Regulation (EC) No 1107/2009 lays down harmonised rules for the approval of active substances and the placing on the market of plant protection products.
Active substances are approved at Community level. One member state, acting as Rapporteur Member State (RMS), is appointed to initially assess and evaluate a dossier from an applicant (producer of an active substance). In the Netherlands, the Ctgb is the designated authority for this assessment and evaluation. For new active substances, the applicant can appoint the RMS of their choice. There is no co-RMS unless explicitly requested by the applicant.
In case you prefer the Netherlands as rapporteur Member State for assessing your application for an active substance (in the EU), please contact as early as possible mr. Geert-Jan Molema to discuss the possibilities.”
Following detailed evaluation of the dossier, the RMS produces a report of their evaluation,. This report is termed the Draft Assessment Report (DAR). The DAR is forwarded to the European Food Safety Authority (EFSA). EFSA is responsible for the peer review process of the active substance. EFSA is also required to provide a conclusion on the active substance.
Finally, a proposal for approval or non-approval of the active substance is prepared by the European Commission and forwarded to the Standing Committee on Pesticides, Animals, Food and Feed (SCoPAFF), attended by all Member States, to formally give an opinion (by qualified majority vote) on the proposal. The Dutch representative in the SCoPAFF is representing four Ministries (Ministerie van Economische Zaken; Ministerie van Volksgezondheid, Welzijn en Sport; Ministerie van Infrastructuur en Milieu; Ministerie van Sociale Zaken en Werkgelegenheid). The Ctgb has a consultative voice in this final process.
The approval of active substances finds its legal base in Articles 7 – 13 of Regulation (EC) No 1107/2009.
Application type criteria
The procedure for approval of active substances applies for:
- new active substances;
- amendment to the conditions of an approval.
Data requirements and dossier structure
To support an application for an active substance a complete ‘dossier’ must be submitted which must fully address the data requirements given in Commission Regulation (EU) No 283/2013 (for the active substance) and Commission Regulation (EU) No 284/2013 (for the plant protection product). The complete dossier is a very extensive set of documentation comprising not only the required tests and studies, but also a series of supporting documents providing background information on the active substance and its uses. A set of ‘tiered’ summaries detailing the applicant’s evaluation and risk assessment for the active substance and product (the summary dossier) is required in addition to full copies of all the individual study reports.
To enable a risk assessment to be conducted, at least one plant protection product must be supported by the dossier with comprehensive data to support the risk assessment required for approval of the active substance.
The dossier should be presented in the format agreed by the Organisation for Economic Co-operation and Development (OECD). This is an internationally agreed format for regulatory dossier structure. This dossier structure consists of a number of documents termed as Documents A – O.
For chemical substances, the OECD Guidelines and criteria for industry for the preparation and presentation of complete dossiers and of summary dossiers for plant protection products and their active substances in support of regulatory Decisions in OECD countries (Revision 2, May 2005)’ should be used.
For microbial pesticides, the OECD Guidance for Industry Data Submissions for Microbial Pest Control Products and their Microbial Pest Control Agents (Dossier Guidance for Microbials), February 2004, Series on Pesticides No. 23’ should be used.
Duration period active substance approval
First approval of an active substance shall be for a period not exceeding 10 years .
The Ctgb charge fees to ensure that the full economic costs of evaluating and processing applications are covered. Each year we review the costs of the work (using detailed work recording data), and following consultation with applicants and approval holders, we set the fees for the next year. Please note that timelines for i.e. admissibility check (45 days) or evaluation of the dossier (12 months) will only start after the relevant fee has been received. Furthermore, the Ctgb will only participate (as RMS) in the peer review process if the peer review fee is settled.