Product Stewardship Information Sheet CH200LN-02
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1 Product Stewardship Information Sheet CH200LN-02 Contents Product Manufacturer... 2 Food Contact... 2 European Union (EU) Food Contact... 2 US Food and Drug Administration (FDA)... 2 Canada Health Protection and Food Branch (HPFB)... 2 Tallow... 2 Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy... 2 (TSE)/"Mad Cow"... 2 Drug Master File (DMF)... 3 US Pharmacopeia (USP)... 3 European Pharmacopeia (EP)... 3 UL... 3 NSF... 3 Phthalates... 3 Metals: May Be Present... 3 REACH (Regulation (EC) No. 1907/2006)... 4 REACH ANNEX XVII STATEMENT... 4 California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)... 4 Chemical Inventories... 4 Cosmetic Act, 76/768/EEC... 4 Metals: Not Present... 5 Disclaimer... 6 NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS:... 6 Revision For Informational Purposes Only Page 1
2 Product Manufacturer This product is manufactured by Phillips 66 Company in Linden, NJ. Food Contact European Union (EU) Food Contact This product complies with applicable European Union (EU) food-contact legislation, including (EU) No 10/2011 and (EU) No 202/2014, as amended, when used in food packaging applications, subject to the following conditions and limitations: All monomers and additives used in this product are included in the positive lists of the (EU) No 450/2009, No 10/2011 and (EU) No 202/2014, as amended. One additive used in the product is subject to a specific migration limit (SML). Information on the applicable SML will be supplied upon request. It is the responsibility of the manufacturer of the finished food-contact article to verify compliance of the finished article with applicable EU legislation, including the SML noted above, as well as the overall migration limit. In addition, it is the responsibility of the manufacturer of the finished article to verify that their final article, made according to good manufacturing practices (GMPs), does not modify the organoleptic properties of the food. Provided that the above limitations are met in the finished article, the product complies with applicable EU law, including Article 3 of the Framework Regulation 1935/2004/EC, and (EU) No 10/2011, as amended. 2008/282/EC CH200LN-02 is manufactured from propylene and does not contain recycled materials and is suitable for food contact applications as defined herein. 2006/2023/EC Good Manufacturing Practices The manufacturing process for CH200LN-02 is compliant with the good manufacturing practices set out in this regulation and its amendments. US Food and Drug Administration (FDA) The base resin in this product complies with 21 CFR (a) (1) (i) and (c) 1.1a. In addition, all other ingredients used in this product meet the requirements of their respective FDA regulations and 21 CFR (b), subject to limitations on temperature or food type contacted. Accordingly, this product can be used in contact with all food types listed in 21 CFR (c), Table 1, under Conditions of use A through H, identified in 21 CFR (c), Table 2. Canada Health Protection and Food Branch (HPFB) A letter of "no objection" for food contact use of this product has been received from HPFB. Tallow Tallow derived additives are not used in the manufacturing of this product. Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE)/"Mad Cow" This product does not contain additives derived from animal sources. Revision For Informational Purposes Only Page 2
3 Drug Master File (DMF) Information on this product is listed in a DMF. US Pharmacopeia (USP) This product has not been tested to obtain USP certification. European Pharmacopeia (EP) This product has not been tested for E.P. UL This product is not UL listed. NSF This product is not NSF listed. Phthalates Phthalates are not used in the manufacture of or the formulation of this product. However, we do not test this product for phthalates. Metals: May Be Present The following metals are used in some Copylene products and may be present at or below the levels indicated below as determined by mass balance calculation: Al Aluminum < 35 ppm Ca Calcium < 0.1 ppm Mg Magnesium < 100 ppm Na Sodium < 200 ppm Zn Zinc < 0.1 ppm Revision For Informational Purposes Only Page 3
