HEALTH & CONSUMERS DIRECTORATE-GENERAL

Transcription

1 EUROPEAN COMMISSION HEALTH & CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO)/ MR - FINAL FINAL REPORT OF A MISSION CARRIED OUT IN SLOVENIA FROM 24 NOVEMBER TO 28 NOVEMBER 2008 IN ORDER TO EVALUATE THE IMPLEMENTATION OF MEASURES CONCERNING OFFICIAL CONTROLS ON FEED AND COMPLIANCE WITH REQUIREMENTS FOR FEED HYGIENE In response to information provided by the Competent Authority, any factual error noted in the draft report has been corrected;any clarification appears in the form of an endnote.

2 Executive Summary This report describes the outcome of a mission carried out by the Food and Veterinary Office (FVO) in Slovenia from 24 to 28 November The overall objective of the mission was to evaluate the measures put in place to give effect to Regulations (EC) No 882/2004 and No 183/2005, and other feed legislation, in particular Regulation (EC) No 1831/2003. The evaluation focused on the implementation of the requirements of the above Regulations, including those that are new in comparison with previous feed legislation now repealed. Overall, the report concludes that registration and approval of feed business operators (FBOs) is complete. Official controls in the feed sector and compliance with requirements for feed hygiene were largely satisfactory; however, the quality controls and HACCP procedures in place in FBOs and the official controls of these could, in some cases, be further developed. With regard to other requirements, the CA have taken largely satisfactory measures to ensure that the ban on using antibiotics as feed additives and the rules on undesirable and prohibited substances are respected. The report makes a number of recommendations addressed to the Slovenian competent authorities, aimed at rectifying the shortcomings identified and further enhancing the implementing and control measures in place. i

3 TABLE OF CONTENTS 1 INTRODUCTION OBJECTIVES OF THE MISSION LEGAL BASIS FOR THE MISSION BACKGROUND MAIN FINDINGS INFORMATION ON THE FEED SECTOR COMPETENT AUTHORITIES Organisation and responsibilities Resources and training Internal supervision OFFICIAL CONTROLS ON FEED LABORATORIES CARRYING OUT OFFICIAL ANALYSES COMPLIANCE WITH REQUIREMENTS FOR FEED HYGIENE Scope Registration and approval of feed business establishments Specific obligations of primary producers Specific obligations of feed operators other than primary producers IMPORTS AND EXPORTS OTHER REQUIREMENTS ALONG THE FEED CHAIN Phasing out of antibiotics Rules on undesirable substances Rules on prohibited materials ACTIONS TAKEN IN CASE OF NON-COMPLIANCE CONCLUSIONS COMPETENT AUTHORITIES OFFICIAL CONTROLS ON FEED LABORATORIES CARRYING OUT OFFICIAL ANALYSES COMPLIANCE WITH REQUIREMENTS FOR FEED HYGIENE IMPORTS AND EXPORTS OTHER REQUIREMENTS ALONG THE FEED CHAIN ACTIONS TAKEN IN CASE OF NON-COMPLIANCE OVERALL CONCLUSION CLOSING MEETING ii

4 8 RECOMMENDATIONS iii

5 ABBREVIATIONS & SPECIAL TERMS USED IN THE REPORT Abbreviation Action plan BIP CA Carry-over CCA Control Plan FBO FEFAC FVO HACCP IRSAFF MAFF MS NVI On-farm mixer Report RO of VARS VARS Explanation Actions announced/undertaken as submitted to the Commission services by the CCA in response to the recommendations made in mission report 7698/2005 Border inspection post Competent authorities Presence, due to production, of additives in feedingstuffs for animal species or categories in which the additives are not authorised Central Competent Authority, Veterinary Administration of the Republic of Slovenia, VARS, Veterinarska uprava Republike Slovenije Animal Feed Control and Monitoring Programme Feed business operator European Feed Manufacturers Federation Food and Veterinary Office Hazard analysis and critical control points Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food Ministry of Agriculture, Forestry and Food Member States National Veterinary Institute Producer mixing feed for the exclusive requirement of its holding Report of a mission carried out in Slovenia from 4 to 8 July 2005 concerning Bovine Spongiform Encephalopathy and animal nutrition Regional offices of VARS Veterinary Administration of the Republic of Slovenia iv

6 1 INTRODUCTION The mission took place in Slovenia from 24 to 28 November The inspection team comprised two inspectors from the Food and Veterinary Office (FVO) and one policy officer from the European Commission, and was accompanied throughout the mission by representatives from the central competent authority (CCA), the Veterinarska Uprava Republike Slovenije, (Veterinary Administration of the Republic of Slovenia VARS). An opening meeting was held on 24 November 2008 with the CCA, during which the mission objectives, itinerary, and the standard reporting and follow-up procedures were confirmed, and additional information required for the satisfactory completion of the mission was requested. 2 OBJECTIVES OF THE MISSION The overall objective of the mission was to evaluate the measures put in place to give effect to: 1. Regulation (EC) No 882/2004 of the European Parliament and of the Council. 2. Regulation (EC) No 183/2005 of the European Parliament and of the Council. 3. Other feed legislation, including implementing measures, in particular Regulation (EC) No 1831/2003 of the European Parliament and of the Council. In terms of scope, the mission focused on the implementation of the requirements of the above Regulations, including those that are new in comparison with previous feed legislation now repealed. The mission covered all stages of the feed chain from the primary production to the use of feed for farmed animals, including traceability. Within this context, and where relevant, the evaluation followed up on the outcome on the previous mission concerning feed safety and the recommendations made in this respect. The mission itinerary included the following visits: 1

7 Competent authorities visits Comments Competent authority Central Opening and closing (de-briefing) meeting Regional Meetings in the two Regions visited Local Discussions held in the course of visits to premises Sites Animal feed processors/manufacturers 2 One approved and one registered feed mill Intermediaries 1 One approved intermediary Farms 1 One on-farm mixer Food operator supplying feed operators 1 One food business operator supplying feed materials 3 LEGAL BASIS FOR THE MISSION The mission was carried out under the general provisions of Community legislation and, in particular: Article 45 of Regulation (EC) No 882/2004. All legal references relevant for this mission are listed in Annex 1. Legal acts quoted refer, where applicable, to the last amended version. 2

8 4 BACKGROUND The previous mission concerning feed safety in Slovenia was carried out from 4 to 8 July 2005, the results of which are described in report DG(SANCO)/7698/2005 MR Final (hereafter: report 7698/2005). This report is accessible at: The report made a number of recommendations to the CCA, which subsequently informed the Commission of actions that had been/would be taken aimed at addressing the recommendations made (hereafter: action plan). Where appropriate, both the relevant recommendations and the action plan are outlined under Section 5. Since the previous mission, the relevant EU legislation concerning feed safety has been modified significantly. Regulation (EC) No 882/2004 has introduced a harmonised framework of general rules for the organisation of official controls on food and feed so as to integrate them at all stages of production and sectors, using the farm to fork principle. Regulation (EC) No 183/2005 recognised the need to ensure feed safety starting with primary production of feed and comprising also the transport, storage and handling of feed; moreover, procedures based on the principles of hazard analysis and critical control points (HACCP) should be in place for feed business operators (FBOs) (except at the level of primary production of feed and certain associated operations), and the compulsory registration of all FBOs was introduced. 5 MAIN FINDINGS 5.1 INFORMATION ON THE FEED SECTOR According to information provided by the CCA on the feed sector, concerning 2007: - Around 528,518 tons of compound feed were produced, consisting, in descending order of importance, of feed for poultry, pigs and cattle. In addition, 11,157 tonnes of medicated feed, 2,454 tonnes of premixtures, and 6,407 tonnes of feed additives were produced. - There were 29 approved FBOs of which 11 produced compound feedingstuffs, four feed additives, two premixtures, one was an importer, and 11 were intermediaries. As regards registered FBOs, there were 2,396, of which, among others, 46 produced feed and 714 were intermediaries. In addition, 59 food business operators are registered as providing by-products to the feed industry (mainly bakeries, oil-plants, and breweries). - Imports of feed of non-animal origin amounted to 155,805 tonnes (of which two thirds were soybean cakes from Brasil). In addition, 1,119,703 tonnes of feed of non-animal origin (mainly soybean cakes from Argentina and Brasil) were imported into the EU via Slovenia. Some FBOs are represented in an organisation of feed producers (the Feed Producers Section of the Chamber of Commerce and Industry which is a member of the European Feed Manufacturers Federation - FEFAC). The members of this Section have to apply 3

