Dietetic Food

In 2013 the old Dietetic Framework Directive, the basis of the German Dietetic Regulation, was replaced by the European Directive (EU) No. 609/2013 about food for specific consumer groups (FSG). The directive has become effective on 20 July 2016. Dietetic food can now only be marketed until stocks of already labelled products are depleted. For new products the specific regulations on composition and labelling according to the European legislation must be applied. We check for you whether your products still meet the new valid regulations.

The scope of the FSG-regulation only includes the following categories:

  • Daily rations for a weight control diet
  • Infant formulae and follow-on formulae
  • Cereal-based foods and other baby foods
  • Food for specific medical purposes

All other dietetic food categories are being dropped, meaning that the concept of dietetic food is more or less being abolished after 30 years.

How future regulations for food for specific medical purposes will be structured is given by the delegated act (EU) 2016/128. The previous definitions of the three sub-groups will be adopted unchanged, but completed by special prerequisites for products intended for infants (iFSMP):

  • Complete dietetic food with a standard nutritional formula
  • Complete dietetic food with a nutritional formula adapted specifically to a certain illness or problem or for certain complaints.
  • Incomplete dietetic food with a standard formula or a nutritional formula adapted specifically to a certain illness or problem or for certain complaints.

The latter are known under the term "supplementary balanced diets", in short SBD.

We continuously monitor any other legislation to highlight the right course for the redevelopment of your products in good time.

We check the very precise regulations about composition and labelling for you as well as the partly abstract provisions of the delegated acts and EFSA-guidances, in particular on dietetic intended purpose, e.g. with certain illnesses and problems. This is particularly important to be able to delimit between food for specific consumer groups and food for general nutrition and to be able to market it in compliance with regulations.

If required, we carry out extensive research of literature on physiological nutritional needs and the respective benefits of food or its ingredients. We document the results, possibly including any existing human studies, in a scientific expert report for you. On request, we initiate double blind studies to back up your health claims in cooperation with our external partners from the university sector.