PBT criteria (Annex XIII of REACH)

Outcome: August 2014

The task force has published its findings as ECETOC Special Report 18: Information to be considered in a weight-of-evidence-based PBT/vPvB assessment of chemicals (Annex XIII of REACH).

The Summary and free PDF of the report are available at http://www.ecetoc.org/publication/special-report-18-information-to-be-considered-in-a-weight-of-evidence-based-pbtvpvb-assessment-of-chemicals-annex-xiii-of-reach/

Download the science newsflash in PDF format: http://www.ecetoc.org/wp-content/uploads/2014/08/ECETOC_2015_Annual_Report.pdf

Background

The need for a further ECETOC Task Force on “PBT Criteria“ has arisen following the revision of Annex XIII of REACH (European Commission, 2011).

This revision introduces additional criteria for categorising chemicals as P, vP, B, vB or T. The criteria for assessment of B or vB properties, which appear to warrant particular attention, are listed in the Appendix to the present document. Prior to the revision, the bioaccumulation endpoints were largely reflective of the freshwater aquatic compartment. The new criteria are clearly intended to extend the scope of the bioaccumulation assessment, so as to make it more protective of terrestrial species, including humans.

A problem is that the new Regulation provides largely descriptive language, while the recommendations in the latest Technical Guidance Document (ECHA, 2008) are considered insufficient to accurately assess the PBT status of chemicals.

Terms of reference

Review and analyse the scientific literature to determine the environmental and human-health relevance of the new Annex XIII assessment information.Review the availability of reliable and relevant test methods and/or models for providing the data required for application of the new criteria.

Identify the advantages, disadvantages and difficulties associated with the application of the new assessment information.

Review and analyse the scientific literature related to P, B and T descriptors (other than those listed in the revised Annex XIII) that might warrant consideration for regulatory purposes.

Identify the need for further research and critically review proposals for projects (e.g. within the CEFIC LRI programme) on the development of alternative information to assess P, B, or T properties.

Serve as a channel for dialogue with ECHA, in order to:

  • contribute to the development of guidance as to how the new Annex XIII criteria should be interpreted and implemented;
  • comment on, and provide input to, the drafts of future revisions of those sections of the REACH guidance pertaining to PBT criteria;
  • propose the adoption, for regulatory purposes, of novel approaches and assessment information that might usefully complement those in the current Annex XIII.

[Organise a workshop with the participation of ECHA and other stakeholders].

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