Legislation

Foods for Special Medical Purposes (FSMPs) are controlled under the umbrella of the PARNUTS  (Foods for Particular Nutritional Uses) Directive (2009/39/EC). This can be viewed here: PARNUTS Framework Directive

Specific legislation on FSMPs provides detail on product composition and labelling (EU Directive 1999/21/EC).  This can be viewed here :  Foods for Special Medical Purposes.

FSMPs also need to comply with all other relevant legislation including food hygiene, food safety and additives.

Further information on FSMP legislation

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 in 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 on foods for special medical purposes of December 1996, provided the scientific advice on which these rules are based. Commission Directive N° 2001/15/EC sets out detailed rules on the sources of certain nutritional substances that may be used in foods for special medical purposes.