Simplified procedure for extending authorisations of low-risk products with minor uses
From 1 January 2023, an accelerated application procedure for extending an authorisation with minor uses is possible for low-risk products (plant protection). By offering this procedure, the Ctgb is responding to a recent motion adopted by the Dutch Lower House of parliament calling for increased availability of these products. The accelerated application procedure is based on the existing procedure for extending authorisations of plant protection products with minor uses (NLKUG). Authorisations for low-risk products can, in principle, be extended with new minor uses without an additional assessment. In some cases, a partial assessment remains necessary, but this takes fewer hours and is less expensive for the applicant.
The Ctgb considers whether the application can be processed entirely through an administrative procedure or whether a partial assessment is still needed. For example, a partial assessment is required in the following situations:
- if the substance has an MRL;
- if a human health impact assessment is required for the low-risk substance;
- if there is no exposure to humans or the environment with a currently authorised product, but such exposure is possible with the minor uses specified in the application for an extended authorisation.
Minor use (NLKUG)
An extension with a minor use can be requested in the following situations:
- for crops that are not grown on a large scale; or
- to meet an exceptional need for plant protection.
The total crop production area must not exceed 5,000 ha. of unprotected cultivation or 1,000 ha. of protected cultivation.
When assessing an extension with a minor use, the assessment of the product from the original authorisation – or a more recent assessment (if available) – shall be used. As a result, relatively little assessment time is required for processing the application.