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EU Steps Up: What We’ve Learned from Assessing Endocrine Disruptors in Pesticides and Biocides

Updated: 5 hours ago

In recent years, few regulatory topics have attracted as much attention as endocrine disruptors, chemicals capable of interfering with hormone systems in humans and wildlife. Their potential effects on development, reproduction, and environmental health have prompted increasingly rigorous scrutiny across the globe. Within the European Union, two major legislative frameworks govern how such substances are assessed: Regulation (EC) No 1107/2009 for plant protection products (PPPs) and Regulation (EU) No 528/2012 for biocidal products (BPs).


In 2018, the EU implemented a harmonised set of scientific criteria for determining whether a substance exhibits endocrine-disrupting (ED) properties. Now, after several years of applying these criteria, the European Commission has evaluated the experience gained, what worked, what stalled, and what still needs to change. The findings illuminate both the scientific complexity behind ED assessments and the administrative challenges facing regulators and industry alike.


This article breaks down the key insights from this extensive review.

 

Why the EU Updated Its Approach

When the PPP and BPR regulations were originally adopted, they included interim criteria for ED identification, with a clear requirement for the Commission to develop more scientifically robust standards. These updated criteria came into force in mid- and late-2018, shaping all ongoing and future assessments of active substances.


To support implementation, the European Chemicals Agency (ECHA) and the European Food Safety Authority (EFSA) jointly developed comprehensive guidance explaining how to evaluate ED properties. This guidance became the backbone of the regulatory process, but it also introduced substantial new workloads for both applicants and evaluators.

 

What Has Happened Since the New Criteria Came into Effect?

1. Plant Protection Products (PPP)

As of January 2025, endocrine disruptor assessments had been completed for 104 active substances used in plant protection.


Key outcomes:

  • 9 substances were identified as endocrine disruptors, either for human health, non-target organisms, or both.

    Interestingly, ED properties were not the sole or decisive reason for their non-approval or non-renewal, other safety concerns also played major roles.

  • 95 substances were concluded not to have ED properties and therefore remained approved or were renewed.

  • 259 substances are still under assessment, illustrating how resource-intensive ED evaluations have become.


Delays have been a major challenge. Many renewal procedures already in progress when the new criteria took effect had to be paused so EFSA could request additional data, a process that could take up to 30 months. Once submitted, these data needed to be reviewed first by Rapporteur Member States and then through EFSA’s peer-review system, creating delays that often exceeded three years overall.


A significant bottleneck has been the shortage of experts trained to evaluate complex toxicological and ecological endocrine data. Another issue: the limited availability of certified laboratories capable of performing the highly specialised studies required.

Some applicants have challenged ED conclusions in court (most notably the case of mancozeb) but so far, no ruling has overturned the adequacy of the ED assessments themselves.

 

2. Biocidal Products (BP)

For biocides, the pace and complexity of ED assessments have likewise influenced regulatory timelines, particularly the EU’s long-running review programme for “existing” active substances (those on the market before 2000).


As of early 2025:

  • Eight substances have been identified as endocrine disruptors for both human health and the environment.

    Some were not approved due to ED concerns; others were approved using derogations where no suitable alternatives exist.

  • Seventeen substances were concluded not to have ED properties.

  • Twenty-nine substances could not be conclusively assessed, either because data were insufficient or because parallel concerns made a full ED conclusion unnecessary at the time.

  • ED assessments are ongoing for 169 substances, with 25 older substances awaiting evaluation during their renewal phase.


Like PPPs, biocidal ED assessments have faced shortages of experts and laboratory capacity. Some Member States adopted a stepwise approach, requesting limited data first, then additional tests, which unintentionally prolonged evaluations. Competent Authorities have since agreed that when in vivo studies are clearly needed, they should be requested upfront to avoid unnecessary delays.


The cumulative burden has been significant enough that the EU extended the biocides review programme until 31 December 2030, highlighting the scale of the task ahead.

 

Shared Challenges Across Both Sectors

Across PPPs and BPs, several consistent issues have emerged:


1. Limited Scientific Expertise

ED assessment is among the most complex areas of modern toxicology. Member States continue to face shortages of skilled experts in endocrinology, ecotoxicology, and evidence synthesis.

2. Insufficient Laboratory Capacity

Many ED-relevant studies require specialised test facilities, yet the number of certified labs capable of conducting these tests remains limited. This creates bottlenecks for applicants needing to generate new data.

3. Heavy Data Requirements

ED evaluations require extensive literature searches and reviews, including mechanistic, in vivo, and ecological data. Processing this volume of information significantly increases assessment time.

4. Ongoing Legal and Technical Interpretation Questions

Some applicants contest ED conclusions, while others question when exactly additional data should be considered sufficient. Though the core criteria remain robust, procedural uncertainties persist.

 

Do the Current ED Criteria Still Hold Up?

Despite operational challenges, the Commission’s assessment confirms that the scientific ED criteria remain valid, scientifically sound, and fit for purpose. They allow for consistent identification of substances with endocrine-disrupting properties, ensuring a high level of protection for human health and the environment.


What is clear, however, is that implementation, not the scientific basis, is the limiting factor. Building expertise, expanding laboratory capacity, and streamlining data requests will be crucial steps in meeting future regulatory deadlines.

 

Looking Ahead

The EU’s experience with ED criteria underscores a broader truth: robust scientific regulation is essential, but it must be matched with strong operational capacity. As Member States and EU agencies continue to refine processes and invest in scientific expertise, the assessment of endocrine disruptors should become more efficient without sacrificing rigor.


For researchers, industry, and policymakers, this review offers a roadmap of where attention is needed most. And for the public, it reaffirms the EU’s commitment to grounding chemical safety decisions in the best available science; while constantly scrutinising how that science is put into practice.


If your organisation is navigating the challenges of ED assessments under PPP or BPR, our CEHTRA experts can support you with strategic, regulatory, and scientific guidance tailored to your substances and timelines.



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