ECHA to put existing data work as it looks beyond registration data – exec

HELSINKI (ICIS)–The European Chemicals Agency (ECHA) is looking to take a step beyond the chemicals registration data evaluation process, set to run through much of this decade, towards more strongly utilising the information it has available, according to the EU chemicals regulator’s director of risk management.

The task of logging information on the properties of every chemical used or sold in the EU has sprawled well beyond the final 2018 registration deadline due to concerns over the quality of the data in many of the dossiers.

The process of checking and improving Reach registration data is expected to run through until 2027, meaning that information gathering continues to take up a lot of the agency’s capacity.

Despite the years of work ahead on evaluating information, requesting additional tests from companies, and evaluating that data, ECHA has started to ramp up the speed of its risk management process by using the data it has already amassed, according to risk management director Peter van der Zandt.

“We’ve been focusing a lot on registration and evaluation and compliance, but we also need to move on to focus on risk management,” he said, speaking on the sidelines of the Helsinki Chemicals Forum.

“We have decided for our assessment of regulatory needs to use what is in the registration files. What is there, not to go first back to the companies and say you need to test and continue to test and whatever, that will take years,” he added.

The process of requesting additional tests or even additional data from companies to bring dossiers up to code can be a time-consuming one, and the move to use the information as is may prompt some players to be more forthcoming with additional information, according to Van der Zandt.

“We use what is there, but that is also an incentive for industry because now they know whatever is in those registration files is what those authorities will use to analyse whether or not risk management is needed,” he said.

Risk management work has already sped up dramatically since 2018, and the organisation is closing on 2,000 substances recommended to the European Commission – the EU’s executive body – for risk management work, compared with around 200 four years ago, according to representatives of the regulator.

EU REVIEW
The intensified focus on risk management comes amid an ongoing review of the Reach regulatory system, announced at the time of its new Chemicals Strategy for Sustainability in October 2020.

The Commission is expected to complete an impact assessment for the review in summer, with an eye to announcing the changes by the end of the year.

The reforms could be dramatic for some parts of the Reach legislation, according to representatives of Commission body DG Grow.

Revisions to the substance authorisation system, which restricts use of chemicals deemed hazardous – could see the process scrapped entirely, according to DG Grow senior expert Otto Linher.

“[The] restriction process is too slow to address new challenges, particularly endocrine disruption, and persistent substances. We have seen delays and we need to speed up,” Linher said.

Other options include leaving the authorisation system as is or introducing more chemical groupings and issuing derogations on a sector or end-use basis rather than case by case, but the scale of the potential revisions indicate that significant changes could be announced by the end of the year.

EXPANSION AND HARMONISATION
ECHA itself has been looking at new methods of utilising the data, according to unit heads within the organisation, such as a more integrated regulatory strategy that would utilise groupings of different chemicals to speed up parts of its mission, such as identifying candidates of risk management.

“We know that there will be some changes to the system, and we have been indicating ourselves based on our learnings from the implementation of the current system,” ECHA’s Van der Zandt said.

This is driving a renewed effort to harmonise methodologies. Former ECHA executive director Bjorn Hansen noted in 2021 that anticipated synergies between Reach and complementary systems like the Classification and Labelling of Packaging (CLP) directives have failed to materialise, which risks muddled regulatory messaging.

“We are seeing in practice that sometimes we are looking at exactly the same substance in different regulatory frameworks, and where the questions that we get from those regulatory frameworks are different,” Hansen said at the time.

“Therefore, even if we look at the same substance the advice that we give to the regulators is sometimes different, simply because it answers a different question.

“This is where we see that one substance, one assessment concept could help can help us to have a more holistic view to regulating chemicals, which can also help us to harmonise methodologies. But it also requires then that there is some harmonisation at the regulatory level,” he added.

However far-ranging the Commission reforms, ECHA’s central mandate of amassing and assessing chemicals data will remain, according to Van der Zandt.

“Our mission is always the same: we want to be the centre of knowledge on sustainable management of chemicals,” he said.

FUNDING
The news of nearly a decade’s worth of additional time to improve dossier quality coming shortly after the 2018 registration deadline slowed ECHA’s plans to make up the anticipated funding shortfall from the loss of registration fees by expanding to become a central hub for chemicals legislation in general.

ECHA has been assisting the Commission in parts of the Chemicals Strategy for Sustainability but, as Hansen noted before his departure from the agency earlier this year, these additional duties have been unpaid and with no increase in workforce, with staffing at the agency remaining in the mid-600s.

“These ad hoc contributions, that come on top of the Agency’s regular work, have been made possible thanks to the exceptional commitment and hard work of our staff, and due to efficiencies gained and increased risk tolerance in our regulatory work,” Hansen wrote in a letter to Commission director Kristin Schreiber in March this year.

Meanwhile, Van der Zandt added last week: “It is true that we are in a process where we had an ongoing implementation then you get a new policy development, where you’re asked to contribute to as well. And that is, of course, something that comes on top of what we were already doing.”

Nevertheless, the agency has an interest in remaining involved in the evolution of the wider EU legislative framework, both in terms of being able to contribute to and influence policy and, potentially, to get the chance to oversee new systems that could be in the pipeline.

“We realised as an agency that it is also in our interest to contribute to that from our learnings from the technical implementation point of view. If we can transmit that to the Commission, and they managed to incorporate that, then we might arrive at a future system that improves,” he said.

“And also, that is something that we can implement.”

The additional work has only been possible by ECHA employees taking on more work on top of their regular jobs, Van der Zandt added, and the regulator does not have the capacity to continually take on more work from the Commission without additional funding.

“That is also where we have indicated as an agency, and where the Commission has also agreed, that if we get new tasks, we also would need to have the additional resources,” said Van der Zandt.

“We cannot just keep onboarding new work tasks without extra resources.”

Front page picture: ECHA’s headquarters in Helsinki
Source: ECHA

Interview article by Tom Brown