Correct application of new criteria for endocrine disrupting chemicals is essential

The European Union’s scientific criteria for identification of EDCs comes into force in the near future. According to Christina Rudén, Professor of Regulatory Ecotoxicology and Toxicology, relevant tests and successful risk management are, among others, essential if these new criteria are to be utilised to protect citizens and the environment.

The EU can soon boast the world’s first legislation regarding a scientific definition of endocrine disruptors. The criteria for plant protection products (pesticides) come into force on 10 November, while the criteria for biocides (disinfectants) come into force as early as 7 June.

This is not to say that the controversial issue of endocrine disruptors in agriculture, among other things, has been overlooked.

“As with all legislation, you have the actual wording of the act on the one hand and the actual implementation of the provisions on the other. It is therefore essential to continue monitoring the process and categorically oversee how the definition is applied,” states Christina Rudén, Professor of Regulatory Ecotoxicology and Toxicology at the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University.

“The purpose of the criteria is to make it easier to determine which compounds can and cannot be used in plant protection products and biocides in the EU. However, as the wording of the act has been formulated comprehensively, there will still be plenty of room for interpretation when it comes to evaluating individual compounds and products,” states Christina Rudén.

“We therefore need relevant and reliable tests, for example, but also statutory test requirements and reasonable criteria specifying how to interpret the results of such tests. We also need an operational process to allow for management of potential risk.”

What Christina Rudén is describing is a long chain with different parts that in total will ensure that the new regulations are applied efficiently to protect the environment and public health from endocrine disruptors.

“The level of protection provided will ultimately always be determined by the weakest link in the chain,” claims Christina Rudén.

As the criteria for and, for that matter, the entire issue of performing risk assessment of different chemicals also comprise a relatively advanced scientific context, it may be difficult for individual authorities to understand how to put the new criteria into practice.

As such, the EU’s European Food Safety Authority (EFSA) and European Chemicals Agency (ECHA) have been commissioned to compile a so-called guide for risk-based identification of endocrine disruptors to make this task more simple for the authorities and other bodies. The guide will be published in June.

“Both the wording of the act and the guide are absolutely key in terms of the future handling of endocrine disruptors in the EU, and how ECHA and EFSA implement them,” states Christina Rudén.

The issue of these criteria has been discussed endlessly within the EU administration since 2013, when the EC started work on formulating the criteria. The initial proposal was submitted in 2016 and was met by harsh criticism from several fields. The chemical industry found the criteria excessively stringent, while scientific and environmental organisations thought they were too lenient. The EC was therefore forced to make concessions before the present criteria could be accepted in April this year.

FACTS: What are endocrine disruptive chemicals?

  • These are chemicals that may disrupt the hormone systems in humans and animals. They may e.g. be carcinogenic or affect the metabolism, immune system or reproduction.
  • Humans are in daily contact with endocrine disruptive chemicals via e.g. food packaging, cosmetic products and clothing. We also consume endocrine disruptors via the residue of pesticides in food and drinking water.
  • It is extremely difficult to study the effect of endocrine disruptors on humans and animals, particularly as it takes a long time between exposure and effect. The most critical stage for exposure is the foetal stage, but the effect on animals and humans is most often not evident until much later in life.

(Sources: KemI, ACES, Baltic Eye)


Henrik Hamrén

science journalist