Application for authorisation of a plant protection product Instructions for completing the application
Contact address: Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Abteilung Pflanzenschutzmittel Messeweg 11/12 38104 Braunschweig Telephone: +49 531 299-3401 Email:
[email protected] www.bvl.bund.de
May 2015
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Index 1
Introduction .............................................................................................................. 4
2
Form of the submitted application .......................................................................... 4
2.1
Application form ......................................................................................................... 4
2.2
Enclosures ................................................................................................................. 4
3
Overview of the enclosures and the structure of the dossier ............................... 5
3.1
Data requirements concerning the plant protection product and active substances .... 5
3.2
Registration Report documents .................................................................................. 5
3.3
Checklist for completeness for applications for zonal authorisation ............................ 6
3.4
Checklist and documentation for applications for mutual recognition .......................... 7
3.5
Other documents ....................................................................................................... 8
3.6
List of enclosures and the correct order in the dossier and CADDY Table of Contents .................................................................................................................................. 9
4
Fees .........................................................................................................................16
5
Further information .................................................................................................17
5.1
Maximum residue levels ............................................................................................17
5.2
Reference to documents already held by the BVL .....................................................17
5.2.1 Reference to the applicant's own documents from the national procedure ................17 5.2.2 Reference to the applicant's own documents from the EU procedure........................18 5.2.3 References which refer to a Letter of Access ............................................................18 5.2.4 Reference to documents from other applicants .........................................................18 5.3
Evidence of GLP/GEP...............................................................................................19
5.4
Internal company codes and compositions for trial formulations ................................19
5.5
Company and trade secrets ......................................................................................19
5.6
Type of application and active substance status .......................................................20
5.7
Further information on Section IV of the application form: Fields of application and further information on correct use..............................................................................21
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Explanatory notes on the entry fields in the application form .............................24
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Abbreviations ..........................................................................................................46
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1 Introduction This guideline is for applications for the authorisation of plant protection products according to Article 29 of Regulation (EC) No 1107/2009, for applications for mutual recognition of authorisations according to Article 40 of Regulation (EC) No 1107/2009 and for applications for the renewal of an authorisation according to Article 43 of Regulation (EC) No 1107/2009. It contains useful advice on completing the application form and information on compiling the documentation to be submitted with the application. For extensions of authorisation regardless of whether these are extensions of uses to the regular authorisation or extensions of authorisation to minor uses according to Article 51 of Regulation (EC) No 1107/2009 there is a separate application form including the corresponding instructions for completing the application.
2 Form of the submitted application The application for the authorisation of a plant protection product consists of the application form and the enclosures. 2.1
Application form
The form must be filled in electronically. To be able to access the portal which has been set up especially for this purpose, the applicant must register once with the BVL. Information on registering and the link to the portal can be found on the BVL website at: www.bvl.bund.de > Plant Protection Products > For applicants > Electronic application. The application form consists of four sections and is available in the German and English language. Special characters should not be used for filling in the application form since these can cause problems when the data is processed. A description of the individual entry fields with information on how to fill them in can be found in the table in Chapter 6.
2.2
Enclosures
The enclosures to the application are to be submitted electronically in the form of a CADDY dossier (one copy). The current standard is CADDY-xml (v3). Due to the volume of data, the CADDY dossier is not sent to the BVL online, but on CD-ROM or DVD instead. Information on compiling the CADDY dossier is available at: www.bvl.bund.de > Plant Protection Products > For applicants > Electronic application. Only letters of access and powers of attorney with original signatures have to be submitted on paper. Applicants who have no possibility of compiling CADDY dossiers can apply to submit the documentation to the BVL on paper (one copy). In this case, the documentation should be sorted and labelled clearly so that it can be allocated to the individual positions in the index of all enclosures or the reference list. File dividers should be used which bear the numbers from the index of all enclosures or the reference list/annex point in order to separate the individual documents. If Germany is to act as the zonal Rapporteur Member State (zRMS) for the
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application which has been submitted, at least the dRR documents should be submitted on storage medium in Word format. Scanned files are requested in colour for colour documents.
Application Application form
Enclosures
electronically via the BVL portal
as a CADDY dossier on storage medium on application also possible on paper
3 Overview of the enclosures and the structure of the dossier The enclosures contain data requirements concerning the plant protection product and the corresponding active substances. The enclosures also include further documentation such as summaries, declarations and lists. These are described in detail in the following chapters.
3.1
Data requirements concerning the plant protection product and active substances
The documentation must cover all the data requirement points for the plant protection product and the corresponding active substances. The data requirements for active substances according to Regulation (EU) No 554/2011 and for plant protection products according to Regulation (EU) No 545/2011 apply. Both regulations will be replaced by Regulation (EU) No. 283/2013 and Regulation (EU) No 284/2013. These data requirements mainly include the tests and studies to be carried out. The regulations stated also provide information on the type of trials and the respective methodology. Further technical details can be taken from the Guidance document of the European Commission. In addition, more detailed information and specifications can be found on the BVL website at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure.
3.2
Registration Report documents
The draft Registration Report (dRR) includes - divided up into several documents - overviews and summarising presentations of the plant protection product applied for. Templates for these documents and advice on how to compile them can be found on the EU Commission website:
Guidance document on the dRR format - General Part (SANCO/6895/2009 rev 1) (pdf)
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Guidance document on the dRR format - Annexes (SANCO/6895/2009 rev 1) (zip)
Templates for the draft Registration Report for micro-organisms
From 1 January 2016 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. The new templates are available on the BVL website at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates. There are two versions of the templates: One contains an additional document template (report.dot) which facilitates the preparation of the dRR by means of macros; (a use instruction is included in the package). The other version does not contain the document template and therefore is free of macros.
Revised templates of the draft registration report without report.dot (effective from 01.01.2016)
Revised templates of the draft registration report with report.dot (effective from 01.01.2016)
The tables in Chapter 3.6 show how the documents are put into order in the dossier. Generally, separate dRRs are to be compiled and submitted for applications relating to the use outdoors and the use in greenhouses. The use outdoors and the use in greenhouses are to be applied for separately, either in the form of one main application and one application for the extension of uses, or as two separate main applications. The consequences of the two options are as follows: If one main application and one application for the extension of uses are submitted, the application for the extension of uses cannot be authorised in case the main authorisation is denied. If two separate main applications are submitted, two different authorisation numbers are assigned. If Germany is to act as the zonal Rapporteur Member State (zRMS) for the application submitted, dRR documents (Part A, Part B, Part C) - apart from being submitted in PDF format - should also be submitted as attachments in Word format. In this case, applicants are also requested to submit the national addenda from other Member States in the relevant zone.
3.3
Checklist for completeness for applications for zonal authorisation
For applications for zonal authorisation, the completed 'Checklist for completeness for applications according to Art. 29' must be submitted together with the documentation listed therein. A checklist template is available at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates.
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3.4
Checklist and documentation for applications for mutual recognition
In addition to the zonal authorisation procedure there is a compulsory mutual recognition procedure which is described in Article 40 and 41 of Regulation (EC) No 1107/2009. Paragraph 1 of Article 42 of Regulation (EC) No 1107/2009 describes which documents are to be included with the application. To facilitate filling in applications, a uniform checklist for the EU has been developed ('Form for checking mutual recognition applications for completeness'). For applications for mutual recognition, this completed 'Checklist for completeness for applications according to Art. 40' must be submitted together with the documentation listed therein. A checklist template is available at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates. The following documents are to be submitted: Description
Advice for the application for authorisation
Authorisation certificate
Copy of the authorisation granted by the reference Member State and a translation of the authorisation into an official language of the Member State for which the authorisation is intended. A translation of the original authorisation certificate in German is expected. A translation in English is also accepted. The copy must be submitted in PDF format. The copy and translation of the authorisation certificate must be archived in two separate files.
