ECHA announces appeal over need to use updated dossier

German-based speciality chemicals producer Thor has requested the European Chemical Agency’s Board of Appeal instruct the agency to use an updated dossier in order to reach a final decision on testing requirements for its dossier on an organic nitrogen-phosphorous compound. ECHA’s compliance check decision on the dossier in question requests Thor to provide a robust study summary for skin sensitisation using the local lymph node assay. It also asks the company to submit information using the following test methods: the 90-day sub-chronic toxicity study on rodents by the oral route; screening for reproductive/developmental toxicity, one species; and pre-natal development toxicity, one species, by the oral route. The company says that although the agency had said an update of the registration dossier was possible at any time during the decision-making process, an update containing an exposure-based waiving strategy had not been taken into account by ECHA “on the grounds that the decision-making process was at its final stages at the time the update was received”. As a result, Thor says the dossier compliance decision was adopted on the basis of an old version of its registration dossier and it does not know if and how its registration dossier update would have affected the contested decision. It says that its data waiving strategy needs to be evaluated before a decision is reached on the need for additional testing. Further information on the appeal is available at: Appeal

Chemical Watch, 9 July 2012 ;http://chemicalwatch.com ;