Proposal fits US demands to weaken EU pesticides regulation
The EU Commission has published its long-awaited proposal for criteria to identify endocrine (hormone) disruptors.
As the online magazine EU Food Policy explains (“Commission defines EDC criteria as having proven human health effect”, subscription only, no direct link), the Commission is proposing to define the criteria for endocrine disruptors by saying there has to be a proven adverse effect on human health.
The Commission is arguing that it is using the World Health Organisation definition of endocrine disruptors.
The Commission said that the WHO defines a substance as an endocrine disruptor if:
* it has an adverse effect on human health;
* it has an endocrine mode of action;
* and if there is a causal link between the adverse effect and the mode of action.
But journalist Stephane Horel told EU Food Policy that the WHO definition does not demand a proven effect on human health. She said that to demand such a high level of proof was “unprecedented”.
Horel’s take on the proposal is reinforced by two comments to Euractiv.com (at the foot of item 1) from public health and consumer groups. One is from Lisette van Vliet, senior policy officer at the Health and Environment Alliance (HEAL), and the other is from Sylvia Maurer, Head of the Sustainability and Safety Department at the European Consumer Organization (BEUC). Van Vliet said of the Commission’s requirements for endocrine disruption that they “are so strict, the burden of proof so high that we’ll have years of harm to health before we can remove them. This is not what the legislation requires, which is, that EDCs [endocrine disrupting chemicals] [that] may cause adverse effects are banned.”
In a Commission press release announcing its proposal, Commission President Jean-Claude Juncker said: “The Commission is committed to ensuring the highest level of protection of both human health and the environment, which is why we are today putting forward strict criteria for endocrine disrupters – based on science – making the EU regulatory system the first worldwide to define such scientific criteria in legislation."
Thus far much of the media has followed the Commission’s spin in suggesting that the proposal is strongly protective of public health and runs agains the interests of industry – see for example the headline of the article below (item 1) from Euractiv.com, “Pesticide industry critical of endocrine disruptors criteria”. In reality the pesticide industry should be (and possibly is) delighted with the proposal.
Commission wants to weaken EU pesticides regulation
Alarmingly, the Commission is also proposing to alter the text of the EU pesticides regulation with regard to endocrine disruptors (see item 2 below), to make it risk-based rather than hazard-based. Currently the regulation is hazard-based and has “cut-off criteria” regarding endocrine disruption, meaning that if a substance is an endocrine disruptor, it has to be banned unless industry can prove that there is “negligible” exposure. No horse-trading over supposedly acceptable levels of exposure (risk-based approach) is allowed.
Making the regulation risk-based regarding endocrine disruptors, as the Commission wants to do, would open the door to industry to argue that any endocrine disruptor can remain on the market on the grounds that exposures would be low enough that they do not cause adverse impacts.
TTIPing Toxics, a coalition of European public interest groups aiming to remove chemicals from the EU-US trade talks, commented on Twitter (@TTIPingToxics) that the Commission’s proposal was an attempt to placate the US in the talks for the TTIP trade deal: “Commission LOWERED ambition to protect consumers [in order] not to jeopardise TTIP”.
TTIPing Toxics give a link to the US government’s comments to the EU Commission’s public consultation on defining criteria for endocrine disruption. Sure enough, the US attacks the hazard-based nature of the EU pesticides regulation and demands a move to risk-based criteria, in which industry can argue that there is no risk from exposure.
The Commission’s proposal and related documents are here.
1. Pesticide industry critical of endocrine disruptors criteria – Euractiv.com
2. EU Health Commissioner Andriukaitis decides to leave Europeans unprotected from endocrine disrupting pesticides – Pesticide Action Network Europe
1. Pesticide industry critical of endocrine disruptors criteria
By Sarantis Michalopoulos
EurActiv.com, 15 June 2016
The pesticide industry is “extremely disappointed” with the European Commission’s proposal to identify endocrine disruptors that was presented on Wednesday (15 June).
The Commission presented a long-awaited science-based set of criteria for identifying substances with endocrine disrupting properties of plant protection products and biocides.
Endocrine disruptors are still not regulated in Europe, as no formal criteria for identifying them in pesticides and biocides have been established so far.
Once adopted, the EU regulatory system will be the first worldwide to define scientific criteria for endocrine disruptors in legislation, confirming the Commission’s commitment to ensuring the highest level of protection of both human health and the environment, an EU source told EurActiv.com.
The same criteria will also apply to products imported into the EU, and that is the reason why they will be notified to the World Trade Organisation.
“Today, Europe took a big step forward in safeguarding the health of its people,” the source added.
The European Commission carried out an impact assessment to set criteria for identifying endocrine disruptors, a process that has been postponed since December 2013 claiming a lack of scientific consensus on the issue (See background).
The European Parliament recently slammed the executive for its inaction, and adopted a resolution on 8 June, demanding immediate action on the definition of endocrine (hormone) disruptors “in an objective manner” and not at the expense of public health.
“The specification of scientific criteria can only be carried out in an objective manner on the basis of scientific data related to the endocrine system, independently of any other consideration,” the non-binding resolution reads.
Adoption of WHO definition
The European Commission said that the scientific criteria are based on the World Health Organisation’s (WHO) definition of an endocrine disruptor, “for which there is a wide consensus”.
The World Health Organisation (WHO) defines an endocrine disruptor 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”.
In order to speed up the procedures, as well as test EU agencies’ readiness to apply the new criteria, the executive requested the European Food Safety Authority (EFSA) and the European Chemicals Agency (ECA) to examine whether already approved individual substances that show indications of being endocrine disruptors could be identified as endocrine disruptors according to the criteria in the draft texts presented today.
A ‘hazard-based’ approach
According to the Commission, the ‘hazard-based’ approach of the Pesticides Regulation will be maintained, meaning that substances are banned on the basis of hazard, without taking into account exposure to the substance. On the other hand, a risk-based approach would also include exposure.
This decision will most likely please countries like France, which insist on an approach “based on the intrinsic properties of hazard, without taking into account the potency” of the substance.
On the other hand, a solely ‘hazard-based’ approach is against the will of the pesticides industry.
Contacted by EurActiv, European Crop Protection, a trade group representing the pesticides industry, said that the Commission’s proposal was disappointing.
“We are extremely disappointed with this proposal from the European Commission. After 6 years of hard work with input from EFSA, scientific, experts, and various stakeholders the criteria are no more than the WHO/IPCS definition, developed over a decade ago. We still consider this definition to be a sensible starting point, but this alone is not appropriate for regulatory purposes,” ECPA’s spokesperson Graeme Taylor stressed.
However, the executive noted that “grounds for possible derogations have been adjusted, so they are based on scientific knowledge and make the best use of available scientific evidence including information related to exposure and risk”.
“Regulation by derogation is not acceptable, nor scientific, and expanding the derogations is essentially signaling a flaw in the criteria,” Taylor added.
President of the European Commission Jean-Claude Juncker said: "Endocrine disruptors can have serious health and environmental impacts and even if many substances containing them are already banned as a result of existing legislation on pesticides and biocides, we have to remain vigilant. The Commission is committed to ensuring the highest level of protection of both human health and the environment, which is why we are today putting forward strict criteria for endocrine disrupters – based on science – making the EU regulatory system the first worldwide to define such scientific criteria in legislation."
The Vice-President for Jobs, Growth, Investment and Competitiveness Jyrki Katainen declared: "The scientific criteria for endocrine disruptors presented today will contribute to the objectives of minimizing exposure to endocrine disruptors and to bringing legal certainty. Today’s Communication outlines the issues we have considered in this process, it defines the scope of what is relevant to determining the scientific criteria, and sets out the implications of setting these criteria – for the two pieces of legislation directly concerned and for other parts of the EU regulatory framework and actions.”
Commissioner for Health and Food Safety, Vytenis Andriukaitis, said: "The scientific criteria that the Commission is presenting today guarantee that the high level of protection of human health and of the environment set in our legislation on plant protection and biocidal products is maintained. The plant protection products and biocides' legislation are among the strictest in the world because of their prior approval system, their extensive data requirements, and their hazard approach for decision making. The Commission reinforces today its commitment to protect people's health in the European Union."
Jean-Charles Bocquet, Director General of ECPA, said: “These criteria fail to distinguish between those substances which may cause actual harm and others which pose no threat to safety. In our view, this could lead to bans on crop protection products with the same endocrine disrupting properties found in everyday products like coffee. We certainly recognise the significant public interest in this topic but believe we need a proposal that targets only those substances which cause actual harm otherwise we risk taking away tools from farmers which they need to sustainably produce our safe, healthy, affordable food”.
Lisette van Vliet, senior policy officer at the Health and Environment Alliance (HEAL) noted: “What the Commission has proposed today will not prevent diseases related to endocrine disrupting chemicals. The requirements are so strict, the burden of proof so high that we’ll have years of harm to health before we can remove them. This is not what the legislation requires, which is, that EDCs may cause adverse effects are banned.”
“Even worse, it would cripple the use of accumulated (and future) knowledge about effects on animals, which should be used to prevent harm to human health. A scientific consensus (3) exists on how best to identify these harmful chemicals (Option 3 of 4 in the roadmap (4)) but the College of Commissioners have not chosen to follow it,” she added.
Marco Mensink, Director General of the European Chemical Industry Council (Cefic) stressed: “Scientific criteria are needed to identify those endocrine disruptors of regulatory concern, and enable harmless substances to bring value to society. Unless potency is taken into account, we will fail to address only those substances that cause harm. Many years down the road, we now have a restatement of the WHO definition. This provides further clarity, but it is not sufficient. We need to ensure the highest standards of protection and also allow for innovation."
Karl-H. Foerster, Executive Director of PlasticsEurope, said: “Finally, the criteria to identify endocrine disruptors are out. We still lack a commonly accepted working criteria that would allow differentiating between a substance of regulatory concern and a substance of no or low concern.”
Sylvia Maurer, Head of the Sustainability and Safety Department at the European Consumer Organization (BEUC), underlined:
“An EU definition of hormone-disrupting chemicals needs to identify all the chemicals that may harm consumers’ health, this means both the chemicals we know are EDCs and those we suspect. This is the only way the EU can protect consumers from these harmful chemicals found in products we use every day such as cosmetics, clothes, and food packaging,”
“This proposal will not properly protect consumers from harmful endocrine disruptors as only a few substances would be defined and regulated as EDCs. This goes against the precautionary principle where protective action should prevail even in the face of scientific uncertainty. Sadly today’s package seems to confirm our concerns that the Commission has lowered its ambition concerning strong EDC criteria so as not to jeopardise the TTIP talks with the US,” she noted, adding that the Commission is heading down a dangerous path of ignoring chemicals’ toxic effects.
The European Commission was supposed to define test criteria for potential endocrine disruptors by December 2013. These chemical substances are present in a large number of everyday products: foods, cleaning products, food containers, etc.
But the initial deadline was missed, and still no official definition has been reached. Without a definition of endocrine disruptors, it is impossible to legislate on the subject.
The Commission has promised to publish this definition by summer this year.
2. EU Health Commissioner Andriukaitis decides to leave Europeans unprotected from endocrine disrupting pesticides
Pesticide Action Network Europe, 15 June 2016
Commissioner Andriukaitis’ choice [of] criteria will effectively result in no single endocrine disrupting pesticide being banned.
Commissioner Andriukaitis' choice for option 2 of the EU 2014-Roadmap already would lead to banning only a few pesticides (Impact endocrine criteria - PAN Europe), but by changing on top of this the legal text and the derogation from negligible exposure to negligible risk (option B of roadmap) zero endocrine disrupting (ED) pesticides will be banned. The change of the derogation is a violation of EU law and of democratically agreed rules with the EU Parliament.
The words of EU Commission Chair Juncker stating that the choice "ensures the highest level of protection" is purely misleading. There cannot be any other conclusion but that Commission lets the interests of trade and industry prevail over the interests of the public and fails to reduce the millions of health costs and the suffering of people in Europe due to endocrine related diseases.
PAN Europe urges the EU Parliament and EU member states to block the choice made by the Commissioners and the change of the derogation which is beyond their legal power.
It is also sad to note that testing of chemicals for endocrine disruption is only foreseen in "midterm". This again shows that in spite of all nice words of the Commissioners, endocrine disruption is not considered a serious health concern.
Not banning ALL EDCs is illegal:
The Pesticide Regulation (PPPR 1107/2009) is a consensus between the European Parliament, European Council and the Commission. Its provisions are underpinned by the precautionary principle to ensure a high level of protection of both human and animal health and the environment and particularly protect vulnerable groups of the population, including pregnant women, infants and children.
These groups are particularly vulnerable to the exposure to Endocrine disrupting Chemicals (EDCs) as any hormonal alterations during these sensitive periods of life could lead to permanent disorders and diseases such as reproductive failure, reproductive organ deformities and cancer, diminished fertility, metabolic disorders (e.g. obesity and diabetes), immune dysfunction, cognitive impairment (e.g. autism, iodine deficiency) among others.
Originally, the Pesticide Regulation (Annex II; 3.6.5 and 3.7) required that a pesticide active ingredient can be approved if it is not considered to have endocrine disrupting properties that may cause adverse effects on humans (3.6.5) and non-target organisms (3.7) unless the exposure is negligible (used in close systems, no contact with humans or non-target organisms).“May cause adverse effects” would mean that both categories of well known EDCs and potential EDCs had to be banned to protect human and animal health and the environment. This has also been the scientific advice of several endocrinologists and the Endocrine Society and reflects our current knowledge on how the endocrine system functions. But the Health Commissioner dismissed all the advice from the experts in the field of endocrine disruption, removed the word “may” from the legal text and in addition decided to require mechanistic information on how the adverse effects are being produced, something that has never been required so far in the assessment of chemicals. This is unacceptable as one would expect that the Health Commission would give a priority in protecting human health than the industry’s interests. Today it’s a sad day for science.
Publication of Criteria http://ec.europa.eu/health/endocrine_disruptors/policy/index_en.htm