A leading international chemical manufacturer.
Manufacturers of chemicals in, or importers into, the European Union are required under the REACH regulation to submit a dossier of information on their substances to the European Chemicals Agency (ECHA). The Agency can, after evaluating the information provided by the registrant, require the company to update or amend their dossier, including with the addition of new experimental data. This is called a “Compliance Check decision”.
Following receipt of Compliance Check decisions for several of their substances, the client asked bibra to provide expert support in revising the dossiers in IUCLID by updating existing study summaries to remedy the issues highlighted by ECHA, and by generating summaries of a large programme of newly-commissioned human health, environmental fate and ecotoxicity data.
Approach and outcome
Bibra was asked to assist with updating the REACH registrations dossiers for several high-volume substances, subject to the maximum information requirements. These substances have a number of industrial, professional and consumer uses, so ensuring that the data package was complete and the risks are adequately controlled was of the utmost importance.
Several of the existing IUCLID study summaries were highlighted by ECHA as being deficient. Bibra worked with the client to improve these and bring them in line with current guidance and rules around completeness. One of the key issues, frequently raised by the Agency, is the identity of the test material. Ensuring that this was properly described in the dossier required several meetings between bibra and the client.
Working closely with the client and other members of the Consortium, bibra provided expert advice on testing strategy and liaised with the subject matter experts to ensure the studies were reported to sufficient detail and in the most appropriate format for inclusion into IUCLID. In several cases, the data being generated were from non-standard methods, and bibra worked with the client to prepare robust explanations for these adaptations, as well as justification for the use of in silico models and read-across approaches.