A traceability system isn't a single checklist. It's a design exercise. We help you define what your system needs to achieve, map the regulations it has to satisfy, and build records that hold up the day you need them.
ISO 22005:2007, Traceability in the feed and food chain, General principles and basic requirements for system design and implementation, gives the principles and specifies the basic requirements for designing and implementing a traceability system applicable to feed and food. It can be applied by an organisation operating at any step of the feed and food chain, and is intended to be flexible enough to allow organisations to achieve their own defined traceability objectives, instead of prescribing one fixed system design.
The standard defines traceability as the ability to trace the history, application, or location of what is being considered. In practice, this means establishing mechanisms that allow data on the location and origin of a product and its components to be retrieved at any time along the production and distribution chain. The traceability system is described as a technical tool to assist an organisation in conforming with its defined objectives, applicable when it becomes necessary to determine the history or location of a product or its relevant components.
A point worth understanding clearly: ISO 22005 explicitly distinguishes traceability from food safety itself. A traceability system is a technical tool supporting food safety management, but the standard states it is insufficient on its own to achieve food safety. Traceability enables rapid response when safety issues occur, and provides information for safety investigations, but preventing hazards in the first place requires complementary systems such as HACCP. A business can have excellent traceability and still have unmanaged food safety hazards, and the reverse is also possible.
Globalisation and cross-national trade in food have increased the consequences of foodborne illness outbreaks, with botulism, salmonellosis and listeriosis among the largest causes of illnesses, hospitalisations and deaths linked to food each year. Traceability has become a regulatory expectation across most major markets specifically because it shortens the time between an outbreak being identified and the affected product being removed from circulation.
ISO 22005 frames traceability system design as a sequence of decisions, starting with objectives and not with a recordkeeping template.
Traceability serves defined goals, regulatory compliance, recall capability, supply chain transparency, or sourcing claim verification, and is not an end in itself. The objectives shape everything that follows.
Relevant regulatory and policy requirements, local, regional, national or international, that the system must meet are identified. These vary by market and product category.
The products, ingredients, materials and components that need to be traceable are defined, along with the level of granularity, batch, lot, or individual unit.
One-step-forward and one-step-backward tracing establishes the minimum link: where an input came from, and where an output went, at each stage of the chain.
Documentation, coordination, and synchronisation of movements within the chain are established, with records retained for a defined period appropriate to the objectives.
The system's performance is measured against its objectives, for example, the time taken to trace a product one step forward and one step backward during a mock exercise.
The traceability system is updated in line with relevant performance indicators and changes to products, suppliers, or regulatory requirements over time.
Traceability investments pay off beyond meeting a regulatory minimum, in ways that matter to operations, brand, and recall economics.
Effective traceability creates strategic value through several channels: rapid, targeted recall capability that minimises product waste and economic impact when safety issues arise, since a narrow, accurate recall affects far less inventory than a broad precautionary one. Supply chain transparency enabling verification of sustainability, animal welfare, fair trade, or other ethical sourcing claims important to brand positioning. Fraud detection and deterrence, protecting brand integrity and consumer trust against substitution or mislabelling. Operational efficiency through better inventory management and loss reduction. Competitive differentiation, as consumers increasingly expect and reward supply chain transparency.
of US consumers consider supply chain transparency important or extremely important
premium some consumers report willingness to pay for verifiably traceable products
directions every link must cover: one step forward, one step backward, at minimum
ISO 22005 provides the framework for realising these benefits through systematic design and not ad hoc recordkeeping. A traceability system designed only to satisfy a specific regulatory checklist may meet that checklist while still falling short on recall speed, sourcing claim verification, or the kind of operational visibility that reduces waste, simply because those weren't among the objectives the system was designed against.
The most significant traceability regulatory development of the past two years had its enforcement date pushed back substantially, but its substance is unchanged.
FSMA 204, the FDA Food Traceability Final Rule under Section 204 of the Food Safety Modernization Act, requires entities that manufacture, process, pack or hold foods on the Food Traceability List to maintain enhanced records, Key Data Elements (KDEs), at Critical Tracking Events (CTEs), and produce records to the FDA within 24 hours of request.
The original compliance date for all persons subject to the rule's recordkeeping requirements.
FDA proposed a 30-month extension, moving the date to 20 July 2028, citing the need for industry-wide coordination across thousands of entities.
