High-tonnage substances that raise potential concern for human health and the environment were prioritized for evaluation based on ECHA’s compliance check strategy. For the majority of the dossiers examined, it was not possible to conclude whether the substance was of concern or not, due to missing data on one or more key endpoints. More specifically, out of 107 dossiers, covering 853 (eco-)toxicology endpoints, data gaps were found in 88 cases. These were “mostly due to poorly justified waiving of standard tests” and most often concerned pre-natal developmental toxicity and mutagenicity endpoints. Overall, in 2015 ECHA concluded 183 compliance check evaluations and issued 144 compliance check decisions. The agency started publishing a list of substances potentially subject to compliance checks, in order to encourage registrants to update their dossiers in advance.
“Our compliance check strategy targets the substances with the greatest impact on people and the environment. The checks have shown that crucial data is missing in many of the registrations we targeted. I encourage industry associations to motivate their members to fill the knowledge gaps in order not to delay the conclusion on whether their substances are of concern or not,” says ECHA’s Executive Director Geert Dancet.
Further, ECHA examined 184 testing proposals and took 194 decisions. With the aim to promote the use of non-animal methods, registrants are now explicitly requested to consider alternatives to their proposed vertebrate testing; this information is published as part of the public consultation on the testing proposal. 300 follow-up evaluations were conducted to see whether the registrants had provided the information requested in previous ECHA decisions. Compliance was found in 86 % of the cases. In 44 cases, national enforcement actions had to be called for.
The report concludes by giving specific recommendations for both current and prospective registrants, concerning in particular alternative testing methods, a read-across assessment framework (RAAF), communication and planning activities during the substance evaluation process, and the need for accurate substance identification.
ECHA (February 25, 2016). “Evaluation report 2015: checking for key data gaps on substances of potential concern.”
ECHA (February 25, 2016). “Evaluation under REACH Progress Report 2015.” (pdf)
ECHA (September 24, 2014). “Safer chemicals – focusing on what matters most.” (pdf)