Baltic Breakfast: New approaches can improve chemical management

“The Baltic Sea is swamped by chemicals that might have been banned if the management system had worked more efficiently,” says Ellen Bruno, introducing the final Baltic Breakfast seminar of 2025.

Marlene Ågerstrand, from the Department of Environmental Science at Stockholm University, has been researching approaches that could lead to more efficient chemical management.

She says that globally, the amount of chemicals used per person per year is continuously increasing.

“These chemicals are, in many ways, unknown to us in terms of their hazardous properties and the exposure we face.”

Globally, there are at least 350,000 registered chemicals in use, 40,000 to 60,000 of which are used extensively. However, information is available on just 10,000 chemicals, and only 500 of them have undergone thorough assessment.

"This is a problem. If you don't have sufficient knowledge, you cannot manage them properly,” Marlene Ågerstrand says.

In addition to the significant knowledge gaps, the regulatory process is slow, which delays management. Under EU regulation REACH, it takes approximately 19 years from registration to the regulation of a hazardous chemical, and even longer for a general ban to be implemented.

Successful regulation is proactive and effective

Marlene Ågerstrand points out that three key characteristics are desirable for successful chemical regulation.

“Firstly, we want to have a proactive regulation. We want to identify hazards before exposure occurs. Secondly, we want an effective regulation, meaning that when we have identified a hazard we need be able to act to ban or to limit the use of the chemical in some way to protect human health and the environment.

The third key characteristic is that we want a regulation that is up to date with science – a regulation that takes new knowledge and new technologies into consideration and make use of it.”

Identification must lead to action

A cornerstone of EU chemical regulations is the CLP Regulation (Classification, Labelling and Packaging).

“This is a tool that provides us with the classification of a hazard of substance and then connects to other regulations downstream, that is responsible for risk management measures,” explains Marlene Ågerstrand.

For example, if a substance is identified as carcinogenic, it could be banned or prohibited for use as a pesticide or in consumer products, such as toys or cosmetics.

However, when it comes to certain hazards, such as when a substance is hazardous to the aquatic environment, this connection is weaker.

“When something is identified as hazardous to the aquatic environment, we can still see a continued use,” says Marlene Ågerstrand. “We need to connect regulations and make sure that we have actions ready for the problems that we see.”

One positive development is the new classifications in the CLP regulations, whereby substances can be categorised as endocrine disruptors, persistent bioaccumulative and toxic (PBT) substances, or persistent, mobile and toxic (PMT) substances.

“This is great. But we have a lack of connection to actions that will reduce the risk for some of the substances, so we need to continue working on connecting regulations and making sure that identification leads to actions,” says Marlene Ågerstrand.

Hazard-based or risk-based approach?

The difference in how chemicals are handled stems from the fact that different approaches are being used. With a hazard-based approach, actions are taken once a hazard has been identified. With a risk-based approach, identification of a hazard is followed by an exposure assessment and risk conclusion. For a substance to be banned under the latter approach, it must be both hazardous and pose a risk; however, it may be permitted for use in certain ways, for example with protective gear.

“Compared to the hazard-based approach, we have found that this approach presents more challenges and leads to unnecessary exposure to human health and the environment," says Marlene Ågerstrand.

“One reason for that is that it is very difficult to understand the actual exposure of a chemical. We have seen over and over again that we tend to underestimate the actual risk.”

Marlene Ågerstrand and her colleagues therefore advocate a transition to a more hazard-based management approach, in which the identification of hazards triggers immediate action, bypassing the need for a risk assessment.

Accounting for the effects of mixtures

Another issue with today's chemical regulations is that substances are assessed individually, despite the fact that humans and other organisms are exposed to mixtures of substances.

“This means that we are systematically underestimating the risk in our management of chemicals, despite the overwhelming evidence that this is not correct”, says Marlene Ågerstrand. "Numerous experiments show that effects which are not individually problematic for an organism become problematic when they are mixed."

If information on all the chemicals in a mixture to which we are exposed and their respective effects were available, it would be possible to make more accurate assessments of the overall impact. However, as this is not possible, researchers have suggested the use of a so-called 'mixture allocation factor'. Marlene Ågerstrand explains how this could work, using a glass as an example.

