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General Provisions of the Hygiene Package

The pursuit of a high level of protection of human life and health is one of the fundamental objectives of food law, as laid down in Regulation (EC) No 178/2002. The Regulation also lays down other common principles and definitions for national and Community food law. It places primary responsibility to produce safe food on the food business operator (FBO). The Regulation defines a food business as "any undertaking, whether for profit or not and whether public or private, carrying out any of the activities related to any stage of production, processing and distribution of food;" and food business operator as " the natural or legal persons responsible for ensuring that the requirements of food law are met within the food business under their control ".

Regulation (EC) 178/2002 places the following responsibilities on FBOs:

  • Safety - FBOs shall not place unsafe food on the market
  • Responsibility - FBOs are responsible for the safety of the food which they produce, transport, store or sell
  • Traceability - FBOs must be able to rapidly identify any supplier or consignee
  • Transparency - FBOs must immediately inform the competent authorities if they have a reason to believe that their food is not safe
  • Emergency - FBOs must immediately withdraw food from the market if they have a reason to believe that it is not safe
  • Prevention - FBOs must identify and regularly review the critical points in their processes and ensure that controls are applied at these points
  • Co-operation - FBOs must co-operate with the competent authorities in actions taken to reduce risks

Regulation (EC) 852/2004 lays down general rules for food business operators on the hygiene of foodstuffs and it applies to all stages of production, processing and distribution of food and to exports. It applies without prejudice to more specific requirements relating to food hygiene. FBOs must ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in Regulation 852/2004.

The Regulation does not apply to:

  • primary production for private domestic use;
  • the domestic preparation, handling or storage of food for private domestic consumption;
  • the direct supply, by the producer, of small quantities of primary products to the final consumer or to local retail establishments directly supplying the final consumer;
  • hunters who supply small quantities of wild game or wild game meat directly to the final consumer or to local retail establishments directly supplying the final consumer.

FBOs whose business involves primary production and associated operations (as listed in Part A of Annex 1 of Regulation (EC) 852/2004 must comply with the general hygiene provisions laid down in Part A of Annex I of Regulation (EC) 852/2004 and the specific requirements provided in Regulation (EC) No 853/2004.

Primary production is defined in Article 3(17) of Regulation (EC) No 178/2002 as 'the production, rearing or growing of primary products including harvesting, milking and farmed animal production prior to slaughter. It also includes hunting and fishing and the harvesting of wild products.' Primary products are defined Regulation (EC) 852/2004 as 'products of primary production including products of the soil, of stock farming, of hunting and fishing'. Fresh meat is not considered a primary product as it is obtained after slaughter.

The rules applicable to primary production are laid down in Annex I, Part A of Regulation (EC) No 852/2004. This Annex also covers the following operations that are associated with primary production:

  • The transport, storage and handling of primary products at the place of production, provided that this does not substantially alter their nature;
  • The transport of live animals, where this is necessary to achieve the objectives of Regulation (EC) 852/2004.

The hygiene provisions Regulation (EC) 852/2004 include that as far as possible; FBOs are to ensure that primary products are protected against contamination, having regard to any processing that primary products will subsequently undergo. FBOs rearing, harvesting or hunting animals or producing primary products of animal origin are to take appropriate measure to ensure the cleanliness of animals going to slaughter and, where necessary, production animals. They must also keep clean and, where necessary after cleaning, to disinfect, in an appropriate manner, equipment, containers, crates, vehicles and vessels.

FBOs must ensure that staff handling foodstuffs are in good health and undergo training on health risks.

FBOs carrying out any stage of production, processing and distribution of food after the above stages must comply with the general hygiene requirements laid down in Annex II of Regulation (EC) 852/2004 and any specific requirements provided for in Regulation (EC) No 853/2004.