[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: 21CFR181.32]
[Page 466-467]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES (CONTINUED)
PART 181 PRIOR-SANCTIONED FOOD INGREDIENTS--Table of Contents
Subpart B Specific Prior-Sanctioned Food Ingredients
Sec. 181.32 Acrylonitrile copolymers and resins.
(a) Acrylonitrile copolymers and resins listed in this section,
containing less than 30 percent acrylonitrile and complying with the
requirements of paragraph (b) of this section, may be safely used as
follows:
(1) Films. (i) Acrylonitrile/butadiene/styrene copolymers--no
restrictions.
(ii) Acrylonitrile/butadiene copolymers--no restrictions.
(iii) Acrylonitrile/butadiene copolymer blended with vinyl chloride-
vinyl acetate (optional at level up to 5 percent by weight of the vinyl
chloride resin) resin--for use only in contact with oleomargarine.
(iv) Acrylonitrile/styrene copolymer--no restrictions.
(2) Coatings. (i) Acrylonitrile/butadiene copolymer blended with
polyvinyl chloride resins--for use only on paper and paperboard in
contact with meats and lard.
(ii) Polyvinyl chloride resin blended with either acrylonitrile/
butadiene copolymer or acrylonitrile/butadiene styrene copolymer mixed
with neoprene, for use as components of conveyor belts to be used with
fresh fruits, vegetables, and fish.
(iii) Acrylonitrile/butadiene/styrene copolymer--no restrictions.
(iv) Acrylonitrile/styrene copolymer--no restrictions.
(3) Rigid and semirigid containers. (i) Acrylonitrile/butadiene/
styrene copolymer--for use only as piping for handling food products and
for repeated-use articles intended to contact food.
(ii) Acrylonitrile/styrene resin--no restrictions.
(iii) Acrylonitrile/butadiene copolymer blended with polyvinyl
chloride resin--for use only as extruded pipe.
(b) Limitations for acrylonitrile monomer extraction for finished
food-contact articles, determined by using the method of analysis titled
``Gas-Solid 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.
[[Page 467]]
(c) Acrylonitrile monomer may present a hazard to health when
ingested. Accordingly, any food-contact article containing acrylonitrile
copolymers or resins that yield acrylonitrile monomer in excess of that
amount provided for in paragraph (b) of this section shall be deemed to
be adulterated in violation of section 402 of the Act.
[42 FR 14638, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982;
54 FR 24899, June 12, 1989]
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