ECHA Will Consider Downgrade of Tonnage Band When Evaluating Dossiers
When a company reduces the production volume of a chemical and updates the dossier accordingly, the ECHA will consider the reduction when evaluating the registration dossier. However, the company involved must present proof indicating the amount of the chemical that was imported or manufactured the previous year. The ECHA clarified its policy at the end of July in a press release.
The policy is based on a decision of the ECHA Board of Appeal (BoA) in November 2021. The Board decided that the agency must take a reduced production volume into account and consider it as substantial new information when evaluating the dossier. The ECHA’s inspectors had originally linked the information to a deadline, so that the company had to report the tonnage downgrade during the ongoing assessment process. If the ECHA already had a draft decision on the dossier, the inspectors did not consider the changes to the dossier and requested more data from the company than was necessary based on the actual tonnage band.
The production volume is a crucial parameter for companies. The smaller the tonnage band is, the less data is required for the dossier.
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