[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Rules and Regulations]
[Pages 51527-51528]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25795]



[[Page 51527]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 175

[Docket No. 98F-0183]


Indirect Food Additives: Adhesives and Components of Coatings

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-hydroxy-1-[4-(2-
hydroxyethoxy)phenyl]-2-methyl-1-propanone as a photoinitiator for 
adhesives and pressure-sensitive adhesives intended for use in food-
contact applications. This action responds to a petition filed by Ciba 
Specialty Chemicals Corp.

DATES: This regulation is effective September 28, 1998. Submit written 
objections and requests for a hearing by October 28, 1998.

ADDRESSES: Submit written objections to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Vir D. Anand, Center for Food Safety 
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3081.

SUPPLEMENTARY INFORMATION: In a notice published in the Federal 
Register of March 31, 1998 (63 FR 15425), FDA announced that a food 
additive petition (FAP 8B4589) had been filed by Ciba Specialty 
Chemicals Corp., 540 White Plains Rd., Tarrytown, NY 10591-9005. The 
petition proposes to amend the food additive regulations to provide for 
the safe use of 2-hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-
propanone as a photoinitiator for adhesives complying with Sec. 175.105 
Adhesives (21 CFR 175.105) and pressure-sensitive adhesives complying 
with Sec. 175.125 Pressure-sensitive adhesives (21 CFR 175.125) 
intended for use in contact with food.
    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 is safe, that the additive will achieve its intended 
technical effect, and therefore, that the regulations in Secs. 175.105 
and 175.125 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 (address above) 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 previously considered the environmental effects of 
this rule as announced in the notice of filing for FAP 8B4589 (63 FR 
15425). No new information or comments have been received that would 
affect the agency's previous determination that there is no significant 
impact on the human environment and that an environmental impact 
statement is not required.
    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.
    Any person who will be adversely affected by this regulation may at 
anytime on or before October 28, 1998, file with the Dockets Management 
Branch (address above) written objection 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 objection 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 in 21 CFR Part 175

    Adhesives, 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 part 175 is amended 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 175.105 is amended in the table in paragraph (c)(5) by 
alphabetically adding an entry under the headings ``Substances'' and 
``Limitations'' to read as follows:


Sec. 175.105  Adhesives.

* * * * *
    (c) * * *
    (5) * * *

------------------------------------------------------------------------
             Substances                          Limitations
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  *                    *                    *                    *
                   *                    *                    *
2-Hydroxy-1-[4-(2-                   For use only as a photoinitiator at
 hydroxyethoxy)phenyl]-2-methyl-1-    a level not to exceed 5 percent by
 propanone(CAS Reg. No. 106797-53-    weight of the adhesive.
 9).
  *                    *                    *                    *
                   *                    *                    *
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    3. Section 175.125 is amended by adding paragraph (a)(8) and by 
revising paragraph (b)(1) to read as follows:


Sec. 175.125  Pressure-sensitive adhesives.

* * * * *
    (a) *  *   *
    (8) 2-Hydroxy-1-[4-(2-hydroxyethoxy)phenyl]-2-methyl-1-propanone 
(CAS Reg. No. 106797-53-9) as a photoinitiator at a level not to exceed 
5 percent by weight of the pressure-sensitive adhesive.
    (b) * * *
    (1) Substances listed in paragraphs (a)(1), (a)(2), (a)(3), (a)(5), 
(a)(6), (a)(7), and (a)(8) 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.
* * * * *

    Dated: September 15, 1998.
L. Robert Lake,
Director, Office of Policy, Planning and Strategic Initiatives, Center 
for Food Safety and Applied Nutrition.
[FR Doc. 98-25795 Filed 9-25-98; 8:45 am]
BILLING CODE 4160-01-F