Document 6bw5De11zVEKr9jv6kQEDO6d3
3 'Goodrich
The BFGoodrich Company 3925 Embassy Parkway Akron. Ohio 44313-1799
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September 13, 1990
Mr. Garret Giffin Pacific Plastics 2005 - 87th Avenue, South Kent, Washington 98031
SUBJECT: GEON 110X500 FDA STATUS
Dear Mr. Giffin:
Mr. Glen Schaaf asked that I write to you regarding the FDA status of Geon 110X500. Geon 110X500 is a homopolymer polyvinyl chloride (PVC) resin. Polyvinyl chloride is prior sanctioned for use in general food contact applications, both flexible and rigid. The prior sanction is based on an article by A. J. Lehman, from the FDA, published in the Journal of the Association of Food and Drug Officials, July, 1951. The current Good Manufacturing Practice (GMP) specifications for prior sanctioned PVC are a maximum volatility of 3.0% (1 hour at 105C) and an inherent viscosity of not less than 0.35 by ASTM D-1243-79. Geon 110X500 meets the GMP specifications for prior sanctioned PVC and therefore meets the current requirements of the FDA for general food contact applications.
PVC is also listed as an acceptable ingredient of food contact articles under 21CFR:
175.105 175.300 176.180 177.1010
177.1200 177.2250 179.45
If you have any further questions, please call me at 216/374-3422.
Sincerely,
THE BFGOODRICH COMPANY
W. C. Bachtel Toxicologist Environment, Health and
Safety Management Systems
0913-1/jp
T00RAF02
BFG07660
KPGoodrich
3925 Embassy Parkway Akron, OMo 44333-1799
Ta<pbon: 216-374-4366 Fax: 216-374-2236
(INCLUDING TNE COVER)
TO: OF: FAX#
Mr. Garret Giffin Pacific Plastics 206/872-3352
FROM: OF:
W. C. Bachtel______________ The BFGoodrich Company
COMMENTS:
BFG07661
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