# 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)

## Preamble

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,

HAS ADOPTED THIS REGULATION:

## **Article 1**

By the way of derogation from Article 2 and Article 4(1) of Directive 91/321/EEC, the placing on the market of infant formulae based on hydrolysates of cows’ milk, as set out in the Annex to this Regulation, is authorised for a two-year period from the date of adoption of this Regulation.

## **Article 2**

This Regulation shall enter into force on the 20th day following its publication in the *Official Journal of the European Union* .

## Final provisions

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 27 October 2006. *For the Commission* Markos KYPRIANOU *Member of the Commisison*

[^1] [OJ L 186, 30.6.1989, p. 27](http://publications.europa.eu/resource/oj/JOL_1989_186_R_TOC) . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council ( [OJ L 284, 31.10.2003, p. 1](http://publications.europa.eu/resource/oj/JOL_2003_284_R_TOC) ).

[^2] [OJ L 175, 4.7.1991, p. 35](http://publications.europa.eu/resource/oj/JOL_1991_175_R_TOC) . Directive as last amended by Directive 2003/14/EC ( [OJ L 41, 14.2.2003, p. 37](http://publications.europa.eu/resource/oj/JOL_2003_041_R_TOC) ).

[^3] The EFSA Journal (2005) 280, p. 1-16.

Specifications for the protein source, protein processing and protein quality used in the manufacture of infant formula based on hydrolysates of whey protein derived from cows’ milk protein

**(1)** Protein content

Protein content = nitrogen content × 6,25

| Minimum | Maximum |
| --- | --- |
| 0,44 g/100 kJ | 0,7 g/100 kJ |
| (1,86 g/100 kcal) | (3 g/100 kcal) |

**(2)** Protein source

Demineralised sweet whey protein derived from cows’ milk after enzymatic precipitation of caseins using chymosin, consisting of:

(a) 63 % caseino-glycomacropeptide free whey protein isolate with a minimum protein content of 95 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3 %; and

(b) 37 % sweet whey protein concentrate with a minimum protein content of 87 % of dry matter and protein denaturation of less than 70 % and a maximum ash content of 3,5 %.

**(3)** Protein processing

Two-stage hydrolysis process using a trypsin preparation with a heat treatment step (from 3 to 10 minutes at 80 to 100 °C) between the two hydrolysis steps.

**(4)** Protein quality

Essential and semi-essential amino acids in breast milk as set out in Annex V to Directive 91/321/EEC.

[^1]: . Directive as last amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council ().
[^2]: . Directive as last amended by Directive 2003/14/EC ().
[^3]: The EFSA Journal (2005) 280, p. 1-16.