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答案(中文)
生物杀灭剂产品必须符合 CLP 法规以及 2015 年 6 月 1 日前指令 1999/45/EC 的分类、标签和包装要求。该义务由生物杀灭剂产品法规 (EU) 528/2012 (BPR) 第 2(3)(e) 和 (m) 条以及第 69(1) 条确认。根据 BPR(第 20(1) 条),生物杀灭剂产品授权申请人必须提供生物杀灭剂产品特性摘要 (SPC) 草案,其中应考虑活性物质以及任何相关辅助配方的特性。作为强制性信息,SPC 包括危险和预防说明(BPR 第 22(2)(i) 条)。一旦获得授权,授权持有人必须确保授权产品按照已批准的SPC、CLP法规以及2015年6月1日之前的1999/45/EC指令(《生物杀灭剂法规》第69(1)条)进行分类、标签和包装。此外,授权的生物杀灭剂产品须遵守特定的标签要素,以确保有效传达其使用风险和风险管理措施的信息(《生物杀灭剂法规》第69(2)条)。当授权持有人希望更改与产品授权中的分类相关的标签要素(即危险和预防说明)或根据 CLP 法规强制要求更改时,必须将更改通知产品获得授权的所有成员国,或在相关情况下通知 ECHA(参见 BPR 第 50(2) 条和委员会实施条例 (EU) No 354/2013 关于生物杀灭剂产品变更的规定)。如果更改导致新的危险或预防说明,则需要更新授权以反映这一新情况。
Answer (EN)
A biocidal product has to comply with the classification, labelling and packaging requirements under the CLP Regulation and until 1 June 2015, Directive 1999/45/EC. This obligation is confirmed by Article 2(3)(e) and (m), and Article 69(1) of the Biocidal Products Regulation (EU) 528/2012 (BPR).
According to the BPR (Article 20(1)), the applicant for an authorisation of a biocidal product will have to provide a draft summary of biocidal product characteristics (SPC), taking into account the properties of the active substance(s) as well as any relevant co-formulant(s). As mandatory information, the SPC includes the hazard and precautionary statements (Article 22(2)(i) of BPR). Once authorisation is granted, the holder of the authorisation must ensure that the authorised product is classified, labelled and packaged in accordance with the approved SPC, as well as with the CLP Regulation and, until 1 June 2015, Directive 1999/45/EC (Article 69(1) of the BPR). In addition, authorised biocidal products are subject to specific label elements to ensure the effective communication of information on risks resulting from their use and risk management measures (Article 69(2)of the BPR).
When an authorisation holder wishes to change the label elements related to classification that are part of the authorisation of a product, i.e. hazard and precautionary statements, or is compelled by the CLP Regulation to do so, the change has to be notified to all the Member States in which the product is authorised or, where relevant, to ECHA (see Article 50(2) of the BPR and Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products. If the change leads to new hazard or precautionary statements, the authorisation needs to be updated to reflect this new condition.