9 the FEFAC guidelines in the production of compound feedingstuffs and premixtures. Within the Twinning Facility project SI05-IB-AG-01 (Strengthening Food Safety in Primary Production), the Chamber of Agriculture and Forestry, in cooperation with Danish experts and Slovenian institutions (Veterinary Faculty, Agricultural Institute, and Biotechnical Faculty) prepared in 2007 Guidelines on Good Practice in Primary Production of Food and Feed; the said Chamber, in cooperation with the CCA, is currently preparing a new version of these Guidelines. 5.2 COMPETENT AUTHORITIES Organisation and responsibilities The relevant recommendation of report 7698/2005 concerned the cooperation and communication between VARS and the Inspectorate of the Republic of Slovenia for Agriculture, Forestry and Food (IRSAFF). In response to this recommendation the CCA undertook to provide the legal basis for improving the cooperation between the different authorities and, in addition, to implement a Twinning project with the purpose of efficiently implementing the new EU feed legislation introduced in In compliance with the Animal and Feed Act (UL RS 127/06) and the Veterinary Compliance Criteria Act (UL RS 93/05), the competences and tasks concerning official controls of feed and feed hygiene are divided between VARS and IRSAFF, both within the Ministry of Agriculture, Forestry and Food (MAFF). In VARS, the Animal Feed and TSE section is responsible for the general policy on feed safety, the transposition of EU legislation regarding feed safety, approval and registration of establishments, feed safety controls and import control of feed materials of animal and mineral origin, compound feedingstuffs, premixes and additives. IRSAFF is responsible for official controls of feed in primary production (with the exception of farms with approved home mixers), feed quality control, labelling and GMOs. There are ten regional veterinary offices under VARS. Each VARS region has one appointed responsible official veterinarian (OV) for feed safety covering all FBOs in that region. IRSAFF has similar local offices covering the same areas as VARS. More background information on the competent authorities can be found in the country profile for Slovenia. It can be accessed at: The CAs responsibilities with regards to official controls on feed hygiene were clearly defined and understood both at VARS and at IRSAFF level, although there was one inspector in one VARS regional office who was not aware about the responsibilities regarding food business operators providing by-products to the feed industry. In the regions visited the mission team confirmed that regular meetings were carried 4

10 out with participation from the responsible feed inspectors from VARS and IRSAFF. According to information received from VARS regular meetings are also carried out at least twice a year between the responsible OVs at central level and the regional inspectors, in particular in order to discuss the implementation of the Animal Feed Control and Monitoring Programme (hereafter, the Control Plan) and also to inform about new developments in EU legislation in the area of feed. A Twinning project was carried out in 2006 between German and Slovenian experts on Food and Feed Safety. The project resulted in closer cooperation between VARS and IRSAFF including jointly preparation of the Control Plan. The project also resulted in further development of the control plan for feed including a detailed manual setting out procedures for cooperation between the CAs Resources and training According to the CCA, resources are available to conduct official controls with regard to feed hygiene and training has been provided to ensure that staff can conduct controls competently and in a consistent manner. Evidence was provided that training on official control and feed hygiene requirements had been given to officials at both CCA and regional level. The training was comprehensive and included among others international seminars in the frame work of TAIEX, Twinning projects and a study trip to Germany for a week, where half of the regional VARS inspectors and the OVs from central level had participated. Officials met during the mission had all received recent training and were well aware of the requirements for official controls on feed and feed hygiene Internal supervision In 2006 VARS introduced an audit system to fulfil the requirements of Regulation (EC) No 882/2004. According to the information received, the CCA sends out an annual audit plan specifying which regions and what specific areas have to be audited. According to the CCA, a new system for internal supervision is being implemented, whereby the directors of the regional offices of VARS would be requested to supervise their staff with a given frequency; this verification could be carried out by the directors themselves, or it could be delegated to experts (within the region, from other regions, or from the CCA). In the regions visited, it could be confirmed that the system was being put in operation. In the regions visited a system of supervision was in place between responsible feed OVs and the regional directors in VARS. The system included meetings and the obligation of OVs to produce weekly reports about the inspections carried out in the feed area and their outcome. The weekly reports made the basis for the directors' 5

