S.I. No. 161/2013 - European Communities (Cosmetic Products) (Amendment) Regulations 2013.

0. 5 % (calculated as hydrochloride)

— Do not use with nitrosating agents

— Maximum nitrosamine content: 50 μg/kg

— Keep in nitrite-free containers

272

1-(4’-Aminophenylazo)-2-methyl- 4-(bis-2-hydroxyethyl) aminobenzene HC Yellow No 7 CAS No 104226-21-3 EC No 146-420-6

Hair dye substance in non- oxidative hair dye products

0.25 %

273

N-(2-Hydroxyethyl)-2-nitro-4- trifluormethyl-aniline HC Yellow No 13 CAS No 10442-83-8 EC No 443-760-2

(a) Hair dye substance in oxidative hair dye products

(b) Hair dye substance in non- oxidative hair dye products

(b) 2.5 %

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.5 % For (a) and (b)

— Do not use with nitrosating agents

— Maximum nitrosamine content: 50 μg/kg

— Keep in nitrite-free containers

(a) As mentioned in reference number 205, column f (a)

274

Benzenaminium, 3-[(4,5-dihydro- 3-methyl-5-oxo-1-phenyl-1H- pyrazol-4-yl) azo]-N,N,Ntrimethyl-, chloride Basic Yellow 57 CAS No 68391-31-1 EC No 269-943-5

Hair dye substance in non-oxidative hair dye products

2.0 %

275

Ethanol, 2,2-[[4-[(4-aminophenyl) azo]phenyl] imino]bis- Disperse Black 9 CAS No 20721-50-0 EC No 243-987-5

Hair dye substance in non- oxidative hair dye products

0.3 % (of the mixture in the ratio 1:1 of 2,2’-[4-(4- amino phenylazo) phenylimino] diethanol and lignosulfate)

276

9,10-Anthracenedione, 1,4-bis [(2,3-dihydroxypropyl) amino]- HC Blue No 14 CAS No 99788-75-7 EC No 421-470-7

Hair dye substance in non- oxidative hair dye products

0.3 %

— Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers

277

2-(4-Methyl-2-nitroanilino) ethanol Hydroxyethyl-2-Nitro-p-Toluidine CAS No 100418-33-5 EC No 408-090-7

(a) Hair dye substance in oxidative hair dye products

(b) Hair dye substance in non- oxidative hair dye products

(b) 1.0 %

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0 % For (a) and (b): — Do not use with nitrosating agents — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers

(a) As mentioned in reference number 205, column f (a)

278

1-Amino-2-nitro-4-(2,3- dihydroxypropyl) amino-5- chlorobenzene + 1,4-bis-(2,3- dihydroxypropyl) amino-2-nitro- 5-chlorobenzene HC Red No 10 + HC Red No 11 CAS No 95576-89-9 + 95576- 92-4

(a) Hair dye substance in oxidative hair dye products

(b) Hair dye substance in non- oxidative hair dye products

(b) 2.0 %

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0 % For (a) and (b)

— Do not use with nitrosating agents

— Maximum nitrosamine content: 50 μg/kg

— Keep in nitrite-free containers

(a) As mentioned in reference number 205, column f (a)’

(

b

) by substituting for the entries at reference numbers 16 and 22 the following

Reference number

Substance

Restrictions

Conditions of use and warnings which must be printed on the label

Field of application and/or use

Maximum authorised concentration in the finished cosmetic product

Other limitations and requirements

a

b

c

d

e

f

16

1-Naphthalenol 1-Naphthol CAS No 90-15-3 EC No 201-969-4

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.0 %

As mentioned in reference number 205, column f (a)

22

1,3-benzenediol Resorcinol CAS No 108-46-3 EC No 203-585-2

(a) Hair dye substance in oxidative hair dye products

1. general use

2. Part 2 of Schedule 3 to the Principal Regulations is amended by deleting the entries at reference numbers 10 and 50.

GIVEN under my Official Seal,

16 May 2013.

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 2012/21/EU of 2 August 2012.

These Regulations may be cited as the European Communities (Cosmetic Products) (Amendment) Regulations 2013.

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

2 O.J. No. L 208, 3.8.2012, p. 8.

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

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

3. In these Regulations, “Principal Regulations” means the European Communities (Cosmetic Products) Regulations 2004 (

S.I. No. 870 of 2004

).

Amendment of Regulation 4(1) of Principal Regulations

4. Regulation 4(1) (as amended by Regulation 5 of the European Communities (Cosmetic Products) (Amendment) Regulations 2012 (

S.I. No. 396 of 2012

)) 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

, Council Directive 2011/84/EU of 20 September 2011

71

and Commission Implementing Directive 2012/12/EU of 2 August 2012

2

.”

Amendments to the Schedule in Principal Regulations

5. The Schedules (as amended by Regulation 6 of the European Communities (Cosmetic Products) (Amendment) Regulations 2012 (

S.I. No. 396 of 2012

)) to the Principal Regulations are amended as provided for in the Schedule.

SCHEDULE

Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of

21

st May

, 2013.

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 Commission Implementing Directive 2012/12/EU of 2 August 2012

2

, hereby make the following regulations

Citation