Endocrine Society Queries European Draft Criteria on Disruptors

Liam Davenport

July 10, 2017

Draft criteria for chemicals in pesticides and biocides that affect the hormone systems of animals and humans have been approved by the European Commission (EC) and were published on July 4. While the commission is hailing this as a major step in health and environmental protection, not everyone is so enthusiastic.

The Endocrine Society, the world's largest organization of endocrinologists, believes that the draft criteria do not go far enough to safeguard human health and that there is a lack of clarity over how they will be applied. These draft criteria "fail to identify [endocrine disrupting chemicals] EDCs that are currently causing human harm and will not secure a high level of health and environmental protection," it noted in a statement.

Consequently, it is "urging the European Parliament to improve transparency surrounding the process for implementing the criteria and to engage endocrine scientists in further decision-making steps."

A Great Success or Falling Short?

The draft criteria issued by the EC identify known and presumed EDCs using evidence from animal, in vitro, or in silico studies and are set to become part of the first legally binding definition of the substances.

Alongside being applied to current and future applications for approval for individual chemicals, the criteria will be used to form the basis of further legislation into restricting the use of EDCs in household objects and toys and to spur research into the chemicals.

In a press release issued last week, Vytenis Andriukaitis, MD, Commissioner for Health and Food Safety at the European Commission, Brussels, Belgium, said the move "represents our determination to devise a real European Union (EU) policy on endocrine disruptors."

He continued: "After months of discussion we are advancing in the direction of the first regulatory system in the world with legally binding criteria to define what an endocrine disruptor is. This is a great success."

The draft criteria of substances are based on the 2002 World Health Organization definition of known and presumed EDCs, which incorporates both the mode of action and effects of a compound.

The criteria state that an EDC is any substance or mixture that alters the functions of the endocrine system to cause adverse health effects in an organism, its progeny, or (sub)populations, while a potential EDC has properties that might be expected to lead to endocrine disruption.

The draft criteria have now been sent to the European Council and European Parliament, which will have 3 months to examine the text and vote on whether to approve the criteria before final adoption by the commission.

The Endocrine Society says, "We encourage the parliament to gather input from endocrine scientists and professional endocrine associations during their deliberations."

If Adopted, Criteria Will Apply to Pesticides, Toys, Cosmetics, and Food Packaging

If these draft criteria are adopted, they will be enforced 6 months later and will apply to ongoing scientific evaluations for the renewal or approval of all active substances used in plant protection products.

Consequently, all applicants, evaluating authorities in the European Union member states, and the European Food Safety Authority will have to "adapt very quickly their procedures, and new data may need to be requested and produced," the commission says in an accompanying fact sheet.

The criteria will also be used as a basis for development of a novel strategy by the commission to minimize exposure to endocrine-disrupting chemicals used in the manufacture of toys, cosmetics, and food packaging.

Alongside, the commission intends to allocate approximately €50 million via the Horizon 2020 Framework Program for Research and Innovation for around 10 basic and applied-research projects to better understand endocrine disruption and develop tools for their assessment and regulation.

Once implemented, the text "will ensure that any active substance used…which is identified as an endocrine disruptor for people or animals can be assessed and withdrawn from the market," noted Dr Andriukaitis.

There were no declarations of relevant financial relationships.  

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European Commission. Endocrine disruptors press release.

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