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Annex XV Dossier
Definition
An Annex XV dossier is the scientific and technical documentation submitted to ECHA to support: (1) identification of a substance as an SVHC for inclusion in the Candidate List; (2) proposals for new or amended restrictions under Annex XVII; or (3) proposals for inclusion in the Authorisation List (Annex XIV). Dossiers may be submitted by ECHA itself or by a Member State. The dossier must demonstrate that the substance meets the relevant hazard criteria and that regulatory action is warranted.
Source
REACH Regulation (EC) No 1907/2006, Annex XV and Articles 58, 69–73.
Practical Explanation (Compliance Context)
Companies whose substances are under Annex XV dossier review face risk of SVHC listing or Annex XVII restriction. Monitoring ECHA's public consultation register for active Annex XV dossiers provides early warning — typically 12–24 months before formal listing — allowing pre-emptive substitution and supply chain communication planning.