Chris Turner explains the changing EU regulations on endocrine disruptors and why smart companies are reviewing their products for chemicals that may be restricted or banned in future.
While the number one environmental issue for the public and media at the moment is plastic waste accumulating in the world’s oceans, other concerns haven’t gone away. One area that continues to attract the attention of regulators is that of chemicals known as endocrine disruptors.
In my last blog on endocrine disruptors I looked at how the EU Commission had finally adopted scientific criteria for identifying chemicals that have endocrine disrupting properties. With this major step forward now completed, the Commission has turned its attention to the bigger picture – its overall strategy on endocrine disruptors.
Updated endocrine disruptor strategyThe new strategy – a comprehensive overhaul and update of 1999’s Seventh Environmental Action Plan and Community Strategy for Endocrine Disruptors – seeks to address several important gaps in the data:
- The impacts of endocrine disruptors on wildlife and their effects on the development of diseases in humans. Crucially, what is the specific contribution of exposure to endocrine disruptors and can this be separated from other factors, such as nutrition and lifestyle?
- Whether the ‘safe threshold’ toxicological principle can be applied to endocrine disruptors. After much debate some toxicity experts believe that safe thresholds cannot be established for endocrine disruptors.
- To fully understanding the effects of combined exposure – the “mixture/cocktail” effect.
- Development of safer alternatives.
- The mechanism of action of endocrine disruption.
- Minimize the overall exposure of humans and the environment to endocrine disruptors, particularly during important periods of development such as fetal development and puberty.
- Accelerate the development of a research base for effective forward-looking decision-making.
- Allow all stakeholders to be heard and to work together.
A coherent approachEU chemical regulations have developed at various times and with varying objectives, leading to different approaches to endocrine disruptors in regulations for different sectors, such as cosmetics, biocides or industrial chemicals. Two points deserve particular attention:
- Using the same definition of endocrine disruptors across all EU legislation – one based on the broadly accepted World Health Organisation definition [see below]. This is known as the horizontal approach. The aim is to provide legal certainty and to avoid the risk that the same substance could be identified as an endocrine disruptor under one set of legislation but not another. While the recently agreed criteria move towards a common definition, other EU legislation does not follow those guidelines. This will be considered further.
- A chemical can currently be regulated differently under different pieces of EU legislation. For example:
- For pesticides and biocides, the precautionary principle applies and a product cannot be approved for use if it is identified as an endocrine disruptor.
- Under REACH, endocrine disruptors can be identified as Substances of Very High Concern and subject to authorization or restriction – but not banned completely.
- The Cosmetics Regulation does not mention endocrine disruptors specifically, but they are considered along with other hazardous substances.
The Commission will launch a comprehensive review of existing legislation to assess whether it delivers on the overall objectives to protect human health and the environment.
This will include a cross-cutting look at endocrine disruptors that will analyse how different provisions for them interact, identify any possible gaps, inconsistencies or synergies, and assess the collective impact in terms of costs and benefits for human health and the environment. It will pay particular attention to those areas where there are no specific provisions for endocrine disruptors, such as toys, cosmetics and food contact materials.
There will also be a focus on protecting vulnerable groups.
Promoting an active dialogue
The Commission plans to organize an annual forum on endocrine disruptors, bringing scientists together with public and private stakeholders to exchange information and best practices, identify challenges and build synergies. This promises a new type of dialogue, one where the public will be able to communicate their views directly to the Commission.
This should be a positive development and it will be interesting to follow the level of public engagement, particularly in those countries where consumer protection NGOs are very active.
There will also be increasing support for the work of international organisations, such as the OECD. The Commission will also develop a ‘one-stop shop’ web portal on endocrine disruptors, making it easier and more transparent for citizens and stakeholders to keep up to date with all the latest developments.
What does this mean for businesses?
It’s clear that the regulation of chemicals will continue to change rapidly in the years to come and nowhere is this truer than for endocrine disruptors.
To get ahead of the game, companies should review their products and highlight those chemicals that may be restricted or even banned in future. Finding cost-effective alternatives that perform well can be difficult and time consuming.
How can Anthesis help?
Anthesis has experts who can guide businesses in assessing the risk to their product portfolio and advise on alternatives.
To talk to us about how we can help in this developing area of chemical regulation, please contact Chris.Turner@anthesisgroup.com or fill out the form below.
Read our three further blogs about endocrine disruptors:
Endocrine Disrupting Chemical Regulation - Could Your Product Be Affected? Read more.
Endocrine Disruptors And REACH Authorization. Read more.
Report from the 7th International Fresenius Conference on Endocrine Disruptors, 2016. Read more.
The WHO definition of endocrine disruptors is widely accepted and is used as the basis for the EU criteria. The key points to note are that any health effects caused should be adverse, in other words an individual’s ability to function normally is impaired, and also any effects should be in an intact organism, which means that it should not already be suffering from some other damaging effect.
The WHO describes an endocrine disruptor as:
An exogenous [ie. externally applied] substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations.
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