An analysis undertaken by the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung: BfR) and the German Environment Agency (Umweltbundesamt: UBA) shows that in the middle tonnage band, at least 46% of the dossiers examined do not meet the information requirements stablished by REACH. The analysis is found in REACH Compliance: Data Availability in REACH Registrations – Part 3: Evaluation of 100 to 1,000 tpa Substances, which the UBA published in March 2020.
The goal of the REACH Compliance project is to evaluate the availability and quality of information on the toxicological and ecotoxicological properties in leading and individual registration dossiers for the middle tonnage band (100-1,000 tpa). The ECHA provides the German agencies with data on a total of 2,053 registration dossiers submitted up to March 2017. The BfR and UBA examined compliance by considering eight endpoints: Developmental, reproductive, and repeated dose toxicity; mutagenicity; biotic and abiotic degradation; bioaccumulation; and ecotoxicity.
On average, the inspectors found 24% of the endpoint entries non-compliant, while the values ranged from 9% for reproductive toxicity to 46% for ecotoxicity.
The current report is the third publication on the REACH Compliance project to treat the availability of data in registration dossiers. The first report, Screening of Chemicals >1,000 tpa appeared in 2015; the second report, Evaluation of Data Waiving and Adaptations for Chemicals ≥1,000 tpa, appeared three years later. Recommendations on how to improve quality of data in registration dossiers has already been published.
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