如果我可以证明该组中纳米形态的危害、暴露和风险评估可以联合进行，我是否可以将纳米形态纳入一组纳米形态中，这与指南中规定的限制相矛盾？

如果我可以证明该组中纳米形态的危害、暴露和风险评估可以联合进行，我是否可以将纳米形态纳入一组纳米形态中，这与指南中规定的限制相矛盾？

Can I include nanoforms within one set of nanoforms, which contradict the limitations set out in Guidance, if I can justify that the hazard, exposure and risk assessment of the nanoforms in the set can be performed jointly?

附录中描述的适用于《注册与物质识别指南》的纳米形态原则，为注册人提供了如何构建纳米形态集合的建议。遵循指南中的原则，可以减少为该集合制定复杂论证的需要。纳米形态集合形成的限制基于科学共识得出的假设。共识越强，限制越严格。对于最严格的限制（例如，纤维和球体形状必须在不同的纳米形态集合中处理），科学共识使得该假设被视为不可反驳。对于其他限制，偏离指南中规定的原则将增加论证的复杂性以及所需的支持证据，这将提高对论证的审查力度。无论如何，对于每组纳米形态，必须始终提供强有力的论证，证明可以对集合中的所有纳米形态进行联合危害、暴露和风险评估。注册人有责任制定论证并提供支持论证的数据。论证的完整性将在技术完整性检查中进行检查，其合规性将在潜在合规性检查中进行检查。

The principles described in the Appendix for nanoforms applicable to the Guidance on Registration and Substance Identification for forming a set of nanoforms give advice to the registrants on how to build a set of nanoforms. Following the principles in the Guidance reduces the need for development of complex justifications for the set.  The limitations for the formation of sets of nanoforms are based on presumptions resulting from a scientific consensus. The stronger the consensus, the stricter the limitation. For the strictest restrictions (e.g. fibres and sphere shapes must be addressed in different sets of nanoforms), the scientific consensus is such that the presumption is considered not rebuttable.    For other restrictions, deviating from the principles set in the Guidance will increase the complexity of a justification as well as the supporting evidence required, and this will increase the level of scrutiny given to the justification.  In any case, for each set of nanoforms a robust justification that the hazard, exposure and risk assessment can be performed jointly for all nanoforms in the set must always be provided. It is the responsibility of a registrant to develop the justification and provide the data supporting the justification. The completeness of the justification is checked during the technical completeness check and its compliance in a potential compliance check.