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Updates to Commission Regulation (EU) 2020/1683, of November 12, 2020, amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, include a number of changes related to hair and eyelash dyes.

SAFEGUARDS | Cosmetics, Personal Care & HouseholdNO. 169/20

 SG 16920 Hair Dye 2

Updates to Commission Regulation (EU) 2020/1683, of November 12, 2020, amending Annexes II and III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products, include a number of changes related to hair and eyelash dyes. The regulation will become effective on December 2, 2020, the 20th day following its publication. 

Considering opinions SCCS/1598/18, SCCS/1497/12 and SCCS/1400/11 from the Scientific Committee on Consumer Safety (SCCS), due to genotoxic and gene mutation potential, without further adequate safety experimental evidence, the European Commission prohibits the use of 1,2,4-Trihydroxybenzene, 4-Amino-3-hydroxytoluene and 2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid as substances in hair and eyelash dye products.

Annex II

  • From September 3, 2021, hair and eyelash dye products containing these substances shall not be placed on the Union market
  • From June 3, 2022, hair and eyelash dye products containing these substances shall not be made available on the Union market
Annex 11  11 11
Ref # 1642 1643 1644
Substance Identification Chemical Name/INN  1,2,4-Trihydroxybenzene 
when used as a substance in hair and eyelash dye products
4-Amino-3-hydroxytoluene 
when used as a substance in hair and eyelash dye products
2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid 
when used as a substance in hair and eyelash dye products 
CAS # 533-73-3
2835-98-5
117907-43-4
EC # 208-575-1
220-620-7
411-260-3
Restrictions Prohibited
Prohibited
Prohibited

2-Methoxymethyl-p-Phenylenediamine and its sulfate are currently restricted under entry 262 of Annex III in Regulation (EC) 1223/2009. The safe use of these substances on eyelashes is concluded in opinion SCCS/1603/18. The application is hence extended by including products intended for coloring eyelashes in this regulation amendment. 

Annex III

Annex III 
Ref # 292
Substance Identification Chemical Name/INN 1,4-Benzenediamine, 2-(methoxymethyl) 1,4-Benzenediamine, 2-(methoxymethyl)-, sulfate
INCI Name 2-Methoxymethyl- p-Phenylenediamine 
2-Methoxymethyl- p-Phenylenediamine Sulfate
CAS # 337906-36-2 337906-37-3
EC # 679-526-3 638-749-6
Restrictions Product type, body parts (a) Hair dye substance in oxidative hair dye products
(b) Products intended for coloring eyelashes
Max. concentration in ready use preparation

Other (a) (b) After mixing under oxidative conditions the maximum concentration applied to hair or eyelashes must not exceed 1.8 % (calculated as free base)
(b) Professional use
Wording of conditions of use and warnings

(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 color your hair if: 

  • you have a rash on your face or sensitive, irritated and damaged scalp,
  • you have ever experienced any reaction after coloring your hair, 
  • you have experienced a reaction to a temporary “black henna” tattoo in the past.’ 

(b) 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 colored if the consumer:

  • has a rash on the face or sensitive, irritated and damaged scalp,
  • has experienced any reaction after coloring 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.’

Considering opinions SCCS/1584/17, SCCS/1609/19, SCCS/1579/16, SCCS/1536/14, SCCS1610/19 and SCCS/1615/20, the European Commission restricts the use of six substances, with appropriate maximum concentrations, for use in hair dye products as new entries in Annex III of Regulation (EC) 1223/2009. 

Annex III III III
Ref # '313 314 315
Substance
Identification
Chemical Name/INN 4-(3-aminopyrazolo[1,5-A]pyridin-2-yl)-1,1- dimethylpiperazin- 1-ium chloride hydrochloride
1-(3-((4-Aminophenyl)amino)propyl)-3-methyl-1H- imidazol-3-ium chloride hydrochloride
Di-[2-[(E)-2-[4-[bis (2-hydroxyethyl) aminophenyl] vinyl]pyridin-1- ium]-ethyl]disulphide dimethanesulfonate
INCI Name Dimethylpiperazinium Aminopyrazolopyridine HCl
Methylimidazoliumpropyl p-phenylenediamine HCl
HC Orange No 6
CAS# 1256553-33-9
220158-86-1
1449653-83-1
EC # 813-255-5
   
Restriction Product type,
body parts

Hair dye substance in oxidative hair dye products
Hair dye substance in non-oxidative hair dye products
Hair dye substance in non-oxidative hair dye products
Maximum concentration in ready use preparation

  As from 3 June 2021: 
0,5 %
Other As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2% (calculated as free base)
As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2% (calculated as free base)
Methanesulfonates impurities, in particular ethyl methanesulfonate shall not be present.
Wording of conditions of use and warnings

As from 3 December 2021, 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 color your hair if: 

  • you have a rash on your face or sensitive, irritated and damaged scalp,
  • you have ever experienced any reaction after coloring your hair,
  • you have experienced a reaction to a temporary “black henna” tattoo in the past.’
 

 

Annex
III III III
Ref #
316 317 318 
Substance
Identification

Chemical Name/INN Sodium 4-[(2- hydroxy-1- naphthyl)azo]benzene sulfonate  Phenol, 4,4'- (4,5,6,7-tetrabromo-1,1-dioxido-3H-2,1-benzoxathiol-3-ylidene)bis[2,6- dibromo- 
Indigofera tinctoria, dried and pulverized leaves of Indigofera tinctoria L
INCI Name Acid Orange 7
Tetrabromophenol Blue
Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extract Indigofera tinctoria extract
CAS # 633-96-5633-96-5
4430-25-5
84775-63-3
EC # 211-199-0
224-622-9
283-892-6
Restriction Product type,
body parts

Hair dye substance in non-oxidative hair dye products
(a) Hair dye substance in oxidative hair dye products 
(b) Hair dye substance in non- oxidative hair dye products
Hair dye substance in non-oxidative hair dye products
Maximum concentration in ready use preparation
As from 3 June 2021: 
0,5 %
(b) As from 3 June 2021: 0,2 %
As from 3 June 2021: 
25%
Other   (a) As from 3 June 2021, after mixing under oxidative conditions the maximum concentration applied to hair must not exceed 0,2 % (calculated as free base)
 
Wording of conditions of use and warnings
 

(a) As from 3 December 2021, 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 color your hair if: 

  • you have a rash on your face or sensitive, irritated and damaged scalp,
  • you have ever experienced any reaction after coloring your hair, 
  • you have experienced a reaction to a temporary “black henna” tattoo in the past.’ 
 

References

[1] Commission Regulation (EU) 2020/1683
[2] SCCS/1598/18
[3] SCCS/1497/12
[4] SCCS/1400/11
[5] SCCS/1603/18
[6] SCCS/1584/17
[7] SCCS/1609/19
[8] SCCS/1579/16
[9] SCCS/1536/14
[10] SCCS1610/19
[11] SCCS/1615/20

With the development of new products, regulations for cosmetics, personal care and household are fast changing and increasingly complex. To stay up-to-date with the latest legislation, check out our powerful regulatory compliance platform, SGS Digicomply.

For enquiries, please contact:

Queenie Ho-yan TSE 
Assistant Technical Service Manager
t: +852 2765 3672

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