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
Date: 2013-07-10
Institutions: European Commission
Subjects: cosmetic product, labelling, market approval, marketing standard




L_2013190EN.01003801.xml










11.7.2013   


EN


Official Journal of the European Union


L 190/38








            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
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.
Done at Brussels, 10 July 2013.


For the Commission


The President

José Manuel BARROSO
            





(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.




ANNEX
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.
‘

 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.’








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.
‘

 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)


2,5  %








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.
‘

 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.’








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.
‘

 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.




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.’










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.
‘

 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  %








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  %