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Unclassified ENV/JM/MONO(2002)25 ENV/JM/MONO(2002)25 8QFODVVLILHG (19-00212 2UJDQLVDWLRQ GH &RRSpUDWLRQ HW GH 'p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ÃFRPSOHWÃGLVSRQLEOHÃVXUÃ2/,6ÃGDQVÃVRQÃIRUPDWÃG RULJLQH &RPSOHWHÃGRFXPHQWÃDYDLODEOHÃRQÃ2/,6ÃLQÃLWVÃRULJLQDOÃIRUPDW ENV/JM/MONO(2002)25 Also published in the Series on the Safety of Novel Foods and Feeds: No. 1, Consensus Document on Key Nutrients and Key Toxicants in Low Erucic Acid Rapeseed (Canola) (2001) No. 2, Consensus Document on Compositional Considerations for New Varieties of Soybean: Key Food and Feed Nutrients and Anti-nutrients (2001) No. 3, Consensus Document on Compositional Considerations for New Varieties of Sugar Beet: Key Food and Feed Nutrients and Anti-Nutrients (2002) No. 4, Consensus Document on Compositional Considerations for New Varieties of Potatoes: Key Food and Feed Nutrients, Anti-Nutrients and Toxicants (2002) No. 5, Report of the OECD Workshop on the Nutritional Assessment of Novel Foods and Feeds, Ottawa, February 2001 © OECD 2002 Applications for permission to reproduce or translate all or part of this material should be made to: Head of Publications Service, OECD, 2 rue André-Pascal, 75775 Paris Cedex 16, France. 2 ENV/JM/MONO(2002)25 OECD Environmental Health and Safety Publications Series on the Safety of Novel Foods and Feeds No. 6 Consensus Document on Compositional Considerations for New Varieties of Maize (Zea Mays): Key Food and Feed Nutrients, Anti-nutrients and Secondary Plant Metabolites Environment Directorate Organisation for Economic Co-operation and Development Paris 2002 3 ENV/JM/MONO(2002)25 ABOUT THE OECD The Organisation for Economic Co-operation and Development (OECD) is an intergovernmental organisation in which representatives of 30 industrialised countries in North America, Europe and the Pacific, as well as the European Commission, meet to co-ordinate and harmonise policies, discuss issues of mutual concern, and work together to respond to international problems. Most of the OECD’s work is carried out by more than 200 specialised committees and subsidiary groups composed of member country delegates. Observers from several countries with special status at the OECD, and from interested international organisations, attend many of the OECD’s workshops and other meetings. Committees and subsidiary groups are served by the OECD Secretariat, located in Paris, France, which is organised into directorates and divisions. The Environmental Health and Safety Division publishes free-of-charge documents in seven different series: Testing and Assessment; Good Laboratory Practice and Compliance Monitoring; Pesticides; Risk Management; Harmonisation of Regulatory Oversight in Biotechnology; Safety of Novel Foods and Feeds and Chemical Accidents. More information about the Environmental Health and Safety Programme and EHS publications is available on the OECD’s World Wide Web site (see below). This publication is available electronically, at no charge. For the complete text of this and many other Environmental Health and Safety publications, consult the OECD’s World Wide Web site (http://www.oecd.org/ehs/) or contact: OECD Environment Directorate, Environmental Health and Safety Division 2 rue André-Pascal 75775 Paris Cedex 16 France Fax: (33) 01 45 24 16 75 E-mail: [email protected] 4 ENV/JM/MONO(2002)25 FOREWORD The OECD’s Task Force for the Safety of Novel Foods and Feeds decided at its first session, in 1999, to focus its work on the development of science-based consensus documents, which are mutually acceptable among member countries. These consensus documents contain information for use during the regulatory assessment of a particular food/feed product. In the area of food and feed safety, consensus documents are being published on the nutrients, anti-nutrients or toxicants, information of its use as a food/feed and other relevant information. This consensus document addresses compositional considerations for new varieties of maize by identifying the key food and feed nutrients, anti-nutrients and secondary plant metabolites. A general description of these components is provided. Also included are considerations to be taken when assessing new maize varieties, including