A new report from the EU group of chief scientific advisors contains clear advice to the politicians on pesticide authorization in Europe. The FRAM Centre Director Thomas Backhaus contributed to the report as an evaluating expert.
A new report (download here) from the EU’s group of chief scientific advisors contains clear advice to the politicians on pesticide authorization in Europe. FRAM’s Centre Director Thomas Backhaus contributed to the report as an evaluating expert.
A number of recommendations are stated in the report from the scientific advisors:
1. The protection goals in the regulation of plant protection products (PPP) in EU may result in unachievable goals in practice. These products will almost always have toxic effects and it is therefore difficult to achieve that “substances (…) do not have any harmful effect on human or animal health” as it is now stated. Risk managers and legislators must instead set clear criteria and levels for acceptable risk, define the minimum levels of certainty that they require from scientific assessments, and better communicate their final decisions.
2. The risk assessment of active ingredients takes place on the EU level. However, the evaluation and approval of the final product takes place on the member state level. This may compromise consistency and efficiency. We therefore recommend that the risk assessors at EU level and member state level should assess the formulation of plant protection products together. We question the added value and efficiency of the current two-step risk management process – approval of the active substance followed by authorisation of the products. We recommend moving to a single-step risk management decision on a PPP including all its ingredients.
3. Systematic monitoring of adverse effects on human health and the environment, that might result from the widespread use of pesticides, should be implemented, analogous to the pharmacovigilance system. We recommend the registration of any acute illness following PPP exposure and landscape-scale monitoring of the environment. We finally recommend that the EC consider implementing a tiered PPP authorization approach with integrated monitoring.
4. To secure and strengthen scientific knowledge and capacity in risk assessment, there is a need to establish a ‘virtual’ European centre of excellence to provide adequate expertise and capacity in risk assessment.
5. Improve guidance, oversight and transparency of pre-market studies to ensure the availability and quality of data to perform proper assessments. To improve openness and public confidence in the process, we recommend mandatory pre-registration of all such studies, including a description of what will be learnt from the test and the names of the test facilities where the tests will take place.
6. Re-examine the treatment of hazards, risks, costs and benefits – to provide reassurance that the system is fit-for-purpose. We recommend that the hazard-based approach be re-evaluated to determine whether it is delivering intended levels of protection and appropriate outcomes.
7. Implement mechanisms to resolve diverging scientific assessments, to safeguard public trust in scentific advise. To pro-actively resolve, or at least adequately explain, divergence in an EU PPP risk assessment, we recommend that the EU Panel on Plant Protection Products and their Residues (PPR) be actively involved in early resolution, within the context of procedures that are already in place. For divergences in scientific assessments that might arise between EU risk assessors and international assessment bodies, we recommend expanding and strengthening international cooperation between the relevant scientific bodies.
The full report: