The European Chemicals Agency (ECHA) has begun work on an open platform of information on chemicals that will collate data from multiple European Union (EU) agencies and some 70 laws under one umbrella.
Due to be operational within the next 3 years, the platform will include data on chemical hazards, exposure, environmental sustainability, and uses; alternatives to substances of concern; and a range of regulatory information, such as upcoming and ongoing substance assessments, scientific opinions, and legislative outcomes.
It forms the core of a series of measures under the one-substance, one-assessment framework, a bundle of three laws that entered into force on Jan. 1.
First proposed as part of the 2020 chemical strategy for sustainability under the EU’s European Green Deal, the framework aims to make chemical safety assessments “more consistent, transparent and efficient,” according to the European Commission, which drew up the laws.
“By establishing a one-stop shop for chemicals data, the framework has the potential to increase the predictability and transparency of regulatory processes.”
Gabriele Collatina, secretary-general, Life Science Manufacturers Association
Single chemicals can undergo multiple safety assessments, initiated under various pieces of EU legislation, by different actors and at different points in time. Public authorities will use the common data platform to share and reuse information, making these assessment processes more transparent and saving authority and industry resources, the commission says.
ECHA is tasked with taking the lead on implementing this ambition. It will establish and manage the data platform with help from other EU bodies, such as the European Environment Agency (EEA), European Food Safety Authority, European Medicines Agency, and European Agency for Safety and Health at Work.
“By joining forces with our partner agencies and authorities, we will create a system that anticipates risks and brings together existing knowledge and supports innovation,” Sharon McGuinness, ECHA’s executive director, says in a press release.
A first version of the platform is due to go live within 3 years, with a fully operational version scheduled for 10 years from now. In the meantime, the law allows ECHA to commission studies to fill knowledge gaps, such as a large-scale human biomonitoring study that is due to begin in 2030.
Support for the data platform exists from all sides
The data platform is popular, with industry seeing it as an opportunity to reduce administrative burden and environmental groups seeing a step toward better protection from chemical hazards.
“We see it as a positive development,” says Gabriele Collatina, secretary-general of the Life Science Manufacturers Association. “By establishing a one-stop shop for chemicals data, the framework has the potential to increase the predictability and transparency of regulatory processes,” he says, but he cautions that it must “rigorously protect” confidential business information and intellectual property.
The European Chemical Industry Council agrees, adding in an email that the new obligation to add industry-commissioned studies to the data platform “should be proportionate, taking into account the very large number of studies, measurements and analyses generated by industry on a daily basis.” A European trade association for small and midsize enterprises, SMEUnited, says the package can improve data- and cost-sharing for small companies. “It gives SMEs [small and medium-sized enterprises] a fair chance to stay on the market,” Marko Sušnik, who advises SMEUnited on chemicals policy, says in an email.
The EEA in an email calls the package “an opportunity to improve chemical risk assessment and data sharing at EU-level, to protect the environment and health.” The agency will cooperate with ECHA on the human biomonitoring study and help establish an early-warning system for emerging chemical risks, another task outlined in the one-substance, one-assessment framework.
Collatina cautions that ECHA’s ability to handle the wave of new tasks coming toward it “depends on the agency being adequately funded and staffed.” The agency is also taking on a series of new responsibilities previously managed by other bodies, such as preparing restriction proposals under the hazardous substances in electrical and electronic equipment (RoHS) directive and setting and reviewing limit values for persistent organic pollutants in waste.
ECHA already has multiple regulatory milestones to tackle this year, such as the mammoth assessment of the EU-wide per- and polyfluoroalkyl substance (PFAS) restriction. Meanwhile, a French ban on the persistent chemicals was enacted on Jan. 1, making France the second EU country after Denmark to preempt EU-wide action.
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