ECHA

How can we identify harmful substances and make sure that their risks are managed if we don’t have enough information on their hazardous properties and uses? The answer is simple – we can’t. But we are not sitting back and waiting – we’ll tell you how sector associations are working with us to identify and address substances that matter the most and at the same time improve data quality.

To date, most of the work done to improve data quality has focused on individual companies and single substances only. To be able to address more substances in one go, improve efficiency and create a common understanding, industry stakeholders, the European Commission, Member State competent authorities and ECHA have started to work together to identify substances that matter the most in sectors.

Case study: petroleum and coal stream substances

Many of the petroleum and coal stream substances are very complex and have variable or partly undefined compositions (UVCBs). Due to their complexity and a lack of sufficient data on their hazards and uses other than as fuel, the substances were prioritised as part of the SVHC Roadmap back in 2013.

A specific working group was set up to identify the substances and form a better understanding of how to best manage their risks. At the moment, nine Member States and six industry stakeholders are involved in the work.

Addressing substances one-by-one would take too much time, so the group mapped how the petroleum and coal stream substances are used. Based on this, the substances that have the greatest potential for exposure and to negatively affect human health and the environment were identified.

The next step for these substances of potential concern is either to:

• Analyse the most appropriate risk management option (RMOA) for each substance. This would be done if, based on the information available, there is a clear concern. Member State authorities do the analysis.
• Decide what additional hazard information is needed and how it can best be generated. This is done if there is not enough information to conclude on the potential hazards. The responsibility for generating the data is in the first place with the sector associations and their members that have registered the substances. Member State authorities could additionally consider requesting further information through substance evaluation.

Registration dossiers for these priority substances need to be updated with the missing information as a matter of urgency.

The benefits of working together?

Eleni Vaiopoulou, Science Executive from Concawe and Fleur van Broekhuizen, Senior Advisor from the Dutch Member State authority are two members of the working group for petroleum and coal stream substances. They agree that the working group has helped its members create a common understanding on the challenges and practicalities. “The word ‘together’ is actually the most important one. Concawe represents industry and we want to make sure there is good communication and understanding between industry and authorities. To do this, we came up with an implementation plan to prioritise petroleum substances, improve data quality and work together with the Member States and ECHA. This was welcomed by the working group,” Ms Vaiopoulou explains.

The working group focuses on substances in groups instead of individual substances. This saves time, but it also gives a broader understanding of the substances. “Looking at groups of substances may show trends that may not be so clear when looking at the same substances with a substance-by-substance approach,” Ms van Broekhuizen says. This can, for example, help hazard identification and may help avoiding regrettable substitutions in the future. “However, it is good to keep in mind that this approach also takes a lot of time and it may sometimes delay the process of deciding on necessary measures for an individual substance of very high concern,” she adds.

Practical examples of the work

According to Ms van Broekhuizen the most important limitation of assessing potential petroleum substances of very high concern is the lack of substance-specific data in most of their registration dossiers. “This involves a lack of detailed compositional data, hazard data and exposure data, as well as reliable information on uses.”

Industry is responsible for improving the data quality of the registrations. “Industry is currently cleaning up the registration dossiers with regard to incorrect uses and is profiling the possible constituents for every individual registration, to better understand the composition,” Ms van Broekhuizen says.

As part of this work, Concawe has gathered more precise information on uses for around 200 substances registered by their members. This information clarifies, for instance, the amount of substances used for other purposes than as fuels and intermediates. Registrations for all these substances are now being updated. But even before that, the new information was shared in the working group and used to identify and prioritise substances that need regulatory action. Other sector representatives are still collecting the use information from their members and are gradually sharing this with the working group.

Because of the UVCB character of most petroleum substances, they have been grouped in substance categories and given an average composition and toxicity profile. “The need to improve data quality was also identified in the working group. Under the ‘one substance, one registration’ principle, we are at the moment updating registration dossiers for 191 petroleum substances. All these registrations will include updated and improved information on substance composition,” Ms Vaiopoulou concludes.

Case study: plastic additives

Sector cooperation has recently also started for plastic additives. These substances are used widely and in many different types of articles, including those used directly by consumers. The potential for exposure to them may vary greatly, and for some of them, assessing their release from the plastics during their lifetime needs further consideration.

The aim of this project is to ensure that there is sufficient information, particularly on use and exposure, to prioritise substances for further regulatory risk management. The overall content of the work is still under discussion, but the focus is now on mapping the substances used as plastic additives and their functions as well as developing sector use maps. This work is very important when we start to think about the circular economy – to recycle plastics safely, we need to collate the existing knowledge of the substances present as well as how they are released.

Further information:

Addressing chemicals of concern

SVHC Roadmap to 2020 implementation

Multilingual explanation of terms

Text by Päivi Jokiniemi
Top image: Fotolia

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