11 monthly report to the central level of VARS, specifying the number of inspections carried out, samples taken, measures taken and sanctions imposed. In addition, the directors of VARS prepare an annual report on all activities carried out the previous year. As regards IRSAFF, a similar system was described where inspectors send monthly reports to their hierarchy on the number of inspections and samples and the number of non compliances and sanctions. Audits had been carried out by VARS in the feed area in three different regions in However, according to the information received from the CCA, these audits were still at a preliminary stage and would be further developed in the future. In one region visited, IRSAFF had also carried out audits of feed inspectors in OFFICIAL CONTROLS ON FEED The relevant recommendation of report 7698/2005 concerned guidelines for inspections and sampling and, in addition, the meeting of targets set out in the Control Plan. In response to this recommendation the CA undertook to provide instructions for sampling and inspections in the framework of the Control Plan. According to the CCA, the Control Plan is prepared annually and jointly by the Animal Feed and TSE Section of VARS and the Feed Inspection Service of IRSAFF. For the purpose of developing the Control Plan, several sources of information are used like: a) results of controls reported from the regions to the CCA, b) consumer complaints, c) national or EU rapid alert notifications, d) laboratory results, and e) outcome from FVO missions. The Control Plan encompasses the whole feed chain including imports, hauliers and home mixers. Since the last mission a new manual for implementing the Control Plan, including checklists for inspections (for both VARS and IRSAFF inspectors) and sampling has been developed. The Control Plan specifies the number of inspections and samples each region has to take, and the laboratories and methods of analysis to use. The Control Plan only specifies the type of premises to be sampled, and the type of analysis to be carried out. It is the decision of the regional inspectors to decide which type of feed to sample, and this decision is based on risk factors and different criteria for implementation of controls like targeted sampling and monitoring. These criteria are the same for all regions, but the individual inspectors are responsible for the final decision on how many inspections to do and how many samples to take; according to OVs in the two regions visited, local knowledge about possible risks and producers past records were taken into consideration when implementing the Control Plan. Concerning official inspections to ensure that the requirements for feed hygiene were complied with, a system was in place where each inspector had to make a written risk assessment (using a standard checklist) of each FBO under their remit; this assessment resulted in a different frequency of the said inspections to each operator. In the establishments visited, it was confirmed that this assessment had 6

12 been carried out. According to the CCA inspection and sampling targets set out in the Control Plan were met in In all FBOs visited, official controls were conducted without prior warning and the above mentioned checklists were used to support the consistent implementation of official controls. 5.4 LABORATORIES CARRYING OUT OFFICIAL ANALYSES The laboratory network in charge of feed safety consists mainly of four laboratories, each specialised in specific analyses of feed: 1. The National Veterinary Institute (NVI) in Ljubljana is responsible for testing samples for zootechnical feed additives, contaminants, residues (veterinary medicinal products and hormones/prohibited substances) and processed animal proteins. NVI has been designated as National Reference Laboratory (NRL) for feed additives, mycotoxins, heavy metals and processed animal proteins. 2. The Agricultural Institute of Slovenia (AIS) in Ljubljana is responsible for testing samples for nutritive feed additives, vitamins, amino acids and oligoelements, and for testing quality parameters. 3. The National Institute of Biology (NIB) in Ljubljana is responsible for testing samples for the presence of GMO. NIB has been designated as NRL for the determination of GMOs in feed. 4. The Regional Institute of Public Health (RIPH) in Maribor is responsible for testing samples for contaminants and pesticides. RIPH has been designated as NRL for dioxins and PCB in feed and food. In addition, some laboratories in other Member States are used for specific analyses. According to the CA, analyses on feed are carried out according to official EU methods or in accordance with other internationally recognised analytical standards; all four laboratories are accredited to carry out their specific activities and, in addition, have participated in relevant ring tests with positive results. According to the CA, there is adequate capacity to analyse for most undesirable substances and other substances included in Commission Recommendations 2005/925/EC and 2006/88/EC. The mission team did not find evidence of any major difficulties as regards the time span for receiving results. 5.5 COMPLIANCE WITH REQUIREMENTS FOR FEED HYGIENE Scope 7

13 An order from 2006 is providing the legal basis for using the derogations mentioned in Art. 2 (2d) of Regulation (EC) No 183/2005. It is noted that the term local farms is applied to all farms within the country; no mention is made to the quantities of feed that are supplied, as long as the feed is used on the farms. According to the CA, this view is justified taking account of the size of the country. The farms are exempted from registration, but their existence is documented, which is the responsibility of MAFF; these farms also have to comply with the requirements for feed hygiene set out in Annex I to the said Regulation, and they are subject to official controls Registration and approval of feed business establishments Implementation of the requirements The procedures for approval and registration by VARS of FBOs including importers of feed are described in two orders from 2006 (approval and registration of establishments of FBOs) and 2007 (importers of feed). The CCA noted that the 29 approved FBOs (notably feed mills and intermediaries) have HACCP systems in place; this was confirmed by the regional offices of VARS visited. The approval was granted following an on-the-spot check by the regional OV, after which a decision was given in writing, including the approval number. As regards registered FBOs, the majority of them submitted a notification on the continuation of their activities, as requested by Art. 18 (1) of Regulation (EC) No 183/2005. Those which did not present the said notification, but whose existence was known by the CAs, have been included as a priority for inspection during In the regions visited it was confirmed that the list of registered establishments in the feed chain included food business operators providing by-products to the feed industry, transporters and importers of feed. The manual included in the Control Plan sets out instructions for approval and registration of FBOs Transitional measures According to the information received from the CCA the transitional measures described in Art. 18 (3) of Regulation (EC) No 183/2005 have been used List of establishments 8

14 The list of approved and registered FBOs has been published on VARS website where it is available to the public. A national list of FBOs at the level of primary production was available; this is under the responsibility of MAFF. OVs from VARS have access to this list Amendments to statuses, including their suspension or revocation According to VARS the requirements of Artt. 14 to 16 of Regulation (EC) No 183/2005 as regards suspension, revocation or amendments to registration or approval of an establishment are directly applicable, and the Manual for the Control Plan describes in more detail the procedures to follow by OVs. The CCA noted that some FBOs had been advised to change their activity (from one requiring approval to another one requiring registration) in view of their difficulties to comply with the relevant hygiene requirements. Moreover, six FBOs had their approvals withdrawn after Regulation (EC) No 183/2005 had been implemented, since they had ceased their activities. In the regions visited it was confirmed that OVs had, where it is considered necessary, the ability to propose the amendment of the registrations or approvals of FBOs including their suspension or revocation Specific obligations of primary producers Hygiene provisions The primary producer visited (an on-farm mixer) had clean and appropriate premises, and pest control programmes were in place. A sample of the compound feedingstuffs produced had been analysed for determining its zinc content, and the result showed a concentration too high for this microelement. The issue had been further investigated by the OV, who contacted the supplier of the premixture to which the problem was linked; as a result of this, a re-formulation of the compound feedingstuffs was made, and the concentration of zinc was back to normal values. The primary producer had a quality control programme in place that included documentation for cleaning of the mixer and other hygiene provisions, including a traceability system for components used during production Record-keeping The primary producer visited kept records of the source and quantity of each input of feed ingredients. 9

15 Official inspections In the regions visited, inspections to verify compliance with the specific obligations had been carried out at on-farm mixers and primary producers that also kept animals. The latter premises were being inspected primarily for other purposes but attention was also paid to their compliance with requirements for feed hygiene. According to representatives of IRSAFF, inspections are carried out by them to primary producers of feed on a random basis and in addition, a checklist for these inspections had been developed at central level Specific obligations of feed operators other than primary producers Facilities and equipment The hygiene standards in the FBOs visited were adequate and they had documented pest control procedures in place in line with the requirements of Annex II of Regulation (EC) No 183/2005. In the feed mils visited, scales and metering devices were tested regularly for accuracy Quality control and HACCP Quality control plans based on HACCP principles were in place in the FBOs visited and specific staff had been allocated responsibility for implementing these plans. However, in the registered FBO visited, there was no HACCP plan available nor flow diagram of the establishment; in the approved FBO visited, the HACCP plan contained some mistakes (e.g. no corrective actions were indicated for certain critical controls points, there was a lack of monitoring procedures and the relevant records were not always indicated). The feed mills visited had conducted homogeneity tests for their equipment. In the approved FBO visited, tests for cross-contamination were carried out in the frame of quality control. In the food business operator dispatching by-products to the feed sector visited, the scope of the HACCP plan includes the said feed. In the feed mills visited samples of feed ingredients and of each batch of products manufactured were taken and retained for appropriate periods Record-keeping and product recall 10

16 All FBOs visited had documentation in place for records of incoming feed ingredients and outgoing feed. The FBOs visited had recall instructions and complaints handling procedures in place. In the two feed mills visited the mission team saw examples of consumer complaints that caused recall of consignments of feed Official inspections Frequent official controls had been carried out in the FBOs visited and comprehensive inspection reports were available. However, the above mentioned deficiencies in the HACCP systems had not been noted during official controls. The CCA declared that food business operators delivering by-products for feed was under the responsibility of the regional feed inspectors and that they had to carry out inspections in such establishments in order to ensure that feed legislation was being complied with. The undertaking of this activity was confirmed in one of the regions visited. However, in another region visited, the inspectors met were not aware of this; as a consequence inspections in the food business operator were only carried out by food inspectors and not by anyone with knowledge of feed requirements. 5.6 IMPORTS AND EXPORTS The Veterinary Compliance Act from 2005, the Animal Feed Act from 2006 and an Order on official control of feed of non-animal origin in imports from third countries provide the legal basis for a system of import controls on feed. In addition, the Manual for the Control Plan provides instructions for inspection procedures for official control of imported feed. Different control procedures have been developed for imported consignments of feed of non-animal origin considered of risk (this applies to products or countries, or both, for which specific import conditions have been set) or not (this applies to the rest of consignments). Documentary and identity checks are done by Customs Authorities; in case of non-risk consignments OVs from VARS or inspectors from IRSAFF conduct physical checks in the importers' warehouses on the basis of the annual sampling plan; in case of certain non-risk consignments or risk consignments OVs conduct the physical, documentary and identity checks in the warehouses controlled by the Customs (points of entry) prior to the release. The Manual in the Control Plan provides a clear attribution of responsibilities for import controls of feed. During 2008 all importers including warehouses storing imported products had to be checked by VARS or IRSAFF according to the Control Plan. Sampling at importers and warehouses seemed comprehensive and well-distributed; 11

17 however, in one case the Control Plan determined the need for analyses on additives in a warehouse only storing soya beans and petfood, where the said analyses did not make sense. For 2008, the risks associated with the type of feed, as laid down in Art. 16 of Regulation (EC) No 882/2004, have not been considered for fixing the frequency of physical checks. The CCA presented a letter addressed to the VARS regional offices that, for 2007, provided some guidance on the said frequency of checks on the basis of these risks. According to the CCA, where feed whose placing in the market is not allowed in the EU is exported, they ascertain whether the placing in the market in the concerned third country is legal or not by means of requests for certification (that the feed has been produced in accordance with feed hygiene requirements) from the authorities therein. 5.7 OTHER REQUIREMENTS ALONG THE FEED CHAIN Phasing out of antibiotics According to the CCA, all the relevant FBOs had been informed in writing about the phasing out of antibiotics as feed additives before this ban entered into force on 1 January 2006; the FBOs were requested to ensure that all stocks of antibiotics were used before this date. The FBOs met during the mission were aware of the ban on use of antibiotics as feed additives. In a region visited, it was confirmed that in one FBO that had used antibiotics as feed additives, additional inspection visits have been carried out from VARS to confirm that all stocks of feed concerned were actually gone. With regards to the analysis of phased out antibiotics, the Control Plan for 2008 have taken into account Commission Recommendations 2005/187/EC and 2005/925/EC on the coordinated inspection programme in the field of animal nutrition. According to the CCA, none of the samples analysed for the presence of prohibited antibiotics has tested positive Rules on undesirable substances According to the information received from the CCA a national order from 2006 implements Directive 2002/32/EC of the European Parliament and of the Council; the Order has been adjusted according to changes to the said Directive. Analyses of undesirable substances mentioned in Commission Recommendations 2005/187/EC and 2005/925/EC are included in the Control Plan. In the regions visited, it was confirmed that these samples were taken as planned. Analyses for these substances were also part of the quality controls carried out by some FBOs. 12

18 5.7.3 Rules on prohibited materials Feed mills visited had measures (HACCP procedures and/or quality controls including visual examination of incoming ingredients) in place to detect the presence of prohibited substances as laid down in Commission Decision 2004/217/EC, such as packaging materials of solid urban waste. 5.8 ACTIONS TAKEN IN CASE OF NON-COMPLIANCE According to the CCA, the Veterinary Criteria Compliance Act (UL RS 93/05) and Animal Feed Act (UL RS 127/06) lay down the legal enforcement powers of VARS and IRSAFF inspectors. Both Acts establish the measures which may be imposed by inspectors, as well as penal provisions, in case of violations of feed safety standards (for instance, problems in labelling, traceability, or expiration date). According to IRSAFF, their inspectors had given six administrative fines to FBOs in 2007; all six fines (between to a legal entity and 400 to sole traders) were given in relation to violations of quality standards for feed. In the regions visited, there was a system in place at VARS offices that included written decisions of carrying out corrective measures within a certain time frame in case of violations of the feed hygiene requirements, for example in case of lack of traceability; this system included a requirement for a written declaration from the FBO that breaches had been corrected within the set time frame. 6 CONCLUSIONS 6.1 COMPETENT AUTHORITIES 1. The CAs responsible for official controls on feed and compliance with requirements for feed hygiene are clearly designated, and the coordination and communication between the CAs required by Art. 4 of Regulation (EC) No 882/2004 have improved significantly since the last mission and it is satisfactory. 2. Training had been given to enable the CA to carry out their tasks competently and in a consistent manner as required by Art. 6 of Regulation (EC) No 882/ The CA has procedures in place to verify the effectiveness of official controls and to ensure that corrective action is taken when needed as required by Art. 8 of Regulation (EC) No 882/ OFFICIAL CONTROLS ON FEED 13

19 1. A comprehensive control programme for feed is in place that is in accordance with the requirements laid down in Art. 3 of Regulation (EC) No 882/2004, since risks were taken into account when drafting and implementing the programme. 6.3 LABORATORIES CARRYING OUT OFFICIAL ANALYSES 1. The CCA has designated accredited laboratories to carry out the analysis of samples taken during official controls in line with Art. 12 of Regulation (EC) No 882/2004. The laboratory network is capable of exercising its responsibilities in relation to feed safety. 6.4 COMPLIANCE WITH REQUIREMENTS FOR FEED HYGIENE 1. Farms supplying feed products to other farms are exempted from the registration, but they are requested to comply with the requirements for feed hygiene, although in accordance with Art. 2 of Regulation (EC) 183/2005, the said legislation does not apply to them. Official controls are organised to ensure that these requirements are complied with. 2. Registration and approval of FBOs is complete, and lists of establishments have been published.. 3. Feed mills and intermediaries visited were all operating in compliance with the requirements of Regulation (EC) No 183/2005 as regards hygiene, traceability and recall systems in place. However, some deficiencies were seen in the implementation of quality controls and HACCP procedures; these had been overlooked during official inspections. Moreover, in one region, some of the registered food business operators supplying by-products to the feed industry are not subject to official controls specifically relating to feed hygiene 6.5 IMPORTS AND EXPORTS 1. The procedures in place concerning the imports of feed generally fulfil the requirements set down in Art. 24 of Regulation (EC) No 183/2005, and data are available on quantities of such imports, which would make it possible to implement a risk based control system on imported feed material. However, the risks that different types of feed presented were not always taken into account when deciding what types of feed to sample, which is not in line with Art. 16 (2) of Regulation (EC) No 882/

20 6.6 OTHER REQUIREMENTS ALONG THE FEED CHAIN 1. Compliance with the phasing out of antibiotics as feed additives, laid down by Art. 11 of Regulation (EC) No 1831/2003 was satisfactory. 2. Official controls to ensure that the maximum content of undesirable substances set out in Directive 2002/32/EEC is not exceeded in feed were satisfactory. 3. There was a largely satisfactory compliance with rules on materials whose circulation or use for animal nutrition purposes is prohibited, as laid down in Decision 2004/217/EC. 6.7 ACTIONS TAKEN IN CASE OF NON-COMPLIANCE 1. A system is in place to ensure that action is taken to remedy identified non-compliances and sanctions are used which can be effective and dissuasive. 6.8 OVERALL CONCLUSION Registration and approval of feed business operators (FBOs) is complete. Official controls in the feed sector and compliance with requirements for feed hygiene were largely satisfactory; however, the quality controls and HACCP procedures in place in FBOs and the official controls of these could, in some cases, be further developed. With regard to other requirements, the CA have taken largely satisfactory measures to ensure that the ban on using antibiotics as feed additives and the rules on undesirable and prohibited substances are respected. 7 CLOSING MEETING A closing meeting was held on 28 November 2008 with the representatives of the CCA. At this meeting, main findings and preliminary conclusions of the mission were presented by the inspection team. The CCA did not indicate any major disagreement with these. During the meeting, additional information requested by the mission team was provided by the CCA. 8 RECOMMENDATIONS The CAs of Slovenia are invited to provide details of the actions taken and planned, including deadline for their completion within 25 working days after receipt of the report. No. 1 Recommendation To reinforce official controls on food business operators that supply by-products to the feed industry, in order to verify compliance with the feed hygiene 15

21 No. 2 3 Recommendation requirements laid down in Regulation (EC) No 183/2005. To further develop the HACCP systems required by Article 6 of Regulation (EC) No 183/2005 and official controls on them. To ensure that the sampling of imported feed is carried out depending on the risks associated with different type of feed, as required by Art. 16 of Regulation (EC) No 882/2004. The competent authority's response to the recommendations can be found at: 16

22 ANNEX 1 - LIST OF LEGISLATION REFERENCED IN THE REPORT Reference OJ Ref. Detail Regulation (EC) No 882/2004 Regulation (EC) No 183/2005 Regulation (EC) No 1831/2003 Decision 98/139/EC Directive 2002/32/EC Decision 2004/217/EC OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 OJ L 35, , p OJ L 268, , p OJ L 38, , p OJ L 140, , p OJ L 67, , p Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition 98/139/EC: Commission Decision of 4 February 1998 laying down certain detailed rules concerning on-the-spot checks carried out in the veterinary field by Commission experts in the Member States Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement 2004/217/EC: Commission Decision of 1 March 2004 adopting a list of materials whose circulation or use for animal nutrition purposes is prohibited 17