Identification of EDCs : people and the environment must be protected without delay

Further delay on flawed EDC criteria maintains unnecessary risks on human health and the environment

Brussels, 18 May 2017 – The criteria to identify hormone disrupting chemicals (or EDCs), for which a decision was expected today, continue to cause disagreements among EU member states.

The EDC-Free coalition urges the European Commission and member states to amend the proposal to ensure that people and the environment are protected and warns that further delays and failure to agree on criteria unnecessarily keep human health at risk.

The coalition has repeatedly criticised that the current proposal requires an unrealistically high burden of proof, which makes the identification of substances as EDCs very difficult and is likely to result in long delays. Another significant loophole is the proposed exemption from identification for certain pesticides and biocides that are designed to be endocrine disrupting, which would strongly undermine protective measures. The EDC-Free coalition also cautions the Commission and member states against industry’s proposals to introduce a derogation based on risk assessment in the pesticides regulation, which would result in continuous exposure of people and the environment to mixtures of toxic pesticides.

After years of setbacks and delays, in June 2016 the European Commission proposed a set of criteria, which have gone through several versions and been the subject of lengthy criticism and controversy. This followed a ruling of the EU Court of Justice, which found that the European Commission breached EU laws by delaying the adoption of measures on EDC criteria.

“The science is clear about the harmful and irreversible effects of endocrine disrupting chemicals. The time for action is now and Europe has the opportunity to lead by example. Protective EDC criteria are needed to reduce people’s exposure to toxic substances and reduce unnecessary burdens on public budgets,”

says Genon K. Jensen, EDC-Free Europe spokesperson.

Scientific professionals and public interest groups such as non-profit health insurers alike have consistently called for the swift adoption of high quality, scientifically sound criteria to accelerate actions to reduce peoples’ exposure to EDCs. Meanwhile over 359,000 citizens have signed a petition calling on member states to take action to ban EDCs.

The failure to minimise exposure to EDCs will maintain a high burden on public health budgets from the diseases arising from exposure to EDCs in the European Union (which is estimated at 163 billion Euro per year). As it stands, it is also a perfect counter-example of the better regulation approach that the Commission has made its motto of.

The EDC-Free coalition calls on the European Commission and member states to amend the proposal so that EDC exposure can be swiftly reduced and environment and health will be protected.

Natacha Cingotti, EDC-Free Europe, 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. 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.

Endocrine Disruptors

Clarity on future of chemicals regulation is needed

MPs call for post-Brexit UK to remain as close as possible to EU’s main chemicals law REACH

The Environmental Audit Committee urges the Government to provide clarity on the future of chemicals regulation after the EU Referendum.

Government must provide certainty

The Environmental Audit Committee has said the Government must urgently provide certainty to the UK chemicals industry over the future of chemicals regulation. The UK chemicals industry is the second largest exporter to the EU after cars, selling almost £15bn of chemical products into the European single market a year.

UK companies will have spent an estimated £250 million in order to comply with an EU registration deadline in May 2018, yet have received no guarantees over whether these registrations will remain valid after the UK leaves the EU. This uncertainty means that one in five UK chemicals companies represented by the Chemical Business Association are already investigating registering elsewhere in the EU, in a move that could cost jobs and investment.

Chair’s comment

“It is disappointing the Government have not provided the certainty that UK businesses urgently need on their plans for the future chemical regulation in the UK. The timing of Brexit means that companies face significant costs to comply with EU regulations before we leave, with no guarantee that that investment will be useful to them in the future. The lack of Government clarity is causing uncertainty and driving billions of pounds worth of businesses to consider leaving our country for the EU. The Government needs to provide certainty to ensure that it encourages continued chemical business investment in the UK.

“This lack of clarity extends to plans for a future chemicals framework for the UK: the Government has admitted that it will be difficult to transpose regulations such as REACH into UK law, yet it has not yet offered a vision for the replacement. The Government needs to ensure it understands the complexity and importance of current regulations in enabling the UK chemicals industry to provide not only value to the economy but their expertise and high standards in protecting public health and the environment.”

said Mary Creagh MP, Chair of the Environmental Audit Committee.

Value to the economy

The Environmental Audit Committee’s report highlights the crucial importance of regulation in enabling the UK chemicals industry to provide value to the economy whilst also protecting public health and the environment. The Committee urges any future Government to ensure this industry is not forgotten during EU negotiations and the development of any future domestic legislative framework for chemicals.

The committee’s key findings are:
  • The chemicals regulation framework established by the EU through REACH is difficult to transpose directly into UK law. Writing EU regulations into UK law could not be done simply by having a line in the “Great Repeal Bill” deeming REACH to apply in the UK. REACH was written from the perspective of participants being within the EU, with much of it also relating to Member State co-operation and mutual obligations, oversight and controls, and freedom of movement of products.
  • Companies face significant uncertainty over the validity of current REACH registrations after the UK leaves the EU: the Government must clarify their position on the future regulatory framework as a matter of urgency. Companies face significant costs relating to the upcoming REACH registration deadline in May 2018, yet it is unclear whether these registrations will remain valid once the UK leaves the EU in 2019. This uncertainty may already be having an impact on long-term investment decisions by companies.
  • In deciding the future of the UK’s relationship with the EU’s single market for chemicals, the Government should take a pragmatic approach. The most important element of REACH, which the Government should seek to remain involved in as a minimum, is the registration process for chemicals. Most of our respondents, from both environmental and industry perspectives, wanted to stay as closely aligned to REACH as possible. Involvement in registration would allow UK companies to share testing data with EU companies, sharing costs and allowing them to enter the market without double registration, even if the UK adopts higher standards of chemicals protection.
  • Establishing a stand-alone UK system of chemicals regulation is likely to be expensive for both the taxpayer and for industry. The Government did not provide us with detail of their scenario planning, although they did admit that the cost of taking on the roles currently provided by the European Chemicals Agency could be in the “tens of millions” of pounds.
  • The experiences of the US as it introduces an improved system of chemicals regulation could be useful for the Government when planning the UK’s approach. The US is in the process of updating its federal chemicals regulations following the introduction of new legislation in June 2016. Federal agencies are currently developing their new approach to the assessment and regulation of chemicals, and the experiences of the US in developing its own system may prove useful to the UK.
Further information

Workplace cancer prevention must be extended to reprotoxic substances

Millions of persons are exposed to substances toxic for reproduction in many work-related activities

Putting more than 10 years of paralysis behind it, the European Commission finally launched a revision of the directive on the prevention of occupational cancers in May 2016. Lawmakers can now address reprotoxic substances in the workplace, writes Laurent Vogel, a researcher at the European Trade Union Institute (ETUI).

Abstract

The rules are insufficient as far as workplace protection is concerned. Whereas carcinogenic and mutagenic substances are the subject of more stringent prevention requirements by employers, reprotoxic substances have the “advantage” of a more lenient framework. A lot is at stake: out of 235 substances identified as proven or suspected reprotoxic substances, over 160 evade the most stringent regulation because they are not also classified as carcinogenic or mutagenic. If we confine ourselves to production volumes, the inadequately controlled risks are considerable. They concern lead, bisphenol A (a massively produced endocrine disruptor) and several phthalates.

A directive concerning the protection of pregnant or breastfeeding workers does certainly exist. But reprotoxic disorders concern men as much as women. Limiting specific measures to pregnant women may lead to various forms of discrimination. Furthermore, reprotoxic substances usually act on sex cells (eggs and spermatozoids) or on the first stages of embryo development. Rules concerning pregnant or breastfeeding workers obviously do not make it possible to prevent harmful effects on fertility. European legislation triggers a specific preventive action only from the time when a woman worker has informed her employer that she is pregnant. Such information is seldom communicated before the tenth week of pregnancy. Now, the risks for foetal development arising from chemical substances are at their highest during the first three months. Legislative provisions are therefore fairly ineffective and are likely to have stigmatising effects on pregnant women.”

Read Workplace cancer prevention must be extended to reprotoxic substances, euractiv, Mar 30, 2017.

European Trade Union Institute Publications

 

Glyphosate and cancer : buying science

How industry strategized (and regulators colluded) in an attempt to save the world’s most widely used herbicide from a ban

Summary

In this report we show how Europe’s pesticide regulation, introduced in 2009, threatened the survival of glyphosate herbicides, the most widely used in the world, and how industry fought back to save its chemical from a ban.

Chapter 1 describes the challenges that confronted manufacturers of glyphosate-based herbicides in 2012 when they had to apply for re-approval in the EU of their active ingredient, glyphosate. Under the 2009 law, pesticide active ingredients are not allowed to be marketed if they have the potential to cause cancer, damage DNA, or have toxic effects on reproduction. This is known as a hazard-based approach. It means that if the pesticide has these effects, in principle, it must be banned. The inherent properties of the chemical are crucial, rather than the – often difficult to predict – risk to humans under certain exposure scenarios. The reasoning that if the pesticide is properly used, people would only be exposed to “safe” doses – the “risk-based approach” – is not permitted for such substances.

This change in law posed a problem for Monsanto and other companies that manufacture or market glyphosate herbicides, because several of the industry’s own animal studies show statistically significant and dose-dependent carcinogenic effects from glyphosate.

Another aspect of the 2009 regulation also posed a problem for industry. In the past, the regulatory assessment of pesticide active ingredients has been based on industry-sponsored studies. These are generally unpublished and are kept hidden from the public and independent scientists on the grounds that they are commercial secrets. But the regulation mandated for the first time that studies from the peer-reviewed open scientific literature must be included in the dossier of documents that the industry submits to regulators in support of the approval of a pesticide.

The challenge to the pesticide companies lay in the fact that while industry studies generally conclude that glyphosate is safe for its proposed uses, many studies conducted independently of the industry disagree. In recent years, a growing number of peer-reviewed studies in the published scientific literature have pointed to the harmful effects of glyphosate and its commercial formulations. Notably, while most industry studies indicate that glyphosate is not genotoxic (damaging to DNA), the majority of independent studies find the opposite.

In 2015 a severe blow hit the industry when the World Health Organization’s cancer research agency IARC published its verdict that glyphosate was probably carcinogenic to humans and that there was strong evidence that it was genotoxic. Glyphosate products represent a lucrative global market that is expected to cross US$ 10 billion by 2021. So the industry had to come up with a strategy to save its chemical.

Monsanto and other glyphosate companies responded to these cumulative threats to their business by sponsoring scientific reviews, published in peer-reviewed journals, which conclude that glyphosate and its commercial formulations are not harmful to health.

In 2016 a series of reviews with favourable conclusions on glyphosate’s safety (we call them the “Intertek papers”) were published in a peer-reviewed journal. The authors were members of the Glyphosate Expert Panel, convened by the commercial consultancy firm Intertek under commission from Monsanto. Monsanto had paid Intertek to convene and facilitate the panel’s work. The specific and stated aim of the Intertek papers was to counter IARC’s evaluation of glyphosate. They unanimously conclude that glyphosate in humans does not harm genetic material or trigger cancer.

In Chapter 2 we identify nine major scientific flaws in the Intertek papers and other industry-sponsored and -supported review articles on glyphosate’s health risks. Specifically, they utilize manipulations such as apparently calculated omissions and the introduction of irrelevant data, confusing the picture and denying the scientific evidence of glyphosate’s harmful effects.

Most importantly, the authors claim to have used a “weight of evidence” approach to assess whether glyphosate is carcinogenic or not, yet in reality, they avoided such an approach.

A weight of evidence approach takes a holistic view of the different lines of evidence, namely:

  • Animal studies
  • Epidemiological data
  • Possible mechanisms of carcinogenesis.

