Document 5DjykgxYe5VXwGyb1K0k03e45

/ j9/U *7/1 SjJrctcL July 8, 1991 gift-gas Jim Gray Subject: Geon 87241 FDA Clearance This letter is in regard to your question regarding the use of Geon 87241 in a housewares application. Those food contact articles used in the household, food service establishments and food dispensing equipment are exempt from FDA Regulatory compliance. I am enclosing a copy of a March, 1983 letter from FDA concerning the so-called "Housewares Exemption." FDA has taken no further action on this issue and is unlikely to do so. However, even though they may be excluded from regulatory control, such items must not adulterate food within the meaning of Section 402 of the FD&C Act. Based on my review of the formulation of Geon 87241 in light of the intended use in refrigeration control housing under the Housewares Exemption, it is my opinion that this compound would be acceptable for use under these intended conditions. All of the ingredients in Geon 87241 are acceptable for use in food contact applications and are listed on a regulation in 21CFR Parts 172 through 182 or are prior sanctioned for use in food contact applications. However, you should note that we are waiting for the letter of confirmation of the FDA acceptability from one of our raw material suppliers. Any other use of this compound in contact with food must be evaluated based on the intended use. Attachment BFG21021 T 22477001 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service March 11, 1983 Food and Drug Administration Washington DC 20204 MAR 17 198j Mr. Wellman C. Bachtel Toxicologist The BF Goodrich Company 500 South Main Street Akron, OH 44318 re: Current status of houseware exemption Dear Mr. Bachtel: This is in regard to your request of January 5, 1983 for the current status of the "Houseware Exemption". In 1974 FDA concluded that the "Houseware Exemption" was not an accurate statement of the scope of the Food Additives Amendment. Accordingly, we proposed to change the agency's longstanding interpretation to the contrary. The proposal explains that it was the intent of the Food Additives Amendment to include in its scope any potentially migratory substances in food-contact articles intended for use in the household, food service establishments, or food dispensing equipment, and that such items currently on the market must be brought into compliance if not already in conformity with the law. Final action has not yet been taken on the 1974 proposal, and housewares remain exempt from the food additive provi sions of the Act. However, housewares are not exempt from the Act's general- safety provisions that apply to the adulteration of food. Anyone manufacturing food-contact articles for use in the household or food service establish ments should make sure that nothing from the article imparts flavor, color, odor, toxicity, or other undesirable charact eristics to food, thereby rendering the food adulterated within the meaning of section 402 of the FDAC Act. 22477002 BFG21022 i Mr. Wellman C. Bachtel Page - 2 If you have further questions on this subject, please do not hesitate to contact us. Sincerely yours, Marvin D. Mack, J.D. Petitions Control Branch, HFF-331* Division of Food and Color Additives Bureau of Foods BFG21023 T IT! 22477003