3600S

QUALITY AND SAFETY

OPERATING PROCEDURE

1 SCOPE

TITLE

HEAVY ELEMENTS

NUMBER REVISION DATE

0006-3600

FOR QUESTIONS CONTACT

S

REVISION AUTHOR

4/1/2010

C. Shultz Y. Gao / C. Shultz

1.1 Products and Components Covered

• Accessible parts of all products, including promotional items and packaging intended to

remain with the product.

• Inaccessible parts that are contained within accessible small parts.

• Inaccessible parts of all products (applicable to total cadmium requirements only).

1.2 Exemptions

1.2.1 Children’s Jewelry Items – test per QSOP 0006-3604

, Heavy Elements - Children’s

Jewelry

1.2.2 Children’s Wearing Apparel – test per QSOP 0006-3606, Heavy Elements – Children’s

Wearing Apparel. Withdrawals

1.2.3 Children’s Cosmetics – test per QSOP 0006-3607, Heavy Elements – Children’s

Cosmetics

1.2.4 Inaccessible parts of electrical and electronic products - test per QSOP 0006-3602,

Restriction of Hazardous Substances (RoHS)

1.2.5 Components that are listed in Appendix A of QSOP 0006-3602, Restriction of Hazardous

Substances (RoHS) are exempt from “additional requirements for accessible parts of

electrical and electronic products only” shown in §2.1 and §2.4-§2.7.

1.2.6 Soluble method 1 if sample material is <10 mg.

1.2.7 Components that are not accessible at any point during assembly, use, and foreseeable

abuse. Inaccessible components that are contained within accessible small parts are not

covered by this exemption. Products intended to be assembled by an adult should be

evaluated after assembly.

1.2.8 Promotional items intended for adults

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

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 0006-3010, Accessibility.

Art materials: Any substance marketed or represented by the producer or repackaged for use in

any phase of the creation of any work of visual or graphic art in any medium such as crayons,

clay/modeling compounds, glues (liquid and stick), paints (finger, watercolor, liquid), markers and

similar “wet” medium, colored pencils, chalk, ball point pens and pencils.

Composite (Sample): A sample made from combining more than one material or color (e.g.

paint: red, yellow and blue), vacuum metalized coating (silver and gold). It is not considered

compositing when colors or materials that can not be separated (e.g. thin stripes, doll eyes, etc.)

are tested together.

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Jewelry Items: Ornamental items that are intended to be worn in the hair or on the body.

Examples would include rings, necklaces, bracelets, etc. This definition also includes jewelry kits

that are intended to create jewelry items.

Paint: solid or liquid intended for use by the consumer.

Promotional Items:

Items provided to the consumer to promote a product or brand. These

items may or may not be included in, or with, a product. Examples include items such as

booklets, catalogs, bookmarks, growth charts, and posters. In some instances, a promotional

item may be an actual product in package that is given away.

Substrate: The base material of an item, regardless of whether or not it has a surface coating.

Suitable: Suitability of a toy for a child of a particular age. Reference data compiled by the

Consumer Product Safety Commission (CPSC) in “Guidelines for Relating Children’s Ages to Toy

Characteristics.” This guideline describes mental, physical and motor skill development of

children from birth to 14 years. See United States regulations 16 CFR 1501.2 and 1501.3 for

additional reference to suitability of small parts.

Surface Coating: All layers of materials such as paint or similar materials, that dry to a solid film

when applied to a substrate and that can be scraped off with a sharp blade or washed off with a

solvent such as acetone or ethanol, without removing the substrate (base) material. These are

factory applied coatings on products.

NOTE: Labels are not considered surface coatings because they do not meet the definition of a

surface coating in 16 CFR 1303. Labels may contain surface coatings—those coatings should be

tested according to §2.4 Surface Coatings. The base material of the label should be tested

according to the appropriate section for substrates (e.g. PVC labels would be tested according to

§2.7). If the surface coating on a label is made inaccessible by way of a permanent seal, such as

lamination, then the coating would no longer be considered a surface coating—the label should

be tested as a substrate.

1.4 Purpose

Evaluate product for compliance to worldwide safety standards for heavy metals content.

2 PERFORMANCE REQUIREMENTS

The following requirements are evaluated before and after all applicable use and abuse testing. See

Appendix 1, Heavy Elements Testing Flow Chart.

