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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

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