Document ZQ40X3wZBQb7QXp73DjBZrmL

KFGoodrich fINTER-ORGANIZATION CO ft5(3~/ Lh TO J.S. Kim FIELD POINT OR DEPT. & BLDG. NO. Avon Lake T.C. FROM W.C. SUBJECT Bachtel FIELD POINT OR DEPT. & BLDG. NO. Akron - D/0020, 5-H DATE THIS LETTER 8-28-85 FDA Acceptability of Experimental Can Coating Resins I reviewed the resins and hydrosol formulation in your memo of 8/21/85 for their FDA acceptance as can coatings under 21 CFR 175.300 "Resinous and Polymeric Coatings". I have the following comments. Resin A This formulation is acceptable for can coatings provided the coating is dried at a temperature of at least 193C (380F) for 4 minutes. The drying limitation is based on the use of Surfynol 104. J^0g g A" terpolymer of vinyl chloride-vinylidene chloride and acrylamide is not acceptable; only those vinyl chloride copolymers listed under 175.300(b)(xv) may be used. Resin C This resin is acceptable without restriction under 175.300. Hydrosol Formuation This formulation is not acceptable regardless of the status of Resins A, B, or C due to the use of morpholine and Thermolite 831. The only FDA clearance for morpholine is in certain fruit coatings, defoaming agents for paper and paperboard manufacture, and as a corrosion inhibitor for steel or tinplate. Thermolite 831 or any of the octyltin stabilizers may only be used with homopolymer PVC resins or vinyl chloride-ethylene copolymers (177.1950), or vinyl chloride-propylene copolymers (177.1980). The only stabilizers that may be used are those listed under 175.300(3)(xxx), which I have checked on the attached copy of 21 CFR 178.2010 or prior sanctioned calcium-zinc-stannous stearate types. Some examples of these are Snyprons 221, 229, 266, 241; Mark QED, Ferro 7-V-l, 760X, 763, 5709, 5711, etc. I have no information on the FDA acceptance status of SAS-30 or Drew L-39. I will contact the suppliers. Please let me know if you have any questions,. 21262001 v cc: B.K. Mikofalvy, ALTC BFG-4956-E 11/80 LITHO IN U S A. W. C. Bachtel BFG11676