[Federal Register Volume 59, Number 212 (Thursday, November 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27315]
[[Page Unknown]]
[Federal Register: November 3, 1994]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 182
[Docket No. 80N-0361]
Thiodipropionic Acid and Dilauryl Thiodipropionate; Proposed
Removal of GRAS Status; Withdrawal of Proposed Rule
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule; withdrawal.
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SUMMARY: The Food and Drug Administration (FDA) is withdrawing its
proposal to remove thiodipropionic acid and dilauryl thiodipropionate
from the list of direct human food ingredients that are generally
recognized as safe (GRAS). FDA proposed to remove these substances
because it had not, at that time, received any reports that these
substances were in use as direct human food ingredients. The agency is
withdrawing the proposal because of a report that these substances are
being directly used in food.
FOR FURTHER INFORMATION CONTACT: F. Owen Fields, Center for Food Safety
and Applied Nutrition (HFS-207), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-254-9528.
SUPPLEMENTARY INFORMATION: Thiodipropionic acid and dilauryl
thiodipropionate are listed in Secs. 182.3109 and 182.3280 (21 CFR
182.3109 and 182.3280), as GRAS for direct food use as chemical
preservatives at levels not exceeding 0.02 percent of the fat or oil
content. Thiodipropionic acid and dilauryl thiodipropionate are listed
in Sec. 181.24 (21 CFR 181.24) as prior-sanctioned ingredients for use
as antioxidants in food-packaging material, and are permitted for use
as antioxidants in Sec. 175.300 Resinous and polymeric coatings (21 CFR
175.300). In addition, indirect use of thiodipropionic acid is listed
in Sec. 178.2010 Antioxidants and/or stabilizers for polymers (21 CFR
178.2010).
In the Federal Register of August 13, 1982 (47 FR 35240), FDA
proposed to remove thiodipropionic acid and dilauryl thiodipropionate
from the list of direct human food ingredients that are GRAS. FDA
stated that it was proposing to take this action because FDA had not,
at that time, received any reports that these substances were in use as
direct human food ingredients.
FDA received three comments in response to its proposal. All three
comments opposed the removal of these substances from the list of
direct human food ingredients that are GRAS. One of the comments
contained information on the direct use of these ingredients in food.
In addition, two of the comments expressed concern that removing these
compounds from the list of direct GRAS ingredients would cause
confusion about the GRAS or prior-sanctioned status of these substances
for indirect uses. Finally, two of the comments stated that the fact
that the agency had not received any reports of these substances being
used in food was not an adequate reason to remove them from the list of
direct food ingredients that are GRAS.
FDA has considered all of these comments. In view of the comment
that these substances are being directly used in food, we have
concluded that the orginal basis for the agency's proposal to remove
these substances from the GRAS list is not valid. FDA also wishes to
clarify that its proposal to remove these substances from the list of
direct human food ingredients that are GRAS would not have affected
their allowed indirect uses under Secs. 175.300, 178.2010, or 181.24,
as suggested by two of the comments.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.), the agency announces that it is withdrawing the
proposal that it published in the Federal Register of August 13, 1982
(47 FR 35240), to remove thiodipropionic acid and dilauryl
thiodipropionate from the list of direct human food ingredients that
are GRAS.
Dated: October 24, 1994.
William K. Hubbard,
Interim Deputy Commissioner for Policy.
[FR Doc. 94-27315; Filed 11-2-94; 8:45 am]
BILLING CODE 4160-01-F
