Food Standards Australia New Zealand Act 1991 - Application Handbook - Part 3

The guideline structures the application process around several recurring legal-administrative concepts and practical thresholds. These core concepts are (with section references to the guideline where they appear):

• Mandatory versus recommended information: The guideline uses must to identify information that is compulsory and omission of which may cause administrative rejection, and should to indicate non-mandatory matters that are nevertheless likely to aid assessment (see “Mandatory information requirements” and “Non-mandatory information requirements”). This creates a two-tier compliance framework in which failure to provide must information is an immediate administrative risk, while failure to provide should information is a potential cause of requests for further information during assessment.

• FSANZ consultation and discretion: Applicants are strongly advised to consult FSANZ before lodging applications and to engage on an ongoing basis during assessment. FSANZ retains discretion to determine the appropriate assessment procedure and cost recovery level, even if the applicant suggests a process for Code variations (F, and note referencing para 22(2)(e) and s 27(c) of the FSANZ Act). This means applicants’ process proposals are advisory rather than binding.

• Relevance to statutory objectives: The application must supply the information necessary for FSANZ to address the objectives specified in s 18 of the FSANZ Act, including safety considerations (E). The guideline therefore anchors procedural requirements to statutory substantive goals, namely FSANZ’s statutory objectives.

• Data quality and transparency: There are detailed data requirements (E.1), including instructions for literature searches (databases, keywords, dates, lists of identified and included papers), standards for study design and reporting (E.1.1-E.1.3), and expectations that data be representative of Australian and New Zealand populations and analysed with appropriate statistical techniques. For safety studies, adherence to GLP principles and recognised OECD or other test guidelines is expected (E.1.1). Raw data and full papers must be provided rather than summaries.

• Confidentiality management: Applicants must identify CCI, separate it, explain why it qualifies under the FSANZ Act definition (G), and provide a non-confidential summary. FSANZ may not accept a CCI claim and may disclose information in certain circumstances under s 114 of the FSANZ Act. Applicants may also flag other non-CCI confidential information with reasons (H).

• Exclusive commercial benefit disclosure (ECCB): Applicants must indicate whether the application will confer an exclusive capturable commercial benefit and justify that view, with factors listed to assist assessment (I). This is a substantive disclosure that may bear on cost recovery and assessment logistics.

• International standards and trade considerations: The application must identify relevant Codex standards and other comparable national requirements and address trade impacts (J). The guideline explicitly links domestic assessment to international obligations under WTO TBT and SPS Agreements.

• Administrative form and submission mechanics: The application must be in English (A.1), follow a specified electronic format with a separate executive summary (A.2), be searchable (A.3), and meet file-size and electronic delivery rules. Templates for statutory declarations are provided online (K).

• Legal sign-off: A statutory declaration must accompany the application, sworn by a senior officer for corporate applicants, confirming completeness and truthfulness (K).

Taken together, these concepts build a gatekeeping architecture that channels applicants to provide comprehensive, auditable, and high-quality evidence and analysis, while giving FSANZ discretion over procedure, confidentiality treatment and the need for additional information under the FSANZ Act (see s 108). The guideline operationalises those goals by specifying data types, formats and administrative practices that shape applicants’ costs and choices.

The guideline affects every potential applicant seeking a new or varied food regulatory measure administered by FSANZ. That includes, but is not limited to:

• Commercial food businesses and industry associations that wish to introduce new ingredients, labelling changes, compositional standards, or health claims that would require a change to the Food Standards Code. The guideline requires these applicants to identify their business nature, provide contact details (B), quantify costs and benefits to industry (D.1.1), and indicate potential exclusive commercial benefits (I).

• Small businesses: the guideline explicitly asks applicants to note any specific effects on small businesses when quantifying costs and benefits (D.1.1(b)). Small businesses face the same data and procedural requirements as larger entities, including preparing literature searches, providing representative data, and possibly funding GLP-conforming studies. The requirement to quantify monetary costs wherever possible is likely to impose a disproportionately larger compliance burden on smaller applicants.

