Approval procedures: underestimated risks

Pesticide Atlas 2022

Before they are put on the market, pesticides go through an approval process in which their impacts on human health and the environment are tested. But their indirect effects on food chains and biodiversity receive little attention, neither do the effects of pesticide mixtures that are hard to predict.

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The results from approval tests with only a few species are subject to uncertainties. To compensate for these uncertainties, safety factors are supposed to help.

EU approval of pesticides is carried out in a two-stage process overseen by the European Food Safety Authority (EFSA). In the first step, active ingredients are approved at the European level, which is divided into different geographic areas: EFSA distinguishes three European zones with comparable ecological and climatic conditions, namely North, Central and South. In the second step, the pesticide products containing these active ingredients are approved by individual EU Member States. The pesticide manufacturers submit their scientific information and studies at the EU level which provides the data necessary to conduct the environmental and health risk assessment. EFSA then commissions different Member States – appointed as rapporteurs – to review these dossiers. The rapporteur prepares a Draft Assessment Report with regards to the risks for humans and the environment which EFSA peer reviews, together with the Member States. If this process concludes that there are no unacceptable effects on environment and human health to fear, the agency gives approval. This ultimately means that adverse effects on the environment or on non-target organisms can not stop registration if they are considered acceptable. This may occur, for example, if a beneficial insect population of for instance ladybugs was to recover after pesticide application.

During the review process, EFSA works with the EU Commission and Member States, and carries out public consultations which includes stakeholder surveys designed to collect the views of stakeholder organizations and Member State Authorities. EFSA prepares a final draft report and a committee of Member State representatives votes on the draft decision. The decision on whether to approve the substance is taken by the European Commission in consultation with Member States.

The approval of an active ingredient is granted for a defined number of years, not exceeding 10 years. For a renewal new data must be included in the decision-making process. It is important to note that active ingredients which meet with certain cut-off criteria – a classification as mutagenic, carcinogenic or harmful to reproduction and endocrine system – will not be approved in the EU.

Dangerous pesticides must be phase out. Biopesticides can be an option for substitution if other measures within the framework of integrated pest management have failed.

Despite independent studies suggesting otherwise, the herbicide glyphosate was granted re-approval by the EU in 2017. The controversial herbicide was first approved in 2002 under the new EU pesticide legislation. Previously, it was only permitted in some Member States. The re-registration of glyphosate was scheduled for 2013, and Germany served as rapporteur country, with Slovakia as co-rapporteur. The process received widespread attention due to environmental and health concerns; meanwhile, the International Agency for Research on Cancer (IARC), which as part of the World Health Organization (WHO) has devised a system of categories to evaluate the carcinogenicity of an substance to humans, has classified glyphosate as “probably carcinogenic” to humans. However so far only Luxembourg was the first EU country to ban glyphosate. However so far only Luxembourg was the first EU country to ban glyphosate. The main reason for differing assessments was that the IARC used independent studies for evaluation, while the national regulatory authorities relied on manufacturer studies. Furthermore, the IARC assessed glyphosate containing products and occupational exposure, while national authorities mainly considered the pure active ingredients only, dietary exposures and risks to the general population. As a compromise, the approval of glyphosate was only granted for another five years instead of ten years. An alliance of glyphosate manufacturers called Glyphosate Renewal Group (GRG) has already submitted a dossier to EFSA to ensure that the herbicide continues to be approved after 2022. It comprises 180,000 pages. To address this, the Commission appointed four Member States acting jointly as ‘rapporteurs’, known as the Assessment Group on Glyphosate (AGG), consisting of EU Member States France, Hungary, the Netherlands, and Sweden.

Although pesticides must meet the strict EU approval criteria, the current environmental impact assessment does not seem to prevent the approval of pesticides that have harmful effects on the environment. The EFSA guidelines focus on how to evaluate the impact of active ingredients with consideration to surrogate species of birds, mammals, honeybees, wild bees or earthworms. Ecologists and civil society organizations demand that the impacts on fungi, amphibians, bats, reptiles, or wild plants are also considered. Interactions between organisms and indirect pesticide effects are left out the approval process as well. Another important aspect not considered in environmental risk assessments is the fact that most agricultural crops are treated not only with a single pesticide but with a variety of pesticides each season. These mixtures’ environmental effects are still largely unknown – evidence is mounting that they are stronger than the effects of individual substances. Because of these fundamental flaws pesticides can not be considered safe for the environment.