Regulatory Compliance and Food Safety Standards
What the exam tests
Jurisdiction, core statutes, preventive controls, HACCP regulations, and labeling and allergen requirements.
Core rules
- US: FD&C Act; FSMA; 21 CFR 117 for human food GMP and preventive controls; 21 CFR 121 for intentional adulteration; 21 CFR Part 1 Subpart L for FSVP; 9 CFR 417 for meat and poultry HACCP.
- FDA Food Code is a model for retail and food service, not federal statute.
- EU: Regulation (EC) 178/2002 general food law; 852/2004 hygiene; 853/2004 specific hygiene; 2017/625 official controls.
- Codex CAC/RCP 1-1969 is the international HACCP reference.
- Allergen labeling, nutrition claims, and traceability duties vary by market; verify the destination market before release.
Worked example
A US processor ships a soy-containing sauce to the EU. US Big 9 labeling is not enough; EU 14 rules require soy declaration and may require a gluten check. The label must be verified against the destination regulation, supplier specifications, and a validated allergen cleaning record before shipment.
Traps
Assuming FDA regulates meat and poultry; treating the Food Code as law; missing FSVP for imported ingredients; using US allergen rules for EU product.