Ertalyte FDA Food-Grade Compliance — PET-P 21 CFR 177.1630
Ertalyte (bearing-grade PET-P) and Ertalyte TX both comply with FDA 21 CFR 177.1630, which covers polyethylene terephthalate resins for use as articles or components of articles in contact with food. This compliance extends to both unfilled Ertalyte and the PTFE-plus-solid-lubricant TX grade, making both suitable for direct food contact in machinery components where a compliant bearing or wear material is required.
At a glance:
- FDA regulation: 21 CFR 177.1630 — applicable to both Ertalyte natural and Ertalyte TX
- USDA: Accepted for incidental food contact in meat and poultry processing plants
- White/off-white color aids visual contamination detection per HACCP protocols
- Low moisture absorption (0.10% at 24 hr) maintains dimensional stability in wash-down environments
- Not NSF-61 listed as standard — verify for potable water line applications
- Certificate of Conformance available confirming lot-specific FDA status
What 21 CFR 177.1630 Covers
Title 21, Code of Federal Regulations, Part 177.1630 defines the permissible composition requirements for polyethylene terephthalate (PET) resins used in food-contact applications. It restricts extractable substances (heavy metals, residual monomers, adjuvants) to levels that present no safety concern when the material is in contact with food.
For Ertalyte (PET-P):
- The base resin is PET polycondensate, which falls under the 177.1630 category
- PTFE filler in Ertalyte TX is separately cleared under 21 CFR 177.1550 (fluoropolymer resins)
- The solid lubricant in TX must also be an FDA-compliant additive — Mitsubishi/Quadrant formulates TX to meet this requirement
FDA compliance is lot-specific. When Ertalyte is required for a regulated food-zone application, request a Certificate of Conformance (COC) from your supplier confirming 21 CFR 177.1630 compliance for the specific production lot. A generic material grade description alone is not sufficient for most food-safety audits.
USDA Acceptance
The U.S. Department of Agriculture (Agricultural Marketing Service) maintains an approved list of materials for use in direct food contact or incidental food contact in federally inspected meat and poultry processing facilities. Ertalyte (PET-P) natural and Ertalyte TX are accepted for incidental food contact.
This USDA acceptance is directly relevant for:
- Conveyor chain guides and wear strips in poultry processing lines
- Pump bushings handling meat slurries or brines
- Wear components in portioning and cutting equipment
Practical Food-Zone Suitability
Why Low Moisture Absorption Matters for Food-Zone Parts
Food processing environments combine high humidity, frequent wash-down, and sometimes immersion in process fluids. PET-P's 0.10% water absorption at 24 hours and 0.26% at saturation — with less than 0.05% dimensional change — means Ertalyte bearings and guides maintain their design clearances and surface finishes throughout the service cycle.
By contrast, nylon (PA6 or PA6/6) absorbs 1.6–1.8% in 24 hours and up to 9.5% at saturation. A nylon bushing bored to a precise fit with a shaft will swell closed over time in a wash-down environment, causing seizure and requiring premature replacement.
Color and Visual Inspection
Ertalyte natural is off-white to translucent white. Ertalyte TX is opaque white. Both colors comply with the food-safety preference for light-colored contact materials, which allow contamination fragments to be visually identified. Many food plant HACCP programs specify white or light-colored contact materials for this reason.
If fragment detectability via metal detector or X-ray is required, note that standard Ertalyte is not detectable by metal detector and has low X-ray contrast. Specify metal-detectable or X-ray-detectable grades (available from some suppliers as specialty compounds) if fragment detection is a critical control point.
Chemical Resistance to Cleaning Agents
CIP (Clean-In-Place) and wash-down in food plants typically involve:
| Cleaning Chemical | Ertalyte Performance |
|---|---|
| Sodium hydroxide (NaOH) <5% | Good |
| Phosphoric acid <10% | Excellent |
| Nitric acid <5% | Good |
| Citric acid solutions | Excellent |
| Quaternary ammonium sanitizers | Good |
| Sodium hypochlorite (bleach) <2% | Good |
| Peracetic acid (PAA) <0.5% | Good |
Avoid prolonged exposure to concentrated chlorinated solvents (methylene chloride, TCE) — these attack PET. Standard food-plant cleaning chemicals are well within Ertalyte's resistance range.
Regulatory Summary
Ertalyte vs. Competing FDA-Compliant Bearing Plastics
Other FDA-compliant bearing materials are available. Here is how they compare for food-zone use:
Ertalyte is particularly favorable over nylon in wet food-zone bearings and over acetal in dilute acid environments (citric, acetic, phosphoric). UHMW polyethylene is softer (better for low-speed, high-impact applications) and cheaper; Ertalyte is harder, stiffer, and dimensionally more stable for precision machined parts.
For higher-temperature food-zone applications (above 212°F) where bearing performance still matters, PEEK or PPS (Ryton) are the next step.
Order FDA-compliant Ertalyte with COC documentation
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