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SYN-BTØ11-1
Transformation Event	Bt11
Trade Name
Applicant	Syngenta
Organism Common Names	Maize
Organism Scientific Names	Zea mays
Centre of Origin and Diversity	Biology Consensus Document on Maize
Food and Feed Safety Issues	Compositional considerations for Maize
Methods for safe handling
Additional Information
Traits	Resistance to Lepidoptera, Tolerance to Glufosinate
Genes	cry1Ab, phosphinothricin acetyltransferase (pat)

Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
Australia
August 30, 2001	Food	Food Standards Australia New Zealand	A386

Canada
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
June 11, 1996	Feed	Canadian Food Inspection Agency - Animal Feed Division	DD96-12
August 15, 1996	Food	Health Canada - GM Foods and Other Novel Foods	FD/OFB-096-228-B

European Union
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
April 22, 1998	Feed	European Commission	EC-Bt11
May 19, 2004	Food	European Commission	EC-Bt11
April 22, 1998	Importing and Processing	European Commission	EC-Bt11

Japan
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
September 26, 1996	Feed	Ministry of Agriculture, Forestry and Fisheries (MAFF)
September 03, 1996	Food	Ministry of Health, Labour and Welfare (MHLW)

Mexico
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
July 16, 2007	Processing	The Federal Commission for the Protection against Sanitary Risk - COFEPRIS (Secretary of Health)
July 16, 2007	Food and Feed	The Federal Commission for the Protection against Sanitary Risk - COFEPRIS (Secretary of Health)

New Zealand
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
October 25, 2001	Food	Food Standards Australia New Zealand	A386

Switzerland
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
October 14, 1998	Feed	Swiss Federal Office of Agriculture	916.307.11 (French)
October 14, 1998	Food	Swiss Federal Office of Public Health	SWI food bt11 (French)

United States of America
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
May 22, 1996	Feed	Food and Drug Administration (USFDA)	BNF17
May 22, 1996	Food	Food and Drug Administration (USFDA)	BNF17

Republic of Korea
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
August 04, 2006	Feed	Rural Development Administration (RDA)
November 27, 2003	Food	Food and Drug Administration (KFDA)
August 04, 2006	Processing	Rural Development Administration (RDA)

Paraguay
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
October 24, 2012	Commercial Release	Ministry of Agriculture and Livestock	PRY 891/2012

Brazil
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
September 20, 2007	Commercial Release	The National Technical Biosafety Committee (CTNBio)	BRA_SYNBT011

South Africa
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
September 26, 2003	Commercial planting	Department of Agriculture, Forestry and Fisheries (DAFF)
September 26, 2003	Importation exportation	Department of Agriculture, Forestry and Fisheries (DAFF)
September 26, 2003	Food and or feed	Department of Agriculture, Forestry and Fisheries (DAFF)
February 01, 2002	Import as food and feed	Department of Agriculture, Forestry and Fisheries (DAFF)

Viet Nam
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
August 11, 2014	Food and Feed	Ministry of Health, Ministry of Agriculture and Rural Development and Ministry of Industry and Trade	3500/QÐ-BNN-KHCN
January 14, 2015	Cultivation	Ministry of Agriculture and Rural Development	170/QÐ-BTNMT

Philippines
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
July 19, 2013	Food and Feed	Department of Agriculture	PHI Bt11 FF
April 23, 2015	Cultivation	Department of Agriculture	PHI Bt11

Uruguay
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
May 05, 2004	Food and Feed	National Biosafty Cabinet	UY Resolución de 5 de Mayo de 2004

Colombia
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
February 11, 2008	Feed	Instituto Colombiano Agropecuario	COL Resolucion 309
May 28, 2008	Cultivation	Instituto Colombiano Agropecuario	COL Resolucion 1679

Argentina
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
July 27, 2001	Cultiv and Food and Feed	Ministry of Agriculture, Livestock and Fisheries (MAGyP)	AR392