REACH 2018 – The Fourth Step: Collect Data and Evaluate the Risks

After you have determined the lead registrant, and all members of the SIEF have agreed on the type of and methodology for collaboration (see step three), your task now is to collate the relevant content and then evaluate the risks.

If you are the lead registrant, you must request all the data on the substance’s properties from the members of the SIEF and then collate it. It’s helpful to use the form on page 165 of the brochure Guidance on Data Sharing.

To find data outside of the SIEF, research into the literature is required. A member of the SIEF or an external service provider can undertake the research. Portals like eChemPortal of the OECD offer good services.

Once you have all the data, your task is to examine its relevance, reliability, and suitability and determine what data is still missing for a complete registration. You and the members of the SIEF might have to purchase data, perform additional studies, and find and engage laboratory service providers. If you buy data, you must have an agreement from the owner of the data. The agreement you reach on the use of the data, either through a special letter of access or a license, should ideally apply to all co-registrants.

If you are a co-registrant, you provide the lead registrant with all the data that is to be submitted jointly. The foundation for this work is provided in Annexes VII–X of the REACH Regulation.

Once all the data is present, you can evaluate the risks. As a rule, the lead registrant and the SIEF partners jointly classify and label the substance and enter all the data into a Chemical Safety Report (CSR). This report is required for all substances that must be registered in quantities of 10 tons or more per year and per registrant. The report evaluates the risks and describes the conditions (exposure scenarios) that must be addressed when manufacturing or using the substance.

No risk disclosure is required when no exposure occurs or when no danger results from an exposure.