolerates that plant passports are not attached to the commercial units which is a general practice in Slovenia and does not comply with Article 88 of Regulation (EU) 2016/2031 (see also finding 30). · Non-compliances regarding plant passports from other MS are not reported via iRASFF contrary to Article 95(5) of Regulation (EU) 2016/2031 and Article 16 of Regulation 2019/1715. · Inspectors verified the records of examinations of plants carried out by authorised operators. However, a single written statement in their records that examinations were regularly carried out, or records containing that plant health checks were done on particular days without any further details, were also accepted. This way inspectors did not consistently verify whether authorised operators carry out meticulous examinations to show that their plants, plant products and other objects fulfil the EU requirements as required by Article 87 of Regulation (EU) 2016/2031. · In line with national procedures, inspectors consistently verified that operators authorised to issue plant passports passed the test organised by the ASFVSPP (see also findings 4 and 14). However, they did not verify if operators are up-to- date and still possess the necessary knowledge to carry out examinations, as required by Article 89(1)(a) of Regulation (EU) 2016/2031. 7 · Inspectors did not consistently verify whether authorised operators provided appropriate training, when necessary, to their personnel involved in the examinations contrary to Article 90(2) of Regulation (EU) 2016/2031 Conclusions on authorisation and supervision of professional operators for issuing plant passports

Weaknesses in the annual official controls weaken the level of assurance that authorised operators fully meet the requirements for issuing plant passports. The lack of notification of non-compliances related to plant passports from other MS prevents the implementation of official measures to avoid further occurrence of such non- compliances.

In general, authorised operators visited by the audit team carried out examinations of plants for regulated pests. Based on the records provided to the audit team, the examinations were carried out at appropriate times with regard to the possibility of detecting the presence of relevant pests or signs or symptoms thereof as required by Article 87(3)(a) of Regulation (EU) 2016/2031. However, some records did not contain the results of the examinations contrary to Article 87(3)(d) of the same Regulation (see also finding 16). Authorised operators take samples in case of the suspected presence of regulated non-quarantine pests and send them for testing to official laboratories of the CAs. Each authorised operator met by the audit team had defined their critical points and had monitoring records for these points as required by Article 90(1) of Regulation (EU) 2016/2031. 5.4.2 Examinations by competent authorities including the verification of examinations carried out by authorised operators

The inspectors met were aware of the relevant regulated pests and demonstrated meticulous examinations. The audit team noted that these inspections are done in line with the documented procedures of the CAs at appropriate times with regard to the possibility of detecting the presence of pests, their signs or symptoms. However, verification of the examinations carried out by authorised operators was not consistently done by the inspectors, contrary to Article 92(1) of Regulation (EU) 2016/2031 (see also finding 16). 5.4.3 Examinations in relation to the protected zones

The CAs carry out meticulous examinations on plants, plant products and other objects to be moved with plant passports to verify that they fulfil the applicable EU requirements regarding the absence of relevant pests. Authorised operators also carry out the required examinations. However, there are cases when the results of the examinations are not recorded. These examinations are not verifiable, therefore do not provide sufficient guarantees for the issuance of plant passports.

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

The issuance of plant passports is generally in line with EU requirements. However, accepting that certain plant passports are not attached to trade units is contrary to EU requirements thus compromising the reliability of the system developed for issuing plant passports in Slovenia.

Member state response

e following measures are proposed for consistently verification hether all authorised operators comply with all requirements listed Article 92 of Regulation (EU) 2016/2031: - A workshop for phytosanitary inspectors was organised by AFSVSPP to discuss on the possible solutions regarding implementation of the measures according to the audit recommendations (27.11.2024); s for operators will be updated by AFSVSPP as regards keeping knowledge up to date (up to 31.1.2025); will be informed by AFSVSPP of the updated Guidelines for operators and will receive instructions on how to follow the recommendations of the audit and remedy the identified shortcomings (up to 31.1.2025); tosanitary Inspection Manual including check lists will be amended regarding official controls of operators' knowledge, demands on record keeping of examinations, attachment of plant passports and training of personal, as pointed in the recommendation of the audit team (up to 28.2.2025); stry Inspection Manual including templates of inspection records/minutes will be amended to include consistence verification of operators' knowledge, demands on record keeping of examinations, attachment of plant Page: 1 ecommendati

The recommendation states as its basis

The audit team noted that the CA has registered 276 "village milk collection points", receiving raw milk from several dairy holdings and storing it under temperature- controlled conditions before its delivery to the dairy establishments. They operate mainly under registered milk buying-in cooperatives and some under dairy establishments. However, Article 4(2) of Regulation (EC) No 853/2004 requires such premised to be approved as milk collection centres (MCCs).

Contrary to the EU legislation, "village milk collection points" are not subjected to approval requirement of Article 4 of Regulation (EC) No 853/2004 and thereby not to other requirements of the same regulation. 7

The recommendation states as its basis

The latest available Multi-annual National Control Plan (MANCP) covered the period 2018-2020. Since then, also due to the COVID pandemic, the official control system 11 has been implemented following single annual control plans. In 2022, the CCA stated that the MANCP for the period 2023­2027 was under development. The new deadline currently defined for the approval of the MANCP is the end of 2024(2). This is not in line with the requirements of Article 109 of Regulation (EU) 2017/625, which stipulates that the official controls shall be carried out on the basis of a MANCP.

No MANCP has been in place since 2021. This compromises the CA's ability to set medium and long-term objectives and indicators and to monitor progress in achieving them and make adjustments as necessary. It also hinders efforts to prioritise official controls and allocate resources to where they are needed. 15

The recommendation states as its basis

Regarding the BCPs designated by AFSVSPP for food and feed of non-animal origin, the facilities were in general not compliant at the BCP Luka Koper port. At the BCP Ljubljana Brnik airport the facilities for controls on consignments of goods of animal origin were shared with controls of food and feed of non-animal origin. The audit team noted that the unloading and storage facilities for food and feed of non-animal origin at the BCP Luka Koper port did not have adequate drainage and most floors were constructed of tarmac which is not easy to clean and disinfect. This is not in line with Article 3(2) and (3) of Regulation (EU) 2019/1014.

The audit team noted that both BCPs designated by HIRS for controls on food contact materials and food supplements were not compliant with the minimum requirements for BCPs due to a lack of facilities and equipment. This is not in line with Article 64(3)(b) and (c) of the OCR and Articles 3 and 4 of Regulation (EU) 2019/1014. In the absence of BCP control facilities, the documentary controls are carried out in regional offices outside the port or airport. The identity and physical checks take place in the storage facilities within the BCP Luka Koper port which do not meet the minimum requirements (see finding 48) or at Ljubljana airport, which also did not have adequate drainage.

Whilst the BCPs Luka Koper and Ljubljana airport were, apart from the housing facilities for animal products to be kept under controlled temperature, compliant with the minimum requirements for BCPs for the categories of animals and goods of animal origin for which they had been designated, both of them and two of the eight listed control points visited were not compliant with the minimum requirements for the categories of goods of non- animal origin for which they had been designated. This latter shortcoming has the potential to reduce the overall effectiveness of the official control system.

Member state response

At BCP in port of Koper storage area for consignments requiring for temperature control are going to be adapted to achieve compliance with the regulation Reg. 2019/1014. Since this requires substantial intervention in the facility (removal of the 3, upper part of the asphalt, application of a new washable layer, incorporation of drainage system with connection to the sewage system), compliance with the regulation is going to be achieved in third quarter of year 2024. For products which require ambient temperature a new location also compliant with the Reg. 2019/1014 is going to be arranged in the same time frame. AFSVSPP and HIRS are going to monitor achievement of compliance within official procedures. Regarding the associated finding 48, point a) that relates to facilities for chilled consignments of animals (fertilised fish eggs intended for breeding) there is a proposal already tabled by the European Commission to amend Regulation (EU) 2019/1014 accordingly.

The recommendation states as its basis

HIRS stated that the documentary checks on consignments of food-contact materials and food supplements did not take place at the BCPs but at regional offices. This is in not in line with Article 49(1) of the OCR (see finding 50).

The control system ensures that consignments of animals and goods entering the EU are presented for official controls, and that those controls are carried out in line with documented procedures and, with few exceptions, EU requirements.

The audit team noted that both BCPs designated by HIRS for controls on food contact materials and food supplements were not compliant with the minimum requirements for BCPs due to a lack of facilities and equipment. This is not in line with Article 64(3)(b) and (c) of the OCR and Articles 3 and 4 of Regulation (EU) 2019/1014. In the absence of BCP control facilities, the documentary controls are carried out in regional offices outside the port or airport. The identity and physical checks take place in the storage facilities within the BCP Luka Koper port which do not meet the minimum requirements (see finding 48) or at Ljubljana airport, which also did not have adequate drainage.

Member state response

Health Inspectorate of the Republic of Slovenia (HIRS) has agreed d with Administration of the Republic of Slovenia for Food Safety, Veterinary Sector and Plant Protection (AFSVSSP) on the temporary sharing of inspection room/inspection areas at BCPs Ljubljana Brnik airport and Luka Koper port. The corresponding written protocols will be coordinated and signed by May 15th, 2024. For the purpose of a long-term solution HIRS and AFSVSSP cooperate with Ministry of Public Administration (which is Page: 1 report ref. DG(SANTE) 2023-7779 of the audit carried out from 27 November s on animals and goods entering the European Union and verification of ne by of

The recommendation states as its basis

The audit team examined several approval files and associated records and noted that the approvals granted for the first time to ABP operators followed appropriately the approval steps. However, in two out of the three processing plants visited and operating under the full approval, the audit team noted that even though the operators made significant changes to the processing treatment subsequently to receiving the original approval, the 6 required validation of the altered ABP processing treatment and the validation checks thereof by the plants' operators and the competent authority, respectively, had not been carried out, in particular: a. in one plant, the operator using the processing method 7 for processing Category 3 material has changed the processing equipment, the processing parameters and the system for processing from batch to continuous, and b. in another plant, also applying the method 7 for processing of Category 3 material, the operator has modified the processing machinery by installing a new cooker. The absence of checks by the competent authority on the operator's validation procedures, in case of any significant alterations are made to the processing treatment, such as modifications of the machinery, is not in line with requirements of Section 2(4) in Chapter I of Annex XVI to Regulation (EU) No 142/2011. The AFSVSPP representatives explained that the above-mentioned deficiencies resulted from some misinterpretation of the approval requirements for already approved and operating plants. The authority undertook to expand the existing approval procedure by including instructions referring to the above situations.

Although the national rules for approval of establishments are in line with EU requirements, they lack clarity with respect to the competent authority actions when significant alterations are made to the process in already approved ABP processing plants. This resulted in the absence of required operator's validation of the so modified processing treatment and validation checks thereof by the competent authority. (1) https://www.gov.si/zbirke/storitve/odobritev-in-registracija-nosilcev-dejavnosti-obratov-in-objektov-ter- izdaja-dovoljenj/ (2) Technical specifications for the format for the lists of approved or registered establishments, plants or operators handling animal by-products inside the European Union and in third countries: (https://ec.europa.eu/food/sites/food/files/safety/docs/fs-animal-products-app-est- technical_spec_04032012_en.pdf) 7

Member state response

in cases 1. Amendment of to the Rules on animal by-products not intended for human consumption (deadline: 31.3.2023) Article 4 of the Rules on animal by-products not intended for EU) human consumption (UL RS 35/15, 82/18, 200/20 - ZNUAPK) will be amended by adding a new paragraph after point 5, reading as follows: "Revalidation of Method 7 in a plant that has already been approved is necessary due to a change in processing system that affects risk analysis and constitutes a new risk that affects the previously approved Method 7. When revalidation of a method is required, the plant is granted provisional approval of the method, to be in force during the period of validation. Any products manufactured under new conditions within this time shall not be placed on the market." 2. Amendment to the Manual on implementation of official control of ABPs (deadline 31.3.2023) In the Manual on implementation of official control of ABPs, the Guidance on Method 7 Validation Procedures (according to Regulation 142/2011/EU; including any other methods requiring validation) will be added. In the Manual on implementation of official control of ABPs, a Check List will be added, containing references t

The recommendation states as its basis

In the slaughterhouses visited, official controls on food hygiene covered ABP related requirements in a comprehensive manner. However, the audit team noted that these controls have in certain cases erroneously concluded on compliance with the applicable requirements while in fact the relevant requirements were not met. For example, the official controls have overlooked: a. Improper categorisation of some ABP, namely not-emptied intestines containing digestive track content (thus entirely consisting of Category 2 material) were categorised and collected as Category 3 material and as such dispatched to Category 3 processing plants producing PAP. b. Incorrect filling in of commercial documents, resulting in dispatching ABP without proper description required by of point (6)(f)(ii) of Chapter III of Annex VIII to Regulation (EU) No 142/2011, namely on the animal species and the specific reference to the applicable point in Article 10 of Regulation (EC) No 1069/2009 for Category 3 material and DP derived from and destined for feeding; and the information on the temperature and intended use, with respect to ABP destined for intra-EU trade.

