6.—(1) Infant formula must be manufactured from—
(a)the protein sources specified in point 2 of Annex I; and
(b)other food ingredients the suitability of which for particular nutritional use by infants from birth has been established by generally accepted scientific data and demonstrated in accordance with paragraph (2).
(2) Suitability must be demonstrated through systematic review of the available data relating to the expected benefits and safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.