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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

gcarroll@fsai.ie

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