© Corporate Europe Observatory
Everything, or almost everything, is contained in a few words: "(Endocrine disruptors) can ... be treated like most other substances of concern for human health and the environment." It is on this simple phrase, which comes from the conclusion of an opinion from the European Food Safety Authority (EFSA) in 2013, that Brussels bases its plan to regulate endocrine disruptors, these ubiquitous substances capable of interfering with the hormonal system, often at low doses.
The proposal, which is due to be voted on by the Member States soon, has not only France, Denmark and Sweden united against it but also all the non-governmental organizations (NGOs) who consider that it does not protect public health and the environment.
The expert scientific community, embodied by the Endocrine Society - a scholarly society that brings together some 18,000 researchers and clinicians specializing in the hormonal system - is also battling against the proposal. This opposition is surprising given that the European Commission insists that it relies on science, in the form of the scientific expertise of EFSA.
The explanation for this singular hiatus is found in a series of internal documents of the European administration obtained by Le Monde. They show, without ambiguity, that the key phrase on which the regulatory edifice proposed by the Commission is built had been drafted even before any scientific expertise had really begun.
Written conclusions in advance
In December 2012, EFSA was already presenting "conclusions/recommendations" in an e-mail to the experts it had assembled to carry out this work.
It said: "...endocrine disruptors and their adverse effects should be treated just like any other chemical of concern for human health or the environment." The key phrase is already there. Yet, the very first meeting to set up work was held only a few days before. At the end of March 2013, three months later, the phrase figures in the conclusions of the opinion published by the agency.
"For sure, the conclusions were written beforehand, if not on paper, but in the heads of some of the participants," a source close to the file at the time told Le Monde. The Commission itself did not respond to our questions. EFSA reacted with an assurance that it had properly fulfilled its mandate.
EFSA's "Scientific Committee took stock of the various views from a number of experts and forums," the European agency said when questioned.
The "EFSA phrase," harmless for the uninitiated, has, in fact, a considerable weight. Because if endocrine disruptors were actually substances that are just like any others, then there would be no need for strict regulation.
The pesticide industry, which is most affected by the issue, has clearly understood the point. Its main lobbying organizations - the European Crop Protection Association (ECPA), CropLife International, CropLife America - or the German agrochemical groups BASF or Bayer, repeat ad libitum the "EFSA phrase" in arguments and correspondence with the European institutions that Le Monde has seen.
In fact, the famous phrase is of major importance for European regulation on plant protection products. It was in 2009 that the European Parliament voted a new "pesticides regulation." According to this legislation, pesticides a priori identified as "endocrine disruptors" would no longer be allowed to enter or remain on the market except when the exposure is considered negligible.
This provision only needs one thing if it is to be applied: the adoption of scientific criteria to define endocrine disruptors - that is, what Brussels is proposing today. But since endocrine disruptors are chemical substances like any others - it's the "EFSA phrase" that prompts the question: why prohibit them a priori?
"Major breach" in health protection
The Commission has therefore made an amendment to the text. Now, it is sufficient to assess the risk that they present on a case-by-case basis if problems arise after they have been placed on the market - and therefore a posteriori. Is this change at the cost of the spirit of the 2009 regulation?
This amendment would open a "major loophole" in the protection of health and the environment, says EDC-Free Europe. This coalition of NGOs accuses the Commission of wanting to distort the intention of European law.
But above all, this amendment to the 2009 regulation poses a democratic problem: it is much as if the officials have taken the initiative to draft an implementing decree that had nothing to do with the intention of the elected representatives.
The European Parliament is also of this opinion. In a copy of a letter seen by Le Monde and dated September 15, the chairman of the Parliament's Environment Committee wrote to the Health Commissioner, Vytenis Andriukaitis, who is responsible for the file, saying that the project: "exceeds the implementing powers of the Commission" by amending "essential elements" of the law. Similarly, in their note of October 10, France, Denmark and Sweden do not say anything different, judging that the Commission has no right to change "a policy choice by the legislator."
This rebuke is all the more unfortunate because it comes when the Commission is already in a state of illegality on this issue. The European Court of Justice actually condemned the Commission in December 2015 for violating EU law: the Commission had been required to settle the question of the criteria to identify endocrine disrupters before the end of 2013.
However, the Commission remains unfazed by the shower of criticism. It offers an assurance that it has fulfilled the condition which authorizes it to "update" the regulation: to take into account the evolution of "scientific knowledge," namely the famous little phrase of EFSA. It is that phrase on which its justification rests.
But why should EFSA have written, in advance, a conclusion in breach of the scientific consensus? An internal Commission document obtained by Le Monde sheds some light on the intentions of the Directorate General for Health and Food Safety (DG Health), which is now responsible for the matter at the Commission.
A meeting report records in black and white that, as of September 2012, DG Health intends to disregard the will of elected representatives in Europe. The health directorate said then that it "did not oppose even the idea to go back to regulating based on risk assessment" and was "ready to change entirely" the part of the regulation concerned.
