RIVM investigates the potential relation between the use of pesticides and Parkinson’s disease. RIVM is undertaking this study because there are significant concerns about this in society. Below, you will find information about the SPARK project (Strategies for regulatory assessment of Parkinson’s disease).
Reason for the Study
In 2021, the RIVM concluded, based on previous research, that there may be a link between exposure to pesticides and the development of neurodegenerative diseases, such as Parkinson's disease. Parkinson’s disease arises because specific neuronal cells in the nervous system progressively die off over time.
Before placement on the market in the European Union (EU), EU (European Union ) Regulation No.283/2013 requires producers to demonstrate that the active ingredient is safe for humans, animals, and the environment. However, research by the RIVM revealed that the current data requirements do not to draw a conclusion on a potential relation between pesticides and Parkinson’s disease as the underlying studies are not able to detect degenerative effects in the nervous system. Therefore, it is essential to improve both the testing methods and the existing approval criteria for pesticides. The SPARK project is commissioned by the Dutch Ministry of Agriculture, Fisheries, Food Security and Nature (LVVN), and the Ministry of Health, Welfare and Sport (VWS).
What is the goal of the SPARK project?
The SPARK project aims to develop test methods to investigate the potential relationship between pesticides and the onset of Parkinson's disease. The project will provide recommendations on which test methods can be used for this purpose. We will make recommendations for both the short and the long term. Short term recommendations will cover adjustments to the current regulatory data requirements in animal studies. Long term recommendations will cover test strategies composed of innovative, preferably animal-free, test methods.
What will happen with the results from SPARK?
The results and recommendations will be published in scientific journals and in one or more RIVM reports. Every half year, the project progress is communicated in progress reports (in Dutch, see Further Reading below).
The results could be applied by (inter)national authorities, relevant organisations involved in test guideline development, and to the pesticide approval process within the EU (European Union). Additionally, the results can be utilised to develop test strategies to examine potential links between other chemical substances and Parkinson's disease.
Execution of the Research
The SPARK project employs two approaches to determine how the potential effects of active substances in pesticides on the development of Parkinson's disease can be identified.
The first approach focusses on adjustments to the current regulatory data requirements using animal studies. The project examines whether more information can be derived from the current OECD guideline studies for regulatory safety assessment to predict whether a chemical substance could trigger processes leading to the development of Parkinson's disease. RIVM will commission an animal experiment at an external party specialised in regulatory testing.
The second approach focusses on developing innovative, and when possible animal-free, test methods. These include methods such as computer models and cell cultures. The test methods must reliably predict whether a chemical substance can trigger Parkinson's disease in humans. Both approaches contribute to the replacement, reduction, and refinement of animal testing.
The reliability of both approaches will be tested using various chemical substances, including pesticides. The aim is that these test methods can be applied to both existing (approved) and new pesticides to determine whether they contribute to the development of Parkinson's disease and, if so, how exactly. This information can be used by regulators to make informed decisions about the approval of these chemical substances for the market.
Collaboration
The RIVM seeks advice from external experts both within and outside of the Netherlands, including neurotoxicologists, pathologists, government agencies, regulatory agencies for pesticides, and physicians specialising in Parkinson's disease. The RIVM is currently composing a scientific advisory board in which these experts will give advice on the set-up, execution and results of the research.
Timeline of the SPARK Study
The study started at the end of 2024 and is expected to be completed in 2029. The project planning can be divided in phases, for example a literature study into available test methods in animals and animal-free models, execution of an animal experiment, development and application of novel (animal-free) test methods, publication of the final results and performing potential follow-up studies. Interim results will be published when available.
Further reading
For more information on RIVM research into pesticides and neurodegenerative diseases: