07 Apr Some tips on how to make your registration fulfil REACH information requirements
Some tips on how to make your registration fulfil REACH information requirements
Some tips on how to make your registration fulfil REACH information requirements Registrants are obliged to keep their REACH dossiers up-to-date by following the latest requirements under REACH. Therefore, registrants need to be aware of the amended REACH annexes, updated guidelines and latest recommendations. ECHA has further updated its recommendations to registrants on how to improve their registrations to meet the compliance checks and following recent changes in information requirements under REACH. However, these recommendations are more like general reminders on things to look out for instead of cooking books with clear step descriptions. So what are the critical points to make a registration fulfil REACH information requirements? We provide the following tips:
Pass manual checks for chemical safety reports: From March 2021, the manual completeness check covers Chemical Safety Report (CSR). This manual check includes several detailed points in the CSR. For example, how to name uses and contributing activities, refer to no effect observation, and report exempted uses in the exposure assessment. To make this relatively detailed check easy to follow, ECHA provided a webinar and addressed some practical advice.
First-time wright principle for read-across approaches: If the read-across approach is rejected under compliance check, testing with the target substance will be requested. Ultimately, the dossier will be more costly and time-consuming. Therefore, it is essential to construct a solid read-across justification in order to pass the compliance check. The read-across justification must address the chemical structure similarity, physical-chemical properties, environmental fate behaviour, the target endpoints, etc., of both target and source substance(s). Documentation should be transparent and the approach should be unbiased.
Legal changes which impact your waiving approaches: The amended column 2 of Annex VII to X of Regulation (EC) 1907/2006 is in force from January 2022. Among the changes, one update deserves extra attention. The low octanol-water partition coefficient (LogKow) property alone is not sufficient to waive studies for bioaccumulation and adsorption//desorption endpoints. This change will result in many waivers in previously submitted dossier becoming invalid since low LogKow value is one of the most commonly used justifications. To apply for waivers, the substance’s adsorptive or bioaccumulative properties have to be not solely driven by lipophilicity. For showing that, an expert statement may be required to discuss the surface active and/or ionisability of the substance.
For 75% of the compliance checks performed in 2021, additional information was requested
Conclusion Due the updates on the REACH information requirements and increasing scrutiny on REACH dossiers in evaluation, it is likely that your REACH dossier needs some attention. We can help you by performing a vulnerability check on your REACH dossiers. This check is based on the latest information requirements and insights in REACH. Potential issues, but also solutions to overcome them will be included in a clear overview report. This is the most efficient way to identify weak points in your dossiers and avoid any “surprises” during dossier evaluation. In addition, it will give you sufficient time to make decisions on handling these issues with minimal impact on your business activities.
Need more information or professional support to your case? Feel free to contact Paul Stoffels tel: +31 6 5280 3578