Apply for a novel food consultation procedure

Do you want to launch a food product on the market in Germany and are unsure whether it is classified as a novel food? Then you can apply for a consultation procedure with the Federal Office of Consumer Protection and Food Safety (BVL).

In the European Union (EU), food products may generally be placed on the market without prior authorization. An exception is made for novel foods, also known as "Novel Foods." These must first undergo a health assessment and be authorized before they can be placed on the market.

If you are unsure whether your food is classified as a novel food, you can consult the competent authority of the EU Member State in which you intend to place the food on the market for the first time regarding this question. In Germany, the Federal Office of Consumer Protection and Food Safety (BVL) is responsible.

With your application to initiate such a consultation procedure, the BVL requires documents and information from you detailing, among other things, the production, composition, and intended use of your food. In the application, you can request confidential treatment of the information you have submitted regarding the food if its disclosure could harm your competitive position.

Please note that your application to the BVL merely initiates the consultation procedure in which the BVL assesses whether your food is to be classified as a novel food. You must apply for the actual authorization for placing a novel food on the market separately from the European Commission.

To determine the novel food status, the BVL consults the food monitoring authorities of the federal states and exchanges information with the authorities of other EU member states and the European Commission. If you submit your application documents in English, this accelerates the procedure since they no longer need to be translated before being forwarded to the European Commission and the EU member states.

First, you must check on your own responsibility whether your food falls under the EU Novel Food Regulation or not. If you are unable to reliably classify the food in question yourself, you can consult the BVL.

You can apply for the consultation procedure online via the federal portal or by e-mail.

Apply for consultation procedure online via the federal portal:

• Access the online application on the federal portal verwaltung.bund.de. This will guide you step by step through the necessary information, which you can enter electronically. 
• Upload the required documents as a file and submit the application.
• You will receive a confirmation that your application has been received. 
• If you are not registered, you can generate your completed application as a PDF file and send it to the BVL by email.
• The BVL reviews your information and documents and coordinates with the authorities in the federal states and EU member states.
• The BVL will contact you if further documents or information are required.
• The BVL informs you of the preliminary result of the consultation procedure.
• They are providing feedback on the preliminary results of the consultation process.
• You will receive a notification of admission digitally via the return channel function of the federal portal or by mail.
• This decision informs you whether your food
  • novel,
  • not novel or
  • is not novel only in dietary supplements.
• In addition, you will receive a separate fee notice. Then you pay the fees.

Apply for a consultation procedure by email:

• Submit an application, for example, by using the sample cover letter in Annex I of Implementing Regulation (EU) 2018/456. Alternatively, access the online application on the federal portal verwaltung.bund.de. Fill out the application online and save it as a print view.
• Attach all required documents. 
• Submit your application to the BVL by email. 
• You will receive a confirmation that your application has been received. 
• The BVL reviews your information and documents and coordinates with the authorities in the federal states and EU member states.
• The BVL will contact you if further documents or information are required.
• The BVL informs you of the preliminary result of the consultation procedure.
• They are providing feedback on the preliminary results of the consultation process.
• The BVL will notify you in writing whether your food
  • novel,
  • not novel or
  • is not novel only in dietary supplements.
• In addition, you will receive a separate fee notice. Then you pay the fees.

• Objection 
  • Further information on how to lodge an appeal can be found in the legal remedy instruction in the notice regarding your application.
• lawsuit before the administrative court
  • Further information on how to file a lawsuit can be found in the legal remedy instruction in the rejection notice of the objection.