12 September 2016

Scientists critical of EU proposal launch new risk-assessment method

The EU proposal to restrict endocrine-disrupting chemicals has severe shortcomings, write Christina Rudén, former Programme Director of MistraPharma, and 14 other researchers in an open letter to the EU Commissioner at the Directorate General for Health and Food Safety. Simultaneously, the scientists are launching a new method of assessing chemical risks.

In June, the European Commission put forward a proposal to restrict the use of endocrine-disrupting chemicals (EDCs), a group of substances suspected of causing, for example, reproductive impairment, overweight and diabetes. The proposal, which has now been circulated for comment, immediately incurred criticism from several quarters. One of the critics is Professor Christina Rudén of Stockholm University, who headed the recently concluded MistraPharma research programme.

‘The proposal goes right against all ideas about creating a non-toxic environment and protecting children, who are particularly susceptible to disruptions of the hormonal system,’ she says.

Jointly with a number of international researchers in the area, she wrote an open letter to Vytenis Andriukaitis, the EU commissioner for health and food safety, criticising the proposal. According to the scientists, it is vague and the requirements it imposes on chemicals producers were too low.

‘Under the proposal, you have to show that people have been both exposed to and harmed by the chemical before it can be restricted. The evidence requirements are extremely high. Industry will still be able to use and sell many of these substances,’ says Rudén, who also wrote a debate article in Svenska Dagbladet during the summer.

Better and more transparent

The research group to which Christina Rudén has recently presented a new, systematic method of assessing environmental and health risks of chemicals. The researchers are now urging the EU to introduce the new method, partly in order to assess the risks of EDCs.

‘Our method wouldn’t solve the whole problem of the EU proposal. But it would clarify the fact that all available studies — not only industry’s own — should be used, and make risk assessment more transparent.’

The initiative for the new risk-assessment method, SYRINA (Systematic Review and Integrated Assessment), was taken in the MistraPharma research programme. During 2014 a number of international experts, from both Europe and the US, were invited to a workshop. The work has now culminated in a new method that was recently presented in the journal Environmental Health. One feature of this method is harmonisation of hitherto different risk-assessment methods between Europe and the US.

‘Our method is based on other proposals that exist and are also partly in use. But to date there hasn’t been a systematic method that covers all the various parts of the risk-assessment process, and at the same time connects differing views in Europe and the US,’ Rudén says.

Testing in case study

In a case study over the year ahead, the method will be tested and developed further in a project funded by the EU and coordinated by the Swedish Toxicology Sciences Research Center (Swetox).

How big an impact the new method has remains to be seen. The EU health commissioner has said that he is interested in meeting the researchers, according to Christina Rudén, but no date has yet been set for such a meeting. The work of shaping opinion by providing information about the new method and influencing decision-makers and government agencies has only just begun, she says.

‘Now we’re embarking on the task of arranging workshops and conferences, and meeting and training agency staff. It’s a long haul and not something that can go fast. But the process of assessing chemical risks must become more systematic and transparent, and so in the long run develop in the direction we recommend.’

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