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

Rationale and background

Regulation (EU) 2021/382 stems from the need to align Union law with evolving international standards. In 2020 the Codex Alimentarius revised the General Principles of Food Hygiene (CXC 1-1969), explicitly introducing the concept of food safety culture as a precondition for the effectiveness of any management system. The Commission transposed this approach by amending Annex II to Regulation (EC) 852/2004 and, in parallel, addressed two practical needs that had emerged in practice: managing allergens upstream in the chain and the safety of food donation operations, which had grown sharply. The legal basis for the intervention is the delegation to amend the annexes under the committee procedure Article 14(3) of Regulation (EC) No 852/2004.

Subject matter: the three amendments

1. Allergens in primary production (Annex I Part A, point 5a). The amendment inserts a new point 5a into Part A of Annex I: equipment, conveyances and containers used for the harvesting, transport or storage of allergenic substances or products listed in Annex II to Regulation (EU) 1169/2011 may not be used for food not containing them, unless first cleaned and checked for the absence of visible debris Annex I, Part A, point 5-bis of Regulation (EC) No 852/2004 Article 9(1) of Regulation (EU) No 1169/2011. It is the first time allergen management enters the requirements of the primary stage.

2. Food redistribution (Annex II, Chapter Va). The new Chapter Va allows operators to redistribute food for donation subject to defined conditions: a routine check that the food is not injurious to health and is fit for human consumption within the meaning of Article 14(2) of Regulation (EC) 178/2002 Annex II, Chapter V bis, point 1 of Regulation (EC) No 852/2004 Article 14(2) of Regulation (EC) No 178/2002, with criteria linked to the 'use by' dates and dates of minimum durability under Regulation (EU) 1169/2011 Annex II, Chapter V bis, point 2 of Regulation (EC) No 852/2004. The rule provides a clear food-safety basis for donations, reducing operator uncertainty.

3. Food safety culture (Annex II, Chapter XIa). The new Chapter XIa requires operators to establish and maintain an appropriate food safety culture and to provide evidence of it, with requirements covering management commitment, staff awareness, open communication and the availability of sufficient resources Annex II, Chapter XI bis, point a of Regulation (EC) No 852/2004 Annex II, Chapter XI bis, point e of Regulation (EC) No 852/2004. Management commitment is set out in a detailed list of actions Annex II, Chapter XI bis, point a-2 of Regulation (EC) No 852/2004.

Coordination with other rules

The three changes build on the existing system. Food safety culture does not replace HACCP: it presupposes it and makes its application effective, requiring the documentary system to be lived rather than merely formal Article 5(1) of Regulation (EC) No 852/2004. Allergen management in primary production coordinates with downstream allergen information duties under Regulation (EU) 1169/2011 Article 9(1) of Regulation (EU) No 1169/2011. Redistribution directly invokes the unsafe-food concept of Regulation (EC) 178/2002 Article 14(2) of Regulation (EC) No 178/2002.

Practical application and interpretative issues

Food safety culture and small businesses. The duty applies to all operators, but Chapter XIa is inherently scalable: in a micro-business, management commitment and communication coincide with the owner. In our view the required evidence ("provide evidence") must be proportionate to the size of the business, consistent with the proportionality principle running through the whole regulation Annex II, Chapter XI bis, point a of Regulation (EC) No 852/2004. No certification. The regulation provides neither a certificate nor a mandatory audit of food safety culture: compliance is demonstrated to the competent authority in the course of official controls Article 5(4) of Regulation (EC) No 852/2004.

Penalties

Regulation (EU) 2021/382 lays down no penalties of its own: breaches of the new duties fall under the national penalty regime for non-compliance with Regulation (EC) 852/2004. For Italy the reference is Legislative Decree 193/2007 Article 6 of Italian Legislative Decree No 193/2007.