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答案(中文)
原则上,根据 REACH 法规第 26(1) 条(IUCLID 中称为“类型 3”),注册物质前始终有义务进行调查。调查流程旨在使同一物质的潜在注册人和先前注册人相互联系,共享数据及其成本,并在相关情况下共同提交信息。当注册人达到下一个吨位门槛且吨位等级增加时,也应进行调查(第 12(2) 条,IUCLID 中称为“调查类型 4”)。同样,如果注册人将其档案从“中间”(即遵循第 17(2) 条或第 18(2) 条的信息要求)更新为“完整”,也适用此规定。在上述两种情况下,如果有相关研究可供参考,且与之前的注册人共享数据的谈判失败,则调查是根据 REACH 第 27 条提交数据共享争议的先决条件。必须注意的是,执法机构可能会将不进行调查视为违反 REACH 第 26 条。这在吨位等级提高的情况下尤其重要,因为第 12(2) 条规定,一旦达到下一个吨位门槛,就必须进行调查。进行调查可以向执法机构表明注册人正在努力采取措施获取下一个吨位门槛所需的数据。上述考虑也适用于主要注册人,特别是因为该物质的其他注册人可能已在选择退出的档案中提交了相关数据。下表列出了(潜在)注册人可能遇到的情况;(潜在)注册人提交调查档案的义务;调查类型将在 IUCLID 档案第 14 节中指定。有关调查程序的更多详情,请访问 ECHA 网站。
Answer (EN)
In principle, there is always an obligation to make an inquiry before registering a substance, in accordance with Article 26(1) of the REACH Regulation (referred to as ‘Type 3’ in IUCLID). The purpose of the inquiry process is to put potential registrants and previous registrants of the same substance in contact with each other. This is to share data and its costs and, where relevant, to submit the information jointly.An inquiry should also be made in situations when a registrant reaches the next tonnage threshold and there is an increase in tonnage band (Article 12(2), referred to as ‘inquiry Type 4’ in IUCLID). Similarly, this also applies in case a registrant updates its dossier from ‘intermediate (i.e. following the information requirements of Article 17(2) or 18(2)) to ‘full’. In both the above scenarios, in case relevant studies are available and the negotiations to share this data with the previous registrants fail, the inquiry is a pre-condition for submitting a data sharing dispute pursuant to Article 27 REACH. It must be noted that not making an inquiry may be regarded by the enforcement authorities as a breach of Article 26 of REACH. This is particularly relevant in case of increase of tonnage band, where Article 12(2) provides that an inquiry must be made as soon as the next tonnage threshold is reached. Having made an inquiry may show to enforcement authorities that the registrant is diligently taking steps to obtain the data required at the next tonnage threshold. The above considerations are also relevant for lead registrants, in particular since other registrants of the substance may have submitted relevant data in an opt-out dossier.The following are grouped in the table below :the scenarios that a (potential) registrant may encounter(potential) registrant’s obligation to submit an inquiry dossierthe type of inquiry to be specified in section 14 of the IUCLID dossier. Further details on the inquiry procedure can be found on ECHA’s website.