impact of the new official controls regulation on laboratories · official controls and other...
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Impact of the new Official Controls Regulation on
Laboratories
Food, Health and the Role of National Reference Laboratories
Gail Carroll, FSAI
Service Contracts Manager
3rd February 2016
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The purpose of official controls
Verify compliance with rules aimed at
Preventing, eliminating or reducing to acceptable levels risks to humans and animals, either directly or indirectly through the environment
And
Guaranteeing fair practices in feed and food trade and protecting consumer interests, including feed and food labelling and other forms of consumer information.
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What is an official control?
Any form of control that the Competent Authority performs for the verification of compliance
Official Controls include Inspection, Sampling & Analysis
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Drivers for revising Reg. 882/2004
Simplify and Clarify
• Inconsistencies
• Overlap and gaps
Consolidate - Whole agri-food chain
• food, feed, plant health, animal health, animal welfare
Resources for official controls through fees
Experience of what can be done better
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Draft Regulation adopted May 2013:
Proposal for a Regulation of the European Parliament and of the Council on official controls
and other official activities
!Still Work in Progress!
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Main changes from 882/2004
• Bigger…
• Expanded Scope
• Empowerments for sector-specific rules
• Import controls
• Fees
• Integrated Information Management System
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Official Controls and Other Official Activities - NEW
• Activities performed by the CA to verify:
•Compliance by operators
•Compliance of animals and goods
Official controls
• Activity (not an OC) performed in accordance with the Reg. or other agri-food rules e.g.
•Activities to verify presence of animal diseases, plant pests or to prevent, contain or eradicating diseases or pests
Other official
activities
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10
Focus on Sampling and Analysis
But: many of the general requirements apply to
laboratories too
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Key
Themes for Labs
More CA oversight
Emphasis on
methods
Accreditation for all tests
Expanded role for NRLs
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EURLs
NRLs
Official Labs
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EURLs
NRLs
Official Labs
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1. Methods
1st Choice: Union Rules
2nd Choice – methods to be used according to their suitability for the specific analytical, testing and diagnostic needs
3rd Choice: NRL can use other methods in urgent situations
Internationally recognised rules or protocols
EURL developed/ recommended
National rules
NRL developed/ recommended and validated
Developed & validated with inter/intra lab validations
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2. Designation – CA Oversight
• Written designation including:
• Tasks
• Conditions
• Arrangements for efficient and effective coordination between CA and lab
• Designated labs must have resources (expertise, equipment, infrastructure, staff, free from conflict, timely results)
• Audit the lab on a regular basis (unless unnecessary due to 17025 audits)
• Withdraw designations if failures found
• Oversee derogations from accreditation
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3. Official lab obligations
• Inform CA immediately if risk identified
• Participate in PT tests by EURL or NRL
• Accreditation
• Have resources (expertise, equipment, infrastructure, staff, free from conflict, timely results)
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4. Accreditation
• All Methods used when operating as an official laboratory
• Flexible scope
• Derogations:
• Permanent (Trichinella or OOA only)
• Temporary – max 2 years
• Commission can adopt more
• CA and NRL supervision
• Funding for plant health labs (NRLs)
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Temporary derogations…CA Decision
When
• Newly required method, change in method, emergency situation, emerging risk
Conditions
• Lab is already accredited for similar method
• QA system in place for this new method
• Done on supervision of CA or NRL
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5. Second Expert Opinion
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EURLs
NRLs
Official Labs
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National Reference Laboratories
Designated by Member States corresponding with each EURL
NRLs must comply with Official Lab requirements
Most of the accreditation derogations available
Commission empowered to adopt derogation from accreditation for all tests for Plant health NRLs
Plant health – funding for NRL accreditation plus longer entry into force for some provisions
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NRL Responsibilities - Strong emphasis on coordination and oversight: Coordinate Official labs to harmonise & improve methods
Organise PT tests, ensure follow up and inform CA of results (where appropriate)
Disseminate info from EURLs
Assist in CA in MANCP implementation
Validate reagents, maintain information on reagents (where relevant)
Training courses for Official Labs
Actively assist MS in diagnosing outbreaks
Collaborate with EU RL incl training courses and PT
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EURLs
NRLs
Official Labs
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EU Reference Laboratories
• Will cover all the areas in the scope of the legislation
• Established where effectiveness of Official Controls and Other Official Activities depends on quality, uniformity and reliability of:
• Methods and results of analysis in the official labs
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EU Reference Laboratories
Strong mandate to improve and harmonise methods used by official labs
•Provide guidance on methods plus reference materials to NRLs
•Coordinating application by NRLs and Official labs of methods
•Organising PT /comparative tests
•Training courses
•Other arrangements necessary to apply new methods
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Challenges and Opportunities for Laboratories?
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Take home Message
• Key role of labs in delivering effective official controls/activities
• Accreditation – for almost everything
• Focus on methods
• Expanded role for Competent Authorities
• More responsibility for NRLs – oversight
• Cross Agency Guidance on NRLs
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Date of Application
• Draft with E Parliament, E Commission, E Council
• Applies + 3 years after entry into force
• Plant health – many lab provisions + 5 yrs
Plenty of time to comply??
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Come to the workshop tomorrow to learn more!
Thank you
Gail Carroll
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