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Allergen Series (1) Precautionary allergen labelling

View profile for Rebecca Ironmonger
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Allergen labelling is a hot topic and continues to be one of the most common breaches of food law. It is a legal requirement for all food business operators (“FBOs”) to declare the presence of any of the 14 major allergens (celery, cereals containing gluten, crustaceans, eggs, fish, lupin, milk, molluscs, mustard, nuts, peanuts, sesame seeds, soya, and sulphur dioxide) if used as an ingredient or processing aid. However, FBOs are not required to declare any unintentional presence of an allergen, usually due to cross-contamination. FBOs may, however, provide this information voluntarily. Such information is called precautionary allergen labelling (“PAL”) but is often referred to as “may contain” statements.
In this blog, our Regulatory Team discusses the recent updates to the FSA’s guidance document in respect of the provision of PAL.

In March 2023, the FSA launched a consultation seeking views on new advice for how and when to apply PAL on food packaging. As part of this consultation, the FSA proposed that FBOs should specify which of the 14 major allergens their PAL refers to – for example, using “may contain peanuts” or “may contain tree nuts” rather than just the broader “may contain nuts”. The FSA also proposed that PAL should only be applied once a risk assessment has been completed.

The FSA also sought views on new guidance that PAL should not be applied for the same allergen that products are claiming to be “free-from” – for example, a product labelled as “dairy free” should not be labelled with a “may contain milk” statement.

In addition, views were sought on the recommendation that businesses should not use No Gluten Containing Ingredients Statements (NGCIs), such as “this menu has been designed for a non-gluten diet”, on the basis that NGCIs had been found to mislead consumers. Instead, it was suggested that only the phrases “gluten free” or “low gluten” should be used.

The consultation closed in May 2023, and the FSA published its updated Technical Guidance in June 2023. The updated guidance incorporates the recommendations that were considered as part of the consultation. First, the updated guidance confirms that a PAL statement should only be applied once a risk assessment has been completed and any such statement should specify which of the 14 major allergens may be unintentionally present in the food.

The guidance document provides the following:

A Precautionary Allergen Labelling statement should only be provided if an unavoidable risk of allergen cross-contamination has been identified following a thorough risk assessment that cannot be sufficiently controlled through risk management actions, such as segregation and cleaning. Its use is not a substitute for good food hygiene and safety practices, and it could be considered misleading food information if it does not convey a real risk to the consumer”.

Precautionary Allergen Labelling statements should make specific reference to one or more of the 14 regulated allergens, that may be unintentionally present in the food, so that consumer food choice is not unnecessarily limited”.

Furthermore, the updated guidance incorporates the recommendation that a PAL should not be applied for the same allergen that products are claiming to be “free-from”. The guidance states: “Precautionary Allergen Labelling statements should not be used in conjunction with a “free from” statement for the same allergen, because a free-from claim is a guarantee that the food is suitable for all with an allergy or intolerance to that allergen”.

Finally, the guidance also incorporates the recommendation that businesses should not use NGCIs. The guidance provides: “Avoid No Gluten Containing Ingredients statements, for example, “this menu has been designed for a non-gluten diet. It's a selection of dishes that do not contain gluten in their ingredients”. Instead, a “gluten-free” statement should be provided where strict controls ensure that food provided contain less than 20ppm of gluten”.

It remains to be seen whether the updated guidance provides sufficient clarity regarding the interpretation and application of PAL for both FBOs and consumers. In an earlier consultation, launched in December 2021, respondents highlighted the lack of clear standards and common risk assessment methods as one of the major problems with PAL guidance. Since this updated guidance fails to address these issues, it is likely that further review and evaluation of PAL will be required.

Whilst this blog only considers the FSA’s Technical Guidance, which is guidance not law, there are numerous legal requirements that an FBO must meet in relation to the presentation of allergen information. FBOs are responsible for complying with labelling requirements, and a failure to supply accurate allergen information can carry criminal penalties. Our Regulatory Team can provide clear advice if you are facing enforcement action by the Food Standards Agency or local authority as a result of alleged non-compliance with the allergen rules. This could take the form of assisting with: the preparation of a response to a warning letter; appealing an enforcement notice; attending an interview under caution;  and defending any criminal prosecution in the courts. Please get in touch for further information.


Written by Rebecca Ironmonger, Katie Temple and Hannah Leese.