Applying for approval of health claims on foods

You can apply for the authorization of health claims electronically via the E-Submission Food Chain (ESFC) platform of the European Commission.

Proceed as follows:

• Go to the European Commission's E-Submission Food Chain (ESFC) platform: https://webgate.ec.europa.eu/esfc
• Use the user manual and other training documents to help you: https://ec.europa.eu/food/horizontal-topics/general-food-law/training-and-support_en
• Create a user account and log in to the portal.
• Select "Food Improvement Agents" from the "Food" domain list. Then select the domain type "Health Claims", the application type, the recipient member state and the relevant competent authority and then click on "Start process".
• Then create your dossier. Your application must contain the following information:
  • Name and address of the person making the application,
  • the name of the nutrient or other substance or food or food category for which the health claim is to be made and its specific properties,
  • a copy of the studies including, where available, independent and peer-reviewed studies on the health claim and any other available documentation demonstrating that the health claim meets the criteria of the Regulation,
  • where appropriate, an indication of which information is to be considered proprietary, together with verifiable justification,
  • a copy of other scientific studies relevant to the health claim,
  • a proposal for the wording of the health claim for which authorization is sought, including, where appropriate, specific conditions of use
  • a summary of the application.
  • EFSA encourages the application dossier to be written in English to avoid delays in the evaluation of the application due to the translation to be arranged there.
• Attach any other necessary documents to the application.
• Submit the application online.

If you have applied for the authorization of health claims, your application will be received by the Federal Office of Consumer Protection and Food Safety (BVL) as follows:

The BVL

• confirms receipt of your application in writing within 14 days of its receipt.
  • The date of receipt of the application will be noted in the confirmation.
• will inform EFSA without delay,
• may ask you, as the applicant, to complete the application documents within a specified period.

• You want to use health claims in the labeling, presentation or advertising of foods that are not yet approved.

• The application must be prepared in accordance with the "Scientific and technical guid-ance for the preparation and presentation of a health claim application (Revision 3)" (https://www.efsa.europa.eu/en/efsajournal/pub/6554).
• The application must contain all (published and unpublished) scientific data in favor of or against the health claim, as well as a comprehensive overview of the data from human studies.
• Summary of the dossier

There are no costs.

• § Section 1 No. 2 of the BVL Task Transfer Ordinance (BVLAÜV)
• Article 15 (2) sentences 1 and 2, Article 16 (2) and Article 18 (2) sentence 1 of Regulation (EC) No 1924/2006 - on nutrition and health claims made on foods
• Regulation (EC) No 353/2008 laying down implementing rules for applications for authorization of health claims pursuant to Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council

• Appeal. Further information on how to lodge an appeal can be found in the information on legal remedies in the notification of your application.
• Appeal to the administrative court. You can find more information on how to lodge a complaint in the legal remedies information in the notice of objection.

• Forms available: No
• Written form required: No
• Informal application possible: No
• Personal appearance necessary: No
• Online services available: Yes

29.03.2023