The EU pesticide regulation 1107/2009 divides Europe into three zones (Northern, Central and Southern). Within each zone, Member States cooperate in evaluating applications for authorisation of pesticides. One country called zonal Rapporteur Member State (zRMS) performs an evaluation on behalf of the zone. The evaluation must cover the uses in all countries in the zone, where it was applied.
For indoor uses and seed treatments, evaluation of applications are not performed on a zonal basis, but across the whole EU. Such evaluations are called interzonal.
What is the difference between zonal and interzonal evaluations?
Regulatory zones have comparable agricultural practices, and comparable plant health and environmental (including climatic) conditions. Denmark is in the Northern zone, together with Estonia, Finland, Latvia, Lithuania, Norway and Sweden. The EU is considered as one zone (Interzone) when it comes to the evaluation of products for use in greenhouses, as post-harvest treatments, for treatment of storage rooms, and for seed treatments since the evaluation of these uses are independent of geographical or climatic conditions in the EU. Interzonal evaluations therefore cover uses throughout the whole 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 (iRMS). If the product is applied in other countries in EU, called concerned Member States (cMS), the countries make a decision based on the registration report from the iRMS and any national requirements.
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.
It is also possible to apply for mutual recognition of a plant protection product, if the product is already authorised in another EU Member State.
Read more on mutual recognition here
Pesticide application fees
As of 1 January 2014 fees for processing applications for Plant Protection Products were introduced in Denmark.
Find out more on fees for processing of pesticide applications
The holder of the authorisation must pay an annual tax per authorisation, and the relevant pesticide tax to the Danish Tax and Customs Administration.
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 |
Pre-notification
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.
Requirements related to dossiers
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.
A completeness check of the application of new products will be initiated before the actual evaluation of the application begins. Thus, the Danish EPA will check if the requirements are fulfilled. If the application contains minor deficiencies, a request for supplementary material will be sent to the applicant via email. 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 make sure that the application is complete, it is recommended to fill out a completeness check form. A completed form can be submitted along with the application form and dossier. Be aware that the form does not contain national requirements and you should therefore refer to Guidance on cooperation in the Northern Zone and The Danish evaluation framework with regard to the environment and health.
The applicant is encouraged to submit the dossier in an easy to read format, as for example Caddy XML. DEPA's requirements for submission of applications and dossiers can be seen in the following document; Requirements for submission of documentation in the Northern Zone.
All applications must be submitted following the dRR format (version 2015). Dossiers related to AIR II renewals can however 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.
Pesticides are divided into two groups depending on whether they are intended for professional or non professional uses:
- 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 intended for both non-professional and professional uses must be split into two products (with different registration numbers and names), and two dossiers must be submitted.
Find out more about specific application requirements under the different types of applications:
- New plant protection product authorisations
- Renewals of authorisation under Article 43
- Amendments of authorisations
- Mutual recognitions
If the application contains a minor use (Article 51 applications)
Minor uses 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. Please note, minor uses must appear in the Part A, and that Denmark has specific requirements regarding how minor uses should appear on the product label.
Minor uses included in the application must follow this template (in Danish) for minor uses applied for separately. Find out more under the section minor use authorisations.
On the product label, the minor use must be placed in a separate field at the end of 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 (In Danish):
”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 electronic format (CD) to:
Danish EPA, Pesticides
Tolderlundsvej 5
DK-5000 Odense C
Denmark
Att. The Pesticide Division “Application for authorisation of pesticide”
Or to: pesticider@mst.dk
Regulations
The requirements for zonal authorisations are described in Articles 33-39 of Regulation (EC) No 1107/2009.
Specific requirements for the Northern Zone are described in Cooperation in the Northern Zone.
The requirements for renewals of zonal authorisations are described in Article 43 of Regulation (EC) No 1107/2009.
Links
Notification form for intended zonal applications
Application form for zonal application
Completeness check form (following the dRR format according to SANCO/6895/2009)
Completeness check form (2015) (following the new dRR format from 2015)
dRR format (2015) – for new applications after the 1st of January 2016
dRR format (following SANCO/6895/2009)
Cooperation in the Northern Zone
Guidance document for evaluation of efficacy in the North zone
Guidance document on zonal evaluation and mutual 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
The Danish evaluation framework
The Danish evaluation framework with regard to the environment and health