Reach for transparency

In the EU, manufacturers and importers of chemicals covered by Reach are required to register and submit data on the safety of their substances to the ECHA. This information forms the basis of subsequent risk management and regulation of the substances.

Considering that conclusions on hazard and risk assessments are known to include scientific uncertainty – and are influenced by expert judgment as well as potential bias – transparency is important in order to evaluate their scientific robustness and validate their assessment.

Unfortunately, our recent study shows that information provided under REACH could be accessible to the public in a more transparent way.^[1]

Full disclosure

In our study, we looked at the data submitted by the industry, and chemical safety reports available on request. We found that these chemical risk assessments lacked transparency for several reasons – and a major limiting factor was the rules for non-disclosure of information.

These rules exist to protect personal data and confidential business information. Some information under REACH is always considered confidential but registrants can also claim certain information is confidential to protect their commercial interests. Thus the ECHA automatically removes data from the submitted dossiers before dissemination to ensure that no confidential information is made publicly available.

However, potentially confidential information – such as such as data waiving and hazard assessment justifications – is also removed in the filter process, even though the information has not been claimed confidential by the registrant. This means that certain information necessary for understanding the conclusions in the risk assessment is not disseminated to the public.

Confidentiality also affected the possibility to identify most of the key and supporting studies for the endpoint we looked at. Furthermore, since registrants only need to provide a summary of the studies and industry studies are intellectual properties, it cannot be verified whether all information necessary for assessing the reliability of the studies has been disclosed.

Safety reports

Registrants also provide information to the ECHA in a chemical safety report, which is only available on request. However, at present accessing these documents takes considerable time and involves extensive work for the ECHA. This is because they need to again consult the registrants for any confidential information, then manually review the document and redact personal or commercial data.

This means that, depending on the scope of the request, it cannot be guaranteed that the initial request will be completed in the required 15 days – or even be fully granted.

Reach has made more information on chemicals publicly accessible than ever before. Nevertheless, more work is needed to allow stakeholders to make an independent evaluation of the data. This is not just down to the quality of information provided by chemical companies. The ECHA must also improve how it shares data on its website, and regulatory changes are needed to improve the accessibility of chemical safety reports.

Ellen Ingre-Khans is a PhD student at the Department of Environmental Science and Analytical Chemistry, Stockholm University, Sweden