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Call to implement Better Regulation principles in EU action on Endocrine Disrupting Chemicals

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Brussels, 14 February 2017

To: Mr Frans Timmermans, European Commission First Vice-President
Cc: Mr Vytenis Andriukaitis, European Commissioner for Health and Food Safety

Subject: Call to implement Better Regulation principles in EU action on Endocrine Disrupting Chemicals

We are contacting you about Better Regulation issues in the EU’s policy on Endocrine Disrupting Chemicals.  First, we would like to express our appreciation to the European Commission for its stated commitment to “listen to the European Parliament, listen to all Member States, and listen to the people” (1)The harm caused by endocrine disrupting chemicals (“EDCs”) on EU citizens’ health and their environment is one of these “big problems” that the European Commission has been mandated to tackle as early as 1998 (2).  However, although laws and policies adopted since then show the EU institutions have been trying to address EDCs, citizens continue to be concerned and scientists continue to sound the alarm (3) (4) (5) (6).

The Commission’s proposals for criteria to identify EDCs, as required by the Pesticides and Biocides Regulations, are a necessary first step towards better protecting citizens and the environment from these harmful substances. However, because the proposals are currently at odds with the founding principles of Better Regulation, which aims at ensuring that the EU delivers high quality legislation, we bring the following concerns to your attention:

(1)   NOT EFFICIENT NOR COHERENT: The Commission is not adhering to existing EU political commitments for horizontal identification criteria enshrined in the Seventh Environment Action Programme (7), commitments which were recently reaffirmed by Council conclusions (8).  Currently the proposed identification criteria are only designed to work specifically for and in the Pesticides and Biocides Regulations (see Annex).

(2)  NOT EFFECTIVE: The Commission proposal on derogation conditions changes the overall Risk Management balance between protection and competitiveness enshrined in the Pesticides Regulation for EDCs and thereby exceeds the Commission’s legal mandate: the Commission was required to adopt scientific criteria to identify EDCs, not to soften the conditions for approval of EDCs in pesticides (see Annex).

(3)  NOT BASED ON EVIDENCE: The Commission is using a misinterpretation of science to justify changing the overall Risk Management balance. The Commission’s justification to make a change to the derogation conditions for pesticides’ authorisation is actually based on a flawed selective reading of the EFSA Scientific Opinion (see Annex).

(4)   NOT COHERENT: The Commission’s criteria proposal is inconsistent with international practices in chemicals classification which jeopardises the adoption of harmonised criteria worldwide and thus creates further uncertainty for businesses and policy makers (see Annex).

(5)  NOT TRANSPARENT: There is insufficient transparency and openness in the recent amendments made to the initial proposed criteria text. Substantial changes in the identification criteria have been made that lack any publically available scientific reasoning or justification and make it a daunting task for stakeholders to follow the process and the impacts of such major changes (see Annex).

As they stand now, the proposed criteria to identify EDCs are a perfect counter-example of Better Regulation. That is why, we call on you, as First Vice-President of the European Commission, in charge of coordinating the work on Better Regulation and the rule of law, and ensuring horizontal responsibility for sustainable development, to act to “break down silos” and adhere to existing EU political commitments (9).  Your action within the Commission to ensure better EDC criteria can send a strong signal to European citizens about what Better Regulation can and ought to be on the big things that concern them, protecting people’s health and the environment from harmful chemicals.

 

Yours sincerely,

Genon K. Jensen, Health and Environment Alliance (HEAL) Executive Director on behalf of the EDC-Free Europe NGO coalition

Jorgo Riss, Greenpeace European Unit Director on behalf of the Green 10 as current Chair

 

EDC-Free Europe is a coalition of more than 70 environmental, health, women’s and consumer groups across Europe who share a concern about endocrine disrupting chemicals (EDCs) and their impact on our health and wildlife.

The Green 10 are ten of the largest environmental organisations and networks active on the European level. They coordinate joint responses and recommendations to EU decision makers. Membership of the Green 10 alone is more than 20 million people.

The complete letter, including the annex and footnotes, can be read online here.

 

EU’s never-ending story on protective criteria to identify hormone disruptors continues

Brussels, 22 December 2016 - EDC-Free Europe, a coalition of NGOs, welcomes the fact that the Commission’s proposals on hormone disrupting chemicals (or EDCs), which have been heavily criticised, failed to obtain enough support yesterday from Member States.

After years of debate and delay, EU member states (through their pesticide officials) met in Brussels to discuss and potentially approve the drafts on identification criteria and a derogation allowing use of Endocrine Disrupting pesticides.  But the Commission shied away from putting their most recent proposals (8 December) to an official vote, because they would not have obtained the sufficient qualified majority from Member States.

The proposal for identification criteria contained some sudden significant text changes derived from Hungarian and German comments. The proposal for a change to the existing derogation from the prohibition of ED pesticides remains mostly unchanged since June.

Despite 3 versions since mid-June, the Commission’s proposals on identification and derogation continue to meet well-founded opposition from countries such as France, Sweden, Denmark, Finland, and the Netherlands, as well as strong criticism from scientific professional and public interest groups, including the EDC-Free coalition[1].  In parallel, over 260,000 EU citizens have signed a petition calling on Member States to reject the EU Commission’s proposal on EDCs.

Several Member States have been repeatedly calling for important improvements to the identification criteria since June, notably on the need to use terms and categories already well-established in chemicals management at both EU and international levels[2].  Member states have also been calling for criteria that identify EDCS solely on a chemical’s inherent capacity to disrupt hormones, and for criteria that can be applied across all relevant EU laws, to both of which the EU is committed in its 7th Environmental Action Plan in 2013[3].  On December 19th, the EU Environment Council issued conclusions on chemicals management which re-affirmed these 7th EAP criteria commitments.

Since June, the NGOs have also heavily criticised the sequential versions of the proposal for not addressing several key issues.  While the NGO coalition has consistently asked for swift adoption of high quality scientifically sound criteria, in order to accelerate actions to reduce peoples’ exposure to EDCs, the coalition emphasizes that the speed of decision making should not be achieved at the cost of the quality and soundness of the criteria.

The NGO coalition continues to criticise the criteria, for the same reasons the coalition highlighted to ministers on December 15 2016[4];

  • The amount of evidence needed to identify EDCs is too high and will leave people and wildlife under threat because some EDCs will not be identified[5].
  • The proposed change to the derogation fundamentally alters the balance of risk management set by Council, Parliament and Commission in agreeing the law in 2009[6].  This change widens an existing limited exemption into a major loophole that can easily be exploited to allow continued widespread use of endocrine disrupting pesticides.  Recent LeMonde investigations have shown that the scientific justification that the Commission uses to alter the derogation are based on a contrived conclusion[7].
  • Recent proposals for new exemptions from identification which would set an automatic and large escape route for EDCs that 1) affect the moulting and growth of bystander (non-pest) species (Hungarian proposal); or 2) that intentionally disrupt the hormones of any bystander species (species not targeted by the pesticide or biocide), (German proposal).

The NGO Coalition commends those Member States opposing these defective criteria, and urges the Commission to finally take on board these key elements so that the criteria are finally legally and scientifically sound, and can finally rightfully gain the Member States’ support.  The EU needs to move on to identifying and phasing out endocrine disrupting pesticides and biocides, in order to reduce people’s exposures.  These actions will help prevent EDC-related diseases and the combat the rising costs of healthcare associated with EDCs-related illnesses as well as the damage to wildlife. Sound criteria can drive innovation for safer chemicals and safer products, which can create a healthier future for us all.


[2] Phrasing such as ‘known or presumed’ which is used in the EU Classification of carcinogens, mutagens, and reproductive toxicants; and the different categories to rank chemicals according to the totality of evidence, for instance the categories used in the EU Classification of carcinogens, or similar to the categories used in the EU Priority List of EDCs for further assessment.

