Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 29th June, 2018.

I, SIMON HARRIS, 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 partial effect to Commission Regulation (EU) 2017/1203 of 5 July 2017¹ , hereby make the following regulations:

1. (1) These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2018.

(2) The Principal Regulations, the European Communities (Food Supplements) (Amendment) Regulations 2010 ( S.I. No. 355 of 2010 ), the Regulations of 2015 and these Regulations may be cited together as the European Communities (Food Supplements) Regulations 2007 to 2018.

2. In these Regulations—

“Principal Regulations” means the European Communities (Food Supplements) Regulations 2007 ( S.I. No. 506 of 2007 );

“Regulations of 2015” means the European Communities (Food Supplements) (Amendment) Regulations 2015 ( S.I. No. 282 of 2015 ).

3. Regulation 2(1) of the Principal Regulation (as last amended by Regulation 3 of the Regulations of 2015) is amended by substituting for the definition of “Directive” the following definition:

“‘Directive’ means Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002² , as amended by Commission Directive 2006/37/EC of 30 March 2006³ , Commission Regulation (EC) No. 1170/2009 of 30 November 2009⁴ , Commission Regulation (EU) No. 1161/2011 of 14 November 2011⁵ , Commission Regulation (EU) No. 119/2014 of 7 February 2014⁶ , Commission Regulation (EU) No. 2015/414 of 12 March 2015⁷ and Commission Regulation (EU) 2017/1203 of 5 July 2017¹;”.

4. Schedule 2 to the Principal Regulations (as last amended by Regulation 4 of the Regulations of 2015) is amended in section “B. Minerals” by inserting—

(a) after “silicic acid”, the following:

“organic silicon (monomethylsilanetriol)”, and

(b) after ‘calcium sulphate’, the following:

“calcium phosphoryl oligosaccharides”.

GIVEN under my Official Seal,

26 June 2018.

SIMON HARRIS,

Minister for Health.

EXPLANATORY NOTE

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

These Regulations give partial effect to Commission Regulation (EU) 2017/1203 of 5 July 2017 amending Directive 2002/46/EC of the European Parliament and of the Council and Regulation (EC) No. 1925/2006 of the European Parliament and of the Council. Under Directive 2002/46/EC, only those vitamins and minerals listed in Annex I thereto and in the forms set out in Annex II thereto, can be used in the manufacture of food supplements. Annex II has been amended on various occasions, most recently by Commission Regulation (EU) 2017/1203 which adds organic silicon (monomethylsilanetriol) and calcium phosphoryl oligosaccharides (POs-Ca®) to the list of substances which may be used in the manufacture of food supplements.

These Regulations amend the European Communities (Food Supplements) Regulations 2007 ( S.I. No. 506 of 2007 ) in the manner specified in these Regulations.

These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2018.

1 OJ No. L 173, 6.7.2017, p.9.

2 OJ No. L 183, 12.7.2002, p. 51.

3 OJ No. L 94, 1.4.2006, p. 32.

4 OJ No. L 314, 1.12.2009, p. 36.

5 OJ No. L 296, 15.11.2011, p. 29.

6 OJ No. L 39, 8.2.2014, p. 44.

7 OJ No. L 68, 13.3.2015, p. 26.