Updated Guidance published – Qualitative Risk Characterisation for Human Health

The scope of this consultation on the update of Part E of the Guidance on IR&CSA concerned sections related to qualitative risk characterisation for human health and, in particular, table E.3-1 which makes suggestions for how to do a qualitative risk characterisation when a quantitative risk characterisation is not possible.

The resulting update includes the addition of an entry to also allow decision-making based on CLP hazard statements (instead of only based on the previous Dangerous Substances Directive (DSD) risk phrases). It also introduces new entries for the hazard class Specific Target Organ Toxicity - Single Exposure (STOT-SE). This class was not included in the previous version.

The update results from a regular guidance consultation process. Additionally, sections of Part E outside the scope of the consultation have been updated via a corrigendum covering mainly two topics:

replacement of references to the DSD by references to the CLP Regulation
addition of two footnotes to ensure consistency with the new Appendices on "recommendations for nanomaterials" published earlier in 2012.