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 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130]
[Page 282-283]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec.
130.3 Definitions and interpretations.
130.5 Procedure for establishing a food standard.
130.6 Review of Codex Alimentarius food standards.
130.8 Conformity to definitions and standards of identity.
130.9 Sulfites in standardized food.
130.10 Requirements for foods named by use of a nutrient content claim
and a standardized term.
130.11 Label designations of ingredients for standardized foods.
130.12 General methods for water capacity and fill of containers.
130.14 General statements of substandard quality and substandard fill
of container.
130.17 Temporary permits for interstate shipment of experimental packs
of food varying from the requirements of definitions and
standards of identity.
[[Page 283]]
Subpart B--Food Additives in Standardized Foods
130.20 Food additives proposed for use in foods for which definitions
and standards of identity are established.
Authority: 21 U.S.C. 321, 336, 341, 343, 371.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.3]
[Page 283]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.3 Definitions and interpretations.
(a) The definitions and interpretations of terms contained in
section 201 of the act shall be applicable also to such terms when used
in regulations promulgated under the act.
(b) If a regulation prescribing a definition and standard of
identity for a food has been promulgated under section 401 of the act
and the name therein specified for the food is used in any other
regulation under section 401 or any other provision of the act, such
name means the food which conforms to such definition and standard,
except as otherwise specifically provided in such other regulation.
(c) No provision of any regulation prescribing a definition and
standard of identity or standard of quality or fill of container under
section 401 of the act shall be construed as in any way affecting the
concurrent applicability of the general provisions of the act and the
regulations thereunder relating to adulteration and misbranding. For
example, all regulations under section 401 contemplate that the food and
all articles used as components or ingredients thereof shall not be
poisonous or deleterious and shall be clean, sound, and fit for food. A
provision in such regulations for the use of coloring or flavoring does
not authorize such use under circumstances or in a manner whereby damage
or inferiority is concealed or whereby the food is made to appear better
or of greater value than it is.
(d) Safe and suitable means that the ingredient:
(1) Performs an appropriate function in the food in which it is
used.
(2) Is used at a level no higher than necessary to achieve its
intended purpose in that food.
(3) Is not a food additive or color additive as defined in section
201 (s) or (t) of the Federal Food, Drug, and Cosmetic Act as used in
that food, or is a food additive or color additive as so defined and is
used in conformity with regulations established pursuant to section 409
or 721 of the act.
(e) Section 403(i) of the act requires the listing of all
ingredients in standardized foods. All ingredients must be listed in
accordance with the requirements of part 101 of this chapter, except
that where a definition and standard of identity has specific labeling
provisions for optional ingredients, optional ingredients may be
declared in accordance with those provisions.
[42 FR 14357, Mar. 15, 1977, as amended at 58 FR 2876, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.5]
[Page 283]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.5 Procedure for establishing a food standard.
(a) The procedure for establishing a food standard under section 401
of the act shall be governed by part 10 of this chapter.
(b) Any petition for a food standard shall show that the proposal,
if adopted, would promote honesty and fair dealing in the interest of
consumers.
(c) Any petition for a food standard shall assert that the
petitioner commits himself to substantiate the information in the
petition by evidence in a public hearing, if such a hearing becomes
necessary.
(d) If a petitioner fails to appear, or to substantiate the
information in his petition, at a public hearing on the matter, the
Commissioner may either (1) withdraw the regulation and terminate the
proceeding or (2) if he concludes that it is in accordance with the
requirements of section 401 of the act, continue the proceeding and
introduce evidence to substantiate such information.
[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.6]
[Page 283-284]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.6 Review of Codex Alimentarius food standards.
(a) All food standards adopted by the Codex Alimentarius Commission
will be reviewed by the Food and Drug Administration and will be
accepted without change, accepted with change, or not accepted.
(b) Review of Codex standards will be accomplished in one of the
following three ways:
[[Page 284]]
(1) Any interested person may petition the Commissioner to adopt a
Codex standard, with or without change, by proposing a new standard or
an appropriate amendment of an existing standard, pursuant to section
401 of the act. Any such petition shall specify any deviations from the
Codex standard, and the reasons for any such deviations. The
Commissioner shall publish such a petition in the Federal Register as a
proposal, with an opportunity for comment, if reasonable grounds are
provided in the petition. Any published proposal shall state any
deviations from the Codex standard and the stated reasons therefor.
