我如何知道何时从提供的物质中创造出了新的纳米形态？

我如何知道何时从提供的物质中创造出了新的纳米形态？

How do I know when I have created a new nanoform from a supplied substance?

纳米形态必须按照 REACH 附件 VI 第 2.4 节进行表征。一种物质可能具有一种或多种不同的纳米形态，这取决于颗粒的尺寸分布、形状和其他形态特征、表面处理和功能化以及比表面积 (SSA) 的差异。这些特征中的一个或多个的变化会产生新的纳米形态。实际上，如果您在使用购买的纳米形态时修改了任何这些特征（例如通过研磨、应用表面处理）或者从非纳米形态创建纳米形态（例如通过研磨非纳米形态，参见 QA 1838），则必须检查您的供应商是否已在其扩展安全数据表 (SDS) 中涵盖了生成的纳米形态（假设已收到一份）。要执行此类检查，您必须拥有有关所创建的纳米形态的特征的足够信息（参见问答 1832）。如果您创建的纳米形态在暴露场景中得到涵盖，则无需采取进一步措施（但您仍需检查所提供的纳米形态的使用是否在涵盖范围内，请参阅问答 1833）。您必须记录您的检查以及为得出结论而采取的措施，并在执法机构要求时提供这些信息。清晰的文档记录有助于您以透明的方式证明您的假设，并帮助执法机构更好地理解您在决策中应用的标准。

A nanoform must be characterised in accordance with section 2.4 of Annex VI to REACH. A substance may have one or more different nanoforms, based on differences in the size distribution, shape and other morphological characterisation, surface treatment and functionalisation and specific surface area (SSA) of the particles. Variation in one or several of these characterisers results in a new nanoform.  In practice, if you modify any of these characterisers while using the nanoform that you have purchased (e.g. by grinding, applying a surface treatment) or if you create a nanoform from a non-nanoform (e.g. by milling the non-nanoform, see QA 1838) you must check whether your supplier has covered the resulting nanoform in their extended safety data sheet (SDS) (assuming one has been received). To perform such a check, you must have enough information on the characterisers of the nanoforms you have created (See Q&A 1832). If the nanoform you create is covered in the exposure scenario, no further action needs to be taken in this respect (but you must still check if your uses of the nanoform supplied are covered, see Q&A 1833). You must document your check and the actions you have taken to reach your conclusion and make this information available to enforcement authorities upon request. Clear documentation helps you to justify your assumptions in a transparent way and helps the authority to better understand the criteria you have applied in your decisions.