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Exploring the universe of registered substances
By 2027, ECHA aims to have full clarity on all registered substances to improve chemicals safety in Europe. ECHA’s annual Integrated Regulatory Strategy report describes how authorities are prioritising substances of concern. It looks at the status of substances and whether they need further hazard data to be generated by registrants or further regulatory risk management actions from authorities.
ECHA’s first Integrated Regulatory Strategy report was published in April 2019. Chrystele Tissier and Eva Valkovicova, scientific officers at ECHA, were responsible for putting the report together.
“Our chemical universe currently contains information on 19 000 substances that were registered by May 2018. The mapping visualises the work ECHA and the Member States have done over the last 10 years,” Ms Tissier explains.
“The aim is to clarify which substances need more hazard data or further risk management measures. We also want to find out for which substances authorities can conclude that they are not a priority for further regulatory work at the moment,” Ms Valkovicova adds.
Substances divided into different pools
In the report, the current overview of substances is presented through different substance pools. These are:
1. High priority substances for data generation and assessment (orange). At present, this pool contains around 1 300 substances that are of potential concern. For these substances, further data needs to be generated or existing data needs to be assessed so that authorities can decide whether regulatory risk management is needed or not.
2. High priority substances for risk management (yellow). This pool contains around 270 substances. These are substances for which a concern has been identified and for which regulatory risk management – such as identification as a substance of very high concern (SVHC) or restriction – is needed. It is also possible that actions need to be taken under other legislation.
3. Low priority substances for further regulatory action. This group contains 450 substances that are considered as already sufficiently regulated (light green) such as substances on the Candidate List. It also includes almost 500 substances that have been concluded to be of low priority after assessment (dark green).
|The chemical universe is based on data from May 2018. Registered substances from the uncertain area of >100 tonnes will be screened and moved to one of the different pools for further regulatory action or concluded as a low priority in the coming years. Image: ECHA.|
“Those substances that fall outside of these three pools have not yet been looked at by authorities. They belong to an uncertain area for which we cannot say yet whether more information or regulatory action are needed. The plan is that these substances would be screened by authorities and assigned to the right pools by 2027,” Ms Tissier explains.
“So far, we have focused on substances registered above 100 tonnes, working with a 2020 deadline in mind. After that, we will target the lower tonnage bands. As a whole, this supports the global 2030 sustainability goals on safer use of chemicals,” Ms Valkovicova says.
Speeding up the work
To speed up the work and to evaluate substances in a more efficient way, ECHA has moved towards applying a grouping approach in its work, assessing structurally similar substances together. “Grouping ensures an effective use of all available information and brings more consistency for generating data and managing the risks of substances. It also supports substitution, as we can treat substances with similar hazards in a similar way,” Ms Tissier points out.
The report also gives recommendations for industry and authorities.
Information in the registrations needs to improve, in particular for substances that have a high potential for exposure and are currently lacking hazard data. “We urge industry, which is ultimately responsible for ensuring the safe use of substances, to be proactive and ensure their dossiers are compliant and up to date. This is needed so that registrants and any of their downstream users can implement the necessary risk management measures and provide adequate safety advice in the supply chain. It is also needed for authorities to efficiently identify substances of potential concern,” Ms Valkovicova underlines.
ECHA is working together with the European Commission and Member States on a joint plan to increase the compliance of registration dossiers. Having more information available on each substance will help authorities identify substances of concern faster. This plan is expected to be finalised in summer 2019.
The Member State authorities are recommended to shorten the time between identifying a concern for a substance and initiating risk management measures. While authorities are normally quick to propose substances for inclusion in the Candidate List or for restriction, they should also prioritise harmonised classification and labelling for substances. The latter has a direct impact on company-level risk management and is often the first step before restriction, authorisation, or other risk management measures.
Integrated Regulatory Strategy report
The annual report on the Integrated Regulatory Strategy combines information from the previous reporting of the SVHC Roadmap to 2020 and evaluation progress reports. It provides an overview of the different REACH and CLP processes and ongoing activities and explains how far we are in mapping the universe of registered substances.
The report targets authorities, policy makers, stakeholders and industry associations, providing a framework to help all actors contribute to identifying substances of concern, planning and monitoring the progress made in regulating these substances.
Interview by Tiiu Bräutigam
Published on: 16 May 2019
Images: © ECHA
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1-4 and 8-11 June (tentative);
7-11 and 14-18 September (tentative)
Committee for Risk Assessment:
1-5 and 8-12 June;
7-11 and 14-18 September (tentative)
Member State Committee:
Biocidal Products Committee:
Management Board meeting: