US FDA 21 CFR 177.2470 Indirect Food Additives: Polymers - Polyoxymethylene Copolymer

The standard “US FDA 21 CFR 177.2470 Indirect food additives: polymers - Polyoxymethylene copolymer” published under the Code of Federal Regulations (CFR) explains that polyoxymethylene copolymer as defined herein can be used safely as a substance or component of substances intended for food contact in accordance with the following prescribed conditions:

• Identity. For the purpose of this section, polyoxymethylene copolymers are defined as: The reaction product of trioxane (cyclic trimer of formaldehyde) and ethylene oxide or the reaction product of trioxane (cyclic trimer of formaldehyde) and a maximum of 5 weight percent butanediol formalin. Certain optional substances may be added to either copolymer to impart desired technological properties to the copolymer.
• Optional adjuvants. The polyoxymethylene copolymer as defined above may contain optional adjuvants as necessary in its manufacture. The amount of any optional adjuvant used in the manufacture of the copolymer shall not exceed that which is reasonably necessary to achieve the intended technical or physical effect. Such adjuvants may include substances generally recognized as safe in foods, substances used in accordance with previous approval, substances permitted under applicable regulations in parts 170 through 189 of this chapter, and:
  • Stabilizers (the total amount of stabilizers should not exceed 2,0 percent and the amount of any one stabilizer should not exceed 1,0 percent by weight of the polymer): calcium ricinoleate, cyanoguanidine, hexamethylene bis(3,5-di-tert-butyl-4-hydroxyhydrocinnamate), melamine-formaldehyde resin, 2,2′-Methylenebis(4-methyl-6-tert-butylphenol), nylon 6/66, 2/3 weight ratio, tetrakis(methylene (3,5-di-tert-butyl-4-hydroxyhydrocinnamate)) methane.
  • Lubricant: N,N′Distearoylethyl-enediamine.
• Features.
  • Polyoxymethylene copolymer can be identified by its characteristic infrared spectrum.
  • The minimum number average molecular weight of the copolymer is 15.000 as determined by a method entitled “Number average molecular weight” incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition or may be inspected at the National Archives and Records Administration.
• Removal limitations.
  • Polyoxymethylene copolymer in finished form intended to come into contact with food, when extracted under the time and temperature conditions determined from the appropriate tables of this section and with the solvent or solvents characterizing the food type, yields net chloroform-soluble extractives not to exceed 0,5 milligrams per square inch of food-contact surface.
  • The polyoxymethylene copolymer, with or without the optional ingredients described herein, when milled or cut into particles passing US standard sieve number 6 and retained on US standard sieve number 10, gives total extractives as follows:
    • It should not exceed 6 percent by weight of the copolymer when extracted with distilled water at reflux temperature for 0,20 hours.
    • It should not exceed 6 percent by weight of the copolymer when extracted with n-heptane at reflux temperature for 0,15 hours.
• Terms of use.
  • Polyoxymethylene copolymer is intended for use as substances or components of substances designed for repeated use.
  • The usage temperature should not exceed 121 degrees.
  • In accordance with good manufacturing practice, finished articles containing polyoxymethylene copolymer should be thoroughly cleaned before their first use in contact with food.

Briefly, 21 CFR 177.2470 is a regulation from the U.S. Food and Drug Administration (FDA) regarding the safe use of polyoxymethylene copolymers in food contact applications. These copolymers are permitted to be used as substances or components of substances designed for repeated use in food contact under certain conditions.

This regulation defines two types of polyoxymethylene copolymers:

• Reaction product of trioxane (cyclic trimer of formaldehyde) and ethylene oxide
• Trioxane and maximum 5 percent by weight butanediol formalin reaction product

The copolymer must have a minimum number average molecular weight of 15, determined by a specified method. The copolymer can be identified by its characteristic infrared spectrum.

Inference limitations were determined as follows:

• When in finished form intended for food contact, the copolymer shall produce net chloroform-soluble extracts not exceeding 0,5 milligrams per square inch of food contact surface under specified conditions.
• When ground or cut into particles of specified sizes, total extractions shall not exceed 0,20 percent by weight when extracted with distilled water and 0,15 percent by weight when extracted with n-heptane, both at reflux temperature for 6 hours.

The copolymer is intended for use in articles or components of articles for repeated use in contact with food. The temperature of use should not exceed 121 degrees. Finished articles containing copolymer should be thoroughly cleaned before their first use in contact with food.

In summary, this regulation is necessary because it ensures that polyoxymethylene copolymers used in food contact applications are safe for human health.

Our organization, which has been trying to support businesses from every sector with its wide range of testing, measurement, analysis and evaluation studies for years, has a strong staff that closely follows the developments in the world in the field of science and technology and constantly improves itself. In this context, testing services in accordance with the "US FDA 21 CFR 177.2470 Indirect food additives: polymers - Polyoxymethylene copolymer" standard are also provided to businesses.