At the end of 2019 the European Commission opened a stakeholder consultation on a fitness check on European Union legislation on endocrine disruptors.
The fitness check aims to look at the coherence of different regulatory approaches to the assessment and management of endocrine disruptors; asking if the current legislation delivers its objectives to protect human health and the environment.
Here at CHEM Trust we are busy preparing our response to the consultation, which ends at the end of January. In the following article (first published in ChemicalWatch) we describe the key elements that need to be addressed to better protect people and wildlife from endocrine disruptors.
The EU has worked on legislative controls for endocrine disrupting chemicals (EDCs) for 20 years, with a range of delaying tactics from industry successfully slowing down the processes at various stages. As a result, despite some progress, the EU’s framework for controlling EDCs remains patchy.
Earlier this year, the outgoing European Commission started yet another review – a ‘fitness check’– instead of adopting immediate measures to minimise exposures to EDCs. What a feeling of déjà vu: How many times will CHEM Trust and other stakeholders be called upon to provide more evidence that current EU laws are not sufficient to protect human health and the environment from the harmful impacts of EDCs?
The results of the EU’s general fitness check on relevant chemicals legislation, published in June, already pointed out gaps in protection in particular for pregnant workers and children. Furthermore the report Endocrine disruptors: from scientific evidence to human health protection, commissioned by the EU Parliament’s petitions committee early this year, summarised the latest science and exposed many regulatory gaps.
Meanwhile, the political pressure to address the growing scientific concerns around EDC exposure has entered a new phase. The new European Commission president Ursula von der Leyen, who took up office on 1 December, has finally promised to “protect citizens’ health from environmental degradation and pollution, addressing air and water quality, hazardous chemicals, industrial emissions, pesticides and endocrine disruptors“.
In April, the European Parliament had had enough of the outgoing Commission’s inaction and adopted a resolution calling on it to make legislative proposals no later than June 2020 for specific provisions on EDCs to be added to the regulations for toys, cosmetics and food contact materials. This would also stop regulatory incoherences, such as a ban on a group of four endocrine disrupting phthalates in consumer products while no ban is yet proposed for their use in food contact materials.
The EU launches a new forum on endocrine disruptors
On 8 November the European Commission organised its first Annual Forum on endocrine disruptors in Brussels – one of the actions promised by a 2018 Commission Communication Towards a comprehensive European Union framework on endocrine disruptors. The evidence presented at this clearly demonstrated the following problems with the EU’s current approach to concerns over EDCs:
- the scientific knowledge is there. Research has shown that EDCs can impact on many different organs and cause serious and irreversible effects, have transgenerational impacts and non-monotonic dose response curves and act at very low doses;
- despite the maturity of knowledge to support regulatory action, EU law has not yet been adapted to minimise the exposure of people and the environment;
- the official EU identification of EDCs is excruciatingly slow: so far only two biocides, no pesticides and only 16 under REACH, now included in its candidate list. To put this into perspective, the list of potential EDCs compiled by US NGO TDEX has more than 1,400 substances;
- partly in response to slow EU action, several countries have adopted their own EDC reduction strategies (for example, France and Denmark), based on the scientific evidence that they contribute to serious diseases such as hormonal cancers, can impact brain development and the immune system, metabolism and reproduction; and
- several member states and NGOs called for a new EU EDC strategy, setting goals with a specific action plan including timelines – rather than the vague approach presented in 2018’s Communication.
The fitness check will investigate whether different areas of EU legislation are effective in protecting human health and the environment from EDCs, with special attention to vulnerable populations. The results are expected to be published in mid 2020 but will be subject to an impact assessment, however, and therefore not directly lead to specific actions.
Several consultations are planned as part of the fitness check, which the European Commission’s Joint Research Centre (JRC) will carry out. They begin with a stakeholder consultation planned from the end of November to end of January 2020, followed by further consultations.
Key elements for a way forward
CHEM Trust is part of the EDC-Free coalition that has adopted eight demands for an EU future without EDCs and submitted comments on the Commission roadmap for the fitness check this summer.