The same document states further on that DG Health will have to "talk with EFSA to try and accelerate the preparation" of its opinion. At this point, EFSA's opinion did not exist ... The agency had only just been asked to set up a working group on endocrine disruptors.
A "mortified" message
The very special conditions in which this working group operated can be read in e-mails exchanged by EFSA experts and officials. One month before the release of the EFSA report, the World Health Organization (WHO) and the United Nations Environment Program (UNEP) published a joint report on endocrine disruptors.
A mortified EFSA expert sent a message to the whole group: "It is almost embarrassing to compare the current draft report with the WHO-UNEP report ... when WHO-UNEP comes to the conclusion that traditional risk assessment of chemicals is not fit for purpose to assess (endocrine disruptors), we are exactly coming to the opposite conclusion."
This scientist considered it essential that the conclusions be radically changed. The EFSA official overseeing the work of the expert group agreed.
The "current conclusions where we explain that [endocrine disruptors] should be considered like most other chemicals [...] puts us in isolation compared to the rest of the world, and may be hard to defend," he writes. However, when EFSA's opinion is published on March 20, 2013, it continued to include, unperturbed, the little phrase.
"This should be a science-based procedure ... evidence-based policy-making," says Axel Singhofen, an adviser to the Greens-European Free Alliance in the European Parliament. "But what we see here is policy-based evidence-making."
Endocrine disruptors: A denial of the state of the science
"The current scientific knowledge:" It is this that the European Commission assures it is using to justify its much criticized choices in the regulation of endocrine disruptors. Yet, the Endocrine Society, a major scholarly society, believes that the Commission "ignores [the] state of science." How can such a hiatus be explained?
To document its considerations, the Directorate-General for Health and Food Safety, responsible for the file at the Commission, carried out an impact assessment of more than 400 pages, which was published in June after having been under lock and key as a state secret. To what specific "scientific knowledge" does it refer?
Above all, the Commission cites the opinion issued by one of its official agencies, the European Food Safety Authority, in 2013. This opinion is indeed the basis of its regulatory proposal. But the decision-making process began in 2009 and the "scientific knowledge" on endocrine disruptors has evolved considerably since then.
The Endocrine Society produced a review of the science in 2015. It examined 1,322 publications that had been published since its last review, which was actually in 2009. Conclusion? They do not leave "any doubt that EDCs [endocrine disruptors] are contributing to increased chronic disease burdens related to obesity, diabetes mellitus, reproduction, thyroid, cancers, and neuroendocrine and neurodevelopmental functions."
In 2013, some 20 researchers working for nearly two years under the auspices of the World Health Organization (WHO) and the United Nations Environment Program (UNEP) had reached similar conclusions. Their report sounded the alarm bell on a "global threat that needs to be resolved."
"Controversial interpretation"
These recent additions to "scientific knowledge" are indeed mentioned in the Commission's impact assessment but disqualified on the basis that they do not deserve to be taken into consideration. "Evidence is scattered and its interpretation controversial," the assessment report says, "so that a causal link or even a possible association between ED [endocrine disruptors] exposure at environmental levels and the diseases is not agreed among experts."
In the wake of this damning reception, it reduces the Endocrine Society to a "stakeholder" who has issued a "statement." As for the WHO/UNEP report, "scientific criticism to the general methodology used ... was raised," it indicates, citing a number of publications which it says show that the controversy "seems not resolved." But what publications would be sufficiently authoritative as to be able to knock down the work carried out by the most respected specialists in the field?
Notably, the Commission's negative comments are based on "critical comments," published in 2014, challenging the methods and conclusions of the WHO/UNEP report. Among the ten authors of the comments, seven are working for two consulting companies, Exponent and Gradient Corp, which specialize in scientific issues and are known as "product-defense firms."
But, most importantly, it was industry that sponsored the article through its lobbying organizations: the chemical sector with the European Chemical Industry Council (Cefic) and the American Chemistry Council and the pesticides sector with CropLife America, CropLife Canada, CropLife International and the European Crop Protection Association.
"Urban legend"
None of this can be unknown to the Commission services. Not only do these sponsors appear clearly in the declaration of interests at the end of the article, but industry itself sent it to them. Cefic sent it by e-mail to about 30 European officials involved in the case on March 17, 2014. In a message consulted by Le Monde, the industrialists explain that they have "commissioned a consortium of scientific experts to independently review the WHO-UNEP report," fearing, in particular, that "despite its serious shortcomings it was being used to call for more precautionary chemicals policy."
Other publications cited in the impact study include a two-page article, one of whose signatories is a person better known for his role as a consultant to the tobacco industry than for his competence on this topic. Among its co-authors are toxicologists paid by the chemical, pesticides and plastic industries.
Another article has again two consultants out of the three authors and talks about endocrine disruptors as an "urban legend" posing "imaginary health risks." Making fun of the "hypothetical" effects of endocrine disruptors, such as the "reduced penis length and size," they pose the question of "whether the whole issue of EDC is more within the competence of Dr. Sigmund Freud than that of toxicology."
Can these texts really be incorporated into "scientific knowledge?" Why does the Commission give so much credit to documents that resemble lobbying material?
In a momentous editorial published today [November 29, 2016] in Le Monde, independent scientists express concerns about a "distortion of the evidence by industrially sponsored actors." Signed by a hundred experts from two very different fields - endocrine disruption and climate change - their text notes the "dangerous consequences for the health of people and the environment" of this strategy of "manufacturing of doubt."
Endocrine Disruptors: The interference of the United States
The United States does not hide it. In some cases, they would like to write European law instead of leaving it to Europe. Among the cases: endocrine disruptors, these chemicals that are present in our everyday environment and capable of hijacking the hormonal system of living beings.
Since 2009, the European Commission has been working on the issue of their regulation. The topic is all the more sensitive as this regulation will be unprecedented, imposing new standards for the rest of the world. All trading partners who want to continue exporting their products to the EU, including the United States, will have to comply with them.
In highly technical documents, the American government expresses its position with unreserved criticism and requests that verge on political interference. Of particular note is this text, conveyed to the Commission on January 16, 2015, within the framework of a consultation on the various regulatory options envisaged. It says: "If the Commission were to be provided with evidence supporting an option not among (those) presented, would this be considered?"
The question is convoluted but the implication is clear: the United States does not only propose rewriting the law but disputes the very principle of the regulation as far as endocrine disruptors are concerned.
The origin of the tension is the European regulation on pesticides of 2009. Very strict, it foresees a ban on pesticides that have endocrine disrupting properties. This principle of "hazard assessment" a priori antagonizes the U.S. government. "Implementation of any hazard-based 'cut off' option," it writes, "could have severe implications for EU imports of U.S. agricultural goods." Contrary to the political will of Europe, the U.S. government calls for a return to the traditional philosophy of "risk assessment," which is undertaken a posteriori.
This U.S. pressure on the EU actually began in June 2013 at the meeting of the World Trade Organization (WTO) Committee on Technical Barriers to Trade. The U.S. representative shared the "concerns" of his government, but also those of its industry, which feared "significant and unwarranted dislocations in trade."
In the months that followed, the American concern spread to another WTO committee specifically responsible for pesticides and food. The "aggressive and well-orchestrated attacks" are recorded in a European Commission internal note of August 2015 seen by Le Monde. No one can be mistaken, there is a threat of prosecution looming.
It is in these WTO committees that the question of non-compliance with "international sanitary and phytosanitary measures," known as SPS, is raised.
A report in March 2016 says that Canada considers the regulation "only served to undermine international trade in agriculture and contravened the fundamental principle of the WTO SPS agreement, which was to base measures on scientific risk assessments and not to maintain them without scientific justification." Indeed, the U.S. has brought other countries onto its side: by summer 2016, the heterogeneous alliance included more than twenty countries, including China, Togo and Jamaica.
Given that the proposal that causes so much bitterness was adopted in 2009, why did the U.S. wait until 2013 to complain about it within the framework of the WTO? Because 2013 was in fact a pivotal moment in the European decision-making process on endocrine disruptors. At the beginning of 2013, the Commission set on a very different path. Its Directorate-General (DG) for the Environment, which was leading on the dossier, had just proposed its chosen option.
Drawing on the classification used for carcinogenic chemicals, it would allow substances to be divided into two categories: 'suspected' or 'known' endocrine disruptors. This option is supported by the scientific community, non-governmental organizations and certain member states, including France, while industry is violently, and openly, opposed to it.
A lobbying blitzkrieg against it took place in June 2013. It was a letter from CropLife America, the lobbying organization for the U.S. pesticide industry, which first suggested to the U.S. authorities that they challenge the option with the help of WTO rules.
"The U.S. Government should defend itself using the authority of the SPS Agreement under WTO if the EU pursues its proposed new regulatory regime .... without an approach based on risk assessment," wrote CropLife America, May 10, 2013, to the office of the U.S. trade representative. The letter added: "CLA stands ready to provide supporting documentation."
Surprisingly, the hostility of the U.S. and its allies has changed little while the position of the Commission has changed radically.
The option of DG Environment, which has since been divested of the file, was buried in July 2013. The new proposal from the Commission announced on June 15, 2016—even though it is judged very protective of the interests of companies—continues to satisfy neither the industry nor the critics at the WTO. A delegation of ambassadors to the EU came to the office of the European Commissioner for Health in July 2016 to express their discontent.
At the end of August, a final warning shot came via WTO. While Canada evoked a "negative, unnecessary and unjustified impact on trade," the U.S. government continued to challenge the "soundness of the EU's approach." As "supporting documentation:" the letters of several industrial organizations including the American Chemistry Council and CropLife America.
Editors Note: This article was originally published by Le Monde on November 29. This version is translated by the Health and Environment Alliance and is republished with permission.
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