Regulation (EC) No 853/2004 of the European Parliament and of the Council of 29 April 2004 laying down specific hygiene rules for food of animal origin

This Regulation lays down specific rules on the hygiene of food of animal origin for food business operators. These rules supplement those laid down by Regulation (EC) No 852/2004. They shall apply to unprocessed and processed products of animal origin.

Unless expressly indicated to the contrary, this Regulation shall not apply to food containing both products of plant origin and processed products of animal origin. However, processed products of animal origin used to prepare such food shall be obtained and handled in accordance with the requirements of this Regulation.

This Regulation shall not apply in relation to:

1. primary production for private domestic use;

2. the domestic preparation, handling or storage of food for private domestic consumption;

3. 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;

4. the direct supply, by the producer, of small quantities of meat from poultry and lagomorphs slaughtered on the farm to the final consumer or to local retail establishments directly supplying such meat to the final consumer;

5. 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.

Member States shall establish, according to national law, rules governing the activities and persons referred to in paragraph 3(c), (d) and (e). Such national rules shall ensure the achievement of the objectives of this Regulation.

1. Unless expressly indicated to the contrary, this Regulation shall not apply to retail.

2. However, this Regulation shall apply to retail when operations are carried out with a view to the supply of food of animal origin to another establishment, unless:

   1. the operations consist only of storage or transport, in which case the specific temperature requirements laid down in Annex III shall nevertheless apply;

      or

   2. the supply of food of animal origin from the retail establishment is to other retail establishments only and, in accordance with national law, is a marginal, localised and restricted activity.

3. Member States may adopt national measures to apply the requirements of this Regulation to retail establishments situated on their territory to which it would not apply pursuant to subparagraphs (a) or (b).

This Regulation shall apply without prejudice to:

1. relevant animal and public health rules, including more stringent rules laid down for the prevention, control and eradication of certain transmissible spongiform encephalopathies;

2. animal welfare requirements;

   and

3. requirements concerning the identification of animals and the traceability of products of animal origin.

Food business operators shall comply with the relevant provisions of Annexes II and III.

Food business operators shall not use any substance other than potable water or, when Regulation (EC) No 852/2004 or this Regulation permits its use, clean water, to remove surface contamination from products of animal origin, unless use of the substance has been approved by the Commission. For that purpose the Commission is empowered to adopt delegated acts in accordance with Article 11a supplementing this Regulation. Food business operators shall also comply with any conditions for use that may be adopted under the same procedure. The use of an approved substance shall not affect the food business operator’s duty to comply with the requirements of this Regulation.