Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 11th October, 2013.

I, JAMES REILLY, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) and for the purpose of giving effect to Commission Directive 2013/26/EU of 8 February 2013¹ (in so far as that Directive relates to infant formulae and follow-on formulae) and for the purpose of giving further effect to Commission Directive 2006/141/EC of 22 December 2006² and to Council Directive 92/52/EEC of 18 June 1992³ , hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2013.

2. In these Regulations “Principal Regulations” means the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 ( S.I. No. 852 of 2007 ).

3. Regulation 2(1) of the Principal Regulations is amended by substituting for the definition of “Directive 2006/141/EC” the following:

“‘Directive 2006/141/EC’ means Commission Directive 2006/141/EC of 22 December 2006², as amended by Commission Regulation (EC) No. 1243/2008 of 12 December 2008⁴ and Commission Directive 2013/26/EU of 8 February 2013¹;”.

4. Regulation 3 of the Principal Regulations is amended by substituting for paragraph (6) the following:

“The other names listed in Articles 11 and 12 of Directive 2006/141/EC, or any of them, may also be included in addition to the names indicated in paragraphs (3) and (5).”.

5. Regulation 28 of the Principal Regulations is amended—

(a) by substituting for paragraph (2)(a) the following subparagraph—

“(a) on summary conviction, to a class A fine or at the discretion of the court to imprisonment for a term not exceeding 6 months, or both, or,”, and

(b) by inserting after paragraph (2) the following paragraphs—

“(3) Where a person is convicted of an offence under these Regulations, the court shall, unless it is satisfied that there are special and substantial reasons for not so doing, order the person to pay to the Authority or the official agency, as the case may be, the costs and expenses, measured by the court, incurred by the Authority or official agency in relation to the investigation, detection and prosecution of the offence, including costs and expenses incurred in the taking of samples, the carrying out of tests, examinations and analyses and in respect of the remuneration and other expenses of employees, consultants and advisors engaged by the Authority or official agency.

(4) An order for costs and expenses under paragraph (3) is in addition to, and not instead of, any fine or penalty the court may impose under paragraph (2).”.

GIVEN under my Official Seal,

8 October 2013.

JAMES REILLY,

Minister for Health.

EXPLANATORY NOTE

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

These Regulations transpose into Irish Law Commission Directive 2013/26/EU of 8 February 2013 (in so far as that Directive relates to infant formulae and follow-on formulae) adapting certain directives in the field of food safety, veterinary and phytosanitary policy, by reason of the accession of Croatia.

These Regulations amend the European Communities (Infant Formulae and Follow-on Formulae) Regulations 2007 ( S.I. No. 852 of 2007 ) in the manner specified in these Regulations, particularly with regard to the extended list of names under which infant formulae and follow-on formulae may be sold and also provide for the recovery of costs from the defendant in the event of a successful prosecution, in addition to any fine or penalty imposed.

These Regulations may be cited as the European Communities (Infant Formulae and Follow-on Formulae) (Amendment) Regulations 2013.

1 OJ No. L. 158, 10.6.2013, p. 376.

2 OJ No. L. 401, 30.12.2006, p. 1.

3 OJ No. L. 179, 1.7.1992, p. 129.

4 OJ No. L. 335, 13.12.2008, p. 25.