ECHA

Addressing the risks of chemicals of concern is at the core of Europe’s chemicals legislation. Being able to do this calls for wide cooperation – national authorities, ECHA and the European Commission all have a role to play. Learn how these actors work together through the voluntary platform RiME+ to help protect human health and the environment.

In mid-May 2020, ECHA published its second report under the Integrated Regulatory Strategy which tells of the progress made in identifying and managing substances of concern under REACH and CLP.

To efficiently implement this strategy, ECHA, the Member States and the Commission need to align their priorities and coordinate how to best carry out the work.

Sharing and coordinating the work

One of the key changes brought about by the strategy has been the move towards addressing substances that are structurally similar in groups rather than individually.

ECHA systematically screens available information from REACH registrations and other databases to identify which substances need further regulatory actions. Some of the follow-up activities are managed by ECHA – in particular when further information on hazards needs to be generated through compliance checks.

Member States are working on other tasks, such as:

• complementing hazard information through substance evaluation;
• carrying out regulatory management option analyses (RMOAs);
• proposing substances to be identified as substances of very high concern (SVHCs);
• preparing harmonised classification and labelling proposals; or
• drafting restriction proposals.

Eva Stocker. Image: Eva Stocker.

“As this work is not legally formalised within REACH, it is very important to have a common understanding on the way substances are selected and further managed, depending on the data needs and risk profile.”

As many different authorities are involved in the work, coordination and informal discussions are needed to build a common understanding on how different types of substance groups should be addressed, which is the best approach to get sufficient clarity on the level of concern and what are the best ways to manage the concerns under the regulatory processes.

To facilitate these discussions, ECHA maintains an informal Risk Management and Evaluation (RiME+) platform where these topics can be further developed and discussed between Member States, ECHA and the Commission.

A platform for exchanging views

“This platform allows us to develop common tools and approaches to harmonise the risk management and screening work as much as possible. As this work is not legally formalised within REACH, it is very important to have a common understanding on the way substances are selected and further managed, depending on the data needs and risk profile,” says Ms Eva Stocker, Senior Expert in risk management at the Austrian Environment Agency, who tells that Austria has been part of the RiME work from the start.

Another longstanding member of the platform is Dr Frauke Averbeck, Scientific Officer at the German Federal Institute for Occupational Safety and Health. “Being part of RiME+ gives REACH colleagues all over Europe a possibility to openly exchange views on planned activities in an informal and confidential setting. Through these discussions we become aware of and can better follow the activities planned by other authorities, ECHA and the Commission. This also helps us avoid double work and supports cooperation between different parties when we are working on the same group of substances.”

No decisions are taken in RIME+ and any advice given or conclusions made within the platform are non-binding. “When we present our own projects, regulatory management option analyses or preliminary ideas in the RiME+ platform, we get a chance to receive feedback in an early phase and, most importantly, before a decision is taken in a certain direction or any formal processes are initiated. This is very valuable,” Dr Averbeck explains.

When a decision or policy level advice is needed, the case is referred to the competent authorities for REACH and CLP (CARACAL) – the early exchanges in RIME+ aim to support the discussion and decision making in CARACAL.

Increasing coherence of authorities' work

Even though RiME+ is a voluntary platform, it can help to harmonise approaches throughout different Member States. “This increases the predictability for industry when it comes to actions taken or planned by regulators and helps level the playing field for companies,” Dr Averbeck says.

Frauke Averbeck. Image: Frauke Averbeck.

“Collaboration could prevent, for example, potential contradicting outcomes if different Member States are assessing the same substance or group of substances.”

Discussing regulatory activities and the way forward with their peers gives the risk management experts opportunities to share expertise and experiences. “Collaboration could prevent, for example, potential contradicting outcomes if different Member States are assessing the same substance or group of substances,” Dr Averbeck explains.

“During the last years, effort has been made into enhancing the transparency of the platform’s work. Activities of Member States and ECHA can easily be tracked through the public activities coordination tool, summaries of regulatory management option analyses are available and an increasing number of Member States even have public consultations for them,” Ms Stocker points out.

Consequently, it will be easier for companies to prepare for the regulatory processes, which always include a consultation, and to make informed decisions when planning to move away from using a harmful substance or considering their future substance portfolios.

Looking to the future

The work under the RiME+ platform will be further optimised in the future to increase efficiencies and to make the best use of available resources. As the grouping approach is at the centre of the Integrated Regulatory Strategy, cooperation in this context is needed to make sure that the data generated through compliance checks can be used effectively to confirm or refute a concern.

Having a proper support network in place allows and can even encourage those Member States with fewer resources to take on some of the work.

“The RiME+ platform gives the opportunity to create smaller ad hoc groups and teams which can help address current issues and upcoming topics in a fast and flexible way. This also enables Member States to contribute with specific expertise on complex subjects even if the issue would have been too big for them to tackle on their own at a national level,” Ms Stocker explains.

As the work under the RiME+ platform shows, every Member State has an important role to play in making sure that hazardous chemicals will not cause risks to human health and the environment.

Did you know?   In 2011, Risk Management Expert (RiME) meetings were kicked off to support discussions taking place in CARACAL. These meetings offered a platform for colleagues from the Member States and the Commission to discuss technical aspects of risk management before those issues were brought to CARACAL.   In 2017, RiME became RiME+ when the scope of these meetings was widened to enhance implementation of ECHA’s Integrated Regulatory Strategy.   The RiME+ platform meets three times a year. In addition, its members are involved in ad hoc working groups and dedicated workshops when further work on particular topics is needed, for example, related to plastic additives or substances of unknown or variable composition, complex reaction products or biological materials (UVCBs).   18-22 Member States and representatives from the Commission regurlarly participate in RiME+ meetings.

Further information:

RiME+

Grouping of chemicals speeds up regulatory action, News release 13 May 2020

Addressing substances of concern

Public activities coordination tool

Text by Päivi Jokiniemi

Published on: 28 May 2020

Top image: © Unsplash/Morgan McKnight

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