EU requirements to provide results for authorised clinical trials – EC, EMA, MHA

Call for all sponsors to publish clinical trial results in EU database (joint letter by the European Commission, EMA and HMA)

 

The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT).

Transparency and public access to clinical trial results, whether positive or negative, are fundamental for the protection and promotion of public health. It assures trial subjects that their voluntary participation in clinical trials is useful and that the results have been collated and reported for the benefit of all. In addition, for those medicines which are placed on the market or used in further clinical trials, it allows patients and healthcare professionals, or any other citizen, to find out more information about medicines they might be taking or prescribing. Transparency also enhances scientific knowledge and helps to advance clinical research and support more efficient medicine development programmes.

It is the responsibility of sponsors to ensure that the protocol information and results of all clinical trials is submitted in EudraCT; this information is publicly available through the EU Clinical Trials Register (EU CTR). Since July 2014, sponsors are required to post results within one year after the end of a clinical trial (or six months for a paediatric trial). This information is also shared with the World Health Organization’s (WHO) International Clinical Trials Registry Platform (ICTRP) of which EU CTR is a primary registry.

As of April 2019, the EudraCT database included 57,687 clinical trials in total, out of which 27,093 were completed. Out of these completed trials, 18,432 should have had results posted; sponsors were in compliance with the publication requirements for 68.2% (12,577) of the trials, however results were still lacking for 31.8% of them (5,855).

The reporting compliance of non-commercial sponsors (e.g. academia) was much lower than for commercial sponsors (i.e. companies), with 23.6% of results posted for non-commercial sponsors vs 77.2% for commercial sponsors. Academic sponsors or smaller companies often lack awareness or incentives to post clinical results, therefore EU authorities are taking various steps to ensure sponsors are aware of their obligations and can act on them.

One of these initiatives is the “letter to stakeholders regarding the requirements to provide results for authorised clinical trials in EudraCT”, co-signed by Anne Bucher, Director General of the EC’s DG Health and Food Safety, Guido Rasi, Executive Director of EMA, and Thomas Senderovitz, Chair of the HMA Management Group. It will be disseminated to various stakeholder groups, with a goal in particular to reach academic sponsors. This should help to spread the word about the importance of making clinical trial results publicly available.

Amongst other initiatives conducted at EU level, EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

Reference.

EU Parliament calling for the EU Commission to stop dithering and start acting on endocrine disruption

Endocrine disruptors drop the curtain on this European Parliament

On Thursday (18 April), the European Parliament adopted a non-binding resolution asking the European Commission to ensure a higher level of protection against endocrine disruptors (EDCs) by making a legislative proposal on the matter no later than June 2020.

It passed with 447 votes in favour, 14 against and 41 abstentions, and was actually the last text to be dealt with by this Parliament.

MEPs proposed treating EDCs or potential EDCs on an equal footing with substances classified as carcinogenic, mutagenic or toxic for reproduction, the so-called CMR substances prohibited in EU cosmetics legislation.

EDCs are a class of chemicals commonly found throughout our environment in children’s products, food containers, personal care products, pesticides and furniture. These hazardous substances alter the functioning of the hormonal system, having a negative effect on the health of humans and animals.

Close to 800 chemicals are known or suspected to be capable of interfering with hormone receptors, hormone synthesis or hormone conversion, according to a report drafted in 2012 by the United Nations Environment Programme (UNEP) and the World Health Organisation (WHO).

The EU started discussing the issue as early as 1996 and recognised EDCs as a health and environmental hazard in its “Community Strategy for endocrine disruptors” adopted by the Commission in December 1999.

The EU executive revamped interest in the topic last November publishing a new strategy for endocrine disruptors and launching a comprehensive screening of the legislation applicable to EDCs through a fitness check.

According to the lawmakers, the response is so far not adequate to the health threat, as the EU framework for EDCs suggested by the Commission in November lacks both a concrete action plan to minimise exposure to EDCs and a timeline for the next steps to move forward.

Plenary debate

Representing the EU executive before the plenary, Violeta Bulc defended the EU efforts:

“We can be proud of the progress we have achieved since there, we are recognised as one of the global leaders in dealing with these substances.”

“However, this is not enough: EDCs remain today a global challenge and a source of concern for many citizens,”

she said.

She added that the Commission adopted its communication in November in order to step up the EU approach and that the cross-cutting fitness check should be finalised in the first half of 2020, followed by a 12-week-long public consultation.

Before the end of the year, the Commission will also organise the first annual meeting of stakeholders and the launch of a new web portal, as part of the comprehensive set of actions to achieve the objectives included in the communication.

Although the resolution was backed by all the political groups within the Parliament, the European People’s Party (EPP) criticised a sort of “ideological hysteria” on EDCs and, in particular, the attempt of putting on the same level suspected and proven EDCs.

