Transitional regulations

In the approval procedure for active substances, the new regulations apply to dossiers submitted as from 1 January 2014.

In the authorisation procedure for plant protection products, the new regulations apply if the dossiers on the active substances in the plant protection products applied for have already been submitted according to the new regulations, but at the latest as from 1 January 2016. However, in other cases applications can be submitted as from 1 January 2014 according to the new regulations. This choice shall be made in writing when submitting the application and shall be irrevocable. A corresponding remark is requested in the comments box on the application form.

Documentation for applications

The EU Commission has published a guidance document which contains instructions for submitting documentation according to the new regulations (Guidance Document for applicants on preparing dossiers, SANCO/10181/2013-rev.2.1, 13 May 2013). This guidance document applies to the preparation of dossiers for assessing active substances; however, some points can also be used for applications for the authorisation of plant protection products.

Please note that due to the new data requirements, the numbering of the documentation to be submitted has changed. Therefore, when applications are submitted according to the new regulations, the new numbering must be used for the application documents. To make things easier, the European Commission has provided a translation list (crosswalk) of the annex points according to the new data requirements (revised EU) and the OECD annex points used up to now. The translation list can be found in the aforementioned guidance document.

The new numbering should also be used for preparing CADDY dossiers. A corresponding Table of Content (CADDY-TOC) can be retrieved from the CADDY website.

Year of issue 2014
Date 19.03.2014