[Federal Register Volume 63, Number 15 (Friday, January 23, 1998)]
[Rules and Regulations]
[Pages 3463-3465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-1539]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 175 and 178
[Docket No. 95F-0210]
Indirect Food Additives: Adhesives and Components of Coatings;
Adjuvants, Production Aids, and Sanitizers
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending the food
additive regulations to provide for the safe use of 2,2'-(2,5-
thiophenediyl)-bis(5-tert-butylbenzoxazole) as an optical brightener in
pressure-sensitive adhesives and in all polymers used in contact with
food. This action is in response to a petition filed by Ciba-Geigy
Corp.
DATES: The regulation is effective January 23, 1998. Submit written
objections and requests for a hearing by February 23, 1998.
ADDRESSES: Submit written objections to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857.
[[Page 3464]]
FOR FURTHER INFORMATION CONTACT: John R. Bryce, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3023.
SUPPLEMENTARY INFORMATION: In a notice published in the Federal
Register of August 18, 1995 (60 FR 43157), FDA announced that a food
additive petition (FAP 5B4471) had been filed by Ciba-Geigy Corp.,
Seven Skyline Dr., Hawthorne, NY 10532-2188. The petition proposed to
amend the food additive regulations in Sec. 178.3297 Colorants for
polymers (21 CFR 178.3297) to provide for the safe use of 2,2'-(2,5-
thiophenediyl)-bis(5-tert-butylbenzoxazole) in all polymers intended
for use in food packaging and in adhesives complying with Sec. 175.125
Pressure-sensitive adhesives (21 CFR 175.125).
In order to clarify the use of this additive as an optical
brightener, the petition also proposed to list the use of the additive
in adhesives complying with Sec. 175.105 (21 CFR 175.105) in
Sec. 178.3297. Because the additive is currently listed in Sec. 175.105
without limitation, use of the additive as an optical brightener in
adhesives complying with Sec. 175.105 is a currently permitted use that
requires no further safety evaluation. Accordingly, this final rule
lists the use of the additive in adhesives complying with Sec. 175.105
in Sec. 178.3297 Colorants for polymers.
FDA has evaluated data in the petition and other relevant material.
Based on this information, the agency concludes that the proposed use
of the additive as an optical brightener in pressure-sensitive
adhesives in Sec. 175.125, and in all polymers intended for use in food
packaging in Sec. 178.3297, is safe; that the additive will have the
intended technical effect; and that therefore, the regulations in
Secs. 175.125 and 178.3297 should be amended as set forth below.
In accordance with Sec. 171.1(h) (21 CFR 171.1(h)), 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 listed above. As provided in Sec. 171.1(h),
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 carefully considered the potential environmental
effects of this action. FDA has concluded that the action will not have
a significant impact on the human environment, and that an
environmental impact statement is not required. The agency's finding of
no significant impact and the evidence supporting that finding,
contained in an environmental assessment, may be seen in the Dockets
Management Branch (address above) between 9 a.m. and 4 p.m., Monday
through Friday.
Any person who will be adversely affected by this regulation may at
any time on or before February 23, 1998, 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.
List of Subjects
21 CFR Part 175
Adhesives, Food additives, Food packaging.
21 CFR Part 178
Food additives, Food packaging.
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 parts 175 and 178 are amended to read as follows:
PART 175--INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF
COATINGS
1. The authority citation for 21 CFR part 175 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
2. Section 175.125 is amended by adding paragraph (a)(7) and by
revising paragraph (b)(1) to read as follows:
Sec. 175.125 Pressure-sensitive adhesives.
* * * * *
(a) * * *
(7) 2,2'-(2,5-Thiophenediyl)-bis(5-tert-butylbenzoxazole) (CAS Reg.
No. 7128-64-5) as an optical brightener at a level not to exceed 0.05
percent by weight of the finished pressure-sensitive adhesive.
* * * * *
(b) * * *
(1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5),
(a)(6), and (a)(7) of this section, and those substances prescribed by
paragraph (a)(4) of this section that are not identified in paragraph
(b)(2) of this section.
* * * * *
PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND
SANITIZERS
3. The authority citation for 21 CFR part 178 continues to read as
follows:
Authority: 21 U.S.C. 321, 342, 348, 379e.
4. Section 178.3297 is amended in the table in paragraph (e) by
revising the entry for ``2,2'-(2,5-Thiophenediyl)-bis(5-tert-
butylbenzoxazole)'' under the headings ``Substances'' and
``Limitations'' to read as follows:
Sec. 178.3297 Colorants for polymers.
* * * * *
(e) * * *
[[Page 3465]]
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Substances Limitations
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* * * *
* * *
2,2'-(2,5-Thiophenediyl)-bis(5-tert- For use as an optical brightener:
butylbenzoxazole) (CAS Reg. No. 1. In all polymers at levels not to
7128-64-5). exceed 0.015 percent by weight of
the polymer. The finished articles
are to contact food only under
conditions of use A through H
described in Table 2 of Sec.
176.170(c) of this chapter.
2. In all polymers at levels not to
exceed 0.05 percent by weight of
the polymer. The finished articles
shall contact foods only of the
types identified in Table 1 of
Sec. 176.170(c) of this chapter,
under Categories I, II, IV-B, VI-
A, VI-B, VI-C, VII-B, and VIII
under conditions of use A through
H described in Table 2 of Sec.
176.170(c) of this chapter.
3. In adhesives complying with Sec.
175.105 of this chapter and in
pressure-sensitive adhesives
complying with Sec. 175.125 of
this chapter.
* * * *
* * *
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Dated: January 5, 1998.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 98-1539 Filed 1-22-98; 8:45 am]
BILLING CODE 4160-01-F
