Precautionary Allergen Labelling

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Under current legislation in the EU there is no specific requirement to provide information on allergens unintentionally present in food or drink. So, when should you provide information on allergens that may be present due to contamination (as opposed to those that are intentionally present) and how should this be done?

It is estimated that around 10% of the population on the island of Ireland have a food hypersensitivity, i.e. a food allergy, food intolerance or coeliac disease. There is no cure; the only way to manage food hypersensitivity is to avoid food that triggers the reaction. It is therefore very important that food businesses provide consumers with clear and accurate information about the presence of substances that cause food hypersensitivity reactions in products, to allow consumers to make informed, safe food choices.

Intentional versus unintentional presence

The intentional presence of any of the 14 “substances or products causing allergies or intolerances” (as listed in EU legislation), and their non-exempt derivatives, must be indicated on the label of prepacked food in the way prescribed by the legislation, e.g., emphasised in the ingredients list or in a ‘contains’ statement if there is no ingredients list. For non-prepacked food (such as food sold loose in restaurants and at deli counters, or food packed on the premises at the request of the consumer) allergen information must be provided as stipulated in national rules.

If it can be shown that there is a risk that any of these “substances or products” could be present in a food unintentionally, there is no specific legal requirement to indicate such possible contamination. Many food businesses, however, provide this information voluntarily in order to fulfil legal obligations to provide safe food; this is permitted and the basis for doing so is contained within Article 14 of the General Food Law Regulation. Such information is often called ‘precautionary allergen labelling’ (PAL) when it is on a label or ‘precautionary allergen information’ when talking about non-prepacked foods.

Sources of allergen contamination

Allergen contamination may occur during the production, especially if several food products are made on the same premises, processing line or equipment. Ingredients may become contaminated in the supply chain, for example during the growing, harvesting and processing of crops, or merely by ingredients containing different substances being handled in the same establishment. EU hygiene legislation makes it clear that any equipment, conveyances and containers used for harvesting, processing, handling, transport or storage of the 14 EU substances/products shall not be used for any food not containing that substance/product, unless it has been cleaned and checked at least for the absence of any visible debris.

Food businesses spend a lot of time, effort and money managing contamination, but when it comes to substances causing food hypersensitivities, very small amounts of food can cause reactions in sensitive people, for example a drop of milk, a fragment of peanut or just one or two sesame seeds. Therefore, and despite the best efforts of the food business, sometimes there is still an unavoidable risk of allergen contamination that cannot be sufficiently controlled.

Precautionary statements: when to use and what to say

Precautionary statements regarding the possible contamination with allergens should be justifiable only on the basis of a meaningful risk assessment applied to a responsibly managed operation. These statements should never be used as a substitute for good hygiene and/or safety practices. They should only be used where there is a demonstrable and significant risk of allergen contamination. Examples of precautionary allergen labelling on prepacked food include statements such as ‘may contain X’ and ‘not suitable for those with X allergy’, while for non-prepacked food, an example would be ‘produced in a kitchen which uses X’. There is currently no precise wording laid down in EU or UK suffice to say that such statements, which are provided on a voluntary basis, must not mislead the consumer or be ambiguous or confusing.

These statements should never be used as a substitute for good hygiene and/or safety practices. They should only be used where there is a demonstrable and significant risk of allergen contamination.

What next for precautionary allergen labelling?

• EU legislation states that implementing acts will be considered regarding precautionary allergen labelling, meaning that we may see EU legislation in this area in future.
• The Food Standards Agency in London launched a consultation on 6 December 2021 on the provision of precautionary allergen labelling and precautionary allergen information on many types of food sold in England, Northern Ireland and Wales. The consultation closed on 14 March 2022 within three months of which the FSA aims to publish a summary of responses. The results of the exercise will be used to determine the next steps in terms of policy.
• Codex Alimentarius Commission (Codex), a collaboration between the Agriculture Organization of the United Nations (FAO) and the World Health Organization (WHO), published a Code of Practice on Food Allergen Management for Food Business Operators in 2020. The Code provides guidance for food business operators, including primary producers, on how to develop policies and procedures to identify allergens in all areas of food production, preparation and service, and then implement allergen management practices. Following on from this, an ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens was set up with three main aims:

1. to review and validate the Codex priority allergen list through risk assessment,
2. to review and establish threshold levels in foods of the priority allergens, and
3. to review and establish precautionary allergen labelling in foods of the priority allergens.

We may see guidance on the use of PAL and/or amendments to existing Codex standards based on the outputs of this work. It should be remembered that Codex Alimentarius Codes of Practice and Standards have no legal basis. However, they represent an international consensus on a specific issue relating to food quality and/or safety, and in many jurisdictions contribute to the development of relevant laws.

• Interest in the use of quantitative risk assessment as a tool to help decide whether precautionary allergen information is required has increased. It is worth being aware of the work of the following groups:

1. The Allergen Bureau (Australia and New Zealand) - Voluntary Incidental Trace Allergen Labelling (VITAL) program
2. FoodDrinkEurope Precautionary Allergen Labelling (PAL): a science-based approach based on Quantitative Risk Assessment
3. International Life Sciences Institute (ILSI) Europe Food Allergy Task Force