S.I. No. 446/2000 - European Communities (Infant Formulae and Follow-On Formulae) (Amendment) Regulations, 2000.

I, MICHEÁL MARTIN, Minister for Health and Children, in exercise of the powers conferred on me by Section 3 of the European Communities Act, 1972 (No. 27 of 1972), for the purposes of giving effect to Commission Directive 1999/50/EC¹ of 25 May 1999 amending Directive 91/321/EEC on infant formulae and follow-on formulae, hereby make the following Regulations:

1. These Regulations may be cited as the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations, 2000.

2. (1) In these Regulations:

“the Principal Regulations” means the European Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 ( S.I. No. 243 of 1998 ).

(2) These Regulations shall be construed as one with the Principal Regulations and may be cited with the Principal Regulations as the European Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 to 2000.

3. The Principal Regulations are hereby amended by:

(a) the substitution, wherever it appears, for “Article” of “Regulation”, for “Articles” of “Regulations”, for “sub-article” of “paragraph”, for “sub-articles” of “paragraphs”, for “paragraph” of “point” and for “paragraphs” of “points”.

(b) the substitution for Regulation 2(2) of the following:

“(2) Subject to paragraph 3, trade in products which do not comply with these Regulations is prohibited with effect from 31st March 1999.

(3) Trade in products which do not comply with Regulation 6A is prohibited with effect from 1st July 2002”.

(c) in Regulation 3(1), the insertion of the following definition:

“Pesticide residue” means the residue in infant formulae and follow-on formulae of a plant protection product, as defined in point 1 of Article 2 of Council Directive 91/414/EEC² , including its metabolites and products resulting from its degradation or reaction;

(d) After Regulation 6, the insertion of the following new Regulation:

“6A (1) Infant formulae and follow-on formulae shall not contain residues of individual pesticides at levels exceeding 0.01 mg/kg of the product as proposed ready for consumption or as reconstituted according to the instructions of the manufacturer.

(2) Analytical methods for determining the levels of pesticide residues shall be generally acceptable standardised methods.”

(e) In Regulation 14, the substitution for paragraph 1(a)(i) of the following:

“(i) the requirements of Regulations 5, 6 and 7 of these Regulations and with effect from 1 July 2002, Regulation 6A of these Regulations, or”

(f) In Regulation 17, the substitution for paragraphs 1 and 2 of the following:

“(1) Subject to paragraph 1A, a person shall not manufacture, prepare, import, export, distribute, market, advertise and/or label any product or promotional material which does not comply with these Regulations.

(1A) With effect from 1 July 2002, a person shall not manufacture, prepare, import, export, distribute, market, advertise and/or label any product or promotional material which does not comply with Regulation 6A of these Regulations.

(2) Subject to paragraph 2A, any person who contravenes any paragraph or sub-paragraph of these Regulations is guilty of an offence.

(2A) With effect from 1 July 2002, any person who contravenes any paragraph or sub-paragraph of Regulation 6A of these Regulations is guilty of an offence.”

EXPLANATORY NOTE.

(This note is not part of the Instrument and does not purport to be a legal interpretation.)

These Regulations give effect to Commission Directive 1999/50/EC amending Directive 91/321/EEC on infant formulae and follow-on formulae.

These Regulations amend the European Communities (Infant Formulae and Follow-on Formulae) Regulations, 1998 ( S.I. No. 243 of 1998 ) to establish a maximum level for pesticides in these products.

¹ OJ L 139, 2.6.1999, p.29

² OJ L 230, 19.8.1991, p.1