Foods for special medical purposes, infant formulae and certain follow-on formulae for sale in Germany
Source: BUS Rheinland-Pfalz
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):
First notification:
You must notify the BVL at the latest when you distribute the product on the German market for the first time 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 product already notified
- has a changed recipe,
- you adapt the consumption recommendations or
- your company has a new address.
Secondary display:
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.