The Short Version
FSMA 204 is the US FDA's food traceability rule — it applies to specific high-risk foods on the Food Traceability List and focuses on tracing a batch backward and forward within 24 hours of a records request. EUDR is the EU's deforestation regulation — it applies to specific commodities regardless of risk category, and focuses on proving a product's origin wasn't deforested land. They solve different problems, and neither one satisfies the other.
Scope: Who's Covered
FSMA 204 covers foods on the FDA's Food Traceability List, plus anything made using one of those foods as an ingredient. EUDR covers specific commodities — cocoa, coffee, rubber, soy, palm oil, cattle, wood, and their derived products — brought into the EU market, regardless of how risky the specific food category is considered.
Deadline: When You Need to Be Ready
FSMA 204 compliance is required by July 20, 2028. EUDR compliance is required by December 30, 2026 for large and medium operators, and June 30, 2027 for micro and small enterprises — both earlier than FSMA 204, and both already delayed once from their original dates.
Core Requirement: What You're Actually Proving
FSMA 204 wants you to prove which batch is which, at 7 specific tracking events, with Traceability Lot Codes and Key Data Elements you can produce within 24 hours. EUDR wants you to prove where the raw material came from, down to plot-level geolocation, with documented evidence it wasn't grown on land deforested after December 31, 2020.
Penalty Exposure
EUDR penalties are reported at a minimum of 4% of a non-compliant company's EU-wide annual turnover, plus confiscation of goods and possible exclusion from public procurement. FSMA 204 doesn't carry a rule-specific fine schedule — enforcement runs through FDA's existing inspection, warning-letter, and mandatory-recall authority.
If You're Facing Both
1. Don't build two separate systems — most of the underlying data (who handled it, where, when) is useful for both, even though what you're proving with it differs. 2. Track your EU-bound and US-bound product lines separately if their compliance timelines differ, since EUDR's deadline arrives well before FSMA 204's. 3. Assign one team or system as the source of truth for traceability data, so an EU auditor and an FDA investigator aren't getting answers from two different records.
See a System Built for Both
reGenesis captures the underlying traceability data — origin, batch, handoffs, timestamps — that both regimes are ultimately asking for, structured so it can answer either kind of question.
See how reGenesis DPP+ works →
