Commission Regulation (EU) 2017/237 of 10 February 2017 amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (Text with EEA relevance. )
Date: 2017-02-10
Institutions: European Commission
Subjects: chemical product, consumer information, cosmetic product, health control, health risk, product safety




L_2017036EN.01001201.xml










11.2.2017   


EN


Official Journal of the European Union


L 36/12








            COMMISSION REGULATION (EU) 2017/237
of 10 February 2017
         
amending Annex 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)


Following the publication of a scientific study in 2001, entitled ‘Use of permanent hair dyes and bladder cancer risk’, the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers, subsequently replaced by the Scientific Committee on Consumer Products (SCCP) pursuant to Commission Decision 2004/210/EC (2), concluded that the potential risks of the use of hair dyes were of concern. The SCCP, in its opinions, recommended that the Commission take further steps to control the use of hair dye substances.












(2)


The SCCP further recommended an overall safety assessment strategy for hair dye substances including the requirements for testing substances used in hair dye products for their potential genotoxicity or carcinogenicity.












(3)


Following the opinions of the SCCP, the Commission agreed with Member States and stakeholders on an overall strategy to regulate substances used in hair dye products according to which the industry was required to submit files, containing updated scientific data on the safety of hair dye substances, for a risk assessment by the SCCP.












(4)


The SCCP, subsequently replaced by the Scientific Committee on Consumer Safety (SCCS) pursuant to Commission Decision 2008/721/EC (3), assessed the safety of individual hair dye substances for which updated files had been submitted by the industry.












(5)


As regards the evaluation of possible consumer health risks by reaction products formed by oxidative hair dye substances during the hair dyeing process, based on the data yet available, the SCCS, in its opinion of 21 September 2010, did not raise any major concern regarding genotoxicity and carcinogenicity of hair dyes and their reaction products currently used in the Union.












(6)


In order to ensure the safety of hair dye products for human health, it is appropriate to set up maximum concentrations of ten assessed hair dye substances by taking into account the final opinions given by the SCCS on their safety.












(7)


Since substances N,N'-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine and 2,6-Dihydroxyethylaminotoluene are currently regulated under generic entries 8 and 9 of Annex III to Regulation (EC) No 1223/2009, separate reference numbers should be created for those substances, taking into account conclusions on their safety in the SCCS opinions 1572/16 and 1563/15.












(8)


The definition of a hair product in Regulation (EC) No 1223/2009 excluded the application of hair dye substances on eyelashes. That exclusion was motivated by the fact that the level of risk is different when cosmetic products are applied on the hair on the head and on eyelashes respectively. A specific safety assessment was therefore needed for the application of hair dye substances on eyelashes.












(9)


The SCCS, in its opinion on oxidative hair dye substances and hydrogen peroxide used in products to colour eyelashes of 25 March 2015 (SCCS/1553/15), concluded that oxidative hair dye substances Toluene-2,5-Diamine, p-Aminophenol, 2-Methylresorcinol, Tetraaminopyrimidine Sulfate, Hydroxyethyl-p-Phenylenediamine Sulfate and 2-Amino-3-Hydroxypyridine, listed in Annex III to Regulation (EC) No 1223/2009 and found safe for use in hair dye products, can be safely used by professionals in products intended for colouring eyelashes.












(10)


On the basis of the scientific assessment of those substances, their use should be allowed in products intended for colouring eyelashes. However, in order to avoid any risk connected with the self-application of products intended for colouring eyelashes by consumers, they should be allowed for professional use only. In order to allow professionals to inform consumers about possible adverse effects of the application of products intended for colouring eyelashes and to lower the risk of skin sensitisation to those products, appropriate warnings should be printed on their labels.












(11)


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












(12)


It is appropriate to provide for reasonable periods of time in order for the industry to adapt to the new requirements and to phase out products concerned which do not comply with those requirements.












(13)


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
Annex III to Regulation (EC) No 1223/2009 is 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.




This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 10 February 2017.


For the Commission


The President

Jean-Claude JUNCKER
            





(1)  
            OJ L 342, 22.12.2009, p. 59.

(2)  Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment (OJ L 66, 4.3.2004, p. 45).

(3)  Commission Decision 2008/721/EC of 5 August 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment and repealing Decision 2004/210/EC (OJ L 241, 10.9.2008, p. 21).




