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Article 2 of Regulation (EC) No 852/2004 — Definitions

Updated 2026-07-12 · Consolidated text as of 2021-03-24 · Reviewed by: Redazione ce85204 — revisione editoriale assistita da AI (2026-07-12)

Article 2 of Regulation (EC) No 852/2004 defines the Regulation's key terms: food hygiene, primary products, establishment, competent authority, equivalent, contamination, wrapping and packaging. The term food business operator is not defined here: it is defined in Article 3(3) of Regulation (EC) No 178/2002.

Article 2 — DefinitionsText consolidated as of 2021-03-24 — source EUR-Lex
1

For the purposes of this Regulation:

  • (a) ‘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;

  • (b) ‘primary products’ means products of primary production including products of the soil, of stock farming, of hunting and fishing;

  • (c) ‘establishment’ means any unit of a food business;

  • (d) ‘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;

  • (e) ‘equivalent’ means, in respect of different systems, capable of meeting the same objectives;

  • (f) ‘contamination’ means the presence or introduction of a hazard;

  • (g) ‘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 ();

  • (h) ‘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;

  • (i) ‘clean water’ means clean seawater and fresh water of a similar quality;

  • (j) ‘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;

  • (k) ‘packaging’ means the placing of one or more wrapped foodstuffs in a second container, and the latter container itself;

  • (l) ‘hermetically sealed container’ means a container that is designed and intended to be secure against the entry of hazards;

  • (m) ‘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;

  • (n) ‘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;

  • (o) ‘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.

2

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

3

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.

At a glance

Commentary

Ratio and background

Article 2 builds the Regulation's terminology on two levels: the technical food hygiene definitions listed in paragraph 1, and a general cross-reference to the definitions of the EU's framework food law in paragraph 2 Article 2(2) of Regulation (EC) No 852/2004. This avoids duplication: the horizontal concepts (food, food business, food business operator, risk, hazard, traceability) stay anchored in Regulation (EC) No 178/2002 Article 3 of Regulation (EC) No 178/2002 and apply uniformly across the Hygiene Package. Paragraph 3 adds an interpretative clause that scales the Annexes to the Regulation's objectives and is one of the textual foundations of flexibility for small businesses Article 2(3) of Regulation (EC) No 852/2004.

Who is covered

The definitions bind everyone applying the Regulation: operators, in their own food safety procedures, and control authorities. Two notions have direct subjective weight. An "establishment" is any unit of a food business Article 2(1) of Regulation (EC) No 852/2004: the notion is deliberately broad (it also captures movable or temporary premises, dealt with in Annex II, Chapter III Annex II, Chapter III of Regulation (EC) No 852/2004) and is the reference unit for registration and approval under Article 6 Article 6(2) of Regulation (EC) No 852/2004. The "competent authority" is the Member State's central authority or any authority to which that competence has been delegated, including third-country authorities where appropriate Article 2(1) of Regulation (EC) No 852/2004; the designation of competent authorities for official controls is now governed by Regulation (EU) 2017/625 Article 4 of Regulation (EU) 2017/625.

What is covered

The key definitions of paragraph 1 Article 2(1) of Regulation (EC) No 852/2004 can be grouped as follows:

GroupDefinitionsPractical relevance
Hygiene and hazardsfood hygiene (point a), contamination (point f)delimit the object of the operator's own controls; "hazard" is defined by Regulation 178/2002 Article 3(14) of Regulation (EC) No 178/2002
Productsprimary products (point b), unprocessed products (point n), processed products (point o), processing (point m)separate primary production from later stages; mark the border with Regulation 853/2004
Waterpotable water (point g), clean seawater (point h), clean water (point i)applied by Annex II, Chapter VII on water supply Annex II, Chapter VII of Regulation (EC) No 852/2004
Wrappingwrapping (point j), packaging (point k), hermetically sealed container (point l)applied by Annex II, Chapter X on wrapping and packaging Annex II, Chapter X of Regulation (EC) No 852/2004
Organisationestablishment (point c), competent authority (point d), equivalent (point e)registration, controls, flexibility and imports

The definition of "food hygiene" (the measures and conditions necessary to control hazards and to ensure fitness for human consumption taking into account the intended use) is functional: hygiene is not cleanliness in the colloquial sense but hazard control. "Equivalent" (capable of meeting the same objectives) is the key to the Regulation's objective-based approach and recurs both in national flexibility and in the imported-food principle of Article 1 Article 1(1) of Regulation (EC) No 852/2004. The definition of potable water refers to Directive 98/83/EC; that reference must today be read as pointing to Directive (EU) 2020/2184, which replaced it with effect from 13 January 2023 (see Sources).

Interaction with other instruments

Paragraph 2 incorporates the definitions of Regulation (EC) No 178/2002 Article 2(2) of Regulation (EC) No 852/2004. The ones most used when applying Regulation 852/2004 are: food Article 2 of Regulation (EC) No 178/2002; food business Article 3(2) of Regulation (EC) No 178/2002; food business operator Article 3(3) of Regulation (EC) No 178/2002; retail Article 3(7) of Regulation (EC) No 178/2002; risk Article 3(9) of Regulation (EC) No 178/2002; hazard Article 3(14) of Regulation (EC) No 178/2002; traceability Article 3(15) of Regulation (EC) No 178/2002; primary production Article 3(17) of Regulation (EC) No 178/2002; final consumer Article 3(18) of Regulation (EC) No 178/2002. For food of animal origin, the specific definitions of Regulation (EC) No 853/2004 apply in addition Article 2 of Regulation (EC) No 853/2004, and that Regulation in turn refers back both to Regulation 178/2002 and to the Article commented on here.

