Australia New Zealand Food Standards Code – Standard 1.5.2 – Genetically modified food

The central definition is “genetically modified food”, which is defined in section 1.1.2-16 of the Code (cross-referenced in note 1 to section 1.5.2-2). A food is genetically modified if it is an organism that contains novel DNA; food derived from such an organism; cells that contain novel DNA; or food derived from such cells. However, the definition expressly excludes certain substances: a substance used as a food additive; a substance used as a processing aid; a substance used to support the growth or processing of cells during cell culture; food derived from part of a grafted plant where that part does not contain novel DNA or novel protein; and food derived from a null segregant. A null segregant is an organism, cell or cells descended from an organism that once contained novel DNA but no longer contains it. This exclusion matters because it means that if you cross a GM plant with a non-GM plant and recover a non-GM offspring, that offspring is not a genetically modified food under the Code, even though its lineage involved a GM parent.

“Novel DNA” is defined in section 1.1.2-17. It means DNA that a person has inserted into the genome of an organism, cell or cells and that meets one of three descriptions: (i) DNA from a species that is not a crossable species; (ii) DNA from a crossable species that contains a coding region that was rearranged or recombined prior to insertion; or (iii) DNA that is not from an existing species. “Crossable species” means a species that can be crossed or hybridised with the recipient species. Importantly, flanking left and right border sequences arising from Agrobacterium-mediated transformation are excluded from the definition of novel DNA. That means the DNA sequences used in Agrobacterium-based transformation to insert the gene construct (the T-DNA borders) are not considered novel DNA, even though they are inserted into the genome. This is a technical carve-out reflecting that those sequences are ubiquitous in nature and not the source of the novel trait.

“Novel protein” is defined as a protein encoded by novel DNA (see note 3). This matters for the labelling trigger: a GM food must be labelled if it contains novel DNA or novel protein, unless it is exempt under section 1.5.2-4(2). So a GM food that has been bred to eliminate the novel DNA (such as a null segregant) would not need labelling under this provision, but would also not be a genetically modified food at all, so the question of labelling does not arise.

Schedule 26 provides definitions of “line” and “transformation event”. A transformation event is a specific insertion of DNA into the genome of an organism, identified by a unique code (e.g. MON810). A line refers to a particular variety that contains that transformation event. The schedule lists approved GM foods by line or transformation event, and may impose conditions such as labelling requirements beyond the default, or restrictions on use. The standard has been amended by Amendment 243 (commenced 2 September 2025) which replaced earlier text and notes, including changing the standard’s title from “Food produced using gene technology” to “Genetically modified food”. The definitions sections were also replaced to incorporate the current notes and cross-references.

Standard 1.5.2 directly affects any person or business that sells, supplies, or imports food for retail sale in Australia or New Zealand. This includes food manufacturers who use ingredients that may be genetically modified, such as oils, starches, flours, proteins, and additives derived from GM crops like soy, maize, canola, cottonseed, and sugar beet. It also affects primary producers who process or sell GM crops directly into the food supply, though the standard does not regulate who may grow GM crops - that is a matter for state and federal gene technology regulators. Importers of processed foods containing GM ingredients must ensure the GM events are listed in Schedule 26. If an ingredient is derived from a GM organism but does not contain novel DNA or protein (e.g. refined oils where DNA and protein have been removed), it may still be a genetically modified food under the definition, because the definition includes food derived from an organism that contains novel DNA. However, if the food does not contain novel DNA or novel protein, it would not need labelling unless listed in section S26-3. The compliance burden falls on supply chain managers to verify the GM status of raw materials, maintain documentation, and ensure labelling where required.

Retailers and food service operators are affected but have a lighter burden because of the exemption for foods intended for immediate consumption and prepared and sold from food premises. That exemption covers all foods sold in restaurants, cafes, takeaway shops, caterers, self-catering institutions, and vending machines, regardless of whether the food contains GM ingredients. The exemption is broad and absolute - no labelling is required for such foods. However, if a packaged GM food is sold through a retail shop that is not a food premise as defined (e.g. a supermarket), the exemption does not apply and the food must be labelled. For wholesalers, distributors, and ingredient suppliers, the responsibility is to pass on accurate information to enable downstream compliance with labelling. New Zealand entities are also affected, as the standard is incorporated under the Food Act 2014 (NZ). Any entity that contravenes the standard may face enforcement action under Australian state and territory food legislation or under New Zealand’s Food Act, depending on where the sale occurs. Consumers are indirectly affected through the availability and labelling of GM foods. The standard does not provide individual rights to sue, but enforcement is public regulatory.