(2) The Commissioner may on his own initiative propose by
publication in the Federal Register the adoption of a Codex standard,
with or without change, through a new standard or an appropriate
amendment to an existing standard, pursuant to section 401 of the act.
Any such proposal shall specify any deviations from the Codex standard,
and the reasons for any such deviations.
(3) Any Codex standard not handled under paragraph (b) (1) or (2) of
this section may be published in the Federal Register for review and
informal comment. Interested persons shall be requested to comment on
the desirability and need for the standard, on the specific provisions
of the standard, on additional or different provisions that should be
included in the standard, and on any other pertinent points. After
reviewing all such comments, the Commissioner either shall publish a
proposal to establish a food standard pursuant to section 401 of the act
covering the food involved, or shall publish a notice terminating
consideration of such a standard.
(c) All interested persons are encouraged to confer with different
interest groups (consumers, industry, the academic community,
professional organizations, and others) in formulating petitions or
comments pursuant to paragraph (b) of this section. All such petitions
or comments are requested to include a statement of any meetings and
discussions that have been held with other interest groups. Appropriate
weight will be given by the Commissioner to petitions or comments that
reflect a consensus of different interest groups.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.8]
[Page 284]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.8 Conformity to definitions and standards of identity.
In the following conditions, among others, a food does not conform
to the definition and standard of identity therefor:
(a) If it contains an ingredient for which no provision is made in
such definition and standard, unless such ingredient is an incidental
additive introduced at a nonfunctional and insignificant level as a
result of its deliberate and purposeful addition to another ingredient
permitted by the terms of the applicable standard and the presence of
such incidental additive in unstandardized foods has been exempted from
label declaration as provided in Sec. 101.100 of this chapter.
(b) If it fails to contain any one or more ingredients required by
such definition and standard;
(c) If the quantity of any ingredient or component fails to conform
to the limitation, if any, prescribed therefor by such definition and
standard.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.9]
[Page 284-285]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.9 Sulfites in standardized food.
(a) Any standardized food that contains a sulfiting agent or
combination of sulfiting agents that is functional and provided for in
the applicable standard or that is present in the finished food at a
detectable level is misbranded unless the presence of the sulfiting
agent or agents is declared on the label of the food. A detectable
amount of sulfiting agent is 10 parts per million or more of the sulfite
in the finished food. The level of sulfite in the finished food will be
determined using sections 20.123 through 20.125, "Sulfurous Acid
(Total) in Food Modified Monier-Williams Method Final Action" in
"Official Methods of Analysis of the Association of Official Analytical
Chemists," 14th ed. (1984), which is incorporated by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51, and the refinements
of the "Total Sulfurous Acid" procedure in the "Monier-Williams
Procedure (with Modifications) for Sulfites in Foods," which is
appendix A to part 101 of this chapter. A copy of sections 20.123
through 20.125 of the "Official Methods of Analysis of
[[Page 285]]
the Association of Official Analytical Chemists" is available from
Association of Official Analytical Chemists International, 481 North
Frederick Ave., suite 500, Gaithersburg, MD 20877-2504 , or available
for inspection at the Office of the Federal Register, 800 North Capitol
St. NW., Suite 700, Washington, DC.
(b) Any standardized food that, as a result of actions that are
consistent with current good manufacturing practice, contains an
indirectly added sulfiting agent that has no functional effect in the
food and that would, in the absence of Sec. 101.100(a)(4) of this
chapter, be considered to be an incidental additive for purposes of
Sec. 130.8, conforms to the applicable definition and standard of
identity if the presence of the sulfiting agent is declared on the label
of the food.
[58 FR 2876, Jan. 6, 1993, as amended at 63 FR 14035, Mar. 24, 1998]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.10]
[Page 285-286]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.10 Requirements for foods named by use of a nutrient content claim and a standardized term.
