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Division 5.2.4 An estimation of the exposure levels shall be performed for all human populations (workers, consumers and humans liable to exposure indirectly via the environment) and environmental spheres for which exposure to the substance is known or reasonably foreseeable. Each relevant route of human exposure (inhalation, oral, dermal and combined through all relevant routes and sources of exposure) shall be addressed. Such estimations shall take account of spatial and temporal variations in the exposure pattern. In particular, the exposure estimation shall take account of:X1

United Kingdom

Original text. Later amendments are not shown.

  • adequately measured, representative exposure data,

  • any major impurities and additives in the substance,

  • the quantity in which the substance is produced and/or imported,

  • the quantity for each identified use,

  • implemented or recommended risk management, including the degree of containment,

  • duration and frequency of exposure according to the operational conditions,

  • the activities of workers related to the processes and the duration and frequency of their exposure to the substance,

  • the activities of consumers and the duration and frequency of their exposure to the substance,

  • the duration and frequency of emissions of the substance to the different environmental compartments and the dilution in the receiving environmental compartment,

  • the physicochemical properties of the substance,

  • transformation and/or degradation products,

  • the likely routes of exposure of and potential for absorption in humans,

  • the likely pathways to the environment and environmental distribution and degradation and/or transformation (see also Section 3 Step 1),

  • scale (geographical) of exposure,

  • matrix dependent release/migration of the substance.

Annotations

Editorial notes

X1

Substituted by Corrigendum to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (Official Journal of the European Union L 396 of 30 December 2006).

Notes on the whole EU Regulation

Textual amendments

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Substituted by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (Text with EEA relevance).