Eldon James (NK) Natural Kynar Material. Regulatory Package Kynar 1000HD

Transcription

1 Eldon James (NK) Natural Kynar Material Regulatory Package Kynar 1000HD Animal Derivative Free Polyvinylidene Fluoride Arkema Philadelphia, PA

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4 Fom William Hartzell Arkema Group 4/23/2008 As for the Kynar 1000HD, it has been used for many years in gamma sterilization applications. On a micro and macro level the material itself is virtually the same as the Kynar 740 and the radiation stability would be equivalent. At 50 kgy very little change takes place. The tensile modulus goes from 6900 to 7200 psi at 8 MRads. It then flattens out again upto about 20 Mrads. I have seen info on the web stating Kynar can handle up to 1000 Mrads and I am guessing this is the reason it is used in the plutonium reclamation projects. Unlike other fluoropolymers, chain scission does not take place at conventional doses. Kynar will first cross link and that is the reason you see the tensile properties increase. A possible yellowing may occur and this is due to the double bonding that occurs. Because there are no additives or stabilizers in the product you only need a few double bonds (1 in 10000) to shift color. Physical properties do not change with this minute change but your eye is more sensitive.

5 Arkema Inc. January 13, 2005 Lisa Mammoser Eldon James Corp. RE: BSE/TSE Letter Lisa, Please be advised that Kynar 1000HD, as manufactured by Arkema Inc., does not contain derivatives of animal or human origin. Furthermore, the equipment used to manufacture these materials does not come into contact with other materials exposed to a BSE/TSE environment. If you have any questions or need more information please feel free to call me at (215) Regards, Daniel K. Juckett, Jr. Regulatory Affairs Manager Arkema Inc. Arkema Inc 2000 Market Street Philadelphia, PA

6 PRODUCT INFORMATION REGULATORY APPROVALS FOR KYNAR AND KYNAR FLEX RESINS National Sanitation Foundation (NSF), NSF-61 Potable Water Kynar 450, 460/1 Kynar 710/1 720/1 740/1, 760/1 Kynar 1000 HD, 6000 HD, 9000 HD NSF-51 Food Equipment Materials Kynar 460, 461 Kynar 710/1, 720/1, 740/1, 760/1 Kynar Flex , , , , Food & Drug Administration (FDA) for Repeated Contact with Food [ ] Kynar 460 Kynar 710, 710 HDP, 720, 720 HDP, 740, 740 HDP, 760, 1000 HD, 6000 HD, 9000 HD FDA for Repeated Contact with Food [ ] Kynar Flex 2500, 2750, 2800, 2850, 3120 U.S. Department of Agriculture (USDA) for Use in Process or Storage Areas to Contact with Meat or Poultry Food Products Kynar 460 Kynar 710, 720, 740, 760 3A Sanitary Standards for Multiple Use Plastic Materials used as Product Contact Surfaces for Dairy Equipment Kynar 710, 720, 740, 760, 1000 HD, 9000 HD Kynar Flex United States Pharmacopeia Classification VI (USP Class 6) Kynar 460, 710, 710 HDP, 720, 720 HDP, 740, 740 HDP, 760, 1000 HD, 6000 HD, 9000 HD Kynar Flex 2800, 2850, 3120, and FDA Single Use Adjuvant for use in Polyolefins to 1% Concentration [ ] Kynar 460/1, 710/1, 720/1, 740/1, 760/1, 2800/1, 2850/1, 3120/1 Kynar 1000 HD, 6000 HD, 9000 HD NSF-14 Plastics Piping Systems Components Kynar 740, 1000 HD, 6000 HD, 9000 HD Kosher Certified by the Chicago Rabbinical Council Kynar Homopolymer, Kynar Flex, Kynar 700, Kynar 700 (EA) DS:jms Formerwdrive:poly/g103/daveseiler/word/regulatoryapprovals forkynarand kynarflexresins Arkema Inc 2000 Market Street Philadelphia, PA

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9 September 23, 2009 REACH Statement for Eldon James Natural Kynar Fittings Eldon James Natural Kynar Fittings are made from Kynar 1000HD and contain no additional additives. Based on information provided to us by Arkema, the resin manufacturer, Kynar 1000HD contains none of the 16 Substances of Very High Concern (SVHCs) listed in the REACH regulatory standards. In addition, none of these substances are intentionally added in the process of manufacture. Arkema Inc. has not run any analysis for concentration levels for these compounds, but has relied on raw material suppliers for this information. Based upon supplier information, an analysis could possibly show trace amounts of these chemicals, but the concentration level would be far below the allowable concentration limit. To the best of our knowledge, and based on the information above, Eldon James Kynar fittings meet the requirements outlined in the REACH regulatory standards for articles manufactured from plastic polymers. William Shedd Marketing/Communications Eldon James Marketing Group Eldon James Corporation 626 West 66th Street Loveland, CO e l d o n j a m e s. c o m fax

