Australia New Zealand Food Standards Code – Standard 1.5.1 – Novel foods

The key concept is novel food, defined in section 1.1.2-8 of the Code (reproduced in the note to s 1.5.1-2). A novel food is a non-traditional food that requires an assessment of public health and safety considerations having regard to six factors: (a) the potential for adverse effects in humans; (b) the composition or structure of the food; (c) the process by which it has been prepared; (d) the source from which it is derived; (e) patterns and levels of consumption; and (f) any other relevant matters. The definition is deliberately broad and discretionary. A food is only a novel food if it is both non-traditional and requires assessment; FSANZ guidelines (not reproduced in the standard) provide illustrative categories such as plants or animals and their components, plant or animal extracts, herbs, dietary macro-components, single chemical entities, microorganisms including probiotics, and foods produced from new sources or by a process not previously applied to food. The note clarifies that these categories are not exhaustive.

The second core concept is non-traditional food, defined in section 1.1.2-8 as: (a) a food that does not have a history of human consumption in Australia or New Zealand; (b) a substance derived from a food, where that substance does not have a history of human consumption in Australia or New Zealand other than as a component of that food; or (c) any other substance, where that substance or its source does not have a history of human consumption as a food in Australia or New Zealand. The definition rests on "history of human consumption", which is not further defined but is presumably a question of fact and degree. Critically, subsection 1.5.1-2(2) (as substituted by Amendment 231) provides that the presence of a food in a food for special medical purposes, a special medical purpose product for infants, or the use of a food as a food for special medical purpose or as a special medical purpose product for infants, does not constitute a history of human consumption for the purposes of the definition. This means that a substance used only in medical foods cannot rely on that use to argue it is traditional and therefore not a novel food. The effect is to treat medical and infant medical uses as irrelevant to establishing a consumption history in the general population, likely raising the bar for products first introduced through those channels.

The standard also introduces the concept of conditions of use attached to each listing in the S25-2 table. These conditions may be specific to a novel food and can change over time; the note explicitly mentions that conditions may apply only during the first 15 months after gazettal. This temporal condition can create market exclusivity for the first applicant, a notable feature that incentivises early compliance but also raises questions about competition and consumer choice.

The standard directly affects any person or business that offers food for retail sale in Australia or New Zealand and that wishes to use an ingredient or product that may be a novel food. This includes food manufacturers, importers, distributors, and retailers. The definition of novel food is broad, so many businesses introducing new ingredients (e.g., a new plant extract, a probiotic strain, a synthetic compound, or a food produced by a novel process such as cell-cultured protein) must determine whether their product is captured. The cost of that determination falls on the business; there is no routine pre-clearance for free. If the product is a novel food, the business cannot sell it at retail until it obtains a listing in the S25-2 table through an application to FSANZ to vary the Code. The application process itself is not detailed in this standard but is known to involve a comprehensive safety assessment, data submission, and public consultation, taking months or years and costing tens to hundreds of thousands of dollars. This disproportionately affects small and medium enterprises that lack the resources to navigate the approval pathway, while larger firms with dedicated regulatory affairs teams are better placed to comply. The standard also affects infant formula manufacturers more severely: for an infant formula product to contain a novel food, the table must expressly permit it (s 1.5.1-3(2)), which is a tighter condition than the general rule for other foods. The transitional arrangement for the infant formula amendments affects businesses already selling such products; they have five years to ensure compliance with either the old or new version of the Code, but after that period only labelling that was done before the end of the transition gets continued protection (subcl 4(3) of the transitional instrument). New Zealand businesses are affected identically, as the standard applies under the Food Act 2014 (NZ) by way of adoption (note 2). Consumers are indirectly affected: the standard restricts the range of foods available at retail, potentially delaying access to innovative products or raising prices due to the cost of approval. It also protects consumers from unknown risks, though the trade-off between safety and innovation is not assessed in the standard itself.

