Home About us MoEF Contact us Sitemap Tamil Website  
About Envis
Whats New
Microorganisms
Research on Microbes
Database
Bibliography
Publications
Library
E-Resources
Microbiology Experts
Events
Online Submission
mn

Site Visitors

blog tracking


 
International Journal of Food Microbiology
Vol.
xx, No. xx, 2013; Pages: xxx - xxx

Principles for the risk assessment of genetically modified microorganisms and their food products in the European Union

Jaime Aguilera, Ana R. Gomes, Irina Olaru

European Food Safety Authority, Via Carlo Magno 1/a, 43126 Parma, Italy.

Abstract

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The release and consumption of these products can raise questions about health and environmental safety. Therefore, the European Union has different legislative instruments in place in order to ensure the safety of such products. A key requirement is to conduct a scientific risk assessment as a prerequisite for the product to be placed on the market. This risk assessment is performed by the European Food Safety Authority (EFSA), through its Scientific Panels. The EFSA Panel on Genetically Modified Organisms has published complete and comprehensive guidance for the risk assessment of GMMs and their products for food and/or feed use, in which the strategy and the criteria to conduct the assessment are explained, as well as the scientific data to be provided in applications for regulated products. This Guidance follows the main risk assessment principles developed by various international organisations ( and ). The assessment considers two aspects: the characterisation of the GMM and the possible effects of its modification with respect to safety, and the safety of the product itself. Due to the existing diversity of GMMs and their products, a categorisation is recommended to optimise the assessment and to determine the extent of the required data. The assessment starts with a comprehensive characterisation of the GMM, covering the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. Evaluation of the composition, potential toxicity and/or allergenicity, nutritional value and environmental impact of the product constitute further cornerstones of the process. The outcome of the assessment is reflected in a scientific opinion which indicates whether the product raises any safety issues. This opinion is taken into account by the different European regulatory authorities prior to a decision regarding authorisation to commercialise the product.

Keywords: Genetically modified organisms; Genetically modified microorganisms; Food safety; Risk assessment; Guidance; Regulation


 

 

 
Copyright © 2005 ENVIS Centre ! All rights reserved
This site is optimized for 1024 x 768 screen resolution