3. Management of EURLs and NRLs

3a. Official Control Regulation (EC) 2017/625 on EURL/EURC and NRL 3b. EURL/EURC latest developments 3c. Expected impact of Brexit on management of EURLs and NRLs Discussion

3a. Official Control Regulation (EC)2017/625 on EURL/EURC and NRL

Official Control Regulation 2017/625 15 June 2016: Political agreement 19 December 2016: Council common position 15 March 2017: European Parliament adoption 7 April 2017:

Entry into force and application Main date of application: 14 December 2019 Entry into force: 29 April 2017 Date of application for Art 92-to 101 EURLs, NRLs and EURCs : 29 April 2018

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

Implementation of Reg. 2017/625 EMPOWERMENTS are given to the Commission to ensure the implementation of the Regulation through… Implemented Acts (IA): HOW? (Uniform conditions for implementation) Delegated Acts (DA): WHAT? (Supplement or amend non-essential elements)

Some criteria for prioritisation (85 empowerments) Legal obligation? Around 50 empowerments handled with priority, e.g import controls of composite products, EURC/EURL Functional need? Deadlines?

Priority projects (IA, Art. 93.1) 2018 2019 2020 Animal welfare ref. centre (IA, Art. 95.1) EU ref. lab. plant health (DA, Art. 92.4) (IA, Art. 93.1) Meat inspection (DA+ IA, Art. 18.7, 18.8) Entry into the Union (>30 empowerments) IMSOC (IA, Art. 103.6, 134) Plant Control Frequencies (IA, Art. 22) Import conditions (DA, Art. 126) This slide was already presented to several stakeholders as a first outcome of prioritization MANCP: multi annual NATIONAL control programmes Residues in Food (IA, Art.19) MANCP reports (IA, Art. 113.2) COM Control Programme (IA, Art. 112)

Timeline for EURLs, EURC, NRLs 1 year 2017 J F March April M J J A S O N D April 2017 2018 ADOPTION APPLICATION DATE 29 April 2018 ENTER INTO FORCE

More specific provisions on EURLs EURC, and NRLs (Art 92-101) Title III -Reference laboratories Key principles: Broader scope (Plant Health) Transparency and efficiency Decision and designation of EURLs (art 92,93) More specific and more precise requirements, responsibilities and tasks Accountability Distribution of responsibilities among COM, MS, EURLs and NRLs

Areas for EURLs and how to designate EURLs Step 1- Decision to establish area EURL Areas where official controls depend on the quality, uniformity and reliability of methods and results and 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

Is the designation of current EURLs still effective after application OCR ? New EURL EURL designated under 2017/625: public selection process limited in time . min 5 years or reviewed regularly Current EURL EURL designated under 882/2004: remains effective until designation of EURL in same area takes place

When and how will the EURLs be reviewed ? EURL/C subject to Commission controls to verify compliance with art 93(3), 94, 95(3) and 97(3). Accreditation Eligibility criteria Staff Equipment (+ biosecurity standards) Review by Desk Officer: performance indicators Review of mandates regularly by policy unit To be further developed…

Are there new rules for accreditation? EURLs/NRLs to operate in accordance with EN ISO/IEC 17025 and be accredited by national accreditation body operating in accordance with Reg (EC)No 765/2008 Flexible scope possible NRLs: same + audits by CA CA to withdraw NRL by non-compliance with accreditation/proficiency tests REGULATION (EC) No 765/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 CA. Withdraw the designation if NRL doesn't comply with: ISO 17025 Obligations Expected results in proficiency tests

Accreditation of national reference laboratories for plant health 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

Additional responsibilities for EURLs One set of tasks for all EURLs: EURL to set out their tasks more specific in work program ! Equipped to comply with biosecurity standards Inform Commission and MS on result proficiency test Collaboration with 3rd countries, EFSA, EMA and ECDC Collaborate to develop new methods

Additional rules on 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

NRLs LIST PUBLICATION, Art 94(3) European Union reference laboratories shall publish the list of the national reference laboratories designated by the Member States in accordance with Article 100(1). by 29 April 2018

Link to EURLs and NRLs network on DG SANTE web NRL list EURL web Link to EURLs and NRLs network on DG SANTE web

Reference centres (Art. 95-98) Animal Welfare (Obligation) Call sent out on 16-10-17 Authenticity and Integrity of the Agri-Food Chain (Optional)

Specific additional tasks for NRLs Art 101 Inform CA on proficiency tests results and follow-up Official communication to COM, EURL + MS: name and address NRLs Conduct training courses for OLs Equipped with relevant biosecurity standards Maintain updated lists reference materials + manufacturers Assist CA in outbreaks

Obligations EC? Art 99:The EC shall: Publish and update list of EURLs and EURCs Adopt DA for additional tasks related to new risks, diseases or plant pests for EURL/NRL Perform controls to verify compliance of EURLs/EURCs Withdraw of EURL in case of Non-Compliance (IA) These are some aspects of the activities done by EC regarding EURLs. -EC organizes the annual Directors meeting and address horizontal issues and improvements. The last directors meeting was in 2014. Due to internal reorganisation we were not able to schedule a meeting in 2015. So now we pick up the routine from 2016. -all EURLs are linked through the desk officer to their specific policy area in DG SANTE; -the work programme and reports are evaluated by these policy areas on the technical aspects; the financial aspects are coordinated by the financial unit. -new calls are managed by the relevant policy area and the coordinating unit; -DG SANTE manages currently a database with details of the different EURL and their NRLs, data protection rules do not allow us to share these data for instance in the contact details. Since granting direct access to the database to EURLs for adding modifications is not possible, EURLs should send alerts to DG SANTE for updating the database. The written agreement of NRL staff for inclusion in the database will also be requested. (DG SANTE will provide a Standard Operating Procedure on the management of this database and the ways forward )