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 (see link to Download page at the bottom) 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.

Downloads

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:

  • The download "EU ToC for chemical AI" is an 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)
  • The download "EU ToC for chemical PPP" is an 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 download "dRR ToC for chemical PPP" contains a ToC that 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 download "EU ToC for micro-organisms and viruses" contains two ToCs in Excel format that 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.

  • 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

The download "dRR ToC for micro-organisms and viruses" should be used by all applicants making submissions to register or renew microbial / virus products following the zonal process in any EU member states.

Registration of plant extracts

For the registration of plant extracts (botanicals, semio-chemicals and terpenes) also the chemical ToCs (see above) are to be used.