EU battle to regulate chemicals that interfere with hormones comes to a head — maybe

A vote by representatives from Commission and member countries is slated for Wednesday, but the long-running drama is far from over.

The European Commission is trying desperately to regulate chemicals that can damage the brain and kidneys and cause infertility.

It has spent more than three years crafting a proposal that member countries will sign onto and Parliament will approve. The Commission was sued for taking so long to figure something out. In the end, it tried to find common ground by basing its definition of the chemicals on that of the World Health Organization. Pesticide and chemical companies say it’s still far too broad and will ensnare chemicals that are safe. Health and environment advocates say the proposal is too lenient and will fail to ban the use of dangerous chemicals.

A vote by representatives from member countries is slated for Wednesday.

But the long-running drama is far from over.

The scheduled vote could fail to validate the Commission’s proposal or be canceled altogether.

Identifying how chemicals interfere with the hormone systems of animals and people is a complex scientific task. Add in a regulation that could undercut big business, a second fight with pesticide companies in a single calendar year, Parliament threatening to trash the proposal before it’s even presented to them, and it’s no wonder no other government in the world has attempted to regulate this class of chemicals.

“Once adopted, the EU regulatory system will be the first regulatory system worldwide to set criteria to identify endocrine disruptors,” EU Commissioner for Health and Food Safety Vytenis Andriukaitis told the European Parliament a day after presenting the proposal. “So please help us become pioneers in this important area.”

This week’s vote deals specifically with how to identify so-called endocrine disruptors in pesticides. The EU’s 2009 pesticides regulation says that if an active substance used in a pesticide is an endocrine disruptor, it should be banned, with some exceptions. But the criteria that will be set at the end of the nauseating EU decision-making roller coaster could influence regulations on industrial chemicals, cosmetics and even in-vitro medical devices.

Industry complains that the Commission has chosen one of the options with the highest impact on the pesticides market, even if the benefits for people and the environment would be the same as for other narrower options it has considered. The European Crop Protection Association (ECPA), representing the pesticides lobby in Brussels, cites the Commission’s own impact assessment as the basis for this argument. It has buried the Commission in letters protesting this choice and asking for potency — the scientific measurement of the chemical’s ability to produce a negative effect — to be taken into consideration.

“The Commission’s continued refusal to include hazard characterization elements, in particular, potency, makes it impossible to see how they will identify those substances which pose a real concern from those that don’t,” said Graeme Taylor, ECPA’s director of public affairs.

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Anticipating the criticism, Andriukaitis said back in June that scientists agree that potency should not be part of the scientific identification of an endocrine disruptor.

That has pleased NGOs. But they are still not happy with the Commission’s proposal, which they say sets the bar ridiculously high for a chemical to be identified as an endocrine disruptor.

“This proposal requires such a high amount of evidence that it will be nearly impossible to identify more than a small fraction of substances posing a threat to human health and the environment from hormone disruption,” said the EDC-Free Europe coalition of NGOs.

Endocrinologists and NGOs argue that the burden of disease that these chemicals can cause could cost health systems billions of euros and must be strictly regulated. A 2012 World Health Organization report said there is “mounting evidence for effects of these chemicals on thyroid function, brain function, obesity and metabolism, and insulin and glucose homeostasis.” Diseases such as diabetes, brain disorders and infertility have been linked to chemicals that disrupt the hormonal system.

‘Hijacking the proposal’

A 2009 EU law regulating the approval of pesticides required the Commission to present draft measures concerning specific scientific criteria for the determination of endocrine disrupting properties by December 14, 2013. Another EU law, governing biocides — chemicals used to destroy harmful microorganisms — set December 13, 2013, as the deadline for these scientific criteria to be presented.

The Commission’s directorate general for environment developed the criteria in 2013. The proposal was leaked later that year, leading to a major debate on the issue at the time. The pesticides and biocides industry were concerned that the criteria developed by DG Environment could end up banning many of the chemicals they used in their products. NGOs liked the criteria, but some scientists accused the Commission of not using sound science in its proposal.

Ultimately the Commission decided to first assess the benefits and economic impact of the criteria on the EU chemicals market before making any official proposal.

French journalist Stéphane Horel, who investigated the issue, concluded that the chemical lobby managed to hijack the proposal and push for this analysis, even if the law did not require one, as the criteria had to be determined based on science, not on potential economic effects. In a documentary, she excoriated the European Commission and the chemical and pesticides industry for this U-turn.

When Jean-Claude Juncker took over as Commission president in 2014, he decided to shift the endocrine disrupting chemical file from DG Environment to DG Sante, arguing that it made sense since the latter was already in charge of the pesticides regulation. Brussels-based NGOs saw it as a punishment for the way DG Environment had handled the issue.

The European Parliament asked the then-new health commissioner, Andriukaitis, to complete the impact assessment and offer a new proposal as soon as possible.

He did so in mid-2016, after speeding up the impact assessment in the aftermath of losing a court case brought by Sweden at the European Court of Justice.

Vote in question

Fast-forward to this month. The June proposal, based on the World Health Organization definition, was tweaked slightly in response to EU countries’ concerns.

One change that angered the European Parliament and countries including Sweden, is in the wording of an exception to the rule banning endocrine disruptors.

The current exception states that a chemical identified as an endocrine disruptor would be banned unless there is negligible exposure to it. The Commission proposed changing it to keeping the chemical on the market if it poses a negligible risk. This increases the possibility that a chemical identified as an endocrine disruptor stays on the market, health and environmental advocates say.

The Parliament and some EU countries believe the Commission did not have the legal authority to propose such a change because it was required only to come up with the criteria defining these chemicals. The Commission disagrees, with Andriukaitis noting that the tweak to the exception is just a technical update, in line with the latest science.

But its inclusion has divided EU countries and thrown this week’s vote into question. Germany is one of the main adversaries, according to two sources with knowledge of the issue.

On the proposed criteria, Sweden wants a stricter proposal, close to the NGOs’ position. The U.K. is closer to the industry’s stance.

To salvage the vote, the Commission is considering separate questions on the criteria and the change in the wording of the exception.

ECPA warned that holding the split vote would add even more uncertainty to what it already sees as a worrying proposal.

“We are disappointed that the Commission is planning to take a vote on Wednesday on such an important issue at such a short notice,” said Thérèse Coffey, U.K. under-secretary of state for the environment and rural life opportunities.

The latest tweaks from the Commission on the criteria have come too late for her government to have time to assess their impact, she said Monday during a meeting of EU environment ministers.