SCHEDULE
Regulation 2(3)
SCHEDULE
“SCHEDULE 4
Regulation 5(5)
Regulation of infant formula and follow-on formula manufactured from protein hydrolysates until 22 February 2022
Interpretation
In this Schedule—
“the Act” (“y Ddeddf”) means the Food Safety Act 1990;
“the Directive” (“y Gyfarwyddeb”) means Commission Directive 2006/141/EC6on infant formulae and follow-on formulae and amending Directive 1999/21/EC;
“follow-on formula” (“fformiwla ddilynol”) 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;
“food authority” (“awdurdod bwyd”) has the meaning that it bears by virtue of section 5(1A) of the Act7;
“health care system” (“system gofal iechyd”) 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;
“infant formula” (“fformiwla fabanod”) 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;
“infants” (“babanod”) means children under the age of 12 months;
“young children” (“plant ifanc”) 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
No person may market infant formula which contravenes or fails to comply with paragraph 4, 5, 7, 9, 10, 11, 13(1), (2) or (3), 14, 16, 18 or 19(1).
No person may market follow-on formula which contravenes or fails to comply with paragraph 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
No person may 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 6 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 nothing more must be required than the addition of water.
Prohibitions and limitations on the use of food ingredients (infant formula and follow-on formula)
The prohibitions and limitations on the use of food ingredients in infant formula and follow-on formula, set out respectively in Annexes I and II, must be observed.
Listed substances and their purity criteria (infant formula and follow-on formula)
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—
mineral substances;
vitamins;
amino acids and other nitrogen compounds; and
other substances having a particular nutritional purpose.
Substances used in the manufacture of infant formula and follow-on formula pursuant to sub-paragraph (1) must meet the relevant purity criteria.
The relevant purity criteria for the purposes of sub-paragraph (2) are—
the purity criteria for substances, as provided for in retained EU law concerning the use of substances listed in Annex III, in the manufacture of foodstuffs for purposes other than those covered by the Directive; and
in the absence of such purity criteria, generally acceptable purity criteria recommended by international bodies.
Notification of infant formula
No food business operator may place an infant formula on the market in Wales that has not yet been placed on the market in the United Kingdom unless the food business operator has given prior notice to the Welsh Ministers by forwarding to them a model of the label used for the product.
Pesticide residues (infant formula and follow-on formula)
Subject to sub-paragraphs (2) and (3), infant formula and follow-on formula must not contain residues of individual pesticides at...
