The draft regulation proposed by the Commission strengthens and clarifies provisions for foods intended for vulnerable groups of the population who need particular protection. The proposal establishes a single EU list of substances that can be added to these foods. The substances covered in the list include, among others, minerals and vitamins.

The proposal repeals the Directive 2009/39/EC and abolishes the concept of dietetic foods because its application differs significantly between Member States and creates distortions in the internal market. Dietetic foods will be solely covered by other already existing legislation. In order to protect vulnerable groups of the population who need particular protection – namely infants and children up to three years old, and people with specific medical conditions, such as cancer patients or individuals with metabolism disorders, the proposal for updating the current regulation by maintaining the existing compositional and labelling rules applicable to infant and follow-on formulae, processed cereal-based foods and other baby foods and foods for special medical purposes.

Specialised "normal" foods have increasingly been targeting sub-groups of the general population. The difference between "dietetic foods" for specific groups of the population and "specialised foods" for the general population or sub-groups is no longer clear for citizens, stakeholders and enforcement authorities given the evolution of food products and the evolution of EU food legislation. Thus, a review of the dietetic food legislation became necessary.

In addition, the new framework will result in less administrative burden, more clarity and consequently allow for more flexibility for the evolving, innovative food market. Now, the proposal will be submitted to the European Parliament and the Council. If these Institutions reach an agreement on it, the new regulation should be in force by the end of 2012. In order to facilitate the adaptation of products and reduce costs for operators, mainly in terms of re-labelling, a two-year transitional period is foreseen.