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vPvB
ARTICLE-14: Chemical safety report and duty to apply and recommend risk reduction measures [go to this ARTICLE]
... (d) persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. ...
... 4. If, as a result of carrying out steps (a) to (d) of paragraph 3, the registrant concludes that the substance meets
the criteria for classification as dangerous in accordance with Directive 67/548/EEC or is assessed to be a PBT or vPvB, the chemical safety assessment shall include the following additional steps: ...
ARTICLE-40: Examination of testing proposals [go to this ARTICLE]
... 1. The Agency shall examine any testing proposal set out in a registration or a downstream user report for provision of the information specified in Annexes IX and X for a substance. Priority shall be given to registrations of substances which have or may have PBT, vPvB, sensitising and/or carcinogenic, mutagenic or toxic for reproduction (CMR) properties, or substances classified as dangerous according to Directive 67/548/EEC above 100 tonnes per year with uses resulting in widespread and
diffuse exposure. ...
ARTICLE-58: Inclusion of substances in Annex XIV [go to this ARTICLE]
... (a) PBT or vPvB properties; or ...
ARTICLE-I: GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... 4. PBT and vPvB assessment. ...
... If as a result of steps 1 to 4 the manufacturer or importer concludes that the substance or the preparation 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: ...
... 4. PBT AND VPVB ASSESSMENT ...
... 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. ...
... 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. ...
... 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. ...
... 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: ...
... This part of the PBT and vPvB assessment shall entail the comparison of the available information, which is submitted as part of the technical dossier,
with the criteria given in Annex XIII and a statement of whether the substance fulfils or does not fulfil the criteria. ...
... If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B and T properties to decide whether further information
needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of further information is necessary and would require testing on vertebrate animals, the
registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant
implements or recommends sufficient risk management measures and operational conditions that enable derogation according to
Section 3 of Annex XI from testing relevant for PBT and vPvB assessment. ...
... If the technical dossier contains for one or more endpoints only information as required in Annexes VII and VIII, the registrant shall consider information relevant for screening for P, B and T properties to decide whether further information
needs to be generated to fulfil the objective of the PBT and vPvB assessment. In case the generation of further information is necessary and would require testing on vertebrate animals, the
registrant shall submit a testing proposal. However, such further information does not need to be generated if the registrant
implements or recommends sufficient risk management measures and operational conditions that enable derogation according to
Section 3 of Annex XI from testing relevant for PBT and vPvB assessment. ...
... For substances satisfying the PBT and vPvB criteria, the manufacturer or importer shall use the information as obtained in Section 5, Step 2 when implementing on its site, and recommending for downstream users, risk management measures which minimise exposures and emissions to humans and the environment, throughout the lifecycle
of the substance that results from manufacture or identified uses. ...
... 8. PBT AND VPVB ASSESSMENT ...
ARTICLE-XII: GENERAL PROVISIONS FOR DOWNSTREAM USERS TO ASSESS SUBSTANCES AND PREPARE CHEMICAL SAFETY REPORTS [go to this ARTICLE]
... If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary. In this case he shall use the relevant information reported by the supplier for the risk characterisation. This shall be stated in the Chemical Safety Report. ...
ARTICLE-XIII: CRITERIA FOR
THE IDENTIFICATION OF PERSISTENT, BIOACCUMULATIVE AND TOXIC SUBSTANCES,
AND VERY PERSISTENT AND VERY BIOACCUMULATIVE SUBSTANCES [go to this ARTICLE]
... A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3. A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2. This annex shall not apply to inorganic substances, but shall apply to organo-metals. ...
... 2. vPvB-SUBSTANCES ...
... A substance that fulfils the criteria of the sections below is a vPvB substance. ...
ARTICLE-XV: DOSSIERS [go to this ARTICLE]
... 2. Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59 ...
... The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f). ...