The Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2008

EXPLANATORY NOTE

(This note is not part of the Regulations)

1.  These Regulations, which apply in relation to England only, make the legislative provisions described in paragraph 2 which are considered necessary to give effect to the judgment in the High Court of Justice in the case called R v. the Secretary of State for Health and the Welsh Ministers on the application of the Infant and Dietetics Food Association Limited (action number CO/230/2008). Judgment was delivered on 29th February 2008. Following that judgment, the High Court granted a declaration that the Infant Formula and Follow-on Formula (England) Regulations 2007 (S.I. 2007/3521) fail to comply with Commission Directive 2006/141/EC on infant formulae and follow-on formulae and amending Directive 1999/21/EC (OJ No. L401, 30.12.2006, p.1) to the extent that they prohibit as from 11 January 2008 (instead of as from 31 December 2009) trade in infant formula and follow-on formula whose labelling satisfies the labelling requirements of the Infant Formula and Follow-on Formula Regulations 1995 (S.I. 1995/77) but does not satisfy the labelling requirements of the Infant Formula and Follow-on Formula (England) Regulations 2007.

2.  These Regulations amend the Infant Formula and Follow-on Formula (England) Regulations 2007 to—

(a) revise the list of regulations that have to be complied with if a person is to market infant formula or follow-on formula (regulation 2(2));

(b) provide that the presentation of infant formula and follow-on formula must comply with the provisions of specified regulations (regulation 2(3));

(c) revise the list of regulations that have to be complied with if a person is to export infant formula to third countries (regulation 2(4));

(d) revise the list of regulations that have to be complied with if a person is to export follow-on formula to third countries (regulation 2(5)); and

(e) create transitional arrangements that apply in relation to the enforcement of—

(i) the labelling requirements for infant formula and follow-on formula, and

(ii) the requirements that apply in relation to the shape, appearance and packaging of infant formula and follow-on formula (regulation 2(6)).

3.  These Regulations also provide transitional arrangements with regard to the Medical Food (England) Regulations 2000 (S.I. 2000/845) (regulation 3).

4.  A full impact assessment has not been produced for this instrument as no impact on the private or voluntary sectors is foreseen.