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 (Text with EEA relevance)
Date: 2008-12-12
Institutions: European Commission
Subjects: animal protein, baby food, early childhood, food safety, food standard, marketing, nitrogen

13.12.2008

EN

Official Journal of the European Union

L 335/25

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

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

(5)

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
the third subparagraph of
Article 4(1) thereof,

the second indent of

Whereas:

(1)

(2)

(3)

(4)

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 criteria for infant formulae.

Directive 2006/141/EC provides that only the substances
listed in Annex III thereto may be used in the manu­
to satisfy the
facture of
requirements on inter
and other
nitrogen compounds.

formulae in order

amino acids

infant

alia

Annex III of that Directive should be amended to permit
the use of L-arginine and its hydrochloride in the infant
formulae.

Directive 2006/141/EC also provides that infant formulae
manufactured from protein hydrolysates defined in point
2.2 of Annex I thereto with a protein content between
the minimum and 0,56 g/100 kJ (2,25 g/100 kcal) are to
be in accordance with the appropriate specifications set
out in Annex VI. That Annex sets out specifications for
the protein content and source and the processing of
such infant
protein used in the manufacture of
formulae manufactured from hydrolysates of whey
proteins derived from cows′ milk protein.

infant

(EC) No

1609/2006

of
Commission Regulation
27 October 2006 authorising the placing on the
market of
formulae based on hydrolysates of
whey protein derived from cows′ milk protein for a
two-year period (3)
the placing on the
authorises
formulae based on hydrolysates of
market of
cows′ milk in accordance with specifications for the
protein content, source, processing and quality set out
in the Annex thereto. That authorisation expires on
27 October 2008.

infant

Directive 2006/141/EC provides on a permanent basis
for the authorisation laid down in Regulation (EC) No
1609/2006. Annex VI to Directive 2006/141/EC set out
the specifications for the protein content, protein source
and protein processing for
formulae in
question. However,
compositional
requirements relating to the protein quality were not
included
such
requirements would prevent the placing on the market
infant formulae manufactured from protein hydro­
of
lysates
following the expiry of Regulation (EC) No
1609/2006.

the infant
particular

that Annex. The

absence

the

of

in

The missing specifications concerning protein quality,
which were included in the authorisation laid down in
Regulation (EC) No 1609/2006, should be added to
Annex VI
to Directive 2006/141/EC. That Annex
should therefore be amended accordingly.

In order to avoid any disruption on the market for infant
formulae, this Regulation should apply from 28 October
2008.

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

opinion

the

the

of

(6)

(7)

(8)

(9)

HAS ADOPTED THIS REGULATION:

Article 1

Annexes III and VI to Directive 2006/141/EC are amended in
accordance with the Annex to this Regulation.

(1) OJ L 186, 30.6.1989, p. 27.
(2) OJ L 401, 30.12.2006, p. 1.

(3) OJ L 299, 28.10.2006, p. 9.

L 335/26

EN

Official Journal of the European Union

13.12.2008

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

Article 2

It shall apply from 28 October 2008.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 12 December 2008.

For the Commission

Androulla VASSILIOU
Member of the Commission

13.12.2008

EN

Official Journal of the European Union

L 335/27

ANNEX

Annexes III and VI to Directive 2006/141/EC are amended as follows:

1. In Section 3 of Annex III, the following substance is inserted at the top of the list entitled ‘Amino acids and other

nitrogen compounds’:

‘L-arginine and its hydrochloride (1)
___________
(1) L-arginine and its hydrochloride shall only be used in the manufacture of infant formulae referred to in the third

subparagraph of Article 7(1).’

2. In Annex VI, the following point 4 is added:

‘4. Protein quality

The indispensable and conditionally indispensable amino acids in breast milk, expressed in mg per 100 kJ and 100
kcal, are the following:

Per 100 kJ (1)

Per 100 kcal

Arginine

Cystine

Histidine

Isoleucine

Leucine

Lysine

Methionine

Phenylalanine

Threonine

Tryptophan

Tyrosine

Valine

(1) 1 kJ = 0,239 kcal.’

16

6

11

17

37

29

7

15

19

7

14

19

69

24

45

72

156

122

29

62

80

30

59

80