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March 12, 1990
Daphene Benderly
ALTC
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SUBJECT: (FDA STATUS - PVC COMPOUNDS )
(compounds 165-46-21-1.2 )
FDA has canceled the provisional listing for FD&C, Red #3, the colorant in 85435, Red MB 702. If this colorant is replaced with an acceptable one, these compounds would be acceptable for use in contact with foods of high water content only.
((compound 165-46-25-1 ^
Compound 165-46-25-1 meets the current requirements of the FDA for use in contact with foods of high water content only. The ingredients in this compound are either listed on an appropriate regulation, or are generally recognized as safe (GRAS) or prior sanctioned for such use.
(compounds 165-46-24-1.2^
Providing these compounds meet the definition (ASTM) of a rigid or semirigid PVC, they meet the current requirements of the FDA for use on contact with foods of high water content only, except liquid milk, malt beverages and carbonated nonalcoholic beverages. The ingredients in these compounds are either listed on an appropriate regulation, are generally recognized as safe (GRAS), or prior sanctioned for such use. The end food contact article must meet the extractive limitations imposed by 21CFR 178.2650 "Organotin Stabilizers In Vinyl Chloride Plastics".
Good-Rite (R) 2601X120 would be acceptable for use in vinyl compounds, providing it can meet the extractive limitations of 177.1010 or 178.3790.
W. C. Bachtel
WCB/jp
cc: Cheryl Brubaker - CL-OTM-3 Carol Schmidt - CL-OTM-3 Ken Srail - ALTC
20839001
BFG07400
DFGoodrich
INTER-ORGANIZATION CORRESPONDENCE
TO Wally Bachtel
FROM SUBJECT
Daphne Benderly
FIELD
MPT & BLDG. NO.
FIELD POgg^ DEPT 4 8106 NO
FDA Status
DATE YOUR LETTER
I am planning to commercialize would like to confirm that they are
recipes for the compounds:
several materials in the near future,
FDA acceptable. I have enclosed the
and
165-46-21-1
165-46-21-2
165-46-24-1
165-46-24-2
165-46-25-1
I would also like to know if the use of Goodrite 2601x120 process aid (BFG code
941710961) is acceptable in FDA compounds.
Z^Ohi2<0 -
Thank yout
cc:
Cheryl Brubaker Carol Schmidt Ken Srail
pi- / ot&
0839002
cmpds.fda BFG-4956-NV 7/86 LITHO IN U.S.A.
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