The placing on the market of active substances and plant protection products is regulated in the European Union in Regulation (EC) No. 1107/2009. The requirements of the German plant protection law (PflSchG) were adapted to the requirements of Regulation (EC) No. 1107/2009 in 2011.
The Regulation (EC) No. 1107/2009 provides a double authorisation procedure. Thereafter, the active substance (i.e. the agent used to achieve the protective effect) contained in the plant protection product must first be approved by the European Commission. In addition, the plant protection product (i.e. the end product) containing the authorised active substance must be authorised in each Member State in which the product should be placed on the market.
The uniform principles for the evaluation and authorisation of plant protection laid down in Regulation (EU) No. 546/2011 are of particular importance for the authorisation decision. The information to be included in an application for authorisation of an active substance or authorisation of a plant protection product are set out in Regulation (EU) No. 283/2013 and Regulation (EU) No. 284/2013 (Data requirements).
The Federal Office of Consumer Protection and Food Safety (BVL) is in Germany responsible for the national authorisation of a plant protection product. The BVL decides in consultation and agreement with the Julius Kühn-Institut (JKI), Federal Institute for Risk Assessment (BfR) and Federal Environment Agency (UBA).
Regulation (EC) No. 1107/2009 provides two application procedures for national authorisation: The zonal authorisation procedure and the mutual recognition procedure.
Zonal authorisation procedures
The Regulation (EG) No. 1107/2009 divides Europe into a northern, central and southern zone. The climatic and cultivation conditions in the respective zone are comparable. An application for authorisation of the plant protection product may be submitted in any Member States belonging to a zone. The Member State examining the application (zRMS) shall make an independent, objective and transparent assessment for the entire zone. The zRMS shall decide within 12 months of receiving it whether the requirements for authorisation are met. If the zRMS needs additional information, this period shall be extendend by an additional period. That additonal period shall be a maximum of 6 months.
The other Member States of a zone, the so called concerned Member States (cMS), decide on the basis of the conclusions of the zRMS. The cMSs can refuse an authorisation in their states only under the restricted conditions regarding to Article 36 (3) sub section 3 of Regulation (EC) No. 1107/2009 ("specific environmental or agricultural circumstances"). The cMS shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the zRMS decide on the application.
Mutual recognition procedure
If a plant protection product has already been authorized in another Member State in accordance with Article 29 of Regulation (EC) No. 1107/2009, the holder of the authorisation may also apply for national authorisation in another Member State through the mutual recognition system. These agricultural conditions must be comparable in the Member States.
In the procedure of mutual recognition the Member State shall decide on the application within 120 days.