The primary duty is imposed by section 1.5.2-3: a food for sale may only contain or consist of a genetically modified food if that food is listed in Schedule 26 and complies with any conditions in that schedule. This is a negative permission: all GM foods are prohibited unless expressly approved. The duty falls on anyone who sells food, which includes manufacturers, importers, wholesalers, retailers, and food service providers. There is also a positive duty under section 1.5.2-4 to label certain GM foods. The labelling duty is triggered when a food for sale contains or consists of a GM food that is listed in Schedule 26 and where that GM food: (i) contains novel DNA or novel protein; or (ii) is listed in section S26-3 as subject to the labelling condition. The labelling statement is “genetically modified” used in conjunction with the name of the GM food. If the GM food is an ingredient, the statement may appear outside the statement of ingredients, for example as “contains genetically modified corn meal”. This flexibility is permitted (see example in the standard).

There are two exemptions from the labelling duty under section 1.5.2-4(2). The first exemption is for GM food that is unintentionally present in a food for sale at no more than 10 grams per kilogram of each ingredient. This is a threshold per ingredient, not per total food. So a product with multiple ingredients could theoretically contain up to 10g/kg of each ingredient of GM material without triggering labelling, so long as the presence was unintentional. The burden of proving unintentional presence lies with the seller; if the seller deliberately added a GM ingredient, the exemption does not apply. The second exemption is for food intended for immediate consumption and prepared and sold from food premises including restaurants, takeaway outlets, caterers, self-catering institutions, and vending vehicles. This exemption is unconditional - no threshold, no requirement of unintentional presence. It covers all food sold through those channels, regardless of GM content. However, if a food is sold through a vending machine, it is covered by the exemption only if the vending vehicle is a food premise, which likely means a food van. Packaged foods sold through vending machines in fixed locations might not qualify.

The standard also confers a right, in a sense, for a person to sell a GM food that is listed in Schedule 26 and complies with conditions. Without that permission, no right to sell exists. There is no right to sell a GM food that is not listed, no matter how low the risk.

Standard 1.5.2 does not itself set out penalties. It is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). Enforcement occurs under Part 4 of that Act and under corresponding state and territory food legislation in Australia, and under New Zealand’s Food Act 2014. In Australia, maximum penalties vary by jurisdiction but can include fines of up to several hundred thousand dollars for individuals and millions for corporations, or imprisonment for serious offences. Selling a food that does not comply with the Code (including selling an unapproved GM food) is an offence under section 48 of the FSANZ Act, and under state equivalents. Typically the penalty for an individual is up to 1,000 penalty units (currently $313,000) and for a corporation up to 5,000 penalty units ($1.565 million), with higher penalties for aggravated offences. Contravening a labelling requirement is also an offence, usually subject to lower penalties. In New Zealand, penalties are set under the Food Act 2014, which provides for fines up to NZ$500,000 for an individual and NZ$5 million for a body corporate, or up to two years imprisonment.

Enforcement is carried out by state and territory food authorities (e.g. NSW Food Authority, SA Health, Queensland Health) and by the New Zealand Ministry for Primary Industries. Powers include inspection, sampling, seizure, recall orders, and prosecution. For serious breaches, regulators may issue infringement notices (on-the-spot fines) or launch criminal proceedings. The standard does not provide a private right of action; consumers cannot directly sue for breach of the Code, though they may have rights under Australian Consumer Law for misleading conduct if a product is falsely labelled as non-GM.

Compliance with Standard 1.5.2 is mandatory and there is no system of waivers or individual exemptions for businesses. The only way to obtain permission to sell a new GM food is to apply to FSANZ for a variation to Schedule 26. That process is separate and involves safety assessment and public consultation. Penalties for non-compliance are real; regulators periodically test products for unapproved GM events, particularly in imported commodities like rice and soy.

