Title, application and commencement

1. These Regulations may be cited as the Infant Formula and Follow-on Formula (Amendment) (England) Regulations 2003; they apply in relation to England only and come into force on 6th March 2005.

Amendment of the Infant Formula and Follow-on Formula Regulations 1995

2.The Infant Formula and Follow-on Formula Regulations 1995( 4 ) shall be amended (in so far as they apply in relation to England) in accordance with regulations 3 to 10.

3. In regulation 1(2) (interpretation), in the definition of “the Directive”, for the words “Commission Directive 5 )”.

4. In regulations 2(ii) and 3(b) (conditions for the sale of infant formulae and follow-on formulae), for the expression “regulation 12” there shall be substituted the expression “regulations 12 and 12A”.

5. In regulations 5(1)(a) and 6(1)(a) (export of infant formulae and follow-on formulae to third countries), for the expression “11 and 12” there shall be substituted the expression “, 11, 12 and 12A”.

6. In regulations 8(2) and 9(2) (composition of infant formulae and follow-on formulae), the words from “and it shall not” to the end shall be omitted.

7. After regulation 12 (composition of infant formulae and follow-on formulae) there shall be inserted the following regulation —

“ 12A. —(1) No infant formula or follow-on formula shall contain —

(a) any pesticide residue of a pesticide specified in Schedule 7A; or

(b) any omethoate, where it is a metabolite of a pesticide not specified in Schedule 7A, or any product resulting from degradation or reaction of that metabolite,

at a level exceeding 0.003 mg/kg.

(2) No infant formula or follow-on formula shall contain any pesticide residue of a pesticide specified in column 1 of Schedule 7B at a level exceeding that specified in column 2 of that Schedule in relation to that pesticide.

(3) No infant formula or follow-on formula shall contain any pesticide residue of any individual pesticide which is not specified in Schedule 7A or column 1 of Schedule 7B at a level exceeding 0.01 mg/kg.

(4) The levels referred to in paragraphs (1) to (3) apply to the infant formula or follow-on formula —

(a) manufactured as ready for consumption, or

(b) if it is not so manufactured, as reconstituted according to its manufacturer’s instructions.

(5) Analytical methods for determining levels of pesticide residues for the purposes of this regulation shall be generally acceptable standardised methods. ” .

8. In regulation 22 (offences and enforcement) —

(a) in paragraph (2) there shall be inserted at the beginning the words “Except where paragraph (2A) below applies,”;

(b) after paragraph (2) there shall be inserted the following paragraph —

“ (2A) Each port health authority shall enforce and execute these Regulations in its district in relation to imported food. ” .

9. For regulation 23 (application of provisions of the Food Safety Act 1990) there shall be substituted the following regulation —

“ Application of various provisions of the Act

23. The following provisions of the Act shall apply for the purposes of these Regulations (except regulation 21) with the modification that any reference in those provisions to the Act or Part thereof shall be construed as a reference to these Regulations (except regulation 21) —

(a) section 2 (extended meaning of “sale” etc. );

(b) section 3 (presumptions that food is intended for human consumption);

(c) section 20 (offences due to fault of another person);

(d) section 21 (defence of due diligence) as it applies for the purposes of section 8, 14 or 15;

(e) section 30(8) (which relates to documentary evidence);

(f) section 33(1) (obstruction etc. of officers);

(g) section 33(2), with the modification that the reference to “any such requirement as is mentioned in subsection (1)(b) above” shall be deemed to be a reference to any such requirement as is mentioned in that subsection as applied by paragraph (f) above;

(h) section 35(1) (punishment of offences) in so far as it relates to offences under section 33(1) as applied by paragraph (f) above;

(i) section 35(2) and (3) in so far as it relates to offences under section 33(2) as applied by paragraph (g) above;

(j) section 36 (offences by bodies corporate); and

(k) section 44 (protection of officers acting in good faith). ” .

10. After Schedule 7 (the mineral elements in cows' milk) there shall be inserted as Schedules 7A and 7B the contents of the Schedule to these Regulations.

Regulation 10

SCHEDULE NEW SCHEDULES 7A AND 7B TO BE INSERTED IN THE INFANT FORMULA AND FOLLOW-ON FORMULA REGULATIONS 1995

“ SCHEDULE 7A PESTICIDES WHOSE RESIDUES MUST NOT BE PRESENT IN INFANT FORMULAE OR FOLLOW-ON FORMULAE AT A LEVEL EXCEEDING 0.003 mg/ kg

Chemical name

• Aldrin and dieldrin, expressed as dieldrin

• Disulfoton (sum of disulfoton, disulfoton sulfoxide and disulfoton sulfone expressed as disulfoton)

• Endrin

• Fensulfothion (sum of fensulfothion, its oxygen analogue and their sulfones, expressed as fensulfothion)

• Fentin, expressed as triphenyltin cation

• Haloxyfop (sum of haloxyfop, its salts and esters including conjugates, expressed as haloxyfop)

• Heptachlor and trans -heptachlor epoxide, expressed as heptachlor

• Hexachlorobenzene

• Nitrofen

• Omethoate

• Terbufos (sum of terbufos, its sulfoxide and sulfone, expressed as terbufos)

SCHEDULE 7B SPECIFIC MAXIMUM RESIDUE LEVELS OF CERTAIN PESTICIDES IN INFANT FORMULAE OR FOLLOW-ON FORMULAE