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

2. 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

3. 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

4. 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

5. 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

6. 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

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