PBT/Vpvbsubstances Under the BPR

CA-March15-Doc.5.3a_PBT Assessment.docx

PBT/vPvBsubstances under the BPR

1.Purpose of the document

This document was first prepared by ECHA for discussion at the 57th CA meeting following questions arising during processes related to PBT assessment.

2.Matters for consideration

• Active substances with borderline PBT properties

The REACH Guidance Chapter R11[1] indicates that where one criterion (P/vP, B/vB or T)is marginally not fulfilled but the other(s) are exceeded considerably, the evidence may be sufficient to conclude that the substance fulfils the Annex XIII criteria (i.e. it is considered as being PBT/vPvB).

However, for the specific purpose of identifying an active substance as candidate for substitution (i.e. only two of the three PBT criteria need to be fulfilled) there is currently no guidance on how to proceed in the case of borderline PBT properties. ECHA would therefore welcome a discussion on how to deal with these cases and sees two possibilities:

1)To apply the cut-off criteria for PT, BT and PB rather strict as these substances would anyhow not fulfil all three criteria (being PBT/vPvB). Borderline cases would still need to be carefully examined to ensure that the criteria are indeed not fulfilled (taking into consideration all the available information as stated in Section 3.2 of Annex XIII to REACH). The disadvantage would be that e.g. a substance, that is vP and marginally not T and not B would not be identified as a candidate for substitution, whereas a substance just fulfilling T and B but not P would, even though the substances might be equally problematic.

2)To assess substances with borderline properties on a case by case basis fully deploying Annex XIII to REACH in the interpretation also of the substitution criteria in order to evaluate the level of concern they give rise to. The advantage would be that it is possible to identify substances more broadly, in the same way as the exclusion criteria are evaluated (as in the example above). However, this approach would be more time/resource consuming and would potentially require the involvement of the ECHA PBT working group.

Question to the CA meeting:

Which approach should be followed when assessing active substances with borderline PBT properties in the context of identifying candidates for substitution?

• Constituents, impurities, non-active isomers and transformation/degradation products

Constituents/impurities/non-active isomers/additives:

The REACH Guidance Chapter R.11 specifies that if a substance contains one or more constituents/impurities with PBT/vPvB properties in individual amounts ≥0.1 % (w/w), they would need to be assessed.

In practice, this means that the applicant should carry out a comparison of the available data with the criteria for all constituents, impurities and additives present in concentration of ≥ 0.1% (w/w). Alternatively, the applicant should provide a justification for why he considers certain constituents, impurities or additives present in concentration of ≥ 0.1% (w/w) are not relevant for the PBT/vPvB assessment.

Transformation/degradation products:

Similar arguments apply to relevant transformation/degradation products. The PBT/vPvB assessment should normally be carried out for each relevant transformation or degradation product.

Under the REACH regulation, the applicant should carry out a comparison of the relevant available data with the PBT/vPvB criteria in principle for each transformation/degradation product unless they are not considered relevant. The REACH R.11 guidance further mentions the following (related e.g. to water/sediment):

“the transformation and degradation products relevant for the registrant’s own PBT/vPvB assessment are those products, which must be identified in tests C.23, C.24 and C.25 carried out in accordance with Council Regulation No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation No 1907/2006 (REACH) (“Test Methods Regulation”). It should be mentioned in particular that guideline C.24 requires that “…in general transformation products detected at ≥ 10% of the applied radioactivity in the total water-sediment system at any sampling time should be identified unless reasonably justified otherwise. Transformation products for which concentrations are continuously increasing during the study should also be considered for identification, even if their concentrations do not exceed the limits given above, as this may indicate persistence. The latter should be considered on a case by case basis....” The latter case always applies”

Question to the CA meeting:

Does the CA meeting agree that for the identification of which constituents/ impurities/non-active isomers/additives as well as transformation/degradation products need to be assessed, the indications provided in REACH R.11 guidance should be applied also for biocides?

Note: The assessment of the criteria for the constituents (including impurities and non-active isomers) or transformation and/or degradation products may potentially require the involvement of the ECHA PBT working group.

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[1]Current version 1.1 (Nov. 2012):

Draft to CARACAL (Aug. 2014):