About the Regulation
The rules for the composition and labelling of foods intended for the dietary management (under medical supervision) of individuals who suffer from certain diseases, disorders or medical conditions have been laid down by the Commission Directive 1999/21/EC, adopted under the old legislative framework of Directive 2009/39/EC.
These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods. The Directive 1999/21/EC lays down essential requirements on their composition and gives guidance for the minimum and maximum levels of vitamins and minerals.
Nutritional substances that may be used in the manufacture of foods for special medical purposes are laid down in Commission Regulation (EC) No 953/2009.
What has the new Regulation done?
For food for special medical purposes, from 20 July 2016;
Sets general compositional and labelling rules
Requires the Commission to adopt, through delegated act, specific compositional and labelling rules for foods for special medical purposes, which will replace Directive 1999/21/EC. Commission delegated Regulation (EU) 2016/128 was adopted on 25 September 2015 and will start to apply on 22 February 2019. Until that date, the rules of Directive 1999/21/EC remain applicable. The new delegated Regulation:
- Maintains the existing rules of Directive 1999/21/EC with some changes to the labelling requirements to ensure consistency with horizontal rules of Regulation (EU) No 1169/2011 on the provision of food information to consumers, taking into account the specificities of the products
- Introduces the prohibition to make nutrition and health claims on foods for special medical purposes, in order to ensure legal clarity and avoid inappropriate promotion of the products
- Extends to foods for special medical purposes intended for infants all rules on labelling, presentation, advertising and marketing applicable to infant formulae for healthy infants that would not be contrary to the products' intended use. This will ensure consistency of EU rules and contribute to avoiding misclassification of products
- Extends to foods for special medical purposes intended for infants and young children the same rules on pesticides that apply to infant formula, follow-on formula, processed cereal-based foods and baby foods.