“This goes too far, goes too quickly and it’s not based on scientific evidence,”

said centre-right British MEP Julie Girling.

Green and liberal lawmakers strongly criticised the definition of EDCs included in the Commission strategy, as it seems to apply only to pesticides and other plant production products.

“Now we know that 80% of exposure comes through the food, so EDCs should be banned in all of the materials in contact with food but also in cosmetics and toys,”

said Belgian liberal Frédérique Ries.

Strong political signal

EURACTIV asked Prof. Barbara Demeneix, chair of Endocrine-Disrupting Chemicals Task Force at Endocrine Society and among the authors of a scientific report on EDCs commissioned by the Parliament’s PETI committee published last March, for her thoughts.

She hailed the call to take concrete action to regulate endocrine disruptors, which are so prevalent in our daily lives.

According to the scientist, the Parliament has sent a strong political signal to both European ministers and the Commission with the adoption of this resolution by a clear cross-party consensus.

“Their call for clear and prompt EU actions is fully justified by the available science-based evidence of increasing damage to public health and it can no longer be ignored by the EU and other countries,”

Demeneix said.

Asked about the Perfluoroalkylated substances (PFAS), she said that the topic is particularly worrying, as several thousand of them exist and only a couple are banned.

“The fact that these substances interfere with thyroid hormone homeostasis and affect immune responses is clearly demonstrated, both by epidemiology and laboratory tests,”

she concluded.

Reference.

Endocrine Disruptors : from Scientific Evidence to Human Health Protection

The European Parliament publishes new report on endocrine disrupting chemicals, 2019

The European Society of Endocrinology welcomes the new European Parliament report on Endocrine Disrupting Chemicals (EDCs) written by Prof Barbara Demeneix of the Muséum National d’Histoire Naturelle in Paris, France and member of the ESE EDC Working Group and Dr Rémy Slama, INSERM (National Institute of Health and Medical Research), Grenoble, France.

Abstracts

Presentation

This study, commissioned by the PETI Committee of the European Parliament, presents the scientific knowledge regarding the health effects of endocrine disruptors, a class of hazards recognized in EU regulation since 1999. This report reviews the scientific evidence regarding the concept of endocrine disruption, the extent of exposure, associated health effects and costs. The existing relevant EU regulations are discussed and recommendations made to better protect human health.

1.1.2 The drug diethylstilboestrol (DES)

DES was developed as a synthetic oestrogen. It was prescribed from the 1940s onwards. Prescriptions were based on the erroneous assumption that it could prevent miscarriage and other pregnancy complications, which was shown to be wrong in 1953. In 1971, the USA Food and Drug Administration (FDA) advised against its use due to vaginal cancers occurrence in girls born to mothers who had used DES, while this cancer usually develops post-menopause. DES was banned in the Netherlands in 1975 and in France and Spain in 1977. Women who took DES have a slightly higher risk of breast cancer, but the most striking effects are seen on offspring exposed during pregnancy. Epidemiology shows in utero DES exposure to be linked not only to vaginal cancer in daughters of exposed women, but also to reproductive tract disorders, infertility and higher rates of spontaneous abortion. Sons display higher rates of genital abnormalities, and increased risks of prostate cancer; in addition, an increased risk of testicular cancer has been suggested. Importantly, effects such as increased risk of malformations of the male genitalia and possibly attention deficit and hyperactivity disorders (ADHD) are also observed in the grandchildren of DES-prescribed women.

In contrast to DDT, which is persistent in the body, DES is quickly eliminated, showing that chemicals can exert effects long after they disappeared from the organism, possibly on successive generations. There are biological mechanisms whereby the organism could keep a memory of exposure. One possibility relates to adverse effects that can be traced to epigenetic modifications. Work on animal models shows that certain DES impacts could result from epigenetic effects on the germ cells (the sperm and egg cells) forming in the in utero DES exposed foetuses).

Both DDT and DES provide examples of compounds able to interact with the endocrine system in humans or wildlife species (DES was designed to mimic a natural hormone, oestrogen; DDT and its metabolites were found to alter hormone production, mimic oestrogen and block androgen actions) and to cause adverse effects. They resonate with a concept developed in 1.7 and 1.9: the Developmental origin of Health and Disease (DOHaD), underlining foetal life as a determinant factor for child and adult health.

The scientific report, commissioned by the Parliament’s Committee on Petitions, provides an excellent overview of the severe threat EDCs pose for EU society and highlights the many shortcomings of current EU policies and legislation. Amongst the many proposed regulatory measures, it urges the European Union to rapidly develop a set of trans-sectorial and harmonised regulations to minimise human and environmental exposure to EDCs. As discussed in the report, based on an extensive literature review, EDCs or suspected EDCs are currently present in all media (water, diet, food contact materials, cosmetics…) and most EU citizens have dozens of (suspected) EDCs in their bodies.

In addition to improved regulatory measures, the report stresses the importance of speeding up test development to effectively identify EDCs and calls for additional research to address the many knowledge gaps in this relatively new scientific area.

These calls for additional regulation and research at the EU level are in line with a recent ESE Statement in response to the disappointing European Commission Communication on EDCs from 7 November 2018, which in ESE’s view lacks ambition to effectively tackle the many challenges in this area.

DES DiEthylStilbestrol Resources

How does the law protect our environment ?

Environmental compliance assurance and combatting environmental crime

The development of detailed, often ambitious laws designed to protect the environment over the past 30 years has been a striking phenomenon of our age. Laws in the statute book may provide some comfort but without effective implementation and enforcement they are meaningless. A Member of the European Parliament once remarked “we are good midwives but bad mothers” — implying that legislators often pay more attention to passing new laws than considering the equally challenging issues of implementation, and what happens after the law has come into force.

The potential gap between the formal law and its enforcement is seen in many fields of law, but it raises particular challenges in the field of environmental protection. In areas of law such as competition, social security, or consumer protections there are clearly defined victims with legal interests who can and will ensure that the law is enforced. In contrast, the environment is often unowned in legal terms — with the consequence that the environment dies in silence, it has been said. The responsibility for its legal protection lies largely on public authorities — the police, local authorities, or specialised regulatory agencies — often under competing policy priorities and severe resource constraints.

Yet, as this Thematic Issue demonstrates, in recent years far greater attention is being paid to the question of enforcement of environmental law — how it should most effectively be implemented, how best to ensure compliance, and how best to deal with breaches of environmental law where they occur.

These issues can raise delicate political issues at both national and regional levels. Deciding how to employ resources and respond to breaches of environmental law often involves considerable discretion amongst enforcement authorities, and national and local administrations have their own traditions and culture in which they operate. Imposing over-elaborate, top-down solutions may therefore be inappropriate. Within the European Union, environmental legislation has generally left the question of enforcement to the discretion of Member States, and it is rare for EU Regulations or Directives to specify the type of sanction that must be employed. The Court of Justice of the European Union has been equally reticent to trespass on the discretion of national authorities in this context, and simply relied upon the general principle that any sanctions employed must be effective, proportionate, and dissuasive.

An important exception to this picture was the passing of the EU Environmental Crime Directive in 2008, requiring that certain types of conduct in relation to EU environmental law must at least be defined as a crime by Member States. The proposal to do so was the subject of legal challenge before the Court of Justice on the grounds that there was no legal competence under the environmental provisions of the European Treaty to do so. Eventually the Court held that if there was a genuine problem of enforcement, this was the proper subject of a European Directive, but recognised the sensitivities of Member States by holding that the question of the size of penalties was a matter of national not European Union law.

Another very important legal development was the decision of the European Court in 2005 in a case taken by the European Commission against Ireland in respect of illegally operated and unlicensed waste sites. Until then enforcement actions concerning the failure by a Member State to implement EU environmental obligations in practice had been confined to specific examples. Here the Court held for the first time that the numerous cases of illegally operated sites represented a systematic failure in the administrative system for enforcement, and that this represented a breach of its obligations under EU law by the Member State.

EU environmental law, such as the 2010 Industrial Emissions Directive, is beginning to contain requirements concerning inspection and enforcement, though still couched in carefully drafted language so as not to over-intrude on areas thought appropriate for national or local discretion. The Make It Work programme, initiated in 2015 by Germany, the Netherlands and the United Kingdom has now drafted common principles on issues of inspection and enforcement which are recommend to be included in future environmental legislation.

Against this background, the papers highlighted in this Thematic Issue provide important insights for policymakers and for enforcement, and reflect the contribution of recent research in this area. Four particular themes emerge — the value of emerging networks of enforcement bodies, the need to exploit new technologies and strategies, the use of appropriate sanctions and the added value of a compliance assurance conceptual framework reflecting the interaction between three main functions — compliance promotion, compliance monitoring (inspections/surveillance) and enforcement.

Environmental networks

We have seen in recent years the growing development of various networks of enforcement agencies, at local, national, regional and international levels. Cross-border cooperation may be essential for issues such as transboundary pollution, the illegal transport of waste, and the illegal trade in endangered species. But the exchange of views and experience at national level where authorities may handle similar problems in different ways may also provide an invaluable learning experience.

Research is now beginning to attempt to evaluate the effectiveness of these networks, and how they might be improved in the future. Contacts, the development of good relationships, sharing best practice, and access to information can provide real benefits, but there are also challenges in funding, participation, and effective administration of the networks. The 2011 survey by one of the earliest such networks, INECE (International Network on Environment Compliance and Enforcement), covered some 10 networks around the world and highlighted a number of critical factors to ensure success. These include the need to prioritise, ensure adequate funding and the translation of key materials. Effective communication and the continuing evaluation of the performance network were equally vital. Ireland has provided a useful example of a national network — the Network for Ireland’s Environmental Compliance and Enforcement (NIECE) established in 2004, operating in the field of waste disposal and involving a national regulator and 34 local authorities. This helped to provide guidance and training for local enforcement officers, improving coordination and consistency in approach. The NIECE appeared to lead to a dramatic improvement in the quality of local authority inspection plans in a short space of time — in 2007 less than a quarter of such plans were given an ‘A’ rating but, by 2009, 85% received such a rating.

Using resources more effectively

Regulators and enforcement agencies never have unlimited budgets, and these days are normally operating under increasing financial constraints. This means developing more effective approaches and strategies. Risk-based enforcement strategies based on focusing efforts on activities judged to be the most problematic have emerged as one response, which is reflected in recent legislation such as the EU Industrial Emissions Directive.

Carrying out the same inspection levels for all industrial installations in a sector may not be the most effective use of scarce resources; it is preferable to give a lighter touch to those considered most compliant, while drilling down on the more problematic. But it is important to first ensure that there is public understanding and confidence in such an approach. Risk assessments are never foolproof. Members of the public who have not been engaged in the development of risk-based strategies are unlikely to react positively to a pollution incident on a site where there have been few inspections because the installation had been previously judged to have little risk, for example.

Against a background of resource constraints, new ways of using technology and data are likely to prove important. The Environment Agency in England provides an example of an intelligence-led policy in the field of illegal export of wastes, using data-collection technologies in a more focused way. The resolution of satellites is becoming ever finer, and a leading British legal expert in the use of space technologies as evidence highlights the potential of such technology to alert authorities of potential breaches of law, to monitor high-risk offenders to ensure compliance, and to check historical data. This research emphasises the need for lawyers to engage with Earth observation specialists so that the disciplines can more fully understand one another’s needs and constraints. A Belgian judge notes that Earth observation techniques are unlikely to replace ground-based monitoring and will have little to offer in some areas of environmental law, but nevertheless have a potential that is yet to be fully exploited.

Appropriate sanctions

The 2008 EU Environmental Crime Directive highlighted the potential significance of criminal law in dealing with breaches of environmental law, especially for those jurisdictions where there had been a heavy reliance of administrative penalties in dealing with regulatory breaches. Studies here include the use of imprisonment as a sanction, and argue for the greater involvement and acknowledgement of victims in the process.

Yet the message of many recent studies is that reliance on a single form of sanction is unlikely to be the most effective approach. A mixture of administrative and criminal enforcement is preferable, but since in many jurisdictions this is likely to involve different agencies (including the police), the development of new coordination strategies will be vital.

It is clear, however, that we still have little robust, comparative data on the real effectiveness of different forms of sanctions — either in terms of their impact on the individuals or business involved in the breach of environmental law, or on how they affect the internal costs of regulators and the public sector, including the courts. This needs to be a continuing area for future research and monitoring.

Regulatory agencies are likely to be under increasing scrutiny for their cost-effectiveness and efficiency. In terms of public accountability, it is important to have performance indicators based on activity such as the number and type of enforcement actions taken. But we must not let these requirements obscure the reason we have environmental law and regulation in the first place. Outcome measures relating to the quality of the environment being protected should be a central aspiration, and studies here indicate how they are being developed in some jurisdictions. But it is not an easy exercise. It is all too easy for outcome measures to become goal-orientated targets which then over-dominate the enforcement body’s strategy and thinking.

The more recent emphasis on implementation and enforcement is to be welcomed, but there are clearly many areas in which the research community has much to offer. Regulators and government should value the input of independent research to improve their own understanding and performance, and work closely with research bodies to help identify key issues that need exploring. Legislative bodies such as the Council of the European Union or UK Parliamentary Select Committees should systematically evaluate the actual implementation of environmental legislation so that improvements can be made to the enforcement of existing laws, and lessons learnt in the design of new legislation. The environmental challenges facing our society are profound, but the signs from the recent research identified in this Thematic Issue give some room for optimism. …

… Read Science for Environment Policy Thematic Issue, Environmental compliance assurance and combatting environmental crime, including an editorial from Professor Richard Macrory.

Beware the mixture

Despite growing scientific evidence for enhanced toxicity of chemical mixtures, regulation does not adequately capture such combination effects

Humans and wildlife are continuously exposed to multiple chemicals from different sources and via different routes, both simultaneously and in sequence. Scientific evidence for heightened toxicity from such mixtures is mounting, yet regulation is lagging behind. Ensuring appropriate regulation of chemical mixture risks will require stronger legal stimuli as well as close integration of different parts of the regulatory systems in order to meet the data and testing requirements for mixture risk assessment.

Until about a decade ago, toxicologists, risk assessors, and regulators regarded risks from chemical mixtures as negligible, as long as exposures to all single chemicals in the cocktail were below the levels judged to be safe for each chemical alone. However, an increasing body of scientific evidence has challenged this notion, showing that a neglect of mixture effects can cause chemical risks to be underestimated. International bodies such as the World Health Organization now acknowledge the need for considering mixtures in chemical risk assessment and regulation. This would align toxicological risk assessment with the clinical sciences and their long tradition of investigating drug-drug interactions. Yet, with few exceptions, regulatory systems around the world still focus overwhelmingly on single-chemical assessments, and the translation of scientific evidence about mixture effects into better regulation is extremely slow.

Continue reading Regulate to reduce chemical mixture risk on ScienceMag, 20 Jul 2018.

Towards a more comprehensive EU framework on endocrine disruptors

Health groups warn proposed change to pesticide law would undermine effective identification and ban of endocrine disruptors

Health and Environment Alliance (HEAL) Press Release, 19/07/2018

A discussion on a controversial proposal to amend the European pesticide legislation started between representatives of European governments on 19-20 July. Health groups warn that such a change would undermine the provisions that foresee the ban of pesticides identified as endocrine disruptors and would only benefit the pesticide industry.

As the European Commission consultation on a roadmap for a framework on endocrine disrupting chemicals (EDCs) is coming to a close, a much less publicised process is starting behind closed doors. Representatives of European member states met in Brussels on 19 and 20 July to discuss a proposal by the European Commission to change the conditions that would allow derogations from the ban of endocrine disruptors planned under the pesticide legislation.

This is not the first time the Commission has proposed such changes. This proposal was originally discussed during the negotiations on the identification criteria for EDCs in 2016. Due to strong opposition from civil society and the public health community at the time, it did not garner the needed support by member states to be included in the criteria.

Following the agreement on identification criteria for endocrine disrupting pesticides in December 2017, it is now technically possible for European countries to ban pesticides that meet the criteria. The pesticide regulation foresees a possible derogation to such bans in cases of “negligible exposure” to the substance – namely conditions in which the exposure is well controlled such as in closed systems.

As brought to the public attention by HEAL’s member Pesticide Action Network Europe, the European Commission is suggesting to change the conditions allowing for such a derogation by replacing “negligible exposure” into “negligible risk”. This slight change of wording might first come across as harmless, but carries the potential to change the hazard-based approach that lies at the foundation of the pesticide legislation. If adopted, it would bring a risk element into the discussion.

This is problematic and should be opposed at all costs for several reasons:

  • The European Commission is suggesting a discussion on this proposal behind closed doors, using the comitology procedure, while the proposed changes touch upon the foundations of the pesticide legislation. Therefore, a fully transparent process involving the European Parliament and the Council (in co-decision) would be the appropriate setting for such a discussion.
    The fact that this is happening just as the public consultation on the roadmap for a framework on EDCs (which HEAL has already criticised for missing concrete measures to reduce exposure to EDCs) comes to a close, also raises questions on the Commission’s willingness to have a fully transparent and democratic debate on such a high profile public health issue.
  • The proposal brings a fundamental change to the hazard-based approach of the pesticide legislation. Based on the precautionary principle, the legislation considers that pesticides identified as EDCs should be banned by default, unless in case of “negligible exposure”. If adopted, the Commission’s proposal would introduce a risk assessment following the EDC identification, based on the flawed idea that safe conditions and levels of exposure exist for EDCs and the risk related to this exposure can be controlled. This would make the evaluation process of pesticides even more lengthy. It would also open a pandora’s box to industry arguments that attempt to justify that a risk is negligible under hypothetical conditions of use and wrongly promote a supposedly safe use of certain chemicals that the pesticide legislation explicitly singled out as dangerous to human health.
    This is even more worrying as the data used to assess supposedly negligible risks will be prepared by companies. While the current derogation in case of negligible exposure foresees that the exposure has to be well controlled (for instance in a closed environment), an approach based on risk would open the door to allowing for a much wider use of endocrine disrupting pesticides – for instance through spraying in the environment – when they should by default be banned under the law.

The Health and Environment Alliance (HEAL) together with members such as PAN Europe and partners of the EDC-Free Europe coalition will continue to oppose this proposed change. We urge member states to defend the existing approach foreseen in the pesticide legislation and strive for its full implementation in the future.

EU Obligation to Protect its People and the Environment from All Harm caused by Endocrine Disrupting Chemicals

A more protective European approach to endocrine disruptors is long overdue. Read our eight demands to the EU Commission for an EDC-Free future

EDC-Free Europe Statement on EU EDCs Strategy, May 2018.

Why we are concerned

Endocrine disrupting chemicals (EDCs) are increasing our chances of getting serious and potentially lethal diseases and health disorders as highlighted by experts from the World Health Organization (WHO), scientists from the Endocrine Society, and others. In these reviews of scientific literature, impacts from EDCs have been linked to reproductive and fertility problems such as drastically falling sperm rates, as well as hormone dependent cancers such as breast and prostate cancers. Neurological impairments including autism and IQ loss as well as metabolic changes including obesity and diabetes have also been associated with exposures to EDCs. In wildlife, there is further evidence of reproductive and developmental harm linked to impairments in endocrine function in a number of wildlife species: EDCs have been associated with changes in immunity and behaviour as well as skeletal deformities.

A growing body of science underpins the ways in which some people are more vulnerable than others to the health impacts of endocrine disruption, even in small doses, with effects sometimes appearing decades later. The time during development in the womb and during early childhood has been found to be a particularly sensitive window of exposure and has raised serious concerns among health professionals. In 2015 over 100 national societies of obstetricians and gynaecologists from around the world called on policymakers to prioritise reducing exposures as an important means of disease prevention.

Avoiding EDCs is not a choice that a person can make anymore. EDCs are found everywhere in our daily lives: from high-profile substances, such as the bisphenols used in the making of certain plastic bottles and can linings, and restricted phthalates that are still found in one out of five toys; the flame retardants used in sofas; the pesticides sprayed on and ending up in our food; and the antimicrobial biocides found in cleaning products. They are nearly everywhere, both at home and in the workplace. The nonprofit research institute the Endocrine Disruption Exchange (TEDX) lists over 1,400 potential EDCs, the WHO mentions over 800 EDCs, and many more suspected EDCs still need to be investigated.

EDCs end up in all of us – children and adults alike – contaminating our bodies without our consent or knowledge. Human biomonitoring samples of urine, hair and blood across Europe are starting to demonstrate the extent of that internal pollution. In France, over 20 EDCs were found in women tested for the presence of these chemicals in 2015. The European Biomonitoring Initiative has included many EDCs and potential EDCs in its priority list and the results will be used to inform policy decisions on specific substances.

Most importantly, EU laws regulating EDCs are not protecting us – the ones that are supposed to do so are patchy, not properly implemented and leave huge gaps where EDCs are not regulated at all such as in cosmetics, toys, textiles, furniture and food packaging and in other articles that we come into contact with every day.

What we want

In 2017 the EU Commission committed to bring out a new integrated strategy on EDCs which is supposed to cover ´for example toys, cosmetics and food packaging´. Previous attempts to update the existing EU Community Strategy on EDCs from 1999 with recent scientific advances and actions to tackle the problem was derailed by intense industry lobby in 2013 as documented by the investigation ‘Toxic Affair’.

We are calling on EU Commission President Jean-Claude Juncker to bring out a fully-fledged strategy before the summer of 2018. This would include a concrete action plan aiming for a high level of protection for human health, especially vulnerable groups, and the environment. Tangible activities should have clear targets, a timeline and a reasonable budget. This would be an opportunity for reconnecting the EU’s agenda with citizens’ demands for better public health protection on EDCs as illustrated by widely supported petitions developed and supported by the EDC-Free campaign partners in 2017. The first one was delivered to member states with almost half a million signatures in July, and the second one with over 300,000 signatures in October.

An EU EDC strategy could also support and build on efforts by progressive countries, such as France, Sweden and Denmark, which are already implementing actions on EDCs. Belgium has just announced the launch of a national action plan on EDCs. It should be in the interest of the European Commission to promote harmonisation when it leads to an equal and high level of protection for all EU citizens, and supports the avoidance of barriers to trade within the European single market. Today, a clear EU commitment is needed to reduce people`s exposure to EDCs in a more comprehensive way throughout Europe.

This is not only a unique opportunity to increase well-being by preventing diseases, but it can also contribute to reducing the rising costs associated with EDC-related illnesses, as showed by a study evaluating the bill at a staggering 163 billion Euros a year for Europe, even though its scope covered only a few, rather than all, EDC-related illnesses. This is also an opportunity for policy coherence and for the EU to set a regulatory framework that builds the foundations for a truly non-toxic circular economy by encouraging industrial innovation through safer substitution. Considering that our exposure to preventable environmental chemicals is estimated to result in health costs worth 10% of global GDP, there is a real business case for promoting safe substitution to toxic EDCs through a comprehensive EU strategy for action.

We need a comprehensive action plan that effectively prevents further impacts on health and ends wildlife loss associated with EDCs. It needs to set out legal actions for eliminating exposure and to contribute towards meeting the 2030 commitments set out in the Sustainable Development Goals to “substantially reduce the number of deaths and illnesses from hazardous chemicals and air, water, and soil pollution and contamination“.

The EU EDC Strategy must reflect the most recent advances in science and draw the logical conclusions from them by complementing existing obligations in the EU regulatory context. The following identifies the eight crucial elements that the EDC strategy needs to include to enable the EU to effectively protect health and the environment against EDCs.

