Explanatory note

(This note is not part of the Regulations)

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.

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)).

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

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