Numerous peer-reviewed articles highlight the possible toxicity of hair dye substances and notably their concerning carcinogenic, genotoxic, and skin sensitizing properties. In order to properly protect consumers, the Scientific Committee on Consumer Safety (SCCS), the European Commission, the Member States, and the Industry developed an overall strategy to evaluate hair dye substances. As their work progresses, new entries are regularly added to the annexes of the European Cosmetics Regulation (EC No 1223/2009), or existing ones revised to become more restrictive.
As part of this general plan to evaluate hair dyes, the European Commission published a new Regulation, (EU) 2020/1683, on November 12th to amend the annexes II (prohibited ingredients) and III (ingredients authorized under specific conditions). Please, find below the details of this new piece of legislation. Concretely, these recent changes do not seem to have a significant impact on products already on the EU Market.
- 3 substances were added to annex II. They will be banned in hair and eyelash products:
| Substance | CAS | Future situation | Application deadline |
| 1,2,4-Trihydroxybenzene | 533-73-3 | Forbidden when used as a substance in hair and eyelash dye products | Hair and eyelash dye products containing those substances shall not be: * placed on the Union market from September 3rd, 2021 * made available on the Union market from June 3rd, 2022 |
| 6-amino-m-cresol | 2835-98-5 | ||
| 4-Amino-2-Nitrodiphenylamine-2′-Carboxylic Acid | 117907-43-4 |
- 1 Modification of annex III: 2-Methoxymethylp-Phenylenediamine has been further allowed to color eyelashes under professional use. Please note that this modification is applicable since December 2nd, 2020.
| Substance | CAS | Previous situation | Current deadline |
| 2-Methoxymethyl-p-Phenylenediamine 2-Methoxymethyl-p-Phenylenediamine Sulfate | 337906-36-2 337906-37-3 | Annex III/292: Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 1,8 % (calculated as free base) 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.” | Update annex III/292: Addition of products intended for colouring eyelashes. Allowed only for professional use To be printed on the label in that case: 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.” |
- 6 substances were added to Annex III allowing them to be used as hair dyes under specific conditions of use and with some warnings to be labeled.
| Substance | CAS | Future situation | Application deadline |
| Dimethylpiperazinium Aminopyrazolopyridine HCl | 1256553-33-9 | Annex III/313: Hair dye substance in oxidative hair dye products. After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base) | June 3rd, 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 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.” | December 3rd, 2021 | ||
| Methylimidazoliumpropyl-p-phenylenediamine HCl | 220158-86-1 | Annex III/314: Hair dye substance in oxidative hair dye products After mixing under oxidative conditions the maximum concentration applied to hair must not exceed 2 % (calculated as free base) | June 3rd, 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 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.” | December 3rd, 2021 | ||
| HC Orange No. 6 | 1449653-83-1 | Annex III/315: Hair dye substance in non-oxidative hair dye products: Max 0.5 %. Methanesulfonates impurities, in particular Ethyl Methanesulfonate shall not be present. | June 3rd, 2021 |
| Acid Orange 7 | 633-96-5 | Annex III/316: Hair dye substance in non-oxidative hair dye products: Max 0.5%. | June 3rd, 2021 |
| Tetrabromophenol Blue | 4430-25-5 | Annex III/317: (a) Hair dye substance in oxidative hair dye products: 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) (b) Hair dye substance in nonoxidative hair dye products: Max 0.2 % | June 3rd, 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 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.” | December 3rd, 2021 | ||
| Indigofera tinctoria leaf Indigofera tinctoria leaf powder Indigofera tinctoria leaf extract Indigofera tinctoria extract | 84775-63-3 | Annex III/318: Hair dye substance in non-oxidative hair dye products: Max 25 % | June 3rd, 2021 |
Biorius can help you to cope with the challenging and fast-moving regulatory environment and keeps you updated on the compliance status of your product portfolio. Don’t hesitate to contact us for more information.
Author: Ms. Stéphanie Annet, EU Regulatory Supervisor
