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What does the EU's new chemicals strategy say when it comes to chemical mixtures? Many "wows" and "buts" were expressed during the FRAM Seminar on the topic.
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How the EU's new chemicals strategy relates to chemical mixtures

The European Commission published the Chemicals Strategy for Sustainability on 14 October. What does this strategy mean for chemical mixtures? Will it be effective? Is anything missing? These issues were part of the discussion in FRAM's seminar on the strategy concerning mixtures, which was held on 3 December.

Urban Boije af Gennäs works at the Swedish Chemicals Agency and was, until recently, Seconded National Expert at the European Commission and working with the strategy. He started the seminar by giving an overview of the content of the new chemical strategy.

Get to know the new chemicals strategy

The name of the strategy is the EU Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment and is based on several extensive policy evaluations regarding for example, batteries, pharmaceuticals, drinking water, fertilisers.

Download the EU Chemicals Strategy for Sustainability – Towards a Toxic-Free Environment

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Urban Boije af Gennäs
Urban Boije af Gennäs works at the Swedish Chemicals Agency and was, until recently, Seconded National Expert at the European Commission and working with the strategy. He started the seminar by giving an overview of the content of the new chemical strategy
Photo: Via Zoom

The chemicals strategy includes the vision “Towards a Toxic-Free Environment” and Urban Boije af Gennäs said that this is a change.

– The idea behind this vision is to be more pro-active and preventive than the current chemicals policy. It tries to avoid problems and exposure before it occurs rather than spending time trying to clean up or stop already occurring exposure, said Urban.

The new vision is supposed to be achieved through the implementation of 56 concrete actions, with deadlines. These actions concern five building blocks or areas of action:

1) Innovating for safe and sustainable EU chemicals

  • Safe and sustainable-by-design: defining properties for these chemicals to have a common idea of the term and also support networking and financing of innovation and commercialisation.
  • Non-toxic materials cycles: improving the information and tracking of chemicals contents in materials and products, through the whole cycle of production, use, and recycling.
  • Innovating industrial production: to include other sustainability aspects like low carbon impact, use of renewable energy in production, etc.
  • Strengthening the EU’s open strategic autonomy: to secure the supply of different chemicals.

2) Stronger EU legal framework to address serious environmental and health concerns

  • Protection against the most harmful chemicals: to apply a more generic approach to substances of very high concern (SVHC) with more group-wise and broader restrictions to protect children, general consumers, and professional consumers.
  • Endocrine disruptors: establish horizontal criteria for identification of these substances and include them in the SVHC under the REACH legislation.
  • Chemical mixtures (combination effects of chemicals)
  • Chemical pollution harmful to the natural environment pinpoints specific substances of particular interest to the environment, among them substances that are very toxic, persistent, and very mobile.
  • PFAS: general ban for the use of PFAS with the possibility of derogation for sustainable uses. Supports research and innovation on substitutes and remediation for PFAS.

3) Simplifying and consolidating the legal framework

  • Coordination and simplification: “one substance, one assessment” to improve risk assessment across legislations and cooperation between authorities and scientific bodies involved in the risk assessments.
  • Methodologies and data: improve access to and sharing of data, to set up a common data platform.
  • Zero tolerance for non-complianceenforcement: improve compliance of REACH registrations and to have the possibility of stronger measures when there is non-compliance.

4) A comprehensive knowledge base on chemicals

  • Strengthening of information requirements: improve information requirements on chemicals by adding new categories of chemicals.
  • A strengthened chemical science-policy interface: having a more comprehensive and long-term agenda for research and innovation with a set of indicators.

5) Setting examples for global chemicals management

  • International leadership: meeting the Global Sustainability Objectives and adopt the global goals for chemicals, work in the SAICM process.
  • Cooperation with third countries: promote multilateral, regional, bilateral cooperation, and no export of chemicals banned in the EU.

Introducing the Mixture Assessment Factor

There are specific actions in the strategy that aims to protect people and the environment from the combined effects of chemical mixtures.

– Strengthening the legal framework to include generic risk assessment and grouping approaches is very important. One action is to assess how to introduce a Mixture Assessment Factor under REACH, another is to introduce or reinforce provisions to take account of the combined effects in other relevant legislation. To work across legislations could also be important to address mixtures, said Urban.

In addition to the list of actions, other aspects are also mentioned that concerns mixtures. For example, to continue to develop methodologies to assess mixtures in the pesticide’s regulation and further develop targeted methodologies for specific policy areas.

– The idea is to open legislations like REACH and CLP to introduce measures, to improve, for example, the assessment of mixtures, said Urban.

Learn more about the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation.

Learn more about the Classification, Labelling, and Packaging (CLP) Regulation.

The next steps regarding the handling of mixtures, according to Urban, are first to introduce a roadmap for an inception impact assessment of the revision of REACH which is to be published soon. This will include a Mixture Assessment Factor. Secondly, a study will be launched on provisions for introducing a Mixture Assessment Factor in REACH.

– The terms of reference are being drafted now and the results may feed into a general impact assessment of the revision of REACH. I also want to mention that there will be possibilities to provide input on this.

Finally, Urban listed a few areas in which aspects of chemical mixtures are missing or less clear.

– The introduction of a Mixture Assessment Factor is only limited to REACH, it is not said that it should be applied in other legislations, only in a much more overall way. Also, there is still no legal mechanism to manage mixtures across legislations or areas of use.

– Furthermore, in general in the strategy, pesticides, biocides, and pharmaceuticals are largely absent. There are few or no concrete actions regarding this, which is of course a problem in relation to mixtures, as these kinds of chemicals are often important in mixtures.

Together with the strategy, a series of background documents, so-called “Staff working documents” were published. One of these was regarding the assessment and management of combined exposures to multiple chemicals and associated risks. This includes the state of the science and the development of chemical mixtures during the last decade.

On the question of whether imported chemicals are included in the strategy, Urban answered that they are mentioned but the strategy is not very clear.

– It refers, to a large extent, to the work done under the action plan for a circular economy where there is a sustainable products initiative being developed. This is supposed to deal with some aspects or problems with chemicals in products – or articles as the strategy calls it. But I have a feeling that this could fall between the cracks. So, this is an area to keep an eye on, finished Urban.

What does the industry think about the strategy?

The next speaker was Kristina Neimert Carne who is the Head of Chemicals Policy at IKEM – Innovation and Chemical Industries in Sweden. She started by explaining the role of chemicals in modern life. Chemicals are everywhere, in everything and the chemical industry is supplying most other industries with chemicals for their production. Everyday products like soap, detergents, batteries, and food are all made with chemicals. Also products that are needed for sustainable living, such as solar panels and wind turbines, need chemicals – and even more chemicals will be used tomorrow.

– With that in mind, we are very happy that the commission has recognised the use, the essential use of chemicals in this strategy. We think that the strategy is very good, and we really welcome it. We know that there are problematic chemicals on the market, and we know that we have to remove those from the market. However, innovation has not waited for this strategy to happen. Companies react to consumers or consumer needs every day, said Kristina.

For IKEM, it is good that the strategy points at a uniform definition of safe and sustainable-by-design. For the companies it is good to have a common understanding of what is seen as sustainable when they are developing new and better chemicals.

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Kristina Neimert Carne
Kristina Neimert Carne from IKEM said that the strategy is very good, and that IKEM welcomes it. However, it comes with a lot of challenges.
Photo: Via Zoom

However, Kristina also said that the chemical strategy comes with a lot of challenges.

– Despite the massive number of components in the strategy and its broad scope, we believe that the commission has missed a bit on the connection to the Green Deal. We had expected this to be more of a growth strategy. We miss the clear incentives that the industry needs to invest in research, development, and green production, said Kristina.

Regulatory predictability is a key component for investments. The strategy lacks the ambition to drive massive amounts of investments. There are suggestions but they are a bit vague.

– We don’t see the key-value chains, and dependencies of those value chains, and that is the kind of information that we need to know, to define business strategies, said Kristina.

The trickiest question, according to Kristina, is only briefly mentioned in the strategy. It has to do with how to determine which properties the chemical compounds should have, or rather not have.

– This challenge will remain tomorrow if we don’t put a lot of effort into finding better and more efficient tools to predict chemical risks.

Kristina also said that there are no chemical companies that want to invest in new chemicals that after years of development, turn out to have unwanted properties.

She ended her presentation by saying that the implementation of this strategy requires cooperation and coordination between industry, authorities, academia, civil society, and politicians – and between authorities involved.

The chemicals strategy from an environmental NGO’s point of view

Dr. Anna Lennquist works with toxicology and substitution at the International Chemical Secretariat, Chemsec. Her aim was to give the environmental perspective on the chemical strategy.

Anna Lennquist started by emphasising the urgency of the issue that the chemical strategy aims to tackle. Chemical production has doubled between 2000-2017 and is expected to double again until somewhere between 2030 and 2040. It’s also the second largest industry in requiring energy.

The rapid development of new chemicals is challenging.

– It is a problem that the production of new chemicals is so much quicker than the knowledge generation of what properties they have, said Anna.

What is known however, is that there are hundreds of manmade chemicals in the blood of each person. It is also known that these chemicals can be linked to health effects and biodiversity loss.

Anna Lennquist from Chemsec:

I almost got goosebumps when I read it in October!

Chemsec welcomes the strategy since it acknowledges the urgency of these problems and is a step forward from the REACH regulation. It also covers important key areas, it is very ambitious in terms of the timed, clear actions, and its focus on the implementation.

– We know that 90% of the illegal chemicals that are found when governments are measuring products for chemicals, comes from imported articles. Even if European companies are doing their homework, we are getting things into the EU through imports, and the companies who do their homework are not well rewarded. The others can just keep using chemicals that are bad because the implementation and the reinforcement are so weak. In the new strategy, people can not get away when not following that, said Anna.

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Anna Lennquist
Today, the companies who do their homework are not well rewarded and the others can just keep using bad chemicals. In the new strategy, people can not get away with that, said Anna Lennquist from Chemsec.
Photo: Via Zoom

Anna also appreciates the toxic-free hierarchy where there is generic risk management for all consumer products and that all hazardous chemicals shall be substituted, with the exemption of essential use.

Another important thing that Anna points out is that there will be “new” hazard categories acknowledged in the classification and regulation. One example is the endocrine-disrupting chemicals, another is mobile chemicals (rather than bio cumulative). There shall also be a joint hazard identification across regulations.

– A hazardous chemical is a hazardous chemical no matter the use of it, explains Anna.

Anna also highlighted that the circular economy is mentioned in the strategy.

– I think it is important that the chemical strategy states that we need to have the same requirements for recycled material as we do for virgin. We cannot continue to circulate toxic chemicals in the loop even though we are striving for more recycling, said Anna.

She also said that transparency is an important key point in circularity.

– We need to know better what we have in the materials that are in use today so that we can use them tomorrow.

Market transition is another area that Chemsec thinks is important. The chemical strategy does not see the industry as a whole but wants to reward front-runners. It acknowledges that there are companies that are progressive and are going in the direction of a sustainable society.

When it comes to chemical mixtures, Anna said that she is very glad that unintentional mixtures are addressed in the strategy.

– This has been an important gap in the regulation for a long time, said Anna.

Research has shown that there is a problem with real-life scenarios, with exposures, in particular for pregnant women and small children. It is also shown that this problem cannot be tackled case by case. There are too many chemicals in too many combinations.

– We cannot predict a mixture in every situation. We have to do this somewhat pragmatic and effective, said Anna.

