EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY

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1 Ref. Ares(2016) /05/2016 EUROPEAN COMMISSION DIRECTORATE-GENERAL FOR HEALTH AND FOOD SAFETY Health and food audits and analysis DG(SANTE) MR FINAL REPORT OF AN AUDIT CARRIED OUT IN BELGIUM FROM 26 OCTOBER 2015 TO 30 OCTOBER 2015 IN ORDER TO SHARE EXPERIENCES ON THE COOPERATION BETWEEN PRIVATE CERTIFICATION SCHEMES AND OFFICIAL 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 The study visit took place in Belgium from 26 to 30 October 2015 and is the second such visit in this series to different Member States. The objectives of this study visit were to gauge the degree of cooperation between private certification schemes and the system of official controls in the feed sector and to identify the potential advantages and drawbacks that such cooperation could offer and to share and promote any good practices identified. Over the last decade, a proactive approach taken by the feed industry and competent authority to work together to increase confidence in the safety of Belgian feed has led to the formation of a Feed Chain Alliance and widely adopted Self-Check Guides which set out the requirements for all key activities in the feed chain. As these guides, Shared Testing Schemes and the certification bodies involved are subject to validation, approval and ongoing scrutiny by the competent authorities, and are mostly accredited in accordance with relevant ISO standards, this has helped build confidence in their performance and integrity and has enabled the operators with a high level of compliance to benefit from a significant reduction in the number of official inspections and samples and in the fees payable for these activities. As such, feed business operators have a clear incentive to participate in the private certification schemes. In addition to the willingness of the feed industry and competent authorities to work closely together and to share relevant information, the National Experts identified a number of other key features which have underpinned the relatively advanced level of interactions between these bodies. These good practices include the (i) incorporation of relevant EU and national legal requirements in the Self Check Guides, (ii) measures to ensure certification bodies carry out their tasks to a high standard and (iii) possibility to take action if deficiencies are found in this respect. It was noted that savings in resources within the competent authority was not one of the main drivers or objectives of developing interactions with the feed industry. All participants in this study visit appreciated the opportunity to share experience and knowledge with colleagues from other Member States and with the representatives of Directorate-General Health and Food Safety. There was broad agreement on the potential advantages and drawbacks described in this report and the opportunities for increasing the interactions between the private certification schemes and the competent authorities. I

3 TABLE OF CONTENTS 1 INTRODUCTION PROJECT RATIONALE OBJECTIVES AND SCOPE LEGAL BASIS AREA STUDIED Certification in the feed industry Certification Schemes The role of the Certification Bodies Accreditation Interaction between official controls/private certification schemes Official Controls Influence of private certification schemes on the system of official controls Shared Testing Scheme Exchanges between national experts OVERALL CONCLUSIONS...9 II

4 ABBREVIATIONS & DEFINITIONS USED IN THIS REPORT Abbreviation BELAC FASFC FCA GMP HACCP OVOCOM SCG STS Explanation Belgian accreditation body Federal Agency for the Safety of the Food Chain Feed Chain Alliance Good Manufacturing Practice Hazard Analysis Critical Control Points Belgian consultation platform for the feed sector Self-Check Guide Shared Testing Scheme III

5 1 INTRODUCTION The study visit took place in Belgium from 26 to 30 October 2015 and is the second such visit in this series to Member States. The study team comprised a team of three auditors from the Directorate-General Health and Food Safety, and five national experts from competent authorities in France, Lithuania, the Republic of Ireland and Slovenia. The study group was accompanied throughout the visit by representatives of the central competent authority: the Federal Agency for the Safety of the Food Chain (FASFC). 2 PROJECT RATIONALE Private standards for certification of quality schemes are becoming widely adopted in the feed (and food) sector to satisfy market and consumer demands for additional assurances on the quality and the safety of the products. These schemes normally require operators to put in place their own sampling plans and also include checks that certain relevant legal requirements are fulfilled. As such, these schemes have the potential to complement or support elements of the system of official controls carried out by competent authorities in the feed sector, although the extent to which Member States have explored or exploited this potential varies considerably. A group of Member States which are known to be relatively advanced in this area have been selected to be involved in a series of study visits during which it is intended to gain a better understanding of the advantages and drawbacks in developing a closer cooperation between the system of official controls and private certification schemes in the feed sector. The involvement of national experts from other Member States in these visits is intended to facilitate an exchange of experience and mutual learning. The outcome of this series of study visits will be summarised in an overview report. 3 OBJECTIVES AND SCOPE The objectives of this study visit were to: Gauge the degree of cooperation between private standards in the feed sector (including transport) and official controls across different Member States; Identify the potential challenges, advantages and drawbacks to such cooperation; Share and promote good practices in this area. In terms of scope the study visit focused on: The current state of interactions (including communication and/or cooperation) between the competent authorities and the owners of private certification schemes (Guidelines on Good Hygiene Practices (GGHP), national and international private standards); The influence, if any, that the private certification schemes may have on the planning and performance of official controls; Any opportunities and challenges that have been identified by the competent authority in developing greater cooperation and interaction with private certification schemes; An exchange of views on this topic based on the experiences and knowledge of the national experts and the approach taken in Belgium. 1

