Our staff, Warren Scott, Robin Blake, and Steven Andrews presented at the SETAC Europe Annual Meeting on 15-19 May 2022 that was held in Copenhagen, Denmark.
Polymer registration under EU REACH: scientific issues & implementation challenges
Author: Warren Scott, Principal Consultant
Key words: Polymers; REACH; PRR; Regulatory, Brexit
Expanding REACH registration requirements to polymers is not as straight forward as it sounds. Due to the complexity of polymer chemistry with its vast array of building blocks and subsequent possible combinations no shoe fits all in terms of using non-polymer registration data requirements. A more targeted approach is required but in order to reduce the burden on industry and reduce animal testing, polymers requiring registration will be linked together as single ‘PRR substance’.
This poster will look at the current EU REACH registration procedures for polymers and their monomers. A look ahead at how industry can identify their polymer substances. If grouped as a PRR substance then what data requirements will they be subject to, and the complication of Brexit and how the HSE plan to tackle polymers under REACH.
Ecotoxicological Concerns Associated with Complex and Variable Nature of Botanical Active Substances
Author: Robin Blake, Principal Consultant
Key words: Botanical active substance; ecotoxicology; lead component
Botanical active substances, or plant extracts/oils, have increased in popularity in recent decades for pest and disease management as alternatives to conventional, synthetic pesticides. According to the SANCO and OECD definition, “a ‘botanical active substance’ consists of one or more components found in plants and obtained by subjecting plants or parts of plants of the same species to a process such as pressing, milling, crushing, distillation and/or extractions. The process may include further concentration, purification and/or blending, provided that the chemical nature of the components is not intentionally modified/altered by chemical and/or microbial processes.” Whilst this biological origin may lead to a more favourable ecotoxicology profile compared to synthetic chemical active substances, natural occurrence does not imply that the use of such botanical active substances is always without risk and their complex and variable nature can make registration equally challenging.
In the EU, botanical active substances fall under the scope of the Plant Protection Products Regulation (EC) No 1107/2009. It is often not technically feasible to radiolabel complex botanical active substances and therefore the SANCO guidance allows one or more component(s) to be identified as analytical “lead component(s)” and traced in the technical grade material. Lead component(s) can be the most frequently occurring substance(s) as demonstrated by analytical techniques or be the most biologically active component(s). However, the identity of the botanical active substance is considered to be the sum of all the components, not just the lead component(s), and this must be considered in the risk assessments. Therefore, it is feasible that other components are present that show a greater ecotoxicological concern compared to the lead component(s).
This poster discusses real-life examples and strategies including (Q)SAR, concentration additivity, literature and comparison of other exposures with pesticide exposure to help alleviate ecotoxicological concerns.
Groundwater Modelling of Volatile Substances in the EU
Author: Steven Andrews, Senior Consultant
Key words: Groundwater; Environmental Fate; Environmental Modelling
The modelling of volatile active substances leaching to groundwater and further refinement of these estimations can be complex, particularly when higher tier environmental fate studies are required either as inputs or to support a hypothesis on which a refinement relies. For active substances with indoor (e.g., permanent glasshouse) and open field uses, consideration must be given to the design and conduct of the higher tier studies to ensure they will be beneficial in the context of the current data package.
This poster will look at groundwater models: comparing the input assumptions and potential for experimental refinement of these; the limitations of the models and the potential for higher tier modelling options. It also aims to outline the current state of applicable guidance in this area for relevant formulation types and uses.
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