Hormone disrupting pesticides (EDCs)

After a very long delay the EU is finally planning to ban the first endocrine-disrupting pesticides (EDP) in 2023. These are the first concrete steps in a process that has been far too slow to protect the most vulnerable. Already in 2009, it was agreed to identify and ban these very dangerous and harmful substances. But for 14 more years EDPs have been on the market, in our food and environment. This has put the health and development of young children at unnecessary risk. Together with our partners, we have been campaigning for an environment free of hormone-disrupting chemicals. But producers have managed to keep them on the market, until today. High time for a change!

What are Endocrine Disruptors

Endocrine disruptors are chemicals that mimic or block the action of hormones. They are known as EDCs, endocrine disrupting chemicals. They can be extremely dangerous for the unborn or young children. Their very specific threat is that they can have devastating effects on the development in extremely low doses, comparable to the ones of natural hormones. They can also cause cancer or brain damage at all ages. For this specific category of chemicals the dose does not make the poison. Paracelsus did not know of the existence of EDCs.

"The dose makes the poison" (Latin: dosis sola facit venenum 'only the dose makes the poison') is an adage intended to indicate a basic principle of toxicology. It is credited to Paracelsus who expressed the classic toxicology maxim "All things are poison, and nothing is without poison; the dosage alone makes it so a thing is not a poison." (source: Wikipedia)

This adage in toxicology does not work for EDCs. That scientific discovery was already made in the sixties of the last century, but proper action was not taken. Many pesticides have endocrine disrupting properties, but until recently these were hardly investigated and not properly regulated.

EU Legislation

In 2009, the EU Commission, Parliament and Council agreed that people and our ecosystems should not be exposed to endocrine disrupting pesticides (1) given their potential long-term and irreparable adverse effects (cancer, brain and developmental damage to the unborn) following low, environmental exposures. Endocrine disrupting pesticides (EDPs) would be considered a ̈hazard ̈ and would be banned, just like all those classified carcinogenic, mutagenic and reprotoxic (toxic to reproduction) pesticides. (2) An exception would be possible in case of “negligible exposure”, defined as use of pesticides in closed systems, excluding contact with humans and resulting in food residues below the limit permitted in baby foods. (3) Another exception is possible when the substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods.

14 years of delay in implementation

However, these rules were substantially delayed in their implementation. At the time of adoption of these approval standards, there were no scientific criteria for identifying endocrine disrupting pesticides. The so-called 'interim criteria', never resulted in a ban. Pesticide approvals were systematically prolonged and not a single pesticide was banned because of the interim EDC criteria. The adoption of science-based criteria to apply the EU legislation was urgent.

In 2013 the EU Commission bypassed the result of the work of endocrinologists and certain Member State experts who prepared a proposal to identify EDPs and provide sufficient protection for population and environment. Then in 2016, the Commission proposed to completely change the rules and return to traditional risk assessment (instead of a hazard-based one). “Negligible exposure” was to be changed to negligible “risk”. This would allow full exposure to EDP residues in food based on Maximum Residue Levels (MRL), as it is the case with any other pesticide. Although the guidance document on negligible exposure was postponed, thanks to the concerns raised by Member States and civil society groups, the intense lobbying by the chemical industry had succeeded to water down the criteria. Now only known and presumed endocrine disruptors would be identified (and not those that are suspected). (See this publication if you want to know more about this lobby).

In 2018, after 5 years of delay, the Commission finally published a set of scientific criteria to identify EDCs together with a guidance document by EFSA/ECHA. Once the scientific criteria entered into force the authorities 'suddenly' realised that for many pesticides there were no tests provided to assess endocrine disruption. So they "stopped the clock" of the assessment to request additional data from applicants. This led to prolongations and more delays in the identification and banning of endocrine disrupting pesticides.

Now finally, 5 years after the criteria entered into force and 10 years after the official request to provide such scientific criteria in 2013, EFSA has identified the first endocrine disrupting pesticides. (4) None of these pesticides have yet been banned because of their endocrine disrupting properties. The reason for this delay is another delay tactics by the chemical industry. First they invoke the 'negligible exposure' exception in the regulation. This causes delay but is never used in practice. Next they claim that these EDPs should be approved by derogation to control a serious danger to plant health which could allegedly not be contained by other available means, including non-chemical methods (5). This claim requires further assessment by Member States and EFSA and therefore triggers additional delays. It also demands that EFSA looks into alternatives, for which it has no expertise. In the meantime, people and the environment are still exposed to these dangerous chemicals. This problem in the regulation is elaborated in our letter to EU Health Commissioner Kyriakides from February 2023. (6)

Finally: pesticides banned because they are endocrine disruptors

The next stage started in May 2023. Finally the first ban for an endocrine disrupting pesticide was proposed by the European Commission during the meeting with EU Member States in the SCOPAFF committee on pesticide legislation. (7) The substance was a herbicide called Triflusulfuron-methyl. According to EFSA, it is an endocrine disrupting pesticide for humans and wild mammals. In this meeting, member States have only discussed this first ban proposal.

Triflusulfuron-methyl is only the tip of the iceberg. This first ban proposal by the Commission was followed by four others of EDPs in the light of EFSA's findings. These four active substances are the herbicide asulam sodium, the fungicides benthiavalicarb and metiram and the insecticide clofentezine. They have all been found by EFSA to be endocrine disruptors for humans in its assessment between 2021 and 2023. While asulam sodium has never been approved in the EU, the four other substances are authorised in pesticide products used in almost all Member States.

These 5-five ban proposals were discussed by Member States during the SCoPAFF meeting on 11 and 12th of July 2023 (8). The decision to ban them took take place in the meeting of October 2023. PAN Europe welcomes these ban proposals. We urged Commission and Member States to quickly concretise them considering the already existing delays. The approval of metiram was due to expire in 2016, that of benthiavalicarb and clofentezine in 2018 and that of triflusulfuron-methyl in 2019. Likewise, the EDC Free Europe coalition which represents more than 70 environmental, health, women's and consumer groups across Europe who share a common concern about EDCs and their impact on our health and wildlife, have openly expressed support for these ban proposals to swiftly enter into force. (9)

In March 2024 the SCoPAFF committee agreed to ban dimethomorph and mepanipyrim. Dimethomorph is a fungicide found to be an endocrine disruptor to humans and wild mammals in May 2023. It is also classified since September 2019 as damaging fertility (toxic for reproduction 1B) but its approval period had been repeatedly prolonged since its initial approval period ended in 2017. In accordance with the pesticide regulation, the 2019 classifications should have already led to ban the dimethomorph more than four years ago. It was therefore high time to ban this very toxic substance. The fungicide Mepanipyrim has been identified as endocrine disruptor for humans and wildlife in August 2023, following a decade of prolongation of its initial approval period.

However, as in the case of other EU-banned endocrine disrupting pesticides, the producers and farmers receive the maximum transitional and next grace period. This means they can be used for another 6 + 12 months. This is delaying the moment when citizens including the most vulnerable groups and the environment will finally be protected from these substances until 2025.

The next substance to be banned should be metribuzin that has been identified as an endocrine disruptor in August 2023. PAN Europe has asked the SCoPAFF members to invite the Commission to propose a non-renewal of the approval of this dangerous substance. Moreover, other active substances including buprofezin, carbendazim, cyprodinil, ethiprole, fenoxaprop, fludioxonil, flufenacet and thiophanate are about to be identified as endocrine disrupting pesticides according to EFSA and should be banned soon.

Notes

1 Regulation 1107/2009, Annex II, 3.6.5, “conditions excluding contact with humans”
2 Regulation 1107/2009, Annex II, 3.6.2, 3.6.3, 3.6.4, categories 1A and 1B.
3 Regulation 1107/2009, Annex II, 3.6.5, “closed systems or in other conditions excluding contact with humans”
4 EFSA overview of endocrine disrupting assessment of pesticide active substances, Feb 2023
5 Regulation 1107/2009, Article 4(7)
6 PAN Europe letter to EU Health commissioner Kyriakides on Asulam Sodium, Feb 2022
7 Agenda of the EU SCoPAFF Committee May 24-25 2023, point C.06
8 Agenda of the EU SCoPAFF Committee July 11-112 2023, points C.07 - C.10
9 EDCFree coalition urges EU Member States to support a ban of 5 endocrine disrupting pesticides