Review of Regulation 882/2004 on official controls

1. Review of Regulation 882/2004 on official controls Francesca Volpi DG SANCO.E5- Enforcement Council Working Party 27 June 2012 Brussels

2. Why review Regulation 882/2004? • In application since 2006 • Analysis (2008-2011) showed that: • The Regulation has established an innovative system based on an integrated and horizontal approach • However, adjustments are necessary in a number of areas

3. Objectives of the review • Simplify and clarify the legal framework applicable to control activities • Consolidate the integrated approach across the food chain intended in its widest sense • Modernise available instruments • "Lisbonise"

4. Scope and subject matter • Sectors • Feed law and food law (including FCM and GMOs) • Animal health law, animal welfare rules, ABP • Plant health law • Plant reproductive material law • Activities • Official controls to verify the compliance with requirements applicable to animals and goods: • - marketed/moved within the Union • - arriving from third countries • - intended to be exported • Certain provisions applicable to other official activities (i.e. survey, surveillance and monitoring, containment, animal diseases control)

5. Definitions • New and existing definitions adjusted to the broader scope • New definitions • ‘Other official activities’ (any activity other than an official control which the CAs should carried out in accordance with, and to ensure the application of, sectoral legislation • Import related definitions (BCP, transit and transhipment etc.) – alignment with MCC • Screening and targeted screening • Definitions laid down in sectoral acts (food, animal, plants, plant reproductive material) applicable as relevant

6. Competent authorities • Single authority responsible for coordination and contact in each sector • Transparency: clarify the content of the information to be made available to the public; the following information shall be made publicly available: • types, number and outcome of official controls • types and the number of non-compliances detected and enforcement action taken • A copy of the report in case of recorded • Non-compliance, or • Compliance • Mechanisms for delegation of official control tasks to delegated bodies (third party)

7. General obligations for official controls • Risk based approach confirmed • Without prejudice to frequency and modalities for controls in view of official certification

8. Methods, analysis and diagnosis • Clarification of the cascade of methods and flexibility for screening and targeted screening • Clarification of the right of operators to a supplementary expert opinion: - Applicable in case of official controls only - Second sample if relevant and technically feasible (not applicable to screening and targeted screening

9. Official laboratories • Mandatory ISO 17025 accreditation for all laboratories: • include all methods used as an official laboratory • 5 years transition for plant health laboratories • temporary derogations (method required by legislation, changes of the method, emergency situations, emerging risks) • permanent derogations (Trichinella, quality and purity tests on plant reproductive material)

10. Official certification • Definitions of ‘official certification’ adjusted to account for the different modalities of official certification in the PH and PRM sectors (plant passport, official label) • Separate sets of rules governing: • Official certificates issued by the CAs and signed by the certifying officer • Official labels, marks or other official attestations issued by operators under the supervision of CAs • Export certification

11. Reference labs and centres • Possibility to establish European Union reference laboratories (EURLs) in new sectors • New tasks for EURLs: • establish and maintain reference collections/strains • coordinate:/harmonise checks to ensure quality of reagents • assist in diagnosis of outbreaks of food born diseases or of organisms harmful to plants • coordinate application of methods by official laboratories other than NRLsand conduct training courses for them • Possibility to designate EU animal welfare reference centres and EU reference centres for the PRM certification that shall support COM and MS • Requirements applicable to EURLs also applicable to NRLs

12. EU PRM certification centres • European Union PRM certification centres to support COM and MS. Tasks may include: • provide technical expertise • organise comparative tests and trials • conduct training courses • contribute to the dissemination of applied research

13. Administrative assistance and cooperation • Re-enforced and clarified to increase usability • General principles • Written requests for assistance and communications • Commission to establish a standard format for requests for assistance, notifications and responses. • Assistance and cooperation 'channelled' through liaison bodies • Role of liaison bodies clarified • COM empowerment to adopt minimum requirements + communication procedures for liaison bodies • Modalities for requesting administrative assistance and for activating cooperation procedures will be clarified • Requested CAs required to acknowledge receipt of requests for assistance/notifications

14. Planning and reporting • Planning (MANCP) • Single authority responsible for preparation and coherence • Reporting • Ongoing initiative to provide MS with standard templates • Legal basis to progressively adopt such templates and, where appropriate, replace existing requirements

15. National enforcement measures • Action in case of suspicion • Investigation to confirm or eliminate the doubt • Intensified controls, official detention • Action in case of non-compliance • Certain actions reformulated to adapt them to all sectors • List completed with further actions (such as the restriction or prohibition of the placing on the market, suspension of operation or closure of business, including websites etc.) • Sanctions • Real deterrent • Appropriate penalties in case of operators failing to cooperate • Obligations for operators to cooperate during official controls

16. Financing of official controls • Ensure the availability of adequate resources for official controls • Ensure equity and fairness in the financing of official controls • Improve transparency

17. Financing of official controls • PRM in 882 will have the following consequences: • full cost recovery for PRM certification • transparency • possibility for MS to refund fees to micro-enterprises (according to state aids rules)

18. Thank you for your attention!