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Guidance on the Risk Assessment of Genetically Modified Microorganisms 1 3 and Their Food and Feed Products

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Guidance on the Risk Assessment of Genetically Modified Microorganisms 1 3 and Their Food and Feed Products EFSA Journal 20YY;volume(issue):NNNN 1 SCIENTIFIC OPINION 2 Guidance on the risk assessment of genetically modified microorganisms 1 3 and their food and feed products 4 EFSA Genetically Modified Organisms (GMO)2, 3 5 European Food Safety Authority (EFSA), Parma, Italy 6 ABSTRACT 7 The EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) published its first 8 Guidance Document for the risk assessment of genetically modified microorganisms and their 9 derived products intended for food and feed use in October 2006. Since then, the EFSA GMO 10 Panel has gained significant experience in assessing applications for marketing food and feed 11 involving genetically modified microorganisms within the EU, which has enabled it to 12 identify areas of the Guidance that needed clarification and issues that should be covered 13 more in depth. In addition, the Panel has received and acknowledged input from different 14 stakeholders, and considered recent developments in relevant European legislation. This 15 revised document provides updated guidance for the preparation and presentation of 16 applications for science-based risk assessment. It describes the steps to be taken and the 17 issues to be considered when carrying out a comprehensive risk characterisation. 18 © European Food Safety Authority, 2010 19 KEY WORDS 20 GMOs, GM microorganisms, GM food and feed, guidance, Regulation (EC) No 1829/2003, Directive 21 2001/18/EC, food safety, feed safety, environment. 1 On request from EFSA, Question No EFSA-Q-2009-521, adopted on DD Month YYYY. 2 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. Correspondence: [email protected] 3 Acknowledgement: The Panel wishes to thank the 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. Suggested citation: EFSA Panel on Genetically Modified Organisms (GMO); Scientific Opinion on Guidance on the risk assessment of genetically modified microorganisms and their derived food and feed products. EFSA Journal 20YY;volume(issue):NNNN. [52 pp.] doi:10.2903/j.efsa.20YY.NNNN. Available online: www.efsa.europa.eu/efsajournal.htm © European Food Safety Authority, 20YY 1 Guidance on the risk assessment of GMMs and their food and feed products 22 SUMMARY 23 The European Food Safety Authority (EFSA) asked the EFSA Panel on Genetically Modified 24 Organisms (EFSA GMO Panel) to establish a self-tasking Working Group with the aim of 25 updating the Guidance Document for the risk assessment of genetically modified 26 microorganisms and their derived products intended for food and feed use. The aim of the 27 Working Group was to provide updated guidance for the preparation and presentation of 28 applications involving genetically modified microorganisms (GMMs). 29 30 To complete its mandate, the self-tasking Working Group: i) reviewed the existing Guidance 31 Document, and identified areas of improvement, ii) considered input received from the 32 Member States and applicants on the existing Guidance Document and iii) discussed and 33 developed improvements for those areas. 34 35 The EFSA GMO Panel published its first Guidance Document for the risk assessment of 36 genetically modified microorganisms and their derived products intended for food and feed 37 use in October 2006. This revised document was adopted on (XX-XX-XXXX). The EFSA 38 and the EFSA GMO Panel published the Guidance on the EFSA web site for public 39 consultation prior to the final adoption of this document. 40 41 Updated guidance for the preparation of applications is given throughout the different 42 chapters of the guidance document. Chapter I clarifies the scope of the document and the 43 regulatory background for the risk assessment of GMMs and their food and feed products at 44 the Community level. Chapter II describes the overall risk assessment strategy. Chapter III 45 describes the steps to be taken and the issues to be considered when carrying out a 46 comprehensive risk characterisation. These issues include general information, information 47 relating to the recipient/parental, the donor(s) of the genetic material, the genetic modification 48 and the final GMM, as well as information relating to the food and/or feed containing, 49 consisting of, produced from and produced with GMMs4. It also includes information on 50 modification of the genetic traits or phenotypic characteristics of the GMM and evaluation of 51 food and feed safety aspects of the GMM and derived products5. Data on composition, 52 toxicity, allergenicity, nutritional value and environmental impact provide, on a case-by-case 53 basis, the cornerstones of the risk assessment process. The characterisation of risk may give 54 rise to the need for further specific activities including post-market monitoring of the GMM 55 and derived food and feed and/or for the environmental monitoring of the GMM. A table 56 (Table 1) summarising the risk assessment requirements for the different categories of GMMs 57 and their products is also provided. 58 59 4 Regulation (EC) No 1829/2003 defines food and feed ‘produced from GMOs’ as derived, in whole or in part, from GMOs, but not containing or consisting of GMOs. “Containing or consisting of GMMs” is understood as products in which GMMs capable of replication or of transferring genetic material are present. “Produced with GMMs” is understood as produced by fermentation using a GMM which is kept under contained conditions and is not present in the final product. Such products are not included in the scope of Regulation (EC) No 1829/2003 (EC, 2004). 5 According to Regulation (EC) No 1829/2003 “Derived (food and/or feed) products” is understood as products containing, consisting of or produced from GMMs, but not produced with GMMs. EFSA Journal 20YY;volume(issue):NNNN 2 Guidance on the risk assessment of GMMs and their food and feed products 60 TABLE OF CONTENTS 61 Abstract ................................................................................................................................................ 1 62 Key Words ........................................................................................................................................... 1 63 Summary .............................................................................................................................................. 2 64 Table of contents .................................................................................................................................. 3 65 Background as provided by the EFSA GMO Panel ............................................................................. 5 66 Terms of reference as provided by the EFSA GMO Panel .................................................................. 5 67 I. INTRODUCTION ................................................................................................................................ 6 68 Scope of the document ..................................................................................................................... 6 69 Legal background ............................................................................................................................. 6 70 II. PRINCIPLES AND STRATEGIES FOR RISK ASSESSMENT OF GENETICALLY MODIFIED 71 MICROORGANISMS ............................................................................................................................ 11 72 Definitions in risk analysis ............................................................................................................. 11 73 Categorisation of the GMMs and derived products for risk assessment purposes ......................... 11 74 Comparative approach ................................................................................................................... 12 75 Intended and unintended effects ..................................................................................................... 13 76 III. INFORMATION REQUIRED IN APPLICATIONS FOR GMMS AND/OR THEIR PRODUCTS ............. 14 77 A. General information .................................................................................................................. 14 78 B. Hazard identification and characterisation ................................................................................14 79 1. Information relating to the GMM ............................................................................... 15 80 1.1. Characteristics of the recipient or (when appropriate) parental organism .................. 15 81 1.2. Characteristics of the origin of the inserted sequences [donor organism(s)] .............. 18 82 1.3. Description of the genetic modification ..................................................................... 19 83 1.4. Information relating to the GMM and comparison of the GMM with an appropriate 84 comparator ................................................................................................................. 20 85 2. Information relating to the product ............................................................................
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