(a) Description. The foods prescribed by this general definition and
standard of identity are those foods that substitute (see Sec. 101.13(d)
of this chapter) for a standardized food defined in parts 131 through
169 of this chapter and that use the name of that standardized food in
their statement of identity but that do not comply with the standard of
identity because of a deviation that is described by an expressed
nutrient content claim that has been defined by FDA regulation. The
nutrient content claim shall comply with the requirements of Sec. 101.13
of this chapter and with the requirements of the regulations in part 101
of this chapter that define the particular nutrient content claim that
is used. The food shall comply with the relevant standard in all other
respects except as provided in paragraphs (b), (c), and (d) of this
section.
(b) Nutrient addition. Nutrients shall be added to the food to
restore nutrient levels so that the product is not nutritionally
inferior, as defined in Sec. 101.3(e)(4) of this chapter, to the
standardized food as defined in parts 131 through 169 of this chapter.
The addition of nutrients shall be reflected in the ingredient
statement.
(c) Performance characteristics. Deviations from noningredient
provisions of the standard of identity (e.g., moisture content, food
solids content requirements, or processing conditions) are permitted in
order that the substitute food possesses performance characteristics
similar to those of the standardized food. Deviations from ingredient
and noningredient provisions of the standard must be the minimum
necessary to qualify for the nutrient content claim while maintaining
similar performance characteristics as the standardized food, or the
food will be deemed to be adulterated under section 402(b) of the act.
The performance characteristics (e.g., physical properties, flavor
characteristics, functional properties, shelf life) of the food shall be
similar to those of the standardized food as produced under parts 131
through 169 of this chapter, except that if there is a significant
difference in performance characteristics that materially limits the
uses of the food compared to the uses of the standardized food, the
label shall include a statement informing the consumer of such
difference (e.g., if appropriate, "not recommended for cooking"). Such
statement shall comply with the requirements of Sec. 101.13(d) of this
chapter. The modified product shall perform at least one of the
principal functions of the standardized product substantially as well as
the standardized product.
(d) Other ingredients. (1) Ingredients used in the product shall be
those ingredients provided for by the standard as defined in parts 131
through 169 of this chapter and in paragraph (b) of this section, except
that safe and suitable ingredients may be used to improve texture, add
flavor, prevent syneresis, extend shelf life, improve appearance, or add
sweetness so that the product is not inferior in performance
characteristics to the standardized food defined in parts 131 through
169 of this chapter.
(2) An ingredient or component of an ingredient that is specifically
required by the standard (i.e., a mandatory ingredient) as defined in
parts 131 through 169 of this chapter, shall not be replaced or
exchanged with a similar
[[Page 286]]
ingredient from another source unless the standard, as defined in parts
131 through 169 of this chapter, provides for the addition of such
ingredient (e.g., vegetable oil shall not replace milkfat in light sour
cream).
(3) An ingredient or component of an ingredient that is specifically
prohibited by the standard as defined in parts 131 through 169 of this
chapter, shall not be added to a substitute food under this section.
(4) An ingredient that is specifically required by the standard as
defined in parts 131 through 169 of this chapter, shall be present in
the product in a significant amount. A significant amount of an
ingredient or component of an ingredient is at least that amount that is
required to achieve the technical effect of that ingredient in the food.
(5) Water and fat analogs may be added to replace fat and calories
in accordance with Sec. 130.10(c), (d)(1), and (d)(2).
(e) Nomenclature. The name of a substitute food that complies with
all parts of this regulation is the appropriate expressed nutrient
content claim and the applicable standardized term.
(f) Label declaration. (1) Each of the ingredients used in the food
shall be declared on the label as required by the applicable sections of
part 101 of this chapter and part 130.
(2) Ingredients not provided for, and ingredients used in excess of
those levels provided for, by the standard as defined in parts 131
through 169 of this chapter, shall be identified as such with an
asterisk in the ingredient statement, except that ingredients added to
restore nutrients to the product as required in paragraph (b) of this
section shall not be identified with an asterisk. The statement
"*Ingredient(s) not in regular ------" (fill in name of the
traditional standardized food) or "*Ingredient(s) in excess of amount
permitted in regular ------" (fill in name of the traditional
standardized food) or both as appropriate shall immediately follow the
ingredient statement in the same type size.
[58 FR 2446, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.11]
[Page 286]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.11 Label designations of ingredients for standardized foods.
Some definitions and standards of identity for foods set forth below
require that designated optional ingredients such as spices, flavorings,
colorings, emulsifiers, flavor enhancers, stabilizers, preservatives,
and sweeteners be declared in a specified manner on the label wherever
the name of the standardized food appears on the label so conspicuously
as to be easily seen under customary conditions of purchase. Such
requirements shall apply to a manufacturer, packer, or distributor of a
standardized food only if the words or statements on the label of the
standardized food significantly differentiate between two or more foods
that comply with the same standard by describing the optional forms or
varieties, the packing medium, or significant characterizing ingredients
present in the food.
[58 FR 2876, Jan. 6, 1993]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.12]
[Page 286-287]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.12 General methods for water capacity and fill of containers.
For the purposes of regulations promulgated under section 401 of the
act:
(a) The term general method for water capacity of containers means
the following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Wash, dry, and weigh the empty container.
(3) Fill the container with distilled water at 68 deg.F to \3/16\
inch vertical distance below the top level of the container, and weigh
the container thus filled.
(4) Subtract the weight found in paragraph (a)(2) of this section
from the weight found in paragraph (a)(3) of this section. The
difference shall be considered to be the weight of water required to
fill the container.
In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraphs (a) (2) to
(4) of this section, except that under paragraph (a)(3) of this section,
fill the container to the level of the top thereof.
[[Page 287]]
(b) The term general method for fill of containers means the
following method:
(1) In the case of a container with lid attached by double seam, cut
out the lid without removing or altering the height of the double seam.
(2) Measure the vertical distance from the top level of the
container to the top level of the food.
(3) Remove the food from the container; wash, dry, and weigh the
container.
(4) Fill the container with water to \3/16\ inch vertical distance
below the top level of the container. Record the temperature of the
water, weigh the container thus filled, and determine the weight of the
water by subtracting the weight of the container found in paragraph
(b)(3) of this section.
(5) Maintaining the water at the temperature recorded in paragraph
(b)(4) of this section, draw off water from the container as filled in
paragraph (b)(4) of this section to the level of the food found in
paragraph (b)(2) of this section, weigh the container with remaining
water, and determine the weight of the remaining water by subtracting
the weight of the container found in paragraph (b)(3) of this section.
(6) Divide the weight of water found in paragraph (b)(5) of this
section by the weight of water found in paragraph (b)(4) of this
section, and multiply by 100. The result shall be considered to be the
percent of the total capacity of the container occupied by the food.
In the case of a container with lid attached otherwise than by double
seam, remove the lid and proceed as directed in paragraphs (b) (2) to
(6) of this section, except that under paragraph (b)(4) of this section,
fill the container to the level of the top thereof.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.14]
[Page 287]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.14 General statements of substandard quality and substandard fill of container.
For the purposes of regulations promulgated under section 401 of the
act:
(a) The term general statement of substandard quality means the
statement "Below Standard in Quality Good Food--Not High Grade"
printed in two lines of Cheltenham bold condensed caps. The words
"Below Standard in Quality" constitute the first line, and the second
immediately follows. If the quantity of the contents of the container is
less than 1 pound, the type of the first line is 12-point, and of the
second, 8-point. If such quantity is 1 pound or more, the type of the
first line is 14-point, and of the second, 10-point. Such statement is
enclosed within lines, not less than 6 points in width, forming a
rectangle. Such statement, with enclosing lines, is on a strongly
contrasting, uniform background, and is so placed as to be easily seen
when the name of the food or any pictorial representation thereof is
viewed, wherever such name or representation appears so conspicuously as
to be easily seen under customary conditions of purchase.
(b) The term general statement of substandard fill means the
statement "Below Standard in Fill" printed in Cheltenham bold
condensed caps. If the quantity of the contents of the container is less
than 1 pound, the statement is in 12-point type; if such quantity is 1
pound or more, the statement is in 14-point type. Such statement is
enclosed within lines, not less than 6 points in width, forming a
rectangle; but if the statement specified in paragraph (a) of this
section is also used, both statements (one following the other) may be
enclosed within the same rectangle. Such statement or statements, with
enclosing lines, are on a strongly contrasting, uniform background, and
are so placed as to be easily seen when the name of the food or any
pictorial representation thereof is viewed, wherever such name or
representation appears so conspicuously as to be easily seen under
customary conditions of purchase.
