Category 4 studies (CAT 4)

Date: 29 April 2020

In the renewal of authorisations according to Article 43 of REGULATION (EC) No 1107/2009, data might be missing due to several circumstances which can be divided into five categories (SANCO/2010/13170 rev. 14). One of them, category 4, is the need to fulfill new data requirements that will be applicable at the date of submission of product re-authorisation according to Art 43 or if endpoints of the active substance have changed. For example: a new residue definition decided upon in the active substance renewal will require new residue trails, which have to be included in the Art. 43 submission to uphold existing uses in the product registration. Another example would be the change in ecotoxicity endpoints for the active substance, leading to higher Tier studies to refine risk assessments for existing uses.

Since time, usually 3 month after renewal of the active substance, might be too short to generate such new data and because applicants often cannot foresee these circumstances, extra time to conduct these so called “category 4 studies” (CAT 4) and for generating the draft Registration Report (dRR) can be requested. The exact procedure has to be discussed with the zonal Rapporteur Member State (zRMS), but the prolongation can be up to 2 years (in exceptional cases even longer), depending on the type of study needed. The prolongation will start at the date of the active substance renewal. Therefore, discussion with the zRMS regarding CAT 4 studies should be undertaken when the EFSA conclusion for the renewal of the active substance is available and the need for CAT 4 studies becomes obvious.

Carla Lorenz