Mutual recognition

Mutual recognition is a simplified authorisation procedure which means that you can quickly receive an authorisation of your product if it has already been authorised, either in the zone or in another zone. Your application should be processed in 120 days. It is possible to apply for mutual recognition within one authorisation zone or across all authorisation zones.

Generally speaking, you are ENTITLED to mutual recognition if:

  • you are the holder of an authorisation granted in another Member State of the same zone
  • you are the holder of an authorisation from another Member State of a product for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments.

A Member State may refuse authorisation if there are substantiated reasons that the product poses an unacceptable risk to health or the environment. Moreover, the Member State to which you apply may impose other risk-mitigation measures than those stipulated in the original authorisation. For example, other requirements relating to distance from the aquatic environment.

Generally speaking, you are NOT ENTITLED to mutual recognition if:

  • you are the holder of an authorisation granted by a Member State in another zone.
  • the authorisation granted by another Member State is provisional.
  • the product contains an active substance that is a candidate for substitution.
  • the product contains an active substance that does not meet the new cut-off criteria.

Application requirements

Pre-notification

Six months before the submission of an application, you must send a notification form.

Download the notification form for mutual recognition applications.

Final application

A new element of the application for mutual recognition is an application form that must be submitted, along with an 'Annex III dossier' (studies on the product) and an 'Annex II dossier' for each active substance in the product (unless this has already been submitted).

Download application form

The evaluation in question must fulfil the following requirements:

  • The format and level of detail must be sufficient to underpin the evaluation (for example in the format of a Registration Report).
  • Danish requirements to documentation (e.g. groundwater modelling).
  • Danish agricultural and environmental aspects must be taken into account.
  • Danish measures with regard to risk mitigtion must be observed.

Until now, the data requirements for applications for approval of active substances and authorisation of plant protection products have been described in Annexes II and III, respectively, of Directive 91/414. These have been transferred to the Pesticide Regulation and continue to apply until the amendments that are in progress have been adopted.

To simplify the application procedure, there is now a completeness check form which allows the applicant to verify that all the requirements are in place. Once completed, the completeness check form must be submitted together with the application form, etc. Note that the form does not include national requirements for applications. For these, please refer to the Guidance document for collaboration in the North zone.

Download completeness check form.

Case processing time

The case processing time is 120 days.

The cost of applying

As of 1 January 2014 fees for processing applications for Plant Protection Products were introduced. The fees cover all expenses related to the assessments according to the rules in the Regulation 1107/2009 on Pesticides and the Plant Protection Directive.

Read more on fees for case processing of pesticide applications.

In addition the holder of the authorisation must pay an annual tax of DKK 500 per authorisation to the Danish Tax and Customs Administration.

Regulations

The requirements for mutual recognition are described in Articles 40-42 of Regulation No 1107/2009.

Further information

The requirements for the application form, procedure and documentation when seeking mutual recognition are described in the following sources.

Guidelines on collaboration and in particular re-evaluations ind the Northern Zone

Guidance document on zonal evaluation and mutual recognition under Regulation (EC) No 1107/2009

 

Application form

Application-product-authorisation-new-or-renewal Denmark.doc

 

Documentation, compilation of dossier, etc.

Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach”

 

The Danish evaluation framework

The Danish evaluation framework with regard to the environment and health

Guidance for evaluation of efficacy in the North zone