In the case of glyphosate, the different lines of evidence complement each other. For instance, the finding of a significantly increased incidence of malignant lymphoma in three mouse studies is complementary to the association between glyphosate exposure and non-Hodgkin lymphoma in humans. These lines of evidence are in turn supported by convincing evidence for genotoxicity and oxidative stress as possible underlying mechanisms for cancer development.

Altogether evidence exists in all three areas of consideration. A holistic consideration of this evidence inevitably leads to the conclusion that glyphosate is carcinogenic. Instead, the Monsanto-sponsored authors considered the different lines of evidence separately, used false arguments, and concealed or distorted the facts, concluding that glyphosate is not carcinogenic.

One episode that is not objectively addressed in the Intertek papers took place in 1985, when the US EPA classified glyphosate as a possible human carcinogen. The EPA had based its verdict on a significant and dose-dependent increased incidence of a rare kidney tumour in a mouse study submitted by Monsanto. But Marvin Kuschner, a consultant pathologist who was reportedly a member of Monsanto’s Biohazards Commission, re-evaluated the data and claimed to find such a tumour in a control mouse (which did not receive glyphosate), thus removing the statistically significant increase in the incidence of this tumour in glyphosate-treated animals. This finding, if confirmed, would have exonerated glyphosate from suspicion of causing kidney cancer.

Pathologists tasked by the EPA with re-examining the original kidney sections and new sections of the same organs were unable to identify the alleged new tumour. However, four consultants commissioned by Monsanto stated that they were able to confirm Kuschner’s extra tumour. After a long back-and-forth discussion, the EPA moved glyphosate from class C (possible human carcinogen) into class D (not classified for carcinogenicity) in 1988.

In addition to the fact that the Intertek papers themselves were commissioned by Monsanto, many of the authors of these and other industry-sponsored or industry-supported reviews have conflicts of interest with the pesticide and chemical industries. This is shown in Chapter 3. Twelve of the 16 members of the Glyphosate Expert Panel have served as consultants to Monsanto and/or have been employed by the company. Others have different conflicts of interest with industry or industry-linked bodies, notably the International Life Sciences Institute (ILSI), an organization funded by (among others) companies that manufacture and/or market glyphosate products, including Monsanto, Dow, and BASF. These conflicts of interest have often not been made clear to members of the public and media.

Only in the case of one panel member were we unable to find any conflicts of interest, apart from her participation in the Intertek papers. In spite of all this, members of the Glyphosate Expert Panel were claimed in the Intertek papers to be independent.

The notion that glyphosate is not carcinogenic has found backing in the verdicts of several regulatory agencies and expert bodies, including BfR (Germany’s Federal Institute for Risk Assessment), the European Food Safety Authority (EFSA), the Joint Food and Agriculture Organization/World Health Organization (FAO/WHO) Meeting on Pesticide Residues (JMPR), and the US Environmental Protection Agency (EPA).

However, the assessments of BfR and EFSA suffer from fundamental scientific weaknesses and the JMPR’s conclusions are marred by a severe lack of transparency and scientific clarity, as shown in Chapter 4.

As an example of the problems with BfR’s assessment, after the cancer research agency IARC found “sufficient” evidence of a carcinogenic effect of glyphosate in the same four industry studies (two studies with rats and two with mice) in which BfR had previously not been able to detect any evidence of cancer activity, the German authority had to evaluate the assessments of the IARC. As a result, BfR was forced to confirm the statistically significant tumour findings noted by IARC in all four studies. Also, in the remaining three mouse studies of the manufacturers, BfR had to admit the existence of statistically significant and dose-dependent increases in tumours, which it had previously overlooked. As an explanation for its colossal error, the BfR admitted that “initially”, it had “relied on the statistical evaluation provided [by the glyphosate manufacturers] with the study reports”.

This failure of the German authority is particularly explosive because the hazard-based approach in the EU pesticide regulation forbids the authorization of an active substance as soon as there are positive cancer findings in at least two independent animal studies.

In addition, BfR repeatedly confused hazard with risk, apparently deliberately. Our presumption is that this was intended to divert attention from the hazard-based approach of EU law, which, in light of the positive cancer findings in mice and rats in the industry cancer studies, would require a ban for glyphosate.

The whole of the evidence on glyphosate, taken together – animal studies, human epidemiological evidence, and mechanistic evidence – provides ample confirmation of glyphosate’s carcinogenicity. Yet in a similar fashion to the Intertek papers, rather than evaluating the evidence as a whole, BfR separated out the various lines of evidence of glyphosate’s carcinogenicity in order to deny them individually, and finally to discard the isolated evidence as a single random result. It concluded that glyphosate does not warrant a carcinogenic classification.

In parallel with these scientific shortcomings, the regulatory and expert agencies’ reports on glyphosate are also compromised by conflicts of interest, as detailed in Chapter 5. For example, the same people who were involved in the European evaluation of glyphosate in Germany in the 1990s are also involved in the current re-evaluation. Some have evaluated glyphosate for national agencies and then re-evaluated their own previous decisions at the EU and international level, in different positions. This is a problem because if individuals are asked to assess their own earlier assessment, they will not be inclined to admit any mistakes – particularly regarding a politically and economically sensitive issue like the re-approval of glyphosate.

Some people who have evaluated glyphosate for regulatory and expert bodies also have conflicts of interest with industry. For instance, the chairman of the JMPR for glyphosate, Alan Boobis, was also the vice-president of ILSI Europe. In 2012 – the year Monsanto submitted the dossier for the re-approval of glyphosate – the ILSI group received a $500,000 (£344,234) donation from Monsanto and a $528,500 donation from the industry group Croplife International, which represents Monsanto, Dow, Syngenta, and others. The co-chair of the JMPR glyphosate sessions was Professor Angelo Moretto, a board member of the ILSI Health and Environmental Sciences Institute (HESI), and of its Risk21 steering group, which Boobis also co-chairs.

Even the EPA’s forthcoming report on glyphosate – which was widely expected to give the chemical a clean bill of health – has become mired in controversy. According to court filings by people who believe that their cancer was caused by exposure to glyphosate herbicides, a former long-time EPA scientist, Marion Copley, accused former top-ranking EPA official Jess Rowland of colluding with Monsanto to protect the company’s interests and deny that glyphosate was carcinogenic. Copley cited evidence from animal studies and wrote to Rowland: “It is essentially certain that glyphosate causes cancer.” Rowland left the EPA in 2016, shortly after the agency’s favourable report on glyphosate was leaked.

In sum, attempts by agencies and individuals to defend glyphosate and its formulations against evidence that they cause cancer and damage DNA are scientifically unsound and undermined by serious conflicts of interest.

In the light of our findings, we recommend that the evaluations of glyphosate and its formulations by individuals and institutions compromised by conflicts of interest are set aside. If these institutions and individuals wish to address their flawed evaluations, they must openly address the scientific points and evidence raised in this report. For the sake of transparency, they should use only studies available in the public domain. In the meantime, glyphosate-based formulations should be phased out as a precautionary measure. The continuation of the European authorization of glyphosate would lead to an unacceptable risk of cancer, which would be avoided by correctly observing the laws and respecting scientific integrity.

  • Read the full report, Glyphosate and cancer: Buying science, How industry strategized (and regulators colluded) in an attempt to save the world’s most widely used herbicide from a ban, global2000, March 2017.
  • Read Green NGOs blame Monsanto for ‘buying science’ to save glyphosate, euractiv, Mar 24, 2017.

Is Glyphosate Carcinogenic ? It’s All Good says the European Chemicals Agency !

Glyphosate not classified as a carcinogen by ECHA, March 2017

Helsinki, 15 March 2017 – The European Chemicals Agency (ECHA)’s Committee for Risk Assessment (RAC) assessed glyphosate’s hazardousness against the criteria in the Classification, Labelling and Packaging Regulation. They considered extensive scientific data in coming to their opinion.