• Overseas applicants: the application must be in English, but supporting information in another language is acceptable if accompanied by a full English translation (A.1). Statutory declarations from overseas applicants may be accepted if they are signed equivalent documents in English (K note). Overseas businesses therefore are able to apply but must arrange translations and equivalent sworn statements.

• Researchers and contract testing laboratories: the guideline specifies detailed data standards, including GLP, validated methods, raw data provision and independent auditing of studies submitted for regulatory purposes (E.1.1). Researchers and labs providing study data to applicants must ensure methods meet these expectations or state reasons why not.

• Consumers and consumer organisations: though not applicants per se, the guideline expects applicants to consider consumer choice issues and target population impacts when justifying proposals (D and D.1). Consumer groups are also encouraged to bring issues to FSANZ’s attention by means other than an application.

• FSANZ staff and advisory committee members: the guideline governs how staff assess applications, including treatment of CCI and the need to evaluate ECCB claims. It empowers FSANZ to request additional information under s 108 and to decide procedure and cost recovery. Advisory committee members will receive CCI where necessary, but are subject to confidentiality obligations (G note).

• Governments with regulatory or trade responsibilities: applicants must quantify costs and benefits to government (D.1.1(c)) and report potential impacts on international trade (D.1.2, J.1). Those parts of government that interact with FSANZ (e.g. OBPR if a RIS is needed) may be engaged, and agencies will face information obligations and possibly increased regulatory costs.

• Intellectual property holders and other third parties: the ECCB requirement asks applicants to state who will benefit from approval, who holds IP, and whether permissions will be required. Thus third parties with IP or licensing rights may be drawn into negotiations or licensing arrangements as a consequence of the application (I).

Who pays: the applicant pays the preparation costs for data, studies, translations, statutory declarations and the application package. FSANZ sets the cost recovery level during administrative assessment based on estimated hours, so applicants also pay regulatory assessment fees (F note).

Who decides: FSANZ makes final decisions on the appropriateness of the assessment procedure, the acceptability of CCI claims, the need for additional information under s 108, and whether the application proceeds or is administratively rejected for missing must information.

What behaviour changes: prospective applicants will need to assemble substantial documented evidence, ensure data quality and representativeness, separate confidential information and provide public summaries, and consider whether to consult FSANZ to reduce the risk of administrative rejection or requests for further information.

Duties imposed on applicants by the guideline are primarily procedural and evidentiary, and can be grouped by theme. Rights are mainly limited to procedural protections and consultation opportunities described by the guideline and the FSANZ Act references within it.

Primary duties

• Provide mandatory information: The guideline emphasises that information marked must is compulsory. Omitting that information may result in administrative rejection of the application. Applicants must therefore ensure they include all items identified as mandatory (see Mandatory information requirements).

• Prepare in English and supply translations where required: Applications must be in English, but highly relevant supporting information in another language is acceptable only if accompanied by a full English translation (A.1).

• Present application in prescribed electronic format and include an executive summary as a separate electronic file: The application should be searchable and must be submitted electronically. The executive summary must be an electronic file separate from the rest of the application (A.2, A.3).

• Provide full copies of references and raw data: The guideline requires full electronic copies of all references cited and raw data where appropriate. Summaries of study findings are not adequate in place of full papers (A.3, E and E.1).

• Follow data and study design standards: Safety and other studies should follow GLP principles and recognised test guidelines such as OECD or other specified standards. Epidemiological and survey studies must include sufficient design and sampling details for assessment, including power and statistical methods (E.1.1-E.1.3).

• Identify and justify CCI claims: Applicants must identify CCI, separate CCI material, provide a written explanation explaining how the material satisfies the FSANZ Act definition of CCI, and provide a non-confidential summary (G).

• Declare ECCB and justify it: Applicants must indicate whether the application is likely to confer an ECCB and provide reasons for that assertion to assist FSANZ (I).