suggested analyses. The Netherlands and the United States served as the lead countries in the preparation of this document. The Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology has recommended that this document be made available to the public. It is published on the authority of the Secretary-General of the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±6HFRQGDU\ SODQW PHWDEROLWHV $ )XUIXUDO % )HUXOLF DFLG DQG SFRXPDULF DFLG 6HFWLRQ 9 )RRG XVH $ ,GHQWLILFDWLRQ RI NH\ PDL]H SURGXFWV FRQVXPHG E\ KXPDQV % ,GHQWLILFDWLRQ RI NH\ SURGXFWV DQG VXJJHVWHG DQDO\VLV IRU QHZ YDULHWLHV 6HFWLRQ 9, )HHG XVH $ ,GHQWLILFDWLRQ RI NH\ PDL]H SURGXFWV FRQVXPHG E\ DQLPDOV % ,GHQWLILFDWLRQ RI 2H\ 3URGXFWV DQG 6XJJHVWHG $QDO\VLV IRU 1HZ 9DULHWLHV 6HFWLRQ 9,, 5HIHUHQFHV 7 ENV/JM/MONO(2002)25 LIST OF TABLES 7DEOH :RUOG PDL]H JUDLQ SURGXFWLRQ ................................................................................12 7DEOH 3UR[LPDWH DQDO\VLV RI ILHOG PDL]H NHUQHOV................................................................................20 7DEOH 3UR[LPDWH DQDO\VLV RI VZHHW PDL]H DQG SRSFRUQ PDL]H NHUQHOV...............................................20 7DEOH /HYHOV RI PLQHUDOV DQG YLWDPLQV LQ ILHOG PDL]H NHUQHOV ...........................................................21 7DEOH /HYHOV RI PLQHUDOV DQG YLWDPLQV LQ VZHHW PDL]H DQG SRSFRUQ PDL]H NHUQHOV ..........................22 7DEOH $PLQR DFLG FRPSRVLWLRQ RI PDL]H NHUQHOV LQ > RI NHUQHO GZ................................................23 7DEOH )DWW\ DFLG FRPSRVLWLRQ RI PDL]H NHUQHOV LQ > RI NHUQHO GZ ..................................................24 7DEOH )DWW\ DFLG FRPSRVLWLRQ RI UHILQHG PDL]H RLO LQ > RI WRWDO IDWW\ DFLGV.......................................24 7DEOH 3UR[LPDWH DQDO\VLV RI JULWV IORXU DQG PHDO LQ > RI GZ .........................................................25 7DEOH /HYHOV RI PLQHUDOV DQG YLWDPLQV LQ JULWV IORXU DQG PHDO .........................................................25 7DEOH 3UR[LPDWH DQDO\VLV RI FRUQ VWDUFK LQ > RI GZ ........................................................................26 7DEOH 3UR[LPDWH RI FRPPRQ PDL]H DQLPDO IHHG SURGXFWV .................................................................26 7DEOH /HYHOV RI PLQHUDOV DPLQR DFLGV DQG IDWW\ DFLGV LQ FRPPRQ PDL]H DQLPDO IHHG SURGXFWV.......27 7DEOH 6XJJHVWHG QXWULWLRQDO DQG FRPSRVLWLRQDO SDUDPHWHUV WR EH DQDO\VHG LQ PDL]H PDWULFHV IRU KXPDQ IRRG XVH..........................................................................................32 7DEOH 6XJJHVWHG QXWULWLRQDO DQG FRPSRVLWLRQDO SDUDPHWHUV WR EH DQDO\VHG LQ PDL]H PDWULFHV IRU DQLPDO IHHG ................................................................................................35 8 ENV/JM/MONO(2002)25 LIST OF FIGURES Figure 1. Wet Processing of Maize..........................................................................................................14 Figure 2. Dry Milling of Maize ...............................................................................................................16 Figure 3. Feed Processing of Maize.........................................................................................................18 9 ENV/JM/MONO(2002)25 Preamble Food and feed products of modern biotechnology are being commercialised and marketed in OECD Member countries. The need has been identified for detailed technical work aimed at establishing appropriate approaches to the safety assessment of these products. At a Workshop held in Aussois, France (OECD 1997), it was recognised that a consistent approach to the establishment of substantial equivalence might be improved through consensus on the appropriate components (e.g., key nutrients, key toxicants and anti-nutritional compounds) on a crop-by- crop basis, which should be considered in the comparison. It is recognised that the components may differ from crop to crop. The Task Force therefore decided to develop consensus documents on compositional data. These data are used to identify similarities and differences following a comparative approach as part of a food and feed safety assessment. They should be useful to the development of guidelines, both national and international and to encourage information
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