避免accks附图vii-x
Posted by Dr. David Howes, Expert Consultant in Chemical Legislation and Chemistry, Covance
在欧盟，Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)regulations address the manufacturing and import of chemicals to ensure they are safe for human health and the environment. The registration dossier outlines the standard information requirements for a substance and minimum data required that describe the physicochemical, toxicological, environmental fate and ecotoxicological properties of the substance.
通过这些信息，欧洲化学物质（ECHA）可以决定该物质的安全。但是，数据要求随着所用物质的量而变化。通常，需要更复杂的信息来制造或导入欧盟和欧洲经济区（EEA）。
覆盖的简要历史
从以前的NONS（新物质通知）的化学登记立法的信息要求出现。REACH提供了一个法律框架，该框架要求在制造或进口公司跨越公司共享的数据共享，促进动物检测的减少，并与更广泛的公众更透明地参与。
Understanding tonnage bands and data requirements
到达有四个吨位乐队管辖annexes：
- 1-10吨/年 - 附件七
- 10-100吨/年 - 附件八
- 100–1,000 tons/year – Annex IX
- > 1000吨/年 - 附件x
在达不到的情况下，申请人现在需要进行一代生殖毒性研究（经合组织测试指南443) when preparing chemical dossiers.
附件七
附件VII的数据要求是最简单的，重点关注关键的物理化学性质，例如物质的蒸气压，水溶性and flammability. The requirements also include assessments for short-term ecotoxicology endpoints like aquatic toxicity and biodegradation and for the toxicology endpoints of in vitro skin and eye irritation, skin corrosion and sensitization, mutagenicity and acute toxicity.
只有后一种毒性的端点只需要在脊椎动物上进行测试。如果可以在1-10吨带中的物质中进行低风险，那么有益处减少了所需的物理化学性质的数据。
附件七I
附件VIII通过进一步的毒理学终点构建附件VII要求 - 其中一些在Vivodata中需要，例如短期重复剂量研究（28天），生殖/发育毒性筛选试验，具有进一步的诱变，生态毒性和环境命运的测试。
Annex IX and X
附件IX和X为毒理学，生态毒理学和环境命运终点增添了更复杂和长期的研究。附件IX涵盖90天重复剂量，延长一代生殖毒性和前产前发育毒性研究以及长期水生毒性，生物降解和生物累积试验。在这个吨位乐队中引入了陆地物种的测试，在无脊椎动物，植物和微生物上进行短期毒性测试。
Annex IX tests further extends the testing requirements with studies for reproductive and developmental toxicity on second species, a test for carcinogenicity and long-term testing on terrestrial species.
If a substance falls under Annex IX and X requirements, then the testing already undertaken at Annex VII and VIII must be taken into account. Some tests are also driven by the outcome of the chemical safety assessment; others are performed in a tiered manner, all of which affects the testing strategy.
As for the lower tonnage bands, the use of alternative test strategies is possible for the higher tonnage bands. For example, use of read across, chemical categories, weight of evidence and quantitative structure-activity relationship (QSAR) models. However, there are fewer opportunities to use such approaches with the more complex endpoints.
通常,客户需要采用thought-out, logical, testing strategy to deliver the most resource and animal-efficient testing plan. Any tests involving animals at Annex IX and X cannot be conducted without first submitting a testing proposal to the European Chemicals Agency (ECHA) within a dossier. The test proposal is reviewed by the ECHA Member State Committee and decisions made available to the general public and any other interested third parties, in line with REACH’s stated aim of openness and transparency.
接触的关键考虑因素
客户应考虑以下内容以确定物质的最佳测试方法：
- 让科学推动测试并遵循逻辑和考虑的方法
- 知道物质的性质，因为许多化学品表现出独特的行为
- 熟悉测试方法，了解他们的目标，方法，结果和潜在限制
- Wherever possible, follow ECHA端点特定指导
- 请注意ECHA文件中的建议：应用CLP标准
- Always consider alternative methods to reduce the use of animals
满足覆盖要求
要成功地浏览不同吨位频段的数据要求，客户需要深入了解其物质的性质和使用，并与关于如何满足覆盖要求的专家技术和监管知识相结合。
期待发现更多？
最后的达额截止日期是2018年5月，并致力于收集关于欧盟/ EEA销售的化学产品安全的积极信息。它导致了有关各种物质的大规模安全信息数据库，并将标注科学和监管思想中的演变令人兴奋的新阶段。随着提交提交期限完成，Echa已迁入粉末审查和评估的新阶段。当档案决定信点击您的收件箱时，您应该期待什么？我们的下一个博客在这个系列中会寻找解决这个问题。
