Food, England Title and commencement 1 These Regulations— a may be cited as the Infant Formula and Follow-on Formula (England) (Amendment) Regulations 2008; and b come into force on 29th October 2008. Amendment of the Infant Formula and Follow-on Formula (England) Regulations 2007 2 1 The Infant Formula and Follow-on Formula (England) Regulations 2007 are amended in accordance with the following paragraphs. 2 For the provisions of regulation 3 (prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met) there are substituted the following provisions— 1 No person shall market infant formula which contravenes or fails to comply with regulation 5, 6, 8, 10, 11, 12, 14(1), (2) or (3), 15, 17, 19 or 20(1). 2 No person shall market follow-on formula which contravenes or fails to comply with regulation 5, 7, 9, 10, 11, 12, 14(1), (2) or (3), 16, 18, 19 or 20(2). . 3 For paragraphs (1) and (2) of regulation 20 (presentation (infant formula and follow-on formula)) there are substituted the following paragraphs— 1 The presentation of an infant formula shall comply with the provisions of regulations 17(1)(e), (2), (3) and (4) and 19. 2 The presentation of a follow-on formula shall comply with the provisions of regulations 18(2) and 19. . 4 For sub-paragraph (a) of paragraph (1) of regulation 26 (export of infant formula to third countries) there is substituted the following sub-paragraph— a regulation 5, 6, 8, 10, 11, 12, 14(1), (2) or (3), 17, 19 or 20(1); . 5 For paragraph (a) of regulation 27 (export of follow-on formula to third countries) there is substituted the following paragraph— a regulation 5, 7, 9, 10, 11, 12, 14(1), (2) or (3), 18, 19 or 20(2); . 6 For paragraph (3) of regulation 31 (revocation and transitional arrangements) there is substituted the following paragraph— 3 In respect of any contravention or failure to comply before 1st January 2010, no person commits an offence under regulation 28(1) consisting of a contravention of or a failure to comply with— a regulation 3(1), where— i the action that would otherwise constitute the offence consists of marketing infant formula which contravenes or fails to comply with regulation 5, 6, 8, 10, 11, 12 or 14 (1), (2) or (3), and ii that action does not constitute an offence under regulation 22(1) of the 1995 Regulations consisting of a contravention of or a failure to comply with regulation 2(a)(i) or (ii) of those Regulations; b regulation 3(1), where— i the action that would otherwise constitute the offence consists of marketing infant formula which contravenes or fails to comply with regulation 17 or 19, and ii that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 2(a)(iii) of those Regulations; c regulation 3(1), where— i the action that would otherwise constitute the offence consists of marketing infant formula which contravenes or fails to comply with regulation 20(1) in so far as regulation 20(1) applies in relation to the shape, appearance and packaging of that infant formula, and ii that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 2(a)(iv) of those Regulations in so far as regulation 2(a)(iv) applied in relation to the shape, appearance and packaging of that infant formula; d regulation 3(2), where— i the action that would otherwise constitute the offence consists of marketing follow-on formula which contravenes or fails to comply with regulation 5, 7, 9, 10, 11, 12 or 14(1), (2) or (3), and ii that action does not constitute an offence under regulation 22(1) of the 1995 Regulations consisting of a contravention of or a failure to comply with regulation 3 (a) or (b) of those Regulations; e regulation 3(2), where— i the action that would otherwise constitute the offence consists of marketing follow-on formula which contravenes or fails to comply with regulation 18 or 19, and ii that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 3(c) of those Regulations; f regulation 3(2), where— i the action that would otherwise constitute the offence consists of marketing follow-on formula which contravenes or fails to comply with regulation 20(2) in so far as regulation 20(2) applies in relation to the shape, appearance and packaging of that follow-on formula, and ii that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 3(d) of those Regulations in so far as regulation 3(d) applied in relation to the shape, appearance and packaging of that follow-on formula; g regulation 4, where the action that would otherwise constitute the offence does not constitute an offence under regulation 22(1) of the 1995 Regulations consisting of a contravention of or a failure to comply with regulation 2(b)(i) or (ii) of those Regulations; h regulation 4, where the action that would otherwise constitute the offence, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 2(b)(iii) of those Regulations; or i regulation 4, where the action that would otherwise constitute the offence, had it taken place on 10th January 2008, would not have constituted an offence under regulation 22(1) of the 1995 Regulations as they then stood consisting of a contravention of or a failure to comply with regulation 2(b)(iv) of those Regulations in so far as regulation 2(b)(iv) applied in relation to the shape, appearance and packaging of the product concerned. . Amendment of the Medical Food (England) Regulations 2000 3 1 The Medical Food (England) Regulations are amended in accordance with paragraph (2). 2 The following regulation is inserted immediately after regulation 7 (application of various provisions of the Food Safety Act 1990)— Transitional arrangements 8 In respect of any contravention before 1st January 2010, no person commits an offence under regulation 5(a) consisting of a contravention of regulation 3(1)(a) where the action that would otherwise constitute the offence consists of selling a medical food whose composition fails to comply with Article 3 of the Directive as read with the row relating to manganese set out in the second part of Table I (minerals) in the Annex to the Directive if the composition of that medical food would have complied with Article 3 of the Directive as read with the row relating to manganese set out in the second part of Table I (minerals) in the Annex to the Directive as it stood before it was amended by Commission Directive 2006/141/EC on infant formulae and follow-on formulae and amending Directive 1999/21/EC . . Signed by authority of the Secretary of State for Health Ben Bradshaw Minister of State, Department of Health 16th September 2008