United States Mission to the European Union
Foreign Agricultural Service
United States Department Of Agriculture
Last modified: December 12, 2017

Allergen Labeling

Reference to allergens in ingredients list

On December 13, 2014, Regulation 1169/2011 on the provision of food information to consumers (FIC) becomes applicable.  This regulation will considerably change the labeling requirements for products containing ingredients, processing aids and other substances causing allergies or intolerances.   Article 21 stipulates that each substance or product causing allergies must be indicated in the list of ingredients with reference to the name of the substance or product as listed in Annex II to the FIC Regulation, for example “tofu (soya)”, whey (milk).  The name of the substance or product must be highlighted through a typeset that clearly distinguishes it from the other ingredients (for example in bold or with a background color).

The following potentially allergenic ingredients listed in Annex II to the FIC Regulation require a mandatory declaration on food and beverage labels, including alcoholic beverages: cereals containing gluten, crustaceans, eggs, fish, peanuts, soybeans, milk, nuts, celery, mustard, sesame seeds, sulfur dioxide and sulfites at concentrations of more than 10mg/kg, lupine and mollusks.

“Contains” statements

All information about allergenic ingredients must be given in the mandatory format in a single place on the label, i.e. the ingredients list.  Where an ingredients list is provided, the voluntary use of warning boxes or statements such as “contains X” to repeat the presence of allergenic ingredients will no longer be allowed.  In the absence of an ingredients list, the presence of allergens must be indicated using the word “contains” followed by the name of the substance or product as listed in Annex II of Regulation 1169/2011.

“May contain” statements

EU rules for precautionary allergen labeling such as “may contain” statements have not yet been adopted.  Article 36 of the FIC Regulation stipulates that the European Commission should adopt implementing measures setting out requirements for the voluntary indication of the possible and unintentional presence of substances and products causing allergies.

EU Industry Guidance Documents: