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EFSA guidance on the submission of applications for authorisation of genetically modified food and feed and genetically modified plants for food or feed uses under Regulation (EC) No 1829/2003

EFSA Journal 2011;9(7):2311 [193 pp.]. doi:10.2903/j.efsa.2011.2311
European Food Safety Authority Acknowledgment EFSA wishes to thank its scientific officers Yi Liu, Nancy Podevin, Christina Ehlert and Karine Lheureux for drafting, its staff, Jaime Aguilera, Per Bergman, Anna Christodoulidou, Yann Devos, Zoltan Diveki, Antonio Fernandez Dumont, Andrea Germini, Luana Giorgini, Ana Gomes, Sonia Hernandez-Valero, Sylvie Mesdagh, Claudia Paoletti, Reinhilde Schoonjans, Mara Todeschi, Ellen Van Haver, Elisabeth Waigmann for providing comments. This guidance has been reviewed by Detlef Bartsch, Gijs Kleter and Huw Jones. Contact gmo@efsa.europa.eu
Type: Guidance of EFSA On request from: EFSA Question number: EFSA-Q-2011-00313 Approved: 07 July 2011 Published: 22 July 2011 Last updated: 06 July 2012. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

This document is intended to provide guidance to applicants submitting under Regulation (EC) No 1829/2003 an application for authorisation of genetically modified food and feed and genetically modified plants for food and feed uses including cultivation in the European Union. It complements two recently updated guidance documents of the EFSA Panel on genetically modified organisms, the Guidance for risk assessment of food and feed from genetically modified plants and the Guidance on the environmental risk assessment of genetically modified plants. This EFSA submission guidance describes the community procedures in the European Union for processing such applications, and provides instructions to applicants on how to prepare and present data in an application to be submitted to EFSA. It is supplemented with ten appendices such as examples of data presentation and a completeness checklist to be filled by the applicants. Instructions described in this EFSA guidance are applicable to applicants submitting under Regulation (EC) No 1829/2003 an application for renewal of authorisation of existing products produced from genetically modified plants.

© European Food Safety Authority, 2011

Summary

This EFSA guidance is intended for applicants submitting under Regulation (EC) No 1829/2003 an application for authorisation of genetically modified food and feed and genetically modified plants for food and feed uses including cultivation in the European Union (EU). It consists of six chapters. Chapter 1 describes the community procedure for processing such applications in the EU. Chapter 2 provides detailed instructions on how to structure an application and present data in the desired format. Chapter 3 explains specific requirements for different parts of an application, in particular, Parts I, II and VIII. Chapter 4 explains requirements specific to applications concerning GM plants containing stacked events. Chapter 5 specifies the applicability of this EFSA guidance to renewal applications notified according to Articles 8 and 20 of Regulation (EC) No 1829/2003.

This EFSA guidance is accompanied by ten appendices: Appendix A describes contact details of applicants for each application; Appendix B is a completeness checklist, which should be filled out by the applicant; Appendix C provides exemplar tables to summarise scientific information and exemplar figures for data presentation; Appendices D-G refer to data provided for the environmental risk assessment; Appendix H is the proof of reception by EU Reference Laboratory for GM Food and Feed; and Appendix I provides the format of the summary of applications. Appendix J outlines the standardised form, which Part II of an application should follow. These appendices should be used by the applicant and by EFSA to ensure: (i) that all required information and all documents, as laid down by EFSA, are provided; and (ii) that an application is in accordance with the recommended structure and format.

This EFSA guidance is available on the EFSA website. Like all EFSA guidance documents, this EFSA guidance will be updated in the future in accordance to relevant changes in legislation and/or in accordance with EFSA procedures and guidance documents under Regulation (EC) No 1829/2003.

Keywords

Application, submission, EFSA guidance, genetically modified, GM plants, GMO, Regulation (EC) No 1829/2003, renewal