Australia New Zealand Food Standards Code - Standard 4.1.1 - Primary Production and Processing Standards - Preliminary Provisions (Australia Only) | Zoe
Australia New Zealand Food Standards Code - Standard 4.1.1 - Primary Production and Processing Standards - Preliminary Provisions (Australia Only)
In ForceCTH
Jurisdiction
Commonwealth
Collection
legislative instrument
Plain English Summary
5/10 complexity
This Standard sets out preliminary rules for Chapter 4 (Primary Production and Processing) of the Food Standards Code (Australia only). It defines key terms, when an animal or food is “unacceptable” (clause 3), and requires businesses covered by Chapter 4 to have an authority‑approved or recognised food safety management statement, operate to it, and keep evidence and verification that hazard controls work (clauses 4–5). Who pays/decides: the business must prepare and verify the statement and keep records; the relevant Authority approves/recognises and may verify (cl.5).
This Standard (Standard 4.1.1) sets out preliminary and cross-cutting requirements that apply where a Primary Production and Processing Standard in Chapter 4 of the Food Standards Code requires compliance with the general food safety management requirements. It does not itself create a universal obligation for every primary producer or processor; rather, it provides the baseline operational mechanics and definitions that Chapter 4 Standards rely on when they require a person or business to “comply with the general food safety management requirements” (clause 4(1)). The Standard operates at two levels.
First, it supplies definitions and scope: it defines key terms used throughout Chapter 4 (clause 1), confirms that Chapter 4 Standards in this Code apply within Australia but not in New Zealand (clause 2(1) and (2)), and clarifies when an animal or food is to be treated as “unacceptable” for food purposes (clause 3). These definitions determine the reach and triggers of obligations elsewhere in Chapter 4, for example by making intra‑company transfers “supply” (clause 1) or by importing the “reasonable person” test for unacceptability (clause 3).
Second, it prescribes the structure of the risk‑management obligations that relevant persons or businesses must adopt where Chapter 4 Standards require them to meet the general food safety management requirements. Those obligations are: hold a food safety management statement and operate according to it (clause 4(1)(a)-(b)); systematically examine operations to identify hazards and implement control measures (clause 4(2)(a)); retain evidence that the systematic examination and controls have been implemented (clause 4(2)(b)); and verify the effectiveness of control measures (clause 4(2)(c)). The Standard defines a food safety management statement as a statement that has been approved or recognised by the authority, is subject to ongoing verification by the business and, if required, by the authority, and sets out how obligations in Chapter 4 are or will be complied with (clause 5).
Current sections
Direct links to the current provisions in Australia New Zealand Food Standards Code - Standard 4.1.1 - Primary Production and Processing Standards - Preliminary Provisions (Australia Only).
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(Australia only)
(Australia only)
(Australia only)
Purpose and commentary
This Standard sets out preliminary provisions which apply to the Primary Production and Processing Standards contained in Chapter 4 of the Code.
Table of Provisions
Division 1 – Preliminary
1 Interpretation
2 Application
3 When an animal or food is unacceptable
Division 2 – General food safety management requirements
4 The general food safety management requirements
5 Food safety management statements
Division 1
Preliminary
Division 1 – Preliminary
1 Interpretation
Unless the contrary intention appears, in this Chapter –
Authority means the State, Territory or Commonwealth agency or agencies having the legal authority to implement and enforce primary production and processing Standards.
control measure means a measure that prevents, eliminates or reduces to an acceptable level, a food safety hazard.
food safety management statement has the meaning given by clause 5 of this Standard.
general food safety management requirements means the requirements in Division 2 of this Standard.
handling of food includes the producing (including growing, cultivation, picking, harvesting or catching), collecting, extracting, processing, manufacturing, storing, transporting, delivering, preparing, treating, preserving, packing, cooking, thawing, serving or displaying of food.
hazard means a biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect in humans.
inputs includes any feed, litter, water (including recycled water), chemicals or other substances used in, or in connection with, the primary production or processing activity.
supply includes intra company transfer of produce.
verification means the application of methods, procedures, tests and other tools for evaluation to determine compliance with the relevant requirement.
2 Application
(1) Unless the contrary intention appears, this Standard applies to Primary Production and Processing Standards in Chapter 4 of this Code.
(2) Standards in Chapter 4 of this Code do not apply in New Zealand.
3 When an animal or food is unacceptable
(1) An animal is unacceptable if –
(a) food derived from that animal would be unsafe;
(b) food derived from that animal would be unsuitable; or
(c) the animal is in a condition which a reasonable person would regard as making food derived from that animal unfit for human consumption.
(2) A food is unacceptable if –
(a) it is unsafe;
(b) it is unsuitable; or
(c) it is in a condition, or contains a substance or organism, which a reasonable person would regard as making that food unfit for human consumption.
(3) To avoid doubt, the standards in this Chapter of the Code may include other matters which, for the purposes of particular standards, make food or animals unacceptable.
