EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
SANCO/13014/2012 Rev. 1 
(POOL/E4/2012/13014/13014R1-EN 
CIS.doc) 
[…](2013) XXX  draft 
  
COMMISSION DIRECTIVE ../…/EU 
of XXX  
amending Directive 2006/141/EC with regard to protein requirements for infant 
formulae and follow-on formulae 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION DIRECTIVE ../…/EU 
of XXX 
amending Directive 2006/141/EC with regard to protein requirements for infant 
formulae and follow-on formulae 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Directive 2009/39/EC of the European Parliament and of the Council of 
6 May 2009 on foodstuffs intended for particular nutritional uses
1, and in particular 
Article 4(1) thereof,  
Whereas: (1) 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 and labelling rules for infant formulae and follow-on formulae. 
(2) Directive 2006/141/EC specifically provide s for infant formulae and follow-on 
formulae to only be manufactured from prot ein sources defined in  that Directive. 
Those protein sources are cows' milk proteins  and soya protein isol ates, alone or in a 
mixture, as well as protein hydrolysates. 
(3) On request from the Commission, the Europ ean Food Safety Authority delivered, on 
28 February 2012, a scientific opinion on the suitability of goat milk protein as a 
source of protein in infant formulae a nd in follow-on formulae. That opinion 
concluded that protein from goats' milk can be suitable  as a protein source for infant 
formulae and follow-on formulae provided th at the final product complies with the 
compositional criteria laid dow n in Directive 2006/141/EC. 
(4) On the basis of that opinion, infant form ulae and follow-on formulae manufactured 
from goats' milk proteins should be allowe d on the market provided that the final 
product complies with the compositional crit eria laid down in Directive 2006/141/EC. 
Directive 2006/141/EC should therefore be amended accordingly. 
(5) On request from the Commission, the Europ ean Food Safety Authority delivered, on 
5 October 2005, a scientific opinion on the sa fety and suitability for particular 
nutritional use by infants of formula based on whey protein partial hydrolysates with a 
protein content of at leas t 1.9 g/100 kcal, which was below the minimum level 
provided for in the Union legislation at that  time. That opinion concluded that infant 
formula, based on hydrolysates of whey pr otein derived from cows' milk with a 
protein content of 1.9 g/100 kcal (0.47 g/ 100 kJ) and corresponding to the protein 
formulation assessed, is safe and suitable fo r use as the sole source of nutrition of 
infants. On the basis of that opini on, Directive 2006/141/ EC, as amended by 
                                                 
1 OJ L 124, 20.5.2009, p. 21. 
2 OJ L 401, 30.12.2006, p. 1.  
EN 3   EN Commission Regulation (EC)  No 1243/2008 of 12 December 2008 amending Annexes 
III and VI to Directive 2006/141/EC as rega rds compositional requirements for certain 
infant formulae3, authorises the marketing of infant formulae manufactured from 
protein hydrolysates with a protein content of 1.9 g/100 kcal (0.47g/100 kJ) provided 
that the product complies with certain specific criteria set out therein.  
(6) That opinion also concluded that, wh ile no data on follow-on formulae based on 
hydrolysed whey protein with a protein content of 1.9 g/100 k cal (0.47g/100 kJ) had 
been submitted, a formula with that protein formulation would be suitable for older infants in conjunction with complementary foods.  
(7) On the basis of that opinion, and in or der to allow the deve lopment of innovative 
products, such follow-on formulae should be allowed on the market. Directive 
2006/141/EC should therefore be amended accordingly.  
(8) The measures provided for in this Direct ive are in accordance with the opinion of 
the Standing Committee on the Food Chain and Animal Health, and neither the 
European Parliament nor the Council have opposed them, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Directive 2006/141/EC is amended as follows: 
(1) Article 7 is amended as follows: 
(a) In paragraph 1, the second subpara graph is replaced by the following: 
"In the case of infant formulae manufactured from cows' milk or goats’ milk 
proteins defined in point  2.1 of Annex I with a pr otein content between the 
minimum and 0,5 g/100 kJ (2 g/100 kcal), the suitability of the infant formula 
for the particular nutritional use by infants shall be demonstrated through 
appropriate studies, performed followi ng generally accepted expert guidance 
on the design and conduct of such studies." 
(b) In paragraph 2, the follo wing subparagraph is added: 
"In the case of follow-on formulae ma nufactured from pr otein hydrolysates 
defined in point 2.2 of Annex II with a protein content between the minimum 
and 0,56 g/100 kJ (2,25 g/100 kcal), the suit ability of the follow-on formula for 
the particular nutritional use by in fants shall be demonstrated through 
appropriate studies, performed followi ng generally accepted expert guidance 
on the design and conduct of such studies  and shall be in accordance with the 
appropriate specifications set out in Annex VI." 
(2) In Article 12, the introductory phrase is replaced by the following: 
"The name under which infant formulae and follow-on formul ae manufactured 
entirely from cows' milk or goats' milk proteins are sold shall be respectively:" 
(3) Annexes I, II, III and VI are amended in accordance with the Annex to this Directive. 
                                                
 
3 OJ L 335, 13.12.2008, p. 25.  
EN 4   EN Article 2 
This Directive shall enter into  force on the twentieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 3 
1. Member States shall bring into force the laws, regulations and administrative 
provisions necessary to comply  with this Directive by … [ six months after the date of 
adoption ] at the latest. They shall forthwith communicate to the Commission the text 
of those provisions. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
2. Member States shall communicate to the Co mmission the text of the main provisions 
of national law which they adopt in the field covered by this Directive. 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels,  
 For the Commission 
 The President  José Manuel BARROSO  
EN 5   EN ANNEX  
Annexes I, II, III and VI are amended as follows: 
(1) Annex I is amended as follows: 
(a) Point 2.1 is amended as follows: 
(i) The title is replaced by the following: 
"2.1 
Infant formulae manufactured fr om cows' milk or goats’ milk 
proteins " 
(ii) Footnote 1 is replaced by the following: 
"(1) Infant formulae manufactured fr om cows’ milk or goats’ milk  
protein with a protein cont ent between the minimum and 
0,5 g/100 kJ (2 g/100 kcal) shall be  in accordance with the second 
subparagraph of Article 7(1)." 
(b) In point 2.3, the title is replaced by the following: 
"2.3 
Infant formulae manufactured from soya protein isolates, alone or in a 
mixture with cows' milk or  goats' milk proteins"  
(c) In point 10.1, the title is  replaced by the following: 
"10.1 Infant formulae manufactured from cows ’ milk or goats' milk proteins or 
protein hydrolysates " 
(d) In point 10.2, the title is  replaced by the following: 
"10.2  Infant formulae manufactured from soya protein isolates, alone or in a 
mixture with cows’ milk or goats' milk proteins "  
(2) Annex II is amended as follows: 
(a) In point 2.1, the title is replaced by the following: 
"2.1 Follow-on formulae manufactured fr om cows' milk or goats’ milk 
proteins " 
(b) In point 2.2, the table is  replaced by the following: 
Minimum
(1) Maximum 
0,45 g/100 kJ 
(1,8 g/100 kcal) 0,8 g/100 kJ 
(3,5 g/100 kcal) 
(1) Follow-on formulae manufactured from protein hydrolysates with a 
protein content between the minimum and 0,56 g/100 kJ 
(2,25 g/100 kcal) shall be in accordance with the second subparagraph 
of Article 7(2).  
  
EN 6   EN (c) In point 2.3, the title is replaced by the following: 
"2.3  
Follow-on formulae manufactured from s oya protein isolates, alone or in a 
mixture with cows' milk or goats’ milk proteins " 
(d) In point 8.1, the title is replaced by the following: 
"8.1 Follow-on formulae manufactured from cows' milk or goats’ milk proteins 
or protein hydrolysates " 
(e) In point 8.2 the title is  replaced by the following: 
"8.2  Follow-on formulae manufactured from s oya protein isolates, alone or in a 
mixture with cows' milk or goats’ milk proteins "  
(3) In point 3 of Annex III, footnot e 1 is replaced by the following: 
"
(1) L-arginine and its hydrochloride shall only be used in the manufacture of infant 
formulae referred to in the third subpara graph of Article 7(1) and follow-on 
formulae referred to in the second subparagraph of Article 7(2)." 
(4) The title of Annex VI is replaced by the following: 
"Specification for the protein content a nd source and the processing of protein 
used in the manufacture of infant formulae and follow-on formulae with a protein content less than 0.56 g/100 kJ (2.25g/100 kcal) manufactured from 
hydrolysates of whey proteins de rived from cows' milk protein"