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General information
Country submitting the decision or communication
  • United States of America
Competent National Authority(ies) responsible for the decision or communication
U.S. Food and Drug Administration
DHHS/FDA/CFSAN
5100 Paint Branch Parkway
College Park, MD
USA, 20740
Email:biotechfood@fda.gov
Title / Reference number of the decision or communication
Biotechnology Consultation Agency Response Letter BNF No. 000052
Date of the decision
1999-07-02
Is the decision taken prior to entry into force of the Protocol?
Yes
Jurisdiction
  • United States of America
Is this an amendment to a previous decision / communication?
No
Decision or communication details
Subject(s) of the decision
Uses of the LMO(s)
  • LMOs for direct use as food
  • LMOs for direct use as feed
Has the decision been taken in the absence of a domestic regulatory framework and in accordance with Article 11.6?
No
Importer’s or Applicant’s contact details
Result of the decision
  • Approval of the import/use of the LMO(s) without conditions
LMO identification
Canola MPS962 Phytaseed™ (phytase-producing )
Changes in quality and/or metabolite content Phytate degradation Resistance to antibiotics - Kanamycin
Show detection method(s)
Risk assessment
Canola which expresses a phytase gene derived from Aspergillus niger
Canola MPS961 Phytaseed™ (phytase-producing )
Changes in quality and/or metabolite content
Phytate degradation
Resistance to antibiotics - Kanamycin
Canola MPS962 Phytaseed™ (phytase-producing )
Changes in quality and/or metabolite content
Phytate degradation
Resistance to antibiotics - Kanamycin
Canola MPS963 Phytaseed™ (phytase-producing)
Changes in quality and/or metabolite content
Phytate degradation
Resistance to antibiotics - Kanamycin
Canola MPS964 Phytaseed™ (phytase-producing)
Changes in quality and/or metabolite content
Phytate degradation
Resistance to antibiotics - Kanamycin
Canola MPS965 Phytaseed™ (phytase-producing)
Changes in quality and/or metabolite content
Phytate degradation
Resistance to antibiotics - Kanamycin