Division 2
General food safety management requirements
Division 2 – General food safety management requirements
4 The general food safety management requirements
(1) Where a standard in this Chapter of the Code provides that a person or business is required to comply with the general food safety management requirements, that person or business must –
(a) have a food safety management statement; and
(b) operate according to its food safety management statement.
(2) A person or business required to comply with the food safety management requirements must also –
(a) systematically examine its operations to identify potential hazards and implement control measures to address those hazards; and
(b) have evidence to show that a systematic examination has been undertaken and that control measures for those identified hazards have been implemented; and
(c) verify the effectiveness of the control measures.
5 Food safety management statements
A food safety management statement is a statement which –
(a) has been approved or recognised by the authority; and
(b) is subject to ongoing verification activities by the business or person; and
(c) if required by the authority, is also subject to ongoing verification activities by the relevant authority; and
(d) sets out how the obligations imposed by this Chapter of the Code are to be, or are being, complied with.
Note: Editorial note:
Note that businesses with existing approved food safety arrangements (for example, HACCP-based food safety programs, Standard 3.2.1 of this Code, DAFF approved arrangements) should be considered to meet the outcomes of a food safety management statement. However, the relevant authority will need to verify that the existing food safety arrangement meets the requirements of this Division.
Note: Some of the standards in this Chapter of the Code contain definitions of ‘food safety management statement’. Those definitions will be removed when FSANZ reviews those standards.
Amendment History
The Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.
These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.
About this compilation
This is compilation No. 3 of Standard 4.1.1 as in force on 19 July 2023 (up to Amendment No. 220). It includes any commenced amendment affecting the compilation to that date.
Prepared by the Office of Parliamentary Counsel, Canberra.
Uncommenced amendments or provisions ceasing to have effect
To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislation including or omitting those amendments and provided in the Amendment History once the date is passed.
The following abbreviations may be used in the table below:
ad = added or inserted am = amended
exp = expired or ceased to have effect rep = repealed
rs = repealed and substituted
Standard 4.1.1 was published in the Food Standards Gazette No. FSC58 on 20 May 2010 as part of Amendment No. 116 (F2010L01310 — 20 May 2010). It was registered as a principal instrument on 10 January 2012 (F2012L00025) and has been amended as follows:
Section affected
A’ment No.
FRL registrationGazette
Commencement(Cessation)
How affected
Description of amendment
4.1.1—1
128
F2012L0002711 Jan 2012FSC7012 Jan 2012
21 May 2012
am
Amend definitions in clause 1.
4.1.1—3
128
F2012L0002711 Jan 2012FSC7012 Jan 2012
21 May 2012
ad
Insert clause 3.
4.1.1—Division 2
128
F2012L0002711 Jan 2012FSC7012 Jan 2012
21 May 2012
ad
Insert Division 2.
4.1.1—4
128
F2012L0002711 Jan 2012FSC7012 Jan 2012
21 May 2012
ad
Insert clause 4.
4.1.1—5
128
F2012L0002711 Jan 2012FSC7012 Jan 2012
21 May 2012
ad
Insert clause 5.
4.1.1—Table of Provisions
135
F2012L0201410 Oct 2012FSC7711 Oct 2012
11 October 2012
rs
Omit and substitute Table of Provisions.
4.1.1—Division 1
135
F2012L0201410 Oct 2012FSC7711 Oct 2012
11 October 2012
ad
Insert Division 1 heading.
4.1.1—5
220
F2023L0100411 July 2023FSC16019 July 2023
19 July 2023
am
Amend editorial note to clause 5.
Source text
Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.
(Australia only) (Australia only)
(Australia only)
Purpose and commentary
This Standard sets out preliminary provisions which apply to the Primary Production and Processing Standards contained in Chapter 4 of the Code.
Table of Provisions
Division 1 – Preliminary
1 Interpretation
2 Application
3 When an animal or food is unacceptable
Division 2 – General food safety management requirements
4 The general food safety management requirements
5 Food safety management statements
Division 1 Preliminary
Division 1 – Preliminary
1 Interpretation
Unless the contrary intention appears, in this Chapter –
Authority means the State, Territory or Commonwealth agency or agencies having the legal authority to implement and enforce primary production and processing Standards.
control measure means a measure that prevents, eliminates or reduces to an acceptable level, a food safety hazard.
food safety management statement has the meaning given by clause 5 of this Standard.
general food safety management requirements means the requirements in Division 2 of this Standard.
handling of food includes the producing (including growing, cultivation, picking, harvesting or catching), collecting, extracting, processing, manufacturing, storing, transporting, delivering, preparing, treating, preserving, packing, cooking, thawing, serving or displaying of food.
hazard means a biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect in humans.
inputs includes any feed, litter, water (including recycled water), chemicals or other substances used in, or in connection with, the primary production or processing activity.
supply includes intra company transfer of produce.
verification means the application of methods, procedures, tests and other tools for evaluation to determine compliance with the relevant requirement.
2 Application
(1) Unless the contrary intention appears, this Standard applies to Primary Production and Processing Standards in Chapter 4 of this Code.
Operational consequences that flow directly from the text: (a) authorities (defined to include State, Territory or Commonwealth agencies) have the legal role to approve or recognise food safety management statements and to undertake verification activities (clauses 1 definition of “Authority” and 5); (b) businesses must generate and retain documentary evidence of hazard analyses, control measures and verification activities (clause 4(2)(b)-(c)); and (c) the Standard contemplates equivalence between existing recognised food‑safety systems (for example, HACCP‑based programs, Standard 3.2.1 programs, or DAFF approved arrangements) and the outcomes required by a food safety management statement, subject to verification and authority recognition (clause 5 note). The Standard does not itself set penalties or detailed enforcement procedures, and does not apply outside Australia (clause 2(2)).
Main concepts
This Standard uses a small set of defined building blocks that shape how Chapter 4 obligations are to be implemented and enforced. The definitions in clause 1 are the primary conceptual tools.
Authority (clause 1): The Standard defines “Authority” to mean the State, Territory or Commonwealth agency or agencies legally empowered to implement and enforce primary production and processing Standards. That definition places the decision‑making and approval power with recognised government agencies rather than private bodies (clause 1).
Control measure (clause 1): Defined as a measure that prevents, eliminates or reduces to an acceptable level a food safety hazard. The definition frames obligations in terms of risk reduction to an acceptable level rather than absolute elimination.
Hazard (clause 1): A biological, chemical or physical agent in, or condition of, food that has the potential to cause an adverse health effect in humans. The definition mirrors standard risk‑based food safety concepts and limits the scope to human health effects.
Handling of food (clause 1): This is a deliberately broad, enumerated definition that covers producing, cultivation, harvesting or catching, collecting, extracting, processing, manufacturing, storing, transporting, delivering, preparing, treating, preserving, packing, cooking, thawing, serving or displaying of food. It therefore captures activities across the supply chain from on‑farm production through to final presentation.
Inputs and supply (clause 1): “Inputs” includes feed, litter, water (including recycled water), chemicals or other substances used in or in connection with production or processing. “Supply” expressly includes intra‑company transfers of produce. These definitions extend culpability and obligations to areas that might otherwise be assumed outside the regulatory perimeter, for example by including recycled water or internal transfers.
Verification (clause 1): Defined as the application of methods, procedures, tests and other tools for evaluation to determine compliance with the relevant requirement. Verification is thus a specified activity distinct from implementation: using methods and tools to evaluate whether the control measures are effective and compliant.
Unacceptable animal or food (clause 3): The Standard sets three alternative prongs for animals (unsafe, unsuitable, or in a condition a reasonable person would regard as making derived food unfit) and the same three prongs for food. That structure embeds an objective “reasonable person” assessment into determinations about fit‑for‑consumption status and gives authorities and businesses a tripartite test for rejection.
Food safety management statement (clause 5): A central administrative instrument. It must be approved or recognised by the authority, be subject to ongoing verification activities by the business (and, if required, by the authority), and set out how Chapter 4 obligations are or will be complied with. The Standard includes an editorial note stating that businesses with existing approved arrangements (such as HACCP programs or Standard 3.2.1 programs) should be considered to meet the outcomes of a food safety management statement, but the authority must verify that the existing arrangement meets the Division’s requirements.
These concepts create a compliance architecture based on documented, approved management statements, systematic hazard identification and control, recordation of evidence, and verification. The Standard binds these concepts together so that when a Chapter 4 Standard invokes the “general food safety management requirements”, the practical implementation is consistent across the Chapter.
Who it affects
The Standard applies to “persons or businesses” that a Chapter 4 Standard has specified must comply with the general food safety management requirements, not to all food businesses automatically. Clause 4(1) is explicit: “Where a standard in this Chapter of the Code provides that a person or business is required to comply with the general food safety management requirements, that person or business must...”. The obligation is therefore contingent on reference by another Chapter 4 Standard. Practically, this means:
Primary producers and processors to whom a Chapter 4 Standard applies, where that Standard specifically invokes the general food safety management requirements, are within scope (clause 4(1)). The Standard does not itself list which operations are captured; those are identified by other Chapter 4 Standards.
Businesses engaged in the range of activities defined as “handling of food” (clause 1) are potentially within scope where the relevant Chapter 4 Standard applies to their activity. The handling definition is broad and covers on‑farm activities, processing, storage, transport, and display.
Internal organisational movements are covered: because “supply includes intra company transfer of produce” (clause 1), internal transfers can constitute supply for the purposes of obligations triggered by Chapter 4 Standards. That affects corporate groups and vertically integrated farms/processors who might otherwise treat internal transfers as outside regulatory supply obligations.
