Explanatory Statement
Food Standards Australia New Zealand Act 1991
Australia New Zealand Food Standards Code – Standard 1.5.4 – Cell-cultured foods
1. Authority
Section 13 of the Food Standards Australia New Zealand Act 1991 (the FSANZ Act) provides that the functions of Food Standards Australia New Zealand (the Authority) include the development of standards and variations of standards for inclusion in the Australia New Zealand Food Standards Code (the Code).
Division 1 of Part 3 of the FSANZ Act specifies that the Authority may accept applications for the development or variation of food regulatory measures, including standards. This Division also stipulates the procedure for considering an application for the development or variation of food regulatory measures.
The Authority accepted Application A1269 which seeks to amend the Code to permit the sale and use of cultured quail cells as a new food. The Authority considered the application in accordance with Division 1 of Part 3 and has approved the following draft regulatory measures:
- Standard 1.5.4 – Cell-cultured‑ foods;
- Schedule 25A – Permitted cell-cultured foods;
- Standard 3.4.1 – Food Safety requirements for processing of cell-cultured food; and
- Food Standards (Application A1269 – Cultured quail as a novel food – Consequential Amendments) Variation.
This explanatory statement relates to Australia New Zealand Food Standards Code - Standard 1.5.4 – Cell-cultured foods (the Standard).
Following consideration by the Food Ministers’ Meeting (FMM), section 92 of the FSANZ Act stipulates that the Authority must publish a notice about the Standard.
2. Standard is a legislative instrument
The Standard is a legislative instrument for the purposes of the Legislation Act 2003 (see section 94 of the FSANZ Act) and is publicly available on the Federal Register of Legislation (www.legislation.gov.au).
This instrument is not subject to the disallowance or sunsetting provisions of the Legislation Act 2003. Subsections 44(1) and 54(1) of that Act provide that a legislative instrument is not disallowable or subject to sunsetting if the enabling legislation for the instrument (in this case, the FSANZ Act): (a) facilitates the establishment or operation of an intergovernmental scheme involving the Commonwealth and one or more States; and (b) authorises the instrument to be made for the purposes of the scheme. Regulation 11 of the Legislation (Exemptions and other Matters) Regulation 2015 also exempts from sunsetting legislative instruments a primary purpose of which is to give effect to an international obligation of Australia.
The FSANZ Act gives effect to an intergovernmental agreement (the Food Regulation Agreement) and facilitates the establishment or operation of an intergovernmental scheme (national uniform food regulation). That Act also gives effect to Australia’s obligations under an international agreement between Australia and New Zealand. For these purposes, the Act establishes the Authority to develop food standards for consideration and endorsement by the FMM. The FMM is established under the Food Regulation Agreement and the international agreement between Australia and New Zealand and consists of New Zealand, Commonwealth and State/Territory members. If endorsed by the FMM, the food standards on gazettal and registration are incorporated into and become part of Commonwealth, State and Territory and New Zealand food laws. These standards or instruments are then administered, applied and enforced by these jurisdictions’ regulators as part of those food laws.
3. Purpose
The Authority approved the Standard to set out when a food for sale may be, or have as an ingredient, a cell-cultured food and to set requirements for the use and labelling of permitted cell-cultured foods.
4. Documents incorporated by reference
The Standard does not incorporate any documents by reference.
5. Consultation
In accordance with the procedure in Division 1 of Part 3 of the FSANZ Act, the Authority’s consideration of Application A1269 included two rounds of public consultation. The 1st call for submissions was held from 11 December 2023 to 5 February 2024. The submissions received informed the Authority’s decision to prepare the draft Standard and other proposed regulatory measures mentioned above. The 2nd CFS was issued in December 2024 and included two draft standards, a draft schedule and draft consequential variations to the Code, and an associated report. It detailed the rationale for the proposed measures and regulatory approach for cultured quail cells and for future cell-cultured‑ foods. FSANZ received 22 submissions in response to the 2nd CFS. Each submission received was considered as part of our assessment. Further details of the consultation process, the issues raised during consultation and by whom, and the Authority’s response to these issues are available in an approval report published on the Authority’s website at www.foodstandards.gov.au.
Changes have been made to the Impact Analysis requirements by the Office of Impact Analysis (OIA) 1. Impact analysis is no longer required to be finalised with the OIA. Under the new approach, FSANZ’s assessment is that a Regulation Impact Statement (RIS) is not required for this application, as the proposed variation to the Code are not likely to create significant impacts on the community, government or industry.
6. Statement of compatibility with human rights
This instrument is exempt from the requirements for a statement of compatibility with human rights as it is a non-disallowable instrument under section 44 of the Legislation Act 2003.
7. The Standard
Standard 1.5.4 is a new Standard incorporated into the Code. The purpose of each provision in the Standard is explained below.
Standard 1.5.4 is introduced by two notes providing information about the place of the Standard within the Code and the application of that Standard in New Zealand. The first note in the Standard explains the instrument is a standard under the FSANZ Act and the Standard and the other standards together make up the Code.
The first note also refers to section 1.1.1—3 of the Code. That section provides that unless otherwise provided, the Standard and the other provisions of the Code apply to food that is sold, processed or handled for sale in Australia or New Zealand; or imported into Australia or New Zealand.
The second note explains that the provisions of the Code that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ). The second note also refers to section 1.1.1—3 of the Code, a note to which lists the provisions of the Code that have not been incorporated in, or adopted under that Act.
Division 1 – Preliminary
Division 1 of the Standard contains sections 1.5.4—1 and 1.5.4—2.
Section 1.5.4—1 provides that the name of the Standard is the Australia New Zealand Food Standards Code – Standard 1.5.4 – Cell-cultured foods.
The note to section 1.5.4—1 explains that the Standard commences on the date of gazettal, being the date specified as the commencement date in notices in the Gazette and the New Zealand Gazette in accordance with sections 92 and 93 of the FSANZ Act.
Section 1.5.4—2 provides or refers to definitions for terms used in the Standard. The note to section 1.5.4—1 refers to the following definition of ‘cell-cultured food’ in section 1.1.2—2 of the Code: a cell-cultured food means a food obtained by culturing cells isolated from any of the following sources: livestock; poultry; game; seafood (including fish); an egg or an embryo of any of the former’.
Division 2 – General requirements
Division 2 of the Standard contains sections 1.5.4—3 to 1.5.4—7.
Section 1.5.4—3 provides that a food for sale may be, or have as an ingredient, a cell-cultured food if:
- the cell-cultured food is listed in Schedule 25A; and
- any corresponding conditions listed in that Schedule are complied with.
Section 1.5.4—4 prohibits the addition of a cell-cultured food to a special purpose food. It provides that a cell-cultured food must not be added to a food standardised by Part 2.9 of the Code; for example, an infant formula product.
Section 1.5.4—5 sets labelling requirements for a food for sale that has a cell-cultured food as an ingredient.
Subsection 1.5.4—5(1) provides that section applies to a food for sale that has a cell-cultured food as an ingredient.
Subsection 1.5.4—5(2) provides that, for the labelling provisions, the reference to ‘information relating to cell-cultured food’ includes or requires the use of the statement ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with the name of the ingredient that is a cell-cultured food. The labelling provisions are set out in Standard 1.2.1. Amendments to Standard 1.2.1 require the labelling for certain foods for sale to include ‘information relating to cell-cultured food’. Subsection 1.5.4—5(2) sets out what that information includes.
The Note to subsection 1.5.4—5(2) explains the reference in that subsection to the labelling provisions and that the labelling provisions apply to both packaged and unpackaged food.
The Note to subsection 1.5.4—5(2) is followed by an example. The example illustrates how the subsection applies in relation to a statement of ingredients required by Standard 1.2.1 and 1.2.4. That is, if those Standards require a food for sale that has a cell-cultured food as an ingredient to bear a label with a statement of ingredients, subsection 1.5.4—5(2) requires the statement of ingredients to list the ingredient that is the cell-cultured food using ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with that ingredient’s name.
Section 1.5.4—6 sets out the labelling requirements for a food for retail sale that has a cell- cultured food as an ingredient and that is represented as being from the animal from which the cell-cultured food was sourced.
Subsections 1.5.4—6(1) and (2) set out the foods for sale that the labelling requirement imposed by subsection 1.5.4—6(3) applies to. That is, to a food for sale that:
- is for retail sale or suitable for retail sale without any further processing, packaging or labelling; and
- is packaged; and
- has a cell-cultured food as an ingredient; and
- is represented in words, images or both as being from the animal from which the cell-cultured food was sourced.
Subsection 1.5.4—6(2) provides that paragraph 1.5.4—6(1)(d) does not apply to a reference in a statement of ingredients to the animal from which the cell-cultured food was sourced.
Subsection 1.5.4—6(3) provides that, for the labelling provisions, the reference to ‘information relating to cell-cultured food’ includes or requires the use in the name of the food for sale of the same statement that is used in conjunction with the name of the ingredient in accordance with section 1.5.4—5. The labelling provisions are set out in Standard 1.2.1. Amendments to Standard 1.2.1 require the labelling for certain foods for sale to include ‘information relating to cell-cultured food’. Subsection 1.5.4—5(2) sets out what that information includes.
As explained, section 1.5.4—5 requires the use of the statement ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with the name of the ingredient that is the cell-cultured food. If, for example, the statement ‘cell-cultivated’ is used in conjunction with the name of the ingredient for the purposes of section 1.5.4—5, then section 1.5.4—6 would require the same statement – ‘cell-cultivated’ – to be used in the name of the food for sale if that food for sale meet the criteria set out in subsection 1.5.4—6(1).
The Note to subsection 1.5.4—6(3) explains the reference in that subsection to the labelling provisions.
The Note to subsection 1.5.4—6(3) is followed by an example. The example illustrates how subsection 1.5.4—6(3) would apply to a packaged food for sale that contains a cell-cultured food as an ingredient and that uses the statement cell-cultured in relation to that ingredient in the statement of ingredients in accordance with section 1.5.4—5. The example explains that, if the food for sale is represented as being from the animal from which the cell-cultured ingredient is sourced (e.g. ‘made from cell-cultured [animal name]’ or ‘cell-cultured [animal name] patties’), subsection 1.5.4—6(3) would require the statement ‘cell-cultured’ to be included in the name of the food on the label.
The example also covers the situation where a packaged food for sale contains a cell-cultured food as an ingredient, but does not represent on its label that it is from the animal from which the cell-cultured food (the ingredient) is sourced. In this situation, subsection 1.5.4—6(3) does not apply. Standard 1.2.2 would still apply and require the use of a name or description in relation to the food for sale that is sufficient to indicate the true nature of that food.
Section 1.5.4—7 sets out the labelling requirements for a cell-cultured food sold other than by retail sale.
Subsection 1.5.4—7(1) provides that section 1.5.4—7 applies to a cell-cultured food that is a food for sale to which Division 3 or 4 of Standard 1.2.1 applies. Division 3 of Standard 1.2.1 applies to food sold to caterers. Division 4 of Standard 1.2.1 applies to sales of food that are not retail sales, sales to caterers, or intra-company transfers.
‑Subsection 1.5.4—7(2) provides that, for the labelling provisions, the reference to ‘information relating to cell-cultured food’ includes or requires the use of the statement ‘cell-cultured’ or ‘cell-cultivated’ in conjunction with the name of the cell-cultured food.
The Note to subsection 1.5.4—7(2) refers to the labelling provisions that are set out in Standard 1.2.1 and states that the labelling provisions apply to both packaged and unpackaged food.
The Note to subsection 1.5.4—7(2) is followed by an example. The example illustrates how the subsection would apply in relation to the labelling requirement imposed by paragraph 1.2.1—15(a) of the Code. The paragraph requires the labelling of food sold to a caterer to state the name of the food in accordance with section 1.2.2—2 (which requires the use of a name or description sufficient to indicate the true nature of the food). The example explains that subsection 1.5.4—7(2) would require the use of the statement ‘cell-cultured’ or ‘cell‑cultivated’ in conjunction with the name of the food for sale required by paragraph 1.2.1—15(a).