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.17]
[Page 287-290]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart A--General Provisions
Sec. 130.17 Temporary permits for interstate shipment of experimental packs of food varying from the requirements of definitions and standards of identity.
(a) The Food and Drug Administration recognizes that before
petitions to amend food standards can be submitted, appropriate
investigations of potential advances in food technology sometimes
require tests in interstate markets of the advantages to and acceptance
by consumers of experimental packs of food varying from applicable
definitions and standards of identity prescribed under section 401 of
the act.
[[Page 288]]
(b) It is the purpose of the Food and Drug Administration to permit
such tests when it can be ascertained that the sole purpose of the tests
is to obtain data necessary for reasonable grounds in support of a
petition to amend food standards, that the tests are necessary to the
completion or conclusiveness of an otherwise adequate investigation, and
that the interests of consumers are adequately safeguarded; permits for
such tests shall normally be for a period not to exceed 15 months. The
Food and Drug Administration, or good cause shown by the applicant, may
provide for a longer test market period. The Food and Drug
Administration will therefore refrain from recommending regulatory
proceedings under the act on the charge that a food does not conform to
an applicable standard, if the person who introduces or causes the
introduction of the food into interstate commerce holds an effective
permit from the Food and Drug Administration providing specifically for
those variations in respect to which the food fails to conform to the
applicable definition and standard of identity. The test period will
begin on the date the person holding an effective permit from the Food
and Drug Administration introduces or causes the introduction of the
food covered by the permit into interstate commerce but not later than 3
months after notice of the issuance of the permit is published in the
Federal Register. The Food and Drug Administration shall be notified in
writing of the date on which the test period begins as soon as it is
determined.
(c) Any person desiring a permit may file with the Team Leader,
Conventional Foods Team, Division of Standards and Labeling Regulations,
Office of Nutritional Products, Labeling and Dietary Supplements, Center
for Food Safety and Applied Nutrition (HFS-822), 5100 Paint Branch
Pkwy., College Park, MD 20740, a written application in triplicate
containing as part thereof the following:
(1) Name and address of the applicant.
(2) A statement of whether or not the applicant is regularly engaged
in producing the food involved.
(3) A reference to the applicable definition and standard of
identity (citing applicable section of regulations).
(4) A full description of the proposed variation from the standard.
(5) The basis upon which the food so varying is believed to be
wholesome and nondeleterious.
(6) The amount of any new ingredient to be added; the amount of any
ingredient, required by the standard, to be eliminated; any change of
concentration not contemplated by the standard; or any change in name
that would more appropriately describe the new product under test. If
such new ingredient is not a commonly known food ingredient, a
description of its properties and basis for concluding that it is not a
deleterious substance.
(7) The purpose of effecting the variation.
(8) A statement of how the variation is of potential advantage to
consumers. The statement shall include the reasons why the applicant
does not consider the data obtained in any prior investigations which
may have been conducted sufficient to support a petition to amend the
standard.
(9) The proposed label (or an accurate draft) to be used on the food
to be market tested. The label shall conform in all respects to the
general requirements of the act and shall provide a means whereby the
consumer can distinguish between the food being tested and such food
complying with the standard.
(10) The period during which the applicant desires to introduce such
food into interstate commerce, with a statement of the reasons
supporting the need for such period. If a period longer than 15 months
is requested, a detailed explanation of why a 15-month period is
inadequate shall be provided.
(11) The probable amount of such food that will be distributed. The
amount distributed should be limited to the smallest number of units
reasonably required for a bona fide market test. Justification for the
amount requested shall be included.
(12) The areas of distribution.
(13) The address at which such food will be manufactured.
[[Page 289]]
(14) A statement of whether or not such food has been or is to be
distributed in the State in which it was manufactured.
(15) If it has not been or is not to be so distributed, a statement
showing why.
(16) If it has been or is to be so distributed, a statement of why
it is deemed necessary to distribute such food in other States.
