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After a long wait, now is the time for the EU to decide on criteria to identify endocrine disrupting chemicals (updated 4th May)

The European Commission has committed to finally proposing scientific criteria to identify hormone (or endocrine) disrupting chemicals (EDCs) by summer 2016. They’ve already been found guilty of breaking EU law by the European Court of Justice for failing to do this by a legal deadline of December 2013.

In CHEM Trust’s view the criteria should be similar to those already used for other particularly problematic chemicals such as carcinogens. Therefore, they should be science-based, and focussed on achieving a high level of protection for human health and the environment, as required by the respective EU laws. We welcome the fact that a consensus statement of scientists hosted by the German Risk Assessment Insitute BfR has today (4th May) backed our view that potency is not relevant for the identification of EDCs.

Many claims have been made by parts of industry about the economic impacts of such criteria, yet careful analysis of the relevant laws shows that, if needed, there are routes available for continued use of particularly important chemicals, if safer alternatives aren’t available.

How did we get here?

The legal requirement on the European Commission to define criteria to identify EDCs is specified in EU pesticide and biocides legislation, with both setting deadlines of December 2013. Draft criteria were put forward in June 2013, but then a major industry-led lobbying campaign led to a halt in the process.

EU Health Commissioner Andriukaitis has now committed to delivering these criteria ‘by the summer’ – which should mean before the end of July. The Commission must therefore decide on which criteria to propose within the next 3 months. As CHEM Trust and HEAL stated in our recent comment piece, we think the answer is clear.

Scientific advice to the Commission

As mentioned above, the European Commission has already got draft criteria in its 2013 document. These highlight that an endocrine disruptor should be defined as having the ability to cause an adverse effect via an endocrine mode of action; in line with the WHO definition of an endocrine disruptor (see the summary of “State of the Science of Endocrine Disrupting Chemicals 2012“, page 4).

The Commission has already obtained scientific advice on science based criteria for identification of EDCs. The Commission set up an Endocrine Disrupters Expert Advisory Group (ED EAG), chaired by the Commission’s Joint Research Centre (JRC), with the aim of supporting the Commission’s decisions on the establishment of EDC criteria.

This group’s work was published in 2013 and their conclusions stated that:

 “ The ED EAG agreed that the elements for identification of an endocrine disrupter were demonstration of an adverse effect for which there was convincing evidence of a biologically plausible causal link to an endocrine disrupting mode of action and for which disruption of the endocrine system was not a secondary consequence of other non endocrine-mediated systemic toxicity.”

The Commission also consulted experts at the European Food Safety Agency (EFSA) about the identification of EDCs. The EFSA report stated in the summary that:

 “To distinguish between EDs and other groups of substances with different modes of action, it was concluded that an ED is defined by three criteria: the presence of i) an adverse effect in an intact organism or a (sub)population; ii) an endocrine activity; and iii) a plausible causal relationship between the two ..”

Therefore, as can be seen above, both of these groups made similar recommendations with respect to what scientifically based criteria for identification should be, specifically that there needs to be an adverse effect linked to an endocrine mode of action (as in the WHO definition and the 2013 criteria).

How should criteria be defined?

In CHEM Trust’s view, in line with this official EU expert advice, identification of an EDC should be based on three factors: an endocrine mode of action; an adverse effect, and a plausible link between them. This comprehensive assessment in itself requires a high level of evidence and will include considerations such as quality, specificity, study reliability. It is likely to identify relatively few substances.

In addition, in CHEM Trust’s view it would be most effective to have a 3 category approach (similar to that used for carcinogens, mutagens and reproductive toxins), where a category 3 EDC could be identified based on in vitro test methods alone, creating an impetus for further testing to find out whether a chemical is a problem.

Potency – not suitable for prioritisation

Potency in toxicology is a measure of how much of a chemical is required to create a particular adverse effect. However, knowing potency in one organism – or for one ‘endpoint’ within the body – doesn’t mean you know potency in other organisms or other systems in the body.