Official controls in ABP plants are, overall, effective in verifying compliance with most of the ABP requirements, and thus provide a satisfactory level of assurance in terms of the overall compliance of operators. However, controls on food operators from the meat producing sector acting along the ABP chain, although regular, do not pay sufficient attention to operators' obligations concerning the categorisation of ABP and information required in documents accompanying ABP consignments dispatched from meat producing establishments, and as a result, weaken confidence in the overall reliability of these controls and in the safe handling of ABP, and the use of DP.

Member state response

of Actions taken g Non-compliances detected during the Mission were promptly rectified in both the slaughterhouses. ation Actions in progress: A: Update of the "Smernice za izvajanje uradnega nadzora pri implementaciji TSE in ZSP Uredbe v obratih nosilcev zivilske dejavnosti" / Guidelines on implementation of official controls at implementation of the TSE- and ABP- Regulations, in establishments of Food Business Operators (FBOs); in the section relevant to categorisation of ABPs especially blood and skins, and to control of traceability, including the control of commercial documents, (31. December 2022) The AFSVSPP Main Office will update the above Guidelines in the part relevant to the appropriate categorisation of ABPs in slaughter establishments, and to the control of implementation of traceability of ABPs from slaughter establishments, in particular in the part referring to the appropriate completion of the commercial document. AFSVSPP Main Office, as originator of the Guidelines, finds that these in the part referring to the removal of intestinal content from the intestines, and to the criteria relevant to subsequent classification of mammalian intestines, are appropriate, and

The recommendation states as its basis

The staff interviewed by the audit team were familiar with the instructions for sampling and targeting animals at slaughter and on farms. However, in contrast to pertinent EU requirements (17) the audit team observed that urine samples collected from live animals at farms for testing steroids (A3) were largely collected from dairy cows ­ which are less likely to have been illegally treated with steroids for growth promotion purposes. (13) Articles 9 and 12 of Regulation (EU) 2017/625. (14) Annex III to Directive 96/23/EC and the Annex to Decision 97/747/EC. (15) Part 3 of Annex II to Commission Implementing Regulation (EU) 2021/808. (16) Chapter 3(1) of Annex IV to Directive 96/23/EC. (17) Annex III to Directive 96/23/EC; Article 2(2) and Annexes II and III to Regulation (EU) 2022/1644 (Note that this Regulation was not in yet force at the time of the audit but entered into force on 15 December 2022). 4

With the exception of the incorrect targeting of live bovine animals on farm for hormone analysis, the implementation of the NRCP in all other regards is fully in line with both the planned sampling arrangements and EU rules positively contributing to guarantees on the residues status of food of animal origin produced in Slovenia.

Member state response

d Training on targeted sampling was implemented within official residue sampling. Attached hereto is the Presentation of training conducted on 27.1.2023. Sampling criteria were also added in Compulsory Instructions (attached document see page 5, points B and C).

The recommendation states as its basis

Letters of designation are in place for all six laboratories providing official testing under the NRCP as required by EU legislation (30). However, some issues were evident at the time of the audit as follows: a. the latest documents relating to the designation of the NVI and NLHEF as NRLs and as official laboratories were dated from 2012 to 2014, respectively. According to national legislation (31), designation and official services are assigned for a period of 10 years. The competent authority indicated that the review process for the re-designation of both NRLs was underway at the time of the audit; however, arising from the reclassification of the groups of residues in EU legislation due to come into effect in December 2022 (32), the competent authority indicated that the formal issuance of designation letters would be delayed to allow for the assignment of the new residues groups to each NRL. b. designation letters to the four official laboratories in other Member States were issued during 2022. While these cover most of the EU requirements (33), the arrangements necessary to ensure efficient and effective coordination and collaboration between the designated official laboratories and the competent authorities in Slovenia are not clearly stated. Further to this, the audit team was (29) Annexes I and II to Council Directive 96/23/EC. (30) Article 37 (3) of Regulation (EU) 2017/625. (31) Article 7 of the (Slovenian) Regulation implementing Regulation (EU) on official controls and other official activities in the field of food, feed, animal health and welfare and plant health and plant protection products (Uredbo o izvajanju uredbe (EU) o uradnem nadzoru in drugih uradnih dejavnostih na podrocju zivil, krme, zdravja in dobrobiti zivali ter zdravja rastlin in fitofarmacevtskih sredstev), in force from 26 September 2020 (link). (32) Annex I to Regulation (EU) 2022/1644. (33) Article 37 of Regulation (EU) 2017/625. 8 informed that in practice, the NVI conducted all of the routine interactions with the foreign laboratories as was expected in case of outsourced testing, however there were no formal contracts or agreements in place between either the AFSVSPP or the NVI and the four laboratories involved. This practice is not in line with current EU rules (34).

Notwithstanding the above, in the NLHEF not all of the methods used for official controls were included in the scope of accreditation as required (36) e.g. the methods for thyrostats (A2) and benzimidazoles (B2a). The laboratory indicated that an update to its accredited scope to include thyrostats (A2) is currently in progress and that the benzimidazoles (B2a) method will be added to the accredited scope in 2023.

Notwithstanding several opportunities for improvement regarding the designation of official laboratories and those related to the validation of analytical methods and approach to internal quality controls, the fact that both NRLs are accredited to EN ISO/IEC 17025, have participated successfully in numerous proficiency testing schemes and have broadly effective measures in place to ensure their satisfactory performance gives the competent authority confidence in the reliability of analytical results.

Member state response

a) Finding 39: Designation of NLHEF / NLZOH and NVI in line with new legislation is under way. As envisaged, the designation s; of the two Laboratories will be finalised by 31.03.2023. ion b) Finding 39: To arrange mutual communication between the National Laboratory (NVI) and Laboratories abroad, to which official samples for analysis are submitted, NVI prepared a Protocol on the Method of Cooperation, which was submitted to the the foreign Laboratories (see document Protocol). c) Finding41: Current status of methods regarding accreditation - Methods for the determination of thyrostats (A2) in urine and in plasma have been accredited ­ flexible scope, https://www.nlzoh.si/wp- content/uploads/2023/01/Obseg_metod_fleksibilni-obseg- CKA_06.01.2023.pdf and Annex LP-014, https://www.slo-akreditacija.si/acreditation/nacionalni- laboratorij-za-zdravje-okolje-in-hrano-nlzoh/; - Methods for the determination of benzimidazoles (B2a) in liver and in milk are in procedure of accreditation for the current year (2023). Application to extend the scope of the method has been submitted to the SA ­ Slovenian Accreditation.

The recommendation states as its basis

At the NVI, the audit team reviewed a number of method validation files: a) stilbenes (Group A1) in drinking water and steroids (Group A3) in urine and plasma by Gas Chromatography ­ (Tandem) Mass Spectrometry: - the method was recently revalidated in line with the EU requirements and CC values determined appropriately (39); - in urine, most of the analytes recommended by the EURL (40) were included in the method with the exception of -boldenone (measured but not validated for quantitation) and 17-trenbolone and 16-hydroxystanozolol; - in plasma, 17-testosterone and 17-oestradiol were analysed with the method, in line with the EURL recommendations matrix for these substances (40); - in drinking water, stilbenes were analysed with this method. While not a recommended matrix in the EURL guidance (40), the use of water for analysis is in line with EU legal acts (41); b) coccidiostats (B2b) in liver and eggs by Liquid Chromatography ­ (Tandem) Mass Spectrometry (LC-MS/MS): - the method was generally validated in line with the requirements for poultry liver and eggs except for relative matrix effects (42). For liver of other species (bovine, porcine, equine), the validation was not completed. The audit team noted that in respect of eggs the laboratory had participated in a collaborative validation project with the EURL (BVL, Berlin) and was in the process of preparing the validation report at the time of the audit. The validation report from BVL, Berlin was provided to the auditors during the visit; c) NSAIDs (B2e) in milk by LC-MS/MS: in the case of diclofenac, - the validated concentrations were in excess of the Maximum Residue Limit (MRL) of 0.1 µg/L in milk, due to the poor sensitivity of the instrument used at the time of the original validation. The laboratory indicated that following the recent introduction of new equipment, the method is currently (38) Section 6.5 of EN ISO/IEC 17025. (39) Article 3 and Chapter 1 and 2 of Annex I to Regulation (EU) 2021/808. (40) EURL Guidance on minimum method performance requirements (MMPRs) for specific pharmacologically active substances in specific animal matrixes, Version 2.0, June 2022 (link). (41) Annex II to Council Directive 96/23/EC, Article 2(2) and Annex II to Commission Delegated Regulation (EU) 2022/1644. (42) Chapter 2, part 2.10 of Annex I to Regulation (EU) 2021/808. 10 undergoing revalidation with the capability to detect diclofenac in milk at 0.05 µg/L in milk; d) screening of aminoglycosides (B1) in muscle and macrolides (B1) in eggs by 5- plate inhibition test: - shortcomings were observed in the validation of aminoglycosides in muscle as the levels used for the validation experiments were in excess of the MRLs for kanamycin and gentamycin and the validation for minor species (for which a lower number of muscle samples were received by the laboratory) was not completed. Furthermore the method for macrolides in eggs was not validated; e) screening of antibiotics (B1) in milk by the Twinsensor method; - validation was generally satisfactory, however only bovine milk was validated whereas ovine and caprine milk are tested under the NRCP; f) screening of sulphonamides (B1) in muscle by High-Performance Thin-Layer Chromatography with Fluorescence Detection: - validation of this method was found to be satisfactory.

At the NLHEF, Maribor, the audit team reviewed a selection of validation files with findings as follows: a) thyrostats (A2) in urine and plasma: - the validation was completed in 2022 under the current method validation requirements (39) and appropriately covered all of the required validation parameters, except relative matrix effect which was not evaluated as required (42); - CC values were established in line with EU requirements and EURL guidance (43) with the use of fortified samples; - the validation only covered matrices of bovine and porcine species. The remaining species (sheep and goat, farmed game) were not fully evaluated at the time of the audit. This is not in line with the EU requirements that all methods used for official testing should be fully validated (36). b) benzimidazoles (B2a) in liver and milk: - the validation was performed under the current method validation requirements (39) and appropriately covered the majority of the required validation parameters, except for relative matrix effect, which is also required (42); - in the case of liver, minor species which are tested in lower sample numbers for official controls were not included in the validation experiments. It was also noted that the calibration curve used for this method was of four concentration levels but omitted the zero-level, which is not in line with the requirements to use a minimum of five calibration levels (44).

Notwithstanding several opportunities for improvement regarding the designation of official laboratories and those related to the validation of analytical methods and approach to internal quality controls, the fact that both NRLs are accredited to EN ISO/IEC 17025, have participated successfully in numerous proficiency testing schemes and have broadly effective measures in place to ensure their satisfactory performance gives the competent authority confidence in the reliability of analytical results.

