Commission Regulation (EU) No 658/2013Show full title

Commission Regulation (EU) No 658/2013

of 10 July 2013

amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products(1), and in particular Article 31(1) thereof,

Whereas:

(1) Regulation (EC) No 1223/2009 replacing Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(2) will apply from 11 July 2013.

(2) Annexes II and III to Directive 76/768/EEC were amended by Commission Implementing Directive 2012/21/EU(3) after the adoption of the Regulation, by including one hair dye substance into Annex II, 26 hair dye substances into Part 1 of Annex III and by changing the maximum authorised concentrations in the finished cosmetic product for two hair dye substances in Part 1 of Annex III. Those amendments should now be reflected in Regulation (EC) No 1223/2009.

(3) In accordance with Implementing Directive 2012/21/EU, Member States are to apply the laws, regulations and administrative provisions adopted in order to comply with that Directive from 1 September 2013. Therefore, this Regulation should apply from that date.

(4) Regulation (EC) No 1223/2009 should therefore be amended accordingly.

(5) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Cosmetic Products,

HAS ADOPTED THIS REGULATION:

Article 1 U.K.

Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.

Article 2 U.K.

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 September 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 10 July 2013.

For the Commission

The President

José Manuel Barroso

ANNEX U.K.

Annexes II and III to Regulation (EC) No 1223/2009 are amended as follows:

(1)

In Annex II, the following entry is added:

Reference number	Substance identification
	Chemical name/INN	CAS number	EC number
‘1373	N-(2-Nitro-4-aminophenyl)-allylamine (HC Red No 16) and its salts	160219-76-1’

(2)

Annex III is amended as follows:

(a)

The following entries concerning reference numbers 198 to 200 are added:

Reference number	Substance identification				Restrictions			Wording of conditions of use and warnings
	Chemical name/INN	Name of Common Ingredients Glossary	CAS number	EC number	Product type, body parts	Maximum concentration in ready use preparation	Other
‘198	2,2'-[(4-Aminophenyl)imino]bis(ethanol) sulphate	N,N-bis(2-Hydroxyethyl)-p-Phenylenediamine Sulfate	54381-16-7	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	To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Hair colorants can cause severe allergic reactions.
199	1,3-Benzenediol, 4-chloro-	4-Chlororesorcinol	95-88-5	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 %	To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Hair colorants can cause severe allergic reactions.
200	2,4,5,6-Tetraaminopyrimidine sulphate	Tetraaminopyrimidine Sulfate	5392-28-9	226-393-0	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 3,4 % (calculated as sulphate)	(a) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
					(b) Hair dye substance in non-oxidative hair dye products	(b) 3,4 % (calculated as sulphate)

(b)

The following entries concerning reference numbers 206 to 214 are added:

‘206	3-(2-Hydroxyethyl)-p-phenylenediammonium sulphate	Hydroxyethyl-p-Phenylenediamine Sulfate	93841-25-9	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)	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
207	1H-Indole-5,6-diol	Dihydroxyindole	3131-52-0	412-130-9	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %	(a) To be printed on the label: The mixing ratio. For (a) and (b): ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
					(b) Hair dye substance in non-oxidative hair dye products	(b) 0,5 %
208	5-Amino-4-chloro-2-methylphenol hydrochloride	5-Amino-4-Chloro-o-Cresol HCl	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)	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
209	1H-Indol-6-ol	6-Hydroxyindole	2380-86-1	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 %	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
210	1H-Indole-2,3-Dione	Isatin	91-56-5	202-077-8	Hair dye substance in non-oxidative hair dye products	1,6 %		‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
211	2-Aminopyridin-3-ol	2-Amino-3-Hydroxypyridine	16867-03-1	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 %	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
212	2-Methyl-1-naphthyl acetate	1-Acetoxy-2-Methylnaphthalene	5697-02-9	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-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %).	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
213	1-Hydroxy-2-methylnaphthalene	2-Methyl-1-Naphthol	7469-77-4	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-Methylnaphthalene are present in a hair dye formulation, the maximum concentration on the head of 2-Methyl-1-Naphthol should not exceed 2,0 %.)	To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
214	Disodium 5,7-dinitro-8-oxido-2-naphthalenesulfonate CI 10316	Acid Yellow 1	846-70-8	212-690-2	(a) Hair dye substance in oxidative hair dye products		(a) After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %	(a) To be printed on the label: The mixing ratio. For (a) and (b): ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’’
					(b) Hair dye substance in non-oxidative hair dye products	(b) 0,2 %’

(c)

The entry with reference number 240 is replaced by the following:

‘240

4-Nitro-1,2-phenylenediamine

4-Nitro-o-Phenylenediamine

99-56-9

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 %

To be printed on the label: The mixing ratio. ‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’’ ’

(d)

The entry with reference number 251 is replaced by the following:

