{"id":"F2025L00688","name":"Australia New Zealand Food Standards Code – Standard 3.4.1 – Food safety requirements for processing of cell-cultured food","slug":"australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":106466,"registerId":"commonwealth-F2025L00688-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Australia New Zealand Food Standards Code – Standard 3.4.1 – Food safety requirements for processing of cell-cultured food","content":"![Food Standards Australia New Zealand logo](image.001.png)\n\nStandard 3.4.1 – Food safety requirements for processing of cell-cultured food\n\nThe Board of Food Standards Australia New Zealand gives notice of the making of this Standard under section 92 of the Food Standards Australia New Zealand Act 1991. The Standard commences on gazettal.\n\nDated 10 June 2025\n\n![The Signature of the delegate of the Board of Food Standards Australia New Zealand](image.002.png)\n\nMatthew O’Mullane, General Manager, Food Safety \n\nDelegate of the Board of Food Standards Australia New Zealand\n\nNote:\n\nThis Standard will be published in the Commonwealth of Australia Gazette No. FSC 179 on 18 June 2025. This means that this date is the gazettal date for the purposes of the above notice.\n\n  \n\nStandard 3.4.1 Food safety requirements for\n\nprocessing of cell-cultured food\n\nNote 1 This instrument is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). The standards together make up the Australia New Zealand Food Standards Code. See also section 1.1.1—3.\n\nNote 2 This Standard applies in Australia only.\n\nDivision 1 Preliminary\n\n3.4.1—1 Name\n\nThis Standard is Australia New Zealand Food Standards Code – Standard 3.4.1 – Food safety requirements for processing of cell-cultured food.\n\nNote Commencement:  \nThis Standard commences on the date of gazettal, being the date specified as the commencement date in notices in the Gazette under section 92 of the Food Standards Australia New Zealand Act 1991 (Cth). See also section 93 of that Act.\n\n3.4.1—2 Definitions\n\nIn this Standard:\n\nanimal means an animal that is one of the following: livestock; poultry; game; seafood (including fish); and includes an egg or an embryo of such an animal.\n\nassessed cell line means a cell line listed in section S25A—6.\n\nbioreactor means a device in which cell proliferation occurs under closed and controlled conditions.\n\ncell bank means a collection of one or more cell lines.\n\ncell biomass means a mass of cells extracted from a bioreactor and that is intended for use in the production of a food.\n\ncell culturing food business means a business, enterprise or activity that undertakes cell proliferation.\n\ncell differentiation means the process by which cells are induced to differentiate into the final cell type(s) of the cell-cultured food.\n\ncell line means a collection of cells that:\n\n(a) are derived from a single source that was prepared under specific culture conditions; and\n\n(b) have a uniform composition; and\n\n(c) are intended for use in the production of a cell biomass.\n\ncell proliferation means the production of a cell biomass.\n\ncell extraction means one or both of the following processes:\n\n(a) extraction of a mass of cells from a bioreactor;\n\n(b) separation of a cell biomass from the media by sedimentation, centrifugation or other action.\n\ncell line supplier means a business, enterprise or activity that involves both of the following:\n\n(a) sourcing cells for use in creating a cell line;\n\n(b) creating a cell line.\n\ndonor animal means an animal from which cells are sourced to create a cell line.\n\nmedia means a growth medium used for one or both of the following purposes:\n\n(a) cell proliferation;\n\n(b) cell differentiation.\n\nDivision 2 Cell line supplier\n\n3.4.1—3 Cell lines – food safety requirements\n\n(1) A cell line supplier must ensure that a cell line does not contain any of the following.\n\n(a) bacteria;\n\n(b) fungi;\n\n(c) prions;\n\n(d) viruses.\n\n(2) A cell line supplier must identify and record the species of the cells that comprise a cell line.\n\n(3) A cell line must be sourced from a donor animal that is free of disease.\n\n3.4.1—4 Traceability\n\nA cell line supplier must have in place a system that:\n\n    identifies and tracks cells from collection from a donor animal through to supply of a cell line; and\n    identifies the donor animal for the cells used to develop each cell line; and\n\n(c) identifies to whom a cell line was supplied.\n\nDivision 3 Cell culturing food business\n\n3.4.1—5 Food safety program\n\n(1) A cell culturing food business must comply with Standard 3.2.1.\n\nNote Standard 3.2.1 sets out other requirements for a food safety program.\n\n(2) The food safety program must also detail each of the following:\n\n(a) the indicators of a loss of process control in a bioreactor;\n\n(b) the food handling activities related to:\n\n(i) cell sourcing, selection and banking; and\n\n(ii) cell proliferation, including serial sub-culturing in flasks; and\n\n(iii) seeding and proliferation of cells in a bioreactor; and\n\n(iv) cell differentiation; and\n\n(v) cell extraction;\n\n(c) how the business will identify when cell proliferation is non-conforming;\n\n(d) how the business will undertake the calibration, cleaning and sterilisation of all relevant equipment.\n\n3.4.1—6 Inputs\n\nA cell culturing food business must ensure that any substance used in or for any of the following does not make \\*cell-cultured food unsafe or unsuitable:\n\n(a) cell proliferation;\n\n(b) cell differentiation;\n\n(c) cell extraction;\n\n(d) handling of a cell biomass;\n\n(e) storage of a cell biomass.