This Regulation determines the necessary conditions for the composition and labelling of foods for particular nutritional use.
Foodstuffs for particular nutritional uses are foods which, by reason of their particular composition or method of processing, are substantially different from the usual foodstuffs which satisfy the nutritional uses and are placed on the market in such a way that their suitability is specifically indicated. This Regulation does not apply to nutrient-based products used as supplements to the daily diet.
These rules are in accordance with the provisions of the Directive 2009/39/EC of the European Parliament and of the Council of 6 May 2009 on foodstuffs intended for particular nutritional uses; and Commission Regulation (EC) No 953/2009 of 13 October 2009 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses.
The Annex is also part of this publication (list of foodstuffs for particular nutritional uses governed by specific rules; list of substances which may be added because of the specific nutritional effects of foods for particular nutritional uses).