ANNEX
Annex III to Regulation (EC) No 1223/2009 is amended as follows:






(1)


The following entry is inserted as reference number 8c:













Reference number


Substance identification


Restrictions


Wordings 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




a


b


c


d


e


f


g


h


i




‘8c


Ethanol, 2,2′-[(2-nitro-1,4-phenylene)diimino]bis-(9CI)


N,N′-Bis(2-Hydroxyethyl)-2-Nitro-p-Phenylenediamine


84041-77-0


281-856-4








(a)


Hair dye substance in oxidative hair dye products






 








(a)


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %




For (a) and (b), as from 3 September 2017:






—


Do not use with nitrosating agents










—


Maximum nitrosamine content: 50 μg/kg










—


Keep in nitrite-free containers












(a)


As from 3 March 2018, to be printed on the label:
The mixing ratio.




“

Hair colourants 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)


As from 3 September 2017: 1,5 %


















(2)


the text in entry 9, column b, is replaced by the following:

                        ‘Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of the substances under reference numbers 9a and 9b of this Annex and substances under reference numbers 364, 1310 and 1313 in Annex II’;










(3)


the entry 9a is replaced by the following:













Reference number


Substance identification


Restrictions


Wordings 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




a


b


c


d


e


f


g


h


i




‘9a


1,4-Benzenediamine, 2-methyl-
2,5-Diaminotoluene sulphate


Toluene-2,5-Diamine
Toluene-2,5-Diamine Sulfate (1)


95-70-5
615-50-9


202-442-1
210-431-8








(a)


Hair dye substance in oxidative hair dye products






 








(a) (i)


General use










(a) (ii)


Professional use












(a)


To be printed on the label: The mixing ratio.




“

Hair colourants 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 phenylenediamines (toluenediamines)






(a) (i)


Do not use to dye eyelashes.










(a) (ii)


Wear suitable gloves.
For professional use only.”










(b)


As from 3 March 2018, to be printed on the label: The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




Rinse eyes immediately if product comes into contact with them.
Contains phenylenediamines (toluenediamines).
Wear suitable gloves.
For professional use only”.’










(b)


Products intended for colouring eyelashes












(b)


Professional use




For (a) and (b): After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 2,0 % (calculated as free base) or 3,6 % (calculated as sulfate salt)














(4)


the following entry is inserted as a reference number 9b:













Reference number


Substance identification


Restrictions


Wordings 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




a


b


c


d


e


f


g


h


i




‘9b


1-Methyl-2,6-bis-(2-hydroxyethylamino)-benzene


2,6-Dihydroxyethylaminotoluene


149330-25-6


443-210-1


Hair dye substance in oxidative hair dye products


 


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %






—


Do not use with nitrosating agents










—


Maximum nitrosamine content: 50 μg/kg










—


Keep in nitrite-free containers






As from 3 March 2018, to be printed on the label:
The mixing ratio.
“

Hair colourants 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”.’


















(5)


the entries 200, 206, 211, 243 and 272 are replaced by the following:













Reference number


Substance identification


Restrictions


Wordings 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




a


b


c


d


e


f


g


h


i




‘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) (c)


After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 3,4 % (calculated as sulfate)












(a)


To be printed on the label:
The mixing ratio.




“

Hair colourants 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.”










(c)


As from 3 March 2018, to be printed on the label:
The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




For professional use only.
Rinse eyes immediately if product comes into contact with them”.’










(b)


Hair dye substance in non-oxidative hair dye products












(b)


3,4 % (calculated as sulfate)






 










(c)


Products intended for colouring eyelashes






 








(c)


Professional use








‘206


3-(2-Hydroxyethyl)- p-phenylenediammonium sulphate


Hydroxyethyl-p- Phenylenediamine Sulfate


93841-25-9


298-995-1








(a)


Hair dye substance in oxidative hair dye products






 








(a)


After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 % (calculated as sulphate)












(a)


To be printed on the label: The mixing ratio.




“

Hair colourants 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)


As from 3 March 2018, to be printed on the label: The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




For professional use only.
Rinse eyes immediately if product comes into contact with them”.’










(b)


Products intended for colouring eyelashes












(b)


After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,75 % (calculated as free base)










(b)


Professional use








‘211


2-Aminopyridin-3-ol


2-Amino-3- Hydroxypyridine


16867-03-1


240-886-8








(a)


Hair dye substance in oxidative hair dye products






 








(a)


After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %












(a)


To be printed on the label: The mixing ratio.




“

Hair colourants 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 b‘lack henna’ tattoo in the past.”










(b)


As from 3 March 2018, to be printed on the label: The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




For professional use only.
Rinse eyes immediately if product comes into contact with them”.’










(b)


Products intended for colouring eyelashes












(b)


After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 0,5 %










(b)


Professional use








‘243


1,3-Benzenediol, 2- methyl


2-Methylresorcinol


608-25-3


210-155-8








(a)


Hair dye substance in oxidative hair dye products






 








(a)


After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 %












(a)


To be printed on the label:
The mixing ratio.




“

Hair colourants 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.”










(c)


As from 3 March 2018, to be printed on the label:
The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




For professional use only.
Rinse eyes immediately if product comes into contact with them”.’










(b)


Hair dye substance in non-oxidative hair dye products












(b)


1,8 %






 










(c)


Products intended for colouring eyelashes






 








(c)


After mixing under oxidative conditions the maximum concentration applied to eyelashes must not exceed 1,25 %










(c)


Professional use








‘272


4-Aminophenol


p-Aminophenol


123-30-8


204-616-2








(a)


Hair dye substance in oxidative hair dye products






 








(a) (b)


After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 0,9 %












(a)


To be printed on the label: The mixing ratio.




“

Hair colourants 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)


As from 3 March 2018, to be printed on the label: The mixing ratio.




“

This product 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 the risk of allergy.
Eyelashes shall not be coloured if the consumer:






—


has a rash on the face or sensitive, irritated and damaged scalp,










—


has experienced any reaction after colouring hair or eyelashes,










—


has experienced a reaction to a temporary ‘black henna’ tattoo in the past.




For professional use only.
Rinse eyes immediately if product comes into contact with them”.’










(b)


Products intended for colouring eyelashes












(b)


Professional use


















(6)


the following entries 298 to 305 are added:













Reference number


Substance identification


Restrictions


Wordings 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




a


b


c


d


e


f


g


h


i




‘298


Di[2-[4-[(E)-2-[4-[bis(2-hydroxyethyl)aminophenyl]vinyl]pyridin-1-ium] butanoyl]aminoethyl]di-sulfanyl dichloride


HC Red No 17


1449471-67-3


 


Hair dye substance in non-oxidative hair dye products


As from 3 September 2017: 0,5 %


As from 3 September 2017:






—


Do not use with nitrosating agents










—


Maximum nitrosamine content: 50 μg/kg










—


Keep in nitrite-free containers






 




299


Di[2-[4-[(E)-2-[2,4,5-trimethoxyphenyl]vinyl]pyridinin-1-ium]butanoyl]aminoethyl]disulfanyl dichloride


HC Yellow No 17


1450801-55-4


 


Hair dye substance in non-oxidative hair dye products


As from 3 September 2017: 0,5 %


 


As from 3 March 2018:
“

Hair colourants 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.”








300


1H-Pyrazole-4,5-diamine, 1-hexyl-, sulfate (2:1)


1-Hexyl 4,5-Diamino Pyrazole Sulfate


1361000-03-4


 


Hair dye substance in oxidative hair dye products


 


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,0 %


As from 3 March 2018, to be printed on the label:
The mixing ratio.
“

Hair colourants 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.”








301


4-Hydroxy-2,5,6-triaminopyrimidine sulfate


2,5,6-Triamino-4-Pyrimidinol Sulfate


1603-02-7


216-500-9


Hair dye substance in oxidative hair dye products


 


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,5 %


As from 3 March 2018, to be printed on the label:
The mixing ratio.
“

Hair colourants 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.”








302


2-[(3-Aminopyrazolo[1,5-a]pyridin-2-yl)oxy]ethanol hydrochloride


Hydroxyethoxy Aminopyrazolopyridine HCl


1079221-49-0


695-745-7


Hair dye substance in oxidative hair dye products


 


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %


As from 3 March 2018, to be printed on the label:
The mixing ratio.
“

Hair colourants 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.”








303


Phenol, 3-amino-2,6-dimethyl


3-Amino-2,6-Dimethylphenol


6994-64-5


230-268-6


Hair dye substance in oxidative hair dye products


 


As from 3 September 2017, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2,0 %


As from 3 March 2018, to be printed on the label:
The mixing ratio.
“

Hair colourants 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.”








304


2-Naphthalenaminium, 8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-N,N,N-trimethyl-, chloride


Basic Brown 17


68391-32-2


269-944-0


Hair dye substance in non-oxidative hair dye products


As from 3 September 2017: 2,0 %


 


 




305


3-Amino-7-(dimethylamino)-2-methoxyphenoxazin-5-ium chloride


Basic Blue 124


67846-56-4


267-370-5


Hair dye substance in non-oxidative hair dye products


As from 3 September 2017: 0,5 %


As from 3 September 2017:






—


Do not use with nitrosating agents










—


Maximum nitrosamine content: 50 μg/kg










—


Keep in nitrite-free containers






As from 3 March 2018:
“

Hair colourants 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”.’