2.1 Products, Accessories, or Peripherals Intended to be Used Exclusively by Adults*

Must be ≤ the following limits:

COMPONENT ELEMENT

TOTAL

(ppm)

Lead (Pb) 90

Surface Coatings

Plastics Lead (Pb) 100

Surface Coatings and Plastics Cadmium (Cd) 75

1

75

Additional Requirements for ACCESSIBLE

Cadmium (Cd)

PARTS OF Electrical/Electronic Products

Lead (Pb) 1000

Only

Hexavalent Chromium (CrVI) 1000

Mercury (Hg) 1000

1

75 ppm total cadmium limit is applied to accessible and inaccessible components.

*Fashion dolls intended for Brazil should not be tested according to §2.1. The product should be tested

according to all other applicable sections.

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2.2 All other products

2.2.1 Art Materials (except finger paints)

Must be ≤ the following limits:

ELEMENT

Antimony (Sb)

Arsenic (As)

Barium (Ba)

Cadmium (Cd)

Chromium (Cr)

Lead (Pb)

Mercury (Hg)

Selenium (Se)

2.2.2 Finger Paints

Must be ≤ the following limits:

TOTAL

(ppm)

SOLUBLE

METHOD1

(ppm)

- 60

- 25

- 250

1

75 50

- 25

9090

- 25

- 500

ELEMENT

Antimony (Sb)

Arsenic (As)

Barium (Ba)

Cadmium (Cd)

Chromium (Cr)

Lead (Pb)

Mercury (Hg)

Selenium (Se)

TOTAL

(ppm)

SOLUBLE

METHOD1

(ppm)

- 10

- 10

- 350

1

75 15

- 25

9025

- 10

- 50

2.2.3 Surface Coatings

Must be ≤ the following limits:

TOTAL

(ppm)

SOLUBLE

METHOD 1

(ppm)

SOLUBLE

METHOD 2

(ppm)

ELEMENT

Antimony (Sb) - 60 1000

Arsenic (As) - 25 1000

Barium (Ba) - 500 1000

Cadmium (Cd) 75

1

75 1000

Chromium (Cr) - 60 -

Lead (Pb) 40 90 -

Mercury (Hg) 10 25 -

Selenium (Se) - 300 1000

ADDITIONAL REQUIREMENTS – ACCESSIBLE PARTS OF

ELECTRICAL/ELECTRONIC PRODUCTS ONLY

Hexavalent Chromium (CrVI) 1000

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2.2.4 Metal, glass, gemstone, and ceramic that is not a small part

2

Must be ≤ the following limits:

ELEMENT

TOTAL

(ppm)

Lead (Pb) 40

3

/100

4,5

Cadmium (Cd) 75

1

ADDITIONAL REQUIREMENTS –

ACCESSIBLE PARTS OF

ELECTRICAL/ELECTRONIC PRODUCTS

ONLY

Hexavalent Chromium (CrVI) 1000

Lead 1000

Mercury (Hg) 1000

2.2.5 Metal, glass, gemstone, and ceramic that is a small part

2

Must be ≤ the following limits:

ELEMENT

TOTAL

(ppm)

SOLUBLE

METHOD 1

(ppm)

Antimony (Sb) - 60

Arsenic (As) - 25

Barium (Ba) - 500

Cadmium (Cd) 75

1,6

75

Chromium (Cr) - 60

34,5

Lead (Pb) 40/100 90

Mercury (Hg) - 60

Selenium (Se) - 300

ADDITIONAL REQUIREMENTS – ACCESSIBLE PARTS

OF ELECTRICAL/ELECTRONIC PRODUCTS ONLY

Hexavalent Chromium (CrVI) 1000

Lead 1000

Mercury 1000

2

Product intended to be adult-assembled should be evaluated in the assembled state before and after use

and abuse testing. This includes the determination of small parts.

The

40 ppm limit is applicable to child care items intended to be placed in the mouth. Examples of child

care items intended to be placed in the mouth include pacifiers, baby bottles, teethers, cups, utensils, etc.

The 100 ppm requirement is to be used for all other items including toys.

3

Product intended for the adult collector is exempted from this requirement. Fashion Dolls do not qualify

for this exemption in Brazil.

5

See Appendix 4 for products and materials that are not subject to this requirement.

6

4

Glass Beads are exempt from total Cd testing. Soluable testing still applies.

