[Federal Register Volume 60, Number 195 (Tuesday, October 10, 1995)]
[Rules and Regulations]
[Pages 52628-52629]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-24953]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. 95C-0091]
Listing of Color Additives Exempt From Certification; Fruit Juice
Color Additive and Vegetable Juice Color Additive
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use in food of dried fruit
juice color additive, dried vegetable juice color additive, and
vegetable juice color additive prepared by water infusion of the dried
vegetable. This action is in response to a petition filed by GNT
Gesellshaft fur Nahrungsmitteltechnologie mbH.
DATES: Effective November 13, 1995, except as to any provisions that
may be stayed by the filing of proper objections; written objections
and request for a hearing by November 9, 1995.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,
Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: Aydin Orstan, Center for Food Safety
and Applied Nutrition (HFS-217), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3076.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of April 28, 1995 (60 FR 20997), FDA announced that a color
additive petition (CAP 5C0245) had been filed by GNT Gesellshaft fur
Nahrungsmitteltechnologie mbH c/o Burditt & Radzius, Chtd., 333 West
Wacker Dr., suite 2600, Chicago, IL 60606-1218. The petition proposed
to amend the color additive regulations in Sec. 73.250 Fruit juice (21
CFR 73.250) to provide for the safe use of dried fruit juice color
additive and in Sec. 73.260 Vegetable juice (21 CFR 73.260) to provide
for the safe use of dried vegetable juice color additive and vegetable
juice color additive prepared by water infusion of the dried vegetable.
The petition was filed under section 721(b)(5) of the Federal Food,
Drug, and Cosmetic Act (the act) (21 U.S.C. 379e(b)(5)). The agency now
notes that this action is more accurately covered under section 721(d)
of the act (21 U.S.C. 379e(d)). The agency finds that because the
regulatory action was described properly in the filing notice, however,
the error in citation was not misleading, and thus, an amended notice
is not necessary.
In two notices published in the Federal Register of May 18, 1965
(30 FR 6735), FDA proposed to list fruit juice color additive and
vegetable juice color additive for food use. The proposed fruit juice
regulation provided for the preparation of fruit juice color additive
either by expression of fresh fruits or by water infusion of the dried
fruit; the proposed vegetable juice regulation provided for the
preparation of vegetable juice color additive only by expression of
fresh vegetables. In the Federal Register of January 27, 1966 (31 FR
1063), FDA published a final rule permanently listing fruit juice color
additive and vegetable juice color additive for food use. In the
preamble to the final rule, the agency indicated that it had received a
comment that the regulation for vegetable juice color additive also
provide for the use of a water infusion of vegetables. However, the
agency declined to revise the proposed rule for the vegetable juice
regulation as suggested because the comment presented no evidence that
water infusions of vegetables were being manufactured or distributed in
the United States for coloring purposes or that authorization for such
water infusions was needed. The current color additive petition (CAP
5C0245) contains information that shows that water infusions of dried
vegetables are being manufactured and that authorization for use of
water infusions of dried vegetables to color food is needed.
FDA has evaluated the data in the petition and other relevant
information and concludes that the petitioned uses of the color
additives fruit juice and vegetable juice in food are safe. Therefore,
the agency is amending Sec. 73.250 to provide for the safe use of dried
fruit juice color additive and Sec. 73.260 to provide for the safe use
of dried vegetable juice color additive and of vegetable juice color
additive prepared by water infusion of the dried vegetable. Also, to
prevent any potential misunderstanding of the amended identity
statements in Secs. 73.250 and 73.260, the agency is revising the
wording of these statements.
In accordance with Sec. 71.15(a) (21 CFR 71.15(a)), the petition
and the documents that FDA considered and relied upon in reaching its
decision to approve the petition are available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person
[[Page 52629]]
listed above. As provided in Sec. 71.15(b), the agency will delete from
the documents any materials that are not available for public
disclosure before making the documents available for inspection.
The agency has previously considered the environmental effects of
this rule and announced its conclusion in the Notice of Filing for CAP
5C0245 (60 FR 20997). No new information or comments have been received
that would affect the agency's conclusion that there is no significant
impact on the human environment and that an environmental impact
statement is not required.
Any person who will be adversely affected by this regulation may at
any time on or before November 9, 1995, file with the Dockets
Management Branch (address above) written objections thereto. Each
objection shall be separately numbered, and each numbered objection
shall specify with particularity the provisions of the regulation to
which objection is made and the grounds for the objection. Each
numbered objection on which a hearing is requested shall specifically
so state. Failure to request a hearing for any particular objection
shall constitute a waiver of the right to a hearing on that objection.
Each numbered objection for which a hearing is requested shall include
a detailed description and analysis of the specific factual information
intended to be presented in support of the objection in the event that
a hearing is held. Failure to include such a description and analysis
for any particular objection shall constitute a waiver of the right to
a hearing on the objection. Three copies of all documents shall be
submitted and shall be identified with the docket number found in
brackets in the heading of this document. Any objections received in
response to the regulation may be seen in the Dockets Management Branch
between 9 a.m. and 4 p.m., Monday through Friday. FDA will publish
notice of the objections that the agency has received or lack thereof
in the Federal Register.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:
PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
1. The authority citation for 21 CFR part 73 continues to read as
follows:
Authority: Secs. 201, 401, 402, 403, 409, 501, 502, 505, 601,
602, 701, 721 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379e).
2. Section 73.250 is amended by removing the first sentence of
paragraph (a)(1) and adding two new sentences in its place to read as
follows:
Sec. 73.250 Fruit juice.
(a) Identity. (1) The color additive fruit juice is prepared either
by expressing the juice from mature varieties of fresh, edible fruits,
or by the water infusion of the dried fruit. The color additive may be
concentrated or dried. * * *
* * * * *
3. Section 73.260 is amended by removing the first sentence of
paragraph (a)(1) and adding two new sentences in its place to read as
follows:
Sec. 73.260 Vegetable juice.
(a) Identity. (1) The color additive vegetable juice is prepared
either by expressing the juice from mature varieties of fresh, edible
vegetables, or by the water infusion of the dried vegetable. The color
additive may be concentrated or dried. * * *
* * * * *
Dated: September 28, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-24953 Filed 10-6-95; 8:45 am]
BILLING CODE 4160-01-F