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Authorisation of plant protection products in the process of mutual recognition: Only limited examination competence of Germany

The Administrative Court Braunschweig upheld the claims of a manufacturer of plant protection products for the authorisation of two plant protection products in Germany, which had already been authorized in the United Kingdom. The Chamber's judgment was given on 30 November 2016 following oral hearing.

The claimant produces plant protection products. In spring / summer 2015 he applied to the Federal Office of Consumer Protection and Food Safety (BVL) to grant two authorisations by mutual recognition. For these products, authorisations has previously been granted in the United Kingdom for the claimant. The mutual recognition procedure is a Community authorisation procedure. Thus, the holder of an authorization could apply for an authorisation for the same plant protection product, for the same uses and under comparable agricultural conditions in another Member State, if the authorisation has been granted by a Member State which belongs to the same zone. The Federal Republic of Germany and the United Kingdom belong to the same zone.

As no authorisation decision was initially taken by the BVL, the claimant filed actions for failure to act in March and April 2016. During the course of the judicial proceedings, the BVL finally refused to grant the authorisations, because the United Kingdom as the reference Member State had not observed various legal requirements for the authorisation of the products. The approval authority should have used inter alia outdated information and guidelines. The approval authority did not grant Germany a comment opportunity before the grant of the authorisation and not created a full assessment report. Therefore the involved German authorities refused their agreement or behavior. The claimant should also submitted only incomplete application documents. The claimant turned against these decisions during the further legal proceeding.

The court ruled that the notice of rejection are annulled and obliged the BVL to take a new decision on the applications considering the legal opinion of the court. The court is of the opinion that the BVL has only limited examination competence in approval procedures in the proceeding of mutual recognition.

In principle, the recognising Member State is bound by the authorisation decision of the reference Member State. Only if a Member State has concerning to specific ecological or agricultural conditions justifiable grounds for assuming that the product concerned represents an unacceptable risk to human or animal health or the environment. The common European system for the authorization of plant protection products is based on the principle of mutual trust that all participating states comply the legal requirements. This permits the assumption that the working procedures regarding the application of plant protection products in each Member State complies the legal requirements. Only when it appears that a reference Member State systematically violates the legislation to be followed in the respective authorisation procedure, there is space for further examination in the national recognition procedure. The court did not consider such systematic deficiencies to be given in the present cases.

However, the court was unable to pronounce an obligation for BVL to grant the authorisation for the plant protection products, because the involved German authorities (Federal Environment Agency (UBA), Federal Institute for Risk Assessment (BfR) and Julius Kühn Institute (JKI)) must be given first the opportunity to comment on whether there is an unacceptable risk to human or animal health or the environment.

Should you have any questions concerning the judgement, please contact Dr. Alexander Koof.