Food allergen management: a complete guide for food businesses

The 14 allergens to declare

The scope is set by Annex II of Regulation (EU) No 1169/2011, referred to by the article governing the labelling of substances causing allergies or intolerances Article 21 of Regulation (EU) No 1169/2011. There are fourteen categories: cereals containing gluten (wheat, rye, barley, oats, spelt, kamut and their derivatives); crustaceans; eggs; fish; peanuts; soybeans; milk (including lactose); tree nuts (almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios, macadamia nuts); celery; mustard; sesame seeds; sulphur dioxide and sulphites above 10 mg/kg or 10 mg/l; lupin; molluscs.

Indicating these allergens is one of the mandatory particulars that must accompany the food Article 9 of Regulation (EU) No 1169/2011. In prepacked foods the allergen is emphasised in the list of ingredients through a typeset that clearly distinguishes it from the rest (font, style or colour) Article 21 of Regulation (EU) No 1169/2011. The Annex II list is exhaustive for declaration duties, but it does not exhaust the allergenic hazards the business must consider in its risk assessment: the allergen concept also covers preventing unintended presence. The text of the fourteen points should be read in the official version of the Regulation; here we set out only its function.

Consumer information and loose foods

The most widespread error is to assume that the duty to inform applies only to packaged products. It does not. The Regulation expressly addresses non-prepacked foods — sold loose, baked on site, served in restaurants — still requiring allergen information and leaving Member States to define the practical arrangements (the medium, the form, any menu or register) Article 44 of Regulation (EU) No 1169/2011. National measures typically allow a choice of medium (a sign, the menu, an allergen register available for consultation), provided the information is available before the purchase is completed and not merely on verbal request.

For prepacked foods the information is carried by the label according to the Regulation's mandatory particulars Article 9 of Regulation (EU) No 1169/2011. In both cases the responsibility for the information rests on the operator Article 17 of Regulation (EC) No 178/2002: missing or incorrect allergen information makes the food potentially dangerous for the allergic consumer and may trigger a withdrawal from the market or a recall from consumers Article 19 of Regulation (EC) No 178/2002.

Allergens in the HACCP plan

Correct information presupposes control of the process. The allergen is, to all effects, a chemical hazard that the permanent procedures based on the HACCP principles must consider in the hazard analysis Article 5(1) of Regulation (EC) No 852/2004 Article 5(2) of Regulation (EC) No 852/2004. In practice this means, within the food safety management manual:

• mapping the allergens present in raw materials and ingredients, step by step along the flow diagram;
• assessing the routes of unintended cross-contamination (equipment, surfaces, staff, environment);
• defining control measures (separation, order of processing, cleaning) and their records.

Building the plan follows the same method set out in the complete guide to HACCP and, at operational level, in writing a HACCP manual: upstream of the critical points sit the hygiene prerequisites, which include the very cleaning and separation that govern allergen risk. In most kitchens allergen control is achieved through good practice and well-managed prerequisites rather than a critical control point with a numerical limit. The international benchmark is Codex Alimentarius CXC 80-2020, dedicated specifically to allergen management by operators. A business drafting its documents can start from the HACCP manual generator and adapt it to its own activity.

Kitchen management and cross-contamination

The operational core is the prevention of cross-contamination: the unintended transfer of an allergen from a food that contains it to one that should be free of it. There are three main levers.

• Separation. Allergenic raw materials stored and identified separately; where feasible, dedicated areas, equipment and utensils (boards, containers, fryers). The layout of premises and equipment answers to the general hygiene requirements of Annex II of the Regulation Annex II of Regulation (EC) No 852/2004.
• Processing procedures. Schedule the order of preparation (allergen-free products before those containing the allergen), avoid promiscuous use of utensils, and manage frying oils and shared surfaces correctly.
• Cleaning. Effective cleaning between tasks is the barrier that removes allergenic residue: cleaning and disinfection procedures are part of the prerequisites and must be recorded Annex II, Chapter I, point 1 of Regulation (EC) No 852/2004.

These measures are not optional: they are the concrete expression of the general duty to ensure food safety at all stages Article 3 of Regulation (EC) No 852/2004. They must also be coordinated with traceability, which makes it possible to trace the batch and the ingredient in the event of an allergen incident Article 18 of Regulation (EC) No 178/2002.

Allergens in primary production

Until 2021 the hygiene rules for primary production did not expressly mention allergens. Regulation (EU) 2021/382, in force since 24 March 2021, filled the gap by inserting into Annex I, Part A, of Regulation (EC) No 852/2004 a specific obligation: primary producers must take adequate measures to prevent, as far as possible, contamination by substances causing allergies or intolerances Annex I, Part A, point 5-bis of Regulation (EC) No 852/2004. Allergen management is thus brought forward to the farming and first-handling stage, in line with the "farm to fork" approach. The framework of primary production requirements is set out in the Annex I, Part A page. The same 2021 regulation also introduced food redistribution and food safety culture, dealt with elsewhere in the knowledge base.

Training and documentation

No allergen procedure works without trained staff. The Regulation requires food handlers to be instructed and adequately trained in food hygiene matters in accordance with their work activity Annex II, Chapter XII, point 1 of Regulation (EC) No 852/2004, and those responsible for procedures based on the HACCP principles to have received adequate training in their application Annex II, Chapter XII, point 2 of Regulation (EC) No 852/2004. Allergen awareness — recognising allergens, avoiding cross-contamination, informing the customer correctly — falls squarely within this obligation, whose practical implementation is described on the mandatory training page and in Chapter XII of Annex II.

On the documentary side, allergen management is evidenced through the food safety management manual and its records: an allergen matrix per recipe, cleaning procedures, an allergen register for loose foods, training evidence. Records are commensurate with the nature and size of the business Article 5(2) of Regulation (EC) No 852/2004: a small cafe does not draft what an industrial plant does, but it must be able to show how it keeps the risk under control. Penalty amounts for hygiene and information breaches should never be promised in the abstract: for Italy, see the penalties under Legislative Decree 193/2007.