Global Food Contact Status:
European Union
This product complies with the relevant requirements of Regulation 10/2011/EC (PIM) as amended,
applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes).
The monomers and additives used to produce this product are listed in the Union List of Authorized
Substances of Regulation 10/2011/EC and subsequent amendments.
EU Regulation 10/2011/EC specifies 10 mg/dm2 as the maximum overall migration (OML) from the
finished plastic food contact material or article. The OML and SMLs (when applicable) should be
determined according to the requirements specified in EU Regulation 10/2011/EC and subsequent
amendments. The OML and SML determinations are the responsibility of the manufacturer of the
finished plastic food contact material or article. In addition, we remind you that the manufacturers of the
finished food contact material or article must verify that the finished material or article, manufactured
according to good manufacturing practices, does not modify the organoleptic properties of the food.
Dual use additives subject to restrictions in food as defined in Regulation 10/2011/EC are not
intentionally used in the manufacture or formulation of this product.
This product contains one or more components with Specific Migration Limit (SMLs)
This product contains one or more process aids that have a Specific Migration Limit (SML).
DNBP and DEHP (see phthalate section below for more information) are impurities of a “technical
support agent” used in this product.
Substance Reference No.: 74880 DNBP has an SML equal to 0.3 mg/kg (300 ppb).
Substance Reference No.: 74640 DEHP has SML equal to 1.5 mg/kg (1500 ppb)
Phthalates are subject to a SML(T) of 60 mg/kg.
This product contains one or more proprietary components with SMLs.
In order to obtain the identity of the component(s) that have an SML, a secrecy agreement may need to
be established with LyondellBasell (or one of its joint ventures or subsidiary companies).
United States
The base resin in this product meets the FDA requirements contained in the Code of Federal
Regulations in 21 CFR 177.1520(a)(3)(i) and (c)3.1a.
This product may contain adjuvant substances that may be safely used in polymers used for the
manufacture of articles that come into direct contact with food. According to our information, all other
substances used in this product meet the requirements of their respective FDA regulations and 21 CFR
177.1520(b).
In summary, this product meets the FDA criteria in 21 CFR 177.1520 for food contact applications,
excluding cooking, listed under conditions of use C through H in 21 CFR 176.170(c), Table 2, and can be
used in contact with all food types as listed in 21 CFR 176.170(c), Table 1.
China
GB9685 – The Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials
All additives used in this product comply with the requirements of GB9685-2008 and Ministry of Health
Announcement 2012 No.5. However, there are substances used in this product for which a Specific
Migration Limit (SML) and/or a Maximum Permitted Quantity (QM) in the final article have been
established in GB9685-2008, and Ministry Of Health Announcement 2012 No.5. We want to remind you
that these specifications apply to the final articles as defined in GB9685-2008, section 2.4 and 2.5.
Allergen Statements
Allergen – General
This product contains no identified allergenic materials including:
Cereals containing gluten or products of these Wheat or wheat products
Dairy or dairy products Egg or egg products
Peanut or peanut products Fish or fish products
Shellfish or shellfish products Soybean or soybean products
Tree nut or tree nut products Seed or seed products
Bananas Phenylalanine
Tartrazine Yeast
Sugar, monosaccharides or disaccharides Modified cornstarch
Preservatives Artificial color
Artificial flavor Sulfur dioxide or sulfites
No identified allergenic materials are present in the manufacturing facility and the product is
manufactured in dedicated equipment.
The food ingredients listed in the Annex IIIa of European Directive 2007/68/EC, are not used in the
manufacture of or formulation of this product. However, this product has not been tested for these
substances.
Animal Based Raw-Materials (BSE/TSE)
Europe – BSE/TSE – “Mad Cow”
Tallow derived materials used in this product fulfill the requirements laid down in the Regulations
1069/2009/EC, and 142/2011/EC, and the “Note for Guidance EMEA/410/01, rev. 3”.
Tallow
Tallow derived additives may be used in the manufacture of this product.
Epoxy Derivatives
The materials BADGE, BFDGE or NOGE are not intentionally added in this product as referenced in
Commission Regulation 1895/2005/EC, on the use of certain epoxy derivatives in materials and articles
intended to come into contact with foodstuffs as plasticizers, additives or raw materials.
California
Prop 65
This product may contain two chemical substances at very low levels (less than 1 ppm) which are known
to the State of California to cause cancer and/or reproductive toxicity under California Proposition 65.
These substances are:
Di-n-butyl phthalate (DnBP) or simply dibutyl phthalate (DBP) (CAS# 84-74-2) – reproductive toxin
Di(2-ethylhexyl) phthalate (DEHP) or di-octyl phthalate (DOP) – carcinogen and
reproductive toxin
DBP and DEHP are not intentionally added or used in the production of this product (see Phthalate
section of the RAPIDS). However, there is potential for trace level DBP and DEHP contamination,
because both are impurities 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 Regulation 10/2011/EC 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 or DEHP that could potentially migrate from the resin is calculated to be less than 10 ppb (parts
per billion) each. Under Proposition 65, DBP has a maximum allowable dose level (MADL) of 8.7
micrograms per day. The DEHP MADL for intravenous exposure is 4200 (adults), 600 (infant boys, age
29 days- 24 mos.) and 210 (neonatal infant boys, age 0-28 days) and for oral exposure is 410 (adults),
58 (infant boys, age 29 days- 24 mos.) and 20 (neonatal infant boys, age 0-28 days), all values in
micrograms per day. DEHP has a no significant risk level (NRSL) of 310 micrograms per day.
It is the responsibility of the California business owner to develop his or her own regulatory compliance
plan.
This product may contain two chemical substances at very low levels (less than 10 ppm), due to
impurities in a manufacturing process aid, which are known to the State of California to cause cancer
and/or reproductive toxicity under California Proposition 65. These substances are:
Ethylene oxide (CAS# 75-21-8) – carcinogen and reproductive toxin
1,4-Dioxane (CAS# 123-91-1) – carcinogen
Under Proposition 65, for carcinogenicity, ethylene oxide has a no significant risk level (NSRL) of 2
micrograms per day, and for reproductive toxicity, ethylene oxide has a maximum allowable dose level
(MADL) of 20 micrograms per day. For carcinogenicity of 1,4-dioxane, the NSRL is 30 micrograms/day.
It is the responsibility of the California business owner to develop his or her own regulatory compliance
plan.
CLP Regulation – Regulation (EC) No. 1272/2008
CLP Regulation (for “Classification, Labeling, and Packaging”) Regulation (EC) No 1272/2008, aligns the
European Union system of classification, labeling, and packaging of chemical substances and mixtures to
the Globally Harmonized System (GHS).
Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on
classification, labeling, and packaging of substances and mixtures, amending and repealing Directives
67/548/EEC (for dangerous substances) and 1999/45/EC (for dangerous preparations), and amending
Regulation (EC) No 1907/2006.
See Product’s European MSDS at http://www.lyondellbasell.com for classification and labeling of
chemicals which are legally binding within the EU – including carcinogen, mutagenic and reproductive
toxins (CMR).
CONEG – Coalition of Northeastern Governors
The chemical materials listed below are not used in the manufacture or the formulation of this product.
However, this product has not been tested for these chemical materials:
Lead, mercury, cadmium, and hexavalent chromium, as identified in the CONEG Model Legislation.
Halogenated Compounds
Halogenated compounds are not used in the manufacture or the formulation of this product. However,
this product has not been tested for these chemical materials.
Latex
No materials containing latex or natural rubber are used in the manufacturing, handling, and packaging
processes for this product.
Medical
European Pharmacopeia (EP)
This product does not meet the EP requirements for 3.1.3, Polyolefins – 7th Edition of European
Pharmacopeia.
USP Class VI
This product has not been tested for USP Class VI.
