(1)

A number of nutritional substances such as vitamins, minerals, amino acids and others may be added to foods for particular nutritional uses in order to ensure that the particular nutritional requirements of the persons for whom those foods are intended are fulfilled and/or in order to satisfy legal requirements laid down in specific directives adopted pursuant to Article 4(1) of Directive 2009/39/EC. The list of those substances had been established by Commission Directive 2001/15/EC of 15 February 2001 on substances that may be added for specific nutritional purposes in foods for particular nutritional uses (2) and, following requests submitted by interested parties, new substances have been evaluated by the European Food Safety Authority, and consequently, that list should be completed and updated. Furthermore, it is appropriate to introduce specifications for some vitamin and mineral substances for their identification.

(2)

It is neither possible to define nutritional substances as a distinct group for the purpose of this Regulation nor to draw up at this stage an exhaustive list of all categories of nutritional substances that may be added in foodstuffs for particular nutritional uses.

(3)

The range of foods for particular nutritional uses is very wide and diversified and the technological processes used for their manufacture are varied. For this reason, the widest possible choice of substances that can be safely used in the manufacture of foods for particular nutritional uses should be available for the categories of nutritional substances to be listed in this Regulation.

(4)

The choice of substances should be based primarily on their safety and subsequently on their availability for use by humans and on their organoleptic and technological properties. Unless otherwise specified in provisions applicable to specific categories of foodstuffs, the inclusion of substances in the list of those that may be used in the manufacture of foodstuffs for particular nutritional uses does not mean that their addition to those foodstuffs is necessary or desirable.

(5)

Where the addition of a nutritional substance has been judged necessary, this has been stipulated by specific rules in the relevant specific directives together with the appropriate quantitative conditions, as the case may be.

(6)

In the absence of any specific rules or in the case of foodstuffs for particular nutritional uses not covered by specific directives, nutritional substances should be used in order to manufacture products that are in conformity with the definition of such products and fulfil the particular nutritional requirements of the persons for whom they are intended. The products in question must also be safe when used as instructed by the manufacturer.

(7)

The provisions concerning the list of the nutritional substances that may be used in the manufacture of infant formulae and follow-on formulae and of processed cereal-based foods and baby foods for infants and young children are laid down in Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (3), and Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (4). Therefore those provisions need not be repeated in this Regulation.

(8)

A number of the nutritional substances may be added for technological purposes as additives, colourings, flavourings or other such uses including authorised oenological practices and processes provided for by relevant Community legislation. In this context specifications are adopted for them at Community level. It is appropriate that those specifications should be applicable for the substances whatever the purpose of their use in foodstuffs.

(9)

Pending the adoption of purity criteria for the rest of the substances at Community level, and in order to ensure a high level of protection for public health, generally acceptable purity criteria recommended by international organisations or agencies including but not limited to the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and EUP (European Pharmacopoeia) should apply. Member States should be permitted to maintain national rules setting stricter purity criteria, without prejudice to the rules set out in the Treaty.

(10)

Some specific nutrients or their derivatives have been identified as specifically necessary for the manufacture of some foodstuffs belonging to the group of foodstuffs for special medical purposes and their potential use should be reserved to the manufacture of these products.

(11)

For the sake of clarity, Directive 2001/15/EC and Commission Directive 2004/6/EC of 20 January 2004 derogating from Directive 2001/15/EC to postpone the application of the prohibition of trade to certain products (5) should be repealed and replaced by this Regulation.

(12)

The measures provided in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,