Transcript European Food Law The Basic Structures

EUROPEAN FOOD LEGISLATION
Neville Craddock
EuropAid Project
Astana
March 2006
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European Food Law
The Basic Structures
Neville Craddock
Who’s Who in Europe
• Institutions of the EU
• Legal instruments
• Decision-making process
• Scientific advice
• EFSA
• National regulatory authorities
• Non-institutional players
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Institutions of the EU
• Institutional system is the only one of its kind in the world
• Institutional triangle:
– European Commission
– European Parliament
– Council of the European Union
• European Court of Justice, Court of Auditors
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European Commission
• Representation of Community interests
• Right of legislative initiative
• DG Health and Consumer [“DG SANCO”]
– Public and animal health, food safety, consumer interests
• DG Enterprise
• DG Internal Market
• DG Development
• …. others
• Key players: civil servants, heads of unit, Commissioners
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European Parliament
• Representation of European citizens
• Directly elected since 1979
• Committee and Plenary Sessions in Strasbourg and Brussels
• Critical legislative role (amends and approves legislation)
• Key players: rapporteur and shadow-rapporteur of relevant
committees which examines Commission proposal,
Intergroups, national and “local” MEPs
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Council of the European Union
• Council of Ministers
• Representation of member states’ governments
• Co-legislator
• Qualified Majority Voting (weighted by size of States)
• Role of Presidency (driving force in the legislative and political
decision-making process, organise and chair all meetings,
work out compromises, rotates every 6 months)
• Key players: Council Secretariat, Permanent Representations
(UKREP), MS government officials
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Decision-Making Process (simplified)
• European Commission
• Proposal for Regulation or Directive
• European Parliament
• Council of the European Union
• First and second reading
• Adoption
• Implementation in Member States
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The European Dimension
• Treaties
– broad direction for policy
– basis for detailed secondary legislation
• Objective of Public Health is to ensure:
‘a high level of human health protection in the definition and
implementation of all Community policies and activities’
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General Principles of EU Food Law
• High level protection: human (and animal) life & health
• Rights to safe food; accurate & honest information
• Taking into account protection of animal health and welfare;
plant health
• Environment
• Free movement of food & feed inside EU
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Legal Instruments
• Regulations - binding in their entirety (verbatim) from date of
entry into force; supersede conflicting national rules:
– complete
– specialised
– narrowly focused
– do not require domestic legislation
– cannot be amended by national Parliament
– cannot be amended by national legislation
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Legal Instruments (cont’d)
• Directives - binding as to the result to be achieved, but left to Member
States to decide form and method of implementation (e.g. Laws or
regulations). No legal force until implemented into national law
• Decisions – binding in their entirety upon those to whom it is
addressed
• Recommendations - not binding, but taken into account when
interpreting domestic legislation
• Commission Communications
– to give guidance on manner policy is to be implemented
– not generally binding
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European Court of Justice
• Infringement procedure (Art 226)
– If the Commission considers that a Member State has
failed to fulfil its obligations under the Treaty, it delivers
a “reasoned opinion” on the matter
• Preliminary Ruling (Art 234)
– Reference from national courts, if in doubt as to the
interpretation or validity of Community law
Ensure that Community law is interpreted and applied
uniformly throughout the EU
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European Court of Justice
• Member State liable for enforcing EU law correctly in its country
– all aspects of EU law (whether Regulation / Directive etc)
– liable to damages for failure to respect EU law
• National courts responsible for EU law implementation, not ECJ
– refer to the ECJ in order to enforce EU law correctly
• ECJ is not an appellate court over the national courts
– ECJ jurisdiction only covers EU law
• Relationship between ECJ and national courts is not the same as
between a Supreme Court and subordinate courts in a classical
hierarchy of courts.