The primary duty imposed by Standard 1.5.1 is a prohibition: a person must not offer for retail sale a food that consists of or has as an ingredient a novel food unless that novel food is listed in the S25-2 table and any conditions of use are complied with (s 1.5.1-3(1)). For infant formula products, the duty is stricter: the novel food must be expressly permitted by the table and all conditions must be complied with (s 1.5.1-3(2)). There is no exception for small quantities, test markets, or research purposes. The duty applies to the offeror, presumably the retailer or the person who places the food into the retail supply chain. The standard does not explicitly impose a duty on upstream suppliers (e.g., ingredient manufacturers) but they are indirectly affected because their customers cannot buy unless the ingredient is permitted. The duty is a strict prohibition: there is no general exemption or transitional period for novel foods other than the specific one for infant formula amendments. The rights created are implicit: a person may apply to FSANZ to vary the Code to add a novel food to the S25-2 table. This right is not stated in this standard but arises from the FSANZ Act and the general amendment process. Once a novel food is listed, the right to sell it is subject to the conditions in the table. Those conditions may include positive obligations such as providing preparation instructions, warning statements, or meeting compositional specifications. The standard also grants a limited right to use the novel food exclusively for the first 15 months under a specific brand, as noted in the commentary. That right is temporary and tied to the brand. For infant formula, the transitional arrangement gives businesses a right to choose between two versions of the Code for five years, and after that, a right to sell product labelled before the end of the transition (subcl 4(3)). The standard does not create a private right of action for competitors or consumers; enforcement is left to state and territory food authorities and the NZ Ministry for Primary Industries.

Standard 1.5.1 does not itself prescribe penalties. Enforcement occurs under the Food Standards Australia New Zealand Act 1991 (Cth) and corresponding state, territory, and New Zealand food legislation. The Code, including this standard, is a legislative instrument; contravening its provisions can lead to criminal or civil penalties under state food acts, typically including fines, prohibition orders, seizure of non-compliant food, and recall orders. For example, in New South Wales the Food Act 2003 creates offences for selling food that does not comply with the Code, with maximum fines in the hundreds of thousands of dollars for corporations. In New Zealand, the Food Act 2014 makes compliance with the Code a requirement, and non-compliance can result in infringement notices, fines up to NZD 200,000 for individuals and NZD 500,000 for bodies corporate, and potentially imprisonment for serious offences. The standard itself is silent on the quantum of penalties, but the practical risk is significant because novel food violations may involve public health concerns, attracting higher penalties. Enforcement agencies have discretion; they may issue warnings or improvement notices for minor breaches, but a sale of a novel food not in the S25-2 table is a strict liability offence in many jurisdictions. The cost of defending an enforcement action, the risk of reputational damage, and the potential for product recall and destruction add to the compliance burden. The standard does not provide any defence for due diligence or reasonable mistake, though state laws may provide limited defences. The enforcement framework thus creates a strong deterrent against non-compliance, which is typical for food safety regulation but also imposes a heavy cost on businesses that inadvertently misclassify a product as non-novel.

Standard 1.5.1 sits within the Australia New Zealand Food Standards Code, a comprehensive set of standards that cover labelling, contaminants, additives, and specific food categories. It directly interacts with Standard 1.1.1 (Preliminary provisions), which contains the general prohibition against selling food that is unsafe or not complying with the Code. Paragraphs 1.1.1-10(5)(b) and (6)(f) are the gateway provisions that this standard overrides for retail sale of novel foods (see note 3). The standard also interacts with Standard 1.5.2 (Food produced using gene technology) - any novel food that is also a genetically modified food must comply with both standards. Similarly, Standard 1.2.4 (Labelling of ingredients) and Standard 1.2.8 (Nutrition information requirements) apply to novel foods once permitted, subject to any specific conditions in the S25-2 table. The infant formula provisions interact with Standard 2.9.1 (Infant formula products). Because the definition of non-traditional food excludes history derived from medical uses (s 1.5.1-2(2)), there is an interaction with Standards 2.9.3 (Formulated supplementary sports foods) and 2.9.4 (Food for special medical purposes): a substance used only in those products cannot rely on that use to claim it is traditional. This may create a regulatory trap: a business that first introduces a new ingredient through the medical foods pathway may later want to sell it in general foods, and will find it is still a novel food under this standard. In New Zealand, the standard is adopted under the Food Act 2014 (NZ), so it has force of law there. There is also potential interaction with international trade obligations; if the approval process discriminates against foreign suppliers or is unduly slow, it could raise issues under the WTO Agreement on Technical Barriers to Trade or the Australia-New Zealand Closer Economic Relations Trade Agreement, though the standard itself does not address this. The standard does not interact with intellectual property law directly, but the 15-month branding condition in the table effectively grants a temporary trademark advantage to the first applicant, which may intersect with competition law.

