Characteristics

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.

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.

Legal base

The approval of active substances finds its legal base in Articles 7 – 13 of Regulation (EC) No 1107/2009.

Data requirements and dossier structure

To support an application for an active substance a complete dossier has to 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).

To enable a risk assessment to be conducted, a safe use of at least one plant protection product must be supported by the dossier.

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.

For guidance documents on preparing dossiers of an active substance (chemical and microbial), please refer to Guidelines on Active Substances and Plant Protection Products (europa.eu).

Duration period active substance approval

First approval of an active substance shall be for a period not exceeding 10 years. If an active substance is approved as a low risk substance, the approval period will be 15 years.

Fees

The Ctgb charge fees to ensure that the full economic costs of evaluating and processing applications are covered.