2014 No. 123 (W. 13)
The Infant Formula and Follow-on Formula (Wales) (Amendment) Regulations 2014
Made
Laid before the National Assembly for Wales
Coming into force
The Welsh Ministers make the following Regulations in exercise of the powers conferred by section 2(2) of the European Communities Act 19721 and sections 16(1)(e), 17(1) and 48(1) of the Food Safety Act 199023.
The Welsh Ministers have been designated for the purposes of section 2(2) of the European Communities Act 1972 in relation to measures relating to food (including drink) including the primary production of food4.
In accordance with section 48(4A) of the Food Safety Act 1990, the Welsh Ministers have had regard to any relevant advice given by the Food Standards Agency5.
As required by Article 9 of Regulation (EC) No 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety6 there has been open and transparent public consultation during the preparation and evaluation of these Regulations.
Title, commencement and application1
1
The title of these Regulations is the Infant Formula and Follow-on Formula (Wales) (Amendment) Regulations 2014.
2
These Regulations come into force on 28 February 2014 and apply in relation to Wales.
Amendment of the Infant Formula and Follow-on Formula (Wales) Regulations 20072
1
The Infant Formula and Follow-on Formula (Wales) Regulations 20077 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/EC8 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—
Compositional criteria for follow-on formula9
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”.
(This note is not part of the Regulations)