№ files_lp_4_process_3_106617
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Regulatory source detailing FSANZ’s assessment and approval of a genetically modified 2′-fucosyllactose ingredient for use in infant formula, including specifications, safety evaluation, submissions received, and associated compliance conditions.
Year:
2022
Region / Jurisdiction:
Australia and New Zealand
Subject:
Food standards and safety assessment
Document type:
Regulatory approval report
Organization:
Food Standards Australia New Zealand (FSANZ)
Applicant:
Friesland Campina Ingredients
Target audience:
Food industry, regulatory authorities, infant formula manufacturers
Date of submission:
6 December 2021
Date of approval:
6 May 2022
Product:
2′-Fucosyllactose (2′-FL) from GM E. coli K-12
Maximum permitted concentration:
2.4 g/L
Review period:
Five-year review to be completed by March 2026
Exclusivity period:
15 months under brand name Aequival® 2′-FL
Specifications:
Harmonized with EU standards for 2′-FL
Safety assessment:
No safety concerns identified for production organism or 2′-FL product
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2024
Region / City:
Africa
Topic:
Vector Control, Malaria, Genetically Modified Organisms
Document Type:
Consultancy Announcement
Organization:
African Union Development Agency-NEPAD (AUDA-NEPAD)
Author:
Not specified
Target Audience:
Individual Consultants
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2025
Region / city:
Scotland
Subject:
Food safety, food additives, feed additives, novel foods, genetically modified organisms
Document type:
Consultation
Organization:
Food Standards Scotland
Author:
Food Standards Scotland
Target audience:
Scottish food and feed businesses, local and district councils, and other stakeholders with an interest in food and feed safety
Period of validity:
From 8th January 2025 to 5th March 2025
Approval date:
8th January 2025
Date of amendments:
N/A
Tracking No:
2023-229-BWCA-002-F
Date:
January 26, 2024
Applicant:
Bayer West-Central Africa S.A.
Organism:
Maize (Zea mays)
Trait:
Resistance to Coleoptera, Tolerance to Glyphosate
Genes:
cp4 epsps, cry3Bb1, DvSnf7
Food and Feed Safety:
Compositional considerations for Maize
Approval History:
Argentina, Australia-New Zealand, Brazil, Canada, Colombia, European Union, Japan, Mexico, Paraguay, Philippines, Republic of Korea, USA, Vietnam
Date of First Approval:
August 06, 2015 (Australia-New Zealand)
Assessment Summary:
Safety and nutritional assessments confirm the event is as safe as its conventional counterpart.
Recommended Terms and Conditions:
Limited to food, feed, and processing use; not for cultivation; compliance with biosafety regulations required.
Note:
Year
Topic:
Cell Biology, Microscopy, Biomedical Sciences
Document type:
Research Project Proposal
Organization / institution:
Biomedical Sciences
Author:
Prof. Stephen Royle
Target audience:
PhD students, researchers in cell biology and microscopy
Year:
2024
Region / City:
Ghana
Theme:
Genetically Modified Organisms, Food Safety
Document Type:
Risk Assessment Report
Organization:
Technical Advisory Committee (TAC)
Author:
Not specified
Target Audience:
National Biosafety Authority, Regulatory Authorities
Period of Validity:
3 years
Approval Date:
January 26, 2024
Date of Amendments:
None
Organization:
APHIS Biotechnology Regulatory Services
Regulatory Framework:
7 CFR Part 340
Issuing Body:
Animal and Plant Health Inspection Service (APHIS), United States Department of Agriculture
Subject:
Site selection planning for environmental releases of regulated genetically engineered organisms
Document Type:
Guidance module with example template
Series:
Biotechnology Quality Management Support Modules
Scope:
Environmental releases of regulated genetically engineered organisms
Intended Users:
Organizations conducting activities subject to APHIS regulations
Referenced Resource:
APHIS BRS website
Sections:
Purpose; Definitions; Responsibilities; Site Selection Planning Procedure; References
Compliance Note:
Use does not guarantee compliance with 7 CFR Part 340 or other statutes and regulations
Year:
2026
Region / City:
Southampton, U.K.; Newcastle upon Tyne, U.K.; Cambridge, U.K.
