Assessment of Hazard Classes in the CLH Process 12th CARACAL meeting Brussels, 14 March 2013 Jani O. Honkanen

ECHA’s proposal in CARACAL-11 (Nov 2012) The dossier submitter (DS) to assess and conclude on: all CMR RS hazard classes in new entries all hazard classes for active substances in PPPs and BPs only the hazard classes that are proposed to be amended when updating Annex VI entries INTERNAL 9/1/2019

ECHA’s proposal was discussed in CARACAL-11 and the DS workshop in January Summary of the comments Assessment of all CMR-RS hazard classes was not supported, mainly due to lack of resources Other proposed changes (e.g. assessment PPP/BP) were supported by (some) commenters INTERNAL 9/1/2019

ECHA’s revised proposal for CMR RS Recommendation to DS: assessment of all CMR-RS hazard classes in new entries If no assessment provided for a particular CMR RS, strong recommendation to provide a brief reasoning why this was the case INTERNAL 9/1/2019

The aim of the current proposal To ensure a CLH process which is coherent, resource efficient and predictable All parties involved would know (latest in PC) which hazard classes were assessed and concluded by the DS open for PC comments consequently evaluated by RAC INTERNAL 9/1/2019

Type of proposal and substance DS’s assessment Commenting during PC RAC evaluation New entry in Annex VI: Active substance in PPP/BP All HCs All HCs for which the DS has provided appropriate information basis, assessment and conclusion (including concluded HCs with no classification) All HCs which were open for comments during the PC All other substances Any HC (+justification for action at the EU); recommendation to include CMR-RS assessment or reasoning for exclusion All HCs for which the DS has proposed classification and provided appropriate information basis, assessment and conclusion; CMR RS if properly assessed and concluded by the DS Update of an entry in Annex VI: All substances HCs for which the DS proposes an amendment; CMR RS may also be included HCs for which an amendment is proposed (appropriate information basis, assessment and conclusion) by the DS; CMR RS if properly assessed and concluded by the DS INTERNAL 9/1/2019

REACH and CLP competent Authorities are invited to: Provide comments by 5 April 2013