Allergen management for food manufacturers: from supplier to label

An allergen error on a label often ends in a product recall. It rarely starts on the production line: it comes from incomplete supplier data, a changed recipe or an outdated spec sheet. Allergen management is first a data chain, from raw material to label.

The 14 allergens you must declare in the European Union

Annex II of Regulation (EU) No 1169/2011 on food information to consumers lists the substances to declare:

• cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk (including lactose);
• tree nuts (almonds, hazelnuts, walnuts, cashews, pecans, Brazil nuts, pistachios, macadamia nuts);
• celery, mustard, sesame seeds, lupin, mollusks;
• sulfur dioxide and sulfites above 10 mg/kg or 10 mg/L, expressed as SO₂.

On prepacked food, Article 21 requires the allergen in the ingredient list, emphasized by font, style or background color. Where no ingredient list is required, allergens must generally be indicated with the word "contains", except in the cases provided for by the regulation.

Non-prepacked food: the information is still mandatory

Article 44 extends the obligation to food sold loose, at the deli counter or in food service. Each member state sets how the information is given. France, for example, requires it in writing, without the consumer having to ask. Manufacturers supplying these channels must send reliable allergen data.

Cross-contact and precautionary allergen labeling

A "may contain" statement is voluntary information under Article 36 of the regulation: it must not mislead consumers. No harmonized EU rule sets thresholds for it yet.

Regulation (EU) 2021/382 added allergen management to the good hygiene practices of Regulation (EC) No 852/2004. Commission Notice 2022/C 355/01 sets out recommendations on this point (Annex I, section 3.7):

• ask suppliers for specifications and, for unintended presence, a quantification in mg of allergenic protein per kg;
• segregate lines, schedule production runs, validate cleaning;
• use precautionary labeling only after a risk assessment, when prevention cannot control the risk;
• never list a cross-contact allergen in the ingredient list.

The allergen data chain in beCPG

In beCPG, each raw material has an "Allergens" list. You record whether the presence is voluntary, with its source ingredient, or due to cross-contamination. An ingredient linked to an allergen in the administration area carries it to every raw material that contains it. With the supplier portal, suppliers fill in these allergens themselves in the referencing form, then your quality team reviews them.

Cross-contact is declared on a "Resource" that represents the line or the site. If cleaning controls the risk, select "Yes" under "Is the risk managed": the allergen does not roll up to the finished product.

Formulation then rolls the allergens of raw materials and resources up to the finished product, with the source of each presence. Each allergen carries its regulatory threshold, such as the one for sulfites, and a cross-contamination threshold. For precautionary labeling, you can replace that fixed threshold with a PAL reference: VITAL 3.0, VITAL 4.0 or the Dutch NL_ED05 reference doses. beCPG then calculates an action limit for each product from the reference dose and the serving size. Example: a 250 g baguette and a 0.5 mg soy protein reference dose give a 2 ppm limit. Cross-contact at 5 ppm exceeds this action limit and may lead to recommending a precautionary statement, depending on the risk assessment.

Labeling shows allergens in bold in the ingredient list by default (see our EU 1169/2011 labeling guide).

Spec sheets display the major allergens of the selected language, whether present or possibly present.

A customer specification can prohibit an allergen, voluntary or from cross-contamination: an alert flags the gap. Finally, a change order lists the semi-finished and finished products that use a raw material, simulates the impact of the change, then reformulates them.

Control points, step by step

Outside the EU: different allergen lists

Each market has its own list. In the United States, nine major food allergens must be declared, with sesame added on January 1, 2023 (FDA). Our guide to US food allergen labeling covers the FDA rules, and the US Nutrition Facts guide covers the rest of the label. Other markets to check:

• Canada: mustard and mollusks are priority allergens, and gluten sources and added sulfites must also be declared (Health Canada);
• Australia and New Zealand: Plain English Allergen Labelling (PEAL) has been mandatory since February 25, 2024 (FSANZ);
• United Kingdom: since October 1, 2021, food prepacked for direct sale carries a full ingredient list with the 14 allergens emphasized (FSA).

In beCPG, each allergen is declared major for one or more report languages. The regulatory compliance page lists the markets covered.

Allergen data entered once, at the source, then calculated all the way to the label, limits errors at every change. Request a demo on your own recipes.

Sources

• Regulation (EU) No 1169/2011, Articles 21, 36, 44 and Annex II
• Regulation (EU) 2021/382 amending the Annexes to Regulation (EC) No 852/2004
• Commission Notice 2022/C 355/01, Annex I, section 3.7
• European Commission: food information to consumers
• FDA: Food Allergies