The committee concluded that the scientific evidence available at the moment warrants the following classifications for glyphosate according to the CLP Regulation:

  • Eye Damage 1; H318 (Causes serious eye damage)
  • Aquatic Chronic 2; H411 (Toxic to aquatic life with long lasting effects)

RAC concluded that the available scientific evidence did not meet the criteria in the CLP Regulation to classify glyphosate for specific target organ toxicity, or as a carcinogen, as a mutagen or for reproductive toxicity.

ECHA’s Committee for Risk Assessment (RAC) agrees to maintain the current harmonised classification of glyphosate as a substance causing serious eye damage and being toxic to aquatic life with long-lasting effects.

RAC concluded that the available scientific evidence did not meet the criteria to classify glyphosate as a carcinogen, as a mutagen or as toxic for reproduction.

The hazard classes for which classification was proposed by the German competent authority were specific target organ toxicity (repeated exposure) (category 2), eye damage/irritation (category 1), and toxicity to the aquatic environment (Aquatic Chronic 2).

ECHA also assessed other hazard classes including carcinogenicity, germ cell mutagenicity and reproductive toxicity.

The adopted opinion will go through a normal editorial check before it is sent to the European Commission. The opinion will also be made available on ECHA’s website at the same time.

The adopted opinion on the harmonised classification for glyphosate will be taken into account when the Commission and Member States consider whether to renew the approval to use glyphosate as an active substance in pesticides, later this year.

Background

Apart from the published studies on glyphosate, the committee also had full access to the original reports of studies conducted by industry. RAC has assessed all the scientific data, including any scientifically relevant information received during the public consultation in summer 2016.

RAC had a first discussion on glyphosate with stakeholders at its 39th meeting in December 2016.

RAC provides an independent scientific opinion on the hazard classification of the substance. The classification is based solely on the hazardous properties of the substance. It does not take into account the likelihood of exposure to the substance and therefore does not address the risks of exposure. The risks posed by exposure are considered for example when deciding whether to renew the approval of glyphosate as a pesticide in accordance with the EU’s Plant Protection Product Regulation (Regulation (EC) N° 1107/2009).

The criteria to identify endocrine disruptors : implications beyond pesticides and biocides

NGOs call for single, unified system to identify hormone disruptors in cosmetics, water, children’s toys, and everywhere they appear

Original press release :
CIEL news.

Image credit : CIEL Facebook.

A single, unified system to identify hormone-harming chemicals is the best way to keep endocrine disrupting chemicals (EDCs) out of our food, water, toys, and household products.

This is the conclusion of a new report by the Center for International Environmental Law (CIEL) and ClientEarth, and endorsed by Members of the European Parliament (MEPs) from five parties.

Executive Summary

Endocrine Disrupting Chemicals (EDCs) are chemicals that interfere with the natural hormones in our bodies. EDCs are very likely to be contributing to serious health disorders such as cancer, fertility problems, obesity, and other debilitating diseases.

“The EU criteria to identify endocrine disruptors would be the first standards for these chemicals worldwide and set a precedent. The Commission must redesign the criteria to identify these hazardous substances wherever they are located.”

Giulia Carlini,
Staff Attorney at CIEL and co-author of the report.

EDCs are used in a wide variety of products. They are present in our food, cosmetics, clothes, cleaning products, and plastics.

The growing scientific evidence of their negative impacts and the wide exposure to them has led the EU legislator to mention, identify, and manage the risks from EDCs despite the lack of internationally harmonised criteria.

For the first time under EU law, the pesticides and biocides regulations both require the European Commission (the Commission) to determine the scientific criteria necessary to identify EDCs. These two regulations also provide for measure to control the risks from EDCs once identified.

Other regulations similarly contain provisions restricting the use of EDCs but have yet to provide identification criteria (e.g. the proposed regulations regarding medical devices). Still other regulations, such as the Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), regulate EDCs as “substances of very high concern” on a case-by-case basis. In some cases, the law mentions EDCs without regulating their use, such as the Cosmetics Regulation or the Water Framework Directive.

“The Commission should look itself in the mirror and set out coherent criteria for identifying endocrine disruptors. These must work alongside other laws, for example on cosmetics, water, or chemicals in general.”

