ECHA records 50% increase in REACH dossier compliance checks in 2019
The Registration, Evaluation, Authorisation, and restriction of Chemicals (REACH) dossiers comprise important safety data that has been requested to clarify long-term effects of chemicals on human health and the environment.
The 3,000 dossiers covered 274 unique chemicals, according to ECHA, with decisions to make the registration compliant sent to all registrants of the chemical. This was amended from an earlier practice, in which only the lead registrant was contacted, and resulted in better collaboration among co-registrants.
More checks were also carried out on dossiers from companies that registered chemicals separately from joint submissions, to ensure that the reason for submitting dossiers separately was legally justified and that data-sharing obligations are met.
Additional information was requested in 245 of the 301 checks, with most asking for clarification on the long-term effects of chemicals on the development of unborn children, genetic mutations and aquatic toxicity.
In the last 10 years, ECHA has carried out in-depth checks of more than 1,000 chemicals across all tonnage bands. Over 20% of the large volume chemicals with the highest potential exposure have been checked in depth. More than 10% of the checked chemicals have been proposed as candidates for harmonised classification at European Union/European Economic Area level.
“Chemical safety impacts citizens’ health,” commented Bjorn Hansen, executive director of ECHA. “We know that European consumers are more worried about impacts of chemicals than ever before. To make sure companies follow the law and ensure the safety of the chemicals they sell, we have stepped up our efforts to check more registrations. This work is crucial to prevent harmful chemicals entering the EU market and ultimately minimising chemical pollution in Europe.”
Cefic, the European Chemical Industry, released the following statement in response to the annual REACH evaluation report:
“Providing high-quality data in REACH dossiers is the industry’s utmost priority and we continuously work with the ECHA to make sure any data and knowledge gaps are addressed.
“We support ECHA’s new approach in 2019 to send decisions on registration dossiers to all registrants of a chemical, not only to the lead registrant. We believe this will accelerate the generation of additional data by all members of a consortium if requested by ECHA.
“One of our priority areas for collaboration with ECHA this year is the development of “best practices” on defining testing strategies for substances, aligned with ECHA’s expectations. This will help to keep animal testing to a strict minimum, as mandated by REACH, and will decrease the number of requests for additional data and tests by ECHA without compromising the quality of safety data.
“This work is part of Cefic’s ongoing Action Plan on REACH dossier improvement launched in 2019. More than 170 companies have already joined this voluntary Action Plan pledging to review chemicals safety data in their dossiers. In practice, this means that the dossiers of nearly 70% of all substances registered in the high volumes (above 100 tonnes) will be reviewed and, if needed, improved over the coming years in close collaboration with ECHA. Cefic will report on the progress of the Action Plan at the end of March.”