Zonal authorisation

A zonal authorisation is based on an evaluation carried out in collaboration between the countries in the zone. A zonal evaluation as far as possible covers the use in all countries in which you have applied.

According to the Regulation, the countries have to work together on the evaluations. Thus Europe is divided into three zones (Northen, Central and Southern), where each zone has to work together on the applications for outdoor use, and one EU zone where the whole of Europe has to work together on applications for indoor use (e.g. greenhouses) and seed treatments.

Denmark is in the Northern zone, together with Estonia, Finland, Latvia, Lithuania, Norway and Sweden. The EU is considered as one zone (Interzonal) 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.

The zonal evaluation is performed by one country in the zone, called Zonal Rapporteur Member State (ZRMS). If the product is applied for in other countries in the Zone, called Concerned Member States (CMS), they make a decision based on the registration report from the ZRMS and any national requirements.

The Inter-zonal evaluation is made by one country in EU, called Interzonal Rapporteur Member State. If the product is applied in other countries in the Zone, called Concerned Member States (ICMS), the countries make a decision based on the registration report from the IRMS and any national requirements.

Regulation (EC) No 1107/2009

Zonal authorisation is not an entitlement to place a product on the market

You must apply for authorisation in each of the countries in the zone, in which you intend to market your product. Authorisation or refusal is given by the 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

The cost for applying

As of 1 January 2014 fees for processing applications for Plant Protection Products were introduced in Denmark. 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

Charge of fees for applications for both outdoor and indoor use

Applications which contain uses for both zonal- and interzonal uses will be dealt with differently depending on which country functions as Rapporteur Member State. In the table below it is specified which fees are charged in Denmark:

The role of DK

The fee

ZRMS and IRMS

9204 and any additional fees  + fee for amendment during the evaluation

ZRMS and ICMS

9202 + 9203 and any additional fees 

ZCMS and ICMS

9203 + 9203 and any additional fees 

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

 

Requirements related to dossiers, etc.

In order for the applicant to verify that all requirements are in place, a completeness check form must be completed before applying:

Completeness check form (2015) (following the new dRR format from 2015)

Completeness check form (following the dRR format according to SANCO/6895/2009)

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 on collaboration in the Northern zone.

The applicant is encouraged to submit the dossier in Caddy XML format. DEPA's requirements for submission of applications and dossiers can be seen in the following document.

As of 1 January 2016 all applications must be submitted following the new format of the dRR from 2015. Dossiers related to AIR II renewals can be submitted in the old dRR format. 

For an application which contains both an outdoor and indoor use, two separate dossiers must be submitted, however only one authorisation will be given.

From 26 November 2015 all pesticides will be split into two groups:

  • Professional pesticides, which can only be bought and used by professional users who have a spray certificate, spray proof or gassing proof
  • Non-professional pesticides which can be bought and used by private garden owners

Thus products which are applied for to both non-professional and professional use must be split into two products (with different registration numbers and names), and two dossiers must be submitted.

 

If the application contains a minor use

A minor use can be included in an application for a new product. Regarding renewals of products, a minor use can only be included if the minor use has been assessed and approved before the renewal is applied for. That is, new minor uses cannot be included in an application for renewal.

Minor uses included in the application must have a separate user’s guide, which must follow this template (in Danish) and be submitted together with the product application. Following an approval, the user’s guide will be published on the Danish EPA’s pesticide database (Bekæmpelsesmiddeldatabasen).

On the product label the minor use must be placed in a separate field last on the label. The wording on the label must be the same as in the user’s guide for the minor use. The text below the headline Ansvar for mindre anvendelse og vejledning on page 1 can, however, be replaced by the following text:   

”Anvendelsen i afgrøden sker på brugerens eget ansvar for så vidt angår midlets effektivitet og eventuelle skader på nytteplanter. Øvrige bestemmelser på etiketten skal også overholdes i forbindelse med den mindre anvendelse”.

 

Submission of an application

The application must be submitted in three electronic copies to:

Danish EPA, Pesticides and Biocides
Tolderlundsvej 5
DK-5000 Odense C
Denmark

Att. The pesticide division “Application for authorisation of pesticide”

Or to:

 

Regulations

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

The requirements for renewals of zonal authorisations are described in Article 43 of Regulation (EC) No 1107/2009.

Links

Cooperation in the Northern Zone

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

Guidance from EU on renewal of authorisation after Article 43

Guidance from the Northern Zone on Article 43 renewals

dRR format (2015) – for new applications after the 1st of January 2016

dRR format (following SANCO/6895/2009)

Notification form for intended zonal applications

Application form for zonal application

Completeness check form (2015) (following the new dRR format from 2015)

Completeness check form (following the dRR format according to SANCO/6895/2009)

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

Requirements for application and dossier

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