EN    EN EN EN 1   EN Draft 
COMMISSION REGULATION (EC) No …/.. 
of […] 
amending Annexes III and VI to Directiv e 2006/141/EC as regards compositional 
requirements for certain infant formulae  
THE COMMISSION OF THE EUROPEAN COMMUNITIES, 
Having regard to the Treaty esta blishing 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 for particul ar nutritional uses1, and in 
particular the second indent of the thir d subparagraph of Article 4(1) thereof , 
Whereas: (1) Commission Directive 2006/141/ EC of 22 December 2006 on infant formulae and 
follow-on formulae
2 lays down inter alia  compositional criteria for infant formulae. 
(2) Directive 2006/141/EC provides that only the substances listed in Annex III thereto 
may be used in the manufacture of infant formulae in order to satisfy the requirements 
on inter alia  amino acids and other nitrogen compounds. 
(3) Annex III of that Directive should be amende d to permit the use of L-arginine and its 
hydrochloride in the infant formulae.  
(4) Directive 2006/141/EC also provides that in fant formulae manufactured from protein 
hydrolysates defined in point 2.2 of Annex I thereto with a protei n content be tween 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 processi ng of protein used in the manufacture of 
such infant formulae manufactured from hydrol ysates of whey proteins derived from 
cows’ milk protein. 
(5) Commission Regulation (E C) No 1609/2006 of 27 Oct ober 2006 authorising the 
placing on the market of infant formul ae based on hydrolysates of whey protein 
derived from cows' milk protein for a two-year period
3 authorises the placing on the 
market of infant formulae based on hydrolys ates of cows' milk in accordance with 
specifications for the protein content, sour ce, processing and qua lity set out in the 
Annex thereto. That authorisa tion expires on 27 October 2008. 
                                                 
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.  EN 2   EN (6) Directive 2006/141/EC provides on a permanen t 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, pr otein source and protein processing for the 
infant formulae in question. However, the particular compositional requirements relating to the protein qualit y were not included in that Annex. The absence of such 
requirements would prevent the placing on the market of infant formulae 
manufactured from protein hydrolysates following the expi ry of Regulation (EC) No 
1609/2006.  
(7) The missing specifications concerning prot ein quality, which were included in the 
authorisation laid down in Regulation (E C) No 1609/2006, should be added to Annex 
VI of Directive 2006/141/EC. That Annex should therefore be amended accordingly. 
(8) In order to avoid any disruption on the ma rket for infant formulae, this Regulation 
should apply from 28 October 2008. 
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on the Food Chain and Animal Health, 
 HAS ADOPTED THIS REGULATION: 
Article 1 
Annexes III and VI to Directive 2006/141/EC ar e amended in accordance with the Annex to 
this Regulation. 
 Article 2 
This Regulation shall enter into force on the […] day following that of its publication in the 
Official Journal of the European Union . 
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, […] 
 For the Commission 
      […] 
      Member of the Commission 
 
ANNEX
 EN 3   EN Annexes III and VI are amended as follows: 
(1) In Section 3 of Annex III, the following substan ce is inserted at the t op of the list entitled 
'Amino acids and other nitrogen compounds': 
'L-arginine and its hydrochloride♣' 
(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 kJ1 Per 100 kcal 
Arginine 16 69 
Cystine 6 24 
Histidine 11 45 
Isoleucine 17 72 
Leucine 37 156 
Lysine 29 122 
Methionine 7 29 
Phenylalanine 15 62 
Threonine 19 80 
Tryptophan 7 30 
Tyrosine 14 59 
Valine 19 80 
1 1 kJ = 0.239 kcal. 
'
                                                 
♣ 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).  EN 4   EN EN 5   EN