# Commission Directive 2013/46/EU of 28 August 2013 amending Directive 2006/141/EC with regard to protein requirements for infant formulae and follow-on formulae (Text with EEA relevance), Annex

Extent: E+W+S+N.I.

Annexes I, II, III and VI to Directive 2006/141/EC 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 from cows’ milk or goats’ milk proteins ’;
(ii) footnote 1 is replaced by the following:
‘(1)
Infant formulae manufactured from cows’ milk or goats’ milk protein with a protein content 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 from cows’ milk or goats’ milk proteins ’;
(b) in point 2.2, the table is replaced by the following:
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).’
‘Minimum
Maximum
0,45 g/100 kJ
(1,8 g/100 kcal)
0,8 g/100 kJ
(3,5 g/100 kcal)
(c) in point 2.3, the title is replaced by the following:
‘2.3.
Follow-on formulae manufactured from soya 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 soya protein isolates, alone or in a mixture with cows’ milk or goats’ milk proteins ’;
(3) in point 3 of Annex III, footnote 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 subparagraph 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 and 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 (2,25 g/100 kcal) manufactured from hydrolysates of whey proteins derived from cows’ milk protein ’.

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Source: https://www.legislation.gov.uk/eudr/2013/46/annex (the official version)
Page: https://openlegislation.uk/eu-directive-2013-46/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.