Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 23rd October, 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 further effect to Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 2011¹ and for the purpose of giving effect to Commission Regulation (EU) No. 1018/2013 of 23 October 2013² , Commission Regulation (EU) No. 40/2014 of 17 January 2014³ , Commission Regulation (EU) No. 686/2014 of 20 June 2014⁴ , Commission Regulation (EU) No. 1135/2014 of 24 October 2014⁵ , Commission Regulation (EU) No. 1226/2014 of 17 November 2014⁶ , Commission Regulation (EU) No. 1228/2014 of 17 November 2014⁷ , Commission Regulation (EU) 2015/7 of 6 January 2015⁸ and Commission Regulation (EU) 2015/539 of 31 March 2015⁹ hereby make the following regulations:

1. (1) These Regulations may be cited as the European Union (Nutrition and Health Claims made on Foods) (Amendment) Regulations 2015.

(2) The Principal Regulations and these Regulations may be cited together as the European Union (Nutrition and Health Claims made on Foods) Regulations 2014 and 2015.

2. In these Regulations-

“Principal Regulations” means European Union (Nutrition and Health Claims made on Foods) Regulations 2014 ( S.I. No. 11 of 2014 ).

3. The Principal Regulations are amended-

(a) in Regulation 2(1), by substituting for the definition of “EC Regulation 1924/2006” the following:

‘“EC Regulation 1924/2006” means Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006¹⁰ as affected by Corrigendum to Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006¹¹ and as amended by Regulation (EC) No. 107/2008 of the European Parliament and of the Council of 15 January 2008¹² , Regulation (EC) No. 109/2008 of the European Parliament and of the Council of 15 January 2008¹³ , Commission Regulation (EU) No. 116/2010 of 9 February 2010¹⁴ , Regulation (EU) No. 1169/2011 of the European Parliament and of the Council of 25 October 20111 and Commission Regulation (EU) No. 1047/2012 of 8 November 2012¹⁵ ;”,

(b) in Regulation 2(1), by substituting for the definition of “list of permitted claims which may be made on foods, as provided for in Article 13(3) of EC Regulation 1924/2006” the following:

‘“list of permitted claims which may be made on foods, as provided for in Article 13(3) of EC Regulation 1924/2006’ means the list of permitted health claims other than those referring to the reduction of disease risk and to children’s development and health, which may be made on foods listed in the Annex to Commission Decision 2009/980/EC of 17 December 2009¹⁶ as amended by Commission Decision 2010/770/EU of 13 December 2010¹⁷ and the Annex to Commission Regulation (EU) No. 432/2012 of 16 May 2012¹⁸ as amended by Commission Regulation (EU) No. 536/2013 of 11 June 2013¹⁹ , Commission Regulation (EU) No. 851/2013 of 3 September 2013²⁰ , Commission Regulation (EU) No. 1018/2013 of 23 October 20132, Commission Regulation (EU) No. 40/2014 of 17 January 20143, Commission Regulation (EU) 2015/7 of 6 January 20158 and Commission Regulation (EU) 2015/539 of 31 March 20159;”, and

(c) in Regulation 2(1), by substituting for the definition of “list of permitted claims which may be made on foods, as provided for in Article 14(1) of EC Regulation 1924/2006” the following:

‘“list of permitted claims which may be made on foods, as provided for in Article 14(1) of EC Regulation 1924/2006’ means the list of permitted reduction of disease risk claims and claims referring to childrens development and health listed in Annex I to Commission Regulation (EC) No. 983/2009 of 21 October 2009²¹ as amended by Commission Regulation (EU) No. 376/2010 of 3 May 2010²² and Commission Regulation (EU) No. 686/2014 of 20 June 20144 and Annex I to Commission Regulation (EC) No. 1024/2009 of 29 October 2009²³ , Commission Regulation (EU) No. 384/2010 of 5 May 2010²⁴ as amended by Commission Regulation (EU) No. 686/2014 of 20 June 20144, Commission Regulation (EU) No. 957/2010 of 22 October 2010²⁵ , Commission Regulation (EU) No. 440/2011 of 6 May 2011²⁶ , Commission Regulation (EU) No. 665/2011 of 11 July 2011²⁷ , Commission Regulation (EU) No. 1160/2011 of 14 November 2011²⁸ , Commission Regulation (EU) No. 1228/2014 of 17 November 20147 and the Annex to Commission Regulation (EU) No. 1048/2012 of 8 November 2012²⁹ , Commission Regulation (EU) No. 1135/2014 of 24 October 20145 and Commission Regulation (EU) No. 1226/2014 of 17 November 20146;”.

