A1269 Cultured Quail as a Novel Food - second call for submissions

NSW Food Authority supports FSANZ’s proposed approach in the 2nd Call for Submissions (CFS). NSW Food Authority concurs with FSANZ that the proposed regulation of cell-cultured food as a distinct food category would provide more clarity on regulatory requirements for cell-cultured food (as defined), compared to the proposed approach in the 1st CFS.

NSW Food Authority is supportive of the framework offered by the new Standards 1.5.4 and 3.4.1 and Schedule 25A, where cell-cultured food must be assessed and approved on a case-by-case basis, and the production of permitted cell-cultured food in Australia is subject to ongoing monitoring based on the food safety program requirement. Given the novelty of this food category and this production method, NSW Food Authority agrees the proposed framework should provide a high level of oversight. This may be re-visited as the industry matures and similar products are assessed as safe and more commonly available.

NSW Food Authority also supports the following consequential amendments as proposed:
• Subsections 1.1.1—10(5) and (6): The proposed amendments would clarify that cell-cultured food (as defined) would be subject to pre-market approval. This is consistent with the Food Ministers’ expectation expressed in November 2022 (1).
• Subsection 1.1.1—15(1): The proposed amendment would require permitted cell-cultured food to comply with the relevant specification in Schedule 3. In the absence of reference to Schedule 3 in Standard 1.5.4 and Schedule 25A, this provision is critical.
• Subsection 1.1.2—8(1): The proposed amendment provides regulatory clarity that a cell-cultured food (as defined) does not meet the definition of a novel food.

NSW Food Authority requests clarity from FSANZ on the following issues:
• Specificity of the proposed permission
The proposed drafting is unclear on the level of specificity in the proposed permission for cell-cultured quail as a permitted cell-cultured food.
NSW Food Authority notes Draft Explanatory Statement for section S25A—3 stating:
‘Item 1 of the table lists in Column 1 of the Table the following as a permitted cell-cultured food: cell-cultured quail derived from the cell-line 221523Fib-Quail; and manufactured by Vow Group Pty Ltd (ABN 49 632 680 472)’ (CFS report page 110)
Whilst this would offer some guidance on interpretation, NSW Food Authority requests more clarity on the regulatory intent of ‘detailed in application A1269’ in section S25A—3.
NSW Food Authority notes the following statements by FSANZ in the CFS report:
o ‘FSANZ is proposing to regulate these foods as products such that all cell media and inputs will be assessed for safety as a part of approval of future cell-cultured foods.’ (page 12)
o ‘Granting a permission to the applicant for the proprietary cell culturing process described in the application will prevent other businesses from producing this food in the same manner. That is unless the applicant permits other businesses to do so.’ (page 23)

• NSW Food Authority supports the regulatory intent as above that a permission for cell-cultured food would be granted on a product-by-product basis. However, the proposed drafting, including ‘detailed in application A1269’ in section S25A—3, is unclear if this intent is achieved. NSW Food Authority recommends clarifying in the Code that the permission granted through Application A1269 is limited to the applicant’s product as assessed by FSANZ. One way to achieve this may be a reference to the applicant in the listing of permitted cell-cultured food in section S25A—3.

• Scope of the capture as ‘cell-cultured food’: See response to Question 4 below.

• GM cell-cultured food
NSW Food Authority requests clarity from FSANZ as to which standard would take precedence – Standard 1.5.2 (GM food) or 1.5.4 (Cell-cultured food), in the event of GM cell-cultured food (i.e. food meeting both definitions of GM food and cell-cultured food in the Code). NSW Food Authority further seeks clarity on labelling requirements for such food.

• Prohibition on the use in Part 2.9 food categories
Whilst generally supporting the proposed prohibition on the use of cell-cultured food in/as Part 2.9 Special purpose foods, NSW Food Authority requests clarity from FSANZ in the Approval report on how an application to seek permission to use cell-cultured food in/as special purpose food would be progressed. Would it be assessed as a novel food? NSW Food Authority notes the recent amendment in the Ministerial Policy Guideline on the Regulation of Infant Formula Products (2) to clarify cell-based human milk products should follow the same principles as traditional infant formula products.