The main added value from this should be to build momentum on specific areas that need addressing to minimise exposures. Here are three priorities for the new Commission:
A crosscutting regulatory framework
A new approach for identifying and controlling EDCs across all relevant laws is needed, including detailed proposals for revisions or new legislation, with the aim of establishing coherent and effective protection. For example, EDCs should not be allowed in consumer products for daily use, such as in food contact materials, toys and cosmetics. Ideally, these substances should be removed from the market and substituted with safer alternatives. The best approach would be to have an identification system that will lead to regulatory consequences, in each of the specific legislative systems.
The need to identify and act on suspected EDCs
Although the EU has finally established criteria for endocrine disrupting pesticides and biocides, we cannot just directly reapply them in the context of other legislation due to the lack of safety data available for other chemicals. The current identification criteria for pesticides and biocides require the demonstration of an adverse effect in an intact organism, endocrine activity and a plausible link between the two. This burden of proof is too high for chemicals with less safety data. So we need to ensure that suspected EDCs – for which there is substantial information on such effects – are also captured and it leads to regulatory consequences based on the precautionary principle.
Extended information requirements to ensure sufficient data
The identification of endocrine disruptors is difficult because, in many cases, the information to give a clear conclusion is missing. CHEM Trust therefore welcomes the planned EU discussions under the Competent Authorities for REACH and CLP (Caracal) on an update of REACH annexes to add new standard information requirements for endocrine disrupting properties, including updated test methods. This is also needed in other sectors.
In CHEM Trust’s view the science shows that EDCs should always be treated as non-threshold substances with the approach applied to chemicals with PBT/vPvB properties under REACH. There can be serious and irreversible effects even at very low doses and many uncertainties in their risk assessment, including the critical role of the timing of exposure and the potential for mixture effects. Another important element of the regulatory solution is the use of a grouping approach in risk management. This can avoid replacing a proven EDC with a similar chemical that later turns out to have the same properties, which CHEM Trust has highlighted in the case of the bisphenols.
Impact assessment must cover all health costs
The fitness check must address all health costs, including impacts on brain development, the immune system and thyroid disruption and those due to adverse effects on the environment in order to properly cover the full costs and not just include those to industry.
A recent study for CHEM Trust has found health costs tend to be underestimated in many assessments, but costs to industry exaggerated according to a report by Swedish NGO ChemSec. This must be avoided in the fitness check on endocrine disruptors.
More research needed, but act now
The WHO/Unep state of the science report concluded back in 2012 the special concern of EDCs. This is due to their effects on the early development of both humans and wildlife. These are often irreversible and may not become evident until later in life.
As in every research field, there are still important questions to be addressed, for example: on the specifics of all the different health effects EDCs can lead to; patterns of exposure; and in the development of appropriate test methods that can adequately predict such properties. The EU’s funding of a new research cluster on test development, EURION, is therefore very much welcomed.
It is important to address the need for additional tests with relevant endpoints for endocrine disruption; improve the sensitivity of current test methods; and develop new in-vitro tests to investigate various ways of endocrine activity. However, this should not be taken as an excuse to justify further delay on regulatory action to protect the most vulnerable groups exposed daily to EDCs.
This fitness check could, at long last, be the European Commission’s chance to put their words into action and start long awaited measures to minimise exposures from endocrine disruptors. The current failure in properly protecting human health and environment from their adverse impact has been to a large part due to industry’s influence but also internal fights between Commission DGs, and a clear disregard by previous Commissions of the expressed wish of member states and the European Parliament to improve the EU framework and enhance the protection from these harmful chemicals.
It will be possible to minimise exposure to EDCs, by ensuring:
- their swift identification (including updated information requirements);
- inclusion of protective rules in all relevant EU legislation, with a focus on a phase out;
- publication of lists of both EDCs and suspected EDCs for more transparency; and
- bans in consumer products.
Transparency is also vitally important to enable businesses to substitute safer alternatives or technologies and achieve clean supply chains for a non-toxic circular economy. This is the way forward to protect the next generations and the environment from the serious and irreversible effects of EDCs.
This article is reproduced with permission from chemicalwatch.com