First assessments of regulatory needs for groups of chemicals published

ECHA/NR/21/28

The first assessments cover over 450 substances in 19 groups. For 18 of these groups, regulatory risk management measures or further data are needed. ECHA and Member States have been assessing the regulatory needs of groups of substances in an effort to speed up regulatory action on chemicals of concern, protecting people and the environment, and avoiding regrettable substitution. Check if your substances have been assessed.

Helsinki, 7 December 2021 – Among the first published assessments are four groups of phthalates and phthalates like substances that were assessed as a group due to their potential reprotoxic, endocrine disrupting, or persistent, bioaccumulative and toxic (PBT) properties.

For some of these phthalates, a restriction has been proposed to limit their potential releases from articles. In addition, some need harmonised classification and labelling as well as identification as substances of very high concern (SVHCs). For other substances in these groups, there is not currently enough information to confirm the potential hazard and a few do not require any new regulatory actions for the time being.

As another example to protect workers and the environment, nine structurally similar substances that include pyrazole moiety are proposed to be restricted in fertilisers. Some of the substances in this group are potentially toxic to reproduction and may be endocrine disruptors. They are also potentially persistent and mobile in the environment.

“Assessing the regulatory needs for groups of substances is a major step forward in speeding up regulatory action to protect people and our environment from the risks posed by hazardous chemicals. It is also a stride towards the ambitions of the EU’s Chemicals Strategy for Sustainability and Green Deal. Group assessments make it easier for companies to predict what actions regulators are planning and, where relevant, help them prepare strategies to replace harmful chemicals with safer alternatives”, says Bjorn Hansen, ECHA’s Executive Director.

Registrants of those substances for which new risk management is expected are encouraged to start preparing by updating their registration dossiers, verifying the use information, and anticipating the impact of the proposed measures.

Background

As part of ECHA’s Integrated Regulatory Strategy, ECHA and EU Member State authorities have assessed the regulatory needs for groups of chemicals since 2019. Authorities decided to address structurally similar substances in groups to accelerate the identification of substances that need to be regulated.

So far, ECHA has assessed the regulatory needs of around 120 groups, covering more than 3 000 substances. For more than half of the assessed substances, based on the available information there is currently no need for additional regulatory action foreseen. To confirm this conclusion, however, for many of these substances, data generation is proposed as an immediate action. All of these assessments will be gradually published on ECHA’s website in the Public Activities Coordination Tool (PACT).