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When Do You Have to Declare Traces of Allergens?

We break down the circumstances under which ‘trace allergens’ need to be declared
21st Jun 2022
Effective communication of allergens through food labelling is imperative for food businesses in ensuring the safety of their customers. But when must a food business declare ‘traces’ of allergens?

What are food allergens?


Before we delve into traces of allergens and when they must be declared, let’s first define an allergen.
The EU defines an allergen as ‘normally harmless substance, such as an ingredient in a foodstuff, that causes an (immediate) allergic reaction in a susceptible person.’[1]

An allergic reaction can range from mild to life threatening in severity, and symptoms include rashes, swelling, nausea and difficulty breathing [2]. If an individual has an allergy to a food, consuming even the smallest quantity of this allergen can cause these reactions: a fragment of a nut or a drop of milk can have serious implications. The most severe of these symptoms is anaphylactic shock, which in some cases can be fatal [3]. Therefore, food businesses must be stringent when assessing and communicating which allergens are or may be present in their products. The correct labelling of allergens can help consumers avoid or mitigate risk.

At EU level, in accordance with the ‘EU Food Information for Consumers (EU FIC) Regulation No.1169/2011’, a food business operator that is producing a pre-packaged food for consumers must provide a full ingredient list on the pack label. The allergens must be clearly stated as well as highlighted within the ingredient list. This can be done through the use of a bold or italic font or even by using a different background colour[4].

There are 14 allergens recognised as the most common and potent causes of food allergies and intolerances across Europe, and these are legally required to be declared on food labels[5]. These allergens may be present as an ingredient or even as a processing aid.

These 14 allergens are as follows:
  • Cereals (that contain gluten, such as wheat, rye, oats, barley)
  • Crustaceans (lobster, prawns, crabs)
  • Eggs
  • Fish
  • Peanuts
  • Soybeans
  • Milk
  • Nuts (almonds, brazil nuts, cashews, hazelnuts, macadamia nuts, peanuts, pecan nuts, pistachios. Note: On food labels, the name of the individual nut must be declared rather than ‘nuts’.)
  • Celery (this includes celeriac)
  • Mustard
  • Sesame seeds
  • Sulphur dioxide and sulphites (at concentrations of more than 10 mg/kg or 10 mg/L in terms of total sulphur dioxide)
  • Lupin
  • Molluscs (mussels, oysters, squid, snails, clams and whelks)

Individuals may have allergies to other foods that are not included on this list. Despite this, it is still only a legal requirement for a food business to declare these 14 allergens.

For food business operators producing foods that are not pre-packaged, there may not always be a legal requirement for allergen labelling; this will depend on the region or country.[3]

Now that we have a bit more understanding around allergens and the effects that they can have on individuals, let’s look at an area which is often misunderstood: the circumstances under which ‘trace allergens’ need to be declared.

Trace allergens[6]


For many food businesses, it may not always be possible to ensure that their respective products contain none of the 14 allergens that must be declared by EU law. Cross contamination during the processing stage can result in products containing ‘trace’ or small amounts of allergens. These trace allergens can be defined as allergens that are present in the food, but not as an intentional ingredient[7]. An example of this may be a food business operator using food preparation utensils that have also been in contact with an allergen.

Good Manufacturing Practices (GMP) should be implemented by all producers to reduce this risk. ‘FoodDrinkEurope’ provides an insightful and evidence based resource on risk management of allergens for food businesses, available here. If it is still not possible to guarantee no cross contamination even with GMP implemented, food businesses should declare traces of the respective allergens.

In this case, food businesses may use the ‘May contain...’ statement to warn customers of any possible allergens that may be present in the food. It is imperative to note that a food business operator should not use this statement as a substitute for GMP and good hygiene practices.

The lack of a rules based framework for the provision of this information regarding trace allergens can be problematic. Currently, this is not a requirement by law and is voluntary for the food business operator. It is purely a precautionary measure, which the regulation states should only be used after a thorough risk assessment where there is still a significant risk for the consumer[3].
PAL which stands for precautionary allergen information labelling is used to help highlight the risk of unintentional cross-contamination of an allergen into a food product. PAL is easily identified by ‘may contain’ and is only used when a business knows that the cross contamination of allergens cannot be controlled as they are prepared in the same areas.

Current updates around PAL labelling


Confusion amongst the general public around the correct interpretation of PAL labelling has led to a recent FSA consultation, which took place between Dec 2021 and March 2022, alongside key stakeholders, such as food businesses, local authority food teams, healthcare professionals, allergy charities and consumers from across the UK.

