Cooperation in the Northern Zone

Denmark, Estonia, Finland, Latvia, Lithuania, Sweden and Norway cooperate on evaluation of applications for authorisation of plant protection products.

This cooperation is part of the implementation of Regulation No. 1107/2009. The purpose is to share the work and harmonise the evaluations.

A guidance document on procedures and evaluation principles for the North Zone has been developed. In addition separate guidance on risk assessment for birds and mammals and efficacy has been developed. See links below. The documents are updated when needed.

Latest version from July 2023:

Guidance document on work-sharing in the Northern zone - version 11.1 - September 2023

This guidance document is mandatory from 1st of November 2023.

Previous versions:

Guidance document on work-sharing in the Northern zone - version 11 - July 2023

Guidance document on work-sharing in the Northern zone - version 10.0 June 2021

This guidance document is mandatory from 1st of November 2021.

Guidance document on work-sharing in the Northern zone - version 9.0 - June 2020

This guidance document is mandatory from the 1st of November 2020.

Guidance document on work-sharing in the Northern zone - version 8.0 - July 2019

This guidance document is mandatory from the 1st of November 2019.

Guidance document on work-sharing in the Northern zone - version 7.0

This guidance document is mandatory from the 1st of November 2018.

Guidance document on work-sharing in the Northern zone - version 6.0.

This guidance document is mandatory from the 1st of November 2017.

Guidance document on work-sharing in the Northern zone - version 5.0.

This guidance document replaces the version of April 2016, and was mandatory from the 1st of October 2016.

Guidance document on work-sharing in the Northern zone, version 4.0.
This guidance document replaces the version of April 2014, and was mandatory from the 1st of January 2016.

Guidance document on work-sharing in the Northern zone, version 3.0.

This guidance document replaced the version from April 2013 and was mandatory from 1 January 2015.

Risk assessment for birds, mammals and plant protection products

The risk assessment of pesticides with regard to birds and mammals is based on the EU guidance documents.

Sometimes there may be a need to perform a 'higher tier' risk assessment for particular Nordic conditions. To this end, a guidance document has been prepared describing the birds and mammals of relevance in the Nordic Zone and presenting scenarios for a series of use areas. The guidance document has been revised in 2020. Among others, it has been ensured that red-list species are also protected. The background document on red-list species is found here. The document is linked to a spreadsheet to be used in connection with the scenarios. Furthermore, a guidance note on additional higher tier risk assessment options for birds and mammals in Denmark is provided as an appendix in the Framework for assessing pesticides in Denmark found here.

The guidance development was supported by funding from the Nordic Council of Ministers.

Current guidance and spreadsheet:

Revised higher tier risk assessment for birds and mammals from December 2020 (v. 2.1)

Spreadsheet for bird mammal GD from 2020 (v. 20.1)

Please note that further guidance on refinements only relevant for Denmark are given in the Danish Framework for risk assessment of pesticides (found here).

Previous guidance:

Higher tier risk assessment for birds and mammals, April 2020

Higher tier risk assessment for birds and mammals, 2018.

Spreadsheet for Birds and Mammals from April 2017.

Higher tier risk assessment for birds and mammals, April 2017.

Higher tier risk assessment for birds and mammals, April 2016.

Higher tier risk assessment for birds and mammals, May 2015.

Guidance on risk assessment for Birds and Mammals, April 2014.

Guidance on risk assessment for birds and mammals, April 2013.

Previous spreadsheets:

Spreadsheet for Birds and Mammals from May 2016.

Spreadsheet for Birds and Mammals from January 2015.

Spreadsheet for birds and mammals, from April 2013.

Bird and mammals mix-tox tool

The below link directs you to a tool for the calculation of the mixture toxicity for birds and mammals following the recommendations in the Guidance document on work-sharing in the Northern zone - version 10.0 - June 2021. You will find instructions on use of the tool in the introduction of the tool (excel spreadsheet). 

B&M mix-tox tool

Aquatic MixTox tool

The below link directs you to a tool for the calculation of Aquatic Mixture Toxicity for the environmental risk assessment of plant protection products containing a combination of active substances, as addressed in section 10.3 of the Guidance on tiered risk assessment for edge-of-field surface waters (EFSA Journal 013;11(7):3290). You will find instructions on use of the tool in the introduction of the tool (excel spreadsheet) and in remarks to each sheet. In addition you will find a live document with FAQ related to MixTox calculations.

Relevant links:

MixTox tool

FAQ

Chronic Bee Risk Assessment tool

The below link directs you to a tool for the calculation of the chronic risk to honey bees following the recommendations in the Guidance document on work-sharing in the Northern zone - version 10.0 - June 2021. You will find instructions on use of the tool in the introduction of the tool (excel spreadsheet). 

Chronic bee calculation tool

Evaluation of efficacy in the North Zone

The document aims to specify the requirements for documentation wherever possible. The references in the text apply to Annex III to Directive 93/71/EEC.

The specifications on requirements for documentation and number of trials are intended as a guide to the common requirements for documentation in connection with efficacy evaluation in the North Zone. For the purpose of this document the North Zone is defined as follows; Denmark, Estonia, Finland, Latvia, Lithuania, Norway and Sweden.

Guidance on efficacy evaluation in the North Zone.