EU chems regulator cools down industry’s confidence on substances dossiers


LONDON (ICIS)–The European chemicals trade group Cefic published this week an optimistic analysis on how chemicals companies across the EU are managing to fulfil their obligations under the 27-country bloc’s regulatory regime Reach.

Under Reach, companies or a group of companies must register the chemicals they are producing or trading; the framework is the strictest chemicals regulation globally, and entrepreneurs often complain its associated costs dent their global competitiveness.


A key concern repeatedly expressed by the EU’s chemicals regulator in charge of policing Reach, the Helsinki-based European Chemicals Agency (ECHA), has always referred to the quality of the dossiers filed, as many are incomplete.

Whether this was done out of naivety or to deliberately delay the implementation of Reach, proposals to fix the data gaps were in quite a small number.

While Cefic praised its relation with ECHA during 2020, arguing that more clarity had been achieved after a joint pilot project was set up for the chemical industry to understand better what ECHA’s expectations of the quality of chemicals safety data were.

“The objective of the project was to explore different read-across approaches and testing strategies in order for companies to provide new data, where needed, and improve compliance of registrations under Reach. New testing has been or will be performed as a result,” said Cefic.

But in a written response to ICIS, a spokesperson for ECHA said that the “commitment and efforts” by the chemicals industry so far were laudable, much more progress would be required to achieve the regulatory regime Reach draws up.

“We welcome the number of dossier updates, but in terms of testing strategies and testing proposals to address data gaps, it is too early to say anything as we have only received few,” the spokesperson added.

“We encourage the companies to continue their efforts and to also check the advice on our website to review their dossiers.”


As progress has overall been slow in filing and updating dossiers, small increase in compliance could be presented as large jumps ahead.

According to Cefic’s second progress report on the implementation of the industry’s voluntary Action Plan for Reach dossiers’ update and improvement, the number of dossiers evaluated in 2020 had shot up by 55% year on year.

Other findings, according to Cefic, included:

– The voluntary commitment was signed by 190 Cefic member companies, representing 1,355 legal entities holding Reach registration dossiers.

– 2,731 Reach registration dossiers were re-evaluated in 2020, which is 55% more compared to reported re-evaluated dossiers in 2019, bringing the total of all evaluated dossiers to 4,489 since June 2019.

– Based on the forecasts submitted by member companies, it is estimated that 7,170 Reach lead registrants’ dossiers will have been reviewed by 2026, representing one-third of all substances or more than half of all non-intermediate substances registered under Reach.

Sylvie Lemoine, the executive director for product stewardship at Cefic, said that Cefic remains committed to working with ECHA to improve the quality of the dossiers.

“More work will be done by participating companies over the next years to better understand potential data gaps and submit testing proposals, where needed,” she said.

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ICIS, 8 April 2021