29.8.2013

EN

Official Journal of the European Union

L 230/16

(1)

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC (2) lays down, inter alia, compositional and labelling rules for infant formulae and follow-on formulae.

(2)

Directive 2006/141/EC specifically provides for infant formulae and follow-on formulae to only be manufactured from protein sources defined in that Directive. Those protein sources are cows‘�milk proteins and soya protein isolates, alone or in a mixture, as well as protein hydrolysates.

(3)

On request from the Commission, the European Food Safety Authority delivered, on 28 February 2012, a scientific opinion on the suitability of goat milk protein as a source of protein in infant formulae and in follow-on formulae. That opinion concluded that protein from goats‘�milk can be suitable as a protein source for infant formulae and follow-on formulae provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC.

(4)

On the basis of that opinion, infant formulae and follow-on formulae manufactured from goats‘�milk proteins should be allowed on the market provided that the final product complies with the compositional criteria laid down in Directive 2006/141/EC. Directive 2006/141/EC should therefore be amended accordingly.

(5)

On request from the Commission, the European Food Safety Authority delivered, on 5 October 2005, a scientific opinion on the safety and suitability for particular nutritional use by infants of formula based on whey protein partial hydrolysates with a protein content of at least 1,9 g/100 kcal, which was below the minimum level provided for in the Union legislation at that time. That opinion concluded that infant formula, based on hydrolysates of whey protein derived from cows‘�milk with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) and corresponding to the protein formulation assessed, is safe and suitable for use as the sole source of nutrition of infants. On the basis of that opinion, Directive 2006/141/EC, as amended by Commission Regulation (EC) No 1243/2008 of 12 December 2008 amending Annexes III and VI to Directive 2006/141/EC as regards compositional requirements for certain infant formulae (3), authorises the marketing of infant formulae manufactured from protein hydrolysates with such a protein content provided that the product complies with certain specific criteria set out therein.

(6)

That opinion also concluded that, while no data on follow-on formulae based on hydrolysed whey protein with a protein content of 1,9 g/100 kcal (0,47 g/100 kJ) had been submitted, a formula with that protein formulation would be suitable for older infants in conjunction with complementary foods.

(7)

On the basis of that opinion, and in order to allow the development of innovative products, such follow-on formulae should be allowed on the market. Directive 2006/141/EC should therefore be amended accordingly.

(8)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health, and neither the European Parliament nor the Council have opposed them,

(1)

Article 7 is amended as follows:

(2)

in Article 12, the introductory phrase is replaced by the following:

‘楾he name under which infant formulae and follow-on formulae manufactured entirely from cows‘�milk or goats‘�milk proteins are sold shall be respectively:‘�

(3)

Annexes I, II, III and VI are amended in accordance with the Annex to this Directive.