This electronic document was downloaded from the GPO web site, November 2003,
and is provided for information purposes only. The Code of Federal Regulations,
Title 21, is updated April 1 of each year.
The most current version of the regulations may be found at the
GPO web site.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189]
[Page 571-572]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart A--General Provisions
Sec.
189.1 Substances prohibited from use in human food.
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
189.110 Calamus and its derivatives.
189.113 Cinnamyl anthranilate.
189.120 Cobaltous salts and its derivatives.
189.130 Coumarin.
189.135 Cyclamate and its derivatives.
189.140 Diethylpyrocarbonate (DEPC).
189.145 Dulcin.
189.155 Monochloroacetic acid.
189.165 Nordihydroguaiaretic acid (NDGA).
189.175 P-4000.
189.180 Safrole.
189.190 Thiourea.
189.191 Chlorofluorocarbon propellants.
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
189.220 Flectol H.
189.240 Lead solders.
[[Page 572]]
189.250 Mercaptoimidazoline and 2-mercaptoimidazoline.
189.280 4,4'-Methylenebis (2-chloroanaline).
189.300 Hydrogenated 4,4'-isopropylidene-diphenolphosphite ester
resins.
189.301 Tin-coated lead foil capsules for wine bottles.
Authority: 21 U.S.C. 321, 342, 348, 371.
Source: 42 FR 14659, Mar. 15, 1977, unless otherwise noted.
Editorial Note: Nomenclature changes to part 189 appear at 61 FR
14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.1]
[Page 572]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart A--General Provisions
Sec. 189.1 Substances prohibited from use in human food.
(a) The food ingredients listed in this section have been prohibited
from use in human food by the Food and Drug Administration because of a
determination that they present a potential risk to the public health or
have not been shown by adequate scientific data to be safe for use in
human food. Use of any of these substances in violation of this section
causes the food involved to be adulterated in violation of the act.
(b) This section includes only a partial list of substances
prohibited from use in human food, for easy reference purposes, and is
not a complete list of substances that may not lawfully be used in human
food. No substance may be used in human food unless it meets all
applicable requirements of the act.
(c) The Commissioner of Food and Drugs, either on his own initiative
or on behalf of any interested person who has submitted a petition, may
publish a proposal to establish, amend, or repeal a regulation under
this section on the basis of new scientific evaluation or information.
Any such petition shall include an adequate scientific basis to support
the petition, pursuant to part 10 of this chapter, and will be published
for comment if it contains reasonable grounds.
[42 FR 14659, Mar. 15, 1977, as amended at 54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.110]
[Page 572]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.110 Calamus and its derivatives.
(a) Calamus is the dried rhizome of Acorus calamus L. It has been
used as a flavoring compound, especially as the oil or extract.
(b) Food containing any added calamus, oil of calamus, or extract of
calamus is deemed to be adulterated in violation of the act based upon
an order published in the Federal Register of May 9, 1968 (33 FR 6967).
(c) The analytical method used for detecting oil of calamus ([beta]-
asarone) is in the "Journal of the Association of Official Analytical
Chemists," Volume 56, (Number 5), pages 1281 to 1283, September 1973,
which is incorporated by reference. Copies are available from the
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, also from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 47 FR 11855, Mar. 19, 1982;
54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.113]
[Page 572]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.113 Cinnamyl anthranilate.
(a) The food additive cinnamyl anthranilate
(C16H15NO2, CAS Reg. No. 87-29-6) is
the ester of cinnamyl alcohol and anthranilic acid. Cinnamyl
anthranilate is a synthetic chemical that has not been identified in
natural products at levels detectable by available methodology. It has
been used as a flavoring agent in food.
(b) Food containing any added cinnamyl anthranilate is deemed to be
adulterated in violation of the act based upon an order published in the
Federal Register of October 23, 1985.
[50 FR 42932, Oct. 23, 1985]
[[Page 573]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.120]
[Page 573]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.120 Cobaltous salts and its derivatives.
(a) Cobaltous salts are the chemicals,
CoC4H6O4, CoCl2, and
CoSO4.They have been used in fermented malt beverages as a
foam stabilizer and to prevent "gushing."
