[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of January 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR180.22]
[Page 458-460]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 180 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN
Subpart B Specific Requirements for Certain Food Additives
Sec. 180.22 Acrylonitrile copolymers.
Acrylonitrile copolymers may be safely used on an interim basis as
articles or components of articles intended for use in contact with
food, in accordance with the following prescribed conditions:
(a) Limitations for acrylonitrile monomer extraction for finished
food-contact articles, determined by a method of analysis titled ``Gas-
Solid
[[Page 459]]
Chromatographic Procedure for Determining Acrylonitrile Monomer in
Acrylonitrile-Containing Polymers and Food Simulating Solvents,'' which
is incorporated by reference. Copies are available from the Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(1) In the case of single-use articles having a volume to surface
ratio of 10 milliliters or more per square inch of food contact
surface--0.003 milligram/square inch when extracted to equilibrium at
120 [deg]F with food-simulating solvents appropriate to the intended
conditions of use.
(2) In the case of single-use articles having a volume to surface
ratio of less than 10 milliliters per square inch of food contact
surface--0.3 part per million calculated on the basis of the volume of
the container when extracted to equilibrium at 120 [deg]F with food-
simulating solvents appropriate to the intended conditions of use.
(3) In the case of repeated-use articles--0.003 milligram/square
inch when extracted at a time equivalent to initial batch usage
utilizing food-simulating solvents and temperatures appropriate to the
intended conditions of use.
The food-simulating solvents shall include, where applicable, distilled
water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and
either n-heptane or an appropriate oil or fat.
(b) Where necessary, current regulations permitting the use of
acrylonitrile copolymers shall be revised to specify limitations on
acrylonitrile/mercaptan complexes utilized in the production of
acrylonitrile copolymers. Such copolymers, if they contain reversible
acrylonitrile/mercaptan complexes and are used in other than repeated-
use conditions, shall be tested to determine the identity of the complex
and the level of the complex present in the food-contact article. Such
testing shall include determination of the rate of decomposition of the
complex at temperatures of 100 [deg]F, 160 [deg]F, and 212 [deg]F using
3 percent acetic acid as the hydrolic agent. Acrylonitrile monomer
levels, acrylonitrile/mercaptan complex levels, acrylonitrile oligomer
levels, descriptions of the analytical methods used to determine the
complex and the acrylonitrile migration, and validation studies of these
analytical methods shall be submitted by June 9, 1977, to the Center for
Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, unless
an extension is granted by the Food and Drug Administration for good
cause shown. Analytical methods for the determination of acrylonitrile
complexes with n-dodecyl-mercaptan, n-octyl mercaptan, and 2-
mercaptoethanol, titled ``Determination of [beta]-Dodecyl-
mercaptopropionitrile in NR.16R Aqueous Extracts'' and ``Measurement of
[beta]-(2-Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating
Solvent,'' are incorporated by reference. Copies are available from the
Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or
available for inspection at the National Archives and Records
Administration (NARA). For information on the availability of this
material at NARA, call 202-741-6030, or go to: http://www.archives.gov/
federal--register/code--of--federal--regulations/ibr--locations.html.
(c) The following data shall be provided for finished food-contact
articles intended for repeated use:
(1) Qualitative and quantitative migration values at a time
equivalent to initial batch usage, utilizing solvents and temperatures
appropriate to the intended conditions of use.
(2) Qualitative and quantitative migration values at the time of
equilibrium extractions, utilizing solvents and temperatures appropriate
to the intended conditions of use.
(3) Data on the volume and/or weight of food handled during the
initial batch time period(s), during the equilibrium test period, and
over the estimated life of the food-contact surface.
[[Page 460]]
(d) Where acrylonitrile copolymers represent only a minor component
of a polymer system, calculations based on 100 percent migration of the
acrylonitrile component may be submitted in lieu of the requirements of
paragraphs (a), (b), and (c) of this section in support of the continued
safe use of acrylonitrile copolymers.
(e) On or before September 13, 1976, any interested person shall
satisfy the Commissioner of Food and Drugs that toxicological feeding
studies adequate and appropriate to establish safe conditions for the
use of acrylonitrile copolymers have been, or soon will be, undertaken.
Toxicity studies of acrylonitrile monomer shall include: (1) Lifetime
feeding studies with a mammalian species, preferably with animals
exposed in utero to the chemical, (2) studies of multigeneration
reproduction with oral administration of the test material, (3)
assessment of teratogenic and mutagenic potentials, (4) subchronic oral
administration in a nonrodent mammal, (5) tests to determine any
synergistic toxic effects between acrylonitrile monomer and cyanide ion,
and (6) a literature search on the effects of chronic ingestion of
hydrogen cyanide. Data on levels of acrylamide extractable from
acrylonitrile copolymers shall also be submitted. Protocols of testing
should be submitted for review to the Center for Food Safety and Applied
Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740.
(f) Acrylonitrile copolymers may be used in contact with food only
if authorized in parts 174 through 179 or Sec. 181.32 of this chapter,
except that other uses of acrylonitrile copolymers in use prior to June
14, 1976, may continue under the following conditions:
(1) On or before August 13, 1976, each use of acrylonitrile
copolymers in a manner not authorized by Sec. 181.32 of this chapter or
parts 174 through 179 of this chapter shall be the subject of a notice
to the Center for Food Safety and Applied Nutrition (HFS-200), Food and
Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740.
Such notice shall be accompanied by a statement of the basis, including
any articles and correspondence, on which the user in good faith
believed the use to be prior-sanctioned. The Commissioner of Food and
Drugs shall, by notice in the Federal Register, identify any use of
acrylonitrile copolymers not in accordance with this paragraph. Those
uses are thereafter unapproved food additives and consequently unlawful.
(2) Any use of acrylonitrile copolymers subject to paragraph (f)(1)
of this section shall be the subject of a petition submitted on or
before December 13, 1976, in accordance with Sec. 171.1 of this
chapter, unless an extension of time is granted by the Food and Drug
Administration for good cause shown. Any application for extension shall
be by petition submitted in accordance with the requirements of part 10
of this chapter. If a petition is denied, in whole or in part, those
uses subject to the denial are thereafter unapproved food additives and
consequently unlawful.
(3) Any use of acrylonitrile copolymers subject to paragraph (f)(1)
of this section shall meet the acrylonitrile monomer extraction
limitation set forth in paragraph (a) of this section and shall be
subject to the requirements of paragraph (b) of this section.
(g) In addition to the requirements of this section, the use of
acrylonitrile copolymers shall comply with all applicable requirements
in other regulations in this part.
[42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982;
54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996]
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