Product Hazard Evaluation
A Critical FSVP Requirement for Ensuring Safe Imported Foods
Published by FSVP SERVICES | A Service by Consultare Inc. Group – A Compliance Company
The FDA’s Foreign Supplier Verification Program (FSVP) requires U.S. importers to determine whether imported food products present biological, chemical, or physical hazards and to verify that the foreign supplier has adequate controls in place.
Product Hazard Evaluation forms the core of this requirement. It provides a structured method for identifying hazards associated with the food, its ingredients, processing, packaging, and distribution environment. Its primary goal is to ensure that the supplier’s preventive controls are scientifically appropriate, effectively implemented, and consistently managed.
This guide outlines the key elements of an effective Product Hazard Evaluation aligned with 21 CFR 1.505, Codex risk analysis principles, and globally accepted food safety best practices.
Product Hazard Evaluation Checklist
✔ Product and Ingredient Hazard Identification
- Identify known or reasonably foreseeable biological, chemical, and physical hazards
- Assess ingredient-level risks (raw materials, additives, preservatives, allergens)
- Evaluate contamination risks during manufacturing, packaging, transportation, and storage
- Consider hazards related to processing methods and consumer preparation
✔ Hazard Characterization
- Determine severity of the hazard (minor illness → serious injury or mortality)
- Estimate likelihood of occurrence based on scientific evidence, process controls, and facility history
- Include recognized high-risk hazards (Listeria monocytogenes, Salmonella, undeclared allergens, etc.)
- Consider hazards unique to the product type or its intended consumer population
✔ Regulatory and Scientific Data Collection
- Use published scientific literature and authoritative hazard references
- Review Codex hazard definitions, FDA guidance documents, and commodity-specific risk profiles
- Integrate epidemiological data, outbreak history, and regulatory enforcement patterns
- Use validated hazard analysis methodologies (e.g., CCP decision trees, risk matrices)
✔ Hazard Evaluation Across the Supply Chain
- Assess hazards originating at farm/primary production level
- Evaluate process-control hazards during manufacturing and packaging
- Consider hazards introduced during cross-contamination, reconditioning, or rework
- Verify hazard risks during transit, distribution, and consumer storage/handling
✔ Relevance to Target Consumer Groups
- Identify general population vs. vulnerable populations (infants, elderly, immune-compromised)
- Review hazards associated with misuse, improper cooking, or cross-contact
- Document disclaimers or label requirements for consumer handling
✔ Hazard Control Assessment
- Determine whether the foreign supplier’s preventive controls adequately address hazards
- Verify adequacy of sanitation, allergen segregation, temperature control, and traceability
- Evaluate lab testing programs, CCP monitoring, corrective actions, and training
- Ensure controls are validated and verified—not simply stated on paper
✔ Documented Risk Determination
- Assign overall product risk (Low, Medium, High) based on science and data
- Document justification linking hazards → severity → likelihood → control capability
- Establish verification actions proportional to risk assessment findings
- Maintain traceable documentation that supports FDA inspection readiness
Support for Product Hazard Evaluation
Food Safety Systems offers specialized services to help importers complete and defend scientifically sound hazard evaluations:
- Hazard assessment tools aligned with Codex HACCP and FSVP standards
- Pre-built risk matrices and severity/likelihood scoring models
- Ingredient-specific hazard profiles and regulatory reference summaries
- Technical reviews of supplier controls and preventives
- Scientific justification templates for FSVP verification decisions
- Fully managed hazard evaluation documentation services
- On-site or virtual consultation with food safety specialists
Let our experts help you build a defensible, compliant hazard evaluation framework tailored to your imported products.
Ready to Evaluate Hazards for Your Imported Products?
Build a risk-based, science-driven FSVP foundation.
Request Product Hazard Evaluation like this…
- Book Your Free FSVP Consultation
- Request a Sample Hazard Evaluation Template
- Get a Custom Proposal for Your Imported Products
This content is adapted from publicly available requirements and guidance related to the Foreign Supplier Verification Program (FSVP), including sections of 21 CFR Part 1 Subpart L, FDA compliance guidance, Codex Alimentarius risk analysis principles, and industry best practices used in global food safety programs.
For regulatory compliance, importers must follow the officially published requirements applicable to their region and product type, as issued by the FDA or other competent authorities. This material is intended for educational and informational purposes and does not substitute for review of official regulations.
FSVP Services is an independent service provider and is not affiliated with, endorsed by, or certified under any specific FSVP, FDA, Codex, or GFSI program owner.
References to FDA regulations, Codex principles, or GFSI frameworks are for informational purposes only and do not imply endorsement, approval, or partnership by any regulatory body, program owner, or certification authority.
Fees and Subscriptions
Optional Add-On Modules (Subscribe per user/month)
| Add-On Feature | Description | Price/User/Month |
|---|---|---|
| Supplier Approval Management | Manage organization’s legal records and entity information | $59 |
| Products Management | Organize product specifications, attributes, labeling, packaging, testing, and category risk | $59 |
| Customer Requirements Management | Maintain customer requirements documentation for traceability | $59 |
| Food Fraud Vulnerability Assessment (FFVA) | Document Food Fraud Vulnerability Assessments and mitigation plans | $69 |
| Corrective and Preventive Action (CAPA) Management | Track and resolve non-conformities, audit findings, and follow-up tasks | $49 |
| E-Forms (up to 10) | Digitized monitoring and verification forms | $99 |
| Custom Digital Form | One-time setup for custom form workflows | $300/form |
| Risk Assessment | Build and manage product- or category-specific hazard evaluations | $59 |
| Internal Audit Module | Schedule and track internal audits, findings, and improvements | $59 |
Custom Packages Available
- • Starts at $649 per month per facility, with core modules and certain add-ons included
- • Ideal for medium to large enterprises, corporations, and multi-facility organizations
Ideal For:
- • U.S. Importers under FSVP
- • Foreign Suppliers using U.S. Agents
- • Food Brands entering the U.S. market
- • Regulatory Consultants managing multiple importers
- • Warehouses or co-packers verifying international shipments
