EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2017) /10/2017 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) FINAL REPORT OF A FACT-FINDING MISSION CARRIED OUT IN ROMANIA FROM 9 TO 18 MAY 2017 IN ORDER TO GATHER INFORMATION CONCERNING RISK-BASED CONTROLS IN THE FEED SECTOR 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 a footnote.

2 Executive Summary This report describes the outcome of a fact-finding mission carried out in Romania from 9 to 18 May 2017 as part of the European Commission s Directorate-General for Health and Food Safety 2017 work programme. The mission is part of a series of fact-finding missions aimed at gathering information on good practices and difficulties faced by the competent authorities in implementing a risk-based approach according to the requirements laid down by Article 3 of Regulation (EC) No 882/2004 when planning and carrying out official controls in the feed sector. Overall the mission has found that the Romanian competent authorities' system of official controls on feed (covering inspections and sampling) is risk-based, utilising advice from experts, registration and approval data for feed business operators and is underpinned by training of official staff and the elaboration of comprehensive guidance documents and checklists for the conduct of controls. With regard to planning of such controls, the establishment of selection criteria and a risk-scoring mechanism by the central competent authority for the categorisation of feed business operators (albeit not covering all relevant types of operator), and the use of these elements in determining the frequency of official controls is a good example of how risk assessment can be integrated into official control activities. Nevertheless, in spite of these positive elements, in practice, variations in the application of riskbased principles by different county competent authority personnel, the above-mentioned gaps on the applicability of risk-scoring to certain types of feed business operators such as retailers, traders and transporters, and out-of-date information on registration and approval of feed business operators, represent opportunities for improvement. The competent authorities indicated that they would appreciate further EU guidance on issues such as the risk-ranking of certain feed materials, planning on sampling and they would welcome the opportunity to share their experiences with other Member States should a workshop to discuss the findings of this mission series be arranged. I

3 Table of Contents 1 Introduction Legal basis Objectives and scope of the mission Background and rationale for the mission series Findings Roles, responsibilities and training of competent authorities Feed business operators and their activities General criteria for the planning of official controls Planning of inspections and audits Planning of the official sampling programme Procedures and guidance for conduct of official controls Procedures and guidance for the follow-up of non-compliances Review of the risk-based planning of official controls Implementation of official controls according to risk criteria Performance of inspections Implementation of the sampling programme Discussions with the competent authorities Overall Summary Closing Meeting...10 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation BIP DG FBO FeBO Food by-products Former foodstuff HACCP PCBs Explanation Border Inspection Post Directorate-General Food business operator Feed business operator In this report these are to be considered as feed materials of plant origin produced in a food establishment as a result of a process primarily intended to produce food Foodstuffs, other than catering reflux, which were manufactured for human consumption in full compliance with the EU food law but which are no longer intended for human consumption for practical or logistical reasons or due to problems of manufacturing or packaging defects or other defects and which do not present any health risks when used as feed Hazard Analysis and Critical Control Points Polychlorinated biphenyls III

5 1 INTRODUCTION This mission took place in Romania from 9 to 18 May 2017 as part of the European Commission s Directorate General for Health and Food Safety 2017 work programme. The mission team comprised two auditors and a national expert. The mission team was accompanied throughout the mission by a representative of the central competent authority, the National Sanitary, Veterinary and Food Safety Authority (Autoritate Nationala Sanitara Veterinara Si Pentru Siguranta Alimentelor). An opening meeting with the central competent authority was held on 9 May 2017, during which the objectives, itinerary and the reporting procedures for the mission were confirmed. 2 LEGAL BASIS The mission was carried out under the general provisions of European Union (EU) legislation and, in particular, Article 45 of Regulation (EC) No 882/2004 of the European Parliament and of the Council. Full legal references are provided in the Annex. Legal acts quoted in this report refer, where applicable, to the last amended version. 3 OBJECTIVES AND SCOPE OF THE MISSION The mission is part of a series of fact-finding missions aimed at gathering information on good practices and difficulties faced by the competent authorities in implementing a riskbased approach according to the requirements laid down by Article 3 of Regulation (EC) No 882/2004 when planning and carrying out official controls in the feed sector. In terms of scope the mission included official controls on feed safety requirements throughout the feed chain (primary producers included) and imported feed of non-animal origin, excluding the part concerning requirements laid down by Commission Regulation (EC) No 669/2009. The itinerary of the mission included the following visits: Visit/meetings No Comments Competent authority Food business operators dispatching food by-products Central 2 Opening and closing meetings County 4 Meetings with three County Sanitary, Veterinary and Food Safety Directorates and one Border Inspection Post 2 One brewery dispatching by-products from the malting process, the other dispatching by-products from potato processing Manufacturers of compound feed 3 Two of the three using coccidiostats Farm mixing feed additives 1 Manufacturers of premixtures 2 Both using coccidiostats 1

6 4 BACKGROUND AND RATIONALE FOR THE MISSION SERIES As highlighted in the Overview Report DG(SANTE) issued following the last series of audits in the feed sector carried out between 2012 and 2014 see in a general context of resource constraints, the risk prioritisation of official controls at that time was weak or at an early stage of development in many Member States. In some cases competent authorities faced difficulties in taking into account the reliability of operators' own checks, and in other cases risks such as those linked to the use of former foodstuffs/food byproducts, mineral feed/feed additives were not adequately taken into account by the competent authorities. However, some Member States had succeeded in putting in place mechanisms to prioritise official controls and such mechanisms could be useful for other Member States. In this context, the current fact-finding series of missions aims at updating the Directorate's knowledge on the risk-based approach implemented by competent authorities for the organisation of official feed controls. Data gathered will be analysed to identify, at EU level, the remaining difficulties faced by the authorities in applying risk-based principles and any examples of good practice or mechanisms which, if adopted by more Member States, may improve the risk-basis for feed controls. 5 FINDINGS 5.1 ROLES, RESPONSIBILITIES AND TRAINING OF COMPETENT AUTHORITIES Legal requirements Articles 4, 5 and 6 of Regulation (EC) No 882/2004 Findings 1. In accordance with the Rules of Organization and Functioning of the National Sanitary, Veterinary and Food Safety Authority, the Animal Nutrition Service of the Veterinary Medicinal Products and Animal Nutrition Directorate is responsible for the annual preparation of the Numerical Plan for Feed Control (the official sampling plan), and the responsibility for coordination of the risk-based official controls lies with the Medicinal Products, Nutrition and Laboratories Control Service. In addition, the Institute for Hygiene and Veterinary Public Health is involved in the preparation of the sampling plan as a scientific advisory body. There are two independent bodies (Scientific Council and Advisory Council) which may be consulted to give advice on the plan or for opinion on other issues relating to the tasks of the central competent authority, including feed issues. 2. Forty-two County Sanitary, Veterinary and Food Safety Directorates (Directia Sanitara Veterinara Si Pentru Siguranta) (county competent authority) are responsible for the implementation of the official inspection and for the sampling plan, including individual risk assessment of the different feed business operators (FeBOs), see section

7 3. The central competent authority has organised targeted training for at least one representative of each county competent authority on the planning and implementation of official controls, including sampling in the feed sector. The last training was organised in October Officials participating in the training went on to deliver the training to their own colleagues in each county competent authority. 4. In two of the three counties visited, there was evidence that the inspectors who are responsible for the control and risk assessment of FeBOs had participated in several training courses in the feed sector. In the remaining county, inspectors responsible for the risk assessment of the FeBOs had not received the training referred to in finding 3 and lacked sufficient knowledge (see finding 32) to evaluate the hazard analysis and critical control points (HACCP) systems of FeBOs, which is an essential part of the individual risk assessment for feed producing establishments (see finding 10). 5.2 FEED BUSINESS OPERATORS AND THEIR ACTIVITIES Legal requirements Articles 9 to 19 of Regulation (EC) No 183/2005 of the European Parliament and of the Council Findings 5. Listing of the approved and registered FeBOs is the task of the county competent authorities. The lists are updated quarterly or when necessary (for example, following changes relating to approved establishments). The updated lists are to be sent to the central competent authority. Service note No issued on 27/01/2017 gives instructions to the county competent authorities about the type of cases (modification, suspension etc) necessitating modification of the lists and the mechanisms to inform to the central competent authority about such changes. The central competent authority is responsible for updating the list of approved FeBOs on the internet. 6. The lists of the approved and registered FeBOs were available in the three counties visited. These lists contained detailed information about the companies including name, address approval/registration number and activities carried out. 7. The type of activities actually carried out by the FeBOs is an aspect checked during routine inspections and relevant information is used to assess the risk-score of feed producers. Nevertheless, the mission team noted a number of inconsistencies between the operational activities mentioned in the approval documentation of different FeBOs and the real operational activities carried out by these businesses. This concerned, in particular, feed retailers being approved for the sale of feed additives and premixes when, in practice, these products were not sold. 8. The mission team also noted some discrepancies in the lists available at the central and county levels, notably concerning certain feed retailers who had communicated their intention to cease their activity to the relevant county competent authority but were still 3

8 included in the national lists. In this regard, the mission team noted that the county competent authority is not obliged to communicate the decision of a FeBO to cease or to suspend its activities to the central competent authority. This may have an impact during the planning stage of the sampling programme due to the fact that the allocation of samples to counties takes account of the number and types of FeBOs present on the lists kept at central level 1 (see finding 38). 9. The central competent authority had already identified that the registration/approval procedure was carried out differently in the different counties and had issued a President order (No 44/2017) on 11/05/2017 intended to give a more detailed explanation about the procedure in order to harmonise the approach throughout the country 5.3 GENERAL CRITERIA FOR THE PLANNING OF OFFICIAL CONTROLS Legal requirements Articles 3, 8, 10, 15, 16, 54 and 55 of Regulation (EC) No 882/2004 Article 1 and Annex I of Commission Regulation (EC) No 152/2009 Article 3 and Annex I of Directive 2002/32/EC of the European Parliament and of the Council Findings Planning of inspections and audits 10. Guidance document (PS-08-DPMVNA, prepared in 2014) contains very detailed procedures about the risk assessment of feed producers (registered and approved feed manufacturers and primary producers mixing feed for their own holdings). Based on this guidance document the county competent authority is responsible for the individual risk assessment of the various feed producers. In the risk assessment, different sources of risks are evaluated such as the characteristics of the establishment (construction, renovation, maintenance of facilities and equipment, hygiene conditions), the type of establishment, the market share of the establishment, the origin of raw materials used and the type of feed produced. An additional element of the risk assessment is the evaluation of the HACCP plan, and the "ability and willingness of the workers and the management to solve potential feed safety problems" (as worded in the guidance document). The assessment also covers the results of the previous inspections and non- 1 In response to the draft report the central competent authority stated that at the time of the visit, the rules for the cessation of activity were provided for in National Sanitary Veterinary and Food Safety Authority (NSVFSA) President Order no. 109/2010; this has since been repealed by NSVFSA President Order no. 44/2017 and Service Note no of 27 January Cessation of activity is notified by the operator to the County Sanitary Veterinary and Food Safety Directorates (CSVFSA) which, in turn, notifies NSVFSA. As regards temporary suspension of the activity at the request of the operator, this was not regulated by the sanitary veterinary legislation, but NSVFSA has developed a draft President Order in this respect, which is currently under consultation. Regarding the allocation of samples, the competent authority stated that for the elaboration of the official control sampling programme, they take into account establishments reported annually by the CSVFSDs using a special template and not the list published on the website. 4

9 compliances. A special score and a weighting factor are allocated for each risk source. To get the final result of the risk assessment, the official has to add each of the individual weighted points. 11. Based on this guidance document there are three risk categories (high >= 43 points; average points and low <=30 points), and the corresponding inspection frequency relating to the different risks is per year. 12. The above-mentioned guidance does not apply to FeBOs which are not producing feedingstuffs (traders, retailers, transporters). For such FeBOs there are no fixed frequencies of inspection established. Nevertheless, a general instruction for official inspections, applicable also to these FeBOs, requires the county competent authorities to inspect all FeBOs taking into account the following priority criteria: new businesses, previous non-compliances, positive laboratory samples, type and volume of turnover and the import/export activity of the business Planning of the official sampling programme 13. The national sampling plan allocates to the different counties the number of feed samples to be taken. The plan contains the number of samples to be taken from a group of matrices in a particular type of establishment and also the type of analyses to be performed, for example, testing for mycotoxins in cereals from samples taken in a compound feed producing establishment. The types of establishment from which the samples have to be taken are established by a group of experts from the central competent authority and from the Institute for Hygiene and Veterinary Public Health. 14. The plan includes analyses for a wide range of undesirable substances and prohibited materials such as dioxins, polychlorinated biphenyls (PCBs), mycotoxins, heavy metals, coccidiostats, harmful botanical impurities, processed animal proteins, melamine, copper, zinc, nitrites and pathogenic microorganisms. Though the range of analytes tested for is wide, some substances for which maximum limits have been established in EU legislation (for example vitamin A in compound feed for fattening pigs) are not included. In spite of this local inspectors can act upon suspicion and take additional samples for such substances, provided that there is analytical capacity and capability in the testing laboratory. 15. The number of samples allocated to each county is based on both the number of establishments included in the national lists of FeBOs and the number of non-compliant results in the county in the previous year. 16. A general requirement is, if possible, to take at least one sample from each FeBO in the county at least once per year. 17. There is a separate sampling plan for the Border Inspection Posts (BIPs). This sampling plan is prepared by the Trade, Import, Export, and Border Inspection Posts Directorate of the central competent authority. The plan was implemented for the first time in 2016 (pilot) and will be reviewed in

10 18. The number of feed samples to be taken at the BIPs is based on the number of feed consignments, the type of feed and the number of previous non-compliances. In 2017, the target number for sampling was around 2-3% of the number of imported feed consignments in The sampling plan for BIPs provides instructions on the matrices to be sampled and the analyses to be carried out and is, in general, comprehensive, although the mission team noted that some potentially risky analyte-matrix combinations were not included in the plan. For example, analyses to detect the presence of PCBs in vegetable oil (one of the five main imported feed materials in Romania) were not included in either the 2016 or 2017 plans. The Animal Nutrition Service was not involved in the preparation of these plans but will be for the 2018 plan Procedures and guidance for conduct of official controls 20. The central competent authority has developed a checklist for the inspection of establishments producing feed additives, premixes, compound feed and medicated feed and a checklist for primary producers using own-mixers and mobile mixers. These checklists were updated in February The mission team noted that there were no checklists available for inspections of food producer establishments providing byproducts to the feed chain. 21. A guidance document including information about HACCP, carry-over of coccidiostats, homogeneity of mixing and other practical feed-related issues has been developed by a feed business association in cooperation with the central competent authority. This guidance was updated in 2009 and was available in all of the county competent authorities visited. 22. A general instruction on sampling is included in the official sampling plan described in finding 13. It contains a list of criteria to be taken into account when the county inspector decides on the matrix and the place (establishment, retail, farm etc.) of the sampling. These criteria are: new businesses, previous non-compliances, positive laboratory samples including results from own controls, production capacity of the establishment, export/import activity of the FeBO, the type of raw materials (additives, medicated, processed animal protein, coccidiostats) used for production, the type of feed produced and the number of species for which the feed was produced Procedures and guidance for the follow-up of non-compliances 23. The county competent authorities visited implement follow-up inspections differently as there are no centrally-provided instructions for follow-up of non-compliances in the feed sector. 24. One county competent authority stated that they have to carry out the follow-up inspection within 30 days of the initial inspection whereas another county competent authority stated that they did not establish a deadline, because the timing of the followup inspection depends on the seriousness of the non-compliance and on the proposed 6

11 corrective action. Both county competent authorities stated that during the follow-up inspections the inspector focuses mainly on the correction of the non-compliances. 25. The number of follow-up inspections in the country was 645 and 602 in 2015 and 2016, respectively Review of the risk-based planning of official controls Legal requirements Articles 4 and 8(3) of Regulation (EC) No 882/2004 Findings 26. County competent authorities have to send quarterly reports to the central competent authority with the number of implemented official controls. The central competent authority stated it evaluates the reports and organises regular meetings with the county competent authorities. During a recent meeting the reasons of the difference between the number of official controls planned vs. implemented concerning in particular traders, retailers and transporters (see finding 29) was discussed, although the root cause of the discrepancy has not yet been identified. 27. The central competent authority can modify the annual sampling plan after assessing the previous year's plan. As an example, in the past, a relatively high number of samples were planned for nitrites in cereals. Testing did not reveal any levels higher than the maximum limit allowed in EU legislation and as a consequence, in the last couple of years, the central competent authority has reduced the number of nitrite samples in cereals as the risk of violations is low. 28. The Audit Directorate of the central competent authority is planning to carry out an audit in the feed sector in the remaining half of A review of the risk-criteria used to target FeBOs for official controls will be included in this audit. 5.4 IMPLEMENTATION OF OFFICIAL CONTROLS ACCORDING TO RISK CRITERIA Legal requirements Articles 3, 8, 9, 10, 11, 15 and 16 of Regulation (EC) No 882/2004 Articles 5, 6, 7 and Annexes I, II and III of Regulation (EC) No 183/2005 Article 1 and Annex I of Commission Regulation (EC) No 152/2009 Article 3 and Annex I of Directive 2002/32/EC Findings Performance of inspections 29. In 2015, the planned number of official inspections of all FeBOs was 3130, of which 1598 (51%) were carried out. In 2016, 3467 were planned and 1973 (57%) were carried 7

12 out. In some counties the proportion of official inspections implemented ranged from 5% to and 20% of those planned in both years. The mission team observed that the biggest discrepancies in the number of planned vs. implemented inspections concerned traders, retailers and transporters whereas for feed producers, the average implementation rate was around 80-90%. 30. In the counties visited, the mission team noted that competent authorities had carried out the risk assessment of feed producers using the risk-criteria described in the guidance document established at central level (see finding 10) and had allocated the FeBOs in the relevant class of inspection frequency. 31. The evaluation of the HACCP plan and the ability of the FeBO's workers and the management to identify and solve potential feed safety problems form part of the competent authority's risk assessment (see finding 10) of feed producers. Notwithstanding the logic of this rationale, in several cases the mission team identified weaknesses in the risk assessment performed. 32. For example, one large capacity compound feed producer visited had obtained the highest risk assessment score for its HACCP plan and for the ability of its workers. However, the HACCP plan did not include a description and hazard analyses of the use of coccidiostats (this establishment produced compound feed with coccidiostats). A second large capacity establishment using coccidiostats had obtained the highest score for its HACCP plan even though the flushing procedure after the use of coccidiostats was not described in the plan or in other instructions. 33. In two of the counties visited, the mission team identified miscalculations in the risk assessments of FeBOs (when adding the individual weighted point to get the final score), resulting in a higher or lower inspection frequency for the assessed feed producers. In one county visited, the risk assessment of FeBOs did not follow the requirements of the centrally-issued guidance document. Risk assessments were only carried out on approved producers (not on registered ones) and the scores given to the use of raw materials from different sources (national, EU and non-eu origin), differed from those provided in the guidance document. 34. In the counties visited, traders, retailers and transporters were inspected with frequencies ranging from once every three years to once every eight years. In some cases the FeBOs were selected for inspection randomly, not using the established priority criteria described in finding The two food establishments visited which provided by-products to the feed chain were registered as FeBOs and their own control systems contained information about the products intended to go to the feed chain. The official inspections of these establishments were carried out by officials who are responsible for the control of FeBOs. In one of the establishments, the HACCP plan contained information about such feed production and general hazard analyses were described. The hazard analysis was incomplete however as risks during the storage of the by-products were not 8

13 assessed. Furthermore the actual storage conditions were very poor and the stored byproducts were contaminated by rain water and signs of bird droppings. The most recent official inspection had identified the problem from a structural point of view (the storage place should be protected), however no amendments of the HACCP plan were requested by the inspector Implementation of the sampling programme 36. In 2015, 9486 feed safety samples were planned and 8166 samples were taken (86%). In 2016, samples were planned and 9309 were taken (90%). In both years the number of non-compliant results was 11, which is 0.1% of the total samples. 37. In two of the three counties visited, more than 90% of the samples were taken according to the sampling plan in 2015 and However, in the third, only 21% of the sampling plan was implemented in 2015 and 33% in The county inspector stated that he could not meet the objectives of the plan as he was the only official in the county responsible for sampling and inspections of all FeBOs and he also had other official control tasks to carry out. 38. In one county visited 14 samples were wrongly allocated by the central competent authority to a county in 2016 due to the presence of a feed warehouse in the list kept at central level who had ceased his activities in County officers followed the general instruction of the central competent authority when deciding the matrices and the type of FeBOs (see findings 13 and 19) from which the samples were taken. 40. In cases where a part of the batch to be sampled was not accessible, the sampling protocol did not require, nor did the inspectors provide, information about the sampled portion. The calculation of the number of incremental samples was based on the size of the whole batch, although part of the batch was inaccessible. In one case it was seen that samples were taken from the accessible part of the batch (the sampled portion) which was only half the size of the total batch and the information was not recorded in the sampling protocol. The procedure was similar at the BIP visited. 5.5 DISCUSSIONS WITH THE COMPETENT AUTHORITIES 41. The representatives of the central competent authority and the county competent authorities did not highlight any difficulties they had in relation to the interpretation and implementation of the EU requirements on risk-based official controls. They mentioned that an EU guidance document on planning official controls would be appreciated and, in particular the planning of official sampling in the feed sector. The central competent 2 In response to the draft report the central competent authority stated that the error was due to the CSVFSD that reported (wrongly) an establishment whose authorization had been repealed. So, based on this erroneous report, a number of samples which were allocated could not be taken. 9

14 authority also remarked that the organisation of annual training for county inspectors is very resource-intensive. 42. The central competent authority suggested establishing a European database on different feed materials, and feed additives, allocating a risk category to these products based on the knowledge of the different Member States. 43. The central competent authority would like to participate in workshops/training where they can share their knowledge with officials from other Member States. They also highlighted, that those Member States should be invited to these trainings/workshop which have a similar official control system in the feed sector; for example a regional workshop with neighbouring countries. 6 OVERALL SUMMARY The Romanian competent authorities' system of official controls on feed (covering inspections and sampling) is risk-based, utilising advice from experts, registration and approval data for feed business operators and is underpinned by training of official staff and the elaboration of comprehensive guidance documents and checklists for the conduct of controls. With regard to planning of such controls, the establishment of selection criteria and a riskscoring mechanism by the central competent authority for the categorisation of feed business operators (albeit not covering all relevant types of operator), and the use of these elements in determining the frequency of official controls is a good example of how risk assessment can be integrated into official control activities. Nevertheless, in spite of these positive elements, in practice, variations in the application of risk-based principles by different county competent authority personnel, the above-mentioned gaps on the applicability of risk-scoring to certain types of feed business operators such as retailers, traders and transporters, and out-of-date information on registration and approval of feed business operators, represent opportunities for improvement. The competent authorities indicated that they would appreciate further EU guidance on issues such as the risk-ranking of certain feed materials, planning on sampling and they would welcome the opportunity to share their experiences with other Member States should a workshop to discuss the findings of this mission series be arranged. 7 CLOSING MEETING A closing meeting was held on 18 May 2017 with the representatives of the central competent authority. At this meeting, the main findings of the mission were presented by the mission team. The central competent authority did not indicate any major disagreement with these. 10

15 The competent authority's response to the recommendations can be found at: 11

16 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 183/2005 OJ L 35, , p Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene Reg. 152/2009 OJ L 54, , p Dir. 2002/32/EC OJ L 140, , p Reg. 669/2009 OJ L 194, , p Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement Commission Regulation (EC) No 669/2009 of 24 July 2009 implementing Regulation (EC) No 882/2004 of the European Parliament and of the Council as regards the increased level of official controls on imports of certain feed and food of non-animal origin and amending Decision 2006/504/EC