Additional Q&A - Steve Corin MPI
Q: Given that some gene editing techniques produce changes that are indistinguishable from
naturally occurring processes, how are these labelling requirement enforced?
Food produced with gene technology must be approved by FSANZ and is subject to labelling
Gene editing is one of the new breeding techniques that FSANZ is reviewing. The focus is on what
should be captured under GM food definitions in the Food Standards Code and hence the need for
pre-market approval and safety assessment by FSANZ. As noted in the excerpt below - gene
technology currently means recombinant DNA techniques that alter the heritable genetic
material. Gene editing that does not involve recombinant DNA techniques falls outside Standard
However, such foods could fall within the wider definition of novel food and if so would require an
assessment if there was a safety issue identified (as with any new or novel food). Also if there was
no novel DNA or protein they would be exempt from GM labelling as they as indistinguishable from
their non-GM versions.
Further information on new breeding techniques and GM foods can be found on the FSANZ site
including Q&As https://www.foodstandards.gov.au/consumer/gmfood/Pages/Review-of-new-breeding-
Q: Moreover, if a producer claims their product contains no GMOs (but it actually does), and they
do not apply for an approval, are there any mechanisms somewhere in the system to pick this
GM foods will need approval regardless of whether the product contains any novel DNA or protein
e.g. GM soybeans need approval even though the refined soy oil from such beans does not need to
be labelled. https://www.foodstandards.gov.au/code/Pages/default.aspx
In this Code (see section 1.1.2—2):
food produced using gene technology
means a food which has been derived or developed from
an organism which has been modified by gene technology.
This definition does not include food derived from an animal or other organism
which has been fed food produced using gene technology, unless the animal or other
organism is itself a product of gene technology.
means recombinant DNA techniques that alter the heritable genetic material of
living cells or organisms.
Definitions for genetically modified food, novel DNA and novel protein are in section 1.5.2—4.
Definitions for conventional breeding, line and transformation event are in Schedule 26.
1.5.2—4 Requirement to label food as ‘genetically modified’
(1) This section applies to a food for sale that consists of, or has as an ingredient, food
that is a genetically modified food, unless:
(a) the genetically modified food:
(i) has been highly refined where the effect of the refining process is to
remove novel DNA or novel protein; and
(ii) is not listed in section S26—3 as subject to the condition that its
labelling must comply with this section; or
(b) both of the following are satisfied:
(i) the genetically modified food is a substance *used as a processing aid
or *used as a food additive in the food in accordance with this Code;
(ii) no novel DNA or novel protein from the substance remains present in
the food; or
(c) the genetically modified food is a *flavouring substance that is present in the
food in a concentration of no more than 1 g of flavouring/kg of food; or
(d) the genetically modified food is:
(i) unintentionally present in the food; and
(ii) present in an amount of no more than 10 g in a kilogram of each
(e) the food is:
(i) intended for immediate consumption; and
(ii) prepared and sold from food premises and vending vehicles, including
restaurants, take away outlets, caterers, or self-catering institutions.
(5) In this section:
and novel protein
mean DNA or protein which, as a result of the use
of gene technology, is different in chemical sequence or structure from DNA or
protein present in counterpart food that has not been produced using gene
technology, other than protein that:
(a) is *used as a processing aid or *used as a food additive; and
(b) has an amino acid sequence that is found in nature.
genetically modified food
means a *food produced using gene technology that
(a) contains novel DNA or novel protein; or
(b) is listed in Section S26—3 as subject to the condition that its labelling must
comply with this section.