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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR177.2410]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 177 -- INDIRECT FOOD ADDITIVES: POLYMERS

Subpart C--Substances for Use Only as Components of Articles Intended for Repeated Use

Sec. 177.2410 Phenolic resins in molded articles.

Phenolic resins identified in this section may be safely used as the food-contact surface of molded articles intended for repeated use in contact with nonacid food (pH above 5.0), in accordance with the following prescribed conditions:

(a) For the purpose of this section, the phenolic resins are those produced when one or more of the phenols listed in paragraph (a)(1) of this section are made to react with one or more of the aldehydes listed in paragraph (a)(2) of this section, with or without aniline and/or anhydro-formaldehyde aniline (hexahydro-1, 3,5-triphenyl-s-triazine):

(1) Phenols:

p-tert- Amylphenol.

p-tert- Butylphenol.

o-, m-, and p- Cresol.

p- Octylphenol.

Phenol.

o- and p- Phenylethylphenol mixture produced when phenol is made to react with styrene in the presence of sulfuric acid catalyst.

(2) Aldehydes:

Acetaldehyde.

Formaldehyde.

Paraldehyde.

(b) Optional adjuvant substances employed in the production of the phenolic resins or added thereto to impart desired technical or physical properties include the following:

Asbestos fiber
Barium hydroxideFor use as catalyst.
Calcium stearateFor use as lubricant.
Carbon black (channel process)
Diatomaceous earth
Glass fiber
HexamethylenetetramineFor use as curing agent.
Mica
Oxalic acidFor use as catalyst.
Zinc stearateFor use as lubricant.

(c) The finished food-contact article, when extracted with distilled water at reflux temperature for 2 hours, using a volume-to-surface ratio of 2 milliliters of distilled water per square inch of surface tested, shall meet the following extractives limitations:

(1) Total extractives not to exceed 0.15 milligram per square inch of food-contact surface.

(2) Extracted phenol not to exceed 0.005 milligram per square inch of food-contact surface.

(3) No extracted aniline when tested by a spectrophotometric method sensitive to 0.006 milligram of aniline per-square inch of food-contact surface.

(d) In accordance with good manufacturing practice, finished molded articles containing the phenolic resins shall be thoroughly cleansed prior to their first use in contact with food.

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