Food-Grade Screening: What EU & FDA Buyers Must Check

When a food line fails an audit, the sieve is rarely the reason — the paperwork around the sieve is. Whether you face FDA 21 CFR, EU 1935/2004 or a customer GMP audit, the same eight checks come up. Demand them at order stage; they cost nothing then and weeks later.

The 8-point checklist

• 1. Material certificates (EN 10204 3.1) for every product-contact component: shell, deck rings, mesh cloth, clamp band. “SUS304” on a drawing is not a certificate.
• 2. Surface finish readings. Product-contact welds ground and polished to Ra ≤ 0.8 μm (≤ 0.6 μm for dairy-class). Ask for the actual roughness map, machine-serial-linked.
• 3. Gasket & seal compliance. FDA 21 CFR 177.2600 silicone for food contact; EU 1935/2004 declaration of compliance for EU-bound machines. Get both documents, not a catalogue claim.
• 4. Crevice & drain design. Self-draining deck outlets, no horizontal dead ledges, welded (not overlapped) screen frames. Auditors run a torch along the frame joints.
• 5. Hygienic cable & motor routing. No product-zone cable runs; motor hood drains downward; food-safe lubricants documented.
• 6. Cleanability validation. Documented CIP or COP procedure with times/temperatures, and a cleanability statement per EHEDG principles (full EHEDG certification where the process demands it).
• 7. Traceability labelling. Each machine serial-linked to its certificate pack, mesh part-numbers logged for repeat orders — because the auditor will ask for “the same mesh as last time”.
• 8. Changeover design. Tool-free clamp bands: if an operator needs a screwdriver, the changeover procedure eventually gets skipped at 2 a.m. Design for the night shift, not the showroom.

Red flags in a supplier conversation

If a supplier cannot produce items 1–3 before shipment, every other promise is decoration. Reputable manufacturers ship the document pack with the machine as standard practice, not as an up-sell.

What we do on this front

Every VortiSep food/pharma build ships with the full pack — 3.1 certificates, finish map, gasket compliance, serial traceability — and our QA team will join your audit call if the auditor has questions. The machines are the easy part; the paper trail is where audits are won.