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What Regulations Apply to Ethylene Bis-Stearamide?

July 14, 2015
Question 

Ethylene Bis-Stearamide is a common enough material used in food packaging, but I am finding that companies that sell it list several FDA regulations. When I check the regulations, I find no mention of that substance. Which regulations apply?

Answer 

Ethylene bis-stearamide, also known as Acrawax C, is included on the 1956 "Lehman's List" of prior-sanctioned materials for use as a release agent, subject to no other limitations. As such, suppliers may legitimately reference the regulatory compliance of ethylene bis-stearamide with the Federal Food, Drug, and Cosmetic Act and its implementing regulations as a "prior-sanctioned" material, in accordance with 21 C.F.R. § 174.5(d)(3).

Ethylene bis-stearamide, which is a saturated fatty acid amide manufactured from fatty acids derived from animal, marine, or vegetable fats and oils, is also cleared under Section 178.3860 ("Release agents") for use as a release agent in polymeric resins that contact food with no limitations as to food type or temperature. Thus, this regulation as well may be cited.