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如果低吨位等级物质的潜在注册人无法参与相关研究,他们是否需要应用同一物质在高吨位等级的分类和标签?他们是否需要承担这项研究的费用?

问题(中文)
如果低吨位等级物质的潜在注册人无法参与相关研究,他们是否需要应用同一物质在高吨位等级的分类和标签?他们是否需要承担这项研究的费用?
Question (EN)
Do potential registrants of a substance in a low tonnage band need to apply the classification and labelling attributed to the same substance at a higher tonnage band, if they have no access to the relevant study? Do they have to contribute to the cost of this study?
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)
所有潜在物质注册人必须审查所有可用信息,并根据与先前注册人达成的共识,应用其物质的相关分类和标签。如果他们不同意该分类,可以决定“退出”此信息要求,并提出不同的分类,只要他们能够合理地解释其决定的理由(REACH 第 11(3)(c) 条)。然而,如果低吨位物质的潜在注册人在其吨位范围内注册不需要进行此类研究,则无需承担研究费用(REACH 第 11(2) 条)。
Answer (EN)
All potential registrants of a substance must examine all available information and apply the relevant classification and labelling for their substance as it has been mutually agreed with the previous registrant(s). If they disagree with this classification, they may decide to ‘opt-out’ from this information requirement and propose a different classification, as long as they appropriately justify their decision (Article 11(3)(c), REACH).Nevertheless, potential registrants of a substance in a low tonnage band do not have to contribute to the cost of a study if this study is not required for a registration in their tonnage band (Article 11(2), REACH).