Member state response

legal Finding 49a: -boldenone will be added to the steroid determination method. Finding 49b: Method of determination of coccidiostats was validated in 2012 in line with Regulation 2002/657/EC, and fferent animal species were tested in line with point 3.1.2.7. Page: 1 of report ref. DG(SANTE) 2022-7489 of the audit carried out from 12 October contaminants in live animals and animal products tion Proposed by the competent authority ggedness (major changes) of this Regulation. Validation of isting methods will need to be harmonised with requirements Commission Implementing Regulation (EU) 2021/808 by .06.2026. Thus, we cooperated in inter-laboratory validation of e European Reference Laboratory (BVL), of the method that mprises also coccidiostats. The method has been validated in ne with Regulation (EU) 2021/808, validation parameters have en collected (Annex 2, No. 18, SOP 458), and the method is in ocedure of accreditation (to be accredited in 2023). nding 49c: Prepared and validated has been a new method, ere diclofenac is determined at concentration level of 0.05 /kg (Annex 2, No. 16, SOP 515). The method is in procedure accreditation (to be accredited in 2023). nding 49d and e:

The recommendation states as its basis

Notwithstanding the above, the audit team found that a number of internal quality control samples used in the NVI for microbiological screening of antibiotics were fortified at inappropriate concentrations in respect of the MRLs for the substance/matrix combination measured. This is not in line with EU requirements (46).

The NVI laboratory used matrix-matched calibration standards fortified at 0.5 and 1.0 x MRL as quality control checks for confirmatory analysis of coccidiostats (B2b) in eggs, with no separate fortified quality control samples in the analytical run. The relevant EU Regulation (47) states that `for quantitative methods with each batch of official samples, a calibration curve shall be analysed and measured before or after the above listed samples' where the listed samples referred to includes fortified quality control samples. The approach taken above for coccidiostats (B2b) in eggs is therefore not fully in line with EU requirements.

Notwithstanding several opportunities for improvement regarding the designation of official laboratories and those related to the validation of analytical methods and approach to internal quality controls, the fact that both NRLs are accredited to EN ISO/IEC 17025, have participated successfully in numerous proficiency testing schemes and have broadly effective measures in place to ensure their satisfactory performance gives the competent authority confidence in the reliability of analytical results.

Member state response

apter 3 of Commission Implementing Regulation (EU) 21/808 requires the use of three control materials in each ries. Page: 2 of report ref. DG(SANTE) 2022-7489 of the audit carried out from 12 October contaminants in live animals and animal products on Proposed by the competent authority creening, we use: olution of analytes in solvent is used as control material at rument verification (system suitability check). atrix-fortified standard (spiked sample), blank enriched with the analytes that are determined by the method on the nning of the clean-up procces at least to CC level (e.g. 0.5 or 0.1 MRL); two controls may be used, one at level and the other at MMPR or MRL. lank sample, which does not contain any of the substances are searched for, and is selected from among the already ed samples. The blank sample contain internal standards, if are used in the procedure. onfirmation, using an external calibration curve, we are: olution of analytes in solvent as control material at rument verification (system suitability check). atrix-fortified standard (spiked sample), blank enriched with the analytes that are determined by the method on the nning of the clean-up procces at least to MMPR

The recommendation states as its basis

For the establishments listed in section 2 of this report, the Commission auditor scrutinised the most recent inspection reports and interviewed the inspectors on the assessment of operators' HACCP plans. The Commission auditor noted that the assessment of the hazard identification part of the HACCP-plan by the inspectors was not always comprehensive: 1) In general, the hazard identification part of the HACCP plans seen was generic without the level of detail necessary for a proper hazard identification and their risk assessment, in particular in feed materials and other ingredients. Notwithstanding that in some cases the inspectors met could notice this deficiency during the interviews, the failure of the operator to identify relevant hazards, as required by Article 6(2)(a) of Regulation (EC) No 183/2005, was not reflected in the most recent inspection reports seen. Consequently, the operators were not notified about those deficiencies and was thus not incentivised to rectify them. 2) During the interviews, the inspectors experienced difficulties to identify the following hazards: i. Pesticides in feed materials of plant origin (vegetable oil; malted barley; barley rootlets); ii. Unauthorised genetically modified organisms in imported feed materials of plant origin (soya); iii. Mycotoxins in a premixture with a carrier of plant origin (rice bran meal); iv. On contrary, one inspector identified aflatoxin B1 as a hazard in imported sodium bicarbonate ­ which is not justified; v. In the case of the mobile mixer, the inspector interviewed did not spot the hazards related to changing of production from one farm to another.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's assessment of (i) operators' HACCP plans, and (ii) appropriateness of operators' tests on homogeneity of mixing and cross-contamination. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

Member state response

Competent authority response submitted on 9 ugust 2021 Training and meeting with compound feed manufacturers will take place in November HACCP refreshment trainings for inspectors. 2021. ting with compound feed manufacturers. Refreshment training for inspectors will be included in the AFSVSPP Training Plan of 2022 (implementation in the first half of 2022).

The recommendation states as its basis

Verification of establishments' tests on homogeneity of mixing and minimisation of cross- contamination, required by part 2(b) and 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005, forms part of the inspections, when applicable. The checklist provides clear assessment criteria to enable the inspectors to effectively evaluate the operators' checks, which is in line with the requirements laid down in Article 5(1)(a)(b) of Regulation (EU) 2017/625. The Commission auditor noted that in three relevant cases scrutinised, the operators used a dye (methyl violet) as a marker for assessment of both homogeneity of mixing and cross- contamination. While it is an acceptable approach to assess the efficiency of mixing (homogeneity), the use of dye cannot be considered appropriate for the check of cross- contamination since the substance is not representative of the physical properties of the substances of concern (e.g. coccidiostats) (1). Only in one case did the inspector request use of the relevant (1) In its response to the draft report, the competent authority acknowledged differences in physicochemical properties between the feed additives in use and the dye but expressed the opinion that the use of the dye may be justified taking 5 coccidiostat for the assessment of cross-contamination, which was done by the operator. The mobile mixer scrutinised did not perform tests on homogeneity of mixing and minimisation of cross-contamination and this omission was not reflected in the most recent inspection report. Thus, combined, the official controls examined by the Commission auditor only partly verified that the operators fully meet the requirements laid down in part 2(b) and 3(b) of section "Facilities and equipment" of Annex II to Regulation (EC) No 183/2005.

The inspection planning system is based on appropriate risk-related factors and thus ensures that the official controls are carried out on all operators regularly, on a risk basis and with appropriate frequency. However, the effectiveness of the official controls system is weakened by shortcomings in the competent authority's assessment of (i) operators' HACCP plans, and (ii) appropriateness of operators' tests on homogeneity of mixing and cross-contamination. 5.2.2 Sampling 5.2.2.1 Planning of official sampling

Member state response

Competent authority response submitted on 9 August 2021 Training and meeting with compound feed manufacturers will take place in November Refreshment trainings for inspectors. 2021. At the meeting, the logistics of implementation of comparative study will be Meeting with compound feed manufacturers. agreed on, and the study will be implemented still this year. We will conduct a comparative study, using in the test as marker a coccidiostat as well as Refreshment training for inspectors will be a dye. included in the AFSVSPP Training Plan of 2022 (implementation in the first half of 2022).

The recommendation states as its basis

The laboratory network consists of four national laboratories (see part 2.4 of the country profile of Slovenia) and one laboratory situated in another EU Member State (involved in a very limited number of examinations). The central level of the AFSVSPP is responsible for the designation of official laboratories. The Commission auditor noted that three of the four national laboratories were designated in line with, since 14th December 2019, the obsolete Regulation (EU) No 882/2004. The competent authority clarified that the designation of the relevant laboratories would be aligned with the requirements laid down in Article 37 of Regulation (EU) 2017/625 when the contracts are renewed, in 2022 as latest.

The laboratory situated in another Member State is sub-contracted by one of the national laboratories without formal designation by the AFSVSPP. Thus, the requirements laid down in Article 37 of Regulation (EU) 2017/625 are not met.

The Commission auditor noted that, at the time of the audit, there were no arrangements in place to ensure compliance with the requirements laid down in Article 39 of Regulation (EU) 2017/625.

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, including the out of date or absent designation of official laboratories and delegation of certain tasks relating to official feed controls, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in Union legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 9 5.2.3 Actions taken on non-compliances

Member state response

y Competent authority response submitted on 9 At the end of 2022, when the Concession August 2021 Agreement with the National Veterinary Laboratory (NVI) expires, we will institute a According to the Veterinary Practice Act, new NVI-designation procedure as the AFSVSPP has signed a 10-year Concession Official Laboratory and at the same time Agreement No. 2333-12-000081with the AFSVSPP will by official duty, call on National Veterinary Institute (NVI) of the Official Laboratories in the other Member Veterinary Faculty of the Ljubljana States, which are currently the NVI- University, on the implementation of public subcontracting laboratories, to place applications for Official Laboratory veterinary service, governing also the designation to conduct particular analyses of implementation of tasks by the NVI as the official feed samples. Following the National Reference Laboratory. acceptance and examination of relevant application dossiers, the Official The NVI is also appointed for carrying out Laboratories in the other Member States will laboratory analyses on samples taken during be designated in Slovenia as Official official veterinary inspections of animal Laboratories in line wi

The recommendation states as its basis

The Commission auditor saw the document delegating official feed sampling to the NVI and noted that it was prepared in line with, since 14th December 2019, the obsolete Regulation (EU) No 882/2004. Consequently, not all requirements laid down in Articles 28, 29 and 33 of Regulation (EU) 2017/625 were met at the time of the audit. In particular, there were no arrangements to organise audits or inspections of the NVI related to the delegated sampling task which is not in line with the requirements laid down in Article 33 of Regulation (EU) 2017/625.

The interpretation of the vast majority of analytical results of official feed samples is carried out by the inspectors of the AFSVSPP regional offices based on laboratory reports provided by the testing laboratories. The only exception is the testing for dioxins/polychlorinated biphenyls (PCBs) where the interpretation is made by the testing laboratory which thus effectively decides upon 7 samples' conformity or non-conformity. The Commission auditor noted that there was no precise description of that task in the formal designation of that testing laboratory which is not in line with the requirements laid down in Article 29(a) of Regulation (EU) 2017/625. No further verification of the dioxin/PCB result interpretations are performed by the AFSVSPP's inspectors. 5.2.2.2 Implementation of official sampling

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, including the out of date or absent designation of official laboratories and delegation of certain tasks relating to official feed controls, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in Union legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 9 5.2.3 Actions taken on non-compliances

Member state response

mpetent authority response submitted 9 August 2021 Procedure is under way. ocedure of designation is under way (legal Decision on designation will foreseeably be service). issued within a month.

The recommendation states as its basis

The Commission auditor noted that, contrary to the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009, none of the samplers (either in the AFSVSPP regional offices included in the scope of this audit or in the NVI) possessed a mechanical or automatic divider necessary for preparing the final samples in case of the control of constituents, including genetically modified material, or substances likely to be distributed in a non-uniform way in feed materials. This is not in line with the requirements laid down in Article 5(1)(f) of Regulation (EU) 2017/625. The AFSVSPP brought to the attention of the Commission auditor the observation that part 9.4 of Annex I to Regulation (EC) No 152/2009 in Slovenian was not fully equivalent to the original version in English.

