FDA Regulations/Food & Beverage Applications
The United States Government regulates the ingredients in rubber products that are intended for use in food contact applications.
The controlling agency is the Food and Drug Administration (FDA), whose guidelines are stated through the Code of Federal Regulations (CFR). The regulations covering rubber articles are contained in CFR Title 21, Chapter 1, Subchapter B, Part 177, Subpart C, and Paragraph 2600.
The FDA provides two categories for individual food types with rubber compatibility. The Class I category designates foods, including edible oils, butter, milk and milk based products and cooking oils. Rubber compounds that meet these requirements are also compliant with foods in Class II. The second category, Class II, pertains to foods that do not contain edible oils or milk products. Water, soft drinks, alcoholic beverages and other aqueous solutions are typical Class II environments. Minnesota Rubber and Plastics has a large selection of compounds with physical property ranges to meet your application needs. The following tables give a listing of recommendations as a starting point.
FDA – Food, Drug and Cosmetic Act CFR 21, Chapter 1, Sub ch. B, Part 177, Subpart C, Section 177.2600
| For foods containing milk and edible oils as well as aqueous beverages Hardness Shore A | For foods containing milk and edible oils as well as aqueous beverages NBR | For aqueous-based foods and beverages only FKM | For aqueous-based foods and beverages only NBR* | For aqueous-based foods and beverages only EPDM |
|---|---|---|---|---|
| 50 | 536DS | —– | 372FX | 565CZ |
| 60 | 536AB | 514ZR | 445A | 558CM, 559PN |
| 70 | 536X | 514YP, 515CG | 525K | 558CH, 559PE, 560YH, 559TM |
| 80 | 536AQ | 514ZM | 446A | 559PM, 561NZ |
| 90 | —- | — | 309BK | 558CK, 559GT |
*These NBR elastomers will provide superior heat and compression set resistance as compared to the 536 series NBR elastomers.
For Aqueous and Fatty Foods and Beverages
| Shore A | NBR | FKM | Silicone |
|---|---|---|---|
| 50 | 536DS | — | 71105B |
| 60 | 536AB | 514ZR | 74116A |
| 70 | 536X, 536EG | — | 74117 |
| 80 | — | — | 761868 |
| 90 | — | — | — |
For Aqueous Foods and Beverages Only
| NBR | Qmonix® EPDM | FKM |
|---|---|---|
| — | 565CZ | — |
| 445A | 560CF, 559PN, 558CM | — |
| 525K | 559PE, 560YH, 559TM, 558CH | 514YP, 515CG |
| 446A | 559PM, 561NZ | 514ZM |
| 309BK | 559GT, 558CK | — |
Minnesota Rubber and Plastics has also worked extensively with a wide variety of soft drinks and has data available.
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