May 24, 2024 by Rhiannon Smith


As discussed in our previous blog, the consultation on the Alternative Transitional Registration model (ATRm) for UK REACH indicates that there is potentially a significant reduction in the amount of hazard data which registrants would need to submit. However, companies should not forget about other aspects of the registration process that they still need to address – key among these is the requirement for each registrant to submit their own analytical data on the substance being registered. This is particularly important for companies who were previously downstream users and who now have registration obligations under UK REACH, who also may not be familiar with the requirements to submit analytical data, or the format needed for registration.

Each registrant must submit suitable analytical data which are sufficient for them to confirm to the regulators the identity of the substance which they are manufacturing/importing. This usually consists of quantitative chromatography (HPLC, GC), and qualitative structural data (e.g. IR, NMR, UV-Vis), though the techniques may vary depending on the properties of the substance. For UVCBs, information on the source (i.e. raw materials) and method (i.e. description of the manufacturing process) are also required. Other analytical techniques may also be expected for certain types of substances.

The requirement for each registrant to submit analytical data is important for confirming substance composition profiles and substance sameness and this information is something which each company needs to generate and submit themselves, unless they are importers and this information is provided by their non-UK suppliers. For companies that have not previously done this, it is important to start early as it is can be complex to prepare the sample for analysis, particularly if the substance needs to be isolated from other components during manufacture, and to develop suitable analytical methods to identify the substance and its typical composition (i.e. identify and quantify constituents present in the sample). All constituents present at ≥10% should be identified as well as all constituents present at ≥0.1% which are relevant to the classification of the substance. The analytical data then needs to be interpreted and used to complete the relevant company-specific sections of the IUCLID dossier.

wca have extensive experience working with companies to assist them with generating and interpreting analytical data for their substances, and with reporting the analytical data and composition of the substances in IUCLID dossiers.