6 In pursuit of these objectives, the following meetings and visits took place: Competent authority Visits / Meetings Central Regional/ Local Certification 1 Certification body Comments Opening and closing (de-briefing) meetings with the national competent authorities 1 Meetings with the Provincial Control Unit of West-Vlaanderen Scheme owners 3 OVOCOM, SYNAGRA and VEGAPLAN Sectorial Associations 3 BEMEFA, SYNAGRA and ARMB Road hauliers 1 Feed Producer (premixtures and compound feed) Accreditation 1 Belgian Accreditation (BELAC) 4 LEGAL BASIS The study visit was carried out in agreement with the competent authorities. 5 AREA STUDIED 5.1 Certification in the feed industry Certification Schemes SELF-CHECK GUIDES 1. In response to Regulations (EC) No 178/2002 and (EC) No 852/2004 the development, dissemination and use of national Guides to Good Practice has been encouraged by the Belgian competent authorities. The Royal Decree of 14 November 2003 sets out requirements related to implementation of own-checks based on Hazard Analysis Critical Control Point (HACCP) principles, the systems to ensure traceability of products and an obligation to notify the competent authority if a hazardous product is put in circulation. This has led to the drawing up of several Self-Check Guides (SCG) by representative associations at different steps in the feed and food chain. 2. The SCG need to be validated by the scientific committee of the FASFC before it approves them. The SCG clarify the legal requirements and good manufacturing/hygienic practices applicable to specific sectors and processes. They include a model HACCP plan and the minimum requirements concerning certification activities such as the qualification of auditors and duration of audits. The SCG may be used on a voluntary basis by feed business operators. 3. The SCG for animal feed G-001 was the first to be introduced for validation by FASFC in 2005 and since then, a total of 42 SCG were submitted out of which 37 covering specific activities all along the feed and food chain were approved by FASFC. 2

7 FEED BUSINESS OPERATORS 4. After several crises involving feed in the 1990s, the feed sector proactively developed a code of Good Manufacturing Practice (GMP) managed via a common platform called OVOCOM, which serves to bring together the main actors in the feed chain (namely the compound feed industry, traders, transporters and the food industry) and facilitate associations with other stakeholders up- and down-stream in the feed chain such as farmer and consumer organisations, retailers and the competent authorities. 5. The first Belgian GMP code was published in 2001 and included: Good management and manufacturing practices; Legal and extra-legal requirements for all categories of activities in the feed chain (except primary production); Regulations for certification and the requirements for the certification bodies. The Belgian GMP code was renamed Feed Chain Alliance (FCA) in In 2015, 95 % of the establishments active in the feed chain in Belgium were FCAcertified (or equivalent system). Internationally, the FCA has equivalence protocols with other private schemes like Qualität und Sicherheit (Germany), GMP+ (The Netherlands), CSA/GTP (French traders), FAMI-QS, Qualimat Transport (French carriers). 7. In order to reduce the costs and administrative burden of certification, the SCG for feed was integrated into a specific module of the FCA to enable audits and certification to be combined: Module A: Legal (Belgian and European) requirements for key activities (production, trade/import, storage/handling and transport). This module is equivalent to the validated SCG for feed; Module B: Additional sectorial requirements and/or requirements for specific activities (for example inland waterway transport, use of processed animal protein); Module C: FCA certification rules and use of the logo (annual announced audits, with an additional unannounced audit for production sites in a three year certification cycle). 8. An integrity preservation program put in place by OVOCOM also requires that the certification bodies : Gain an accreditation for the FCA certification and if possible also for the SCG G-001; Only use auditors who have undergone initial and continuous training and demonstrated their competence in regular examinations on feed legislation, HACCP principles in feed, knowledge of sectorial processes and techniques and the requirements of the FCA standard; Participate in regular harmonisation meetings and undertake to ensure their organisation is kept up-to-date. OVOCOM has also defined a sanction procedure and assesses the performance of the certification bodies by regular audits of the organisation and participating in witness audits. 3

