The new Pesticide Regulation No 1107/2009, concerning the placing of plant protection products on the market entered into force on 14 June 2011. This pesticide regulation repealed and replaced Council Directives 79/117/EEC and 91/414/EEC and has altered several of the procedures to which applicants and authorities have been accustomed.
Active substances are still approved at EU level and products are authorised by individual Member States but the new rules mean, for instance, that the authorization of plant protection products is now given for one of three geographical zones. Denmark, Sweden, Estonia, Finland, Latvia and Lithuania belong to the North Zone.
The Regulation aims to harmonise, as far as possible, the overall arrangements for authorization of plant protection products within the EU.

Tox Regulatory Advisor offers full support concerning preparation of an application for a zonal authorization, mutual recognition and a parallel trade permit authorization, and a strategy to support companies in meeting the pesticides compliance requirements.

Some of the services that Tox Regulatory Advisor offers for pesticides include:

•  Preparation, submission and registration of maximum residue levels dossiers
•  Preparation, submission and registration of Biological Assessment Dossiers and efficacy data
•  Preparation, submission and registration of toxicological and ecotoxicological data
•  Applying mutual recognition, zonal authorization and parallel trade permit               authorization
•  Preparation of Draft Registration report and material safety data sheets
•  Preparation of directions for use, GAP scheme and labels
•  Classification and labeling of pesticides according to the CLP regulation

If you would like help with any of the above, or would like further information, please contact us at +45 26 70 96 48 and send questions to