Evidence of the identity of the plant protection product
Official declaration that the plant protection product is identical to the plant protection product authorised by the reference Member State. Evidence of the actual identity of the plant protection product is neither requested nor expected.
Draft label
Draft label for Germany
Copy of label from zRMS
Copy of the label for the product authorised in the reference Member State (zRMS) (if not provided in the assessment report from the reference Member State) and a translation.
Assessment report
Assessment report from the reference Member State with information on the assessment of the plant protection product and the corresponding decision. At this point the submission of a Registration Report is expected in the form agreed on between the Member States. A copy of the assessment report must be submitted in German, or in English if agreed upon beforehand.
The documents are to be submitted to the BVL electronically as attachments to the application form. According to Article 42 (1) (c) of Regulation (EC) No 1107/2009, a complete dossier must be submitted for such applications or a summary dossier according to Article 33 (3) of Regulation (EC) No 1107/2009 if this is requested by the Member State. Due to the short period of time of 120 days allocated for the recognition of authorisation, and taking into
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consideration the fact that harmonisation is not yet complete in all test areas, the BVL always expects a complete dossier, preferably an electronic dossier in CADDY or PDF format.
3.5
Other documents
Description
Advice for the application for authorisation
Index of all enclosures
All enclosures must be listed in PDF format in an index of all enclosures.
Letters of access
Letters of access from previous applicants concerning the use of protected data (if relevant); a template is available at at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates. If letters of access are required, these must also be submitted in PDF format. They must also be submitted by post and provided with an original signature.
Power of attorney
If it is intended for a consultant to manage authorisation or for third parties to submit documentation for the application or for third parties to be able to receive information on the status of the procedure, e. g. distribution partners, a power of attorney must be submitted. This power of attorney must be submitted in PDF format. This must also be submitted by post and provided with an original signature.
GLP/GEP certificates
GLP/GEP certificates (when studies where GLP/GEP is required are enclosed with the application documentation). If GLP/GEP certificates are required, they must also be submitted in PDF format.
List of abbreviations of active substances and degradation products
List of abbreviations of active substances and degradation products; this list can be integrated into the dRR documents.
Reference lists
Generally required for each application, see publication BVL 11/02/28 of 16 December 2011, published on 6 January 2012 in the 'Bundesanzeiger'), a template is available at at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates.
The other documents (and a cover letter, if applicable) are to be submitted to the BVL electronically as attachments to the application form. Reference lists (documents LCA and LCP) are to be submitted as part of the CADDY dossier. If no documents are submitted in the form of a CADDY dossier, e.g. in case of letters of access or references to other documents, the reference lists are to be submitted as attachments to the application form, as well. For further information, also see Chapter 5.2.
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3.6
List of enclosures and the correct order in the dossier and CADDY Table of Contents
All the enclosures for the application form a dossier. In principle there are two templates for dossier structures, which should be used for the corresponding versions of the data requirements: OECD format Applies to applications which are based on the old data requirements of Regulation (EU) No 544/2011 (active substance) and No 545/2011 (plant protection product). This format follows the "OECD Guidance for Industry Data Submissions on Plant Protection Products and their Active Substances" (Dossier Guidance). EU revised format Applies to applications which are based on the new data requirements of Regulation (EU) No 283/2013 (active substances) and No 284/2013 (plant protection products). This format follows guideline SANCO/10181/2013: Guidance Document for applicants on preparing dossiers for the approval of a chemical new active substance and for the renewal of approval of a chemical active substance according to Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013. The introduction of the new data requirements in Regulation (EU) No 283/2013 (active substances) and No 284/2013 (plant protection products) is associated with transitional measures, which were published in guideline SANCO/11509/2013 rev. 2. According to this, the EU revised format applies in the approval procedure of active substances on the EU level for all active substances from January 2014. The format to be used and the respective data requirements applying for the authorisation procedure of plant protection products depend on the contained active substances:
According to Article 4 of Regulation (EU) No 283/2013 (active substances) (taking into account Amending Regulation (EU) No 1136/2014), the new data requirements for active substances only become effective when the assessment of active substances according to Regulation (EC) No 1107/2009 has been concluded.
According to Article 4 of Regulation No 284/2013 (plant protection products), the old data requirements for plant protection products apply for all applications which are submitted before 31 December 2015, provided that the contained active substance is covered by the transitional measures of Article 3, i.e. which contain active substances the approval of which or the renewal of the approval of which has been applied for by 31 December 2013. Plant protection products with other active substances are not covered by the transitional measure. For them, the requirements of Regulation (EU) No 284/2013 apply immediately. On 1 January 2016, Regulation (EU) No. 284/ 2013 will enter into force without any restrictions.
Until 31 December 2015, applications in the new and in the old format will be accepted.
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In the authorisation procedure for plant protection products documents A, B, C, D1, D3, E2 and F as well as P are not relevant and are therefore not to be submitted. According to Article 8 paragraph 5 of Regulation (EC) No 1107/2009, a literature research is not part of the dossier and is therefore not compulsory. The Table of Contents (TOC) in the electronic CADDY dossier also corresponds to the dossier structure. The “OECD Table of Contents” relates to OECD format, the ”revised EU CADDY Table of Contents” relates to the EU revised format. The following tables contain each a complete overview of all the documentation to be submitted with the application including its correct order in both dossier formats. List of enclosures to the application in OECD format Number (CADDY TOC)
Title (CADDY TOC)
Advice for the application for authorisation
Document A
Statement of the context in Does not have to be submitted for the which the dossier is submitted authorisation procedure for plant protection products.
Document B
Documentation relating to the joint submission of dossiers
Does not have to be submitted for the authorisation procedure for plant protection products.
Document C
Existing or proposed labels
Does not have to be submitted for the authorisation procedure for plant protection products.
Document D
Uses
D1
Intended uses supported in the EU for which data have been provided
Does not have to be submitted for the authorisation procedure for plant protection products.
D2
List of currently authorized uses and extent of use
A list of currently authorized uses in the Member States in which the application is submitted must be provided and a statement on whether the product is actually used or not.
D3
List of supported uses in exporting countries
Does not have to be submitted for the authorisation procedure for plant protection products.
Document E
MRLs
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Number (CADDY TOC)
Title (CADDY TOC)
Advice for the application for authorisation
E1
Listing of Community and Member States MRLs
If available, a list of MRLs determined for the active substance in the Member States where the application is to be submitted together with a list of the MRLs fixed or proposed by the CAC or CCPR, and the corresponding residue definitions should be submitted.
E2
Listing of MRLs in exporting countries
Does not have to be submitted for the authorisation procedure for plant protection products.
Document F
Notification submitted to the Commission
Does not have to be submitted for the authorisation procedure for plant protection products.
Document G
Permission of each formulant in accordance with EU legislation
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), a statement is necessary as to whether the substance is permitted for food, fodder, medicinal products or cosmetics according to the legislation of the Member States in which the application is submitted.
Document H
Safety data sheets for the formulants
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), a copy of the safety data sheet is necessary; can also be integrated into the dRR documents.
Document I
Other data on the formulants
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), other toxicological, exposure and environmental data should be submitted on request; can also be integrated into the dRR documents.
Document J
Confidential data and information
Part C of the dRR and if appropriate summaries of confidential information on the active substance or product. For further information see also Chapter 5.5.
