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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: 21CFR189]





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 189SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
 

Subpart D--Substances Prohibited From Indirect Addition to Human Food Through Food-Contact Surfaces

Sec. 189.220 Flectol H.

(a) Flectol H is the chemical 1,2-dihydro-2,2,4-trimethylquinoline, polymerized, C12H15N. It is a synthetic chemical not found in natural products, and has been used as a component of food packaging adhesives.

(b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of April 7, 1967 (32 FR 5675).

[42 FR 14659, Mar. 15, 1977, as amended at 58 FR 17099, Apr. 1, 1993]

Sec. 189.240 Lead solders.

(a) Lead solders are alloys of metals that include lead and are used in the construction of metal food cans.

(b) Food packaged in any container that makes use of lead in can solder is deemed to be adulterated in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the Federal Register of June 27, 1995.

[60 FR 33109, June 27, 1995]

Sec. 189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.

(a) Mercaptoimidazoline and 2-mercaptoimidazoline both have the molecular formula C3H6N2S. They are synthetic chemicals not found in natural products and have been used in the production of rubber articles that may come into contact with food.

(b) Food containing any added or delectable levels of these substances is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of November 30, 1973 (38 FR 33072).

Sec. 189.280 4,4'-Methylenebis (2-chloroanaline).

(a) 4,4'-Methylenebis (2-chloroanaline) has the molecular formula, C13H12Cl2N2. It is a synthetic chemical not found in natural products and has been used as a polyurethane curing agent and as a component of food packaging adhesives and polyurethane resins.

(b) Food containing any added or detectable level of this substance is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of December 2, 1969 (34 FR 19073).

Sec. 189.300 Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins.

(a) Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester resins are the condensation product of 1 mole of triphenyl phosphite and 1.5 moles of hydrogenated 4,4'-isopropylidene-diphenol such that the finished resins have a molecular weight in the range of 2,400 to 3,000. They are synthetic chemicals not found in natural products and have been used as antioxidants and as stabilizers in vinyl chloride polymer resins when such polymer resins are used in the manufacture of rigid vinyl chloride polymer bottles.

(b) Food containing any added or detectable levels of these substances is deemed to be adulterated and in violation of the Federal Food, Drug, and Cosmetic Act, based upon an order published in the Federal Register of September 9, 1987 (52 FR 33929).

[54 FR 7188, Feb. 17, 1989]

Sec. 189.301 Tin-coated lead foil capsules for wine bottles.

(a) Tin-coated lead foil is composed of a lead foil coated on one or both sides with a thin layer of tin. Tin-coated lead foil has been used as a capsule (i.e., as a covering applied over the cork and neck areas) on wine bottles to prevent insect infestation, as a barrier to oxygen, and for decorative purposes. Information received by the Food and Drug Administration establishes that the use of such a capsule on wine bottles may reasonably be expected to result in lead becoming a component of the wine.

(b) The capping of any bottles of wine after February 8, 1996, with a tin-coated lead foil capsule renders the wine adulterated and in violation of section 402(a)(2)(C) of the Federal Food, Drug, and Cosmetic Act because lead from the capsule, which is an unsafe food additive within the meaning of section 409 of the act, may reasonably be expected to become a component of the wine.

[61 FR 4820, Feb. 8, 1996]

Authority: 21 U.S.C. 321, 342, 348, 371, 381.
Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted.

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