Efficacy requirements for existing active substances (EAS)

Date: 4 May 2020

As already explained in Academy Article “Efficacy requirements for new active substances”, issued on Wednesday, 16th of April, the detailed focus of efficacy issues is on the authorization process of the plant protection products and less on the approval process of active substances. Nevertheless, certain efficacy aspects have to be addressed in the data package to be submitted for the approval process of new active substances with the accordant efficacy data requirements laid down in the Guidance Document SANCO/10054/2013.

Compared to the efficacy information to be submitted for a new active substance, the accordant data requirements for existing active substances within the renewal process are further reduced. According to draft Guidance Document SANCO/2012/11251, the dossier to be submitted for renewal of approval should just include an overview of the efficacy information concerning the uses already authorised in Member States with this overview to be based on the format provided in Guidance Document SANCO/10181/2013. This means that the range of supported uses should reflect a representative use pattern and including the uses evaluated for the first approval. The efficacy data compilation has just to consider formal requirements, including e.g. the description of function and mode of action, application details and basic resistance information.

Considering that the substance is approved and authorisations of plant protection products containing the substance have already been evaluated according to the Uniform Principles (Regulation (EC) No 546/2011), no other efficacy documentation is considered to be necessary for the renewal process.

Joachim Kranz