Potency therefore depends on the test method and which endpoint is being looked at. With chemicals like EDCs which tend to have the ability to disrupt several pathways, it is difficult to predict potency across all endpoints from a limited number of tests. The test methods may not be sensitive enough, or not focussed on the tissue where adverse effects occur at the lowest levels. As we explained in our EDC FAQ it is therefore very hard to identity the ‘true’ potency of an EDC.

Regulating a chemical based on its potency also makes no sense as it does not consider exposure.  Therefore, it could result in a substance which was considered to be highly potent being regulated, even if there was no exposure, whereas a chemical with relatively low potency, but to which there was ubiquitous high exposure, could escape the regulatory net.

These major scientific limitations of potency are why CHEM Trust is particularly concerned about the way some parties have been arguing for a potency ‘cut-off’ to be used to limit the number of chemicals identified as EDCs. This would lead to many chemicals with ED properties, including those to which we are frequently exposed, not being addressed. Avoiding an artificial ‘cut off’ is even more important considering the likely cumulative health and environmental effects from exposure to many EDCs from multiple sources.

For further details see our analysis of a proposal made in June 2015 by the German BfR Risk Assessment Insitute, which we believe is flawed.

What about economic impacts?

Parts of industry have claimed that there would be substantial economic impacts from the identification of economically important substances as EDCs.

However, a careful reading of the relevant legislation demonstrates that measures have already been put in place to avoid these impacts.

  • As explained in our recent blog, for Plant Protection Products (Pesticides) there is an option to continue use of chemicals if exposure is negligible, or if they are needed to control a serious danger to plant health
  • For Biocides, Article 5(2) of the Biocidal Products Regulation specifies that use can continue if the risks are negligible, if the substance is essential to prevent or control serious dangers to human health, animal health or the environment, or if not approving the substance would have disproportionate negative impacts on society when compared with the risks.
  • Within REACH there is consideration of the availability of safer alternatives, see our blog on DEHP in PVC for an example of this debate.

Time for action

Gwynne Lyons, Policy Director of CHEM Trust said:

“It’s time to cut through the web of confusion and misinformation on these criteria for identifying EDCs. The Commission has already received plenty of scientific advice, which clearly calls for an approach based on adverse effect and endocrine mode of action.

Attempts are being made to confuse the discussion by, in effect, suggesting there is a need for a sieve with large holes to allow some EDCs to escape adequate regulation. But let’s call an EDC an EDC! Anything else will not meet the intention of the legislators to identify all chemicals with endocrine disrupting properties that may cause adverse effects.

It’s also very important to note that all the relevant legislation already considers potential economic impacts of controls on chemical use, through the provision of certain clauses or ‘derogations’ which allow continued use in certain circumstances”

Update, 26th April 2016

  • A commentary by seven independent scientific researchers, published in the journal Environmental Health Perspectives, has provided additional support to the above approach to setting criteria to identify EDCs. They clearly state that potency should not be part of the criteria to identify EDC chemicals:

“We argue that potency is dependent on the adverse effect considered, is scientifically ambiguous and note that potency is not used as a criterion to define other particularly hazardous substances such as carcinogens and reproductive toxicants…

The potency concept is not relevant to the identification of particularly serious hazards such as EDs

Update, 4th May 2016 – Scientific Consensus Statement published

On 11-12th April 2016 the German Federal Institute for Risk Assessment (BfR) held a meeting of scientists in an attempt to get a consensus among these scientist regarding how to identify an EDC chemical. The conclusions of this meeting, published on 4th May 2016, include the following key statements:

“The identification of a compound as an endocrine disruptor is a hazard identification procedure…

potency is not relevant for identification of a compound as an endocrine disruptor”

Gwynne Lyons, Policy Director of CHEM Trust, said:

“Once again scientists have agreed that potency should not be a decisive factor in the identification of EDCs. This consensus statement from scientists on both sides of the fence paves the way for the Commission to finally adopt the criteria for EDC identification without any potency cut off. “

Hopefully DG Sante will heed this  clear message that  ‘potency is not relevant for identification of a compound as an endocrine disruptor’ and finally ensure an EDC can be called an EDC.   Anything less would fail the public.”

Unfortunately, there is a misconception that regulating EDC pesticides will adversely affect the EU’s ability to grow crops.  But this is nonsense as derogations for use are allowed if certain pesticides are still needed.”