‘Food Business’ definition
NSW Food Authority offers the following comments on the ‘food business’ definition.
The proposed amendment to Standard 3.1.1 to specifically include a cell culturing food business and a cell line supplier in the meaning of a ‘food business’ does not affect operation of ‘food business’ as defined in the NSW Food Act 2003 (3), that is:
a business, enterprise or activity that involves—
(a) the handling of food intended for sale, or
(b) the sale of food,
regardless of whether the business, enterprise or activity concerned is of a commercial, charitable or community nature or whether it involves the handling or sale of food on one occasion only.
NSW considers that a cell culturing food business and a cell line supplier would be considered as a food business, through the proposed definition of cell biomass in Standard 3.4.1. The proposed cell biomass definition (as an output of a cell culturing food business) provides a clear link to a food production activity. The proposed section 3.4.1—10 further supports interpretation that cell biomass is potentially hazardous food. The cell biomass, cell line, cell line supplier and cell proliferation definitions equally combine to ensure a clear link to the production of food.
The NSW Food Authority considers cell culturing food businesses and cell line suppliers would be considered food businesses as both are regulated through Standard 3.4.1. NSW Food Authority is of the view that the proposed Code requirements for cell culturing food business and cell line supplier would be enforceable through the NSW Food Act 2003 as activities of a food business.

NSW Food Authority further offers the following comments on the proposed provisions in the draft variation (Attachment A to the 2nd CFS report).
Standard 1.5.4
• Section 1.5.4—2: See response to Question 4.
• Section 1.5.4—3: NSW Food Authority recommends including ‘component’ in addition to ingredient to be consistent with the provision in section 1.1.1—10.
• Section 1.5.4—4: NSW Food Authority supports the general prohibition on use of cell-cultured food in/as special purpose foods. NSW Food Authority recommends adding ‘used’ to provide clarity that the prohibition is on the use as food for sale as well as ingredient or component of food for sale.
• Sections 1.5.4—5 and 6: See response to Question 5.
Schedule 25A
• Sections S25A—3 and S25A—6: See response to Question 3.
• Section S25—5: See response to Question 5.
Standard 3.4.1
• Section 3.4.1—2:
o Cell biomass: NSW Food Authority supports the proposed definition that clarifies its use in food production, so that non-food products would be excluded. For further clarity, NSW Food Authority recommends explicitly stating in the definition that its scope is limited to the production of a cell-cultured food or words of similar effect, so that a mass of cells for the production of food other than cell-cultured food (e.g. precision fermentation product) would be excluded.
o Cell line: NSW Food Authority considers the proposed definition (c) needs re-considering. Given the short history of use of a cell line in food production, it is quite possible that a cell line used for cell-cultured food production was developed with no intention for use in the production of a cell biomass. NSW Food Authority recommends replacing ‘are intended for use’ with ‘are used’. This would enhance the clarity of when a cell line is relevant for the purposes of regulation under a food safety program.
• Paragraph 3.4.1—7(2)(c): The term ‘a cell culture’ is undefined and unclear as to what it applies to. NSW Food Authority recommends rewording this term using reference to the activities mentioned in (b)(i)-(v).
• Subsection 3.4.1—9: See response to Question 3b.
• Subsection 3.4.1—10: NSW supports the clarity offered by this clause in that potentially hazardous food requirements in Standard 3.2.2 will apply to food businesses that handle cell biomass.
• Cell-cultured food production including activities of cell line suppliers and cell culturing food businesses in Australia would be subject to ongoing regulatory supervision in accordance with the food safety program requirement. There needs to be an arrangement to ensure that cell-cultured food imported into Australia is also produced under the equivalent food safety standard. NSW Food Authority urges early conversations be initiated with the Australian Government to develop a system at the Australian border to confirm equivalent proof of compliance with requirements in Standard 3.4.1 for imported cell-cultured food.

