Gluten-free Declarations | Food Safety Authority of Ireland

What is gluten?

Gluten is a mixture of proteins found in certain cereals, like wheat, rye and barley. As a result, gluten can be found in foods made from these cereals such as bread, biscuits, cakes, pasta, beer, and pizza. Whilst its presence is quite obvious in those foods, gluten can also be found in other processed foods such as soups, sauces, gravy, salad dressings, crisps, chocolate, and ready-meals.

When can I use the statement ‘gluten-free’?

The use of the ‘gluten-free’ declaration is voluntary and can only be used where the food as sold to the final consumer (either prepacked or non-prepacked) contains no more than 20 mg/kg of gluten. The use of the ‘gluten-free’ declaration should not mislead consumers, in line with the requirements of Article 7 of the legislation on the provision of food information to consumers (Regulation (EU) No. 1169/2011). For example, stating that a jam is gluten-free is misleading to the consumer, as it implies that this jam is special when, in fact, all jams are gluten-free.

When can I use the statement ‘very low gluten’?

The use of the statement ‘very low gluten’ is voluntary and can only be used where the food, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties, which have been specially processed to reduce the gluten content, contains no more than 100 mg/kg of gluten in the food as sold to the consumer. The use of the ‘very low gluten’ declaration should not mislead consumers, in line with the requirements of Article 7 of the legislation on the provision of food information to consumers (Regulation (EU) No. 1169/2011).

What happens if a food with a ‘gluten-free’ declaration contains more than 20 mg/kg of gluten?

Regardless of the reasons, the food business is ultimately responsible for the accuracy of the information they provide on their food products. Not only is a food containing more than 20 mg/kg of gluten but with a gluten-free declaration a technical breach of the legislation, it is also a health risk to people with a sensitivity to gluten.

What does cross-contamination mean?

In relation to gluten, cross-contamination refers to a situation where a food is accidentally contaminated with gluten-containing cereals during harvest, transport, storage, processing or preparation.

How can cross-contamination be avoided?

Food businesses must put in place systems to limit the opportunities for cross-contamination, for example and where possible, through segregation of materials, use of separate, dedicated processing equipment, proper supplier control and adequate staff training.

I am using oats as an ingredient in my product and overall the product has less than 20 mg/kg gluten so I can call it gluten-free. Do I still have to highlight oats in the list of ingredients?

Yes. The legislation on the provision of food information to consumers (Regulation (EU) No. 1169/2011) requires that where cereals containing gluten are used as an ingredient, they must be listed in the list of ingredients with a clear reference to the name of the cereal and they must be emphasised in some way, e.g., using bold type.

So, even if the product has less than 20 mg/kg of gluten, oats must still be highlighted in the list of ingredients.

My product contains wheat but has less than 20 mg/kg gluten so I can call it gluten-free. Do I still have to highlight wheat in the list of ingredients?

Yes. The legislation on the provision of food information to consumers (Regulation (EU) No. 1169/2011) requires that where cereals containing gluten are used as an ingredient, they must be listed in the list of ingredients with a clear reference to the name of the cereal and they must be emphasised in some way, e.g., using bold type.

So, even if the product has less than 20 mg/kg of gluten, wheat must still be highlighted in the list of ingredients.

When can the statements ‘specially formulated for people intolerant to gluten’ and ‘specially formulated for coeliacs’ be used?

These statements can be used in addition to (not instead of) the terms ‘gluten free’ and ‘very low gluten’ if the food is specially produced, prepared and/or processed to:
(a) reduce the gluten content of one or more gluten-containing ingredients; or
(b) substitute the gluten-containing ingredients with other ingredients naturally free of gluten.

Can I say ‘suitable for coeliacs’ or ‘suitable for people intolerant to gluten’ in relation to my product?

Yes, these statements can be used in addition to (not instead of) the statements ‘gluten-free’ or ‘very low gluten’ if your product meets the conditions for use of those statements.

My product naturally contains no gluten. Can I still call it gluten-free?

This depends on the product. If all similar products are naturally gluten free, then in accordance with the legislation on the provisions of food information to consumers (Regulation (EU) No. 1169/2011), you cannot say yours is gluten-free as it may mislead consumers to believe that other similar products are not gluten-free. For example, milk cannot be called gluten-free since all milk is gluten free. Declaring milk as ‘gluten-free’ may mislead the consumer into thinking this particular milk is different by being ‘gluten-free’.

Are there specific requirements for oats used in gluten-free foods?

Yes, oats contained in a food presented as ‘gluten-free’ or ‘very low gluten’ must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley or their crossbred varieties and the gluten content of such oats cannot exceed 20 mg/kg.

Can information on the presence or absence of gluten be provided for infant formulae or follow-on formulae?

No. Ingredients containing gluten are not permitted in infant formulae or follow-on formulae under Commission Delegated Regulation (EU) 2016/127 and the provision of information on the absence of gluten is prohibited for these types of products.

Does the legislation apply only to prepacked foods?

No, this legislation applies to both prepacked and non-prepacked foods. Non-prepacked food includes foods sold loose, e.g., foods in restaurants, at deli counters, butcher counters, bakeries, etc., as well as food packed on the premises at the consumer’s request or prepacked on the premises for direct sale from that premises.

What legislation applies to voluntary information provided on the absence or reduced presence of gluten in a food?

If a food business chooses to provide information on the absence or low-level presence of gluten, they must do so in line with the requirements set out in Commission Implementing Regulation (EU) No. 828/2014.

This legislation has applied since 20 July 2016 and is designed to ensure the consistency and reliability of statements declaring the absence or reduced presence of gluten in food sold to the final consumer.

In addition, when providing this information, it must meet the requirements for the provision of voluntary information set out in Article 36(2) of the legislation on the provision of food information to consumers (Regulation (EU) No. 1169/2011), namely:

it shall not mislead the consumer, as referred to in Article 7
it shall not be ambiguous or confusing for the consumer, and
it shall, where appropriate, be based on the relevant scientific data.