Data requirements and risk assessments

The data requirements for the dossier laid down by the Plant Protection Product Regulation  1107/2009/EC can be found in Annexes II−III to the repealed Directive (91/414/EEC). The requirements set for an active substance are given in Annex II and are generally fulfilled and assessed when the active substance is included in Annex I.


The data requirements for chemical plant protection products which must be fulfilled for an application to take a plant protection product on market are listed in Annex III, Part A to Plant Protection Product Directive. The data requirements for plant protection products containing microorganisms including viruses are found in Annex III, Part B.


The European Commission has produced technical guidance documents on the application of the requirements.

The data requirements for the Nordic Zone are included in the 'Guidance document on the work-sharing in the Northern zone in the authorization of plant protection products', which is found here.


National data requirements

In addition to the common risk assessment conducted at EU-level, Tukes carries out a national risk assessment for soil organisms. For the purpose of soil concentration calculations Finnish Environment Institute has developed a national tool, a PEC soil calculator, which takes into account the effects of Finnish soil temperature and moisture on the degradation rate. Based on the results of the PEC soil calculator the applicant has to provide the risk assessment for the soil organism when submitting application for product authorisation.


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