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Country's Decision or any other Communication
(DEC)
last updated: 26 Nov 2025
No
Approval report – Application A1239 Food derived from EPA and DHA producing and herbicide tolerant canola line LBFLFK
EN
08 Dec 2022
No
- Decision on LMOs for direct use as food or feed, or for processing (Article 11, LMOs-FFP)
- Decision on domestic use of an LMO, including its placing on the market (Article 11.1)
- LMOs for direct use as food
- LMOs for direct use as feed
- LMOs for processing
No
-
Melbourne,Organization:BASF Australia Ltd ()
, AustraliaPhone: 61 3 8855 6600,Fax:Email: reception-au@basf.com,Website:
Approval of the import and/or use of the LMO(s) with conditions
- Oil derived from EPA and DHA producing and herbicide-tolerant canola line LBFLFK must not be used as an ingredient in infant formula products.
- FSANZ has determined that whole seeds from canola line LBFLFK contain novel DNA, novel protein and an altered nutritional profile that is outside the compositional variation found in existing counterpart food. As such, whole canola seeds and food products containing whole canola seeds as an ingredient (e.g. bread products) will require the mandatory statement ‘genetically modified’ on the label of a package of food. Where products are not required to bear a label and are not packaged (e.g. ‘fresh’ bread that is made and consumed on the premises from which it is sold), the mandatory statement will need to accompany the food or be displayed in connection with the display of the food.
Highly refined canola oil is the major product intended for human consumption. Canola oil is unlikely to contain novel DNA or novel protein due to the refining process used to extract the oil from the seed. The product will, however, have a nutritional profile that differs from canola oil derived from conventional (non-GM) canola. Consequently, the approved draft variation lists food derived from canola line LBFLFK in subsection S26—3(2) of Schedule 26 which will require that food to be labelled with the mandatory ‘genetically modified’ statement irrespective of the presence of novel DNA or novel protein.
- FSANZ has determined that whole seeds from canola line LBFLFK contain novel DNA, novel protein and an altered nutritional profile that is outside the compositional variation found in existing counterpart food. As such, whole canola seeds and food products containing whole canola seeds as an ingredient (e.g. bread products) will require the mandatory statement ‘genetically modified’ on the label of a package of food. Where products are not required to bear a label and are not packaged (e.g. ‘fresh’ bread that is made and consumed on the premises from which it is sold), the mandatory statement will need to accompany the food or be displayed in connection with the display of the food.
Highly refined canola oil is the major product intended for human consumption. Canola oil is unlikely to contain novel DNA or novel protein due to the refining process used to extract the oil from the seed. The product will, however, have a nutritional profile that differs from canola oil derived from conventional (non-GM) canola. Consequently, the approved draft variation lists food derived from canola line LBFLFK in subsection S26—3(2) of Schedule 26 which will require that food to be labelled with the mandatory ‘genetically modified’ statement irrespective of the presence of novel DNA or novel protein.
The applicant has not requested permission to use oil from canola line LBFLFK in infant formula products (including infant formula, follow-on formula and infant formula products for special dietary use).
Canola meal is a by-product of seed oil extraction. The extraction process means the nutritional profile of meal from canola line LBFLFK would be comparable to meal from conventional (non-GM) canola (Section 5.2.2 of the SD1). However, novel DNA and novel protein will be present. The effect of the approved draft variation will be that meal and food products containing canola meal from canola line LBFLFK as an ingredient that are intended for human consumption will require the mandatory labelling statement in accordance with the Code. The mandatory ‘genetically modified’ statement will also apply to protein isolate derived from the canola meal.
Section 1.5.2—4 of the Code generally requires a food for sale that consists of a GM food or has a GM food as an ingredient to be labelled as ‘genetically modified’, unless one of the exemptions listed in that subsection apply. If the GM food is present in the food for sale as an ingredient, the ‘genetically modified’ statement must be in conjunction with the name of the GM food (subsection 1.5.2—4(2)) and it may be included in the statement of ingredients for the food for sale (subsection 1.5.2—4(3)).
Canola meal is a by-product of seed oil extraction. The extraction process means the nutritional profile of meal from canola line LBFLFK would be comparable to meal from conventional (non-GM) canola (Section 5.2.2 of the SD1). However, novel DNA and novel protein will be present. The effect of the approved draft variation will be that meal and food products containing canola meal from canola line LBFLFK as an ingredient that are intended for human consumption will require the mandatory labelling statement in accordance with the Code. The mandatory ‘genetically modified’ statement will also apply to protein isolate derived from the canola meal.
Section 1.5.2—4 of the Code generally requires a food for sale that consists of a GM food or has a GM food as an ingredient to be labelled as ‘genetically modified’, unless one of the exemptions listed in that subsection apply. If the GM food is present in the food for sale as an ingredient, the ‘genetically modified’ statement must be in conjunction with the name of the GM food (subsection 1.5.2—4(2)) and it may be included in the statement of ingredients for the food for sale (subsection 1.5.2—4(3)).
Yes
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BCH-LMO-SCBD-115656-1 Living Modified Organism BPS-BFLFK-2 - EPA+DHA canolaBASF Plant Science GmbH | Changes in quality and/or metabolite content (Lipid and fatty acids), Production of medical or pharmaceutical compounds (human or animal) (Omega-3 fatty acids (e.g. DHA)), Resistance to herbicides (Imidazolinone, Sulfonylurea), Selectable marker genes and reporter genes
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BCH-RA-NZ-281126-1 Risk Assessment generated by a regulatory process Safety assessment – Application A1239 Food derived from EPA and DHA producing and herbicide tolerant canola line LBFLFKBPS-BFLFK-2 - EPA+DHA canola | Resistance to herbicides, Changes in quality and/or metabolite content, Production of medical or pharmaceutical compounds (human or animal), Selectable marker genes and reporter genes
- A1239_Decision_NZg_2022-gs5359.pdf [ English ]