4 REACH (Regulation (EC) No. 1907/2006) Substances of Very High Concern (SVHC) This product does not contain any of the candidate chemical substances proposed to be Substances of Very High Concern (including the most recent list dated 6/27/2018) above the 0.1% threshold as stated in REACH (Article 57, Regulation No. 1907/2006) determined either through (i) non-use of the substance, (ii) mass balance calculation, or (iii) specific testing. REACH ANNEX XVII STATEMENT This product does not contain any of the chemical substances listed in the Annex XVII to REACH as of 22 January 2018 which includes all the restrictions adopted in the framework of REACH and the previous legislation, Directive 76/769/EEC. This was determined either through (i) non-use of the substance, (ii) mass balance calculation, or (iii) specific testing. California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) This product presents ""no significant risk"" for cancer to the people of California. This product contains no substances known to the State of California to cause reproductive toxicity at a level of exposure subject to the requirements of Proposition 65 (including the most recent list dated May 25th, 2018). Chemical Inventories All ingredients in this product are in compliance with the following chemical inventories: United States: Toxics Substances Control Act Inventory (TSCA) Canada: Domestic Substances List Europe: EINECS/ELINCS replaced by REACH Korea: Korean Existing Chemicals List (KECL) Australia Inventory of Chemical Substances (AICS) Japan: Japanese Inventory of Existing and new Chemical Substances (ENCS) The Philippines: Philippines Inventory of Chemicals and Chemical Substances (PICCS) China: Inventory of Existing Chemical Substances Manufactured or Imported in China (IECSC) New Zealand: New Zealand inventory of Chemicals (NZIoC) This product has no special requirements under US TSCA (e.g. consent orders, test rules, 12(b) requirements, etc.). Cosmetic Act, 76/768/EEC The product does not contain any of the chemical substances listed in Annex II of the EU Council Directive 76/768/EEC determined through non-use of the substance. However, this product has not been tested for all of these chemical substances. Revision For Informational Purposes Only Page 4
5 Metals: Not Present This product does not contain any of the substances listed below as determined either through (i) non-use of the substance, (ii) mass balance calculation, or (iii) specific testing. Ag Silver As Arsenic Au Gold B Boron Ba Barium Cd Cadmium Co Cobalt Cr Chromium Cu Copper Fe Iron Hg Mercury Ir Iridium K Potassium Li Lithium Mn Manganese Mo Molybdenum Ni Nickel Os Osmium Pb Lead Pd Palladium Pt Platinum Rh Rhodium Ru Ruthenium Sb Antimony Se Selenium Sn Tin Tl Thallium V Vanadium W Tungsten Revision For Informational Purposes Only Page 5
6 Disclaimer This Product Stewardship Information sheet ( PSI ) is intended for informational purposes only. Phillips 66 Company makes no representations or warranties with respect to the accuracy or completeness of the information contained herein. This information in no way modifies, amends, enlarges or creates any specification or warranty, and ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY EXCLUDED. The information contained herein relates only to the specific product and/or material designated and may not be valid for such product and/or material used in combination with any other product and/or material. Determination of the suitability and fitness of the specific product and/or material for any particular application is the sole responsibility of the purchaser. Phillips 66 Company shall not be responsible for any damage or injury resulting from abnormal use, from any failure to follow appropriate practices or from hazards inherent in the nature of the product and/or material, nor for toxicological effects or industrial hygiene associated with particular use of any product described herein. Purchaser must make its own determination that its use of the product is safe and lawful (except as provided in the certifications set forth herein). Information provided is of the date hereof and Phillips 66 Company assumes no responsibility to update, revise or amend this PSI or the information contained herein. NOTICE REGARDING MEDICAL APPLICATION RESTRICTIONS: In no event should a Phillips 66 Company COPYLENE product be used in any US FDA Class III Medical Device or Health Canada Class IV Medical Device. No Phillips 66 Company COPYLENE product should be used in any US FDA Class II Medical Devices or Health Canada Class II or Class III Medical Devices without prior written approval by Phillips 66 Company for each specific product or application. Certified by/contact: Ming Wu TS&D Specialist COPYLENE Polypropylene (office) ming.wu@p66.com Revision: For Informational Purposes Only Page 6
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