Overview of the EU Food Safety Requirements

1. Overview of the EU Food Safety Requirements EU Food Safety Acquis Communautaire Matti Lampi Deputy Team Leader, Food Safety Expert

2. Basic Goals for Developing EU Food Legislation • Ensure high level of protection of public health • Farm to fork approach with unbroken traceability • Ensure free movement of foodstuffs in the internal market • Ensure competitiveness of EU food businesses • Ensure legislation based on scientific evidence and risk assessment • Precautionary principle • Place the primary responsibility for safe food on food enterprises • HACPP principle • Ensure coherent, rational and user friendly (transparent) legislation • Transparent public consultation

3. EU ”Hygiene Package” of 2004

4. General principles of food law Regulation (EC) No 178/2002 of the European Parliament and of the Council • (Article 1.3) Covers all stages of production, processing and distribution of food and feed (not applied to primary production or domestic preparation, handling or storage of food for private domestic use) • (Article 5.1) Food law shall pursue one or more of the general objectives of • a high level protection of human health and • the protection of consumers’ interests, including fair practices in food trade, taking account of, where appropriate, the protection of • animal health and welfare, plant health and the environment • (Article 5.2) Food law shall aim to achieve the free movement in the Community of food and feed • (Article 5.3) Where international standards exist, they shall be taken into consideration

5. Specific principles of food law Regulation (EC) No 178/2002 of the European Parliament and of the Council • (Article 7) Precautionary principle allows temporary protective measures to be adopted also when scientific uncertainty persists • (Article 8) Protection of consumers’ interests means that the food law shall aim at the prevention of • fraudulent or deceptive practices; • the adulteration of food; and • any other practices which may mislead the consumer. • (Article 9) Public consultation needs to be open and transparent during the preparation, evaluation and revision of food law, except in cases of urgency • (Article 10) Public needs to be appropriately informed, where there are reasonable grounds to suspect that a food or feed may present a risk for human or animal health

6. National Guides to Good Practice Regulation (EC) No 852/2004 of the European Parliament and of the Council • (Article 7) Member States shall encourage the development of national guides to good practice for hygiene and for the application of HACCP principles in accordance with Article 8. Community guides shall be developed in accordance with Article 9. The dissemination and use of both national and Community guides shall be encouraged. Nevertheless, food business operators may use these guides on a voluntary basis. • (Article 8.4) Member States shall forward to the Commission national guides complying with the requirements of paragraph 3. The Commission shall set up and run a registration system for such guides and make it available to Member States.

7. Hygiene of foodstuffs Regulation (EC) No 852/2004 of the European Parliament and of the Council (Article 1) General principles for food business operators: • primary responsibility for food safety rests with the food business operator; • it is necessary to ensure food safety throughout the food chain, starting with primary production; • it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain; • general implementation of procedures based on the HACCP principles, should reinforce food business operators’ responsibility; • guides for good hygiene and HACCP practice are valuable instruments to aid food business operators at all levels of food chain; • it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment; • it is necessary to ensure that imported foods are at least the same or equivalent hygiene standard as food produced in the Community.

8. Specific hygiene of foods of animal originRegulation (EC) No 853/2004 of the European Parliament and of the Council • (Article 4.1) No establishment shall place products in the market unless the competent authority has registered it or approved it, where required in 4.2 • (Article 4.2) Approval of the competent authority prior to operation is required as mentioned in Annex III, with the exception of establishments carrying out only: • primary production • transport operations or retail operations • the storage of products not requiring temperature-controlled storage • (Article 5.1) Food business operators shall not place on the market a product of animal origin handled in an establishment subject to approval unless it has either: • a health mark applied in accordance with 854/2004; or • if not necessary, an identification mark according to Annex II

9. Official Control of foodsRegulation (EC) No 882/2004 of the European Parliament and of the Council • (Article 1.1) General rules for official controls to verify compliance with feed, food and animal health rules aiming, in particular: • preventing, eliminating or reducing risks to humans and animals, either directly or through environment • guaranteeing fair practices in feed and food trade and • protecting consumers’ interests • (Article 1.4) The performance of official controls shall be without prejudice to feed and food business operators’ primary legal responsibility for ensuring feed and food safety, as laid down in Regulation (EC) No 178/2002, and any liability arising from the breach of their obligations.

10. Official Control Competent Authority Regulation (EC) No 882/2004 of the European Parliament and of the Council (Article 4) Member states shall designate the competent authorities responsible for the purposes and official controls set out in this Regulation, who shall ensure: • the effectiveness of official controls on live animals, feed and food at all stages of production, processing and production, and feed use; • that staff carrying out official controls are free from conflict of interest; • that they have, or have access to, and adequate laboratory capacity; • that they have properly maintained facilities and equipment; • that they have legal powers to carry out official controls and to take measures provided for in this Regulation; • that they have contingency plans in place, and are prepared to operate such plans in the event of emergency; • that the feed and food business operators are obliged to undergo any inspection carried out in accordance with this Regulation and to assist staff of the competent authority in accomplishing their tasks

11. Specific Organisation of Official Controls Regulation (EC) No 854/2004 of the European Parliament and of the Council • (Article 4.1) Member States shall ensure that food business operators offer all assistance needed to ensure that official controls carried out by the competent authority can be performed effectively. They shall in particular: • give access to all buildings, premises, installations or other infrastructures; • make available any documentation and record required under the present regulation or considered necessary by the competent authority for judging the situation. • (Article 4.3)Official controls in relation to community establishments is based on-site visits of establishments for performing: • audits of good hygiene practices and HACCP-procedures; • product specific official controls; • any particular auditing tasks specified in the Annexes

12. Delegation of Competent Authority tasksRegulation (EC) No 882/2004 of the European Parliament and of the Council • (Article 5.1)The competent authority may delegate specific tasks related to official controls to one or more control bodies in accordance with paragraphs 2 to 4. A list of tasks that may or may not be delegated may be established in accordance with the procedure referred to in Article 62(3). However, the activities referred to in Article 54 (i.e. Action in case of non-compliance) shall not be the subject of such a delegation.

13. Official Controls on imports to EURegulation (EC) No 854/2004 of the European Parliament and of the Council CHAPTER IIIPROCEDURES CONCERNING IMPORTS (of products of animal origin) • (Article 10)To ensure the uniform application of the principles and conditions laid down in Article 11 of Regulation (EC) No 178/2002 and Title VI, Chapter II, of Regulation (EC) No 882/2004 the procedures laid down in this Chapter shall apply. • (Article 11.1)Products of animal origin shall be imported only from a third country or a part of third country that appears on a list drawn up and updated in accordance with the procedure referred to in Article 19(2).

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