[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR80.32]
[Page 430-431]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 80 COLOR ADDITIVE CERTIFICATION--Table of Contents
Subpart B Certification Procedures
Sec. 80.32 Limitations of certificates.
(a) If a certificate is obtained through fraud or misrepresentation
of a material fact, such certificate shall not be effective, and a color
additive from the batch on which such certificate was issued shall be
considered to be from a batch that has not been certified in accordance
with the regulations in this part. Whenever, the Commissioner learns
that any certificate has been obtained through fraud or material
misrepresentation, he shall notify the holder of the certificate that it
is of no effect.
(b) If between the time a sample of color additive accompanying a
request for certification is taken and the time a certificate covering
the batch of such color additive is received by the person to whom it is
issued, any such color additive becomes changed in composition, such
certificates shall not be effective with respect to such changed color
additive and such changed color additive shall be considered to be from
a batch that has not been certified in accordance with the regulations
in this part.
(c) If at any time after a certificate is received by the person to
whom it is issued any color additive from the batch covered by such
certificate becomes changed in composition, such certificate shall
expire with respect to such changed color additive. After such
expiration, such color additive shall be considered to be from a batch
that has not been certified in accordance with this part; except that
such color additive shall not be so considered when
[[Page 431]]
used for coloring a food, drug, or cosmetic, or for the purpose of
certifying a batch of a mixture in which such color additive was used as
an ingredient, or for use in preparing a batch of a mixture for which
exemption from certification has been authorized, if such change
resulted solely from such use.
(d) A certificate shall expire with respect to any color additive
covered thereby if the package in which such color additive was closed
for shipment or delivery is opened. After such expiration such color
additive shall be considered to be from a batch that has not been
certified, except that such color additive shall not be so considered
when the package is opened;
(1) and such color additive is used, subject to the restrictions
prescribed by paragraphs (f), (g), and (h) of this section, in coloring
a food, drug, or cosmetic;
(2) for the purpose of certifying a batch made by repacking such
color;
(3) for the purpose of certifying a batch of a mixture in which such
color is used as an ingredient; or
(4) for the purpose of preparing a batch of a mixture for which
exemption from certification has been authorized; or
(5) when the package is reopened solely for repackaging by the
person to whom such certificate was issued.
(e) A certificate shall not be effective with respect to a package
of color additive and such color additive shall be considered to be from
a batch that has not been certified if such package is shipped or
delivered under a label which does not bear all words, statements, and
other information required by Sec. 70.25 of this chapter to appear
thereon.
(f) A certificate shall not be effective with respect to a package
of color additive, and such color additive shall be considered to be
from a batch that has not been certified if:
(1) Such package has not been sealed in accordance with Sec. 70.20
of this chapter.
(2) Such package has been sealed in accordance with Sec. 70.20 of
this chapter and the seal has been broken, intentionally or
accidentally, unless such seal has been broken for the purpose of using
color additive in accordance with Sec. 80.38, or, such package has been
opened by a duly authorized representative of the Administration or
Department in the performance of his official duties, and he has
immediately resealed the package in conformance with Sec. 70.20 of this
chapter.
(g) A certificate shall not be effective with respect to a package
of color additive and such color additive shall be considered to be from
a batch that has not been certified if such color additive is used in
any manner other than that for which it was certified.
(h) When the listing or the specifications for a color additive are
revoked or amended, the final order effecting the revocation or
amendment may specify, in addition to its own effective date, a date on
which all certificates for existing batches and portions of batches of
such a color additive theretofore issued under such revoked or amended
regulations shall cease to be effective; and any such lots of the color
additive shall be regarded as uncertified after the date specified
unless a new certificate can be and is obtained in conformance with the
new regulations. When a certificate thus ceases to be effective for a
color additive, any certificates previously issued for a color additive
mixture containing that color additive shall cease to be effective on
the same date. Use of such color additive or color additive mixture
after such specified date without the new certificate in preparing
foods, drugs, or cosmetics will result in such food, drugs, or cosmetics
being adulterated. When a certified color additive has been used in
food, drugs, or cosmetics and the status of the color additive is
thereafter changed by amendment or revocation of its listing or
specification regulations, such food, drugs, and cosmetics will not be
regarded as adulterated by reason of the use of such color additive,
unless the hazard to health is such that existing stocks of the foods,
drugs, or cosmetics cannot be safely used, in which cases findings to
that effect will be made and regulations appropriate for such special
cases will be issued.
[[Page 432]]
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