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 dietary foods for special medical purposes), and for the purpose of giving further effect to Commission Directive 1999/21/EC of 25 March 1999² , hereby make the following regulations:

1. These Regulations may be cited as the European Communities (Dietary Foods for Special Medical Purposes) (Amendment) Regulations 2013.

2. In these Regulations, “Principal Regulations” means the European Communities (Dietary Foods for Special Medical Purposes) Regulations 2009 ( S.I. No. 187 of 2009 ).

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

“‘Directive’ means Commission Directive 1999/21/EC of 25 March 1999², as affected by Corrigendum to Commission Directive 1999/21/EC of 5 January 2000³ , and as amended by Commission Directive 2006/82/EC of 23 October 2006⁴ , Commission Directive 2006/141/EC of 22 December 2006⁵ and Commission Directive 2013/26/EC of 8 February 20131;”.

4. Regulation 25 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 dietary foods for special medical purposes) 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 (Dietary Foods for Special Medical Purposes) Regulations 2009 ( S.I. No. 187 of 2009 ) in the manner specified in these Regulations, particularly with regard to the extended list of names under which dietary foods for special medical purposes 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 (Dietary Foods for Special Medical Purposes) (Amendment) Regulations 2013.

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

2 OJ No. L. 91, 7.4.1999, p. 29.

3 OJ No. L. 2, 5.1.2000, p. 79.

4 OJ No. L. 362, 20.12.2006, p. 94.

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