In recent blogs on the subject of endocrine disruptors, we have talked about proposals for how these substances can be identified and then options for potential regulation once they’ve been categorised.
In this blog, we describe some updates on the identification criteria and also a new guidance document, which should help all actors involved – regulators, industry and NGOs.
The criteria were discussed at two EU Commission meetings, in November and December. From the minutes of these meetings, it’s clear that there is still a wide divergence of opinions and there was no agreement on the revised texts. There are two major factors which meant that it was not possible to secure an agreement.
The first focuses on the fact that some pesticide products mimic insect growth hormones. Some Member States think the way the criteria are currently worded will discriminate against these products. So instead of the rather general term ‘non-target organisms’, they have proposed new text which refers to ‘non-target vertebrates’ which is much more specific and means that pesticides which act as growth regulators could still be approved. This has been opposed by NGOs and several member states, arguing that all products should be assessed by the same criteria.
The second area of contention is around the wording of ‘exposure’ versus ‘risk’. A quick word of explanation – in a classic risk assessment, the inherent hazard of something is assessed first, then the chances of being exposed to that hazard are also investigated. The risk is a function of the hazard and exposure. So for example, a busy road full of traffic is a hazard but it only becomes a risk if you cross it – that is, you are exposed to it. The original text of the criteria talked about ‘negligible exposure’ but this has been changed to ‘negligible risk’. Some Member States think talking about exposure is more specific, whilst others prefer to discuss risk, as they think it’s a more realistic representation of the real world.
So there is currently no clear agreement between the 27 Member States. The Commission is considering its options and will report in due course.
On a more positive note, the Commission has announced that a guidance document is being drafted, which will help all interested parties – industry, regulators, NGOs, academia – interpret the legislation. The document will put out for public consultation around in the summer, with the finalized version scheduled to be available in the early part of 2018. We will keep an eye on progress and provide further updates on both the criteria and guidance document as further news becomes available.
