• A call for action on the development and implementation of new methodologies for safety assessment of chemical-based products in the EU – A short communication

      Knight, Derek J.; Deluyker, Hubert; orcid: 0000-0002-3490-8661; Chaudhry, Qasim; Vidal, Jean-Marc; orcid: 0000-0002-4422-5880; de Boer, Alie
      Safety assessment of chemicals and products in the European Union (EU) is based on decades of practice using primarily animal toxicity studies to model hazardous effects in humans. Nevertheless, there has been a long-standing ethical concern about using experimental animals. In addition, animal models may fail to predict adverse effects in humans. This has provided a strong motivation to develop and use new approach methodologies and other alternative sources of evidence. A key challenge for this is integration of evidence from different sources. This paper is a call for action with regard to development, validation, and implementation of modern safety assessment approaches for human health assessment by means of focused applied research and development with three strands: (a) to improve screening and priority setting, (b) to enhance and partially replace animal studies under the current regulatory schemes and eventually (c) to fully replace animal studies, while achieving at least the same level of protection. For this gradual but systematic replacement of animal studies, a long-term concerted and coordinated effort with clear goals is needed at EU level, as a societal and political choice, to plan and motivate research and innovation in regulatory safety assessment.
    • Ecotoxicological and regulatory aspects of environmental sustainability of nanopesticides.

      Grillo, Renato; email: renato.grillo@unesp.br; Fraceto, Leonardo F; Amorim, Mónica J B; Scott-Fordsmand, Janeck James; Schoonjans, Reinhilde; Chaudhry, Qasim (2020-10-02)
      Recent years have seen the development of various colloidal formulations of pesticides and other agrochemicals aimed at use in sustainable agriculture. These formulations include inorganic, organic or hybrid particulates, or nanocarriers composed of biodegradable polymers, that can provide a better control of the release of active ingredients. The very small particle sizes and high surface areas of nanopesticides may however also lead to some unintended (eco)toxicological effects due to the way in which they interact with the target and non-target species and the environment. The current level of knowledge on ecotoxicological effects of nanopesticides is scarce, especially in regard to the fate and behaviour of such formulations in the environment. Nanopesticides will however have to cross a stringent regulatory scrutiny before marketing in most countries for health and environmental risks under a range of regulatory frameworks that require pre-market notification, risk assessment and approval, followed by labelling, post-market monitoring and surveillance. This review provides an overview of the key regulatory and ecotoxicological aspects relating to nanopesticides that will need to be considered for environmentally-sustainable use in agriculture. [Abstract copyright: Copyright © 2020 Elsevier B.V. All rights reserved.]
    • Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials.

      Isigonis, Panagiotis; orcid: 0000-0002-8404-7708; Afantitis, Antreas; Antunes, Dalila; Bartonova, Alena; Beitollahi, Ali; Bohmer, Nils; Bouman, Evert; Chaudhry, Qasim; Cimpan, Mihaela Roxana; Cimpan, Emil; et al. (2020-07-23)
      Nanotechnologies have reached maturity and market penetration that require nano-specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)-by-Design (SbD) concepts. This paper provides an overview of the state-of-the-art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re-thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science-based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally. [Abstract copyright: © 2020 The Authors. Published by WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.]
    • The Importance of Metrology and Standardization of Nanomaterials for Food Industry and Regulatory Authorities in Europe

      Schoonjans, Reinhilde; Chaudhry, Qasim (Wiley-VCH Verlag GmbH & Co. KGaA, 2017-01-20)