Agricultural pesticides - commonly known as plant protection products (PPPs) - must be authorised in each EU country where they are to be marketed. If an authorisation is needed in more than one EU member state, the manufacturer can choose one state, which then examines the product for its efficacy and its risks to the environment and health. The company can then submit this evaluation to additional states in the EU. These must also authorise the product unless there are country-specific reasons against it, such as certain landscape or climatic conditions or special agricultural conditions. However, the EU Plant Protection Products Regulation provides the possibility to interpret the framework for this so narrowly that practically no deviation in the authorisation decision is possible, even if there are solid scientific arguments. According to current court decisions in Germany, an own national evaluation, even if based on scientific evidence, undermines the goal of a harmonized EU internal market for plant protection products. The German authorities are therefore bound to the expert decision of the first evaluating Member State - even if the latter has recognizably violated evaluation guidelines or if their evaluation is incorrect from today's perspective.
In several cases, authorisation was granted despite of high risks
In Germany, the Federal Environment Agency (UBA) is responsible for assessing the environmental risks of pesticides. For some pesticides, UBA assesses the environmental risks as so high that, according to technical criteria, they could not be authorised or only under restrictions. Nevertheless, the manufacturing companies were able to push through authorisations in Germany through the court without such restrictions.
The degradation of the weedkiller flufenacet, for example, produces trifluoroacetate (TFA) - a substance that does not further degrade and is rapidly distributed within the water cycle, albeit not been found to have any toxicological effects so far. The maize herbicide S-metolachlor degrades in soil to several substances, one of which even has a similar efficacy as the active ingredient itself. For both cases, UBA has demonstrated a high potential for groundwater leaching and has already detected elevated concentrations in many groundwater bodies throughout Germany. Nevertheless, the German authorities were not allowed to include this data in their decision: both a refusal of authorisation and measures to reduce inputs were declared inadmissible. Accordingly, UBA should have followed the decision of the first evaluating state. That, however, does not correspond to the current state of knowledge and does not take into account the specific pollution of groundwater bodies in Germany.
In Germany, water suppliers are sounding the alarm because the degradation products of the above-mentioned substances already exceed the threshold values in raw water and impair its marketability. The current authorisation conditions for flufenacet and S-metolachlor therefore questions the high national standard of groundwater protection and may lead to an overall deterioration of groundwater quality - also with regard to other substances. The conflict over the agricultural use of drinking water abstraction areas increases when the proper use of pesticides leads to enormous groundwater and drinking water contamination.
Another case: For pesticide applications with the active ingredient fluazinam, UBA predicts high residues in soil that harmful effects on earthworms are expected. UBA included studies in their assessment that examined earthworm populations directly in the field and showed a strong effect due to the application of the product. However, since these fungicides had been authorised in other Member States without taking these studies into account, authorisation had to be granted in Germany as well. Earthworms are evaluated as a representative of many other soil organisms. They play a crucial role in maintaining soil fertility. Their protection is therefore strongly in the interest of agriculture. Farmers can now no longer assume that authorised products are harmless to their soils.
Germany is less and less involved in scientific evaluation
The manufacturing companies can choose the Member State to which they submit their product for initial evaluation and authorisation. This allows them to submit their applications specifically to those EU states that keep a lower standard of environmental protection in their assessments than Germany. Since all other EU states are bound to the conclusion drawn from this assessment, the lowest standard gradually prevails in Europe. Data shows that manufacturing companies are making use of this option: while in 2011 to 2013, 46 percent of all German authorisations were evaluated in Germany, in 2019/2020 the share was only 9 percent. This means that for more than 90 percent of all authorisations in Germany, the German authorities can no longer decide independently on evaluation and authorisation.
The authorities in the EU countries are very unevenly resourced
The division of labour in the authorisation procedure aims harmonise the protection level within the EU and to reduce the amount of work for everyone. In practice, however, the authorities in the individual states are set up very differently in terms of personnel and work routines. Some states decide to use only the data and studies that were available at the time of the last active substance approval - even if new findings have been obtained in the meantime that indicate significantly higher risks. As a basis for product authorisations in the Member States, each active substance is reviewed at EU level every 7 to 15 years. However, re-approval procedures at EU level are often delayed for years. Then, the existing approval is repeatedly extended beyond the statutory deadlines. As a result, new data and findings may sometimes have been available for years, but still are not taken into account by many Member States - even though the Plant Protection Products Regulation clearly requires that the reporting Member State must carry out an evaluation considering the latest state of science and technology. For example, the active ingredient flufenacet mentioned above was last approved in 2004. To date, the re-evaluation has not been formally completed and is expected in 2024 at the earliest. Many approvals of flufenacet-containing products are thus based on a state of knowledge from 20 years ago. The court decisions nevertheless prohibit the use of more recent findings if they were not used by the first evaluating Member State.
UBA assesses the risks of pesticides according to the current state of science and technology, as required by the EU Plant Protection Products Regulation. This means that all relevant data and findings are to be considered in the decision-making process. Pesticide residues measured in groundwater in Germany are a valuable database for quantifying the risks of these pesticides. It is highly worrying that, according to the court decisions, new studies as well as monitoring data from Germany may not be used if a product has already been approved in another state. It contradicts the scientific claim of a risk assessment.
No method - no risks
Often, new EU assessment guidelines are developed with a time lag after a new state of knowledge has been available for some time. And the subsequent harmonisation between the Member States is time consuming as well. It usually takes many years until a new guideline is implemented. According to current court decisions, however, new scientific findings cannot be used for risk assessment until an EU-approved assessment method is available. UBA has pointed out this assessment gap with regard to biodiversity for a couple of years. The large-scale application of weed killers, for example, leads to a significant decline in plants in the agricultural landscape. This in turn leads to a decline in insects, which ultimately endangers birds such as the skylark, which feed on these insects. There is still no agreed assessment method for impacts on the food web - despite the fact that the European Plant Protection Product Regulation explicitly stipulates that impacts on the food web and biodiversity should be considered when authorising plant protection products. Therefore, UBA is currently unable to fulfill its mandate of comprehensively assessing the environmental impacts of pesticides.
Authorisation practice contradicts sustainability strategies
The "National Action Plan for the Sustainable Use of Pesticides", the Farm-to-Fork Strategy and the Zero Pollution Ambition of the EU Commission as well as other programs have formulated the legal and political mandate to reduce the use of pesticides and their risks to humans and the environment. Nevertheless, more hazardous pesticides are currently threatening to enter the market and the environment. This represents a setback for the compatibility of agriculture and environmental protection. This way, the environmental protection goals set out in the Plant Protection Products Regulation and the German Plant Protection Act cannot be achieved.
From UBA's point of view, the problems mentioned can only be regulated at the European level. The EU Plant Protection Products Regulation must be implemented in a way that meets the original goal – to increase the level of protection instead of decreasing it. A major step would be taken if all active substances were re-evaluated and approved within their scheduled time period. This would provide a relatively up-to-date basis to be used for the authorisation of products. In addition, applications for authorisations should in future be distributed among the Member States by an independent body. At the European level, it must be clearly defined to what extent Member States are requested to address particularly sensitive ecosystems and measured contamination in their national authorisations. Also, the EU level should decide whether the Member States can implement own risk mitigation measures if these are necessary. Last but not least, existing assessment gaps, such as effects on the food web and biodiversity, should be addressed. The German government has included this goal in its coalition agreement. The assessment method for effects on biodiversity developed by UBA is now to be discussed and implemented at the European level.