ECHA

The EU wants to identify all relevant, known substances of very high concern by 2020. We have screened ChemSec’s “Substitute it Now” (SIN List) to check if it includes substances that are not yet under regulatory scrutiny. The results show that the majority of the more than 900 substances are regulated or under scrutiny, but more work still needs to be done.

Identifying substances that matter most

ECHA’s integrated regulatory strategy focuses on substances that matter the most. It sets criteria for identifying substances of potential concern and defining how to further regulate them.

The starting point for this work is the screening of information that companies have sent to ECHA in their REACH registration dossiers and classification and labelling notifications.

The common screening approach goes beyond this. It also looks at external sources including other lists of substances of concern published by regulatory bodies, agencies, trade unions and NGOs.

After screening, authorities need to determine whether the risks of substances of concern are adequately controlled at EU level. And, if this is not the case, they need to make sure that the best regulatory action is taken.

The SIN List is a database of chemicals that Chemsec considers to fulfil the criteria for being a substance of very high concern (SVHC) and that are likely to be banned or restricted in the near future.

ECHA’s analysis of the SIN List is an example of how lists from other bodies can be scrutinised to make sure that all relevant substances are considered for risk management.

Criteria to identify substances for further regulatory action

“In our work, we focus on substances that matter most. We are interested in potentially hazardous substances with exposure to workers, consumers or the environment. Our aim is to identify new substances of concern that merit being regulated and we welcome help from both industry and NGOs,” says Elina Karhu, Head of the Classification and Prioritisation Unit contributing to the cross-agency work on identifying substances of concern.

Chemsec’s SIN List currently contains publicly available information on 912 substances from existing databases and scientific studies, as well as new research.

The list was developed in collaboration with scientists and technical experts, as well as an NGO advisory committee of environmental, health, women and consumer organisations mainly in Europe, but also in the United States.

What makes the list particularly valuable for identifying new substances of concern, is that it follows the same hazard criteria defined in REACH for identifying SVHCs. So which substances do these criteria cover?

• Carcinogenic, mutagenic or reprotoxic (CMR) substances that can cause cancer, trigger mutations or damage reproductive systems.
• Persistent, bioaccumulative and toxic (PBT) substances that accumulate in the food chain.
• Substances of equivalent concern covering those not automatically covered by the first two categories, but that still give rise to equivalent levels of concern in terms of potential damage to health and the environment.

These hazard criteria alone are not enough to consider if a substance matters according to the integrated strategy and would require further action. Authorities have agreed on how to set priorities among these hazardous substances and to focus resources where we can expect to have the highest impact on the protection of human health and the environment. Therefore, the substances that matter are those with a hazard concern and potential for exposure, either to human health or the environment.

Consequently, substances that are considered hazardous but do not meet the exposure criteria may be considered as a low priority for further work by authorities which is reflected in ECHA’s analysis of the SIN List.

The priority criteria are regularly being reviewed under the common screening approach. As a consequence, the priority for a substance or group of substances may change, when the use patterns, registration status or hazard information changes.

Despite some differences in ECHA and Chemsec’s views on how substances of concern should be tackled, ChemSec’s Senior Policy Advisor Frida Hök appreciates the work done.

“We are pleased to see that ECHA values the SIN List and has done this thorough work in going through its substances. It sends a clear signal that companies can safely keep using the SIN List knowing the methodology behind it is well founded and valued by an EU body like ECHA. However, ChemSec strongly believes that all SVHCs belong on the Candidate List. Member States and ECHA need to assure that SIN substances currently discussed in expert groups, under CoRAP evaluation or even classified as CMRs are not getting stuck in the process for years, but are nominated for the Candidate List at a much quicker pace,” she explains.

Working towards a common goal

The outcome of the analysis done by ECHA clearly shows that there is considerable overlap between the SIN List and the work done by authorities. As the vast majority of substances in the list are already (or in the process of being) regulated or under scrutiny by authorities, which suggests that the SIN list is a valuable tool for identifying which substances merit specific attention.

This highlights that the common screening approach has been able to identify those substances with known hazardous properties and consider them for further action. Lists such as ChemSec’s SIN List brings added value to authorities’ work.

Even if a substance is of low priority for further work under REACH and CLP, this does not mean that there are no further risk management measures taking place on the substance. Other regulations are in place and contribute to the safe use of chemical substances such as the Occupational Health and Safety Regulation for substances with industrial uses.

Identifying and regulating substances of very high concern is an on-going process. To ensure that the most hazardous chemicals are effectively dealt with, close collaboration with key stakeholders such as industry, NGOs and the Member States is vital.

Further information:

SIN List report

Information on chemicals

SVHC Roadmap to 2020

Screening

Multilingual explanation of terms

Text by Adam Elwan

Published on: 16 November 2017

Top image: © iStock.com/Francis Black

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