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New official Control regulation

New official control regulation (OCR) and EURLs agenda item 5 Meeting of the EU Reference Laboratories in the field of animal health and food and feed safety 2 December 2016 Brussels Maria del Mar Llorente Alonso Official controls and eradication of diseases in animals.

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New official Control regulation

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  1. New official control regulation (OCR) and EURLsagenda item 5Meeting of the EU Reference Laboratories in the field of animal health and food and feedsafety2 December 2016 BrusselsMaria del Mar Llorente AlonsoOfficial controls and eradication of diseases in animals

  2. New official Control regulation Regulation on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products……

  3. Structure of the Regulation General Principles Articles 1 – 15 Subject matter, scope & definitions, Competent Authorities general requirements Sector Specific Requirements Articles 16 – 27 e.g. products of animal origin, residues, animal welfare, plant health, GMOs, plant protection products, organic production, PDO/PGI/TSGs, new risks Art. 28–33 Delegation of tasks Art. 34–42 Sampling, analyses, tests & Diagnoses Art. 43– 76 IMPORT CONTROLS Art. 77-91 financing OC & official certification Article 92– 101 EURLs & EURCs Art. 102–108 Administrative Assistance & Cooperation Common Provisions - Articles 142 – 167

  4. Reference centres • Animal Welfare (Obligation) • Authenticity and Integrity of the Agri-Food Chain (Optional)

  5. Provisions on EURLs and NRLs • Title III -Reference laboratories • Key principles: • Broader scope (Plant Health) • Transparency and efficiency • Decision and designation of EURLs • More specific and more precise requirements, responsibilities and tasks • Accountability • Distribution of responsibilities among COM, MS, EURLs and NRLs

  6. Building-up the legislative framework • Step 1- Decision to establish a EURL • official controls depends on the quality, uniformity and reliability of methods and results • need to promote uniform practices in relation to the development or use of the methods • Step 2- Designation of EURL • Public selection process • Limited in time, with minimum period of 5 years or reviewed regularly • Accredited according to ISO/IEC 17025 (operating, methods of laboratory analysis and others and in a flexible manner) DA IA

  7. EURLs Requirements OCR • Equipped to comply with relevant biosecurity standards 882 • Staff: • Impartial, confidentiality • Suitably, training + support • International Standards • Updated • Infrastructure, equipment + products • According to needs • Emergency situations

  8. Responsibilities and tasks of EURLs • 882 • Improvement + harmonization of tests • develop annual/multi-annual WP + report (Reg. 652/2014) • Scientific + technical assistance COM + NRLs (incl. training courses) • assist during outbreaks • OCR • publish list of NRLs • provide reference materials • more specific: • proficiency tests: inform COM + MS • cooperate to develop new methods • collaborate with Third Countries, with EFSA, EMA and ECDC

  9. Reference materials • Establish and maintain reference materials of: • Pests of plants and/or reference strains of pathogenic agents • Materials intended to come into contact with food used to calibrate analytical equipment • Provide reference materials to NRLs • Update lists available reference substances/ reagents/manufacturers/suppliers • Perform tests verification of the quality of reagents and lots of reagents

  10. Designation of NRLs • OCR • MS may designate a NRL even if no EURL • Official communication to COM, EURL + MS and public information of the name and address 882 • MSs to designate > 1 NRLs for each EURL • MS may designate lab in another MS/ 3rd Country • NRL may be designated > 1 MS

  11. DA NRLs Requirements 882 • Staff: • Impartial, confidentiality • Suitably and training + support • International Standards • Infrastructure, equipment and products • According to needs • Emergency situations OCR • Scope of accreditation • Equipped with relevant biosecurity standards • CA shall organise audits • Withdraw the designation if doesn't comply with: • ISO 17025 • Obligations • Expected results in proficiency tests

  12. Amendments to Regulation 652/2014 NRLs: Plant Health Accreditation of national reference laboratories for plant health • Grants may be awarded to NRLs for costs incurred for obtaining accreditation according to the standard EN ISO/IEC 17025  • Grants may be awarded to a single NRL in each MS for each EURL for plant health, up to three years after the designation of that EURL

  13. DA Responsibilities and tasks of NRLs OCR • Inform CA proficiency tests results and follow-up • Conduct training courses for OLs • Reference materials • Validate • establish + maintain updated lists reference materials + manufacturers • Assist CA in outbreaks 882 • Methods of analysis + tests to official labs (OL) • ensure dissemination to CA + OLs of info provided by EURL • Scientific + technical assistance to CA for Multi Annual National Control Plan (MANCP)

  14. Obligations of Official Laboratories (OL)Title II, Chapter IV, Article 38 • Inform immediately CA if results • indicate risk to human, animal or plant health, or as regards GMOs and plant protection products, also to the environment • or point to the likelihood of non-compliance • Upon request by: • EURL or NRL  OL shall take part in proficiency tests. • Competent Authorities: • OL shall make available to the public methods used for analyses performed official controls • OL shall indicate the results together with the method used for each analysis

  15. Timeline for EURLs 1 year 2017 J F March April M J J A S O N D April 2017 2018 ADOPTION APPLICATION DATE ENTER INTO FORCE

  16. review mandates: timeline & responsibilities 2017/2018 J F M A M J Jl A S O N D 2019/-/2021 • Review of mandates (overlaps, synergies, gaps) • New needs (JRC EURLs April2018, Plant Health14/12/2019 and Animal Health21/04/2021) DA launch call for selection Assessment of the applications appoint the new EURL IA DESIGNATION UNDER 882 REMAINS EFFECTIVE !!

  17. Other obligations of the COM Work ongoing • publish and update the list of EURLs • Develop additional DAs & IAs if necessary EMERGENCIES NON COMPLIANCE COHERENCE

  18. Obligations of the MS OCR • Update and make available to public details NRLs (name and address) 882 • designate NRLs • ensure coordination between NRLs work closely together • communicate details of NRLs to COM, EURLs and other MS

  19. N O V E L T I E S

  20. Thanks for your attention!

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