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.
The fragrance ingredient butylphenyl methylpropional (Lilial, BMHCA) was listed on 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 EU Cosmetic Products Regulation (CPR) prohibits substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMR) under the CLP Regulation from being used in cosmetic products, unless a specific exemption is granted.
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. No dossier for exemption has been or will be submitted for BMHCA. The SCCS have previously concluded that the use of BMHCA is not considered safe for use in cosmetics (SCCS/ 1591/17). 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.
All products containing BMHCA must be off the shelf by this date.