The Infant Formula and Follow-on Formula (Wales) Regulations 2007

Made: 18 December 2007

Laid before the National Assembly for Wales: 20 December 2007

Coming into force in accordance with regulation 1

As required by Article 9 of Regulation (EC) No. 178/2002 of the European Parliament and of the Council laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety[^f00005] there has been open and transparent public consultation during the preparation and evaluation of these Regulations.

Title, commencement and application

1

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Interpretation

2

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Prohibition on the marketing of infant formula or follow-on formula unless certain conditions are met

3

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Prohibition on the marketing of products other than infant formula for normal health infants

4

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Substances in such quantity as to endanger the health of infants and young children

5

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Protein sources and other food ingredients suitable for infants from birth (infant formula)

6

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Protein sources and other food ingredients suitable for infants aged over six months (follow-on formula)

7

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Compositional criteria for infant formula

8

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Compositional criteria for follow-on formula

9

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Addition of water (infant formula and follow-on formula)

10

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Prohibitions and limitations on the use of food ingredients (infant formula and follow-on formula)

11

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Listed substances and their purity criteria (infant formula and follow-on formula)

12

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Notification of infant formula

13

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Pesticide residues (infant formula and follow-on formula)

14

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Naming of infant formula

15

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Naming of follow-on formula

16

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Labelling of infant formula

17

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Labelling of follow-on formula

18

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Avoidance of the risk of confusion between infant formula and follow-on formula

19

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Presentation (infant formula and follow-on formula)

20

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Restrictions on advertising infant formula

21

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Restrictions on advertising follow-on formula

22

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Restrictions on the promotion of infant formula

23

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Provision of informational and educational material dealing with the feeding of infants

24

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Free or reduced rate infant formula

25

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Export of infant formula to third countries

26

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Export of follow-on formula to third countries

27

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Offences and enforcement

28

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Application of various sections of the Food Safety Act 1990

29

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Amendment of the Medical Food (Wales) Regulations 2000

30

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Revocation and transitional arrangements

31

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Signed

G. Thomas — Under authority of the Minister for Health and Social Services, one of the Welsh Ministers — 2007-12-18

Explanatory note

(This note is not part of the Regulations)

1These Regulations, which apply in relation to Wales, give effect to Commission Directive 2006/141/EC on infant formula and follow-on formula and amending Directive 1999/21/EC (OJ No. L401, 20.12.2006, p.1) and Council Directive 92/52/EEC on infant formulae and follow-on formulae intended for export to third countries (OJ No. L179, 1.7.1992, p.129).

2These Regulations make provision for a purpose mentioned in section 2(2) of the European Communities Act 1972 (1972 c. 68) and references to Annex to Directive 2006/141/EC are to be construed as references to that Annex as amended from time to time (regulation 2(6)).

3These Regulations—aprohibit marketing of infant formula and follow-on formula which contravenes or fails to comply with specified regulations (regulation 3);bprohibit marketing or otherwise representing 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 (regulation 4);cprovide that infant formula and follow-on formula must not contain any substance in such quantity as to endanger the health of infants and young children (regulation 5);dprovide that infant formula must be manufactured from specified protein sources and other suitable food ingredients (regulation 6);eprovide that follow-on formula must be manufactured from specified protein sources and other suitable food ingredients (regulation 7);fprovide that infant formula must comply with specified compositional criteria (regulation 8);gprovide that follow-on formula must comply with specified compositional criteria (regulation 9);hprovide that in order to make infant formula or follow-on formula ready for use nothing more must be required than the addition of water (regulation 10);iprovide that the use of food ingredients in infant formula and follow-on formula must observe specified prohibitions and limitations (regulation 11);jprovide that only specified substances may be used in the manufacture of infant formula and follow-on formula in order to satisfy specified requirements of Directive 2006/141/EC and that those substances must meet specified purity criteria (regulation 12);kprohibit a food business operator placing an infant formula on the market that has not yet been placed on the market in the United Kingdom unless that food business operator has given prior notice to the Food Standards Agency (regulation 13);lprovide that infant formula and follow-on formula may not contain pesticide residues above specified levels (regulation 14);mprovide that infant formula may only be sold under certain names (regulation 15);nprovide that follow-on formula may only be sold under certain names (regulation 16);oprovide for the labelling of infant formula (regulation 17);pprovide for the labelling of follow-on formula (regulation 18);qprovide that infant formula and follow-on formula must be labelled to make a clear distinction between such products so as to avoid any risk of confusion between them (regulation 19);rapply the provisions of specified regulations to the presentation of infant formula and follow-on formula (regulation 20);sprohibit advertising of infant formula except in specified publications unless the advertisement complies with the provisions of specified regulations (regulation 21(1));timpose restrictions on the content of advertisements for infant formula (regulation 21(2) and (3));uprohibit advertising of follow-on formula where the advertisement contravenes or fails to comply with the provisions of specified regulations (regulation 22);vimpose restrictions on the promotion of infant formula (regulation 23);wimpose restrictions on the production or publication of informational or educational material dealing with the feeding of infants and intended to reach pregnant women and mothers of infants and young children (regulation 24(1), (2) and (3));xprohibit donation of informational or educational equipment or materials by manufacturers or distributors of infant formula unless certain conditions are met (regulation 24(4));yimpose restrictions on what an institution or organisation may do with infant formula that it has received free of charge or at a reduced rate (regulation 25);zprohibit export to a third country of infant formula which contravenes or fails to comply with specified regulations, a specified international standard or the Food (Lot Marking) Regulations (S.I. 1996/1502) (regulation 26(1));aaprohibit export to a third country of a product represented as suitable for satisfying by itself the nutritional requirements of normal healthy infants during the first four to six months of life unless that product is infant formula (regulation 26(2));bbprohibit export to a third country of follow-on formula which contravenes or fails to comply with specified regulations, a specified international standard or the Food (Lot Marketing) Regulations 1996 (regulation 27);ccprovide that a person who contravenes or fails to comply with specified regulations is guilty of an offence and provide a penalty for contravening or failing to comply with those regulations (regulation 28(1));ddprovide that each food authority must enforce and execute these Regulations within its area (regulation 28(2));eeapply specified provisions of the Food Safety Act 1990 (1990 c. 16) with modifications (regulation 29);ffamend the Medical Food (Wales) Regulations (S.I. 2000/1866 (W.25)) (regulation 30); andggrevoke the Infant Formula and Follow-on Formula Regulations (S.I. 1995/77) in so far as they apply in relation to Wales (S.I. 1995/77 applies in relation to the whole of Great Britain) and provide transitional arrangements with regard to S.I. 1995/77 (regulation 31).