The Continuing Appropriations Act of 2026 directed FDA not to enforce the rule before 20 July 2028. FDA intends to comply. The Food Traceability List, CTEs, KDEs and recordkeeping obligations remain unchanged.
The practical takeaway for businesses with US market exposure is that the extension is additional preparation time, not a change in direction. FDA has stated it remains fully committed to FSMA 204's implementation and has no plans to alter the rule's requirements. The extension exists because industry-wide coordination across growers, shippers, processors and receivers was not achievable on the original timeline. Businesses that build CTE and KDE capability into their traceability system design now, using the additional time productively, are positioned well ahead of the 2028 date, instead of facing a compressed timeline as it approaches. For businesses also selling into Canada or the EU, FSMA 204's CTE/KDE approach maps reasonably well onto the one-step-forward, one-step-backward principles already familiar from frameworks like Canada's SFCR, making this a useful opportunity to design a single system that satisfies multiple markets' requirements together.
Traceability system design is relevant to any organisation in the feed and food chain, regardless of size or position in the supply chain.
Operations relying on informal or ad hoc recordkeeping needing a system designed against clear objectives and regulatory requirements.
Manufacturers, processors and distributors handling foods on the FSMA 204 Food Traceability List, using the extended timeline to build CTE/KDE capability properly.
Businesses needing a traceability system design that satisfies overlapping requirements across the US, EU, Canada, and other markets without duplicated systems.
Operations making sustainability, animal welfare, or fair trade claims needing traceability records that can substantiate those claims under scrutiny.
Organisations needing traceability system design that supports the traceability elements of broader food safety management system certification.
Operations with documented traceability procedures that have never been tested through a mock recall exercise under realistic time pressure.
We cover the full scope of traceability system design, from objective-setting through to mock recall testing.
A review of existing traceability records and processes against ISO 22005 principles and applicable regulatory requirements, identifying gaps and producing a written action plan.
Definition of traceability objectives and mapping of relevant regulatory requirements across your target markets.
Design of a traceability system covering what and how to trace, one-step-forward and one-step-backward links, documentation, and performance indicators.
Support for businesses preparing for Critical Tracking Events and Key Data Elements under the FSMA 204 Food Traceability Rule, using the extended timeline productively.
Mapping of a single traceability system design against overlapping requirements from multiple markets, avoiding duplicated recordkeeping systems.
Traceability documentation designed to substantiate sustainability, animal welfare, or fair trade claims under scrutiny.
A full mock recall exercise testing one-step-forward and one-step-backward traceability and recordkeeping under realistic time constraints.
Development of measurable performance indicators to test the traceability system against its defined objectives on an ongoing basis.
Ongoing monitoring of traceability regulatory developments across your target markets, with practical guidance issued as requirements change.
Implementation follows a defined sequence. Our part of the process typically takes 1 to 2 weeks. Implementation timelines vary depending on how much existing recordkeeping needs restructuring.
| Stage | What happens | Our role | Duration |
|---|---|---|---|
| 1. Objective definition | Traceability objectives are defined, regulatory compliance, recall capability, sourcing claims, or a combination. | We facilitate the objective-setting process with your team. | 1 to 2 days |
| 2. Regulatory requirement mapping | Relevant regulatory requirements across target markets are identified and mapped. | We map requirements for each market you operate in. | 2 to 3 days |
| 3. Gap assessment | Existing records and processes are reviewed against the defined objectives and regulatory mapping. | We conduct the assessment and deliver a written action plan. | 2 to 3 days |
| 4. System design | The traceability system is designed: what to trace, how to trace it, documentation structure, and retention periods. | We design the system in collaboration with your team. | 1 to 2 weeks |
| 5. Performance indicator development | Measurable indicators are defined to test the system against its objectives. | We develop indicators appropriate to your objectives. | 2 to 3 days |
| 6. Implementation | The system is put into practice. Records begin to accumulate against the new structure. | We provide implementation support and review emerging records. | 2 to 4 weeks |
| 7. Mock recall exercise | A mock recall tests one-step-forward and one-step-backward tracing under realistic time pressure. | We conduct the exercise and issue a findings report. | 2 to 3 days |
| 8. Ongoing review | The system is reviewed and updated as products, suppliers, or regulatory requirements change. | We monitor relevant developments and flag updates needed. | Ongoing |
Our gap assessment tests whether your current traceability records would support a fast, accurate recall, beyond confirming that records simply exist.