Standard 1.5.2 sits within the broader Australia New Zealand Food Standards Code. It is supplemented by other standards that apply generally, particularly Standard 1.2.1 (labelling provisions) and Standard 1.2.4 (ingredient labelling). Section 1.5.2-4 note references these standards; labelling of GM food must comply with the general labelling provisions as well as the specific GM labelling requirements. Standard 1.2.1 sets out general labelling requirements for packaged and unpackaged food. Standard 1.2.4 specifies how ingredients must be declared, including compound ingredients. The GM labelling requirement is additional; if both apply, both must be satisfied.

Outside the Code, the Gene Technology Act 2000 (Cth) and corresponding state acts regulate the release of genetically modified organisms into the environment. A food manufacturer does not need a gene technology licence to sell a GM food ingredient, but the grower or producer of the GM crop must be licensed. The Food Standards Code approval (listing in Schedule 26) is independent of gene technology regulatory approval; in practice FSANZ would not list a GM food that had not been assessed for safety, which often requires gene technology regulator approval for earlier stages. The Australian Pesticides and Veterinary Medicines Authority (APVMA) regulates GM crops that produce pesticides (e.g. Bt corn) for agvet chemical purposes, but that does not affect food standards compliance directly.

Import laws also interact. The Biosecurity Act 2015 (Cth) may require import permits for GM commodities. An imported food that contains unapproved GM events may be refused entry by the Department of Agriculture, Fisheries and Forestry, even if it is not prohibited under the Food Standards Code. Conversely, even if an imported food is permitted under biosecurity law, it must still comply with Standard 1.5.2. For New Zealand, the Food Act 2014 adopts the Code, and New Zealand’s Hazardous Substances and New Organisms Act 1996 regulates the introduction of GM organisms.

State fair trading or consumer protection laws (e.g. Australian Consumer Law) may also apply if a product makes claims about being non-GM or GM free; those claims must be truthful. There is no mandatory labelling requirement for non-GM foods under Standard 1.5.2. Voluntary labels such as “non-GM” are regulated by the ACCC and state fair trading, and must not be misleading. The standard also intersects with organic certification schemes, which typically prohibit GM ingredients. The standard is part of a treaty between Australia and New Zealand (the Food Standards Treaty), ensuring alignment.

Standard 1.5.2 as currently compiled is compilation No. 3, in force as at 2 September 2025 (up to Amendment No. 243). The original standard was published in Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (registered as F2015L00404 on 31 March 2015). It commenced on 1 March 2016. Since then there have been three substantive amendments.

Amendment 157 (registered 1 September 2015, gazette FSC99) corrected a numbering error in the note to section 1.5.2-2. The earlier version had misnumbered the note references; this amendment renumbered them for clarity.

Amendment 161 (registered 18 February 2016, gazette FSC103, commenced 1 March 2016) corrected a typographical error in Note 3 of the standard heading. This was a minor editorial change.

Amendment 177 (registered 21 February 2018, gazette FSC118, commenced 22 February 2018) amended section 1.5.2-4. It omitted the words “subsections S26-3(2) and (3)” from subparagraph 1.5.2-4(1)(a)(ii) and substituted “section S26-3”. This reflected a change in Schedule 26’s structure, consolidating multiple labelling condition provisions into a single section.

Amendment 243 (registered 26 August 2025, gazette FSC183, commenced 2 September 2025) was a major revision. It replaced the standard title from “Food produced using gene technology” to “Genetically modified food”, and replaced the note 3 text. It also replaced section 1.5.2-1 (name) to reflect the new title. The notes to section 1.5.2-2 were replaced with new notes 1 to 4. Section 1.5.2-3 (permission for sale) was replaced with new text. Section 1.5.2-4 (labelling requirement) was replaced. The amendment appears to have been driven by a policy decision to update terminology, make the standard consistent with modern usage, and streamline cross-references. The effect was to clarify that the concept of “gene technology” was not limited to one technique, and to ensure the labelling triggers aligned with Schedule 26 as restructured. The compilation notes indicate that later uncommenced amendments may exist but are not shown in this version.

