European Parliament and Council Regulation 1924/2006 sets EU-wide conditions for the use of nutrition claims such as “low fat” or “high in vitamin C” and health claims such as “helps lower cholesterol.” The regulation applies to any food or drink product produced for human consumption that is marketed on the EU market. In order to carry a claim, foods should fit a certain “nutrient profile” (below certain salt, sugar and/or fat levels). Food products carrying claims must comply with the provisions of Article 30 of the EU’s “Food Information to Consumers” Regulation 1169/2011.
The European Commission adopted a list of permitted general function health claims, the so-called “article 13” list, and their conditions of use in Regulation 432/2012.
The EU’s online “Register of nutrition and health claims” contains not only with the authorized claims but also with the rejected claims and the reasons for their non-authorization. A large number of health claims referring to botanical substances have been put on hold because the Commission and Member States are still discussing how to address the potential conflict of the Health Claims Regulation with the Traditional Herbal Medicinal Products Directive.
The list of permitted health claims is different from the individual applications for health claims relating to the reduction of disease risk and the development of children and claims based on new science and proprietary data. Anyone can use the permitted health claims established by Regulation 432/2012 provided the conditions of use are met. All claims that are not authorized and not on hold or under consideration are prohibited. Claims that are on hold or under consideration may continue being used under the conditions that applied before the adoption of the list of permitted health claims.
Commission Regulation 907/2013 sets out rules for the use of “generic descriptors” which could be interpreted by consumers as health claims. Generic descriptors such as “digestive biscuit” and “cough drop” would normally be banned under the Nutrition and Health Claims Regulation because they suggest a beneficial effect on health but the implied health effect has not been evaluated by the European Food Safety Authority. Under Regulation 907/2013, companies using generic descriptors may apply for an exemption from this ban. For more information see GAIN Report “Health Claims – New EU Regulation on Generic Descriptors”.
Disease risk reduction claims and claims referring to the health and development of children require an authorization on a case-by-case basis, following the submission of a scientific dossier to EFSA. Health claims based on new scientific data will have to be submitted to EFSA for evaluation but a simplified authorization procedure has been established.
Only nutrition and health claims included in one of the EU positive lists may be used on food labels.
Regulation 353/2008 sets out implementing rules for applications for the authorization of health claims as provided for in Article 15 of Regulation 1924/2006. GAIN Report E48055 describes how application dossiers for authorization of health claims should be prepared and presented. Guidance documents on how companies can apply for health claim authorizations can be downloaded from EFSA’s website at http://www.efsa.europa.eu/en/applications/nutrition/regulationsandguidance.
Regulation 2013/63 establishes guidelines for the implementation of Article 10 of Regulation 1924/2006 on specific conditions that have to be met when using health claims.