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

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

8. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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 NRLs and 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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. Health and Consumers Health and Consumers 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) 17

18. Health and Consumers Health and Consumers 18 Thank you for your attention!