[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
