Conclusions by EFSA of a critical assessment of the endocrine disrupting properties of a series of pesticides

Introduction

The European Union introduced in 2009 new standards for the approval of pesticides, including to determine if a substance poses a potential hazard in terms of endocrine disrupting properties. Pending adoption of final criteria to identify these properties, the relevant Regulation¹ enacted the so-called ‘interim criteria’, based on classification considerations and ‘toxic effects on the endocrine organs’. An endocrine disrupting substance is one that has an effect on the system of hormones that regulates many aspects of our the organism, and has a significant effect on reproduction and development.

¹Regulation EC) No 1107/2009

What is the purpose of this specific report of EFSA ?

In the past, the European Food Safety Authority (EFSA) has conducted assessments of potential endocrine effects on 41 active substances. For 15, concerns were detected and more information was deemed necessary. For 24 active substances, the available information has not led to the detection of specific concerns and for the two remaining substances additional studies were recommended by EFSA in order to confirm the conclusion of no concern.

This report presents an overview of the EFSA conclusions, summarising and highlighting the evidence suggesting possible endocrine concerns for a series of pesticide active substances. It presents also the recommendations of additional studies to finalise the assessment of their potential endocrine-mediated adverse effects. The term “toxic effects on endocrine organs” has been interpreted in line with the current scientific knowledge, to include adverse structural or functional alterations involved in the regulation of endocrine systems.

What were the sources of information available to EFSA to make these assessments and their conclusions?

The EFSA conducts assessments when a new pesticide that is to be used in the food chain is proposed for use. The industry that is proposing the new active substance applies for approval by the European Commission, and provides an extensive regulatory dossier to support the application. EFSA then designates one of the EU member state as the ‘rapporteur’, which will conduct the risk assessment and prepares a draft of conclusions. The information that is made available to EFSA to complete its scientific evaluation thus combines:

1. the regulatory dossier prepared by the applicant;
2. the draft risk assessment prepared by the rapporteur Member State;
3. additional information, including a public consultation and several commenting rounds with the risk assessors experts in the Member States, collected during the EFSA peer-review process;
4. complementary information networks, which include general scientific knowledge, peer-review publications, relevant information from previous assessments by EFSA and other risk assessment bodies, related grants and procurements including systematic literature reviews, etc.…, which were made available to EFSA and the EU Member States.

The outcome of the scientific evaluation is then compared with hazard-based criteria and then used in the hazard characterisation and the risk assessment.

For an explanation of the distinction between “hazard” and “risk” in this regulatory context, you can see the short GreenFacts animation video: www.youtube.com/watch?v=PZmNZi8bon8 

The two interim criteria that are in use are that should be considered as characterising an endocrine effect are :

1. substances that are classified as causing some cancers and having a toxic effect on reproduction;
2. substances that have a toxic effect on reproduction and on endocrine organs.

Are there specific requirements for the assessment of a endocrine disruption potential?

Regarding endocrine effects, specific criteria for evaluating such hazardous properties are actually developed. Interim criteria were defined focusing on observed adverse effects, which are plausibly linked to endocrine modes of action. An overview of the outcome of the assessments based on the interim criteria and the concerns identified regarding endocrine disrupting properties is then presented. This assessment approach is also used in the hazard characterisation and risk assessment to identify critical areas of concern as well as issues that could not yet be addressed.

What are the conclusions of the overview presented in this report?

EFSA highlighted the evidence that suggests possible concerns related to adverse endocrine effects, and underlined the need for additional studies to finalise the assessment of the potential endocrine mediated adverse effects for 15 active substances used as pesticides.

The term “toxic effects on endocrine organs” has been interpreted, in line with the current scientific knowledge, to include adverse structural or functional alterations involved in the regulation of endocrine systems. With this approach, EFSA Conclusions offer risk managers, stakeholders and citizens a transparent assessment process of the available evidence regarding the potential endocrine effects of substances to be used as pesticides, thus providing information that can be used to support the decision-making process.

The conclusions of EFSA also include specific sections where health and environmental concerns are clearly listed, in order to facilitate communication of their assessment to risk managers, stakeholders and the public.