27 CFR 4.32a-432.b

Alcohol and Tobacco Tax and Trade Bureau, Treasury
(d) Declaration of cochineal extract or
carmine. There shall be stated on a
front label, back label, strip label, or
neck label a statement that the product contains the color additive cochineal extract or the color additive carmine, prominently and conspicuously,
using the respective common or usual
name (‘‘cochineal extract’’ or ‘‘carmine’’), where either of the coloring
materials is used in a product that is
removed on or after April 16, 2013. (For
example: ‘‘Contains Cochineal Extract’’ or ‘‘Contains Carmine’’ or, if applicable, ‘‘Contains Cochineal Extract
and Carmine’’).
(e) Declaration of sulfites. There shall
be stated on a front label, back label,
strip label or neck label, the statement
‘‘Contains sulfites’’ or ‘‘Contains (a)
sulfiting agent(s)’’ or a statement identifying the specific sulfiting agent
where sulfur dioxide or a sulfiting
agent is detected at a level of 10 or
more parts per million, measured as
total sulfur dioxide. The provisions of
this paragraph shall apply to:
(1) Any certificate of label approval
issued on or after January 9, 1987;
(2) Any wine bottled on or after July
9, 1987, regardless of the date of
issuance of the certificate of label approval; and,
(3) Any wine removed on or after
January 9, 1988.

(ii) A food ingredient that contains
protein derived from a food specified in
paragraph (a)(1)(i) of this section, except:
(A) Any highly refined oil derived
from a food specified in paragraph
(a)(1)(i) of this section and any ingredient derived from such highly refined
oil; or
(B) A food ingredient that is exempt
from major food allergen labeling requirements pursuant to a petition for
exemption approved by the Food and
Drug Administration (FDA) under 21
U.S.C. 343(w)(6) or pursuant to a notice
submitted to FDA under 21 U.S.C.
343(w)(7), provided that the food ingredient meets the terms or conditions, if
any, specified for that exemption.
(2) Name of the food source from which
each major food allergen is derived. Name
of the food source from which each major
food allergen is derived means the name
of the food as listed in paragraph
(a)(1)(i) of this section, except that:
(i) In the case of a tree nut, it means
the name of the specific type of nut
(for example, almonds, pecans, or walnuts);
(ii) In the case of Crustacean shellfish, it means the name of the species
of Crustacean shellfish (for example,
crab, lobster, or shrimp); and
(iii) The names ‘‘egg’’ and ‘‘peanuts’’,
as well as the names of the different
types of tree nuts, may be expressed in
either the singular or plural form, and
the term ‘‘soy’’, soybean’’, or ‘‘soya’’
may be used instead of ‘‘soybeans’’.
(b) Voluntary labeling standards.
Major food allergens (defined in paragraph (a)(1) of this section) used in the
production of a wine may, on a voluntary basis, be declared on any label
affixed to the container. However, if
any one major food allergen is voluntarily declared, all major food allergens used in production of the wine, including major food allergens used as
fining or processing agents, must be declared, except when covered by a petition for exemption approved by the appropriate TTB officer under § 4.32b. The
major food allergens declaration must
consist of the word ‘‘Contains’’ followed by a colon and the name of the
food source from which each major
food allergen is derived (for example,
‘‘Contains: egg’’).

(Paragraph (e) approved by the Office of
Management and Budget under Control
Number 1512–0469)
[T.D. 6521, 25 FR 13835, Dec. 29, 1960]
EDITORIAL NOTE: For FEDERAL REGISTER citations affecting § 4.32, see the List of CFR
Sections Affected, which appears in the
Finding Aids section of the printed volume
and at www.fdsys.gov.

§ 4.32a Voluntary disclosure of major
food allergens.

pmangrum on DSK3VPTVN1PROD with CFR

§ 4.32a

(a) Definitions. For purposes of this
section the following terms have the
meanings indicated.
(1) Major food allergen. Major food allergen means any of the following:
(i) Milk, egg, fish (for example, bass,
flounder, or cod), Crustacean shellfish
(for example, crab, lobster, or shrimp),
tree nuts (for example, almonds, pecans, or walnuts), wheat, peanuts, and
soybeans; or

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§ 4.32b

27 CFR Ch. I (4–1–14 Edition)

(c) Cross reference. For mandatory labeling requirements applicable to
wines containing FD&C Yellow No. 5
and sulfites, see §§ 4.32(c) and (e).

time. TTB will treat this submission as
a new petition for purposes of the time
frames for decision set forth in paragraph (b) of this section.
(d) Availability of information—(1) General. TTB will promptly post to its public Web site, http://www.ttb.gov, all petitions received under this section as
well as TTB’s responses to those petitions. Any information submitted in
support of the petition that is not posted to the TTB Web site will be available to the public pursuant to 5 U.S.C.
552, except where a request for confidential treatment is granted under
paragraph (d)(2) of this section.
(2) Requests for confidential treatment
of business information. A person who
provides trade secrets or other commercial or financial information in
connection with a petition for exemption under this section may request
that TTB give confidential treatment
to that information. A failure to request confidential treatment at the
time the information in question is
submitted to TTB will constitute a
waiver of confidential treatment. A request for confidential treatment of information under this section must conform to the following standards:
(i) The request must be in writing;
(ii) The request must clearly identify
the information to be kept confidential;
(iii) The request must relate to information that constitutes trade secrets
or other confidential commercial or financial information regarding the business transactions of an interested person, the disclosure of which would
cause substantial harm to the competitive position of that person;
(iv) The request must set forth the
reasons why the information should
not be disclosed, including the reasons
the disclosure of the information would
prejudice the competitive position of
the interested person; and
(v) The request must be supported by
a signed statement by the interested
person, or by an authorized officer or
employee of that person, certifying
that the information in question is a
trade secret or other confidential commercial or financial information and
that the information is not already in
the public domain.

pmangrum on DSK3VPTVN1PROD with CFR

[T.D. TTB–53, 71 FR 42267, July 26, 2006]

§ 4.32b Petitions for exemption from
major food allergen labeling.
(a) Submission of petition. Any person
may petition the appropriate TTB officer to exempt a particular product or
class of products from the labeling requirements of § 4.32a. The burden is on
the petitioner to provide scientific evidence (including the analytical method
used to produce the evidence) that
demonstrates that the finished product
or class of products, as derived by the
method specified in the petition, either:
(1) Does not cause an allergic response that poses a risk to human
health; or
(2) Does not contain allergenic protein derived from one of the foods identified in § 4.32a(a)(1)(i), even though a
major food allergen was used in production.
(b) Decision on petition. TTB will approve or deny a petition for exemption
submitted under paragraph (a) of this
section in writing within 180 days of receipt of the petition. If TTB does not
provide a written response to the petitioner within that 180-day period, the
petition will be deemed denied, unless
an extension of time for decision is mutually agreed upon by the appropriate
TTB officer and the petitioner. TTB
may confer with the Food and Drug
Administration (FDA) on petitions for
exemption, as appropriate and as FDA
resources permit. TTB may require the
submission of product samples and
other additional information in support of a petition; however, unless required by TTB, the submission of samples or additional information by the
petitioner after submission of the petition will be treated as the withdrawal
of the initial petition and the submission of a new petition. An approval or
denial under this section will constitute a final agency action.
(c) Resubmission of a petition. After a
petition for exemption is denied under
this section, the petitioner may resubmit the petition along with supporting
materials for reconsideration at any

[T.D. TTB–53, 71 FR 42267, July 26, 2006]

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