10 January 7, 2011 RE: List of the Substance of Very High Concern (SVHC) for REACH Dear Sir or Madam: Please be advised that Arkema Inc. s products KYNAR 100HD PLT, as supplied to your company, does not contain any of the chemicals listed below. We also certify that none of these chemicals are intentionally added to the formulation, nor is it part of our manufacturing process. SVHC: Acrylamide, CAS number Anthracene, CAS number ,4 -Diaminodiphenylmethane, CAS number Dibutyl phthalate, CAS number Cobalt dichloride, Diarsenic pentaoxide, CAS number Diarsenic trioxide, CAS number Sodium dichromate, dihydrate, CAS number tert-Butyl-2,4,5-trinitro-m-xylene (musk xylene), CAS number Bis (2-ethyl(hexyl)phthalate), CAS number Hexabromocyclododecane, CAS number Alkanes, C10-13, chloro (short chain chlorinated paraffins), CAS number Bis(tributyltin)oxide, CAS number Lead hydrogen arsenate, CAS number Triethyl arsenate, CAS number Benzyl butyl phthalate, CAS number Anthracene oil, CAS number Anthracene oil, anthracene paste, distn lights, CAS number Anthracene oil, anthracene paste, anthracene fraction, CAS number Anthracene oil, anthracene-low, CAS number Anthracene oil, anthracene paste, CAS number Pitch, coal tar, high temp., CAS number Aluminosilicate Refractory Ceramic Fibers Zirconia Aluminosilicate, Refractory Ceramic Fibers 2,4-Dinitrotoluene, CAS number Arkema Inc Market Street Philadelphia, PA Tel.: Fax: Arkema Inc. believes that the information and recommendations contained herein (including data and statements) are accurate as of the date hereof. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY, OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated. Arkema Inc. reserves the right to change, reformulate or modify the products designated herein at any time.

11 Diisobutyl phthalate, CAS number Lead chromate, CAS number Lead chromate molybdate sulfate red (C.I. Pigment Red 104), CAS number Lead sulfochromate yellow (C.I. Pigment Yellow 34), CAS number Tris(2-Chloroethyl)phosphate, CAS number Sodium chromate, CAS number Ammonium dichromate, CAS number Potassium chromate, CAS number Potassium dichromate, CAS number Boric acid, CAS number , Disodium tetraborate, anhydrous, CAS number , , Trichloroethylene, CAS number Tetraboron disodium heptaoxide, hydrate, CAS number Ethoxyethanol, CAS number Methoxyethanol, CAS number Chromic acid, CAS number Oligomers of chromic acid and dichromic acid Dichromic acid, CAS number Chromium trioxide, CAS number Cobalt(II) carbonate, CAS number Cobalt(II) diacetate, CAS number Cobalt(II) dinitrate, CAS number Cobalt(II) sulphate, CAS number Alpha-hexabromocyclododecane,, CAS number Beta-hexabromocyclododecane,, CAS number Gamma-hexabromocyclododecane,, CAS number , Arkema Inc. has not run any analysis for concentration levels for the components listed above, but has relied on raw material suppliers for this information. Based upon supplier information, an analysis could possibly show trace amounts of these chemicals, but the concentration level would be far below the allowable concentration limit. We trust this information is responsive to your request. If you have any questions, please feel free to contact me at or Sincerely, Christine M. Trumpfheller Product Safety and Regulatory Affairs Manager Arkema Inc Market Street Philadelphia, PA Tel.: Fax: Arkema Inc. believes that the information and recommendations contained herein (including data and statements) are accurate as of the date hereof. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY, OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated. Arkema Inc. reserves the right to change, reformulate or modify the products designated herein at any time.

12 April 19, 2013 Subject: KYNAR 1000 HD To Whom It May Concern Thank you for your interest in the referenced product. The following letter is provided in response to your request for information on the referenced product. Please note that Arkema does not routinely analyze for additional substances that are not listed in the MSDS. Unless otherwise indicated, the information provided herein is based upon information from raw material suppliers, product composition and Arkema s manufacturing process. Information on any OSHA hazardous components above 1% (by weight) and carcinogens above 0.1% (by weight) is provided in Section 3 of Arkema s Material Safety Data Sheet (MSDS). Bisphenol A (BPA) CAS#: IUPAC name: 4,4'-dihydroxy-2,2-diphenylpropane. Based on a review of the final product composition and the specifications of the raw materials, this product is not known or expected to contain BPA. Bovine Spongiform or Transmissible Spongiform Encephalopathy (BSE/TSE) Animal derived materials are primarily a concern with regard to the infectious agent associated with Bovine/Transmissible Spongiform Encephalopathy (BSE/TSE). Based on a review of the raw materials, there are no animal derived substances used in or around the manufacturing of this product. China RoHS In 2006 the Chinese Ministry released Administrative Measures on the Control of Pollution Caused by Electronic Information Products (EIP) # 39, also known as China RoHS. The product has been reviewed for the following substances and concentrations: lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated diphenyl ethers (PBDE) to a level equal to or less than 0.1% by weight and cadmium to a level equal to or less than 0.01% by weight. Based on a review of the final product composition and the specifications of the raw materials, this product is not known or expected to contain any of the above listed substances. CONEG Model Toxics in Packaging Legislation (also referred to as CONEG) concerns restrictions on the use of certain hazardous substances in packaging or packaging components (including printing inks used in packaging), and restricts the sum of the incidental concentration levels of lead, mercury, cadmium and hexavalent chromium present in the product to a level equal to or less than 100 parts per million by weight. Based on a review of the final product composition and the specifications of the raw materials, the sum total CONEG substances is not expected to be present above the regulatory limit of 100 ppm. US FDA Food Packaging

13 The following applications of the subject product can be said to fully comply with the US Federal Food, Drug and Cosmetic Act and all applicable food additive regulations subject to any limitations provided herein. 21 CFR Sec (a) Polyvinylidene flouride resins articles intended for repeated use. Continuing Guaranty Sec. 303(c)(2) of The Federal Food, Drug, and Cosmetic Act Each shipment or other delivery hereafter made by Arkema, Inc., whose address is 900 First Ave, King of Prussia, PA for the referenced product, is hereby guaranteed, as of the date of such shipment or delivery, to be on such date, not adulterated or misbranded within the meaning of the Federal, Food, Drug and Cosmetic Act, and not an article which may not, under the provisions of Section 404, 409, 505, or 706 of the Act, be introduced into interstate commerce; provided, however, that this guaranty shall be of no effect if your use of such products is not authorized by and in accordance with the provisions of the Federal, Food, Drug and Cosmetic Act. This guaranty is in like terms extended and shall be applicable to any state law or municipal ordinance in which the definitions and official interpretation of adulteration or misbranding are substantially the same as those in the Federal Food, Drug and Cosmetic Act. This guaranty is not assignable and is given solely for the purpose of Section 303 (c)(2) of the Federal Food, Drug and Cosmetic Act. By acceptance of this guaranty, the abovenamed holder agrees to promptly notify the undersigned in writing, within ten (10) days, of any demand, compliant, or proceeding for a claimed violation of the above-mentioned Federal Act or state act, give the name and address of the complaining party and the product concerned. Unless such notice is give within ten (10) days of such claim, demand or proceeding, the guaranty shall be of no effect. This guaranty shall be binding for 1 year from the day hereof, unless sooner terminated by written notice. Genetically Modified Organisms (GMO) A Genetically Modified Organism (GMO), for purposes of this review, is considered to be an organism that contains recombinant DNA elements. The genome of these organisms has been altered by insertion of foreign DNA sequences by means of genetic engineering. They are referred to as transgenic or bioengineered organisms. Determination of the presence of GMOs is currently limited to substances derived from agricultural plants. Based on a review of the final product composition and the specifications of the raw materials, this product is not known or expected to contain substances identified as GMOs. Material containing HAP(s) Material containing HAP(s) : Hazardous air pollutants (HAPs) are defined in Section 112(b) of the Clean Air Act Amendments of Materials that contain HAPs are defined under 40 CFR as materials that contain 0.1 percent or more by mass of any individual HAP that is an OSHA-defined carcinogen as specified in 29 CFR (d)(4), or 1.0 percent or more by mass for any other individual HAP. Please refer to section 3 of the MSDS for the most current information regarding the presence of any HAP (as defined above) for the listed product. Lactose-Free Lactose is a sugar derived from dairy products. The concern for the presence of lactose generally applies to substances used as food ingredients. Arkema has not labeled the subject product for use as a food ingredient but recognizes the product may be used in food processing or packaging facilities where food contact is likely. Based on the final product composition and the specifications of the raw materials, the subject product is not known to contain or be derived from lactose or lactose containing dairy by-products. Latex Containing Products 21 CFR requires labeling of all devices composed of or containing, or having packaging or components that are composed of, or contain, natural rubber that contacts humans. The term "natural rubber" includes natural rubber latex, dry natural rubber, and synthetic latex or synthetic rubber that contains natural rubber in its formulation.

