Characteristics

Plant protection products are authorised at the national level. Per zone, one member state, acting as zonal Rapporteur Member State (zRMS), is responsible for conducting the assessment and preparing a comprehensive assessment report (draft Registration Report, dRR). This dRR is made available to the other concerned member states (CMS) for commenting. The zRMS finalises the Registration Report (RR) under consideration of the comments received. The finalised RR then forms the basis for national product authorisations in all EU memberstates in the zone. On national level the basic zonal assessment (core assessment) can be extended with complementing assessments for national aspects.

Specific national aspects have been established for the Netherlands. Also some specific technical and agronomic circumstances and common practices can be of influence on the dossier preparation and assessment.

The legal basis

The zonal application finds its legal basis in article 28 - 37 of the Regulation (EC) No 1107/2009

Application type criteria

The zonal procedure applies for:

• new authorisations,
• major amendments to existing authorisations:
  • extending (the scope of) the authorisation;
  • major changes in product composition.

Also minor uses can be applied for using a zonal application. For more information about minor uses, please refer to the page about minor uses.

Prior condition for a zonal application of a plant protection product:

• its active substances, safeners and synergists have been approved (PPPR 1107/2009, art.29).
  Search status active substances in EU pesticides database
  If the active substance is approved but classified as a Candidate for Substitution, a product application with this active substance will be preceded by an evaluation of available alternatives. Therefore, the form for a Comparative Assessment has to be included in the zonal application.
  More about Comparative Assessment.
• If the active substance(s) of your product is/are low risk substance(s) shorter timelines are followed according to Article 47 of the regulation. However the data requirements are exactly the same. Please note that for biopesticides (products based on microorganisms, plant extracts and semiochemicals) there is a separate Evaluation Manual available, which gives an interpretation of the European guidelines for these products. The low risk status of the substance is also mentioned in the EU pesticides database.
• for use on feed or food crops, an MRL (covering the requested use) has been published in the EU.
  Search the EU pesticide database on published MRL's.

The applications are evaluated according the procedures defined in Regulation (EC) No. 1107/2009 and follow the zonal procedure.

An applicant can also choose to apply for a zonal assessment in a member state, without applying for a registered use in that country.

Example:

An applicant might apply for assessment by The Netherlands (NL = zonal reporting member state) to obtain product authorizations of a fungicide in potatoes and wheat in the central zone:

Example

Central zone MS	Uses applied for
Belgium, Germany, Poland	Potatoes, wheat
Czech republic, Ireland, Hungary, Slovakia	Potatoes
Austria, Romania,  UK	Wheat
The Netherlands, Luxemburg, Slovenia	None

 In this case less information has to be submitted with the application. See instructions for submission, paragraph “completeness check”.

Data Requirements

Data requirements for an application depends on the date of submission of that application. See Regulation (EC) No 283/2013 and 284/2013 for the applicable data requirements for the approval of active substances and the authorisation of plant protection products.

Please note that the dossier structure should follow the Table of Contents (ToC) and numbering set by the data requirements.  Electronic submission of dossiers (application form, dRR, study summaries and reports) can be presented in CADDY (not required for product submission).

For products based on microorganisms the “old” format of the dRR (B1-7) is still applicable.

Duration Period Product Authorisation

An authorisation will be granted for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product (Regulation1107/2009, art.32).

Coordination zonal applications: Central Zone Steering Committee

The czSC is a co-ordination body dealing with issues of work-sharing (which is seen to be the key function of the group). Within the Central Zone Steering Committee (czSC) agreements are made to achieve effective and harmonised cooperation on zonal applications. The czSC does not address questions on product specific risk assessments.

With three zones, there are three zonal steering committees (page 20 and 22) and one interzonal steering committee. In the SC the Member States of the zone are represented.