These Regulations amend the Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 (S.R. 2007 No. 506) (“the 2007 Regulations”).

The amendments are required to give effect to the order of the High Court of Justice in Northern Ireland of 25th June 2008 in the matter of an application by the Infant and Dietetic Foods Association Ltd (“the IDFA”) for Judicial Review and in the matter of the Infant Formula and Follow-on Formula Regulations (NI) 2007 (case ref. CO1932838).

The order recited that the 2007 Regulations 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 (Northern Ireland) 1995 (S.R. 1995 No. 85, as amended) but does not satisfy the labelling requirements of the 2007 Regulations.

These Regulations amend the Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 to— a revise the list of regulations that must 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 must be complied with if a person is to export infant formula to third countries (regulation 2(4)); d revise the list of regulations that must 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, (regulation 2(6) and ii the requirements that apply in relation to the shape, appearance and packaging of infant formula and follow-on formula (regulation 2(6)). This amendment is considered necessary as a result of the judgments of the Court of Session in Scotland in the related case of the Petition of the IDFA and others for Judicial Review of a decision by the Scottish Ministers to make and lay before the Scottish Parliament the Infant Formula and the Follow-on Formula (Scotland) Regulations 2007 ([2008] CSOH87, case ref. P126/08)) and the High Court in England in the related case of R v the Secretary of State for Health and the Welsh Ministers on the application of the IDFA ( [2008] EWHC 575 (Admin), action number CO/230/2008.).

These Regulations also provide transitional arrangements with regard to the Medical Food Regulations (Northern Ireland) 2000 (S.R. 2000 No. 187) (regulation 3).

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