Introducing the Mixture Assessment Factor is both pragmatic and effective, according to Anna, when it comes to stepping up the level of protection. It is not possible to have a safe level on each chemical; they need to be seen together. She said that it needs to be science-guided but in the end, the exact size of the Mixture Assessment Factor, will be a policy decision.

Are there any negatives to say about the chemical strategy?

– Actually, I am quite rosy. I almost got goosebumps when I read it in October, said Anna. But of course, there are challenges. It includes a lot of things, there are short times and a lot of stakeholders need to come together.

She also added that it is important to get the definition of, for example, “safe and sustainable chemicals” and “essential use” right. Other concerns are what will happen when REACH is opened, and what the impact assessments will result in.

The strategy in relation to research about chemical risk assessment of mixtures

Professor Thomas Backhaus is the FRAM Centre Director and works with risk management of chemical mixtures. He agreed with the previous speakers and said that the new chemical strategy for sustainability is a great step forward.

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Thomas Backhaus
FRAM researcher Thomas Backhaus said he has mixed feelings about the new chemical strategy. "We need to be sure that we are also accounting for the details to implement things in a long-term, sustainable and sound way to move things forward."
Photo: Via Zoom

When going into detail about the strategy, Thomas started to focus on the issue of chemical mixtures.

Cumulative exposure is still not counted for

Thomas Backhaus started with stressing that the registrant is not obliged to take into account the exposure to the same substances from other manufacturers or importers. (REACH Guidance on information requirements and chemical safe assessment, chapter R20). One example he presented was that for the chemical Bisphenol A there are as many as 64 registrants in the ECHA database, with the same or different purposes of use.

– We simply do not know how the total exposure piles up in the end, said Thomas.

According to Thomas, the conceptual picture within REACH is that there is only one company affecting the environment – but in reality, there are many.

– This leads to an underestimation of the overall risks that we have, he said.

Thomas Backhaus:

We simply do not know how the total exposure piles up in the end.

Uneven consideration of different chemical groups or regulatory areas

When it comes to the time plan, which also Anna and Urban mentioned, Thomas said that it is ambitious and wants to push things forward. However, the chemicals that are listed in the action plans are only chemicals in water, food contact materials, food additives, toys, detergents, and cosmetics. The important area of pesticides is missing.

– We know that we have a problem with pesticide mixtures, with empirical data for all chemical groups of pesticides, but they are not listed here as an area where action is going to happen soon.

Pesticides are mentioned in the strategy but not clear enough, according to Thomas. It mentions that existing provisions shall be fully implemented. However, when looking at the PPP regulation the accumulative effect on the environment is not clearly stated.

– We need to expand here. Otherwise, we are losing the environmental compartment completely, said Thomas.

The necessary holistic perspective is underdeveloped

To illustrate this problem, Thomas Backhaus presented the results from a study made in a small water stream north of Gothenburg. In total, a mixture of 84 chemicals was found. Only 37 of these might fall under REACH – only half of the chemicals. This is problematic, according to Thomas, since the chemical strategy aims to introduce the Mixture Assessment Factor in REACH.

– We really need to be careful that we are not overlooking 50% of the chemicals we are dealing with, said Thomas. We need to look into this. How do we get the holistic view so that we are looking at all the chemicals that we are finding in the environment or in a human body?

All in all, Thomas Backhaus said he has mixed feelings about the new chemical strategy.

We need to be sure that we are also accounting for the details to implement things in a long-term, sustainable and sound way to move things forward.

See the video from the recorded webinar.

Video (1:24:08)
How the EU's new chemicals strategy relates to chemical mixtures
The European Commission published the Chemicals Strategy for Sustainability on 14 October. What does this strategy mean for chemical mixtures? Will it be effective? Is anything missing?
The EU’s chemicals strategy for sustainability towards a toxic-free environment

The European Commission published a chemicals strategy for sustainability on 14 October 2020. It is part of the EU’s zero pollution ambition, which is a key commitment of the European Green Deal.