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Number (CADDY TOC)
Title (CADDY TOC)
Advice for the application for authorisation
Annex IIA
Active substance:
Document KIIA
Individual test and study reports
Studies on the active substance
Document LIIA
Quality check of reports (Tier I) and reference lists
Quality tests for individual trials and studies and reference lists (active substance)
Document MIIA
Summary and evaluation (Tier II)
Summaries and evaluations for individual tests and studies and groups of tests and studies (active substance)
Annex IIIA1
Plant protection product
Document KIIIA1
Individual test and study reports
Studies on the plant protection product
Document LIIIA1
Quality checks of reports (Tier I) and reference lists
Quality tests for individual trials and studies and reference lists (plant protection product)
Document MIIIA1
Summary and evaluation (Tier II)
Part B of the dRR (except section 8)
Document N
Overall conclusions (Tier III)
Part A of the dRR and Part B, section 8 of the dRR
Document O
Initial evaluation forms
Checklists for the completeness of applications. - Checklist for the completeness of applications according to Article 29 of Regulation (EC) No 1107/2009 - Checklist for the completeness of applications according to Article 40 of Regulation (EC) No 1107/2009 A checklist template is available on the BVL website at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates.
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List of enclosures to the application in EU revised format Number (CADDY-TOC)
Title (CADDY-TOC)
Advice for the application for authorisation
Document A
Statement of the context in Does not have to be submitted for the which the dossier is submitted authorisation procedure for plant protection products.
Document B
Documentation relating to the joint submission of dossiers
Does not have to be submitted for the authorisation procedure for plant protection products.
Document C
Existing or proposed labels
Does not have to be submitted for the authorisation procedure for plant protection products.
Document D
Uses
D1
Intended uses supported in the EU for which data have been provided
Does not have to be submitted for the authorisation procedure for plant protection products.
D2
List of currently authorized uses and extent of use
List of currently authorized uses and extent of use
D3
Intended uses supported in the EU for which data will be provided
Does not have to be submitted for the authorisation procedure for plant protection products. Required only by request of the RMS or Co-RMS
Document E
MRLs
E1
Listing of Community and Member States MRLs
Listing of Community and Member States MRLs
E2
Listing of MRLs in exporting countries
Does not have to be submitted for the authorisation procedure for plant protection products
Document F
Notification submitted to the Commission
Does not have to be submitted for the authorisation procedure for plant protection products
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Number (CADDY-TOC)
Title (CADDY-TOC)
Advice for the application for authorisation
Document G
Permission of each formulant in accordance with EU legislation
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), a statement is necessary as to whether the substance is permitted for food, fodder, medicinal products or cosmetics according to the legislation of the Member States in which the application is submitted.
Document H
Safety data sheets for the formulants
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), a copy of the safety data sheet is necessary; can also be integrated into the dRR documents.
Document I
Other data on the formulants
If a complete data package has not been submitted for every formulation ingredient which is contained in the preparation (except active substance), other toxicological, exposure and environmental data should be submitted on request; can also be integrated into the dRR documents.
Document J
Confidential data and information
Part C of the dRR and if appropriate summaries of confidential information on the active substance or product. For further information, see also Chapter 5.5.
CA
Chemical active substance
Active substance
Document KCA
Individual test and study reports
Studies on the active substance
Document LCA
Quality check of reports and reference lists
Quality tests for individual trials and studies and reference lists (active substance).
Document MCA
Summary and evaluation
Summaries and evaluations for individual tests and studies and groups of tests and studies (active substance).
CP
Chemical plant protection product
Plant protection product
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Number (CADDY-TOC)
Title (CADDY-TOC)
Advice for the application for authorisation
Document KCP
Individual test and study reports KCP
Studies on the plant protection product
Document LCP
Quality checks of reports and reference lists
Quality tests for individual trials and studies and reference lists (plant protection product)
Document MCP
Summary and evaluation
Part B of the dRR (except section 8)
Document N
Overall summaries
Part A of the dRR and Part B, section 8 of the dRR.
Document N1
Overall conclusions
Reflecting Annex to Regulation (EU) No 283/2013 (active substance) and No 284/2013 (plant protection products). Required only by request of the RMS or Co-RMS. Template available, see Guidance Document SANCO/10181/2013, rev. 2, Appendix A.
Document N2
Endpoints
Developed from Annex to Regulation (EU) No 283/2013 (active substance) and No 284/2013 (plant protection products). Template available, see Guidance Document SANCO/10181/2013, rev. 2, Appendix A.
Document N3
Substances and metabolites; structures, codes, synonyms
New template available, see Guidance Document SANCO/10181/2013, rev. 2, Appendix A.
Document N4
Relevance of metabolites in ground water
New template available, see Guidance Document SANCO/10181/2013, rev. 2, Appendix A.
Document N5
Consideration of isomeric composition on the risk assessment
New template available, see Guidance Document SANCO/10181/2013, rev. 2, Appendix A.
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Number (CADDY-TOC)
Title (CADDY-TOC)
Advice for the application for authorisation
Document O
Initial evaluation forms
Checklists for the completeness of applications - Checklist for the completeness of applications according to Article 29 of Regulation (EC) No 1107/2009. - Checklist for the completeness of applications according to Article 40 of Regulation (EC) No 1107/2009. A checklist template is available on the BVL website at: www.bvl.bund.de > Plant Protection Products > For applicants > Authorisation procedure > Forms and Templates.
OCA
Active substance
Reflecting Annex to Regulation (EU) No 283/2013 (active substance). Required only by request of the RMS or Co-RMS
OCP
Plant protection product(s)
Reflecting Annex to Regulation (EU) No 284/2013 (plant protection products). Required only by request of the RMS or Co-RMS
4 Fees The BVL charges fees and expenses for the respective official acts according to the stipulations of plant protection legislation. The amount of the fees is stated in the appendices to the Plant Protection Fee Ordinance of 22 October 2013 which contains the individual factors which are subject to fees and the corresponding scale of fees. The legal provision stated concerning the setting of fees can be found on the Internet (German text only) at www.bvl.bund.de > Plant Protection Products > Legal Regulations > National Regulations. The applicant receives a separate notification after the main notification has been issued (for authorisation, approval etc.) with regard to fees and how they are calculated.
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5 Further information 5.1
Maximum residue levels
Since Regulation (EC) No. 396/2005 entered into force on 1 September 2008, applications have to be submitted to an independent procedure for setting/amending or deleting maximum residue levels, including setting import tolerances. The respective applications must be submitted to the BVL. Relevant details can be found on the Internet at: www.bvl.bund.de > Plant Protection Products > For applicants > MRL procedure.
5.2
Reference to documents already held by the BVL
It is possible to refer to documents submitted with applications for authorisation which were submitted to the BVL after 1 July 2007. The exact name of the individual studies must be indicated; it is not sufficient to refer overall to studies which have already been submitted. If the enclosures which are referred to were delivered a long time ago, the applicant must ensure that the trial methodology and execution, which forms the basis for the enclosures, still corresponds to current scientific and technical knowledge, otherwise new studies may be necessary. Complete lists of trial and study reports for each active substance, safener, synergist and adjuvant as well as the plant protection product must be submitted for each application. The rules and regulations are explained in detail in the following chapters. 5.2.1
Reference to the applicant's own documents from the national procedure
References in an application to complete dossiers concerning the active substance or the plant protection product which have already been submitted are possible but only if the documents have already been submitted to the BVL, either physically or with a reference, for a paper-based application after 1st July 2007 or for an electronic application. Information on references to documentation which has already been submitted to the BVL is entered as free text in section I of the application form in the field "Comments", e.g.: "With regard to the documentation concerning the active substance xyz I refer to documentation already submitted to the BVL on XX.XX.XXXX for the evaluation of the active substance, registration no. XXXXXX-XX/XX, which should be used for this application." As far as the documentation on the active substance or plant protection product is concerned, the studies must always be enclosed in the CADDY dossier, according to the respective numbers on the application form, even if these studies are submitted more than once. This procedure also applies to applications for renewed authorisation concerning documentation which was submitted earlier for the same product. In addition, corresponding reference lists for documents which are referred to must be submitted or the reference lists to be submitted must be completed with the corresponding information.
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If an applicant submits several applications at the same time or at different times referring to the same active substance, the enclosures which refer to the active substance only do not have to be enclosed each time. However, they do have to be submitted once. Reference to the date of the application and the registration number of the application containing these enclosures is sufficient. 5.2.2
Reference to the applicant's own documents from the EU procedure
Reference to documentation from the EU evaluation program for active substances is only possible for active substances which were not yet available for sale on 27 July 1993 or if Germany is or was the Rapporteur Member State (RMS) and all the documentation for this procedure is already held by the BVL. 5.2.3
References which refer to a Letter of Access
Information on references to documentation which has already been submitted to the BVL is entered as free text in section I of the application form in the field "Comments", e.g.: "With regard to the studies concerning the active substance xy I refer to a Letter of Access from company zzz, which is enclosed". Applicants applying for the authorisation of a plant protection product which contains an active substance from another company do not need to submit the documentation for the active substance themselves. If questions on the application form cannot be answered because the licenser holds the information concerned, a reference must be made to the Letter of Access. A current Letter of Access is also required for applications for renewed authorisation. The applicant must state in this Letter of Access when and for which registration number of an application for authorisation or an active substance dossier these enclosures were submitted. However, the applicant must always ensure that all data requested in Regulations (EU) No 544/2011 and (EU) No 545/2011, or (EU) No 283/2013 and (EU) No 284/2013 are made available (for example, by the licenser directly to the BVL). A justification must always be given if no enclosures are submitted although these are requested by the application. 5.2.4
Reference to documents from other applicants
It is not necessary to submit documents if the BVL already has sufficient information from documentation which was submitted by a previous applicant and if this applicant has given his permission in writing to use this documentation, or if the first authorisation of the plant protection product granted to the previous applicant, to which the intended use of data refers, was in an EU Member State and was longer than 10 years ago. Deviating from this, a tenyear deadline for documentation which must be submitted together with the application for the evaluation of an active substance, which was not yet available for sale on 27 July 1993, begins with the first inclusion of the active substance in Annex I of Directive 91/414/EEC. Furthermore, the ten-year deadline for documentation which must be submitted together with the application for the evaluation of an active substance, which was available for sale on 27
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July 1993, begins with the first authorisation granted in Germany for which the documentation was used. Although no documents are generally required for a second application, reference lists must be submitted.
5.3
Evidence of GLP/GEP
The following is required as evidence of compliance with authorisation requirements according to Article 2 (2) PflSchMV (German Plant Protection Products Regulation) for every experimental, non-clinical laboratory study which began on or after 1 April 1990:
a declaration that the active substance was evaluated according to the principles of Good Laboratory Practice (GLP) (GLP declaration according to Article 19a (2) of the 'Chemikaliengesetz' = Toxic Substances Control Act) and
a certificate from the competent authority that the testing facility complies with the principles of GLP (GLP certificate according to Article 19b 'Chemikaliengesetz').
Please also refer to Guideline Doc 7109/VI/94-Rev. 6 ("Guideline developed within the Standing Committee on Plant Health with regard to the applicability of Good Laboratory Practice to data requirements according to Annex II, part A and Annex III, part A, of Council Directive 91/414/EEC"). Analogous provisions on Good Experimental Practice (GEP) (a declaration and a certificate) apply according to Article 2 (1), (2) and (3) PflSchMV to efficacy studies which began after 1 July 1999. For all official and officially recognised testing facilities the corresponding GLP/GEP certificates are to be summarised in a separate document. This document must be archived in "Other documents" to complement the standard TOC (see Chapter 3.6). Following this advice helps to simplify and accelerate the initial evaluation at the BVL.
5.4
Internal company codes and compositions for trial formulations
Since many studies which are submitted contain internal company codes for active substances, metabolites and degradation products from active substances as well as trial formulations, such designations must be summarised in a list. For active substances/metabolites, the chemical designations (in IUPAC nomenclature) and structural formulae must be stated. This list must be included in the CADDY dossier in Document N (OECD format) or as Document N3 (EU revised format) if it is not included in the dRR. The exact compositions of the trial formulations must be included in Part C of the dRR.
5.5
Company and trade secrets
According to Article 63 of Regulation (EC) No 1107/2009, data which represent or contain a company or trade secret may not be disclosed by the BVL as long as the applicant or
20
authorisation holder has applied for the data to be handled confidentially. Company and trade secrets are kept absolutely confidential by the BVL. Each individual case is checked carefully. Communications regarding the confidentiality of data and documents are submitted in Part C of the dRR. The relevant supplementary data submitted must also be labelled correspondingly. The summarised studies in Part C of the dRR are however to be archived in Document K under “vertraulich” (confidential) in conformity with the CADDY format specifications.
5.6
Type of application and active substance status
It must be made clear in the application form which type of authorisation is being applied for. This determines the procedure which is then followed at the BVL. Among other criteria, the status of the active substance in EU procedures is important for the type and scope of the documents which have to be submitted and also for fixing fees. The following alternatives are available on the form. They are present in the electronic application form as a code list:
ZV1: First authorisation according to Article 29 of Regulation (EC) No 1107/2009, Germany is the zonal Rapporteur Member State (zRMS).
ZV2: Renewal of authorisation according to Article 43 of Regulation (EC) No 1107/2009, Germany is the zonal Rapporteur Member State (zRMS).
ZV3: First authorisation according to Article 29 of Regulation (EC) No 1107/2009, Germany is the concerned Member State (cMS).
ZV4: Renewal of authorisation according to Article 43 of Regulation (EC) No 1107/2009, Germany is the concerned Member State (cMS).
ZVU: Mutual recognition of an authorisation for a plant protection product authorised in another Member State according to Article 40 of Regulation (EC) No 1107/2009.
ZN8: Authorisation before the decision by the European Union according to Article 15c of the Act governing the Protection of Crop Plants (PflSchG) as amended in the notification of 14 May 1998 (BGBl. I p. 971, 1527, 3512), last amended by Article 4 of the Act of 2 November 2011 (BGBl. I p. 2162) in conjunction with Article 80 (5) (a) of Regulation (EC) No 1107/2009, plant protection product which contains at least one active substance which has not yet been included in the Regulation concerning approved active substances according to Article 13 (4) of Regulation (EC) No 1107/2009 and was not yet on the market on 27 July 1993 and for which the completeness of the dossier was determined before 14 June 2011.
