Update of Regulation (EU) 2021/1902 on the prohibition of the marketing of cosmetics containing Lilial
Commission Regulation (EU) 2021/1902 of 29/10/2021 amending Annexes II, III and V to Reg. (EC) 1223/2009 as regards the use in cosmetics of certain substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) PROHIBITS from 1 March 2022 the marketing of cosmetics containing the substance 2-(4-tert-butylbenzyl) propionaldehyde, INCI name: Butylphenyl methylpropional (Lilial).
Regulation (EC) 1272/2008 on the classification and labelling of substances (CLP) updated on 19.5.2020 has led to the amendment of Annex II to Regulation 1223/2009 (list of substances not allowed in cosmetics) – (European Journal L 387/3.11.2021).
The substance in question is a synthetic molecule widely used as an odorous component – fragrance in cosmetic products in particular perfumes, shampoos, soaps, body creams, cleansing milks but also in some household hygiene products such as detergents.
Structurally it is an aldehyde with a floral smell reminiscent of the fragrant notes of lilac, lily of the valley and cyclamen that is present in the list of perfume allergens along with several other substances.
The Scientific Committee for Consumer Safety of the European Commission (SCCS) has re-evaluated this substance and in its opinion of 14.12.2017 it considered that its genotoxicity cannot be excluded. The Regulation (EU) 2021/1902, in a nutshell, in the light of the studies conducted prohibits the use of BMHCA – Butylphenyl methylpropional in cosmetic products.
In the light of the above, it is therefore necessary to withdraw from the market all cosmetic products containing this substance, which will no longer be allowed to be marketed from 1 March 2022. It is therefore necessary to ask its suppliers whether such substances are present in the purchased products and it is still necessary to check the IBCs of the cosmetic products held in order to verify the presence of BMHCA through its INCI name.
In the case of the presence of BMHCA, the cosmetic products must be stored and sealed in a container with the words “Products not saleable or transferable – to be returned to the supplier” and returned to the supplier in the appropriate manner. Trace of the entire operation should be maintained in case of checks by health authorities.
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