Brazil | BCH-DEC-BR-299610 | Country's Decision or any other Communication

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Country's Decision or any other Communication (DEC)

BCH-DEC-BR-299610-1 | PDF | Print |

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last updated: 25 Jun 2026

Amendment

Is this an amendment to a decision or communication already published on the BCH?

General Information

Country

Brazil

Competent National Authority(ies) responsible for the decision or communication

- Competent National Authority: | BCH-CNA-BR-45556-3

Competent National Authority:

National Technical Biosafety Commission ()

Setor Policial Sul -SPO Área 5 Quadra 3 Bloco B - Térreo Salas 10 à 14
Brasília, DF
CEP - 70610-200, Brazil
Phone: (5561) 3411-5516,

Fax: (5561) 3317-7475,

Email: ctnbio@mct.gov.br,

Website: http://www.ctnbio.gov.br,

BCH-CNA-BR-45556-3

Title / Reference number of the decision or communication

Commercial release of cotton event MON 15985 x MON 88913 - Technical Opinion No. 3365/2012.

Date of the decision

16 Aug 2012

Is the decision taken prior to entry into force of the Protocol?

Subject of the decision, notification, communication or declaration

Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)

LMOs for intentional introduction into the environment

Was the decision triggered by a request for a transboundary movement of LMOs into your country?

Does the decision apply to transboundary movements of LMO(s) into the country?

Yes

Applicant’s contact details

- Organization: Monsanto do Brasil Ltda () | BCH-CON-BR-244799-1

Organization:

Monsanto do Brasil Ltda ()

Private sector (business and industry)

Geraldo Ubirajara Berger Avenida das Nações Unidas, 12901 - Torre Norte - 7º andar
Sao Paulo, SP
04578-000, Brazil
Phone: +55(11) 3383-8356,

Fax: +55(11) 3383-8102 ; +55 (61) 3245-2523,

Email: geraldo.u.berger@monsanto.com,

Website:

Does the decision involve field trials?

Yes

Does the decision involve commercial release?

Yes

Will the decision apply to subsequent introductions of the same LMO(s) into the environment?

Yes

LMOs for direct use as food or feed, or for processing (LMOs-FFP)

Use(s) of LMO

LMOs for direct use as food
LMOs for direct use as feed
LMOs for processing

Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?

Result of the decision

Approval of the import and/or use of the LMO(s) without conditions

Information sharing with other databases

Is this decision related to an LMO for commercial use?

Yes

Should this decision be forwarded to the OECD Secretariat for possible inclusion in the BioTrack Product Database?

Yes

Is this decision related to food safety?

Yes

Was it conducted in accordance with the Codex Alimentarius Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants?

Yes

Should this information be forwarded to the Secretariat of the FAO GM Foods Platform?

Yes

LMO identification & risk assessment

LMO identification

BCH-LMO-SCBD-15215-11 Living Modified Organism MON-88913-8 × MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton

Monsanto | Resistance to antibiotics (Kanamycin, Streptomycin), Resistance to diseases and pests (Insects, Lepidoptera (butterflies and moths)), Resistance to herbicides (Glyphosate)

Risk assessment

BCH-RA-BR-299518-1 Risk Assessment generated by a regulatory process Risk assessment of cotton event MON 15985 x MON 88913 - Technical Opinion No. 3365/2012.

MON-88913-8 × MON-15985-7 - Roundup Ready™ Flex™ Bollgard II™ cotton | Cotton, Resistance to diseases and pests, Resistance to herbicides, Resistance to antibiotics

Document on the decision, communication, notification or declaration

Commercial release 3365-2012.pdf [ Portuguese ]

BCH-DEC-BR-299610-1 Report

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