Source: BUS Sachsen-Anhalt (Linie6Plus)

Request consultation procedure for novel foods

Description

In the European Union (EU), foodstuffs may generally be placed on the market without prior authorization. Novel foods are an exception to this rule. These must first undergo a health assessment and be approved before being placed on the market.

If you are unsure whether your food is to be 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 first. 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 which, among other things, show the production, composition and intended use of your food. In your application, you can request confidential treatment of the food information you have submitted if its disclosure could harm your competitive position.

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

In order to determine the novel food status, the BVL consults the food control 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 will speed up the procedure as they no longer need to be translated before being forwarded to the European Commission and the Member States.

Prerequisites

You cannot independently determine beyond doubt whether your food falls under the EU Novel Food Regulation.
You want to place your food on the market in Germany first, not in another EU member state.

Required documents

Technical documentation: A corresponding template can be found in Annex II of Implementing Regulation (EU) 2018/456.
Documents to support your request for consultation. If available, evidence of significant consumption of the food before 15.05.1997 in the EU: for example, evidence of import and sales figures, evidence of actual availability on the market as a food, labels, technical literature if available.
A note in which you explain the purpose and relevance of the documents submitted.
If you are submitting the application by e-mail: Cover letter. A sample cover letter can be found in Annex I of Implementing Regulation (EU) 2018/456
If you request confidential treatment of the information submitted with the application: corresponding statement.
If the application is made by proxy: Power of attorney.

Depending on the circumstances, you may have to submit further documents with your application, for example study results or product images. You can obtain information on this from the BVL.

Legal remedy

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.

Applications / Forms

Forms available: No

Written form required: No

Informal application possible: Yes

Personal appearance necessary: No

Procedure

First of all, you are responsible for checking whether or not your food falls under the EU Novel Food Regulation. If you cannot identify the food in question with certainty, you can consult the BVL.

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

Apply for the consultation procedure online via the federal portal:

Call up 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 confirmation that your application has been received.
The BVL will check your details and documents and coordinate with the authorities of the federal states and EU member states.
The BVL will contact you if further documents or information are required.
The BVL will inform you of the provisional result of the consultation procedure.
You comment on the preliminary result of the consultation procedure.
You will receive a notification of approval digitally via the feedback channel function of the federal portal or by post.
In this notification, you will be informed whether your foodstuff
- novel,
- not novel or
- non-novel only in food supplements.
You will also receive a separate notification of fees. You will then pay the fees.

Request consultation procedure by e-mail:

Formulate an application 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. Complete the application online and save it as a print preview.
Attach all required documents.
Send your application to the BVL by e-mail.
You will receive confirmation that your application has been received.
The BVL will check your details and documents and coordinate with the authorities of the federal states and EU member states.
The BVL will contact you if further documents or information are required.
The BVL will inform you of the provisional result of the consultation procedure.
You comment on the preliminary result of the consultation procedure.
The BVL will inform you by official decision whether your food is
- novel,
- not novel or
- is only non-novel in food supplements
You will also receive a separate notification of fees. You will then pay the fees.

Further information

The BVL does not carry out the actual authorization procedure for novel foods. The authorization of novel foods is carried out by the European Commission and must be applied for separately. This is about determining whether a food is novel, i.e. whether there is a need to submit an application to the European Commission.