6. Assessing and Documenting the Intrinsic Properties of Substances in REACH

  1. Peter Fisk

Published Online: 1 NOV 2013

DOI: 10.1002/9781118683989.ch6

Chemical Risk Assessment

Chemical Risk Assessment

How to Cite

Fisk, P. (2013) Assessing and Documenting the Intrinsic Properties of Substances in REACH, in Chemical Risk Assessment, John Wiley & Sons, Ltd, Chichester, UK. doi: 10.1002/9781118683989.ch6

Publication History

  1. Published Online: 1 NOV 2013
  2. Published Print: 13 DEC 2013

ISBN Information

Print ISBN: 9781119953685

Online ISBN: 9781118683989

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Keywords:

  • REACH;
  • Strictly controlled conditions;
  • PBT;
  • test proposal rule;
  • existing data;
  • letter of access;
  • data reliability;
  • Klimsche;
  • persistence;
  • bioaccumulation potential;
  • toxicity;
  • very persistant;
  • vP;
  • very bioaccumalative;
  • vB;
  • vPvB;
  • bioconcentration factor;
  • BCF

Summary

Overview of REACH requirements in respect of the basics of how hazards and risks are assessed.

The data requirements applying for most substances to be registered are set out in Annexes VII to X to the REACH regulation and these apply at specified tonnage thresholds unless the potential for exposure is very limited due to use under ‘strictly controlled conditions.’ Each Annex presents lists data requirements for physical chemistry, chemical hazards, toxicology, ecotoxicology and environmental fate. The higher the tonnage, the more complex and hence cost to test as the annex number increases. In addition, Annex XIII requires registrants to evaluate the substance's properties of persistence, bioaccumulation potential and toxicity. Very persistent (vP) substances are determined by their half life in water, sediment or soil. Very bioaccumulative (vB) substances are defined in terms of bioconcentration factor (BCF). Toxicity is defined in terms of harm to aquatic organisms or certain mammalian toxicity classifications. There are currently no criteria for toxicity to terrestrial or sediment organisms.