Operators who use particular inputs are implicated because “inputs” includes recycled water, feed, chemicals and other substances (clause 1). If a Chapter 4 Standard applies to a business that uses these inputs, the business must examine those inputs as part of systematic hazard identification and control.
Authorities are directly engaged: the Authority defined in clause 1 is the body that must approve or recognise the food safety management statement and , where required by clause 5(c) , can perform ongoing verification activities. That places enforcement and recognition responsibilities on State, Territory or Commonwealth agencies, so compliance will be assessed and managed by government agencies with legal authority.
Businesses with existing approved food safety arrangements are explicitly anticipated by the Standard. The editorial note to clause 5 states that arrangements such as HACCP‑based programs, Standard 3.2.1 programs, and DAFF approved arrangements should be considered to meet the outcomes of a food safety management statement, subject to verification by the relevant authority. This affects operators already operating under another recognised scheme.
Geographically, the Standard applies within Australia only; clause 2(2) expressly states that Standards in Chapter 4 do not apply in New Zealand. That affects trans‑Tasman operators and any business that has operations in both jurisdictions: the Chapter 4 mechanics (including food safety management statements and the particular baseline duties in this Standard) do not apply in New Zealand.
Key duties and rights
The Standard prescribes a discrete set of operational duties for persons and businesses when a Chapter 4 Standard requires compliance with the general food safety management requirements. It also creates administrative rights for authorities.
Obligations placed on persons or businesses (clause 4):
Maintain a food safety management statement (clause 4(1)(a)). The statement must exist and be aligned with clause 5 requirements (approved or recognised by the authority and setting out how Chapter 4 obligations are or will be complied with).
Operate according to the food safety management statement (clause 4(1)(b)). This is a duty of implementation: the business must not merely hold a statement but must act in accordance with it.
Systematically examine operations to identify potential hazards and implement control measures to address those hazards (clause 4(2)(a)). The Standard requires a systematic process for hazard analysis and mitigation; this mirrors common preventive control logic by requiring both identification and remedial action.
Keep evidence that a systematic examination has been undertaken and that control measures for identified hazards have been implemented (clause 4(2)(b)). This is a recordkeeping duty, tied to accountability and auditability.
Verify the effectiveness of the control measures (clause 4(2)(c)). Verification is defined in clause 1 as the application of methods, procedures, tests and other tools for evaluation to determine compliance with the relevant requirement. The obligation therefore extends beyond implementing controls to applying evaluative activities that demonstrate they work.
Nature and form of the food safety management statement (clause 5):
Approval or recognition by the Authority: Clause 5(a) requires the statement to “have been approved or recognised by the authority”. This confers a gatekeeper role on the Authority , the statement is not solely a private artefact.
Ongoing verification by the business: Clause 5(b) requires ongoing verification activities by the business or person. The Standard therefore imposes a continuous compliance effort, not a one‑off statement.
Possible ongoing verification by the authority: Clause 5(c) says that the statement, if required by the authority, is subject to ongoing verification by the relevant authority. This gives authorities discretion to require their own verification, in addition to the business’s activities.
Content requirement: Clause 5(d) requires the statement to set out how the obligations imposed by Chapter 4 are to be, or are being, complied with. The statement must be operational and descriptive of compliance pathways.
Rights and administrative powers:
Approval/recognition power is vested in the Authority (clause 1 definition of Authority; clause 5(a)). That places the authority as the deciding body for accepting a business’s proposed or existing arrangements.
Verification power: Clause 5(c) allows the Authority to require ongoing verification by the Authority itself. That is an administrative right to audit, test or otherwise verify compliance.
Duties implied by definitions and structure:
The definition of “control measure” (clause 1) frames the duty in performance‑based terms: prevent, eliminate or reduce hazards to an acceptable level. The Acceptable Level is the normative target for implementation and verification.
The “unacceptable” tests for animals and food (clause 3) supply operational triggers for removal from the food chain. Businesses and authorities must use these three prongs (unsafe, unsuitable, or condition/contaminant such that a reasonable person would regard it as unfit) when deciding to dispose of, segregate, or otherwise manage material.
What the Standard does not specify:
The Standard does not prescribe specific control measures, validated limits, sampling frequencies, or test methods; it sets the management framework and leaves technical specifics to other standards, approved arrangements, or authority determinations.
The Standard does not itself state sanctions or penalty levels. Enforcement mechanics are therefore to be found in the legislative framework and in the powers of the Authority outside this text.
Penalties and enforcement
The text of this Standard sets out the administrative architecture for approval, recordation and verification but does not itself create a schedule of offences or specify monetary penalties or criminal sanctions. There are two key enforcement‑relevant facts in the text.
The Authority is the designated enforcer/approver. Clause 1 defines “Authority” as the State, Territory or Commonwealth agency or agencies having the legal authority to implement and enforce primary production and processing Standards. The practical consequence is that agencies with legal powers in each jurisdiction will be the bodies to approve or recognise food safety management statements (clause 5(a)) and, where required, to conduct ongoing verification (clause 5(c)). The Standard thus places approval and verification under the control of government agencies that have statutory enforcement powers outside the Standard itself.
