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如果我的混合物也属于另一项立法的管辖范围,我是否需要根据第 45 条进行通知?
问题(中文)
如果我的混合物也属于另一项立法的管辖范围,我是否需要根据第 45 条进行通知?
Question (EN)
Do I need to notify under Article 45 if my mixture also falls under another legislation?
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)
在某些情况下是的。CLP 附件 VIII 提出的要求可能与其他现有欧盟法规部分重叠。在这种情况下,责任人需要同时遵守这两项法规。例如,《生物杀灭剂产品法规》(BPR)和《植物保护产品法规》(PPPR)就是如此。它们要求责任人提供有关混合物的鉴别、化学成分和危害的完整信息。在其他情况下,则不是。如果产品处于成品状态并在投放市场时供最终用户使用,则 CLP 及其第 45 条不适用于第 1(5) 条规定的任何特定产品法规所涵盖的产品,例如化妆品、食品和饲料以及药品。同样,如果医疗器械是侵入性的或用于与人体直接接触,则不受此限制。如果您不确定您的产品是否属于这些法规的管辖范围,请咨询相关国家主管部门。
Answer (EN)
In some cases, yes. The requirements introduced by Annex VIII to CLP may partially overlap with other existing EU legislation. In such cases, the duty holder needs to comply with both regulations. This is the case, for example, of the Biocidal Products Regulation (BPR) and the Plant Protection Products Regulation (PPPR). They require duty holders to provide full information on the identification, chemical composition and hazards of the mixture.In other cases, no. CLP and subsequently Article 45, does not apply to products that are covered by any of the product-specific legislation specified in Article 1(5) if they are in their finished state and intended for the final user at the moment of placing on the market e.g. cosmetics, food and feedstuffs, and medicinal products. Similarly, medical devices are exempt if invasive or used in direct physical contact with the human body. Please consult with your relevant national authority if you are unsure whether your products fall under these legislations.