The Commission auditor interviewed several samplers from the AFSVSPP regional offices and the NVI on the implementation of sampling provisions laid down in Article 1 of, and Annex I to, Regulation (EC) No 152/2009. In addition, a number of sampling records from 2018 and onwards were scrutinised. Based on these, the Commission auditor observed the following: 1) Based on many sampling records seen and one interview, the concept of "sampled portion" was not implemented properly by the samplers. 2) The determination of the analyte's distribution pattern in the matrix was largely properly defined by the samplers. 3) The calculation of the number of incremental samples was largely correct. 4) The legal requirements on the size of the aggregate sample and size/number of final samples were largely properly implemented. 5) Due to the absence of mechanical or automatic dividers (within the respective service), all of the final samples were prepared by quartering, which cannot ensure representative division in case of the control of constituents, including genetically modified material, or substances likely to be distributed non-uniformly in feed materials. This is not in line with the requirements laid down in part 1 of Annex I to Regulation (EC) No 152/2009. 8 6) From 2021, the central level of the AFSVSPP requested that one official sample should be taken for the purpose of official feed controls. Another sample can be taken only if the operator requires that with reference to Article 35 of Regulation (EU) 2017/625. This arrangement is not in line with the requirements laid down in part 9.4 of Annex I to Regulation (EC) No 152/2009 that final samples for control (enforcement), defence and reference ­ thus three final samples ­ shall be prepared.

The Commission auditor noted (both via check of the sampling records and during the interviews) several instances where the samples taken by the operators for the purposes of own control were used by the inspectors of the AFSVSPP regional offices for the purposes of official feed control. This arrangement is not in line with the requirements laid down in Articles 2(1) and 34(1) of Regulation (EU) 2017/625, and Article 1 of, and part 3 of Annex I to, Regulation (EC) No 152/2009.

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, including the out of date or absent designation of official laboratories and delegation of certain tasks relating to official feed controls, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in Union legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 9 5.2.3 Actions taken on non-compliances

Member state response

CA response submitted 9 August 2021 Feed sampling equipment (feed dividers) has est for corrigendum of Slovenian already been ordered. Delivery is expected in version (point 9.4 of Annex I) of Commission November 2021. On acceptance thereof, a Regulation 691/2013/EU was submitted to workshop for inspectors and NVI sampling the European Commission on 17.6.2021. The staff will be held for presentation in practice. corrigendum has not yet been published in the EU OJ. Hereby we confirm that all official feed sampling staff will have the appropriate feed Divider procurement process is under way. sampling equipment for implementation of the 2022 Feed Sampling Programme.

The recommendation states as its basis

The Commission auditor interviewed the inspectors of the AFSVSPP's regional offices responsible for the evaluation and interpretation of the analytical results and establishing non- compliance as regards undesirable substances within the meaning of Article 1 of, and Annex I to, Directive 2002/32/EC. In addition, the Commission auditor scrutinised a number of analytical reports from 2018 and onwards and interviewed a representative of one national official laboratory which produced the reports examined. It was noted that in general the inspectors experienced difficulties to properly use all of the technical parameters necessary for a legally valid interpretation of laboratory results of the official feed samples in line with the requirements laid down in parts 3, 5 and 6 of section C of Annex II to Regulation (EC) No 152/2009. This lack of knowledge was in many cases mitigated by presentation of the necessary parameters and related calculations in the laboratory reports. However, the Commission auditor noted several instances where, while the result of the first determination exceeded 50% of the specification to be controlled, no second determination was carried out and/or measurement uncertainty was not reported. The laboratory representative stated that this would be done only when the result exceeded the maximum permitted level. This approach is not in line with the requirements laid down in parts 3 and 6 of section C of Annex II to Regulation (EC) No 152/2009 and, consequently, the legal validity of the decisions made based on such results cannot be ensured. Conclusion on the planning and implementation of official sampling

Notwithstanding the risk-based approach adopted for the planning of official sampling, its implementation, including the out of date or absent designation of official laboratories and delegation of certain tasks relating to official feed controls, and absence of suitable sampling equipment, does not ensure official samples' legal and technical validity. Furthermore, the test results interpretation approach for determining non-compliance in case of analysis of undesirable substances does not take into account all of the relevant factors set out in Union legislation. This may affect the legal validity of the decisions made on non-compliant samples, and thus weakens the overall effectiveness of the official controls. 9 5.2.3 Actions taken on non-compliances

Member state response

Competent authority response submitted on 9 August 2021 Already accomplished. The requirements of Part C (points 3 and 6) of Annex II to Regulation (EC) No 152/2009 (number of determinations, correction for recovery, expanded measurement Page: 2 d by the competent authorities of Slovenia in response to Report ref. DG(SANTE) 2021-7211 of the audit carried out from 17 May 2021 to 28 May 2021 in order to evaluate the hority Action Proposed by the competent authority (additional information) t is indicated lt is at 12% d Page: 3

The recommendation states as its basis

However, the control system was not fully effective, as certain non-compliances went unnoticed and/or not recorded concerning the absence of a temperature recording device in a cold store for frozen products. 8 5.3.2 Official control of fishery products Legal requirements Article 18 of Regulation (EU) 2017/625. Articles 70, 71 and Chapter I of Annex VI to Regulation (EU) 2019/627. Findings

Member state response

- Check Lists (fishery products, cold stores) used by Official Veterinarians during official inspection and control are supplemented with the warning to the effect that the storage facilities need to be equipped with temperature recording devices as required in Chapter III, Part B of Annex III to Regulation (EC) No 853/2004. - Familiarisation of OVs with FVO Mission findings and recommendations, at coordination meeting on food safety. - At central level (AFSVSPP I UVHVVR), verification of implementation of new Check Lists as to checks of temperature recording devices in storage facilities - no later than within three months from introduction of new Check Lists.

Member state response

- Method of detennination of maximum limits in cases of sampling smaller numbers of sample units, than those laid down in (3) Article 5 of Regulation (EC) No 2073/2005, will be laid down in the national legal order. - Training for OVs will be implemented, on the topic of official inspection and controls, and in conjunction with implementation of (3) Article 5 of Regulation (EC) No 2073/2005. Page: 1

The recommendation states as its basis

Supervision of the OVs' performance in slaughterhouses falls under the responsibility of the regional offices. There are no procedures on how supervision should be carried out at national level. The arrangements in place and, particularly, the scope, frequency and supervisory methods varies from one region to another. The CA from one region explained that their supervision consists of the inspection of the establishment and of the operator's record keeping. If significant problems are not noted, this is taken to imply that the OVs have performed their duties adequately. This is not in line with Article 5(1)(a) of Regulation (EU) 2017/625, which requires the CA to have procedures and/or arrangements in place to ensure the effectiveness and appropriateness of official controls. In another region, supervision directly targets the OVs' performance and official records; for this case the CA explained that there is a coordinator for the slaughterhouses that prepares weekly plans and checks all the slaughterhouses under his/her responsibility on a monthly basis.

Supervisory mechanisms are in place and applied. However, the system is impacted upon by differences in the application between regions, in particular in terms of focus. Moreover, the arrangements applied in one of the two regions interviewed are not adequate to provide assurances about the effectiveness and appropriateness of official controls.

The recommendation states as its basis

The CCA informed the audit team that they have recently started to collect information about the diagnosis reported in the AMI certificates accompanying the cattle that have been emergency slaughtered. The data shows that: the majority of animals fall into the category "an otherwise healthy animal which has suffered an accident that prevents its transport to the slaughterhouse for welfare reasons" and for a small number of animals the diagnosis was a disease (e.g. pneumonia) and/or specified that the animal could not stand. This situation raises clear doubts about the health status of the emergency slaughtered animal and, therefore, its eligibility for slaughter for human consumption, because the AMI certificates should only be issued for animals declared fit for slaughter, in line with Article 4 of Regulation (EU) 2019/624.

Concerning emergency slaughter, the system in place is in general in line with Regulation (EC) No 853/2004. However, for a small number of emergency slaughtered animals the diagnosis reported in the AMI certificates calls into question the reliability of the statements contained in these certificates declaring that the animals are fit for slaughter and therefore eligible for emergency slaughter.

The recommendation states as its basis

The CCA explained that the veterinarians performing AMI at holdings can carry out the stunning and bleeding of animals. Other people can also perform these activities. In this regard, the CCA explained that no specific requirements are necessary. This is not in line with Article 7(1) of Regulation (EC) No 1009/2009, which requires that killing and related operations shall only be carried out by persons with the appropriate level of competence to do so without causing the animals any avoidable pain, distress or suffering.

In addition, the system in place is not in line with Article 7(1) of Regulation (EC) No 1099/2009 because it does not require persons killing animals in case of emergency slaughtering on farms to have the appropriate level of competence.

The recommendation states as its basis

Procedures do not indicate that port inspectors should enter data in Traces when a check is undertaken pertaining to part III of a health certificate. The port inspectors do, nevertheless, enter data in Traces according to Article 3(2) of Decision 2004/292/EC for each consignment of animals using the reporting model provided in Commission Regulation (EC) No 599/2004. The data from Traces indicated: 1,925 consignments of cattle were checked in 2017 with 59 consignments (3%) with deficiencies including 24 dead animals in 23 consignments and nine unfit animals in seven consignments. 74 consignments of sheep were checked in 2017 with 18 dead animals in 10 consignments and 16 unfit in five consignments. Records in the port indicated 72 cattle were dead on arrival or euthanised because they were unfit to continue their journey in 2017 and 40 sheep the same; i.e. an additional 39 cattle and 6 sheep above that reported in Traces. The combined total of dead and unfit animals, from the port records, represents 0.09% of cattle and 0.18% of sheep transported by road to the port in 2017. The competent authority had not entered data corresponding to the additional 39 cattle and 6 sheep in Traces, contrary to Article 3(2) of Decision 2004/292/EC which indicates that Member States shall ensure that such data is entered in Traces, i.e. including part III.10 "impact of transport on the animals" which includes fields for numbers of dead and unfit animals. The port inspectors explained that the reason for this under-reporting was that they euthanised unfit animals after they had completed their administrative tasks in Traces and had failed to record these cases. The national contact point for animal welfare during transport stated that all animals arriving at the exit point had been certified by an official veterinarian as fit for transport at the place of departure and therefore only a small number of animals, which get sick or injured during transport, should account for such incidents, and considered it necessary to report all such cases back to the Member State of departure.

All journey logs reviewed by the audit team, some 30 journey logs were reviewed, had deficiencies in the planning for the journey by sea to the non-EU country. The competent authority's checks had not detected this despite, as already mentioned in paragraph 1, their procedures indicating the need for inspectors to take account of the Zuchtvieh ruling and that a transporter needs to be established4. The audit team noted that: 4 In their response to the draft report the authorities argue that a lack of clarity in the provisions of Regulation 1/2005 has led to a lack of clarity in the documentary procedures of the Slovenian competent authorities. They also argue that the mission's finding that none of the journey logs that were examined, irrespective of the country in which they had been filled in, contained an indication of the transporter for transport by vessel is the result of the unclear and tenuous link between the livestock vessel and the transporter in Regulation 1/2005. 6 Port inspectors failed to detect that journey logs did not indicate an authorised transporter responsible for the journey by sea, this should have been indicated in box

Procedures emphasise that if animals do not have to rest in the control post, the organisers must ensure that time of arrival at the port should coincide with the start of loading onto the livestock vessel in order to minimise the waiting time inside the port. Journey logs for two consignments, from some 30 reviewed by the audit team, indicated that there had been a delay in unloading animals at the control post, as these two consignments arrived at night and were not unloaded until the following morning, which resulted in journey times being exceeded. The port inspectors indicated that on these occasions, the forwarding agent, who operates in the port to co-ordinate the export, had not notified the port authority which operates the control post of the time the consignments would arrive. There was no evidence that the port inspectors had indicated to the central authority that this issue should be raised with the organisers concerned, who, as highlighted in procedures and as required by Article 5(3)(a) of the Regulation, are legally responsible for coordinating the different parts of the journey. 7

Port inspectors carry out official controls in accordance with Article 21(1)(a),(b) and (c) of the Regulation, and the results of these checks confirm that the majority of animals arrive at the port in good condition, and where necessary, the port inspectors take action to ensure that any unnecessary suffering is dealt with. However, procedures do not indicate that port inspectors should enter all relevant data in Traces after the checks and although port inspectors do enter certain data in Traces they have under-reported the numbers of animals deemed unfit for transport. As a result useful information is not readily available to the authorities in the Member State of departure.

