Proposal for a harmonised PBT identification across different regulatory frameworks

Rauert et al. Environmental Sciences Europe 2014, 26:9 http://www.enveurope.com/content/26/1/9 DISCUSSION Open Access Proposal for a harmonised PBT identification across different regulatory frameworks Caren Rauert1*, Anton Friesen2, Georgia Hermann3, Ulrich Jöhncke4, Anja Kehrer2, Michael Neumann4, Ines Prutz5, Jens Schönfeld5, Astrid Wiemann5, Karen Willhaus2, Janina Wöltjen3 and Sabine Duquesne3 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. Keywords: PBT identification; Persistence; Bioaccumulation; Toxicity; REACH; Plant protection products; Biocides; Human medicinal products; Veterinary medicinal products; Harmonisation; Regulatory framework Background 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 be * Correspondence: 1 Section International Chemicals Management, Federal Environment Agency (UBA), Wörlitzer Platz 1, 06844 Dessau-Roßlau, Germany Full list of author information is available at the end of the article considered as hazardous for the environment due to their potential for eliciting long-term adverse effects. The goal of preventing exposure of humans and the environment to PBT and vPvB substances is thus shared among all EU-based regulatory frameworks. In a comparison between different European and International regulations, Moermond et al. [6] reported that there are differences in how this goal is achieved, not only regarding technical criteria but also conceptual criteria (e.g. regulatory consequences for PBT and vPvB substances). In terms of numerical criteria, the identification of PBT and vPvB substances is based on substance properties © 2014 Rauert et al.; licensee Springer. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. Rauert et al. Environmental Sciences Europe 2014, 26:9 http://www.enveurope.com/content/26/1/9 Page 2 of 13 substance included in Annex XIV, a deadline will be set after which use of that substance in the EU must stop (known as the ‘sunset date’), 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]. However, for biocides, generally no authorisation will be granted for products containing substances identified as PBT or vPvB. Additionally, biocides that fulfil two of the three criteria are flagged as candidates for substitution and are subjected to a comparative assessment. – For the assessment of veterinary medicinal products, guidance has been developed by the European Medicines Agency [10], which also refers to ECHA guidance [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. – For medicinal products for human use (which are usually emitted via sewage treatment plants), no restrictions are envisaged as human health is prioritised over environmental issues [4]. ECHA guidance [8,9] is used for the assessment. – By contrast, the PPP Regulation [2] simply stipulates the PBT/vPvB criteria, oblivious to any other guidance. As for biocides, no authorisation will be granted for those substances identified as PBT or vPvB. Additionally, 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. which are addressed by the same trigger values in all European substance regulations (see Table 1). Therefore, 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. However, the decision on whether a substance fulfils the PBT or vPvB criteria not only depends on substance properties, but also on the framework under which the substance is evaluated. For substances whose properties are near the trigger values, this decision may differ due to differe (...truncated)