Document MZDnB2by365onnk0vGbw4nwj

y I FIELD POINT OR DEPT. h. BLDG. NO. ------ -A_.X 1 Hastings^-----------!Cleveland Chemical| .< ' ' fFiIcEiLnD pPnOiMINTT nCoR nDEPrT. i&mSLnOiG: . uNOrt. __________ W.C.___BachPeJ_______________ ___________ Akrnn - D/Q02Q, t OAT? YOUR LETTER nDATnE mTH<IeS iLmETTrEnR 5-H________________________ 2-21-an Hugh Marty asked that I write you about Hooker's request concerning the FDA status of PVC resins. Polyvinyl chloride is prior sanctioned for use in general food contact applications. The prior sanctioned status of PVC was established by Dr. A.J. Lehman of the FDA in publications of the Quarterly Bulletin of the Association of Food & Drug Officials of the United States, 1951 and 1956. The specifications for PVC resins which apply to the prior sanctioned use are: 1. Maximum volatility - 3% (1 hour @ 105C) 2. Inherent viscosity of not less than 0.35 (ASTM D1243-66, Method A) Consequently, any PVC resins which comply with the specifications may be used in contact with food. There are currently no regulations which specifically deal with the food contact use of PVC resins per se. For example, the use of PVC in bottles is covered by the prior sanction while the modifier and octyl tin stablizer used in the PVC bottles were covered by regulations Although proposed in 1975, a regulation entitled "Vinyl Chloride Poly mer Resins" has never been promulgated. In addition, PVC is listed as an acceptable ingredient under several use oriented regulations. These regulations, which contain no specifications for the PVC resins, are: 175.105 175.300 176.180 177.1010 177.1200 177.2250 179.45 "Adhesives" "Resinous and Polymeric Coatings" "Components of Paper and Paperboard in Contact with Dry Food" "Acrylic and Modified Acrylic Plastics, Semirigid and Rigid" "Cellophane" "Filters, Microporous, Polymeric" "Packaging Materials for Use During the Irradiation of Prepackaged Foods" Also, because of the prior sanctioned status of PVC it may be used under the following regulations, although not specifically listed: m 'oO a CD 175.320 176.170 177.2600 "Resin and Polymeric Coatings for Poly Olefin Films" "Components of Paper and Paperboard in Contact with Aqueous and Fatty Foods" "Rubber Articles Intended for Repeated Use" too I hope this will answer your questions, if not please contact me. & \a cc: H. Marty; R.K.Hinderer ifi- w . T -H ^ US