GIVEN under my Official Seal,

21 October 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) No. 1018/2013 of 23 October 2013, Commission Regulation (EU) No. 40/2014 of 17 January 2014, Commission Regulation (EU) No. 1135/2014 of 24 October 2014, Commission Regulation (EU) No. 1226/2014 of 17 November 2014, Commission Regulation (EU) No. 1228/2014 of 17 November 2014, Commission Regulation (EU) 2015/7 of 6 January 2015, Commission Regulation (EU) 2015/539 of 31 March 2015 authorising health claims made on foods referring to the reduction of disease risk and authorising health claims made on foods other than those referring to the reduction of disease risk and to childrens development and health.

They also give effect to Commission Regulation (EU) No. 686/2014 of 20 June 2014 amending Regulations (EC) No. 983/2009 and (EU) No. 384/2010 as regards the conditions of use of certain health claims related to the lowering effect of plant sterols and plant stanols on blood LDL-cholesterol and further effect to Regulation (EU) No. 1169/2011 of 25 October 2011 as affected by the Corrigendum to Regulation (EU) No. 1169/2011.

These Regulations amend the European Union (Nutrition and Health Claims made on Foods) Regulations 2014 ( S.I. No. 11 of 2014 ) in the manner specified in these Regulations.

These Regulations may be cited as the European Union (Nutrition and Health Claims made on Foods) (Amendment) Regulations 2015.

1 OJ No. L. 304, 22.11.2011, p. 18. as affected by Corrigendum (OJ No. L. 247, 13.9.2012, p. 17).

2 OJ No. L. 282, 24.10.2013, p. 43.

3 OJ No. L. 14, 18.1.2014, p. 8.

4 OJ No. L. 182, 21.6.2014, p. 27.

5 OJ No. L. 307, 28.10.2014, p. 23.

6 OJ No. L. 331, 18.11.2014, p. 3.

7 OJ No. L. 331, 18.11.2014, p. 8.

8 OJ No. L. 3, 7.1.2015, p. 3.

9 OJ No. L. 88, 1.4.2015, p. 7.

10 OJ No. L. 404, 30.12.2006, p. 9.

11 OJ No. L. 12, 18.1.2007, p. 3.

12 OJ No. L. 39, 13.2.2008, p. 8.

13 OJ No. L. 39, 13.2.2008, p. 14.

14 OJ No. L. 37, 10.2.2010, p. 16.

15 OJ No. L. 310, 9.11.2012, p. 36.

16 OJ No. L. 336, 18.12.2009, p. 55.

17 OJ No. L. 328, 14.12.2010, p. 18.

18 OJ No. L. 136, 25.5.2012, p. 1.

19 OJ No. L. 160, 12.6.2013, p. 4.

20 OJ No. L. 235, 4.9.2013, p. 3.

21 OJ No. L. 277, 22.10.2009, p. 3.

22 OJ No. L. 111, 4.5.2010, p. 3.

23 OJ No. L. 283, 30.10.2009, p. 22.

24 OJ No. L. 113, 6.5.2010, p. 6.

25 OJ No. L. 279, 23.10.2010, p. 13.

26 OJ No. L. 119, 7.5.2011, p. 4.

27 OJ No. L. 182, 12.7.2011, p. 5.

28 OJ No. L. 296, 15.11.2011, p. 26.

29 OJ No. L. 310, 9.11.2012, p. 38.