98-29562. Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers  

  • [Federal Register Volume 63, Number 214 (Thursday, November 5, 1998)]
    [Rules and Regulations]
    [Pages 59709-59710]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 98-29562]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Food and Drug Administration
    
    21 CFR Part 178
    
    [Docket No. 98F-0432]
    
    
    Indirect Food Additives: 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 chromium oxide 
    green, Cr2O3 (C.I. Pigment Green 17) as a 
    colorant for polymers intended for use in contact with food. This 
    action is in response to a petition filed by Ticona.
    
    DATES:  The regulation is effective November 5, 1998; written 
    objections and requests for a hearing by December 7, 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 June 22, 1998 (63 FR 33935), FDA announced that a food 
    additive petition (FAP 8B4603) had been filed by Ticona, c/o Keller and 
    Heckman, 1001 G St. NW., suite 500 West, Washington, DC 20001. 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 chromium oxide green, Cr2O3 (C.I. 
    Pigment Green 17) as a colorant for polymers 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 Sec. 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 previously considered the environmental effects of 
    this rule as announced in the notice of filing for FAP 8B4603 (63 FR 
    33935). 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 
    any time on or before December 7, 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
    
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    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 in 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 part 178 is amended as follows:
    
     PART 178--INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND 
    SANITIZERS
    
        1. The authority citation for 21 CFR part 178 continues to read as 
    follows:
    
        Authority:  21 U.S.C. 321, 342, 348, 379e.
    
        2. Section 178.3297 is amended in the table in paragraph (e) by 
    revising the entry for ``Chromium oxide green'' under the headings 
    ``Substances'' and ``Limitations'' to read as follows:
    
    
    Sec. 178.3297  Colorants for polymers.
    
    * * * * *
        (e) * * *
    
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                 Substances                          Limitations
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      *                    *                    *                    *
                       *                    *                    *
    Chromium oxide green, Cr2O3 (C.I.    For use only:
     Pigment Green 17, C.I. No. 77288).  1. In polymers used in contact with
                                          food at a level not to exceed 5
                                          percent by weight of the polymer,
                                          except as specified below.
                                         2. In olefin polymers complying
                                          with Sec.  177.1520 of this
                                          chapter.
                                         3. In repeat-use rubber articles
                                          complying with Sec.  177.2600 of
                                          this chapter; total use is not to
                                          exceed 10 percent by weight of
                                          rubber articles.
      *                    *                    *                    *
                       *                    *                    *
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        Dated: October 15, 1998.
     L. Robert Lake,
     Director, Office of Policy, Planning and Strategic Initiatives, Center 
    for Food Safety and Applied Nutrition.
    [FR Doc. 98-29562 Filed 11-4-98; 8:45 am]
    BILLING CODE 4160-01-F
    
    
    

Document Information

Effective Date:
11/5/1998
Published:
11/05/1998
Department:
Food and Drug Administration
Entry Type:
Rule
Action:
Final rule.
Document Number:
98-29562
Dates:
The regulation is effective November 5, 1998; written objections and requests for a hearing by December 7, 1998.
Pages:
59709-59710 (2 pages)
Docket Numbers:
Docket No. 98F-0432
PDF File:
98-29562.pdf
CFR: (1)
21 CFR 178.3297