• Provide a statutory declaration: The application must include a signed statutory declaration stating the application fully sets out required matters and that the information is true, made by a senior officer in the case of bodies corporate (K).

• Complete checklists for all relevant guidelines: Where more than one guideline applies, the applicant must submit completed checklists for all, with page numbers (L).

Administrative and procedural duties

• Suggest, but not determine, assessment procedure: For Code variations, the applicant must provide details of the assessment procedure it considers appropriate (general, minor, major, or high level health claim variation) but FSANZ will make the final determination (F; para 22(2)(e) and s 27(c) references).

• Provide regulatory impact information: Applicants must provide quantified costs and benefits to consumers, industry and government where possible and information on international trade impacts (D.1).

Rights and expectations

• Right to consult: Applicants are strongly advised to consult FSANZ prior to lodging applications, and ongoing consultation is encouraged, giving applicants the right to seek pre-lodgement clarification and thereby reduce administrative risk.

• Right to re-lodge: If an application is rejected at administrative assessment for missing mandatory information, the applicant may re-lodge at a later date; rejection does not permanently preclude resubmission (Mandatory information requirements note).

• Right to have CCI considered: Applicants may claim CCI under the FSANZ Act definition and have FSANZ treat that material as confidential, subject to FSANZ’s assessment of the claim and statutory disclosure obligations under s 114.

• Procedural transparency: FSANZ will communicate the process to the applicant in accordance with s 27(c) of the FSANZ Act (F). The guideline also notes that FSANZ will advise applicants if it does not accept CCI claims.

• Right to appeal or be advised: The guideline indicates FSANZ will advise an applicant if it does not accept that material is CCI, which implies an opportunity to respond, although the guideline does not set out an internal appeal mechanism for that decision.

Limits and discretionary powers

• FSANZ discretion on procedural and cost recovery matters: FSANZ decides the process and the cost recovery level during administrative assessment, taking into account purpose and complexity (F note). Applicants should therefore anticipate FSANZ’s determinations on these points.

• FSANZ may request additional information under s 108 of the FSANZ Act: The guideline signals FSANZ’s statutory power to require further information if the application lacks sufficient material for assessment (see E and note referencing s 108).

• FSANZ may disclose CCI in limited circumstances: The guideline warns that an agreement to accept information on a confidential basis does not guarantee it cannot be made public or disclosed; FSANZ can be required by law, Parliament and the courts to disclose information provided on a confidential basis (H note; see also G note and reference to s 114).

In short, the guideline places structured duties on applicants to provide high-quality, transparent, and auditable evidence in a defined format, while providing applicants rights to consult, to claim confidentiality and to be informed about procedural choices. FSANZ retains significant discretionary powers to require more information, decide procedures and recover costs.

The guideline itself is a procedural document; it does not create criminal offences or prescribe monetary fines within the text provided. Enforcement and administrative consequences set out within the guideline are administrative and procedural rather than penal. The following enforcement mechanisms and administrative consequences are provided or referenced in the guideline:

• Administrative rejection at the administrative assessment stage: The guideline warns that failure to provide information marked must may result in the application being rejected at the administrative assessment stage. Rejection is not permanent and the applicant may re-lodge the application later (see Mandatory information requirements). This is an administrative gatekeeping mechanism rather than a penal sanction.

• Requests for additional information under the FSANZ Act: FSANZ may request additional information from an applicant under section 108 of the FSANZ Act if the provided material is insufficient for assessment. The need to provide such additional material may delay the assessment and increase the applicant’s costs.

• FSANZ refusal to accept CCI claims: If FSANZ is not satisfied that material is CCI, it will advise the applicant that it does not regard the material as protected by section 114 of the FSANZ Act. That decision could lead to disclosure of information the applicant had sought to protect, with attendant commercial consequences.

• Disclosure obligations under s 114 and other legal compulsion: The guideline explicitly cautions that agreement to accept information on a confidential basis does not guarantee non-disclosure, because FSANZ can be required by law, Parliament and the courts to disclose information provided on a confidential basis (H note; G note references s 114). Thus legal compulsion may override confidentiality commitments.

