East European Research and Innovation Enterprise (EMERGE), Otets Paisiy Str. 46, 1303 Sofa, Bulgaria.
Department of Environmental Sciences, Informatics and Statistics, Ca' Foscari University of Venice, Via Torino 155, 30172 Venice, Italy.
NanoImpact. 2024 Jul;35:100523. doi: 10.1016/j.impact.2024.100523. Epub 2024 Jul 24.
This manuscript discusses the challenges of applying New Approach Methodologies (NAMs) for safe by design and regulatory risk assessment of advanced nanomaterials (AdNMs). The authors propose a framework for Next Generation Risk Assessment of AdNMs involving NAMs that is aligned to the conventional risk assessment paradigm. This framework is exposure-driven, endpoint-specific, makes best use of pre-existing information, and can be implemented in tiers of increasing specificity and complexity of the adopted NAMs. The tiered structure of the approach, which effectively combines the use of existing data with targeted testing will allow safety to be assessed cost-effectively and as far as possible with even more limited use of vertebrates. The regulatory readiness of state-of-the-art emerging NAMs is assessed in terms of Transparency, Reliability, Accessibility, Applicability, Relevance and Completeness, and their appropriateness for AdNMs is discussed in relation to each step of the risk assessment paradigm along with providing perspectives for future developments in the respective scientific and regulatory areas.
这篇手稿讨论了将新方法方法（NAMs）应用于先进纳米材料（AdNMs）的安全设计和监管风险评估所面临的挑战。作者提出了一个涉及 NAMs 的下一代 AdNMs 风险评估框架，该框架与传统的风险评估范式一致。该框架以暴露为驱动，针对终点，充分利用现有信息，并可以在采用 NAMs 的特异性和复杂性不断增加的层次上实施。该方法的分层结构有效地将现有数据的使用与有针对性的测试相结合，将使安全性评估具有成本效益，并且尽可能使用更少的脊椎动物。根据透明度、可靠性、可及性、适用性、相关性和完整性评估最先进的新兴 NAMs 的监管准备情况，并讨论它们在风险评估范式的每一步中的适用性，以及为各自的科学和监管领域的未来发展提供观点。