[3] General Union Environment Action Programme to 2020 “Living well, within the limits of our planet” (the 7th EAP) , http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013D1386

[5] The criteria are very difficult to fulfil because of the requirement to prove a consequential link between the adverse effect and the endocrine mode of action.  In particular, the ‘biological plausibility’ is not included in the three main conditions of identification for bringing together the adverse effect and the alteration of the function of the endocrine system.   In addition, the draft does not include categories in order to reflect the different levels of scientific evidence available, in spite of the fact that both EU Biocides and Pesticides Laws require the identification of EDCs that `may` cause adverse effects (i.e. suspected/probable EDCs)

[6] The proposed change to the derogation from `negligible exposure` to `negligible risk` introduces new risk elements to the legislation. The Commission is using a flawed justification of adaptation to scientific progress. This change can easily be exploited to get endocrine disrupting pesticides authorised for widespread use. But this change touches on an ‘essential element’ of the law, something the Commission is not allowed to change in a committee procedure (for an implementing act). Such changes must be done involving Parliament and Council in a fully transparent and democratic ‘co-decision’ legislative process. See http://www.environmentalhealthnews.org/ehs/news/2016/dec/endocrine-disruptors-the-manufacture-of-a-lie

Endocrine disruptors: the discreet but major gift to the pesticides lobby

by Stephane Horel, Le Monde, 20 December
Original French version can be found online here.

The European Commission submits its proposal for regulation of chemical substances on Wednesday.

It’s a paragraph that does not look like anything, added at the bottom of the document at the last minute. In a tortuous and impenetrable formulation, it refers to a derogation for products acting on the “moulting and / or growth of harmful organisms”. But, reformulated in common language, it is no more or less a concession from the European Commission to the pesticide lobby.

A few days before Christmas, Wednesday 21 December, three years late, the Commission is due to submit to a vote its proposed regulation on endocrine disruptors, these ubiquitous chemicals capable of interfering with the hormonal system of living beings at sometimes tiny doses. This proposal is supposed to implement a very strict provision of the European regulation on pesticides: the ban on pesticides that will be recognized as endocrine disruptors.

It is therefore the criteria that allow them to be identified which the Commission has drawn up and which the representatives of the Member States must adopt or reject. The vote will be held in the Standing Committee on the Food Chain and Animal Safety after six months of negotiations.

If the devil is hiding in the details, the paragraph inserted by the Commission at the last minute is anything but anecdotal. While the “pesticides regulation” requires removing endocrine disruptors from the market, the paragraph creates a derogation from identification for a whole group of pesticides that have the particularity of … being endocrine disruptors. Indeed some pesticides wipe out insects or plants known as “pests” to crops by acting on their hormonal system to block their moulting or growth. In other words, these are pesticides that have been designed to be endocrine disruptors. Rather than using this knowledge to identify and prohibit them, the Commission proposes that they be spared.

Request from the trio BASF, Bayer and Syngenta

This major derogation is in fact an old request of the pesticide industry. It was developed by the trio of pesticide manufacturers who will be most affected by the regulation: the German giant BASF (the world leader in chemistry) and Bayer (being merged with Monsanto) and the Swiss group Syngenta. In a document dated 2013, employees of these groups argue for a “derogation” for what they refer to as “endocrine disruptors by design”:

“Strictly speaking, such compounds would fulfil the endocrine disruptor definition as their endocrine mechanism and adverse population-relevant effects are intended and well-described.  (…) Consequently, an exemption category for these chemicals should be defined.. ”

The new paragraph resembles in an unmistakable way the article written by employees of pesticide manufacturers.

But the exemption is problematic for living beings, which could be affected by these endocrine disrupting pesticides, from plants to ladybugs, passing by nearby squirrels,  that is all those that the law calls “non-target organisms” but are also equipped with a hormonal system liable to be hijacked by these products.

Weed killer classified as “possible human carcinogen”

While there is no assessment of the consequences of this clause on the ecosystem, it will undoubtedly have a positive impact on the industry. According to information gathered by Le Monde, this exception would correspond to about 15 insecticides and a handful of herbicides including 2,4-D, a herbicide that has also been classified as a “possible human carcinogen” by the International Agency for Research on Cancer (IARC) in 2015.

According to the calculations made by the NGO Générations futures, the derogation concerns more than 8 700 tonnes of commercial products per year, just for France. Francois Veillerette, the spokesperson of the NGO, is indignant:

“It is aberrant in a regulation that wants to remove endocrine disruptors to protect the ecosystem.”

“This request doesn’t come from us but from the German authorities”, said Graeme Taylor, director of public affairs for the European Crop Protection Association (ECPA). The lobbying organization of the pesticide industry rejected the Commission’s proposal “as a whole”, considering that it “does not go far enough”.

Uncertain majority, proposal cut in half

Uncertain to get a majority on Wednesday, the European Commission cut off its contested proposal in two. The first scientific part contains an environmental component, including this new derogation, and a human health component, which is also the subject of strong criticism from the relevant scientific community, NGOs and certain Member States, including France.

They all denounced the inadequacy of the text to protect the population from diseases linked to exposure to endocrine disruptors (cancers, brain development problems, infertility, diabetes, etc.).

The second part of the proposal, on regulatory aspects, also contains a substantial derogation. If kept, the risks posed by endocrine disrupting pesticides would be assessed on a case-by-case basis after being placed on the market, whereas the law requires their a priori prohibition. This part is not only considered illegal by the European Parliament, NGOs and certain countries, but Le Monde revealed at the end of November, with supporting documents, that it was based on conclusions written in advance by an official European agency.

Read ‘Endocrine Disruptors: the manufacture of a lie’

“These proposals are unacceptable and they do not respond to growing public concern or mobilization for genuine action that would reduce the presence of endocrine disruptors in our daily lives”, said the coalition of NGOs EDC- Free Europe. An online petition from SumOfUs, calling to reject the proposal, has collected more than 260,000 signatures.

At the highest political level in Europe, where “good work” is considered to have been done, it is argued that there was a “scientific controversy” about endocrine disruptors to deal with. Yet a hundred respected scientists have warned decision-makers against a “manufacturing of doubt” financed by industries whose commercial interests are threatened, in the manner of the oil industry with climate change (Le Monde, November 30). Facts that a European official sweeps away, however, as “conspiracy theories”.

EDC-Free Europe urges Member States to reject Commission’s 3rd revised proposal on EDC criteria

Brussels, 15 December 2016 –  Today EDC-Free Europe sent a letter to EU Environment, Health and Agriculture ministers urging them to reject the 3rd revision which is to be discussed and possibly voted on in a meeting on December 21st.

Update 16 December: the text of the pesticides proposals can now be found online here.

To Health, Environment and Agricultural Ministers

Dear Minister,

The EDC-Free Europe NGO coalition urges your country to reject the European Commission’s 3rd revised proposal for identifying endocrine disrupting chemicals during the December 21st meeting of the Standing Committee of Food Animals Food and Feed.   Although the revised version for pesticides has not been made public, we assume the identification criteria are the same as for biocides, whose texts have been released.  We also understand that the proposal on the derogation remains the same – see point 1 below.

We are very concerned that this 3rd proposal fails to protect citizen’s health or the environment for the following reasons:

1)      Derogation change from `negligible exposure` to `negligible risk`

The Commission claims legal authority to make the change from an article in the pesticides law that permits adjustments according to scientific advances. The scientific advance, which the Commission uses to justify the change to the risk-based approach is a key sentence in the 2013 scientific opinion from the European Food Safety Authority (EFSA). But recent newspaper investigations reveal that this key sentence was a pre-fabricated conclusion prior to the EFSA group even starting their work (For more details see the annex to this letter.)  This news is deeply troubling and throws into serious doubt the scientific justification which underpins the Commission’s change to the derogation.

2)      An excessively high burden of proof for identifying EDCs

Under the identification criteria proposed, it will be extremely difficult to identify an endocrine disruptor for regulatory action before people or the environment have been harmed. This is also the conclusion of the world’s leading scientific society specializing in hormones, The Endocrine Society, when they evaluated the prior proposal.

3)      A new exemption for certain endocrine-disrupting characteristics

A new exemption has been introduced to excuse certain substances from identification (those with effects on moulting and/or growth), which could have wide ranging negative implications, in particular for wildlife. Firstly it contradicts the aim of the pesticides law to phase out use of endocrine disrupting pesticides and should therefore not be introduced as part of the identification criteria. Secondly, the identification criteria must be horizontally applicable, because they will have implications for the identification of EDCs under other laws.  Exempting some Endocrine Disrupting characteristics from identification for purposes specific to the pesticides and biocides laws contradicts the commitment under the 7th Environmental Action Programme for horizontal criteria.

In summary, we understand that this 3rd version continues to propose a risk-based derogation that is founded on a contrived scientific justification to introduce an illegal change in the previously democratically agreed legislative text; contains mostly cosmetic changes to the overly-stringent identification criteria; and introduces a new exemption which excuses a certain set of endocrine disrupting characteristics from identification.

These proposals are unacceptable, and they do not respond to the growing public concern and mobilization for real action to reduce EDCs in our daily life. Over 220,000 EU citizens have signed an urgent petition to all European governments asking you to reject the EU Commission’s proposal.

With kind regards on behalf of the EDC-Free Europe coalition,

Genon K. Jensen

Executive Director, Health & Environment Alliance (HEAL)

In the view of the public interest in this matter we will make this letter available more widely.

ANNEX

New information on how DG Sante is using a pre-manufactured scientific conclusion for the risk based derogation, relies on industry funded studies and has been influenced by the US

In the first article of a three-part series published in Le Monde in French and in Environmental Health News in English, it is revealed that “the European Commission has developed its own evidence to avoid an overly stringent regulation” of EDCs. They have then used this to justify the change in the derogation from `negligible exposure` to `negligible risk` which illegally introduces new risk elements to the legislation.

“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.”

Euractiv reveals how Commissions’ proposal put private profit and trade concerns over public health

Earlier this week, Euractiv’s article, “New endocrine disruptor rules address your trade concerns, EU tells US” illustrates how private profit and trade concerns are put above public health and democratically agreed laws.  In July, the Health Commissioner met with EU trade partners about the Commission’s June draft proposal on the EDC criteria and assured them their proposals would use a different risk-evaluation method.

Endocrine Disruptors: the interference of the United States

Since 2013, the United States has been contesting by all means available the European regulation of these chemicals in the name of free trade.

HEAL has translated this article which originally ran in French on 29 November 2016 in LeMonde. It is Part 3 of a 3 part series, accompanied by a commentary signed by nearly 100 scientists:

By Stéphane Horel

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 16 January 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 antagonises the US government. “Implementation of any hazard-based ‘cut off’ option,” it writes, “could have severe implications for EU imports of US agricultural goods.” Contrary to the political will of Europe, the US government calls for a return to the traditional philosophy of “risk assessment”, which is undertaken a posteriori.

This US 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 US 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 US 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 United States 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 US pesticide industry, which first suggested to the US authorities that they challenge the option with the help of WTO rules. “The US 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, 10 May 2013 to the office of the US trade representative. The letter added: “CLA stands ready to provide supporting documentation”.

Surprisingly, the hostility of the United States 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 15 June 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 US 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.

This article has been translated by the Health and Environment Alliance from the original French version here: http://www.lemonde.fr/sante/article/2016/11/29/perturbateurs-endocriniens-l-ingerence-des-etats-unis_5040055_1651302.html#OVD1DbSRPcFKvC3H.99

This article ran on 29 November 2016 in LeMonde, France, alongside 3 other articles :

Endocrine disruptors: a denial of the state of the science

The European Commission relies on studies financed by industry.

HEAL has translated this article which originally ran in French on 29 November 2016 in LeMonde. It is Part 2 of a 3 part series, accompanied by a commentary signed by nearly 100 scientists:

Open Letter: Let’s stop the manipulation of the science.

Endocrine Disruptors: The manufacture of a lie (Part 1)

Endocrine Disruptors: The interference of the United States (Part 3)

By Stéphane Horel

The current scientific knowledge”: It is this that the European Commission assures it is using to justify its much criticised 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 (Le Monde, 20-21 May). 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 to disqualify them 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 specialise 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 thirty European officials involved in the case on 17 March 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 [29 November 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”.

This article has been translated by the Health and Environment Alliance from the original French version here: http://www.lemonde.fr/planete/article/2016/11/29/perturbateurs-endocriniens-un-deni-de-l-etat-de-la-science_5039870_3244.html

This article ran on 29 November 2016 in LeMonde, France, alongside 3 other articles :

  • Let’s stop the manipulation of the science.
    A commentary by nearly one hundred scientists, asking the European Union and the international community to act against endocrine disruptors. They condemn the use of strategies for manufacturing doubt employed by industries in the climate change battle.

 

Endocrine disrupters: the manufacture of a lie

The European Commission has developed its own evidence to avoid what it considers to be an overly stringent regulation of these hazardous substances.

HEAL has translated this article which originally ran in French on 29 November 2016 in LeMonde. It is Part 1 of a 3 part series, accompanied by a commentary signed by nearly 100 scientists:

Open Letter: Let’s stop the manipulation of the science

Endocrine Disruptors: A denial of the state of the science (Part 2)

Endocrine Disruptors: The interference of the United States (Part 3)

By Stéphane Horel

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’s (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 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 specialising 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 organisations – 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 15 September, 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 10 October, France, Denmark and Sweden do not say anything different, judging that 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 20 March 2013, it continued to include, unperturbed, the little phrase.

“This should be a science-based procedure – so 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.”

This article has been translated by the Health and Environment Alliance from the original French version here: http://www.lemonde.fr//planete/article/2016/11/29/perturbateurs-endocriniens-la-fabrique-d-un-mensonge_5039862_3244.html

 

EDC-Free Europe letter to EU Ministers on revised EDC criteria

Monday 14th of November 2016
To: Health, Environment and Agriculture Ministers

Dear Minister,

Ahead of the discussions on the criteria for endocrine disrupting chemicals in the Standing Committee of Food Animals Food and Feed on 18.11.2016 under the Pesticides 1107/2009 and Biocides 528/2012 Regulations, we would to like to share our concerns regarding the revised draft Commission proposal.

The EDC-Free Europe coalition opposes this revised proposal because the text still demands too high a burden of proof, fails to address the requirements of the Pesticide and Biocide Laws and is hence also unfit to apply to other EU regulations. The criteria will still fail to protect EU citizens and the environment the way the law intends.

Our two main concerns we would urge you to address:

1) The revised proposal continues to impose an unreasonably high burden of proof to identify EDCs. Although there have been some useful clarifications, the criteria are very difficult to fulfil because of the requirement to prove a consequential link between the adverse effect and the endocrine mode of action. In addition, the draft does not include categories in order to reflect the different levels of scientific evidence available, in spite of the fact that both EU Biocides and Pesticides Laws require the identification of EDCs that `may` cause adverse effects (i.e. suspected/potential EDCs).

2) The revised proposal still keeps the amendments to the Annex of the Plant Protection Product Regulation that alter in a fundamental way the risk management choice agreed by Council, Parliament and Commission in the co-decision procedure. The change in the derogation from `negligible exposure` to `negligible risk` introduces new risk elements to the legislation. By this change, the Commission widens an existing limited exemption into a major loophole that can easily be exploited to enable continued use of identified EDCs. This would allow endocrine disrupting pesticides to be authorised for widespread use. Europeans and the environment will remain unprotected for the harmful effects of EDCs.

The EDC criteria are expected to have wide ranging implications for all EU chemicals laws and therefore the proposal needs to be changed to ensure coherence and to protect human health and the environment. We therefore call on you to oppose the revised Commission proposal and ensure the EDC criteria will provide a high level of protection, are in line with the European law and can be applied across all Regulations pertaining to chemicals.

Your decision will be a critical contribution in the urgent efforts to prevent endocrine-related diseases for Europeans and averting damage from our ecosystems.

With kind regards on behalf of EDC-Free Europe coalition,

Francois Veillerette
President of Pesticide Action Network (PAN) Europe 

Genon Jensen
Executive Director, Health & Environment Alliance (HEAL)

Letter available to download here