ALTEX. 2012;29(2):157-72. doi: 10.14573/altex.2012.2.157.
On June 12, 2009, the European Commission adopted a proposal for a Regulation concerning the placement on the market and use of biocidal products, which, when it enters into force on January 1, 2013, will repeal and replace Directive 98/8/EC. The main reason for the revision of the current Directive was to promote best practices for environmental and human health protection, along with implementation of current developments in safety testing in order to create safer biocides. Moreover, the proposed Regulation aims to take into consideration the newest legislation on chemicals. This article evaluates the proposed Regulation in comparison to Directive 98/8/EC. Although the new proposal requires the sharing of vertebrate animal test data, both for product authorization and for newly developed active substances, it misses - in contrast to REACH - the opportunity to recognize the accelerating development of alternative approaches to animal testing, most recently with new momentum provided by "Toxicity Testing for the 21st Century", and to support the evolution of toxicology towards a new approach to testing. The new methods promise not only to decrease animal pain and suffering, but also to provide faster results and better prediction for human risk assessment compared to traditional methods. Unfortunately, methods mandated for human risk assessment in the proposal are still mainly based on traditional animal study extrapolation. We put forward and discuss possible alternative strategies, such as in vitro testing, integrated testing strategies, toxicokinetics, "omics", systems biology, bioinformatics, and computational modeling, all of which could be more encouraged by the proposal. Current opportunities to improve our tools for biocide risk assessment are discussed, delineating advantages, limitations, and development needs. It is suggested to open the proposed Regulation to alternative approaches that are based on human biology more than on extrapolation from animals to humans.
2009 年 6 月 12 日，欧盟委员会通过了一项关于在市场上投放和使用杀生物剂产品的法规提案，该提案将于 2013 年 1 月 1 日生效，届时将取代 98/8/EC 指令。修订现行指令的主要原因是为了促进环境保护和人类健康保护的最佳实践，同时实施安全测试的最新进展，以创造更安全的杀生物剂。此外，拟议的法规旨在考虑最新的化学品立法。本文将对拟议的法规与 98/8/EC 指令进行比较评估。尽管新提案要求在产品授权和新开发的活性物质方面共享脊椎动物动物测试数据，但与 REACH 不同的是，它错过了利用替代动物测试方法的最新发展的机会，最近由于“21 世纪的毒性测试”，这方面的发展势头更为强劲，并支持毒理学向新的测试方法的发展。与传统方法相比，新方法不仅有望减少动物的痛苦和苦难，而且还能提供更快的结果和更好的人类风险评估预测。不幸的是，提案中规定用于人类风险评估的方法仍然主要基于传统的动物研究外推。我们提出并讨论了可能的替代策略，如体外测试、综合测试策略、毒代动力学、“组学”、系统生物学、生物信息学和计算建模，所有这些都可以通过该提案得到更多的鼓励。讨论了当前改进杀生物剂风险评估工具的机会，阐述了优势、局限性和发展需求。建议向更多基于人体生物学而不是从动物外推到人体的替代方法开放拟议的法规。
