[X1 ANNEX I U.K. GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS

Editorial Information

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).

4. PBT AND VPVB ASSESSMENT U.K.

4.0. Introduction U.K.

4.0.1. The objective of the PBT and vPvB assessment shall be to determine if the substance fulfils the criteria given in Annex XIII and if so, to characterise the potential emissions of the substance. A hazard assessment in accordance with Sections 1 and 3 of this Annex addressing all the long-term effects and the estimation of the long-term exposure of humans and the environment as carried out in accordance with Section 5 (Exposure Assessment), step 2 (Exposure Estimation), cannot be carried out with sufficient reliability for substances satisfying the PBT and vPvB criteria in Annex XIII. Therefore, a separate PBT and vPvB assessment is required. U.K.

[F1 4.0.2. The PBT and vPvB assessment shall comprise the following two steps, which shall be clearly identified as such in Part B, Section 8 of the Chemical Safety report. The assessment shall address all nanoforms that are covered by the registration: U.K.

Step 1	:	Comparison with the Criteria.
Step 2	:	Emission Characterisation.

The assessment shall also be summarised in the Safety Data Sheet under heading 12.]

Textual Amendments

F1 Substituted by Commission Regulation (EU) 2018/1881 of 3 December 2018 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes I, III,VI, VII, VIII, IX, X, XI, and XII to address nanoforms of substances (Text with EEA relevance).

[F2 4.1. Step 1: Comparison with the criteria U.K.

This part of the PBT and vPvB assessment shall entail the comparison of the available information with the criteria given in Section 1 of Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. The assessment shall be conducted in accordance with the provisions laid down in the introductory part of Annex XIII as well as Sections 2 and 3 of that Annex.

Textual Amendments

F2 Substituted by Commission Regulation (EU) No 252/2011 of 15 March 2011 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annex I (Text with EEA relevance).

[F1 4.2. Step 2: Emission Characterisation U.K.

If the substance fulfils the criteria or it is considered as if it is a PBT or vPvB in the registration dossier an emission characterisation shall be conducted comprising the relevant parts of the exposure assessment as described in Section 5. In particular it shall contain an estimation of the amounts of the substance released to the different environmental compartments during all activities carried out by the manufacturer or importer and all identified uses, and an identification of the likely routes by which humans and the environment are exposed to the substance. The estimation shall address all nanoforms that are covered by the registration.] ] ]