New bans, restrictions and SCCS opinions

5th CMR Omnibus Regulation Published

On 16 September 2022, 5TH CMR Omnibus regulation (Regulation 2022/1531 (https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=uriserv%3AOJ.L_.2022.240.01.0003.01.ENG&toc=OJ%3AL%3A2022%3A240%3ATOC) ) was published by the EU Commission. This regulation will apply from 17 December 2022, which relates to the making available of cosmetic product on the EU market. It will apply in the EU and Northern Ireland. It is currently unclear when the bans and restrictions for these substances will occur in the UK.

The Regulation includes the following entries:

  1. Addition of 14 substances to Annex II of the EU Cosmetics Regulation:
  • The list includes two cosmetic ingredients – METHYLENE DI-T-BUTYLCRESOL and METHYL ISOBUTYL KETONE (MIBK)

 

  1. Addition of METHYL SALICYLATE to Annex III of the EU Cosmetics Regulation:
  • METHYL SALICYLATE will be restricted as follows:
Type of cosmetic product exposure Maximum % concentration
Hydroalcoholic based fragrances 0.600%
Rinse-off skin products (except hand wash) and rinse-off hair products 0.060%
Hand wash products 0.600%
Leave on skin & hair products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic based fragrances) and leave on hair products (except spray/aerosol products) – with the note that it must not be used in preparations for children under 6 years of age) 0.060%
Face makeup products (except lip products, eye makeup and makeup remover) 0.050%
Lip products 0.030%
Eye makeup products & Makeup remover 0.002%
Toothpaste 2.250%
Mouthwash intended for children aged 6–10 years 0.100%
Mouthwash intended for children above 10 years of age and adults 0.600%
Mouth spray 0.650%
Deodorant spray/aerosol 0.003%
Leave on hair products (spray/aerosol) 0.009%
Body lotion spray/aerosol 0.040%

 

  • The restriction includes a note that the ingredient is not to be used in preparations for children under 6 years of age

 

  1. Correction of entries for preservative SODIUM HYDROXYMETHYLGLYCINATE (SHMG)
  • According to the clarification the preservative SHMG is prohibited for use in cosmetic products unless it can be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is < 0,1 % w/w