EFSA provides scientific basis for labelling of food allergens: current evidence does not allow determination of intake thresholds

The European Food Safety Authority’s (EFSA) Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) has published today an opinion relating to the evaluation of allergenic foods for labelling purposes. The Panel concluded that there is ample evidence to justify the mandatory inclusion of the following allergenic ingredients and their derivatives in the list of ingredients on food labelling: cereals containing gluten, fish, crustaceans, egg, peanut, soy, milk and dairy products including lactose, nuts, celery, mustard, sesame seed, and sulphites. These are the most common food allergens which can trigger an allergic reaction in sensitive individuals. This list should be reviewed on an ongoing basis in light of changing dietary habits, food processing practices as well as the emergence of new scientific and clinical findings. Current scientific evidence is insufficient to establish for any of these ingredients an intake threshold below which an allergic reaction does not occur, or to predict the effect of food processing on allergenic potential. The possibility that specific derivatives of these food allergens are unlikely to trigger an allergic reaction would need to be evaluated on a case by case basis.

The opinion of the EFSA Scientific Panel on Dietetic Products, Nutrition and Allergies is based on a request from the European Commission to give advice on 1) the scientific basis for the identification of allergenic food ingredients for foodstuff labelling purposes; and 2) the possibility of determining intake thresholds and factors including food processing which might eliminate or reduce the allergenicity of a food ingredient.

EU legislation has recently been modified regarding the declaration of ingredients in food labelling for prepackaged foods including alcoholic beverages. The overall aim of the amended legislation is to provide consumers with more comprehensive information regarding the composition of foods and to help those with food allergies to identify those ingredients they need to avoid. More specifically, Annex IIIa of Directive 2003/89/EC lists 12 ingredients which may induce food allergies or intolerances and for which any derogations to the obligatory declaration of food ingredients are not applicable. This requirement pertains to: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk and dairy products including lactose, nuts, sesame seeds, celery, mustard, and sulphites.

Summarising the Panel’s assessment, Professor Albert Flynn, Chair of EFSA’s NDA Panel explained: “A review of the scientific evidence regarding the allergenic potential of each of the ingredients listed in the Annex has confirmed that all have the potential to cause allergic reactions in sensitive individuals. Furthermore, in no case is the available evidence sufficient to establish an intake threshold below which allergic reactions are not triggered, or to predict reliably the effect of food processing on allergenic potential. While it is possible that specific derivatives of these known ingredients might not trigger an allergic reaction, this would need to be evaluated on a case by case basis”.


  1. Food allergies

    The prevalence of food allergy and intolerance in the general population has been estimated to be around 1-3% in adults and 4-6% in children, resulting in conditions ranging from very mild to potentially life threatening reactions. Avoidance of the offending foods is the only practical means available to consumers who have allergies or intolerances. Comprehensive labelling of allergenic food ingredients is therefore essential in order to provide consumers, and in particular sensitive individuals, with the information they require in selecting appropriate foodstuffs.

  2. Food labelling legislation

    Directive 2003/89/EC of the European Parliament and Council amending Directive 2000/13 (on the approximation of the laws of the Member States relating to the labelling, presentation and advertising of foodstuffs) as regards the indication of ingredients present in foodstuffs, was adopted on 10 November 2003 (OJ L308 of 25.11.2003) and will be brought into force by Member States by 25 November 2004. This Directive abolishes the 25% rule for compound ingredients, thereby enshrining the principle that all ingredients should be labelled, regardless of the quantity contained in the finished food. In addition, some exceptions regarding the mandatory declaration of ingredients in the labelling of foodstuffs (e.g. option to declare certain ingredients by category; declaration of the source of natural flavours not required; ingredient lists not mandatory for alcoholic beverages…) will no longer apply to the most common food allergens listed in Annex IIIa of Directive 2003/89/EC.

The list of allergenic food ingredients included in Annex IIIa shall be systematically reexamined and updated as required, on the basis of the most recent scientific knowledge. The first reexamination shall take place at the latest on 25 November 2005.

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