Consolidated text – Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs
In force
Publication date: 24/03/2021
ELI: http://data.europa.eu/eli/reg/2004/852/2021-03-24
| ►B | REGULATION (EC) No 852/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 April 2004 on the hygiene of foodstuffs (OJ L 139 30.4.2004, p. 1) |
Amended by:
| ►M1 | COMMISSION REGULATION (EC) No 1019/2008 of 17 October 2008 | L 277 | 7 | 18.10.2008 |
| ►M2 | REGULATION (EC) No 219/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 March 2009 | L 87 | 109 | 31.3.2009 |
| ►M3 | COMMISSION REGULATION (EU) 2021/382 of 3 March 2021 | L 74 | 3 | 4.3.2021 |
Corrected by:
| ►C1 | Corrigendum, OJ L 226, 25.6.2004, p. 3 (852/2004) |
CHAPTER I – GENERAL PROVISIONS
Article 1 – Scope
- This Regulation lays down general rules for food business operators on the hygiene of foodstuffs, taking particular account of the following principles:
- (a) primary responsibility for food safety rests with the food business operator;
- (b) it is necessary to ensure food safety throughout the food chain, starting with primary production;
- (c) it is important, for food that cannot be stored safely at ambient temperatures, particularly frozen food, to maintain the cold chain;
- (d) general implementation of procedures based on the HACCP principles, together with the application of good hygiene practice, should reinforce food business operators' responsibility;
- (e) 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;
- (f) it is necessary to establish microbiological criteria and temperature control requirements based on a scientific risk assessment;
- (g) 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, without prejudice to more specific requirements relating to food hygiene.
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This Regulation shall not apply to:
- (a) primary production for private domestic use;
- (b) the domestic preparation, handling or storage of food for private domestic consumption;
- (c) 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;
- (d) 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.
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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.
Article 2 – Definitions
For the purposes of this Regulation:
- ‘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;
- ‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing;
- ‘establishment’ means any unit of a food business;
- ‘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;
- ‘equivalent’ means, in respect of different systems, capable of meeting the same objectives;
- ‘contamination’ means the presence or introduction of a hazard;
- ‘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;
- ‘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;
- ‘clean water’ means clean seawater and fresh water of a similar quality;
- ‘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;
- ‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;
- ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards;
- ‘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;
- ‘unprocessed products’ means foodstuffs that have not undergone processing, and includes products that have been divided, part‑ed, severed, sliced, boned, minced, skinned, ground, cut, cleaned, trimmed, husked, milled, chilled, frozen, deep‑frozen or thawed;
- ‘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.
CHAPTER II – FOOD BUSINESS OPERATORS' OBLIGATIONS
Article 3 – General obligation
Food business operators shall ensure that all stages of production, processing and distribution of food under their control satisfy the relevant hygiene requirements laid down in this Regulation.
Article 4 – General and specific hygiene requirements
- Food business operators carrying out primary production and those associated operations listed in Annex I shall comply with the general hygiene provisions laid down in part A of Annex I and any specific requirements provided for in Regulation (EC) No 853/2004.
- Food business operators carrying out any stage of production, processing and distribution of food after those stages to which paragraph 1 applies shall comply with the general hygiene requirements laid down in Annex II and any specific requirements provided for in Regulation (EC) No 853/2004.
- Food business operators shall, as appropriate, adopt the following specific hygiene measures:
- (a) compliance with microbiological criteria for foodstuffs;
- (b) procedures necessary to meet targets set to achieve the objectives of this Regulation;
- (c) compliance with temperature control requirements for foodstuffs;
- (d) maintenance of the cold chain;
- (e) sampling and analysis.
- The criteria, requirements and targets referred to in paragraph 3, and associated sampling and analysis methods shall be laid down by the Commission.
- When this Regulation, Regulation (EC) No 853/2004 and their implementing measures do not specify sampling or analysis methods, food business operators may use appropriate methods laid down in other Community or national legislation or, in the absence of such methods, methods that offer equivalent results to those obtained using the reference method, if they are scientifically validated.
- Food business operators may use the guides provided for in Articles 7, 8 and 9 as an aid to compliance with their obligations under this Regulation.
Article 5 – Hazard analysis and critical control points
- Food business operators shall put in place, implement and maintain a permanent procedure or procedures based on the HACCP principles.
- The HACCP principles consist of:
- (a) identifying any hazards that must be prevented, eliminated or reduced to acceptable levels;
- (b) identifying the critical control points at the step or steps at which control is essential to prevent or eliminate a hazard or to reduce it to acceptable levels;
- (c) establishing critical limits at critical control points which separate acceptability from unacceptability for the prevention, elimination or reduction of identified hazards;
- (d) establishing and implementing effective monitoring procedures at critical control points;
- (e) establishing corrective actions when monitoring indicates that a critical control point is not under control;
- (f) establishing procedures, which shall be carried out regularly, to verify that the measures outlined in sub‑paragraphs (a) to (e) are working effectively;
- (g) establishing documents and records commensurate with the nature and size of the food business to demonstrate the effective application of the measures outlined in sub‑paragraphs (a) to (f).
- Paragraph 1 shall apply only to food business operators carrying out any stage of production, processing and distribution of food after primary production and those associated operations listed in Annex I.
- Food business operators shall:
- (a) provide the competent authority with evidence of their compliance with paragraph 1 in the manner that the competent authority requires, taking account of the nature and size of the food business;
- (b) ensure that any documents describing the procedures developed in accordance with this Article are up‑to‑date at all times;
- (c) retain any other documents and records for an appropriate period.
- Detailed arrangements for the implementation of this Article may be laid down in accordance with the procedure referred to in Article 14(2).
Article 6 – Official controls, registration and approval
- Food business operators shall cooperate with the competent authorities in accordance with other applicable Community legislation or, if it does not exist, with national law.
- Every food business operator shall notify the appropriate competent authority, in the manner that the latter requires, of each establishment under its control that carries out any of the stages of production, processing and distribution of food, with a view to the registration of each such establishment.
- Establishments shall be approved by the competent authority, following at least one on‑site visit, when approval is required:
- (a) under the national law of the Member State in which the establishment is located;
- (b) under Regulation (EC) No 853/2004;
- (c) by a decision adopted by the Commission.
The above text is provided for documentation purposes only and has no legal effect. The authentic versions of the relevant Acts, including their preambles, are those published in the Official Journal of the European Union and available on EUR‑Lex.