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关于电子液体的分类、标签和包装,CLP 和 TPD 之间有何相互作用?

问题(中文)
关于电子液体的分类、标签和包装,CLP 和 TPD 之间有何相互作用?
Question (EN)
What is the interplay between CLP and TPD regarding the classification, labelling and packaging of e–liquids?
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)
电子烟的电子液体受《烟草制品指令》(TPD,指令 2014/40/EU)监管。TPD 要求成员国确保电子烟及其补充容器只有在符合 TPD 和所有其他相关欧盟立法(第 20(1) 条)的情况下才能投放市场,包括 CLP 法规规定的义务。根据 CLP,电子烟液体的分类、标签和包装由液体的配方师或进口商负责。根据 TPD,他们还必须向成员国主管部门提交其打算投放市场的任何此类产品的通知。该通知应包括根据 CLP 对混合物的分类。TPD 对电子烟的单位包装和补充容器设定了自己的标签要求(TPD 第 20(4) 条)。此外,如果电子烟液体被归类为危险品,补充容器也必须根据 CLP 进行标签和包装。在这种情况下,单位包装必须带有 CLP 标签,并补充 TPD 相关信息。重叠信息只需指示一次:例如,TPD 要求的所有成分列表与有助于 CLP 分类的成分列表。应当注意,TPD 规定尼古丁含量不得超过 20 mg/ml,并且只有加热或非加热形式下不会对人体健康构成风险的成分才可用于含尼古丁的液体中。然而,电子液体的其他成分也被确定为危险成分,需要在电子液体的分类和标签中予以考虑。根据 TPD,电子烟装置和补充容器必须防儿童和防篡改,防止破损和泄漏,并且必须具有确保补充时不会泄漏的机制(第 20(3)g 条)。投放市场时为空的可再填充电子烟设备不受 CLP 下的标签义务约束,因为其危害取决于再填充容器的内容物。
Answer (EN)
E-liquids for electronic cigarettes are regulated by the Tobacco Products Directive (TPD, Directive 2014/40/EU). The TPD requires Member States to ensure that electronic cigarettes and their refill containers are only placed on the market if they comply with the TPD and with all other relevant Union legislation (Article 20(1)), including the obligations under the CLP Regulation. Under CLP, the classification, labelling and packaging of an e-liquid is the responsibility of the formulators or importers of the liquid. Under TPD, they must also submit a notification to the competent authorities of the Member States of any such products which they intend to place on the market. This notification should include the classification of the mixture in accordance with CLP.  The TPD sets its own labelling requirements for the unit packets of electronic cigarettes and refill containers (TPD Article 20(4)). In addition, the refill containers must also be labelled and packaged in accordance with CLP if the e-liquid is classified as hazardous. In that case, the unit packet must have a CLP label, with TPD-related information as supplemental. Overlapping information only needs to be indicated once: for example, the list of all ingredients required by TPD vs the list of ingredients contributing to classification under CLP. It should be noted that the TPD provides that the nicotine content must not exceed 20 mg/ml and only ingredients that do not pose a risk to human health in heated or unheated forms may be used in the nicotine-containing liquid. However, other components of e-liquids have also been identified as hazardous and need to be considered in the classification and labelling of the e-liquid.  According to TPD, electronic cigarette devices and refill containers have to be child- and tamper-proof, protected against breakage and leakage and have to have a mechanism that ensures refilling without leakage (Article 20(3)g). A refillable electronic cigarette device that is empty when placed on the market is not subject to the labelling obligations under CLP, as the hazards are dependent on the contents of the refill container.