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Source: BUS Sachsen-Anhalt (Linie6PLus)

Foodstuffs for special medical purposes, infant formulae and certain follow-on formulae for sale in Germany

Description

The following foods must meet certain legal requirements for food safety and consumer protection. This applies not only to production or declaration, but also when you make the product available for sale or use:

- Foods for special medical purposes, so-called balanced diets, for use under medical supervision. They cover all or part of the nutritional requirements of sick people when this is not possible with conventional foods.
- Infant formula and
- certain follow-on formulas.

In the following cases, please send a notification to the Federal Office of Consumer Protection and Food Safety (BVL):
Initial notification:
You must notify the BVL at the latest when you first redistribute the product on the German market or offer it for use or sale. You must submit a separate notification for each product.

Notification of change:
Notify the BVL, for example, if the already notified product
- has a changed recipe,
- you change the consumption recommendations or
- your company has a new address.

Second notification:
You must also send a notification if the product
- is already registered in another EU member state and
- you wish to place the product on the market in Germany for the first time.

The BVL will forward your information to the competent authorities in the federal states and to the Federal Ministry of Food and Agriculture. The competent authorities of the federal states monitor compliance with the legal requirements. As a company, you are responsible for implementing these requirements.
The BVL does not assess the marketability of the products, i.e. the extent to which they comply with food law regulations.
Therefore, the BVL cannot confirm whether your product complies with the food law regulations within the scope of the notification.
No approval or authorization is granted following the submission of the notification of a food for special medical purposes, an infant formula or certain follow-on formulas.

  • You are planning to launch foods for special medical purposes, infant formula or certain follow-on formulas on the German market.
  • Sample of the label in German to be used for the product
  • Proof of suitability
  • If there are several pack sizes or flavors, please submit all corresponding product labels.
  • Authorization if you are notifying the product on behalf of the responsible food business operator
  • If you have already notified your product in another EU Member State, the following documents are optional:
    • Confirmation of the first notification as a copy
    • German or English translation of the confirmation, if applicable

You must make the notification at the latest when you make the product available for sale or use in Germany.

Duration: 0.5 hours


Processing is completed once the notification form has been sent or confirmation of receipt has been received.

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

You can submit the notification online via the federal portal:

  • Call up the online form on the federal portal verwaltung.bund.de. This will guide you step by step through the necessary information.
  • Complete the form, upload the required documents and submit the notification online.
  • You will receive a confirmation of receipt.

The following information is available:

The confirmation of receipt of the notification does not constitute a certificate as to whether the product is marketable. The marketability of the product (e.g. labeling) is not checked in the notification.
A notification does not replace the individual obligation to comply with food law regulations.

Federal Ministry of Food and Agriculture (BMEL)

The text was automatically translated based on the German content.