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

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 1979

3

, Commission Directive 82/147/EEC of 11 February 1982

4

, Council Directive 82/368/EEC of 17 May 1982

5

, Commission Directive 83/191/EEC of 30 March 1983

6

, Commission Directive 83/341/EEC of 29 June 1983

7

, Commission Directive 83/496/EEC of 22 September 1983

8

, Council Directive 83/574/EEC of 26 October 1983

9

, Commission Directive 84/415/EEC of 18 July 1984

10

, Commission Directive 85/391/EEC of 16 July 1985

11

, Commission Directive 86/179/EEC of 28 February 1986

12

, Commission Directive 86/199/EEC of 26 March 1986

13

, Commission Directive 87/137/EEC of 2 February 1987

14

, Commission Directive 88/233/EEC of 2 March 1988

15

, Council Directive 88/667/EEC of 21 December 1988

16

, Commission Directive 89/174/EEC of 21 February 1989

17

, Council Directive 89/679/EEC of 21 December 1989

18

, Commission Directive 90/121/EEC of 20 February 1990

19

, Commission Directive 91/184/EEC of 12 March 1991

20

, Commission Directive 92/8/EEC of 18 February 1992

21

, Commission Directive 92/86/EEC of 21 October 1992

22

, Council Directive 93/35/EEC of 14 June 1993

23

, Commission Directive 93/47/EEC of 22 June 1993

24

, Commission Directive 94/32/EC of 29 June 1994

25

, Commission Directive 95/34/EC of 10 July 1995

26

, Commission Directive 96/41/EC of 25 June 1996

27

, Commission Directive 97/1/EC of 10 January 1997

28

, Commission Directive 97/45/EC of 14 July 1997

29

, Commission Directive 98/16/EC of 5 March 1998

30

, Commission Directive 98/62/EC of 3 September 1998

31

, Commission Directive 2000/6/EC of 29 February 2000

32

, Commission Directive 2000/11/EC of 10 March 2000

33

, Commission Directive 2002/34/EC of 15 April 2002

34

, Commission Directive 2003/1/EC of 6 January 2003

35

, Commission Directive 2003/16/EC of 19 February 2003

36

, Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003

37

, Commission Directive 2003/80/EC of 5 September 2003

38

, Commission Directive 2003/83/EC of 24 September 2003

39

, Commission Directive 2004/87/EC of 7 September 2004

40

, Commission Directive 2004/88/EC of 7 September 2004

41

, Commission Directive 2004/93/EC of 21 September 2004

42

, Commission Directive 2004/94/EC of 15 September 2004

43

, Commission Directive 2005/9/EC of 28 January 2005

44

, Commission Directive 2005/42/EC of 20 June 2005

45

, Commission Directive 2005/52/EC of 9 September 2005

46

, Commission Directive 2005/80/EC of 21 November 2005

47

, Commission Directive 2006/65/EC of 19 July 2006

48

, Commission Directive 2006/78/EC of 29 September 2006

49

, Commission Directive 2007/1/EC of 29 January 2007

50

, Commission Directive 2007/17/EC of 22 March 2007

51

, Commission Directive 2007/22/EC of 17 April 2007

52

, Commission Directive 2007/53/EC of 29 August 2007

53

, Commission Directive 2007/54/EC of 29 August 2007

54

, Commission Directive 2007/67/EC of 22 November 2007

55

, Commission Directive 2008/14/EC of 15 February 2008

56

, Commission Directive 2008/42/EC of 3 April 2008

57

, Commission Directive 2008/88/EC of 23 September 2008

58

, Directive 2008/112/EC of the European Parliament and of the Council of 16 December 2008