21
5.7
Further information on Section IV of the application form: Fields of application and further information on correct use
A description of the individual entry fields on the application form with information on how to fill them in can be found in the table in Chapter 6. Further information on selected entry fields is given below. General information on use Information on the plant protection product use must be given in this chapter. Information must be provided separately for each use. In the electronic application form, each use is automatically allocated a consecutive number. One use is represented by one data set which consists of the field of application and further information on correct use. Each use must be described in the biological dossier (BAD) and be supported by submitting the corresponding trial reports, comments or literature. Care must be taken to number and describe the applications applied for in an identical manner throughout the entire dossier (application form, GAP tables, dRR and BAD), because otherwise the subject matter of the application submitted is not clear and the authorisation procedure may subsequently have to be interrupted (the particularities when applying for fields of application described in the following chapter should be noted). According to Article 12 (3) p. 2 no. 1 of the Plant Protection Act, only plant protection products which are authorised for use by non-professional users may be used for home gardening, or plant protection products which are authorised for professional users according to no. 2 and which the BVL has determined suitable for use in home gardening according to Article 36 (1) sentence 2 no. 3 or (2). If the plant protection product is intended for use in amateur gardening, 'yes' should be selected in the field 'Use intended for amateur gardening?'. It is important to note that special requirements apply to plant protection products which are intended for use in amateur gardening. In this regard the BVL publication should be consulted. Pflanzenschutzmittel für nicht-berufliche Anwender und den Haus- und Kleingartenbereich (plant protection products for non-professional users and home gardening) Field of application Under 'field of application' plants/plant species/plant produce/object and harmful organism/purpose are grouped together. To describe the field of application, the respective destination should still be stated, if appropriate, for plants/plant species/plant produce/object. The Bayer Code System by EPPO should be used to name plants/plant species/plant produce/object and harmful organism/purpose. The BVL has added its own nomenclature to the code lists which has been required in the past for processing applications for authorisation. These codes have not (yet) been adopted by EPPO. It is possible to create groups as long as the BVL’s plant protection products index, the standards for carrying out efficacy trials or BBA leaflet no. 60 show that such groups are already common. In such cases the corresponding codes must be used. However, when forming groups, only those
22
crops or harmful organisms which are similar in their biology and phenology, and also in production techniques, should be grouped together. For example, for herbicides, winter and summer wheat cannot be grouped together; they have to be separated into two different fields of application; pre- and post-emergence applications and autumn and spring applications must also be applied for separately. Timing and conditions for application The timing of application should be described phenologically using the international BBCH codes if possible (for example, before sprouting, after flowering and up to harvesting, at oviposition, etc.), represented by the fields "Growth stage of plant/plant species from/up to" and "Development stage of harmful organism from/up to". Furthermore, timing of application which cannot be defined by growth/development stages can be recorded in the field "Timing of application". In certain situations for example, the calendar date can be stated. Other details are possible if the timing of application cannot be given in greater detail. In some cases, information on the possible timing of applications in order to achieve certain targets can also be taken from the EPPO Standards. Timing should comply with the principles of good professional practice for plant protection. Dose A product application rate must be entered in the entry field "Dose for the intended application and one treatment“ for each application rate condition. In the entry field "Dose", the application rate must be stated in kg/ha or l/ha, or g/ha or ml/ha, or for seed treatment in g/unit, or g/dt or ml/unit, or ml/dt, including seed units per ha and application rate per ha. In special cases, if for example use is intended for amateur gardening, it can also be stated in g/m2 or ml/m2. Concentration data are only acceptable in exceptional circumstances (e.g. for wiping applications). Additionally, the dose in kg/ha or l/ha still has to be calculated for these cases. The water volume which is also stated in the latest version of the BVL's plant protection products index is to be used as a basis. For fields of application in vegetables, ornamentals and tall growing crops, the dose and water volume must be staggered if appropriate, for example according to crop height. Where the product application rate cannot be stated in relation to the area treated, as is the case for seed treatment products, the application rate per hectare must be given. In some cases such as storage protection, it is not possible to convert the dose into kg/ha or l/ha. For applications for controlling harmful organisms in empty rooms or in occupied rooms which do not constitute storage protection (simultaneous treatment of storage goods), the dose for fumigants, fogging concentrates and vapour-releasing products must be stated as an adequate unit (for example in kg, cans or strips) and in terms of the room size in m3 . The dose for storage protection products for use in storage goods (for example spray, spreading and fumigation products) must be stated as an adequate unit (for example in kg, bags, bag chains) in terms of the weight or volume of the goods to be treated. In special cases (for example, the use of inert gases, pressure chamber methods, surface treatments of storage goods for preventing infestation, pest infestation of equipment) other units are acceptable.
23
The dose for products for treating walls, ceilings and floors must be stated in kg or l (if necessary in g or ml) in terms of the area in m2. Mixing partner If an application is made for the plant protection product together with another plant protection product or adjuvant as a mixing partner, the trade name, authorisation or listing number, type of mixture (required or recommended tank mixture) and dose must be stated. In the entry field "BVL identification no. mixing partner", the corresponding BVL authorisation number for the plant protection product or the listing number for the adjuvant must be stated. Enter the application rate for the mixing partner and the respective unit in the box "Dose". Furthermore, the type of mixture must be stated. Further information on how to describe applications can be found on the BVL website, for example at: Beschreibung von Anwendungen (GAP) im zonalen Zulassungsverfahren für Pflanzenschutzmittel (Description of uses (GAP) in the zonal authorisation procedure for plant protection products)
24
6 Explanatory notes on the entry fields in the application form Section I: Data on the product No. Term used in the application
Mandatory text
Explanation
yes
Inserted automatically by the system into the electronic application form
Trade name of plant protection product
yes
Name of the plant protection product under which it is to be placed on the market
Product code (EU) of plant protection product
no
EU wide code to be allocated by the applicant
Date of application
1.
Code list
Data on the product
Trial code: in addition to the trade name, a plant protection product must also have a trial code relating to the preparation which, unlike the trade name, is generally not changed. The trial code is structured as follows: Company code-numerical code-function-number of the formulation-type of formulation. Subsequently, the trial code may look like the following example: ABC-12345-AI0-WP, i.e. product from company ABC with the internal company number 12345, used as an acaricide and an insecticide, the first formulation notified; the product is a wettable powder. Trial code: company code
yes
Three-digit code of the applicant (code list 410)
410
Trial code: numerical code
yes
Numerical code to be allocated by the applicant (five digits)
Trial code: function
yes
Identification letters for the 21 product's function (e.g. herbicide), one letter for each of a maximum of 3 categories (code list 21)
Trial code: number of formulation yes
Single-digit number of the formulation. The first application is allocated '0‘. Each subsequent application for changing a formulation is given the next consecutive number.
Trial code: type of formulation
Two-letter identification code for 22 the type of formulation, based on the code list of the ECPA „GIFAP - Technical Monograph No 2, 1989" (code list 22)
yes
25
No. Term used in the application
Mandatory text
Explanation
2.
yes
Type of authorisation procedure 204 depending on the status of the active substances at EU level. In the case of several active substances, the active substance with the 'lower' status is decisive (i.e. the active substance that is not included in the regulation concerning approved active substances according to Article 13 (4) of Regulation (EC) No 1107/2009) (code list 204).
Type of application
ZV1
First zonal application for a plant protection product according to Article 29 of Regulation (EC) No 1107/2009 for which Germany intends to act as the zonal Rapporteur Member State (zRMS)
ZV3
First zonal application for a plant protection product according to Article 29 of Regulation (EC) No 1107/2009 for which Germany intends to act as the concerned Rapporteur Member State (cRMS)
ZV2
An application for the renewal of an authorisation (according to Article 29, 40 of Regulation (EC) No 1107/2009, etc.) can be submitted according to Article 43 of Regulation (EC) No 1107/2009 once the period of authorisation stipulated by law has expired. Renewed zonal application for a plant protection product according to Article 43 of Regulation (EC) No 1107/2009 for which Germany intends to act as the zonal Rapporteur Member State (zRMS).
Code list
26
No. Term used in the application
Mandatory text
Explanation
ZV4
An application for the renewal of an authorisation (according to Article 29, 40 of Regulation (EC) No 1107/2009, etc.) can be submitted according to Article 43 of Regulation (EC) No 1107/2009 once the period of authorisation stipulated by law has expired. Renewed zonal application for a plant protection product according to Article 43 of Regulation (EC) No 1107/2009 for which Germany intends to act as the concerned Rapporteur Member State (cRMS).
