[Federal Register Volume 65, Number 114 (Tuesday, June 13, 2000)]
[Rules and Regulations]
[Pages 37040-37041]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-14905]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 175
[Docket No. 92F-0443]
Indirect Food Additives: Adhesives and Components of Coatings;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending its food
additives regulations to correct two typographical errors in the
Chemical Abstracts Service (CAS) registry number. This document
corrects those errors.
DATES: This rule is effective June 13, 2000.
FOR FURTHER INFORMATION CONTACT: Julius Smith, Center for Food Safety
and Applied Nutrition (HFS-215), Food and Drug Administration, 200 C
St. SW., Washington, DC 20204, 202-418-3091.
SUPPLEMENTARY INFORMATION: In the Federal Register of February 11, 2000
(65 FR 6889), the agency amended the food additive regulations to
provide for the safe use of: (1) 1,2-dibromo-2,4-dicyanobutane, and (2)
a mixture of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-
isothiazolin-3-one, optionally containing magnesium nitrate, as
antimicrobial agents in emulsion-based silicone coating formulations.
The CAS registry number for 2-methyl-4-isothiazol-3-one was incorrectly
published. The agency is amending both 21 CFR 175.300 and 175.320 to
correct those errors.
List of Subjects in 21 CFR Part 175
Adhesives, Food additives, Food packaging.
[[Page 37041]]
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 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.
Sec. 175.300 [Amended]
2. Section 175.300 Resinous and polymeric coatings is amended in
paragraph (b)(3)(xxxiii), under the entry ``5-Chloro-2-methyl * * *'',
by removing ``(CAS Reg. No. 2628-20-4)'' and adding in its place ``(CAS
Reg. No. 2682-20-4)''.
3. Section 175.320 is amended in the table in paragraph (b)(3) by
revising the entry under item (iii) for ``5-Chloro-2-methyl-4-
isothiazolin-3-one'' under the headings ``List of substances'' and
``Limitations'' to read as follows:
Sec. 175.320 Resinous and polymeric coatings for polyolefin films.
* * * * *
(b) * * *
(3) * * *
----------------------------------------------------------------------------------------------------------------
List of substances Limitations
----------------------------------------------------------------------------------------------------------------
* * * * * *
*
(iii) Adjuvants (release agents, waxes, and
dispersants):
* * * .......................................................
*
5-Chloro-2-methyl-4-isothiazolin-3-one (CAS Reg. No. For use only as an antimicrobial agent in emulsion-
26172-55-4) and 2-methyl-4-isothiazolin-3-one (CAS based silicone coatings at a level not to exceed 50
Reg. No. 2682-20-4) mixture, at a ratio of 3 parts to milligrams per kilogram (based on isothiazolone active
1 part, respectively, manufactured from methyl-3- ingredient) in the coating formulation.
mercaptopropionate (CAS Reg. No. 2935-90-2) and
optionally containing magnesium nitrate (CAS Reg. No.
10377-60-3) at a concentration equivalent to the
isothiazolone active ingredients (weight/weight).
* * * * * *
*
----------------------------------------------------------------------------------------------------------------
* * * * *
Dated: June 7, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-14905 Filed 6-12-00; 8:45 am]
BILLING CODE 4160-01-F