Mutual recognition - Articles 40 - 42

Mutual recognition of a plant protection product offers a simplified application procedure for authorisation. If a product is authorised in one EU Member State, it is possible to apply for mutual recognition in other Member States in the EU. It is possible to apply for mutual recognition both within and across zones.

An application for mutual recognition of a plant protection product must be for the same product and for the same uses as the originally authorised product. In addition, the climatic and environmental conditions as well as the agricultural practices must be comparable between Denmark and the country in which the product is already authorised. The Danish requirements for the protection of human health and the environment must also be fulfilled.

You can apply for mutual recognition of the same product if:

  • An authorisation was granted in another Member State, which belongs to the same zone
  • The authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty storage rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs

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

It is also possible to apply for a mutual recognition if:

  • An authorisation was granted by a Member State in another zone
  • The application concerns a provisional authorisation granted by another Member State
  • 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
  • It can be demonstrated that the Danish requirements are met

Application requirements - mutual recognition

Pre-notification

Six months before the submission of an application, a notification form including a GAP table must be submitted.

Download the pre-notification form for mutual recognition applications.

Application

In Denmark, applications for mutual recognitions must fulfill the same requirements as for zonal authorisations. In other words, the dossier must follow the endpoints listed in the latest EU approval as well as the latest guidance documents and data requirements in force at the time of application for mutual recognition. In addition, national requirements for Denmark must be met.

There are specific requirements regarding the structure of the application and dossier.
Download Requirements for submission of documentation in the Northern Zone.

The following must be submitted as part of the application for mutual recognitions:

  • A cover letter explaining the purpose of the application including areas of use and a complete application form. Download application form
  • A copy of the authorisation letter for the reference product in the reference MS translated to English
  • The final Registration Report (RR) for the reference product as evaluated by the iRMS/zRMS
  • A complete Annex III dossier including product studies
  • A complete Annex II dossier for every active substance in the product (unless this information already has been submitted)
  • A statement that the uses (GAP Table / B0), the technical specification of the active substance, the product composition, the type of packaging and the classification are identical to those applicable to the approval of the product in the rerence Member State and that the assessment is based on the "Uniform Principles", according to Regulation (EU) No 1107/2009
  • Complete detailed composition of the formulation and co-formulants (including full compisition of mixtures)
  • A draft label/instructions for use of the product
  • A dRR part A for Denmark, and national addenda to dRR part B for all relevant sections, where specific national requirements are necessary (e.g. groundwater modelling)

The following requirements must be met:

  • Data requirements (Commission Reg. (EU) No 284/2013) including specific national requirements for Denmark (e.g. groundwater modelling)
  • The submitted registration report must meet requirements for evaluation in the Northern Zone (please refer to the Northern Zone Guidance document and the Danish Framework for Evaluation of Plant Protection Products)
  • The dossier must take into account Danish agricultural practices and environmental conditions
  • The risk assessment must be carried out with risk mitigation measures that are accepted in Denmark

If in the dossier, the applicant uses data which they do not own, and for which data protection has expired, a clear reference must be made to the specific studies in question in the reference list, and the studies must be made available to the Danish EPA.

The rules for mutual recognitions are set out in articles 40-42 in Reg. No 1107/2009.

Please note, it is important that the application is complete and meets all the requirements for the specific type of application. The evaluation will only begin when all relevant material and information is received. If the application is repeatedly found to be incomplete, it will be rejected. See examples of frequent deficiencies here: link

A completeness check of the application for mutual recognition will be initiated before the actual evaluation of the final application begins. Thus, the Danish EPA will check if the abovementioned requirements for the application are fulfilled. If the application contains deficiencies, a letter of request for supplementary material will be sent to the applicant via email. The requested data must be submitted within a short deadline for mutual recognitions. If the requested data is not delivered in due time the application will be rejected. The evaluation of the application will only commence when it is assessed as being complete.

To ensure that the application is complete, we recommend that the applicant fill out a completeness check form. The completed form can be submitted with the application form and dossier. Please note that the form does not contain the national requirements and you should therefore consult the Guidance on cooperation in the Northern Zone.

Submission of the application

The application must be submitted in electronic format (CD) to:

The Environmental Protection Agency, Pesticides and Biocides 
Tolderlundsvej 5 
DK-5000 Odense C

Att. Pesticides “Application for mutual recognition”

Or through email (link to email address)

Processing time and decisions

The application processing time is 120 days from the day on which the dossier is determined to be complete. The application process will be paused if additional information is required from the applicant (clock stop procedure). The clock stop will be in place until the applicant has submitted the requested information. The application process will recommence when the requested information and/or material has been submitted. The Danish EPA accepts a maximal clock stop period of 6 months, after which the application will be rejected.

Pesticide application fees

Fees are charged for the processing and evaluation of applications of pesticides. The fees cover all expenses related to the assessment and authorisation according to Regulation 1107/2009 on Pesticides and the Plant Protection Directive. Further information on fees can be found here.

In addition the authorisation holder must pay an annual tax of DKK 500 per authorisation and the relevant pesticide tax 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

Guidance for evaluation of efficacy in the North zone 

The Danish evaluation framework

The Danish evaluation framework with regard to the environment and health

Application form

Download application form

Documentation, compilation of dossier, etc.

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