Abstract
European regulatory frameworks for chemicals (i.e. registered under REACH, plant protection products (PPPs), biocides, human and veterinary medicinal products) require that substances undergo an assessment to identify whether they are persistent (P), bioaccumulative (B) and toxic (T), or very persistent (vP) and very bioaccumulative (vB), i.e. to identify them as PBT substances or vPvB substances according to their properties. We screened current practices, evaluated possibilities and made a proposal for a harmonised assessment. Our proposal assumes that it should be possible to identify PBT and vPvB substances on the basis of the data available according to the requirements of the respective legal frameworks. For substances registered as PPPs and mostly also biocides and medicinal products, a ‘definitive assessment’ is often possible. Within REACH, the registrant has to provide all information necessary for PBT assessment regardless of the yearly tonnage of chemicals. But in cases of limited data availability, we suggest using a weight of evidence approach to account for such differences in data availability and type of data across different frameworks and to make use of valuable additional information. We propose to base the evaluation of persistence on degradation half-lives and to normalise a number of parameters (e.g. type of kinetics used, temperature). But further work is needed, e.g. for deriving DegT50 for water and sediment compartments. For the B-criterion, information other than BCF in fish could be considered and more information related to bioaccumulation processes should be gathered (e.g. in species other than fish, different uptake routes). Testing for T identification is focused on standard aquatic species but could also be complemented by e.g. information from other species. Information such as those read-across from structurally related substances and QSAR are often of importance for screening assessments. The aim of PBT and vPvB identification is to reliably target the problematic substances, with as few false negatives or positives as possible, regardless of the regulatory framework. Each aspect was thus considered in the context of the others for a final balanced decision. As the need for conservatism is interpreted differently under the various frameworks, harmonizing this identification is a challenging task.
Highlights
The different European substance regulations (e.g. REACH [1], plant protection products regulation [2], biocidal products regulation [3], human and veterinary medicinal products regulations [4,5]) have all recognised that substances that are either persistent (P), bioaccumulative (B) and toxic (T) (PBT substances) or very persistent and very bioaccumulative must beIn terms of numerical criteria, the identification of PBT and vPvB substances is based on substance properties which are addressed by the same trigger values in all European substance regulations.it could be assumed that the identification of a PBT or vPvB substance should be independent of both the use of the substance and the regulatory framework under which it is assessed
For each substance included in Annex XIV, a deadline will be set after which use of that substance in the European Union (EU) must stop, unless authorized by the European Commission. – The EU Biocidal Products Regulation [3] refers to Annex XIII of REACH [7] and to the ECHA guidance for PBT/vPvB assessment [8,9]
The various European regulatory frameworks on chemical substances agree that exposure of humans and the environment to substances identified as PBT or vPvB must be avoided
Summary
The different European substance regulations (e.g. REACH [1], plant protection products regulation [2], biocidal products regulation [3], human and veterinary medicinal products regulations [4,5]) have all recognised that substances that are either persistent (P), bioaccumulative (B) and toxic (T) (PBT substances) or very persistent (vP) and very bioaccumulative (vB) (vPvB substances) must beIn terms of numerical criteria, the identification of PBT and vPvB substances is based on substance properties which are addressed by the same trigger values in all European substance regulations (see Table 1).it could be assumed that the identification of a PBT or vPvB substance should be independent of both the use of the substance and the regulatory framework under which it is assessed. In terms of numerical criteria, the identification of PBT and vPvB substances is based on substance properties which are addressed by the same trigger values in all European substance regulations (see Table 1). – The EU Biocidal Products Regulation [3] refers to Annex XIII of REACH [7] and to the ECHA guidance for PBT/vPvB assessment [8,9]. A benefit-risk analysis is conducted in support of the decision on whether to authorise the substance or not [5] In this context, an identification as a PBT substance is generally regarded as a serious concern. PPPs that fulfil two of the three criteria are flagged as candidates for substitution and are subjected to a comparative assessment, as is the case for biocides. The draft guidance developed by DG Sanco [11] focuses primarily on the identification of candidates for substitution
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
