United States Mission to the European Union
Foreign Agricultural Service
United States Department Of Agriculture
Last modified: February 1, 2017

Nutrition & Health Claims

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 Nutrition & Health Claims Regulation required the development of nutrient profiles by January 2009 but a Commission proposal was never tabled.  In October 2015, the European Commission published a “roadmap” announcing the launch of a public consultation to examine whether the development of nutrient profiles is still necessary to ensure the adequate implementation of the Nutrition & Health Claims Regulation.

More than two years after the due date set by Regulation 1924/2006, the European Commission adopted a list of 222 permitted general function health claims, the so-called “article 13” list, and their conditions of use.  Regulation 432/2012 establishing the list of EU-approved health claims was published in the EU’s Official Journal on May 25, 2012 and became applicable on December 14, 2012.  The EU’s online “Register of nutrition and health claims” has been updated not only with the 222 authorized claims but also with the more than 1600 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 will be able to use the permitted health claims established by Regulation 432/2012 provided the conditions of use are met.  Rejected claims will be considered as non-compliant with the Nutrition and Health Claims Regulation.  All claims that are not authorized and not on hold or under consideration are prohibited since December 14, 2012.  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.  The EU Register of nutrition and health claims on foods can be consulted online at http://ec.europa.eu/food/safety/labelling_nutrition/claims/register/public/?event=register.home.  Some sections of the Register are missing but will be completed as appropriate.

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.

Trademarks and brand names that suggest health and/or nutritional benefits but do not comply with the new rules must be entirely removed from the EU market by January 19, 2022.

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