[Federal Register Volume 60, Number 59 (Tuesday, March 28, 1995)]
[Rules and Regulations]
[Pages 15871-15872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-7616]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 184

[Docket No. 93P-0024]


Diacetyl Tartaric Acid Esters of Mono- and Diglycerides; Revision 
of Common or Usual Name

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is revising its 
regulations to recognize the acronym ``DATEM'' as the alternate common 
or usual name of the ingredient diacetyl tartaric acid esters of mono- 
and diglycerides. This action responds to a citizen petition submitted 
by Grindsted Products Co. requesting approval of the alternate name.

EFFECTIVE DATE: April 27, 1995.

FOR FURTHER INFORMATION CONTACT: Gerad L. McCowin, Office of Food 
Labeling (HFS-151), Food and Drug Administration, 200 C St. SW., 
Washington, DC 20204, 202-205-4561.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of December 1, 1994 (59 FR 61560), FDA 
published a proposal to revise Sec. 184.1101(a) and (e) (21 CFR 
184.1101(a) and (e)) on diacetyl tartaric acid esters of mono- and 
diglycerides to provide for the use of the acronym ``DATEM'' in food 
labeling as the alternate common or usual name of this ingredient. The 
proposal was issued in response to a citizen petition submitted by 
Grindsted Products Co. No comments were received by the agency in 
response to the proposal.

II. Conclusion

    The agency received no comments on the proposed rule. Thus, the 
agency concludes that, for the reasons set forth in its proposal, it is 
appropriate to revise Sec. 184.1101 (e) governing generally recognized 
as safe (GRAS) food substances to provide for the use of the acronym 
``DATEM'' as the alternate common or usual name of the ingredient 
diacetyl tartaric acid esters of mono- and diglycerides on food 
labeling. The agency concludes that there has been sufficient exposure 
to the term ``DATEM'' to allow the American consumer to recognize and 
understand the meaning of this term. The term ``DATEM'' is acceptable 
and favorable to both industry and the consumer and, therefore, should 
be allowed to be used interchangeably with the term ``diacetyl tartaric 
acid esters of mono- and diglycerides.'' [[Page 15872]] 

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(a)(9) and (a)(11) that 
this action is of a type that does not individually or cumulatively 
have a significant effect on the human environment. FDA did not receive 
any comments on this issue and, thus, is aware of no reason to alter 
this determination.

IV. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because FDA did not receive any comments or new 
information on this issue, the agency certifies that the final rule 
will not have a significant economic impact on a substantial number of 
small entities. Therefore, under the Regulatory Flexibility Act, no 
further analysis is required.

List of Subjects in 21 CFR Part 184

    Food ingredients.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
184 is amended as follows:

PART 184--DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED 
AS SAFE

    1. The authority citation for 21 CFR part 184 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).

    2. Section 184.1101 is amended by revising paragraphs (a) and (e) 
to read as follows:


Sec. 184.1101  Diacetyl tartaric acid esters of mono- and diglycerides.

* * * * *
    (a) Diacetyl tartaric acid esters of mono- and diglycerides, also 
know as DATEM, are composed of mixed esters of glycerin in which one or 
more of the hydroxyl groups of glycerin has been esterified by diacetyl 
tartaric acid and by fatty acids. The ingredient is prepared by the 
reaction of diacetyl tartaric anhydride with mono- and diglycerides 
that are derived from edible sources.
* * * * *
    (e) Labeling: The acronym ``DATEM'' may be used on food labeling as 
the alternate common or usual name for the ingredient diacetyl tartaric 
acid esters of mono- and diglycerides.

    Dated: March 17, 1995.
Fred R. Shank,
Director, Center for Food Safety and Applied Nutrition.
[FR Doc. 95-7616 Filed 3-27-95; 8:45 am]
BILLING CODE 4160-01-F