ECHA recommends 8 substances for REACH authorisation list
Ingredients: ETHYLENEDIAMINE, GLUTARAL

Date of publication: 12/04/2023

On 12 April 2023, the European Chemicals Agency (ECHA) recommended that the European Commission adds 8 substances to the REACH Authorisation List, including ingredients reportes as used in cosmetics - Ethylenediamine and Glutaral.

On 12 April 2023, the European Chemicals Agency (ECHA) recommended that the European Commission adds 8 substances to the REACH Authorisation List, namely:

  • Ethylenediamine (CAS 107-15-3)
  • 2-(4-tertbutylbenzyl)propionaldehyde and its individual stereoisomers (EC 799-970-2)
  • Lead (CAS 231-100-4)
  • Glutaral (CAS 111-30-8)
  • 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS 71868-10-5)
  • 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone (CAS 119313-12-1)
  • Diisohexyl phthalate (CAS 71850-09-4)
  • Orthoboric acid, sodium salt (EC 237-560-2)

Among the recommended substances for inclusion in the authorization list, most of the substances are listed in Annex II of the Cosmetics Regulation (CE) n.º 1223/2009 – List of substances prohibited in cosmetic products.

However, 2 are reported as being used in cosmetic products:

  • Ethylenediamine (CAS 107-15-3), proposed as potential respiratory sensitizer
  • Glutaral (CAS 111-30-8), proposed as potential respiratory sensitizer

Overall, although Glutaral and Ethylenediamine are recommended for inclusion in the Authorization List due to the intrinsic properties of respiratory sensitizers (Article 57(f) –human health), their use in cosmetics will not be affected as according to the REACH Regulation 1907/2006, cosmetic products that contain substances subject to authorization only because they meet the criteria in Article 57(a), (b), or (c) or because they are identified in accordance with Article 57(f) only because of hazards to human health, are exempted from the authorization requirement in Annex XIV.

References:

News release ECHA/NR/23/11 – ECHA proposes eight substances for authorisation to protect people and the environment

other REGULATORY UPDATES

Regulation (EU) 2022/692 – OMNIBUS ACT VI – New and Updated Classification of Cosmetic Ingredients

Ingredients: BENZOPHENONE, TEOPHYLLINE, MELAMINE, AZADIRACHTA EXTRACTS, TRIMETHYLOLPROPANE TRIACRYLATE, PENTETIC ACID, PENTASODIUM PENTETATE

Date of publication: 03/05/2022

Date of application: 01/12/2023

The Commission Delegated Regulation (EU) 2022/692 includes new or updated classification for 12 chemicals that may be used as cosmetic ingredients. Seven out of these 12 are now classified as carcinogenic, mutagenic or toxic to reproduction (CMR) and are banned from cosmetic products marketed in the EU.

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Regulation (EU) 2022/1531 – OMNIBUS ACT V – applicable as of 17 December 2022

Ingredients: METHYL SALICYLATE, SODIUM HYDROXYMETHYLGLYCINATE, DBMC, MIBK

Date of publication: 15/09/2022

Date of application: 17/12/2022

The European Commission has published the Commission Regulation (EU) 2022/1531, which amends the Regulation (EC) No 1223/2009 as regards the use in cosmetic products of certain substances classified as CMR, by adding new entries to Annex II and Annex III and revising an entry in Annex V.

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Ingredients: SODIUM BROMOTHYMOL BLUE (C186)

Date of publication: 28/10/2022

Following the request from the EU Commission for a scientific opinion on the hair dye Sodium Bromothymol Blue (C186), on October 2022 the Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion. In light of the data provided, when used in non-oxidative hair colouring products up to a maximum on-head concentration of 0.5%, the SCCS is of the opinion that the complete safety of Sodium Bromothymol Blue could not be assessed.

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RESPONSIBLE PERSON

Date of application: 31/12/2025

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