Information on the submission of dossiers

General information

The new Transparency Regulation was published in the Official Journal on 6 September 2019. It entered into force 20 days after publication and is applicable since 27 March 2021. This new Regulation mainly amends the General Food Law Regulation. It aims at increasing the transparency of the EU risk assessment in the food chain, on strengthening the reliability, objectivity and independence of the studies used by European Food Safety Authority (EFSA), and revisiting the governance of EFSA in order to ensure its long-term sustainability. Please make sure that the submitted dossier meets the requirements of the regulation.

Delieveries

Please do not address your deliveries directly to individual staff members, but always to the following address without stating a specific name:

Bundesamt für Verbraucherschutz und Lebensmittelsicherheit
Abteilung 2, Pflanzenschutzmittel
Bundesallee 51
38116 Braunschweig
Germany

Or 200@bvl.bund.de (only for general correspondence)

Each delivery requires a covering letter. This letter is important in order to assign the document to the respective administrative procedure. To enable the handling of your application, the BVL reference number (if already allocated) must be given in the letter in full. Companies are informed about the reference number in the confirmation of receipt for the application for approval and/or the dossier.

If the dossier is not available in CADDY-xml (v3) Format Specification Version 03.07.00, the documents have to be submitted as electronic documents on CD-ROM. A single copy of the CADDY-xml (v3) CD/DVD is sufficient.

Please do not submit the documents via a download link. Due to security policies, we cannot download data from external servers. Please submit the data as hardcopy to the BVL.

Dossier requirements

Dossiers have to be submitted in the content and format as defined in the following Guidance Documents, which can be accessed via the website of the European Commission:

  • For chemical active substances:
    SANCO/10181/2013– latest version - 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 (Annex Part A) and Regulation (EU) No 284/2013
  • For microorganisms:
    SANCO/12545/2014– latest version - on preparing dossiers for the approval or renewal of approval of a micro-organism including viruses according to Regulation (EU) No 283/2013 (Annex Part B) and Regulation (EU) No 284/2013
  • For semiochemicals:
    SANTE/12815/2014-latest version - Guidance Document on “Semiochemical active substances and plant protection products”
  • For plant extracts:
    SANCO/11470/2012- latest version, Guidance Document on "Botanical active substances used in plant protection products"

Registration fees

The fees to be paid in order to start the review procedure are specified in the document "Special Fees Ordinance of the Federal Ministry of Food and Agriculture, BMEL" (German only).

The fees must be paid into the correct account (Bundeskasse Trier). An invoice for an advance payment (first instalment) according to the minimum fee can be sent by the BVL as soon as the dossier is considered to be complete after the completeness check. A further invoice is always sent after the decision on approval. In case further confirmatory information in the Implementing Regulation is requested, the final invoice is sent after the respective decision in the SCoPAFF (Standing Committee on Plants, Animals, Food and Feed).

New active substances

Pre-submission meeting

After Germany, represented by the BVL, agreed to be the Rapporteur Member State for the new active substance, it is advised to attend a pre-submission meeting with the BVL. In the pre-submission meeting procedural formalities and specific questions about the assessment can be discussed. The applicant should contact the BVL for organisation of the meeting and propose questions to be discussed.

