Friday, May 27, 2011

ECHA Issues New Substance Evaluation Criteria for REACH Chemical Assessments

The European Chemicals Agency (ECHA) has issued "selection criteria" for substance evaluation under the REACH program.  These criteria will be used by ECHA and the Members States to identify candidate substances for the first Community Rolling Action Plan (now called CoRAP after someone pointed out the inadequacy of its original acronym, CRAP).

According to ECHA:

Substance evaluation aims to clarify whether a given substance constitutes a risk to human health or the environment in cases where insufficient information is available. Substance evaluation will be conducted only in relation to a selected number of substances which will be chosen according to risk-based criteria. The prioritisation criteria cover hazard information, exposure information and tonnage of substances including the aggregated tonnage from the registrations submitted by several registrants. The first set of criteria is adopted by ECHA according to Executive Director's decision taken on 26 May 2011. ECHA and the Member States are using these criteria to identify possible substances that may be listed on the CoRAP and evaluated by Member States. In addition to this the Member States can also propose substances to be prioritised at any time on other risk-based grounds too. In the future, this first set of criteria will be further refined by ECHA in cooperation with the Member States.

The criteria identified by ECHA include the following:

Hazard related selection criteria:
  • Suspected PBTs, vPvBs, and PBT-like substances
  • Known PBTs/vPvBs
  • Suspected endocrine disruptors
  • Suspected CMRs
  • Known CMRs
  • Suspected sensitizers
  • Known sensitizers
Exposure related selection criteria:
  • Wide dispersive use
    • Number of sites of use
    • Pattern and amount of releases/exposure
    • Number and type of reported uses and exposure scenarios
    • Incorporation into mixtures or articles used by the public
    • Potential size of the exposed population
  • Number of using sites if emission is due to industrial use
  • Consumer use and exposure of sensitive subpopulations such as children
  • Aggregated tonnage
Risk related selection criteria:
  • The risk assessment in the chemical safety report shows the risk characterization ratio is not well below 1 for human and/or environmental exposure
  • Cumulative exposure from related substances with critical hazardous properties
More information on the criteria can be downloaded as a PDF file here.

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