EU Table of Contents

Introduction

This section is about the Dossier Table of Contents needed to support registrations of active ingredients, plant protection products and microorganisms in the EU.

The files available for download here are extracted from the respective legal framework, converted in Excel and partly modified (e.g. some titles are shortened due to node heading length restrictions within CADDY). The information can be used to be imported into the dossier management systems for the correct creation and publication of dossiers. This information is provided only for reference purposes.

EU regulations can be found on EUR-Lex, EU guidelines can be found here.

Registration of active ingredients

As described in the SANCO/10181/2013 guidance document, these Table of Contents should be used by all applicants making submissions to register or renew chemical active ingredients within the EU.

Two ToCs are published:

  • Excel file with the ToC for the active ingredient following data requirements laid out in Commission Regulation (EU) No 283/2013 (also known as "KCA" Table of Contents)
  • Excel file with the ToC for the representative product following data requirements laid out in Commission Regulation (EU) No 284/2013 (also known as "KCP" Table of Contents)

This information was extracted from the Excel files that are embedded in the guidance document SANCO/10181/2013– rev. 3 12 December 2014 of the European Commission. The entry for KCA 8.2.4.2 in the Excel REVISED_EU_KCA_XWALKS_20 was updated to be “Acute toxicity to an additional aquatic invertebrate species” to resolve an inconsistency between the document content and the extracted Excel list.

Registration of products

The published ToC should be used by all applicants making submissions to register or renew chemical plant protection products in dRR format (dRR = draft Registration Report) following EU guidance SANTE/6895/2009 (rev. 1) - 7 October 2016 in the zonal process in any EU member state. It follows the data requirements laid out in Commission Regulation (EU) No 284/2013.

Registration of microorganisms

The two ToCs in the published Excel file should be used by all applicants making submissions to register or renew microbial pest control agents and microbial pest control products for the purpose of crop protection.

Two ToCs are published in the Excel file:

  • The worksheet "ToC MA 160203 EU" for the microbial pest control agent following data requirement laid out in Commission Regulation (EU) No 283/2013
  • The worksheet "ToC MP 160203 EU" for the microbial pest control products following data requirement laid out in Commission Regulation (EU) No 284/2013

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