This Regulation sets out the general food safety rules aimed for foods classified as special-purpose foodstuffs. See article 2 for the definition of terms (special-purpose foodstuffs include infant food; special nutritional and health or medical purpose foods).
This kind of foodstuff has to be labelled in accordance with the regulations governing the general labelling of foodstuffs and has to contain the labeled "Dietary special-purpose food", which must appear on the visible part of the packaging next to the name under which the food is sold.
This text is in accordance with the Commission Directive 1999/21/EC of 25 March 1999 on dietary foods for special medical purposes; Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC; Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae; Commission Directive 2006/82/EC of 23 October 2006 adapting Directive 91/321/EEC on infant formulae and follow-on formulae and Directive 1999/21/EC on dietary foods for special medical purposes, by reason of the accession of Bulgaria and Romania; and other, see article 1 for the complete list.
Articles 5, 6, 7, 8 and 9 are setting the basic and special or additional labelling rules.
The list of indispensable (essential) composition of foods intended for special medical purposes is in Annex 1, which is part of this publication; the list of names under which special-purpose foodstuffs are placed on the market are listed in Annex 2.