The glass represents the maximum exposure an organism can undergo without experiencing a negative effect. When more chemicals are added, the quantity of each one must be reduced to prevent the glass from overflowing.

Depending on the mixture, research suggests that each chemical should be reduced by a factor of between 5 and 300 to prevent negative effects.

Regrettable substitution

Yet another problem within chemical regulation is regrettable substitution. Once a chemical has been identified as problematic and banned, the industry switches to using another chemical that is structurally very similar and therefore later turns out to have the same properties as the original chemical.

Marlene Ågertrand uses Bisphenol A as an example, which has been substituted by other bisphenols after being banned. Given that it took 15 years or more to determine the effects of Bisphenol A, it is reasonable to assume that assessing and banning all the bisphenols one by one would take a long time. One solution to this problem is grouping, whereby chemicals are assessed as a group.

“We have knowledge about one substance and we transfer that knowledge to the other substances in the group, and say that unless we have evidence of the opposite they will be treated the same way and we will ban all of them,” explains Marlene Ågerstrand.

This approach has been discussed at EU level for five bisphenols, but the outcome is still unclear.

Persistence – problematic in itself

Today, chemicals are generally regulated based on their toxic properties, with their persistence or bioaccumulative properties also sometimes being taken into account. However, Marlene Ågerstrand points out that history has shown persistence to be grounds for regulation in itself, since several examples of the use of persistent chemicals (such as CFS and PCPs) were not initially identified as problematic.

“When they later become a problem it's too late, or it’s very costly and very difficult to remove them from our society and from our environment,” she says.

A current example is PFAS, where the EU is now discussing a ban on the manufacture, import and use of over 10,000 PFAS based on persistence alone using the grouping approach.

“This is heavily discussed so we don’t know if it will fly or not.”

Although the new methods and approaches, such as grouping, have been developed in collaboration between scientists and regulators, there are strong forces opposing them, partly because they would be effective, says Marlene Ågerstrand. According to her, there are two main things needed globally when it comes to chemicals.

“We need to reduce our use of hazardous chemicals, and we need to reduce the total use of chemicals and the methods presented here will address that, maybe not to a sufficient level but they will do a take a first good step in that direction and that's why we see this strong lobbying against all these methods.”

Since the EU Chemicals Strategy for Sustainability was first presented in 2020, the focus has shifted towards simplification for industry and promoting industrial needs.

“I feel that this might be at expense of human health and the environment”, says Marlene Ågerstrand.

The essential use concept

Romain Figuiere, a colleague of Marlene Ågerstrand, recently finished a PhD focusing on another approach with the potential to improve chemical regulation: the essential use concept.

This concept was first introduced in the 1987 Montreal Protocol, which was created to regulate the use of CFCs (also known as Freons), which cause ozone depletion.

The parties agreed that CFCs should be banned by default, unless their use was 'essential', defined as necessary for health or safety, or critical for the functioning of society, and no safer alternative was available to provide the same function.

When the European Commission published the chemical strategy for sustainability in 2020, they suggested to implement the essential use concept in the European chemical regulation, REACH, for the most harmful substances in use. In 2024, guidance was published on how this could be achieved.

“The whole purpose of my research was to try to implement the concept in practice and see what type of information we need and whether we can include it in chemical regulations,” says Romain Figuiere.

Assessing essentiality in three steps

Romain Figuiere explains that to assess the essentiality of the use of a chemical, three questions must be asked. The first is to determine whether the function provided by the chemical is necessary. Does the technical function delivered by the substance in question need to be present in the final product?

The second question aims to evaluate the necessity of the use for society. Is the use necessary for health and safety, or critical for the functioning of society?

The third question is whether there are safer alternatives available from the standpoint of human health and the environment.

To answer the first question Romain Figuiere is using the so-called functional substitution approach, that was developed in the United States in 2015.

This approach distinguishes three levels of function. The first level is the chemical function of the substance, which is basically determined by its physical and chemical properties (it could for example function as a solvent or a binder). The second level looks at the end-use function of the chemical substance, i.e. what the product gains from this function, and the third level looks at the service gained from the product with that specific property.

Use of Allura Red and fluorinated gases

To demonstrate how an essentiality assessment can be conducted, Romain Figuiere considers the use of Allura Red in lipsticks and soaps, as well as fluorinated gases in insulation foams.