Vito Buonsante,
Law and Policy Adviser at ClientEarth and co-author of the report.

In June 2016, the European Commission proposed criteria for the identification of EDCs.

However, despite the variety of sources of exposure to EDCs, a mandate given to the Commission by the 7th Environmental Action Programme (7th EAP) to draft harmonised hazard-based criteria for EDCs, and seven years of work to establish these criteria, the European Commission chose a very narrow approach. It decided to set scientific criteria exclusive for relevant chemicals in pesticides and biocides.

The following report demonstrates that the Commission’s proposal is problematic and could:

  • Further delay the identification of EDCs and their proper regulation. Until horizontal criteria are developed as stipulated in the 7th EAP, EDCs cannot be regulated under other legislation. This is also at odds with the founding principles of Better Regulation, which aim at ensuring that the EU delivers high quality legislation.
  • Lower the level of protection from EDCs due to the misapplication of criteria relevant for biocides and pesticides to other regulatory frameworks. Applying sector-specific criteria to non-pesticides and biocides creates a risk that certain chemicals will not be identified as EDCs.
  • Lead to inconsistencies between the EDCs identified under the Pesticides and Biocides Regulations and those identified under other regulatory frameworks. The consequences of such approach may lead to a lower level of protection from EDCs, particularly for uses in consumer products (e.g. cosmetics, food contact materials, and toys).
  • Create an unclear, unstable, and unpredictable regulatory framework for businesses, workers, and citizens for as long as the scientific criteria are not applicable to chemicals under all regulatory frameworks.

In light of these concerns, CIEL and ClientEarth recommend:

  • The Commission should amend its proposed draft criteria to ensure they are applicable across all relevant EU law. The new criteria must be designed to identify EDCs in whatever product they are used, irrespective of the sector. This means that no sector-specific notions such as “non-target organisms” should be used. It should also follow the methodology of hazard identification under the United Nations Globally Harmonised System of Classification and Labelling of Chemicals and the Classification, Labelling and Packaging Regulation by providing three hazard categories based on the differing strength of evidence: “known” (category 1A), “presumed” (category 1B), and “suspected” EDCs (category 2).
  • If the Commission refuses to change its approach and adopts the proposals, the European Parliament and the Council should reject them, in compliance with the regulatory procedure with scrutiny and the procedure applicable to delegated acts under Article 290(2) TFEU, respectively.
  • If the current sector-specific scientific criteria are nonetheless approved, the Commission must immediately begin review of the criteria to comply with the objective of setting harmonised EDC criteria by 2020, as provided by the 7th EAP.

The Burden of Endocrine Disruptors

Endocrine disrupting chemicals and reproductive health, by “Bonhomme”

Around a hundred scientists asked Europe and the international community to act against endocrine disrupting chemicals. They condemned the use of strategies for manufacturing doubt employed by industries in the climate change battle.

  • Image sources: Let’s stop the manipulation of science, Le Monde, 29.11.2016.
The Investigation
  1. The Manufacture of a Lie.
  2. A Denial of the State of the Science.
  3. The Interference of the United States.
  4. The Discreet but Major Gift to the Pesticides Lobby.
Endocrine Disruptors

Endocrine Disruptors: The Discreet but Major Gift to the Pesticides Lobby

The European Commission submited its proposal for regulation of chemical substances on 21.12.2016

This article by Stéphane Horel was originally published by Le Monde on December 20. This translated version published by EDC-Free Europe.  This work is licensed under a Creative Commons Attribution-ShareAlike 4.0 International License. Image thecvopros.

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.

“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”.

What happened on the 21.12.2016

MORE INFORMATION

The Investigation
    1. The Manufacture of a Lie.
    2. A Denial of the State of the Science.
    3. The Interference of the United States.
    4. The Discreet but Major Gift to the Pesticides Lobby.

 

Endocrine Disruptors

Endocrine disruptors: EFSA and ECHA outline Guidance plans

How to identify substances with endocrine disrupting properties in pesticides and biocides

EFSA and the European Chemicals Agency (ECHA) have published an outline of the Guidance they are developing on how to identify substances with endocrine disrupting properties in pesticides and biocides.

