The European chemical industry has long been asking for regulation to be based on science, but also proportionate. It should avoid restrictions on chemical substances that would lead to the loss of useful products with no gain in chemical safety for people or the environment.
It is a priority for us and indeed the whole supply chain that chemicals should always be used safely, so that chemicals can always contribute to a high quality of life.
Defining endocrine disruption
Watch Peter Smith reiterating Cefic’s position on endocrine disruptors following the recent EU public consultation.
Public Consultation on Defining criteria for identifying Endocrine Disruptors in the context of the implementation of the Plant Protection Product Regulation and Biocidal Products Regulation.
Endocrine disruption is an issue of global interest. It is mentioned in many regulations and policies, such as REACH, the Water Framework Directive, the Biocides Directive and the Pesticides Regulation (find out how ECPA is making sense of endocrine disruption).
Many substances interact with the hormonal system without harming it. That means that endocrine-active substances are not necessarily harmful to organisms. The WHO definition of an endocrine disruptor requires more than an effect: it refers to substances that cause harm (adverse effects).
Unfortunately, people use the term too loosely: they say ‘endocrine disruptor' when there is any interaction with the endocrine system. We say that ‘disruption’ has to have a real adverse effect.
Our position is:
- That potency, a fundamental and well established principle of toxicology, should be considered as a key element for the identification of endocrine disruptive substances of regulatory concern. Ignoring potency could lead to the prohibition of many synthetic substances that have similar potency to everyday plant-based foods such as grains, vegetable and fruits.
- That a threshold, the level at which exposure to a substance is considered to be safe for human health and/or the environment, should be determined for endocrine disruptive substances (on a case-by-case basis) and should be used in the regulatory context.
- That a regulatory threshold is several times lower, thereby building in additional margins of safety, which means that exposure to endocrine disruptive substances can be considered safe for human health and/or the environment.
The endocrine system is complex and designed to respond to, and also filter out, external stimuli. Many plant-based foods contain substances (e.g. caffeine in coffee, gingerol in ginger, carrots, soy beans etc), which may interact with the hormonal system without leading to “disruption” or harm. We call these “adaptive responses”, because they are both temporary and reversible.
The same is true for many synthetic substances, so it is important to distinguish between harmless and harmful interaction. Only a few substances can damage the function of the hormonal system, and only those should be regulated as endocrine disruptive substances.
Deciding whether a substance is harmful or not needs to follow on robust scientific evidence, i.e. taking into account key factors such as the potency and severity of effects, as well as their (ir)reversibility.
If there is sufficient evidence that harm may be caused, then regulators and industry should and can take risk management measures to protect people and the environment. This is done by ensuring that the substance is only used safely, and that any incidental exposure is well below the safe threshold.
Committed to supporting health and environmental safety, Cefic will continue to contribute its expertise to the work of the European Commission, OECD and EU member states, developing a framework for systematically identifying substances with endocrine properties of concern.
Read the interview with Craig Barker, Cefic product stewardship and regulatory affairs manager, about endocrine disruptors.
For more information about Cefic positions and joint statement on endocrine disruptors, visit the document page.
WHO-UNEP State of the Science on Endocrine Disrupting Chemicals 2012
In early 2013 the United Nations Environment Programme (UNEP) and the World Health Organization (WHO) published a report entitled, “State of the Science on Endocrine Disrupting Chemicals – 2012” which was accompanied by a “Summary for Decision Makers”. At the time the general chemicals and crop protection products industries both in Europe and the US held significant concerns with the report(s).
Our industries therefore jointly commissioned a scientific review of the WHO-UNEP report, published in the scientific journal Regulatory Toxicology and Pharmacology. The scientific review highlights a number of significant shortcomings with the WHO-UNEP report and its conclusions. It particular the review concludes that the WHO-UNEP report does not accurately reflect the state of the science on endocrine disruption.