The Standard prescribes duties and evidence obligations that enforcement can rely on. Clause 4(2)(b) requires persons or businesses to “have evidence to show” that systematic examination and control measures have been implemented. Clause 4(2)(c) mandates verification of effectiveness. Those documentation and verification obligations create the primary points of proof that an enforcement agency will examine in assessing compliance. Failure to hold an approved or recognised food safety management statement, or to operate according to it, are express duties (clause 4(1)). Non‑compliance with those duties would therefore be a basis for administrative or enforcement action under the broader legal regime administered by the Authority; however, the Standard itself does not set out specific penalties.
Other enforcement footprints and discretion:
Clause 5(c) gives authorities discretion to require ongoing verification by the authority. In practice, that discretion allows authorities to allocate inspection and auditing resources to businesses or sectors they consider higher risk. The Standard does not specify triggers or criteria for exercising that discretion.
The unacceptable food/animal criteria in clause 3 can operate as an immediate enforcement trigger: where an animal or food is “unacceptable” under clause 3, decisions to remove, segregate or prevent supply follow from the Standard’s substantive test. But again, remedies or penalties for supplying unacceptable food are not set out in this Standard.
The editorial note to clause 5 indicates that existing approved food safety arrangements should be considered to meet the outcomes of a food safety management statement, but the relevant authority “will need to verify” that the existing arrangement meets Division requirements. That verification process is an enforcement interaction point: recognition is conditional on authority verification.
In short: the Standard creates duties and a documentation/verification framework that enforcement bodies will use, assigns approval and verification authority to governmental agencies, and leaves the actual legal powers to impose sanctions to other provisions of the regulatory framework. Practitioners should therefore map this Standard’s recordkeeping, approval and verification requirements onto the enforcement powers and penalty schedules in the relevant State, Territory or Commonwealth statutes and administrative instruments that empower the Authority.
How it interacts with other laws
The Standard is explicitly framed as a preliminary instrument that operates in conjunction with other standards in Chapter 4 of the Food Standards Code. Clause 2(1) states that, “Unless the contrary intention appears, this Standard applies to Primary Production and Processing Standards in Chapter 4 of this Code.” That creates a dependent relationship: the Standard supplies baseline requirements that other Chapter 4 Standards can invoke by reference to “the general food safety management requirements” (clause 4).
Specific interactions and cross‑references visible in the text:
Chapter 4 relationship: The Standard is not self‑standing for all food businesses; other Chapter 4 Standards determine who must comply and in what circumstances. The Standard provides the management and verification backbone for those standards.
External recognised arrangements: Clause 5’s editorial note identifies existing approved food safety arrangements, for example HACCP‑based programs, Standard 3.2.1 programs and DAFF approved arrangements, as being capable of meeting the outcomes of a food safety management statement, subject to verification by the relevant authority. This places the Standard in alignment with other parts of the Code (Standard 3.2.1 is part of the broader Food Standards Code) and with Departmental approval processes, and permits equivalence between different recognised systems.
Regulatory jurisdiction: Clause 2(2) states that Standards in Chapter 4 do not apply in New Zealand. The Standard therefore applies only within Australia; any interactions with New Zealand law or trans‑Tasman regulatory harmonisation are expressly excluded from the text. Businesses with operations across Australia and New Zealand must manage differing obligations.
Administrative law and the FSANZ Act: The Amendment History expressly notes that amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. While the Standard itself does not reproduce the enforcement powers or penalty regimes of the FSANZ Act, the Amendment History makes plain that amendment and commencement are anchored in that statute.
State, Territory and Commonwealth enforcement powers: The definition of “Authority” in clause 1 places implementation and enforcement with governmental agencies that have legal authority, which implies interaction with State, Territory and Commonwealth statutes that grant inspection, seizure, compliance notice and penalty powers. The Standard sets the substantive expectations that those agencies are to enforce where Chapter 4 Standards require it.
Recordkeeping and evidentiary interactions: Clause 4(2)(b) and (c) require evidence and verification. In practice, that evidence will be cross‑referenced against administrative procedures, inspection protocols and potentially civil or criminal proceedings under food safety offences in other legislation. The Standard itself does not set rules of admissibility or confidentiality for records; those will be governed by other statutes and administrative rules.
Future review and definition removal: Clause 5 includes an editorial note that some standards in Chapter 4 contain their own definitions of “food safety management statement” and that those definitions will be removed when FSANZ reviews those standards. This indicates anticipated statutory housekeeping and potential future shifts in how definitions are distributed across the Code.
Overall, the Standard is designed to be a harmonising, technical companion to Chapter 4 Standards rather than a freestanding statute. Practitioners must therefore align the Standard’s management, approval and verification requirements with the substantive obligations and enforcement regimes in other statutory instruments and in the Code itself.