Allura Red is a PMT (persistent, mobile, toxic) substance. PMTS are highly soluble in water, meaning they are difficult to remove in water treatment processes.

“Once they emitted in the environment, they can go through any drinking water treatment and then we are just drinking them back”, Romain Figuiere says. “If they are toxic on top of that well we're drinking toxic chemicals.”

Allura Red's chemical function is as a pigment, providing a red colour to products such as lipstick. Its purpose is to colour a surface, such as the lips. When Allura Red is used in soap, the technical and end-use functions are the same: to provide colour. However, the purpose is different. When Romain Figuiere and his colleagues spoke to people in the cosmetics industry, they discovered that the pigment in soap is solely used for marketing purposes.

“As consumers, we like it when a soap is red if it smells like strawberries or cherries,” he says. “It would be a bit weird for us if the soap were blue and still smelled like strawberries.”

Fluorinated gases are a type of PFAS used in many different products, including refrigerators and heat pumps, solvents for cleaning electronics, and foam blowing agents for insulation foam. As foam blowing agents, the chemical's end-use function is to extend the foam so that it occupies all the space. The service provided is insulation for buildings.

Is the chemical necessary?

Once the purpose of the chemical has been established, it is quite easy to answer the question of whether the chemical is needed for the product to provide that service.

“In the case of Allura Red used in red lipstick, it’s quite easy to say that ‘yes, it's needed’, because if you take out the red pigment from the red lipstick, it’s basically useless,” says Romain Figuiere. “But in the case of soap, the colour doesn’t play any role for the cleaning properties. So, you could say that use if Allura Red in soap is not essential, and we don’t need to go further with the assessment.

However, in the case of lipstick, one has to take the assessment one step further to question number two. The red pigment is necessary for the product, but is it necessary for health and safety or is it critical for the functioning of society to have red lipstick containing PMT substances?

“I'm not going to answer that myself simply because I'm not using red lipsticks. So who am I to know that?” Romain Figuiere says.

The European Commission has published a list of criteria to guide this assessment, but, he adds, the problem is that these criteria are currently extremely broad.

Assessing alternatives

Setting this question aside shifts the focus to the third question: are there safer alternatives available? In his research, Romaine investigated other red pigments and compared their hazard profile with that of Allura Red using different methods.

“With each method, we found at least one alternative that ranked better than Allura Red, so no, the use of Allura Red in cosmetics is non-essential,” he concludes.

In the case of fluorinated gases in insulation foam, the researchers found that the available chemical alternatives to be used as blowing agents in the foam were not unsuitable. They were either highly flammable, which is not ideal for building insulation, or their performance was inadequate. However, when considering the product's primary function of insulating buildings, they found several alternative insulation materials, such as fibreglass, rockwool, cellulose, and recycled textiles.

Comparing the PFAS-containing material with these other alternatives in terms of insulation performance and environmental impact throughout their life cycles revealed that four materials performed well enough and were considered safer than foam containing PFAS.

“So, in our perspective, the use of PFAS in insulation foams is non-essential as well,” Romain Figuiere concludes.

This reasoning differs from current restrictions in that other types of insulation material are not today considered as potential alternatives. The foam producers claim that there are no alternatives and that a derogation is needed. Currently, a 13-year derogation has been proposed for this use of PFAS.

“I think that the nice potential of the essential use concept, among other things, is to give this real societal perspective and discuss a variety of alternatives,” says Romain Figuiere.

Restricting PFAS considered most important

If you were the king and could decide, which of the new approaches would be the most important to implement right now? moderator Ellen Bruno asks both the researchers.

“I would implement the essential use definitely, but I would need to be the king of the world and implement it everywhere. To stop using really bad chemicals for things that we don't need. I think that would be a fair transition,” says Romain Figuiere.

“For me I think the most important thing that we are ahead of us is the restriction of PFAS, and we want to see a broad restriction, not only focusing on consumer products”, says Marlene Ågerstrand. “We want to see a restriction that also addresses industrial use. That is going to improve not only the environment, but also human health for very long time, and also have good economic consequences for our society.”

“But since I am the king,” she adds, “I give myself another wish and take the mixture assessment factor which is one of the few things that actually address this the second goal that we have – to reduce the overall use of chemicals.”

Text: Lisa Bergqvist

Watch a recording of the seminar