How to make your research relevant for EU's chemicals regulation?
European Chemicals Agency
The European Chemicals Agency works for chemical safety in the EU. We are a regulatory Agency of the European Union.
Scientific research provides essential information to better understand the properties and to manage the possible hazards of chemicals. Only with this information it is possible to identify and regulate those that may harm our health or the environment.
In this article, two of our experts Wim De Coen , Head of Unit in our hazard assessment directorate, and Fleur Broekhuizen, van , a member of the team coordinating our activities under the Partnership for the Assessment of Risks from Chemicals (PARC), explain how your research can help regulators to better protect us all from hazardous chemicals.
You can also listen to their full discussion in our #SaferChemicalsPodcast:
Increasing the understanding for regulatory relevance
Regulating chemicals always relies on scientific data or models. Before taking any decisions, we need to weigh the hazards and risks of chemicals against their benefits and possible safer alternatives. It is also important to consider how the decisions can be enforced.
When generating new scientific data, we need to keep in mind that regulation often has specific requirements on the information that can be used to describe a chemical and its possible hazards. “For example, the Classification, Labelling and Packaging Regulation sets very strict conditions for the type of data that can be used to justify certain hazards,” Wim explains.
Therefore, scientists need to be aware of these requirements and understand that models they develop need to be fit for purpose.
“We are now putting more efforts into explaining these requirements to help the scientific community make their research more regulatory relevant. For the first time, we have also put together a report that highlights those areas where more research is needed,” Fleur says.
But regulatory relevance does not only refer to what kind of information is needed and how that information fits to our regulatory frameworks, it also has a strong link to which chemicals we see as a priority for regulatory action in Europe.
These priorities are presented in the European Union's chemicals strategy for sustainability. “This strategy has also led our work in identifying areas where more research is needed to improve chemicals management in the EU,” Wim adds.
Key areas of regulatory challenge
The aim of the recently published Key Areas of Regulatory Challenge report is to inform the scientific community about areas where we see that more research is needed. The key areas are summarised below.
To provide better protection against the most harmful chemicals, we must invest in method development and data generation. “For example, neurotoxic, immunotoxic and endocrine disrupting properties can have long term negative effects on people and the environment. We need more information on these properties as the current data and methods to identify such effects are not sufficient to ensure efficient regulation,” Wim highlights.
To address chemical pollution, we need to better understand how chemicals behave in the environment. “We would like to see more research focusing on chemical accumulation in the food chain, for example, in air-breathing organisms. Our ongoing work, investigating how biocidal active substances affect bees and non-bee pollinators, is another example of a topic where further research is needed to improve hazard assessment and regulation,” Fleur says.
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To shift away from animal testing, we must continue working on new approach methodologies (NAMs). One of the most frequently used approaches to minimise the use of animal testing is read-across where information on one chemical is used to inform on the possible hazardous properties of another one. Wim reflects that ECHA’s recent report lists more ideas for different alternative methods that could be used to further increase knowledge on toxicology and eco-toxicology.
“We believe that there are ways to combine alternative methods and available information so that we can get better predictions and more efficient safety assessments without animal testing in the future.”
Making relevant data on chemicals available for companies, scientists, experts and decision makers is key for successful regulation. In this context, Fleur mentions nanomaterials and polymers as important fields that require further research. “We need more information, for example, about nanomaterials’ transport and their toxicity for people and the environment. For polymers, further insight is needed on how to assess hazards and risks in the light of their highly variable composition.”
In addition, Wim emphasises the need to develop methods that would help, for example, enforcement authorities to successfully carry out their work. “We would like to see scientists work on new analytical methods that help control the presence of restricted hazardous chemicals in consumer articles imported in the EU. To do this, inspectors need high throughput screening methods to efficiently check big volumes of articles.”
PARC
The Partnership for the Assessment of Risks from Chemicals (PARC) started in 2022. It is a seven-year European programme that brings regulators and scientists closer to each other. It has a budget of around EUR 400 million and is funded by the European Union and the participating EU countries.
Fleur explains that ECHA helps to prioritise and review projects that apply for funding through PARC. The aim is to identify those projects that could be relevant for regulation. “Currently, there are over 60 projects ongoing within PARC and we are following just over 30 of them. We join the discussions around these projects to support and, if needed, steer them in the direction that would be most relevant for EU chemicals legislation,” she says.
These international partnerships, as well as scientific conferences and workshops, are important in fostering dialogue and collaboration.
“The more we share knowledge and experiences, the better we can ensure that the future research projects help regulators and benefit society. As both scientific research and regulation can take several years to show results, we urge researchers to read the report and factor it in when planning their future studies and projects,” Wim concludes.
Join us
If you are interested in tailoring your research to help protect people and the environment from hazardous chemicals, contact us at [email protected] to learn more.
Follow our #ECHAscience hashtag on LinkedIn to stay updated with the latest developments. Remember also to read our report and our topical page about scientific research.
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