EU Bans the Use of a Common Fragrance Ingredient: Butylphenyl Methylpropional (BMHCA, Lilial).
Commission Delegated Regulation (EU) 2020/1182 the 15th Adaptation to Technical Progress (ATP) of the Classification, Labelling and Packaging (CLP) Regulation, has been published in The Official Journal of the European Union on 11 August 2020.
Butylphenyl methylpropional (also known as BMHCA, Lilial) is a widely used fragrance ingredient in cosmetics that currently must be labelled as an allergen in the EU if present at greater than 0.01% in rinse-off products and 0.001% in leave-on products.
The fragrance ingredient butylphenyl methylpropional (Lilial, BMHCA) was listed on
Regulation (EU) 2020/1182 Annex VI as a reprotoxic category 1B substance. This Regulation will enter into force on the twentieth day following the date of publication and applicable from 1 March 2022.
Article 15 of the Regulation EC 1223/2009 prohibits substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under the CLP.
Exemption conditions for CMR category 1A and 1B substances include:
- Compliance with the food safety requirements as defined in Regulation (EC) No 178/2002;
- There are no suitable alternative substances available;
- The application is made for a particular use of the product category with a known exposure;
- The substance has been evaluated and found safe by the Scientific Committee on Consumer Safety (SCCS) for use in cosmetic products.
BMHCA does not meet the criteria for exemption.
Subsequently, the EU Commission will include BMHCA into Annex II (prohibited substances) of the Cosmetic Product Regulation via the fourth CMR Omnibus Regulation, also expected to apply from 1 March 2022.
The exact timing for the prohibition of placing or making available of cosmetic products containing the BMHCA on the EU market is not known with certainty.
The implementation time after the publication of an Omnibus Act is very short, practically they apply immediately after the publication.
All products containing BMHCA must be off the shelf by this date.
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.