Essential elements of an EU Endocrine Disrupting Chemicals Strategy

  1. Consider public health and precaution as the cornerstones of a new EU EDC Strategy
    Protect those who are most vulnerable. Reduce exposures to children to prevent suffering from EDC-related diseases and the spiralling costs associated with treating them. Build on and expand the short-, medium- and long-term actions from the 1999 EU EDC strategy and augment their effectiveness.
  2. Enhance public awareness of EDCs – connect it with the EU’s work on protecting citizen’s health
    A recent Eurobarometer survey found that two out of three European citizens are concerned about exposure to chemicals in their daily lives through food, air, drinking water and consumer products or other items, as well as in the workplace. Less than half of the same group felt well informed about the potential dangers of chemicals. A Europe-wide campaign to raise awareness on EDCs is needed.
    Specific focuses of such a campaign should include:

    • Informing parents before and during pregnancy, and families in general, about ways to minimise exposures in everyday life.
    • The dissemination of good practice for exposure reductions and health advice connected to grassroots and local agendas and the creation of a bank of success stories showing how the EU is making a difference.
    • Information and training materials for medical, health and educational professionals and multiplier groups so that they can advise the public on reducing their exposures.
    • A response to consumers’ concerns and the provision of tools for traceability and the right to know for chemicals in products.
  3. Improve regulation: Increase the control of the use of EDCs across all sectors
    • Make a plan with timetables to implement suitable EDC criteria in all relevant EU laws to identify and reduce exposures to EDCs.
    • Address missed deadlines first, like the 2015 one for cosmetics and obvious loopholes like toys, food packaging regulations. Commit to addressing other relevant EU legislation and sources of exposure, such as public procurement, worker’s exposure, textiles, etc. and deliver on the 7th EAP commitment.
    • Support the implementation of the EU Plastics Strategy by banning the presence of EDCs in plastics in particular as the presence of EDCs can hinder recyclability and negatively affect the value of recyclates.
    • EDCs should be regulated with the presumption that no safe threshold for exposure can be set with sufficient certainty.
    • EDCs should be regulated by using group approaches based on similar structures and similar properties to avoid regrettable substitution.
    • Implement and enforce, efficiently and ambitiously, the existing regulatory obligations controlling the use of EDCs. This includes speeding up the inclusion of EDCs in the REACH candidate list of substances of very high concern and the adoption of measures to limit exposure, such as REACH restrictions or REACH authorisation. Currently only 12 substances have been identified as EDCs under REACH.
    • Accelerate the assessment of EDCs to implement restrictions on them in pesticides and biocides.
    • Create new sectorial laws to ensure robust protection in priority for consumer products. For most consumer products, e.g. textiles, child care articles, plastics there is no specific provision addressing EDCs.
  4. Reduce our EDC daily cocktail: Replace the substance-by-substance approach by including all possible sources of exposure to multiple chemicals
    • Prioritise the identification and regulation of the most problematic groups of hormone disrupting chemicals and swiftly act on known co-exposures to harmful chemicals from various sources (e.g. indoor air pollution, dust, food contact materials). Move from a single substance risk assessment to cumulative assessments for chemicals acting on the same adverse outcome and similar chemicals. Sweden and Denmark are looking at this issue in the context of their national work.
    • Respond more swiftly to early warning signals from new scientific findings about potential health or environmental damages in re-approvals and authorisations of substances. When concerns show up in one chemical use, a risk evaluation should automatically be triggered across legislative ‘silos’ to fully assess the impact of cumulative exposures and to ensure swift action in the absence of full scientific certainty.
  5. Speed up testing, screening and identification of EDCs
    • Update test requirements with new and updated screens and test methods in all relevant EU laws so that data gaps will be closed and EDCs can be identified. The EU should systematically make industry responsible for providing sufficient evidence to demonstrate safety.
    • Prioritise data collection on potential EDCs and draw up lists to communicate to consumers and business alike.
    • Improve the screening and testing guidelines used to identify EDCs and address data gaps.
  6. Work towards a clean ´Circular economy´ and a non-toxic environment: Avoid toxic substances such as EDCs in products from the start
    • Need to have full traceability to avoid finding EDCs in recycled materials.
    • Need to have producer responsibility. Each company should be obliged to inform consumers about the chemical content of their products, including the packaging.
    • Need to have the same level of protection from EDCs for primary and secondary materials, which means that when an EDC is banned from a virgin material, it should be banned from recycled materials as well, contrary to current practice.
  7. Enhance European market leadership for safer substitution with no regrets and promotion of innovative solutions
    • Support initiatives that guide companies to move away from EDCs. Some examples can be found at chemsec.org – market place, the ‘dating platform’ for companies trying to meet a provider of safer alternatives.
    • Limit and avoid the use of pesticides in agriculture and the management of green or urban areas and set specific targets for an overall reduction of pesticide use in line with the Sustainable Use of Pesticides Directive (2009/128/EC).
    • Encourage communication campaigns at a national level in order for citizens to be 1) more mindful about chemical use in their daily lives, in particular during pregnancy and with children, 2) to have the right to know about EDCs in products.
  8. Monitor the health and environmental effects of single, groups and mixtures of ED substances to capture all sources of EDC exposure ‘across the board’ and respond swiftly to minimise them
    • Ensure sufficient focus on investigating chemicals of new and emerging concern which are used as replacements for banned chemicals in the context of the EU Human Biomonitoring Initiative.
    • Develop sensitive test methods with new endpoints such as chemicals interfering with brain development and ensure they are appropriately considered within the regulatory evaluations.