(d) The Food and Drug Administration may require the applicant to
furnish samples of the food varying from the standard and to furnish
such additional information as may be deemed necessary for action on the
application.
(e) If the Food and Drug Administration concludes that the variation
may be advantageous to consumers and will not result in failure of the
food to conform to any provision of the act except section 403(g), a
permit shall be issued to the applicant for interstate shipment of such
food. The terms and conditions of the permit shall be those set forth in
the application with such modifications, restrictions, or qualifications
as the Food and Drug Administration may deem necessary and state in the
permit.
(f) The terms and conditions of the permit may be modified at the
discretion of the Food and Drug Administration or upon application of
the permittee during the effective period of the permit.
(g) The Food and Drug Administration may revoke a permit for cause,
which shall include but not be limited to the following:
(1) That the permittee has introduced a food into interstate
commerce contrary to the terms and conditions of the permit.
(2) That the application for a permit contains an untrue statement
of a material fact.
(3) That the need therefor no longer exists.
(h) During the period within which any permit is effective, it shall
be deemed to be included within the terms of any guaranty or undertaking
otherwise effective pursuant to the provisions of section 303(c) of the
act.
(i) If an application is made for an extension of the permit, it
shall be accompanied by a description of experiments conducted under the
permit, tentative conclusions reached, and reasons why further
experimental shipments are considered necessary. The application for an
extension shall be filed not later than 3 months prior to the expiration
date of the permit and shall be accompanied by a petition to amend the
affected food standard. If the Food and Drug Administration concludes
that it will be in the interest of consumers to issue an extension of
the time period for the market test, a notice will be published in the
Federal Register stating that fact. The notice will include an
invitation to all interested persons to participate in the market test
under the same conditions that applied to the initial permit holder,
including labeling and the amount to be distributed, except that the
designated area of distribution shall not apply. The extended market
test period shall not begin prior to the publication of a notice in the
Federal Register granting the extension and shall terminate either on
the effective date of an affirmative order ruling on the proposal or 30
days after a negative order ruling on the proposal, whichever the case
may be. Any interested person who accepts the invitation to participate
in the extended market test shall notify the Food and Drug
Administration in writing of that fact, the amount to be distributed,
and the area of distribution; and along with such notification, he shall
submit the labeling under which the food is to be distributed.
(j) Notice of the granting or revocation of any permit shall be
published in the Federal Register.
(k) All applications for a temporary permit, applications for an
extension of a temporary permit, and related records are available for
public disclosure when the notice of a permit or extension thereof is
published in the Federal Register. Such disclosure shall be in
accordance with the rules established in part 20 of this chapter.
(l) Any person who contests denial, modification, or revocation of a
temporary permit shall have an opportunity for a regulatory hearing
before
[[Page 290]]
the Food and Drug Administration pursuant to part 16 of this chapter.
[42 FR 14357, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977;
46 FR 37500, July 21, 1981; 54 FR 24892, June 12, 1989; 59 FR 15051,
Mar. 31, 1994; 66 FR 17359, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001]
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR130.20]
[Page 290]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 130--FOOD STANDARDS: GENERAL--Table of Contents
Subpart B--Food Additives in Standardized Foods
Sec. 130.20 Food additives proposed for use in foods for which definitions and standards of identity are established.
(a) Where a petition is received for the issuance or amendment of a
regulation establishing a definition and standard of identity for a food
under section 401 of the act, which proposes the inclusion of a food
additive in such definition and standard of identity, the provisions of
the regulations in part 171 of this chapter shall apply with respect to
the information that must be submitted with respect to the food
additive. Since section 409(b)(5) of the act requires that the
Commissioner publish notice of a petition for the establishment of a
food additive regulation within 30 days after filing, notice of a
petition relating to a definition and standard of identity shall also be
published within that time limitation if it includes a request, so
designated, for the establishment of a regulation pertaining to a food
additive.
(b) If a petition for a definition and standard of identity contains
a proposal for a food additive regulation, and the petitioner fails to
designate it as such, the Commissioner, upon determining that the
petition includes a proposal for a food additive regulation, shall so
notify the petitioner and shall thereafter proceed in accordance with
the regulations in part 171 of this chapter.