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Mutual Recognition Principle
• Any product imported from a Member State should in principle
be allowed entry into another Member State’s territory if it has
been lawfully produced and marketed in that country
• Principle developed on the basis of ‘Cassis de Dijon’
judgement (1979) in connection with Article 28 of the Treaty
(free movement of goods)
• Only applies in non-harmonised areas
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Mutual Recognition Principle
• Member States can waive this principle only under very strict
conditions:
– If restrictions to free movement justified by grounds of
public policy or security, protection of health and life of
persons, animals, plants (art 30) and (more recently)
environment protection
– overrides requirements of general public importance: fair
trade, consumer protection
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European Food Safety Authority
• Independent scientific point of reference in risk assessment
• Scientific Committee and permanent Panels
– consulted in cases laid down by legislation or on request
from the Commission
• Provision of
– Scientific opinions and technical support
– Data collection; Identification of emerging risks
– Information to public and interested parties
• consumer confidence
• transparency of policy making & legislation
• Effective contacts with “stakeholders”
– consumers, producers, processors, other interested parties
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National Regulatory Authorities
• Ministries and – increasingly – Food Agencies responsible for
– food and feed manufacturing
– agriculture (aspects related to food and feed safety)
– consumer protection (food-related)
• UK Food Standards Agency
– Government agency, but formally ‘independent’ responsible for
• Food Safety Policy
– Primary production, chemical, microbiological, emergencies
• Enforcement and Food Standards
– Veterinary, BSE, food hygiene, imports
• Consumer choice and nutrition
– Nutrition, labelling, novel foods, additives, surveys etc
• Corporate Resources and Strategy
– Risk management decisions (c.f. EFSA: scientific advice only)
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General Food Law Regulation
REGULATION (EC) No 178/2002 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
28 January2002
laying down the general principles and requirements of food law,
establishing the European Food Safety Authority and laying
down procedures in matters of food safety
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General Food Law Regulation
• Basis for
– assurance of a high level of consumer protection,
– whilst ensuring effective functioning of the Internal Market
• Establishes
– common principles and responsibilities
– the means to provide a strong science base
– arrangements and procedures to underpin decision-making
• Lays down general principles governing food and feed - and in
particular their safety
• Establishes the European Food Safety Authority
• Rapid Alert System
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General Food Law Regulation
• single framework / common principles
• dual aim: public health / free movement
• feed and food: “farm to fork”
• based on transparent, independent advice
– linked to risk analysis
• “precautionary principle” - (if appropriate) applied to risk
management
• accurate, and not misleading, information for consumers
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General Food Law Regulation
• Transparency and expediency in development of food law
• Recognition of international obligations
• Business responsible for safety and legal compliance
• Member States responsible for monitoring, control, enforcement,
public communication and penalties
• Risk analysis
– risk assessment
– risk management
– risk communication
• Use of precautionary principle where unacceptable levels of risk
• Provides legal basis for European Food Safety Authority
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Food Legislation Structures
General Food Law Regulation 178/2004 sets framework but is
dependent on numerous other pieces of legislation for its
practical effect – an “umbrella” or “roof”
• Dependent on a structure of secondary Regulations and
Directives to further (and specifically) define parameters used
when determining concepts such as “safe”, e.g.
– General Food Hygiene Regulation 852/2004
– Animal Products Hygiene Regulation 853/2004
– Directives on Additives, Contaminants, Pesticides,
Labelling, Metrology, etc
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EU Food Legislation
Legislation that “sits” under the “roof / umbrella” of 178/2004
- may be considered as “pillars” supporting the roof
3 Main Groups:
• Product Safety
-
• Consumer Information
"horizontal" and "vertical"
-
• Quality Requirements
largely "horizontal"
-
largely "vertical"
plus
Other legislation relevant to food:
• Product liability
• Misleading advertising
• Weights and Measures
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EU Framework Regulations
• Hygiene of Foodstuffs
– General Regulation 852/2004
– Products of animal origin Regulation 853/2004
e.g. meat, fish, eggs, milk, honey
• Official Control Regulations 854/2004 and 882/2004
– inspection procedures; effectiveness of enforcement
– protect public health
– protect consumer interests
– guarantee fair competition
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EU Framework Directives
• Food Additives
– colours, sweeteners, miscellaneous
– positive lists by foods and / or additive
– criteria for use: quantitative / qualitative
– purity criteria
• Contaminants
– heavy metals - Pb, Hg, Cd….
