Dossier Submitter workshop Jan 2013 Key issues and way forward

Key issues Accordance check Dossier quality essential element in CLH process Large percentage of dossiers fail accordance check Issues raised by dossier submitters and RAC Prioritisation of CLH candidates from Inventory data Importance of CLH to other risk management options might require “fast track” Role of DS in streamlining RAC opinion development Report format Address workload, minimise duplication INTERNAL 1/1/2019

Key issues (continued) Support form ECHA Substance identification to be addressed early in the process Facilitate cooperation among dossier submitters and between dossiers submitters and RAC Clarifications, scientific support Alignment of PPP approval and CLH process Adjust timelines Consistency in report formats Coordinate preparation of PPP and CLH dossiers in Member States Hazard classes to be assessed in CLH proposals INTERNAL 1/1/2019