European Commission draft rules to identify and ultimately ban endocrine disruptors are illegal because they clash with existing pesticide and biocide regulations, Alice Bernard writes. The environmental lawyer warned that EU judges could throw out the changes to the long-awaited scientific criteria for the chemicals.
Alice Bernard is a lawyer for the environmental NGO ClientEarth.
On June 15 2016, the European Commission finally proposed scientific criteria to identify endocrine disruptors (EDCs) in pesticides and biocides. Once identified, they will be banned to protect people and the environment.
This is long overdue. The Commission was supposed to make this proposal more than two years ago, and last year was condemned by the European Court of Justice for failure to act.
Unfortunately, the long delay has not resulted in a workable solution. In fact, the Commission’s draft definition of EDCs is illegal. If it is forced through, judges at the European Court of Justice could annul the criteria and the illegal changes to the regulations on pesticides and biocides.
ClientEarth has warned the Commission about these fundamental legal issues.
In 2009, the European Parliament and the Council adopted a regulation on pesticides to “ensure that industry demonstrates that substances […] produced or placed on the market do not have any harmful effect on human or animal health or any unacceptable effects on the environment“.
In 2012, a similar regulation was adopted covering biocides, used to kill bacteria. Both ban substances like carcinogens, mutagens and endocrine disruptors, unless strictly defined conditions are met.
As there was no scientific consensus as to what EDC meant at the time, the Parliament and Council gave the European Commission the mission to define these criteria, taking into account the available scientific knowledge. The Commission had to limit its proposal to modifying non-essential elements of the regulation and to respect the aim set out in the pesticides and biocides regulations – to protect human health and the environment.
However, the Commission did the exact opposite.
First, the Commission proposes to limit the identification of EDCs to those “known to cause adverse effects”. This wording is crucial. Current regulations ban carcinogens not only “known” to cause adverse effects, but also those “presumed” to cause such effects.
The fundamental difference of meaning between the terms “known” and “presumed” is obvious. It affects the level of evidence required. In practice, of all carcinogens identified so far under the EU legal framework, about 75% are “presumed” to cause adverse effects, and all mutagenic substances identified are “presumed” to cause adverse effects.
Waiting until a chemical is “known” to harm human health before it can be banned is the exact opposite of a precautionary approach. Precaution is the cornerstone of EU chemical laws. The Commission cannot ignore it.
Considering the harm caused by endocrine disruptors, it is not justified to treat them with less scrutiny than carcinogenic, mutagenic and reprotoxic (CMR) chemicals. The fact that the regulations currently provide for the same legal regime for endocrine disruptors as they do for CMRs strongly suggests that the Council and Parliament view these substances as raising an equivalent level of concern.
In any event, the Commission does not have the power to limit the definition of endocrine disruptors to those known to cause harm. The Pesticides and Biocides Regulations clearly state that a substance cannot be approved if it is considered to have endocrine disrupting properties “that may cause adverse effect“. The word “may” expresses a possibility, not a certainty. With its proposal, the Commission is therefore rewriting an essential element of the regulations. This exceeds the power given to it by the EU Council and the Parliament.
Second, the Commission also proposes to change the legal test determining when a pesticide, despite being a known endocrine disruptor, can be authorised. While the current regulation only grants such authorisation when “exposure is negligible”, under the proposed amendment, EDCs would be allowed as soon as the “risk” is negligible.
The difference between exposure and risk goes well beyond semantics. It affects the way in which the risk of these chemicals is managed. Negligible exposure derogations allow only uses that are well controlled, such as in a closed system. “Negligible risk” allows humans and the environment to be exposed to EDCs without clear limits.
The Council and the Parliament together chose the negligible exposure test for a reason. They considered that, for pesticides, this was necessary to ensure a high level of protection for health and the environment. As a matter of principle, the Commission is not entitled to use the delegated act procedure to make such a fundamental change which violates the objectives of the regulation, as well as the precautionary principle.
Not only is Commission’s proposal for identifying EDCs unsatisfactory. In making it, the Commission violated its legal mandate by modifying democratically agreed rules, disregarding their objectives and the underlying risk management approach chosen by EU Council and Parliament.
A new proposal for endocrine disruptors must be drawn up. It must respect EU law and provide proper protection for our health and the environment.
Read ClientEarth’s legal analysis of the Commission’s EDC proposal, written with experts from University Applied Sciences in Darmstadt. And here’s our response to the public consultation on biocides and pesticides.