Health claim applications
Health claims based on newly developed scientific evidence or health claims that include a request for the protection of proprietary data can be included in the list by a separate application.
A link to the Commission's rules for the implementation of health claim applications (358/2008) is provided in the right-hand side column.
Application for inclusion of health claims referred to in Article 13(5) (Regulation on nutrition and health claims, Article 18)
A food business operator intending to use a health claim not included in the list provided for in Article 13 may apply for the inclusion of the claim in that list.
Applications for inclusion in the list of health claims referred to in Article 13, of claims, which are
- based on newly developed scientific evidence or
- claims that include a request for the protection of proprietary data are processed following the procedure referred to in Article 18
1. The application for this inclusion shall be submitted to the national competent authority, which in Finland is Evira.
- The application shall include the data provided for in Article 15(3) and the reasons for the request.
- The application shall be submitted in compliance with the instructions issued by EFSA
- In order to make the procedure quicker, Evira recommends that the application be submitted in the English language. The link in the right-hand side column provides more information.
The application for inclusion shall include
- A paper copy of the application, which is of good print quality, appropriately presented, e.g. in a folder with interleaves.
- Two identical CD disks, which contain all the same information as the paper copy. Evira retains one disk for use in case EFSA should contact Evira.
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A summary of the application (Appendix B) to be provided as a paper copy and as a separate electronic file on a CD disk for use by EFSA in publishing the summary.
2. Evira will acknowledge receipt of the application in writing within 14 days of its receipt and will forward the application and the information provided by the applicant without delay to EFSA for a scientific assessment and to the Commission and the Member States for information. A fee based on Decree 638/2010 of the Ministry of Agriculture and Forestry on fees to be collected on services performed by Evira is charged for the processing of the health claim application.
3. EFSA shall issue its opinion within a time limit of five months from the date of receipt of the application. If EFSA considers it necessary to seek supplementary information from the applicant, such time limit may be extended by up to one month. The applicant shall provide the requested information within 15 days.
4. EFSA checks that the health claim is substantiated by scientific evidence and that the wording of the health claim meets the conditions laid down in the Regulation
5. EFSA issues an opinion to the Commission, the Member States and to the applicant, and makes the opinion public. More information about the NDA panel's opinions published by EFSA can be found through the link on the right hand side column.
6. The applicant or a member of the public may make comments to the Commission within 30 days of such publication.
7. Within two months after receiving a positive opinion from EFSA and after having heard the Member States, the Commission shall take a decision. An up-to-date list of authorised health claims is published on the Commission's web site.
Application for inclusion of health claims referred to in Article 14 (Regulation on nutrition and health claims, Articles 15, 16, 17 and 19)
Health claims referred to in Article 14, i.e.
- reduction of disease risk claims
- claims referring to children's development and health are authorised on application in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of the Regulation on nutrition and health claims.
1. The application shall be submitted to the national competent authority, which in Finland is Evira.
- The application shall include the data provided for in Article 15(3).
- The application shall be submitted in compliance with the instructions issued by EFSA
- In order to make the procedure quicker, Evira recommends that the application be submitted in the English language. The link in the right-hand side column provides more information.
The application shall include
- A paper copy of the application, which is of good print quality, appropriately presented, e.g. in a folder with interleaves.
- Two identical CD disks, which contain all the same information as the paper copy. Evira retains one disk for use in case EFSA should contact Evira.
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A summary of the application (Appendix B) to be provided as a paper copy and as a separate electronic file on a CD disk for use by EFSA in publishing the summary.
2. Evira will acknowledge receipt of the application in writing within 14 days of its receipt and will inform the European Food Safety Authority EFSA about the application without delay. Evira also makes the application and any additional information submitted by the applicant available to EFSA.
A fee based on Decree 638/2010 of the Ministry of Agriculture and Forestry on fees to be collected on services performed by Evira is charged for the processing of the health claim application.
3. EFSA informs the other member states and the Commission about the application without delay and makes the application and any additional information submitted by the applicant available to them.
4. EFSA shall issue its opinion within a time limit of five months from the date of receipt of the application. If EFSA considers it necessary to seek supplementary information from the applicant, such time limit may be extended by up to two months from the date the requested information was received from the applicant.
5. EFSA checks that the health claim is substantiated by scientific evidence and that the wording of the health claim meets the conditions laid down in the Regulation
6. If the opinion issued by EFSA is in favour of the authorisation of the health claim, the opinion contains the following detailed information:
a) name and address of 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 proposal for the wording of the health claim including, as the case may be, specific conditions for use;
d) where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.
7. EFSA issues an opinion to the Commission, the member states and the applicant, and makes the statement public. More information about the NDA panel's opinions published by EFSA can be found through the link on the right hand side column.
8. The applicant or a member of the public may make comments to the Commission within 30 days of such publication.
9. Within two months after receiving the opinion of EFSA, the Commission shall submit to the Standing Committee a draft decision on the lists of authorised health claims.
10. A final decision on the application shall be taken by the Standing Committee that assists the Commission.
11. The Commission shall without delay inform the applicant of the decision taken and publish the decision in the Official Journal. An up-to-date list of authorised health claims is published on the Commission's web site.
12. Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use on the basis of a request for protection of proprietary data.
If the applicant applies for a modification of a claim included in one of the lists provided for in Articles 13 and 14, the user of the claim may apply for a modification of the relevant list following the procedure laid down in Articles 15 to 18 of the Regulation on nutrition and health claims.
