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Endocrine disrupting chemicals (EDCs) are chemicals that can disrupt the functioning of the endocrine (or hormonal) systems of humans or wildlife. There are EU laws in place that can restrict their use – but they will only work if there is agreement on how to decide if a chemical is an EDC.

The issue of criteria to identify EDCs is therefore vital, as it affects which chemicals will be regulated – for example the pesticides and biocides regulatory system can ban the use of EDCs. The system for regulating industrial chemicals (REACH) can subject EDCs to authorisation, where companies must apply to continue to use them, otherwise they are off the market.

The EU Commission has just released a consultation on what the criteria should be. Here’s the CHEM Trust response:

“We welcome the Commission’s consultation on the urgent and important issue of how to identify endocrine disrupting chemicals.

It’s particularly good news that this consultation is launching in the week that the Environment & Health Commissioners-nominate are having their hearings in the European Parliament. This should help ensure that endocrine disruption is viewed as priority for new Commission.

We will look at consultation closely and we hope that this consultation can help ensure that this important issue is addressed urgently”

Today (Monday 29th September) the European Parliament will start questioning the proposed new European Commissioners – the launch of the EDC criteria consultation should help ensure this is an important part of the discussion. However, this is only one of the environmental concerns about the new Commission, with the main EU-based environmental groups – the Green 10 – calling for major changes to ensure Europe makes continued progress on sustainable development.

Of course, dealing with EDCs isn’t just an issue for governments. Responsible companies should already be working to avoid chemicals with endocrine disrupting properties, and there is a lot of information available on what chemicals should be avoided. The most important tool, the International Chemical Secretariat’s SIN List will be updated next week.

Unfortunately much of the effort from the chemical industry has been focussed on delaying action on EDCs. For example, industry pressure led to the European Commission doing an impact assessment on setting EDC criteria, delaying action and moving the focus away from science & towards the policy’s effects on individual companies. If you want to know more about this industry campaign, the documentary Endocrination spells out what has been happening.

The success – so far – of the chemical industry policy to delay action on EDCs means that it’s important that the new Commission finalises these criteria and starts getting endocrine disrupting chemicals off the market. We and wildlife are being exposed to these hazardous chemicals – they need to be taken off the market.

ENDS Europe, Chemical Watch and Food Quality News have covered this story & quoted CHEM Trust.

A new report  “Chemical conflicts”, from Corporate Europe Observatory (CEO) – who specialise in exposing corporate lobbying – finds that two-thirds of scientists advising the EU on controversial substances have industry links.

CEO looked at four recent case studies of chemicals that had been examined by the European Commission’s Scientific Committees: parabens, nano titanium dioxide, nano-silver and mercury.

The Scientific Committees involved included the Scientific Committee on Consumer Safety (SCCS), the Scientific Committee on Health and Environmental Risks (SCHER) and the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).

CEO found that 67% of the scientists who drafted opinions had at least one conflict of interest, while some had as many as 20 – due to their direct and indirect links with affected industries. Conflicts included working in a consultative/advisory role for industry, research funding, employment, ownership of shares or other investments and intellectual property rights.

In CHEM Trust’s view this report raises serious concerns. The European Commission’s scientific committees provide crucial guidance for assessing the risk to humans and the environment of chemicals found in a huge range of everyday items, from shampoo to baby bottles. The failure to adequately regulate such chemicals could potentially cause great harm to human health and the environment.

It is vital that the scientific advice used in the regulation of potentially hazardous chemicals are of the highest quality and free from industry influence. CHEM Trust therefore encourages the Commission to look into ways of better separating the technical advice they need from the interests of affected industries.

In addition, CHEM Trust suggests this debate should also be seen in the context of the recent more general discussions on how the EU Commission should obtain scientific advice for decision making – see our earlier post, “Science policy is about debate and discussion – not one person working in secret“.

Chemical Watch has reported that the chemical-industry backed ECETOC organisation is pushing to change the way hazardous chemicals are classified & labelled.

The group aims to change the safety labels on chemical that are carcinogenic (cancer causing) or toxic to reproduction. These labels inform users of the chemicals about their hazards, so that risk management measures can be taken. ECETOC wants to move to a situation where the potency is considered when deciding what to put on the label.

CHEM Trust senior policy advisor Ninja Reineke explains why this is the wrong approach:

“This industry proposal is deeply worrisome,” said Ninja Reineke from the NGO ChemTrust.

“Chemical companies should be trying to design chemicals which don’t cause cancer or toxicity to reproduction, or avoid and limit their use. But instead, here they are suggesting to downgrade the classification of carcinogens and reproductive toxicants, which would open the door to the use of more harmful chemicals,” she says.

“Exposure to a weakly potent carcinogen might still result in some cancers, in particular, when exposure occurs at critical times and in combination with other carcinogens,” Ms Reineke adds.

Chemical Watch is reporting that the European Commission is re-organising responsibility for  the setting of criteria for endocrine disrupting chemicals (EDCs), moving it from the Environment Directorate General (DG) to DG Health and Consumer Affairs (or ‘Sanco’), though DG Environment will remain in charge of overall EDC policy. In addition, responsibility for biocides and pesticides policies is transferring to DG Sanco:

The European Commission’s directorate general for health (DG Sanco) will lead development of criteria to identify endocrine disrupting chemicals (EDCs), according to Bjørn Hansen, head of the chemicals unit at DG Environment, which has been in charge of the work until now. The switch is part of the changes planned for the new Commission, which is scheduled to start its mandate on 1 November (CW 10 September 2014).

The EDC criteria feature in the EU’s biocidal products (BPR) and pesticides Regulations (PPPR), and with DG Sanco in charge of the two policy areas starting next year, it will have “a higher stake” in proposing the new criteria, says Mr Hansen. His unit has been working with DG Sanco over the past few months on the issue (CW 16 June 2014), and he expects the two DGs will launch a public consultation on the criteria, before the end of the year.

DG Environment will still be in charge of the European Commission’s overall strategy on EDCs, as well as overseeing rules for test methods needed to detect chemicals with endocrine-disrupting properties, according to Mr Hansen.

At CHEM Trust we are concerned about these changes, and our Policy Director Gwynne Lyons is quoted in the article:

Meanwhile, a number of NGOs voiced concerns about DG Sanco taking over biocides and leading development of the EDC criteria. Gwynne Lyons of ChemTrust said: “Moving biocides from DG Environment to Health makes a mockery of the good work done in DG Environment, which had solicited democratic input from member states, all stakeholders and scientists to come up with draft criteria for EDCs back in June 2013. This restructuring and reassignment of the file is short-term politics to appease industry and it bodes ill for the environment and human health.”

She notes that DG Environment had been pursuing a hazard-based approach, but it seems that “powerful forces” have resulted in a more risk-based approach emerging, she says, pointing the finger at industry and the trade negotiations currently underway with the US. Ms Lyons also points out there is a legal issue, as the criteria are written in the BPR and PPPR. The NGO is keen to see the interim criteria implemented – these would see category 2 reprotoxins and carcinogens, and substances toxic to endocrine glands, classified as EDCs. This would catch a lot of EDCs so it is important they are imposed, she says. DG Sanco declined to comment on the changes.

We will be keeping a close eye on the European Commission’s work on endocrine disrupters – in DG Sanco, DG Environment and beyond.

Back in July, worrying new research on hazardous chemicals in food packaging led to CHEM Trust writing a letter to the current EU Commissioner for Health, Tonio Borg – more details in this blog post.

We are particularly concerned about gaps in regulation for chemicals in non-plastic food contact materials (cardboard, ink, glue etc), and the fact that the new research found that many chemicals with hazardous properties – such as endocrine disrupting chemicals – were in use in food contact packaging.

The Head of the Commissioner Borg’s Cabinet of advisors, Joanna Darmanin, responded to our letter towards the end of August – you can read her response here.

The letter admits that the legislation in this area does not fully cover all types of food contact materials:

I would like to underline that Regulation (EC) No 1935/2004 specifies that food contact materials must not transfer their constituents to food in quantities that could endanger human health. This principle is directly applicable in all Member States. Specific EU legislation is in place not only for plastics but also for regenerated cellulose films (Directive 2007/42/EC), ceramics (Directive 84/500/EEC). active and intelligent materials (Regulation EC 450/2009″) and recycled plastics (Regulation EC 282/2008).

Yet the concept of food contact materials covers many other materials such as glass, metal, paper, adhesives, printing inks, coatings etc., produced by very diverse industries adapted to at times distinct national rules. The Commission’s Joint Research Centre has recently agreed to analyse the situation in detail. The resulting study should be finalised within a year. It will help to decide which action at EU level will be appropriate.

This response backs our view that the EU regulations are not properly protecting us from exposure to endocrine disrupting chemicals.

It’s good to know that the Commission’s Joint Research Centre (JRC) are studying the chemicals in packaging problem – but how long will this really take and will the Commission act on the results?

We believe that the Commission needs to act rapidly to properly protect our health, through:

  • Ensuring that all food packaging materials can only contain chemicals that are approved for food contact use
  • Acting to get endocrine disrupting chemicals out of all food packaging

A new Commission is approaching

A new European Commission team is now preparing to take over from the existing Commissioners. Countries have nominated their new candidates for Commissioners, and incoming Commission President Jean-Claude Juncker last week published his proposal for which jobs these candidates should get.

There is a lot of controversy about President Juncker’s proposed re-structuring of Commission, and over some of the candidates – see, for example, the letter from the main environmental groups (the ‘Green 10′) which particularly focusses on the apparent downgrading of EU environmental policy. CHEM Trust fully supports the Green 10’s concerns. President Juncker also has a strong focus on ‘better regulation’ – which is often interpreted as ‘deregulation’, yet regulation is vital to protect our health and that of the environment, and it also helps create innovation.

Vytenis P. Andriukaitis, from Lithuania, has been nominated for the role of the new Commissioner for Health and Food Safety. President Juncker has sent him a letter with Juncker’s view of the priorities for this role – and it doesn’t mention packaging or chemicals. We disagree!

The European Parliament will now get the chance to question the nominated Commissioners in hearings, and they must vote to approve them all before they can start their new jobs. The Parliament can vote to reject all the Commissioners, though in the past they have threatened to do this in order to get one or two of the nominees replaced.

Key questions for a new Commissioner for Health & Food Safety:

Will the new Health Commissioner work to better protect us from hazardous chemicals in food packaging, by acting to:

  • Ensure that all food packaging materials can only contain chemicals that are approved for food contact use?
  • Get endocrine disrupting chemicals out of all food packaging?

Chemical Watch has reported that officials from Europe and the US are planning to have a formal meeting on 15th October 2014 to discuss increased co-operation on endocrine disrupting chemicals (EDCs).

This comes as there are increased concerns among many that the EU-US “Transatlantic Trade and Investment Partnership” (TTIP), currently being negotiated, may undermine the regulation of EDCs in Europe. CHEM Trust has already joined with a large number of other groups to call for chemicals to be excluded from TTIP.

This meeting – which isn’t ‘for the time being’ part of the TTIP trade negotiations – has been welcomed by the chemical industry, according to Chemical Watch.

CHEM Trust is rather less convinced:

However, NGOs in Europe have expressed their concerns about the impacts of any formal co-operation between the EU and US on endocrine disruptors.

Gwynne Lyons, policy director of ChemTrust and a nominated stakeholder expert of the Echa endocrine disruptor expert group, says: “The EU process is moving very slowly already, and regulatory collaboration with the US can only make things worse. The US system has failed to regulate chemicals, including endocrine disruptors, effectively, so the US will almost certainly be a barrier to progress,” she adds.

Ms Lyons says co-operation on developing test methods and prioritisation methodology might sound useful, but there is a “hidden agenda to make sure only the most potent, and probably no longer used, chemicals fall under a blunted regulatory axe”

CHEM Trust, with over 20 other European civil society organisations, have today sent a letter to the President-Elect of the European Commission, Jean-Claude Juncker. In the letter we propose that the next Commission adopts a revised model of scientific advice, rather than the current single ‘Chief Scientific Officer’ approach.

The link between science and policy – and how uncertainty is understood and acted on – are key issues for any government or similar organisation. Many aspects of science are well understood, but in many areas of great controversy the science is subject to great uncertainty and dispute.

Science moves forward through such debate, with ideas that are now well established – like plate tectonics or the idea that most stomach ulcers are caused by bacteria – widely dismissed when they were first proposed. The debate continues in many other areas, such as on the risk of hormone disrupting chemicals, nanotechnology or the role of statins in preventative medicine.

One of the best examples of government failure when dealing with scientific uncertainty was in the UK, after a new disease had appeared in cattle – Bovine Spongiform Encephalopathy (BSE). One major question was whether this disease could spread to humans. For some years it was claimed that this was impossible, until the government in 1996 had to admit that in fact a new human disease, vCJD, was caused by exposure to BSE. They also had to admit that the public had not been properly protected from exposure to BSE; this disease has killed more than 100 people.

BSE and vCJD were a major failure of government, and led to a very extensive public enquiry, published in 2000, reviewing the failings that lead to the spread of CJD. Many recommendations where made on how to prevent this sort of case happening again.

The inquiry’s conclusions on scientific committees & on uncertainty are particularly relevant to the Commission Scientific Advisor discussions, notably:

  • The composition of the committee should include experts in the areas of the advice that is likely to be required.
  • Trust can only be generated by openness.
  • Openness requires recognition of uncertainty, where it exists.
  • The importance of precautionary measures should not be played down on the grounds that the risk is unproved.
  • Scientific investigation of risk should be open and transparent.
  • The advice and the reasoning of advisory committees should be made public.

Contrast this with the role of the Commission Scientific Advisor, who is one individual – not a committee with varying expertise and experience – but seems to have the power to over-rule other scientific advisory bodies. In addition, the current holder of the position – Anne Glover – believes that this post should operate in secret, with no disclosure of what the advisor is being asked to consider, nor of the advice they have given:

Anne Glover, the EU’s Chief Scientific Advisor, has said that her opinions to the European Commission should remain independent from politics and therefore “not transparent” and immune from public scrutiny.”

As the letter points out, we – and many others – believe that any advice should be published, and that the Commission’s scientific advice shouldn’t be concentrated in one person, however good a scientist they are.

Update on 2nd September:

ENDS Europe’s coverage of the letter has a link to this blog.

Chemical analysis has found that some loom bands & charms have very high levels of phthalates in them – well over 50% in the case of some charms. As the analysts themselves say:

 The latest loom bands craze in particular is throwing up some alarming results considering these products are so child appealing”

Loom bands – an astoundingly popular craze with children – are elastic bands that are woven together to make bracelets and other items. Sometimes they have ‘charms’ attache to them as extra decoration. Due to their popularity, there are now many different brands available in the shops.

Phthalates are a family of chemicals with similar (though not identical) properties. EU regulations currently restrict 6 phthalates to a maximum of 0.1% in toys, while other phthalates are restricted in items that can go in the mouth of children. It is clear that loom bands (or at least their charms) are breaching this regulation.

Phthalates aren’t just causing concern in Europe – for example in the US a scientific panel recently expressed their concern about the impact some phthalates could be having on male reproductive organ development.

However, consumers have no information as to which brands of bands exceeded the EU limits for phthalates – the analysts state:

“Unfortunately due to customer confidentiality we are unable to publish news on the brands that failed.”

This means that, other than the companies who have commissioned these tests, other retailers and the general public have no information as to which brands are a problem. There is no visible effort to withdraw the phthalate-laden toys from shops, nor to notify the public to stop using the affected products

It’s in Ireland that these results have received most coverage, but no regulatory action has happened up until now.

We have regulations that are supposed to protect us from hazardous chemicals, yet this case – and others – show that these are not being properly monitored and enforced.

These products should be being withdrawn from the market, and both Governments and retailers need to act now!

 Update, 14th August 2014:

The Daily Mail has now covered this story, including some new pieces of information:

  • All 16 packs of ‘unofficial’ charms tested had >0.1% phthalates, with two having >50%
  • The tests were done for retailers and trading standards offices
  • The spokesperson for the lab – Birmingham Assay Office – makes the point that “The worrying thing is the charms are the bits that are most likely to end up in children’s mouths
  • A spokesperson for the Trading Standards Institute: “I would warn parents to be vigilant about loom bands – only buy from respected shops, not off market stalls, and look for a UK distributor’s address on the packing as well as a CE mark. Don’t allow your children to put them in their mouths.

This story re-affirms the fact that the current system of monitoring – mainly local authority trading standards offices in the UK – does not have the resources to properly protect consumers.

Update 2, 18th August 2014:

The Daily Mirror has now covered the story, including a quote from CHEM Trust:

The Chem Trust – which exists to help protect people and animals from dangerous chemicals – was worried by the research.

“It is clear that loom bands, or at least their charms, are breaching this regulation,” the Trust’s Dr Michael Warhurst said.

Update 3, 2nd September 2014:

The UK toy retailer “The Entertainer” last week removed loom band charms from its shelves, following the discovery of high levels of phthalates in them – here’s coverage of the story in the Independent.

Carmarthenshire Council’s Trading Standards get a pat on the back for organising testing of loom band charms in their area & emphasising the safety advice above – respected shops, CE mark & don’t allow children to put them in their mouths.

An article in Wales online on 17th August quoted CHEM Trust’s views on this issue:

The Chem Trust – which exists to help protect people and animals from dangerous chemicals – was worried by the research.

“It is clear that loom bands, or at least their charms, are breaching this regulation,” the Trust’s Dr Michael Warhurst said.

“Phthalates aren’t just causing concern in Europe – for example in the US a scientific panel recently expressed their concern about the impact some phthalates could be having on male reproductive organ development.”

Getting dangerous products off the shelves is down to council’s trading standards departments.

“Other than the companies who have commissioned these tests, other retailers and the general public have no information as to which brands are a problem,” Dr Warhurst said.

“There is no visible effort to withdraw the phthalate-laden toys from shops, nor to notify the public to stop using the affected products.”

Dr Warhurst feared there not enough trading standards officers to look into the problem.

“We have regulations that are supposed to protect us from hazardous chemicals, yet this case – and others – show that these are not being properly monitored and enforced.

“These products should be being withdrawn from the market, and both governments and retailers need to act now.”

Do Endocrine Disrupting Chemicals (EDCs) have a safe limit?

One of the big debates about endocrine disrupting chemicals is: Is there a threshold (a ‘safe level’) below which they don’t disrupt the endocrine (hormone) system?

The European Commission set up an expert advisory group on Endocrine Disrupters in 2011; CHEM Trust are part of this group. At their 5th meeting in February 2013 the experts discussed key scientific uncertainties when trying to determine thresholds for EDCs

The EU Commission’s Joint Research Centre (JRC) has finally published a report of this meeting, “Thresholds for Endocrine Disrupters and related Uncertainties”, which looks at the threshold issue in depth. Some key points from the report:

  • Most of the experts in the group agreed that thresholds of adversity for EDCs may be very low or absent during early development
  • Several experts also highlighted that it may be very difficult to determine thresholds with the current available standard tests.
  • Thresholds determined in laboratory experiments are not equivalent to the true biological threshold, as a study with more sensitive endpoints may lead to a lower threshold. This calls into question the reliability of current risk assessment approaches
  • Additional relevant uncertainties discussed ranged from low dose effects, non-monotonic dose response curves to mixture effects and critical windows of exposure.

Chemical Watch covered the report, including comments from CHEM Trust director Gwynne Lyons:

“The [JRC] report is a very considered piece,” says Gwynne Lyons, director of NGO ChemTrust and a member of the Endocrine Disruptors Expert Advisory Group (ED EAG). She highlights the fact that “several experts said that although thresholds may exist, it is going to be difficult to measure them with any confidence, given current test methods.”

Some NGOs are concerned that the lack of clarity in establishing whether or not thresholds exist may lead to lengthy delays in substituting EDCs. The review document quotes extensively another ED EAG report on identifying EDCs, which also covers thresholds (CW 25 March 2013).

Ms Lyons is now fearful that ECHA’s Risk Assessment Committee (Rac) “will ignore the carefully considered voice of the experts”.  “I think they will just have an eye on the difficulty of regulating, or requiring, industry to find safer alternatives and just go along with the normal risk assessment, using the outdated test methods that are not well targeted to pick up endocrine disruptors,” she says.

In CHEM Trust’s view, in the absence of evidence that thresholds exist, the EU and others should treat EDCs as non-threshold substances and work to ensure that they are substituted with safer alternatives.

Fracking – CHEM Trust’s position

Fracking remains in the news – in the United Kingdom and also around the world.

Much has been written about the carbon balance of fracking, for example the risks of fugitive emissions of methane, and the simple reality that taking more fossil fuels out of the ground will simply increase the carbon dioxide in the atmosphere.

However, the potential pollution caused by fracking shouldn’t be forgotten – and it’s worth pointing out that CHEM Trust already has a position paper on fracking, (from January 2013) which concludes:

CHEM Trust has severe concerns about fracking in the UK, particularly because of its potential for intractable pollution of water resources. CHEM Trust’s focus is on the pollution aspects of the technology, as its mission is to protect humans and wildlife from harmful chemicals. Therefore, the potential long term environmental contamination and possible health effects of fracking are the focus of this briefing.

We conclude that widespread fracking in the UK would pose a considerable threat, particularly to water resources.

One of our Directors, Gwynne Lyons, also wrote a blog on fracking on the Green Alliance web site in October 2013, and called for:

  1. A moratorium on fracking in the UK, until there has been full public disclosure of all the chemicals used and the companies involved have provided adequate data on their hazard profiles, and undertaken a full assessment of all the potential health and environmental effects. Unfortunately, since full disclosure isn’t required in the US, there is a lack of information about the full range of dangerous chemicals which may be used.
  2. No fracking near potable groundwater sources, in National Parks, or on or near environmentally sensitive areas or sites of special scientific interest (SSSIs).
  3. Extensive air, land and water monitoring in the vicinity prior to and during operation, including vigilance for emerging health effects in residents, livestock and wildlife.
  4. Detailed and ongoing inspection of operations by experts in geology and ground water protection to ensure proper disposal of all chemicals, including contaminated water, muds and other wastes.
  5. Companies undertaking fracking should have to deposit bonds sufficient to cover any future compensation claims. Measures to enforce the polluter pays principle are necessary to ensure that the proper checks and balances are in place.