NSW Food Authority supports no transition period for the Code amendments through Application A1269. As currently there is no permitted cell-cultured food in Australia New Zealand and no cell line supplier or cell culturing food businesses operating in NSW, the Code amendment through A1269 would not result in an immediate ban on any existing food production activities due to non-compliance with Standards 1.5.4 or 3.4.1. Businesses producing non-food products as well as research and development activity that is not food for sale would not be prohibited from continuing with their work by the proposed Code changes.

NSW Food Authority supports the proposed approach. Although FSANZ’s assessment has not fully characterised the risk at the applicant’s commercial production scale, the proposed microbiological specifications for cell-cultured food would require the applicant to implement measures to address identified microbiological hazards, regardless of production scale. The proposed Standard 3.4.1 would enable the enforcement agency to provide regulatory oversight in their production process including microbiological risk mitigation measures on an ongoing basis. Modification to the applicant’s production process would be captured by the requirement to operate and maintain a food safety program.

NSW Food Authority supports FSANZ’s proposed approach to restrict processing to only an assessed cell line for the production of cell-cultured food for sale. This would enable an enforcement agency to remove food for sale produced using an un-assessed cell line from the market based on non-compliance with the Food Standards Code. NSW Food Authority considers this appropriately protects public health and safety as it requires pre-market safety assessment of all cell lines used for production of food for sale. This determination would not apply to a company producing research products from cell culture using an un-assessed cell line for non-food purposes or research and development activities, as they are not producing food for sale.

The term ‘cell line’ is used in Schedule 25A—3 to determine permitted cell-cultured food and in S25A—6 to specify the assessed cell lines. However, the term ‘cell line’ is defined in Standard 3.4.1 and applies only to Standard 3.4.1 of the Code. As it is Standard 1.5.4—3 which requires compliance with Schedule 25A, NSW Food Authority suggests FSANZ consider either relocating the definition of ‘cell line’ to Standard 1.1.2 or Standard 1.5.4 so that it applies more broadly in the Code, or repeating the definition of ‘cell line’ in other parts of the Code as required to ensure consistency in application of this term to all parts of the Code.

NSW Food Authority supports listing the name of the cell line ‘221523-Fib-Quail’ in the table for permitted cell-cultured foods and the table for assessed cell lines in Schedule 25A. This would effectively link the pre-market safety assessment pre-requisite for permission to sell as food with the food processing requirements. Taken together, NSW Food Authority supports the proposed drafting as it would make food for sale derived from a cell line other than ‘221523-Fib-Quail’ non-compliant food.

Section 3.4.1—9 requires a cell culturing food business must only use an assessed cell line for ‘cell proliferation’ to produce cell biomass. For more clarity, NSW Food Authority recommends adding the concept of ‘food for sale’ to section 3.4.1—9 so this subsection does not impede research and development of new cell lines for future cell-cultured food production.

NSW Food Authority agrees with FSANZ that the proposed definition is appropriate for the purposes Application A1269. However, the definition does not provide enough regulatory certainty for future cell-cultured foods. NSW Food Authority requests more clarity from FSANZ in the Approval report on what products will be captured as cell-cultured food and what products will not. NSW Food Authority further requests commentary from FSANZ in the Approval report as to what regulatory pathway should be followed if a product is not captured by the proposed definition of a cell-cultured food. For example:

• Precision fermentation
NSW Food Authority supports that precision fermentation products should be out of scope of cell-cultured food. However, the proposed drafting does not clearly exclude precision fermentation. The rationale for exclusion of precision fermentation foods from cell-cultured foods provided as general text in the 2nd CFS for Application 1269 is not sufficient to remove doubt. NSW Food Authority recommends including commentary from FSANZ as below in the Explanatory Statement to clarify the intent:
‘Precision fermentation is a well-established technique that utilises bacterial or fungal cell cultures to produce various food substances and specific ingredients, such as proteins, enzymes, and other compounds, through controlled fermentation processes. FSANZ has assessed numerous applications for precision fermentation products over the years. These products have been regulated under the Code as foods produced using gene technology (Standard 1.5.2) and, depending on their intended use in food, as processing aids, food additives, or nutritive substances. Consequently, they fall outside the scope of the proposed definition for ‘cell-cultured food’ and this application more broadly.’ (CFS report page 14)

