Directive 2006/141 - Infant formulae and follow-on formulae

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1.

Current status

This directive was in effect from January 19, 2007 until February 21, 2020 and should have been implemented in national regulation on December 31, 2007 at the latest.

2.

Key information

official title

Commission Directive 2006/141/EC of 22 December 2006 on infant formulae and follow-on formulae and amending Directive 1999/21/EC Text with EEA relevance
 
Legal instrument Directive
Number legal act Directive 2006/141
CELEX number i 32006L0141

3.

Key dates

Document 22-12-2006
Publication in Official Journal 30-12-2006; Special edition in Croatian: Chapter 13 Volume 029,Special edition in Bulgarian: Chapter 13 Volume 059,OJ L 314M , 1.12.2007,Special edition in Romanian: Chapter 13 Volume 059,OJ L 401, 30.12.2006
Effect 19-01-2007; Entry into force Date pub. +20 See Art 20
End of validity 21-02-2020; Partial end of validity See 32016R0127
21-02-2022; Repealed by 32013R0609 See 32016R0127 And 32021R0572
Transposition 31-12-2007; At the latest

4.

Legislative text

30.12.2006   

EN

Official Journal of the European Union

L 401/1

 

COMMISSION DIRECTIVE 2006/141/EC

of 22 December 2006

on infant formulae and follow-on formulae and amending Directive 1999/21/EC

(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(1) thereof,

After consulting the European Food Safety Authority (the Authority),

Whereas:

 

(1)

Directive 89/398/EEC concerns foodstuffs intended 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. That Directive has been substantially amended several times (3). Since further amendments are to be made, it should be recast in the interests of clarity.

 

(3)

In the light of discussions in international fora, in particular Codex Alimentarius, in relation to the timing of the introduction of complementary foods into the diet of infants, it is appropriate to amend the current definitions of infant formulae and follow-on formulae and certain provisions on the labelling of follow-on formulae in Directive 91/321/EEC.

 

(4)

Infant formula is the only processed foodstuff which wholly satisfies the nutritional requirements of infants during the first months of life until the introduction of appropriate complementary feeding. In order to safeguard the health of such infants it is necessary to ensure that the only products marketed as suitable for such use during the period would be infant formulae.

 

(5)

The essential composition of infant formulae and follow-on formulae must satisfy the nutritional requirements of infants in good health as established by generally accepted scientific data.

 

(6)

The requirements concerning the essential composition of infant formulae and follow-on formulae should include detailed provisions on the protein content. Notwithstanding that traditionally different appropriate conversion factors have been used for the calculation of the protein content from the nitrogen content of different protein sources, recent scientific advice indicates that for the specific purposes of calculating the protein content of infant formulae and follow-on formulae it is appropriate to use a single conversion factor adapted to these products. As infant formulae and follow-on formulae are sophisticated products that are specially formulated for their intended purpose, additional essential requirements on protein, including minimum and maximum levels of protein and minimum levels of certain amino acids, should be established. The protein requirements specified in this Directive should relate to the final products as such, prepared ready for consumption.

 

(7)

On the basis of such data, the essential composition of infant formulae and follow-on formulae manufactured from cows' milk proteins and soya proteins alone or in a mixture, as well as infant formulae based on protein hydrolysates, can already be defined. The same is not true for preparations based wholly or partly on other sources of protein. For this reason specific rules for such products, if necessary, should be adopted at a later date.

 

(8)

It is important that ingredients used in the manufacture of infant formulae and follow-on formulae are suitable for the particular nutritional use by infants and that their suitability has been demonstrated,...


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This text has been adopted from EUR-Lex.

 

5.

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