Article 1 of Regulation (EC) No 852/2004 — Scope

Ratio and background

Article 1 opens the Regulation by setting out its seven guiding principles: primary responsibility of the food business operator, food safety along the whole chain starting with primary production, maintenance of the cold chain, general implementation of procedures based on the HACCP principles, the value of guides to good practice, science-based microbiological criteria and temperature control requirements, and equivalent hygiene standards for imported food Article 1(1) of Regulation (EC) No 852/2004. The Regulation belongs to the "Hygiene Package" adopted on 29 April 2004 and replaces Directive 93/43/EEC, which it expressly repeals Article 17(1) of Regulation (EC) No 852/2004. The operator-responsibility principle builds on the general rule already laid down in the EU's framework food law Article 17(1) of Regulation (EC) No 178/2002.

Who is covered

The addressees are food business operators. Regulation 852/2004 does not define the term: the definition sits in Article 3(3) of Regulation (EC) No 178/2002 Article 3(3) of Regulation (EC) No 178/2002, which applies by virtue of the cross-reference in Article 2(2) Article 2(2) of Regulation (EC) No 852/2004. A "food business" is any undertaking, public or private, whether or not for profit Article 3(2) of Regulation (EC) No 178/2002: school canteens, charities serving food on an organised and continuous basis, farm shops and street vendors are all within scope.

What is covered

The Regulation covers all stages of production, processing and distribution of food, and exports, "without prejudice to more specific requirements relating to food hygiene" Article 1(1) of Regulation (EC) No 852/2004. Primary production is included, subject to the lighter regime of Annex I Annex I of Regulation (EC) No 852/2004, while all later stages are subject to Annex II and to the obligation to put in place procedures based on the HACCP principles under Article 5 Article 5(1) of Regulation (EC) No 852/2004.

Paragraph 2 lists four exclusions Article 1(2) of Regulation (EC) No 852/2004: (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; and (d) collection centres and tanneries which qualify as food businesses only because they handle raw material for the production of gelatine or collagen. The domestic exclusion covers private consumption only: a person preparing food at home in order to sell it runs a food business and remains within scope, including the registration duty under Article 6 Article 6(2) of Regulation (EC) No 852/2004.

For point (c), paragraph 3 refers the matter to national law: Member States must establish rules governing direct supply and those rules must ensure that the Regulation's objectives are achieved Article 1(3) of Regulation (EC) No 852/2004. The Regulation deliberately sets no EU-wide threshold for "small quantities": each Member State fixes its own limits, and they differ considerably across the Union.

Interaction with other instruments

Three main connections. First, Regulation (EC) No 178/2002 supplies the general definitions (food, food business, food business operator, retail, primary production, final consumer) Article 3 of Regulation (EC) No 178/2002 and the general principles of food law. Second, Regulation (EC) No 853/2004 lays down specific hygiene rules for food of animal origin, which apply on top of — not instead of — the general rules Article 1 of Regulation (EC) No 853/2004; the "without prejudice to more specific requirements" clause in Article 1 makes this two-tier architecture explicit. Third, official controls on compliance are now governed by Regulation (EU) 2017/625 Article 1 of Regulation (EU) 2017/625, which repealed Regulations (EC) No 854/2004 and No 882/2004 Article 146 of Regulation (EU) 2017/625. The microbiological criteria contemplated by principle (f) are implemented by Regulation (EC) No 2073/2005 Article 1 of Regulation (EC) No 2073/2005.

Practical application and open questions

The most litigated boundary in practice is the one between excluded direct supply and regulated activity. The point (c) exclusion covers primary products only (for the definition, see Article 2 Article 2(1) of Regulation (EC) No 852/2004): direct sales of processed products (jams, cheeses, preserves) are never covered by it, whatever the quantity. The exclusion also works only towards the final consumer or local retail establishments directly supplying that consumer: supplying wholesalers or distribution platforms brings the activity back within scope. A second recurring question concerns "private domestic use": the Commission's guidance document on the implementation of the Regulation (see Sources) indicates that the occasional handling of food by private persons at events such as charity fairs does not normally amount to a food business, whereas continuity and a degree of organisation trigger the obligations.

Penalties

Article 1 contains no penalty provisions: enforcement is national, under the Member States' general duty to lay down effective, proportionate and dissuasive measures and penalties Article 17(2) of Regulation (EC) No 178/2002. In Italy, breaches of Regulation 852/2004 are punished under Legislative Decree No 193/2007 Article 6 of Italian Legislative Decree No 193/2007. Country-by-country enforcement is covered in the country pages.

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 1 of Regulation (EC) No 852/2004. Scope questions have mainly been addressed administratively, through the Commission's guidance documents (see Sources).

The Regulation is directly applicable in every Member State and needs no transposition. Paragraph 3, however, requires national implementation for the direct supply of small quantities of primary products Article 1(3) of Regulation (EC) No 852/2004: thresholds and conditions vary significantly between Member States, and in Italy regional rules add a further layer. The Italian operational framework (registration, competent authorities, penalties under Legislative Decree 193/2007) is described in the country pages.