Food allergens

The 14 allergens of Annex II

The list of allergens subject to mandatory declaration is exhaustive and is found in Annex II to Regulation (EU) 1169/2011 Annex II of Regulation (EU) No 1169/2011: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, tree nuts, celery, mustard, sesame seeds, sulphur dioxide and sulphites (above 10 mg/kg or 10 mg/l), lupin and molluscs. They are fourteen categories, some with specifications (gluten-containing cereals and tree nuts include several species). The list may be updated by the Commission in the light of scientific knowledge.

The information regime is in the same regulation: any ingredient or processing aid causing allergies or intolerances used in the manufacture and still present in the finished product is a mandatory particular Article 9(1) of Regulation (EU) No 1169/2011. In the list of ingredients such substances are emphasised through a typeset that clearly distinguishes them from the other ingredients, for example by means of the font, style or background colour Article 21(1) of Regulation (EU) No 1169/2011.

Allergens in non-prepacked food

The point most often misunderstood concerns non-prepacked food — catering, deli counters, loose products. For these too, allergen information is mandatory: where food is offered for sale to the final consumer or to mass caterers without prepackaging, allergen information is provided in the manner Member States may lay down Article 44(1) of Regulation (EU) No 1169/2011. The form (menu, notice, consultable register, verbal information supported by documentation) is left to the national legislator, but the informational content is due everywhere. For a restaurant or a café this means the absence of a label does not exempt from communicating the presence of allergens.

Preventing spread: the 2021/382 changes

Downstream information is not enough: the allergen must be kept from ending up where it should not. Regulation (EU) 2021/382, in force from 24 March 2021, inserted specific duties into Regulation (EC) 852/2004 Article 1 of Regulation (EU) 2021/382. In primary production, equipment, conveyances and containers used to harvest, transport or store allergenic substances of Annex II to Regulation 1169/2011 must not be used for food not containing them, unless cleaned and checked for the absence of visible debris Annex I, Part A, point 5-bis of Regulation (EC) No 852/2004. A mirror rule applies to later stages: equipment, conveyances and containers used to process, handle, transport or store allergenic products must not be used for food not containing them without cleaning and a check for the absence of visible debris Annex II, Chapter IX, point 9 of Regulation (EC) No 852/2004. It is the regulatory bridge between allergen management and cross-contamination.

Allergens and HACCP

Allergen management is a chemical hazard to be addressed in the hazard analysis of the HACCP system Article 5(2) of Regulation (EC) No 852/2004. In many businesses control is achieved through prerequisites — dedicated cleaning, separation, production procedures — rather than a CCP. The Codex Alimentarius has devoted a specific code of practice to the topic, CXC 80-2020, on food allergen management for operators. The traceability of allergenic ingredients along the chain is the premise for correctly managing labelling and recalls.