Document 2q8EjQx6D6d0vDMk8qRjKdx2R

Henkel Corporation Emery Group October 1, 1992 Mr. Bob Hinderer The B.F. Goodrich Company 6100 Oaktree Blvd. Cleveland, OH 44131 Dear Mr. Hinderer: In reference to our telephone conversation, the Emersol 132 Stearic Acid would be suitable for uses which fall under the indirect or incidental food contact applications. Title 21 Parts 174-178, subject of course to any limitations which appear in the specific regulation for your intended use. We trust this information will satisfy your request. If we can provide any additional information or assistance, please feel free to contact us. Sincerely, Technical Service Oleochemicals Group (513) 482-2257 SAM/alm WPDOC\BOBH.BFGOOD T0068ST 4900 Este Avenue, Cincinnati, Ohio 45232 Phone: 513/482-2100 BFG15555 7A/0- s'? / INTEROFFICE MEMORANDUM Date From Dept: Tel No: 01--Oct--1992 08:10am EDT KMA KMA@ALTC0MRGATE@CLE TO: DILLON, CONNIE0A1 TO: hinderer, robert@Al TO: KOVAC, JOHNgAl TO: HORTON, BILL0A1 Subject: Stearic Acid Consolidation Bob Hinderer contacted me today with regard to conversations he has had recently with Henkel and Keller and Heckman concerning the FDA status of Emersol 132. You will remember that we had asked Henkel to write us a letter that would allow us to use Emersol 132 as our Food Grade stearic acid. Henkel sells Emersol 132 as a USP grade, not a Food Grade stearic acid. However, the Henkel representative felt that the USP grade could be considered Food Grade as far as PVC usage was considered. The Henkel Technical Service Manager did write us such a letter, however, the bottom line is that the language is not exactly what Bob would have ideally wanted. Bob indicated that, while we could probably "get by" with the use of Emersol 132 in Food Grade applications, based on this letter, the use ^ of the actual Emersol Food Grade version, 6332, will give us "an added degree of security." ' In light of this, I wonder if we want to pursue this any further. How much savings would we lose by not consolidating to Emersol 132 (What is the cost difference between L22 and Emersol 132, and what is our usage?) Will the savings be too small to trade for the peace of mind? Are inventory irnpl i cati nns i help us detern Thanks Bud ASP/kma 1589002 BFG15556 ! JSFGoodrid jTl TO TO: FROM FROM: J, POWELL C. V. PTTRTC.-' _________________ 'ALTC_________ I & BLDG NO ,-R ?T. & BLDG. NO w DATE YOUR LETTER DATE THIS LETTER May -28---- ----------------------- FDA ACCEPTABILITY OF EMERSOL 132 STEARIC ACID. THERE IS A PROGRAM OF RAW MATERIAL CONSOLIDATION IN PROGRESS WHICH IS DESIGNED TO DEVELOP A NARROWER LINE OF RAW MATERIAL CODES WHICH WILL BE EASIER TO MANAGE, AND IN THE LONG TERM OFFER LOWER RAW MATERIAL COSTS. STEARIC ACID IS A RAW MATERIAL WHICH WAS IDENTIFIED AS A CANDIDATE FOR CONSOLIDATION SINCE THERE WERE THREE PRIMARY AND ONE SECOUNDARY STEARIC ACID CODES IN OUR SYSTEM. THE CODES IN USE PRIOR TO THE CONSOLIDATION EFFORT WERE AS FOLLOWS: L-2 L-21 L-22 630353 EMERSOL 410 EMERSOL 13 2. EMERSOL 6320 EMERSOL 120 SINGLE PRESSED RUBBER GRADE DOUBLE PRESSED USP GRADE DOUBLE PRESSED FDA GRADE