Amendment history
This compilation is No. 3 of Standard 4.1.1 as in force on 19 July 2023 (up to Amendment No. 220). The text provides a concise amendment table and provenance which is relevant for practitioners tracking changes to procedural and definitional elements.
Key entries from the table:
Original publication and registration: Standard 4.1.1 was published in the Food Standards Gazette No. FSC58 on 20 May 2010 as part of Amendment No. 116 (F2010L01310 , 20 May 2010). It was registered as a principal instrument on 10 January 2012 (F2012L00025).
Amendment No. 128 (FRL F2012L00027, Gazette FSC70 11 Jan 2012): Commenced 21 May 2012. This amendment (A’ment No. 128) amended definitions in clause 1 (item: 4.1.1,1 am), inserted clause 3 (4.1.1,3 ad), added Division 2 (4.1.1,Division 2 ad), and inserted clauses 4 and 5 (4.1.1,4 ad; 4.1.1,5 ad). In effect, Amendment No. 128 materially introduced the Division 2 general food safety management regime and the unacceptable animal/food tests, and updated the definitions.
Amendment No. 135 (FRL F2012L02014, Gazette FSC77 10 Oct 2012): Commenced 11 October 2012. This amendment omitted and substituted the Table of Provisions and inserted the Division 1 heading (4.1.1,Table of Provisions rs; 4.1.1,Division 1 ad). This is editorial and structural housekeeping to the Table of Provisions and headings.
Amendment No. 220 (FRL F2023L01004, Gazette FSC160 19 July 2023): Commenced 19 July 2023. This amendment is recorded as amending the editorial note to clause 5 (4.1.1,5 am). The compilation reflects that change.
Other compilation notes:
The Amendment History block indicates that amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated.
The compilation was prepared by the Office of Parliamentary Counsel, Canberra.
The text also describes the practice for uncommenced amendments or provisions ceasing to have effect: these may be reflected in compilations as shaded boxed text with commencement or cessation dates until the Federal Register of Legislation compilation is updated.
For practitioners the practical takeaways from the amendment record are:
The core operational turn in this Standard , the general food safety management requirements as a discrete Division with food safety management statements, systematic hazard identification, evidence holdings, and verification , stems from the 2012 amendments (A’ment No. 128) that inserted Division 2 and clauses 4 and 5.
The most recent recorded change in this compilation (A’ment No. 220) was limited to the editorial note to clause 5, indicating that substantive obligations (clauses 4 and 5) have remained stable since the 2012 restructure.
When citing the Standard historically, note the publication and registration dates and the compilation number (Compilation No. 3, in force 19 July 2023).
Litigation history
The compilation provided contains no case law, judicial decisions, or references to litigation arising from Standard 4.1.1. The text of the Standard does not list any judicial determinations, and the Amendment History and editorial notes do not cite litigation.
Accordingly, within the contents of this compilation:
There are no reported cases, judicial interpretations, or tribunal decisions recorded in the document that construe clauses 1 through 5, or which interpret the “general food safety management requirements”.
The Standard does not itself supply precedent‑level guidance on how courts or tribunals have interpreted terms such as “unacceptable”, “reasonable person”, “approved or recognised by the authority”, or the sufficiency of evidence and verification activities.
Practitioners seeking litigated interpretations, precedent on enforcement actions, or judicial guidance about the Standard’s practical application will need to consult external legal databases, State or Territory enforcement decisions, or administrative review outcomes. The compilation as given does not provide that material.
Gotchas
The text contains several drafting features and administrative constructs that can create practical traps if overlooked. These are grounded in the clauses themselves and the editorial notes.
Obligations are conditional on Chapter 4 cross‑reference (clause 4(1)). The Standard’s duties apply only when a Chapter 4 Standard expressly requires a person or business to comply with the general food safety management requirements. A common compliance error is to assume the Standard applies universally to all primary producers or processors. Practically, businesses should verify the relevant Chapter 4 Standard to see whether it invokes clause 4; otherwise the duties in clause 4 do not automatically bind them.
Authority approval/recognition is required (clause 5(a)). A food safety management statement must be “approved or recognised by the authority”. Holding an internal statement alone is not sufficient where the applicable Chapter 4 Standard requires an approved or recognised statement. Businesses should not treat private assurance documents as a substitute for formal approval.
Ongoing verification by both business and possibly authority (clause 5(b)-(c)). The Standard requires ongoing verification activities by the business and allows the Authority to require ongoing verification by the Authority itself. This creates a continuous compliance burden. Operators cannot consider verification a one‑off exercise.
Existing arrangements are not automatically accepted without verification (clause 5 note). The editorial note advises that existing approved arrangements (HACCP, Standard 3.2.1, DAFF arrangements) “should be considered to meet the outcomes” but adds that “the relevant authority will need to verify” that they meet Division requirements. That verification step is an operational gate: businesses with an existing system must still satisfy the authority that it aligns with the Standard’s expectations.
Broad scope of “handling of food” and “inputs” (clause 1). The Standard’s enumerated definition of handling covers virtually the entire supply chain, and “inputs” includes recycled water and chemicals. Operators using recycled water, particular feeds or chemicals may be required to examine those inputs in their hazard analysis. Ignoring these elements can lead to incomplete hazard identification.
“Supply includes intra company transfer” (clause 1). Intra‑group transfers are treated as supply. That can bring internal transfers within recordkeeping and verification obligations where the relevant Chapter 4 Standard applies, affecting multi‑site or vertically integrated enterprises.
“Unacceptable” uses a “reasonable person” test (clause 3). The test for when an animal or food is “unacceptable” includes a subjective, objective standard: “in a condition which a reasonable person would regard as making food derived... unfit”. That invites interpretive questions about community standards and commercial practice , and creates exposure to contestable determinations absent precise thresholds.
No penalty schedule in the Standard. The Standard does not set out sanctions or offence provisions. Practitioners must align the Standard’s duties with enforcement provisions in the relevant jurisdiction and cannot rely on this document alone to determine penalties or enforcement procedures.
Geographical limit: Not applicable in New Zealand (clause 2(2)). Operators with cross‑border operations must manage separate regimes; assuming Chapter 4 mechanics apply in New Zealand is an error.
Authority discretion is opaque (clause 5(c) and clause 1 definition of Authority). The Standard gives authorities discrete powers , approve/recognise statements and require ongoing verification , but it does not provide criteria for approval, recognition or the triggers for Authority verification. This absence of procedural detail can produce uncertainty and variable outcomes across jurisdictions.
Removal of duplicate definitions in future reviews (clause 5 note). The editorial note states that some standards in Chapter 4 contain their own definitions which will be removed when FSANZ reviews those standards. This means future changes to where definitions are located could affect how the terms are interpreted or applied.
These “gotchas” indicate where compliance problems and administrative friction are most likely to arise. They point practitioners to the practical controls to put in place: checking whether a particular Chapter 4 Standard invokes clause 4, securing Authority recognition, documenting ongoing verification, and ensuring input streams and internal movements are included in hazard analyses.
How to comply
This Standard sets a concise compliance architecture. The following checklist translates clauses 1, 4 and 5 into practical, source‑grounded steps. Each step is tied to the clause(s) that create the duty or requirement.
Establish whether the Standard applies to you (clause 2(1) and clause 4(1))
Review the specific Primary Production and Processing Standard in Chapter 4 that applies to your activity to confirm whether it expressly requires compliance with the general food safety management requirements. Clause 4(1) makes the Standard’s duties conditional on that cross‑reference.
Prepare or align a food safety management statement (clauses 4(1) and 5)
Draft a food safety management statement that sets out how the Chapter 4 obligations are or will be complied with (clause 5(d)).
Ensure the statement documents the systematic examination, identified hazards, control measures and verification activities specified by clause 4.
Submit the statement to the relevant Authority for approval or recognition (clause 5(a)). Do not assume internal acceptance suffices.
Implement and operate according to the approved or recognised statement (clause 4(1)(b))
Once approved or recognised by the Authority, put the procedures, controls and records in place, and operate day‑to‑day in accordance with the statement.
Conduct a systematic hazard analysis and implement control measures (clauses 4(2)(a) and 1)
Use the definitions in clause 1 to scope the analysis: include biological, chemical and physical hazards, and examine feeding, litter, water (including recycled water), chemicals and other inputs.
Treat “handling of food” broadly to ensure processing, storage, transport, packing and display are considered.
For each identified hazard, design and implement a control measure that prevents, eliminates or reduces the hazard to an acceptable level (clause 1 definition of control measure).
Record evidence that the systematic examination and controls have been implemented (clause 4(2)(b))
Maintain contemporaneous records that demonstrate the hazard analysis was performed and the control measures were implemented. These records are the primary documentary evidence enforcement agencies will request.
Verify effectiveness (clauses 4(2)(c) and 1)
Establish verification activities using methods, procedures, tests and other tools sufficient to determine that control measures achieve the intended outcome (clause 1 definition of verification).
Schedule verification activities at appropriate intervals and retain verification records.
Be prepared for Authority verification (clause 5(c))
Understand that the Authority may require ongoing verification by the Authority itself. Maintain records and be ready to facilitate Authority verification activities.
Map existing approved arrangements to the Statement (clause 5 note)
If your business operates under an existing approved food safety program (HACCP, Standard 3.2.1 program, DAFF approved arrangement), prepare a cross‑walk showing how that arrangement achieves the outcomes required by a food safety management statement, and present that to the Authority for verification and recognition.