The assessment covers whether traceability objectives have been clearly defined, whether relevant regulatory requirements for your markets have been identified and mapped, whether one-step-forward and one-step-backward tracing is achievable with current records, and whether documentation and performance indicators support the defined objectives.
For businesses with US market exposure, the assessment also reviews readiness for FSMA 204 Critical Tracking Events and Key Data Elements, using the extended 2028 timeline to identify what needs building instead of treating the extension as a reason to defer.
We review whether traceability objectives and applicable regulatory requirements have been clearly identified.
We assess whether current records support one-step-forward and one-step-backward tracing.
We check readiness against FSMA 204 and other applicable market requirements.
We produce a written gap assessment with a prioritised action plan.
If you are also pursuing ISO 22000 or FSSC 22000 certification, we identify how this traceability work supports that scheme's requirements directly.
The same issues appear across traceability reviews regardless of sector. Knowing where these gaps cluster is the most effective preparation.
Records that establish where ingredients came from but not where finished product went, or vice versa, fail to provide the one-step-forward and one-step-backward links a recall requires, even where each individual record is well-kept.
Records kept in formats or locations that cannot be retrieved within regulatory timeframes, such as FSMA 204's 24-hour record production requirement, do not meet the requirement even when the underlying data is accurate.
A traceability system built without clearly defined objectives cannot demonstrate it meets any specific regulatory or business requirement, since there's no defined target to assess it against.
Performance indicators that are not tested until an actual recall mean gaps in the system become apparent under pressure, not during a planned mock exercise where they can be addressed calmly.
A traceability system designed against one regulatory framework, then not mapped against the requirements of other markets a business also sells into, can leave gaps that only surface when an issue arises in the unmapped market.
Treating an enforcement date extension, such as FSMA 204's move to 2028, as a reason to defer traceability work overlooks that the substantive requirements are unchanged and the extension exists because the work takes longer than originally estimated.
Understanding how ISO 22005's general principles relate to specific national traceability rules clarifies how one design can satisfy several requirements.
| ISO 22005 | FSMA 204 (US) | SFCR (Canada) | |
|---|---|---|---|
| Nature | General principles, flexible design guidance | Specific recordkeeping rule (CTEs/KDEs) | Regulatory traceability requirement |
| Core mechanism | One-step-forward/backward (general) | Critical Tracking Events, Key Data Elements | One-step-forward/backward, 2-year retention |
| Status | 2007 standard, no confirmed revision | Enforcement extended to 20 Jul 2028 | In force |
| Our consulting | ISO 22005 | FDA FSMA | Canada Food Safety |
What drives the timeline and cost of a traceability system project. We provide a written proposal with a fixed fee after the initial consultation.
Timeline
How long our consulting work takes
Cost factors
What drives the consulting fee
No documented traceability system, one regulatory framework. Our consulting work typically takes 1 to 2 weeks.
Businesses building CTE/KDE capability ahead of the extended 2028 enforcement date. Scope depends on Food Traceability List exposure.
Operations needing a single system mapped against multiple markets' requirements, scoped to the number of markets involved.
Testing an existing system's one-step-forward/backward capability under realistic time pressure, typically 2 to 3 days.
Additional documentation design for businesses needing to substantiate sustainability, animal welfare, or fair trade claims.
A single-product, few-supplier operation requires less mapping than a multi-product business with a complex supplier network.
Businesses with digital recordkeeping systems already in place often require documentation and mapping work and not system replacement.
A gap assessment only, a full system design, or an ongoing monitoring retainer each carry different fees. All scopes are defined in writing before work begins.
Answers to the questions we hear most often from organisations designing or reviewing traceability systems.
ISO 22005:2007, Traceability in the feed and food chain, General principles and basic requirements for system design and implementation, gives the principles and specifies the basic requirements for designing and implementing a traceability system applicable to feed and food. It can be applied by an organisation operating at any step of the feed and food chain, and is intended to be flexible enough to allow organisations to achieve their own defined traceability objectives, instead of prescribing a single fixed system design.
No. ISO 22005 explicitly distinguishes traceability from food safety itself, describing a traceability system as a technical tool that assists an organisation in conforming with its defined objectives, but states that traceability is insufficient on its own to achieve food safety. Traceability enables rapid response when safety issues occur, and provides information for safety investigations, but preventing safety hazards in the first place requires complementary systems such as HACCP. A business can have excellent traceability and still have unmanaged food safety hazards, and vice versa. The two systems serve different, complementary purposes.