US
CONEG
Based on the available documentation provided by our raw material suppliers, this product complies with
the CONEG Model Legislation for requirements regarding the defined limit for the sum of heavy metals
(lead, mercury, cadmium, and hexavalent chromium).
EU Packaging and Packaging Waste
Based on the available documentation from raw materials suppliers, this product complies with the
directive 94/62/EC and its following amendments concerning the defined limit(s)of heavy metals.
Heavy Metals Testing
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 ppm).
End of Life Vehicle
To the best of our knowledge, based on the available documentation from raw materials suppliers, we
deem that this product complies with the directive 2000/53/EC and its following amendments as
concerns the defined limit(s) of heavy metals.
Restriction of Hazardous Substances in Electric and Electronic Equipment (RoHS)
RoHS Regulation refers to electrical and electronic equipment and not specifically to plastic raw
materials. However, based on the available documentation from raw materials suppliers, this product
complies with the requirements of the Directives 2002/95/EC, as amended, and 2011/65/EU concerning
the limits of cadmium, lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and
polybrominated diphenyl ethers (PBDE).
Other Chemicals
The chemical materials listed below are not used in the manufacture or the formulation of this product
and are not expected to be present. However, this product has not been tested for these chemical
materials.
2-(2H-1, 2, 3-Benzotriazol-2-yl)-4,6-di-tert-butylphenol; (Benzotriazole); CAS# 3846-71-7;
2,4,4’-trichloro-2’-hydroxydiphenyl ether; (Triclosan); CAS# 3380-34-5;
2-mercaptobenzothiazole; MBT; CAS# 149-30-4;
Acrolein; (propenal); (CAS# 107-02-8);
Acrylamide; CAS# 79-06-1;
Aromatic amines;
Asbestos;
Azo Dyes and Pigments;
Polyaromatic Hydrocarbons – PAHs:
1,2-dihydro-acenaphthene; (CAS# 83-32-9);
9H-Fluorene; (CAS# 86-73-7);
Acenaphthylene; (CAS# 208-96-8);
Anthracene; (CAS# 120-12-7);
Benz(a)anthracene; (CAS# 56-55-3);
Benzo(a)pyrene; (CAS# 50-32-8);
Benzo(b)fluoranthene; (CAS# 205-99-2);
Benzo(e)pyrene; (CAS# 192-97-2);
Benzo(ghi)perylene; (CAS# 191-24-2);
Benzo(j)fluoranthene; (CAS# 205-82-3);
Benzo(k)fluoranthene; (CAS# 207-08-9);
Chrysene; (CAS# 218-01-9);
Dibenz(a,h)anthracene; (CAS# 53-70-3);
Fluoranthene; (CAS# 206-44-0);
Indeno(1,2,3-cd)pyrene; (CAS# 193-39-5);
Naphthalene; (CAS# 91-20-3);
Phenanthrene; (CAS# 85-01-8);
Pyrene; (CAS# 129-00-0);
Bisphenol A; (BPA); CAS# 80-05-7;
Bisphenol A diglycidyl ether; (BADGE); CAS# 1675-54-3;
Bisphenol F diglycidyl ether; BFDGE; CAS# 2095-03-6;
Butylated hydroxyanisole; (BHA); CAS# 121-00-6 & 25013-16-5;
Butylated hydroxytoluene; (BHT); CAS# 128-37-0
Chlorinate flame retardants;
Chlorinated paraffins;
Cyanuric acid; (Isocyanuric Acid or CYA); CAS# 108-80-5;
Dimethyl fumarate; (DMF); CAS# 624-49-7;
Dioxins;
Epichlorohydrin; (ECH); CAS# 106-89-8;
Fluorocarbons;
Fluorotelomers
Formaldehyde; CAS# 50-00-0;
Gold; CAS# 7440-57-5;
Halogenated Flame Retardants
Melamine; (1,3,5-Triazine-2,4,6-triamine); CAS# 108-78-1;
Nickel; CAS# 7440-02-0;
Nonylphenol; CAS# 25154-52-3;
Nonylphenol ethoxylates;
Novolac glycidyl ether;
Organotin compounds;
Perfluorochemicals; (PFCs);
Perfluorooctane sulfonate; (PFOS); CAS# 1763-23-1;
Perfluorooctanoic acid; (PFOA); CAS# 335-67-1;
Plasticizers:
1,2-Cyclohexanedicarboxylic acid, 1,2-diisononyl ester; DINCH; (CAS# 166412-78-8);
Bis(2-ethylhexyl) adipate; DEHA; (CAS# 103-23-1);
Butyryl tri-n-hexyl citrate; BTHC; (CAS# 82469-79-2);
Glycerides, castor-oil mono-, hydrogenated, acetates; (CAS# 736150-63-3);
Tris(2-ethylhexyl)benzene-1,2,4-tricarboxylate; (CAS# 3319-31-1);
Polybrominated biphenyls; (PBBs);
Polybrominated diphenyl ethers; (PDBEs);
Polybrominated terphenyls; (PBTs);
Polychlorinated biphenyls; (PCBs);
Polychlorinated naphthalenes; (PCNs);
Polychlorinated terphenyls; (PCTs);
Polystyrene;
Polyvinyl chloride; (PVC); CAS# 9002-86-2;
Radioactive substances;
Styrene monomer; CAS# 100-42-5;
Tris-nonylphenol phosphite; (TNPP); CAS# 26523-78-4;
Vinyl chloride; CAS# 75-01-4;
Ozone Depleting Substances
United States
Materials listed in the Clean Air Act Amendments of 1990 (Class I, CFC’s and Class II, HCFC’s, Halons
and the solvents, carbon tetrachloride and 1,1,1-trichloroethane) are not intentionally used in the
production of this product.
Montreal Protocol
ODCs listed in the Montreal Protocol are not used in the manufacture of or formulation of this product.
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. Polyolefins do not require the use of plasticizers to make them soft and
flexible. No phthalates plasticizers, such as di(2-ethylhexyl) phthalate (DEHP) or di-octyl phthalate
(DOP) , di-iso-nonyl phthalate (DINP) , di-iso-decyl phthalate (DIDP)
, di-butyl phthalate (DBP) or di-n-butyl phthalate (DNBP) , butyl
benzyl phthalate (BBP) and di-n-octyl phthalate (DNOP) , are
intentionally used in the formulation of this product. However, a phthalate compound, diisobutyl
phthalate (DIBP) , is used in the manufacturing process as a “technical support agent”
(as defined by the European Union), i.e. a minor component of the catalyst system. This is typical of
polypropylene and polybutene resins produced with high mileage catalysts.
Testing of several resins has resulted in the identification of the overall residual phthalate content no
more than 10-15 parts per million. Further testing with food simulants (per EU Regulation 10/2011/EC)
has resulted in phthalates not detected at a sensitivity of 20 parts per billion (0.02 parts per million). 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 in them.
REACh Information
This product is manufactured by affiliates and subsidiaries of the LyondellBasell group of companies
around the world.
Under the EC Regulation REACh, this product is classified as a preparation. If the product has been
purchased from Basell Sales & Marketing Company B.V. BSM), we confirm that all substances of this
preparation are compliant with the pre-registration requirements of REACh, and that we have the
intentions to proceed with the registration of these substances, or to procure substances only from
suppliers from which confirmation has been received that the suppliers are aware of their REACh
requirements, that they have pre-registered and/or will timely register their substances, and that they will
supply the relevant Safety Data Sheets (SDS) with REACh registration numbers as soon as the
registrations occur. BSM shall in no event be liable for any non-compliance deriving from false or
incorrect statements of its suppliers.
We remind you, if this product is purchased from any supplier other than BSM, including other
companies of the LyondellBasell group, the importer into the European Economic Area (EEA) is
responsible for compliance with the requirements of the REACh Regulation. Please contact our helpdesk
if you need to discuss the potential compliance with REACh before importing this product into the EEA.
