Infant Formula and Follow-on Formula Regulations 1995
| Jurisdiction | UK Non-devolved |
| Citation | SI 1995/77 |
| Year | 1995 |
1995 No. 77
FOOD
The Infant Formula and Follow–on Formula Regulations 1995
Made 15th January 1995
Laid before Parliament 16th January 1995
Coming into force 1st March 1995
The Minister of Agriculture, Fisheries and Food, the Secretary of State for Health and the Secretary of State for Wales, acting jointly, in relation to England and Wales, and the Secretary of State for Scotland in relation to Scotland, in exercise of the powers conferred on them by sections 6(4), 16(1)(a), (b), (e) and (f), 17(1), 26(1) and (3) and 48(1) of the Food Safety Act 19901, and of all other powers enabling them in that behalf, and, in respect of regulation 21 of the following Regulations, the Secretary of State (being the Minister designated2for the purposes of section 2(2) of the European Communities Act 19723in relation to informational and educational materials dealing with the feeding of infants and young children, donations of informational or educational equipment or materials, and donations and low price sales of supplies of infant formulae), in exercise of the powers conferred on him by the said section 2(2), and of all other powers enabling him in that behalf, after consultation in accordance with section 48 of the said Act of 1990 with such organisations as appear to them to be representative of interests likely to be substantially affected by the Regulations (in so far as the Regulations are made in exercise of the powers conferred by the said sections of the said Act of 1990), hereby make the following Regulations:—
Title, commencement and interpretation
1.—(1) These Regulations may be cited as the Infant Formula and Follow–on Formula Regulations 1995 and shall come into force on 1st March 1995.
(2) In these Regulations, unless the context otherwise requires—
“the Act” means the Food Safety Act 1990;
“advertisement” has the same meaning as in the Act, except that it does not include any label or wrapper, and “advertise” and “advertising” shall be construed accordingly;
“follow-on formula” means a food intended for particular nutritional use by infants in good health who are aged over four months, and constituting the principal liquid element in a progressively diversified diet;
“food authority” has the same meaning as in the Act, except that it does not include either the council of any district in a non–metropolitan county in England and Wales or the appropriate Treasurer referred to in section 5(1)(c) of the Act (which deals with the Inner Temple and the Middle Temple);
“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;
“infant” means a child under the age of twelve months;
“infant formula” means a food intended for particular nutritional use by infants in good health during the first four to six months of life, and satisfying by itself the nutritional requirements of such infants;
“member State” means a member State of the European Community other than the United Kingdom;
“presentation”, in relation to an infant formula or a follow-on formula, includes the shape, appearance or packaging of the product concerned, the way in which the product is arranged when it is exposed for sale and the setting in which the product is displayed with a view to sale, but does not include any form of labelling or advertising;
“sell” includes possess for sale and offer, expose or advertise for sale, but does not include—
(a) an advertisement of the type described in section 22 of the Act (publication in the course of business), or
(b) anything not qualifying as a placing on the market for the purposes of Council Directive 89/398/EEC4on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses;
“third country” means a country or territory other than a member State, the United Kingdom, the Isle of Man or any of the Channel Islands;
“young children” means children aged between one and three years.
(3) Any reference in these Regulations to a numbered regulation or Schedule shall be construed as a reference to the regulation or Schedule bearing that number in these Regulations.
Conditions for the sale of infant formulae and follow-on formulae
2. No person shall sell any food which is labelled or otherwise represented as—
(a) being an infant formula; or
(b) satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life,
unless that food—
(i) has been manufactured in accordance with the requirements set out in regulations 8(1) and (2), 10 and 11;
(ii) complies with the compositional criteria referred to in regulation 8(3), and the compositional requirements of regulation 12;
(iii) is labelled in accordance with the requirements for an infant formula of regulations 13 and 15; and
(iv) complies with the requirements as to presentation referred to in regulation 16(1).
3. No person shall sell any food which is labelled or otherwise represented as being a follow-on formula unless that food—
(a) has been manufactured in accordance with the requirements set out in regulations 9(1) and (2), 10 and 11;
(b) complies with the compositional criteria referred to in regulation 9(3), and the compositional requirements of regulation 12;
(c) is labelled in accordance with the requirements for a follow-on formula of regulations 14 and 15; and
(d) complies with the requirements as to presentation referred to in regulation 16(2).
4. Nothing in regulation 2 or regulation 3 shall apply to a sale of any food solely intended for export to a third country.
Export of infant formulae and follow-on formulae to third countries
5.—(1) No person shall export from Great Britain to a third country any infant formula which does not comply with—
(a)
(a) the requirements referred to in regulations 8, 10, 11 and 12 or the Codex Standard for Infant Formula5established by the Codex Alimentarius;
(b)
(b) the requirements referred to in regulations 13(1)(c)–(h), (2) and (3), 15 and 16(1); and
(c)
(c) the provisions of the Food (Lot Marking) Regulations 19926.
(2) The provisions referred to in paragraph (1) above shall not apply to the extent that any of them are dispensed with or varied by provisions laid down by the importing country.
(3) No person shall export from Great Britain to a third country any food, other than an infant formula, which is labelled or otherwise represented as capable of satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life.
6.—(1) No person shall export from Great Britain to a third country any follow-on formula which does not comply with—
(a)
(a) the requirements referred to in regulations 9, 10, 11 and 12 or the Codex Standard for Follow–up Formula7established by the Codex Alimentarius;
(b)
(b) the requirements referred to in regulations 14(c)–(f), 15 and 16(2); and
(c)
(c) the provisions of the Food (Lot Marking) Regulations 1992.
(2) The provisions referred to in paragraph (1) above shall not apply to the extent that any of them are dispensed with or varied by provisions laid down by the importing country.
7. No person shall export from Great Britain to a third country any infant formula or follow-on formula which is not—
(a) labelled in an appropriate language (or appropriate languages); and
(b) labelled in such a way as to avoid any risk of confusion between an infant formula and a follow-on formula.
Composition of infant formulae and follow-on formulae
8.—(1) An infant formula shall be manufactured only from—
(a)
(a) the protein sources and food ingredients specified in Schedule 1, and
(b)
(b) other food ingredients the suitability of which for particular nutritional use by infants from birth has been established by generally accepted scientific data.
(2) In the manufacture of any infant formula the prohibitions and limitations on the use of food ingredients set out in Schedule 1 shall be observed.
(3) The composition of an infant formula shall conform to the criteria specified in Schedule 1.
(4) In this regulation a reference to Schedule 1 shall be read as a reference to that Schedule as read with Schedules 5 and 6.
9.—(1) A follow-on formula shall be manufactured only from—
(a)
(a) the protein sources and food ingredients specified in Schedule 2, and
(b)
(b) other food ingredients the suitability of which for particular nutritional use by infants aged over four months has been established by generally accepted scientific data.
(2) In the manufacture of any follow-on formula the prohibitions and limitations on the use of food ingredients set out in Schedule 2 shall be observed.
(3) The composition of a follow-on formula shall conform to the criteria specified in Schedule 2.
(4) In this regulation a reference to Schedule 2 shall be read as a reference to that Schedule as read with Schedules 6 and 7.
10. If an infant formula or a follow-on formula is not at the time it is sold ready for use, nothing more...
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