Deficient Registration Dossiers

Experts from the [German] Federal Institute for Risk Assessment (Bundesamt für Risikobewertung (BfR)) and the Federal Environment Agency (Umweltbundesamt (UBA)) have collaborated to examine some 1,932 registration dossiers of leading and individual registrants of phase-in substances that have an annual production of 1,000 tons or more. The results? Six of ten dossiers do not meet legal requirements. The study thus confirms the results of the ECHA Progress Report published in 2014.

Above all, the examiners criticized the data gaps in the use of read across methods and quantitative structure – activity relationship models (QSAR) along with unclear entries for substance identification. They also found fault with the information given for the physical and chemical properties of substances of unknown or variable composition (UVCB), complex reaction products, and biological materials. In addition, they criticized the documentation of the test methods that did not follow standard procedures.

However, the authors of the study also see an obligation for the regulators. The experts support clearer test requirements and greater clarity about the cases that permit the use of substitute data. Previous formulations in the annexes of the REACH regulation or in the ECHA Guidelines allow too much room for interpretation.

At the same time, the study’s sponsors appeal to companies that must register materials to continue to improve the quality of the dossiers. At KFT, we’re pleased to support you in this undertaking. Please contact us at reach@kft.de.