S.I. No. 396/2012 - European Communities (Cosmetic Products) (Amendment) Regulations 2012.

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 12th October, 2012.

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 further effect to Council Directive 76/768/EEC of 27 July 1976¹ , as amended by Council Directive 2011/84/EU of 20 September 2011² , hereby make the following regulations:

Citation

1. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2012.

Collective citation and construction

2. The Principal Regulations and these Regulations may be cited together as the European Communities (Cosmetic Products) Regulations 2004 to 2012 and shall be construed together as one.

Commencement

3. These Regulations come into operation on 31 October 2012.

Interpretation

4. In these Regulations, “Principal Regulations” means the European Communities (Cosmetic Products) Regulations 2004 ( S.I. No. 870 of 2004 ), as amended.

Amendment of Regulation 4(1) of Principal Regulations

5. Regulation 4(1) of the Principal Regulations is amended by substituting for the definition of “Directive” the following definition:

“ ‘Directive’ means Directive 76/768/EEC, as amended by Council Directive 79/661/EEC of 24 July 1979³ , Commission Directive 82/147/EEC of 11 February 1982⁴ , Council Directive 82/368/EEC of 17 May 1982⁵ , Commission Directive 83/191/EEC of 30 March 1983⁶ , Commission Directive 83/341/EEC of 29 June 1983⁷ , Commission Directive 83/496/EEC of 22 September 1983⁸ , Council Directive 83/574/EEC of 26 October 1983⁹ , Commission Directive 84/415/EEC of 18 July 1984¹⁰ , Commission Directive 85/391/EEC of 16 July 1985¹¹ , Commission Directive 86/179/EEC of 28 February 1986¹² , Commission Directive 86/199/EEC of 26 March 1986¹³ , Commission Directive 87/137/EEC of 2 February 1987¹⁴ , Commission Directive 88/233/EEC of 2 March 1988¹⁵ , Council Directive 88/667/EEC of 21 December 1988¹⁶ , Commission Directive 89/174/EEC of 21 February 1989¹⁷ , Council Directive 89/679/EEC of 21 December 1989¹⁸ , Commission Directive 90/121/EEC of 20 February 1990¹⁹ , Commission Directive 91/184/EEC of 12 March 1991²⁰ , Commission Directive 92/8/EEC of 18 February 1992²¹ , Commission Directive 92/86/EEC of 21 October 1992²² , Council Directive 93/35/EEC of 14 June 1993²³ , Commission Directive 93/47/EEC of 22 June 1993²⁴ , Commission Directive 94/32/EC of 29 June 1994²⁵ , Commission Directive 95/34/EC of 10 July 1995²⁶ , Commission Directive 96/41/EC of 25 June 1996²⁷ , Commission Directive 97/1/EC of 10 January 1997²⁸ , Commission Directive 97/45/EC of 14 July 1997²⁹ , Commission Directive 98/16/EC of 5 March 1998³⁰ , Commission Directive 98/62/EC of 3 September 1998³¹ , Commission Directive 2000/6/EC of 29 February 2000³² , Commission Directive 2000/11/EC of 10 March 2000³³ , Commission Directive 2002/34/EC of 15 April 2002³⁴ , Commission Directive 2003/1/EC of 6 January 2003³⁵ , Commission Directive 2003/16/EC of 19 February 2003³⁶ , Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003³⁷ , Commission Directive 2003/80/EC of 5 September 2003³⁸ , Commission Directive 2003/83/EC of 24 September 2003³⁹ , Commission Directive 2004/87/EC of 7 September 2004⁴⁰ , Commission Directive 2004/88/EC of 7 September 2004⁴¹ , Commission Directive 2004/93/EC of 21 September 2004⁴² , Commission Directive 2004/94/EC of 15 September 2004⁴³ , Commission Directive 2005/9/EC of 28 January 2005⁴⁴ , Commission Directive 2005/42/EC of 20 June 2005⁴⁵ , Commission Directive 2005/52/EC of 9 September 2005⁴⁶ , Commission Directive 2005/80/EC of 21 November 2005⁴⁷ , Commission Directive 2006/65/EC of 19 July 2006⁴⁸ , Commission Directive 2006/78/EC of 29 September 2006⁴⁹ , Commission Directive 2007/1/EC of 29 January 2007⁵⁰ , Commission Directive 2007/17/EC of 22 March 2007⁵¹ , Commission Directive 2007/22/EC of 17 April 2007⁵² , Commission Directive 2007/53/EC of 29 August 2007⁵³ , Commission Directive 2007/54/EC of 29 August 2007⁵⁴ , Commission Directive 2007/67/EC of 22 November 2007⁵⁵ , Commission Directive 2008/14/EC of 15 February 2008⁵⁶ , Commission Directive 2008/42/EC of 3 April 2008⁵⁷ , Commission Directive 2008/88/EC of 23 September 2008⁵⁸ , Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008⁵⁹ , Commission Directive 2008/123/EC of 18 December 2008⁶⁰ , Commission Directive 2009/6/EC of 4 February 2009⁶¹ , Commission Directive 2009/36/EC of 16 April 2009⁶² , Commission Directive 2009/129/EC of 9 October 2009⁶³ , Commission Directive 2009/130/EC of 12 October 2009⁶⁴ , Commission Directive 2009/134/EC of 28 October 2009⁶⁵ , Commission Directive 2009/159/EU of 16 December 2009⁶⁶ , Commission Directive 2009/164/EU of 22 December 2009⁶⁷ , Commission Directive 2010/3/EU of 1 February 2010⁶⁸ , Commission Directive 2010/4/EU of 8 February 2010⁶⁹ , Commission Directive 2011/59/EU of 13 May 2011⁷⁰ and Council Directive 2011/84/EU of 20 September 20112”

Amendments to the Schedule in Principal Regulations

6. Part 1 of Schedule 3 to the Principal Regulations is amended by the substitution for Reference Number 12 of the following schedule:—

SCHEDULE

Referencenumber	Substance	Restrictions			Conditions of use and warnings which must be printed on the label
		Field of applicationand/or use	Maximum authorised concentration in the finished cosmetic product	Other limitations and requirements
a	b	c	d	e	f
‘12	Hydrogen peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide	(a) Hair care mixtures (b) Skin care mixtures (c) Nail hardening mixtures (d) Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products (e) Tooth whitening or bleaching products	(a) 12% of H₂O₂ (40 volumes), present or released (b) 4% of H₂O₂, present or released (c) 2% of H₂O₂, present or released (d) ≤ 0.1 % of H₂O₂, present or released (e) > 0.1 % ≤ 6% of H₂O₂, present or released	(e) To be only sold to dental practitioners. For each cycle of use, first use by dental practitioners as defined under Directive 2005/36/EC (*) or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use. Not to be used on a person under 18 years of age.	(a) Wear suitable gloves (a) (b) (c) (e) Contains hydrogen peroxide Avoid contact with eyes Rinse immediately if product comes into contact with them. (e) Concentration of H₂O₂ present or released indicated in percentage. Not to be used on a person under 18 years of age. To be only sold to dental practitioners. For each cycle of use, the first use to be only done by dental practitioners or under their direct supervision if an equivalent level of safety is ensured. Afterwards to be provided to the consumer to complete the cycle of use.’

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GIVEN under my Official Seal,

10 October 2012.

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 amend the European Communities (Cosmetic Products) Regulations 2004. They update the law in relation to the manufacture, marketing and sale of cosmetic products by the implementation of Council Directive 2011/84/EU of 20 September 2011. These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2012.

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15 OJ No. L 105, 26.4.1988, p. 11.

16 OJ No. L 382, 31.12.1988, p. 46.

17 OJ No. L 64, 8.3.1989, p. 10. As affected by Corrigendum to Commission Directive 89/174/EEC, OJ No. L 199, 13.7.1989, p. 23.

18 OJ No. L 398, 30.12.1989, p. 25.

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25 OJ No. L 181, 15.7.1994, p. 31. As affected by Corrigendum to Commission Directive 94/32/EC, OJ No. L 273, 25.10.1994, p. 38.

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35 OJ No. L 5, 10.1.2003, p. 14.

36 OJ No. L 46, 20.2.2003, p. 24.

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40 OJ No. L 287, 8.9.2004, p. 4.

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55 OJ No. L 305, 23.11.2007, p. 22.

56 OJ No. L 42, 16.2.2008, p. 43.

57 OJ No. L 93, 4.4.2008, p. 13. As affected by Corrigendum to Commission Directive 2008/42/EC, OJ No. L 136, 24.5.2008, p. 52.

58 OJ No. L 256, 24.9.2008, p. 12. As affected by Corrigendum to Commission Directive 2008/88/EC, OJ No. L 263, 2.10.2008, p. 26.

59 OJ No. L 345, 23.12.2008, p. 68.

60 OJ No. L 340, 19.12.2008, p. 71.

61 OJ No. L 36, 5.2.2009, p. 15.

62 OJ No. L 98, 17.4.2009, p. 31. As affected by Corrigendum to Commission Directive 2009/36/EC, OJ No. L 103, 23.4.2009, p. 30.

63 OJ No. L 267, 10.10.2009, p. 18.

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68 OJ No. L 29, 2.2.2010, p. 5.

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