\n\n3.4.1—7 Cell line used for cell proliferation\n\nA cell culturing food business must only use an assessed cell line for cell proliferation.\n\n3.4.1—8 Cell biomass – temperature control\n\nA cell biomass is a potentially hazardous food for the purposes of Standard 3.2.2.\n\n3.4.1—9 Traceability\n\nA cell culturing food business must have in place a system that identifies each of the following:\n\n(a) the cell line used for cell proliferation;\n\n(b) the supplier of the cell line used for cell proliferation;\n\n(c) to whom the cell biomass was supplied.","sortOrder":0}],"analysis":{"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"This Standard narrows geographic application by applying in Australia only (Note 2), whereas many Food Standards operate Australia‑New Zealand jointly. It also narrows regulatory scope by limiting cell proliferation to 'assessed' cell lines (3.4.1–7) and treating cell biomass as a potentially hazardous food (3.4.1–8), thereby extending mandatory safety, traceability and program requirements to cell line suppliers and cell‑culturing businesses (3.4.1–3 to 3.4.1–9)."},"complexity_factors":["Technical biological safety requirements (exclusion of bacteria, fungi, prions, viruses) and donor‑animal health checks (3.4.1–3(1),(3)) increase substantive scientific complexity.","Mandatory traceability obligations for both cell line suppliers and producers require end‑to‑end record systems (3.4.1–4; 3.4.1–9).","Cross‑references to other Standards (must comply with Standard 3.2.1; cell biomass treated as potentially hazardous under Standard 3.2.2) create regulatory interdependence and add interpretation burden (3.4.1–5(1); 3.4.1–8).","Use‑restriction to 'assessed cell lines' links this Standard to an external list (section S25A—6), creating reliance on material outside the instrument.","Operational requirements for food‑safety programs (indicators of loss of control, calibration/sterilisation, non‑conformance handling) demand detailed procedures and validation (3.4.1–5(2)(a),(d),(c)).","Definitions and novel concepts (cell bank, bioreactor, cell biomass, cell proliferation, cell extraction) introduce sector‑specific interpretation needs (3.4.1–2).","Compliance and enforcement may require laboratory testing, supplier auditing and specialised equipment checks, raising administrative and technical cost burdens for small producers.","Jurisdictional limitation to Australia only (Note 2) creates potential complexity for businesses operating trans‑Tasman or under broader Code expectations."],"plain_english_summary":"Creates mandatory food‑safety rules for production of cell‑cultured food in Australia, covering cell line suppliers and cell‑culturing food businesses. \n\nIt requires disease‑free, identified cell lines, end‑to‑end traceability, use of listed “assessed” cell lines for proliferation, documented food‑safety programs (including bioreactor controls and equipment sterilisation), controls on inputs, and treats extracted cell biomass as potentially hazardous — imposing recordkeeping, operational controls and supplier choices that affect costs and business practices."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"This is a new Standard (3.4.1) introduced to regulate an emerging food technology. It appears tightly scoped to its original purpose: establishing food safety requirements specifically for cell-cultured food processing. The scope covers the supply chain from cell line creation through to cell biomass production, which is appropriate for the novel risks this technology presents. No evidence of scope creep beyond the core objective of ensuring food safety in cell-cultured food production."},"complexity_factors":["15 defined terms in the interpretation section, several with nested definitions (e.g., 'animal' includes livestock, poultry, game, seafood, eggs and embryos)","Cross-reference to Standard 3.2.1 (food safety programs) and Standard 3.2.2 (potentially hazardous food) without reproducing their content","Reference to external listed standard (section S25A—6 for 'assessed cell lines') requiring lookup in another part of the Code","Nested obligations: cell line suppliers have requirements, then cell culturing businesses have overlapping but distinct requirements","Technical terminology requiring scientific understanding (bioreactor, cell differentiation, serial sub-culturing, prions)","Note indicating the Standard applies in Australia only, creating a jurisdictional limitation that requires awareness of the broader Code structure"],"plain_english_summary":"This law sets food‑safety, traceability, and recordkeeping rules for businesses producing cell‑cultured meat, seafood, and other animal products, covering both firms that supply starter cell lines and those that grow cells in bioreactors. It requires pathogen‑free, documented cell sources, the use of assessed/listed cell lines, hazard‑focused safety programs, and treating cell biomass as potentially hazardous food.\n\nIt matters because it creates a legal framework to ensure safe production, traceability, and consumer confidence in lab‑grown foods."}},"importantCases":[],"_links":{"self":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-","history":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-/history","analysis":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-/analysis","conflicts":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-/conflicts","importantCases":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-/important-cases","documents":"/api/acts/australia-new-zealand-food-standards-code-standard-3-4-1-food-safety-requirements-for-processing-of-/documents"}}