Characteristics
Regulation 1107/2009 requires Member States to perform a comparative assessment when evaluating applications for plant protection products containing an active substance approved as a candidate for substitution. Member States are not to authorise, or must restrict the use of such products, where a comparative assessment in accordance with the regulation demonstrates that there is a significantly safer option for that use. This is called substitution.
Member States must weigh the risks and benefits of the use and must include consideration of resistance risk management and minor uses, and ensure that the alternatives do not present significant practical or economic disadvantages. The alternatives available will depend on national practices and differ between Member States.
Ctgb will apply the comparative assessment for applications submitted from 1 August 2015.
The legal basis
The comparative assessment finds it legal basis in Regulation 1107/2009, article 50 and Annex IV, Comparative assessment pursuant to Article 50.
Application type criteria
Prior condition for a comparative assessment requires that (one of) its active substances have been identified as candidate for substitution.
Search status active substance in EU pesticides database.
When evaluating an application for authorisation for a plant protection product containing an active substance approved as a candidate for substitution, a comparative assessment on a national level shall be performed by the Member State in case of:
- Zonal application for new Plant Protection Product
- Re-registration of a Plant Protection Product
- Applications with extension of uses. In this case, the comparative assessment shall be performed only for the additional uses applied for (not for the currently authorised uses).
No Comparative Assessment is executed as part of the evaluation of:
- a derived authorisation. The derived authorisation will follow the decisions on the authorisation of mother product. The Comparative Assessment on the derived authorisation Active Substance will be executed during the evaluation for renewal of the mother product.
- a parallel trade permit. The parallel trade product will follow the decisions on the authorisation of the mother. product The Comparative Assessemnt on the Active Substance in the parallel trade product will be executed during the evaluation for renewal of the mother product.
- minor uses.
For the time being no Comparative Assessment will be executed for:
- applications for Mutual Recognition
- applications for non-professional use
Data Requirements
It is the responsibility of the applicant to provide additional information for the comparative assessment, when submitting an application for the authorisation of a product containing a CfS.
The registered uses of pesticides per crop and per pest / plague in The Netherlands can be found in our pesticides database.
Duration Period Product Authorisation
Where a Member State decides to withdraw or amend an authorisation pursuant to art.50 (4), that withdrawal or amendment shall take effect 3 years after the decision of the Member State or at the end of the approval period of the candidate for substitution where that period ends earlier (Regulation 1107/2009, art.50(5)).
Applicants may want to make use of the derogation in Art.50 (3) to perform a comparative assessment for uses where it is necessary to acquire experience in practice. Such authorisation shall be granted once for a period not exceeding five years, following with a new application with a comparative assessment which will be required to continue the authorisation.
Where an alternative product will be found for the product of one of its uses, the authorisation of the concerning use will revoked.