Food for special medical purposes legislation

EU food for special medical purposes legislation

Commission Regulation (EU) No 609/2013 of 12 June 2013 aims to protect specific vulnerable groups of consumers including people with specific medical conditions, by regulating the content and marketing of food products specifically created for and marketed to them. It also aims to increase legal clarity for business and facilitate correct application of the rules.

Commission delegated Regulation (EU) 2016/128 was adopted on 25 September 2015 and will come into force 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 the 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 help avoid any 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.

Belgian legislation regarding food for medical use

At the national level, (diet) food for medical use is regulated by the Royal Decree of 18 February 1991 on foodstuffs intended for particular nutritional uses.

These foodstuffs can only be used under medical supervision. They can only be sold in pharmacies, and before being placed on the market, must be notified of with the Federal Public Service Public Health, Food Chain Safety and Environment.


Last updated: 21/01/2019