Basell polyolefine - rapids preview

Regulatory Affairs Product StewardshipInformation /
Certification Data Sheet
(RAPIDS)
Pro-fax PD626
Product Manufacturer
This product is manufactured by Equistar Chemicals, LP.
REACH (Regulation (EC) No. 1907/2006)
This product does not contain any of the Annex XIV candidate chemicals proposed to be Substances of Very High Concern (List as of December 15, 2010) 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.
The current list of all SVHCs can be found at the following link to the ECHA website: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp Chemical Inventories
All ingredients in this product are in compliance with the following chemical inventories: United States: Toxics Substances Control Act Inventory (TSCA) https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (1 of 10)2/15/2011 1:25:11 AM 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) China: Inventory of Existing Chemical Substances Manufactured or Imported in China New Zealand: New Zealand Inventory of Chemicals (NZIoC) This product has no special requirements under US TSCA (e.g. consent orders, test rules, 12 Food Contact
This product does not meet the EU requirements for food contact.
The base resin in this product meets the FDA requirements contained in the Code of Federal Regulations in 21 CFR 177.1520(a)(1)(i) and (c)1.1a. According to our information, all other ingredients used in this product meet the requirements of their respective FDA regulations and 21 CFR 177.1520(b). However, due to the limitations of one ingredient, this product can only be used in applications at room temperature, refrigerated or freezer temperatures listed under conditions of use E through G in 21 CFR 176.170(c), Table 2, with the parts in contact with food being of a maximum thickness of 100 mils (0.100 inches). This product can be used in contact with all food types as listed in 21 CFR 176.170 Canada Health Protection and Food Branch (HPFB) A letter of "no objection" for food contact use of this product has not been obtained from HPFB. If a "no objection" letter is needed, contact your company representative.
https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (2 of 10)2/15/2011 1:25:11 AM Tallow derived additives may be used in the manufacture of this product.
Bovine Spongiform Encephalopathy (BSE)/Transmissible Spongiform Encephalopathy
(TSE)/"Mad Cow"
One additive in this product is derived from animal sources. Our suppliers have stated that their additive is derived from bovine material. They have assured us that the animal material is sourced from the United States, Canada or Mexico. The bovine material can be any part of the animal. There were two sets of process conditions specified by our suppliers for processing the bovine material. These are: (1) Hydrogenation of tallow @200 deg. C, hydrolysis @260 deg. C, and 48 bar for 1.5-2 hours and vacuum distillation @232 deg. C; (2) Hydrolysis of tallow @260 deg. C and 700 psig for 3 hours, hydrogenation of stearic acid @232 deg. C and 300 psig for 2.5 hours, and distilled at 232 deg. C for 5 minutes.
We do not certify our resins to be Kosher or in compliance with Kosher requirements.
Genetically Modified Organisms (GMO)
The additives in this product are not derived from vegetable sources. However, our operations are continuous and our Good Manufacturing Practices call for transitions between product types to be of sufficient length in order to prevent cross contamination. So there could be a very small amount of an additive that is derived from a vegetable source present in this Food Allergens
The following list of allergens are not used in the manufacture of or formulation of this Peanuts, peanut oil, any peanut products; tree nuts (almonds, Brazil nuts, chestnuts, filberts, hazelnuts, hickory nuts, macadamia nuts, pecans, pine nuts, pistachios, and walnuts); Milk (casein) or milk products, dairy products, dairy derivatives, lactose with protein; Fish (e.g. cod, salmon) or fish products; Shellfish, crustaceans (e.g. shrimp, crabs, lobsters, oysters, clams, scallops, crayfish); Molluscs (e.g. snails, clams, squid, octopi) or mollusc products; Seeds (e.g. cotton, poppy, sesame, sunflower, mustard) or seed products; https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (3 of 10)2/15/2011 1:25:11 AM European Pharmacopeia (EP)
This product cannot be certified for compliance to EP requirements.
This product has not been tested for E.P.
Drug Master File (DMF)
Information on this product is listed in DMF# 16853. Contact LyondellBasell for a DMF authorization letter to be sent to FDA.
"Natural rubber latex", "dry natural rubber", "synthetic latex" or "rubber that contains natural rubber" are not used in the manufacture of or the formulation of this product.
Coalition of Northeastern Governors (CONEG)
Cadmium, chromium (VI), lead and mercury are not used in the manufacture of or the formulation of this product. In addition, this product meets the CONEG requirements of less than 100 ppm for total incidental cadmium, chromium, lead and mercury. European Union (EU) Directive - Packaging and Packaging Waste - 94/62/EC (as
amended)
Cadmium, chromium (VI), lead and mercury are not used in the manufacture of or the formulation of this product. This product meets the year 2001 requirements of less than 100 ppm for total incidental cadmium, chromium (VI), lead and mercury. In addition, this product has the potential to be recycled according to these requirements.
Heavy Metals testing results
Testing of resins similar to this product has shown the following metals are not present at the sensitivities listed in parenthesis: antimony(3 ppm), arsenic(2 ppm), barium(2 ppm), cadmium (1 ppm), chromium(1 ppm), lead(2 ppm), mercury(0.01 ppm), selenium(3 ppm), silver(1 California's Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65)
This product presents "no significant risk" for cancer (as the term is used in Proposition 65) to https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (4 of 10)2/15/2011 1:25:11 AM Reproductive toxicant, di-n-butyl phthalate (DnBP) or simply dibutyl phthalate (DBP) (CAS# 84-74-2), could be present in this product at levels below the detectable threshold (see, phthalate section of the RAPIDS). DBP is not intentionally added or used in the production of this product. However, there is potential for trace level DBP contamination, because DBP is a possible contaminant in diisobutyl phthalate (DIBP), which is a minor component of the catalyst system used to make the base resin in this product. Calculated estimates confirmed by testing of several resins indicate a potential total residual phthalate (all phthalates) content of less than 10-15 ppm (parts per million). Further testing with food simulants, per general conditions of use as established in European Union Directives 2002/72/EC and 82/711/EEC and their amendments, did not detect any phthalate migration at a detection sensitivity of 20 ppb (parts per billion) (0.02 parts per million or 0.02 mg/kg). A worst case estimate of the amount of DBP that could potentially migrate from the resin is calculated to be less than 10 ppb (parts per billion). Under Proposition 65, DBP has a no observable effect level of 8.7 micrograms per day. DBP has NOT been detected in our resins.
It is the responsibility of the California business owner to develop his or her own regulatory Butylated Hydroxytoluene (BHT) and Butylated Hydroxyanisole (BHA)
BHT and BHA are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemical substances.
Ozone Depleting Chemicals (ODCs)
Class I and Class II ODCs listed in the US Clean Air Act Amendments of 1990 are not used in the manufacture of or formulation of this product.
ODCs listed in the Montreal Protocol are not used in the manufacture of or formulation of this Phthalates
LyondellBasell is aware of the publicity about phthalate plasticizers. Phthalate plasticizers are in general used in specific non-olefinic resin systems to soften these resins and make them flexible. When phthalate plasticizers are added, they can constitute up to 50% of the resultant plastic material. LyondellBasell does not use any plasticizers in the resins it supplies. Polyolefins do not require the use of plasticizers to make them soft and flexible. Those phthalate plasticizers that have been associated with potential health issues, specifically di(2- ethylhexyl) phthalate (DEHP), di-iso-nonyl phthalate (DINP),di-iso-decyl phthalate (DIDP), di- n-butyl phthalate (DBP) and butyl benzyl phthalate (BBP), are not intentionally used by Basell in the manufacture of or formulation of its resins.
All LyondellBasell operations are guided by our commitment to be a responsible supplier, always respecting the health and safety of our employees, our contractors, our customers and the community, as well as the quality of the environment in which we live and operate. LyondellBasell is a firm supporter of the chemical industry's Responsible Care® program and https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (5 of 10)2/15/2011 1:25:11 AM the Product Stewardship code. LyondellBasell supplies polyolefin resins that are safe when used properly for their intended applications. In keeping with the principles of Responsible Care®, LyondellBasell is supporting industry efforts to study chemicals for their potential to cause endocrine disruption. As for this product, a phthalate compound, diisobutyl phthalate (DIBP), is a minor component of the catalyst system used to manufacture some of the base polyolefin resins. This is typical of polypropylene resins produced with high mileage catalysts. An impurity in the DIBP is di-n- butyl phthalate (DNBP), sometimes referred to as dibutyl phthalate(DBP). During processing, DIBP reacts and converts to two related phthalate compounds diethyl phthalate (DEP) and ethyl isobutyl phthalate. The phthalates are "technical support agents" as defined by European Union Directive 2007/19/EC. None of the four phthalates has been determined to be human carcinogens or endocrine disrupters at the low levels as suggested by environmentalists. Testing of several resins has resulted in the identification of residual phthalates content no more than 10-15 parts per million. Further testing with food simulants, per general conditions of use as established in European Union Directives 2002/72/EC and 82/711/EEC and their amendments, has resulted in phthalate migration not detected at a sensitivity of 20 parts per billion (0,02 parts per million or 0,02 mg/kg).
A SML (Specific Migration Limit) equal to 0,3 mg/kg (300 ppb) has been established in To put these results in perspective, plastic materials that require phthalate plasticizers, referred to above, can have up to 500,000 parts per million (50%) of the phthalate plasticizer Acrylamide
Acrylamide (CAS number 79-06-1) is not used in the manufacture of or the formulation of this product. However, we do not test this product for acrylamide.
Aromatic Amines
Aromatic amines are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemical substances.
Asbestos
Asbestos is not used in the manufacture of or formulation of this product. However, this product has not been tested for this chemical substance.
Bisphenol A
Bisphenol A is not used in the manufacture of or the formulation of this product. However, this product has not been tested for this chemical substance.
https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (6 of 10)2/15/2011 1:25:11 AM Dioxin is not used in the manufacture of or formulation of this product. Dioxin is not known to be formed during processing of this product.
Epichlorohydrin
Epichlorohydrin (CAS number 106-89-8) is not used in the manufacture of or the formulation of this product. However, we do not test this product for epichlorohydrin.
Nonylphenol
Nonylphenol and Nonylphenol ethoxylates are not used in the manufacture of or the formulation of this product. However, this product has not been tested for these chemical Organo-tin Compounds
Tributyl-tin (TBT), dibutyl-tin (DBT), monobutyl-tin (MBT) or any other organo-tin compounds are not used in the manufacture of or the formulation of this product. However, this product has not been tested for these chemical substances.
Fluorocarbons
Fluorotelemers, Zonyl fluoroadditives (DuPont trade name), perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), perfluorochemicals (PFC) or other fluorocarbon substances are not used in the manufacture of or formulation of this product. However, this product has not The PFOA issue has definitely been a “hot” one. It is recommended that customers look at the following websites for information about the safety of PFOA and certain PFOA products. Information from these sources may help alleviate concerns about using PFOA products.
Polychlorinated Biphenyls (PCBs), Polychlorinated Terphenyls (PCTs),
Polychlorinated Naphthalenes (PCNs), Polybrominated Biphenyls (PBBs),
Polybrominated Diphenyl Ethers (PBDEs) and Polybrominated Terphenyls (PBTs)
Polychlorinated biphenyls (PCBs), polychlorinated terphenyls (PCTs), polychlorinated naphthalenes (PCNs), polybrominated biphenyls (PBBs), polybrominated diphenyl ethers (PBDEs) and polybrominated terphenyls (PBTs) are not used in the manufacture of or formulation of this product. However, this product has not been tested for these chemical https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (7 of 10)2/15/2011 1:25:11 AM Styrene and Polystyrene
Styrene (chemical name: ethenylbenzene) (CAS number 100-42-5) and polystyrene resins are not used in the manufacture of or the formulation of this product. However, we do not test this product for these chemical substances.
Vinyl Chloride and Polyvinyl Chloride (PVC)
Vinyl chloride (CAS number 75-01-4) and PVC resins are not used in the manufacture of or the formulation of this product. However, we do not test this product for these chemical Chlorinated Paraffins
Chlorinated paraffins, including short-chain chlorinated paraffins, are not used in the manufacture of or the formulation of this product. However, this product has not been tested Benzotriazole and 2-Mercaptobenzothiazole(MBT)
2-(2H-1, 2, 3-Benzotriazol-2-yl)-4,6-di-tert-butylphenol [also called 2-(2'-Hydroxy-3',5'-di-t- butylphenyl)benzotriazole] (CAS No. 3846-71-7) and 2-Mercaptobenzothiazole [also called 2 (3H)-Benzothiazolethione or Benzothiazole-2-thiol or MBT] (CAS No. 149-30-4) are not used in the manufacture of or formulation of this product. However, this product is not tested for these Azo Dyes and Pigments
Azo dyes and pigments are not used in the manufacture of or the formulation of this product. However, this product has not been tested for these chemical substances.
Regulation (EC) N.1895/2005
BADGE, NOGE and BFDGE are not used in the manufacture of or the formulation of this product according to requirement of Regulation N.1895/2005.
Polycyclic Aromatic Hydrocarbons (PAHs)
We do not intentionally use the following polycyclic aromatic hydrocarbons (PAHs) in the manufacture of or formulation of this product: 9H-fluorene (CAS# 86-73-7) anthracene (CAS# 120-12-7) https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (8 of 10)2/15/2011 1:25:11 AM However, we do not test our resins for these substances.
Dimethyl Fumarate (DMF) - EU Commission Decision 2009/251/EC
Dimethyl fumarate [2-butenedioic acid (2E)-, dimethyl ester] (DMF) (CAS#: 624-49-7) is not used in the manufacture of or formulation of this product. However, we do not test this Restriction of Hazardous Substances in Electric and Electronic Equipment (RoHS) -
Directive 2002/95/EC, as amended.
The information for RoHS can be found in the "Heavy Metals" (cadmium, chromium, lead, mercury) and the "Polychlorinated Biphenyls (PCBs), Polybrominated bipheyls (PBBs), etc." (PBBs, PBDEs) sections above.
Composting - CEN Standard prEN 13432
This product is not suitable for composting.
Energy Recovery - CEN Standard prEN 13431
The calorific gain from polypropylene in an energy recovery process is 24 MJ/kg.
Ultimately customers must make their own determination that their use of our
product is safe, lawful (except as provided in the above certifications) and
technically suitable in their intended applications. Because of possible changes in the
law and in regulations, LyondellBasell recommends that customers continuing to use
our product verify status every year from the issue date of the RAPIDS.
https://polymers.lyondellbasell.com/portal/binary/co.3c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (9 of 10)2/15/2011 1:25:11 AM Manager, NA Regulatory Affairs and Product Stewardship (Product Safety) Approved on Friday, January 07, 2011. Valid for 1 year.
https://polymers.lyondellbasell.com/portal/binary/c.c14RCRD&type=rapids&rapid_key=PRO-FAXPD626--ENGLISH (10 of 10)2/15/2011 1:25:11 AM

Source: http://valueplastics.cc/technical/material/Basell_Profax_PD626_RAPIDS_info.pdf