Guidance and forms - p...
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Guidance and forms - plant protection products

Guidance documents and forms for approval of new plant protection products, re-registration and change of conditions for already approved products.

 

Pre-notification form

Form to notify intended zonal applications. The notification form should be submitted to all concerned Member States within the zone at least six months in advance of an application and preferable in time for an appropriate steering committee meeting.

 

Application forms

MIP-0007-E Plant protection products containing nematodes, insects and arachnids

MIP-0012-E Product authorisation (new or renewal)

MIP-0016-E Amendment or withdrawal

MIP-0017-E Parallel trade permit

MIP-0019-E Derogation in plant protection

MIP-0023-E Extension of authorisation for minor uses

 

Repayment of fee

MIP-0025-E Form for repayment of fee

 

Guidance documents

Guidance document for application in the Northern Zone 2013

Unfortunately, the document has a few broken links. They concern the guidance and calculation tools for risk assessment of birds and mammals. Please, find the correct links on the website of the Danish Environmental Protection Agency.

New version
A new version of the guidance for application in the Northern Zone is published. It can be voluntarily applied from April, 2014, and must be applied from the dates given in the table on page 2 in the document.
Guidance document for application in the Northern Zone 2014.

Swedish guidance documents:

Data requirements - pesticide residues, from the National Food Administration

Guidance on Letter of Access

Guidance for applications for mutual recognition in Sweden

Leaching to groundwater 

EC guidance documents:

Instructions for industry on dossier submission

Submission of dossiers for authorisation

Standard phrases for special risks and safety precautions for plant protection products (Directive 2003/82/EC)

Microbiological Plant Protection Products - Workshop on the Scientific Basis for Risk Assessment (1998)

 

Completeness check

Form for completeness check of application and dRR

  

Operator exposure models 

The mathematical model of UK-POEM is available through the Health and Safety Executive´s website (Chemicals Regulation Directorate).

PSD's interpretation of the German Operator Exposure Model (BBA 1992) is available here:

The German Operator Exposure Model (BBA 1992)
Microsoft Excel workbook containing 3 pages: operating instructions, a model based on geometric mean values (appropriate for EC regulatory use) and a model using the 75th percentile exposure values.

 

Application for approval of active substance

See information on plant health on the website of the Health and Consumer Protection Directorate General

Last review
2014-06-27
Created
2011-10-05