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2.—(1) The Infant Formula and Follow-on Formula (Wales) Regulations 2007(1) are amended as follows.
(2) In regulation 2(1) (interpretation) for the definition of “the Directive” substitute the following definition—
““the Directive” (“y Gyfarwyddeb”) means Commission Directive 2006/141/EC on infant formulae and follow-on formulae and amending Directive 1999/21/EC(2) as amended by Directive 2013/46/EU;”.
(3) In regulation 8(2) (compositional criteria for infant formula) after the words “cows’ milk proteins” insert “or goats’ milk proteins”.
(4) For regulation 9 (compositional criteria for follow-on formula) substitute the following regulation—
9.—(1) Subject to paragraph (2), follow-on formula must comply with the compositional criteria set out in Annex II taking into account the specifications in Annex V.
(2) In the case of follow-on formula manufactured from those protein hydrolysates specified in point 2.2 of Annex II with a protein content between the minimum and 0.56g/100kJ (2.25g/100kcal)—
(a)the suitability of the follow-on formula for satisfying the nutritional requirements of normal healthy infants in conjunction with complementary feeding must be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies; and
(b)the follow-on formula must be in accordance with the appropriate specifications set out in Annex VI.”
(5) In regulation 15 (naming of infant formula) in both paragraphs, after “cows’ milk proteins” insert “or goats’ milk proteins”.
(6) In regulation 16 (naming of follow-on formula) in both paragraphs, after “cows’ milk proteins” insert “or goats’ milk proteins”.
S.I. 2007/3573 (W.316), amended by S.I. 2008/2602 (W.228). There are other amending instruments but none is relevant.
OJ No L 401, 30.12.2006, p.1. The Directive was last amended by Commission Directive 2013/46/EU (OJ No L 230, 29.08.2013, p.16).
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