Governments who want to limit the use of toxic chemicals are being set a high burden of proof while industry concerns are being accepted with little evidence by the European Chemicals Agency (ECHA), analysis by the European Environmental Bureau (EEB) has found.

This finding comes from a report by the EEB into the restriction of hazardous chemicals under the EU’s REACH chemical regulations.

The EEB is Europe’s largest network of environmental organizations with 141 members in over 30 countries.

Key findings of the report include:

• Member states have a high burden of proof put on them if they propose restricting a hazardous chemical to protect human health and the environment.
• ECHA committees arbitrarily modify proposals to restrict chemicals usually weakening and undermining them with little transparency.
• Decisions by ECHA committees have underestimated the benefits of restricting hazardous chemicals because of an over-reliance on quantitative evidence.

In the report, entitled ‘Restricted Success: EEB’s appraisal of restriction under REACH’, the EEB describes how the implementation of the restriction process by ECHA Committees and the Commission is reducing the capacity of REACH to protect people and the environment.

Dolores Romano  EEB Chemicals Policy Officer said:

“Since the REACH restriction process entered into force eight years ago, the pace of restrictions has increased only slightly, while the scope of the final restrictions has narrowed.  Although the dossier submitter is held to very high standards for data and evidence, industry isn’t hold to the same standards, and industry concerns are often accepted with little or no evidence.”

Case Study

That was the case with the restriction of PFOA, a substance known to be very persistent, bioaccumulative and toxic. Germany and Norway proposed to ban the use of this substance at concentrations above 2 parts per billion (ppb). However, following industry’s request, the ECHA Committees proposed new limits of 25 ppb despite a lack of supporting evidence from industry.  ECHA made no attempt to evaluate the impacts to health and the environment of this change to the proposal.

“This makes the revised proposal,essentially meaningless”, added Romano.

PFOA has been classified by the International Agency for Research on Cancer (IARC) as “possibly carcinogenic to humans” (Group 2B), based on limited evidence in humans that it can cause testicular and kidney cancer, and limited evidence in lab animals.

Industry evidence

The EEB report also points out that by privileging industry studies, ECHA’s Risk Assessment Committee (RAC) effectively dismisses independent scientific evidence from academics and other researchers. This Committee also rejects in practice health and environmental effects — such as endocrine disruption, immunotoxicity, neurodevelopmental toxicity, and other low dose effects — when they are difficult to quantify and don’t fit well with traditional risk assessment models. This was the case, for example, when the committee assessed the restriction of BPA in thermal paper, as well as proposed restrictions for PFOA and nonylphenol.

The report also describes how ECHA’s evaluation of socio-economic impacts relies far too much on a very narrow understanding of cost-benefit assessment, underestimating the benefits for society and overestimating costs for industry.

Recommendations

In order to improve the implementation of the restriction process, the EEB recommends that the appropriate roles of the Committees be more carefully defined; that evidence supplied by industry be held to the same standards as that supplied by the Member States; and that the Committees better identify and communicate uncertainty.  EEB also suggests that  the Commission use the “fast-track” restriction process described by REACH to speed up the elimination of the most hazardous substances, and that registration dossiers that fail to demonstrate adequate control of risks should automatically trigger the restriction process.