Specific content requirements

  • It is advised to submit active substance and product data as separate CADDY-xml (v3) dossiers on separate CD-ROMs/DVDs. The supporting documentation (i.e. Documents A-J, N and O) should be incorporated into the CADDY-xml (v3) dossier for the (representative) product. CADDY v2 dossiers are not accepted by the BVL anymore.
  • Reference lists for the documents submitted must be compiled according to the format given in the current guidance documents. The annex-point for each document should be assigned in accordance to the data requirements (see SANCO/12580/2012 above).
  • In the case of subsequent deliveries (e.g. additional information during the peer review), respective reference lists detailing only the new documents must be attached including the numbering according to the Regulations (EU) No 283/2013 and No 284/2013. This is also required if only a few additional studies are submitted.
  • If the dossier has been delivered in CADDY-xml (v3) in dossier version 01.00, respective CADDY supplements (version 01.01 etc.) become necessary in the case of any subsequent delivery. To ensure access to data archived in this way, it is inevitable that the submitted CADDY-xml version complies with the CADDY-xml (v3) Format Specification Version 03.07.00 (http://esubmission.ecpa.eu/caddy), paying particular attention to the correct management of the various versions.
    If documents have not been submitted in CADDY-xml (v3) format, but as electronic files (PDF format), Document L, Document M and Document N (i.e. Tier I-Summaries, Reference Lists, Tier II-Summaries, Tier III-Summaries) should additionally be submitted in WORD format. This significantly facilitates entering the bibliographical data and the preparation of the assessment report. The title, author/s and report number of the reference lists must be consistent with the statements made in the original report.
  • According to Article 10 of Regulation (EC) No 1107/2009, EFSA shall make the summary dossier available to the public, with the exception of parts for which confidential treatment has been requested and is justified according to Article 63. To facilitate this the applicant should identify the respective information by completing the respective form (see administrative guidance above – appendix A1).
  • If documents are submitted concerning negligible exposure they should be included in the associated sections of the dossier, documents concerning Art. 4(7) should be included in document D2, respectively.
  • A template of the latest version for the GAP-table can be found on the website of the European commission (Templates To Be Used For Assessment Reports and Proposals for Classification – latest version)
  • If MRLs will be proposed a respective application has to be submitted in parallel according to Regulation (EC) No. 1107/2009 Article 8(1)(g). Therefore, the MRL-application form (SANCO 4044/2008 - current version) has to be used.
    In general, the MRL procedure is regulated by Regulation (EC) No. 396/2005. For further information on the submission in the BVL click here.
  • According to Regulation (EC) No. 1107/2009 Article 8(1)(g) MRL-applications should be submitted in combination with an application for approval of an active substance, if applicable. EFSA will evaluate the MRL-applications within the framework of the approval of an active substance. EFSA reserves the right to postpone the evaluation of MRL applications submitted outside of the assessment until the procedure is completed. Therefore, a delayed setting of MRLs is possible.
  • In parallel to the peer review of the new active substance the procedure for classification and labelling harmonisation (CLH) will be initiated with ECHA being the responsible authority. Therefore, Vol. 1 of the draft assessment report contains the proposal for classification and labelling. In Germany the BAuA (Federal Institute for Occupational Safety and Health) coordinates the process and is responsible for submitting a CLH proposal to ECHA.

Special content requirements

For approval a representative range of uses should be applied for. Furthermore, it is strongly advised that at least one representative plant protection product applied for is a mono formulation i.e. only contains the respective active substance as effective ingredient.
All relevant information concerning the batches used in toxicological and ecotoxicological studies have to be submitted. This requirement is part of Regulation (EU) Nr. 283/2013 and Regulation (EU) Nr. 284/2013. See Appendix J of ‘Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances doi: 10.2903/sp.efsa.2019.EN-1612’.

EFSA usually checks during the Peer Review whether this information is available. Further studies might be necessary if the specifications do not match.

Renewal of active substances

Pre-submission meeting

It is advised to attend a pre-submission meeting with the BVL at least 6 months before the application is submitted. In the pre-submission meeting procedural formalities and specific questions about the assessment can be discussed. The applicant should contact the BVL for organisation of the meeting and propose questions to be discussed.

Application and New Information Statement

According to Commission Implementing Regulation (EU) No 844/2012 an application for renewal of the approval of an active substance has to be submitted three years before the current approval expires. The "Guidance Document on the renewal of approval of active substances to be assessed in compliance with Regulation (EU) No 844/2012" (SANCO/2012/11251; current version) provides information on the format of an Application and the New Information Statement to be submitted. The applicant may pursuant to Article 63 of the same Regulation request certain information of the application to be kept confidential (see Appendix A1 of Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances). The RMS will check the application for its completeness.

Concerning the New Information Statement Germany as RMS emphasises that it includes the following information in chapter 3 for the different sections:

  • Does the active substance fulfill the cut-off criteria according to Implementing Regulation (EU) No 1107/2009?
  • Which new guidance documents will be used for the preparation of the dossier?
  • How will current technical innovations be addressed in the dossier?
  • How will data requirements according to Regulation (EU) No 283/2013 and Regulation (EU) No 284/2013 be addressed for which the guidance has not been finalised?

Specific dossier requirements

It is advised to submit active substance and product data as separate CADDY-xml (v3) dossiers on separate CD-ROMs/DVDs. The supporting documentation (i.e. Documents A-J, N and O) should be incorporated into the CADDY-xml (v3) dossier for the (representative) product. CADDY v2 dossiers are not accepted by the BVL anymore.

Submission of the old dossier of the preceding approval:

  • A new CADDY-xml (v3) full version with the complete old dossier containing all data submitted and evaluated up to the first decision on Annex I-inclusion/approval. Preferably, the CADDY-xml (v3) dossier should be constructed according to the current CADDY requirements, i.e. the numbering according to the guidance document (see below) should be used. In the old Tier II/III-summaries the original numbering may be kept. In this case or if the CADDY-xml (v3) dossier is submitted with EC or OECD Annex points, a reference list with both the old EC Annex points or the OECD Annex points and the new numbering has to be submitted (see SANCO/12580/2012 above). CADDY v2 dossiers are not accepted by the BVL anymore.

