Review of Regulation
882/2004 on official
controls
Francesca Volpi
DG SANCO.E5- Enforcement
Council Working Party
27 June 2012
Brussels
Health and
Consumers
1
Why review Regulation
882/2004?
• In application since 2006
• Analysis (2008-2011) showed that:
• The Regulation has established an innovative
system based on an integrated and
horizontal approach
• However, adjustments are necessary in a
number of areas
Health and
Consumers
2
Objectives of the review
• Simplify and clarify the legal framework
applicable to control activities
• Consolidate the integrated approach across the
food chain intended in its widest sense
• Modernise available instruments
• "Lisbonise"
Health and
Consumers
3
Scope and subject matter
• Sectors
•
•
•
•
Feed law and food law (including FCM and GMOs)
Animal health law, animal welfare rules, ABP
Plant health law
Plant reproductive material law
• Activities
• Official controls to verify the compliance with requirements
applicable to animals and goods:
- marketed/moved within the Union
- arriving from third countries
- intended to be exported
• Certain provisions applicable to other official activities (i.e.
survey, surveillance and monitoring, containment, animal
4
diseases control)
Health and
Consumers
Definitions
• New and existing definitions adjusted to the broader scope
• New definitions
• ‘Other official activities’ (any activity other than an official
control which the CAs should carried out in accordance with,
and to ensure the application of, sectoral legislation
• Import related definitions (BCP, transit and transhipment etc.)
– alignment with MCC
• Screening and targeted screening
• Definitions laid down in sectoral acts (food, animal, plants,
plant reproductive material) applicable as relevant
Health and
Consumers
5
Competent authorities
• Single authority responsible for coordination and
contact in each sector
• Transparency: clarify the content of the information to be
made available to the public; the following information shall
be made publicly available:
• types, number and outcome of official controls
• types and the number of non-compliances detected and enforcement
action taken
• A copy of the report in case of recorded
• Non-compliance, or
• Compliance
• Mechanisms for delegation of official control tasks to
delegated bodies (third party)
6
Health and
Consumers
General obligations for
official controls
• Risk based approach confirmed
• Without prejudice to frequency and modalities for
controls in view of official certification
Health and
Consumers
7
Methods, analysis and diagnosis
• Clarification of the cascade of methods and
flexibility for screening and targeted screening
• Clarification of the right of operators to a
supplementary expert opinion:
- Applicable in case of official controls only
- Second sample if relevant and technically
feasible (not applicable to screening and
8
targeted screening
Health and
Consumers
Official laboratories
• Mandatory ISO 17025 accreditation for all
laboratories:
• include all methods used as an official laboratory
• 5 years transition for plant health laboratories
• temporary derogations (method required by legislation,
changes of the method, emergency situations, emerging
risks)
• permanent derogations (Trichinella, quality and purity
tests on plant reproductive material)
Health and
Consumers
9
Official certification
• Definitions of ‘official certification’ adjusted to
account for the different modalities of official
certification in the PH and PRM sectors (plant
passport, official label)
• Separate sets of rules governing:
• Official certificates issued by the CAs and signed by the
certifying officer
• Official labels, marks or other official attestations issued by
operators under the supervision of CAs
• Export certification
Health and
Consumers
10
Reference labs and centres
• Possibility
to
establish
European
laboratories (EURLs) in new sectors
Union
reference
• New tasks for EURLs:
• establish and maintain reference collections/strains
• coordinate:/harmonise checks to ensure quality of
reagents
• assist in diagnosis of outbreaks of food born diseases or
of organisms harmful to plants
• coordinate application of methods by official laboratories
other than NRLs and conduct training courses for them
• Possibility to designate EU animal welfare reference centres
and EU reference centres for the PRM certification that shall
support COM and MS
Health and
Consumers
• Requirements applicable to EURLs also applicable to NRLs
11
EU PRM certification centres
• European Union PRM certification centres to
support COM and MS. Tasks may include:
• provide technical expertise
• organise comparative tests and trials
• conduct training courses
• contribute to the dissemination of applied
research
Health and
Consumers
12
Administrative assistance and
cooperation
•
Re-enforced and clarified to increase usability
•
General principles
• Written requests for assistance and communications
• Commission to establish a standard format for requests for assistance,
notifications and responses.
•
Assistance and cooperation 'channelled' through liaison bodies
• Role of liaison bodies clarified
• COM empowerment to adopt minimum requirements + communication
procedures for liaison bodies
•
Modalities for requesting administrative assistance and for activating
cooperation procedures will be clarified
13
Requested CAs required to acknowledge receipt of requests for
assistance/notifications
•
Health and
Consumers
Planning and reporting
• Planning (MANCP)
• Single authority
coherence
responsible
for
preparation
and
• Reporting
• Ongoing initiative to provide MS with standard templates
• Legal basis to progressively adopt such templates and,
where appropriate, replace existing requirements
Health and
Consumers
14
National enforcement measures
• Action in case of suspicion
• Investigation to confirm or eliminate the doubt
• Intensified controls, official detention
• Action in case of non-compliance
• Certain actions reformulated to adapt them to all sectors
• List completed with further actions (such as the restriction or
prohibition of the placing on the market, suspension of
operation or closure of business, including websites etc.)
• Sanctions
• Real deterrent
• Appropriate penalties in case of operators failing to cooperate
• Obligations for operators to cooperate during official
controls
Health and
Consumers
15
Financing of official controls
• Ensure
the
availability
of
resources for official controls
adequate
• Ensure equity and fairness in the financing
of official controls
• Improve transparency
Health and
Consumers
16
Financing of official controls
• PRM
in
882
consequences:
will
have
the
following
• full cost recovery for PRM certification
• transparency
• possibility for MS to refund fees to micro-enterprises
(according to state aids rules)
Health and
Consumers
17
Thank you for your attention!
Health and
Consumers
18