REACh Substances of Very High Concern (SVHC)
This product does not contain any of the Annex XIV candidate chemicals proposed to be Substances of
Very High Concern (List as of June 20, 2013) 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 ECHA website link listed below:
http://echa.europa.eu/web/guest/candidate-list-table
Global Chemical Control RegulationsPhthalates
All ingredients in this product are in compliance with the following chemical inventories:
United States: Toxic Substances Control Act Inventory (TSCA)
Canada: Domestic Substances List (DSL)
Europe: EINECS/ELINCS replaced by REACH
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(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.).
Global Toy Regulations:
CEN EN standards refer to safety toys and not specifically to plastic raw materials. According to the
information provide by our raw material suppliers, this product complies with the requirements of CEN
standards EN71-3 and EN71-9 as applicable to plastic raw materials (pellets, powder, flakes).
We have reviewed Standard Consumer Safety Specification on Toy Safety: ASTM F-963-96. It appears
that Section 4.3.5 applies to paints or similar coatings and section 8.3 describes a testing protocol for
these coatings. Our conclusion is that the standard is to be applied to paint or coatings on a finished toy
(8.3.3), therefore the standard is not applicable to the resin supplied by the companies of LyondellBasell.
Analyses of representative polyolefin resin samples have shown metal content to be less than 2 ppm.
Disclaimer
The information in this document is, to our knowledge, true and accurate at the time and date
downloaded by the user. However, information in this document may be updated periodically due to
changes in laws or regulations, or for other reasons. Unless required by law, LyondellBasell will not
notify users when changes are made to this document. LyondellBasell may also, at its sole discretion,
notify users of other, non-regulatory, changes made to this document. Users are expected to regularly
visit the PSInfo Website to obtain the most current information on this product.
Before using a product sold by a company of the LyondellBasell family of companies, users should make
their own independent determination that the product is suitable for the intended use and can be used
safely and legally.
SELLER MAKES NO WARRANTY, EXPRESS OR IMPLIED (INCLUDING ANY WARRANTY OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY WARRANTY) OTHER
THAN AS SEPARATELY AGREED TO BY THE PARTIES IN A CONTRACT.
This product(s) may not be used in:
(i) any U.S. FDA Class I, Health Canada Class I, and/or European Union Class I medical devices,
without prior notification to Seller for each specific product and application; or
(ii) the manufacture of any of the following, without prior written approval by Seller for each specific
product and application: U.S. FDA Class II medical devices; Health Canada Class II or III medical
devices; European Union Class II medical devices; or any equivalent U.S. FDA, Health Canada, or
European Union regulations pertaining to medical devices; packaging in direct contact with a
pharmaceutical active ingredient and/or dosage form; and tobacco-related products and applications.
This product(s) may not be used in the manufacture of any of the following applications: U.S. FDA Class
III medical devices; Health Canada Class IV medical devices; European Class III medical devices;
applications involving permanent implantation into the body; life-sustaining medical applications; and
lead, asbestos or MTBE related applications. All references to the U.S. FDA, Health Canada and
European Union regulations include another country’s equivalent regulatory classification.
Adflex, Adstif, Adsyl, Akoafloor, Akoalit, Alastian, Alathon, Aquathene, Catalloy, Clyrell, Dexflex,
Flexathene, Hifax, Histif, Hostacom, Hostalen, Indure, Integrate, Koattro, Lucalen, Luflexen, Lupolen,
Metocene, Microthene, Moplen, Nexprene, Petrothene, Plexar, Pristene, Pro-fax, Purell, Sequel, Softell,
Starflex, Ultrathene, and Valtec are trademarks owned or used by the LyondellBasell family of
companies.
Adsyl, Akoafloor, Akoalit, Alastian, Alathon, Dexflex, Flexathene, Hifax, Hostacom, Hostalen, Integrate,Koattro, Lucalen, Lupolen, Microthene, Moplen, Nexprene, Petrothene, Plexar, Pristene, Pro-fax, Purell,Sequel, Softell, Starflex, and Ultrathene are registered in the U.S. Patent and Trademark Office.
