Product Regulatory Certificate

Transcription

1 Product Regulatory Certificate Product Name : InnoPlus LD2420M Chemical Name and Synonyms : Low Density Polyethylene CAS No.: Formula: (CH2-CH2) n Company Identification/Supplier: PTT Polyethylene Company Limited 555/1, Energy Complex, Building A, 15 th Floor, Vibhavadi Rangsit Road, Chatuchak, Bangkok Compliance lists i) Chemical Inventories This product is used the chemicals or ingredients which are comply with following chemical inventories: Europe : EINECS/ELINCS replaced by REACH United States : Toxics Substances Control Act Inventory (TSCA) Canada: Domestic Substances List (DSL) Australia: Australian Inventory of Chemical Substances (AICS) Korea: Korean Existing Chemicals List (KECL) Japan: Japanese Inventory of Existing and New Chemical Substances (ENCS) The Philippines: Philippines Inventory of Chemicals and Chemical Substances (PICCS) Rev 1 : September 2011 Page 1

2 ii) REACH (Regulation (EC) No.1907/2006) On behalf of PTT Global Chemical Group, we would hereby certify that we do NOT intend to use the substances listed in Annex XIV candidate chemicals proposed to be Substances of Very High Concern (SVHC). The list SVHCs can be found as following link below, Moreover, polymer molecules are generally regarded as representing a low concern due to their high molecular weight, this group of substances is exempted from registration and evaluation under REACH. Nonetheless, manufacturers or importers of polymers in supply chain may still be required to register the monomers. We recommend you to consult in detail for further clarification concerning your own obligations related to the REACH legislation. iii) Food Contact China Food Contact Regulation The additives used for manufacturing this product comply with GB The Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials EU Directive 2002/72/EC In accordance with EU Directive 2002/72/EC and amendments up to Regulation 975/2009/EC, Plastic materials and articles shall not transfer their constituents to foodstuffs in quantities exceeding 10 milligrams per square decimetre of surface area of material or article (mg/dm2) (overall migration limit). The migration should be measured by using the actual foodstuff. Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives 82/711/EEC and 85/572/EEC. We recommend that the users must verify that the finished items according to the rules specified in this regulation. The monomers used for manufacturing this product, are listed in Annex II of EU Directive 2002/72/EC and amendment up to Regulation 975/2009/EC. Rev 1 : September 2011 Page 2

3 The additives used for manufacturing this product, are listed in Annex III of EU Directive 2002/72/EC and amendment up to Regulation 975/2009/EC. There are NO restrictions (SML; QMA) specified by the regulations for the components (monomers/additives) of this resin. US Food and Drug Administration (FDA) This product complies with the Food and Drug Administration (FDA) Specifications according to U.S. FDA 21 Code of Federal Regulations part which allows for polyethylene unmodified used in articles that contact food except for articles used for holding food during cooking. iv) Hazardous Substances Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy (TSE)/ Mad Cow The derived from animal sources are not intentionally used in this product recipe. California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65) We do NOT intend to use the chemicals listed in California Proposition 65 implemented by The office of Environmental Health Hazard Assessment of California Environmental Protection Agency, in this product recipe. There is no significant risk for cancer to California people from this product. Coalition of Northeastern Governors (CONEG) We hereby certify that we do NOT intend to use lead, mercury, cadmium and chromium (VI) in this product recipe. Furthermore, this product meets the CONEG requirement of less than 100 ppm for total incidental lead, mercury, cadmium and chromium (VI). Directive 2002/95/EC (RoHS) This product complies with the RoHS Directive 2002/95/EC and its subsequent amendments, the restriction of the use of certain hazardous substances in electrical and electronic equipment. Directive 2009/251/EC According to the requirement of Member States (2009/251/EC) to ensure that products containing the biocide dimethylfumarate (DMF) are not placed or made available on the market. We hereby certify that we do not intend to use DMF in this product recipe and manufacturing process. Rev 1 : September 2011 Page 3

