S.L. 449.52 Art. 6Manufacture of infant formulae and follow-on formulae.

(1) Infant formulae shall be manufactured from protein sources defined in point 2 of the First Schedule and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants from birth has been established by generally accepted scientific data.

(2) Follow-on formulae shall be manufactured from protein sources defined in point 2 of the Second Schedule and other food ingredients, as the case may be, whose suitability for particular nutritional use by infants aged over six months has been established by generally accepted scientific data.

(3) Such suitability, as mentioned in sub-regulations (1) and (2), shall be demonstrated through a systematic review of the available data relating to the expected benefits and to safety considerations as well as, where necessary, appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies.

(4) The prohibitions and limitations on the use of food ingredients in infant formulae and follow-on formulae set out in the First and Second Schedules shall be observed.