The European Commission intends to reform key provisions governing the approval of pesticides through a new legislative package. Scientists from 27 European research institutions point out that the “Food and Feed Safety simplification package” weakens key safeguards in the approval process – with consequences for people and the environment.
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 simplifcation 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 the prestigious journal Science, scientists from 27 European research institutions are now 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 whilst at the same time streamlining the approval process.
“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,” 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.”
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.
The authors highlight that, under the simplifcation package, most active substances would be approved indefinitely and the requirement for periodic re-assessment 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 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,” says Wintermantel.
Incorporation of scientific findings
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 taken into account 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. Although the package would not formally abolish this requirement, it would redefine it: in 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 re-approved, products containing it may, under the current regulation, continue to be used up 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 Ostermann. “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.”
Recommendations for reform to promote environmental protection and efficiency
According to the authors, the current backlog in re-approval applications, caused by delayed assessments, could be cleared within three years through an annual investment of 15 million euros. Furthermore, 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 – for example, those relating to pollinators. Farmers are already collecting such application data. Furthermore, pesticide residues in the environment should be measured more extensively. Joint analysis of this data would identify pesticides with a high-risk potential and enable targeted follow-up investigations.
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.