ISO 22005:2007 requires organisations to identify the objectives of the traceability system, since traceability serves defined goals such as regulatory compliance, recall capability, or supply chain transparency, and is not an end in itself. It also requires identifying the relevant regulatory and policy requirements, local, regional, national or international, that the traceability system must meet, since these requirements vary by market and product category. From there, the standard guides organisations through decisions about what to trace, how to trace it, what documentation to maintain, and how to measure the system's performance against its objectives.
Effective traceability creates strategic value beyond meeting regulatory requirements: rapid, targeted recall capability that minimises product waste and economic impact when safety issues arise, supply chain transparency enabling verification of sustainability, animal welfare, fair trade, or other ethical sourcing claims important to brand positioning, fraud detection and deterrence protecting brand integrity, operational efficiency through better inventory management and loss reduction, and competitive differentiation as consumers increasingly expect supply chain transparency. Industry research consistently shows that supply chain transparency matters to a large share of consumers, and that some are willing to pay more for traceable products.
FSMA 204, the FDA Food Traceability Final Rule under Section 204 of the Food Safety Modernization Act, requires entities that manufacture, process, pack or hold foods on the Food Traceability List to maintain enhanced records, Key Data Elements, KDEs, at Critical Tracking Events, CTEs, and produce records to the FDA within 24 hours of request. The original compliance date of 20 January 2026 was extended by 30 months to 20 July 2028, following an FDA proposal in August 2025 and the Continuing Appropriations Act of 2026, enacted in November 2025, which directed FDA not to enforce the rule before that date. The substantive requirements of the rule, the Food Traceability List, CTEs, KDEs, and recordkeeping obligations, remain unchanged. Only the enforcement date moved.
ISO 22005 is not typically used as a standalone certification. It provides general principles and design guidance for traceability systems that support broader food safety management systems such as ISO 22000, and underpin traceability clauses found in schemes like FSSC 22000 and regulatory frameworks such as the EU's General Food Law or Canada's Safe Food for Canadians Regulations. An organisation typically demonstrates traceability system effectiveness as part of a broader audit, such as an ISO 22000 or FSSC 22000 assessment, or a regulatory inspection, instead of receiving a separate ISO 22005 certificate.
An ISO 22005 gap assessment reviews existing traceability records and processes against ISO 22005 principles, covering whether traceability objectives have been clearly defined, whether relevant regulatory requirements for your markets have been identified and mapped, whether one-step-forward and one-step-backward tracing is achievable with current records, and whether documentation and performance indicators support the defined objectives. For businesses with US market exposure, the assessment also reviews readiness for FSMA 204 Critical Tracking Events and Key Data Elements.
The most common issues are: traceability records that establish where ingredients came from but not where finished product went, or vice versa, failing to provide the one-step-forward and one-step-backward links a recall requires. Records kept in formats or locations that cannot be retrieved quickly enough to meet regulatory timeframes such as FSMA 204's 24-hour record production requirement. Traceability objectives that were never clearly defined, leaving the system unable to demonstrate it meets any specific regulatory or business requirement. Performance indicators that are not tested until an actual recall, by which point gaps in the system become apparent under pressure and not during a planned mock exercise. Traceability systems designed for one regulatory framework not mapped against the requirements of other markets a business also sells into.
Our consulting work moves fast. A traceability gap assessment typically takes a few days, and designing or restructuring a traceability system against ISO 22005 principles typically takes 1 to 2 weeks, depending on the number of products, suppliers, and markets involved. A mock recall exercise to test the system typically takes 2 to 3 days. Implementation timelines depend on whether existing recordkeeping systems need significant restructuring or only documentation and mapping work.
Yes. Gap assessments, traceability system design, FSMA 204 readiness reviews, and mock recall exercises are all available remotely. We work with clients worldwide. On-site visits are available where a physical review of recordkeeping practices at a facility is needed.
You can commission any of these on their own, with an agreed scope and a written quote, without taking on ongoing consulting. See all food safety services.
Where the system design is the limitation.
Read about A traceability system assessment →To test the chain under timed conditions.
Read about A mock recall exercise →Where visibility stops at the business that invoices you.
Read about A supply chain review →Tell us about your products, your markets and your current recordkeeping. We will tell you exactly what your traceability system needs to do.