Lyondellbasell Product Stewardship Information Date: 8/20/2018 Petrothene Ga635962 Recipient Tracking #: Request #: 1498061
Lyondellbasell Product Stewardship Information Date: 8/20/2018 Petrothene Ga635962 Recipient Tracking #: Request #: 1498061
Lyondellbasell Product Stewardship Information Date: 8/20/2018 Petrothene Ga635962 Recipient Tracking #: Request #: 1498061
J. Halderman
NEXEO
5200 Blazer Parkway, 43017
Petrothene GA635962
A product of Equistar Chemicals, LP
Dear J. Halderman:
The following is in response to your request for Product Stewardship Information (PSInfo) for the product
listed above. The attached Product Stewardship Bulletin (PSB) details the regulatory status of this
product.
Please note that compliance with these regulations should not be interpreted to guarantee that the
product, will, in fact, perform in a particular application. Your Technical Service Representative can help
you determine that the characteristics of the product are compatible with the desired conditions of use.
Should you have any further questions concerning a LyondellBasell product, or if we can assist in any
other way, please do not hesitate to contact us.
Best regards,
Andy Scheie
Lead Business Consultant
513-530-4229
andrew.scheie@lyondellbasell.com
Petrothene GA635962
A product of Equistar Chemicals, LP
European Union
This product complies with the relevant requirements of Regulation 1935/2004/EC (Framework
Regulation) as applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic
flakes).
This product complies with the relevant requirements of Regulation 2023/2006/EC (GMP) and as
amended, applicable to intermediate materials (e.g. plastic powders, plastic granules or plastic flakes).
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.
SML Components
This product contains one or more components with Specific Migration Limits (SMLs).
81200; poly[6-[(1,1,3,3-tetramethylbutyl)amino]-1,3,5-triazine-2,4-diyl]-[(2,2,6,6-tetramethyl-4-piperidyl)-
imino] hexamethylene[(2,2,6,6-tetramethyl-4-piperidyl) imino]; SML = 3 mg/kg
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)3.2a.
This product may also 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, the
substances 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 cannot be used at temperatures above
212°F (100°C) and can only be used in certain sized containers when contacting certain fatty food types.
In summary, this product meets the FDA criteria for food contact applications, including cooking up to a
temperature not to exceed 212°F (100°C), listed under conditions of use B through H in 21 CFR 176.170
(c), Table 2, and can be used in contact with food types I, II, IV-B, VI-A, VI-B, VI-C, VII-B and VIII as
listed in 21 CFR 176.170(c), Table 1 with no limitations on the size of the food contact article. However,
when contacting fatty food types III, IV-A, V, VII-A and IX under conditions of use B through H, the
finished article in contact with food must have a volume of at least 18.9 liters (5 gallons).
Allergen Statements
The food ingredients listed in Annex II of Regulation (EU) No 1169/2011, are not used in the
manufacture of or formulation of this product. However, this product has not been tested for these
substances.
Allergen - Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA)
No major food allergens (e.g., Milk, Eggs, Fish, Crustacean Shellfish, Tree Nuts, Wheat, Peanuts,
Soybeans, Sesame Seeds, Sulphites) nor protein derived from them are used in the formulation or
manufacture of this product. However, this product has not been tested for these substances.
Food Allergens
Biomedical Policy
(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: (1) U.S.
FDA Class II, Health Canada Class II or Class III, and/or European Union Class II Medical Devices; (2)
film, overwrap and/or product packaging that is considered a part or component of one of the
aforementioned Medical Devices; (3) packaging in direct contact with a pharmaceutical active ingredient
and/or dosage form that is intended for inhalation, injection, intravenous, nasal, ophthalmic (eye),
digestive, or topical (skin) administration; (4) tobacco related products and applications; (5) electronic
cigarettes and similar devices.
(iii) Additionally, the product(s) may not be used in: (1) U.S. FDA Class III, Health Canada Class IV,
and/or European Class III Medical Devices; (2) applications involving permanent implantation into the
body; (3) life-sustaining medical applications.
All references to U.S. FDA, Health Canada, and European Union regulations include other country’s
equivalent regulatory classifications.
United States
One or more additives in this product may be 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.
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
Please refer to the SDS for communications regarding California Proposition 65.
Articles made from this product are not expected to contain any materials in the CEPA Challenge
Program Lists 1 through 12 at levels that would trigger reporting when the items are imported into
Canada.
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.
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.
Additives derived from Genetically Modified Organisms (GMO’s) are not intentionally used in the
formulation of this product.
