Lilial classified as a CMR substance

On August 11, 2020, the European Commission published in the Official Journal of the EU a Delegated Regulation amending the Classification, Labelling and Packaging Regulation (CLP Regulation). The change concerns several ingredients, which were classified as CMR substances, and notably the allergen Buthylphenyl Methylpropional, also known as BMHCA or Lilial. Lilial is a well-known fragrance ingredient, commonly found in cosmetic products.


What is the CLP Regulation and how does it interact with the Cosmetics Regulation?

One of the main purposes of the CLP Regulation is to ensure a high-level protection of health and of the environment, by determining whether a substance or mixture can be classified as hazardous. If so, the identified hazards must be communicated to all the actors of the supply chain.

Cosmetic products are normally excluded from the application of the CLP Regulation, except for aerosols. Nevertheless, the Cosmetics Regulation (EC) 1223/2009 (Cosmetics Regulation) prohibits the use of substances classified as carcinogenic, mutagenic or toxic to reproduction (CMR) under the CLP Regulation in cosmetic products, and allows it only whenever there is an exemption under art.15.


Lilial as a CMR substance

The amendment to the CLP Regulation classifies Lilial as a CMR 1B and applies from March 1, 2022. The exact timing for the prohibition of placing or making available of cosmetic products containing the allergen on the EU market is not known with certainty. The Commission will have to add the ingredient to Annex II of the Cosmetics Regulation, which  will most probably happen through Omnibus Act IV which is to be published beginning of next year. The implementation time after the publication of an Omnibus Act is very short, practically they apply immediately after the publication. As such, it is highly advisable for cosmetic manufacturers to immediately start the process of replacing fragrances with Lilial-free ones and to refrain from placing new products containing Lilial on the EU market.


Efrosina Zhivkova

Expert Consultant at Regulatory Affairs Department

24/09/2020


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