SCHEDULE
Regulation 2(3)
SCHEDULE
“SCHEDULE 4
Regulation 6(5)
Regulation of infant formula and follow-on formula manufactured from protein hydrolysates until 22 February 2022
Interpretation
In this schedule—
“the Act” means the Food Safety Act 1990,
“the Directive” means Commission Directive 2006/141/EC5on infant formulae and follow-on formulae and amending Directive 1999/21/EC,
“follow-on formula” means foodstuffs intended for particular nutritional use by infants when appropriate complementary feeding is introduced and constituting the principal liquid element in a progressively diversified diet of such infants,
“health care system” means institutions or organisations engaged, directly or indirectly, in health care for mothers, infants and pregnant women, including nurseries or child care institutions and health workers in private practice,
“infants” means children under the age of 12 months,
“infant formula” means foodstuffs intended for particular nutritional use by infants during the first months of life and satisfying by themselves the nutritional requirements of such infants until the introduction of appropriate complementary feeding,
“young children” means children aged between one and three years.
Subject to sub-paragraph (3), any expression other than one defined in sub-paragraph (1) that is used both in this schedule and in the Act has the meaning it bears in the Act.
Any expression used both in this schedule and in the Directive has the meaning that it bears in the Directive.
In this schedule any reference to a numbered Annex is a reference to the Annex bearing that number in the Directive.
Prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met
It is an offence for a person to market infant formula which contravenes or fails to comply with paragraphs 4, 5, 7, 9, 10, 11, 13(1), (2) or (3), 14, 16, 18 or 19(1).
It is an offence for a person to market follow-on formula which contravenes or fails to comply with paragraphs 4, 6, 8, 9, 10, 11, 13(1), (2) or (3), 15, 17, 18 or 19(2).
Prohibition on the marketing of products other than infant formula for normal healthy infants
It is an offence to market or otherwise represent a product as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first months of life until the introduction of appropriate complementary feeding unless that product is infant formula.
Substances in such quantity as to endanger the health of infants and young children
Infant formula and follow-on formula must not contain any substance in such quantity as to endanger the health of infants and young children.
Protein hydrolysates and other food ingredients suitable for infants from birth (infant formula)
Infant formula must be manufactured from —
protein hydrolysates, and
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 sub-paragraph (2).
Suitability is to 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.
Protein hydrolysates and other food ingredients suitable for infants aged over six months (follow-on formula)
Follow-on formula must be manufactured from—
protein hydrolysates, and
other food ingredients the suitability of which for particular nutritional use by infants aged over 6 months has been established by generally accepted scientific data and demonstrated in accordance with paragraph 5(2).
Compositional criteria for infant formula
Subject to sub-paragraph (2), infant formula must comply with the compositional criteria set out in Annex I taking into account the specifications in Annex V.
In the case of infant formula manufactured from protein hydrolysates specified in point 2.2 of Annex I with a protein content between the minimum and 0.56g/100kJ (2.25g/100 kcal)—
the suitability of the infant formula for the particular nutritional use by infants must be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies, and
the infant formula must be in accordance with the appropriate specifications set out in Annex VI.
Compositional criteria for follow-on formula
Subject to sub-paragraph (2), follow-on formula must comply with the compositional criteria set out in Annex II taking into account the specifications set out in Annex V.
In the case of follow-on formula manufactured from those protein hydrolysates specified in point 2.2 of Annex II with a protein content between the minimum and 0.56g/100kj (2.25g/100kcal)—
the suitability of the follow-on formula for satisfying the nutritional requirements of normal healthy infants in conjunction with complementary feeding must be demonstrated through appropriate studies, performed following generally accepted expert guidance on the design and conduct of such studies, and
the follow-on formula must be in accordance with the appropriate specifications set out in Annex VI.
Addition of water (infant formula and follow-on formula)
In order to make infant formula or follow-on formula ready for use...
