It is finally here! The long-announced and awaited regulation prohibiting the use in cosmetic products, incl. lilial (INCI: Butylphenyl Methylpropional) and zinc pyrithione (INCI: Zinc Pyrithione). Therefore, Comission Regulation (EU) 2021/1902 of 29 October 2021 amends Annexes II, III and V to the Regulation (EC) No 1223/2009 of the European Parliament and of the Council with regard to the use of certain CMR substances – classified as carcinogenic, mutagenic or toxic to reproduction, in cosmetics.
Lilial is one of the 26 fragrance allergens that is known under the names Butylphenyl Methylpropional, p-BMHCA, 2-(4-tert-butylbenzyl) propionaldehyde or Lily Aldehyde. It is an organic chemical compound from the group of aromatic aldehydes. It is characterized by a floral scent, reminiscent of cyclamen or lily of the valley. Until now, it has been one of the most popular allergens and has been found in many synthetic fragrances.
However, lilial has been shown to be toxic to reproduction. According to the CLP Regulation, it is classified as a CMR substance: Repr. 2, H361 – Suspected of damaging fertility or the unborn child. This compound was assessed by the SCCS Committee, which concluded that Butylphenyl Methylpropional cannot be considered as safe: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_213.pdf
In connection with the above, Butylphenyl Methylpropional, under the Regulation 2021/1902, was included in the Annex II, i.e. on the list of substances banned in cosmetic products (new entry – 1666). Therefore, the entry 83 was deleted from the Annex III – the list of substances restricted by the Regulation 1223/2009, where lilial has been previously found. The ban of placing and making products with lilial available on the market will apply from March 1st, 2022.
Another substance that so far has been widely used in the cosmetics industry and has been classified to the CMR category is zinc pyrithione. It has been a popular anti-dandruff ingredient used in hair shampoos, regulating sebum production, antibacterial and anti-itching.
Zinc Pyrithione is currently listed in entry 8 of Annex V to Regulation 1223/2009 as a preservative allowed in rinse-off hair products in a concentration not exceeding 1% and in other rinse-off products that are not oral hygiene products at a concentration of up to 0.5%. In addition, this compound appears in entry 101 of Annex III as a restricted substance: permitted only when used for purposes other than as a preservative – in leave-on hair products at a concentration of max. 0.1%.
The substance is currently classified as CMR category 1B (toxic for reproduction). In the opinion No. SCCS / 1614/19 of March 2020, the SCCS concluded that Zinc Pyrithione can be considered safe when used as an anti-dandruff ingredient in rinse-off hair products at a maximum concentration of 1%: https://ec.europa.eu/health/sites/default/files/scientific_committees/consumer_safety/docs/sccs_o_236.pdf
However, the above SCCS opinion has not demonstrated that there are no suitable alternative anti-dandruff substances for use in rinse-off hair products. As a result, Zinc Pyrithione will disappear both from the list of restricted substances (Annex III) and from the list of preservatives allowed in cosmetic products (Annex V). Instead, it will be included in the list of prohibited substances and will be listed as entry 1670 in Annex II.
Other prohibited substances and changes
In addition to the above-mentioned key substances for the cosmetics industry, Regulation 2021/1902 also includes a number of other compounds in Annex II, such as: Silicon carbide fibres (with diameter < 3 μm, length > 5 μm and aspect ratio ≥ 3:1), 2-methoxyethyl acrylate, dichlorodioctylstannane and bis(α,α-dimethylbenzyl) peroxide. Therefore, new entries will be added to the list of banned substances – from 1658 to 1680.
What else is introduced by this Regulation?
- In entry 24 in Annex III, the zinc pyrithione has been renumbered. It was: “Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8)“. Now it is: “Water-soluble zinc salts with the exception of zinc 4- hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (Annex II, entry X)“.
- In entry 51 of Annex V, new conditions for the use of Sodium Hydroxymethylglycinate have been added: “Not to be used if the maximum theoretical concentration of releasable formaldehyde, irrespective of the source, if the mixture as placed on the market is ≥ 0,1 % w/w”.
The entire new regulation will come into force on 1st March 2022.
You can read the content of this legal act at the link: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1902&from=EN