A substance that has raised many questions
Zinc Pyrithione is one of the substances mainly concerned by this project. This substance is used as an antifungal and antibacterial agent and would be removed from Annex III (substances subject to restrictions) and Annex V listing the preservatives authorised in cosmetics. It would therefore be included in Annex II, which lists substances prohibited in cosmetic products.
However, in 2019, the industry defended the exemption of zinc pyrithione from the ban. Indeed, companies in the sector claimed that zinc pyrithione was safe when used as an anti-dandruff agent in rinse-off hair products up to a maximum concentration of 1%.
The Scientific Committee on Consumer Safety (SCCS) had also found it safe up to a maximum level of 1% and 0.5% in other products.
Despite this, in 2020, and following a proposal from the Swedish authorities, the 15th Adaptation to Technical and Scientific Progress of the CLP Regulation (Classification, Labelling and Packaging of Substances) formalised the carcinogenic classification of category 1B; Thus banning the substance in cosmetic products, with entry into force set for 1st March 2022.
The European Commission has therefore notified the draft Regulation providing for a total ban on zinc pyrithione to the WTO, including as an anti-dandruff agent. As a matter of fact, there is no evidence that there are no suitable alternative substances available.
The importance of the Omnibus Regulation
The European Community designed the "Omnibus" Regulation to provide greater clarity and legal certainty regarding the use of ingredients classified as CMR (Carcinogenic, Mutagenic, Reprotoxic) by the Cosmetics Regulation.
Twenty-three substances classified as CMR (including zinc pyrithione) will be added to the list of prohibited substances in Annex II, such as Butylphenyl methylpropional, an allergen, or Sodium hydroxymethylglycinate, a preservative. Some manufacturers will therefore have to change the formulation of their products in order to remain compliant in Europe.
The adoption of this draft regulation is necessary to reflect the new CMR classification provided for by Commission Regulation n°2020/1182 in the Cosmetics Regulation. The objective is to ensure legal certainty and a high level of human health protection.
Wish to know more about the compliance of cosmetic products ?
For more information, do not hesitate to contact Nataliya Muller or one of our experts!
