Listed substances and their purity criteria (infant formula and follow-on formula)
12.—(1) Only the substances listed in Annex III may be used in the manufacture of infant formula and follow on formula in order to satisfy the requirements of Annexes I and II respectively on–
(a)mineral substances;
(b)vitamins;
(c)amino acids and other nitrogen compounds; and
(d)other substances having a particular nutritional purpose.
(2) Substances used in the manufacture of infant formula and follow on formula pursuant to paragraph (1) must meet the relevant purity criteria.
(3) The relevant purity criteria for the purposes of paragraph (2) are–
(a)the purity criteria for substances, as provided for in Community legislation concerning the use of substances listed in Annex III, in the manufacture of foodstuffs for purposes other than those covered by the Directive; and
(b)in the absence of such purity criteria, generally acceptable purity criteria recommended by international bodies.