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OECD Unique Identifier details

GOR-7324Ø-2
Commodity: Safflower
Traits: High oleic acid
Australia
Name of product applicant: GO Resources Pty Ltd
Summary of application:

GO Resources Pty Ltd submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from either of two lines of genetically modified (GM) super high oleic (SHO) safflower (Carthamus tinctorius) (herein referred to as SHO safflower). The two lines have OECD Unique Identifiers GOR-73226-6 and GOR-73240-2 and will be referred to as SHO26 and SHO40 respectively. The lines have been genetically modified to increase the proportion of oleic acid (18:1) produced in the seed oil from around 75% to around 92%, with concomitant reduction in linoleic acid (18:2) from approximately 15% to 2%, and palmitic acid (16:0) from approximately 6% to 3% (Wood et al. 2013).


The genetic modification uses RNA interference (RNAi) to suppress the expression of two native safflower genes involved in fatty acid synthesis – the palmitoyl-ACP thioesterase (CtFATB) gene and the Δ12 desaturase (CtFAD2-2) gene. Fragments of these genes, derived from safflower, have been introduced and their transcription results in the formation of double-stranded RNA (dsRNA) which is processed by the endogenous cellular machinery of the host into short interfering RNAs (siRNAs). In turn, these siRNAs then direct the degradation of the messenger RNA (mRNA) transcribed from the host endogenous genes, thereby suppressing translation into proteins. The result of suppressing the genes is that the proportion of oleic acid in the safflower seed oil is increased.


SHO26 and SHO40 also contain the hygromycin resistance gene, hph, expressing the enzyme hygromycin B phosphotransferase (HPH) also known as aminoglycoside phosphotransferase (APH4), which confers resistance to the antibiotic hygromycin. The gene is derived from a plasmid from the common bacterium Escherichia coli. It was used as a selectable marker to assist with identification of transformed safflower cells in the early stages of selection. APH4 has been previously assessed by FSANZ in cotton application A509.


The applicant states the main use of SHO safflower will be for production of oil for use in the lubricant, fine chemical, bioplastics, pharmaceutical and cosmeceutical industries but could also be applicable to the food and personal care industries. The technology will be commercialised within a specialised, ‘closed-loop’ identity preserved (CLIP) quality assured management program. The oil will be sold to domestic and export market processors, with the meal being directed to use as a stock feed. There is no intention that SHO safflower grain would enter the export or domestic grain markets.


An application for commercial release of the two safflower lines was submitted to the Office of the Gene Technology Regulator and a licence was issued in June 2018 . It is possible that, in the future, the Applicant may seek regulatory approval for environmental release in the U.S. It is therefore anticipated food products derived from SHO safflower will enter the Australian and New Zealand food supplies mainly through local production with possible future supplementation from imports.

Upload:
Date of authorization: 23/01/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Australia
Name of product applicant: GO Resources Pty Ltd
Summary of application:

GO Resources Pty Ltd submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from either of two lines of genetically modified (GM) super high oleic (SHO) safflower (Carthamus tinctorius) (herein referred to as SHO safflower). The two lines have OECD Unique Identifiers GOR-73226-6 and GOR-73240-2 and will be referred to as SHO26 and SHO40 respectively. The lines have been genetically modified to increase the proportion of oleic acid (18:1) produced in the seed oil from around 75% to around 92%, with concomitant reduction in linoleic acid (18:2) from approximately 15% to 2%, and palmitic acid (16:0) from approximately 6% to 3% (Wood et al. 2013).


The genetic modification uses RNA interference (RNAi) to suppress the expression of two native safflower genes involved in fatty acid synthesis – the palmitoyl-ACP thioesterase (CtFATB) gene and the Δ12 desaturase (CtFAD2-2) gene. Fragments of these genes, derived from safflower, have been introduced and their transcription results in the formation of double-stranded RNA (dsRNA) which is processed by the endogenous cellular machinery of the host into short interfering RNAs (siRNAs). In turn, these siRNAs then direct the degradation of the messenger RNA (mRNA) transcribed from the host endogenous genes, thereby suppressing translation into proteins. The result of suppressing the genes is that the proportion of oleic acid in the safflower seed oil is increased.


SHO26 and SHO40 also contain the hygromycin resistance gene, hph, expressing the enzyme hygromycin B phosphotransferase (HPH) also known as aminoglycoside phosphotransferase (APH4), which confers resistance to the antibiotic hygromycin. The gene is derived from a plasmid from the common bacterium Escherichia coli. It was used as a selectable marker to assist with identification of transformed safflower cells in the early stages of selection. APH4 has been previously assessed by FSANZ in cotton application A509.


