Danielle Tan
Chief Operating Officer
Packaging is a critical food safety control that protects the product, preserves shelf life and supports traceability. Here is a clear six-step method to assess packaging risk under FSSC 22000 and stay audit-ready.
Quick answer: Conduct a packaging risk assessment for FSSC 22000 in six steps: scope definition, packaging hazard identification, risk evaluation, control measure establishment, packaging performance validation and verification, then assessment documentation and review. Applying the same risk-based discipline you use for ingredients and production keeps packaging risks under control and simple to prove at audit.
A comprehensive assessment should consider packaging design, food-contact suitability, supplier risks, contamination hazards, labelling accuracy, traceability, storage, transportation and change management. By adopting a risk-based approach, organisations can prevent packaging-related food safety incidents while demonstrating compliance with FSSC 22000 requirements.
Why Packaging is a Critical Food Safety Control
Packaging plays a direct role in keeping food safe. It protects products from contamination, preserves shelf life, communicates essential consumer information and enables traceability throughout the supply chain. If packaging fails, even a perfectly manufactured product may become unsafe or non-compliant.
FSSC 22000 promotes risk-based thinking across all processes, and packaging is no exception. Even when packaging comes from approved vendors, a structured risk assessment before introducing new materials or making packaging changes confirms the packaging is suitable for the specific application.
At a Glance: The 6 Steps of a Packaging Risk Assessment
| # | Step | What it involves | Key output |
| 1 | Define the scope | • Identify the packaging and its intended food application • Cover primary, secondary and tertiary packaging • Note storage conditions, distribution method and shelf life • Capture target market and regulatory requirements |
A defined scope so controls target the specific application rather than generic risks |
| 2 | Identify potential hazards | • Physical: fragments, loose staples or clips, damaged cartons, broken pallets • Chemical: migration, printing ink, adhesive, cleaning residues • Biological: storage contamination, pests, mould from moisture • Quality: seal or barrier failure, incompatibility, poor shelf-life performance • Legal: allergen, label, mandatory-information and barcode errors |
A documented hazard list covering every risk category, ideally built with a cross-functional team |
| 3 | Evaluate the risks | • Rate the likelihood of occurrence • Rate the severity if the hazard occurs • Rate the ability to detect it before release • Prioritise with a risk matrix (for example, incorrect allergen labelling = high risk) |
A prioritised list that separates high, medium and low risks |
| 4 | Establish control measures | • Approve suppliers and review food-contact documentation • Run packaging validation trials and verify artwork • Test seal integrity and monitor incoming quality • Protect packaging in storage and apply change management |
Preventive controls for every significant risk, favouring prevention at source |
| 5 | Validate and verify performance | • Validate via shelf-life studies, seal integrity and transport simulation • Confirm machine compatibility and food-contact compliance • Add environmental testing where applicable • Keep verifying after launch through audits, complaints and supplier reviews |
Objective evidence that packaging performs as intended, maintained over time |
| 6 | Document and review | • Record the full assessment as documented evidence • Review on changes to materials, suppliers or formulations • Review on design changes, new regulations or packaging failures • Review when customer complaints increase |
A living, documented assessment with clear review triggers, held within the food safety management system |
Step 1: Define the Scope of the Assessment
Begin by identifying the packaging being assessed.
Consider:
• Product name and packaging type
• Primary, secondary and tertiary packaging
• Intended food application
• Storage conditions
• Distribution method
• Shelf life
• Target market and regulatory requirements
Defining the scope ensures the assessment addresses the specific risks associated with each packaging application rather than applying generic controls.
Step 2: Identify Potential Packaging Hazards
The next step is to identify anything that could compromise food safety, quality or regulatory compliance. Typical packaging hazards fall into five categories:
| Hazard category | Typical packaging hazards |
| Physical | • Packaging fragments • Loose staples or clips • Damaged cartons • Broken pallets |
| Chemical | • Chemical migration • Printing ink contamination • Adhesive contamination • Cleaning chemical residues |
| Biological | • Contaminated packaging during storage • Pest contamination • Moisture leading to mould growth on packaging materials |
| Food safety and quality | • Seal failure • Barrier failure • Packaging incompatibility • Incorrect shelf-life performance |
| Legal and consumer | • Incorrect allergen declarations • Incorrect labels • Missing mandatory information • Barcode errors |
A cross-functional team involving Quality Assurance, Production, Purchasing, Packaging Development and Regulatory Affairs often identifies more risks than one department working independently.
