Principal Consultant Chris Turner recently attended the ‘7th International Fresenius Conference on Endocrine Disruptors’ in Bonn, Germany. Here are his insights from the conference.
Specific in title and topic, the conference brought together industry, NGOs, academia and regulators to discuss progress and developments on ‘endocrine disruptors’ – chemical substances which are thought to interfere with the hormonal systems of living organisms, including humans. The fact that this is the seventh of these conferences highlights the importance attached to this developing area.
First, a brief history of the issue. Concerns about potential endocrine disrupting chemicals first arose in the mid-1990s with publications focussing on the possible impacts on wildlife and human health. A conference in Weybridge in the UK in 1996 kick-started the regulatory response and in 1999, the European Commission published its ‘Community Strategy for Endocrine Disruptors’ which established principles for the current activities in Europe.
Assessing the scale of the problem is difficult, and while it’s true that potential endocrine disrupting chemicals are detected in the environment, linking these with specific endocrine related diseases is a particular challenge. One thing which industry, regulators, academics and NGOs all agree on is that any regulatory actions should be based on sound science. So the development of agreed scientific criteria for identifying potential endocrine disruptors is seen as a key step in achieving judicious regulation of this class of chemicals. Last week’s conference in Bonn provided a blend of the latest scientific understanding of the mechanisms at work, and the regulatory framework under which can be controlled.
It’s not surprising that the ‘hot topic’ at the conference was the June 2016 announcement by the European Commission of draft identification criteria. These were originally scheduled to have been published in 2013, so have been eagerly awaited by all stakeholders. In the absence of anything formal from the European Commission, individual Member States, NGOs and industry associations have proposed their own versions, so all have been interested to see what, if any, of their own proposals have been included. Since June, the draft criteria have been discussed between experts and the Member States at meetings held in June and September, and the outcome is a set of revised criteria which were published during this conference on November 15, 2016.
In summary, the key principles of the criteria are based on ideas established by the WHO in 2002, so that’s a good starting point. These are that a substance shall be considered an ‘endocrine disruptor’ if:
- It produces an adverse effect in an intact organism, or its progeny
- An endocrine mode of action can be demonstrated; in other words, the effect which the chemical has in the body is clearly defined AND it can be shown they affect the natural hormone system in the body
- The adverse effect is a consequence of the endocrine mode of action
Evidence of these ‘adverse effects’ should be based on:
- All available relevant scientific data; i.e. scientific data generated in accordance with internationally agreed study protocols, as well as other relevant scientific data which applies a systematic review methodology, for example assessing study design and reliability of data
- A weight of evidence assessment to take into account positive and negative results and quality and consistency of data
So, what comes next? It’s clear the European Commission now wishes to move quickly to adopt these criteria and to get them published in the relevant legislation. The draft legal acts are now following the relevant processes and will be subject to scrutiny by the European Parliament and Council.
Alongside getting the criteria adopted, another important step is that the head of DG Health and Food Safety has engaged the European Food Safety Authority (EFSA) and the European Chemical Agency (ECHA) to bring forward proposals for a ‘guidance document’ which will help stakeholders to implement the criteria, particularly across different sectors of chemical legislation (so called ‘horizontality’). The timetable for the guidance document is to have an outline ready by December 2016 and a first draft available between April and June 2017. This guidance document will be key to industry and other stakeholders understanding the criteria and how they will be implemented.
We’ll be continuing to follow updates in relation to endocrine disruptors and will provide updates in coming months.
To talk to us about how we can help in this developing area of chemical regulation, please contact Chris.Turner@anthesisgroup.com or use our fill out form below.