EUROPEAN FOOD LEGISLATION

1. EUROPEAN FOOD LEGISLATION Neville Craddock EuropAid Project Astana March 2006 Astana March 2006

2. European Food LawThe Basic Structures Neville Craddock

3. Who’s Who in Europe • Institutions of the EU • Legal instruments • Decision-making process • Scientific advice • EFSA • National regulatory authorities • Non-institutional players Astana March 2006

4. 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 Astana March 2006

5. 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 Astana March 2006

6. 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 Astana March 2006

7. 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 Astana March 2006

8. 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 Astana March 2006

9. 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’ Astana March 2006

10. 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 Astana March 2006

11. 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 Astana March 2006

12. 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 Astana March 2006

13. 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 Astana March 2006

14. 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. Astana March 2006

15. 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 Astana March 2006

16. 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 Astana March 2006

17. 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 Astana March 2006

18. 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) Astana March 2006

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20. 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 Astana March 2006

21. 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 Astana March 2006

22. 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 Astana March 2006

23. 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 Astana March 2006

24. 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 Astana March 2006

25. 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 - "horizontal" and "vertical" • Consumer Information - largely "horizontal" • Quality Requirements - largely "vertical" plus Other legislation relevant to food: • Product liability • Misleading advertising • Weights and Measures Astana March 2006

26. 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 Astana March 2006

27. 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 Astana March 2006

28. 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 Astana March 2006

29. EU Framework Directives • Other framework Directives: • Food Irradiation: • Materials and Articles in Contact with Foods • Packaging Waste • Extraction solvents • Radio-activity • Etc … Astana March 2006

30. Casein & Caseinates Cocoa & Chocolate Coffee & Chicory Extracts Drinking Milk Erucic Acid Quick Frozen Foods Fruit Juices / Nectars Honey Jams, Jellies etc Preserved Milks Dairy Product Designations Natural Mineral Waters Novel Foods & Processes Organic Foods Particular Nutrition Uses Specified Sugars Spirit Drinks Water (Human Consumption) Yellow Fat Spreads EU Vertical Directives coverComposition, Labelling, Weights and Measures for: Astana March 2006

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32. EU OFFICIAL CONTROLS on FEED and FOOD IMPORTSRegulation 882 / 2004Neville Craddock Astana March 2006

33. 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 / 2004complements this “umbrella” Regulation by establishing for businesses the basic principles of hygienic construction of premises and all aspects of food manufacture • Regulation 853 / 2004complements Regulation 178/2002 by establishing the basic hygiene principles for businesses handling food of animal origin at all stages of the chain Astana March 2006

34. 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 EU-produced 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 Astana March 2006

35. 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. Astana March 2006

36. 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 Astana March 2006

37. 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 Astana March 2006

38. 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 Astana March 2006

39. 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 Astana March 2006

40. 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] Astana March 2006

41. 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 Astana March 2006

42. 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) Astana March 2006

43. 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 Astana March 2006

44. 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 Astana March 2006

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46. Genetically Modified Foods

47. 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 Astana March 2006

48. 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 Astana March 2006

49. SOYA Oil Protein Bran Fermented Beans, Flakes Flours Isolate Concentrate Textured/powder Enzymatic conversion Chemical conversion Flavour Enhancers Lecithins Vitamins Antioxidants Sterols Isoflavones Emulsifiers Hydrogenation etc Hydrolysates Flavours Amino acids Astana March 2006

50. 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 Astana March 2006