The outline includes a projected table of contents, as well as a plan of the drafting process, including timelines, responsibilities, consultations with relevant parties and an explanation of how the document will be endorsed.

The Guidance will enable applicants and regulatory authorities to identify endocrine disruptors among chemical substances proposed as pesticides and biocides using hazard-based scientific criteria currently being finalised by EU Member States and the European Commission.

The Guidance is to be drafted by a joint team of scientific staff from ECHA and EFSA, supported by the European Commission’s Joint Research Centre. Minutes of meetings of this drafting group will be published.

Endocrine disruptors: EFSA and ECHA outline Guidance plans, European Food Safety Authority, 20 December 2016.

Additional support to the group will be provided by a specially constituted Consultation Group, which will include members of ECHA’s Endocrine Disruptors Expert Group, and pesticide experts from EU Member States and other stakeholder groups. The drafting group may also consult other scientific bodies, such as EFSA’s Scientific Committee or its Panel on Plant Protection Products and their Residues (PPR) and this panel’s working groups.

A public consultation on the draft Guidance is scheduled for the summer of 2017.

More Information

  • Outline of draft Guidance for the implementation of hazard-based criteria to identify endocrine disruptorsefsa.europa.eu, 16 December 2016.
  • Request from the European Commission, ec.europa.eu, 17/10/2016
  • Minutes of joint EFSA/ECHA/JRC kick-off meeting on endocrine disruptors guidance, efsa.europa.eu.
  • European Commission’s proposed criteria for endocrine disruptors, ec.europa.eu.

Endocrine Society Experts Concerned EU new Regulations will Undermine Chemicals Assessment

European Commission Proposal Leaves Public Exposed to Harmful Endocrine-Disrupting Chemicals

The Endocrine Society expressed disappointment today in the European Commission’s revised proposal on defining and identifying endocrine-disrupting chemicals (EDCs), citing unnecessarily narrow criteria for identifying EDCs that will make it nearly impossible for scientists to meet the unrealistically high burden of proof and protect the public from dangerous chemicals.

A new provision in the revised proposal also creates an extremely problematic exemption for EDCs that act by regulating the growth of harmful organisms via the endocrine system. This exemption would include pesticides that primarily aim at preventing certain insects from growing or reproducing, even though these chemicals also could have effects on non-target species.

European Commission Proposal Leaves Public Exposed to Harmful Endocrine Disrupting Chemicals, The Endocrine Society, December 19, 2016.

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EDCs can mimic, block or interfere with hormones that regulate key biological functions, including brain development, reproduction, metabolism and growth. Bisphenol A and other EDCs can be found in common products, including food containers, plastics, cosmetics and pesticides.

More than 1,300 studies have found connections between endocrine-disrupting chemical (EDC) exposure and serious health conditions such as infertility, diabetes, obesity, hormone-related cancers and neurological disorders, according to the Endocrine Society’s 2015 Scientific Statement.

The European Union is the largest single economy with regulations specific to EDCs. Enforcement of these regulations requires the European Commission to propose criteria to identify EDCs. The latest proposal asks for an unrealistically high level of scientific evidence for endocrine disruptors, limiting the ability to identify and regulate EDCs.

To effectively identify EDCs, the Endocrine Society supports creating multiple categories based on the amount of evidence that exists to show how specific chemicals act as EDCs. This approach would be similar to the classification scheme used for carcinogens. This would help prioritize chemicals for assessment and regulation and allow for incorporating new data as more studies are published. The latest proposal from the European Commission does not include categories for identifying EDCs.

Failure to effectively regulate EDCs comes with a high price tag. Recent studies have found that adverse health effects from EDC exposure cost the European Union more than €163 billion each year in healthcare expenses and lost productivity.

As the European Parliament and member countries consider whether to implement the European Commission’s criteria, the Society will continue to advocate for criteria that reflect the state of the science.