The European Commission, with the help of EFSA, has set itself at odds with the mainstream scientific community in order to avoid stringent regulation of these hazardous substances
EXCERPT: "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: The manufacture of a lie
By Stéphane Horel
Environmental Health News, December 1, 2016
* The European Commission has developed its own evidence to avoid an overly stringent regulation of these hazardous substances. Part 1 of 3.
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. We are also republishing other parts of the investigation: A denial of the state of the science (Part 2) and The interference of the United States (Part 3).
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."