• Cost recovery and fee assessment: FSANZ makes the final determination on the appropriate cost recovery level during the administrative assessment, based on the estimated number of hours required for the assessment (F note). This imposes a financial obligation on the applicant; it is an enforceable administrative cost recovery, not a criminal penalty.

• Use of advisory committees: The guideline states that FSANZ will provide CCI to advisory committees or groups established by FSANZ when required for expert advice; members are subject to the same confidentiality obligations under the FSANZ Act as FSANZ staff (G note). While this is a confidentiality control, it also creates an enforcement mechanism in which disclosure is permitted to named experts subject to statutory confidentiality duties.

What is not present in the guideline

• The guideline does not specify civil liability, criminal penalties, infringement notices, or sanctioning regimes for providing false information beyond the statutory declaration requirement. The statutory declaration requires the applicant to state the application fully sets out required matters and is true to the best of their knowledge and belief (K). False statutory declarations may attract legal consequences under general law, but the guideline itself does not spell out those consequences.

• The guideline does not set time limits for FSANZ decisions or timelines for administrative assessment or for resubmission following rejection. It does not provide an internal appeals process for procedural determinations such as classification of CCI, though it says FSANZ will advise the applicant of its view.

Practical enforcement risks and costs

• Disclosure risk: An applicant who claims CCI but is unsuccessful risks wider disclosure. Even when CCI is accepted, FSANZ can be required to disclose by law, Parliament or the courts.

• Financial exposure: Applicants should budget for FSANZ cost recovery fees, for producing high-quality data to GLP standards and for responding to possible requests for additional information under s 108. If OBPR determines a regulatory impact statement is required, FSANZ will need to meet OBPR requirements and may request further information.

• Administrative delay: Non-compliance with must requirements or inadequate data may lead to administrative rejection or repeated rounds of information requests, each causing delay and additional cost.

In summary, the guideline enforces compliance through administrative rejections, information requests under the FSANZ Act, confidentiality procedures and cost recovery. The document does not set out criminal or express civil penalties within the text provided, but it imposes practical and financial enforcement consequences and highlights statutory disclosure obligations that can supersede confidentiality.

The guideline explicitly links application requirements to specific provisions and external legal frameworks and instruments. The interaction points are operational, referencing FSANZ’s statutory powers and broader international obligations. Key interactions described within the guideline are:

• FSANZ Act: The guideline repeatedly ties evidentiary and procedural requirements to the FSANZ Act. Applications must contain sufficient information to address the objectives in section 18 of the FSANZ Act (E). The guideline notes that FSANZ may request additional information pursuant to section 108 of the FSANZ Act (E note). It also instructs applicants to identify an appropriate procedure for Code variations pursuant to paragraph 22(2)(e) of the FSANZ Act, while noting FSANZ has final say and will communicate the process in accordance with section 27(c) (F). Confidential commercial information handling is governed by section 114 of the FSANZ Act, and the guideline observes FSANZ will deal with CCI in accordance with s 114 (G). These references embed the guideline within FSANZ’s statutory framework and bring the guideline under the operation of those statutory provisions.

• OBPR and Regulatory Impact Statements: The guideline requires applicants to include regulatory impact information including quantified costs and benefits. If the Office of Best Practice Regulation (OBPR) decides that a Regulatory Impact Statement (RIS) is required, FSANZ must meet OBPR’s information requirements and may request further information from the applicant before proceeding (D.1 note). This places the application process in the broader Australian regulatory impact assessment regime and may require additional work to satisfy OBPR standards.

• International instruments and trade agreements: The guideline requires applicants to provide details of relevant Codex Alimentarius standards and encourages details of relevant national standards in comparable jurisdictions (J.1, J.2). The note emphasises that Codex standards are regarded as international standards under the World Trade Organization and draws attention to Australia and New Zealand’s obligations under WTO Technical Barriers to Trade and Sanitary and Phytosanitary Agreements. Therefore, application assessment will consider international standards and trade law obligations as part of FSANZ’s statutory objectives.

