[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