• Food produced using cell culture from other sources
NSW Food Authority supports limiting the sources for cell-cultured food to cells obtained from animals with a history of human consumption. NSW Food Authority recommends close alignment between the source species for cell-cultured food and the range of animal species that have a safe history of human consumption in Australia or New Zealand (e.g. dairy, meat, seafood).
Food produced using cell culture from cell sources other than mentioned above should be considered a novel food, because such food would meet the definition of non-traditional food and would require an assessment of the public health and safety consideration having regard to the novel production process, composition of the food, potential food allergenicity risk etc. NSW Food Authority recommends FSANZ provide clarity in the Approval report so that future applicants are adequately informed. NSW Food Authority supports clear guidance from FSANZ that any food for sale produced using cell culture is subject to pre-market assessment. This is consistent with the Food Ministers’ expectation (1).
NSW Food Authority considers it would be prudent for FSANZ to explore how to regulate cell-based human milk products. In line with the revised Ministerial Policy Guideline (2), NSW Food Authority considers cell-based human milk products should be regulated under Standard 2.9.1. Furthermore, now that Standard 2.9.1 applies in Australia only, NSW Food Authority is concerned about the implication to future innovation for cell-based human milk products in New Zealand.

Cell-cultured food definition
• The scope of animals considered as ‘game’ in the cell-cultured food definition is unclear on what species are captured. NSW Food Authority requests FSANZ provide clarity in the Approval report on the range of animal species captured as ‘game’ and capable of being a source animal of cell-cultured food (as defined).
• To clarify that a source animal for cell-cultured food has a history of safe human consumption, NSW Food Authority requests FSANZ consider parity with the existing capture of source species for conventional animal-derived food in the Code in the relevant Standards (e.g. Standard 2.2.1 Meat and meat products, Standard 2.2.2 Egg and egg products, Standard 2.2.3 Fish and fish products, Standard 2.5.1 Milk).

NSW Food Authority generally supports the proposed labelling requirements. The proposed requirement for a prescribed statement (i.e. ‘cell-cultured’ or ‘cell-cultivated’) would assist consumers to make informed food choices.

NSW Food Authority offers the following comments on labelling issues:
• Cell-cultured food for sale that is not required to bear a label
The proposed subsection 1.5.4—5(2) requires the statement either ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with the name of the ingredient in a food for sale. Note the same section states ‘labelling provisions apply to both packaged and unpackaged food’. The proposed amendment in subsection 1.2.1—9(3) requires ‘information relating to *cell-cultured food’ for unpackaged food to ‘accompany or be displayed with the food’.
A statement of ingredients as per sections 1.2.1—8 and 1.2.4—2 is required only for packaged food. For unpackaged food, there is no requirement in the Code to display ingredients. NSW Food Authority requests clarity from FSANZ as to how to require a statement ‘cell-cultured’ or ‘cell-cultivated’ for an unpackaged food when the name of the ingredient is not available to consumers.

• Compound ingredient
The proposed requirements in sections 1.5.4—5 and 1.5.4—6 apply to food for sale that has a cell-cultured food as an ‘ingredient’. Similarly, the proposed section S25A—5 also applies to a food for retail sale that has cell-cultured quail as an ‘ingredient’.
This drafting is unclear if the requirements as above apply to a food for sale that has a cell-cultured food/quail as a compound ingredient. As per the existing section 1.2.4—5, if the cell-cultured food/quail as a compound ingredient comprises less than 5% of the food for sale, the cell-cultured food/quail would not be required to be listed in the statement of ingredients. NSW Food Authority recommends adding food for sale that has a cell-cultured food/quail as a ‘component ’ in scope of labelling requirements, as well as an ingredient, so that all food containing cell-cultured food/quail would be subject to the labelling requirements.

