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3.—[F1(1) Subject to paragraph (5), no person shall sell any designated PNU food being a food to which a substance falling within one of the categories mentioned in paragraph (2) has been added for a specific nutritional purpose unless —
(a)that substance is listed under that category —
(i)in the case of any food for special medical purposes, in Schedule 1 or 2; and
(ii)in any other case, in Schedule 1;
(b)that substance complies with the relevant purity criteria referred to in paragraph (3); and
(c)in the case of a substance listed in Schedule 2, the conditions of use (if any) set out in that Schedule relating to that substance are met.]
(2) For the purposes of paragraph (1), the categories are—
(a)vitamins,
(b)minerals,
(c)amino acids,
(d)carnitine and taurine,
(e)nucleotides, and
(f)choline and inositol.
(3) The relevant purity criteria for the purposes of paragraph (1)(b) are—
(a)the purity criteria, if any, specified by Community legislation for the use of the substance in question in the manufacture of food for purposes other than those covered by Directive 2001/15, or
(b)in the absence of such purity criteria, generally acceptable purity criteria for the substance in question recommended by international bodies.
(4) No person shall sell any designated PNU food in the manufacture of which any substance has been used for a specific nutritional purpose unless that food—
(a)is safe when used in accordance with the manufacturer’s instructions (if any); and
(b)fulfils the particular nutritional requirements of the persons for whom it is intended,
as established by generally accepted scientific data.
[F2(5) The restrictions in paragraph (1) shall not apply until [F31st January 2010] in the case of a substance falling within one of the categories mentioned in paragraph (2) and listed under that category in Schedule 3 if —
(a)the European Food Safety Authority has not given an unfavourable opinion in respect of the use of that substance in the manufacture of any designated PNU food; and
(b)that substance was used in the manufacture of a food for a particular nutritional use which was on sale in the European Community on 11th February 2004.]
Textual Amendments
F1Words in reg. 3(1) substituted (1.4.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2004 (S.I. 2002/1012), regs. 1(2), 4(a)
F2Words in reg. 3(5) inserted (1.4.2004) by The Food for Particular Nutritional Uses (Addition of Substances for Specific Nutritional Purposes) (Wales) (Amendment) Regulations 2004 (S.I. 2002/1012), regs. 1(2), 4(b)
F3Words in reg. 3(5) substituted (15.10.2007) by The Food for Particular Nutritional Uses (Miscellaneous Amendments) (Wales) Regulations 2007 (S.I. 2007/2753), regs. 1, 5(2)