Port inspectors had not detected systematic deficiencies in journey logs and although procedures indicate the relevant legal requirements, they do not instruct inspectors to check critical points such as the planning for a transfer onto a livestock vessel and an identifiable authorised transporter for the journey by sea. The central competent authority was not aware of these deficiencies as it had not supervised the work of inspectors to ensure the quality of controls carried out at exit points. As a result, the competent authorities had not ensured the effectiveness and appropriateness of official controls, contrary to Article 4(2)(a) of Regulation (EC) No 882/2004, and these deficiencies have not been raised with the authorities of the Member States of departure who have the primary responsibility for verifying journey planning.

Procedures include checklists with sections indicating legal requirements, some of which are additional to those needed for the mandatory controls. For example section 3. of procedures "Performing the checks listed in Section 3 of the Journey log ­ for each journey log" provides requirements for road transport vehicles ("additional provisions for long journeys road transport vehicle"). In practice port inspectors did not perform these additional checks of road vehicles, but did carry out checks, according to Article 21(d) of the Regulation, of the means of transport by which the animals are to continue their journey, i.e. the livestock vessel. The procedures do provide another checklist "requirements for sea transport", but this is a list of legal requirements and there are no instructions for staff, contrary to Article 8(1) of Regulation (EC) No 882/2004, which would be suitable for making a practical assessment of a livestock vessel.

Procedures emphasise that a transporter, as required by Article 10(1) of the Regulation, needs to be established, or in the case that the applicant is established in a third country is represented in the Member state; however the port inspectors had not identified, for any 10 sailings from this port, any natural or legal person as the authorised transporter for the journey by sea. Procedures do not provide sufficient information or instruction to the port authorities, contrary to Article 8(1) of Regulation (EC) No 882/2004, how the legal responsibilities for organisers and transporters should be implemented in relation to actors involved in the transport of animals by sea. In practice, the port inspectors make all requests regarding fulfilling the legal requirements for the export of animals to a forwarding agent, or the captain of the livestock vessel, but the competent authority have not defined if either of these actors have any legal responsibilities in relation to the welfare of animals during transport.

The inspection reports of approximately 70 loadings each year, which involve some 18 different vessels, did not indicate any checks of power sources, ventilation or alarms. This is contrary to Article 20(1)(c) of the Regulation which requires the authorities to verify before any loading of animals that all the equipment referred to in Chapter IV of Annex I remain in good working order. Procedures did indicate legal requirements for ventilation and alarms but did not indicate how to check these and also, procedures did not indicate the requirements of point 9 of Section 1 of Chapter IV to Annex I of the Regulation, in relation to primary and secondary sources of power.

The competent authority had not provided sufficient information, instructions or access to suitably qualified staff, contrary to Article 4 and 8 of Regulation (EC) No 882/2004, to support port inspectors in checking the technical requirements of Section 1, Chapter IV of Annex I to the Regulation, such as air changes per hour on board a livestock vessel. Therefore, the competent authority has not ensured adequate inspections of livestock vessels, as required by the Regulation, and has been repeatedly recommended in previous DG Health and Food Safety audit reports.

The recommendation states as its basis

Procedures emphasise that if animals do not have to rest in the control post, the organisers must ensure that time of arrival at the port should coincide with the start of loading onto the livestock vessel in order to minimise the waiting time inside the port. Journey logs for two consignments, from some 30 reviewed by the audit team, indicated that there had been a delay in unloading animals at the control post, as these two consignments arrived at night and were not unloaded until the following morning, which resulted in journey times being exceeded. The port inspectors indicated that on these occasions, the forwarding agent, who operates in the port to co-ordinate the export, had not notified the port authority which operates the control post of the time the consignments would arrive. There was no evidence that the port inspectors had indicated to the central authority that this issue should be raised with the organisers concerned, who, as highlighted in procedures and as required by Article 5(3)(a) of the Regulation, are legally responsible for coordinating the different parts of the journey. 7

The competent authority had not verified the effectiveness and appropriateness of controls at the exit point; Article 4(2)(a) of Regulation (EC) No 882/2004 requires the competent authority to ensure the effectiveness and appropriateness of official controls, and the central level were not aware that: Port inspectors were under-reporting the number of unfit animals (see 3 above) and that procedures do not indicate that such checks should be entered into Traces; Port inspectors had not detected the systematic deficiencies in journey logs where organisers had failed to indicate the transfer of animals onto the livestock vessel and to identify a transporter responsible for that part of the journey outside the EU (see 7 above). Procedures do not explicitly instruct inspectors, as part of the checks required by Article 21(2) of the Regulation, to check journey logs and record the result in Section 3 of the journey log. Port inspectors had not raised any issues regarding the failure of certain organisers to plan the journey so that animals could be accommodated in the control post when arriving at night (see 9 above). Procedures indicate organisers' legal responsibilities but apart from indicating the need to minimize the waiting time inside the port, do not indicate how to check and what actions to take in relation to organisers' responsibilities.

Port inspectors had not detected systematic deficiencies in journey logs and although procedures indicate the relevant legal requirements, they do not instruct inspectors to check critical points such as the planning for a transfer onto a livestock vessel and an identifiable authorised transporter for the journey by sea. The central competent authority was not aware of these deficiencies as it had not supervised the work of inspectors to ensure the quality of controls carried out at exit points. As a result, the competent authorities had not ensured the effectiveness and appropriateness of official controls, contrary to Article 4(2)(a) of Regulation (EC) No 882/2004, and these deficiencies have not been raised with the authorities of the Member States of departure who have the primary responsibility for verifying journey planning.

The authorities' actions, including communications with the Member State of departure, resolved a problem with unweaned calves arriving at the control post which is not equipped to feed these animals. However, the existing procedures were insufficient to enable all relevant levels of the competent authority to be aware of another, albeit less significant problem, where inadequate planning by organisers resulted in animals waiting all night to be unloaded at the control post. As a result, the authorities in the Member State where these organisers operate were not informed of the deficiencies in planning by these organisers.

During the audit, the port inspectors refused the loading of a livestock vessel which arrived, as planned by the organiser, to transport a consignment of 640 pregnant heifers. This livestock vessel had many long standing deficiencies, it was in a generally poor state of repair with many corroded and injurious fittings and lacked several essential systems, but nevertheless it had been allowed to load animals in the Slovenian port in 2017. The port inspectors had not refused any loadings of livestock vessels during the previous four years. The audit team noted that, in its last 10 sailings, this livestock vessel had also loaded animals at the ports of two other Member States. It had a valid certificate of approval issued by the authorities of a fourth Member State.

The competent authority had not verified the effectiveness and appropriateness of controls at the exit point; Article 4(2)(a) of Regulation (EC) No 882/2004 requires the competent authority to ensure the effectiveness and appropriateness of official controls, and the central level were not aware that: Procedures which list legal requirements for livestock vessels did not provide a sufficient instruction for carrying out a practical assessment of these requirements; Procedures for inspections of livestock vessels did not include the legal requirement for primary and secondary power sources (point 9 of Section 1 of Chapter IV to Annex I of the Regulation); Port inspectors did not carry out the additional checks of requirements for road vehicles listed in the procedures; Port inspectors had not identified an authorised transporter for any journeys by sea, although procedures emphasised that a transporter needs to be established or represented in the Member State. 12 Conclusions on welfare of animals during sea transport

Procedures include the relevant legal requirements but do not provide instructions for inspectors on how to verify these requirements as part of a practical inspection of a livestock vessel. Inspections of livestock vessels are therefore based on the experience of the inspectors, but not all requirements are adequately verified, which could have major implications for animal welfare during sea journeys. The competent authority had not ensured the effectiveness and appropriateness of official controls, contrary to Article 4(2)(a) of Regulation (EC) No 882/2004.

The recommendation states as its basis

The capacity of the control post is not sufficient to accommodate all the animals loaded onto certain livestock vessels. Co-ordination of the arrival of animals has taken place so that this has not been a problem; i.e. there have been no major delays in transferring animals from road vehicles to livestock vessels. However, the authorities had no arrangements to care for animals where they refused the loading of a livestock vessel and where the number of animals exceeded the capacity of control post. Article 22(2) of the Regulation requires the competent authority to ensure that appropriate arrangements are made to care for animals, and if necessary to unload, accommodate, feed and water them if they are detained for more than two hours. Article 23 of the Regulation also requires the competent authority to be able to take action to safeguard the welfare of animals in situations where it finds non-compliance.

The audit team saw that when the port inspectors refused the loading of a ship (see section 5.5) they had ad hoc discussions with their national contact point, who accompanied the audit team, regarding who to consult and what actions to take and 5 https://ec.europa.eu/food/sites/food/files/animals/docs/aw_list_of_approved_control_posts.pdf 8 initially they did not have a clear course of action to follow regarding how to deal with consignments in the port and those on their way to the port. The audit team also noted that the transporter responsible for the road transport did not have a contingency plan to put into operation in the event that the authorities refused the loading of animals onto a livestock vessel. Article 11(1)(b)(iv) of the Regulation makes it a prerequisite, in order to be authorised as a transporter they shall have submitted contingency plans for use in the event of emergencies. These should have been provided to the authority in the Member State which granted the transporter his authorisation. Conclusions on welfare of the animals arriving at the port

The authorities deal with situations such as their refusal to allow the loading of a livestock vessel on a case by case basis; however, there is a risk that animal welfare may not be safeguarded if there is a delay in a sailing and the capacity of the control post is exceeded as the authorities have not determined any options for the arrangements they are required to make in such situations.

The recommendation states as its basis

The central authority has given repeated commitments, first given in 2009, that a system was being devised which included sufficient competence for inspection of livestock vessels. The central authority did give port inspectors opportunities to acquire knowledge and skills, by allowing them to take part in study visits and to take part in drafting the network document on livestock vessels. However, this knowledge was not transferred to create a system which adequately covered the requirements for livestock vessel inspection. 2 Judgment of the Court of Justice of the European Union (Fifth Chamber) of 23 April 2015 ­ Case C424/13 see: http://curia.europa.eu/juris/liste.jsf?num=C-424/13 4

The competent authority indicated in response to a recommendation in report 2012/6375 and again as part of an action plan for 2015 that they would provide a manual to support inspectors in this task. This has not been provided. The competent authority also failed to deliver on commitments made in response to a recommendation in report 2009/8241, and repeated in report 2012/6375, to set up a system so that the port inspectors would have sufficient professional support for carrying out inspections of livestock vessels. The only evidence of close cooperation between the port inspectors and the Slovenian Maritime Agency was in relation to an incident in 2017 where a livestock vessel loaded with cattle suffered engine failure on leaving the port and had to be towed back to port. However, the port inspectors did not have any professional support for inspecting the "non-veterinary" requirements in Annex I Chapter IV Section 1 of the Regulation for livestock vessels.

The port inspectors concluded that this livestock vessel was deficient regarding points 2(a), 4, 5, 6 and 7 of Section 1 of Chapter IV of Annex I to the Regulation, i.e.: ventilation, the fresh water system, drainage, lighting, no alarms for these systems and no fire alarms in the decks accommodating animals. However, they had not identified these system failures in their report of their inspection of this vessel in 2017 and admitted that they were not competent to assess some of the "non-veterinary" requirements of the Regulation, such as the number of air exchanges required to provide sufficient ventilation.

In the last five years, the competent authority approved one vessel, according to Article 19 of the Regulation, for the transport of cattle and sheep. Prior to the approval inspection, the forwarding agent submitted certain documents: A declaration from the ship's master that the vessel was a suitable means of transport; A plan of the ship including the animal accommodation, disinfection certificates; A list of crew members; and A list of the last ten ports visited. The competent authority indicated in a checklist that various legal requirements, including those for generators, ventilation and alarms, were compliant. The inspection concluded that the vessel, excluding certain pens and indicating that one deck was only suitable for sheep, met the requirements of the Regulation. The inspectors confirmed to the audit team that they assess ventilation subjectively, based on their experience, and did not verify the air changes per hour required by Annex I Chapter IV, Section 1 point 2(a) of the Regulation. The competent authority has not approved a classification society to verify the strength calculations of pen rails and decks on livestock vessels contrary to Annex I Chapter IV Section I point 1 of the Regulation and this aspect was also not verified.

The competent authority had not provided sufficient information, instructions or access to suitably qualified staff, contrary to Article 4 and 8 of Regulation (EC) No 882/2004, to support port inspectors in checking the technical requirements of Section 1, Chapter IV of Annex I to the Regulation, such as air changes per hour on board a livestock vessel. Therefore, the competent authority has not ensured adequate inspections of livestock vessels, as required by the Regulation, and has been repeatedly recommended in previous DG Health and Food Safety audit reports.

Procedures include the relevant legal requirements but do not provide instructions for inspectors on how to verify these requirements as part of a practical inspection of a livestock vessel. Inspections of livestock vessels are therefore based on the experience of the inspectors, but not all requirements are adequately verified, which could have major implications for animal welfare during sea journeys. The competent authority had not ensured the effectiveness and appropriateness of official controls, contrary to Article 4(2)(a) of Regulation (EC) No 882/2004.

The recommendation states as its basis

The SAB notifies the AFSVSPP of the results of the accreditation audits carried out on CBs. However, this information is not taken into account for their supervisory task which is not in line to Article 92c(1) of Regulation (EC) No 889/2008. Moreover, The AFSVSPP does not require the CBs to submit their risk analysis procedure which is not in line to Article 92c(2) of Regulation (EC) No 889/2008. This may reduce the effectiveness of supervision as any deficiency related to the CBs' risk analysis may only be detected post factum.

CBs are accredited and approved in accordance with national and EU rules. CBs are generally subject to effective annual supervision by the CA which includes office and witness audits. However, the CA neither takes into account the reports of the accreditation body audits nor requires the CBs to submit their risk analysis procedures before supervising CBs which may undermine the effectiveness of the CA supervision. 5.2.2 Registration of Operators Legal Requirements Article 28(1), (2) and (5) of Council Regulation (EC) No 834/2007. Article 92(2) and 92b of Commission Regulation (EC) No 889/2008. 6 Findings

Member state response

odila za izvajanje nadzora nad delom kontrolnih UVHVVR Do konca leta 2018 organizacij se dopolni s poglavjem "Priprave na opravljanje adnega nadzora in pridobitev dokumentacije" in izvajanje skladu s posodobljenimi navodili. Pojasnilo: V tem poglavju se opredelji, da UVHVVR pred zacetkom nadzorov v koledarskem letu vse imenovane organizacije za kontrolo in certifikacijo pozove, da mu posredujejo dokumentacijo (nasteje se dokumentacija, ki je ze bila ljucena v poziv za leto 2017, dodatno se izpostavi se postopke analize tveganja, vkljucno s podatki, ki gocajo ocene ucinkovitosti teh postopkov in po potrebi druga dokumentacija). VVR ­ glavni urad v skladu s protokolom medsebojnega obvescanja prejme porocila o akreditacijskih postopkih, ki jih izvaja Slovenska akreditacija. GU prejeta porocila posreduje kot del dokumentacije inspektorju, ki bo opravljal uradni nadzor posamezne organizacije za kontrolo in certificiranje.

The recommendation states as its basis

The two CBs have procedures in place requiring the operators to submit a full description of their activities, including a description of precautionary measures put in place to avoid potential contamination of organic products. CBs' inspectors are required to verify the implementation of these precautionary measures when visiting the operators. However, the audit team noted that in relation to both CBs, the operators did not submit the description of precautionary measures contrary to Article 63(1) and (2) of Regulation (EC) No 889/2008. The CBs stated that precautionary measures put in place by operators are verified during the inspections. The audit team noted, during the inspections observed, that CBs did verify the precautionary measures put in place by operators.

CBs generally required sufficient information from their operators in order to plan inspections. However, certain relevant information such as the description of precautionary measures is not available for the risk evaluation and for proper preparation of inspections. 5.2.4 Controls of operators Legal Requirements Titles II and III of Regulation (EC) No 834/2007. Title II of Regulation (EC) No 889/2008. Title IV of Commission Regulation (EC) No 889/2008. Article 65 of Commission Regulation (EC) No 889/2008. Articles 8 and 9 of Regulation (EC) No 882/2004. Findings

Member state response

organizacije za kontrolo in certificiranje morajo v Kontrolne obrazce za prvo prijavo izvajalcev v kontrolo in organizacije certificiranje vkljuciti akcijski nacrt. Za obstojece stranke rajo akcijske nacrte vkljuciti v prijave za naslednje leto. UVHVVR Navodila za izvajanje nadzora nad delom kontrolnih organizacij UVHVVR dopolni na nacin, da se v opomnik vkljuci preverjanje priprave in ustreznosti vsebine akcijskih Page: 1 ed 06 March 2018 dations of report ref. DG(SANTE)/2017-6074-MR of the audit carried out from 26 l systems for organic production and labelling of organic products Action Proposed by the competent authority/Nacrtovan Kdo Rok ukrep nacrtov. MKGP bo na spletni strani MKGP objavljalo azurni seznam MKGP Do konca je izvajalcev, ki so v tekocem letu vkljuceni v kontrolo marca ekoloske pridelave in predelave. 2018 s

The recommendation states as its basis

The registration of organic operators is managed by the MAFF. The MAFF prepares a list of organic operators taking into account all information provided by the CBs. This list is updated daily. However, the list of operators as such, is not publically available although a search facility on the MAFF webpage permits searches for specific operators which is not fully in line with Article 92b of Regulation (EC) No 889/2008 which require the list of operators to be made public by MSs. All the relevant information, including documentary evidence is present when/if one has a specific name to undertake the research.

There is an adequate system in place for the registration of operators and overall it is effectively implemented. The CA makes available to the public regularly updated relevant information on organic operators. However, the list of operators as such, is not publically available which is not in line with EU legislation. The system in place also ensures that exempted retailers continue to fulfil the conditions for exemption. 5.2.3 Planning and Prioritisation of Controls Legal Requirements Article 41 and Article 92f of Regulation (EC) No 882/2004. Article 3 of Regulation (EC) No 882/2004. Article 27(3) of Regulation (EC) No 834/2007. Articles 65(1) and (4) of Commission Regulation (EC) No 889/2008. Article 92c(2) of Commission Regulation (EC) No 889/2008. 7 Findings.

Member state response

Organizacije za kontrolo in certificiranje prevetrijo svoje Kontrolne Do konca modele analize tveganja, da zagotovijo dobro podlago za organizacije leta 2018 izbiro izvajalcev, pri katerih bodo opravljene dodatne in nenapovedane kontrole ter vzorcenje. UVHVVR Odgovor glede zahtevane dokumentacije je zajet v

The recommendation states as its basis

The two CBs have procedures in place for the selection of operators for additional controls and sampling. Both CBs apply these procedures when selecting operators for sampling and additional controls. Scores are given for each criterion and a final score is given to each operator which allows the CB to rank operators according to their risk profile. However, the system applied by CB1 does not ensure that operators with several past non-compliances are classified as high risk. In relation to the risk 8 assessments prepared by CB2, the procedure in place to select operators for additional visits does not ensure that most of the additional visits are carried out at high risk operators. Conclusions on Planning and Prioritisation of Controls

However, the effectiveness of the system is reduced as there is a risk that not all high risk operators may be selected for additional inspections.

The audit team reviewed the scope of the PPP residues that can be analysed at the one designated laboratory. It was noted that some substances commonly detected by MSs in organic products were not included in the analytical scope (such as anthraquinone, piperonyl, 2,4D). Moreover, substances that can only be detected when using single methods and which are frequently notified in the Organic Farming Information System (OFIS) are also not included (such as Glyphosate, Chlormequat). This is not in line with Article 65(2) of Regulation (EC) No 889/2008.

However, the limited scope and testing methods used for organic samples and the inappropriate selection of operators for sampling carried out by one CB may reduce the effectiveness of the sampling programme. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008. Article 22(2) of Regulation (EC) No 834/2007. Findings

Member state response

priporocilu st. 1. to Na podlagi prejete dokumentacije UVHVVR v postopkih Page: 2 ed 06 March 2018 dations of report ref. DG(SANTE)/2017-6074-MR of the audit carried out from 26 l systems for organic production and labelling of organic products Action Proposed by the competent authority/Nacrtovan Kdo Rok ukrep Do konca leta 2018 uradnega nadzora nad delom kontrolnih organizacij presodi cinkovitost analize tveganja.

The recommendation states as its basis

However, the audit team noted that some aspects were not always covered during the inspections even though they were included in the checklists used. This concerned in particular the following aspects: the inspector did not visit all the premises on the farm where potential storage of non-authorised substances could take place; inspectors did not check all the neighbouring cultivations to rule out the risk of potential contamination; inspectors did not always verify the information provided by the operator through checking of relevant documents such as invoices or other records demonstrating the results of the verification at reception of organic products by operators; inspectors checked if cleaning took place between batches of organic and batches of conventional products. The operators visited kept records of the verification of the effectiveness of the cleaning. However, the inspectors did not verify such records. Conclusions on Controls of Operators

Although inspections observed were overall effective, some important aspects were not sufficiently covered during the visits which may undermine the effectiveness of the inspections. 5.2.5 Controls on Labelling and Traceability Legal Requirements Article 23 of Regulation (EC) No 834/2007. Article 23(1) of Regulation (EC) No 834/2007 Regulation. Title III of Commission Regulation (EC) No 889/2008. Article 27(13) of Council Regulation (EC) No 834/2007. 10 Article 18 of Regulation (EC) No 178/2002. Findings

Member state response

Organizacije za kontrolo in certificiranje pregledajo svoje Kontrolne topke (navodila, opomnike, obrazce za pisanje zapisnika organizacije o opravljeni kontroli...) in dodatno izpostavijo in in pri izvajalcih preverijo nastete zahteve. UVHVVR VHVVR dodatno izpostavi in po potrebi s podrobnimi odili razsiri nastete zahteve v Navodilu za izvajanje nadzora nad delom kontrolnih organizacij, vkljucno z opomniki. Page: 3 ed 06 March 2018 dations of report ref. DG(SANTE)/2017-6074-MR of the audit carried out from 26 l systems for organic production and labelling of organic products Action Proposed by the competent authority/Nacrtovan Kdo Rok ukrep

The recommendation states as its basis

The audit team reviewed the scope of the PPP residues that can be analysed at the one designated laboratory. It was noted that some substances commonly detected by MSs in organic products were not included in the analytical scope (such as anthraquinone, piperonyl, 2,4D). Moreover, substances that can only be detected when using single methods and which are frequently notified in the Organic Farming Information System (OFIS) are also not included (such as Glyphosate, Chlormequat). This is not in line with Article 65(2) of Regulation (EC) No 889/2008.

However, the limited scope and testing methods used for organic samples and the inappropriate selection of operators for sampling carried out by one CB may reduce the effectiveness of the sampling programme. 5.2.7 Exceptional production rules and other derogations. Legal Requirements Article 29 of Regulation (EC) No 889/2008 and Annex IX of the same Regulation. Sections 2 to 4 of Chapter 6 of Title II of Regulation (EC) No 889/2008. Article 22(2) of Regulation (EC) No 834/2007. Findings

Member state response

MKGP in UVHVVR pripravita smernice glede parametrov, MKGP in Do konca leta 2018 atere se analizirajo vzorci v postopkih kontrole in UVHVVR certificiranja. Pri pripravi smernic se uporabi podatke o ugotovljenih ostankih FFS javljenih v OFIS kot tudi sposobnosti laboratorija. Pri pripravi smernic sodeluje tudi laboratorij. MKGP bo po spremembi nacionalnega pravilnika za MKGP Do konca ekolosko pridelavo in predelavo zacelo izdajati dovoljenja leta 2018 za vezano rejo na manjsih kmetijskih gospodarstvih.

