The European Food Safety Authority (EFSA) has endorsed the World Health Organization's (WHO) definition of endocrine disruptors, paving the way for the European Commission to regulate those chemicals in food. The pesticide industry reacted angrily, saying the scientific process has been "rushed to meet political deadlines".
In its opinion, published on Wednesday (20 March), the EFSA's Scientific Committee underlined that not all endocrine active substances have a adverse effect on the hormone system and that a distinction needs to be made between those that do and those that don't.
The committee defined endocrine-active substances as essentially harmless. These are defined as "any chemical that can interact directly or indirectly with the endocrine system, and subsequently result in an effect on the endocrine system, target organs and tissues."
By contrast, endocrine disruptors are defined as "an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations."
EFSA's opinion came after the European Commission requested the Parma-based agency in 2012 to define scientific criteria for endocrine disruptors in view of possibly regulating them in the future.
"The authority has reviewed the currently available testing methods to assist risk managers in defining what may or may not be an endocrine disruptor using science-based criteria. Our opinion also underlines the need for further testing strategies to be developed to test these substances in a systematic and transparent way,” said EFSA’s director of Science Strategy and Coordination, Hubert Deluyker.
Opinion faces criticism
The pesticides industry reacted angrily, saying the EFSA science review process had been "rushed to meet political deadlines" and "ignored established scientific principles".
"ECPA appreciates EFSA’s scientific input but sees its contribution as unfortunately late when the ED criteria are all but finalised," said Friedhelm Schmider, director-general of the European Crop Protection Association (ECPA).
"Endocrine disruption is a complex scientific issue and the Commission’s own scientific committees could have made an invaluable contribution in providing clear expert advice to European regulators and politicians."
According to ECPA, the science review was based on perceived risks rather than actual ones.
"Robust and independent scientific advice is important to ensure European regulation addresses substantiated concerns rather than fear. A broader return to risk assessment over hazard assessment would meaningfully contribute towards this goal," ECPA said in a statement.
The result, ECPA said, is that Europe risked depriving EU farmers from "essential and innovative plant protection products which they safely use today".
Environmentalists too criticised EFSA but for different reasons.
The Pesticide Action Network Europe (PAN Europe) said EFSA had ignored the so-called "cocktail effects", underlining that the combination of many otherwise harmless chemicals in the human body can affect the endocrine system.
PAN Europe contends that EFSA did not calculate the numerous mixtures of pesticides in the food sold in European shops and wrongly assumed that people were exposed to only one single pesticide in their life.
In reality, European consumers will eat dozens of different pesticides on a daily basis, PAN Europe stated.
"Calculating the risk just based on one pesticide makes no sense and is unscientific. The EFSA claim should therefore be abandoned since it creates a false feeling of safety," PAN Europe said in a statement.
Asked by EurActiv how much EFSA was looking into the issue of chemical cocktail effects, Tony Hardy, chair of the agency's Scientific Committee, said at a press briefing that the question of mixtures was very important.
"It is a topic which EFSA at the moment is doing quite a lot with. We are looking at the ways of assessing mixtures of chemicals and in relation to the pesticide area which is the most pressing because the legislation requires cumulative assessment of pesticides in similar groups. There is work underway which I guess will be published later this year," Hardy stressed.
EFSA's experts also concluded that available or soon to be available internationally agreed testing methods can identify interference of chemical substances in mammals and fish, which are known to be sensitive to endocrine disruption.
This, it said, can happen via four major endocrine pathways - oestrogen, androgen, thyroid and stereoidogenesis.
In its recommendation to policymakers, the scientific committee concluded that a "risk assessment approach which considers both potential adverse effects of endocrine active substances together with the likelihood of exposure makes the best use of available information to regulate their use."
Deluyker said that EFSA was aware that national, European and international organisations have done science reviews looking at the possible health effects of endocrine active substances.
"EFSA's opinion complements this work," Deluyker stated.
Hardy said that reviewing current test methods was an important part of EFSA's work and contributes to EU and international discussions in the area.
"However, no single test is sufficient to decide whether a substance is an endocrine disruptor and several tests need to be done and then assessed together by experts in a weight-of-evidence approach," Hardy added.
PAN Europe said in a statement that EFSA's opinion on endocrine disruption is a big disappointment.
"The introduction of a new category of Endocrine Active Substances (EAS) by EFSA makes no sense. Legal text defines endocrine disrupting properties, while DG Environment is discussing endocrine disruptors. This will only add confusion and is a counterproductive move from EFSA. EFSA should in fact define the legal text, within their remit of food, and develop criteria for chemicals with endocrine disrupting properties, but they didn’t," PAN Europe stated.
The Health and Environment Alliance (HEAL) and the Chemicals Health and Environment Monitoring Trust (CHEM Trust) said that EFSA's opinion report on endocrine disrupting chemicals is problematic in a number of areas:
"Firstly, the EFSA opinion tries to re-introduce risk assessment via the backdoor," Gwynne Lyons of CHEM Trust said in a statement.
"The opinion says that risk assessment makes the best use of information for the purposes of risk management. This contradicts both the spirit and letter of the EU Pesticides law, which bans endocrine disruptors for their inherently harmful nature."
"Risk assessment is not the way forward for endocrine disrupting chemicals as it is unlikely that they have thresholds for effects, because they are acting on top of our own hormones, on a biochemical system that is already active. Moreover, it is well known that some endocrine disrupting chemicals can cause opposite effects at low doses as compared to high doses, such that it is impossible to be certain that so-called no observed effect levels derived by a risk assessment are really correct, without an enormous amount of animal testing – covering a very wide spectrum of doses and endpoints, which is clearly unacceptable," Lyons explained.
"The EU must stick to the letter of the law, and not be deflected by those who want to pander to industry. We urge people to support our joint call for an endocrine disrupting chemicals free future," said Lisette van Vliet, senior policy adviser for HEAL.
The Cancer Prevention and Education Society (CPES), a UK-based public health organisation, reacted belatedly to the EFSA opinion, saying it was “a technical but important process because we need to have agreement on what is an edocrine disrupting chemical and what is not in order to have a clear target for regulation.”
In an online statement, CPES said it had “some serious concerns” about EFSA’s definition of endocrine disrupting chemicals “and consequently about the level of health protection which can be offered” by EU regulators.
“CPES’s worry is that not many chemicals, if any, can definitively be pointed at and described as endocrine disrupting chemicals under EFSA’s definition. If no chemicals qualify as endocrine disrupting chemicals under EFSA’s definition, then none can be regulated, resulting in… no regulation of endocrine disrupting chemicals as a potential health threat, even though we know that endocrine disrupting chemicals are a health threat!”
This, it stressed, is “a totally unacceptable paradox” since the objective is to regulate those chemicals.
Furthermore, CPES said it was concerned that EFSA’s opinion did not follow the precautionary principle. “EFSA’s definition encourages us to wait for proof that a compound is an endocrine disrupting chemicals before taking action to limit exposure to it. We made this mistake with asbestos, tobacco, leaded petrol and many, many other substances, paying for certainty with illness and premature death.”
- Spring 2013: EFSA expects to publish a full risk assessment of the chemical bisphenol A.