Notice of the making of this Statutory Instrument was published in

"Iris Oifigiúil" of 7th July, 2015.

I, LEO VARADKAR, Minister for Health, in exercise of the powers conferred on me by section 3 of the European Communities Act 1972 (No. 27 of 1972) for the purpose of giving effect to Commission Regulation (EU) 2015/414 of 12 March 2015¹ , partial effect to Commission Regulation (EU) No. 1161/2011 of 14 November 2011² and Commission Regulation (EU) No. 119/2014 of 7 February 2014³ and for the purpose of giving further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002⁴ , hereby make the following regulations:

1. (1) These Regulations may be cited as the European Communities (Food Supplements) (Amendment) Regulations 2015.

(2) The Principal Regulations, the Regulations of 2010 and these Regulations may be cited together as the European Communities (Food Supplements) Regulations 2007 to 2015.

2. In these Regulations-

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

"Regulations of 2010" means European Communities (Food Supplements) (Amendment) Regulations 2010 ( S.I. No. 355 of 2010 ).

3. Regulation 2(1) (as amended by Regulation 3(a) of the Regulations of 2010) of the Principal Regulations is amended by substituting for the definition of "Directive" the following:

"‘Directive’ means Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002⁴, on the approximation of the laws of the Member States relating to food supplements, as amended by Commission Directive 2006/37/EC of 30 March 2006⁵ , Commission Regulation (EC) No. 1170/2009 of 30 November 2009⁶ , Commission Regulation (EU) No. 1161/2011 of 14 November 2011², Commission Regulation (EU) No. 119/2014 of 7 February 2014³ and Commission Regulation (EU) 2015/414 of 12 March 2015¹."

4. Schedule 2 to the Principal Regulations, as amended by the Regulations of 2010, is amended-

(a) in section "A. Vitamins" by inserting under the heading "10. FOLATE" after "(b) calcium-L-methylfolate", the following:

"(c)(6S)-5-methyltetrahydrofolic acid, glucosamine salt", and

(b) in section "B. Minerals"-

(i) by inserting after "ferrous phosphate", the following:

"ferrous ammonium phosphate ferric sodium EDTA",

(ii) by inserting after "sodium salts of orthophosphoric acid", the following:

"sodium sulphate potassium sulphate",

(iii) by inserting after "chromium (III) chloride", the following:

"chromium enriched yeast (******)",

(iv) by substituting for "silicic acid (******), the following:

"silicic acid (*******)", and

(v) by substituting for "(******) In the form of gel.", the following:

"(******) chromium enriched yeast produced by culture of Saccharomyces cerevisiae in the presence of chromium (III) chloride as a source of chromium and containing, in the dried form as marketed, 230-300 mg of chromium/kg. The content of chromium (VI) shall not exceed 0.2% of total chromium.

(*******) In the form of gel.".

GIVEN under my Official Seal,

2 July 2015.

LEO VARADKAR,

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 effect to Commission Regulation (EU) 2015/414 of 12 March 2015, partial effect to Commission Regulation (EC) No. 1161/2011 of 14 November 2011 and Commission Regulation (EU) No. 119/2014 of 7 February 2014 and further effect to Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002, the latter Directive being amended by the first three Regulations.

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 2015.

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

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

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

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

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

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