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NGOs’ verdict to Commission’s revised proposal on EDC criteria: not right again!

Brussels, 8 November 2016 – EDC-Free Europe has reacted strongly to the European Commission’s revised proposal on EDC criteria because it will fail to protect health and environment.

“Despite some clarifications, the proposed criteria will not protect citizen’s health or the environment the way the law intends.  The burden of proof to identify EDCs is still too high. But even worse, the Commission kept in the massive and illegal loophole to the EDC ban on pesticides, against the spirit and intention of the law,” says EDC Free Europe spokesperson Genon K. Jensen.

The NGOs criticise:

  • the unreasonably high burden of proof to identify EDCs
  • the exemption that allows widespread use of endocrine disrupting pesticides
  • the absence of multiple categories to rank chemicals according to scientific evidence
  • the discrimination against independent studies.

The Commission has retained its proposed change to the exemption from “negligible exposure” to “negligible risk” using a flawed justification of adaptation to scientific progress.  This change allows endocrine disrupting pesticides to be authorised for widespread use.  But this change touches the essential balance in the law, something the Commission is not allowed to change in a committee procedure.  Such changes must be done via Parliament and Council in a fully transparent and democratic ‘co-decision’ process.

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This postcard is available in EnglishFrench, Dutch and Danish.

Photo opportunity

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EDC-Free Europe campaign partners will meet with MEPs outside the European Parliament on Wednesday 9 November to highlight a citizen’s call on endocrine disruptors. A petition from SumOfUs calls on European leaders to protect the public and environment from endocrine disrupting chemicals (EDCs). (1)

EDC-Free campaign partners will hand over a postcard to MEPs highlighting recommendations on how to achieve an EDC-Free future, how to get EDCs properly identified, and how to reduce people’s exposure to these chemicals.

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Contacts

Lisette van Vliet, Lisette@env-health.org Mobile: +32 484 614 528
Vito A. Buonsante, vbuonsante@clientearth.org, Mobile: +32 475 239 402
Francois Veillerette, francois@generations-futures.fr, Mobile: +33 681 64 65 58
Hans Muilerman, hans@pan-europe.info, Tel: +31 6 55 80 72 55

Notes

1. View the petition: Reject the EU Commission’s disastrous draft proposal on endocrine disruptors to protect public health and the environment at https://actions.sumofus.org/a/eu-endocrine-disruptors
The petition is available in English, French, Spanish, German.

2. EDC Free Europe reaction to EU Commission proposal (released 15 June 2016) http://www.edc-free-europe.org/edc-free-europe-reaction-on-commissions-edc-criteria-proposal/

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 coalition aims to raise awareness and urge faster governmental action on these chemicals. Over 11,000 individuals support the campaign, communicating in seven languages.

SumOfUs is a global consumer watchdog group that campaigns to hold big corporations accountable. Over 10 million people have taken over 50 million actions worldwide with SumOfUs since it launched.

EU member states have chance to decide on the future of our health

On the 15 June, the European Commission finally released its proposal for criteria to identify hormone disrupting chemicals (also known as endocrine disrupting chemicals or EDCs) for the EU biocides and pesticides laws. It then held meetings with member states and with stakeholders to explain the proposals, and conducted 2 parallel public consultations on these proposed EDC Criteria in July. 

Draft general message 2_opt

Experts and official representatives of the 28 member states met on 21 September (separately a biocides expert group and the Pesticides Standing Committee) in Brussels to discuss the proposed criteria. The country representatives in the Pesticides Standing Committee will vote on the proposals in a future Committee meeting. Under the biocides law, no vote is required on the biocides proposal.

To date, the proposals have been widely criticised by scientific and medical professionals. The Endocrine Society noted that the overly strict [draft] criteria would result in very few EDCs being identified and regulated, at a high cost to the public’s health [1]. Leading EDC researchers have criticised both the high burden of proof required to identify an EDC, and the «confused set of processes for identifying, evaluating and integrating scientific evidence which unnecessarily privilege certain types of data, and cannot be adequately operationalised for regulatory identification of EDCs» [2].

If the Pesticides Committee approves the final proposal, which the Commission may still change as a result of the discussions before the vote, the approved proposal then proceeds to Parliament and Council, who have 3 months to decide if they want to reject the proposal.

Our verdict on Commission proposal

Despite a delay of nearly three years, the Commission’s June proposal still fails to satisfy, both in terms of the scientific content and parameters, and in terms of protecting the health of humans, wildlife and the environment. When the criteria proposal was released in June, the EDC-Free Europe Coalition expressed its astonishment, strongly condemning the proposal.

For these reasons, the EDC-Free Europe Coalition urges all national governments to reject the proposal as it currently stands and insists on major changes to ensure that the EDCs to which we are exposed will be identified as such and therefore be prohibited from use as the laws intended, in order protect our health.

Want to know what you can do?

Use our infographics and tell your governments to demand better criteria for better health protection!

Draft general message 1

Copy of EDCFree September template (positive) (7)

Draft general message 3

[1] https://www.endocrine.org/news-room/current-press-releases/european-commissions-overreaching-decision-fails-to-protect-public-healthhttp://www.thelancet.com/journals/landia/article/PIIS2213-8587(16)30121-8/abstract

[2] http://policyfromscience.com/wp-content/uploads/2016/07/Open-Letter-to-Andriukaitis-about-EDC-Criteria1.pdf

European Commission launches two public consultations on hormone disrupting chemicals in midst of summer

18 July 2016, Brussels – Following the Commission`s proposed criteria for identifying hormone disrupting chemicals, also known as endocrine disrupting chemicals (EDCs) on 15 June, it has now launched two more public consultations, which close on 28 July.

After a delay of nearly three years, the Commission’s proposal still fails to protect the health of humans, wildlife and the environment. On the day of the announced criteria in June, the EDC-Free Europe Coalition expressed its astonishment, strongly condemning the proposal.

The current proposal fails to address the pressing public health threat from EDCs and fulfill the legal mandate to protect health, wildlife and the environment from exposure to these chemicals. The Commission has ignored the majority of respondents to its 2015 public consultation who supported the most effective use of science to protect humans and wildlife, especially vulnerable groups such as pregnant women, babies and children. At that time over 20,000 citizens made their voice heard in this first European Commission public consultation. Despite this public demand to protect our health and the environment, the Commission has ignored these concerns.

Over 1,300 scientific studies link exposure to EDCs to spiraling rates of hormone-related cancers, diabetes, obesity and behavioral problems in children. In addition, the health costs of diseases associated with exposure to these chemicals are estimated at 158 billion EUR per year.

The proposal must be rectified to ensure a high level of protection for health and the environment, preventing endocrine- related diseases for Europeans and averting damage from our ecosystems. Our everyday exposure must stop to protect current and future generations.

EDC-Free campaign partners have started providing feedback to the EU Commission. You can join them by following these links:

 

Contact:
For any questions, please contact the EDC-Free Secretariat info@env-health.org

EDC-Free Coalition asks Environment Ministers to say NO to hormone disruptors

Dear Environment Minister,

Ahead of the June Environment Council, we are writing to you on behalf of EDC-Free Europe, a coalition representing over 70 organisations who have come together because of our concern about endocrine disrupting chemicals (EDCs).

The EDC-Free Europe coalition strongly condemns the Commission proposal for criteria to identify endocrine disrupting chemicals (EDCs) presented on June 15th. It will fail to protect wildlife and to address this urgent public health threat. We have reason for concern – over 1,300 studies have linked EDC exposure to serious health problems including infertility, diabetes, obesity, hormone-related cancers and neurological disorders.

We see two major problems with the proposals which we ask you to rectify:

1)      The Commission proposes to identify EDCs only if they have been proven to cause adverse effects in humans or non-target organisms. Requiring this unprecedentedly high level of proof means that humans and the environment will most likely have to be harmed before action is taken. This level of proof is incoherent with the usual approach taken in the EU for e.g. identifying carcinogens which uses both the wording `known` (CLP cat 1 A) and `presumed` (CLP cat 1B). The proposal will have wide ranging implications for all EU chemicals laws and therefore needs to be changed in order to ensure coherence, and to protect wildlife and people.

2)      The Commission proposes amendments to the Plant Protection Product Regulation that alter the agreement taken between Council, European Parliament and Commission in the co-decision procedure. They propose changing the legal text from endocrine disruptors that “may cause adverse effect” to endocrine disruptors “known to cause an adverse effect”.  Furthermore, the Commission goes beyond their task on identification criteria and actually reintroduces new specific risk assessments for all EDC pesticides, which changes the balance and approach agreed between Council and Parliament. They propose widening an existing exemption into a major loophole for those cases where chemicals have been identified as EDCs (changing `negligible exposure’ to ‘negligible risk´). This would allow continued uncontrolled exposure to these chemicals of high concern.

We therefore call on you to use the opportunity at the Environment Council meeting on Monday, 20th of June, to insist on major changes. Thank you very much for ensuring a high level of protection for human health and the environment, preventing endocrine-related diseases for Europeans and averting damage from our ecosystems.

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

Translations of this letter are available in English, Spanish, and French.

EDC-Free Europe reaction on Commission’s EDC criteria proposal

Commission’s EDC criteria proposal:  More humans will have to be harmed before action is taken

The EDC-Free Europe coalition is astounded at and strongly condemns today`s Commission proposal for criteria to identify endocrine disrupting chemicals (EDCs).

EDCFree reaction

The Commission proposed to identify EDCs based on an unprecedentedly high level of proof.  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. The health costs of diseases associated with exposure to endocrine disrupting chemicals, including infertility and male reproductive dysfunctions, female reproductive problems (endometriosis and uterine fibroids), birth defects, obesity, diabetes, cardiovascular disease, and neurobehavioral and learning disorders, have been estimated at 158.4 billion Euros per year in the EU.

Moreover, the Commission ignored that:

  • This approach is inconsistent and incoherent with the current, well established, and successful approach to identifying and ranking carcinogens, mutagens and chemicals toxic to reproduction according to the level of evidence;
  • The majority of respondents to the Commission`s public consultation supported to use multiple ranking categories (option 3) to effectively use the science to protect human health; 
  • The leading scientists recommended option 3 as the right option because it
    • takes up the latest science and new emerging research, and;
    • enables the regulation to protect pregnant women, babies and children.

Potential EDCs will not be captured – “MAY” cause adverse effects deleted
The proposal further undermines the current biocides and pesticide legislation by ignoring a key aspect – “potential” EDCs. The current law covers hormone disrupters which ` may cause adverse effects [in humans or animals]´. This shows the clear intention of the entire EU Parliament and Council to regulate not only definite but also strongly suspected EDCs. However, the Commission proposal gets rid of this wording in the proposed changes to the pesticide law.  Furthermore, the Commission proposes only one category, and sets restrictive conditions on the evidence which means that humans will most likely (continue to) be harmed before action is taken.  This is not only a glaring departure from the EU precautionary approach both enshrined in the EU Treaties and carefully and intentionally built into the biocide and pesticides laws, it is simply not an acceptable level of protection.

Sneaky: Changing negligible EXPOSURE to negligible RISK
Moreover, in a move that is potentially illegal the Commission goes beyond identification criteria to propose widening an existing exemption in the Pesticides law into a major loophole for those cases where chemicals have been identified as EDCs (changing `negligible exposure’ to ‘negligible risk´).

We urgently call on the Member States to insist on major changes because these proposals will do nothing to protect human health and environment from further harm but instead allows the pesticide and chemical industries to continue using harmful substances to which we are all daily exposed.

Anti-EDC Campaigners Are Bubbling Up With Determination

Say “No” to hormone disruption, say “Yes” to citizens’ wishes

Partners in the EDC-Free coalition gathered outside the European Commission building at Berlaymont in Brussels on Monday, 13 June. They called for more attention to be given to citizens’ wishes and independent science in EU decisions on endocrine disrupting chemicals (EDCs).

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Lisette van Vliet, Senior Policy Adviser at the Health and Environment Alliance (HEAL), calls on European Commission President Jean-Claude Juncker and his 27 Commissions to protect health from exposure to hormone, or endocrine, disrupting chemicals, which are found in everyday products.

The EDC-Free coalition anticipates that the Commission will come forward with its proposal on the scientific criteria for identifying EDCs on Wednesday, 15 June. HEAL’s Lisette van Vliet is ready to answer questions on the citizens’ perspective and issue a call to action on EDCs. She says: “There exists a scientific consensus on how best to identify these harmful chemicals.  We want the EU to choose the best criteria and make the best use of the science to distinguish between them. This means sticking with the successful practice used to rank other harmful chemicals (1) into at least three categories.”

She will also talk about the recent vote in the European Parliament which overwhelmingly condemned the Commission for its failure to comply with the original deadline and thus with the EU Treaty. Sweden, working with several other Member State governments, the European Parliament and the European Council took the Commission to court and won. The European court judgement made clear that the impact assessment can have no bearing on the decision about which scientific identification criteria are chosen.

On June 20, the Council of Environment Ministers will discuss the EDCs criteria. (2)

The health costs of diseases associated with exposure to endocrine disrupting chemicals, including infertility and male reproductive dysfunctions, female reproductive problems (endometriosis and uterine fibroids), birth defects, obesity, diabetes, cardiovascular disease, and neurobehavioral and learning disorders, have been estimated at 158.4 billion Euros per year in the EU. (3)

Contacts:
Lisette van Vliet, Senior Policy Adviser, Health and Environment Alliance (HEAL), Mobile: +32 484 614 528, Email: lisette@env-health.org

Lucy Mathieson, Communications Manager, Health and Environment Alliance (HEAL), Mobile: +32 470 84 75 73, Email: lucy@env-health.org

Notes for journalists:

  1. Carcinogens, mutagens and reproductive toxicants 
  2. The discussion in the Council was requested by France, which has a strong position on the criteria. (France had also joined Sweden in the court case.) Once the criteria have been endorsed by the EU Commissioners, the Commission must submit them to a standing committee on pesticides, and the Commission has also chosen to consult an expert group on biocides, probably in early July.  The subsequent text would then be presented to Parliament and Council for approval or rejection, before returning to the Commission for final publication (or for the whole process to be re-started).
  3. Two recent studies have analysed the economic impact that exposure to endocrine-disrupting chemicals may be having on health.  The first estimated costs at 157 billion Euros a year (taking into account impacts on infertility and male reproductive dysfunctions, birth defects, obesity, diabetes, cardiovascular disease, and neurobehavioral and learning disorders associated with certain endocrine disrupting chemicals) see http://press.endocrine.org/doi/10.1210/jc.2014-4324. The second estimated costs associated with two female reproductive health conditions, endometriosis and uterine fibroids attributable to certain EDCs, at 1.4 billion Euros per year. Clin Endocrinol Metab. 2016 Mar 22. doi: 10.1210/jc.2015-2873. See https://www.endocrine.org/news-room

EDC-Free Coalition Letter to Head of European Commission

8 June 2016

To: President Jean-Claude Juncker, Head of the European Commission
CC: EU Commissioners, EU Environment Ministers, and EU Health Ministers

Dear President Juncker,

On 15 June, you and the EU College of Commissioners will be taking a major decision on the criteria to identify Endocrine Disrupting Chemicals (EDCs). We write to you about this decision as representatives of society, and members of 70 organisations from the EDC-Free Europe coalition across the EU and beyond.  Our public interest groups include public health and cancer prevention advocates, health care professionals, consumers, farmers, and environment and health organisations.

We are expecting from you and your colleagues that:

  1. The EU Commission will uphold its obligations under specific EU laws and under the Treaty on the Functioning of the EU;
  2. The EU Commission will take up the best available scientific evidence, and;
  3. The EU Commission will think and act effectively to move the EU into a more dynamic, innovative, healthy and environmentally sustainable industrial and agricultural future.

a)   Will the EU Commission uphold its obligations under the TFEU and under 1107/2009 and 528/2012?

The obligation of the EU Commission is to now decide on scientific criteria by which endocrine disrupting properties can be IDENTIFIED.  This means any potential text changes beyond pure identification, such as potency or ‘hazard characterisation(see below), would change the balance which the law strikes between protection of human/animal health/environment and the internal market and would be unacceptable and illegal, as per the EU court of justice ruling in December 2015.

b) Will the EU Commission acknowledge and incorporate the best science in its decision and in the criteria?

The simplest and most robust reflection of the available scientific data is captured with the World Health Organization (WHO) definition and three categories (Option 3 of the Commission Criteria Roadmap).  This importantly ensures coherence with other EU laws, such as the CLP Regulation, and allows the most effective decision making on how to convey the total weight of scientific evidence.

In contrast, option 4 of the Roadmap or variations thereof use potency, or how much of a chemical is needed to create an effect, to identify EDCs.  Potency will not work for EDCs which affect multiple systems within the body, and also can affect wildlife. Potency, which is addressed in ‘hazard characterisation’ is distinct from and not relevant to EDC identification.  Consistent with the various scientific reports that the EU Commission has obtained since 2011 from contracted scientists (Kortenkamp et al), the JRC, and EFSA, the most recent papers are categorical that potency is not relevant to EDC identification:  see the Consensus Statement from the April 2016 Berlin meeting hosted by the German government, which was hailed as a ‘breakthrough’, and a paper published by Slama et al in a leading Environmental Health journal (1).

c) Will the EU Commission effectively move us to a dynamic industrial and agricultural future by enabling innovation in safer chemicals?

The EU pesticides and biocides laws of 2009 and 2012 complement and build on the transition that the REACH chemicals management system is developing towards safer chemicals. The EDC identification criteria are therefore a coherent part of creating the conditions for innovation of safer chemicals, for synergising the potential of these laws, and for consolidating opportunities to expand advances into other product sectors.

The pesticides and biocides laws set out strict controls for EDCs and chemicals that cause cancer, change DNA and harm reproduction. But these laws still allow continued use if needed when there are no safer alternatives, so claims of major agricultural and economic disruption must be treated with caution.

At the same time, the societal impacts of health problems arising from EDCs are typically underestimated.  Scientific studies show that these chemicals are very likely contributing to the increases in hormone-related diseases such as breast or testicular cancer, fertility problems, diabetes and obesity as well as learning and behavioural problems in children.  In addition to the suffering of individuals and their families,  these life threatening diseases come with a cost to Europe’s health systems and worker productivity, estimated in the billions annually for just a few of Endocrine Disrupting Chemicals assessed.  A recent study on the “Health costs that may be associated with Endocrine Disrupting Chemicals” found that when looking at only five potentially EDC-health related effects “according to currently available literature, the socio-economic burden … for the EU may be substantial, ranging between 46 – 288 billion EUR per year” (2).

We therefore look to you to instill confidence in European citizens by upholding the treaty and laws and to choose a path which triggers innovation and protects health at the same time.

Moving us to an environmentally sustainable, healthy, and economically vigorous future requires taking effective steps: choosing the right EDC identification criteria is one of those, and will substantially contribute to the goal of the EU’s 7th Environmental Action Programme to minimise exposure to EDCs.

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

Sincerely,

GENON new signature

 

 

 

 

Genon K. Jensen, Executive Director, Health and Environment Alliance (HEAL)

On behalf of the EDC-Free Europe coalition:

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08062016 – EDC Free_Criteria decision Juncker Letter FINAL

 

Endocrine disrupters: the secret history of a scandal

Le Monde | 20.05.2016 à 09h16 | By Stéphane Horel

This is a translation of an article in Le Monde article by Stéphane Horel entitled ‘Perturbateurs endocriniens : l’histoire secrète d’un scandale’, translated by the Health and Environment Alliance on May 20 2016. 

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This is one of the best kept secrets in Europe. It is locked up somewhere in the maze of corridors in the European Commission, in a guarded room that only about 40 accredited officials have the right to enter. And then only with paper and pen. Smartphones are not allowed. This is a stricter safety protocol than even for transatlantic free trade agreement (or TTIP) between the European Union and the United States: If Members of the European Parliament want to access TTIP documents they can enter the reading room without anyone checking the contents of their pockets.

The secret is a report of about 250 pages. Its title, in the jargon of the Commission, is “Impact Assessment”. It assesses the “socio-economic” impact of regulations related to a group of chemical pollutants. Known as endocrine disrupters, these chemicals are capable of interfering with the hormones of animal species, including humans, and are believed to be the cause of many serious diseases (hormone-dependent cancers, infertility, obesity, diabetes, neuro-behavioral disorders …). They are found in a multitude of consumer items, cosmetics, pesticides and plastics (such as bisphenol A – BPA). Whole sectors of industry will be affected by regulation of these chemicals in the medium term. Billions of Euros are at stake.

Defining criteria
The prospect of restrictions, perhaps even bans, raises serious worries among manufacturers. The pesticide industry has never hidden its hostility to the European Regulation on “plant protection products”, from which originates a decision-making process with twists and turns worthy of a TV series. Adopted by the European Parliament in 2009, the text provided for special treatment of pesticides: those recognised as endocrine disruptors would not be allowed on the market. But they must be able to be recognised.

The Commission was therefore obliged to find a way to distinguish endocrine disrupters from other chemicals. In concrete terms, its job was to lay down criteria to identify these substances. Without the criteria, the law cannot be implemented. National health authorities, industry and NGOs are thus in suspended animation awaiting a decision on these criteria for identification – a regulatory tool which will then enable restricting or, more radically, prohibiting the use of certain endocrine disrupters. Today, seven years later, these criteria still do not exist.

It is this impact assessment, with its highly confidential conclusions (as secret as the location of the fountain of youth), which is largely responsible for this delay. It was not originally part of the plan but industry called for it as a way to weaken the Regulation and then achieved its desire in early summer of 2013 after a lobbying blitzkrieg by pesticide and chemical industries working in tandem. Activities were coordinated mainly through their Brussels lobbying organizations: European Crop Protection Association (ECPA) and European Chemical Industry Council (CEFIC).

A hypersensitive file
The giants of agrochemicals were also on the battlefield: both the two German heavyweights, BASF and Bayer and the Swiss multinational, Syngenta. The Commission’s Secretary General Catherine Day finally yielded to their request for an impact assessment on the basis of “divergent opinions” in the scientific community and the “potential impacts on sectors of the chemical industry and international trade” – a direct reference to TTIP, on which negotiations were then just beginning. In an internal memo dated 2 July 2013, Ms Day, the then highest European Union official, described the criteria for endocrine disruptors as a “sensitive subject”. Sensitive, it stayed. And hypersensitive, it became.

The European Parliament had given a deadline for the Commission to write these infamous criteria: December 2013. Not seeing anything coming, Sweden had decided to take the Commission to court. This move was supported by France, Denmark, Finland and the Netherlands and also by the Parliament and the Council – a rare configuration.

The Court of Justice of the European Union did not delay in its response. Just before Christmas 2015, it found that the Commission, which is after all the guardian of the treaties, had “violated the law of the Union”. The judgement swept away the “alleged need for an impact assessment of the scientific criteria” that the Commission had placed at the heart of its defence. But the same day, the spokesperson of the European Commissioner for Health, the Lithuanian Vytenis Andriukaitis announced bluntly that the impact study would still be carried through. Already hypersensitive, the file became inflammable.

What cost of illness?
The European parliamentarians are furious. Some of them have already sent several letters to the President of the Commission. These had no effect. On 13 January, the President of the Parliament wrote to Jean-Claude Juncker. The Commission’s delay was “unacceptable”, underlined Martin Schulz. Equally, continuing the impact assessment was “in defiance of the judgment” of the highest court of the EU, to which he asked the Commission to “comply without delay”. The message was repeated in a second letter on 10 March. Sweden, for its part, continues to keep up the pressure. In a document dated 13 May that Le Monde has obtained, Sweden curtly reminds the Commission services that the Court “prohibits the use of economic considerations to define criteria”.

So what is the nature of the “economic considerations” contained in the pages of the impact study under lock and key? In addition to the impact on the industry, will they take into account the cost of diseases related to exposure to endocrine disruptors in Europe, which was estimated by independent studies to be at between 157 billion and 288 billion euros per year (University of Utrecht, 2016)? The suspense will end on 15 June. According to our sources, the final proposal on the criteria for the identification of endocrine disrupters will be presented in a meeting of the college of European Commissioners that day.

• Stéphane Horel
Journalist for Le Monde