4A full regulatory impact assessment of the effect that this instrument will have has been prepared. Copies may be obtained from the Food Standards Agency, 11th Floor, Southgate House, Wood Street, Cardiff, CF10 1EW.

Footnotes

[^f00001]: 1990 c. 16. Section 1(1) and (2) (definition of “food”) was substituted by S.I. 2004/2990. Sections 17 and 48 were amended by paragraphs 12 and 21 respectively of Schedule 5 to the Food Standards Act 1999 (1999 c. 28), “the 1999 Act”. Section 48 was also amended by S.I. 2004/2990. Section 26(3) was amended by Schedule 6 to the 1999 Act.

[^f00002]: 1972 c. 68. In relation to Wales, the functions formerly exercised by “the Ministers” (being, in relation to England and Wales and actin jointly, the Minister of Agriculture, Fisheries and Food and the Secretaries of State respectively concerned with health in England and food and health in Wales and, in relation to Scotland, the Secretary of State) were transferred to the National Assembly for Wales by S.I. 1999/672 as read with section 40(3) of the 1999 Act and thereafter transferred to the Welsh Ministers by sections 58 and 59 of and paragraph 30 of Schedule 11 to the Government of Wales Act 2006 (c. 32).

[^f00003]: S.I. 2005/1971.

[^f00004]: OJ No. L401, 30.12.2006, p.1.

[^f00005]: OJ No. L31, 1.2.2002, p.1, as last amended by Commission Regulation (EC) No. 575/2006 amending Regulation (EC) No. 178/2002 of the European Parliament and of the Council as regards the number and names of the permanent Scientific Panels of the European Food Safety Authority (OJ No. L100, 8.4.2006, p.3).

Editorial notes

[^key-761a4e3b2ad5df6e18b5137030e9e022]: Regs. 26, 27 revoked (2.8.2016) by The Food for Specific Groups (Information and Compositional Requirements) (Wales) Regulations 2016 (S.I. 2016/639), regs. 1(3), 5(b)

[^key-952a2c8f4666f7a3ae216d3262ccb9dc]: Reg. 30 revoked (22.2.2020) by The Food for Specific Groups (Information and Compositional Requirements) (Wales) (Amendment) Regulations 2020 (S.I. 2020/92), reg. 1(2), Sch. (with reg. 9(2))

Application of the improvement notice provisions of the Act

28A

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Application of various sections of the Food Safety Act 1990

Amendment of the Medical Food (Wales) Regulations 2000

Revocation and transitional arrangements

SCHEDULE — Modification of the improvement notice provisions of the Act

PART 1 — Modification of section 10(1)

1

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PART 2 — Modification of section 32(1)

2

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PART 3 — Modification of section 35

3

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PART 4 — Modification of section 37(1), (5) and (6)

4

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5

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6

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