‘251

2-(4-Amino-3-nitroanilino)ethanol

HC Red No 7

24905-87-1

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

‘ Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’’ ’

(e)

The entry with reference number 253 is replaced by the following:

‘253

2-[bis(2-Hydroxyethyl)amino]-5-nitrophenol

HC Yellow No 4

59820-43-8

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’

(f)

The entries with reference numbers 255 and 256 are replaced by the following:

‘255	2-[(2-Nitrophenyl)amino]ethanol	HC Yellow No 2	4926-55-0	225-555-8	(a) Hair dye substance in oxidative hair dye products		(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) To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
					(b) Hair dye substance in non-oxidative hair dye products	b) 1,0 %
256	4-[(2-Nitrophenyl)amino]phenol	HC Orange No 1	54381-08-7	259-132-4	Hair dye substance in non-oxidative hair dye products	1,0 %’

(g)

The following entries concerning reference numbers 258 to 264 are added:

‘258	2-Nitro-N1-phenyl-benzene-1,4-diamine	HC Red No 1	2784-89-6	220-494-3	Hair dye substance in non-oxidative hair dye products	1,0 %		‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
259	1-Methoxy-3-(β-aminoethyl)amino-4-nitrobenzene, hydrochloride	HC Yellow No 9	86419-69-4	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
260	1-(4’-Aminophenylazo)-2-methyl-4-(bis-2-hydroxyethyl) aminobenzene	HC Yellow No 7	104226-21-3	146-420-6	Hair dye substance in non-oxidative hair dye products	0,25 %
261	N-(2-Hydroxyethyl)-2-nitro-4-trifluormethyl-aniline	HC Yellow No 13	10442-83-8	443-760-2	(a) Hair dye substance in oxidative hair dye products		(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) To be printed on the label: The mixing ratio. ‘ Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’ Hair colorants can cause severe allergic reactions.
					(b) Hair dye substance in non-oxidative hair dye products	(b) 2,5 %
262	Benzenaminium, 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,Ntrimethyl-, chloride	Basic Yellow 57	68391-31-1	269-943-5	Hair dye substance in non-oxidative hair dye products	2,0 %
263	Ethanol, 2,2’-[[4-[(4-aminophenyl)azo]phenyl]imino]bis-	Disperse Black 9	20721-50-0	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-aminophenylazo)phenylimino]diethanol and lignosulfate)
264	9,10-Anthracenedione, 1,4-bis[(2,3-dihydroxypropyl)amino]-	HC Blue No 14	99788-75-7	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’

(h)

The entries with reference numbers 16, 22, 221, 250 are replaced by the following:

Reference number	Substance identification				Restrictions			Wording of conditions of use and warnings
	Chemical name/INN	Name of Common Ingredients Glossary	CAS number	EC number	Product type, body parts	Maximum concentration in ready use preparation	Other
‘16	1-Naphthalenol	1-Naphthol	90-15-3	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 %	To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Hair colorants can cause severe allergic reactions.
22	1,3-benzenediol	Resorcinol	108-46-3	203-585-2	(a) Hair dye substance in oxidative hair dye products		(a) 1. general use 2. professional use For 1 and 2: After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,25 %	(a) 1. To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Contains resorcinol. Rinse hair well after application. Rinse eyes immediately if product comes into contact with them. Do not use to dye eyelashes or eyebrows. Hair colorants can cause severe allergic reactions. 2. To be printed on the label: The mixing ratio. For professional use only. Contains resorcinol. Rinse eyes immediately if product comes into contact with them. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. (b) Contains resorcinol.
					(b) Hair lotions and shampoos	(b) 0,5 %
221	2-(4-Methyl-2-nitroanilino)ethanol	Hydroxyethyl-2-Nitro-p-Toluidine	100418-33-5	408-090-7	(a) Hair dye substance in oxidative hair dye products		(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) To be printed on the label: The mixing ratio. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past. Hair colorants can cause severe allergic reactions.
					(b) Hair dye substance in non-oxidative hair dye products	(b) 1,0 %
250	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	95576-89-9 + 95576-92-4		(a) Hair dye substance in oxidative hair dye products		(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) To be printed on the label: The mixing ratio. Hair colorants can cause severe allergic reactions. Read and follow instructions. This product is not intended for use on persons under the age of 16. Temporary ‘black henna’ tattoos may increase your risk of allergy. Do not colour your hair if: you have a rash on your face or sensitive, irritated and damaged scalp, you have ever experienced any reaction after colouring your hair, you have experienced a reaction to a temporary ‘black henna’ tattoo in the past.’
					(b) Hair dye substance in non-oxidative hair dye products	(b) 2,0 %

(1)

OJ L 342, 22.12.2009, p. 59.

(2)

OJ L 262, 27.9.1976, p. 169.

(3)

OJ L 208, 3.8.2012, p. 8.