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These Regulations—
(a) may be cited as the Infant Formula and Follow-on Formula (Amendment) Regulations (Northern Ireland) 2008; and
(b) come into operation on 4th November 2008.
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(1) The Infant Formula and Follow-on Formula Regulations (Northern Ireland) 2007 are amended in accordance with paragraphs (2) to (6).
(2) For the provisions of regulation 3 (prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met) substitute —“
(1) A person shall not market infant formula which contravenes regulation 5, 6, 8, 10, 11, 12, 14(1), (2) or (3), 15, 17, 19 or 20(1).
(2) A person shall not market follow-on formula which contravenes regulation 5, 7, 9, 10, 11, 12, 14(1), (2) or (3), 16, 18, 19 or 20(2).”.
(3) In regulation 20 (presentation (infant formula and follow-on formula))—
(a) for paragraph (1) substitute —“
(1) The presentation of an infant formula shall comply with the provisions of regulations 17(1)(e), (2), (3) and (4) and 19”; and
(b) for paragraph (2) substitute —“
(2) The presentation of a follow-on formula shall comply with the provisions of regulations 18(2) and 19.”.
(4) For regulation 26(1)(a) (export of infant formula to third countries) substitute—“
(a) regulation 5, 6, 8, 10, 11, 12, 14(1), (2) or (3), 17, 19 or 20(1);”.
(5) For regulation 27(a) (export of follow-on formula to third countries) substitute—“
(a) regulation 5, 7, 9, 10, 11, 12, 14(1), (2) or (3), 18, 19 or 20(2);”.
(6) For regulation 31(3) (revocation and transitional arrangements) substitute—“
(3) In respect of any contravention before 1st January 2010, a person does not commit an offence under regulation 28(1) consisting of a contravention of —
(a) regulation 3(1), where—
(i) the action that would otherwise constitute the offence consists of marketing infant formula which contravenes regulation 5, 6, 8, 10, 11, 12 or 14(1), (2) or (3), and
(ii) that action does not constitute an offence under regulation 10(1) of the 1995 Regulations consisting of a contravention of regulation 2(1)(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 regulation 17 or 19, and
(ii) that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(1)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 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 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(1)(a)(iv) of those Regulations in so far as regulation 2(1)(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 regulation 5, 7, 9, 10, 11, 12 or 14(1), (2) or (3), and
(ii) that action does not constitute an offence under regulation 10(1) of the 1995 Regulations consisting of a contravention of regulation 2(2)(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 regulation 18 or 19, and
(ii) that action, had it taken place on 10th January 2008, would not have constituted an offence under regulation 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(2)(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 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 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(2)(d) of those Regulations in so far as regulation 2(2)(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 10(1) of the 1995 Regulations consisting of a contravention of regulation 2(1)(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 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(1)(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 10(1) of the 1995 Regulations as they then stood consisting of a contravention of regulation 2(1)(b)(iv) of those Regulations in so far as regulation 2(1)(b)(iv) applied in relation to the shape, appearance and packaging of the product concerned.”.
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(1) The Medical Food Regulations (Northern Ireland) 2000 are amended in accordance with paragraph (2).
(2) The following regulation is inserted immediately after regulation 7 (application of various provisions of the Order)—“
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In respect of any contravention before 1st January 2010, a person does not commit 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.”.
Sealed with the Official Seal of the Department of Health, Social Services and Public Safety on  2nd October 2008.
Christine Jendoubi
A senior officer of the
Department of Health, Social Services and Public Safety
