REACH Annex XIV: ECHA Recommends Amending Entry for Dibutyl Phthalate (DBP)

January 16, 2025

On November 27, 2024, the European Chemicals Agency (ECHA) announced its recommendation to amend the REACH Authorisation List (Annex XIV) entry for dibutyl phthalate (DBP). This follows the identification of DBP as a substance of very high concern (SVHC) due to its endocrine disrupting properties for the environment in December 2023.
Key points:

  • The Candidate List entry for DBP has already been amended to reflect this new SVHC identification.
  • The proposed amendment to Annex XIV would expand the scope of authorisation requirements for DBP.
  • Notably, if approved, uses of DBP in medical devices that were previously exempt would become subject to authorisation requirements.

Companies using DBP, particularly in medical devices, should prepare for potential changes in regulatory obligations. This development highlights the increasing regulatory scrutiny on phthalates and underscores the importance for companies to stay informed and prepared for potential regulatory changes.
 

Stay informed. Get the latest regulatory updates, compliance insights, and CDX news delivered to your inbox.

Subscribe to our Newsletter