Practical application and open questions

The most frequent stumbling block is simply one of retrieval: anyone looking for the FBO definition in Article 2 will not find it, because it sits in Regulation 178/2002 Article 3(3) of Regulation (EC) No 178/2002. A great deal of secondary content wrongly attributes it to Regulation 852/2004. A second point concerns the wrapping/packaging pair: wrapping is the wrapper or container in direct contact with the food, packaging is the second, outer container Article 2(1) of Regulation (EC) No 852/2004; the distinction drives different requirements in Annex II, Chapter X Annex II, Chapter X of Regulation (EC) No 852/2004 and intersects with the rules on food contact materials Article 3 of Regulation (EC) No 1935/2004. Finally, paragraph 3: the terms "where necessary", "where appropriate", "adequate" and "sufficient" in the Annexes mean what is necessary, appropriate, adequate or sufficient to achieve the objectives of the Regulation Article 2(3) of Regulation (EC) No 852/2004. This is the textual basis for calibrating the general and specific hygiene requirements Article 4(2) of Regulation (EC) No 852/2004 to the nature and size of the business — it is not an exemption, and the operator's assessment remains open to challenge by the competent authority during official controls.

Penalties

Article 2 carries no penalties of its own, but the definitions delimit what conduct can be sanctioned: classifying a unit as an "establishment" or an activity as a food business determines whether the registration and own-control duties apply, and non-compliance with those duties is punished under national law — in Italy under Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007. The country-by-country picture is in the country pages.

Case law

As at the date this page was last updated, we are not aware of any Court of Justice of the European Union rulings specifically interpreting Article 2 of Regulation (EC) No 852/2004. The most significant definitional questions (the concepts of food, food business and food business operator) concern Articles 2 and 3 of Regulation (EC) No 178/2002 Article 3 of Regulation (EC) No 178/2002.

Implementation in the Member States

The definitions are directly applicable and require no national transposition. Implementation matters for the notion of "competent authority": each Member State designates its own control architecture under Regulation (EU) 2017/625 Article 4 of Regulation (EU) 2017/625, and the arrangements differ markedly (in Italy: the Ministry of Health, the regions and the local health authorities). Country detail is in the country pages.

Common errors

Frequently asked questions

Where is the food business operator (FBO) defined?

In Article 3(3) of Regulation (EC) No 178/2002 Article 3(3) of Regulation (EC) No 178/2002: the natural or legal person responsible for ensuring that the requirements of food law are met within the food business under their control. Regulation 852/2004 incorporates it through Article 2(2) Article 2(2) of Regulation (EC) No 852/2004 without restating it.

What does food hygiene mean under Regulation 852/2004?

The measures and conditions necessary to control hazards and to ensure fitness for human consumption of a foodstuff taking into account its intended use Article 2(1) of Regulation (EC) No 852/2004. The concept is therefore wider than cleanliness: it coincides with hazard control throughout the process.

What is an establishment?

Any unit of a food business Article 2(1) of Regulation (EC) No 852/2004: a workshop, a shop, a warehouse, even a movable or temporary structure. It is the reference unit for registration and, for establishments handling food of animal origin, for approval under Article 6 Article 6(3) of Regulation (EC) No 852/2004.

What is the difference between wrapping and packaging?

Wrapping is the placing of a foodstuff in a wrapper or container in direct contact with it; packaging is the placing of one or more wrapped foodstuffs in a second container Article 2(1) of Regulation (EC) No 852/2004. The related hygiene requirements are in Annex II, Chapter X Annex II, Chapter X of Regulation (EC) No 852/2004.

What are primary products?

Products of primary production, including products of the soil, of stock farming, of hunting and fishing Article 2(1) of Regulation (EC) No 852/2004. Primary production itself is defined by Regulation 178/2002 Article 3(17) of Regulation (EC) No 178/2002 and delimits both the application of Annex I and the small-quantities exclusion in Article 1 Article 1(2) of Regulation (EC) No 852/2004.

What does equivalent mean?

In respect of different systems, capable of meeting the same objectives Article 2(1) of Regulation (EC) No 852/2004. The notion underpins the Regulation's objective-based approach: measures other than those indicated are acceptable if they achieve the same safety result, as with the standards required of imported food Article 1(1) of Regulation (EC) No 852/2004.

The potable water definition refers to Directive 98/83/EC: is that directive still in force?

The consolidated text of Article 2 still cites Directive 98/83/EC Article 2(1) of Regulation (EC) No 852/2004, but that directive has been replaced by Directive (EU) 2020/2184 on the quality of water intended for human consumption, applicable from 13 January 2023: the reference must be read as pointing to the new directive (see Sources).

Sources

Drafting and review

Editorial team, ce85204. Draft generated with AI from primary sources; AI-assisted editorial review (see methodology).