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申请人有时会声称,其产品(使用附件XIV物质制造)的性能要求是必要的,并且源于其直接客户的需求。申请人需要提供哪些证据来证实此类声明?

问题(中文)
申请人有时会声称,其产品(使用附件XIV物质制造)的性能要求是必要的,并且源于其直接客户的需求。申请人需要提供哪些证据来证实此类声明?
Question (EN)
Applicants sometimes claim that the performance requirements for their products (made with the Annex XIV substance) are necessary and arise from demands of their immediate customers. What kind of evidence is required from applicants to substantiate such claims?
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)
申请人应提供证据,证明其产品的性能要求对于继续向客户供应产品和维持业务是必要的。在大多数情况下,这意味着申请人需要证明使用现有替代品生产的产品不符合客户规定的要求(即“不合格产品”)。一种典型的情况是,零散电镀商在向非常大的客户供货时处于弱势,他们可能难以与这些客户协商实施(目前表现较差的)替代方案。申请人负有举证责任,应就其具体情况和申请中规定的要求或 SEAC 的要求提供充分可靠的证据,例如:·规格表(几个典型示例通常就足够了)·参考相关监管批准(例如型式批准)·参考相关技术和/或行业标准/测试·与客户讨论的书面摘要·市场分析报告(包括有关欧洲经济区内外竞争对手的信息以及在欧洲经济区进口电镀产品的可能性)·客户调查(例如,关于替代品的接受度和/或可接受的性能损失)·有关以前尝试向客户提供替代品的产品的信息此列表并不详尽,根据具体情况,其他类型的文档也可能适合目的。证据应该足够清晰,以便 SEAC 能够确信,如果产品未达到规定的性能,客户就会拒绝该产品,无论要求的性质如何。
Answer (EN)
Applicants should provide evidence that performance requirements for their products are necessary to continue to supply products to their customers and maintain their business. In most cases, this implies that the applicant needs to demonstrate that products made with available alternatives do not fulfil the requirements specified by the customers (i.e. they are “off-specifications”). One typical situation is the weak position of job platers supplying to very large customers with whom they may have difficulties to negotiate the implementation of (currently lower performing) alternatives.Applicants have the burden of proof and should provide sufficient and credible evidence for their particular case and the stated requirements in their application, or on SEAC’s request, such as: ·specification sheets (a few typical examples are generally enough)·references to relevant regulatory approvals (e.g. type approvals)·references to relevant technical and/or sectorial standards/tests·written summaries of discussions with their customers·market analysis reports (including information about competitors inside and outside the EEA and possibilities to import plated products in the EEA)·customer surveys (e.g. on acceptance of alternatives, and/or acceptable loss of performances)·information about previous attempts to supply customers with products made with an alternativeThis list is not exhaustive and, depending on the case, other types of documentation could be fit for purpose. The evidence should be clear enough for SEAC to find credible that customers would reject the product if it doesn’t reach the performance stated, irrespective of the nature of the requirement.