ZVU
Application for mutual recognition of the authorisation for a plant protection product authorised in another Member State according to Article 40 of Regulation (EC) No 1107/2009
ZN8
This is an application for a provisional authorisation of a plant protection product before the decision of the European Union concerning the inclusion of the active substance/s in the regulation concerning approved active substances according to Article 13 (4) of Regulation (EC) No 1107/2009 (previously Annex I of Directive 91/414/EEC). Plant protection products which contain active substances which have as yet not been authorised in an EU Member State can be authorised provisionally for three years if an application for inclusion in the regulation concerning approved active substances according to Article 13 (4) of Regulation (EC) No 1107/2009 (previously Annex I of Directive 91/414/EEC) has been submitted for this new active substance in a Member
Code list
27
No. Term used in the application
Mandatory text
Explanation
Code list
State and it can be assumed that the documentation submitted fulfils the requirements of Annexes II and III of Directive 91/414/EEC. An active substance is new if it is not listed in EU document 3010/VI/91 rev. 14 ("Active substances on the market in plant protection products on 25 July 1993 (Art. 4 Directive 91/414/EEC) and their present authorizations"). Other Member States in which the application is also submitted
yes
In which EU Member States the application is also submitted?
Zonal Rapporteur Member State for the application
no (yes)
Which Member State intends to 3 act as the zonal Rapporteur Member State (zRMS)? (code list 3)
Product already authorised in DE?
no (yes)
If already authorised, select Yes, if not select No.
BVL identification no.
yes
If the product is already authorised in DE, state the identification number under which the product is already authorised in DE (format NNNNNN-NN).
Renewed authorisation in conjunction with changed formulation?
no (yes)
If renewed authorisation is in conjunction with a changed formulation select Yes, if not select No.
Other Member State whose authorisation shall be recognised
no ( yes)
If ZVU is selected as the type of 3 application (application for mutual recognition), the Member State of the EC, from whom the authorisation is to be recognised, must be stated (ISO code; code list 3).
Authorisation in the other Member State according to Regulation (EC) No 1107/2009?
no (yes)
If the authorisation in the other Member State according to Regulation (EC) No 1107/2009 has been granted, select Yes, if not select No.
28
No. Term used in the application
3.
Mandatory text
Explanation
Authorisation in the other Member State according to Directive 91/414/EEC?
no (yes)
If the authorisation in the other Member State has been granted according to Directive 91/414/EEC, select Yes, if not select No.
Name of new active substance not yet approved
no (yes)
State the active substance/s which has/have not yet been approved and which is/are contained in the product applied for (max. four entries possible).
Rapporteur Member State for new active substance
no (yes)
If ZN8 is selected as the type of 3 application, the Rapporteur Member State in the EU must be stated for each active substance which has not yet been approved (ISO code; code list 3).
yes
If an application for a reduction or remission of fees is justified, select Yes, if not No.
Company code
yes
Company code of the applicant (code list 410)
Name
yes
Name of the applicant
Contact person (title)
no
Title of applicant's contact person
Contact person (name)
yes
Last name of applicant's contact person
Contact person (first name)
yes
First name of applicant's contact person
Address (street)
yes
Street
Address (street number)
no
Street number
Address (addition to street number)
no
Addition to street number
Postcode
yes
Postcode
Place
yes
Town
Country
yes
Country names worldwide according to the ISO code (code list 3)
Data on fees charged Application for reduction of fees due to public interest and minor economic benefit
4.
Code list
Applicant's address 410
3
29
No. Term used in the application
5.
Mandatory text
Explanation
Telephone (dialling code)
yes
Area code for the telephone number of the applicant's contact person at the aforementioned address (without international code)
Telephone (telephone number)
yes
Telephone number of the applicant's contact person at the aforementioned address (without international and area code)
Telefax (dialling code)
no
Area code for the fax number of the applicant's contact person at the aforementioned address (without international code)
Telefax (fax number)
no
Fax number of the applicant's contact person at the aforementioned address (without international and area code)
Email
yes
Email address of the applicant's contact person
Company code
yes
Company code of the leading company if it deviates from that of the applicant (code list 410)
Name
yes
Name of leading company
Contact person (title)
no
Title of leading company's contact person
Contact person (first name)
yes
First name of leading company's contact person
Contact person (name)
yes
Last name of leading company's contact person
Address (street)
yes
Street
Address (street number)
no
Street number
Address (addition to street number)
no
Addition to street number
Postcode
yes
Postcode
Place
yes
Town
Code list
Address details for the leading company 410
30
No. Term used in the application
6.
Mandatory text
Explanation
Code list
Country
yes
Country names worldwide according to the ISO code (code list 3)
3
Telephone (dialling code)
yes
Area code for the telephone number of the leading company's contact person at the aforementioned address (without international code)
Telephone (telephone number)
yes
Telephone number of leading company's contact person at the aforementioned address (without international and area code)
Telefax (dialling code)
no
Area code for the fax number of leading company's contact person at the aforementioned address (without international code)
Telefax (fax number)
no
Fax number of leading company's contact person at the aforementioned address (without international and area code)
Email
yes
Email address of leading company's contact person
Power of attorney from the applicant submitted as enclosure?
yes
A power of attorney must be submitted by the applicant for authorising the leading company
Address details for the distributor
multiple entries possible (max. three entries)
Company code
yes
Company code of the distributor (code list 410)
Name
yes
Name of the distributor
Contact person (title)
no
Title of the distributor's contact person
Contact person (first name)
no
First name of the distributor's contact person
Contact person (name)
no
Last name of the distributor's contact person
410
31
No. Term used in the application
Mandatory text
Explanation
Address (street)
yes
Street
Address (street number)
no
Street number
Address (addition to street number)
no
Addition to street number
Postcode
yes
Postcode
Place
yes
Town
Country
yes
Country names worldwide according to the ISO code (code list 3)
Telephone (dialling code)
yes
Area code for the telephone number of the distributor's contact person at the aforementioned address (without international code)
Telephone (telephone number)
yes
Telephone number of the distributor's contact person at the aforementioned address (without international and area code)
Telefax (dialling code)
no
Area code for the fax number of the distributor's contact person at the aforementioned address (without international code)
Telefax (fax number)
no
Fax number of the distributor's contact person at the aforementioned address (without international and area code)
Email
no
Email address of the distributor's contact person
Comments
no
Comments can be entered as free text. If applicable state the representative who is to receive access to the data in the BVL portal in addition to the leading company. Indicate whether the data requirements according to Regulation (EU) No 283/2013 or No 284/2013 were applied.
Code list
3
32
Section II: Data on the plant protection product No. Term used in the application 7.
8.
Mandatory text
Explanation
Code list
Letter of Access required?
yes
If a Letter of Access is required for the use of documentation select Yes, if not No.
Packaging information
multiple entries possible
Type of packaging
yes
Information on the type of packaging which comes into contact with the plant protection product (code list 61)
61
Packaging material
yes
Information on the packaging material which comes into contact with the plant protection product (code list 62)
62
Packaging intended for nonprofessional users?
yes
If the packaging is intended for non-professional users select Yes, if not No.
Number of units per packaging: from
yes
Minimum number of packages or minimum unit in packaging
Number of units per packaging: up to
yes
Maximum number of packages or maximum unit in packaging
Packaging size: from
yes
Minimum amount in one package
Packaging size: up to
no
Maximum amount in one package
Packaging size: unit of measurement
yes
Unit of measurement for the 25 packaging size (code list 25, only CX, GX, KX, SX, LX, TX, ZC)
Letter of Access for the plant protection product
Use of nanomaterials Does the formulation contain yes intentionally added nanomaterials in the sense of the current EU definition to achieve a defined effect?
If the formulation contains nanomaterials select Yes, if not No.
Detailed information on kind and effect of nanomaterials
Information on the substances, their content and function in the formulation.
no (yes)
33
No. Term used in the application 9.
Mandatory text
Data on classification and labelling
Explanation
Code list
Substances and mixtures and also products containing explosive material are classified, labelled and packaged according to the provisions of Regulation (EC) No 1272/2008 (CLPRegulation). As from 1 June 2015 all mixtures have to be classified and labelled according to the CLP-Regulation.
GHS pictograms
yes
Check the box(es) for the relevant hazard symbols (multiple entries possible).
