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如果已指定注册机构 (OR) 履行非欧盟制造商的注册义务,但不履行其授权义务,欧盟进口商是否可以申请授权?如果可以,以哪个角色(进口商还是下游用户 (DU))申请?
问题(中文)
如果已指定注册机构 (OR) 履行非欧盟制造商的注册义务,但不履行其授权义务,欧盟进口商是否可以申请授权?如果可以,以哪个角色(进口商还是下游用户 (DU))申请?
Question (EN)
If ORs have been appointed to fulfil the registration obligations of non-EU manufacturers but not their authorisation obligations, can the EU importer instead apply for authorisation? If so, under which role (importer or downstream user (DU))?
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)
非欧盟制造商的欧盟进口商,无论其是否受附件XIV物质注册机构(OR)的管辖,均可申请授权。如果OR的任命未涵盖进口商履行授权义务,则进口商可自行申请授权。在这种情况下,进口商将以附件XIV物质进口商的身份提出申请。此外,进口商无需在提交给欧洲化学品管理局(ECHA)的授权申请中注明非欧盟制造商或OR的名称,因为OR的任命及其各自的义务仅限于附件XIV物质的注册。
Answer (EN)
EU importers of a non-EU manufacturer can apply for an authorisation irrespective of whether they are covered by an OR for registration of the Annex XIV substance. If the appointment of the OR does not extend to also cover the fulfilment of the obligations of the importers with regard to authorisation, then the importers themselves can apply for an authorisation. In such a case, the importers will apply in their role as importers of an Annex XIV substance. Furthermore, the importers are not required to indicate the name of the non-EU manufacturer or the OR in their application for authorisation sent to ECHA, since the OR's appointment and their respective obligations are limited to the registration of the Annex XIV substance.