Amendment of authorisations - Articles 33 - 42

All amendments in the authorisation of plant protection products (PPP) need to be authorised by the Danish EPA. Such amendments may include for example extensions of use (i.e. label extensions), formulation changes or change of production site for the active substance. Amendments of authorisations should be applied for at zonal level, while minor amendments are handled nationally. The applicant should consult the zonal Rapporteur Member State (zRMS) regarding the format of the application. Please note that different types of documentation and information are required depending on the type of application.

Amendment types:

  1. Amendment of use
  2. Formulation changes, significant/non-significant
  3. Minor changes that require technical assessments

Requirements for submission of applications

Pre-notification

For some types of amendments of authorisation, it is required to send a pre-notification six months before the submission of an application to all countries in which you as an applicant wish to apply for the amendment. This is the case for major amendments of authorisations such as amendments/extensions of use (label extensions), and formulation changes, however a pre-notification is not required for minor types of amendments such as changes of production/manufacturing sites or administrative amendments.

Download pre-notification form

1. Amendments of use

An amendment in the use of a pesticide product covers an extension of the use by i.e. adding new crops, growth stages or pests and changes in dose rates. A distinction is made between major and minor amendments of use and it is ultimately up to the Danish EPA to assess the type of change in question.

Applications for minor amendments of use

Minor amendments may cover new targets within the current authorised uses, reduction of dose rates and modifications of BBCH stages within the current "risk envelope".

The following must be submitted:

  • A cover letter

  • A complete application form

  • An updated instructions for use which covers the amendments to the current authorisation such as new targets within the current authorised uses, reduction of dose rates and modifications of BBCH stages within the current “risk envelope”

  • An updated GAP table

  • An updated Part A, which is based on the current Part A. Changes must be marked with a colour (please note it is important that the same colour is used for all revised RR sections). The original text should not be changed

  • An new efficacy section (part B section 3)

  • Annex III studies necessary for the amendment of use. Please note that the amendment of use follows the data requirements of the product that were in force at the time of the first application for authorisation of the product

Applications for major amendments of use

Major amendments of use include changes such as new crops, changes in BBCH stages outside of the current risk envelope and higher dose rates.

The following must be submitted:

  • A cover letter

  • A complete application form

  • An updated instructions for use

  • An updated GAP table

  • An updated Part A, which is based on the current Part A. Changes must be marked with a colour (please note it is important that the same colour is used for all revised RR sections). The original text should not be changed

  • Updates of the core Registration Report (RR) sections relevant for the amendment of use. All additions must be clearly marked with a colour in the core RR sections to which the change relates (please note that it is important that the same colour is used for all revised RR sections)

  • Annex III studies necessary for the amendment of use. Please note that the amendment of use follows the data requirements of the product that were in force at the time of the first application for authorisation of the product

Different options are possible regarding the format of the application and this must be agreed with zRMS in advance:

  • Updates of the core Registration Report (RR) sections

or

  • Addenda to the core RR sections relevant relevant for the amendment of use. Note that an addendum may only contain information relating to the amendment of use

Download Requirements for submission of documentation in the Northern Zone

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. See examples of frequent deficiencies here: link

A completeness check of the applications for amendments of use will be initiated before the actual evaluation of the final application begins. Thus, the DEPA will check if the abovementioned requirements are fulfilled. If the application only 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 ensure that the application is complete, it is recommended to fill in a completeness check form. The form can be submitted together with the dossier. Please note that the completeness check form does not contain the national requirements by Member State (when relevant). In case national approaches are required, please refer to Guidance on cooperation in the Northern Zone.

2. Formulation changes

A formulation change is a change in the chemical composition of an already approved plant protection product. Applications for formulation changes can be processed at both zonal and national level. All applications for formulations changes require a pre-notification. All formulation changes must be applied for. DEPA does not accept notifications for formulation changes. Applications for alternative co-formulants must be applied for as non-significant formulation changes and fulfil the requirements for this type of application.

Applications for non-significant formulation changes

The following must be submitted:

  • A cover letter (optional)

  • A complete application form

  • Safety Data Sheets (SDS) and detailed composition of all new co-formulants (when relevant), which also must be submitted to all concerned Member States (cMS)

  • SDS for the new formulation of the product

  • An updated core RR part C, where all changes in the text are clearly marked in one colour. The update must be made on the currently accepted part C

Applications for significant formulation changes

The following must be submitted:

  • A cover letter

  • A complete application form

  • Safety Data Sheets (SDS) and detailed composition of all new co-formulants (when relevant), which also need to be submitted to all concerned Member States (cMS)

  • SDS for the new formulation of the product

  • An updated core RR part C, where all changes in the text are clearly marked in one colour (please note that it is important that the same colour is used for all revised RR sections).The update must be made on the currently accepted part C

  • Updates of the core Registration Report (RR) sections when relevant for the formulation change. All additions must be clearly marked with a colour in the core RR sections to which the change relates (please note that it is important that the same colour is used for all revised RR sections).The original text should not be changed

When relevant, new analytical methods should be added to the core RR Part B5

Different options are possible regarding the format of the application and this must be agreed on with zRMS in advance:

  • Updates of the core Registration Report (RR) sections

or

  • Addenda to the core RR sections relevant for the amendment of use. Note that an addendum may only contain information relating to the formulation change

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. See examples of frequent deficiencies here: link

A completeness check of the applications for significant formulation changes will be initiated before the actual evaluation of the final application begins. Thus, the DEPA will check if the abovementioned requirements are fulfilled. If the application only 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 ensure that the application is complete, it is recommended to fill in a completeness check form. The form can be submitted together with the dossier. Please note that the completeness check form does not contain the national requirements by Member State (when relevant). In case national approaches are required, please refer to Guidance on cooperation in the Northern Zone.