• Evidence and reporting standards: The guideline directs applicants to recognised standards for study design and reporting such as OECD GLP and testing guidelines, FDA Redbook 2000, and links to reporting guidance like CONSORT, PRISMA, STROBE and others (E.1.1, E.1.3 and the appended notes). These references integrate internationally recognised scientific and methodological standards into the administrative assessment framework.

• Confidentiality and other statutes: The guideline warns that an agreement by FSANZ to accept information as confidential does not prevent FSANZ being required to disclose it by law, Parliament or the courts (H note). That point explicitly acknowledges that statutory confidentiality under the FSANZ Act is subject to overriding legal obligations such as subpoenas, parliamentary orders, or judicial directions, and interacts with general law disclosure obligations.

• Domestic procedural law: The requirement for a statutory declaration follows domestic evidence and statutory declaration regimes; for overseas applicants equivalent signed documents in English are acceptable (K). The requirement to provide a statutory declaration connects the application to the legal consequences of false declarations under general law.

Consequences of these interactions

• Multi-agency compliance: An applicant may need to prepare material that meets FSANZ evidentiary standards, OBPR RIS requirements and international trade consistency obligations. Meeting each of these can increase the scope and cost of evidence-generation and consultation.

• Confidentiality limits: Confidentiality claims rest on the FSANZ Act but can be overridden by other legal processes, which limits the protective effect of CCI claims in practice.

• Standardisation of scientific requirements: By prescribing adherence to GLP and recognised reporting standards, the guideline raises the evidentiary bar to internationally accepted scientific norms, which can help FSANZ assessments but increases the cost of compliance.

The guideline therefore functions at the intersection of administrative, scientific and trade law frameworks, and applicants must recognise that the application will be assessed against FSANZ’s statutory objectives, OBPR procedural expectations if triggered, and relevant international standards.

The text provided contains no explicit legislative or editorial amendment history for Guideline 3.1.1. There are no dates of enactment, amendment notes, version numbers, legislative citations for amendments, or footnotes indicating which parts have been amended over time within the excerpt supplied.

What the source does include that bears on update pathways

• Templates are hosted on the FSANZ website: The guideline refers to statutory declaration templates provided on the FSANZ website at a specified URL (K). That indicates the practical administration and ancillary materials may be updated online even if the guideline text itself is static in the supplied excerpt.

• Cross-references to other chapters and appendices: The guideline anticipates that more than one guideline may apply to an application and requires completed checklists for all relevant guidelines (L). That cross-referencing implies that changes in the content or structure of Chapters 3.2-3.7 or of other guidelines could affect the application requirements in 3.1.1, even if no amendment to 3.1.1 is recorded in the supplied text.

Absence of amendment metadata in the supplied text

• No internal revision history: The document excerpt does not include the typical "history of amendments" section, tracked changes, version control, repeal or replacement notes, or a date stamp.

Implications for practice

• Confirm current text on FSANZ website: Because the provided excerpt lacks amendment history, practitioners should verify the current operative version on the FSANZ website or the Federal Register of Legislation to ensure they apply the current requirements. The guideline itself points readers to online resources for templates and supplementary guidance.

• Watch for related guideline changes: Given the guideline’s cross-references to other chapters and to OBPR processes, an applicant should monitor both FSANZ guideline updates and OBPR guidance for changes that would affect application content and process.

In short, the supplied material does not provide an amendment history. For an authoritative record of amendments, the practitioner must consult the formal FSANZ publication channels and legislative registers.

The supplied guideline text contains no litigation history. It does not cite any judicial decisions, tribunal rulings, or litigation outcomes that interpret Guideline 3.1.1, the FSANZ Act provisions it references (such as ss 18, 108, 114), or disputes over the administrative processes described. There are no named cases, no references to precedent, and no discussion of how courts have interpreted the obligations or procedural rights set out in the guideline.

