In real life we are all exposed to hundreds of chemicals from multiple sources including from food, consumer products, household dust and drinking water. The environment – rivers, oceans and countryside – is also polluted by hundreds of different substances, including pesticides, plasticisers, flame retardants and pharmaceuticals. However, current safety assessments of chemicals mainly focus on single substances.
Scientific research has shown that mixtures are a real-world issue, with mixtures of chemicals creating combination effects even if each individual chemical is present at levels below which it is known to cause an effect. In 2019, an important conference organised by the EU research projects EDCMixRisk and EuroMix highlighted once more the urgent need to act on this research by adopting more effective regulatory approaches, and the use of better assessment tools for tackling mixture effects.
For example, one project looked at chemicals that could be found in blood or urine of pregnant women in Sweden. Many of the chemicals identified were already known to be Endocrine Disrupting Chemicals (EDCs) and associated with adverse health outcomes in children. The scientists then looked at how a model mixture of these chemicals, at concentrations similar to those found in the women, would affect the development of a number of organisms and cell culture tests. These mixtures were found to cause adverse effects and dysfunctions in these animal and cell models; for example changes in reproductive organs and brain development. The overarching conclusion was that the current regulation of man-made chemicals – based on individual substances – systematically underestimates the health risks associated with combined exposures to EDCs, or potential EDCs.
Lack of progress in policy to protect from mixtures
Despite the growing scientific evidence EU decision makers have neglected the mixtures topic for many years. Back in 2009 EU Council conclusions invited the Commission to further assess this topic. In a Commission communication in 2012 the Commission promised to publish a report on the assessment of chemical mixtures by the end of June 2015 but this has still not seen the light of day. In addition, the Commission has failed to meet its obligations as outlined by the 7th EAP to develop and implement approaches to address combination effects of chemicals by 2020.
In 2019 EU environment ministers again called on the European Commission to introduce requirements in the relevant pieces of EU chemicals legislation to ensure that the combination effects of chemicals and the combined exposure of humans and the environment from all relevant sources are properly and consistently addressed in the risk assessment and risk management processes.
There are now new signs of progress, with discussions in the context of REACH and also progress to address this issue is expected in the upcoming EU Chemicals Strategy for Sustainability.
Dutch – Swedish initiative proposes to address combined exposure to chemicals in REACH
A new start was made at the recent “Workshop on a pragmatic approach to regulatory measures addressing the risk from combined exposure to chemicals – REACH as an example” organised by RIVM and KEMI in Leiden, the Netherlands, at the beginning of March. The participants expressed general support for learning from the latest research results and moving from science to policy action. CHEM Trust presented the NGO perspective on behalf of ChemSec, HEAL and EEB.
More specifically, the idea of implementing a Mixture Assessment Factor (MAF) under REACH was discussed. This would be an adjustment factor to use in the risk assessment of an individual chemical in order to reflect the potential for mixture effects. A 2019 joint statement from the Joint Research Centre of the EU Commission (JRC) and researchers from EDCMixRisk, EuroMix, EUToxRisk, HBM4EU and SOLUTIONS recommended an application of a MAF as a way to decrease the total burden of exposure to chemical mixtures.
It is an insurmountable task to assess the risk of all the different possibilities of chemical mixtures. Therefore, the MAF is proposed as a pragmatic tool to remedy the current flawed approach that a risk assessment simply compares the lowest effect concentration with the expected exposure and derives a concentration which is deemed safe, but completely ignores the mixture effects. According to the proposal, a MAF should be included in Annex 1 of REACH, which would mean that companies registering chemicals will have to integrate the MAF as an additional factor in their risk assessments (required for chemicals with a production volume above 10 tonnes per year).
Obviously the most important question regarding the effectiveness of any MAF will be its size; we and other NGOs propose 100, see below.
CHEM Trust perspective – good start but more is needed
In our joint NGO comments we share reasons for supporting the MAF as a generic approach; supporting a MAF of 100 in Annex 1 of REACH to account for the contribution of the chemical in a mixture; as well as the fact that substances from non-REACH sources (e.g. food contact materials, cosmetics, pesticides) would also contribute to mixture effects.
However, the MAF approach by itself is not enough to ensure people and the environment are properly protected and we therefore emphasise the need for additional action including:
- Establishing an overarching framework across EU laws for consideration of mixtures;
- Stricter risk management to minimise exposures to harmful substances of very high concern (SVHCs), in particular non-threshold SVHCs.
The next step on exploring a MAF approach in REACH is a planned discussion at the next REACH competent authorities meeting (CARACAL) on 30.6./1.7.2020.
EU Chemicals Strategy for Sustainability
The European Commission has committed to producing a new Chemicals Strategy for Sustainability as part of its European Green Deal. Last week the Commission published a roadmap for this new EU chemicals strategy including the recognition of the need to strengthen the regulatory framework to increase the level of protection from combinations of chemicals. Together with more action on EDCs, and a larger emphasis on grouping, CHEM Trust views the issue of combination effects as a priority for where real progress can be made and a significantly better protection of human health and the environment can be achieved.
Ninja Reineke, CHEM Trust Head of Science said:
“Addressing chemical mixture effects is an urgent task and was neglected for too long. After years of investments in EU research projects on mixture effects, it is now high time for decision makers to act. What is needed is an easy manageable tool like the mixture assessment factor to improve human and wildlife protection from mixtures of chemicals.
The new Chemicals Strategy for Sustainability must commit the EU to rapidly adopt new and more protective regulatory approaches.”
UPDATE: CHEM Trust submitted feedback on the report for the Swedish government Future chemical risk management – Accounting for combination effects and assessing chemicals in groups for the Swedish government (Inquiry Chair: Cristina Rudén).
