聚合物进口商有义务注册单体或其他与聚合物化学结合的物质。他们是否必须提交用于生产该聚合物的原始物质的光谱数据和色谱图？

聚合物进口商有义务注册单体或其他与聚合物化学结合的物质。他们是否必须提交用于生产该聚合物的原始物质的光谱数据和色谱图？

Importers of polymers are obligated to register monomers or other substances chemically bound to the polymers. Do they have to submit spectral data and chromatograms of the original substances used to manufacture the polymers?

是的。注册与聚合物化学结合的单体或其他物质时，必须包含用于制造该聚合物的原始单体或其他物质的光谱数据和色谱图。如果技术上不可行，或者科学上似乎没有必要包含这些信息，则需要明确说明原因。通用光谱数据或通用色谱图不予接受，因为它们无法反映用于制造该聚合物的单体或其他物质的实际成分。一家公司可能从不同来源进口某种聚合物，因此用于制造该聚合物的单体或其他物质也可能来自不同的来源。即使一家公司只从一个来源进口聚合物，也可能发生用于制造该聚合物的单体或其他物质来自不同来源的情况。在这种情况下，聚合物进口商有责任评估来自不同来源的单体或其他物质的同一性。如果他们认为不同来源的物质相同，则只需为该物质提交一份注册，其中包含一组光谱数据和一张代表性色谱图。在此过程中，他们可能仍然会发现不同来源的物质具有不同的杂质谱。然后，他们需要在注册卷宗中参考该物质的这些不同成分。

Yes. The registration of a monomer or other substance chemically bound to a polymer has to include spectral data and a chromatogram of the original monomer or other substance used to manufacture the polymer.If it is not technically possible, or if it does not appear scientifically necessary to include this information, the reasons need to be clearly stated. Generic spectral data or a generic chromatogram cannot be accepted as this would not reflect the actual composition of the monomer or other substance used to manufacture the polymer.It may be the case that a company imports a type of polymer from different sources, and therefore a monomer or other substance used in the manufacture of this polymer probably also stems from different sources. Even when a company imports a polymer from just one source, it can happen that a monomer or other substance used in the manufacture of this polymer stems from different sources.In these cases, the importer of the polymer is responsible for assessing the sameness of the monomer or other substance from the different sources. If they consider that the substances from the different sources are the same, they have to submit just one registration for this substance with one set of spectral data and one representative chromatogram. In this process, they might still have found out that the substance from the different sources has different impurity profiles. They need to then refer to these different compositions of the substance in their registration dossier.