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)
Date: 2006-10-27
Institutions: European Commission
Subjects: baby food, early childhood, food substitute, foodstuffs legislation, market approval, prepared foodstuff

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,

(4)

Having regard to the Treaty
Community,

establishing the European

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:

(5)

(6)

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.

Accordingly, pending the
91/321/EEC,
should be authorised for a two-year period.

the marketing of

amendment of Directive
formula
infant

that

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

opinion

the

the

of

(1)

(2)

(3)

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.

Commission Directive 91/321/EEC of 14 May 1991 on
infant formulae and follow-on formulae (2) is a specific
to Directive 89/398/EEC.
Directive adopted pursuant
Directive
compositional
91/321/EEC
requirements for infant formulae.

down

lays

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.

HAS ADOPTED THIS REGULATION:

Article 1

By the way of derogation from Article 2 and Article 4(1) of
Directive 91/321/EEC,
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.

the placing on the market of

Article 2

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

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. 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).

(2) OJ L 175, 4.7.1991, p. 35. Directive as last amended by Directive

2003/14/EC (OJ L 41, 14.2.2003, p. 37).

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

L 299/10

EN

Official Journal of the European Union

28.10.2006

ANNEX

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

0,44 g/100 kJ

(1,86 g/100 kcal)

Maximum

0,7 g/100 kJ

(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.