Omnibus V Regulation and Omnibus IV Reminder

Following the Omnibus IV article, we remind you that Commission Regulation (EU) 2021/1902, the so-called Omnibus IV Regulation, enters into force on the 1st of March 2022. Thus, from now on, only compliant products can be placed on the market and made available on the market.

A market withdrawal of non-compliant products must be organized if it is not already done.

There is, however, one exception: SODIUM HYDROXYMETHYLGLYCINATE (CAS 70161-44-3) will not be forbidden as foreseen by this regulation. Indeed, it has been erroneously added in annex II, the list of forbidden ingredients. Its classification as carcinogenic of category 1B is only applicable if it cannot be shown that the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, in the mixture as placed on the market is less than 0.1%. Therefore, SODIUM HYDROXYMETHYLGLYCINATE will be kept in annex V entry 51 as a preservative allowed at the conditions below:

  • Maximum concentration of 0.5%
  • Not to be used if it cannot 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.

This correction is set out in the upcoming Omnibus V Regulation.

The draft Omnibus V Regulation has been notified to the World Trade Organization (WTO) with an expected date for adoption during the 3rd quarter of 2022 and an application date on 17 December 2022.

In addition to the correction related to SODIUM HYDROXYMETHYLGLYCINATE, this Omnibus V regulation also includes the ban of 14 substances classified as CMR by the ATP 17 of the CLP (in annex), and the restriction of METHYL SALICYLATE. Indeed, the SCCS concluded in its opinion of October 2021 (SCCS/1633/21) that METHYL SALICYLATE can be considered safe in cosmetic products up to the maximum concentrations evaluated. Thus, METHYL SALICYLATE will be added in annex III, and could be used under the conditions below:

  • Leave-on skin products (except face makeup, spray/aerosol body lotion, spray/aerosol deodorant and hydroalcoholic-based fragrances) and leave-on hair products (except spray/aerosol products): Maximum 0.06%
  • Face makeup (except lip products, eye makeup and makeup remover): Maximum 0.05%
  • Eye makeup and makeup remover: Maximum 0.002%
  • Leave-on hair product (spray/aerosol): Maximum 0.009%
  • Deodorant spray/aerosol: Maximum 0.003%
  • Body lotion spray/aerosol: Maximum 0.04%
  • Rinse-off skin products (except hand wash and rinse-off hair products): Maximum 0.06%
  • Hand wash: 0.6%
  • Hydroalcoholic-based fragrances: Maximum 0.6%
  • Lip products: Maximum 0.03%
  • Toothpaste: Maximum 2.52%
  • Mouthwash intended for children aged 6-10 years: Maximum 0.1%
  • Mouthwash intended for children above 10 years of age and adults: Maximum 0.6%
  • Mouth spray: Maximum 0.65%

Moreover, it cannot be used in preparations for children under 6 years of age.

If BIORIUS is your Responsible person, please feel free to contact your dedicated Account Manager for more explanation.

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