1. 3. Management of EURLs and NRLs

2. 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

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

4. 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:

5. 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

6. 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 financing OC & official certification
Article 92– 101
EURLs &
EURCs
Art. 102–108
Administrative Assistance & Cooperation
Common Provisions - Articles 142 – 167

7. 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)

8. 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?

9. 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 , 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 )
COM Control Programme (IA, Art. 112)

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

11. 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

12. 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 (operating, methods of laboratory analysis and others and in a flexible manner) IA

13. 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

14. 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…

15. 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 Obligations Expected results in proficiency tests

16. 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

17. 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

18. 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

19. 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

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

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

22. 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

23. 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 Due to internal reorganisation we were not able to schedule a meeting in 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 )