Guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment

According to Section 4 of Annex I to the REACH Regulation, the objective of the PBT/vPvB assessment is to determine if the substance fulfils the criteria given in Annex XIII to the REACH Regulation (“Step 1: Comparison with the Criteria”), and if so, to characterise the potential emissions of the substance to the different environmental compartments during all activities carried out by the registr. [...] The objective of the PBT/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. [...] If the registrant has new information available which was not referred to in the support document of the relevant ECHA decision, the registrant must include the new information in the registration dossier and may reflect his opinion of the relevance of the new information to the conclusion in the CSR. [...] Although the registrant would in this case present in the CSR the opinion that the new information would trigger another conclusion than the one drawn by the MSC, the registrant is further obliged to implement the conclusion of the MSC as the conclusion in force in his CSR. [...] Whereas for substances meeting the classification criteria for Article 14(4) hazard classes or categories the objective of an exposure assessment is to make qualitative or quantitative estimates of the dose/concentration of the substance to which humans and the environment are or may be exposed, the main objective of the emission characterisation for “a PBT or vPvB substance” is to estimate the am.