Compliance frameworks

Darwin is framework-agnostic: the platform records a single underlying event stream and emits regulatory bundles per framework as configuration (not code). Adding a new framework usually means adding a mapping, not building a new pipeline.

The frameworks supported today:

FSMA 204 (US FDA)

Scope: high-risk foods entering the US. Effective 2028-07-20.

Obligations:

• Record Critical Tracking Events (CTEs) at receiving, transformation, shipping.
• Carry Key Data Elements (KDEs): date, location, quantity, lot code.
• Assign Traceability Lot Codes (TLCs) that follow the batch.
• Respond to recall within 24h.

What Darwin gives you: a dedicated reporting service auto-generates the FSMA 204 bundle (CTE + KDE + TLC per lot) from your captured events in Tracium.

EUDR (EU Deforestation Regulation)

Scope: 7 commodities entering the EU (cattle, cocoa, coffee, oil palm, rubber, soya, wood). Effective 2026-12.

Obligations:

• File a Due Diligence Statement (DDS) per shipment.
• Prove geolocation of origin (plot-level GPS).
• Demonstrate no deforestation post-2020 cutoff.

What Darwin gives you: Captia captures plot-level GPS at origin. Tracium consolidates plot evidence and chain of custody. The DDS regulatory bundle is available on demand: the mapping is defined and the dedicated endpoint can be activated for your tenant. Today you can also extract the data via operational reports and assemble the DDS externally.

USMCA + IATF 16949

Scope: auto parts crossing US / MX / CA borders.

USMCA obligations:

• Self-certified Certificate of Origin with BOM-by-origin (which components, where each was made).
• Traceable customs filing trail (MX pedimento + US CBP entry).

IATF 16949 obligations (quality records the OEM and certification body audit):

• PPAP (Production Part Approval Process)
• FAI (First Article Inspection)
• SPC (Statistical Process Control with Cp/Cpk)

What Darwin gives you: Captia digitizes tier-2 / tier-3 workshops that have no MES. Tracium consolidates the multi-tier custody chain. Formatted USMCA Certificate of Origin and IATF 16949 quality-records bundles are available on demand. Today you can extract the data via operational reports and assemble the bundles externally.

Records, not certification

Darwin produces audit-ready records compatible with these frameworks. It is not the certification body. Self-certification under USMCA stays with the producer / exporter. IATF 16949 certification is issued by the certifying body. Darwin produces records that hold up under audit.

ESPR Digital Product Passport (EU)

Scope: textiles, batteries, electronics, furniture, others. Progressive enforcement from 2027 by product category.

Obligations:

• Digital Product Passport accessible via QR or NFC.
• Composition, origin, recyclability, and repair info per product.
• Verifiable evidence chain back to source materials.

What Darwin gives you: Fidenta mints the DPP per product. Tracium backs each claim with the on-chain provenance. The passport viewer ships GS1 Digital Link compatible URLs out of the box. The dedicated ESPR DPP regulatory JSON-LD bundle is available on demand.

EU 2023/1542 (Battery Regulation)

Scope: industrial / EV / LMT batteries. Effective 2027-02.

Obligations: battery passport with carbon footprint, recycled content, hazardous-substance disclosure, end-of-life pathway.

What Darwin gives you: the protocol supports the schema. Activation is on demand, scoped to your battery program.

Additional frameworks on demand

The data model is agnostic. If your integration requires a framework not listed here, contact the team at tech@darwinevolution.io. We will evaluate coverage for your specific case and respond with the supported scope.