Previous version and overview changes
The registration manual will be updated monthly. An overview of the changes in comparison with the previous version will be presented together with each updated manual. Important changes will be preceded with announcements and clarifications in news items on our internet site and / or our e-zine. The updated version of the manuals will be published at the beginning of each month.
Archive and overview changes 2021
Monthly update archived version registration manuals
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2021
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Below you select a month to see the archived registration manual at that moment and see which changes are made in comparison with the version of the previous month.
Archive Registration Manual
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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1. Transparency rules incorporated in the active substance pages
Description: The active substance approval process and timelines have been updated as a result of the transparency regulation. In the manual also the use of IUCLID for submission of active substance dossiers has been taken up.
Manual parts:
- Active substance and all its linked ‘registration manual’ pages
2. Low risk pages updated
Description: the pages on the subject of low risk substances and low risk products have been updated; reference has been made to the amended low risk requirements. (EDITORIAL change)
Manual parts:
- Zonal application (NL-zRMS)
Also the information on low risk subject has been updated.
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1. How do data gaps defined in the EFSA conclusion on the active substance affect the assessment for plant protection product registration?
Description: In the EFSA conclusions on the assessment for the active substance approval or renewal or amendment, data gaps can be defined. Depending on the character and subject of the data gap, the data gap can affect the registration process for a plant protection product containing that substance.
Manual parts:
- Application types – zonal application (NL-zRMS) – registration process
2. When does an applicant a zonal application form and dossier / dRR to NL as a CMS?
Description: the description of the timing of the submission of the zonal application to CMS’s has been edited. (EDITORIAL change)
Manual parts:
- Zonal application (NL-CMS) – registration process
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1. Co-formulants as listed in Annex III of Reg 1107/2009 are not allowed to be part of the formulation of plant protection products or adjuvants.
Description: Annex III has been published by the EU commission. In annex II all co-formulants are listed that are prohibited to be part of a plant protection product or adjuvant. Some for some co-formulants a threshold concentration has been established.
Manual parts:
- Application types – zonal application (NL-zRMS) - documentation
- Application types – applications other substances (new: evaluation other substances)
Documents: Keypoints for submission
Also the Dutch website has been modified accordingly:
- Documenten - Aandachtspunten intake gewasbeschermingsmiddelen
2. Guidance for drafting legal instructions for use of PPP – only available in Dutch
Description: the Guidance for drafting legal instructions for use of PPP is only available in Dutch. This is explained on our website. (EDITORIAL change)
Manual parts:
- Zonal application (NL-zRMS) – instructions for submission
3. Draft Registration Report template, National addendum (NL) ecotoxicology
Description: Following a discussion about alleged plagiarism by a competent authority on documents from applicants, the Ctgb has clarified its method for drafting and compiling the ‘draft Registration Report’. In addition to a general disclaimer, the purpose of this clarification is to clearly distinguish between the positions of the applicant and Ctgb in the text of the risk assessment. This is briefly explained in the introduction of the NL addendum. In the core dRRs where Ctgb is zRMS, the same type of text will be added by Ctgb. (EDITORIAL change)
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1. Scope interpretation of applications for extension of national authorisations with minor uses (NL-KUG)
Description: Addition to clarify the scope of the application type, especially on the these criteria: this application type does apply to extensions with the same or lower application rate, application interval, application frequency and application dose. Furthermore it is not possible to extend a use from greenhouse / indoor to a field use using this application type. (The scope has not been changed).
Manual parts:
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NLKUG – Characteristics & Registration process & Instruction for Submission
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Chronologic overview asessement framework
An overview of amendments in the registration manual for plant protection products is presented in the table in the document at the bottom of this page. The amendments are presented in chronologic order. The amendments can be clustered on certain subjects. In every column title you find a selection list to select all items for a subject. For each amendment is stated in what manual version it has been presented for the first time, and when that manual version has been released on the website.
Archive and overview changes 2020
Monthly update archived version registration manuals
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2020
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Below you select a month to see the archived registration manual at that moment and see which changes are made in comparison with the version of the previous month.