8 TRADERS 9. Thanks to its vertical approach, all of the general activities carried out by traders of feed can be certified within the FCA code. This has been supplemented by a further SCG (G-038) developed by the Association of Traders which provides for the certification of the diverse range of specific activities which a trader can carry out including the trading of cereals and protein crops and additional supplies for use in primary production (sales of feed, plant protection products, organic and mineral fertilisers, seeds, and growing substrates). This SCG has also been approved by the FASFC and is subject to private certification. FEED TRANSPORTERS 10. The transport activities by road, inland waterways and rail can also be certified in the FCA guide. For the certification of road transport and storage of food and feed, a specific SCG (G-017) has also been validated by the FASFC and is subject to private certification. OTHER SCHEMES 11. Due to customer and/or export requirements, some additional, mainly product-based certification schemes can also apply in feed establishments. SHARED TESTING SCHEME 12. The FCA standard describes requirements relating to the monitoring of hazards in feed and establishes a testing scheme based on three levels of monitoring: Level 1: products entering the FCA system from non-certified suppliers or having new hazards related to the specific processes of the operator; Level 2: incoming materials before processing coming from certified suppliers; Level 3: produced compound feed. The testing plan can be organised individually or be shared at sectorial level. 13. Several sectorial associations (compound feed producers, cereal and protein crop traders and the Belgian millers) have created Shared Testing Schemes (STS), which have been recognised by FASFC. These STS may be based on different statistical approaches or sampling methodologies to those used by the FASFC when preparing the official monitoring plan for feed. 14. Each year, the results of the STS and the official monitoring plan for feed are shared between the different stakeholders and the competent authority and are taken into account in the risk assessment and monitoring plans for the following year. 4

9 Conclusion on certification schemes 15. The proactive approach taken by the feed industry and competent authority to develop SCG which incorporate the relevant legal requirements together with the undertakings given by the operators of the schemes to ensure a high standard of implementation provides a sound basis for close interactions between the private certification schemes and the system of official controls in the feed sector. This applies similarly to the STS developed by the industry associations and validated by the competent authority, where the results are taken into account in the preparation of the official monitoring programme, although there may be differences in the statistical approaches and sampling methodology used The role of the Certification Bodies 16. Nine certification bodies are accredited (ISO for the certification of the production activities and ISO for the services) for the certification of the FCA and six of them accredited and approved by FASFC, for the certification of the SCG G-001 for animal feed. 17. To be approved by FASFC, the certification bodies should be accredited for the relevant SCG and commit to respect the procedures and tools (audit checklists and guidelines) and to submit and keep up evidence of the qualification and impartiality of each auditor. The FASFC monitors the performance of these approved certification bodies and conducts regular audits to verify that the relevant requirements are fulfilled. It may also take part in the accreditation process. 18. In addition, the FCA certification scheme owner OVOCOM has set out clear requirements for the performance of its recognised certification bodies (see point 8) and subjects them to regular audits and on-the-spot checks. 19. Certification bodies are required to ensure information concerning the issuance or withdrawal of certificates is entered into the FASFC database within three working days and to make available on request all audit reports and any other documentation relating to the audited companies. The establishment of the common database also enables the certification bodies to confirm the authorisation, registration or approval status for all activities carried out by feed or food business operators. Any discrepancies identified by the certification bodies must be notified to the FASFC and measures taken to ensure the operator correctly notifies their activities. 20. FASFC organises regular coordination meetings with all of its approved certification bodies to update the guidelines and exchange experience and questions. Conclusion on the role of the Certification Bodies 21. The arrangements in place for the approval and supervision of certification bodies combined with the on-going training and development of auditors' competencies enables the competent authority to be confident that the work of the bodies certifying feed business operators in accordance with the SCG is carried out consistently and to a high standard. 5

10 5.1.3 Accreditation 22. When a certification body requests an accreditation for the certification of a private certification scheme, this standard is also subject to an evaluation by the Belgian accreditation body (BELAC) although in the case of the validated SCG, they rely on the work carried out by FASFC and its scientific committee. 23. The BELAC accreditation audits involve, where appropriate, technical auditors experienced in the animal feed sector, official controls and the approval process of certification bodies by FASFC. In the case of a Dutch certification body (which has been approved by the FASFC with an accreditation delivered by the Dutch accreditation body), a technical auditor qualified for the relevant feed SCG was sent by BELAC to participate in the accreditation audit performed by the Dutch accreditation body. Conclusion on accreditation 24. As the certification bodies approved by the competent authority for private certification schemes in the feed sector are accredited in accordance with relevant ISO standards and as such are subject to regular oversight by BELAC, with input from FASFC, this provides additional assurances regarding the reliability and standardisation of their work. 5.2 Interaction between official controls/private certification schemes Official Controls 25. FASFC is responsible for the control of feed establishments in Belgium. The federal level is responsible for preparing a control plan which is implemented by the 11 provincial control units. A detailed description of the organisation and responsibilities of FASFC is given in the country profile available here: 26. All feed and food business operators which are subject to these controls pay an annual fee to FASFC based on the category and size of their activities and additional contribution to the costs of any further services such as for new approvals or authorisations or for the issuance of certificates. 27. The controls carried out by FASFC include checks on the fulfilment of requirements contained in the SCG (which include those in Regulation (EC) No 183/2005) and in national legislation, most notably the Royal Decree of 14 November 2003 (see point 1). An audit of the own-checks systems put in place by the feed business operators can be performed by the competent authority or by a certification body approved FASFC (if the operator uses a validated SCG) Influence of private certification schemes on the system of official controls 28. The certification of an establishment by an FASFC approved certification body (see section ) for relevant validated SCG is one of the most important criteria taken into account in determining the risk categorisation of feed business operators and accounts for half of the total number of points which can be allocated to an establishment. The other half of the points are equally divided between the records of operator compliance found in previous inspections and the imposition of penalties. 6

11 29. In this way, feed business operators which have all their activities certified according to a relevant validated SCG and in which a sound level of compliance ( 7% noncompliances) has been found during controls and no penalties have been imposed in the last two years can benefit from a significant reduction in the level of official inspections carried out. In the case of producers of compound feed, premixtures or additives and critical medicated feed, inspections would be carried out biennially instead of annually; in the case of producers of feed materials and wholesalers, these would be controlled every five years instead of every three. 30. Feed business operators are given a further incentive to achieve the certification for all their activities in the form of a 75% reduction in the fees payable to FASFC. For example, the annual fee payable by a producer of compound feed manufacturing between 75,001 and 100,000 tonnes/year will be reduced from 6,245 to 1, FASFC systematically collects information regarding the scope and results of the certification process and any major non-conformity that must be notified to the competent authorities according to national law. While certification bodies should take into account any issues raised in the reports of official inspections, the provincial units of the FASFC do not need to consider the outcome of audits carried out by certification bodies. 32. Information regarding any serious deficiencies identified in the self-check system during official controls is passed to the central level and can lead to its validation being cancelled. The certification body concerned is also requested to provide an explanation Shared Testing Scheme 33. The official sampling plan is made up of three elements: (a) mandatory analyses (b) a vigilance plan to detect contamination within certain confidence limits and (c) a surveillance plan to estimate the prevalence of specific hazards with a certain level of precision. 34. The presence of a relevant STS which has been recognised by the FASFC can lead to a reduction of between 5 and 20% in the number of official samples taken depending on the adverse effect of the substance being analysed. A number of conditions must be fulfilled in order for an STS to be accepted by the FASFC. In particular, it should be based on a statistical methodology validated by the scientific committee of the FASFC and be implemented by a representative proportion of the operators in the sector. Furthermore, at least some of the samples should be collected by qualified external bodies (accredited to ISO 17020) using an official or equivalent method and these should be analysed in laboratories which have as a minimum participated in relevant proficiency tests. Lastly, the results should be evaluated using the same interpretation limits as FASFC and be provided to the competent authority. 35. The results of the STS and official sampling plans are shared between the different parties in order to improve their knowledge and to enable plans to be modified where appropriate. 7

