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
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Whereas:
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.
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.
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.
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.
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.
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,
HAS ADOPTED THIS DIRECTIVE: