Gluten-free on the label: which rules apply to food businesses?

Gluten as an allergen: the legal basis

Cereals containing gluten, namely wheat (such as spelt and khorasan wheat), rye, barley, oats and their hybridised strains, are listed in Annex II of Regulation (EU) No 1169/2011 among the substances or products causing allergies or intolerances. This means you must mention them on the label (Article 9(1)(c)).

Under Article 21 of the same regulation, the allergen must be emphasised in the list of ingredients, for example through the font, style or background colour. Name the specific cereal, such as "wheat flour" or "barley malt", and not just "gluten". Allergen information must also be available for non-prepacked foods, for example in catering, bakeries or food service (Article 44). How this must be done in practice is further regulated at national level.

"Gluten-free" and "very low gluten": the thresholds

Statements on the absence or reduced presence of gluten are voluntary, but if you use them, the conditions of Commission Implementing Regulation (EU) No 828/2014 apply:

• "Gluten-free" may only be used if the food, as sold to the final consumer, contains no more than 20 mg of gluten per kg.
• "Very low gluten" is reserved for foods containing one or more ingredients made from wheat, rye, barley, oats or their hybridised strains that have been specially processed to reduce the gluten content, with no more than 100 mg of gluten per kg in the final product.
• Oats in a product bearing one of these statements must be specially produced, prepared and/or processed to avoid contamination by wheat, rye, barley or their hybridised strains, and may themselves contain no more than 20 mg of gluten per kg.

Gluten-free oats: still emphasise them in the list of ingredients. In practice, we still see frequent mistakes here. Even when a product containing oats complies with Implementing Regulation (EU) No 828/2014 and bears the statement "gluten-free" or "very low gluten", the oats must still be mentioned and emphasised in the list of ingredients, in accordance with Articles 9 and 21 of Regulation (EU) No 1169/2011. This is set out in the Commission Notice relating to the provision of information on substances or products causing allergies or intolerances (2017/C 428/01).

Other wording suggesting the same is not permitted. The regulation does allow additional statements, such as "suitable for people intolerant to gluten". That is why you should always have your labels reviewed through a thorough label control.

From claim to proof: controlling cross-contamination

You must be able to substantiate a "gluten-free" claim. Since Regulation (EU) 2021/382, Annex II of Regulation (EC) No 852/2004 contains explicit requirements on allergen management, including for equipment, means of transport and containers that come into contact with allergens. Certification standards such as BRCGS Food Safety and IFS Food also expect a documented allergen management plan.

In practice, a reliable gluten-free claim is based on:

• a risk assessment of raw materials, suppliers and production processes;
• clear specifications and guarantees from suppliers, especially for oats and starch derivatives;
• physical or time-based separation of gluten-containing and gluten-free production;
• validated and verified cleaning procedures;
• a substantiated sampling and analysis plan with an accredited laboratory, using a method suitable for the 20 mg/kg gluten threshold;
• staff training, as part of a strong food safety culture.

Also pay attention to the combination with precautionary allergen labelling: a product you sell as "gluten-free" that also carries a statement such as "may contain traces of gluten" sends a contradictory message to the consumer. Want to know more about a well-considered approach? Discover how we support you with allergen management.

The Crossed Grain symbol

Many gluten-free products carry a symbol of a crossed-out ear of grain. Note, however, that not every crossed-out grain symbol is the official mark. In practice, you will also see variants that simply illustrate the "gluten-free" claim. The official Crossed Grain symbol is not a legally required logo, but a registered trademark used under licence from the national coeliac society, affiliated with the European umbrella organisation AOECS. Anyone wishing to use it must meet the requirements of that licensing scheme, on top of the legal thresholds of Implementing Regulation (EU) No 828/2014.

Practical checklist for your gluten-free claim

• Check that the wording on the label matches Implementing Regulation (EU) No 828/2014 exactly.
• Make sure cereals containing gluten are listed correctly and emphasised in the list of ingredients.
• Emphasise oats in the list of ingredients, even when the product is sold as "gluten-free".
• Record your allergen risk assessment, cleaning validation and analysis results in your food safety system.
• Review your claim whenever a raw material, supplier or production line changes.