The regulation of Free-from allergen claims at a European and global level


Regulatory Affairs Technician, RNI Consulting, United Kingdom


Allergen labelling of food is regulated in the EU under General Food Law and the provision of Food Information to Consumers, with a separate set of regulation existing for specific food groups such as infant formula. There is no specific EU legislation covering ‘free from’ allergen labelling, except for gluten. Regulation (EU) No 828/2014 states the general requirements for ‘gluten free’ and ‘very low gluten’ claims. Many European countries have set specific thresholds for allergen-free claims such as that of lactose, where thresholds vary between EU Member States. Future work is required for harmonised EU Regulation regarding ‘free from’ labelling of allergens other than gluten.


Whilst the terms ‘food allergy’ and ‘food intolerance’ are often used interchangeably, they are both very different in nature. A food allergy involves an adverse reaction to specific foods, caused when normal proteins in food are mistaken as a threat by the body’s immune system. A food allergy can result in a number of adverse reactions, with anaphylaxis being the most severe, as it is life-threatening. One the other hand, a food intolerance involves difficulty digesting certain foods, causing symptoms such as bloating, diarrhoea and cramps. This reaction does not involve the immune system and is not life-threatening (1).


A ‘free-from’ claim is a communication of the absence of an ingredient from a product, with popular claims communicating absence of GMO’s, additives and allergens. Whilst individuals with allergies and intolerances tend to look out for ‘free-from’ allergen claims, these have shifted from attracting a relatively specialist group of consumers to a now mainstream market. Allergies and intolerances are no longer the only reason for purchasing ‘free-from’ foods, such that an increas ...