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Why has the European Commission’s review of REACH rules for controlling hormone disrupting chemicals been watered down?

It is clear that some very powerful forces within the European Commission are working to undermine effective regulation of hormone (endocrine) disrupting chemicals (EDCs).  On 20th December 2016, buried in the pre-Christmas wind-down, the Commission released its review of how EDCs should be treated by the authorisation process in the EU’s main REACH chemicals legislation.

The Commission missed its legal deadline for this review by over 3 years, and has significantly weakened the review text compared to an earlier draft that was discussed by EU government experts in July 2014. This is in spite of being reported as claiming, at that time, that it “does not intend to make further amendments to the document”, with this report also saying that the document was generally supported at that meeting.

The Commission’s review accepts that “it may be difficult to determine a safe threshold with reasonable certainty for EDs“, but then considers that it should be up to the applicants to demonstrate that a threshold exists and to determine the threshold. They are therefore not proposing any strengthening of the REACH text to give a clear signal that EDCs should be replaced whenever there are safer alternatives.

CHEM Trust’s view, as explained in our  position paper from 2013, is that due to uncertainties in risk assessment, EDCs should be viewed as non-threshold chemicals, as it is not possible to identify a safe level of exposure to them. This would have meant that any chemicals that selected for regulation through REACH’s Authorisation procedure would only have continued use permitted if there were no safer alternatives available, and if the benefits of use outweighed the risks.

The 2014 draft of this review included several important elements that backed the non-threshold approach, but these have now been deleted:

  • A reference to the 2012 report for the European Commission on “State of the art assessment of Endocrine Disrupters” which noted that experimental approaches cannot prove or disprove the existence of thresholds.
  • consensus statement that was agreed in a meeting with the European Commission’s then Chief Scientific Officer, Anne Glover in October 2013, which included phrases such as “It is possible that thresholds do not exist” and “non-monotonic effects do exist for some EDCs”.
  • A whole list of other issues which are of particular concern for EDCs, including: (i) mixture effects, (ii) lack of appropriate animal models and sensitive strains for some known effects in humans, and (iii) a lack of sensitive endpoints and life stages in current ecotoxicological test methods.

Coming after the debacle of the European Commission proposing too high a burden of proof for the criteria to identify EDCs, this watering down of the supporting text is another example of the way the Commission now seems to be trying to chip away at adequate regulation of EDCs.

Dr Ninja Reineke of CHEM Trust is quoted on this issue in an article in Chemical Watch:

[the review] “now misses important sections on the scientific [evidence pointing to] uncertainties around thresholds for EDCs.” As a result, she said, this has “considerably weakened” the text.

Overall, the review is a missed opportunity, Ms Reineke said. “Ideally you always need to look at the availability of safer alternatives – when there are safer alternatives, companies should not be granted an authorisation for continued use. The report has the fingerprints of those that want business as usual, both in the Commission and within industry.”