Omnibus Act 2021: Ban of Butylphenyl Methylpropional (Lilial) and other CMR substances in cosmetic products

 

The European Commission published Regulation (EU) 2021/1902 o 29th October 2021 .

The text includes the now official ban of the fragrance substance “Butylphenyl Methylpropional” (2-(4-tert-butylbenzyl) propionaldehyde, “Lilial”, CAS No. 80-54-6) with effect from 1st March 2022.

This is the latest of the potential allergic fragrance substances formerly indicated in Annex III. Those substances must be indicated additionally in the list of ingredients referred to in Article 19.1g of the Regulation (EC) 1223/2009, when its concentration exceeds 0.01% in rinse-off-products or 0.001% in leave-on-products.

With “Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde” (4-(4-Hydroxy-4-methylpentyl)cyclohex-3-en-1-carbaldehyd, “Lyral”, CAS No. 31906-04-4), another of these substances has been recently banned from cosmetic ingredients. However, this ban has taken a slightly different way: In the conclusion of SCCS Opinion 1459/11 of December 2011, based on several studies, the substance has been identified as contact allergen, implying a potential risk for human health. With the Commission Regulation (EU) 2017/1410, it has been banned from cosmetic products . Since 23rd August 2021, cosmetic products containing this substance shall not be made available anymore on the European market.

On the other side, Butylphenyl Methylpropional has been classified as “CMR” (Carcinogenic, mutagenic, reprotoxic) substance according Annex II of Regulation (EC) No 1272/2008 (“CLP Regulation”). Article 15 of EU Cosmetics Regulation (EC) No 1223/2009 provides that substances which have been classified as CMR substances of category 1A, 1B or 2 care to be prohibited from use in cosmetic products (“Omnibus Act”). Regulation (EU) 2021/1902 is the formal act for this ban and will be applicable from 23rd November 2021.

Among other substances, the Regulation also includes the ban of Zinc Pyrithione (CAS No. 13463-41-7) from 1st March 2022.

In the course of the “Omnibus Act”, there will be follow-up regulations in the future for the purpose of continuous synchronization of the CLP and Cosmetics Regulation and to implement a clear process for the handling of CMR classified substances.

 

[1] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R1902&from=EN (Annex II, No. 1666)

[2] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R1410&from=EN (Annex II, No. 1380)



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