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Restrictions on sale

3.—(1) 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 that substance –

(a)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; and

(b)complies with the relevant purity criteria referred to in paragraph (3).

(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, 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.