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12.—(1) The Food Supplements (England) Regulations 2003(1) are amended as follows.
(2) In regulation 2(2) (interpretation) omit—
(a)the definitions of “Directive 2001/83” and “Directive 2002/46”;
(b)paragraphs (3) and (4).
(3) In regulation 3 (scope of regulations) in paragraph (2), for “as defined by Directive 2001/83” substitute “as defined by regulation 2(1) of the Human Medicines Regulations 2012(3)”.
(4) In regulation 5(4) (prohibitions on sale relating to composition of food supplements)—
(a)in paragraph (1)—
(i)in sub-paragraph (a) for “Annex I to Directive 2002/46” substitute “Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019”;
(ii)in sub-paragraph (b)(i) for “Annex II to Directive 2002/46” substitute “Schedule 2 to the Nutrition (Amendment) (EU Exit) Regulations 2019”;
(b)in paragraph (2) for sub-paragraph (a) substitute—
“(a)the purity criteria, if any, specified in EU-derived domestic legislation, retained direct EU legislation or in regulations made by the Secretary of State under regulation 3 of the Nutrition (Amendment) (EU Exit) Regulations 2019; or”.
(5) In regulation 6(5) (restrictions on sale relating to labelling etc of food supplements) in paragraph (3)(b) for “Annex I to Directive 2002/46” substitute “Schedule 1 to the Nutrition (Amendment) (EU Exit) Regulations 2019”.
S.I. 2003/1387 relevant amending instruments are S.I. 2005/2626, 2009/3251 and 2014/1855.
Relevant amendments to regulation 2 were made by S.I. 2009/3251.
Relevant amendments to regulation 5 were made by S.I. 2009/3251.
Regulation 6 was amended by S.I. 2009/3251 and 2014/1855.
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