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.
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.
(b) To be printed on the label: The mixing ratio.
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.
| |||
| 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.
| |||
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
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