4 ELV Directive 2000/53/EC and its following amendments The quantity of Cd, Pb, Cr(VI) and Hg present in this product are in compliance with 2005/673/EC, amending Annex II of Directive 2000/53/EC of the European Parliament and of the Council on end-oflife vehicles. A maximum concentration value up to 0,1 % by weight and per homogeneous material, for lead, hexavalent chromium and mercury and up to 0,01 % by weight per homogeneous material for cadmium shall be tolerated. EU Directive 94/62/EC According to EU Directive 94/62/EC on Concentration Levels of Heavy Metals Article, Lead, Cadmium, Mercury and Hexavalent Chromium, we hereby certify that we do not use these in our product recipe. Regulation (EC) No.1895/2005 BADGE, NOGE and BFDGE are not intentionally use in this product formulation and manufacturing process according to the requirement of Regulation (EC) No. 1895/2005. Regulation 1935/2004/EC PTT Global Chemical PLC maintains sales and purchase record through all stages of manufacture, processing and distribution in order to meet the requirement of traceability in article 17 of the Regulation 1935/2004/EC. Ozone Depleting Substances Ozone depleting substances listed in Annex I and II in the Regulation (EC) No 1005/2009 OF The European Parliament and of the Council of 16 September 2009 on substances that deplete the ozone layer are not intentionally use in the product recipe and manufacturing process. Moreover, we hereby certify that we do not intend to use the Substances/Chemicals listed below in our product recipe, Rev 1 : September 2011 Page 4

5 Chemicals list Phthalates Group Dioxin Polychlorinated Biphenyls (PCBs) (DEHP, DINP, DIDP, DBP, BBP, DNOP) Aromatic Amines Epichlorohydrin Polychlorinated Terphenyls (PCTs) Asbetos Nonylphenol Polychlorinated Naphthalenes (PCNs) Bisphenol A Alkylphenol-tin Compounds Polybrominated Biphenyls (PBBs) [ Tributyl-tin (TBT), dibutyl-tin (DBT), monobutyl-tin (MBT) or any other organo-tin compounds ] Benzotriazole and 2- Mercaptobenzothiazole(MBT) Vinyl Chloride and Polyvinyl Chloride (PVC) Polybrominated Diphenyl Ethers (PBDEs) Polycyclic Aromatic Nanomaterials Polybrominated Terphenyls (PBTs) Hydrocarbons (PAHs) Butylated Hydroxytoluene(BHT) Butylated Hydroxyanisole(BHA) Perfluorooctanoic acid (PFOA) Perfluorooctane sulphonic acid(pfos) Trinonylphenyl Phosphite(TNPP) Semicarbazide Nuclear radioactive v) Other regulations Animal Derived Material We do NOT intend to use animal derived material in this product recipe. REGULATION (EU) No 10/2011 Regarding to regulation (EU) 10/2011, we would like to inform that directive 2002/72/EC could be used and valid until the end of We would notify after the certification process will be accomplished. Annex I of Directive 67/548/EEC Our raw materials used for producing this grade are listed of harmonized classifications and labeling for substances or groups of substances, which are legally binding within the EU. Food Allergens and their derivatives We do NOT intend to use food allergens and their derivatives in this product recipe. Rev 1 : September 2011 Page 5

6 Latex We hereby certify that we do NOT intend to use Natural Rubber Latex, Dry Natural Rubber and Synthetic Latex in this product recipe. Tallow We do NOT intend to use Tallow derived additives in this product recipe. Toys Relating to restrictions on the marketing and use of certain dangerous substances and preparations (phthalates in toys and childcare articles) in Directive 76/769/EEC and its amendment 2005/84/EC, we would like to inform that we do not intend to use Phthalates in this product formulation. Non-Compliance List We would inform you that we do not confirm this product will be compliance with the regulation listed below, European Pharmacopeia (EP) Drug Master File (DMF) Kosher US Pharmacopeia (USP) PTT Global Chemical shall not notify you in case changes in the regulations occur. For any limitations with are part of the regulations should be consulted in details. Yours Faithfully, (Nuchanan Utairatana) Technical Support, Polymer Products Value Center Approved on September 2011 and valid until September Rev 1 : September 2011 Page 6