Regulation (EU) 2021/382: food safety culture, redistribution and allergens in 852/2004

Background

Regulation (EC) No 852/2004 is the framework regulation on the hygiene of foodstuffs. Its architecture remains that of 2004, but the Commission updated its annexes through Regulation (EU) 2021/382 to address two needs that had emerged over the following decade — the donation of surplus food and a systematic focus on food safety culture — and to align primary production with the rules on allergens. The act entered into force and has applied since 24 March 2021 Article 2 of Regulation (EU) 2021/382: from that date the consolidated text of the Regulation incorporates the three changes.

What it provides

Regulation (EU) 2021/382 acts exclusively by amending the annexes to Regulation 852/2004 Article 1 of Regulation (EU) 2021/382. The three changes are:

• Food safety culture. The new Chapter XIa of Annex II requires the food business operator to establish, maintain and provide evidence of an appropriate food safety culture Annex II, Chapter XI bis, point a of Regulation (EC) No 852/2004, with management commitment and the involvement of all staff Annex II, Chapter XI bis, point b of Regulation (EC) No 852/2004.
• Redistribution of food. The new Chapter Va of Annex II sets the conditions under which food may be redistributed for donation, placing on operators an assessment of the food's continued suitability for consumption Annex II, Chapter V bis, point 1 of Regulation (EC) No 852/2004.
• Allergens in primary production. Annex I, Part A, is supplemented with point 5a, which extends to primary production the management of substances or products causing allergies or intolerances Annex I, Part A, point 5-bis of Regulation (EC) No 852/2004, consistently with the consumer information required by Regulation (EU) 1169/2011 Article 9 of Regulation (EU) No 1169/2011.

What changes for operators

For operators the most significant change is the food safety culture: it is not a stand-alone documentary requirement but one that must be demonstrable during an official control. It sits alongside — without replacing — the HACCP-based self-monitoring system already required by Article 5 Article 5(1) of Regulation (EC) No 852/2004. Operators donating surplus find in Chapter Va an explicit set of conditions Annex II, Chapter V bis, point 2 of Regulation (EC) No 852/2004. Primary producers must consider allergens in risk management already upstream of the chain.

Coordination with 852/2004

Regulation (EU) 2021/382 introduces no new articles: it acts on the annexes, which are an integral part of the Regulation and as binding as the enacting terms. The general obligations remain those of the base text — registration of the establishment under Article 6 Article 6(2) of Regulation (EC) No 852/2004 and self-monitoring under Article 5 Article 5(1) of Regulation (EC) No 852/2004 — while the new chapters specify operational requirements. For the overall picture see the amendment page and Annex I, Part A.