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ECHA's Integrated Regulatory Strategy Annual Report Reveals Increased Need for Risk Management Actions

The European Chemicals Agency (ECHA) has recently published its latest annual report on the Integrated Regulatory Strategy. Within the report, a significant message highlights the importance of dossier evaluation in ensuring the availability of data for hazard assessment, identification of hazardous substances, and effective risk management. The report reveals that approximately 20% of completed dossier evaluation cases between 2020 and 2022 indicated the necessity for potential risk management actions.

Notably, the report provides examples where compliance checks have led to the identification of substances as vPvB (substances of very high concern) based on biodegradation simulation tests. Over the past few years, the number of Dossier Evaluation requests related to biodegradation has surged more than five-fold since 2018. Currently, approximately 100 new simulation tests are being requested each year, even for substances with relatively low volumes ranging from 10 to 100 tonnes per annum.

This significant increase in biodegradation-related evaluations marks a noteworthy shift in the use of simulation testing, which historically has been infrequently conducted on industrial chemicals. These tests are not only highly complex but also entail considerable expenses, and they pose several potential challenges. Therefore, having appropriate study monitoring support is essential for their effective implementation.

ECHA expects that the forthcoming years will bring valuable insights into the biodegradation of substances and the performance of these tests when applied to a diverse range of chemistries. This newfound emphasis on biodegradation evaluation reflects the agency's commitment to ensuring comprehensive hazard assessment and the proper management of potentially risky substances.

LINK TO THE REPORT: ECHA | Speeding up the identification of chemicals of concern Integrated Regulatory Strategy Annual Report July 2023

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