STANDARD PLASTICS GRADE USED BY BFG CANADA A STRATEGY DEVELOPED TO KEEP EMERSOL 132 AS THE ONLY STEARIC ACID IN OUR SYSTEM, ROLLING THE USES FOR EMERSOL 410, AND EMERSOL 120 INTO EMERSOL 132. THIS STRATEGY HAS BEEN IMPLIMENTED. THE BULK OF COMPOUND RECIPES USED CODE L-2, SO WE DISQUALLIFIED EMERSOL 410 FROM CODE L-2, APPROVED EMERSOL 132 AS THE ONLY SOURCE OF CODE L-2, AND REISSUED ALL RECIPES CALLING FOR L-21 AND 630353 WITH L-2. ' THIS LEFT CODE L-22, THE FDA GRADE STEARIC ACID. THE CHOICE OF EMERSOL 132 WAS MOTIVATED BY CONVERSATIONS I HAD WITH HENKEL CORP., THE MANUFACTURER OF ALL FOUR OF THE STEARIC ACIDS IDENTIFIED ABOVE. THE HENKEL SALES REPRESENTATIVE FRANK VILALLI HAD TOLD ME THAT IN THE OPINION OF HIS COMPANY EMERSOL 132 COULD BE USED FOR APPLICATIONS IN WHICH THE CONTACT OF THE PACKAGING PRODUCT WITH FOOD WAS INDIRECT; THAT IS, WHEN THE STEARIC ACID WAS NOT BEING ADDED TO FOOD. I ASKED FOR A LETTER FROM HENKEL STATING THEIR POSITION, AND INCLUDE A COPY OF THE RESPONCE I RECEIVED. PLEASE EXAMINE THE CONTENTS OF THIS LETTER AND TELL US WETHER YOU FEEL THE ASSURANCES GIVEN BY HENKEL SUPPORT OUR USE OF EMERSOL 132 IN FOOD CONTACT APPLICATIONS SUCH AS PVC BLOWN BOTTLES AND FOOD WRAP. THANK YOU, C.V.PURKS DISTRIBUTION: R.HINDERER C.A.DANIELS A.S.PAZUR S.J.MATHER S.A.KLEIN BFG-49S6-E 11 /80 UTHO INUSA BFG15557 JSJ in cc (X O o CC ! Henkel MAY , q 1992 Henkel Corporation Emery Group May 11, 1992 Mr. c.V. Purks The B.F. Goodrich Company 6100 Oaktree Blvd. Cleveland, OH 44131 Dear Mr. Purks: In reference to your recent request, the Emersol 132 Stearic Acid would be suitable for use in indirect or incidental food contact applications where either Stearic Acids or Fatty Acids are mentioned, subject to any limitations in the specific regulation which covers the intended in use. We trust this information will satisfy your request, if we can provide any additional information or assistance, please feel free to contact us. sincerely. Oleochemicals Group (513) 482-2401 SAM/alm 21569004- BFG15558 4900 Este Avenue, Cincinnati, Ohio 45232 Phone: 513/482-2100 C614D011 C614F011 13 00 L002 L-2 PRM 481754 MATERIALS CATALOG GEON PROD PAGE STEARIC ACID-USP / NF GRADE----- EMERSOL 132 STEARIC ACID SPEC DT 03/30/92 HENKEL CORPORATION USERID: N50CND1A PTERMID: PV120099 0001 NEXT PAGE 000 PROD NO 943 00 L020 STEARYL AMIDE L-20 ARMOSLIP 18 SPEC DT 07/29/86 PROD NO 943 00 L021 STEARIC ACID TRIPLE PRESSED-USP GRADE-FLAKES / ,a,-` i. L-21 STEARIC ACID USP GR SPEC DT U/30/89 PROD NO PRM 481754 HENKEL CORPORATION r->4 do, MERSOL 132 943 00 L022 STEARIC ACID FOOD GRADE-FLAKES L-22 STEARIC ACID-FDA SPEC DT 08/06/90 PRM 481754 HENKEL CORPORATION EMERSOL 6320DP -> (r 943 00 L023 REFER TO RAW MATERIAL NUMBER - 94300L042 OBSOLETE L-23 ERUCYL AMIDE SPEC DT 05/22/84 PROD NO 943 00 L024 TRIGLYCERIDE OF OCTADECADIENOIC ACID NEXT RESPONSE: NEXT KEY: 1589005 BFG15559 MEMO COMPANY: A'fitfSIsTT THTragnOff; T-JlDa Teleohoned \/[Q Mease Call Returned Your Call Q will Call * Vtocs To S Too Q Coae to So Too j S?SClAl A.ITESTIOS Q URGENT Q ",ssi"; ml MZr^ <p^3 ooLoo-?