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Plant protection product approval: precaution at the forefront

09/2019, 15.03.2019

Independent expert opinion from the Advocate General at the European Court of Justice confirms BfR point of view

The European system of authorisation for plant protection products is sound and pays due consideration to protection against the risks to health and the environment. This conclusion was arrived at by Eleanor Sharpston, Advocate General at the Court of Justice of the European Union (ECJ). The re-approval of the active substance glyphosate is not an "example of supposed flaws" in the system. "This independent legal assessment confirms that preventative health care is the main focus in the regulation of plant protection products in Europe," says Professor Dr. Dr. Andreas Hensel, President of the German Federal Institute for Risk Assessment (BfR). "Even though consumer protection was of paramount importance in the re-approval of glyphosate, the BfR continues to work on further improvements to the process".

EuGH press release:

The background of Sharpston's considerations is criminal proceedings against French environmental activists who damaged shops in several cities in which plant protection products containing glyphosate were sold. The responsible court referred the case to the ECJ because it doubted that the European plant protection product regulation paid sufficient heed to the precautionary principle, i.e. the protection of health and the environment. Sharpston dealt with this issue in her conclusions. The conclusions of the advocates general at the ECJ are recommendations for a ruling, but they are not binding for the court of justice. The verdict is still pending.

In Sharpton's view, the plant protection product regulation is a precautionary measure in itself, as it introduces a system of prior approval for a product group (plant protection products). In response to the question raised by the French court as to whether or not the regulation pays sufficient consideration to the "cocktail effect", the fact that a marketed end product can contain several active substances, Sharpton replied that there are "safety nets" which permit the correction of possible assessment errors in cases of this kind. The BfR has been involved for many years in comprehensive research work in this particular field. It works in cooperation with a pan-european network so that "cocktail effects" of this kind can also be better assessed in regulatory processes.

The French court also questioned the regulation by which the companies can conduct the tests required for approval themselves. Sharpton countered that applicants must present complete dossiers with data, thus ruling out partiality and bias.

If there are indications of damage caused by the long-term use of an active substance, another possible problem mentioned by the court, the plant protection product regulation does not prevent the responsible authorities from refusing approval. To demand an analysis of long-term toxicity prior to putting a plant protection product onto the market, however, delays the point in time from which the product is available to farmers. A balance has to be found here between appropriate protection for humans, animals and the environment and the assurance of agricultural productivity.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.

This text version is a translation of the original German text which is the only legally binding version.

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