Claims under Article 14 of the EC Regulation on nutrition and health claims refer to the reduction of disease risk or to children's development or health. In August 2008 EFSA has adopted its first series of opinions on health claims under Article 14.
The opinions published by EFSA provide information on the scientific substantiation of the proposed health claims to the European Commission and Member States, which will then decide whether to authorise the claims.
Applications are transmitted to EFSA by competent authorities in Member States. Afterwards EFSA carries out a completeness check of the application according to the guidance document for the preparation and presentation of the application. The objective of this document is to assist applicants in preparing and presenting their applications for authorisation of Art. 14 health claims. It contains guidance on:
- Format: for a well-structured application;
- Content: information and data required/optional;
- Criteria for substantiation: the key issues to be addressed to substantiate a health claim.
EFSA is required to deliver its opinions within five months after the completeness check has been performed. If during the evaluation phase supplementary information is needed from the applicant, the clock can be stopped and EFSA then has an additional two months for the evaluation.
Article 14 applications submitted to EFSA are included in the Register of Questions, with indication of the food substance and claimed effect. The panel has received to date 268 applications, 103 applications have been withdrawn and so far 75 scientific opinions have been adopted.