December 6, 2021
by Percefoni Doufou-Shafiq, Ph.D., senior regulatory specialist, UL’s Supply Chain team
On Oct. 29, 2021, the EU published amendment (EU) 2021/1902 to Cosmetics Regulation 1223/2009, updating Annexes II (substances prohibited for use in cosmetics), III (substances allowed to be used with restrictions) and V (preservatives authorized for use in cosmetics).
Annex II to the Cosmetics Regulation was amended to include the addition of 27 substances due to updated classifications in the 15th ATP to CLP ((EU) 2020/1182). It follows the Article 15 provision of the Cosmetics Regulation, which states that substances with a harmonized classification as carcinogenic, mutagenic or toxic for reproduction (CMR) categories 1A, 1B or 2 are prohibited for use in cosmetic products.
An exception to this provision is laid out in paragraphs 1 and 2 of Article 15. If certain requirements are met, upon request, a CMR substance can still be used in cosmetic products with restrictions. Only zinc pyrithione (CAS No. 13463-41-7) was requested to be considered for an exemption, therefore all other 15th ATP CMR substances were readily listed in Annex II.
In the case of zinc pyrithione, which is classified as a Reproductive toxin 1B substance, a request was submitted on April 11, 2019 to allow the substance to be used in anti-dandruff rinse-off hair products in concentration up to 1%. In Opinion SCCS/1614/19, published by the Scientific Committee on Consumer Safety (SCCS), it was concluded that zinc pyrithione is considered safe when used as anti-dandruff ingredient in concentrations up to 1%; however, it did not meet the requirement that there be no suitable alternative ingredients. Therefore, based on the recent amendment, zinc pyrithione is now included in Annex II of the Cosmetic Regulation and deleted from the list of restricted substances (Annex III) and authorized preservatives (Annex V).
Sodium hydroxymethylglycinate (CAS No 70161-44-3) is now prohibited from use (and therefore added to Annex II) if the maximum concentration of releasable formaldehyde, irrespective of source, in the mixture as placed in the market is ≥ 0.1% w/w. The substance is still authorized for use as a preservative at a maximum concentration of 0.5%, but its entry in Annex V has been updated to reflect the requirements set in Annex II.
The above changes to the Annexes will be applicable from March 1, 2022. UL’s ChemADVISOR™ Regulatory Database is being updated to reflect the changes.