BioTrack Product Database

MON-15985-7
Transformation Event	15985
Trade Name	Bollgard II cotton
Applicant	Monsanto
Organism Common Names	Cotton
Organism Scientific Names	Gossypium
Centre of Origin and Diversity	Biology Consensus Document on Cotton
Food and Feed Safety Issues	Compositional considerations for Cotton
Methods for safe handling
Additional Information
Traits	Resistance to Lepidoptera
Genes	aad, cry1Ac, cry2Ab, neomycin phosphotransferase II (npt II), uidA

Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
Australia
October 24, 2002	Food	Food Standards Australia New Zealand	A436
September 23, 2002	Commercial Release	Office of the Gene Technology Regulator	DIR 012-2002	DIR-012/2002

Canada
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
June 27, 2003	Feed	Canadian Food Inspection Agency - Animal Feed Division	DD2003-45
June 27, 2003	Food	Health Canada - GM Foods and Other Novel Foods	CN food 15985

European Union
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
April 24, 2015	Food and Feed	European Commission	EC-MON15985		Method for detection: http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx

Japan
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
March 27, 2003	Feed	Ministry of Agriculture, Forestry and Fisheries (MAFF)
October 01, 2002	Food	Ministry of Health, Labour and Welfare (MHLW)
December 10, 2004	Importing and Processing	Ministry of Agriculture Forestry and Fisheries and Ministry of the Environment	JP_D_15985	JP_A_15985

Mexico
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
September 15, 2003	Food	Sanitary Services and Regulations Directorate (Secretary of Health)

New Zealand
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 20, 2002	Food	Food Standards Australia New Zealand	A436

United States of America
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 23, 2002	Biopesticide	Environmental Protection Agency (USEPA)	EPA-Cry2Ab2	EPA-Cry2Ab2
July 16, 2002	Food and Feed	Food and Drug Administration (USFDA)	BNF74	BNF74

Republic of Korea
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 10, 2004	Feed	Rural Development Administration (RDA)
September 30, 2003	Food	Food and Drug Administration (KFDA)
December 10, 2004	Processing	Rural Development Administration (RDA)

Brazil
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
May 21, 2009	Commercial Release	The National Technical Biosafety Committee (CTNBio)	BRA_MON15985

South Africa
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 11, 2003	Commercial planting	Department of Agriculture, Forestry and Fisheries (DAFF)
December 11, 2003	Importation exportation	Department of Agriculture, Forestry and Fisheries (DAFF)
December 11, 2003	Food and or 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
January 21, 2020	Feed	Ministry of Agriculture and Rural Development

Philippines
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 05, 2013	Food and Feed	Department of Agriculture	PHI MON15985 FF

Costa Rica
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
December 15, 2009	Seed production for expor	Ministry of Agriculture and Livestock State Phytosanitary Service	BCH44764	BCH43298	Method for detection: http://gmo-crl.jrc.ec.europa.eu/gmomethods/entry?db=gmometh&id=qt-eve-gh-005&rq=ac%3aMON-15985-7

Colombia
Date of approval	Type of use	Authority	Decision	Risk assessment	Methods for detections-Reference materials
February 11, 2008	Feed	Instituto Colombiano Agropecuario	COL Resolución 310