The provided legislation text contains no references to any court cases. Standard 1.5.2 has been the subject of little reported litigation. There have been no high-profile challenges to the validity of the standard or to specific decisions by FSANZ to list or not list a GM food. This is unsurprising because the standard creates a permission regime; businesses that want to sell a new GM food typically apply to FSANZ for a variation, and if denied, they may seek merits review in the Administrative Appeals Tribunal under the FSANZ Act. However, such reviews are rare. There have been occasional food prosecution matters where state regulators charged companies with selling unapproved GM foods (particularly in relation to GM rice and linseed), but these prosecutions are typically resolved by way of guilty pleas or contested hearings in lower courts and are not widely reported in appellate judgments. The absence of litigation history may also reflect the fact that the standard is relatively prescriptive and its requirements are clear, reducing scope for interpretive disputes. Additionally, FSANZ substantially consults with stakeholders before adding foods to Schedule 26, so most commercial interests are accommodated. There is, however, potential for future litigation concerning the boundaries of the definition of “genetically modified food”, particularly with newer techniques such as gene editing (e.g. CRISPR) that do not necessarily involve insertion of novel DNA as defined. The definition of novel DNA focuses on insertion into the genome, but many gene edits involve deletions or substitutions without insertion. Those foods might not meet the definition of genetically modified food, meaning they would not be prohibited by Standard 1.5.2 at all. That could lead to disputes if regulators argue that the definition should be applied expansively. As of this compilation date no cases are cited.

Several features of Standard 1.5.2 create traps for the unwary. First, the exemption for unintentional presence of GM food at no more than 10 grams per kilogram of each ingredient is per ingredient, not per total product. A product with ten ingredients could theoretically contain up to 10g of GM material per kg of each ingredient, meaning total GM content in the product could approach 10g per kg overall if most ingredients contain it. But the exemption applies only if the presence is unintentional. If a manufacturer knowingly uses a GM ingredient but argues it is unintentional, that argument will fail. The burden of proof for unintentionality is on the person selling the food. Without adequate supply chain records, a regulator could allege the presence was intentional or could not be shown to be unintentional.

Second, the exemption for food prepared and sold from food premises is broad but not universal. The definition of “food premises” includes restaurants, takeaway outlets, caterers, self-catering institutions and vending vehicles. It does not include retail shops that sell packaged food for preparation at home, such as supermarkets. If a packaged GM food is sold in a supermarket, even if it is intended for immediate consumption (like a sandwich), the exemption likely does not apply because the sale is not from a food premise as defined. However, if the same sandwich is sold from a food outlet in the supermarket, it might be exempt. The distinction depends on whether the premises fall within the listed categories. “Vending vehicles” means mobile food vans, not fixed vending machines. A fixed vending machine in a kiosk is unlikely to be a vending vehicle, but may be covered if the machine is part of a food premise.

Third, Grafted plants: food derived from part of a grafted plant where that part does not contain novel DNA or novel protein is excluded from the definition of GM food. This means that if a scion from a GM plant is grafted onto a non-GM rootstock, the fruit from that scion would still be a GM food because the scion contains novel DNA. But if a non-GM scion is grafted onto a GM rootstock, and the fruit does not contain novel DNA or protein (e.g., because the novel DNA is not expressed in the fruit), the fruit may not be a GM food. This requires careful analysis.

Fourth, the definition of novel DNA excludes flanking left and right border sequences from Agrobacterium-mediated transformation. So a transgenic event may contain those border sequences without them counting as novel DNA. That means a food derived from a GM organism might have those sequences present but not trigger the definition if no other novel DNA is present. However, the definition of GM food requires the organism or derived food to contain novel DNA; if only the border sequences are present, the food may not be a GM food. That is a technical loophole that regulators have likely closed through the interpretation that the inserted gene construct contains novel DNA beyond the borders.

Fifth, the labelling requirement applies only if the GM food contains novel DNA or novel protein OR is listed in S26-3 as subject to labelling. Some GM foods may be listed in Schedule 26 without being subject to the labelling condition (e.g., highly refined oils where DNA is not detectable). In such cases, labelling is not required. But if a food is listed in S26-3 as requiring labelling, then even if the food does not contain novel DNA or protein (e.g., because processing removed them), it must still be labelled. So the default rule is label if novel DNA/protein present; the rule can be overridden by a specific condition in Schedule 26 that either imposes or removes the requirement.

