Commentary: Transparency on chemical risks under REACH needs to be improved.

Information on the safety of chemicals submitted to the European Chemicals Agency by industry under the European chemicals legislation REACH needs to be more transparent to allow scrutiny of the science.

It is important to know how industry arrive at their conclusions regarding hazard and risk of their substances, especially since risk assessments are known to be dependent on expert judgement and may be biased. Transparency is particularly important under REACH since the information that industry registers with the European Chemicals Agency is used for identifying potentially hazardous substances that need to be regulated further.

The REACH regulation requires industry to provide information on and assess the safety of substances they produce or import into the EU at or above one metric ton per year. Substances that fall under REACH must be registered with the European Chemicals Agency to be allowed on the European market and the agency is obliged to make the submitted information accessible to the public.

Our recently published study shows that rules for confidentiality is one major factor affecting the transparency of the system. Under the REACH regulation certain information is always considered confidential and additional information can be claimed confidential by the registrants to protect their business information.

The European Chemicals Agency automatically filters the submitted information to remove potentially confidential information before it is published on their website. This includes information on data waiving justifications and hazard assessment that is important for understanding the conclusions reached. Since the filter step is an automatic process also non-confidential data that could otherwise be published are sometimes removed.

As a result of this confidentiality, it was not possible to identify the majority of the key and supporting studies included in the hazard assessment for the cases we investigated. For industry studies only the date when the study was performed is published, which means that industry studies that were included in the assessment could not be identified. Moreover, since industry studies are owned by the companies they are not publicly accessible and therefore we cannot verify that all information that is important for evaluating the study has been provided by the registrant.

When the REACH regulation was drafted, one of the main goals was to increase public access to hazard information. The European Chemicals Agency is achieving this by disseminating information on their website and providing access to chemical safety reports on request. However, according to our study, more work is needed to attain sufficient transparency. Transparency was shown in our study to be restricted by several factors and to improve the situation would require legislative changes, improving the dissemination process, as well as improving the quality of the data provided by the registrants.

Transparency is important for judging the robustness of the chemical risk assessments made by industry since we rely on this information for regulating chemicals and keeping people safe.