What the absence of litigation citations implies

• No precedent provided: Because the guideline excerpt does not include litigation references, it does not provide guidance on how courts have treated CCI claims, ECCB disputes, or FSANZ administrative decisions such as application classification or rejection. Practitioners must therefore rely on the statutory text, the guideline, and any separate judicial or tribunal materials that are not included here.

• Potential for judicial review: The guideline references FSANZ’s discretionary powers (for example to decide procedure and to refuse CCI claims). Such discretionary administrative decisions are typically susceptible to administrative law remedies such as merits review or judicial review in the corresponding jurisdictions, but the guideline does not discuss judicial review procedures or attach any litigation history to its provisions.

Practical steps in the absence of litigation guidance

• Check separate sources: If a practitioner requires litigation precedent on FSANZ processes, CCI treatment, or ECCB determinations, they should consult case law databases, administrative law decisions, or FSANZ’s own decisions and reasons published elsewhere, because those materials are not present in this excerpt.

• Treat FSANZ guidance as administrative practice: In the absence of case law within the text, the guideline should be treated as binding administrative guidance on application content and form, with the knowledge that procedural determinations by FSANZ may be subject to review under administrative law principles, though the guideline does not address that.

In summary, the document provides no litigation history. Users requiring precedent must research case law separately.

This guideline contains numerous procedural and evidentiary pitfalls that can affect the acceptability, timing and cost of an application. The following are concrete risks and common traps drawn directly from the guideline text and its notes.

1. Omission of must items leads to administrative rejection

• The guideline uses must to mark mandatory information; omission may lead to rejection at the administrative assessment stage. Rejection is not fatal but causes delay and duplication of costs. Ensure all must items are included (see “Mandatory information requirements”).

2. Drafting your own Code text can limit scope

• The guideline recommends applicants not include proposed drafting because FSANZ is responsible for drafting and will treat applicant drafting as an example unless the applicant expressly asks for it to be put into the Code. Including drafting may unintentionally narrow the assessed scope (Drafting section). If an applicant wishes FSANZ to adopt specific wording, they must state that explicitly.

3. Confidential commercial information claims require a non-confidential summary

• Claiming CCI does not remove the duty to provide a sufficiently detailed non-confidential summary useful for assessment. If the non-confidential summary is inadequate, FSANZ may not be able to progress assessment, and FSANZ may decline a CCI claim and advise the applicant (G).

4. CCI is not absolute; statutory disclosure can override confidentiality

• The guideline warns FSANZ can be required by law, Parliament or the courts to disclose confidential material, and that CCI may be provided to advisory committees subject to confidentiality obligations (G, H). Plan for scenarios where confidential material may become public.

5. ECCB identification can have consequences

• Applicants must indicate whether the proposal confers an exclusive capturable commercial benefit and justify that assertion. A poorly justified or contested ECCB claim can affect FSANZ’s assessment or cost recovery approach, as FSANZ considers circumstances related to ECCB in its decision-making (I).

6. Data quality standards are exacting and can be costly

• Safety studies should follow GLP and recognised test guidelines; surveys and epidemiological studies must report full methodology, sampling frames, power calculations and raw data where appropriate (E.1.1-E.1.3). Failure to meet these standards will likely trigger requests for additional information under s 108, and generating GLP-quality studies can be expensive.

7. Literature searches must be documented and complete

• When a literature search is undertaken, the application must list databases and journals searched, provide search criteria, list all papers identified and include in full all papers relied upon. Summaries are not adequate (E.1). Omitting full papers will impede assessment.

8. Executive summary is required as a separate electronic file

• The executive summary must be separate from the main application and in electronic form. If omitted or embedded, administrative queries or rejection could follow (A.2).

9. File format and delivery pitfalls

• The application must be submitted electronically, must be searchable, and applicants are advised to test files on a different computer to ensure readability. If files are too large, follow the <20MB email rule or use compressed files or web upload channels (A.3). Corrupted or unreadable files can delay or derail administrative assessment.