The recommendation states as its basis

According to the national organic rules, the MAFF has the competence to grant derogations, except for the use of conventional seeds and propagating material, which has been delegated to the CBs. However, the derogation for tethering of animals had been delegated to CBs which is contrary to Article 27(7) of Regulation (EC) No 834/2007.

However, the CA delegated to the CBs the competence for authorisation to tethering of animals which is not in line with EU requirements. 5.2.8 Imports of Products from Organic Production Legal Requirements Article 33 of Regulation (EC) No 834/2007. 14 Chapter 3 of Title III of Regulation (EC) No 1235/2008. Annexes II, III, V and VI of Regulation (EC) No 1235/2008. Findings

Member state response

Page: 4 ed 06 March 2018 dations of report ref. DG(SANTE)/2017-6074-MR of the audit carried out from 26 l systems for organic production and labelling of organic products ction Proposed by the competent authority/Nacrtovan Kdo Rok krep

The recommendation states as its basis

Generally there is good communication between the CAs and CBs with regard notification of irregularities. CBs notify the AFSVSPP of irregularities found during the year by means of their annual and weekly reports. Major and severe irregularities affecting the organic status of the product are weekly notified by the CBs to the AFSVSPP which is not fully in line with in line with Articles 27(5) and 30(2) of Regulation (EC) No 834/2007 and Article 92(4) of (EC) Regulation 889/2008 which prescribe that irregularities or infringement affecting the organic status of the product shall be immediately notified by the CBs to the CAs. The procedures of CB2 require inspectors to immediately inform the CB headquarters when a serious non-compliance is identified during inspection. The CB must also inform the AFSVSPP in a weekly basis. The files reviewed by the audit team confirmed these practices were implemented.

The system in place is effective as it is based on a catalogue of measures providing a framework for harmonized and adequate measures in case of irregularities and infringements of EU organic rules. However, major non-compliances are not immediately notified between CBs and the CAs and other bodies involved, which may not allow the relevant bodies to take enforcement actions in a timely manner.

Member state response

sporazumu medsebojnega obvescanja se rok za Do konca leta 2018 vescanje o ugotovljenih neskladnostih ali verjetnih eskladnostih skrajsa z 8 na takoj oz. najkasneje 3 delovne ni.

The recommendation states as its basis

The audit team reviewed two cases notified in OFIS. In both cases the CA launched an investigation. The CA, for different reasons, were not able to upload the results of the investigations in OFIS within 30 days as required in Article 92a(4) of Regulation (EC) No 889/2008. In one case, the regional office took more than 3 months to respond to the CA (then the CA took one more month to reply to the notification), in the other case, the CA uploaded the notification in OFIS in October 2017, seven months after having the relevant information collected (by 31.03.2017). The CA acknowledges the lack of written procedures to deal with these matters. Conclusions on Measures in cases of Irregularities and Infringements

However, the CA does not always respond on a timely basis to OFIS notifications to 17 the EU as there is not a procedure in place to properly follow-up in a timely manner which may prevent MSs involved taking appropriate actions.

Member state response

KGP in UVHVVR pripravita standardni operativni MKGP in Do konca UVHVVR leta 2018 ostopek za namen spremljanja in obravnave OFIS otifikacij. Page: 5 ed 06 March 2018 dations of report ref. DG(SANTE)/2017-6074-MR of the audit carried out from 26 l systems for organic production and labelling of organic products Action Proposed by the competent authority/Nacrtovan Kdo Rok ukrep Page: 6

Member state response

or the purpose of harmonising the official confirmatory sampling with the requirements of EU legislation, a Government Decree will be adopted, which will define anew the implementation of national Salmonella Control Programmes in poultry populations. AFSVSPP will begin preparing the relevant regulation by the end of 2016, in line with the Government Work Programme. Adoption of relevant regulation by the Government may, considering the rules and procedures applicable to the adoption of Government Decrees, be expected by the end of 2017 or in the beginning of 2018.

The recommendation states as its basis

The laboratory runs molecular methods to detect norovirus and hepatite A virus in food using some principles of EN ISO/TS 15216-2:2013 and reports results. These methods do not fall within the laboratory's scope of accreditation.

The main principle of virological analysis of soft berries lies in the virus concentration from 25g of berries. The most reliable method is the Polyethyleneglycol Precipitation. This method is part of ISO 15216-1 and 15216-2 and has been successfully tested in an inter-laboratory trial. Other methods for virus concentration are so far not as efficient and this has been shown in the Norovirus outbreak 2012 in Germany. The results are published and available as open access (Mäde, D.; and collaborators. Detection and Typing of Norovirus from Frozen Strawberries Involved in a Large-Scale Gastroenteritis Outbreak in Germany. Food and Environmental Virology. Volume 5 (2013), Issue 3, pp 162-168). The method used in Slovenia is not fit for purpose to concentrate virus particles from soft berries and cannot ensure that the presence of such pathogens can be reliably detected in official samples. In addition, it does not follow the internationally 13 recognised rules EN ISO/TS 15216-2, contrary to the requirements of Article 11(1)(a) of Regulation (EC) No 882/2004. Conclusions on Laboratory Performance

For virus analysis in soft fruit, the method used does not follow the applicable international rules. It can prevent official controls from reliably detecting viral pathogen in official samples while these pathogens are considered relevant hazards by the CAs. 5.2.7 Procedures for Performance and Reporting of Control Activities Legal Requirements Article 8, and Article 9 of Regulation (EC) No 882/2004 Findings

The recommendation states as its basis

AFSVSPP had at the time of the audit not made plans for independent scrutiny.

IRSAFHF has not engaged in independent scrutiny so far. One external audit is planned for 2018, but at the time of this audit, no terms of reference for this external audit had been determined.

HIRS is subject to an external evaluation every year, as part of its ISO accreditation. These external evaluations focus on compliance with ISO standards and cover a much wider scope than their official controls which fall under Regulation (EC) No 882/2004. The external evaluator gives an opinion on the independence of the audit body/auditors in the context of the Quality Management system, but does not demonstrate that Article 4(6) of Regulation (EC) 882/2004 has been taken into consideration. However, as the evaluation reports identify areas for improvement and best practices, they can provide for some aspects of independent scrutiny. Conclusions

AFSVSPP does at present not have a system in place for independent scrutiny.

IRSAFHF is in the early stages of planning for independent scrutiny.

HIRS has a quality system in place that gives limited assurances to the management on the audit processes' achievement of the objectives of Article 4(6) of Regulation (EC) No 882/2004. 5.2.3 Auditor competence 5.2.3.1 Legal requirements Articles 2(6) and 4(6) of Regulation (EC) No 882/2004 do not lay down specific requirements regarding the competence of auditors. Article 6 of the same Regulation requires that staff performing official controls "receive, for their area of competence, appropriate training enabling them to undertake their duties competently" and "keep up-to-date in their area of competence and receive regular additional training as necessary" Section 6.6 of the Annex of Commission Decision 2006/677 provides guidance on auditor competence: "Auditor competence and selection criteria should be defined under the following headings: 8 -- generic knowledge and skills -- audit principles, procedures and techniques; management/organisational skills, -- specific technical knowledge and skills, -- personal attributes, -- education, -- work experience, -- auditor training and experience. It is essential to put a mechanism in place to ensure auditors are consistent and their competencies are maintained. Competencies required by audit teams will vary depending on the area they are auditing within the control or supervision systems. As regards the technical knowledge and skills required by auditors, the training requirements for staff performing official controls (Chapter 1 of Annex II to Regulation (EC) No 882/2004) should also be considered." 5.2.3.2 Findings

The recommendation states as its basis

AFSVSPP establishes its programme based on specific food and feed risks. There are documented procedures for development and approval of audit programmes. A risk assessment with risk analysis and its impact, considering "effectiveness" and "sensitivity", has been done with participation of the Director of Food Safety, Veterinary and Plant Health Inspection; the Heads of Professional Divisions and the Heads of Regions. The participants did their assessments on their own and separately for each area/topic. The total results were compiled and the areas/topics with highest scores were prioritised for audits. The Director General approves the plan and can propose areas to include. Recommendations in audits from DG SANTE have also brought about changes to the audit plan (residues and border inspection posts were added in 2015 for this reason). The plan is to cover three to four of the 46 audit areas each year. When the audit unit was formed, there were three full-time positions. However, currently only one staff member is active in the audit unit who, moreover, has additional tasks. Thus all areas cannot be covered in a five year plan.3 3 In their response to the draft report the CA noted that this was true at the time of the audit, but this year a staff member who had been on a long-term absence has returned to the Office, which means there are now two active staff members in the Office. These two staff are assisted by technical support staff in audits. 10

IRSAFHF has a plan for internal audits of all inspectors working with official controls falling under Regulation No 882/2004 for 2013 ­ 2016, but do not include in their audits the activities of central level such as development of documented procedures, and planning and co-ordination of official controls. Audit topics are selected for each inspector from the cases that have been handled by them. Cases that contain non-conformities, sampling, penalties, complaints, etc. are prioritised. The Head of the Agriculture Service approves the plan. All inspectors are audited within a four year period (2013 ­ 2016).

The range of official controls that must be covered by audit programmes has been adequately identified and considered by two of the three audit bodies. IRSAFHF does not include relevant activities at central level.

AFSVSPP has a system in place for development and approval of audit programmes. However, all areas cannot with current arrangements be covered in a reasonable timeframe.

The recommendation states as its basis

AFSVSPP follow-up procedures include the role of management and state: 'If the auditee does not follow the recommendations and not implement corrective or preventive measures or improvements, the Director of the Internal Audit Office informs the Director General of the AFSVSPP by means of a written report'. There is no clear indication at what point after the deadline for submission of an action plan, or after deadlines for completion of actions proposed in the action plan, the Director General should be informed. The audit team noted that actions to address the audit recommendations are still awaited in: Two of the three AFSVSFF audits in 2014 where clarification of the action plan has not been provided as requested; Two out of the two AFSVSFF audits in 2015 where no action plan was provided in response to the recommendations; So far in 2016 an action plan to address the recommendations is overdue for one audit and the response for the second audit is still within the deadlines. This has been communicated to senior management, but remedial action has not been taken to date.

AFSVSPP indicated that certain audits (e.g. border inspection posts) lead to recommendations which are focused on the inspection level and follow-up is easier than when audits identify certain policy measures which need to be improved. When recommendations address policy level issues it is sometimes less clear who should take responsibility to develop an action plan.

In AFSVSPP the impact of the audits is undermined by the failure to address recommendations in a systematic and timely fashion.

Member state response

e are preparing the Protocol on mutual notification of official control procedures and other administrative tasks concerning quality schemes for ly agricultural products and foodstuffs as governed by Regulation (EU) No n 1151/2012. The deadline for completion and signing of the protocol is the January 30, 2015.

Member state response

ing of results of laboratory analyses and subsequent use n targeted sampling within the NRCP (National Residue mme) has been facilitated by upgrading the relevant IT Compulsory instructions on the implementation of programme will comprise written instructions on the tion on results obtained from samples which had been asis of reasonable suspicion, so as to improve the targeted reparation of NRCP.

Member state response

udit Office, carrying out the auditing in compliance with of Regulation 882/2004 and operating within AFSVSPP, rate residue monitoring areas into its audit programme of audit programme is to be approved by AFSVSPP Director

Member state response

ompliances found, NRL will supplement its existing the subcontracting laboratory, and AFSVSPP will check icial controls the compliance of NRLs with conditions as rticle 14 of Council Directive 96/23/EC.