-- -- BFG15560 0\ C'O O'" V ! P HviJ^g.tW r'Wn TO Distribution FROM A.S. Pazur SUBJECT FIELD POINT OR DEPT. & BLDG. NO &i .D POINT OR DEPT. & BLDG. NO. Stearic Acid DATE YOUR LETTER DATE 'THIS L The Raw Materials Council is proposing the consolidation of L2, L21 and L22 - the goal is to use only one stearic acid, Emersol 132 (now L21), in all compounds. This would be accomplished as follows: 1. All current stearic acids approved under code L2 would be disqualified. 2. Emersol 132, currently approved under L21 would be qualified under L2. This would have the effect of utilizing what is currently L21 (Emersol 132) in all recipes currently calling for L2. This avoids having to change the hundred of recipes which currently specify L2. 3. Manually changing L21 to L2 in all recipes which currently specify L21. This would result in no change in stearic acid utilization for those recipes, since what used to be L21 will now be L2. This is manageable as the number of recipes containing L21 is reasonably small. 4. I will be pursuing with Bob Hinderer, Divisional Toxicologist, and Joe Powell, Legal Department, the possibility of using Emersol 132 in those food grade recipes now specifying L22. Our L22 source, Emersol 6320, is listed as "food grade" by the supplier, however, this designation for stearic acid means it is suitable as a food additive for direct addition to food. Our feeling is that Emersol 132, a USP grade, should be acceptable as a "food grade" plastic additive^ L21 is suitable for ingestion, in small amounts, as it is used as a USP tablet coating. The amount which would be extracted from a plastic used for food packaging would be much smaller than the amounts ingested in the tablet application. If we can get this clarified, we will change those recipes now specifying L22 to an L2 specification also. This memo is for the purpose of soliciting your comments on these proposed changes. Please see me or C.V. Purks for copies of the supplier and BFG specifications for these stearic acids. Please submit any questions or issues you have with these proposals in writing to me by February 21st. I would like to implement the L21/L2 change by March 15th. Thanks for your cooperation. Bud Pazur BFG-4956-E 11/80 LIThO IN US A BFGV556V 21589006 8 I Distribution via email message 2/5/92: Managers and Scientists in Departments 5050, 5052, 5054, and 2376 cc: C.V. Purks W. Horton/J. Kovac D. Marshall C.A. Daniels L.M. Maresca B. Hinderer J. Powell 21589007 [rhs]stearicacidioc.asp BFG15562 ! October 10, 1990 K. B. Srail ALTC, B/416 SUBJECT: CODE L-21-FDA STATUS Stearic acid that meets the specifications of the Food Chemicals Code, 3rd Edition and the requirements of 21CFR 172.860(b)(2) (i.e., free of chick edema factor), has been affirmed as generally recognized as safe (GRAS) as a direct food additive (21CFR 184.1090). Those substances that are GRAS as direct food additives are also GRAS as indirect food additives. Consequently, if<^6ode L-2~2^js food grade stearic acid, it can be used in food contact articles with no specific restrictions. /. _ / ' ' W. C. Bachtel 0 1010-3/jp cc: C. V. Purks - ALTC '" w 21583003 BFG15564