Released Procedures ReleasedProcedures 3627

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3627 PolyCarbonate - Bisphenol A

Number Revision Date Assigned Author

QSOP 3627 4.00 2021-07-20 Ying Gao

FOR QUESTIONS CONTACT


QUALITY SAFETY OPERATING PROCEDURE
Ying Gao
Mattel Confidential Information | May Include Trade Secrets | Property of Mattel

1 - SCOPE (3627)

1.1 - Products and Components Covered

Accessible portions of products intended to be put in the mouth


Material intended to contact food
Products or components with a BPA-free claim

1.2 - Exemptions

1.2.1 - Packages intended to be discarded.

1.2.2 - Parts which are molded or formed at a Mattel vendor, Mattel subcontractor, or Mattel owned-and-operated
factory from non-polycarbonate resin are exempted from §2.1

1.3 - Definitions (Words that are defined are italicized and bolded once per section)

1.3.1 - Accessible: Any area of the product that can be contacted by any portion forward of the collar of the
accessibility probes when inserted to the depth determined in QSOP 3010, Accessibility.

1.3.2 - Bisphenol A (BPA): A key monomer used in the production of most polycarbonate resin.

1.4 - Purpose
To evaluate products for compliance to Mattel’s internal policy regarding the use of polycarbonate

2 - PERFORMANCE REQUIREMENTS

2.1 - Polycarbonate must not be used.

2.2 - Additional requirements for any product with a BPA free claim

2.2.1 - The total BPA content in any material shall be not detected when tested with the method described in the
§3.4.3.

2.2.2 - Refer to QSOP 3510, Labeling - Package Copy for the claim information

3 - PROCEDURE

3.1 - Test Environment

3.2 - Equipment

3.3 - General Test Requirements

3.4 - Method

3.4.1 - Any of the following methods may be used to determine compliance with §2.1

3.4.2 - Verification through a bill of materials (BOM) or bill of substance (BOS)

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3.4.3 - Plastics Screening Test

3.4.3.1 - Plastics less than 90 Shore A in hardness do not need to undergo further examination

3.4.3.1.1 - Plastics ≥ 90 shore A in hardness may be subjected to a series of qualitative tests (density/specific
gravity testing, flame testing, etc) to further characterize the materials or they may be identified directly
according to the testing described in §3.4.2.
If the results of any testing are inconclusive or ambiguous, samples should be subjected to testing according
to §3.4.2.

3.4.3.2 - Plastics Identification Method

3.4.3.3 - Unknown polymers can be identified using Fourier Transform Infrared Spectroscopy (FTIR)

3.4.4 - Test method for a product/component with a BPA Free Claim

3.4.4.1 - A 3rd-party laboratory's in-house testing method to determine total BPA is acceptable as long as it has
a method detection limit <=0.1 ppm.

4 - DOCUMENT HISTORY AND SUPPORTING DOCUMENT

4.1 - Significance
Documents Mattel’s policy for the use of polycarbonate made from bisphenol A and the voluntary BPA free claim
requirement.

4.2 - Reason For Revision (3627)

Section Revision 4.00 Implementation

Complete re-write as part of a GQMP simplification


All Editorial
project

1.1& 2.1 Revised the scope of document and section Editorial

1.2.3 Obsoleted the section as they are not in the scope Editorial

3.3 Obsoleted these sections to simply this GQMP Editorial

3.4.4 Re-wrote it for a clarification purpose Editorial

Section Revision 3.00 Implementation

Obsoleted the restriction of polycarbonate on all accessible parts


of products intended for children <3, but applied the restriction of
Applies to products manufactured on and after:
2.1 polycarbonate for any food contact items and any products
March 1, 2019
intended to be mouthed including the products for children less
than 3 years old.

4 Revised title of section. Editorial

Added section to identify any Mattel internal requirements


4.4 Editorial
contained in this procedure.

Updated section to remove previous references and replace with


4.3 a hyperlink to a Detailed Procedure to Source Document report in Editorial
Polarion.

4.3 - Referenced Documents

The following link contains the source documents and requirements related to this procedure:

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Detailed Procedure to Source Document Report

4.4 - Identification of Mattel Internal Requirement

The following table identifies the Mattel internal requirements in this document.

Section Requirement Note

2.1 EU Toy Safety Directive set up a migration limit for BPA used in toys intended for children under 36 months or in other
toys intended to be placed in the mouth. Other laws from Algeria and Rockland County in New York ban certain childcare
articles contain BPA, such as sucking/teething products. As plolycarbonate is the most common accessible material
containing BPA, BPA is the building block of Polycarbonate, Mattel internally ban polycarbonate used in these products,

2.2 This is Mattel internal requirement that was established in conjunction with the Legal department. If the label "BPA Free"
is added to a product it is required to demonstrate that BPA is not present in the product. Testing with a result of BPA
content "not detectable" by the most sensitive methodology is a demonstration approach that Mattel chose based on the
advice of 3rd party labs which have established an industry standard to a degree.

5 - FREQUENTLY ASKED QUESTIONS (None)

6 - ATTACHMENTS (None)

7 - APPENDICES (None)

Mattel – Confidential Information


3627 PolyCarbonate - Bisphenol A

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