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在根据用途和暴露信息进行优先排序时,ECHA 能否澄清通用筛选中使用的信息?
问题(中文)
在根据用途和暴露信息进行优先排序时,ECHA 能否澄清通用筛选中使用的信息?
Question (EN)
Can ECHA clarify the information used in the common screening when it comes to prioritisation based on uses and exposure information?
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)
用于确定物质优先次序的用途和暴露相关筛选标准的详细描述,请参阅每年更新的筛选定义文件:http://echa.europa.eu/screening。优先考虑那些用途吨位高、且被认为具有广泛分布性的物质。需要注意的是,IUCLID6 已从用途和暴露角度进行了进一步增强,同时也考虑了主管部门的筛选需求。注册信息是筛选的主要信息来源,因此,确保这些信息保持最新至关重要。我们还使用筛选定义文件中列出的外部信息来源来支持注册信息。筛选的目的是优先考虑那些重要的、预计需要采取监管行动的物质,以便最大限度地利用主管部门和行业的资源。例如,如果一种物质的年注册量为 100 吨,其中 99 吨用于中等用途,只有 1 吨用于广泛分布的用途,那么与吨位相同但 99 吨用于广泛分布用途的物质相比,其优先级较低。这凸显了需要以下信息来最好地为物质分配优先级这一事实:有关用途监管状态范围的信息(例如中间用途、杀生物剂);每次使用的吨位;用途是否受到严格控制以决定物质是否具有广泛分散用途。当局对用途可受 REACH 监管的物质感兴趣。对于每个 REACH 流程,都有可用的豁免,这些豁免既记录在 REACH 法规中,也记录在筛选定义文件中。还需要注意的是,这些信息用于确定物质的优先级。到目前为止,筛选已将用途广泛(即可能接触人体或释放到环境中的专业、消费者和/或物品服务)的物质作为高优先级。但是,工业用途也可被视为广泛分散,并且可以按照筛选定义文件中的说明稍后确定优先级。如果专业、消费者用途和物品使用寿命被默认为广泛(许多用户和/或许多站点),则工业用途并非如此,每个注册人必须表明他们是否认为其用途仅在少数站点发生,并在 IUCLID6 中证明其合理性。没有广泛用途的物质暂时被视为优先级较低,不会被列入成员国手动筛选的候选名单,除非有迹象表明此类物质可用作已接受监管审查的结构相似物质的替代品。务必确保注册档案中报告的用途是最新的,并反映市场上的用途。
Answer (EN)
The detailed description of the uses and exposure related screening criteria used to prioritise substances is available in the screening definition document updated annually at: http://echa.europa.eu/screening. Priority is given to those substances having a high tonnage in uses considered as being wide dispersive.
Note that IUCLID6 has been further enhanced from a use and exposure perspective also taking into account the needs from the screening by authorities. Registration information is the main source of information for screening and it is therefore important that this information is up to date. We are also using external sources of information as listed in the screening definition document to support registration information.
The aim of the screening is to prioritise those substances that matter and for which the need for regulatory action is expected in order to best use the resources of both authorities and industry. For instance a substance registered at 100 tonnes per year for which 99 tonnes goes to intermediate uses and only 1 tonne to wide dispersive uses would be of lower priority compared to a substance with the same tonnage but for which 99 tonnes would go to wide dispersive uses.
This highlights the fact that the following information are needed to best assign priorities to substances:
Information on the scope of the regulatory status of the uses (e.g. intermediate use, biocide);
Tonnage per use;
Whether the use is under rigorous containment to decide whether the substance has wide dispersive use or not.
Authorities are interested in substances where the uses can be regulated by REACH. For each REACH process, exemptions are available and documented both in the REACH Regulation but also in the screening definition document. It is also important to note that this information is used to set priorities among substances.
The screening has so far considered those substances with wide dispersive uses (i.e. professional, consumer and/or article service with potential for exposure to human or release to the environment) as a high priority. However, industrial uses can also be considered wide dispersive and may be prioritised later on as described in the screening definition document.
If professional, consumer uses and article service life are considered by default as being widespread (many users and/or many sites) this is not the case for industrial uses for which it is up to each registrant to indicate whether they believe their uses only take place for instance at few sites and to justify it in IUCLID6.
Substances that have no widespread uses are considered of lower priority for the time being and will not be included in the short-list for manual screening by Member States except if they are indications that such substance can be used as a substitute for a structurally similar substances already under regulatory scrutiny.
It is important to ensure that the uses reported in your registration dossiers are up-to-date and reflect uses that are on the market.