Application, fees, data
Application, fees, data
The EU country doing the initial scientific and technical evaluation of an active substance dossier is called a "Rapporteur Member State" (RMS). The producer of an active substance applying for EU approval can choose the RMS and should contact the national authority well before applying. An alternative is the co-rapporteur system where 2 EU countries collaborate.
The RMS checks if the applicant has provided tests and study reports before admitting it.
Most countries charge a fee for the evaluation of new active substances.
All EU countries and the Commission need a dossier. There is a common format agreed at European and OECD level. The RMS advises when to send paper and CADDY dossiers to the other EU countries. Dossiers must comply with the data requirements in Regulations EU 543/2011 and 544/2011.
- Number of dossiers to be submitted - New active substances
- Number of dossiers to be submitted - Existing active substances
Draft Assessment Report
Based on the applicant's dossier, the Rapporteur Member State prepares a Draft Assessment Report (DAR).
It submits it to the Commission and to the European Food Safety Authority 1-1,5 years after the admissibility of the application.
There is a common structure for the DAR agreed by the EU and OECD.
Regulation 1107/2009 introduces a new category of "basic substances" which are described in one of the recitals as "active substances, not predominantly used as plant protection products but which may be of value for plant protection and for which the economic interest of applying for approval may be limited".
Criteria for their approval are laid down and specific provisions are set to ensure that such active substances, as far as they do not have an immediate or delayed harmful effect on human and animal health nor an unacceptable effect on the environment, can be legally used in the EU after having been approved as "basic” under Regulation 1107/2009.
Approved basic substances are included in the Pesticides Database on active substances. Also substances for which the dossier has been considered admissible, but the approval is still pending, are included in this database. A summary of the approved uses and conditions of approval, such as the purity and the preparation to be used, for a basic substance can be found in the Review Report. This report is uploaded on the page showing the details of that substance.