Instruction for submission (NL=zRMS)

Before submission

When preparing the application, applicants should contact the zonal Rapporteur Member State of their choice, with the request to process the application. For the Netherlands, applicants can contact Mr Geert-Jan Molema, at least six months before you intend to submit the application. When agreement has been reached with the zRMS, the completed form 'notification zonal application' must be submitted to the zRMS and all cMS (only necessary for application for new authorisations and amendmends (art 33 of PPPR), not necessary for applications for renewal (art. 43 of PPPR).

If required, the central zone Steering Committee (czSC) will coordinate the distribution of the work amongst the Member States. Six months before submitting the application, the applicant can propose a Member State as zonal rapporteur to the czSC.

If the Netherlands is the rapporting memberstate, the Ctgb highly recommends the applicant to request a Pre-submission Meeting before the application is submitted. During this meeting, the content of the application is discussed and inventoried with the applicant (see Pre-Application Support).

Application forms and templates

The content and structure of dossiers is precisely and comprehensively defined in several guidance documents.  From January, 1, 2017, the revised templates for the draft registration report have to be used for applications for authorisation as well as for applications for extension or renewal of authorisations for which the data requirements of Regulation (EU) No. 284/2013 apply. If the active ingredient is a microorganism, the old dRR format (B1-B7) is still applicable. 

With the updated Guidance document on zonal evaluation and mutual recognition, withdrawal and amendment of authorisations under Regulation (EC) No 1107/2009 (SANCO/13169/2010), some issues regarding the forms and templates are clarified.

Field and glasshouse uses

If there is both an indoor and an outdoor use, two dRRs should be submitted, the zonal dRR covering the field uses and an interzonal dRR for the indoor/glasshouse uses. 
In the Netherlands we want to receive one part A, where all uses applied for in the Netherlands are mentioned (outdoor and indoor). 
Part C and zone independent aspects should be evaluated by only one zRMS, also when the field uses applied for cover different zones. Please indicate clearly if the Netherlands or another zRMS is responsible for the evaluation of Part C. 

Extension of use

For applications for extensions of use the information that has to be submitted is restricted to the relevant dRR parts related to the extension/amendment.
Appendix 4 "Recommendations for applications for extension of use" of the guidance, indicates which information should be provided in case of a zonal application for a label extension/amendment.

Low risk

If your product is based on an active substance which is approved as a low risk active substance please indicated this on the application form. 
For the product to be autorised as low risk, the applicant shall demonstrate that all the requirements for low-risk PPPs set in Article 47.1 are met and in particular show that for each intended use no specific risk mitigation measures are needed following from the risk assessment. The applicant shall include a specific conclusion on the low-risk requirements in each section of the dossier, where relevant.
These applications are eligible to reduced time lines as mentioned in Article 47 of (EC) No 1107/2009 and the EPPO guidance for low risk products (). Currently the Ctgb is not able to answer the legal timelines, this also applies for the timelines for low risk products. However low risk applications will be treated with more priority than non-low risk dossiers, resulting in relatively shorter timelines.

Legal instructions for use

Guidance for writing the Dutch label is available, however only in Dutch. Understanding of the Dutch language is required for drafting the label.

Reference lists

Part A and each section of Part B (including national addenda) should have 4 reference lists of tests and studies as Appendix 1. Two lists need to be filled by the applicant (“All studies required to address the data points in the dRR and not previously evaluated at EU level” & “All studies required to address the data points in the dRR and already evaluated at EU level”). Each reference should only appear in one of the two lists. All 4 reference lists need to be considered by the zRMS (i.e. the first two lists and ”Data not relied on” & “Data not submitted but relied on”). Such data lists should be prepared in the format as required in SANCO 12580/2012.  If additional data are submitted during the evaluation, they should be added to the lists in the dRR. An updated data list should be supplied by the applicant. Note that the applicant must also indicate in the list in part A (provided separately for each country in the zonal/interzonal application) for which studies protection was claimed, as necessary to meet the requirements of Art 60 (2 b).  For more information about the dRR format please refer to SANCO/6895/2009 rev 2.2:  Technical guidelines on the presentation and evaluation of plant protection product dossiers in the format of a (draft) Registration Report.

Minor uses: in the GAP table, minor uses have to be specified and identified separatly, by using a separate line in the GAP table for every minor use (see also explanation in template of the GAP). Note: when a minor use is not identified as such in the GAP table  and draft label, it will not be assessed like a minor use and not registered as one.

 Application forms, instructions and addenda

Form notification zonal application

Form G-zRMS

dRR template

Instruction and forms Legal use (WG)

professional  and non professional use


LoA (Part A section 1)

GAP (Part A section 2)

Reference list

Reference list vertebrates

National addenda:

Efficacy NL (Part B section 3)

Environmental Fate NL (Part B section 8)

Ecotoxicology NL (part B section 9)

Check for completeness application

The application for a zonal authorisation should consist of the following documentation:

  • Cover letter
  • Form Notify Zonal Application (already sent 6 month before product application)
  • Form G – zRMS
  • dRR + National addenda
    • LoA (Letter of Access)
    • Concept WG (Legal instructions for use)
    • GAP (Description of use)
  • Reference list
  • Supporting data, if relevant. Summaries + Trial/study reports (Caddy)

When The Netherlands is zonal Rapporteur member state, but no authorization of the product is applied for in The Netherlands, the application for a zonal authorization should consist of the following documentation:

  • Cover letter
  • Form Notify Zonal Application (already sent 6 month before product application)
  • Form G – zRMS
  • dRR (without part A and other national addenda)
  • LoA (Letter of Access)
  • GAP (Description of use)
  • Reference list
  • Supporting data, if relevant. Summaries + Trial/study reports (Caddy)