32004R0852

WHAT IS THE AIM OF THE REGULATION?

• The European Union (EU) seeks to ensure food hygiene at all stages of the production process, from farms to processing plants and retailers to the final consumer.
• The regulation and its annexes define a set of requirements for the EU that firms working with food must meet in order to ensure that food is safe for consumers.

KEY POINTS

The key principle is that everyone working in the food business must ensure food is dealt with in a hygienic and safe way, i.e. free of contamination from foodborne hazards, at every stage of the production process. This is achieved through:

• good hygiene practices;
• procedures based on the hazard analysis and critical control points (HACCP) principles.

Good hygiene practices

Annex I lays down good hygiene practices applicable during the primary production stage (i.e. farming, hunting or fishing) and during the transport, handling and storage of primary products and the transport of live animals.

The good hygiene practices set out in Annex II apply to food operators after primary production (slaughterhouses, processing plants, retailers, etc.) and cover areas such as:

• cleanness of food premises and equipment;
• transport conditions;
• food waste management;
• water supply;
• personal hygiene and training of food workers;
• wrapping and packaging;
• heat treatment processes.

Procedures based on the HACCP principles

Businesses in the food sector (except those involved in primary production) should apply procedures based on HACCP principles in line with the general principles of food hygiene of the Codex Alimentarius. These principles include:

• identifying any hazards that must be controlled;
• identifying the critical control points and establishing critical limits;
• establishing and implementing effective monitoring;
• establishing corrective actions when needed;
• establishing procedures to verify that HACCP procedures are working effectively;
• establishing documents and records to demonstrate the effective application of the HACCP procedures.

The development of national and EU guidance to implement the good hygiene practices and HACCP procedures in a specific food sector is encouraged.

Other requirements of Regulation (EC) No 852/2004

Where required by national or EU legislation, businesses in the food sector must be approved and all premises registered with the appropriate authority, allowing this authority to visit them and verify compliance with the hygiene requirements.

Food imported into the EU and exported food of animal origin must comply with EU standards or their equivalent, as well as any requirements which the importing country may impose.

Closely related EU legislation

Regulation (EC) No 853/2004 (see summary) sets out additional specific hygiene rules for food of animal origin, for example meat, fishery products and cheeses.

Regulation (EC) No 178/2002 on the general principles and requirements of EU food law (see summary), also supplements the hygiene requirements by laying down obligations on the traceability¹ of food and requiring that when discovering that a food consignment presents a serious health risk, a food business must immediately withdraw that food from the market and inform users and the relevant authority.

Amendments to Regulation (EC) No 852/2004

The regulation has been amended several times, including by the following regulations.

• Regulation (EC) No 1019/2008 clarifies the rules regarding the water used for whole fishery products and for the external washing of live bivalve molluscs, echinoderms, tunicates and marine gastropods.
• Regulation (EU) No 579/2014 grants exceptions from certain rules in Regulation (EC) No 852/2004 to allow liquid oils or fats intended for or likely to be used for human consumption to be transported in seagoing vessels which are not reserved for the transport of foodstuffs, subject to certain conditions which ensure the protection of public health and the safety and wholesomeness of the foodstuffs concerned.
• Regulation (EU) 2021/382, which concerns food allergen management, redistribution of food and food safety culture, amends Annexes I and II of Regulation (EC) No 852/2004 to take into account certain advice from the European Food Safety Authority, and the adoption of new standards by the Codex Alimentarius Commission. These changes seek to:
  • include requirements introducing good hygiene practices to prevent or limit the presence of substances causing allergies or intolerances;
  • lay down certain requirements to promote and facilitate redistribution of food (e.g. food donations), while guaranteeing its safety for consumers;
  • include general requirements on food safety culture to increase awareness and improve the practices of food establishment employees.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 1 January 2006.

BACKGROUND

For more information, see:

• Food hygiene (European Commission).

KEY TERMS

1. Traceability. The ability to trace and follow a food or food-producing animal through all stages of production, processing and distribution.

MAIN DOCUMENT

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, 30.04.2004, pp. 1–54). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 3–21).

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.

RELATED DOCUMENTS

Commission Regulation (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs (OJ L 338, 22.12.2005, pp. 1–26).

See consolidated version.

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 (OJ L 139, 30.4.2004, pp. 55–205). Text republished in corrigendum (OJ L 226, 25.6.2004, pp. 22–82).

See consolidated version.

Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1–24).

See consolidated version.