10. Multi-guideline applications need multiple checklists and pagination

• More than one guideline may apply. The applicant must complete checklists for all relevant guidelines and include page numbers as indicated (L). Failure to do so invites administrative friction.

11. OBPR RIS requirement can be triggered

• If OBPR decides a Regulatory Impact Statement is required, FSANZ must meet OBPR information requirements and may request further information. Applicants should be prepared for RIS-level scrutiny and attendant resource requirements (D.1 note).

12. Representative data expectations

• The guideline expects data to be representative of Australian and New Zealand populations (E.1). Reliance on foreign-only datasets without representative local data may be insufficient.

13. Statutory declaration formalities

• For bodies corporate, the statutory declaration must be made by a senior officer authorised to make the declaration and must include sufficient explanation of their role and authority. Failures in statutory declaration formalities may invalidate the application formality (K).

14. Unpublished manuscripts and author awareness

• If applicants submit unpublished manuscripts, they must indicate whether the author is aware the manuscript has been provided to FSANZ, which could create disclosure or publication complications (H note).

15. Non-exhaustive guidance may result in FSANZ requests under s 108

• The guideline permits FSANZ to request additional information under s 108 of the FSANZ Act where the information required by the guidelines is insufficient. Applicants must be prepared for follow-up evidence demands.

To manage these gotchas, applicants should treat the guideline as a strict checklist and adopt conservative practices: consult FSANZ in advance, avoid unnecessary drafting of Code text, prepare full non-confidential summaries, ensure studies meet prescribed standards, and test electronic submissions.

This section provides an actionable, section-referenced checklist and recommended practice steps based strictly on the guideline text. It is structured to align with the guideline’s A-L headings so an applicant can map their work directly to the required items.

Pre-lodgement steps

1. Early consultation with FSANZ

• Follow the guideline’s encouragement to consult FSANZ prior to lodging to confirm information expectations and process. Document the consultation (top note). Consult on the likely assessment pathway (general, minor, major, or high level health claim) but expect FSANZ to make the final determination (F).

2. Assemble project budget and timelines

• Account for costs of studies (GLP, validated methods), literature retrieval and translation, preparing a statutory declaration, preparing a non-confidential summary of CCI, and possible OBPR RIS work if triggered (D.1 note; E.1.1).

3. Decide on use of drafting

• Do not include proposed Code drafting unless you explicitly want FSANZ to consider that text for adoption. If including drafting, state whether it is being sought to be included in the Code or is merely illustrative (Drafting section).

Document and formatting checklist (A.1-A.3) 4. Language and translations

• Prepare the application in English. If supporting material is in another language, produce a full English translation to accompany it (A.1).

5. Structure and pagination

• Create a table of contents using the guideline heading titles relevant to your application. Number pages sequentially (A.2).

6. Executive summary

• Prepare an executive summary as a separate electronic file. Keep it concise but sufficiently informative to stand alone (A.2).

7. Electronic submission standards

• Ensure all documents are searchable by word and phrase. Check files on a different computer to ensure they open. If under 20MB, you may email to the Standards Management Officer; otherwise use FSANZ’s website upload or deliver via thumb drive or courier as permitted (A.3). Follow the contact details provided.

Applicant identity and purpose (B-C) 8. Applicant contact details

• Provide the applicant’s name, contact person, street and postal addresses, telephone, email, nature of business and details of associated individuals or organisations (B).

9. Clear statement of purpose

• Provide a concise statement of the purpose of the application and, where possible, identify existing food regulatory measures to be varied (C). For matters dealt with in Chapters 3.2-3.7, provide purpose relevant to those guidelines.

Justification, regulatory impact and trade (D, D.1) 10. Prepare the justification section

• Address the need for the proposed change and the advantages over the status quo, including public health and safety issues, consumer choice impacts, and evidence of industry interest or support (D and note). Identify target groups likely to be affected.

11. Quantify costs and benefits

• Provide current information on costs and benefits to consumers, industry (including small business effects), and government. Quantify in monetary terms where possible, otherwise provide other quantitative and qualitative evidence. Reference supporting sections in the application (D.1.1).

12. Address international trade impacts

• Provide information on potential impacts on international trade and cross-reference Codex standards if relevant (D.1.2; J).

Data and evidence package (E, E.1, E.1.1-E.1.3) 13. Collect and certify data

• Ensure all evidence necessary to address s 18 objectives is included, particularly safety data (E). Where mandatory data cannot be met, explain why.

14. Conduct and document literature searches

• List databases and journals searched, provide search criteria (keywords, time period, limits), list all papers identified, and include full copies of all papers relied upon. Provide raw data where appropriate (E.1).

15. Ensure study quality and transparency

• For safety studies follow GLP principles and recognised testing guidelines (OECD, FDA Redbook etc), provide evidence of quality control/auditing and include full study detail and raw data (E.1.1). For surveys, detail design, sampling method, sample size and power calculations, quality assurance, and limits of reporting (E.1.2). For epidemiological studies, include study design, objectives, participant characteristics, methodology, duration, outcomes, confounders and statistical analyses (E.1.3).

Confidentiality and commercial considerations (G-I) 16. Prepare CCI and confidentiality materials

• Identify CCI, separate it from the body of the application, provide a written explanation demonstrating how it meets the definition of CCI in s 4 of the FSANZ Act, and prepare a sufficiently detailed non-confidential summary for use in the assessment (G).

17. Mark other confidential material

• Identify any other non-CCI information you wish treated as confidential, separate it, mark it and provide reasons why confidentiality is requested (H). If providing unpublished manuscripts, indicate whether the author is aware the manuscript has been provided to FSANZ.

18. State ECCB position

• Advise whether the application is expected to confer an exclusive capturable commercial benefit and provide a justification addressing the factors listed in I (who benefits, IP ownership, permission requirements) to assist FSANZ’s decision-making.

International standards (J) 19. Catalogue relevant standards

• Provide details of relevant Codex standards and other comparable national standards or regulations. If no direct Codex standard exists, explain the comparative regulatory context (J.1, J.2).

Procedure, fees and statutory declaration (F, K) 20. Suggest an assessment pathway and expect FSANZ determination

• For Code variations, indicate the applicant’s view on the appropriate procedure (general, minor, major, or high level health claim variation) but prepare for FSANZ to set the procedure and cost recovery based on estimated assessment hours (F).

21. Anticipate OBPR interaction

• If an RIS is required by OBPR, be prepared to provide further information to FSANZ to meet OBPR requirements (D.1 note).

22. Include statutory declaration

• Include a signed statutory declaration affirming completeness and truth, made by an appropriately authorised senior officer for corporate applicants. Use FSANZ templates where helpful (K).

Final checks and lodgement (L) 23. Complete all checklists

• Complete checklists for all relevant guidelines, include page numbers and ensure all cross-referenced materials are present (L).

24. Technical submission checks

• Test files on different hardware, ensure searchability, confirm the executive summary is a separate file and all references are included in full. If emailing, confirm the total package is under 20MB or compress/arrange alternative upload.

25. Retain audit trail

• Keep an internal audit trail of all communications with FSANZ, copies of documents lodged, translations obtained, and statutory declarations signed.

Post-lodgement readiness 26. Be prepared for additional information requests

• Expect that FSANZ may request further data under s 108 if the application lacks sufficient material. Allocate resources and timing buffers accordingly.

27. Confidentiality contingency planning

• Assume that CCI may be disclosed in limited circumstances. Consider whether redacted public versions of the application should be prepared for FSANZ publication, as recommended in the guideline (H note).

28. Budget for FSANZ cost recovery

• Expect FSANZ to set a cost recovery level based on estimated hours during the administrative assessment. Include contingency funding for additional rounds of information requests.

Following this checklist will align an applicant’s submission with the explicit requirements and expectations set out in Guideline 3.1.1 and reduce the chance of administrative rejection or avoidable requests for supplementary information.