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

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……

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

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

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

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 DA 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) IA

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

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

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

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

NRLs Requirements OCR 882 Staff: DA NRLs Requirements 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 882 Staff: Impartial, confidentiality Suitably and training + support International Standards Infrastructure, equipment and products According to needs Emergency situations

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

Responsibilities and tasks of NRLs DA Responsibilities and tasks of NRLs 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) 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

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

J F March April M J J A S O N D April 2017 2018 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

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 April 2018, 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 !!

Other obligations of the COM publish and update the list of EURLs Develop additional DAs & IAs if necessary Work ongoing EMERGENCIES COMPULSORY DA IA Additional requirements/tasks for EURL-new or emerging risks Withdrawal of EURL in case on non-compliance Requirements for NRLs Responsibilities and tasks for NRLs NON COMPLIANCE COHERENCE

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

RECAP: GENERAL ASPECTS EURLs Establishment-designation (Limited in time) Requirements-ISO 17025: Obligation to accredit official methods of analysis Flexible manner and temporary derogations More explicit, concrete and accurate describing tasks: Reference materials To inform to the COM and MSs as regards proficiency tests To collaborate EFSA, EMA and ECDC RECAP: OBLIGATIONS COM To develop tertiary legislation: DA/IA-EURL and NRL Initiate decision to establish and appointment a/an EURLs Review designations regularly Publish and update the list of the EURLs Control-Now it is compulsory (may vs shall) Withdraw–From "measures may be taken" to withdraw EURLS Publish and update the list of NRLs MS Designate NRL + OL, audit of labs NRL Participate in training courses and proficiency tests and to inform CA N O V E L T I S

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