Request for addition to the community list
To request the addition of a health claim to the Community list under Article 13 or to seek individual authorization for claims referring to Article 14, applicants must follow the procedures outlined in Commission Regulation (EC) No 353/2008, which establishes the implementing rules for health claim authorization applications as provided in Article 15 of Regulation (EC) No 1924/2006.
For guidance, applicants can refer to the "Scientific and Technical Guidance for the Preparation and Presentation of a Health Claim Application (Revision 3)". It is important to note that health claims under Article 13, known as Functional Health Claims, are already listed in Commission Regulation No 432/2012.
However, Article 14 claims, which pertain to the reduction of disease risk or children’s development, require a more rigorous individual authorization process.
For the authorization of an Article 14 health claim, applicants must submit a detailed application to national authorities, including the following information as specified in Article 15 of Regulation (EC) No 1924/2006:
the name and address of the applicant; a description of the nutrient, substance, food, or food category and its characteristics; copies of relevant studies, including independent, peer-reviewed research, to demonstrate compliance with the regulation; proprietary information, if applicable, with verifiable justification; additional scientific studies relevant to the claim; a proposal for the wording of the health claim, including any specific conditions for use; and a summary of the application.
If proprietary data protection is granted, the restriction on the use of the claim expires after five years. To date, the European Food Safety Authority (EFSA) has received 268 applications for Article 14 claims, of which 103 have been withdrawn, and 75 scientific opinions have been adopted, reflecting the stringent evaluation process for these claims.
The application process according to Art. 15 to Art. 18. An applicant submits an application through the EU Food Chain E-Submission Platform. Member States perform an admissibility check, after which EFSA conducts a completeness check and informs the Commission, Member States, and the public. EFSA evaluates the scientific evidence and issues a scientific opinion within 5 months, with up to 2 additional months if further information is required from the applicant. The process then differs depending on the type of claim: Article 13 claims (Function Health Claims): The European Commission takes a decision within 2 months, and approved claims are added to the Community List. Article 14 claims (Disease Risk Reduction and Children’s Health Claims): The European Commission prepares a draft decision within 2 months, followed by a final decision by the Regulatory Committee, leading to authorization of the individual claim if approved.
For the application, which needs to be submitted to national authorities, the following information must be included (Reg. No 1924/2006; Art. 15):
The application shall include the following:
(a) the name and address of the applicant;
(b) the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
(c) a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;
(d) where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
(e) a copy of other scientific studies which are relevant to that health claim;
(f) a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
(g) a summary of the application.
If a request for the protection of proprietary data is granted and the use of the Claim is restricted, the restriction expires after five years.
Regarding Article 14 applications, EFSA has received 268 applications, of which 103 applications have been withdrawn and 75 scientific opinions have been adopted.