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


Notice of the making of this Statutory Instrument was published in

“Iris Oifigiúil” of 21st 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 19761 , as amended by Commission Implementing Directive 2012/12/EU of 2 August 20122 , hereby make the following regulations:

Citation

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

Collective citation and construction

2. These Regulations, the European Communities (Cosmetic Products) Regulations 2004 to 2010, the European Communities (Cosmetic Products) (Amendment) Regulations 2011 ( S.I. No. 723 of 2011 ) and the European Communities (Cosmetic Products) (Amendment) Regulations 2012 ( S.I. No. 396 of 2012 ) may be cited together as the European Communities (Cosmetic Products) Regulations 2004 to 2013 and shall be construed together as one.

Interpretation

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 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 , Council Directive 2011/84/EU of 20 September 201171 and Commission Implementing Directive 2012/12/EU of 2 August 20122.”

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

1. Schedule 2 to the Principal Regulations is amended by inserting the following entry:

Reference Number

Chemical Name/INCI-Name

CAS NumberEC Number

‘1373

N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts

CAS No 160219-76-1’

2. Part 1 of Schedule 3 to the Principal Regulations is amended—

(a) by inserting the following entries:

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

253

2,2-[(4-Aminophenyl))- imino]bis (ethanol) sulphate N,N-bis(2-Hydroxyethyl)- p-Phenylenediamine Sulfate CAS No 54381-16-7 EC No 259-134-5

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.5 % (calculated as sulphate)

— Do not use with nitrosating agents

— Maximum nitrosamine content: 50 μg/kg

— Keep in nitrite-free containers

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

254

1,3-Benzenediol, 4-chloro- 4-Chlororesorcinol CAS No 95-88-5 EC No 202-462-0

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.5 %

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

255

2,4,5,6-Tetraamino- pyrimidine sulphate Tetraamino- pyrimidine Sulfate CAS No 5392-28-9 EC No 226-393-0

(a) Hair dye substance in oxidative hair dye products

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

(b) 3.4 % (calculated as sulphate)

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3.4 % (calculated as sulphate)

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

256

3-(2-Hydroxyethyl)-p- phenylene- diammonium sulphate Hydroxyethyl-p- Phenylene- diamine Sulfate CAS No 93841-25-9 EC No 298-995-1

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.0 % (calculated as sulphate)

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

257

1H-Indole-5,6-diol Dihydroxyindole CAS No 3131-52-0 EC No 412-130-9

(a) Hair dye substance in oxidative hair dye products

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

(b) 0.5 %

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0.5 %

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

(b) As mentioned in reference number 208, column f

258

5-Amino-4-chloro-2-methylphenol hydrochloride 5-Amino-4-Chloro-o-Cresol HCl CAS No 110102-85-7

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.5 % (calculated as hydrochloride)

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

259

1H-Indol-6-ol 6-Hydroxyindole CAS No 2380-86-1 EC No 417-020-4

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0.5 %

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

260

1H-Indole-2,3-Dione Isatin CAS No 91-56-5 EC No 202-077-8

Hair dye substance in non- oxidative hair dye products

1.6 %

As mentioned in reference number 208, column f

261

2-Aminopyridin-3-ol 2-Amino-3-Hydroxypyridine CAS No 16867-03-1 EC No 240-886-8

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.0 %

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

262

2-Methyl-1-naphthyl acetate 1-Acetoxy-2-Methylna- phthalene CAS No 5697-02-9 EC No 454-690-7

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.0 % (When both 2-Methyl- 1-Naphthol and 1-Acetoxy-2-Methylna- phthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2.0%.)

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

263

1-Hydroxy-2-methylna- phthalene 2-Methyl-1-Naphthol CAS No 7469-77-4 EC No 231-265-2

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2.0 % (When both 2-Methyl- 1-Naphthol and 1-Acetoxy-2-Methylna- phthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2.0%.)

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

264

Disodium 5,7-dinitro-8-oxido-2- naphthalene- sulfonate Acid Yellow 1 CAS No 846-70-8 EC No 212-690-2 CI 10316

(a) Hair dye substance in oxidative hair dye products

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

(b) 0.2 %

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

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

(b) As mentioned in reference number 208, column f

265

4-Nitro-1,2-phenylenediamine 4-Nitro-o-Phenylenediamine CAS No 99-56-9 EC No 202-766-3

Hair dye substance in oxidative hair dye products

After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0.5 %

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

266

2-(4-Amino-3-nitroanilino) ethanol HC Red No 7 CAS No 24905-87-1 EC No 246-521-9

Hair dye substance in non- oxidative hair dye products

1.0 %

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

As mentioned in reference number 208, column f

267

2-[bis(2-Hydroxyethyl) amino]-5- nitrophenol HC Yellow No 4 CAS No 59820-43-8 EC No 428-840-7

Hair dye substance in non- oxidative hair dye products

1.5 %

— Do not use with nitrosating agents

— Maximum nitrosamine content: 50 μg/kg

— Keep in nitrite-free containers

268

2-[(2-Nitrophenyl) amino] ethanol HC Yellow No 2 CAS No 4926-55-0 EC No 225-555-8

(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 0.75 % 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)

269

4-[(2-Nitrophenyl) amino]phenol HC Orange No 1 CAS No 54381-08-7 EC No 259-132-4

Hair dye substance in non- oxidative hair dye products

1.0 %

270

2-Nitro-N1-phenyl-benzene-1,4- diamine HC Red No 1 CAS No 2784-89-6 EC No 220-494-3

Hair dye substance in non-oxidative hair dye products

1.0 %

As mentioned in reference number 208, column f

271

1-Methoxy-3-(-aminoethyl) amino-4-nitrobenzene, hydrochlorideHC Yellow No 9 CAS No 86419-69-4 EC No 415-480-1

Hair dye substance in non-oxidative hair dye products

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. professional use (b) Hair lotions and shampoos

(b) 0.5 %

(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1.25 %

(a) 1. Contains resorcinol Rinse hair well after application.Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact with them. As mentioned in reference number 205, column f (a).

2. For professional use only Contains resorcinol. Rinse eyes immediately if product comes into contact with them. As mentioned in reference number 205, column f (a) (b) Contains resorcinol.’

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

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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.

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

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

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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

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

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

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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.

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

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