The long saga of Europe’s process to agree criteria to identify endocrine (hormone) disrupting chemicals (EDCS) has reached a new stage, with the European Commission publishing revised draft criteria, following extensive criticism of their previous draft. These draft criteria will be discussed today (Friday 18th November) by experts from EU countries. Unfortunately this new draft retains main of the problems in the previous one, and in CHEM Trust’s view it will not properly protect public health.
Last week CHEM Trust criticised this draft in a joint reaction with the EDCFree coalition, and we and the rest of the coalition have also shared our concerns in a letter to Ministries for Environment, Health and Agriculture.
Once the Member States have approved the proposals they will be voted on by the European Parliament, who are able to veto the Commission’s proposal. When agreed, the criteria will immediately apply in the regulation of pesticides and biocides, though both laws have derogations allowing continued use of particularly important chemicals.
What’s the problem?
There are two main problems with the revised criteria:
- They require an unreasonable quantity of scientific research and evidence before taking action
- They continue to include a loop hole which would allow continued use of those chemicals that are identified as EDCs, by modifying the current law regulating pesticides.
Here is more detail on these two issues:
High burden of proof
These revised criteria require the adverse effect to be a consequence of the endocrine mode of action and this is likely to lead to numerous inconclusive decisions. Even in previous cases where adverse effects of chemicals have been shown, and there are data showing altered hormone levels or indicating disruption of the endocrine system, getting proof that the adverse effects are a consequence of an endocrine disrupting mode of action may be almost impossible. For example, researchers on chemicals such as PCBs and TBT have found that that getting proof of modes of action may be elusive or take decades.
If this requirement is enshrined in legislation it will lead to paralysis and also open the door for legal challenges from industry whenever a chemical is identified as an EDC.
CHEM Trust instead proposes the wording ‘there are data indicating it has an endocrine mode of action’ (for para 126.96.36.199.2.(2) and ‘considered a likely consequence of an ED mode of action’ (for para 188.8.131.52.2 (3)).
Furthermore, requiring that a chemical “shows an adverse effect in an intact organism or its progeny” will lock the EU into animal testing, even when there are reliable non animal methods. CHEM Trust suggests it would be better to instead use the wording ‘it is known or presumed to cause an adverse effect in an intact organism or its progeny.’ As we’ve said before, it would be much better to have categories in order to reflect the different levels of scientific evidence available. It’s important to note that both EU Biocides and Pesticides Laws require the identification of EDCs that ‘may’ cause adverse effects (i.e. suspected/potential EDCs).
A change in the ability to use a pesticide if it is claimed that there is ‘negligible risk’ instead of ‘negligible exposure‘
The proposal changes the derogation the Plant Protection Products (PPP) Regulation from ‘negligible exposure’ to ‘negligible risk’. This alters in a fundamental and non-democratic way the risk management choice agreed by Council, Parliament and Commission in the co-decision procedure. It introduces new risk elements to the legislation and with this change, the Commission widens an existing limited exemption into a major loophole. This can easily be exploited to enable continued use of identified EDCs. Moreover, whether these changes are legally acceptable is an open question. The EU Parliament’s legal advice is that that the Commission has exceeded its powers with this amendment.
Implications for other laws
The EDC criteria are immediately applied in EU laws on pesticides and biocides, but will have implications for EDC regulation in other laws, including cosmetics and medical devices. The main industrial chemicals law REACH does not mention the criteria, but it is very likely that the identification discussions in pesticides and biocides will affect the discussion for listing of EDCs as substances of very high concern (SVHC) under REACH. Moreover, exposure reductions are needed in critical uses such as food packaging, as a recent EU Parliament report has highlighted.
A disturbing lack of safety data
Once the criteria are in law it will be important to improve and implement more effective test methods for EDCs in the test requirements of EU laws, otherwise we will not know if the majority of chemicals are EDCs or not. This lack of test data – and therefore lack of knowledge highlighted in two recent reports by the Dutch National Institute for Public Health and the Environment, RIVM, on human health and on environment.
Criticism of the new draft
The Endocrine Society, the world’s largest organisation of endocrinologists, have reacted with disappointment to the revised proposal, stating: ‘The latest proposal asks for an unrealistically high level of scientific evidence for endocrine disrupters, limiting the ability to identify and regulate EDCs.’
The proposal has also received criticisms from researchers working on EDCs and systematic review methodologies.
Ninja Reineke, Senior Policy Advisor at CHEM Trust, said:
“The EU needs to ensure that it puts in place criteria that will properly protect human health and the environment.
These are chemicals that people and wildlife are being exposed to at the moment, and we must act when there is reasonable evidence of harm.”
Update, 23rd November 2016
The scientist Leonardo Trasande has published a comment piece in Nature, “Stand firm on hormone disruptors” in which he argues that:
“as with the debate on climate change, a small group of scientists — many with well-documented links to industry — have endeavoured to manufacture a level of doubt that is out of proportion to the level of scientific disagreement.
The scientists who deny endocrine disruption and dismiss the expert reviews on EDCs make many scientific inaccuracies and misrepresentations. Critics dismiss low-dose, nonlinear and non-monotonic exposure–response relationships for EDCs, even though they are well documented. They select studies with contaminated controls and other methodological problems to claim limited effects. They have argued that many studies of EDCs are based on correlation, not causation.
Endocrine-mediated adverse outcomes are complex. Too often lost in the debate, however, is that findings about the impacts of EDCs carefully control for confounding factors. Results in humans are consistent with those from the laboratory, strengthening the evidence for causation.”
- CHEM Trust has been quoted on these revised draft guidelines by Chemical Watch.