PPP authorization in the EU

The authorization of plant protection products in the European Union operates under a zonal system regulated by the European Parliament and Council (EC) No 1107/2009 (21 October 2009). Under this legislation EU member states are divided into 3 zones, each representing its own zone (North, South and Central). An authorization obtained from one of the member states of a zone shall be valid in the other member states of the same zone. This requires a mutual acceptance procedure to be initiated from the country of destination.

Hungary along with Belgium, the Czech Republic, Germany, Ireland, Luxembourg, the Netherlands, Austria, Poland, Romania, Slovenia, Slovakia and the United Kingdom belongs to the Central Zone (also known as Zone B, Central Zone).

The registration authority for plant protection products in Hungary is NÉBIH.

Authorization is done in several steps:

The applicant (manufacturer, registration owner) shall compile a dossier for the plant protection product and/or its active substance, containing studies and justifications on safety and efficacy. It takes 2-4 years to complete the studies in the dossier. The results of the studies in the dossier are the result of field and laboratory experiments covering 8 different disciplines, which will all be eventually covered as separate chapters in the dossier (biological efficacy, physicochemical studies, toxicological and Eco toxicological parameters, environmental fate etc.).

Once the dossier has been submitted, the registering authority will assess it and decide whether to grant or refuse it. In the event of a positive decision, they shall issue a permit, in possession of which the plant protection product is approved to be placed on the market on the country’s territory.