3. Minor changes that require technical assessments

Minor changes that require technical assessments are handled nationally, fx. changes to active substance sources, CLP-reclassification or change in packaging.

Changes to or addition of active substance sources

If there are changes or additions for active substance sources an application must be submitted. Note that the new source must be evaluated as equivalent in the EU by a Member State (a final equivalence assessment must be available). DEPA only accepts applications for equivalence assessments for new sources if DK is the RMS for the active substance and the source is used in a product for which an application has been submitted in DK.

The following must be submitted:

  • A cover letter

  • A complete application form

  • Relevant documentation for the assessment of equivalens (e.g. 5-batch analysis)

  • An updated Part C, including the additions that must be clearly marked with a colour

Please note it is important that the application is complete and meets all the requirements for the specific type of application.

Applications for change of classification

CLP reclassification may be necessary if e.g. new knowledge arises about the classification of the active substance or the co-formulants. Likewise, reclassification may also be necessary when modifying co-formulants in the product.

The following must be submitted:

  • A cover letter

  • A complete application form

  • A written justification for the new classification

  • Relevant documentation

Please note it is important that the application is complete and meets all the requirements for the specific type of application.

Applications for change of packaging

Changes in packaging cover e.g. changes in packaging material and changes in container type or size.

The following must be submitted:

  • A cover letter

  • A complete application form

  • Specifications of the new and the current packaging

  • Relevant product studies

  • Updated phys-chem section for part B and (if relevant) part A. All changes must be clearly marked with a colour in the core RR sections to which the change relates (please note that it is important that the same colour is used for all revised RR sections). The original text should not be changed

Different options are possible regarding the format of the application and this must be agreed on with zRMS in advance:

  • Updates of the core Registration Report (RR) part B

or

  • Addenda to the core RR sections relevant for the amendment. Note that an addendum may only contain information relating to the formulation change.

Please note it is important that the application is complete and meets all the requirements for the specific type of application.

Submission of the application

The application must be submitted in electronic format (CD) to:

Danish EPA, Pesticides and Biocides
Tolderlundsvej 5
DK-5000 Odense C
Denmark

Att. The pesticide division “Application for authorisation of pesticide”

Or through email (link to email address)

Processing of your application

ZRMS starts by performing an initial screening (completeness check) of the application. A decision is made as to whether the application meets current data requirements and whether relevant information is present in order to be able to carry out an evaluation. The application is then assessed as complete. During the evaluation, zRMS has the option to pause the application process for up to six months if additional information is required from the applicant (clock stop procedure). If more than 6 months of clock stop is required, because additional information was requested from the applicant, the application will be rejected.

Applications for amendments of authorisation are evaluated according to the data requirements, which were in force when the product was authorised.

The zRMS produces a draft evaluation, which is sent to all Member States in the zone and the applicant for commenting. Upon receipt of comments, the zRMS will finalise the evaluation. The evaluation is performed in accordance with the Uniform Principles set out in Annex VI of the Plant Protection Product Directive and referred to in Regulation (EC) No 1107/2009.

The cMS can subsequently finalise their evaluation and either authorise or refuse the application. 

Minor amendments of authorisation are handled nationally by the Danish Environmental Protection Agency.

Processing time and decisions

ZRMS has six months from the date of the application to make their decision, unless it was necessary to request further information from the applicant. In this case, the period can be extended to a maximum of 12 months.

The application process will be paused if additional information is required from the applicant (clock stop procedure). The clock stop will be in place until the applicant has submitted the requested information. The application process will recommence when the requested information and/or material has been submitted.

The cMS in the zone have the option to:

  • Accept the evaluation without changes

  • Accept the evaluation, but impose other risk mitigation measures, for instance relating to distance from the aquatic environment

  • Refuse authorisation, if it is concluded that unacceptable health or environmental risks cannot be excluded in the Member State. This may occur, even if other Member States in the zone grant an authorisation

Minor amendments of authorisation are handled nationally by the Danish Environmental Protection Agency. Expected processing time is 4 months.

Pesticide application fees

Fees are charged for the processing and evaluation of applications for amendments of authorisation. Further information can be found under the menu item Fees.

Regulations

The requirements for zonal authorisations are described in Articles 33-39 of Regulation (EC) No 1107/2009.

The requirements for renewals of zonal authorisations are described in Article 43 of Regulation (EC) No 1107/2009.

Relevant links to applications for amendment of authorisations

Notification form for intended zonal applications

Application form for amendment of authorisations

Completeness check form (2015)

Requirements for submission of documentation in the Northern Zone

dRR format (version 2015)

Cooperation in the Northern Zone

Guidance document for evaluation of efficacy in the North zone

Guidance document on zonal evaluation and mutal recognition under Regulation (EC) No 1107/2009

Guidance document on the preparation and submission of dossiers for plant protection products according to the “risk envelope approach”

The Danish evaluation framework

The Danish evaluation framework with regard to the environment and health