The Poison Paradigm

Debate on the European Commission's Regulation of EDCs

By: Franklynn Bartol

While our latest documentary the Poison Paradigm, focuses on the debate around regulating endocrine disrupting chemicals (EDCs) in North America, another heated debate was happening in Europe. 

In 2013, the European Commission was reviewing their policy on endocrine disruptors. As a first step toward regulation of EDCs (not just BPA—the first attempt to do this), they sought to develop guidelines for identifying EDCs. If clear guidelines were developed that identified EDCs, these chemicals would have to undergo much stricter regulations.

A draft of the report leaked, prompting a group of scientists—including lead author Daniel Dietrich and 18 editors of various other journals—to publish a highly critical response and an open letter to the European Commission (Dietrich, et al. 2013).

They accused the European Commission of planning a regulatory system for “so-called endocrine disrupting chemicals” that was “based on virtually complete ignorance of all well-established and taught principles of pharmacology and toxicology”.  These well-established principles include the assumption that compounds, including EDCs, have a safe threshold for exposure.

“‘The idea you have to show a product is not an endocrine disrupter is ludicrous,” says Dietrich in Nature (Sept 2013), advocating for another common practice of the risk approach: chemicals are generally considered safe unless otherwise proven. The authors, along with additional researchers, also wrote an open letter to the EU chief scientific adviser, making similar arguments.

In response, other scientists and journalists accused these authors of industry ties. Environmental Health News quickly published an article revealing that 17 of the 18 toxicology journal editors who signed the editorial had worked with chemical, pharmaceutical, cosmetic, tobacco, pesticide or biotechnology industries.

“Some have received research funds from industry associations, while some have served as industry consultants or advisors.” For example, the lead author Daniel Dietrich is a former advisor for an industry organization funded by chemical, pesticide and oil companies that lobbies the European Commission on endocrine disruptors. These were not disclosed in their editorial.

EHN also revealed that over half of the 71 researchers who signed the open letter to the European Commission had clear industry ties which had not been disclosed, and industry itself supported the letter (e.g. The European Crop Protection Association, the lobby organization for the pesticides industry). Several of those authors, including Dietrich, are quoted offering their opinion that it’s necessary to accept industry funding for their research and that this doesn’t present a conflict of interest.

Forty-one scientists published a response to the Deitrich et al. editorial in Environmental Health (Bergman et al, 2013) saying the editorial “confuses and conflates several aspects of the current debate”, reminding that the existence of a threshold for endocrine disruptors “remains under debate”.

They noted their concern “that the Dietrich editorial appears to be intended as an intervention designed to impact imminent decisions by the European Commission.” Other academic articles also strongly condemned the editorial. For example, Gore et al (2013) in Endocrinology call the editorial a “profound disservice” to public health.

The European Commission, after this furor, side-stepped the issue by deciding to look at the economic impact of the EU Chemicals market before it made an official ruling on how to regulat EDCs.

French Journalist Stephane Horel, in his investigation "A Toxic Affair"  found the chemical lobby essentially railroaded the European Commission into looking at the economic effects of regulating EDCs, even though the law required only looking at the scientific evidence -- esssentially putting off the responsibility of any regulation of EDCS.

In 2015, Sweden sued the EC for this delay. Finally in 2016, the European Commission suggested some regulations -- including one exception: that a chemical identified as an EDC must be banned, unless exposure to it is negligible.

Critics say this would allow many EDCs to go unregulated. It also sets an ‘impossibly high’ burden of proof of public harm, rather than putting the onus on chemical industry to prove safety.

While the EC claims the guidelines follow a ‘hazard’ approach, critics point out the industry groups got what they wanted:  the requirement of a case-by-case risk assessment. The proposed regulations were eventually rejected by EU member states in 2017. Members were urged to vote against it after the exemption was deemed unlawful by the Centre for International Environmental Law.

New guidelines were passed by EU members in 2017. Only Sweden, Czech Republic, and Denmark voted against the proposed guidelines, while Latvia, Poland, Hungary and the UK abstained from voting.

While these were somewhat improved, endocrinologists and NGOs criticized the regulations have having many loopholes and being inadequately clear and  rigorous.

They warn that many EDCs will go unregulated under the new guidelines. In April 2018, the guidelines were passed in EU Parliament. As it stands, BPA is only strictly regulated in toys and food-contact items for infants, and is now banned from thermal receipts (with no ban on its harmful replacement, BPS).