[Title 21 CFR 186]
[Code of Federal Regulations (annual edition) - April 1, 1996 Edition]
[Title 21 - FOOD AND DRUGS]
[Chapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)]
[Subchapter B - FOOD FOR HUMAN CONSUMPTION]
[Part 186 - INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE]
[From the U.S. Government Publishing Office]
21
FOOD AND DRUGS
3
1996-04-01
1996-04-01
false
INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
186
PART 186
FOOD AND DRUGS
FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
FOOD FOR HUMAN CONSUMPTION
PART 186--INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE--Table of Contents
Subpart A--General Provisions
Sec.
186.1 Substances added indirectly to human food affirmed as generally
recognized as safe (GRAS).
Subpart B--Listing of Specific Substances Affirmed as GRAS
186.1025 Caprylic acid.
186.1093 Sulfamic acid.
186.1256 Clay (kaolin).
186.1275 Dextrans.
186.1300 Ferric oxide.
186.1316 Formic acid.
186.1374 Iron oxides.
186.1551 Hydrogenated fish oil.
186.1555 Japan wax.
186.1557 Tall oil.
186.1673 Pulp.
186.1750 Sodium chlorite.
186.1756 Sodium formate.
186.1770 Sodium oleate.
186.1771 Sodium palmitate.
186.1797 Sodium sulfate.
186.1839 Sorbose.
Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
Source: 42 FR 14658, Mar. 15, 1977, unless otherwise noted.
Subpart A--General Provisions
Sec. 186.1 Substances added indirectly to human food affirmed as generally recognized as safe (GRAS).
(a) The indirect human food ingredients listed in this part have
been reviewed by the Food and Drug Administration and determined to be
generally recognized as safe (GRAS) for the purposes and under the
conditions prescribed, providing they comply with the purity
specifications listed in this part or, in the absence of purity
specifications, are of a purity suitable for their intended use in
accordance with Sec. 170.30(h)(1) of this chapter. Certain ingredients
in this part may also be used in food-contact surfaces in accordance
with parts 174, 175, 176, 177, 178 or Sec. 179.45 of this chapter.
Ingredients affirmed as GRAS for direct use in part 184 of this chapter
are also GRAS as indirect human food ingredients in accordance with
Sec. 184.1(a) of this chapter.
(b) The regulations in this part do not authorize direct addition of
any food ingredient to a food. They authorize only the use of these
ingredients as indirect ingredients of food, through migration from
their immediate wrapper, container, or other food-contact surface. Any
ingredient affirmed as GRAS in this part shall be used in accordance
with current good manufacturing practice. For the purpose of this part,
current good manufacturing practice includes the requirements that an
indirect human food ingredient be of a purity suitable for its intended
use, and that it be used at a level no higher than reasonably required
to achieve its intended technical effect in the food-contact article.
(1) If the ingredient is affirmed as GRAS with no limitations on its
conditions of use other than current good manufacturing practice, it
shall be regarded as GRAS if its conditions of use are consistent with
the requirements of paragraphs (b), (c), and (d) of this section. When
the Food and Drug Administration (FDA) determines that it is
appropriate, the agency will describe one or more current good
manufacturing practice conditions of use in the regulation that affirms
the GRAS status of the indirect ingredient. For example, when the safety
of an ingredient
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has been evaluated on the basis of limited conditions of use, the agency
will describe in the regulation that affirms the GRAS status of the
indirect ingredient, one or more of these limited conditions of use,
which may include the category of food-contact surface(s), technical
effect(s) or functional use(s) of the indirect ingredient, and the
level(s) of use. If the ingredient is used under conditions that are
significantly different from those described in the regulation, such use
of a substance may not be GRAS. In such a case, a manufacturer may not
rely on the regulation as authorizing that use but shall independently
establish that the use is GRAS or shall use the ingredient in accordance
with a food additive regulation. Persons seeking FDA approval of an
independent determination that a use of an ingredient is GRAS may submit
a GRAS petition in accordance with Sec. 170.35 of this chapter.
(2) If the ingredient is affirmed as GRAS with specific
limitation(s), it shall be used in food-contact surfaces only within
such limitation(s), including the category of food-contact surface(s),
the functional use(s) of the ingredient, and the level(s) of use. Any
use of such an ingredient not in full compliance with each such
established limitation shall require a food additive regulation.
(3) If the ingredient is affirmed as GRAS for a specific use, prior
to general evaluation of use of the ingredient, other uses may also be
GRAS.
(c) The listing of a food ingredient in this part does not authorize
the use of such substance for the purpose of adding the ingredient to
the food through extraction from the food-contact surface.
(d) The listing of a food ingredient in this part does not authorize
the use of such substance in a manner that may lead to deception to the
consumer or to any other violation of the Federal Food, Drug, and
Cosmetic Act (the Act).
(e) If the Commissioner of Food and Drugs is aware of any prior
sanction for use of an ingredient under conditions different from those
proposed to be affirmed as GRAS, he will concurrently propose a separate
regulation covering such use of the ingredient under part 181 of this
chapter. If the Commissioner is unaware of any such applicable prior
sanction, the proposed regulation will so state and will require any
person who intends to assert or rely on such sanction to submit proof of
its existence. Any regulation promulgated pursuant to this section
constitutes a determination that excluded uses would result in
adulteration of the food in violation of section 402 of the Act, and the
failure of any person to come forward with proof of such an applicable
prior sanction in response to the proposal will constitute a waiver of
the right to assert or rely on such sanction at any later time. The
notice will also constitute a proposal to establish a regulation under
part 181 of this chapter, incorporating the same provisions, in the
event that such a regulation is determined to be appropriate as a result
of submission of proof of such an applicable prior sanction in response
to the proposal.
[42 FR 14658, Mar. 15, 1977, as amended at 48 FR 48457, 48459, Oct. 19,
1983]
Subpart B--Listing of Specific Substances Affirmed as GRAS
Sec. 186.1025 Caprylic acid.
(a) Caprylic acid [CH3(CH2)6COOH, CAS Reg. No. 124-
07-2] is the chemical name for octanoic acid. It is considered to be a
short or medium chain fatty acid. It occurs normally in various foods
and is commercially prepared by oxidation of n-octanol or by
fermentation and fractional distillation of the volatile fatty acids
present in coconut oil.
(b) The ingredient meets the specifications of the ``Food Chemicals
Codex,'' 3d Ed. (1981), p. 207, which is incorporated by reference.
Copies may be obtained from the National Academy Press, 2101
Constitution Ave. NW., Washington, DC 20418, or may be examined at the
Office of the Federal Register, 800 North Capitol Street, NW., suite
700, Washington, DC 20408.
(c) The ingredient is used as an antimicrobial (preservative) in
cheese wraps as defined in Sec. 170.3(o)(2) at levels not to exceed good
manufacturing practice.
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(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 19843, May 9, 1978, as amended at 49 FR 5613, Feb. 14, 1984]
Sec. 186.1093 Sulfamic acid.
(a) Sulfamic acid (H3NO3S, CAS Reg. No. 5329-14-6) is a
white crystalline solid manufactured from urea, sulfur trioxide, and
sulfuric acid. It is soluble and highly ionized in water.
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as
an indirect food ingredient with no limitations other than current good
manufacturing practice. The affirmation of this ingredient as generally
recognized as safe (GRAS) as an indirect human food ingredient is based
upon the current good manufacturing practice of using this ingredient in
the manufacture of paper and paperboard that contact food.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[47 FR 29954, July 9, 1982]
Sec. 186.1256 Clay (kaolin).
(a) Clay (kaolin) Al2O3.2SiO2.nH2O, Cas Reg. No. 1332-58-
7) consists of hydrated aluminum silicate. The commercial products of
clay (kaolin) contain varying quantities of alkalies and alkaline
earths. Clay (kaolin) is a white to yellowish or grayish fine powder.
There are at least three different minerals, kaolinite, dickite, and
nacrite, classified as kaolin. Kaolinite or china clay is whiter, less
contaminated with extraneous minerals, and less plastic in water.
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as
an indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used in the manufacture of paper and
paperboard that contact food.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this regulation do not exist or have been waived.
[47 FR 43367, Oct. 1, 1982]
Sec. 186.1275 Dextrans.
(a) Dextrans (CAS Reg. No. 9004-54-0) are high molecular weight
polysaccharides produced by bacterial fermentation of sucrose.
Commercially available dextrans are synthesized from sucrose by
Leuconostoc mesenteroides strain NRRL B-512(F). Partial depolymerization
and purification of the fermented mixture shall produce a product that
is free of viable microorganisms.
(b) The ingredient is used or intended for use as a constituent of
food-contact surfaces.
(c) The ingredient is used at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 29288, July 7, 1978, as amended at 48 FR 48457, Oct. 19, 1983]
Sec. 186.1300 Ferric oxide.
(a) Ferric oxide (iron (III) oxide, Fe2O3, CAS Reg. No.
1309-37-1) occurs naturally as the mineral hematite. It may be prepared
synthetically by heating brown iron hydroxide oxide. The product is red-
brown to black trigonal crystals.
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as
an indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
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(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]
Sec. 186.1316 Formic acid.
(a) Formic acid (CH2O2, CAS Reg. No. 64-18-6) is also
referred to as methanoic acid or hydrogen carboxylic acid. It occurs
naturally in some insects and is contained in the free acid state in a
number of plants. Formic acid is prepared by the reaction of sodium
formate with sulfuric acid and is isolated by distillation.
(b) Formic acid is used as a constituent of paper and paperboard
used for food packaging.
(c) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 186.1(b)(1).
(d) Prior sanctions for formic acid different from the uses
established in this section do not exist or have been waived.
[45 FR 22915, Apr. 4, 1980]
Sec. 186.1374 Iron oxides.
(a) Iron oxides (oxides of iron, CAS Reg. No. 97705-33-85) are
undefined mixtures of iron (II) oxide (CAS Reg. No. 1345-25-1, black
cubic crystals) and iron (III) oxide (CAS Reg. No. 1309-37-1, red-brown
to black trigonal crystals).
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as
an indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based upon the following current good manufacturing practice
conditions of use:
(1) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[53 FR 16867, May 12, 1988; 53 FR 20939, June 7, 1988]
Sec. 186.1551 Hydrogenated fish oil.
(a) Hydrogenated fish oil (CAS Reg. No. 91078-95-4) is a class of
oils produced by partial hydrogenation of oils expressed from fish,
primarily menhaden, and secondarily herring or tuna. Hydrogenation of
fish oils uses catalysts composed of either elemental nickel, elemental
copper, or a mixture of these elements. The crude hydrogenated fish oil
is further processed by alkali refining, bleaching, and deodorization by
steam stripping.
(b) Hydrogenation of fish oils results in a final product with a
melting point greater than 32 deg. C as determined by Section Cc 1-25,
Official and Tentative Methods of the American Oil Chemists' Society
method (reapproved 1973) or equivalent. The product has an approximate
fatty acid composition of 30 to 45 percent saturated fatty acids, 40 to
55 percent monoenoic fatty acids, 7 to 15 percent dienoic fatty acids, 3
to 10 percent trienoic fatty acids, and less than 2 percent tetraenoic
or higher polyenoic fatty acids. The approximate percentages of total
fatty acids by carbon chain length are 15 to 30 percent each of
C16, C18, C20, C22, less than 10 percent C14 or
lower carbon chain length, and less than 1 percent C24 or higher
carbon chain length fatty acids.
(c) The ingredient is used as a constituent of cotton and cotton
fabrics used for dry food packaging.
(d) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 186.1(b)(1).
(e) Prior sanctions for this ingredient different from the use
established in this section do not exist or have been waived.
[44 FR 28323, May 15, 1979, as amended at 49 FR 5614, Feb. 14. 1984; 58
FR 17099, Apr. 1, 1993]
Sec. 186.1555 Japan wax.
(a) Japan wax (CAS Reg. No. 8001-39-6), also known as Japan tallow
or sumac wax, is a pale yellow vegetable tallow, containing glycerides
of the C19-C23 dibasic acids and a high content of
tripalmitin. It is prepared from the mesocarp by hot pressing of
immature fruits of the oriental sumac, Rhus succedanea (Japan, Taiwan,
and Indo-China), R. vernicifera (Japan), and R.
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trichocarpa (China, Indo-China, India, and Japan). Japan wax is soluble
in hot alcohol, benzene, and naphtha, and insoluble in water and in cold
alcohol.
(b) In accordance with paragraph (b)(1) of this section, the
ingredient is used as an indirect human food ingredient with no
limitation other than current good manufacturing practice. The
affirmation of this ingredient as generally recognized as safe (GRAS) as
an indirect human food ingredient is based on the following current good
manufacturing practice conditions of use:
(1) The ingredient is used as a constituent of cotton and cotton
fabrics used for dry food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[60 FR 62208, Dec. 5, 1995]
Sec. 186.1557 Tall oil.
(a) Tall oil (CAS Reg. No. 8002-26-4) is essentially the sap of the
pine tree. It is obtained commercially from the waste liquors of
pinewood pulp mills and consists mainly of tall oil resin acids and tall
oil fatty acids.
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as
an indirect human food ingredient with no limitation other than current
good manufacturing practice. The affirmation of this ingredient as
generally recognized as safe (GRAS) as an indirect human food ingredient
is based on the following current good manufacturing practice conditions
of use:
(1) The ingredient is used as a constituent of cotton and cotton
fabrics used for dry food packaging.
(2) The ingredient is used at levels not to exceed current good
manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section, or from those listed in part 181 of this
chapter, do not exist or have been waived.
[51 FR 16830, May 7, 1986]
Sec. 186.1673 Pulp.
(a) Pulp is the soft, spongy pith inside the stem of a plant such as
wood, straw, sugarcane, or other natural plant sources.
(b) The ingredient is used or intended for use as a constituent of
food packaging containers.
(c) The ingredient is used in paper and paperboard made by
conventional paper-making processes at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
Sec. 186.1750 Sodium chlorite.
(a) Sodium chlorite (NaCLO2, CAS Reg. No. 7758-19-2) exists as
slightly hygroscopic white crystals or flakes. It is manufactured by
passing chlorine dioxide into a solution of sodium hydroxide and
hydrogen peroxide.
(b) the ingredient is used at levels from 125 to 250 parts per
million as a slimicide in the manufacture of paper and paperboard that
contact food.
[45 FR 16470, Mar. 14, 1980]
Sec. 186.1756 Sodium formate.
(a) Sodium formate (CHNaO2, CAS Reg. No. 141-53-7) is the
sodium salt of formic acid. It is produced by the reaction of carbon
monoxide with sodium hydroxide.
(b) The ingredient is used as a constituent of paper and paperboard
used for food packaging.
(c) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 186.1(b)(1).
(d) Prior sanctions for sodium formate different from the uses
established in this section do not exist or have been waived.
[45 FR 22915, Apr. 4, 1980]
Sec. 186.1770 Sodium oleate.
(a) Sodium oleate (C18H33O2Na, CAS Reg. No. 143-19-1)
is the sodium salt of oleic acid (cis-9-octadecenoic acid). It exists as
a white to yellowish powder with a slight tallow-like odor.
Commercially, sodium oleate is made by mixing and heating flaked sodium
hydroxide and oleic acid.
[[Page 532]]
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a
constituent of paper and paperboard for food packaging and as a
component of lubricants with incidental food contact in accordance with
Sec. 178.3570 of this chapter, with no limitation other than current
good manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[51 FR 39372, Oct. 28, 1986]
Sec. 186.1771 Sodium palmitate.
(a) Sodium palmitate (C16H31O2Na, CAS Reg. No. 408-
35-5) is the sodium salt of palmitic acid (hexadecanoic acid). It exists
as a white to yellow powder. Commercially, sodium palmitate is made by
mixing and heating flaked sodium hydroxide and palmitic acid.
(b) In accordance with Sec. 186.1(b)(1), the ingredient is used as a
constituent of paper and paperboard for food packaging with no
limitation other than current good manufacturing practice.
(c) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[51 FR 39372, Oct. 28, 1986]
Sec. 186.1797 Sodium sulfate.
(a) Sodium sulfate (Na2SO4, CAS Reg. No. 7757-82-6), also
known as Glauber's salt, occurs naturally and exists as colorless
crystals or as a fine, white crystalline powder. It is prepared by the
neutralization of sulfuric acid with sodium hydroxide.
(b) The ingredient is used as a constituent of paper and paperboard
used for food packaging, and cotton and cotton fabric used for dry food
packaging.
(c) The ingredient is used at levels not to exceed good
manufacturing practice in accordance with Sec. 186.1(b)(1).
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[45 FR 6086, Jan. 25, 1980]
Sec. 186.1839 Sorbose.
(a) Sorbose (L-sorbose, sorbinose) (C6H12O6, CAS Reg.
No. 87-79-6) is an orthorhombic, bisphenoidal crystalline ketohexose. It
was originally identifed in the juice of mature berries from the
mountain ash (Sorbus aucuparia) where it occurs as the result of
microbial oxidation of sorbitol. It also occurs naturally in other
plants. Sorbose can be synthesized by the catalytic hydrogenation of
glucose to D-sorbitol. The resulting sorbitol can be oxidized by
Acetobacter xylinum or by Acetobacter suboxydans.
(b) The ingredient is used or intended for indirect food use as a
constituent of cotton, cotton fabrics, paper, and paperboard in contact
with dry food.
(c) The ingredient migrates to food at levels not to exceed good
manufacturing practice.
(d) Prior sanctions for this ingredient different from the uses
established in this section do not exist or have been waived.
[43 FR 11698, Mar. 21, 1978, as amended at 48 FR 48457, Oct. 19, 1983]