59

, Commission Directive 2008/123/EC of 18 December 2008

60

, Commission Directive 2009/6/EC of 4 February 2009

61

, Commission Directive 2009/36/EC of 16 April 2009

62

, Commission Directive 2009/129/EC of 9 October 2009

63

, Commission Directive 2009/130/EC of 12 October 2009

64

, Commission Directive 2009/134/EC of 28 October 2009

65

, Commission Directive 2009/159/EU of 16 December 2009

66

, Commission Directive 2009/164/EU of 22 December 2009

67

, Commission Directive 2010/3/EU of 1 February 2010

68

, Commission Directive 2010/4/EU of 8 February 2010

69

, Commission Directive 2011/59/EU of 13 May 2011

70

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 H

2

O

2

(40 volumes), present or released

(

b

) 4% of H

2

O

2

, present or released

(

c

) 2% of H

2

O

2

, present or released

(

d

) ≤ 0.1 % of H

2

O

2

, present or released

(

e

) > 0.1 % ≤ 6% of H

2

O

2

, 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 H

2

O

2

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.

1 O.J No. L 262, 27.9.1976, p. 169.

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

3 OJ No. L 192, 31.7.1979, p. 35.

4 OJ No. L 63, 6.3.1982, p. 26.

5 OJ No. L 167, 15.6.1982, p. 1.

6 OJ No. L 109, 26.4.1983, p. 25.

7 OJ No. L 188, 13.7.1983, p. 15.

8 OJ No. L 275, 8.10.1983, p. 20.

9 OJ No. L 332, 28.11.1983, p. 38.

10 OJ No. L 228, 25.8.1984, p. 31.

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

12 OJ No. L 138, 24.5.1986, p. 40.

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.

20 OJ No. L 91, 12.4.1991, p. 59.

21 OJ No. L 70, 17.3.1992, p. 23.

22 OJ No. L 325, 11.11.1992, p. 18.

23 OJ No. L 151, 23.6.1993, p. 32.

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.

26 OJ No. L 167, 18.7.1995, p. 19.

27 OJ No. L 198, 8.8.1996, p. 36.

28 OJ No. L 16, 18.1.1997, p. 85.

29 OJ No. L 196, 24.7.1997, p. 77.

30 OJ No. L 77, 14.3.1998, p. 44.

31 OJ No. L 253, 15.9.1998, p. 20.

32 OJ No. L 56, 1.3.2000, p. 42.

33 OJ No. L 65, 14.3.2000, p. 22.

34 OJ No. L 102, 18.4.2002, p. 19. As affected by Corrigenda to Commission Directive 2002/34/EC, OJ No. L 341, 17.12.2002, p. 71 and OJ No. L 151, 19.6.2003, p. 44.

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

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

37 OJ No. L 66, 11.3.2003, p. 26.

38 OJ No. L 224, 6.9.2003, p. 27. As affected by Corrigendum to Commission Directive 2003/80/EC, OJ No. L 58, 26.2.2004, p. 28.

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.

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

41 OJ No. L 287, 8.9.2004, p. 5.

42 OJ No. L 300, 25.9.2004, p. 13. As affected by Corrigendum to Commission Directive 2004/93/EC, OJ No. L 97, 15.4.2005, p. 63.

43 OJ No. L 294, 17.9.2004, p. 28.

44 OJ No. L 27, 29.1.2005, p. 46.

45 OJ No. L 158, 21.6.2005, p. 17.

46 OJ No. L 234, 10.9.2005, p. 9.

47 OJ No. L 303, 22.11.2005, p. 32.

48 OJ No. L 198, 20.7.2006, p. 11.

49 OJ No. L 271, 30.9.2006, p. 56.

50 OJ No. L 25, 1.2.2007, p. 9.

51 OJ No. L 82, 23.3.2007, p. 27.

52 OJ No. L 101, 18.4.2007, p. 11.

53 OJ No. L 226, 30.8.2007, p. 19. As affected by Corrigendum to Commission Directive 2007/53/EC, OJ No. L 22, 25.1.2008, p. 21.

54 OJ No. L 226, 30.8.2007, p. 21. As affected by Corrigendum to Commission Directive 2007/54/EC, OJ No. L 258, 4.10.2007, p. 44.

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.

64 OJ No. L 268, 13.10.2009, p. 5.

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

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

12

th 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 1976

1

, as amended by Council Directive 2011/84/EU of 20 September 2011

2

, hereby make the following regulations

Citation