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EU Rules regarding Food Hygiene cover all stages of the production, processing, distribution and placing on the market of food intended for human consumption.

"Placing on the market" means the holding of food for the purpose of sale, including offering for sale, or any other form of transfer, whether free of charge or not, and the sale, distribution and other forms of transfer themselves.

The rules adopted in April 2004 and that came into force on 1 January 2006 are provided for in the following key acts:

  • 29 April 2004 - Regulation (EC) 852/2004 on the hygiene of foodstuffs

  • 29 April 2004 - Regulation (EC) 853/2004 laying down specific hygiene rules for food of animal origin

  • 29 April 2004 - Regulation (EC) 854/2004 laying down specific rules for the organisation of official controls on products of animal origin intended for human consumption

  • 21 April 2004 - Directive 2004/41/EC - repealing certain Directives concerning food hygiene and health conditions for the production and placing on the market of certain products of animal origin intended for human consumption and amending Council Directives 89/662/EEC and 92/118/EEC and Council Decision 95/408/EC

The new hygiene rules take particular account of the following principles:

  • Primary responsibility for food safety borne by the food business operator

  • Food safety ensured throughout the food chain, starting with primary production

  • General implementation of procedures based on the Hazard Analysis and Critical Control Points principles (HACCP)

  • Application of basic common hygiene requirements, possibly further specified for certain categories of food

  • Registration or approval for certain food establishments

  • Development of guides to good practice for hygiene or for the application of HACCP principles as a valuable instrument to aid food business operators at all levels of the food chain to comply with the new rules (see RELATED DOCUMENTS box)

  • Flexibility provided for food produced in remote areas (high mountains, remote islands) and for traditional production and methods

NB: Primary production for domestic use and domestic preparation of food for private consumption are not regulated by Community rules.

Implementing and delegated acts (former PRAC) of the hygiene package

  • Regulation (EC) No 2073/2005 on microbiological criteria for foodstuffs

  • Regulation (EC) No 2074/2005 laying down implementing measures for certain products under Regulation (EC) No 853/2004 of the European Parliament and of the Council and for the organisation of official controls under Regulation (EC) No 854/2004 of the European Parliament and of the Council and Regulation (EC) No 882/2004 of the European Parliament and of the Council, derogating from Regulation (EC) No 852/2004 of the European Parliament and of the Council and amending Regulations (EC) No 853/2004 and (EC) No 854/2004

  • Commission Implementing Regulation (EU) 2016/759 drawing up lists of third countries, parts of third countries and territories from which Member States are to authorise the introduction into the Union of certain products of animal origin intended for human consumption, laying down certificate requirements, amending Regulation (EC) No 2074/2005 and repealing Decision 2003/812/EC

  • Commission Implementing Regulation (EU) 2015/1375 laying down specific rules on official controls for Trichinella in meat

Related key rules

  • Regulation (EC) No 178/2002 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

  • Regulation (EC) No 882/2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules

  • Directive 2002/99/EC laying down the animal health rules governing the production, processing, distribution and introduction of products of animal origin for human consumption, 16 December 2002