Guidance To The Genetically Modified Organisms Deliberate Release And Risk Assessment Amendment Regulations 1997

Genetically Modified Organisms (Deliberate Release and Risk Assessment - Amendment) Regulations 1997

Enabling power:European Communities Act 1972, 2 (2) & S.I. 1991/1714 (NI. 9), arts. 5 (7), 8 (1) (4) (7).. Issued:18.12.97.. Made:11.12.97.. Coming into force:30.01.98.. Effect:S.R. 1994/144; 1996/442 amended.

The Scientific Panel on Genetically Modified Organisms (GMO Panel) adopted its guidance document for the risk assessment of genetically modified (GM) plants and derived food and feed on 24 September 2004. The European Food Safety Authority (EFSA) and the GMO Panel have consulted stakeholders prior to the final adoption of this document. This document provides guidance for the preparation and presentation of applications submitted within the framework of Regulation (EC) 1829/2003 on GM food and feed, and of Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms (GMOs). This document therefore covers the full risk assessment of GM plants and derived food and feed. Issues related to risk management of GMOs (traceability, labelling, co-existence) are outside the scope of the guidance document. Guidance for the preparation of applications is given throughout the different chapters of the document. The first chapter of the guidance document clarifies the scope of the document and the legal background for the risk assessment of GMOs, GM food and feed at Community level. Chapter II describes the overall risk assessment strategy. Chapter III describes the issues to be considered when carrying out a comprehensive risk characterisation. These include molecular characterisation of the inserts, assessment of modification to the agronomic characteristics of the GM plant and evaluation of food/feed safety aspects of the GM plant and/or derived food and feed. Data on composition, toxicity, allergenicity, nutritional value and environmental impact provide, on a case-by-case basis, the cornerstones of the risk assessment process. The characterisation of risk may give rise to the need for further specific activities including post-market monitoring of the GM food/feed and/or for the environmental monitoring of GM plants. Finally, Chapter IV summaries the overall risk characterisation process.

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Suitable for anyone undertaking either AS or A level law examinations, this text covers all subjects offered under the AQA and OCR specifications. It has been fully updated and revised to incorporate both legal developments and experience of the specifications in practice

This guide has been prepared by the IUCN Environmental Law Programme and the Foundation for International Environmental Law and Development (FIELD), in cooperation with the World Resources Institute (WRI). The main goal of the guide is to facilitate the understanding of the obligations of Parties to the Protocol, by providing an information base on the content and origin of the Protocol provisions, accessible to the non-specialist and useful for those who will be involved in the development and implementation of national safety frameworks.