Sixth, the “genetically modified” statement must be used in conjunction with the name of the GM food. “In conjunction with” means the statement must be directly associated with the name, not buried in a footnote. The example shows “corn meal (genetically modified)” or “contains genetically modified corn meal”. Labelling elsewhere on the package is allowed only if the GM food is an ingredient; if the GM food is the whole food (e.g., GM soybeans sold as a food), the statement must appear as part of the name or immediately adjacent.

Seventh, the standard applies to food for sale. If you produce a food that contains GM ingredients but only for personal consumption, the standard does not apply. But once offered for sale, compliance is required.

Eighth, the 10g/kg threshold is per kilogram of each ingredient, not per kilogram of the total food. If an ingredient is used at a low inclusion rate, say 1% of the total food, the threshold is 10g per kg of that ingredient, not 10g per kg of the final food. So the GM content in the ingredient could be up to 1% of the ingredient weight and still be within the threshold if ingredients are weighed separately. But the measure is “10 g in a kilogram of each ingredient”. That means if the ingredient itself is GM, it cannot be unintentional; the exemption only applies to unintentional presence in the ingredient, not to the ingredient itself. Confusing.

Compliance with Standard 1.5.2 requires a systematic approach to supply chain management. The first step is to determine whether any of your ingredients or food products fall within the definition of a genetically modified food under section 1.1.2-16. This requires knowledge of whether the raw material was derived from an organism that contains novel DNA. For commodity crops such as soy, maize, canola, cottonseed, and sugar beet, GM varieties are widely grown. You must decide whether you source GM or non-GM. Many large food manufacturers segregate supply chains to avoid GM content altogether, making compliance simpler.

If you intend to use GM ingredients, you must check Schedule 26 to confirm that the specific transformation event (line) is listed and that any conditions are met. The current Schedule 26 includes many events for maize, soy, canola, cotton, potato, alfalfa, sugar beet, and others. For each, there may be conditions such as “the food must be labelled in accordance with section 1.5.2-4” or “the food must be used only as a processing aid”. Not all listed items require labelling; some may be approved without a labelling requirement because the GM modification does not result in novel DNA or protein in the final food (e.g., highly refined oil). Review the entry carefully.

If the ingredient is an approved GM food that contains novel DNA or novel protein, you must label it unless one of the two exemptions applies. The unintentional presence exemption requires documentation showing that the GM presence was not intended and that you have taken reasonable steps to source non-GM or to minimise contamination. Keep supplier declarations, test results, and records of storage segregation. The threshold is 10 grams per kilogram of each ingredient. That is a low threshold - 1% by weight of the ingredient. If you purchase a commodity that may contain traces of GM material, you need either a certificate of analysis showing no GM content above that level, or a contract that guarantees non-GM supply. For food service operators, the exemption for immediate consumption foods prepared and sold from food premises is absolute, so no action is needed regarding labelling. However, you must still ensure that any GM ingredient you use is approved in Schedule 26. You cannot simply rely on the labelling exemption to avoid the permission requirement.

For importers, check that your foreign supplier can identify the GM events present and that those events are listed in Schedule 26. If the event is not listed, the food cannot be sold in Australia or New Zealand. In some cases, the event may be approved in the country of origin but not in Australia. You may need to apply to FSANZ for a variation to add the event, which is a lengthy and costly process. For packaged foods, ensure labels comply with Standard 1.5.2-4 and Standard 1.2.1. The “genetically modified” statement must be prominent and in conjunction with the food name. If the GM food is an ingredient, you may place the statement elsewhere, but common practice is to include it in the ingredient list or as a separate “Contains genetically modified [name]” declaration. Maintain records of all compliance decisions, including test results, supplier declarations, and internal assessments. Under the Food Standards Code, the burden of proving compliance rests with the seller. If a regulator tests a product and finds an unapproved GM event, you will need to show you took all reasonable steps to avoid it. Keep a compliance manual detailing your GM policy, segregated supply chain, and testing regimen. For New Zealand businesses, the same requirements apply. Engage with FSANZ and the New Zealand Ministry for Primary Industries for guidance. Periodically check the Federal Register of Legislation for updates to Standard 1.5.2 and Schedule 26, as new approvals occur. Compliance is not optional; the penalties for non compliance can severely affect business reputation and finances.