• The use of meat-related terms
NSW Food Authority supports the proposed prohibition on use of the term ‘poultry meat’ and restriction on the use of the term ‘meat’ to the specific circumstances where the statement ‘cell-cultured’ or ‘cell-cultivated’ would always appear nearby. This is in line with the existing requirement in subsection 1.1.1—13(4).
While understanding that utility terms such as ‘patty’, ‘burger’, ‘sausage’ would not be restricted, NSW Food Authority requests clarity from FSANZ in the Approval report if use of terms containing ‘meat’ (e.g. ‘meatball’, ‘meatloaf’) would also be captured by the proposed prohibition.

• Directions for use labelling requirement
NSW Food Authority supports applying the existing labelling requirements for directions for use and storage in the Code to permitted cell-cultured food and food containing permitted cell-cultured food. If such food is sold directly to consumers in a package, directions for use to the extent that the food needs to be cooked thoroughly would need to be on label in accordance with sections 1.2.1—8 and 1.2.6—2.

• Comparative claims
NSW Food Authority notes FSANZ’s view ‘a mixed food containing cultured quail cells as being a suitable dietary substitute for a mixed food containing conventional quail meat’ (CFS report page 75).
Regarding comparative claims for food containing cell-cultured quail with food containing conventional quail meat as a reference food, NSW Food Authority agrees with FSANZ that the application of part (b) of the definition of reference food is incorrect. There is no defined food group for cell-cultured food, and furthermore, as FSANZ’s statement in Attachment 5 to the Final Assessment Report for Proposal P293 – Nutrition health and related claims (4): ‘comparative claims about composite foods or products, i.e. foods made up of foods from more than one individual food group, are not permitted under the “dietary substitute” option’ (page 42).
However, NSW Food Authority does not agree to FSANZ’s position in the CFS report page 75 stating that part (a) of the definition of reference food would apply to justify the comparative claims between food containing cell-cultured quail and food containing conventional quail meat. The application of part (a) of the definition of reference food in relation to the regulation of comparative claims about dietary substitutes is not consistent with the original intent in P293. In operation, NSW Food Authority considers it is arguable if food containing conventional quail meat is ‘of the same type’ as food containing cell-cultured quail and ‘that has not been further processed, formulated, reformulated or modified’.
NSW Food Authority requests stronger rationale from FSANZ in the Approval report about comparative claims on food containing cell-cultured quail.

The proposed regulatory framework would provide clarity on the regulatory requirement for cell-cultured food for sale in Australia and New Zealand, and for production of these foods in Australia. This would assist future applicants prepare their application to FSANZ.

NSW Food Authority supports the intent of FSANZ to grant product-by-product permission for cell-cultured food. This approach would require any new cell-cultured food manufacturer to undergo FSANZ’s application process regardless of similarity to the existing permitted cell-cultured food listed in Schedule 25A. While it may seem costly and burdensome for future applicants, NSW Food Authority supports FSANZ’s approach as this is the best way to protect public health and safety while the cell-cultured food industry is in its infancy. This would nurture consumer confidence in the safety of cell-cultured food over time, and consequently the industry would see the benefit.

A cell line would be considered as food when used for cell-cultured food production, then sale of a cell line/cell bank between cell line suppliers or between cell line supplier and cell culturing food business would need to comply with the requirements in the Code (e.g. labelling requirements in Standard 1.2.1). As these businesses are likely to be new to food regulation, NSW Food Authority recommends FSANZ provide guidance on the Code requirements relevant to their activities.

1. https://www.foodregulation.gov.au/activities-committees/food-ministers-meeting/communiques/food-ministers-meeting-communique-25-november-2022
2. https://www.foodregulation.gov.au/food-ministers-meeting-communique-15-november-2024
3. https://legislation.nsw.gov.au/view/html/inforce/current/act-2003-043#sec.6
4. https://www.foodstandards.gov.au/sites/default/files/food-standards-code/proposals/Documents/P293%20Health%20Claims%20FAR%20Attach%205%20FINAL.pdf