Chalmers University of Technology
The regulation of hazardous chemicals in Europe has been shaped by economic interests, according to a study published in Nature Communications. The researchers behind the study have found that European regulators have tended to focus on chemicals of low economic importance, leading to lower than anticipated hazard reduction within the union.
"We show that the most important factor determining whether a substance is subjected to binding limitations and conditions is whether it is being produced in, or imported into, the European Economic Area. The regulators are less likely to list a substance as hazardous in the Candidate List of substances of very high concern if it affects the economic interests of European firms", says Jessica Coria, Associate Professor in Economics at the School of Business Economics and Law at University of Gothenburg.
This is the main conclusion of the study Economic interests cloud hazard reductions in the European regulation of substances of very high concern, which was recently published in Nature Communications, and which she carried out together with Mikael Gustavsson and Erik Kristiansson from the Department of Mathematical Sciences.
In 2016, the European Environment Agency estimated that more than 60 percent of the total weight of chemicals used in Europe is, in one way or another, harmful to human health. At the same time, there is an explicit ambition in the European chemicals legislation to provide strong protection for the environment and human health. For example, within REACH (Registration, Evaluation, Authorization and Restriction of Chemicals, a piece of legislation that currently covers more than 20,000 registered chemicals), the manufacture and use of certain particularly hazardous substances can be subject to various binding restrictions and conditions, including bans on usage.
Economic factors play a large role
Within REACH, implementing a ban on a substance is normally a two-stage process. First, a member state, or the European Chemical Agency, propose that a specific substance should be included on the so-called Candidate list. The substances on the Candidate list then undergo a prioritisation process for inclusion on the so-called authorization list. Once a substance is finally on the authorization list, a special approval is required for all forms of continued use.
The presented study examines how different driving forces affect which chemicals that are proposed for regulation. The study shows that both risk minimisation as well as the amount of scientific evidence available on the chemicals effects are of great importance in the regulatory process. But the study also shows that chemicals with low economic importance have been included in the list at a greater rate than anticipated. This means that the candidate list to a large extent consists of substances where production and import to the European Economic Area had already ceased prior to the listing, and that several listed substances never had been produced in or imported to the area at all. Regardless of the specific reason, this results in a overall risk reduction that is lower than expected.
Finding and structuring data
"Compiling and structuring data has taken up a considerable amount of time during this study. This information is not readily available for download in a preprocessed, curated form. Instead we have had to merge several different data sources", says Erik Kristiansson. "For example, we have analysed close to 200,000 scientific articles in PubMed to obtain information on how well-studied various substances are."
Information on the chemicals toxicological properties, how harmful they are to humans and how harmful they are in the environment, was also collected. Combining different large data sources, i.e. data integration, is a specialty of the research group. The raw material, data produced in different places for different purposes and collected in different ways, is complex and therefore unusual in this type of research.
"Normally, you settle for one source, because you want your data to be well structured from the start. We are just a little bit more used to having to massage it into a useable shape", says Mikael Gustavsson.
One challenge the researchers have encountered while working on the study is that large amounts of data are simply not available. In some cases because the data is considered sensitive, but also because companies are not used to there being an interest in their data and they also often don't know what can be accomplished with modern statistical methods.
"Data availability is a very important issue that needs to be discussed in the future. Authorities need to work more transparently and make more of the information they gather more accessible. That would open up a lot of opportunities for the research community", says Erik Kristiansson.
Delivering reliable results
There are lots of uncertainty in the collected data. As an example, the measurements that generate data on toxicity can be of different quality. Therefore, it is extremely important to perform a thorough statistical analysis on the deviations found in the material. In the study, the researchers have, among other things, started from parameters that are supposed to influence the regulatory system, and examined how well they describe the outcome since the introduction of the chemical regulation REACH in 2008.
For example, substances that are so-called CMR, (carcinogenic, mutagenic, or toxic to reproduction), should be on the Candidate list. Therefore, information on these toxic properties has been included in the analysis and proved to be of importance for the listing. But the analysis also showed that various economic parameters played a big role. By combining data of both types, the researchers thus gained a better basis for understanding the overall picture, and thereby a greater confidence in the reliability of the patterns identified in the data.
"This work allows us to feel confident in our conclusions. It's not just that we 'saw' this, but we have results from a careful statistical analysis to prove it", says Mikael Gustavsson.
Redesign of the process may be required
"It's not surprising that economic interests influence which chemicals that are regulated, but that these parameters are as significant as our stuyd shows gives us reason to question how effective the system is in removing harmful substances from the market" says Erik Kristiansson.
Seen from a regulatory perspective, the results of the study indicate that low-hanging fruit have been picked first. Unfortunately, this might lead to difficulties in the future when EU member states try to agree on which additional chemicals that should be included in the Candidate list, because listing locally produced chemicals is more likely to meet stronger political resistance.
"This might indicate a need to redesign the regulatory process to ensure that hazardousness becomes the most important driver of inclusion on the Candidate List and that hazardous chemicals produced or imported in the EEA are listed, even if they affect the economic interests of European companies", says Jessica Coria.
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