Kosher Certification
The additives and ingredients used to manufacture this resin may be derived from animal sources. The
authorities holding the strictest interpretation within the Kosher certification community maintain that use
of an additive from an animal source, such as tallow, in the packaging material disqualifies the packaging
material and, in turn, the food from Kosher certification. Other rabbinical authorities assert with equal
firmness that such additives used in the packaging materials do not affect the Kosher status of foods if
the materials are safe in the public health sense and do not affect the taste or odor.
Latex
No materials containing latex or natural rubber are used in the manufacturing, handling and packaging
processes for this product.
Metals Content
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).
Based on the available documentation from raw materials suppliers, this product complies with the
directive 94/62/EC and as amended concerning the defined limit(s)of heavy metals.
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 and 2011/65/EU, as amended, concerning
the limits of cadmium, lead, mercury, hexavalent chromium, polybrominated biphenyls (PBB),
polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl)phthalate (DEHP), butyl benzyl phthalate
(BBP), Dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP).
Other Chemicals
The chemical materials listed below are not intentionally used in the manufacture or the formulation of
this product. However, this product has not been tested for these chemical materials.
European Union
The ozone-depleting substances (ODS), listed in the Annexes I & II of the Regulation ( EC ) No
1005/2009 of 16 September 2009, are not intentionally used in the manufacture of or formulation of this
product.
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.
Please note that as of June 1, 2009 REACH Annex XVII replaces Directive 76/769/EEC – The
“Limitation Directive” for Dangerous Substances and Preparations which places restrictions on the
marketing and use of certain dangerous substances and preparations namely pentabromodiphenyl ether,
and octabromodiphenyl ether.
Neither pentabromodiphenyl ether nor octabromodiphenyl ether are used in the formulation of this
product and will not be found in concentrations higher than 0.1 % by mass in this product.
REACh Information
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 in this
preparation have been pre-registered or, where required under REACh, registered, and that we have the
intention either to proceed with their registration in accordance with the deadlines set forth in REACh, 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 met their pre-registration and applicable
registration obligations of their substances, and that they will supply the relevant Safety Data Sheets
(SDS) with REACh registration numbers as soon as the registrations occur. In no event shall any
LyondellBasell group 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, including other companies of the
LyondellBasell group, which is not established in the European Union, the importer into the European
Economic Area (EEA) is responsible for compliance with the requirements of REACh.
Please contact REACh@LyondellBasell.com if you need to discuss the potential compliance with
REACh before importing this product into the EEA.
REACH Annex XVII – Restriction on the Manufacture, Placing on the Market and Use of Certain
Dangerous Substances, Preparations and Articles.
The chemical materials listed are not used in the manufacture or the formulation of this product.
However, this product has not been tested for these chemical materials.
This product does not contain any of the Annex XIV candidate chemicals proposed to be Substances of
Very High Concern (List as of June 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. The current list of all SVHCs can be found at ECHA website link listed
below:
http://echa.europa.eu/web/guest/candidate-list-table
H.R. 4040 establishes consumer product safety standards and other safety requirements for children's
products and reauthorizes and modernizes the Consumer Product Safety Commission. The product
listed above is a commercial product, not a consumer product although some manufacturers may choose
to use this material in consumer products. We have reviewed the act and believe that this material will
not impair the ability of our customers to comply with the act, however it is the responsibility of our
customers to insure compliance and provide any required testing.
We have reviewed Standard Consumer Safety Specification of Toy Safety: ASTM F-963-2017. It
appears that Section 4.3.5 applies to paints or similar coatings, and accessible parts of toys, and section
8.3 describes corresponding testing protocol. Metal elements mentioned in Section 4.3.5 are not
intentionally used in the production or formulation of this product.
USDA
It is our understanding that it is not necessary to obtain a letter of chemical acceptance from USDA prior
to using a packaging material for meat or poultry products provided that the packer has on file a letter
from the materials supplier assuring that its products are in compliance with the Federal Food, Drug and
Cosmetic Act.
Disclaimer
Information in this document is accurate to the best of our knowledge at the date of publication. The
document is designed to provide users general information for safe handling, use, processing, storage,
transportation, disposal and release and does not constitute any warranty or quality specification, either
express or implied, including any warranty of merchantability or fitness for any particular purpose. Users
shall determine whether the product is suitable for their use and can be used safely and legally.
In addition to any prohibitions of use specifically noted in this document, LyondellBasell may further
prohibit or restrict the sale of its products into certain applications. For further information, please contact
a LyondellBasell representative.
The Trademark referenced within the product name is owned or used by the LyondellBasell family of
companies.