Zonal authorisation

A new way of obtaining authorisations has been introduced – zonal authorisation based on an evaluation for the zone. A zonal evaluation covers, in as far as is possible, use in all countries in the zone for which you have sought authorisation. The countries in the zone collaborate on the evaluation. 

Denmark is in the North zone, together with Estonia, Finland, Latvia, Lithuania and Sweden. Norway also participates in the collaboration. The EU is considered as one zone when it comes to the evaluation of products for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, and for seed treatments. This means that the evaluation must cover use throughout the EU.

Zonal authorisation is not an entitlement to place a product on the market
As under the previous rules, you must apply for authorisation in each of the countries in a zone where you intend to market your product. Authorisation or refusal is given by individual Member States. If you have applied for authorisation in two countries only, you can subsequently seek mutual recognition of the product – both within and outside the zone.
Read more on mutual recognition here

Application requirements – new products
Six months before the submission of an application, you must send a notification form to all countries in which you wish to market your product. In it, you can propose the country you would like to undertake the zonal evaluation (the Zonal RMS – Rapporteur Member State).
Download Notification form for planned zonal applications (word)

The application itself
A new element of the application is an application form that must be completed and submitted together with other documents including a complete "Annex III dossier" (studies on the product), a "Draft Registration Report" and an "Annex II dossier" for each active substance in the product (unless this has already been submitted). Furthermore, a list must be attached of the intended uses in each zone and in the Member States for which an application is being made (GAP table) as well as the draft label/instructions for use for the product. The requirements for a master label are described in the ‘Guidance document for evaluation of efficacy in the North zone’.
Download Guidance document for evaluation of efficacy in the North zone
Download Application form for zonal applications

A plant protection product may only be authorised if:

• the active substances are approved
• the product is sufficiently effective
• it has no harmful effects on human or animal health or on the groundwater
• it has no unacceptable effects on the environment
• a maximum residue level (MRL) in foodstuffs or animal feeds has been set.
  

Requirements relating to dossiers, etc.
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. The annexes 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

Processing of your application
The zonal evaluation is prepared by one Member State in the zone, known as the Zonal Rapporteur Member State (ZRMS).
If your application for authorisation relates to a product for use in greenhouses, as post-harvest treatments, for treatment of empty storage rooms, or for seed treatments, the evaluation is undertaken at EU level by an EU RMS.

The ZRMS begins by carrying out a completeness check on your application. This means that all information should be in place before the evaluation can begin. Once the evaluation is underway, the ZRMS can prolong the process for up to six months if information is missing.

The ZRMS produces a draft evaluation which is sent to all Member States in the zone for their comments. Once the Member States have provided comments, the ZRMS will finalise your case. The evaluation is conducted based on the Uniform Principles which have been transferred from Annex VI of the Plant Protection Product Directive to a separate Regulation.

The remaining Member States now have four months in which to either authorise or refuse the application.

Processing time and decisions

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PROCESSING TIME: 12 months (plus six months). The other Member States in the zone must take their decision no later than 120 days after the completion of the zonal evaluation.

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The zonal rapporteur has one year from the date of the application in which to make their decision, unless it was necessary to request further information from the applicant. In this case, the period can be extended to a maximum of 18 months.

If the ZRMS determines that a product shall receive an authorisation, the other Member States in the zone have four months in which to decide whether they too can grant an authorisation. These Member States have various options:

• to accept the evaluation without reservation
• to accept the evaluation but to impose new risk reduction measures, for instance relating to distance from the aquatic environment
• to refuse authorisation if unacceptable health or environmental risks exist in the Member State. This may occur, even where other Member States grant an authorisation.

The EU has prepared guidelines for the processing of your application.
For the North zone, a guidance document has also been drawn up which describes how to apply for authorisation and how the application will be evaluated by the ZRMS. Both documents can be found under LINKS below.

The cost of applying
The application for a zonal authorisation in Denmark is free of charge. The holder of the authorisation must however pay an annual fee of DKK 500 per authorisation together with the relevant duties due to the Danish Tax and Customs Administration.

Regulations
The requirements for zonal authorisations are described in Articles 33-39 of Regulation No 1107/2009.

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LINKS
Guidelines on collaboration and in particular re-evaluations ind the North zone

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

Application forms for zonal authorisation
Application form for zonal applications

Notification form for planned zonal applications (word)


Documentation, compilation of dossier, etc.
Guidance document on the presentation and evaluation of dossiers according to annex III of Directive 91/414/EEC in the format of a (draft) Registration Report

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 document for evaluation of efficacy in the North zone