The supplementary dossier:

  • The new dossier parts (i.e. the supplementary dossier) should be submitted as a separate CADDY-xml (v3) Format Specification Version 03.07.00 dossier. It should contain all new data and documents additionally submitted for the renewal (including updated Tier Doc. M and N). It should also contain a separate reference list with the new studies only.

Further details:

  • It is advised to submit active substance and product data as separate CADDY-xml(v3) dossiers on separate CD-ROMs/DVDs. The supporting documentation (i.e. Documents A-J, N and O) should be incorporated into the CADDY-xml (v3) dossier for the (representative) product.
  • Reference lists for the documents submitted must be compiled according to the format given in the current guidance documents. The annex-point for each document should be assigned in accordance to the data requirements (see SANCO/12580/2012 above). Studies which were considered essential for the first Annex I inclusion can be found in the “List of studies relied upon” for the respective active substance in the EU pesticides database.
  • In the case of subsequent deliveries (e.g. additional information during the peer review), respective reference lists detailing only the new documents must be attached including the numbering according to the Regulations (EU) No 283/2013 and No 284/2013. This is also required if only a few additional studies are submitted.
  • If the dossier has been delivered in CADDY-xml (v3) in dossier version 01.00, respective CADDY supplements (version 01.01 etc.) become necessary in the case of any subsequent delivery. To ensure access to data archived in this way, it is inevitable that the submitted CADDYxml version complies with the CADDY-xml (v3) Format Specification Version 03.07.00 (http://esubmission.ecpa.eu/caddy), paying particular attention to the correct management of the various versions.
    If documents have not been submitted in CADDY-xml (v3) format, but as electronic files (PDF format), Document L, Document M and Document N (i.e. Tier I-Summaries, Reference Lists, Tier II-Summaries, Tier III-Summaries) should additionally be submitted in WORD format. This significantly facilitates entering the bibliographical data and the preparation of the assessment report. The title, author/s and report number of the reference lists must be consistent with the statements made in the original report.
  • According to Article 12 (4) of Commission Regulation (EU) No 844/2012, EFSA shall make the supplementary summary dossier available to the public, with the exception of parts for which confidential treatment has been requested and is justified according to Article 63 of Regulation (EC) No 1107/2009. To facilitate this the applicant should identify the respective information by completing the respective form (see Appendix A1 of the Administrative guidance).
  • If documents are submitted concerning negligible exposure they should be included in the associated sections of the dossier, documents concerning Art. 4(7) should be included in document D2, respectively.
  • A template of the latest version for the GAP-table can be found on the website of the European commission (Templates To Be Used For Assessment Reports and Proposals for Classification – latest version)
  • If MRLs will be proposed a respective application has to be submitted in parallel according to Regulation (EC) No. 1107/2009 Article 8(1)(g). Therefore, the MRL-application form (SANCO 4044/2008 - current version) has to be used.
    In general, the MRL procedure is regulated by Regulation (EC) No. 396/2005. For further information on the submission in the BVL click here.
  • According to Regulation (EC) No. 1107/2009 Article 8(1)(g) MRL-applications should be submitted in combination with an application for renewal of an active substance, if applicable. EFSA will evaluate the MRL-applications within the framework of the renewal of an active substance. EFSA reserves the right to postpone the evaluation of MRL applications submitted outside of the assessment until the procedure is completed. Therefore, a delayed setting of MRLs is possible.
  • In parallel to the peer review of the new active substance the procedure for classification and labelling harmonisation (CLH) will be initiated with ECHA being the responsible authority. Therefor, Vol. 1 of the draft assessment report contains the proposal for classification and labelling. In Germany the BAuA (Federal Institute for Occupational Safety and Health) coordinates the process and is responsible for submitting a CLH proposal to ECHA.

Specific content requirements

For renewal of approval a representative range of uses should be applied for. Furthermore, it is strongly advised that at least one representative plant protection product applied for is a mono formulation i.e. only contains the respective active substance as effective ingredient.

Concerning the studies for the first approval Document M and N have to be revised according to the new requirements.

With respect to new guidance documents the necessity of further studies and/or respective revisions of the risk assessment has to be considered. The guidance documents can be found via the website of the European Commission.

All relevant information concerning the batches used in toxicological and ecotoxicological studies including the "old" Annex II-studies which were submitted for the first application for approval/Annex I inclusion have to be submitted. See Appendix J of ‘Administrative guidance on submission of dossiers and assessment reports for the peer-review of pesticide active substances doi: 10.2903/sp.efsa.2019.EN-1612’.

EFSA usually checks during the Peer Review whether this information is available. Further studies might be necessary if the specifications do not match.