Member state response

oratories will continue the validation of methods ommission Decision 2002/657/EC. The validation, e missing screening methods, is envisaged to be he end of 2014. Page: 1 Action Plan received from CA on 25 September 2013 DG(SANCO)/2013-6768-MR of an audit carried out n live animals and animal products rity y tests on all samples are to be using methods validated according

Member state response

ication of sample transport procedures within the NRCP, nalyte stability and sample integrity of RMP samples) e regime recording during transport of samples to the Page: 2

Member state response

re UVHVVR bo v letni program uradnega nadzora kot posebno on nalogo vkljucila tudi preverjanje odobrenih aktivnosti v obratih. Uradni veterinarji bodo morali preverit ali so aktivnosti, ki se izvajajo v posameznem odobrenem obratu skladne z aktivnostmi navedenimi v odlocbi o odobritvi.

re AFSVSPP will in the annual work plan of official inspection and on control incorporate as a specific task the verification of the approved activities in establishments. Official veterinarians will need to check, whether the activities to be implemented in a particular approved establishment are in compliance with the activities laid down in the Approval Decision.

Member state response

UVHVVR je konec leta 2013 nadgradila IT sistem tako, da imajo sion do podatkov o prepovedih oddaje surovega mleka dostop vsi uradni veterinarji na celotnem ozemlju RS. Nadgraditev IT sistema omogoca dostop do naslednjih podatkov: datum izdane prepovedi oddaje mleka, nosilca zivilske dejavnosti, kateremu je bila izdana prepoved, vzrok prepovedi, predelovani obrat mleka, kamor se mleko oddaja, datum prenehanja prepovedi oddaje mleka. Nadgraditev omogoca vpogled v zgodovino zapisov.

At the end of 2013, AFSVSPP upgraded its IT-system so that all sion the official veterinarians in the entire territory of the Republic of Slovenia have access to the data on prohibitions of placing on the market of raw milk. IT-system upgrading facilitates the access to the following data: date of prohibition of placing on the market of raw milk; food business operator, who had been issued the prohibition; cause for prohibition; milk processing establishment whereto the milk is placed; date of cessation of prohibition of placing on the market of raw milk. Upgrading facilitates the insight into the history of records.

Member state response

Skladno z veljavno EU zakonodajo (Uredba ES/178/2002, EC) ES/852/2004 in ES/853/2004) in skladno s Smernicami Komisije o razumevanju nekaterih dolocb o prilagodljivosti iz sveznja o higieni je UVHVVR mnenja, da notifikacija nacionalnega predpisa v povezavi z Uredbo ES/2005/2073 ni potrebna. Iz vsebina nacionalnega predpisa je namrec razvidno, da predpis ne uvaja morebitnih odstopanj, izjem ali prilagoditev. Nosilci zivilske dejavnosti morajo, ne glede na dolocbe nacionalnega predpisa, izpolnjevati vse zahteve predpisane z Uredbo ES/2005/2073. UVHVVR bo takoj ko bo mogoce sprejela odlocitev, ali pricne s postopkom notifikacije nacionalnih pravil v povezavi z Uredbo 2073/2005/ES, kot doloca 8. clen Direktive 98/34/ES Evropskega parlamenta in sveta, ali pa omenjena pravila razveljavi. V drugem 014 eport ref. DG(SANCO)/2013-6883 -MR of a/an audit carried out from 02 taken by the competent authorities with regard to official controls related to cts. rimeru bo UVHVVR pripravila smernice za izvajanje zahtev goraj navedene uredbe.

According to applicable EU legislation (Regulation 178/2002/EC, EC) 852/2004/EC and 853/2004/EC) and according to Commission Guides on the comprehension of certain provisions on the adaptability of the Hygiene Package, AFSVSPP believes that the notification of national regulation linked to Regulation 2005/2073/EC is not necessary. It is evident from the purport of national regulation that it does not introduce any derogations, exceptions or adaptations. Food business operators need to comply with all the requirements of Regulation 2005/2073/EC irrespective of provisions of the national regulation. AFSVSPP will as early as possible decide either to initiate the eport ref. DG(SANCO)/2013-6883 -MR of a/an audit carried out from 02 taken by the competent authorities with regard to official controls related to cts. ure of notification of national rules linked to Regulation 073/EC as required by Article 8 of Directive 98/34/EC of ropean Parliament and of the Council or to repeal these In the second case AFSVSPP will prepare a guidance nt for implementation of the provisions of the above ned regulation.

Member state response

nd UVHVVR je za leto 2014 predvidela: a) revizijo navodil za zvajanje nadzora na podrocju splosnih in posebnih higienskih ahtev; b) izobrazevanje nadzornega osebja za podrocje nadzora zpolnjevanja higienskih pogojev; c) uvrstila nadzor izpolnjevanja igienskih zahtev nosilcev dejavnosti med prioritetne naloge adzora.

nd AFSVSPP has envisaged for 2014: a) revision of instructions on he implementation of inspection and control in the field of the l and specific hygiene requirements; b) training of tion staff in the field of inspection and control of ance with the hygiene requirements / conditions; c) llance of compliance with the hygiene requirements by food ss operators has been ranked among the priority tasks of the al inspection and control service.

Member state response

nts UVHVVR je za leto 2014 predvidela: a) pripravo navodil za zvajanje nadzora nad notranjimi kontrolami po principu HACCP; ) izobrazevanje nadzornega osebja za izvajanje nadzora nad otranjimi kontrolami po principu HACCP; c) uvrstila nadzor nad otranjimi kontrolami po principu HACCP nosilcev dejavnosti ed prioritetne naloge nadzora.

nts AFSVSPP has for 2014 envisaged: a) preparing the instructions implementation of supervision of internal controls ted according to the HACCP principles; b) training of the isory staff in the implementation of supervision of internal ls conducted according to the HACCP principles; c) llance of compliance of internal controls conducted by food ss operators according to the HACCP principles has been among the priority tasks of the official inspection and l service.

Member state response

UVHVVR je za leto 2014 predvidela: a) revizijo navodil za zvajanje nadzora na podrocju izpolnjevanja mikrobioloskih riterijev; b) izobrazevanje nadzornega osebja za podrocje adzora mikrobioloskih kriterijev; c) uvrstila nadzor izpolnjevanja ikrobioloskih kriterijev pri nosilcih dejavnosti med prioritetne aloge nadzora.

AFSVSPP has for 2014 envisaged: a) revision of instructions on plementation of inspection and control in the field of ance with the microbiological criteria; b) training of the isory staff in the implementation of supervision of iological criteria; c) surveillance of compliance with the iological criteria at food business operators has been among the priority tasks of the official inspection and l service. eport ref. DG(SANCO)/2013-6883 -MR of a/an audit carried out from 02 taken by the competent authorities with regard to official controls related to cts.

Member state response

VHVVR bo do druge polovice leta 2014 pripravila prijavnico za icle usposabljanje po novem programu v skladu z Uredbo 1099/09. menjena prijavnica bo vsebovala izjavo v skladu s clenom 21(6) menjene Uredbe.

FSVSPP will by the second half of 2014 prepare an application icle form for the training according to the new training programme as aid down in Regulation 1099/2009. his application form will include a declaration in compliance ith Article 21(6) of the above Regulation.

Member state response

egulation 1107/2009, re-authorisations are done at the or this reason, procedures will be more transparent and be easier to meet and respected.

Member state response

nt authority will ensure extension of the scope of s in cooperation with the National Reference extension will include analyses of possible co- uvants and physical-chemical properties in order to eit actions, if necessary. A prerequisite for the more es is the availability of analytical methods, analytical lose collaboration with CRL.

Member state response

tween the Agency for Agricultural Markets and Rural e Ministry of Agriculture and the Environment, s and the competent authority for official control visions for IPM and regarding controls on the use of tion with cross compliance will be ensured in the e new Administration of the Republic of Slovenia for terinary sector and Plant Protection, established on 1 Page: 1

Member state response

equested the DG SANCO's Legal Service for he FVO's competences/authorisations concerning on of recommendations of the European on of Animals Kept for Farming Purposes.

Member state response

ll the registered establishments keeping laying been compliant with the provisions of Directive that date, the registration numbers have been blishments which had failed to comply with A took all the necessary steps to prevent the establishments from being placed on the

Member state response

an CCA will ask the Centre for Permanent within the Veterinary Faculty of the Ljubljana a relevant training programme primarily for the in Slovenia.

Member state response

ting relevant measures and other activities mpliance with group housing for sows by ticle 3 of Directive 2008/120/EC.

Member state response

the Head of the Port of Koper BIP odies of the Member States performing Page: 1 )/2012-6375-MR of an audit carried out on farms and during transport he Competent Authority of third country flag livestock vessels, which was éte, France. been continuing the practice of close cooperation inspection services, which have sufficient for the implementation of all the checks required by 1/2005.

Member state response

utumn of 2012 until the Spring of 2013, the xamine and improve the existing guidelines for involved in animal transport, which will be ant training for official veterinarians. Page: 2

Member state response

The FVO Mission Report and Additional clarification: Recommendations were forwarded by VARS VARs Main Office representatives will ES, Main Office to all the Slovenian BIPs. verify within the internal audit to be The FVO Recommendation in relation to the conducted by the end of October 2012 at all use of TRACES, the correctness of veterinary the BIPs in Slovenia, whether the above non- checks and decision on the consignments and compliances found by the FVO Mission have ) the follow-up of consignments where it is been rectified, and the effectiveness and required, was promptly taken into account at the correctness of the official controls in BIP of Obrezje and Gruskovje in implementing particular. the official checks, where the FVO Mission had found certain non-compliances. Thus, at the BIP of Obrezje, final destinations of channelled consignments are regularly entered into the TRACES System, as well as laboratory test results, and at the BIP of Gruskovje, feedback information is received through the TRACES System on the channelled consignments of poultry by-products. Heads of BIPs specifically notified all the official veterinarians involved in the official checks to be even more a

Member state response

s Recommendation has already been id implemented, meaning in practice that registers ve already been in place for all the - consignments requiring further processing and mation of arrival to the controlled place tination (e.g. channelled, re-imported and ed consignments or consignments in transit), and in cases where the BIP official nt veterinarians will not be notified on the arrival signment to the final place of destination, eive a relevant confirmation therefrom, ill take the relevant necessary steps. has been introduced, on which basis the ures relevant to consignments in transit, ed consignments, channelled Page: 2 Updated Action Plan received from CA 19 July 2012 the Competent Authorities of Slovenia on 15 June in response to Report ref. from 05 to 09 March 2012 in order to evaluate the follow-up action taken by the t/transit control system and border inspection posts ction Proposed by the Competent Authority Updated Action proposed by the Competent Authority onsignments or re-imported consignment are onitored. On completion of form for a articular consignment as referred to above, uch a form is archived in the relevant dossier.

Member state response

At all the BIPs inspected by the FVO Mission, based on the above Report, the Heads f BIPs prepared meetings with the forwarding gents, and repeatedly notified them of the gency of prenotification of consignments in ompliance with the applicable EU veterinary aw. ith reference to prenotification of onsignments, the following activities were mplemented: Meetings with forwarding agents and courier ervices were held; these were notified in riting that omission of prenotification of onsignments was to be penalised; We proposed to introduce a procedure of otification of customers (importers); A list was prepared of importers, who have ailed to pre-notify the arrival of consignments Page: 3 Updated Action Plan received from CA 19 July 2012 the Competent Authorities of Slovenia on 15 June in response to Report ref. from 05 to 09 March 2012 in order to evaluate the follow-up action taken by the t/transit control system and border inspection posts on Proposed by the Competent Authority Updated Action proposed by the Competent Authority IP or forwarding agents prior to their arrival border crossing; notified all the parties involved that in of their non-compliance with requirements prenotific

Member state response

Additional requirements concerning the Additional clarification: equipment for physical checks on animals at the The additional equipment (e.g. dog muzzles, A BIP of Brnik: collars and leashes) required has already Momentarily, a call for tenders is under way been purchased. A contractor for installation installation of aquaria for fishes or of aquaria for fishes and terrariums for ely terrariums for reptiles for the case of need of reptiles has already been selected, and an of prolonged detention of relevant animal species agreement between the contractor and VARS he BIP. is to be signed by the end of September rchasing procedure is underway of the 2012. tional required equipment (e.g. dog les, collars and leashes). Page: 4