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Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes (as amended by Directive 2006/141/EC)sets out rules for the composition and labelling of foods that are specifically formulated, processed and intended for the dietary management of diseases, disorders or medical conditions of individuals who are being treated under medical supervision. These foods are intended for the exclusive or partial feeding of people whose nutritional requirements cannot be met by normal foods. The Directive gives guidance for the minimum and maximum levels of vitamins and minerals. Directive 2006/141/EC amended the levels of manganese in products intended for infants and young children. The Scientific Committee on Food has in its opinion (see below) on foods for special medical purposes of December 1996 provided the scientific advice on which these rules are based. 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 will the new Regulation 609/2013 on Food for Specific Groups (FSG) do for foods for special medical purposes from 20 July 2016?

  • Set general compositional and labelling rules;
  • Require the Commission to adopt through delegated act specific compositional and labelling rules for foods for special medical purposes including infants. This delegated act will replace Directive 1999/21/EC.

Scientific advice

Scientific Opinion on a request from the Commission related to N-Acetyl-L-methionine for use in foods for special medical purposes (Published: 4 February 2004 Adopted: 10 December 2003) pdf

Scientific Opinion on foods for special medical purposes (FSMPs) (expressed on 13 December 1996) pdf

 
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