As part of the revision of legislation on the hygiene of foodstuffs ("hygiene package"), this Regulation focuses on defining the food safety objectives to be achieved, leaving the food operators responsible for adopting the safety measures to be implemented in order to guarantee food safety.
This Regulation replaces Directive 93/43/EEC on the hygiene of foodstuffs *, with a view to establishing a comprehensive and integrated policy covering all food from the farm to the point of sale to the consumer.
This Regulation seeks to ensure the hygiene of foodstuffs at all stages of the production process, from primary production * up to and including sale to the final consumer. It does not cover issues relating to nutrition or to the composition or quality of foodstuffs.
This Regulation applies to food businesses but not to the primary production of food for private domestic use or the domestic preparation of foodstuffs for private consumption.
General and specific provisions
All food business operators shall ensure that all stages for which they are responsible, from primary production up to and including the offering for sale or supply of foodstuffs to the final consumer, are carried out in a hygienic way in accordance with this Regulation.
Food business operators carrying out primary production and certain associated activities shall comply with the general hygiene provisions of part A of Annex I. Derogations may be granted for small businesses, provided that they do not compromise achievement of the Regulation's objectives.
These associated activities are:
- the transport, handling and storage of primary products at the place of production, where their nature has not been substantially altered;
- the transport of live animals, where this is necessary;
- transport, from the place of production to an establishment, of products of plant origin, fishery products and wild game, where their nature has not been substantially altered.
In addition, food business operators carrying out activities other than primary production shall comply with the general hygiene provisions of Annex II.
This Annex sets out the hygiene requirements for:
- food premises, including outside areas and sites;
- transport conditions;
- food waste;
- water supply;
- personal hygiene of persons in contact with food;
- wrapping and packaging;
- heat treatment, which may be used to process certain foodstuffs;
- training of food workers.
Member States may adapt the requirements laid down in Annex II to accommodate the needs of food businesses situated in regions suffering from special geographical constraints or affected by supply difficulties which are serving the local market, or to take account of traditional methods of production and the size of farms. The objectives of food safety * shall not however be compromised.
In addition, all food business operators shall comply with the provisions of Regulation (EC) No 853/2004 on specific hygiene rules for food of animal origin and, where appropriate, certain specific rules concerning microbiological criteria for foodstuffs, temperature control and compliance with the cold chain, sampling and analysis.
The HACCP system
Food business operators (other than at the level of primary production) shall apply the principles of the system of hazard analysis and critical control points (HACCP) introduced by the Codex Alimentarius (code of international food standards drawn up by the United Nations Food and Agriculture Organisation).
These principles prescribe a certain number of requirements to be met throughout the cycle of production, processing and distribution in order to permit, via hazard analysis, identification of the critical points which need to be kept under control in order to guarantee food safety:
- identify any hazards that must be prevented, eliminated or reduced to acceptable levels;
- identify the critical control points at the step or steps at which control is essential;
- establish critical limits beyond which intervention is necessary;
- establish and implement effective monitoring procedures at critical control points;
- establish corrective actions when monitoring indicates that a critical control point is not under control;
- implement own-check procedures to verify whether the measures adopted are working effectively;
- keep records to demonstrate the effective application of these measures and to facilitate official controls by the competent authority.
Guides to good practice and guides to the application of HACCP
Member States shall encourage the development of national guides to good practice by food business operators, which shall include guidance on compliance with the general rules of hygiene and the HACCP principles. Member States shall assess such national guides to ensure that their contents are practicable, that they have been developed having regard to the general principles of food hygiene of the Codex Alimentarius and that all interested parties have been consulted. Those national guides deemed to comply with these requirements shall be forwarded to the Commission.
Where a Member State or the Commission considers that there is a need for uniform Community guides, the Commission shall consider the case for such guides. The Standing Committees set up to assist the Commission shall ensure that the contents of these guides are practicable, that they have been developed having regard to the general principles of food hygiene of the Codex Alimentarius and of national guides, and that all interested parties have been consulted.
Food business operators may refer to national guides or Community guides equally.
Registration or approval of food businesses
Food businesses operators shall cooperate with the competent authorities and in particular ensure that all establishments under their control are registered with the appropriate authority and keep this authority informed of any changes (e.g. closure of the establishment).
Where required by national or Community legislation, businesses in the food sector must be approved by the competent authority and shall not operate without such approval.
Traceability and withdrawal of food products
In accordance with Regulation (EC) No 178/2002, food business operators shall set up traceability systems and procedures for ingredients, foodstuffs and, where appropriate, animals used for food production.
Similarly, where a food business operator identifies that a foodstuff presents a serious risk to health it shall immediately withdraw that foodstuff from the market and inform users and the competent authority.
The application of HACCP principles by food business operators shall not replace the official controls carried out by the competent authority. Operators are required to collaborate with the competent authorities in accordance with Community legislation or, where none exists, national legislation.
Foodstuffs imported into the Community shall comply with the Community hygiene standards or with equivalent standards.
Foodstuffs of animal origin exported out of the Community shall at least comply with the requirements that would apply if they were marketed within the Community, as well as to any requirements that may be imposed by the importing country.
Report to the Council and Parliament
The Commission shall submit a report to the European Parliament and the Council, where appropriate with any relevant proposals, within five years of this Regulation entering into force, reviewing the experience gained from implementing this Regulation and determining whether it is appropriate to apply HACCP principles to food business operators carrying out primary production activities and the associated activities described above.
This Regulation forms part of the "hygiene package", a body of law laying down hygiene rules for foodstuffs, which, in addition to this Regulation, includes the following acts:
- Regulation (EC) No 853/2004 laying down specific hygiene rules for food of animal origin in order to guarantee a high level of food safety and public health;
- Regulation (EC) No 854/2004 putting in place a Community framework for official controls on products of animal origin intended for human consumption and laying down specific rules for fresh meat, bivalve molluscs, milk and milk products.
The following acts supplement Community legislation on food hygiene:
- Regulation (EC) No 178/2002 laying down the general principles of food law. This Regulation explains the food safety procedures and establishes the European Food Safety Authority;
- Regulation (EC) No 882/2004 reorganising official controls on foodstuffs and feedingstuffs so as to integrate controls at all stages of production and in all sectors;
- Directive 2002/99/EC laying down the conditions for placing products of animal origin on the market and the restrictions applicable to products from non-EU countries or regions of non-EU countries subject to animal health restrictions.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 852/2004
OJ L 139 of 30.04.2004
|Amending act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 219/2009
OJ L 87 of 31.3.2009
The successive amendments and corrections to Regulation (EC) No 852/2004 have been incorporated into the original text. This consolidated version is of documentary value only.