(b) Food containing any added cobaltous salts is deemed to be
adulterated in violation of the act based upon an order published in the
Federal Register of August 12, 1966 (31 FR 8788).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.130]
[Page 573]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.130 Coumarin.
(a) Coumarin is the chemical 1,2-benzopyrone,
C9H6O2. It is found in tonka beans and
extract of tonka beans, among other natural sources, and is also
synthesized. It has been used as a flavoring compound.
(b) Food containing any added coumarin as such or as a constituent
of tonka beans or tonka extract is deemed to be adulterated under the
act, based upon an order published in the Federal Register of March 5,
1954 (19 FR 1239).
(c) The analytical methods used for detecting coumarin in food are
in sections 19.016-19.024 of the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.135]
[Page 573]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.135 Cyclamate and its derivatives.
(a) Calcium, sodium, magnesium and potassium salts of cyclohexane
sulfamic acid,
(C6H12NO3S)2Ca,
(C6H12NO3S)Na,
(C6H12NO3S)2Mg, and
(C6H12NO3S)K. Cyclamates are synthetic
chemicals having a sweet taste 30 to 40 times that of sucrose, are not
found in natural products at levels detectable by the official
methodology, and have been used as artificial sweeteners.
(b) Food containing any added or detectable level of cyclamate is
deemed to be adulterated in violation of the act based upon an order
published in the Federal Register of October 21, 1969 (34 FR 17063).
(c) The analytical methods used for detecting cyclamate in food are
in sections 20.162-20.172 of the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.140]
[Page 573]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.140 Diethylpyrocarbonate (DEPC).
(a) Diethylpyrocarbonate is the chemical pyrocarbonic acid diethyl
ester, C6H10O5. It is a synthetic
chemical not found in natural products at levels detectable by available
methodology and has been used as a ferment inhibitor in alcoholic and
nonalcoholic beverages.
(b) Food containing any added or detectable level of DEPC is deemed
to be adulterated in violation of the act based upon an order published
in the Federal Register of August 2, 1972 (37 FR 15426).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.145]
[Page 573-574]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.145 Dulcin.
(a) Dulcin is the chemical 4-ethoxyphenylurea,
C9H12N2O2. It is a synthetic
chemical having a sweet taste about 250 times that of sucrose, is not
found in natural products at levels detectable by the official
methodology, and has been proposed for use as an artificial sweetener.
(b) Food containing any added or detectable level of dulcin is
deemed to be adulterated in violation of the act, based upon an order
published in the Federal Register of January 19, 1950 (15 FR 321).
(c) The analytical methods used for detecting dulcin in food are in
sections 20.173-20.176 of the "Official Methods of
[[Page 574]]
Analysis of the Association of Official Analytical Chemists," 13th Ed.
(1980), which is incorporated by reference. Copies may be obtained from
the Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.155]
[Page 574]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.155 Monochloroacetic acid.
(a) Monochloroacetic acid is the chemical chloroacetic acid,
C2H3C1O2. It is a synthetic chemical
not found in natural products, and has been proposed as a preservative
in alcoholic and nonalcoholic beverages. Monochloroacetic acid is
permitted in food package adhesives with an accepted migration level up
to 10 parts per billion (ppb) under Sec. 175.105 of this chapter. The
official methods do not detect monochloroacetic acid at the 10 ppb
level.
(b) Food containing any added or detectable level of
monochloroacetic acid is deemed to be adulterated in violation of the
act based upon trade correspondence dated December 29, 1941 (TC-377).
(c) The analytical methods used for detecting monochloroacetic acid
in food are in sections 20.067-20.072 of the "Official Methods of
Analysis of the Association of Official Analytical Chemists," 13th Ed.
(1980), which is incorporated by reference. Copies may be obtained from
the Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24899, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.165]
[Page 574]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.165 Nordihydroguaiaretic acid (NDGA).
(a) Nordihydroguaiaretic acid is the chemical 4,4'-(2,3-
dimethyltetramethylene) dipyrocatechol,
C18H22O4. It occurs naturally in the
resinous exudates of certain plants. The commercial product, which is
synthesized, has been used as an antioxidant in foods.