– industrial contaminants - dioxins, PCBs
– food processing - MCPD
– agricultural: nitrates, mycotoxins,
(aflatoxins, ochratoxin, others)
– sampling and analysis
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EU Framework Directives
• Flavourings
– purity criteria, definitions and labelling
– contaminants
– register (‘positive list’) of substances
– smoke flavourings – authorisations
•
Labelling, Nutrition Labelling, Quantitative declarations
– detailed provisions: e.g. allergens, meat and fish
– ongoing developments
• Claims and other nutrition-related communications
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EU Framework Directives
• Other framework Directives:
– Food Irradiation:
– Materials and Articles in Contact with Foods
– Packaging Waste
– Extraction solvents
– Radio-activity
– Etc …
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EU Vertical Directives
cover Composition, Labelling, Weights and Measures for:
Casein & Caseinates
Dairy Product Designations
Cocoa & Chocolate
Natural Mineral Waters
Coffee & Chicory Extracts
Novel Foods & Processes
Drinking Milk
Organic Foods
Erucic Acid
Particular Nutrition Uses
Quick Frozen Foods
Specified Sugars
Fruit Juices / Nectars
Spirit Drinks
Honey
Water (Human Consumption)
Jams, Jellies etc
Yellow Fat Spreads
Preserved Milks
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EU OFFICIAL CONTROLS on FEED and
FOOD IMPORTS
Regulation 882 / 2004
Neville Craddock
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Background to Regulation 882/2004
• Regulation 178 / 2002 (“General Food Law”) defines basic legal
responsibilities of EU MS authorities and businesses to ensure that all
feed and food for sale in the EU is safe, accurately described and,
where appropriate, complies with defined standards.
• Regulation 852 / 2004 complements this “umbrella” Regulation by
establishing for businesses the basic principles of hygienic
construction of premises and all aspects of food manufacture
• Regulation 853 / 2004 complements Regulation 178/2002 by
establishing the basic hygiene principles for businesses handling
food of animal origin at all stages of the chain
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Scope of Regulation 882/2004
• Regulation 882 / 2004 also complements Regulation 178/2002 by
establishing for authorities how these basic food law principles will be
interpreted, implemented and enforced via Official Controls of both EUproduced and imported products.
• It provides for EC Official Controls in 3rd Countries
• It establishes principles for 3rd Countries’ control operations
Does NOT require formal control plans by 3rd countries
It does not apply directly to feed or food businesses
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Scope of Regulation 882/2004
• Scope includes most activities covered by FEED and FOOD law:
– feed and food safety
– animal health and welfare (aspects relating to slaughter)
– plant health inspection
– consumer protection aspects
• labelling, additives, irradiation, GM, contact materials etc
• quality aspects
• Must be considered in parallel with Regulation 178/2002, plus new
Hygiene Regulations 852, 853 and 854/2004 and specific, existing
consumer protection and food safety legislation.
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Provisions for 3rd Countries
Requires “Official Guarantees” that EU imports meet EU or “equivalent”
safety standards and provides for assessment of 3rd country control
mechanisms
•
Requires accurate, up-to-date information on organisation, management
and results of control systems and procedures for:
– legislation (adopted or proposed)
– pesticide tolerances, additive approval etc
– risk assessment basis to determine “appropriate level” of protection
– follow-up to previous FVO inspections
– changes proposed to meet EU requirements / recommendations
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Requirements of Official Controls
Official Controls
• must enable verification of, or enforce compliance with, law
• must be carried out regularly; risk-based and appropriate frequency
• take account of operators’ past compliance, reliability of checks
already carried out, and any indications of non-compliance
• without prior warning (generally), at any stage of production,
processing and distribution; in accordance with written procedures
• legal procedures must be in place to enable relevant access to
premises and documentation
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Requirements of Official Controls
• Competent Authorities must meet operational criteria that guarantee
efficiency, effectiveness and impartiality
• Control staff:
– adequate training to be able to perform duties competently
– free from conflicts of interest
– must respect professional confidences
• Specific tasks may be delegated to independent body, but only under
strict conditions
– must be impartial; have legal powers necessary to perform tasks
– systems to ensure co-ordination between relevant bodies
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Requirements of Official Controls
• access to adequate laboratory capacity
– appropriate, properly-maintained facilities and equipment
– sufficient, suitably qualified and experienced staff
• sampling and analysis methods
– validated - internationally-accepted protocols (e.g. CEN / ISO /
IUPAC) including those based on performance criteria
– carried out by accredited laboratories
• if non-compliance: appropriate measures to be taken; measures and
sanctions must be effective, dissuasive and proportionate
• contingency plans: measures to be taken, reviewed as appropriate
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EU Food & Veterinary Office - Extended Role
• Periodic, general audits by FVO
