Application for authorisation of plant protection products

Published 01.06.2015     Modified 05.06.2018

Rules for the authorisation of plant protection products are set out in the Norwegian regulation with the implemented EU Regulation (EC) 1107/2209. The Norwegian Food Safety Authority is in charge of national authorisations for plant protection products, and national requirements and conditions may apply.

Work-sharing in the Northern zone

The evaluation of plant protection products in the EU is divided into three zones. This is in order to promote work-sharing and increase harmonization. Norway is part of the Northern zone together with Denmark, Estonia, Finland, Latvia, Lithuania, Sweden and Iceland. The Member States in the northern zone (Denmark, Estonia, Finland, Latvia, Lithuania, Sweden) and Norway have agreed to co-operate in sharing the work to evaluate applications for authorisation of plant protection products.

Procedures and details about content and format of applications as well as assessments are described in the Guidance document for applications in the Northern zone. By mistake the footnote on page 18 was not deleted from the version 7. Norway accept the Guidance document on significant and non-significant formulation changes SANCO 12638/2011, 20th November 2012.

Requirements for efficacy data for zonal evaluation in the Northern zone are specified in the Guidance document for efficacy data in the Northern zone and Annex 1 - Guidance on number of trails in the Northern Zone

Procedures

The procedures regarding applications for approval of plant protection products according to Regulation (EC) No 1107/2009 are described in the latest version of the following guidance documents (published on the website of the European Commission):

An application must be sent to each country where the plant protection product is intended to be placed on the market. You can find the Norwegian application form here. Each country in the Northern zone makes a final decision on the approval of the product, based on the zonal evaluation and specific national requirements. The specific national requirements are described in the Northern Zone Guidance Document.

A pre-notification of intended application must be submitted to all concerned Member States within the zone at least six months in advance of an application. You can find the pre-notification form here.

If the plant protection product contains an active substance that is a candidate for substitution, a comparative assessment will be conducted with the aim of replacing the plant protection product by products which require less risk mitigation.

Plant protection products for use either in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments are jointly assessed in the EU and not at zonal level. You can find more information about the assessment of such products here.

Application forms:

Guidance on how to apply:

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