Archive Registration Manual
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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1. Comparative asssessment; scope: description amended
Description: EDITORIAL change of the description of the scope of the comparative assessment for applications for plant protection products.
Manual parts:
- General - comparative-assessment - characteristics
2. Parallel trade permits
Description: EDITORIAL amendments of text for consistency reasons.
Manual parts:
- Application types - parallel-authorisation - characteristics
3. Direction for submission of applications (administrative)
Description: EDITORIAL change: simplification to enhance readability, mostly about the administrative applications..
Manual parts:
- General – Directions for submission
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1. Use of PPP Application Management System for CMS's, Mutual recognitions and derogations for emergency situations
Description: The mentioning of the use of the PPP application management system of the EU commission for submission of applications is added to some application types. It is an editorial addition.
Manual parts:
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Zonal application NL=CMS: Derogations for an emergency situation
2. Request for information on animal testing
Description: Ctgb does not act as a mediator in case of disagreement on the sharing of animal data. (Besluit bestuursreglement regeling toelating gewasbeschermingsmiddelen en biociden’, - in Dutch - Ctgb 2018).
Manual parts:
- Request for information vertebrates testing - Characteristics
3. Minor and administrative changes and equivalence checks
Description: the text of the manual part on the equivalence checks and minor and administrative changes has been restructured, to make it more transparent and clear (editorial).
Manual parts:
4. Minor use application for seed treatment
Description: seed treatments can only be applied for as a minor use, using the interzonal application. Extra explanation added (editorial).
Manual Parts
- General – minor uses
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Timelines for submission of supplementary dossiers for active substance renewal
Description: information on the timelines for submission of active substance renewal applications and supplementary dossiers, as well as the timelines for the assessment have been drawn up in the manual. The changes of these timelines, according to “COMMISSION IMPLEMENTING REGULATION (EU) 2020/103 of 17 January 2020 amending Implementing Regulation (EU) No 844/2012 as regards the harmonised classification of active substances” have been taken into account.
Editorial rectification
The text going with the timelines has been rectified and made consistent again with the scheme.
Manual parts:
- Active substance approval - Renewal active substance
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Archive and overview changes 2019
Monthly update archived version registration manuals
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2019
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Below you select a month to see the archived registration manual at that moment and see which changes are made in comparison with the version of the previous month.
Archive Registration Manual
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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1. Data requirements for zonal applications NL-zRMS, no uses applied for in NL
Description: more extensive explanation has been given on the data requirements for zonal applications for which The Netherlands acts as a zonal Rapporteur member state, when no authorisation is applied for in The Netherlands. (EDITORIAL)
Manual parts:
- Application type - Zonal application NL=zRMS Characteristics and Instructions for submission.
2. Equivalence checks for active substances or new sources of a.i.’s are carried out by the Reporting member state.
Description: Ctgb will assess equivalence of (new sources of) active substances for which the Netherlands is the reporting member state. For other active substances the equivalence has to checked by the Reporting member state of that substance.
Manual parts:
- Active substance approval - Assessment of equivalence active substance or additive
3. Some links changed for the administrative applications – explanation added
Description: in a few parts of the manual new links to relevant manual parts have been inserted. EG on the page on adjuvants, parallel and derived trade permits. (EDITORIAL)
Manual parts:
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Application types: other authorisations.
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1. Date of application of the guidance on comparative assessment
Description: The date of application of the Guidance on Comparative assessment has been changed from 10-09-2016 to 01-08-201, due to a legal procedure.
Manual parts:
- General - Comparative assessment
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1. Additional explanation of the terms and conditions for applications for minor uses (editorial)
Description: Additional explanation is given about the scope of applications or minor use (professional use, function of the applied use and efficacy).
Manual parts:
- General - Minor uses
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1. Extra data protection for data used for applications for minor uses (art. 51 of regulation (EC) no 1107/2009)
Manual parts:
- General - Minor uses
2. Editorial changes: Derived trade permits – Adjuvants – Export certificates - Withdrawals
Description: changes are all editorial changes; text restructuring, extra explanation, and fixing omissions.