Standard 1.5.1 was first published on 10 April 2015 in the Food Standards Gazette as part of Amendment 154 (F2015L00403, 31 March 2015). It commenced on 1 March 2016. Since then it has been amended twice. Amendment 168 (F2017L00414, registered 11 April 2017, Gazette FSC110, 13 April 2017) made cross-reference amendments to Note 3 and section 1.5.1-3, updating references to other provisions. Amendment 231 (F2024L01151, registered 13 September 2024, Gazette FSC 171, 13 September 2024) is the most significant. It repealed subsection 1.5.1-2(2) and section 1.5.1-3 and substituted new versions. The effect was to tighten the rules for infant formula products: the old subsection 1.5.1-2(2) likely had a different exclusion for medical purposes; the new one explicitly excludes foods for special medical purposes and special medical purpose products for infants from counting as a history of human consumption. The new section 1.5.1-3 added the requirement that for infant formula products, the novel food must be "expressly permitted by that table" rather than merely listed. Amendment 231 also introduced a transitional arrangement (cl 4 of the instrument) allowing a five-year period from 13 September 2024 to 13 September 2029 during which products could comply with either the old or new Code, and a labelling grace period after that. The compilation notes that this is compilation No. 2 as at 13 September 2024, prepared by FSANZ. There are no uncommenced amendments or provisions ceasing to have effect indicated in the provided text. The amendment history table uses abbreviations: ad (added or inserted), am (amended), rep (repealed), rs (repealed and substituted). The table shows that s 1.5.1-2(2) and s 1.5.1-3 were both repealed and substituted by Amendment 231. No other sections have been amended.

The provided source does not record any litigation history for Standard 1.5.1. The amendment history table does not mention any court decisions, and the compilation notes contain no references to legal challenges. This does not mean no litigation has ever occurred; but based on the source, there is no recorded litigation directly concerning this standard. Given that the standard has been in force since 2016 and has only had two amendments, it is plausible that no major disputes have reached published decisions. However, litigation might arise in the future from several sources: a refusal by FSANZ to list a novel food in the S25-2 table could be challenged by a commercial applicant under administrative law; an enforcement action by a state authority could be defended on the grounds that the food is not novel; or a competitor could argue that a listing was granted improperly. The standard's broad definition of novel food (non-traditional food that "requires an assessment") gives FSANZ considerable discretion, which may be difficult to overturn in court unless the decision was unreasonable or procedurally flawed. The exclusion of medical use from history of consumption could also be litigated if a business argues that its product had a longer history than FSANZ acknowledges. Without any reported cases, the litigation risk remains theoretical, but the standard's structure leaves room for legal contestation. The transitional arrangement for infant formula amendments may also generate disputes about whether a product complies with "the Code as in force without the variations" or "the Code as amended" during the transition period. The lack of litigation history suggests the standard has been relatively settled, but this may change as more novel food applications are made and enforcement actions increase.

Several provisions in Standard 1.5.1 can catch businesses off guard. First, the definition of novel food is not self-executing; a food is a novel food only if it is non-traditional and requires an assessment under the six factors. But the "requires an assessment" test is subjective and FSANZ has the final say. A business that genuinely believes its ingredient is safe and traditional may still find it classified as novel if FSANZ decides an assessment is needed. There is no formal pre-determination process in this standard. Second, the definition of non-traditional food depends on "history of human consumption in Australia or New Zealand". This is a factual question that may be difficult and expensive to prove. The note's categories of novel foods (plants, animals, extracts, herbs, micro-organisms, etc.) are illustrative only; any food that does not have a clear history of consumption could be captured. For example, a probiotic strain that has been used in other countries but not in Australia or New Zealand is likely non-traditional. Third, the exclusion in subsection 1.5.1-2(2) regarding medical foods is a trap: a business that has used an ingredient in a medical food for years cannot rely on that history to claim the ingredient is traditional for general food use. This may complicate expansion from medical foods to mainstream retail. Fourth, the standard applies only to retail sale. Wholesale or manufacturing supply may not be directly caught by this prohibition, but the general Code provisions may apply. Still, a business that sells a novel food ingredient to a manufacturer might not breach this standard if the manufacturer does not offer the final food for retail sale. This is a narrow loophole but risky. Fifth, the conditions of use in the S25-2 table can include a mandatory branding requirement for the first 15 months. A business that obtains listing is locked into selling under that brand, which may affect distribution arrangements. Sixth, the transitional arrangement for infant formula amendments spells trouble: it allows compliance with either the old or new rules for five years, but after that, only product labelled before the end of the transition is safe. Anyone labelling later must comply with the new rules. Seventh, there is no grandfathering for novel foods that were not listed before certain dates; once the Code is amended to add a novel food, all unlisted novel foods remain illegal. Eighth, the note to section 1.5.1-3 warns that conditions may apply only during the first 15 months; after that, the listing may require no conditions or different conditions. Businesses must monitor the S25-2 table constantly. Finally, the standard does not address the situation where a novel food is already an ingredient in a product that was lawfully sold before the standard commenced (2016). Any such product would need to comply with this standard from commencement, so transitional issues may have arisen for products that were already on the market in 2016.

For a business seeking to sell a food that may be a novel food, compliance begins with self-assessment. The business must determine whether the food or ingredient is a "non-traditional food" by gathering evidence on its history of human consumption in Australia and New Zealand. This may involve searches of historical food databases, import records, and scientific literature. If there is a credible history of consumption (e.g., the food has been widely eaten in Australia for decades), it is likely not a novel food. If there is doubt, or if the food is clearly new, the business should treat it as a novel food and follow the approval pathway. That pathway is not detailed in this standard but involves applying to FSANZ for a variation to the Code to add the novel food to the S25-2 table. The application will require a comprehensive safety assessment, including toxicological studies, compositional analysis, proposed conditions of use, and evidence of intended consumption levels. The process is expensive and time-consuming; businesses should budget for regulatory affairs staff or consultants and allow for at least 12-24 months. Once FSANZ approves the application, the novel food will be listed in the table with specific conditions. The business must comply with those conditions: if the conditions require specific labelling (e.g., warning statements, preparation instructions), those must be on the retail packaging. If the conditions specify a class of food (e.g., "bakery products only"), the food must be sold within that class. If the conditions include a 15-month branding restriction, the business must sell under that brand name. For infant formula products, the business must ensure the table expressly permits the novel food for that use; a general listing is insufficient. During the transition period (13 Sept 2024 to 13 Sept 2029 for infant formula amendments), the business may choose to comply with either the old or new version of the Code, but must keep records of which version it is following. Labelling done before the end of the transition period may be used after it, but new labelling after that date must comply with the amended Code. The business should also monitor the amendment history of the standard and the S25-2 table regularly because conditions can change. If a novel food is not listed, the only compliance option is to not sell it at retail. There is no low-volume exemption. The business should document its compliance decisions, including evidence of consumption history or safety assessments, to demonstrate due diligence in case of enforcement action. For New Zealand operations, the same standard applies by adoption under the Food Act 2014, so no separate compliance regime is needed.