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Applying for approval of health claims on foods

Service Description

In the European Union (EU), certain requirements apply to the labeling and presentation of foodstuffs, as well as to the advertising of foodstuffs, which are particularly intended to contribute to consumer protection.

Regulation (EC) No. 1924/2006 serves to harmonize regulations for nutrition and health claims in the labelling, presentation and advertising of foodstuffs. So-called voluntary claims on foods must be clear, precise and substantiated in EU countries. This is intended to enable consumers to make informed and sensible decisions.

Applying for authorization

You can apply for the authorization of a new health claim or the amendment of an existing authorization of a health claim electronically via the European Commission's E-Submission Food Chain (ESFC) platform:

  • In each application, you may only apply for the authorization of the use of a health claim. Furthermore, it is only permitted to present the link between a precisely defined health effect per advertised food or food category or nutrient or substance.
  • Note: EFSA suggests that the application dossier be written in English in order to avoid delays in the evaluation of the application due to the translation to be arranged there.

Acceptance of the application

The Federal Office of Consumer Protection and Food Safety (BVL) is the competent national authority for receiving applications for the authorization of health claims made on foods. The BVL confirms receipt of your application, informs EFSA and is entitled to request additional documents from you within a certain period of time.

Process flow

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 required 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.

Requirements

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

Which documents are required?

  • 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

What are the fees?

There are no costs.

What deadlines do I have to pay attention to?

Objection Deadline: 1 Month
In accordance with Section 70 of the German Code of Administrative Court Procedure (VwGO), the objection must be lodged in writing, in electronic form in accordance with Section 3a (2) of the German Administrative Procedure Act or for the record with the authority that issued the administrative act within one month of the administrative act being notified to the complainant. The deadline is also met by lodging the appeal with the authority that issued the notice of appeal. §§ Sections 58 and 60 (1) to (4) shall apply accordingly.

Processing duration

Processing Time: 8 - 24 Months
The additional request for documents leads to an extension of the processing deadlines.

Legal basis

Applications / forms

  • 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.

Appeal

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

Further Information

Author

Forwarding service: Deep link to the portal of origin

Federal Office of Consumer Protection and Food Safety (BVL)

The text was automatically translated based on the German content.

Technically approved by

Federal Ministry of Food and Agriculture (BMEL)

Professionally released on

29.03.2023

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

Start your request directly online:

Competent Authority

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL) – Dienststelle Berlin Gerichtstraße, Referat 111

Address
Gerichtstraße 49
13347 Berlin, Stadt
Link to the directions:
BVL-Dienststelle Berlin Gerichtstraße

Postal address
Post office box 110260
10832 Berlin, Stadt
Telephone
+49 3018 44499999
Fax
+49 3018 44489999
E-Mail
Contact us
WWW
Website of the Federal Office of Consumer Protection and Food Safety