New Swedish report about Future Risk Management of Chemical Mixtures

In a new report to the Swedish government, researchers state that future chemical risk management must account for combination effects and assessing chemicals in groups. Today's legislation is not enough.

Tens of thousands of individual chemicals are currently available on the EU and global markets, either as more or less pure substances or as technical mixtures (for example paint and glue). We have learned to appreciate the positive aspects of chemical use, but we don’t have full knowledge of the effects. It has been estimated that 95 percent of all goods is directly linked to chemicals or chemical processes. Therefore, the flow of products and materials in society can indeed be seen as a flow of chemicals. This also means that throughout life, humans and other organisms are exposed to complex mixtures of chemicals of varying degrees of harmfulness. How does that affect us? And our environment? Whose responsibility is this and what could be done about it?

The report calls for major changes in the legislation

The Swedish report Future chemical risk management (SOU2019:45) shows that major changes need to be made to the current chemical control system. Substances are almost always considered one by one in current risk assessments. The science is clear: the risk with a mixture is usually greater than the sum of each chemical alone. Today's legislation thus means a systematic underestimation of environmental and health risks.

Download the report - Future chemical risk management (SOU2019:45)

Today, each substance is allowed to be emitted up to 100 percent of the level considered safe. In this way, the regulations assume that each chemical is released into a completely separate part of the world, where no other chemicals may be present. This is an assumption that the researchers in the report find unreasonable. The report concludes that limits should be lowered so that emissions of one single chemical may only amount to a maximum of ten percent of what is considered safe. Such a measure would lead to a general reduction in chemical risks and help to manage combination effects.

In an interview at Stockholm University, Christina Rudén, professor in Regulatory ecotoxicology and toxicology and the leader of the inquiry, says that “To ensure a high level of protection for humans and the environment, coordinated action is required at different levels and within different parts of the regulatory system. It will take time and cost money and must be seen as a complement to everything else that is already being done today,”.

Read the full interview with Christina Rudén at the Stockholm University webpage.

Eleven recommendations with two objectives

The needed changes are summarized into eleven recommendations that have two objectives:

  1. to improve the regulatory assessment and management of risks from exposures to unintentional chemical mixtures,
  2. to strengthen group-wise approaches to hazard and risk assessment with the aim to support the implementation of the substitution principle, and to make chemical regulation more efficient.

The recommendations are derived from the reviews of the existing legislation and the scientific state-of-the-art background described in the report.

The report presents eleven recommendations on how modern European chemical regulation can keep up with this complexity of chemicals surrounding us.
1. Establish consistent requirements for mixture risk assessments in all pieces of chemical legislation
2. Establish cross-cutting European legislation on chemical pollution with a focus on mixture risks
3. Establish a Human Health Directive that protects the human population from the combined action of chemicals and non-chemical stressors
4. Establish a database on the use and emissions of chemicals
5. Establish a research program on real-life exposure patterns to chemical mixtures
6. Use an allocation factor to account for the total risk of chemical mixtures
7. Establish the substitution principle in all relevant pieces of legislation
8. Strengthen the mandate in REACH* to manage groups of chemicals
9. Establish a system for flagging chemicals as suspected SVHCs* under REACH* based on a group-wise assessment and read-across
10. Strengthen requirements for mixture risk assessment and grouping in the upcoming revision of the Water Framework Directive
11. Establish a Swedish interagency task force on mixture risk assessment

The expert team behind the inquiry and the report

Sex personer
From left: Thomas Backhaus, Michael Faust, Per Bergman, Christina Rudén, Daniel Slunge, and Linda Molander. 
Photo: Miljödepartementet

In March 2018, the Swedish government decided to commission a Special Inquiry with the task to investigate how the group-wise management of hazardous chemicals can be improved, and how ‘‘combination effects’’ can be taken into account in regulatory risk assessment (Miljödepartementet Dir. 2018:25).

Read about the Special Inquiry at the Swedish government website.

Christina Rudén from the Stockholm University was appointed as the special investigator. She brought together a team of experts consisting of;

  • Thomas Backhaus (professor in ecotoxicology, FRAM Centre, University of Gothenburg),
  • Per Bergman (lawyer and former General Counsel at the Swedish Chemicals Agency),
  • Dr Michael Faust (environmental scientist, independent environmental consultant),
  • Dr Linda Molander (toxicologist, Public Health Agency), and
  • Dr Daniel Slunge (economist, FRAM Centre, University of Gothenburg)

In addition, the group consulted a number of national and international experts, from different government agencies, industry, the academic community, and various non-governmental environmental organisations.

The FRAM Centre participated with two researchers in the team producing the report.
FRAM director Thomas Backhaus was responsible for the mixture risk assessment part of the inquiry.
– The recommendations we give are important to include in modern risk assessment and account for the complex exposure situations we experience today. They will contribute to achieving important health and environmental objectives as well as the sustainable development goals and the Swedish environmental quality goal of a non-toxic environment, says Thomas Backhaus.

FRAM researcher Daniel Slunge was in charge of the impact analysis and how benefits to society of implementing the recommendations compare with the societal costs of more restrictive use of chemicals.
– I see our recommendations as cost-effective ways to tackle serious environment and health concerns compared to treating chemical pollution at a later stage. In similarity with the conclusions from the recent evaluation of REACH, the most ambitious chemical regulation in the world, we assess that the benefits of implementing our recommendations will be much larger than the associated costs. And we don´t foresee significant impact on the competitiveness of Swedish or European industry from implementing the recommendations.

Get to know more

The report was presented to the Ministry of the Environment on Friday, the 8th of November.
On December 5, Christina Rudén will come to Gothenburg and present and discuss the inquiry at an open FRAM seminar held at the Museum of World Culture.

Find more information about the seminar with Christina Rudén and how to register here.

REACH is an EU Regulation (1907/2006) that entered into force on 1 June 2007. REACH was adopted to improve the protection of human health and the environment from risks that may be caused by chemicals, while at the same time increasing the competitiveness of the EU chemicals industry. REACH stands for registration, evaluation, authorisation, and restriction of chemicals. SVHCs are “Substances of very high concern”, considered as especially hazardous, and require authorization under REACH and are listed on the so-called 'Candidate list'.

Learn more about REACH.
Learn more about the Candidate list.