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Oct 29, 2019

The European Court of Justice was asked whether numerous aspects of the EU approval procedure of plant protection products are respecting the precautionary principle. The Court argued that none of the objections shows a manifest error of assessment by the EU legislator which would be capable of affecting the validity of Regulation 1107/2009 concerning the placing of plant protection products on the market.

The request for a preliminary ruling was made by a French criminal Court deciding on the action brought against four individuals charged of damaging bottles containing the popular weed killer glyphosate in a shop. In their defence, the defendants argued that with their actions they aimed to protect the public from the supposedly harmful weed killer. To judge whether that argument would be well founded, the referring court decided to ask the EU Court of Justice to assess whether EU Regulation is sufficiently capable of protecting public health. The European Court scrutinized 4 questions in the application of the precautionary principle which is the fundament of the risk assessment procedure of Regulation 1107/2009 concerning the placing of plant protection products on the market.

Firstly, the Court considered that the requirement for the applicant to identify the active substance in the plant protection product would not be incompatible with the precautionary principle. The Court further clarified that in the case where the plant protection product is a combination of different substances, the application should consider the cumulative effects of these substances and not the active substance alone. Secondly, the ruling examined the data requirements as part of a plant protection product authorization procedure. The Court was asked on the risk of bias in the data considering the submitted scientific studies are predominantly generated by the applicant alone. The Court dismissed the claim noting that the competent authorities should conduct their safety assessment in the light of the current scientific and technical knowledge.

In response to the third question questioning the confidentiality of the application procedure, the Court of Justice found that within the authorization procedure, important aspects are made available to the public. Consequently it held that the Regulation sufficiently ensures public access to information on the application dossier in order to scrutinize the potential risks related to the use of the plant protection product at stake.

Lastly, the absence of the obligation to carry out tests of long-term carcinogenicity and toxicity as part of the authorization procedure had been scrutinized by the referring court. The Court of Justice replied that although no such obligation is specifically prescribed, there is the obligation for the applicant to proof that a plant protection product has no immediate or delayed harmful effect on human health. It is for the competent authorities examining the application whether studies of long-term carcinogenicity and toxicity would not be required in the application.

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