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EU struggles to define what constitutes an endocrine disruptor

Criteria will determine regulation of pesticides and biocides

by Paula Dupraz-Dobias, special to C&EN
May 29, 2017 | APPEARED IN VOLUME 95, ISSUE 22

Credit: Shutterstock
The EU is wrestling with how to legally define endocrine-disrupting chemicals as part of its regulation of pesticides and biocides.

Nearly a year after the European Commission (EC) proposed criteria to define endocrine disruptors, experts say talks aimed at ultimately banning toxic chemical substances continue to be bogged down by a mix of politics and science.

For years, reports have shown that hormone-disrupting chemicals are in cosmetics, food packaging, cleaning products, and even baby creams, and calls to ban them have increased. And recently, the European Food Safety Authority reported that 97% of European food products contain pesticide residues within legal limits, some of which are substances suspected of being endocrine disruptors.

According to the World Health Organization, exposure to endocrine-disrupting chemicals is “suspected to be associated with” breast cancer, changes in immune function, abnormal growth, neurodevelopmental delays, and adverse effects on human reproductive functions.

In 1999, the EC, which is the administrative branch of the European Union, developed a strategy on endocrine disruptors, prompted by the growing evidence of health issues related to their use. The European Parliament then passed laws in 2009and 2012 on pesticides and biocides requiring that these types of products containing endocrine disruptors be regulated on the basis of the hazards they pose.

But EU movement toward achieving a comprehensive ban of endocrine-disrupting substances has been slow. In 2015, the European Court of Justice condemned the EC for failing to act on the European Parliament’s 2012 regulation to identify and ban endocrine disruptors by 2013.

Although the EU already regulates some chemicals that may be endocrine disruptors, it lacks comprehensive benchmarks for classifying substances as endocrine disruptors. Last year’s complex proposal by the EC—albeit limited to biocides and pesticides—marked the first time a government anywhere presented scientific criteria to identify these chemicals.

The EU’s work on setting standards to identify endocrine-disrupting chemicals is crucial, says Pelle Moos, a project officer on chemicals and international trade agreements at European consumer group BEUC. “While we would like those set higher, there are no other countries, certainly not the U.S., that have that level of regulatory development.”

The EC’s criteria under discussion are widely expected to serve as a model in other sectors, including medical devices.

But so far, despite multiple meetings of expert committees since last June, the EC’s proposals have not received the necessary support among member states for it to take the next step toward implementation. EU member states would have to agree on the criteria before they are submitted as legislation for a vote in the European Parliament and to the European Council for adoption. The council includes heads of government who have the power to commit member states to EU policies.

Discussions in the EC’s biocides and pesticides committees have shown that proposals on how to identify endocrine-disrupting chemicals remain problematic.

“The commission has a difficult balancing act in coming forward with a proposal that addresses the concerns reaching from the industry all the way to member states and the [nongovernmental organizations, such as environmental activists] on the other end of the debate,” says Graeme Taylor, spokesperson for the European Crop Protection Association, a pesticide industry group. “Politically, this has been an incredibly sensitive issue.”

Some groups critical of the EC’s proposals cite the high level of scientific evidence required for the identification of endocrine-disrupting chemicals as a major issue in the formal discussions.

Moos says modifications made to the proposals since last June—from requiring evidence that the chemicals affect endocrine function to requiring evidence that the chemicals harm human health—could exclude many substances from a ban.

“Getting data to fulfill the criteria on consequential causes is very demanding, some say unrealistic,” Moos comments, referring to the difficulty of proving a causal link between the chemicals and endocrine disorders.

A letter published earlier this year by the Endocrine Society, an international scientific and research group, argues that narrowing the criteria “will make it nearly impossible for regulatory agencies to meet the unrealistically high burden of proof and protect the public from dangerous chemicals.”

For Giulia Carlini, project attorney on environmental health at the Center for International Environmental Law, different interests are at play in determining the criteria.

“The more substances are identified as endocrine disruptors, the more consequences for the pesticide and biocide industry. On the other hand, this will also mean that fewer endocrine disruptors will end up in products that we use, and it will promote safer alternatives,” she says. Carlini authored a study on the EC’s elaboration of criteria for identifying endocrine-disrupting chemicals.

On the industry side, Taylor regrets that the EC removed a clause that would allow industry to use chemicals identified as endocrine disruptors if people had only “negligible exposure” to them. This plan was called derogation.

“Endocrine substances should be risk assessed just like any other potentially hazardous substance,” Taylor says. “There is no reason to treat them in any other way.” Risk assessment considers both a chemical’s hazard, such as endocrine disruption, and people’s level of exposure to the substance.

He adds that the industry was “increasingly frustrated” by the elaboration of hazard-based legislation.

The German chemical industry association Verband der Chemischen Industrie (VCI) tells C&EN in an e-mail, “The proposal is not suitable for distinguishing between harmless and harmful substances because it lacks important assessment criteria (e.g., the potency of a substance).”

VCI adds that removing the derogation clause “would block any possibility for an urgently needed risk analysis.”

Carlini, however, says industry’s emphasis on risk as opposed to solely the hazards posed by chemicals mixes risk assessment into the criteria. “The identification of an endocrine disruptor is a hazard identification procedure required by both law and science.”

Equally contentious is a December 2016 addendum to the pesticides and biocides proposals known as the exclusion clause. It states that endocrine-disrupting chemicals that affect only specified “target organisms”—pests—will not be identified as endocrine disruptors even though they in fact are.

“This is mixing the science of how to identify an endocrine disruptor with how it should be regulated,” comments Moos of the consumer group BEUC.

But the European Crop Protection Association sees the situation differently. If the exclusion clause is adopted, Taylor says, “it is recognition of the fact that these substances are designed or produced to only target certain organisms and there is no impact on human health.”

VCI, the German industry association whose members collectively represent the world’s second-largest chemical exporting bloc after U.S. manufacturers, meanwhile questions the science at the center of the debate on endocrine-disrupting chemicals. The group says the EC should not overlook the complexity of human hormone systems.

Credit: Shutterstock
The EC is expected to complete its work on endocrine-disruption criteria later this year.

“There is no general answer to the question whether endocrine-active substances are harmful to the organism,” VCI argues. “Every day we take in hormonally active substances through food or the environment,” it says, adding that organisms have natural mechanisms for keeping a healthy balance when responding to hormonal stimuli. Commercially produced chemicals “constitute only a small part of the entirety of endocrine-active substances and factors.”

Moos says the planned exclusion clause “illustrates how the problem has become politicized,” referring to the consequences of the regulation on industry.

He claims that national and international business groups were approaching the EC committee experts to argue against the endocrine disruptor legislation because they predict it will harm their products.

The question of how much industry is influencing the EC decision looms large. Journalist Stéphane Horelreports in December 2016 articles in the French newspaper Le Monde that the exclusion clause’s language represents “a concession from the European Commission to the pesticide lobby.”

Horel refers to a 2013 document written by representatives of three major European chemical manufacturers—German firms BASF and Bayer and Swiss group Syngenta. The document argues in favor of including exposure information when determining which chemicals are what the companies call “endocrine disruptors by design,” she reports.

Horel claims that the European Chemical Industry Council and the European Crop Protection Association sponsored a 2016 EC impact assessment that invalidated a World Health Organization/United Nations Environment Programme scientific report on the health effects of endocrine-disrupting chemicals. Joining the European groups were the American Chemistry Council, which is an association of U.S. chemical makers, and the pesticide makers’ organizations CropLife America, CropLife Canada, and CropLife International, Horel asserts.

Taylor, the European Crop Protection Association spokesperson, calls the accusations “nonsense.” The group asked to conduct its planned impact assessment before the EC released its proposal, Taylor tells C&EN. The European Chemical Industry Council did not respond to questions for this article.

The EC says the preparation of that assessment report caused the delays for which it was censured by the European Court of Justice.

Enrico Brivio, EC spokesperson on environmental issues, refutes speculations that the chemical industry unduly pressured member states as they considered endocrine-disrupting chemical criteria.

“We contacted all interested stakeholders: NGOs, industry, all the members,” Brivio says. “It is all transparent.”

To boost its arguments, the European Crop Protection Association issued a report in February predicting negative impacts on EU agriculture if endocrine-disrupting pesticides and biocides are banned. It claims the ban would harm EU’s trade balance, cut farmers’ incomes, and put 800,000 jobs at risk.

As the debate has gone on over the years, France has emerged as a leader in the fight to control endocrine-disrupting chemicals. In 2015, it became the first EU country to ban bisphenol A, a substance with estrogenic activity, in food packaging.

French environment minister Ségolène Royal wrote in December 2016 to EC President Jean-Claude Juncker that the proposals “would appear to be a step backward from the EU’s mission to protect the environment and citizens.”

After EC committee discussions in March, she said the EC’s criteria were “still unacceptable.”

France, Denmark, and Sweden have opposed the EC’s criteria plans. A number of other EU countries, including Germany, Italy, Ireland, and Finland, have been favorable to them.

Moos speculates that France’s presidential campaign, which ended in a vote earlier this month, put progress on the endocrine-disruptor criteria on hold.

Brivio says the EC hopes to have constructive relations with France, but he emphasizes that delays in completing the endocrine-disruptor policy resulted from the EC being “too ambitious.”

Although some states find the proposed endocrine-disrupting chemical criteria to be too lax, “a good number of members think that proposals are too restrictive,” he states.

“We are trying to find the right balance to get solid science-based criteria and a legally sound decision that can be accepted by all member states,” Brivio adds.

Taylor, the pesticide industry group spokesperson, says that although states increasingly support returning exposure considerations to the draft, “till now, the commission seems to have ignored that.”

Carlini, the legal expert at the Center for International Environmental Law, explains that formal votes have not yet been held. The EC appears to prefer gauging whether a qualified majority could be achieved as a test for adopting the criteria.

The center is calling for the EU’s criteria to identify endocrine-disrupting chemicals in any kind of product, not just pesticides and biocides. Moos from BEUC agrees that a single set of health-based criteria is needed to prevent piecemeal, case-by-case regulation of chemicals.

Talks have continued in May. Brivio predicts that “a few clarifications will be made” to current drafts at meetings later this year. “We hope we are getting there.”

Carlini agrees. “The commission seems to be pushing member states to agree on the draft criteria in the next weeks.”

But she warns: “Just speeding up the process to adopt any criteria for the sake of having them might be counterproductive to achieve the objectives of the regulations.” 

Paula Dupraz-Dobias is a freelance journalist based in Geneva.



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