Commission Regulation (EC) No 1609/2006 of 27 October 2006 authorising the placing on the market of infant formulae based on hydrolysates of whey protein derived from cows’ milk protein for a two-year period   (Text with EEA relevance)

28.10.2006 EN Official Journal of the European Union L 299/9
COMMISSION REGULATION (EC) No 1609/2006
of 27 October 2006
authorising the placing on the market of infant formulae based on hydrolysates of whey protein derived from cows’ milk protein for a two-year period
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses (1), and in particular Article 4(1a) thereof,
Having consulted the European Food Safety Authority,
Whereas:
(1) Directive 89/398/EEC concerns foodstuffs for particular nutritional uses. The specific provisions applicable to certain groups of foods for particular nutritional uses are laid down by specific Directives.
(2) Commission Directive 91/321/EEC of 14 May 1991 on infant formulae and follow-on formulae (2) is a specific Directive adopted pursuant to Directive 89/398/EEC. Directive 91/321/EEC lays down compositional requirements for infant formulae.
(3) The Commission received a application for the placing on the market of an innovative infant formula based on hydrolysates of whey protein derived from cows’ milk with a protein content below the minimum of 0,56 g protein/100 kJ (2,25 g protein/100 kcal), as referred to in point 2.2 of Annex I to Directive 91/321/EEC.
(4) On 5 October 2005, the European Food Safety Authority delivered its opinion (3). That opinion stated that infant formula, based on hydrolysates of whey protein derived from cows’ milk with a protein content of 0,47 g/100 kJ (1,9 g/100 kcal), is safe and suitable for use as the sole source of nutrition of infants.
(5) Accordingly, pending the amendment of Directive 91/321/EEC, the marketing of that infant formula should be authorised for a two-year period.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,