(b) Food containing any added NDGA is deemed to be adulterated in
violation of the act based upon an order published in the Federal
Register of April 11, 1968 (33 FR 5619).
(c) The analytical method used for detecting NDGA in food is in
section 20.008(b) of the "Official Methods of Analysis of the
Association of Official Analytical Chemists International," 13th Ed.
(1980), which is incorporated by reference. Copies may be obtained from
the Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504, or may be
examined at the Office of the Federal Register, 800 North Capitol
Street, NW., suite 700, Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24900, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.175]
[Page 574]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.175 P-4000.
(a) P-4000 is the chemical 5-nitro-2-n-propoxyaniline,
C9H12N2O3. It is a synthetic
chemical having a sweet taste about 4000 times that of sucrose, is not
found in natural products at levels detectable by the official
methodology, and has been proposed for use as an artificial sweetener.
(b) Food containing any added or detectable level of P-4000 is
deemed to be adulterated in violation of the act based upon an order
published in the Federal Register of January 19, 1950 (15 FR 321).
(c) The analytical methods used for detecting P-4000 in food are in
sections 20.177-20.181 of the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24900, June 12, 1989]
[[Page 575]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.180]
[Page 575]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.180 Safrole.
(a) Safrole is the chemical 4-allyl-1,2-methylenedioxy-benzene,
C10H10O2. It is a natural constituent
of the sassafras plant. Oil of sassafras is about 80 percent safrole.
Isosafrole and dihydrosafrole are derivatives of safrole, and have been
used as flavoring compounds.
(b) Food containing any added safrole, oil of sassafras, isosafrole,
or dihydrosafrole, as such, or food containing any safrole, oil of
sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is
intended solely or primarily as a vehicle for imparting such substances
to another food, e.g., sassafras tea, is deemed to be adulterated in
violation of the act based upon an order published in the Federal
Register of December 3, 1960 (25 FR 12412).
(c) The analytical method used for detecting safrole, isosafrole and
dihydrosafrole is in the "Journal of the Association of Official
Analytical Chemists," Volume 54 (Number 4), pages 900 to 902, July
1971, which is incorporated by reference. Copies are available from the
Division of Food and Color Additives, Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, or available for inspection at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 42 FR 56729, Oct. 28, 1977;
47 FR 11855, Mar. 19, 1982; 54 FR 24900, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.190]
[Page 575]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.190 Thiourea.
(a) Thiourea is the chemical thiocarbamide,
CH4N2S. It is a synthetic chemical, is not found
in natural products at levels detectable by the official methodology,
and has been proposed as an antimycotic for use in dipping citrus.
(b) Food containing any added or detectable level of thiourea is
deemed to be adulterated under the act.
(c) The analytical methods used for detecting thiourea are in
sections 20.115-20.126 of the "Official Methods of Analysis of the
Association of Official Analytical Chemists," 13th Ed. (1980), which is
incorporated by reference. Copies may be obtained from the Association
of Official Analytical Chemists International, 481 North Frederick Ave.,
suite 500, Gaithersburg, MD 20877-2504, or may be examined at the Office
of the Federal Register, 800 North Capitol Street, NW., suite 700,
Washington, DC 20408.
[42 FR 14659, Mar. 15, 1977, as amended at 49 FR 10114, Mar. 19, 1984;
54 FR 24900, June 12, 1989]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.191]
[Page 575]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart B--Substances Generally Prohibited From Direct Addition or Use
as Human Food
Sec. 189.191 Chlorofluorocarbon propellants.
The use of chlorofluorocarbons in human food as propellants in self-
pressurized containers is prohibited as provided by Sec. 2.125 of this
chapter.
[43 FR 11317, Mar. 17, 1978]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.220]
[Page 575]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.240]
[Page 575]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
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]
[[Page 576]]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.250]
[Page 576]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
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).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.280]
[Page 576]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
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).
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.300]
[Page 576]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
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]
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR189.301]
[Page 576]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 189--SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD--Table of Contents
Subpart C--Substances Prohibited From Indirect Addition to Human Food
Through Food-Contact Surfaces
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]