EDC-Free Europe is a coalition of public interest groups representing more than 70 environmental, health, women’s and consumer groups across Europe who share a concern about hormone disrupting chemicals (EDCs) and their impact on our health and wildlife. Campaign partners include trade unions, consumers, public health and healthcare professionals, advocates for cancer prevention, environmentalists and women’s groups.

Reference. Image credit @EDCFree

The Lie about Glyphosate

Glyphosate must no longer be allowed on our fields nor in our foods

Toxic chemicals are working their way into your food, thanks to devious scheming by some big corporations. The EU can stop this.

  • Video published on 12 May 2016 by wemove.eu.
  • By the way, did you know that some vaccines and GMOs have more in common than many people realize? Read this post, October 13, 2015 by Joel Edwards.

Making safer chemicals : solutions to encourage alternatives

How to find and analyse alternatives in the authorisation process

Analysis by ChemSec and ClientEarth shows the chemicals approval process gives undue influence to companies producing dangerous chemicals and stifles information on safer alternatives, limiting the market for companies that produce them.

The main goal of the authorisation process is to promote the replacement of substances of very high concern (SVHC) with substances or technologies that are safer.

However, during the “stocktaking conference on authorisation” held in November 2017, it emerged that the authorisation process has not delivered its full potential. In particular, authorisations have been granted even when alternatives did exist, contrary to the requirements of REACH and having negative effects on alternative providers.

When an authorisation is granted under Article 60 despite the existence of a suitable alternative, it not only violates REACH, it also rewards the laggards and frustrates the frontrunners.

On the basis of the conference on authorisation, experience as observers in the socio-economic committee (SEAC) and extended exchanges with alternative providers, ChemSec and ClientEarth have identified two of the issues in the way SEAC operates, that prevent the authorisation process to fully deliver.

First, applicants do not always comply with their obligation to provide ECHA with accurate and comprehensive information on alternatives. The way to find existing alternatives has to be re-thought.

Second, SEAC does not use clear and appropriate criteria to assess the feasibility of suitable alternatives. The way that SEAC assesses the feasibility of alternatives needs to be improved.

This publication aims to explain the current challenges and recommend solutions that could be implemented without changing the existing regulatory framework.

Read the full report How to find and analyse alternatives in the Authorisation Process on chemsec and press release EU chemicals approval process stifles safer alternatives on clientearth.

Europeans will remain exposed to Bisphenol A in food packaging

MEPs reject ban on BPA in food packaging, Brussels, 11th January 2018

A European Commission proposal to regulate bisphenol A in food contact materials was discussed today in the European Parliament Environment Committee (ENVI). The Health and Environment Alliance (HEAL) regrets that Members (MEPs) gave the green light to a piece of legislation that fails to protect citizens’ health and will mainly benefit the chemical industry.

The European Commission regulation foresees to simply lower the migration limit rather than ban bisphenol A in the coatings and varnishes used in food packaging. This contradicts the European Parliament’s own 2016 demand to fully ban bisphenol A from food contact materials [3].

Bisphenol A has been listed as a substance of very high concern (SVHC) by the European Chemicals Agency due to its endocrine disrupting properties , and it is also classified as toxic for reproduction. HEAL alongside numerous civil society groups have long demanded its full ban, because exposure to even very low doses can have serious long-term health impacts.

Commenting on the outcome of the vote, Natacha Cingotti, HEAL’s policy officer on health and chemicals, said:

“The adverse health effects of Bisphenol A, even at low doses, are so well documented that it should already have been banned from all consumer products a long time ago – citizens shouldn’t have to worry that their food wrapper or packing contains BPA and might seep into their food and harm their health.”

“European politicians are failing in their responsibility to protect people’s health and to act on their earlier commitments, although safer alternatives are available and some governments such as France and industry retailers are already on the path to substitution. It’s not only dangerous but also incoherent – we should be getting the toxics out of the economy if we want it to be truly circular.”

HEAL has repeatedly called on European decision-makers to take steps to fix the loopholes that currently exist in terms of the evaluation and regulation of chemicals in food packages, and will continue to promote more ambitious action to protect Europeans – in particular vulnerable groups – as a formal evaluation of the European legislation on food contact materials is about to start.