Step 3: Evaluate the Risks
Once hazards have been identified, evaluate each risk by considering:
• Likelihood of occurrence
• Severity if the hazard occurs
• Ability to detect the problem before product release
Many organisations use a simple risk matrix to prioritise actions. High-risk issues should receive immediate attention, while lower-risk items can be managed through routine controls. For example:
| Example hazard | Risk level |
| Incorrect allergen labelling | High |
| Damaged transport cartons | Medium |
| Cosmetic print variation | Low |
The purpose is to ensure significant risks are effectively controlled, focusing effort where it matters most.
See where your packaging risks really sit.
A short gap assessment reviews your packaging hazards, controls and documentation against FSSC 22000, so you can close any gaps well before your certification or surveillance audit.
👉 Book a packaging risk gap assessment
Step 4: Establish Control Measures
For each significant risk, determine appropriate preventive controls.
Examples include:
• Approving packaging suppliers
• Reviewing food-contact compliance documentation
• Conducting packaging validation trials
• Verifying packaging artwork
• Performing seal integrity testing
• Monitoring incoming packaging quality
• Protecting packaging during storage
• Implementing change management procedures
Where possible, controls should prevent problems at source, with detection after production as a secondary safeguard.
Step 5: Validate and Verify Packaging Performance
A risk assessment should be supported by objective evidence that packaging performs as intended.
Validation may include:
• Shelf-life studies
• Seal integrity testing
• Transportation simulation
• Machine compatibility trials
• Food-contact compliance verification
• Environmental testing where applicable
Verification activities should continue after implementation through inspections, internal audits, customer feedback, complaint analysis and periodic supplier reviews.
Step 6: Document and Review the Assessment
Packaging risk assessment is an ongoing activity. Review the assessment whenever:
• New packaging materials are introduced.
• Packaging suppliers change.
• Product formulations change.
• Packaging design is modified.
• New regulations are introduced.
• Customer complaints increase.
• Packaging failures occur.
Maintaining documented evidence demonstrates that packaging risks are continuously monitored and managed as part of the food safety management system.
Packaging Risk Assessment Supports Continuous Improvement
One of the strengths of FSSC 22000 is its emphasis on continual improvement. Packaging risk assessments should evolve as products, technologies and regulations change.
For example, new sustainable packaging materials may introduce different barrier properties, while smart packaging technologies may create opportunities to improve traceability and product monitoring. Regularly reviewing packaging risks enables organisations to adapt proactively rather than reacting after incidents occur.
A well-structured packaging risk assessment does more than support audit compliance. It helps prevent contamination, reduce product recalls, improve customer confidence and protect brand reputation. When packaging is managed with the same level of discipline as ingredients and production processes, it becomes a valuable contributor to overall food safety performance.
Common Questions About Packaging Risk Assessment in FSSC 22000
How Nexus Consultancy Can Help
Most packaging findings are avoidable. Nexus Consultancy helps food manufacturers turn packaging risk into a controlled, audit-ready system, so you walk into certification and surveillance audits prepared.
Through consultancy and training, we can:
• Review your packaging risk assessment against FSSC 22000 and highlight where the gaps sit
• Guide your hazard identification, risk-ranking and control approach
• Advise on food-contact compliance, supplier approval and change control
• Support your validation, artwork and labelling checks so they stand up to audit
• Train your team to run and maintain the system independently
Explore our Food Safety Management Systems consultancy and FSMS training for the full scope.
Ready to close the gaps? Book a call and we will review your packaging risk assessment and pinpoint what to fix before your next audit.
👉 Book Your Professional 1-on-1 Consultation
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