Annex I to Regulation (EC) No 852/2004 — Primary production

Rationale and origin

Annex I is, for the primary stage, the counterpart of the general requirements that Annex II lays down for every later stage of the chain Annex II of Regulation (EC) No 852/2004. The 2004 legislature brought primary production within the scope of horizontal hygiene law for the first time, consistently with the "farm to fork" approach of the general food law, which covers all stages of production, processing and distribution Article 1 of Regulation (EC) No 178/2002. The rules are, however, calibrated to farming: the requirements are qualified by adequacy clauses ("as appropriate", "where necessary", "as far as possible") that scale the obligation to the actual risk, and hazard control rests on good practice rather than on a formalised management system.

Primary production is defined by the general food law, whose definitions apply to the Regulation through the cross-reference in Article 2 Article 2(2) of Regulation (EC) No 852/2004: the production, rearing or growing of primary products, including harvesting, milking and farmed animal production prior to slaughter, as well as hunting, fishing and the harvesting of wild products Article 3 of Regulation (EC) No 178/2002. The associated operations are those listed in point 1 of Part A Annex I, Part A, point 1 of Regulation (EC) No 852/2004.

Structure: two parts

Part A imposes directly enforceable obligations; Part B imposes nothing by itself but steers the guides to good practice drawn up nationally under Article 8 or at Union level under Article 9 Article 8(1) of Regulation (EC) No 852/2004.

Personal scope and coordination

The addressees are food business operators carrying out primary production and associated operations. Outside the scope of the Regulation lie the domestic preparation, handling and storage of food for private use and the direct supply of small quantities of primary products from the producer to the final consumer or to local retail, which is left to national law Article 1(2) of Regulation (EC) No 852/2004. For products of animal origin, the Annex I requirements add to the specific rules of Regulation (EC) No 853/2004 Article 1 of Regulation (EC) No 853/2004. Registration of the establishment with the competent authority also applies to primary production Article 6(2) of Regulation (EC) No 852/2004.

The 2021 amendment: allergens in primary production

Regulation (EU) 2021/382 inserted point 5-bis into Part A. It prohibits using equipment, conveyances or containers that have handled allergenic substances or products — those listed in Annex II to Regulation (EU) No 1169/2011 Annex II of Regulation (EU) No 1169/2011 — for food not containing them, unless they have first been cleaned and checked for the absence of visible debris Annex I, Part A, point 5-bis of Regulation (EC) No 852/2004. This is the first time cross-contamination by allergens is addressed explicitly at the primary stage. The same amending package introduced, in Annex II, Chapter V-bis on food redistribution and Chapter XI-bis on food safety culture.

Penalties

Annex I contains no penalties: enforcement is a matter for national law. Member States lay down effective, proportionate and dissuasive penalties for breaches of food law Article 17(2) of Regulation (EC) No 178/2002. Country-by-country enforcement is covered in the countries section.