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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 2020.

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, 2020]
[CITE: 21CFR177.2355]



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. 177.2355 Mineral reinforced nylon resins.

Mineral reinforced nylon resins identified in paragraph (a) of this section may be safely used as articles or components of articles intended for repeated use in contact with nonacidic food (pH above 5.0) and at use temperatures not exceeding 212 deg.F. in accordance with the following prescribed conditions:

(a) For the purpose of this section the mineral reinforced nylon resins consist of nylon 66, as identified in and complying with the specifications of § 177.1500, reinforced with up to 40 weight percent of calcium silicate and up to 0.5 weight percent 3-(triethoxysilyl) propylamine (Chemical Abstracts Service Registry No. 000919302) based on the weight of the calcium silicate.

(b) The mineral reinforced nylon resins may contain up to 0.2 percent by weight of titanium dioxide as an optional adjuvant substance.

(c) The mineral reinforced nylon resins with or without the optional substance described in paragraph (b) of this section, and in the form of 1/8-inch molded test bars, when extracted with the solvents, i.e., distilled water and 50 percent (by volume) ethyl alcohol in distilled water, at reflux temperature for 24 hours using a volume-to-surface ratio of 2 milliliters of solvent per square inch of surface tested, shall meet the following extractives limitations:

(1) Total extractives not to exceed 5.0 milligrams per square inch of food-contact surface tested for each solvent.

(2) The ash after ignition of the extractives described in paragraph (c)(1) of this section, not to exceed 0.5 milligram per square inch of food-contact surface tested.

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

[42 FR 54533, Oct. 7, 1977, as amended at 42 FR 61594, Dec. 6, 1977]

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