Join Compliance Services International (CSI) Principal Consultant, Robin Blake, and Senior Consultant, Steven Andrews as they present at SETAC SciCon – SETAC Europe 30th Anniversary Online Meeting – May 3-7, 2020. You can contact Robin (RBlake@complianceservices.com) and Steven (SAndrews@complianceservices.com) or call CSI directly (Tel: +44 (0)131 445 6080). #SETACEurope #SETACSciCon
CSI Staff Presentations
Robin Blake – Principal Consultant:
Poster Presentation Title: Challenges Associated with Registration of Botanical Active Substances in the EU
Session Title: Developments in the Ecological and Human Health Risk Assessment of Biopesticides: Microorganisms, Botanicals and Semiochemicals (P)
Botanical active substances, or plant extracts/oils, together with other biological pesticides (“biopesticides”) 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.” The qualitative and quantitative composition of botanical active substances depends on the origin of the biological material which is influenced by many factors including geography, climate and soil conditions, as well as processing methods, and therefore their complex and variable nature can make registration challenging.
This paper discusses two key challenges of botanical active substance registration in the EU: (1) the lead component concept; and (2) evaluation of technical equivalence. Identification of lead component(s) can benefit risk assessments as long as this approach is fully justified. It is feasible that botanical active substances of the same biological origin will have different compositions. The use of (Q)SAR, literature and comparison of other exposures with pesticide exposure can help to alleviate any toxicological or ecotoxicological concerns and demonstrate that difference source(s) of technical material can have a comparable level of hazard for human health and the environment to that of the reference specification, such that technical equivalence can be concluded. Real-life examples and strategies are discussed; however, the substance identities have been sanitised to ensure confidentiality.
Steven Andrews – Senior Consultant:
Poster Presentation Title: Derogation Considerations in the Context of Guidance for Endocrine Disruptor (ED) Assessment
Session Title: Assessment of Chemical Mixtures and Multiple Stressors: From Additivity and Synergy to Policy Options (P)
Under the ‘Guidance for the identiﬁcation of endocrine disruptors in the context of Regulations (EU) No 528/2012 and (EC) No 1107/2009’, it is stated “There may be cases in which due to the knowledge on the physico-chemical and (eco)toxicological properties of the substance an ED assessment does not appear scientifically necessary…”. There are additional factors which could be taken into consideration when assessing if it is scientifically necessary to perform an ED assessment, e.g. substances ubiquitous in the environment and existing use(s).
There are many substances which are ubiquitous in the environment including nitrate, chloride, sulphate and phosphate salts present in between 111,180 and 945,404 km2 of groundwater bodies in the EU. Thus, humans or non-target organisms can be exposed to these substances as they are exposed to groundwater.
The existing use of a substance could be a suitable indicator of the relevance of an ED assessment, for example substances used as food materials and flavourings.
This poster will review the relevance of conducting an ED assessment for co-formulants where they are either environmentally ubiquitous or already have a use which causes high environmental or consumer exposure.
Compliance Services International (CSI) is a leading regulatory consultancy providing innovative solutions for organizations faced with regulatory and environmental challenges. CSI’s experienced scientists and regulatory specialists in the USA and the EU provide innovative approaches to solving regulatory and environmental challenges – combining traditional sciences with developing technologies to deliver economically sensible and scientifically sound results. Whether we serve you in the field, laboratory, courtroom or boardroom, we apply our knowledge of regulatory guidelines and scientific principles to ensure your regulatory success.
For a complete list of events that CSI will be attending in 2020, please visit our Events page.