新产品上线! Email验证工具 - 限时免费试用中立即试用

外贸营销群发邮件之前,先批量验证邮箱地址是否有效,可节省成本,提高发送成功率,减少被列入黑名单风险。 更多需求:邮箱采集/邮件群发

制造商或进口商是否必须对未包含在 CLP 附件 VI 中的物质或包含在附件 VI 中但未分类为特定物理危害的物质进行物理危害测试,并且对于这些物质尚无足够可靠的物理危害信息?

问题(中文)
制造商或进口商是否必须对未包含在 CLP 附件 VI 中的物质或包含在附件 VI 中但未分类为特定物理危害的物质进行物理危害测试,并且对于这些物质尚无足够可靠的物理危害信息?
Question (EN)
Must a manufacturer or importer do physical hazard testing for classification purposes for substances not included in Annex VI to CLP or for substances included in Annex VI, but not classified for a specific physical hazard, and for which no adequate and reliable information is already available for the physical hazards?
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)
根据 CLP 第 40(3) 条,2010 年 12 月 1 日或以后投放市场的物质必须在投放市场后一个月内进行通报。此外,CLP 第 4(1) 条规定,制造商或进口商必须根据 CLP 第二章对其物质进行分类,然后才能将其投放市场。此外,CLP 第 8(2) 条要求,为确定某种物质是否具有 CLP 附件一第二部分所述的任何物理危害,制造商或进口商必须进行该部分所要求的测试,以便对物质进行分类,除非已有充分可靠的信息。因此,制造商和进口商必须进行物理危害测试,对未包含在 CLP 附件六中的物质或包含但未分类为特定物理危害的物质进行分类,并在其投放市场后一个月内将此分类通报给 ECHA。然而,物质可以仅以非常小的数量投放到市场上(例如,用于研发(研究与开发)的物质的数量)。这些数量可能不足以进行物理危害测试。当没有关于这些物质的物理危害的充分和可靠的信息时,制造商或进口商可能无法和/或不适合执行 CLP 附件 I 第 2 部分所要求的测试。在这种情况下,不应要求进行物理危害测试。尽管如此,应尽一切努力使用任何可用的理论方法(例如联合国测试方法筛选测试)以及专家判断来评估物理危害,并应应用最严重的分类。最后,正如 FAQ ID=186 中针对研发物质所解释的那样,如果没有可用的测试数据,也没有任何其他足够的信息表明物质应该被分类,则不需要通知 C&L 清单。
Answer (EN)
According to CLP Article 40 (3), substances placed on the market on or after 1 December 2010 must be notified within one month after their placing on the market. In addition, CLP Article 4 (1) stipulates that the manufacturer or importer must classify their substances in accordance with Title II of CLP before placing them on the market. Furthermore, CLP Article 8 (2) requires that for the purposes of determining whether a substance entails any of the physical hazards referred to in Part 2 of Annex I to CLP, the manufacturer or importer must perform the tests required in that Part, to allow classification of the substance, unless adequate and reliable information is already available. Therefore, manufacturers and importers are required to perform physical hazard testing so as to classify their substances not included in Annex VI to CLP, or included but not classified for a specific physical hazard, and to notify this classification to ECHA within one month after their placing on the market. However, substances may be placed on the market in very small quantities only (e.g. the quantity of a substance used in R&D (Research and Development)). These quantities may not be sufficient for the testing of physical hazards. When there is no adequate and reliable information already available on the physical hazards of these substances, it may not be feasible and/or proportionate for the manufacturer or importer to perform the tests required in Part 2 of Annex I to CLP. In those cases physical hazard testing should not be required. Nevertheless, every effort should be made to assess the physical hazards using any available theoretical methods e.g. UN test methods screening tests, along with expert judgment, and the most severe of the resulting classifications should be applied. Finally, as it is explained in FAQ ID=186 for R&D substances in particular, if neither test data are available nor any other adequate information indicates that a substance should be classified, a notification to the C&L Inventory is not required.