14 Based on a review of the composition of the product and the specifications of the raw materials, this product is not known to contain latex. Ozone Depleting Substances For the purpose of responding to your inquiry, Arkema defines ozone depleting substances (ODS) in accordance with section 602 of the United States Clean Air Act (40 CFR Part 82). Based on the final product composition and the specifications of the raw materials, this product is not known or expected to contain substances that are identified as Ozone Depleting Substances California Proposition 65 Proposition 65, the Safe Drinking Water and Toxic Enforcement Act of 1986, was enacted as a ballot initiative in November The Proposition was intended by its authors to protect California citizens and the State's drinking water sources from chemicals known to cause cancer, birth defects or other reproductive harm, and to inform citizens about exposures to such chemicals. Please refer to the MSDS for the most current information regarding the presence of any Proposition 65 listed chemicals. Polybrominated diphenylethers (PBDEs) flame retardant chemicals PBDEs (Polybrominated Diphenyl Ethers), also called brominated flame retardants, are a group of flame retardant chemicals that are added to foam padding, plastics and fabrics. Common PBDEs are pentabde (five bromine molecules), octabde (eight bromine molecules) and decabde (ten bromine molecules). Based on a review of the final product composition and the specifications of the raw materials, this product is not known or expected to contain any of the above-referenced PBDE chemicals. Phthalates Substances in this review: Bis(2-ethylhexyl)phthalate (DEHP), Dibutyl phthalate (DBP), benzyl butyl phthalate (BBP), Diisononyl Phthalate (DINP), Diisodecyl phthalate (DIDP), Di-n-octyl phthalate (DnOP) or Di-n-hexyl phthalate (DnHP). Based on the final product composition and the specifications of the raw materials, this product is not known or expected to contain substances that are identified as Phthalates. Persistant Organic Pollutants (POP) The Stockholm Convention on Persistent Organic Pollutants (POPs) concerns restrictions on the release of POPs into the environment. The following response applies to those 12 POPs identified in the original Convention and 9 additional POPs added by amendment in May Based on the final product composition and the specifications of the raw materials, this product is not known or expected to contain substances that are identified as Persistent Organic Pollutants. Substance of Very High Concern (SVHC) In accordance with Article 59 of the European Regulation 1907/2006 on Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), from time to time, the European Chemicals Agency (ECHA) publishes lists identifying substances of very high concern (SVHCs) (as defined in Article 57 of REACH and included in the REACH Candidate List for further regulation). Based on the final product composition and the specifications of the raw materials, this product is not known to contain substances that are identified on the December 2012 Candidate list. Material containing TAP(s) Certain states have Toxic air pollutants (TAPs) lists. Arkema defines Materials containing TAPs as materials that contain 0.1 percent or more by mass of any individual TAP that is an OSHA-defined carcinogen as specified in 29 CFR (d)(4), or 1.0 percent or more by mass for any other individual TAP. Please refer to section 3 of the MSDS for the most current information regarding the presence of any TAP (as defined above) for the listed product. Volatile Organic Compounds (VOCs) In the Clean Air Act, 40 Code of Federal Regulations Section , the Environmental Protection Agency (EPA) defines a VOC as any compound of carbon excluding carbon monoxide, carbon dioxide, carbonic acid, metallic carbides or carbonates, and ammonium carbonate, which participates in atmospheric photochemical reaction. EPA has excluded many compounds, which have been

15 determined to have negligible photochemical reactivity such as: ethane, methane, methylene chloride, methyl chloroform, perchloroethylene, acetone, and numerous fluorochemicals. Water is not considered a VOC. Arkema Inc. recommends review of State and Federal regulations to determine if a more restrictive requirement exists regarding analytical methods or chemical exclusions during the consideration of VOC content. Based on the final product composition and the specifications of the raw materials, this product is not known or expected to contain substances identified as VOCs. The forgoing is subject to the terms and conditions set forth in the invoice or other contract or shipping document issued by Arkema Inc. with respect to the shipment or delivery, including any limitations on liability. Sincerely, Christine Trumpfheller Manager, Product Safety and Regulatory Affairs Arkema Inc. 900 First Avenue King of Prussia, PA USA christine.trumpfheller@arkema.com KYNAR is a registered trademark belonging to Arkema.

