EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

Transcription

1 Ref. Ares(2018) /02/2018 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 SWEDEN FROM 19 TO 28 SEPTEMBER 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 Sweden from 19 to 28 September 2017 as part of the European Commission s Directorate-General for Health and Food Safety's 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 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. The Swedish competent authorities have developed a largely comprehensive risk classification model for feed business operators covering the entire feed chain. With the exception of primary producers, the classification is clearly linked to inspection frequencies which are, in general, applied. Among other criteria, the participation of feed business operators in private quality assurance schemes is taken into account in determining the frequency of official controls on such establishments. The database for the registration of feed business operators other than primary producers contains useful and regularly updated data for their risk classification such as the amounts of feed produced by manufacturers. However, it does not include all operators' activities and thus official controls may not necessarily be targeted at those operators which would warrant inspection. This is in particular the case for feed importers. In the primary production sector operators are not selected according to the model for risk classification established by the Swedish Board of Agriculture because not all relevant risk criteria are considered. The Swedish Board of Agriculture has determined priorities for sampling based on a risk evaluation; these are established in guidance documents for its inspectors. Within a general sampling plan, the inspectors are free to choose the establishments, the types of feed and the analytes to sample for. As the Swedish authorities have defined Salmonella contamination as a very important risk in feed production, official samples are taken as environmental samples in the production of compound feed and from feed itself, including feed introduced into Sweden. However, due to procurement issues, the general sampling plan did not include analyses for heavy metals, dioxins and pesticides in the last two years; these substances are expected to be included in the 2018 sampling programme Whereas the training and technical knowledge of inspectors was in general found to be sufficient to ensure a risk-oriented approach during inspection and sampling, some weaknesses in feed inspector performance were identified by the mission team mainly in relation to the assessment of the adequacy of feed business operators' Hazard Analysis, Critical Control Points plans and the interpretation of the appropriateness of homogeneity tests carried out by the operators. I

3 Table of Contents 1 Introduction Legal Basis Objectives and Scope Background Findings Roles, responsibilities and training of competent authorities List of feed business operators and their activities General criteria for the planning of official feed controls Planning of inspections and audits Planning of the official sampling programme Procedures and guidance for official controls Procedures and guidance for the follow-up of non-compliances Review of the risk-based planning of official feed controls Implementation of official feed controls according to risk criteria Performance of inspections Implementation of the sampling programme Discussions with the competent authorities Overall Conclusions Closing Meeting...13 II

4 ABBREVIATIONS AND DEFINITIONS USED IN THIS REPORT Abbreviation CAB CCP DG SANTE DJUHR EU FANNY FeBO HACCP SBA SVA Explanation County Administrative Board Critical Control Point The European Commission's Directorate-General for Health and Food Safety A register maintained by the Swedish Board of Agriculture for Feed Business Operators, other than primary producers, with activities such as producing, importing or placing feedingstuffs on the market European Union A register maintained by the Swedish Board of Agriculture for primary producers, warehouses, shops, transporters and mixing services Feed Business Operator Hazard Analysis and Critical Control Points Swedish Board of Agriculture National Veterinary Institute III

5 1 INTRODUCTION The mission took place in Sweden from 19 to 28 September 2017 as part of the European Commission s Directorate General for Health and Food Safety (DG SANTE) 2017 work programme. The mission team comprised two auditors and a national expert from a European Union (EU) Member State and was accompanied throughout the mission by representatives of the central competent authority, the Swedish Board of Agriculture (SBA). An opening meeting with the competent authorities was held on 19 September 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 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 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 Central 2 Opening and closing meetings with the SBA Local 3 Meetings with inspectors from County Administrative Boards (CABs) and a Point of Entry/Border inspection post Compound feed producer 2 One approved for mixing coccidiostats Food business operator marketing by-products of non-animal origin as feed material (food mill) Bioethanol producer marketing by-products as feed material Producer of premixtures 1 Approved for mixing veterinary medicines Producer of feed additives 1 Farm with own-mixer 2 One approved for mixing coccidiostats 1 1 1

6 4 BACKGROUND 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, 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 by-products, 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. The organisation of official controls of feed business operators (FeBOs) is largely described in the Commission services' country profile for Sweden 2 valid as of November 2016, although with some minor changes. 2. In short, the SBA is the central competent authority with the overall responsibility for the official control of feed. The National Veterinary Institute (SVA) provides the risk assessment for the feed controls. 3. Within the SBA, the feed unit of the Animal Welfare and Health Department is responsible for establishing legislation on feed and the coordination of controls in the feed sector. The SBA's control department is responsible for the implementation of official controls, except on primary producers. Currently, there are four inspectors in the control unit of the control department, responsible for feed controls in feed establishments throughout the whole of Sweden. 1 Available at: 2 Available at: 2

7 4. The county administrative boards (CABs) are the competent authorities which plan and implement feed controls at primary producers, including farmers which use feed additives and veterinary medicines in feed. The CABs have a relatively autonomous and independent position and are not directly under the responsibility of the SBA. 5. The SBA's feed unit disseminates information including annually updated risk analysis in the feed sector to the control department and the CABs. CABs receive also other relevant information, e.g. on updates of feed legislation or of guidance documents, regularly by , at least twice per year. Regular meetings between the SBA and CABs take place. 6. CABs have established a network among themselves where they exchange information and meet monthly, to discuss questions mainly related to the implementation of official controls, also with a view to adopting a harmonised approach, and to plan future training. The SBA participates in some meetings. Of the two CABs visited, one is part of the network's subgroup which deals with food and feed safety in primary production. The other CAB stated that it receives regular information on the outcome of meetings and discussions on feed safety issues through the network. 7. The qualifications requirement for inspectors of control department and CABs is a relevant university degree, such as agricultural engineering, or, alternatively, the corresponding competences can be acquired through experience. The mission team was presented with a list that showed that staff from the SBA and also some inspectors of the CABs, have participated in Better Training for Safer Food courses on feed. SBA administrators provide annual training to inspectors of the control department and CABs. 8. A specific training course for control department inspectors on sampling, with a focus on the requirements of Commission Regulation (EC) No 152/2009, was provided in May 2017 by the SVA, including a practical exercise on sampling for salmonella and contaminants on distiller's dried grains with solubles. The last training by the SVA for CAB inspectors on sampling took place in 2015; the schedule for an upcoming training on primary production in 2017 includes sampling as well. No specific training on hazard analysis and critical control points (HACCP) has been provided for the CAB inspectors. 5.2 LIST OF 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 9. The general system of registration and approval of FeBOs is largely described in part 2.4 of the country profile for Sweden 2 valid as of November 2016, although with some minor changes. 3

8 10. FeBOs are responsible for registering their business and activities with the SBA. Information on the registration procedure is available on the SBA's website, including application forms for different kinds of FeBOs. Primary producers are also made aware of the requirement for registration in connection with the submission of applications for subsidies by the advisers hired by the farmers to help with the applications. 11. The SBA keeps two electronic registers: FANNY, a register for primary producers, warehouses, shops, transporters and mixing services, and DJUHR, a register for other FeBOs with activities such as producing, importing or placing feedingstuffs on the market. A database with registered and approved operators from both registers is available on the website of the SBA 3. Operators are obliged to notify the SBA of any change of activity carried out. The SBA updates the register regularly. 12. In 2015, there were 53,481 primary production FeBOs, 552 establishments which were producing, importing or placing on the market types of feed other than from primary production, 479 retail outlets and warehouses, 353 transporters and 10 operators providing mixing services. 13. The operators have to notify to the SBA all the different activities they are carrying out according to a pre-defined list. However, the SBA includes in the database DJUHR which is used as a source of information when planning official controls, only the activity which is considered as the most risky. Primary producers can be registered with more than one activity. 14. FeBOs in Sweden, other than primary producers, are required to register all feed products they place on the market, and to notify the SBA annually of the quantity of raw materials used in the production of compound feed to be placed on the market, as well as the quantity of feed materials, feed additives, premixes and compound feed produced, traded into Sweden, or placed on the market. These data are included in the DJUHR register which also contains additional information such as an approval for production of medicated feed and criteria for the risk classification of the operator. 5.3 GENERAL CRITERIA FOR THE PLANNING OF OFFICIAL FEED CONTROLS Legal requirements Articles 3, 8, 10, 15, 16, 54 and 55 of Regulation (EC) No 882/2004. Article 1 of, and Annex I to, Commission Regulation (EC) No 152/2009. Article 3 of, and Annex I to, Directive 2002/32/EC of the European Parliament and of the Council. Findings 3 Available at: 4

9 5.3.1 Planning of inspections and audits 15. National Regulation SJVFS 2007:21 on official controls on feedingstuffs and animal byproducts (hereafter referred to as the national regulation on official controls on feedingstuffs), which was last amended in 2014, lays down requirements for the determination of a control frequency for feed establishments other than primary producers. This determination is based on three criteria: a) The type of activity of the establishment. There are four main activities production, placing on the market, retail, and transport and storage - and a subdivision of these activities depending on the different types of feed produced or placed onto the market, e.g. feed additives, premixtures, compound feed; b) An 'experience' factor which reflects the experience from previous official feed controls as well as third party control performed by a certification body, or implementation of a national or European Community guide to good practice concerning feed safety; and, c) A volume factor which reflects the amounts of feed produced or placed onto the market. 16. This system, which is in place for feed and animal by-products establishments, provides 10 different risk classes linked to the FeBO's main activities. Within the feed sector, currently no establishments are grouped in the highest risk categories of 1 to 4. For instance, a producer of premixtures containing coccidiostats is classified into risk class 5. Where an establishment is carrying out several activities, it is classified according to the activity with the highest risk class. 17. The "experience" factor depends on the outcome of previous controls and considers mainly the compliance of the operator with the legal requirements, and in addressing identified non-compliances. Within this "experience" factor, the certification from a private assurance scheme and/or adherence to a national or EU guide of good practice might be taken into account by the inspector, who will upgrade the basic classification of the establishment by one or two steps, respectively. 18. There are seven different experience classes in a range from AAA to E, AAA being the best and E the worst classification. New establishments start with the basic classification "C". A guidance document on how to determine this "experience" factor, based on a weighting of individual non-compliances in the checklists, is available to inspectors. 19. The classification of the FeBOs is reviewed after each official control and can be revised upwards or downwards. Within the "experience" factor, the certification from a private assurance scheme and/or adherence to a national or EU guide of good practice might be taken into account by the inspector. This factor may upgrade the classification of the establishment by one or two steps, respectively, and thus reduce the control frequency. 5

10 20. The classification of a FeBO according to the main activity and the experience class (ex. "5 C") is linked to a frequency of official controls, e. g. for "5C" it means one official control every year. Frequencies may vary between one control every ten years as a minimum up to a maximum of six controls per year, although, in practice, not more than three official controls per year are carried out. 21. For the final determination of the number of official controls, this frequency has to be multiplied by the volume factor. The volume factor is determined according to the amounts and the type of feed produced and placed on the market. This factor may vary between 0,25 and 3. For instance, a manufacturer of premixtures containing coccidiostats which produces more than 40,000 tonnes per year would be subject to a volume factor "2". If this FeBO is classified as "5C", the standard frequency of one official control every year will be multiplied by two, resulting in a frequency of two official controls every year. Within the list of risk classified feed establishments in Sweden, there is currently one establishment with a calculated frequency of six official controls per year, and at the other end of the range, two establishments which have to undergo an official control every eight years. 22. The competent authorities stated that priority of controls is given to newly registered operators which have to be checked as soon as possible, at least within the first year after the registration. 23. Based on the risk categorisation of the FeBOs, every year on 31 October, a control plan is generated from the system DJUHR for the next year containing, among other information, the total number and the type of controls to be performed. The planning is based on the planned controls of the previous year. The register does not include the dates when the controls were actually carried out. (For consequences of this lack of information see finding 59). 24. The head of the control department, or, on a rotating basis, one of the four inspectors of the control department, then assigns the individual FeBOs selected for official controls to one of the inspectors of the control department, taking into account mainly the distance of the establishments to the place where the inspectors are located in the country. Each inspector then has to draw up his/her own programme to ensure that the controls in the assigned establishments are carried out during the year. 25. On average, around 200 official controls have to be carried out per year. Official controls can take the form of an inspection focused on the hygienic conditions of the establishment, of checking the operator's documentation, of carrying out sampling, but most frequently the official control is a combination of these. 26. On the basis of the annual control plan, inspectors send at the beginning of every year a notification to the operators other than primary producers and inform them on the fees they have to pay for the scheduled inspections and sampling. In Sweden, FeBOs other than primary producers have to pay for all types of official controls. 6

11 27. The national regulation on controls of feedingstuffs (see finding 15) also requires that feed establishments which are authorised to produce feed containing veterinary medicines have to undergo at least an annual official control. During the visit to a producer of premixtures containing veterinary medicines, the mission team noted that the database system does not consider this requirement but determined an inspection frequency of once every four years. This discrepancy had not been detected by the competent authorities and a manual correction had not been carried out. The last inspection had been carried out in The national regulation on controls of feedingstuffs stipulates that at least one per cent of primary producers of feed should be controlled every year on the basis of a risk analysis. The SBA has developed a risk classification model for primary production (feed and food chain) and also guidelines for the feed control of primary producers which are updated annually. 29. The risk classification model provides four risk categories of primary producers. Risk category 1 is the most risky. Producing own feed with self-grown cereals and the use of additives are considered as the main risks. 30. Each CAB draw up individual annual control plans by selecting primary producers located in their county from the FANNY register. However, FANNY does not provide the classification of primary producers according to the risk classification model. 31. The mission team noted that CABs do not prioritise inspections on the basis of risk criteria described in the guideline, as only certain criteria are used to select primary producers, such as animal species. In one CAB visited, for example, there were 13 operators approved for the mixing of veterinary medicines which is considered a very important factor according to the guideline. Out of ten primary producers due to be inspected, however, only one of those selected was a mixer of veterinary medicines Planning of the official sampling programme 32. The SBA provides to the inspectors an annual analysis of risks in feed, which constitutes support for the official controls of feed in general. This risk analysis is performed in close collaboration with the SVA, to which the National Food Agency and the CABs also provide input. It describes in detail the hazards which are linked to single substances and includes an assessment of the risks in different types of feed which should be taken into account for prioritising the sampling without determining the numbers. 33. The SBA decide the minimum numbers of annual samples which have to be paid for according to an agreement with the laboratory. The 2017 agreement covers analyses on aflatoxins (30), mycotoxins (45), ionophores (coccidiostats, 10) and processed animal protein (65). 34. The numbers of samples to be taken, the decision on which specific FeBO is chosen for official sampling, the type of feed to be sampled and the contaminant to be tested for is 7

12 left to the decision of the inspectors. Some sampling is planned before the beginning of the control year, other sampling is planned in connection to the inspections. The SBA stated they moved to this approach a few years ago in order to make the control planning more efficient. The inspectors had encountered difficulties in implementing a fixed sampling plan, as it was not always possible to take the planned samples in the establishments The agreement between the SBA and the SVA laboratory does not cover testing for dioxins, heavy metals and pesticides, for reason that the official laboratory of the SVA is not accredited to carry out these analyses. As a procurement procedure for these analyses could not be finalised since 2016, no such samples were taken by the inspectors in 2016 and 2017, nor was such sampling included in the sampling plan. The SBA stated that they are currently in the process of finalising the procurement procedure with an official laboratory in another Member State, and expect that relevant samples can be analysed from 2018 onwards. 36. In addition, samples may be taken in risk-based projects which are initiated by the SBA. These samples do not have to be paid by the FeBOs and are analysed by private accredited laboratories. Currently, there is a project running on dioxins in organic egg production which schedules ten samples in fishmeal and 17 samples in feed for laying hens. 37. No central planning of sampling is established for the primary production sector. CAB inspectors avail of guidelines issued by the SBA on official controls in primary production which they may use for determining the samples to be taken. Several CABs have participated in a recently finished programme on dioxins in direct drying of feed. 38. Official controls on imported feed of non-animal origin, not subject to a regulated increased level of control (e.g. by Commission Regulation (EC) No 669/2009), are not carried out at the point of entry, but during regular controls at the premises of feed importers or establishments using importing feed. Nevertheless, relevant controls on imported feed may not take place as the competent authorities might not be aware of all operators with import activities as FeBOs are registered in the database system only with the most risky activity (see finding 13). 39. Swedish national legislation provides for an own-control monitoring programme of sampling for Salmonella. Salmonella contamination is considered as a very important risk in feed production according to the SBA risk analysis. All producers of compound feed have to take at least two environmental samples for Salmonella per week and producers of compound feed for poultry at least five samples per week. The legislation gives details on the points where the samples have to be taken. Samples for Salmonella are also required for certain types of feed which is imported or introduced from other Member States. Official samples are taken with the objective of verifying the results of FeBOs' own checks, but also in order to cover other types of feed. In addition, there is a 8

13 national requirement for analyses of aflatoxin B1 in imported or intracommunity feed for dairy cows and certain feed materials which are also considered risky Procedures and guidance for official controls 40. The SBA has developed several guidance documents for the control department and CAB inspectors, including guidelines for a risk analysis for controls of FeBOs, and for the risk classification of primary producers. 41. Checklists are made available for inspectors by the SBA. There are two different types for operators other than primary producers and one for official controls of feed in the primary production sector. The checklists consist of questions related to the applicable legal requirements which require ticking one box out of several alternatives, and there is space for additional comments. The checklist for FeBOs contains a clearly defined section on the FeBOs' documentation and HACCP. 42. As regards sampling, the SBA provides instructions for the control department inspectors on relevant issues referred to in Commission Regulation (EC) No 152/2009. In addition, following ad-hoc advice given to inspectors who have to sample unusual types of feed, the SVA has compiled the requests from inspectors and its response. For sampling of contaminants in primary production, the CABs have established guidance documents for their own inspectors, which are generally in line with the requirements of Commission Regulation (EC) No 152/ Procedures and guidance for the follow-up of non-compliances 43. The national regulation on official controls on feedingstuffs stipulates that a report with the results of the controls has to be sent to the FeBO as soon as possible after the inspection. The guideline for the controls of FeBOs defines four types of noncompliances and provides details on its determination: a. Comments minor non-compliances; b. Remarks mainly in relation to the FeBOs' system of own checks; c. Non-compliances with legal requirements; and d. Serious non-compliances. 44. The FeBO's corrective action in response to minor non-compliances identified can be verified during the next scheduled inspection. For other shortcomings, FeBOs are requested to take action within a deadline determined by the inspector which is usually one month after receiving the report. Operators are asked to provide documented evidence to the competent authority in order to demonstrate that corrective measures have been taken. 45. The guideline also defines serious non-compliances which may entail a risk of widespread contamination, such as the absence of checks on handling coccidiostats; 9

14 such serious risks require immediate action by the FeBO. In such cases, a follow-up inspection shall be carried out at the latest within one month. The FeBO must pay an additional inspection fee. 46. An injunction may be imposed on the FeBO in cases of serious infringements, although this happens very rarely according to the competent authorities. 47. Non-compliances found during the inspection, and any delay in taking appropriate measures may lead to a change in the "experience" level (see also finding 19) and, consequently result in a higher frequency of inspections and thus higher fees for the operator Review of the risk-based planning of official feed controls Legal requirements Articles 4 and 8(3) of Regulation (EC) No 882/2004. Findings 48. During the planning process an annual meeting is scheduled with all authorities involved in official feed controls where the authorities share their experience of the previous control year and discuss issues for consideration in the upcoming control year. New control projects are discussed which aim at gathering data required for better risk assessment of risk-sensitive areas. Following this annual meeting, a dedicated follow-up meeting of all authorities involved in feed controls for the coming year takes place where the SBA's feed unit presents the updated draft risk analysis of feed for discussion. Changes in the guidelines for control for the inspectors related to amendments in the risk analysis are presented and discussed. The mission team followed several steps in the planning for The animal control unit at the SBA's department for joint systems and control is in the process of preparing audits to the CABs which should cover all areas of activities including feed. The preliminary audit programme schedules audits of all 21 CABs within five years. 5.4 IMPLEMENTATION OF OFFICIAL FEED 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, and 7 of, and Annexes I, II and III to, Regulation (EC) No 183/2005. Article 1 of, and Annex I to, Commission Regulation (EC) No 152/2009. Article 3 of, and Annex I to, Directive 2002/32/EC. Findings 10

15 5.4.1 Performance of inspections 50. In 2016, 39 out of 166 (23%) of the official controls on FeBOs with activities other than primary production, retail and transport could not be carried out. The main reason for this was the turn-over of the control department inspectors. In 2015, the number of inspections completed was 96% of the planned inspections. Inspectors put a focus on controls of retailers in 2015 with a high number of establishments checked (ca. 50%); in 2016, a smaller number of retailers was checked, closer to the frequencies determined according to the risk classification. Inspectors of CABs carried out 397 control visits of 416 planned on primary producers in 2016, and 654 of 637 planned in The inspectors of the control department and CABs met demonstrated good knowledge of the general requirements laid down in Regulation (EC) No 183/2005 and were, in general, familiar with the use of checklists provided by the SBA. 52. In some cases, the mission team noted that the inspectors found some of the technical areas to be challenging, for example, the assessment of FeBOs' homogeneity tests and the verification of calibration of weighing equipment used for the measurement of the quantity of coccidiostats added (identified as a critical control point in the FeBO s HACCP Plan). Furthermore, the mission team noted the following: a) in a farm manufacturing complete feed with coccidiostats, the measures put in place by the FeBO to control the carry-over of coccidiostats within the HACCP system had not been assessed by the inspector; and b) in a food establishment suppling by-products as feed materials to the feed chain, some weaknesses as regards the hazard analysis of the byproduct used as feed in the HACCP-plan had not been noted during official controls Implementation of the sampling programme 53. Samples at FeBO establishments other than primary producers were taken in general according to the instructions produced by the SVA, and in line with legal requirements according to Commission Regulation (EC) 152/2009. For substances where there is an agreement with the laboratory of the SVA on a minimum amount of samples that SBA need to pay for, the inspectors take at least the number of samples stated in the agreement (aflatoxins, other mycotoxins, processed animal protein, veterinary medicines and coccidiostats, as regards declared content and carry-over). The mission team noted that inspectors also take samples of imported feed materials from operators, when available, during routine official controls. For Salmonella, 408 official samples were taken as environmental and process samples, and 26 samples were taken for feed in Inspectors met during the visits showed a sufficient knowledge of the relevant requirements laid down in Annex I to Commission Regulation (EC) No 152/2009. However, it was noted that there were some cases of limited knowledge of distribution of analytes in the products to be sampled (some lack of awareness of the possibility of 11

16 non-uniform distribution of coccidiostats when testing for carry-over) and as regards the definition of the "sampled portion". 55. The mission team noted that inspectors followed the SBAs instructions that only in the case of feed constituents uniformly distributed throughout the feed, a divider may be used to reduce the amount of the aggregate sample. 56. In the primary production sector, no samples were taken during the planned official controls in 2015 and Only a few samples have been taken in the primary production sector to date, mainly in the framework of additional projects on feed issues which were initiated by the CABs. 57. The mission team noted that the inspectors use the possibility to contact the experts at SVA directly when they need advice on specific issues arising from sampling. However, during the farm visit, the mission team noted that an inspector at one CAB was not aware of how to sample a product stored in a silo which was not accessible from the top. 58. The SVA laboratory used for analysing the official feed samples is accredited according to EN ISO and includes the analytical methods within its scope of accreditation. 5.5 DISCUSSIONS WITH THE COMPETENT AUTHORITIES 59. The mission team highlighted in discussions with the SBA that the registration of only the riskiest activity of the FeBO in the DJUHR database might hamper the inspectors' overview of all the FeBOs' activities being carried out, in particular when planning the inspections and sampling. This is evident with regards to import activities which may not appear in the database if the importing establishment also carries out an activity as a feed manufacturer. The central competent authorities stated that they are in the process of amending the database and switching to a system where all activities are registered. 60. As regards the determination of which operators are to be inspected during the following year, the DJUHR database does not consider the specific requirement for FeBOs which are authorised for the mixing of veterinary medicines. It also does not show the dates of the inspections which have already been carried out. This hinders the inspectors' overview of the fulfilment of the inspection frequency and may have an adverse impact on the planning for the upcoming year. According to the competent authorities, they are aware of these issues and plan to make the necessary adjustments when the system is being upgraded. 61. The database for the registration of primary producers does not give full support to the inspectors either in identifying the risk classes of the operators as laid down in the guidelines on risk classification, or identifying suitable establishments, or in determining the control frequency. CAB inspectors have to draw up their control plans based on the principles described in the guideline, but the planning is in general not done following the risk-based criteria of the guideline (see finding 31). The SBA stated that they are 12

17 working on a revised version of the guidelines which would simplify the model for risk classification. 62. No samples had been taken for the detection of heavy metals, pesticides and dioxins as there was no procurement in place for these analytes. The competent authority has made significant efforts to finalise procurement with an official laboratory in another Member State in order to be able to include these types of analyses in the sampling programme from next year onwards. 6 OVERALL CONCLUSIONS The Swedish competent authorities have developed a largely comprehensive risk classification model for FeBOs covering the entire feed chain. With the exception of primary producers, the classification is clearly linked to inspection frequencies which are, in general, applied. Among other criteria, the participation of FeBOs in private quality assurance schemes is taken into account in determining the frequency of official controls on such establishments. The database for the registration of the FeBOs other than primary producers contains useful and regularly updated data for the risk classification such as the amounts of feed produced by manufacturers. However, it does not include all operators activities and thus official controls may not necessarily be targeted at those operators which would warrant inspection. This is in particular the case for feed importers. In the primary production sector operators are not selected according to the model for risk classification established by the SBA because not all relevant risk criteria are considered. The SBA has determined priorities for sampling based on a risk evaluation; these are established in guidance documents for its inspectors. Within a general sampling plan, the inspectors are free to choose the establishments, the types of feed and the analytes to sample for. As the SBA has defined Salmonella contamination as a very important risk in feed production, official samples are taken as environmental samples in the production of compound feed and from feed itself, including feed introduced into Sweden. However, due to procurement issues, the general sampling plan did not include analyses for heavy metals, dioxins and pesticides in the last two years; these substances are expected to be included in the 2018 sampling programme. Whereas the training and technical knowledge of inspectors was in general found to be sufficient to ensure a risk-oriented approach during inspection and sampling, some weaknesses in feed inspector performance were identified by the mission team mainly in relation to the assessment of the adequacy of FeBOs' HACCP plans and the interpretation of the appropriateness of homogeneity tests carried out by the operators. 13

18 7 CLOSING MEETING A closing meeting was held on 28 September 2017 with representatives of the central competent authorities. At this meeting, the main findings of the mission were presented by the mission team. The central competent authorities did not indicate any major disagreement with these. 14

19 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 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 Reg. 183/2005 OJ L 35, , p Reg. 396/2005 OJ L 70, , p Reg. 152/2009 OJ L 54, , p Reg. 669/2009 OJ L 194, , p Reg. 767/2009 OJ L 229, , p 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 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC Commission Regulation (EC) No 152/2009 of 27 January 2009 laying down the methods of sampling and analysis for the official control of feed 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 Regulation (EC) No 767/2009 of the European Parliament and of the Council of 13 July 2009 on the placing on the market and use of feed, amending European Parliament and Council Regulation (EC) No 1831/2003 and repealing Council Directive 79/373/EEC, Commission Directive 80/511/EEC, Council Directives 82/471/EEC, 83/228/EEC, 93/74/EEC, 93/113/EC and 96/25/EC and Commission Decision 2004/217/EC

20 Reg. 1306/2013 OJ L 347, , p Dir. 2002/32/EC OJ L 140, , p Regulation (EU) No 1306/2013 of the European Parliament and of the Council of 17 December 2013 on the financing, management and monitoring of the common agricultural policy and repealing Council Regulations (EEC) No 352/78, (EC) No 165/94, (EC) No 2799/98, (EC) No 814/2000, (EC) No 1290/2005 and (EC) No 485/2008 Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed - Council statement