[X10.6. A chemical safety assessment performed by a manufacturer or an importer for a substance shall include the following steps in accordance with the respective sections of this Annex: U.K.
Human health hazard assessment.
Human health hazard assessment of physicochemical properties.
Environmental hazard assessment.
PBT and vPvB assessment.
If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the [F1mixture] meets the criteria for classification as dangerous according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed to be a PBT or vPvB, the chemical safety assessment shall also consider the following steps:
Textual Amendments
F1Substituted 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).
Exposure assessment
The generation of exposure scenario(s) or the generation of relevant use and exposure categories if appropriate.
Exposure estimation.
Risk characterisation
A summary of all the relevant information used in addressing the points above, shall be presented under the relevant heading of the Chemical Safety Report (Section 7).]
Editorial Information
X1Substituted 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).