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Clear and accurate allergen information is critical to protect consumers with allergies or intolerances. It also enables consumers to make informed choices when buying and consuming food. Yet in practice, things still often go wrong. In this article, we once again clearly outline the labeling rules and developments for allergens.
Allergen disclosure remains a bottleneck for the food industry. The Netherlands Food and Consumer Product Safety Authority(NVWA) reported a total of 165 recalls and safety warnings in the Netherlands in 2022. As in 2020 and 2021, most notifications were issued because of allergens. The reasons were failure to mention allergens, wrong product in the packaging and wrong label.
For prepackaged foods, allergen information must appear on the package. There are five different forms for providing allergen information, which we explain further below:
Regulation (EU) 1169/2011 defines 14 specific substances as substances or products that can cause allergic reactions or intolerances. These are cereals containing gluten, crustaceans, eggs, fish, groundnuts (or peanuts), soy, milk (including lactose), tree nuts, celery, mustard, sesame seeds, sulfites, lupin and mollusks. These substances and products should be highlighted in the ingredient list so that consumers can clearly distinguish them from the other ingredients. This can be done through a specific font, style or background color. In practice, these ingredients are often displayed in bold or capital letters.
Sometimes the allergens from the ingredient list are also summarized in a separate "allergen box. However, according to a Commission notice, it is not allowed to repeat allergen information outside the ingredient list. The NVWA indicates that in practice the chance of errors is higher when allergen information is repeated voluntarily. To date, only incorrect repetition of allergen information is enforced.
Food packaging may also carry claims such as 'gluten-free' and 'lactose-free'. For the claim 'gluten-free', a maximum gluten content is set in Implementing Regulation (EU) 828/2014. In addition, for infant formula, a legal standard has been established for the claim 'lactose-free' in Regulation (EU) 2016/127. For regular products, no legal standard has been established; the NVWA uses the guideline value from the Nutrition and Health Claims Manual. However, for other free-from claims, such as 'egg-free', 'dairy-free' or even 'allergen-free', there is no specific European legislation. In practice, 'undetectable' is often used as the limit value.
Some Novel Foods require an additional allergy warning for new allergens or cross-reactions. For example, you see this with products containing turnip seed protein: "Turnip seed protein can cause allergic reactions in people with mustard allergy." These types of allergy warnings are also increasingly used voluntarily.
A warning about "traces of" allergens is often placed below the ingredient list. This warning, also called Precautionary Allergen Labeling (PAL), indicates that the listed allergens may have unintentionally entered the product due to cross-contamination. The European Commission (EC) has indicated through a communication that PAL is allowed as voluntary food information. However, this is only allowed when it is not possible to effectively apply a preventive strategy and the product may pose a risk to consumers with allergies or intolerances. PAL should be based on a quantitative risk assessment, such as VITAL, and should not be used as an alternative to management measures. In fact, companies must do their best to prevent cross-contamination. For example, all equipment that comes into contact with one of the legal allergens must be cleaned and visually inspected before being used for foods that do not contain the allergen.
European and national legislation is adopted on the basis of Codex Alimentarius. Several developments regarding allergens and cross-contamination are ongoing through Codex. First, an expert group from the Food and Agriculture Organization (FAO) and the World Health Organization (WHO) has issued scientific advice on the list of priority allergens, based on risk assessment. According to the opinion, the allergens soy, celery, mustard, lupin and oats are not considered priority allergens because of their limited severity and frequency of allergic reactions. For the allergen mollusks, insufficient data was available to make a statement. This may mean removal of these allergens from the list. There is still some debate about this, especially with regard to soy. In addition, legumes, insects and kiwi have been given the status of "emerging allergens" and are included in the so-called "watch list. This means they are being closely monitored and more research is needed to assess the risks.
Furthermore, the expert group provided scientific advice on reference values for various allergens. Based on this advice, the Bureau of Risk Assessment & Research Programming (BuRO) issued advice to the Minister of Health Welfare and Sport (VWS). According to the advice, the minister should set reference values, allowing risk assessment. It also advised the minister to establish a single PAL formulation to eliminate consumer confusion and ambiguity. Finally, the group provided advice regarding PAL. In line with the EC communication, the use of PAL is only allowed after taking preventive measures and when the reference values are exceeded. PAL is useful, but it should not be applied too frequently to maintain its credibility. It is also recommended that PAL be applied to non-prepackaged products as well and that symbols be used on the label showing that a risk assessment has been carried out for products that do not require PAL.
For now, additional attention can be given to providing allergen information in the current legally required manner. If cross-contaminations are mentioned, make sure they are substantiated by quantitative risk assessment. Be sure to stay up-to-date on developments.
Our Food Law Guide is the solution for you. For more information, contact us at info@precongroup.com, NL +31 (0)30 65 66 010 or BE +32 (0)11 26 99 07.
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