Manual parts; Application types:
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1. Delay of comparative assessment (art 50.3 of regulation)
Description: Applicants can request postponement of a comparative assessment under Article 50.3 of the Regulation. This Article states that the comparative assessment can be postponed if it is necessary to first acquire experience through use in practice. This postponement can be issued for a maximum of 5 years. The procedure for this is described in the manual.
Manual parts:
- Comparative assessment: “Characteristics” and “Instructions for submission”
2. Low risk product application process (120 days)
Description: application process for authorisation of a product based on a low risk substance has been described in line with the Regulation. The “low risk” process is designed to take 120 days.
Manual parts:
3. Change of production process
Description: Production processes of active substances and f formulations (plant protection products) can be changed. A production process for a PPP can be changed by using the minor and administrative change procedure; a change in the production process of the active substance can be applied for at the Rapporteur member state for the active substance. If this is the Netherlands; the procedure for minor or administrative changes can be used.
Manual parts:
4. Parallel trade permits
Description: Editorial changes have been made to make the explanation more clear. Also the waiting time for inspection (after import of the products) has been clarified.
Manual Parts:
- Parallel trade permits: all parts
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1. Reporting of new information on authorisation
Description: Authorisation holders are obliged to report Ctgb immediately about indications of harmful or unacceptable effects concerning the specified plant protection product, the active substance or its metabolites, a safener, synergist or co-formulant. Authorisation holders have to report annually about information on efficacy ( below expectations), development of resistance and about any unexpected effect on plants, plant products or the environment.
Manual parts:
- Newly added: New information on authorisation
- Amended: 'How to apply', step 1 and 3.
- Newly added: form Immediate Notification by Authorisation Holder
- Newly added: form Annual Notification by Authorisation Holder
2. Derived trade permit: update of chapter characteristics
Description: editorial: change of name of “derived authorisation” to 'derived trade permit'.
Manual part:
- Derived trade permits - Characteristics
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As a result of the Board Regulations authorisation procedure concerning plant protection products and biocidal products Ctgb 2018 (Bestuursreglement toelatingsprocedure gewasbeschermingsmiddelen en biociden Ctgb 2018) that entered into force on 18 December 2018, the manual has been changed for the following subject:
Approval of active substances
The description of the starting point of the assessment process has been amended.
Manual parts:
- Active substance approval – Characteristics
- Active substance approval – Approval process
Other amendments: Directions for submission
- Multiple product names for one approval number not possible. Explanation added in manual.
- Editorial amendments: no cover letter needed for administrative applications; description of which “third parties” may apply for a minor use, parallel trade permit or permit for trial purposes
Manual parts:
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1. Intake process
Intake phase will take less time: reaction terms for applicants for label text adjustments and submission of missing data have been shortened.
Manual part:
2. Terminology has been amended: derived authorisations are changed to derived trade permits
Terminology has been adjusted to the terminology of the regulations.
Manual part:
- Grace periods
- Derived authorisations / Derived trade permits
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Archive and overview changes 2017 - 2018
Monthly update archived version registrationmanuals
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2017 - 2018
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Below you select a month to see the archived registration manual at that moment and see which changes are made in comparison with the version of the previous month.
Archive Registration Manual
On Archive Web you can retrieve an archive version of the Ctgb site for every desired date. Choose a date and archiveweb shows the information that was online at that time. For example, you can consult the assessment framework that applies to applications submitted at that time.
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Reference list with the draft Registration Reports
Instructions for the types and structure of reference lists that have to accompany the zonal applications is added. Links to the Guidances in place about ref. lists have been added.
Manual parts:
- Zonal application NL=zRMS - Instructions for submission: information on reference lists for study reports has been added.
Endocrine disruptors: link to EU information site is added.
The EU-commission maintains a website on the process and developments of the endocrine disruptive properties assessment for active substances for plant protection. A link to this site has been added in the registration manual of the Ctgb
Manual parts:
- Active substance approval – link to endocrine properties assessment has been added
Notification form for new applications for PPP (art.33) has been amended
The EU commission has decided to change the form for notification of a new application for an plant protection product. Low risk indication has been added. The form is no longer obligatory for renewal applications.
Manual parts:- Template of notification form
- Product renewals – registration process
- Zonal application NL-zRMS – instructions for submission
- Application process: pre-application support
MRL Art. 12 review: additional information added about the review process
Extra information about EU review process for Maximum Residue Limits according to article 12 of Regulation (EC) No. 396/2005 has been taken up in the Registration Manual.
Manual parts:- Application for setting Maximum Residue Limit – Registration process & Instruction for submission.
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Changes in Instructions for submission Mutual recognition
The notification to a member state of an application for mutual recognition is not necessary. Information in the instructions for submission about notification is obsolete for mutual recognition.
Manual parts:- Mutual recognition – Instructions for submission: information on notification of application to Member state and notification forms have been removed.
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Change in list of minor uses: ornamentals
A change has been made in the list of minor uses (only available in Dutch) for the crop groups for ornamentals. Most of these ornamental crop groups are smaller than the limit for crop area for a minor crop (1.000 ha for greenhouse (covered) crops, 5.000 ha field crops, for the Netherlands).
Manual parts:
- Minor uses - Documentation List of minor uses: extra document about ornamentals has been added to the Dutch list of minor crops.
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Permit for trial purposes, instructions for submission
Link to the Directions for submission have been added, leading to information on the practical issues for application (how to submit (paper / digitally, accompanying documents, how to write instructions for use, product names, etc.).
Manual parts: Permit for trial purposes - Instruction for submission
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d)RR for label extensions/amendments
In the Central zone it has been agreed that for label extensions and amendments the (d)RR should be restricted to the relevant parts for the application. This is now specified in the registration manual for each section of the (d)RR.
Manual parts: Major changes PPP
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Description of process and application form for administrative prolongation of authorisations granted by mutual recognition
A new application form has been placed on the Ctgb website and linked to the registration manual. This form is meant to apply for a administrative prolongation for authorisations granted by mutual recognition with shortened authorisation period. In some member states post registration requirements are set for the original authorisation. The authorisation period can be reduced by the MS granting the original authorisation. The authorisation period in the Netherlands then will be reduced likewise. As soon as the requirements are met in the original member state and hence the authorisation is extended, the application holder can apply for a prolongation of the authorisation in the Netherlands as well. This concerns an administrative application only.
Manual parts:
- How to apply – step 3
- Mutual recognition
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Registration manual version february 2018.
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In this new release, several points are amended / added. In the overview presented on this page, you will find an explanation and a designation of the exact location in the manual for each amendment or addition:
1. Version management of the Legal Instructions for Use (WG) for plant protection products
New item explaining the version management on legal instructions for use. It answers questions like:
What does the version code mean?
How is it communicated?
When does a version number of a legal instruction for use change?Manual parts:
PPP Finish (renamed to: “Decisions” )
PPP minor or administrative changes2. Application process of active substance ends when EFSA conclusion is published
Application processes for active substances for plant protection products are ended as soon as the EFSA conclusion on the application is published. Ctgb will complete the application financially and send a final invoice.
Manual parts:
PPP: Application for active substance – new active substance approval: approval process
3. Grace periods for plant protection products: extensive explanationGrace periods for amended labels (legal instructions for use) and products that are no longer authorised can be established by the Ctgb. The possibilities and conditions for grace periods (applying for, granting, conditions for the authorisation holder, etc.) are explained. A lot of specific conditions to different application types are described.
Manual parts:
PPP: Grace periodRegistration manual version January 2018.
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Revised Product Renewal
Renewals of active substances are followed by renewals for plant protection products. EU Guidances on the renewals have changed this year. The way the Ctgb deals with the applications for renewal, the timelines and (im)possibilities of this complex part of the PPP registration scenery are more extensively described and explained in this version.
Manual part: PPP RenewalRegistration manual version december 2017.
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Re-registration
Applications for re-registration of plant protection products for which the active substance has been included in Directive 91/414/EEC, or for which the active substance has been approved according to the first clause of Article 80 will be assessed according to the Dutch law in force under 91/414/EEC. This manual part gives an overview of the procedures of reregistration.
Registration manual version november 2017.
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Registration manual version october 2017.
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