FDARegulatory IntelligenceRegulation
21 CFR Part 1, Subpart L

Foreign Supplier Verification Programs (FSVP)

An FSMA rule requiring US importers of food for humans and animals to verify that their foreign suppliers produce food meeting US safety standards. Importers must conduct hazard analysis, evaluate supplier performance and risk, and perform supplier verification activities — extending preventive-controls thinking across the border.

LAST REVISED
May 2017
PRODUCT AREAS
FoodDietary Supplement
SCOPE & APPLICABILITY

US importers of human and animal food — supplier verification to ensure imported food meets US safety requirements.

KEY REQUIREMENTS
  • 01Conduct a hazard analysis for each imported food
  • 02Evaluate and approve foreign suppliers on a risk basis
  • 03Perform verification activities proportionate to the hazard
  • 04Maintain FSVP records and provide importer identification at entry
IMPLEMENTATION TIPS
Match verification intensity to the hazard — audits for serious hazards, lighter checks otherwise
Keep the importer-of-record identification accurate at entry to avoid holds
Align FSVP with your 21 CFR 117 preventive-controls program rather than duplicating it
REVISION NOTES

Finalised under FSMA in 2015 with staggered compliance dates from 2017; a core pillar of import food safety.

21 CFR Part 1, Subpart L: frequently asked questions

Quick answers to common questions about 21 CFR Part 1, Subpart L.

What is 21 CFR Part 1, Subpart L?

21 CFR Part 1, Subpart L — Foreign Supplier Verification Programs (FSVP) — is a regulation issued by the Food and Drug Administration (United States). An FSMA rule requiring US importers of food for humans and animals to verify that their foreign suppliers produce food meeting US safety standards. Importers must conduct hazard analysis, evaluate supplier performance and risk, and perform supplier verification activities — extending preventive-controls thinking across the border.

Who does 21 CFR Part 1, Subpart L apply to?

US importers of human and animal food — supplier verification to ensure imported food meets US safety requirements.

What are the key requirements of 21 CFR Part 1, Subpart L?

FDA 21 CFR Part 1, Subpart L requires, among other things: Conduct a hazard analysis for each imported food; Evaluate and approve foreign suppliers on a risk basis; Perform verification activities proportionate to the hazard; Maintain FSVP records and provide importer identification at entry.

When was 21 CFR Part 1, Subpart L last updated?

The current version of 21 CFR Part 1, Subpart L dates from May 2017. Finalised under FSMA in 2015 with staggered compliance dates from 2017; a core pillar of import food safety.

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