Regulation (EC) No 852/2004 of the european parliament and of the council of 29 April 2004 on the hygiene of foodstuffs

This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:

1. primary responsibility for food safety rests with the food business operator;

2. it is necessary to ensure food safety throughout the food chain, starting with primary production;

3. it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;

4. general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility;

5. guides to good practice are a valuable instrument to aid food business operators at all levels of the food chain with compliance with food hygiene rules and with the application of the HACCP principles;

6. it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment;

7. it is necessary to ensure that imported foods are of at least the same hygiene standard as food produced in the Community, or are of an equivalent standard.

This Regulation shall apply to all stages of production, processing and distribution of food and to exports, and without prejudice to more specific requirements relating to food hygiene.

This Regulation shall not apply 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. collection centres and tanneries which fall within the definition of food business only because they handle raw material for the production of gelatine or collagen.

Member States shall establish, under national law, rules governing the activities referred to in paragraph 2(c). Such national rules shall ensure the achievement of the objectives of this Regulation.

For the purposes of this Regulation:

1. ‘food hygiene’, hereinafter called ‘hygiene’, means the measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use;

2. ‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing;

3. ‘establishment’ means any unit of a food business;

4. ‘competent authority’ means the central authority of a Member State competent to ensure compliance with the requirements of this Regulation or any other authority to which that central authority has delegated that competence; it shall also include, where appropriate, the corresponding authority of a third country;

5. ‘equivalent’ means, in respect of different systems, capable of meeting the same objectives;

6. ‘contamination’ means the presence or introduction of a hazard;

7. ‘potable water’ means water meeting the minimum requirements laid down in Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption⁽¹⁾;

8. ‘clean seawater’ means natural, artificial or purified seawater or brackish water that does not contain micro-organisms, harmful substances or toxic marine plankton in quantities capable of directly or indirectly affecting the health quality of food;

9. ‘clean water’ means clean seawater and fresh water of a similar quality;

10. ‘wrapping’ means the placing of a foodstuff in a wrapper or container in direct contact with the foodstuff concerned, and the wrapper or container itself;

11. ‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;

12. ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards;

13. ‘processing’ means any action that substantially alters the initial product, including heating, smoking, curing, maturing, drying, marinating, extraction, extrusion or a combination of those processes;

14. ‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, parted, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep-frozen or thawed;

15. ‘processed products’ means foodstuffs resulting from the processing of unprocessed products. These products may contain ingredients that are necessary for their manufacture or to give them specific characteristics.

The definitions laid down in Regulation (EC) No 178/2002 shall also apply.

In the Annexes to this Regulation the terms ‘where necessary’, ‘where appropriate’, ‘adequate’ and ‘sufficient’ shall mean respectively where necessary, where appropriate, adequate or sufficient to achieve the objectives of this Regulation.