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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
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
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
OJ L 190, 11.7.2013, p. 38–53
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
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
Annexes II and III to Regulation (EC) No 1223/2009 are amended in accordance with the Annex to this Regulation.
Article 2
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.
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.
‘ 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.’
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.
‘ 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.’
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.
‘ 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.’
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):
‘ 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)
0,5 %
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.
‘ 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.’
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.
‘ 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.’
210
1H-Indole-2,3-Dione
Isatin
91-56-5
202-077-8
Hair dye substance in non-oxidative hair dye products
1,6 %
‘ 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.’
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.
‘ 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.’
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.
‘ 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.’
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.
‘ 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.’
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.
‘ 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)
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 %
‘ 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.’
In force