Article 36 (3) Zonal examination for product authorization and the possibility of an individual rejection of a cMS due to an unacceptable risk

Date: 2 June 2020

Reg. (EU) 1107/2009 Article 36, states the conditions of evaluation with regards to the zonal authorization procedure, where one Member state examines the application on behalf of the other Member States (concerned Member States or cMS’s) within the zone. In principle, this Member State is responsible for the authorization within a zone and decides on the authorization or rejection or admission restrictions in accordance with Reg (EU) 1107/2009 Art. 35 for all cMS’s where core issues are concerned.

However, Reg. (EU) 1107/2009 Article 36 paragraph 3 opens up the possibility for the concerned Member States to take different authorization decisions based on their respective national issues, both in the zonal authorization procedure as well as in the framework of mutual recognition.

Article 36 (3) states that: “Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment.”

This gives the concerned Member States the opportunity to set their own national authorization conditions and if this is not sufficient as a protective measure, to refuse the authorization.

In summary, Member states of concern in a zonal product authorization procedure are allowed to reject the authorization of a product in their Country if the risk is considered unacceptable.

Annerie Liebenberg