Apply the “unacceptable” tests where relevant (clause 3)
Implement operational checks using clause 3’s three prongs to determine when animals or food should be treated as unacceptable: unsafe, unsuitable, or in a condition that a reasonable person would regard as making derived food unfit for consumption. Ensure that segregation, disposal and documentation processes are in place for unacceptable material.
Treat intra‑company transfers and inputs as within scope where relevant (clause 1)
Incorporate intra‑company transfers into supply chain controls, and evaluate inputs such as recycled water and chemicals within the hazard analysis and control measures.
Understand jurisdictional limits and enforcement context (clauses 1 and 2(2))
Recognise that the Authority is a State/Territory/Commonwealth agency (clause 1) that will approve and verify statements, and that Chapter 4 Standards do not apply in New Zealand (clause 2(2)). For cross‑border operations, maintain separate compliance strategies for Australia and New Zealand.
Retain audit trails and compliance reports
Since clause 4(2)(b) requires evidence, maintain document control, versioning of the statement, verification reports, test results and corrective action records to demonstrate continuous compliance.
Engage early with the Authority
Given the Authority’s role in approval and possible ongoing verification, engage early to confirm expectations, obtain recognition, and identify any additional verification the Authority will require.
Keep an eye on FSANZ reviews and local enforcement practice
The editorial note indicates possible future removal of duplicate definitions during FSANZ reviews; remain alert to updates. Also, because the Standard does not set penalties or procedural enforcement rules, consult relevant State, Territory or Commonwealth legislation and the Authority’s published guidance for inspection and enforcement expectations.
By following these source‑rooted steps , prepare an Authority‑approved statement, perform systematic hazard analysis that includes inputs and intra‑company transfers, implement control measures, keep and maintain evidence, and verify effectiveness , a business aligns its practices with the mechanics of Standard 4.1.1. The final compliance burden, and any sanctions for failure to comply, will depend on the specific Chapter 4 Standard that invokes clause 4 and on the enforcement powers and procedures of the relevant Authority.
(2) Standards in Chapter 4 of this Code do not apply in New Zealand.
3 When an animal or food is unacceptable
(1) An animal is unacceptable if –
(a) food derived from that animal would be unsafe;
(b) food derived from that animal would be unsuitable; or
(c) the animal is in a condition which a reasonable person would regard as making food derived from that animal unfit for human consumption.
(2) A food is unacceptable if –
(a) it is unsafe;
(b) it is unsuitable; or
(c) it is in a condition, or contains a substance or organism, which a reasonable person would regard as making that food unfit for human consumption.
(3) To avoid doubt, the standards in this Chapter of the Code may include other matters which, for the purposes of particular standards, make food or animals unacceptable.
Division 2 General food safety management requirements
Division 2 – General food safety management requirements
4 The general food safety management requirements
(1) Where a standard in this Chapter of the Code provides that a person or business is required to comply with the general food safety management requirements, that person or business must –
(a) have a food safety management statement; and
(b) operate according to its food safety management statement.
(2) A person or business required to comply with the food safety management requirements must also –
(a) systematically examine its operations to identify potential hazards and implement control measures to address those hazards; and
(b) have evidence to show that a systematic examination has been undertaken and that control measures for those identified hazards have been implemented; and
(c) verify the effectiveness of the control measures.
5 Food safety management statements
A food safety management statement is a statement which –
(a) has been approved or recognised by the authority; and
(b) is subject to ongoing verification activities by the business or person; and
(c) if required by the authority, is also subject to ongoing verification activities by the relevant authority; and
(d) sets out how the obligations imposed by this Chapter of the Code are to be, or are being, complied with.
Note: Editorial note:
Note that businesses with existing approved food safety arrangements (for example, HACCP-based food safety programs, Standard 3.2.1 of this Code, DAFF approved arrangements) should be considered to meet the outcomes of a food safety management statement. However, the relevant authority will need to verify that the existing food safety arrangement meets the requirements of this Division.
Note: Some of the standards in this Chapter of the Code contain definitions of ‘food safety management statement’. Those definitions will be removed when FSANZ reviews those standards.
Amendment History
The Amendment History provides information about each amendment to the Standard. The information includes commencement or cessation information for relevant amendments.
These amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.
About this compilation
This is compilation No. 3 of Standard 4.1.1 as in force on 19 July 2023 (up to Amendment No. 220). It includes any commenced amendment affecting the compilation to that date.
Prepared by the Office of Parliamentary Counsel, Canberra.
Uncommenced amendments or provisions ceasing to have effect
To assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Standard as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislation including or omitting those amendments and provided in the Amendment History once the date is passed.
The following abbreviations may be used in the table below:
ad = added or inserted am = amended
exp = expired or ceased to have effect rep = repealed
rs = repealed and substituted
Standard 4.1.1 was published in the Food Standards Gazette No. FSC58 on 20 May 2010 as part of Amendment No. 116 (F2010L01310 — 20 May 2010). It was registered as a principal instrument on 10 January 2012 (F2012L00025) and has been amended as follows: