Directive 2006/141/EC is amended as follows:

1. (1)

   Article 7 is amended as follows:

   1. (a)

      in paragraph 1, the second subparagraph 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 protein 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 following generally accepted expert guidance on the design and conduct of such studies.’;

   2. (b)

      in paragraph 2, the following subparagraph is added:

      ‘In the case of follow-on formulae manufactured from protein 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 suitability of the follow-on formula for the particular nutritional use by infants shall be demonstrated through appropriate studies, performed following 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. (2)

   in Article 12, the introductory phrase is replaced by the following:

   ‘The name under which infant formulae and follow-on formulae manufactured entirely from cows’ milk or goats’ milk proteins are sold shall be respectively:’;

3. (3)

   Annexes I, II, III and VI are amended in accordance with the Annex to this Directive.