The European Commission is currently consulting on its proposed criteria to identify endocrine (hormone) disrupting chemicals (EDCs). In mid-June the European Commission proposed draft criteria, which CHEM Trust has strongly criticised for not adequately dealing with the threat to health and the environment from EDCs.
The proposals have also been criticised by EU governments, scientists and by the construction company Skanska for not being protective enough. CHEM Trust has today submitted its response to the consultation, which is open for comments until July 28th.
The problem with the Commission’s proposal
As we pointed out in our blog on the day that Commission published its proposed criteria for pesticides and biocidal products, their proposal requires an extremely high burden of proof to identify a chemical as an EDC. This makes it very likely that human health and the environment will be harmed before regulatory action is taken, which is in opposition to the precautionary principle that the EU is bound to apply.
The requirement for “known adverse effects relevant to humans” makes this a much more demanding definition in comparison to how, for example, carcinogens (chemicals that cause cancer) are identified. In the case of carcinogens (and also mutagens and reprotoxic compounds) European laws trigger legal action when effects are “known and presumed” to cause adverse effects – not just when it is ‘known‘.
In CHEM Trust’s view the most effective – and scientifically realistic – way to identify EDCs is through a three category approach, as is already used for carcinogens, mutagens and reproductive toxins. This approach has been supported by endocrinologists in a recent opinion piece in The Lancet Endocrinology & Diabetes.
The Commission are also proposing to change the legal text of the law on pesticide approval, to change a derogation from being based on ‘negligible exposure’ to ‘negligible risk’, which we consider to be unjustified and reducing the level of protection; our submission to the consultation therefore criticises this change. A recent legal analysis for the NGO ClientEarth concludes:
“that the proposed criteria are illegal because they limit the identification of endocrine disruptors to those that are known to cause adverse effects, excluding those presumed to cause adverse effects. Also, it found that, by proposing a change in the approval mechanism for endocrine disrupting chemicals, the Commission has exceeded its delegated powers. The proposed criteria alter the balance between environmental and health protection, and functioning of the internal market, that was democratically established by the co-legislators.”
A growing chorus of dissatisfaction with the criteria
A growing number of other stakeholders have also criticised that Commission’s draft criteria, including:
- The Governments of France, Sweden and Denmark have sent a joint letter to the European Commission with similar criticisms to those above.
- The Endocrine Society, the global voice of endocrinologists, commented that “a narrow definition will prevent effective regulation of endocrine disruptors“.
- The construction group Skanska has called for the criteria to be strengthened.
Conclusions and next steps
Ninja Reineke, CHEM Trust Senior Policy Adviser, said
“The European Commission is supposed to ensure that there is a high level of protection for human health and the environment, yet these proposals basically force human harm before action is taken.
This approach is not acceptable, as hormone-related diseases and exposures to hormone disrupting chemicals have been a concern for many years, and it’s already been demonstrated that EDCs can be scientifically identified by other EU processes such as REACH.
This is Europe’s chance to put in place a protective, scientific, approach, but that will mean important modifications to the Commission’s proposal.”
The consultation continues until July 28th; you can access the consultation and also see what others have submitted through this link.
The proposals are also being reviewed by technical experts from all EU governments, who will have to approve the Commission’s proposals. These discussions will continue in the relevant biocides and pesticides expert committees in September 2016. 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.
Once the criteria are in law it will be important to improve and implement more effective test methods for EDCs, otherwise we will not know if the majority of chemicals are EDCs or not. This lack of test data – and therefore lack of knowledge – was found to be a major problem during the screening of available evidence during the Commission’s impact assessment of this proposal.