In an article published on March 17, 2016 news provider Chemical Watch reports on a ruling by the European Chemicals Agency’s (ECHA) Board of Appeal (BoA) stating that ECHA “has failed to adequately examine the completeness of [a registrant’s] dossier.” In the case at hand, the lead registrant of the substance charcoal claimed that another registrant’s dossier for the same substance should be deemed invalid because it lacked “basic physicochemical and toxicological data, including any vertebrate animal studies, and is devoid of all relevant content.” Therefore, said registrant should not have received a registration number by ECHA, the lead registrant argued. ECHA stated that the dossier “completeness check process is fully automated from the point of receipt of the registration dossier to the issuing of the decision.” Further, “the IT system used for performing completeness checks is not designed to verify whether the text inserted by registrants in their registration dossiers is meaningful but merely if information exists,” ECHA added.
According to the European regulation on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), “[t]he completeness check shall not include an assessment of the quality or the adequacy of any data or justifications submitted.” However, the BoA judged that determining the presence of all the elements required by REACH in a registration dossier “does not constitute an assessment of the quality or the adequacy of any information submitted.” Further, ECHA acknowledged that “there are certain flaws in the automated system” which apparently allow the processing of incomplete registration dossiers. Therefore, the BoA found that ECHA has failed to adequately check the dossier in question regarding the data requirements of REACH.
The non-profit organization for environmental law ClientEarth commented on the situation by stating that “ECHA has created […] a system that made the REACH basic principle of ‘no data, no market’ meaningless” and “now potentially thousands of chemicals are on the market without any safety information.”
Chemical Watch (March 17, 2016). “Board of Appeal upholds Osor principle.”
ECHA BoA (March 15, 2016). “Decision of the Board of Appeal of the European Chemicals Agency – 15 March 2016.” (pdf)