Subject:
Biochemistry, Cancer Research
Document Type:
Research Article
Organization / Institution:
University of Southampton, Newcastle University, AstraZeneca
Author:
Eliot L. Osher, Francisco Castillo, Nagarajan Elumalai, Michael J. Waring, Garry Pairaudeau, Ali Tavassoli
Target Audience:
Researchers, Scientists, Medical Professionals
Duration:
Ongoing
Approval Date:
Not specified
Modification Date:
Not specified
Year:
Not specified
Region / city:
Not specified
Theme:
Genetically modified organisms, food production, world hunger
Document type:
Article
Organization / institution:
Not specified
Author:
Chris Cagle
Target audience:
General public
Period of validity:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Note:
Year
Contextual Description:
Debate format document for agricultural students addressing genetically modified crop production.
Note:
Year
Recipient:
Director, Japan Synchrotron Radiation Research Institute
Country:
Germany
Regulatory framework:
Gentechnik-Aufzeichnungsverordnung (GenTAufzV); Gentechnikgesetz (GenTG)
Subject:
Classification of genetically modified organisms by biological risk group
Document type:
Administrative form for GMO classification and shipment documentation
Organizations referenced:
Zentrale Kommission für die Biologische Sicherheit (ZKBS); Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL); Eurofins
Related databases:
ZKBS organism, recipient strain, vector, and oncogene databases
Required information:
Donor organism; recipient organism; vector; recombinant DNA description; GMO description; assigned risk group
Risk group categories:
1; 2; 3; 4
Responsible roles:
Project manager; customer; Eurofins project manager
Intended users:
Customers shipping genetically modified organisms and project managers responsible for GMO work
Purpose:
Documentation of biological origin, genetic modification details, and assigned biosafety risk group for a GMO shipment
Submission method:
Attached to GMO shipment or sent by email
Completion sections:
Customer information; GMO technical description; signatures; Eurofins internal processing records
Year:
2026
Region / Institution:
Tongji University, China
Type of Document:
Laboratory resource table
Organism:
Mouse, Rat
Strains / Modifications:
USP25 knockout, USP25 variants
Materials:
Antibodies, DNA/cDNA clones, Plasmids
Source / Vendor:
Abcam, Santa Cruz Biotechnology, Proteintech, Cell Signaling Technology, MGI, RGD, Taogene, Shanghai Genechem Co., Ltd.
Applications:
Western blot (WB), Immunoprecipitation (IP), PCR primers
Persistent IDs / URLs:
Provided for all reagents and clones
Parent Animals:
Male and female USP25-KO mice
Target Antigens:
MYHC, TGF-β, COL-1, USP25, ANP, Flag, HA, GAPDH, Bcl-2, Bax, Cleave-Caspase-3, P38, p-P38, JNK, p-JNK, ERK, p-ERK, P65, p-P65, AKT, p-AKT, TAK1, p-TAK1, TBK1, P62, LC3B
Primer Sequences:
Provided for multiple mouse and rat genes
Plasmid Details:
USP25 constructs with various mutations or deletions, with URLs to sources
Year:
2024
Region / city:
Ghana
Topic:
Genetically Modified Organisms, Soybean
Document Type:
Risk Assessment Recommendation
Organisation:
Technical Advisory Committee (TAC)
Author:
Technical Advisory Committee (TAC)
Target Audience:
National Biosafety Authority (NBA), Regulatory Authorities
Validity Period:
3 years, renewable
Approval Date:
January 26, 2024
Date of Changes:
N/A
Grade:
9-12
Subject:
Math
Lesson Duration:
3 days
Lesson Summary:
Students examine the relationship between diet, GMOs, and health through the article “This ‘Super Banana’ Was Designed To Save Lives. Will It Matter That It’s Orange?” and create an infographic defending their answer to the question: “Can GMOs be part of a healthy diet?”
Standards:
CCSS.MATH.S-IC.B.6, CCSS.MATH.S-MD.B.7
Focus Pulitzer Center news story:
"This ‘Super Banana’ Was Designed To Save Lives. Will It Matter That It’s Orange?" by Agostino Petroni for National Geographic
Additional Resources:
“GMOs, Farm to Table” video, MyPlate Quiz, FDA resources, and more
Lesson Objective(s) or Essential Question(s):
Should GMOs be banned from our food supply?
Date:
2023
Region:
USA
Institution:
National Geographic
Author:
Agostino Petroni
Target Audience:
High school students
Period of Application:
3 days
Date Approved:
N/A
Date Updated:
N/A