EU Commission's draft legislation on pesticides

The European Commission has presented a new legislative package. It is intended to reform key provisions that have hitherto governed the approval of pesticides. The "Food and Feed Safety simplification package" is part of a comprehensive strategy through which the Commission aims to simplify legislation in the European Union (EU) and reduce the administrative burden.

In an article published in the Policy Forum section of Science, scientists from 27 European research institutions are highlighting the risks posed by the new regulations. The group of authors, led by Dr. Dimitry Wintermantel of the University of Freiburg and Dr. Julia Osterman of the University of Gothenburg, point out that the planned reform would weaken key safeguards in the approval process.

In their article, the researchers set out recommendations on how the EU could reduce the harmful effects of pesticides in the long term while at the same time streamlining the approval process.

"The simplification package would largely do away with the periodic reassessment of active substances in pesticides and leave existing weaknesses in premarket risk assessment unaddressed," says Wintermantel.

"This increases the risks posed by pesticides to biodiversity and human health. We believe that the package thus clearly undermines the precautionary principle and runs counter to European and international environmental protection objectives."

Reassessment of active substances

At present, active substances in pesticides are generally approved at the EU level for 10 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.

The authors highlight that, under the simplification package, most active substances would be approved indefinitely and the requirement for periodic reassessment would be removed. The problem here is that, once approval has been granted, there is neither systematic monitoring to identify pesticide risks nor a mechanism that would automatically trigger a review. Furthermore, this would result in a reversal of the burden of proof from the manufacturer to the authorities.

"In practice, periodic reassessment has proved to be an important tool. Since 2011, 59 active substances have not been granted new authorization due to health or environmental concerns," says Wintermantel.

Incorporation of scientific findings

While the EU is responsible for the approval of active substances in pesticides, individual pesticide products are authorized at the national level by the member states. According to the authors, the simplification package would result in scientific evidence being taken into account to a lesser extent when authorizing such products.

To date, EU member states have been required to take the current state of scientific knowledge into account. Although the package would not formally abolish this requirement, it would redefine it: In the future, the state of knowledge at the time of the most recent EU active substance assessment would be deemed decisive, which—in the case of indefinite approval—could date back a long time.

Transitional periods for active substances whose approval has expired

If an active substance in a pesticide is not reapproved, products containing it may, under the current regulations, 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 actually carries the risk of undermining incentives for innovation," says Osterman. "If older products remain on the market for longer and are no longer subject to periodic reassessment, the pressure to develop safer and more innovative alternatives is reduced."