12 Conclusion on the interaction between official controls/private certification schemes 36. Feed business operators have a clear incentive to be certified by an FASFC approved body in accordance with the validated SCG as those with a consistently high level of compliance may benefit from a significant reduction in the number of official controls and in the fees payable for these activities. Similarly, significant reductions in the number of official feed samples collected can be achieved where industry associations operate a validated STS. These initiatives are underpinned by the sharing of relevant information, including mandatory notification of non-compliances, and the measures taken by the competent authority to ensure the certification bodies and SCG involved operate to a high standard and are kept up-to-date. 5.3 Exchanges between national experts 37. The five national experts from other Member States who took part in this study visit actively exchanged views and raised questions with the competent authorities and operators visited. 38. Overall, it was agreed that the interactions between the system of official controls and the private certification schemes for the feed sector are quite advanced in comparison to that seen in other Member States. This has been made possible by a willingness throughout the entire chain to work closely together, on the one hand, including sharing information and being open to scrutiny and assessment by competent authorities and, on the other hand, by providing a reduction in the number of controls and associated costs to those operators which participate in the private schemes. This has helped to encourage widespread participation in the relevant private schemes. 39. A number of factors which support the level of interaction between the system of official controls and private certification schemes in the feed sector, and so may be considered as good practice, were highlighted: The relevant EU and national legal requirements are incorporated into the SCG on which the private certification schemes are based. To be eligible to be taken into account, these SCG must be evaluated and validated by the competent authority. The procedures in place for the approval and supervision by the competent authorities of the certification bodies (including participation in accreditation audits) and the clear requirements in place for the training and evaluation of auditors and participation in regular coordination meetings gives confidence in the quality and reliability of the certification and audit work carried out by these bodies. There are mechanisms in place which enable the competent authority to change the validation status of the operators' SCG and/or remove the approval of certification bodies involved if serious deficiencies in their performance are identified. The development of common databases and undertakings to share information, including mandatory notification of certain non-compliances, enables the competent authorities to be aware of and react to situations if necessary. 40. While the potential benefits of taking into account the results of the validated STS in the design of the official monitoring plan were acknowledged, reservations were expressed about the potential impact of differences in the statistical approach and sampling methodology used. 8

13 41. The national experts also conclude that this approach is globally seen as a complementary part of official control, but not as an alternative. While it has led to the reallocation of some personnel it has not reduced their number. Conclusion on the exchanges between national experts 42. The level of interaction between the private certification schemes and system of official controls in the feed sector is relatively advanced in Belgium. This has been made possible by a willingness throughout the entire chain to work closely together, on the one hand, including sharing information and being open to scrutiny and assessment by competent authorities and, on the other hand, by providing an incentive in the form of reduced controls and costs for operators to participate in the private schemes. Four key elements which underpin the current approach were highlighted as good practice including the (i) incorporation of relevant EU and national legal requirements in the SCG, (ii) measures to ensure certification bodies carry out their tasks to a high standard, (iii) possibility to take action if deficiencies are found in this respect and (iv) undertakings to share relevant information. It was noted that savings in resources within the competent authority was not one of the main drivers or objectives of developing interactions with the feed industry. 6 OVERALL CONCLUSIONS Over the last decade, a proactive approach taken by the feed industry and competent authority to work together to increase confidence in the safety of Belgian feed has led to the formation of a FCA and widely adopted SCG which set out the requirements for all key activities in the feed chain. As these guides, STS and the certification bodies involved are subject to validation, approval and on-going scrutiny by the competent authorities, and are accredited in accordance with relevant ISO standards, this has helped build confidence in their performance and integrity and has enabled the operators with a high level of compliance to benefit from a significant reduction in the number of official inspections and samples and in the fees payable for these activities. In addition to the willingness of the feed industry and competent authorities to work closely together and to share relevant information, the National Experts identified a number of other key features which have underpinned the relatively advanced level of interactions between these bodies. These good practices include the (i) incorporation of relevant EU and national legal requirements in the Self Check Guides, (ii) measures to ensure certification bodies carry out their tasks to a high standard and (iii) possibility to take action if deficiencies are found in this respect. It was noted that savings in resources within the competent authority was not one of the main drivers or objectives of developing interactions with the feed industry. All participants in this study visit appreciated the opportunity to share experience and knowledge with colleagues from other Member States and with the representatives of the Directorate-General Health and Food Safety. There was broad agreement on the potential advantages and drawbacks described in this report and the opportunities for increasing the interactions between the private certification schemes and the competent authorities. 9

14 ANNEX 1 LEGAL REFERENCES Legal Reference Official Journal Title Reg. 852/2004 OJ L 139, , p. 1, Corrected and re-published in OJ L 226, , p. 3 Reg. 882/2004 OJ L 165, , p. 1, Corrected and re-published in OJ L 191, , p. 1 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs 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 Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene

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