16 5/21/2012 Shelf-life and storage Eldon James NK products All Eldon James and EJ BioMed products with an NK suffix are manufactured from Kynar 1000HD. The manufacturer of this material, Arkema, makes no declaration regarding its shelf- life or expiration; however, it has been Eldon James experience in over 20 years of manufacturing products made from this resin, that no detectable degradation of product has taken place in products held for 5-7 year periods. Our experience is limited to small amounts of product left in inventory that have exceeded the normal turnover rate. The products have not been lab tested. Eldon James does not list an expiration date on any of its NK products. This is simply because we have never received any indication or feedback from customers that degradation related to age of the product occurs. We consider the shelf-life estimate given above to be conservative. Of course, it is highly dependent on storage conditions. Under well managed storage, the product could potentially have a shelf life that easily exceeds 7 years. Storage guidelines: (1) room temperature 70 (2) humidity < 75% (3) UV protected storage. Note: Plastics in general are very durable and these conditions are not absolute. Please feel free to contact me if you need any additional information. Kind regards, William Shedd Marketing/Communications bill@eldonjames.com Eldon James Corporation 626 West 66th Street Loveland, CO e l d o n j a m e s. c o m fax

17 August 31, 2009 To whom it may concern: RE: PFOS (Perfluorooctane sulfonates) and PFOA (Perfluorooctyl acid) Dear Sir or Madam: Please be advised that Arkema Inc. s product KYNAR 1000 HD PLT, as supplied to your company, does not contain any Perfluorooctane sulfantes (PFOS) and PFOA (Perfluorooctyl acid). Arkema Inc. has not run any analysis for concentration levels for the components listed above, but has relied on raw material suppliers for this information. Based upon supplier information, an analysis could possibly show trace amounts of these chemicals, but the concentration level would be far below the allowable concentration limit. We trust this information is responsive to your request. If you have any questions, please feel free to contact me at or christine.trumpfheller@arkema.com. Sincerely, Christine M. Trumpfheller Product Safety and Regulatory Affairs Manager Arkema Inc Market Street Philadelphia, PA Tel.: Fax: Arkema Inc. believes that the information and recommendations contained herein (including data and statements) are accurate as of the date hereof. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY, OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated. Arkema Inc. reserves the right to change, reformulate or modify the products designated herein at any time.

18 August 13, 2009 RE: Component and Material information Dear Sir or Madam: Please be advised that Arkema Inc. s product KYNAR 1000HD, as supplied to your company, is Latex Rubber Free material. Arkema Inc. has not run any analysis for concentration levels for the components listed above, but has relied on raw material suppliers for this information. Based upon supplier information, an analysis could possibly show trace amounts of these chemicals, but the concentration level would be far below the allowable concentration limit. We trust this information is responsive to your request. If you have any questions, please feel free to contact me at or christine.trumpfheller@arkema.com. Sincerely, Christine M. Trumpfheller Manager, Product Safety and Regulatory Affairs Arkema Inc Market Street Philadelphia, PA Tel.: Fax: Arkema Inc. believes that the information and recommendations contained herein (including data and statements) are accurate as of the date hereof. NO WARRANTY OF FITNESS FOR ANY PARTICULAR PURPOSE, WARRANTY OF MERCHANTABILITY, OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, IS MADE CONCERNING THE INFORMATION PROVIDED HEREIN. The information provided herein relates only to the specific product designated. Arkema Inc. reserves the right to change, reformulate or modify the products designated herein at any time.

19 5/18/2012 Bernadette Vail Eldon James Corp 626 W 66th Street Loveland, CO Bernadette, This letter is in response to your inquiry on melamine in KYNAR 1000 HD. Based on the final product composition and the specifications of the raw materials, this product is not known or expected to contain melamine. Sincerely, Josh Gingras Market Manager, Fluoropolymers Arkema Inc. 900 First Avenue King of Prussia, PA Tel.:

20 February 17, 2012 To whom it may concern: RE: Kynar 1000 HD Compliance with 21 CFR 189 Subpart D Dear Sir or Madam: Thank you for your continued interest for Arkema Inc. s product KYNAR 1000 HD. As requested, Arkema has reviewed the product formulation for the substances listed in 21 CFR 189 Subpart D "Substances Prohibited From Indirect Addition to Human Food Through Food- Contact Surfaces". We can confirm that none of the listed substances in this Subpart were intentionally added during the manufacturing or packaging of the Kynar product. Arkema has not conducted tests for determination of any residuals of these substances. We trust this information is responsive to your request. If you have any questions, please feel free to contact me at or christine.trumpfheller@arkema.com. Sincerely, Christine M. Trumpfheller Product Safety and Regulatory Affairs Manager Arkema Inc. 900 First Avenue King of Prussia, PA Tel.: