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

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

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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.’
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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2 OJ No. L. 283, 29.10.2011, p. 36.

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11 OJ No. L 224, 22.8.1985, p. 40.

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13 OJ No. L 149, 3.6.1986, p. 38.

14 OJ No. L 56, 26.2.1987, p. 20.

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.

19 OJ No. L 71, 17.3.1990, p. 40.

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24 OJ No. L 203, 13.8.1993, p. 24.

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.

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39 OJ No. L 238, 25.9.2003, p. 23. As affected by Corrigendum to Commission Directive 2003/83/EC, OJ No. L 58, 26.2.2004, p. 28.

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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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65 OJ No. L 282, 29.10.2009, p. 15.

66 OJ No. L 336, 18.12.2009, p. 29.

67 OJ No. L 344, 23.12.2009, p. 41. As affected by Corrigendum to Commission Directive 2009/164/EU, OJ No. L 3, 7.1.2010, p. 30.

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

69 OJ No. L 36, 9.2.2010, p. 21.

70 OJ No. L 125, 14.5.2011, p.17

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