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Guidance on the risk assessment of genetically modified microorganisms and their products intended for food and feed use

EFSA Journal 2011;9(6):2193 [54 pp.]. doi:10.2903/j.efsa.2011.2193
  EFSA Panel on Genetically Modified Organisms (GMO) Panel Members Hans Christer Andersson, Salvatore Arpaia, Detlef Bartsch, Josep Casacuberta, Howard Davies, Patrick du Jardin, Gerhard Flachowsky, Lieve Herman, Huw Jones, Sirpa Kärenlampi, Jozsef Kiss, Gijs Kleter, Harry Kuiper, Antoine Messéan, Kaare Magne Nielsen, Joe Perry, Annette Pöting, Jeremy Sweet, Christoph Tebbe, Atte Johannes von Wright, and Jean-Michel Wal Acknowledgment The Panel wishes to thank the following members of the Updated GMM GD Working Group: Niels Bohse Hendriksen, John Heritage, Klaus-Dieter Jany, Martinus Løvik and John Threlfall for the preparatory work on this scientific opinion and EFSA staff: Jaime Aguilera and Ana Gomes for the support provided to this scientific opinion. Detlef Bartsch was member of the Updated GMM GD Working Group until 28 March 2011. Contact gmo@efsa.europa.eu
Type: Guidance of the Scientific Committee/Scientific Panel On request from: EFSA Question number: EFSA-Q-2009-00521 Adopted: 25 May 2011 Published: 09 June 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Genetically modified microorganisms (GMMs) are involved in the production of a variety of food and feed. The marketing of these products within the European Union falls under different legislative instruments, which establish the requirement for a risk assessment for the authorisation of the product. The present guidance describes the principles to be followed when conducting such a risk assessment, as well as the scientific information required in applications for authorisation to be evaluated by the Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority (EFSA GMO Panel). Products form four categories, depending on their nature and the level of scientific information required for their evaluation by the EFSA GMO Panel. The guidance details the data to be provided for the assessment of products of each category, providing reference to other guidance that is also applicable. This document draws on the experience gained by the EFSA GMO Panel in assessing applications for marketing food and feed involving GMMs and takes into account the input received from different stakeholders, and updates the “Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed”, adopted by the EFSA GMO Panel in 2006.

© European Food Safety Authority, 2011

Summary

The European Food Safety Authority (EFSA) asked the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) to establish a Working Group with the aim of updating the Guidance Document for the risk assessment of genetically modified microorganisms and their derived products intended for food and feed use. The aim encompasses providing updated guidance for the preparation and presentation of applications involving genetically modified microorganisms (GMMs).

The Working Group: i) reviewed the existing Guidance Document in the light of experience gained, technological progress and scientific developments, ii) considered input received from the Member States and applicants on the existing Guidance Document, and iii) completed a public consultation of the draft Guidance.

Guidance for the preparation of applications is given throughout the different chapters of the document. Chapter I clarifies the scope of the document. This guidance covers GMMs and their products falling under Regulation (EC) No 1829/2003 on GM food and feed, as well as those falling under Regulations 1332/2008 (on food enzymes), 1333/2008 (on food additives), 1334/2008 (on food flavourings), and 1831/2003 (on feed additives) when GMMs are involved. Chapter II describes the strategy, the steps to be taken, and the issues to be considered when carrying out a comprehensive risk characterisation. GMMs and their products are divided in four categories, depending on their nature and the level of scientific information required for their risk assessment. Depending on the category to which a product is allocated, its use, and the legislations applicable to the product, it is specified which Sections of this guidance document must be followed, and what other guidelines and guidance are also applicable. Chapter III describes the scientific information that should be provided in applications, and which is required for the risk assessment by the EFSA GMO Panel. This should include a comprehensive characterisation of the GMM and cover the recipient/parental organism, the donor(s) of the genetic material, the genetic modification, and the final GMM and its phenotype. 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 GMM and derived food and feed and/or for the environmental monitoring of the GMM.

Keywords

GMOs, GM microorganisms, GM food and feed, guidance, Regulation (EC) No 1829/2003, Directive 2001/18/EC, food safety, feed safety, environment