40
Signal word
no
Signal word (code list 76)
76
Hazard statement
no
Hazard statements (multiple entries possible) (code list 70)
70
Precautionary statement
no
Precautionary statements (multiple entries possible) (code list 71)
71
34
Section III: Data on the active substance No. Term used in the application
Mandatory text
Explanation
Code list
10.
Data on the active substance
multiple entries possible
Active substance number
yes
BVL active substance number (code list 400)
400
German name for the active substance
no (yes)
German name for the active substance. This field must be filled in if the dummy code for the active substance number (0000) has been selected.
English name for the active substance
no (yes)
English name for the active substance. This field must be filled in if the dummy code for the active substance number (0000) has been selected.
Chemical active substance?
yes
If the active substance in the product applied for is a chemical active substance select Yes, if not (= microorganism) No. If the latter applies, the field "Content of the active substance in biological units in the product" has to be filled in, see below.
Letter of Access required?
yes
If a Letter of Access is required for the use of documentation select Yes, if not No.
Is an MRL application necessary?
yes
If an MRL application is necessary select Yes, if not No.
In which Member State was (will) the MRL application (be) submitted?
no (yes)
Member State in which the application was/will be submitted (ISO code; code list 3)
Has the MRL already been submitted?
yes
If the MRL application has already been submitted select Yes, if not No.
Data on the MRL procedure
Data on the technical active substance
3
35
No. Term used in the application
Mandatory text
Explanation
Code list
Has the specification submitted yes for the technical active substance contained in the plant protection product being applied for already been assessed in the EU evaluation program for active substances?
If the specification for the technical active substance in the plant protection product being applied for has already been assessed in the EU evaluation program for active substances select Yes, if not No.
Has it already been assessed by a Member State?
no (yes)
If the specification for the technical active substance in the plant protection product being applied for has already been assessed by a Member State select Yes, if not No.
By which Member State?
no (yes)
The Member State which has already assessed the specification submitted for the technical active substance in the plant protection product being applied for (ISO code; code list 3).
Declared content of the pure active substance
yes
Declared content of the pure active substance in the product with three decimal places.
Typical content of the technical active substance
yes
Typical content of the technical active substance in the product with three decimal places.
Content of pure/technical active substance: unit
yes
Unit of pure/technical active substance content in g*kg-1 or g*L-1
Has a variant been submitted for the active substance?
yes
If the active substance is submitted as a variant instead of a parent substance select Yes, if not No.
Active substance variant: code
no (yes)
If the active substance is 66 submitted as a variant instead of a parent substance the code for the active substance variant must be stated (code list 66).
3
Data on the content of the active substance
36
No. Term used in the application
Mandatory text
Explanation
Active substance variant: name
no (yes)
This free entry field must be filled in if the dummy code (???) has been selected for the active substance variant.
Declared content of pure active substance variant
no (yes)
Declared content of the pure active substance variant in the product with three decimal places.
Typical content of technical active substance variant
no (yes)
Typical content of the technical active substance variant in the product with three decimal places.
Content of pure/technical active substance variant: unit
no (yes)
Unit of pure/technical active substance variant content in g*kg-1 or g*L-1
Active substance content in the product in biological units
no (yes)
For biological active substances: number of biological units of active substance in the product
Active substance content in the product in biological units: unit
no (yes)
For biological active substances: unit of active substance content (code list 25, only XA, XB, XG, XL, SPK, SPL)
Code list
25
37
Section IV: Fields of application and further information on correct use No. Term used in the application
Mandatory text
Explanation
Code list
1.
General information on use
multiple entries possible
Consecutive no. of use
yes
The consecutive number of the use is assigned automatically in the electronic application form by the system.
Use covered by EU evaluation program for active substances?
yes
If an active substance in a plant protection product has been approved according to Regulation (EC) No 1107/2009, the applicant should state whether the use applied for was taken into consideration.
Function
yes
Function of the plant protection product for the corresponding use (e.g. herbicide) For several functions, further uses must be created (code list 21).
21
Field of use
yes
Field of use for the plant protection product for the corresponding use (e.g. field crops) For several fields of use, further uses must be created (code list 11).
11
Area of application
yes
Area of application for the plant protection product for the corresponding use (e.g. outdoors) For several areas of application, further uses must be created (code list 4).
4
Intended for use in amateur gardening?
yes
If use is intended for amateur gardening select Yes, if not No. If both are intended, separate uses must be applied for.
38
No. Term used in the application 2.
Mandatory text
Explanation
Code list
Plants/plant species/plant produce/object
yes
Designation of plant/plant species/plant produce/object according to the EPPO code system (max. five entries possible). It is possible to group crops together according to the BVL plant protection products index, the evaluation guidelines for performing efficacy trials or BBA leaflet no. 60. Only crops which are similar in their biology and phenology, and which are similar in production techniques should be grouped together. Individual data are preferable (code list 948).
948
Except plants/plant species/plant produce/object
yes
If the first entry for the plant/plant species/plant produce/object is a group, all further entries can be
Field of application
excluded. In this case select Yes, if not No. Crop destination
no
The crop destination for plant/plant species/plant produce/object must be stated (max. three entries possible) (code list 31).
31
Harmful organism/purpose
yes
Designation of harmful organism/purpose according to the EPPO code system (max. five entries possible) Groups are possible (code list 947).
947
Except harmful organism/purpose
yes
If the first entry for the harmful organism/purpose is a group, all further entries can be excluded. In this case select Yes, if not No.
39
No. Term used in the application 3.
Mandatory text
Explanation
Code list
Selection code list for growth stage of plant/plant species
no
Designation of code list used for 430 selecting the growth stage for the plant/plant species (code list 430). The current BBCH codes can be found on the Internet at the following address: www.jki.bund.de > Veröffentlichungen > BBCHCodes.
Growth stage of plant/plant species from/up to
no
Growth stage of plant/plant species at which treatment is to be carried out (BBCH code). If no specific BBCH code exists, the general BBCH scale must be used. An entry made only in entry field "from" means the same as "as from". If treatment is to be carried out at a certain stage, the same value must be entered in both entry fields. The growth stage should always be specified. The content of the code list depends on the selected code list in the entry field "Selection code list for growth stage of plant/plant species“ (code list 150 to 158, 160 to 164, 170 to 178 or 190).
150 to 158, 160 to 164, 170 to 178 or 190
Selection code list for development stage of harmful organism
no
Designation of the code list used for selecting the growth stage of the harmful organism. The relevant BBCH scale should be used for weeds/grass weeds (code list 150), and code list 98 for animal pests (code list 431).
431
Details on the field of application
40
No. Term used in the application Development stage of harmful organism from/up to
4.
Mandatory text
Explanation
no
Development stage of the 98 or 150 harmful organism on which treatment is to be carried out. An entry made only in entry field "from" means the same as "as from". If treatment is to be carried out at a certain stage, the same value must be entered in both entry fields. The stage should always be specified. The content of the code list depends on the selected code list in the entry field “Selection code list for development stage of harmful organism” (code list 98 or 150).
Frequency of treatments
Number of treatments applied for per year for the intended use
In the following, the term 'crop' applies to the plant or plant species, plant produce or object. Similarly, all statements concerning the harmful organism also apply to a certain purpose being achieved. yes
Number of treatments required for controlling the harmful organism concerned (or group of harmful organisms) on the specified crop or in permanent crops per year. If this number is not sufficient to control the harmful organism in annual crops for the entire crop growing season or in perennials for a calendar year, the period in which the treatment(s) is/are intended must be stated in the entry field "Further details on application".
Code list
41
No. Term used in the application
Mandatory text
Explanation
Code list
Number of treatments applied for per year for the intended crop
yes
Number of treatments in the intended crop or in the case of permanent crops per year taking into consideration all uses of the plant protection product concerned. This means that not only one field of application must be considered, but all harmful organisms which are to be controlled with the plant protection product applied for in the relevant crop. This number is always larger than or the same as the number in the previous entry field.
Maximum number of treatments per year for the intended crop
yes
Number of treatments which would be required for the exclusive application of the respective plant protection product for the continuous control of harmful organisms concerning all fields of application applied for in the intended crop, or in the case of permanent crops per year. This number is always larger than or the same as the number in the previous entry field.
Intervals between treatments from/up to
no
If more than one treatment is intended, the interval between treatments must also be stated; it is possible to state from/up to. An entry in entry field "from" means the same as 'at least', an entry in entry field "up to“ means the same as 'at the most'. If a specific value is to be determined for the interval between treatments, the same value must be entered into both entry fields.
Interval: unit
no (yes)
Selection of unit for interval (code 29 list 29)
42
No. Term used in the application 5.
Mandatory text
Explanation
Code list
Timing of application
yes
Timing of application; the 30 description should be phenological, if possible, using the BBCH codes in the corresponding entry fields. Other details are possible if the time of treatment cannot be given in greater detail. In special cases it is possible, for example, to state a calendar date. Timing should comply with the principles of good professional practice for plant protection. A maximum of three entries is possible (code list 30).
In relation to previous timing of application
no (yes)
Nature of relationship of timing to previous timing. The entry field is mandatory if several entries are made for timing. The entry field is provided with a selection list.
Dose applied for per year for the intended crop
yes
Dose for the respective crop over the entire crop period or for permanent crops over a calendar year taking all applications into consideration. This entry field considers not only the dosage for one field of application but for all harmful organisms to be controlled on or in the relevant crop.
Maximum dose for the intended crop per year
yes
Dose for exclusive application of the respective plant protection product for continuous control in all fields of application applied for in the respective crop during the entire crop growing season or in permanent crops during the calendar year
Dose: unit
yes
Dose unit (code list 25, without N4, S2, S5)
Timing and conditions for application
25
43
No. Term used in the application
6.
Mandatory text
Explanation
Code list
Application technique
yes
Technique used to apply the product (e.g. spraying, spreading, fumigating). If different techniques are used, further uses must be created (code list 27).
27
Details on the application technique
no
Details on the application technique (max. three entries possible) (code list 75, only AT)
75
Dose
multiple entries possible
Condition for application rate
yes
More detailed information on the 28 specific conditions for the application rate stated, e.g. in the case of infestation (code list 28)
Dose for the intended application and one treatment
yes
Dose related to the condition for the application and one treatment. Only one application rate may be stated per treatment, ranges (from - up to) are not permissible.
Dose: unit
yes
Unit of measurement for the dose 25 (code list 25, without N4, S2, S5)
Water volume from/up to
no
Intended minimum ("from“) and maximum ("up to“) water volume for one treatment of the respective use in l/ha or ml/m 2 (amateur gardening) depending on the condition for the application rate. If only data on the minimum or maximum water volume is required, the other entry is not applicable. If an exact value is required for the water volume, the same value should be entered in both entry fields, as a rule a range which is common in practice (from-up to) should be stated.
44
No. Term used in the application
7.
Mandatory text
Explanation
Code list
Water volume: unit
no (yes)
Unit for water volume (code list 25 25, only CA, CD, CE, CF, CG, CK, CM, CO, CP, CQ, CR, CS, CT, CU, CX, CZ, C5, K7, LA, LD, LH, LK, LM, LO, LP, LQ, LR, LS, LT, LU, LX, L4, L5, L6, L7, M2, M4, M5, N2, N4, O4, P2, P4, P6, P8, S2, S4, S5, T4)
Mixing partner
optional, multiple entries possible
Trade name of mixing partner
no
Designation of plant protection product or adjuvant as mixing partner
BVL identification no. of mixing partner
yes
BVL identification number for mixing partner. The last identification no. assigned by the BVL should be stated in the following format: NNNNNN-NN. If no identification no. is available for the mixing partner, please enter dummy entry 000000-00. In this case an application for authorisation or listing of the mixing partner must be submitted. The composition of the mixing partner must be available to the BVL.
Type of mixture
yes
Type of compound for mixing partners (code list 82)
Dose
yes
Dose for mixing partner.
Dose: unit
yes
Unit of measurement for the dose 25 (code list 25, without N4, S2, S5)
Further details on application
no
Further details on the application as free text
82
45
No. Term used in the application
Mandatory text
Explanation
8.
Pre-harvest intervals
multiple entries possible
An pre-harvest interval is required for each use. This can either be stated as a period in days or as a code. Pre-harvest intervals refer to the harvested product, therefore several entries (but no more than 5) are possible for each use.
Crop
no
Crop affected by the pre-harvest interval (max. three entries possible) (code list 948)
Except crop?
no
If the first entry made for the crop is a group, all further entries can be excluded. In this case select Yes, if not No.
Proposed pre-harvest interval in days
no (yes)
Pre-harvest interval in days. Default: 0.
Code list
948
Note: a pre-harvest interval can either be stated as a period in days or as a code (see entry field "Proposed pre-harvest interval (code)“. If the pre-harvest interval has been entered as a code, the entry in this box will not be considered. Proposed pre-harvest interval (code)
no (yes)
Code XN must be selected if the respective crop is not for human consumption (e.g. ornamentals). Select XF, for example, for seed treatment, fungicide/insecticide uses at clearly defined times such as 'before flowering' and for uses where harvesting can be excluded (e.g. seed collection) (code list 89, only XF, XN). Note: if a pre-harvest interval is stated as a code, the entry in the entry field "Proposed pre-harvest interval in days" is not considered. Therefore, the default in this entry field does not have to be deleted.
89
46
7 Abbreviations BAD
Biological Assessment Dossier
BBA
Biologische Bundesanstalt für Land- und Forstwirtschaft Biological Research Centre for Agriculture and Forestry
BBCH
Description of growth stages as a BBCH code, named after the original organisations, the Biologische Bundesanstalt, the Bundessortenamt and the chemical industry (represented by 'Industrieverband Agrar')
BGBl.
Bundesgesetzblatt Federal Law Gazette
BVL
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit Federal Office of Consumer Protection and Food Safety
CA
Chemical active substance (EU-revised format)
CAC
Codex Alimentarius Commission
CADDY
Computer Aided Dossier And Data Supply
CCPR
Codex Commission on Pesticide Residues
CLP
Regulation (EC) No. 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures
cMS
concerned Member State
CP
Chemical plant protection product (EU-revised format)
dRR
draft Registration Report
EC
European Community
EEC
European Economic Community
EPPO
European and Mediterranean Plant Protection Organisation
EU
European Union
GAP
Good Agricultural Practice
GEP
Good Experimental Practice
GHS
Globally Harmonized System of Classification, Labelling and Packaging of Chemicals
GLP
Good Laboratory Practice
IUPAC
International Union of Pure and Applied Chemistry
JKI
Julius Kühn-Institut – Bundesforschungsinstitut für Kulturpflanzen Julius Kühn Institute - Federal Research Centre for Cultivated Plants
MRL
Maximum Residue Level (general term)
47
OECD
Organisation for Economic Co-operation and Development
PflSchG
Gesetz zum Schutz der Kulturpflanzen (Pflanzenschutzgesetz) German Plant Protection Act
PflSchMV
Verordnung über Zulassungs- und Genehmigungsverfahren für Pflanzenschutzmittel (Pflanzenschutzmittelverordnung) German Plant Protection Products Regulation
RMS
Rapporteur Member State
RR
Registration Report
TOC
Table of Contents (index in CADDY)
XML
Extended Mark-up Language
zRMS
zonal Rapporteur Member State
