Grouping of chemicals speeds up regulatory action

ECHA/NR/20/14

To speed up identifying and managing the risks of hazardous chemicals, ECHA is screening structurally similar substances in groups. Last year, the Agency together with national authorities reviewed around 220 high-volume substances of which 56 % needed more hazard data.

Helsinki, 13 May 2020 – ECHA’s second report on the Integrated Regulatory Strategy gives an overview on the progress in addressing substances of concern and in the “mapping of the chemical universe”. It includes recommendations to authorities and industry on managing chemicals’ risks.

In 2019, ECHA moved from a substance-by-substance approach to addressing structurally similar chemicals in groups. The aim is to speed up the identification of hazardous substances and get their risks controlled more quickly. 

Together with Member States, the Agency reviewed around 220 substances registered above 100 tonnes per year and allocated them to different pools of the chemical universe for regulatory action. For 56 % of them, more data was needed to clarify the need for further risk management. For 22 % of the substances, no further action was proposed and 7 % were considered as high priority for EU regulatory risk management.

The number of substances registered above 100 tonnes and not yet assigned to a pool in the chemical universe has reduced to around 2 400. The grouping approach also enabled ECHA to scrutinise more than 300 low-production volume substances in 2019.

“The progress we have made with the Integrated Regulatory Strategy is a step towards better protecting Europe’s citizens. To gain the most impact, we have focused the work on high-volume substances, and we aim for more clarity on all chemicals registered above 100 tonnes by the end of 2020. Grouping similar substances helps to speed up and make regulatory actions more consistent. It also helps national authorities step up their efforts to manage chemical risks under REACH and other pieces of legislation,” says Jack de Bruijn, ECHA’s Director of Prioritisation and Integration.

Mapping the chemical universe and assigning substances for further action is a key part of the Integrated Regulatory Strategy. The aim is to have full clarity for all registered substances by 2027.

Report's recommendations

ECHA’s Integrated Regulatory Strategy report covers an overview of the pre-regulatory steps (screening of groups by ECHA or Member States, expert group assessment and regulatory management option analysis), the evaluation processes and the regulatory risk management activities under REACH and CLP.

It gives the following recommendations:

• Screening groups of substances, data generation and assessment should be further optimised to ensure substances are progressed to regulatory risk management without delay.
• Harmonised classification and labelling should become a priority, as it has a direct impact on company-level risk management, and is often the step before restriction, authorisation or other measures under other pieces of legislation are taken.
• The priority and appropriateness of previously identified, but still pending, follow-up actions should be reviewed and those substances which need further regulatory risk management should be progressed without delay.
• The compliance of registration information needs to be improved, in particular, for substances with a high potential for exposure and currently lacking appropriate hazard data.
• Compliance of dossiers, their systematic review and updates of registrations based on new information, remains industry’s responsibility. ECHA welcomes the initiative of industry associations to develop review programmes to help registrants review chemical safety data.
• Further enhance cooperation and coordination between authorities.

Background: chemical universe

Overall, the chemical universe of over 21 000 registered substances (both high-volume and low volume substances) includes approximately:

• 330 substances have regulatory risk management under consideration;
• 1 550 substances are under data generation;
• 390 substances that already have regulatory risk management ongoing; and
• 700 substances where currently no further actions have been proposed after authority reviews.