The applicant states the main use of SHO safflower will be for production of oil for use in the lubricant, fine chemical, bioplastics, pharmaceutical and cosmeceutical industries but could also be applicable to the food and personal care industries. The technology will be commercialised within a specialised, ‘closed-loop’ identity preserved (CLIP) quality assured management program. The oil will be sold to domestic and export market processors, with the meal being directed to use as a stock feed. There is no intention that SHO safflower grain would enter the export or domestic grain markets.


An application for commercial release of the two safflower lines was submitted to the Office of the Gene Technology Regulator and a licence was issued in June 2018 . It is possible that, in the future, the Applicant may seek regulatory approval for environmental release in the U.S. It is therefore anticipated food products derived from SHO safflower will enter the Australian and New Zealand food supplies mainly through local production with possible future supplementation from imports.

Upload:
Date of authorization: 23/01/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

Australia
Name of product applicant: GO Resources Pty Ltd
Summary of application:

GO Resources Pty Ltd submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from either of two lines of genetically modified (GM) super high oleic (SHO) safflower (Carthamus tinctorius) (herein referred to as SHO safflower). The two lines have OECD Unique Identifiers GOR-73226-6 and GOR-73240-2 and will be referred to as SHO26 and SHO40 respectively. The lines have been genetically modified to increase the proportion of oleic acid (18:1) produced in the seed oil from around 75% to around 92%, with concomitant reduction in linoleic acid (18:2) from approximately 15% to 2%, and palmitic acid (16:0) from approximately 6% to 3% (Wood et al. 2013).


The genetic modification uses RNA interference (RNAi) to suppress the expression of two native safflower genes involved in fatty acid synthesis – the palmitoyl-ACP thioesterase (CtFATB) gene and the Δ12 desaturase (CtFAD2-2) gene. Fragments of these genes, derived from safflower, have been introduced and their transcription results in the formation of double-stranded RNA (dsRNA) which is processed by the endogenous cellular machinery of the host into short interfering RNAs (siRNAs). In turn, these siRNAs then direct the degradation of the messenger RNA (mRNA) transcribed from the host endogenous genes, thereby suppressing translation into proteins. The result of suppressing the genes is that the proportion of oleic acid in the safflower seed oil is increased.


SHO26 and SHO40 also contain the hygromycin resistance gene, hph, expressing the enzyme hygromycin B phosphotransferase (HPH) also known as aminoglycoside phosphotransferase (APH4), which confers resistance to the antibiotic hygromycin. The gene is derived from a plasmid from the common bacterium Escherichia coli. It was used as a selectable marker to assist with identification of transformed safflower cells in the early stages of selection. APH4 has been previously assessed by FSANZ in cotton application A509.


The applicant states the main use of SHO safflower will be for production of oil for use in the lubricant, fine chemical, bioplastics, pharmaceutical and cosmeceutical industries but could also be applicable to the food and personal care industries. The technology will be commercialised within a specialised, ‘closed-loop’ identity preserved (CLIP) quality assured management program. The oil will be sold to domestic and export market processors, with the meal being directed to use as a stock feed. There is no intention that SHO safflower grain would enter the export or domestic grain markets.


An application for commercial release of the two safflower lines was submitted to the Office of the Gene Technology Regulator and a licence was issued in June 2018 . It is possible that, in the future, the Applicant may seek regulatory approval for environmental release in the U.S. It is therefore anticipated food products derived from SHO safflower will enter the Australian and New Zealand food supplies mainly through local production with possible future supplementation from imports.

Upload:
Date of authorization: 23/01/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): OECD BioTrack Product Database
Summary of the safety assessment (food safety):
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Food Standards Australia New Zealand
Contact person name:
Website:
Physical full address:
Level 4, 15 Lancaster Place, Majura Park ACT 2609, Australia
Phone number:
+61 2 6271 2222
Fax number:
+61 2 6271 2278
Country introduction:

Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of food standards in Australia and New Zealand. The main office (approximately 115 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 10 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

No separate approval or safety assessment is necessary for foods derived from a stacked GM line that is the result of traditional breeding between a number of GM parent lines for which food has already been approved. Food from the parent lines must be listed in the Australia New Zealand Food Standards Code. The parent lines may contain any number of different genes. If food from any of the GM parent lines has not been approved, then a full pre-market safety assessment of food from the stacked line must be undertaken.

No separate approval is required for food derived from a line that is the product of a GM line, for which food has been approved, crossed traditionally with a non-GM line.

Where a single line containing a number of genes has been produced as a result of direct gene technology methods (rather than traditional crossing) then food derived from the line must undergo a full pre-market safety assessment before approval can be given

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)

New Zealand
Name of product applicant: GO Resources Pty Ltd
Summary of application:

GO Resources Pty Ltd submitted an application to FSANZ to vary Schedule 26 in the Australia New Zealand Food Standards Code (the Code) to include food from either of two lines of genetically modified (GM) super high oleic (SHO) safflower (Carthamus tinctorius) (herein referred to as SHO safflower). The two lines have OECD Unique Identifiers GOR-73226-6 and GOR-73240-2 and will be referred to as SHO26 and SHO40 respectively. The lines have been genetically modified to increase the proportion of oleic acid (18:1) produced in the seed oil from around 75% to around 92%, with concomitant reduction in linoleic acid (18:2) from approximately 15% to 2%, and palmitic acid (16:0) from approximately 6% to 3% (Wood et al. 2013).


The genetic modification uses RNA interference (RNAi) to suppress the expression of two native safflower genes involved in fatty acid synthesis – the palmitoyl-ACP thioesterase (CtFATB) gene and the Δ12 desaturase (CtFAD2-2) gene. Fragments of these genes, derived from safflower, have been introduced and their transcription results in the formation of double-stranded RNA (dsRNA) which is processed by the endogenous cellular machinery of the host into short interfering RNAs (siRNAs). In turn, these siRNAs then direct the degradation of the messenger RNA (mRNA) transcribed from the host endogenous genes, thereby suppressing translation into proteins. The result of suppressing the genes is that the proportion of oleic acid in the safflower seed oil is increased.


SHO26 and SHO40 also contain the hygromycin resistance gene, hph, expressing the enzyme hygromycin B phosphotransferase (HPH) also known as aminoglycoside phosphotransferase (APH4), which confers resistance to the antibiotic hygromycin. The gene is derived from a plasmid from the common bacterium Escherichia coli. It was used as a selectable marker to assist with identification of transformed safflower cells in the early stages of selection. APH4 has been previously assessed by FSANZ in cotton application A509.


 


The applicant states the main use of SHO safflower will be for production of oil for use in the lubricant, fine chemical, bioplastics, pharmaceutical and cosmeceutical industries but could also be applicable to the food and personal care industries. The technology will be commercialised within a specialised, ‘closed-loop’ identity preserved (CLIP) quality assured management program. The oil will be sold to domestic and export market processors, with the meal being directed to use as a stock feed. There is no intention that SHO safflower grain would enter the export or domestic grain markets.


An application for commercial release of the two safflower lines was submitted to the Office of the Gene Technology Regulator and a licence was issued in June 2018 . It is possible that, in the future, the Applicant may seek regulatory approval for environmental release in the U.S. It is therefore anticipated food products derived from SHO safflower will enter the Australian and New Zealand food supplies mainly through local production with possible future supplementation from imports.

Upload:
Date of authorization: 20/03/2019
Scope of authorization: Food
Links to the information on the same product in other databases maintained by relevant international organizations, as appropriate. (We recommend providing links to only those databases to which your country has officially contributed.): BioTrack Product Database
Summary of the safety assessment (food safety):
No potential public health and safety concerns have been identified in the assessment of SHO26 and SHO40. On the basis of the data provided in the present application, and other available information, food derived from SHO26 or SHO40 is considered to be as safe for human consumption as food derived from conventional safflower varieties.
Upload:
Where detection method protocols and appropriate reference material (non-viable, or in certain circumstances, viable) suitable for low-level situation may be obtained:
Relevant links to documents and information prepared by the competent authority responsible for the safety assessment: A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40
Upload:
Authorization expiration date (a blank field means there is no expiration date)
E-mail:
Organization/agency name (Full name):
Ministry for Primary Industries
Contact person name:
Fiapaipai Auapaau
Website:
Physical full address:
Pastoral House, 25 The Terrace, Wellington, 6012
Phone number:
+6448314946
Fax number:
Country introduction:

New Zealand and Australia share a joint food regulation system for the composition of labelling of most foods. Food Standards Australia New Zealand (FSANZ) is the regulatory agency responsible for the development of the joint food standards in Australia and New Zealand. The main office (approximately 120 staff) is located in Canberra (in the Australian Capital Territory) and the smaller New Zealand office (approximately 15 staff) is located in Wellington on the North Island.

Useful links
Relevant documents
Stacked events:

FSANZ does not: Separately assess food from stacked event lines where food from the GM parents has already been approved; Mandate notification of stacked events by developers; Notify the public of stacked event ‘approvals’; List food derived from stacked event lines in the Code, unless the stacked event line has been separately assessed as a single line e.g. Application A518: MXB-13 cotton (DAS-21023-5 x DAS-24236-5)

Contact details of the competent authority(s) responsible for the safety assessment and the product applicant:

Food Standards Australia New Zealand (FSANZ) (http://www.foodstandards.gov.au)