– to verify compliance or “equivalence” and validity of “guarantee”
– frequency based on nature of products, perceived risk and
compliance history
• assessment of overall operation of national control systems
• FVO will also address identified, specific problems as necessary
• Wider focus to include plant-based food and plant health sectors
[Historically, FVO primarily in veterinary sector, (minor) in feed sector (BSE
aspects) and limited in plant health]
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FVO - Scope of Inspections
• legislation
• organisation, powers, independence, supervision of competent
authorities and their authority to enforce legislation effectively
• training and competence of staff
• resources, including diagnostic facilities, available to authorities
• existence and operation of documented control procedures and
systems based on priorities
• animal health, zoonoses and plant health status, and procedures for
international notification of outbreaks of animal and plant diseases
• extent of controls on imports of animals, plants and their products
• assurances on compliance or ”equivalence” to EU requirements
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FVO - Typical Report Structures
• Refer to the two FVO Mission Reports available under
references 1500/1998 and 1004/2000 by searching
“Kazakhstan” on
http://europa.eu.int/comm/food/fvo/ir_search_en.cfm
Report on mission in field of animal and public health and fishery
products (November – December 1998)
Report on mission to assess compliance with Directive 91/493 on
fishery products (April 2000)
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3rd Country - Likely Consequences
• Outlines Operating Principles for 3rd Country Official Control
• Systems must be auditable if EC is to verify guarantees of compliance
or “equivalence”
• Greater emphasis on formal accreditation of laboratories and control
systems by independent, internationally-recognised bodies
• Improved co-ordination of regional / delegated official controls
• Possible additional layer of control to accommodate extended role of
existing issuers of SPS certificates and / or establishment of new
Authorities with wider responsibilities
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Private Sector Systems - Recognition
• Many fruit and vegetable imports currently subject to stringent
private sector schemes (e.g. EU retailers), often operating to safety
and hygiene standards in excess of legislation
• Essential part of commercial requirements for international trade
• Recognition essential in providing significant, practical contribution
in establishing confidence in “guarantees” supplied by 3rd Countries
• Pre-export checks by “control bodies” may be approved
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Genetically Modified Foods
GM LABELLING and TRACEABILITY
Legislation since April 2004
• labelling required for ALL ingredients derived from GMOs
• ‘adventitious’ thresholds exemptions:
– 0.9% for all EU-approved GMOs and derivatives
– 0.5% for “non-EU approved” GMOs
– zero tolerance for non-approved varieties
• traceability required - “one up / one down” principle
– 5-year record-keeping – ‘standardised’ procedures
• post-market monitoring for all approved GM materials
• equivalent requirements for GM foods / animal feed / petfoods
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GM FOOD & FEED: uncertain scope
• ‘Foods containing GMOs’ (none at present)
– potentially includes yoghurt, cheese, salami, beer ….
• ‘Foods derived from GMOs, in whole or in part’
– could currently include ~35 ingredients and additives from GM crops
(soya, maize, cotton and rapeseed)
– sugar beet, potato and rice etc (globally)
– increasing number of GM crops, GMMs and ‘derivatives’
– fermentation products (vitamins, amino acids etc)
• on a case-by-case basis
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SOYA
Oil
Protein
Bran
Fermented
Beans,
Flakes
Flours
Isolate
Concentrate
Textured/powder
Enzymatic
conversion
Chemical
conversion
Lecithins
Vitamins
Antioxidants
Sterols
Isoflavones
Emulsifiers
Hydrogenation
etc
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Flavour
Enhancers
Hydrolysates
Flavours
Amino acids
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ADVENTITIOUS PRESENCE
•
Thresholds of 0.9% / 0.5% / zero according to status of GMO
•
To establish presence as “adventitious or technically
unavoidable”, operators must be able to show they have taken
appropriate steps to avoid the presence of the GM food or feed
As yet, no official Guidance produced
Numerous commercial Identity Preservation protocols available
GM derivatives are non-detectable, non-quantifiable …
… must rely on DOCUMENTATION
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GMO Detection and Analysis
• Only applicable when Novel DNA and/or Protein is present
– cannot be used for refined derivatives
• Most appropriate methods are based on extraction and
multiplication of DNA (“PCR” tests)
• BUT ...
– although detection is reliable down to ~0.01%
– accurate quantification is possible only to ~1%
Considerable work being done through EU Joint Research Centre:
http://biotech.jrc.it/
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GMO Detection and Analysis
Searchable database organized into three sections:
• General information on GMO and corresponding method (i.e.
producer, host plant, trait, purpose of method, specificity etc);
• Essential technical information on method (i.e. primer and
probe sequences, description of genetic target, amplicon
length, apparatus, use of certified reference materials, amplicon
verification etc);
• Specific information on the method’s proficiency and its
validation status (ring trials, repeatability, statistics etc)
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