Document ggBjqJv3dGNJKm8OV46YmrDN

$a/ "*/ y <? 5 February 1, 1989 Daphene Benderly Avon Lake Technical Center SUBJECT: GEON 86403 TRANS 001 The FDA acceptable methyl tin stabilizers are cleared for use only in rigid FVC and vinyl chloride-propylene copolymers at levels not-to-exceed 2% by wt. Geon 86403 trans 001 contains more than 2% S-86 and therefore is not acceptable for use in contact with food. If the stabilizer level were 2% or less and the compound met the ASTM definition of a rigid plastic, there would be limited FDA clearance. The methyl tins are also limited to use on contact with food types I, II, III, IV (except liquid mills), V, VI, VII, VIII and IX under use conditions D, E, F and G as described in Tables 1 and 2 of 21CFR176.170. However, the prior sanction limitations for DOP limit its use to foods of high water content only. Consequently, if Geon 86403 trans 001 contained <2% methyl tin stabilizer and was classed as rigid, it would be limited to general use in contact with food types I, II, III and IV only under use conditions D, E, F and G. Use in accordance with 21CFR175.300, 177.1200 and 177.2600 would have the same limitations as the methyl tin stabilizer itself. If you have any questions, please call. W. C. Bachtel 90201-5/jp BFG18484 22059001