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我应该如何在申请中制定“申请用途”和暴露场景?
问题(中文)
我应该如何在申请中制定“申请用途”和暴露场景?
Question (EN)
How should I develop the ‘uses applied for' and exposure scenarios in my application?
中文内容由 Google Cloud Translation 自动生成,仅供参考;请以英文原文为准。问答资料来自欧盟化学品管理局(ECHA)官方网站。
答案(中文)
对“申请用途”及其相关暴露场景的描述是授权申请准备的关键步骤。授权申请中“申请用途”的概念可能与工业界在日常实践中通常理解的“用途”存在显著差异。“申请用途”的描述、范围和详细程度不仅与附件XIV物质暴露/释放相关的风险有关,还与替代品分析以及相关情况下的社会经济分析和替代计划有关。以下文件对此问题进行了更详细的描述:如何在授权中制定用途描述 [PDF] [EN] 授权申请研讨会演示文稿 信息要求和化学品安全评估指南 - 暴露场景格式
Answer (EN)
The description of the ‘uses applied for' and of the related exposure scenarios is key step in the preparation of an application for authorisation. The concept of "use applied for" in the context of applications for authorisation might significantly differ from what industrial actors usually understand by a "use" in their day-to-day practice. The ‘use applied for' description, scope and level of details are not only related to the risks linked to the exposure/release of the Annex XIV substance but also to the analysis of alternatives and, where relevant, to the socio-economic analysis and substitution plan. The following documents describe this issue in more details:
How to develop the description of uses in the context of Authorisation [PDF] [EN]
Presentations from seminars on applications for authorisation
Guidance on information requirements and chemical safety assessment - Exposure Scenario Format