The “Food and Feed Safety simplifcation package” is part of a comprehensive strategy through which the European Commission aims to simplify legislation in the European Union (EU) and reduce the administrative burden. It is intended to reform key provisions that have hitherto governed the approval of pesticides.
In an article published in the prestigious journal Science, scientists from 27 European research institutions are now highlighting the risks posed by the new regulations. Among the authors are Julia Osterman and Daniel Slunge of the University of Gothenburg.
“The simplification package would largely do away with the periodic re-assessment of active substances in pesticides and leave existing weaknesses in pre-market risk assessment unaddressed. This increases the risks posed by pesticides to biodiversity and human health,” says Dimitry Wintermantel of the University of Freiburg who together with Julia Osterman is the leading authors.
Re-assessment of active substances
At present, active substances in pesticides are generally approved at EU level for ten years. After this period, manufacturers can apply for renewal of approval and must submit data on the safety of the active substance. This is then subject to a fresh risk assessment.
Under the simplification package, most active substances would be approved indefinitely and the requirement for periodic re-assessment would be removed. In practice, periodic re-assessment has proved to be an important tool. Since 2011, 59 active substances have not been granted new authorisation due to health or environmental concerns.
Whilst the EU is responsible for the approval of active substances in pesticides, individual pesticide products are authorised at national level by the Member States. According to the authors, the simplification package would result in scientific evidence being considered to a lesser extent when authorising such products. To date, EU Member States have been required to take the current state of scientific knowledge into account.
Longer transitional periods
If an active substance in a pesticide is not re-approved, products containing it may, under the current regulation, continue to be used for up to 18 months. The simplification package extends this transitional period to up to three years – even if the active substance has lost its approval due to health or environmental concerns, provided these are not classified as immediate and serious.
“Contrary to the simplification proposal’s aim of promoting innovation, the proposal carries the risk of undermining incentives for innovation. If older products remain on the market for longer and are no longer subject to periodic re-assessment, the pressure to develop safer and more innovative alternatives is reduced,” says Julia Osterman.
Standardise criteria
According to the authors, in order to speed up assessments and ensure high standards of protection, applicants should not be allowed to choose which Member State assesses their pesticides. Instead, the EU should allocate this task on the basis of expertise. The EU must standardise assessment criteria and clearly place the burden of proof on pesticide manufacturers.
Furthermore, regulatory studies should be made publicly available to enable independent research. To identify potential risks following authorisation, application data should be linked to existing monitoring programmes. Pesticide residues in the environment should be measured more extensively.
The authors conclude that these measures would make the approval of pesticides more scientifically sound, transparent and efficient, without undermining the precautionary principle or European environmental protection objectives.
Original publication in Science:https://www.science.org/doi/10.1126/science.aeg8744
Contact: Julia Osterman, researcher at the Department of Biological and Environmental Sciences at the University of Gothenburg, phone: 070-751 72 80, email: julia.osterman@bioenv.gu.se
Daniel Slunge, Director of the FRAM Centre for Future chemical Risk Assessment and Management at the University of Gothenburg, phone: 076-622 92 05, email: daniel.slunge@gu.se
