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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 foods containing milk and edible oils
as well as aqueous beverages
FKM
For aqueous-based foods
and beverages only
NBR*
For aqueous-based foods
and beverages only
EP
50536DS—–372FX565CZ
60536AB514ZR445A559PN
70536X514YP525K559PE, 560YH, 559TM
80536AQ514ZM446A559PM
90—-514ZC309BK559GT

*These NBR elastomers will provide superior heat and compression set resistance as compared to the 536 series NBR elastomers.

Most Minnesota Rubber and Plastics silicones meet the above requirements. The following compounds are examples of the unique features available in silicone elastomers:

71417CGeneral purpose; very versatile, excellent compression set properties, heat resistant.
73117AUltra low temperatures.
74115High strength at low temperatures, high tensile strength.
74115CTear resistant and high strength for good mechanical durability.

Minnesota Rubber and Plastics has also worked extensively with a wide variety of soft drinks and has data available.