The consultation aimed to gather opinions from a wide panel of experts and survey respondents around the appropriate use of PALs and future directions in the area. The consultation consisted of questions based around: information, compliance, standards for risk analysis and advice and training. Around 84% of survey responses came from the public (97% of these respondents reported having or caring for someone with a food hypersensitivity) and around 11% worked for businesses or related organisations. The majority of respondents found PAL statements such as 'not suitable for those with an allergy to [allergen]' to be effective, but over half of respondents felt that PAL statements such as ‘may be present’ or ‘cannot be guaranteed to be [allergen] free’ were not effective.[8] For more information on the consultation and a deeper insight into the results, click here. The results of the consultation across the UK will be used to inform future policies and legislation for PAL labelling.

An emerging area of interest within PAL labelling relates to new threshold levels for allergens. A blanket level threshold of 0.5mg per 100g for all allergens has been previously proposed by Torsten Zuberbier et al. However, on behalf of the EAACI task force of food allergen thresholds, a group of experts led by Turner et al. has argued that, while 0.5mg of allergenic protein or less has never been reported to have caused death, it has the potential to still result in consumers experiencing allergic reactions and, in some cases, anaphylaxis. It was also argued that a blanket threshold would be too lengthy to be advertised on a product and would go against the needs of the consumers as it would not convey sufficient, clear information around the level of risk for vulnerable groups. An example of this would be “this product contains [the named allergens in the list of ingredients], it may contain traces of other contaminations [to be named, e.g. nut] at concentrations less than 0.5mg per 100g of this product”.[9]
Currently, PAL is not regulated through EU legislation but EFSA has previously stated that implementing acts may be considered in the future. Certainly, renewed interest in the area may lead to further updates in the coming months and years at an EU wide level. It is worth noting that the Codex Alimentarius Commission has also published a Code of Practice on Food Allergen Management for Food Business Operators in 2020 to help provide guidance on identifying allergens in areas of food production and implementing allergen management practices. It is important to know that Codex Standards have no legal basis but are seen as the international standard on the specific issue and are followed for that reason. While there is no Code of Practice for PALs currently, we could potentially see these released in the near future due to the growing interest and the foundations that are already in place [10].

How Nutritics can help


At Nutritics, we understand that the correct labelling of allergens is of the highest priority to food business operators; that’s why we’ve automated as much of the allergen management process as possible. To help food businesses comply with regulation and regular audits, Nutritics has also built-in app verification and prompts regarding allergens, while the system allows you to communicate allergens to your customers with ease. 

In conclusion, declaring traces of allergens on food products is a voluntary option that food business operators can undertake to help protect customers. However, it should be a last resort that is only implemented if a business cannot mitigate the risk of cross contamination through the use of Good Manufacturing Practices (GMP) and good hygiene. For more articles about food labelling, visit our blog.

References:

  1. European Food Safety Authority (EFSA). ‘Glossary: Allergen’. [Cited 27th May 2022.] Available at: https://www.efsa.europa.eu/en/glossary/allergen.
  2. Food Standards Agency. ‘Allergy: what to consider when labelling food’. [Cited 13th April 2022.] Available at: https://www.reading.ac.uk/foodlaw/pdf/uk-14019-allergen-guidance-FSA.pdf
  3. Leatherhead Food Research. ‘A Cautionary Tale of Allergen Labelling’. [Cited 13th April 2022.] Available at: https://www.leatherheadfood.com/white-paper/a-cautionary-tale-of-allergen-labelling/
  4. Regulation (EU) No. 1169/2011 on the provision of food information to consumers (“FIC”): www.legislation.gov.uk/eur/2011/1169/contents.
  5. Erudus. ‘What are the 14 major food allergens?’. [Cited 25th May 2022.] Available at: https://erudus.com/food-allergens/
  6. FSAI. ‘Allergens’. [Cited 13th April 2022.] Available at: https://www.fsai.ie/legislation/food_legislation/food_information_fic/allergens.html#may_contain
  7. FDA. ‘Food Allergies’. [Cited 15th April 2022.] Available at: https://www.fda.gov/food/food-labeling-nutrition/food-allergies
  8. Precautionary Allergen Labelling (PAL) & Precautionary Allergen Information: the ‘may contain’ consultation. [Cited 15th June 2022.] Available at: https://www.food.gov.uk/sites/default/files/media/document/PAL_Consultation%20report_Final_May%202022%201.pdf
  9. EAACI taskforce of food allergen thresholds suggest that complexities exist with blanket thresholds. [Cited 15th June 2022.] Available at: https://allergenbureau.net/eaaci-taskforce-of-food-allergen-thresholds-suggest-that-complexities-exit-with-blanket-thresholds/
  10. Precautionary Allergen Labelling. [Cited 15th June 2022.] Available at: https://www.safefood.net/food-safety/news/precautionary-allergen-labelling