1. 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 Brussels Maria del Mar Llorente Alonso Official 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 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 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

7. 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

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 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

11. 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

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. Responsibilities and tasks of NRLsDA
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

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. 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
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 /-/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 !!

17. 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

18. 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)

19. 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

20. Thanks for your attention!