Experts from the 28 EU member states approved on Tuesday (4 July) a proposed list of criteria to identify endocrine disruptors in plant protection products – a move presented by the European Commission as a step towards a broader regulatory system for similar chemicals used in cosmetics, toys and food packaging.
The scientific criteria determining hormone-disrupting chemicals used in pesticides and biocides was adopted by EU member state representatives sitting in the European Commission’s Standing Committee on Plants, Animals, Food and Feed.
Vytenis Andriukaitis, the EU Commissioner for Health and Food Safety, described the agreement as “a great success” and called on the European Parliament and the Council, involved in the decision-making process, to ensure its smooth adoption.
The list “will provide a stepping stone for further actions to protect health and the environment by enabling the Commission to start working on a new strategy to minimise exposure of EU citizens to endocrine disruptors, beyond pesticides and biocides”, the Commission said in a statement.
The new strategy will aim to cover for example toys, cosmetics and food packaging, the EU executive added.
The decision is meant to bring to an end a protracted controversy surrounding the definition of endocrine disruptors, which has divided EU member states for years.
The European Commission published its proposed set of scientific criteria to identify chemicals with endocrine disrupting properties in June 2016 – three years later than legally required – prompting Sweden to sue the EU executive.
Hazard vs. potency
Behind the scenes, France – backed by Sweden and Denmark – led a campaign for regulators to adopt a definition “based on the intrinsic properties of hazard, without taking into account the ‘potency’” of the substance – or the amount required for a drug to generate an effect on the human organism.
Based on this definition, Paris suggested establishing three broad sets of criteria based on the level of certainty of the scientific community over their impact on the hormone system – “verified”, “presumed” and “suspected”.
But these three categories were resisted by Germany and its powerful chemicals lobby, which insisted on the need to consider hazard and exposure jointly – as well as potency – in order to evaluate the actual risk for humans.
“Without potency built-in, substances present in everyday food and drinks which are safe for consumption such as caffeine or soybean proteins could be identified as an endocrine disruptor,” warned CEFIC, the EU chemical industry association.
The pesticides industry also underlined the need to consider “potency” as an essential criteria, saying the notion is a fundamental principle of toxicology.
‘Turnaround’ by France
Paris finally bowed to pressure from Berlin and the adopted text doesn’t include the three sets of criteria, making it harder for substances to be classified in broad categories of toxicity.
The French socialist party, which lobbied for strict criteria while in power, condemned the “turnaround” of the government on the issue, and pointed the finger at Nicolas Hulot, a former environmental activist turned ecology minister.
“The text validated today by France is simply unacceptable because it provides for a very high burden of proof” to define harmful substances, said the French socialist delegation in the European Parliament.
The Greens group in Parliament agreed, saying “the European Commission’s criteria will make it very difficult to identify endocrine disruptors, meaning that few if any products would be removed from the market.” It vowed to build a majority in the European Parliament to “veto” the proposed criteria.
“Like the European Commission, most member states have put the interests of a handful of big agrochemical companies ahead of the safety of the public, with negative effects that go well beyond pesticides,” the Greens said in a statement.
Those calls were echoed by the consumer organisation BEUC, which urged the European Parliament and member states to “send this proposal back to the drawing board”.
Others, on the other hand, called on the Parliament to accept the criteria as a basis for future regulation.
“Some, of course, will prefer to see the glass half empty,” said Françoise Grossetête, a French MEP from the centre-right European People’s Party (EPP). “But after so many hurdles and delays, it would be unthinkable for Parliament to obstruct the implementation of these criteria. On the contrary, I believe that, on this basis, we must work on a rapid application of this definition, so as to preserve the health of our fellow citizens. “
The European Crop Protection Association (ECPA), representing pesticides manufacturers, called on EU legislators to reject the proposed criteria, saying they "do not allow authorities to clearly separate those substances that have the real potential to cause harm from those that do not".
"By the Commission’s own admission the criteria provide no additional protection for health and the environment and only serve to have a disproportionate and discriminatory impact on European farmers who will suffer from yet another arbitrary reduction in the number of tools available to them. In the absence of the derogation, we hope that the Council and EP will reject this proposal," ECPA said in a statement.
EDC-Free Europe, a coalition of more than 70 environmental NGOs, said it "regrets the last-minute change of position of France," on endocrine disruptors and also called on Parliament to reject the proposed definition. "The criteria require a very high burden of proof, which makes the identification of substances as EDCs very difficult and is likely to result in long delays," the coalition said in a statement.
It drew attention to a joint statement by the Endocrine Society, the European Society of Endocrinology and the European Society for Paediatric Endocrinology, representing the world’s leaders in endocrinology and endocrine science, which expressed serious concern with the European Commission’s proposed criteria.
According to the three scientific societies, "the criteria contain arbitrary exemptions for chemicals specifically designed to disrupt target insect endocrine systems that have similarities to systems in wildlife and humans. Consequently, the criteria cannot be called science‐based," the three societies wrote in a June position paper.
"While the Commission’s current proposal is largely based on the World Health Organization’s definition of an ED, the criteria will not be effective in protecting public health because they do not integrate a process to address those chemicals where additional scientific evidence may be needed," the three societies wrote at the time. As a consequence, "many EDs will not be identified as such via the criteria as currently written," they claimed.
“We regret that a majority of Member State experts have agreed to the Commission’s flawed proposal,” said Monique Goyens, Director General of the European Consumer Organisation (BEUC), adding that the proposed criteria “contradicts the precautionary principle, namely that protective action should prevail in the face of scientific uncertainty.”
According to BEUC, an EU definition of endocrine disruptors needs to capture “all chemicals that may disrupt the hormonal system” meaning both substances that are “known” endocrine disruptors and “suspected” ones. BEUC urged the Parliament and Council to adopt criteria that:
- require a reasonable burden of proof and respect the precautionary principle;
- introduce multiple classification categories according to the available level of evidence, i.e. known, presumed and suspected endocrine disruptors. This is already the case for chemicals that cause cancer, change DNA or are toxic to reproduction;
- are applicable to all relevant laws protecting EU citizens and the environment ranging from pesticides to cosmetics and toys.
"This can barely be called a success,” said PAN Europe, a network of over 600 non-governmental organisations working to minimise the negative effects of hazardous pesticides. “The current EDC criteria proposal has repeatedly received criticism from experts in the field of endocrinology because it will fail to efficiently protect human and environmental health,” the NGO recalled.
“Sadly today, we've seen that the European Commission and most EU member states are more concerned about the economic impact of removing endocrine disrupting pesticides from the market than protecting our people, the environment and the future generations. […] Now it is up to the Parliament to demand what the European Commission has refused to carry out, so far."
Rising levels of cancers and fertility problems have attracted scientists’ attention to endocrine disrupting chemicals, with some calling for strict regulation of the substances, in line with the precautionary principle.
People are exposed to hormone-disrupting chemicals through everyday products including food and drink, medications, pesticides, cosmetics, plastics, detergents, flame retardants, and toys – to name a few. They can even be found in air and dust and can enter our bodies via the skin, breathing, drinking or eating. These chemicals can also be transferred from a woman to her child via the placenta or breast milk.
But others have stressed the worthiness of those chemicals in everyday products such as plastics and pesticides and warned about the economic consequences of banning substances using a precautionary approach.
According to the World Health Organization, an endocrine disruptor is a substance (or a mixture of substances) which disrupts the functions of the hormonal system and consequently is harmful to human health and reproduction, including at very weak levels of exposure.
The European Commission was supposed to define scientific criteria for defining potential endocrine disruptors by December 2013 but delayed its decision because it wanted to make an impact analysis first. Sweden, which backed quick regulatory action on the matter, sued the Commission and eventually won.
In June 2016, the EU executive finally presented its long-awaited set of criteria for identifying substances with endocrine disrupting properties in plant protection products and biocides.
Once adopted, the EU regulatory system will be the first worldwide to define criteria for endocrine disruptors in legislation.