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Our take on ECHA’s Integrated Regulatory Strategy report
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Our take on ECHA’s Integrated Regulatory Strategy report

Published on 20 May 2021

The third time’s the charm for the European Chemicals Agency, ECHA, who have stepped up their efforts and are communicating their actions better in the Integrated Regulatory Strategy annual report for 2020, compared to the two previous ones. ChemSec’s Senior Chemicals Advisor Jerker Ligthart has read and reflected.

ECHA’s Integrated Regulatory Strategy annual reports provide updates on the agency’s progress regarding identifying substances of concern and prioritizing them for risk management or data generation. This third annual report contains many significant improvements, even though much remains to be done.

Grouping is great – but it doesn’t solve everything

Of course, we are pleased that the grouping approach applied by ECHA is a real efficiency leap when it comes to dealing with the vast number of chemicals. The necessity to apply a group approach instead of one-by-one assessments is something we at ChemSec have been vocal about for years.

However, we need to be careful not to rely on grouping as a silver bullet to solve all problems; especially since the groups become smaller and smaller, and more and more difficult to define, as the work progresses.

Lack of compliant registration dossiers is disheartening

The registrants are always responsible to keep their registration dossiers up to date, which ECHA has communicated to the industry many times.

Especially in light of CEFIC’s (the European Chemical Industry Council’s) boasting about boosting their efforts to get the registration dossiers updated and compliant, it is very disappointing to read over and over again that the dossiers are still not in compliance with the letter of the law, triggering a high number of corrective decisions from the performed compliance checks.

Obviously, all these deficient registration dossiers should never have been allowed to enter the system in the first place. They ought to have been blocked by a completeness check worthy of the name.

The ”low exposure” criteria is a high stakes gamble

When pooling substances to the group “Substances with no further EU RRM (Regulatory Risk Management) action currently proposed”, only one of the “low hazard“ and “low exposure” criteria need to apply.

Considering the limited amount of credible information on use, exposure and volumes available in the registration dossiers, any decision based on “low exposure” is a gamble.

Give ECHA more tasks – and money

ECHA has limited resources, and so do the member states. But looking at the statistics of which member states actually contribute, it’s clear that a majority of the states don’t invest enough in the tasks laid upon them. Instead, they rely on ECHA to do most of the work intended to be shared.

For that reason, it would be highly beneficial if ECHA would be allowed – and funded – to take over certain tasks from the member states. Of course, this doesn’t mean that the member states should surrender all of their responsibilities to ECHA; the burden should and must be shared.

Introduce fast-track classification

ECHA identifies CLH (harmonised classification and labelling) as a major roadblock to effectively deal with substances of concern.

We propose the introduction of a fast-track classification, which should be used whenever a registrant self-classifies its substance beyond the CLH. An additional upside would be a leveled playing field for all users/producers of the substance, since everyone would need to adhere to the strictest label.

Jerker Ligthart
Senior Chemicals Advisor