EC the summary information format relating to the placing on the market of genetically modified organisms as or in products - Main contents

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dossier	COM(2002)362 - Pursuant to Directive 2001/18/EC the summary information format relating to the placing on the market of genetically ...
document	COM(2002)362
date	October 3, 2002

ANNEX

SUMMARY INFORMATION FORMAT IN RELATION TO THE PLACING ON THE MARKET OF A GMO OR A COMBINATION OF GMOs AS OR IN PRODUCTS

INTRODUCTION

The following format must be used for the summary of the dossier to accompany a notification, for submission to the competent national authority, concerning the placing on the market of a GMO or a combination of GMOs as or in products.

This document, when completed, will present a summary of the information entered under the corresponding points of the full dossier. It is recognised, therefore, that the risk assessment required under Directive 2001/18/EC cannot be carried out solely on the basis of this document.

The space provided after each question is not indicative of the depth of the information required for the purposes of the Summary Information Format.

The Summary Information Format is divided into Parts 1 and 2.

Part 1 applies to products consisting of or containing genetically modified organisms other than higher plants and contains the following sections:

A General Information

B Nature of the GMOs contained in the product

C Predicted behaviour of the product

D Information relating to previous releases

E Information relating to the monitoring plan

Part 2 applies to products consisting of or containing genetically modified higher plants. The term "higher plants" means plants which belong to the taxonomic group Gymnospermae and Angiospermae. Part 2 contains the following sections:

A General Information

B Nature of the GMHP contained in the product

C Information relating to previous releases

D Information relating to the monitoring plan

PART 1

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PART 2

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