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2.2.6 Plastic and All Other Materials

Must be ≤ the following limits:

ELEMENT

TOTAL

(ppm)

SOLUBLE

METHOD 1

(ppm)

Antimony (Sb) - 60

Arsenic (As) - 25

Barium (Ba) - 500

Cadmium (Cd) 75

1

75

Chromium (Cr) - 60

Lead (Pb) 40

7

/ 100

8

90

Mercury (Hg) - 60

Selenium (Se) - 300

ADDITIONAL REQUIREMENTS – ACCESSIBLE PARTS

OF ELECTRICAL/ELECTRONIC PRODUCTS ONLY

Hexavalent Chromium (CrVI) 1000

Lead (Pb) 1000

Mercury 1000

7

The 40 ppm limit is applicable to child care items intended to be placed in the mouth. Examples of child

care items intended to be placed in the mouth include pacifiers, baby bottles, teethers, cups, utensils, etc.

The 100 ppm requirement is to be used for all other items including toys.

8

See Appendix 4 for products and materials that are not subject to this requirement

3 TEST METHODS

3.1 Test Environment (not applicable)

3.2 Equipment

Use equipment specified in procedures referenced in §3.4

3.3 General Test Requirements

3.3.1 All accessible materials must be tested—surface coatings, substrates, base materials,

etc.

3.3.2 If feasible, samples are to be tested in the same form they appear on the finished product,

e.g. paint is tested in the dry state.

3.3.3 Coated surfaces require testing of both the surface coating and the base material with the

coating removed.

3.3.4 Colors or materials can be combined if they cannot be physically separated (e.g.

overlapping colors of paint, adhesive on a label). This is not considered composite

testing. For example, glues or adhesives that can not be physically separated from the

substrate (e.g. adhesive on a paper label) should be tested together with the substrate.

3.3.5 Composite testing is not permitted for Soluble 1 and 2 testing. This does not apply to

Total digestion testing that is used to satisfy Soluble 1 and 2 limits per § 3.4.1.

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3.3.6 The analytical correction factors found in EN71-3/ISO 8124-3 should be applied to Soluble

1 results. These correction factors should not be applied to total digestion results or

Soluble 2 results.

3.3.7 Composite testing, when permitted, must meet the following criteria:

• No more than 3 samples may be used

• Equal weights of each sample should be used

• Compositing must be done using similar materials with similar properties

• Measures must be taken to ensure a failing result is not masked by the other

samples in a composite. Acceptable methods for calculating the maximum possible

concentration of an analyte in a single sample are detailed in CPSC test method

CPSC-CH-E1003-09 and Mattel GLOP 0006-7406,

Total Digestion for Heavy

Element Analysis

3.3.8 Test frequency is per the following:

• GQMP 0006-2112, Heavy Elements Control on Surface Coatings for Mattel and

Mattel OEM

• GQMP 0006-2113, Heavy Elements Control on Surface Coatings for Specialty

Vendors

• GQMP 0006-2118, Heavy Elements Control on Substrates for Mattel Owned and

Operated Plants

• GQMP 0006-2119, Heavy Elements Control on Substrates for Mattel OEM and

Specialty Vendors

3.4 Procedure

3.4.1 Laboratories may use the results from the Total test to satisfy Soluble 1 and Soluble 2

requirements, if they have demonstrated that the Total digestion and analysis methods

they employ are capable of accurately testing for all analytes of interest (As, Ba, Cd, Cr,

Hg, Pb, Sb, and Se).

3.4.1.1 For As, Cd, Cr, Hg, Pb, Sb, and Se, if the total element test result is ≤ the total

and soluble limits, soluble test methods 1 and 2 are not required. For Barium (Ba),

total result must be ≤50% of the respective Soluble 1 or Soluble 2 limit. If result is

>50% of the respective limit, then the related soluble test must be performed (e.g.

if the result is greater than 50% of Soluble 1 requirement, then the Soluble 1 test

must be performed).

3.4.1.2 If the total test result is > the total limit the material fails and no further testing is

performed.

See Appendix 2 for examples.

3.4.1.3 For surface coatings, follow Appendix 3 if sufficient sample to conduct the testing

cannot be collected from 12 samples.

3.4.2 Mattel Internal Labs

Mattel internal test laboratories must follow appropriate Global Laboratory Operating

Procedure

3.4.2.1 Total Test Methods

• Test Glass and Ceramic at an external laboratory.

• Test all other materials per GLOP 0006-7406, Total Digestion for Heavy

Element Analysis

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• For surface coatings, follow Appendix 3 if sufficient sample to conduct the

testing cannot be collected from 12 samples.

3.4.2.2 Soluble Method 1

• Test per GLOP 0006-7408, Soluble Extractions for Heavy Metal Analysis

• If 10 mg of sample cannot be collected from 1 sample, do not perform an

analysis.

3.4.2.3 Soluble Method 2

• Test per GLOP 0006-7408

, Soluble Extractions for Heavy Metal Analysis

• Follow Appendix 3 if sufficient sample to conduct the testing cannot be

collected from 12 samples.

3.4.3 External Labs

3.4.3.1 Total Test Methods

3.4.3.1.1 Total Hexavalent Chromium - Cr VI

Use one of the following methods as applicable:

• ISO 3613, Chromate Conversion Coatings on Zinc, Cadmium,

Aluminum-zinc Alloys, Zinc-aluminum – Test Methods or

equivalent.

• EPA Test Method 3060, Alkaline Digestion for Hexavalent

Chromium or equivalent.

Variations of these extraction and analysis methods and/or use of

an alternate method are acceptable if, in the expert opinion of the

test laboratory, they are declared to be equivalent or better.

3.4.3.1.2 Total All Other Elements

3.4.3.1.2.1 Use one of the following digestion methods as applicable:

• AOAC Official Method 974.02, Lead in Paint

• EPA Method 3051A, Microwave Assisted Digestion

of Sediments, Sludge, Soils, and Oils

• EPA Method 3052, Microwave Assisted Digestion of

Siliceous and Organically Based Matrices.

Variations of these digestion methods are acceptable if,

in the expert opinion of the test laboratory, they are

declared to be equivalent or better.

3.4.3.1.2.2 Analyze the digestion utilizing any suitable method

based on the equipment used (AA or ICP) and the

element content to be determined.

3.4.3.1.3 Follow Appendix 3 if sufficient sample to conduct the testing

cannot be collected from 12 samples

3.4.3.2 Soluble Method 1

3.4.3.2.1 Test and evaluate surface coating material per the latest revision

ASTM F963.

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3.4.3.2.2 Test and evaluate non-surface coated material per the latest

revision EN 71-3.

3.4.3.2.3 Analyze the solution for heavy elements content using either

atomic absorption spectroscopy (AA) or inductively coupled

plasma spectrometry (ICP).

3.4.3.3 Soluble Method 2

3.4.3.3.1 Test and evaluate for soluble cadmium, barium, antimony,

selenium and Arsenic per the latest revision of Health Canada

Book 5 Laboratory Policies and Procedures, Part B, test method

“C03-1, Determination of Leachable Cadmium, Barium, Antimony,

Selenium and Arsenic in Applied Coatings”.

3.4.3.3.2 Follow Appendix 3, if sufficient sample to conduct the testing

cannot be collected from 12 samples

4 HISTORY

4.1 Significance

Compliance can be assured by using a testing and compliance system that will reduce the risk of

finished products having an excessive amount of heavy elements.

Total Lead testing is required per CFR 1303 and the Consumer Product Safety Improvement Act

of 2008. No testing methodology is specified.

Soluble test method 1 is required per ASTM F963-07, EN 71-3, ISO 8124-3, Mexico’s NOM’s,

and India’s IS 9873-3.

Soluble test method 2 is required per Canada’s Hazardous Products Act (HPA). The HPA

specifies that the test sample must be stirred in 5% hydrochloric acid for ten minutes at 20°C. A

detailed methodology has been supplied by Health Canada (C03-1, Determination of Leachable

Cadmium, Barium, Antimony, Selenium and Arsenic in Applied Coatings).

Total Cadmium testing is based on European Regulation (EC) No 1907/2006 Restriction,

Evaluation, Authorization, and Restriction of Chemicals (REACH) and Danish Ordinance

prohibiting the importation, sale and manufacture of cadmium containing products (BEK nr 858 of

05 Sept 2009)

The total mercury testing is also required per Canada’s Hazardous Products Act. The Canadian

HPA does not allow mercury to be intentionally added to the surface coating materials (SCM). A

test result of ≤10 mg/kg (ppm) total mercury is considered the most reliable way to determine that

no mercury has been introduced. No testing methodology is specified in the HPA.

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4.2 Reason for Revision

Section

1.1

1.2.5

1.3

Revision S

Adds inaccessible portions of all products for the

total cadmium testing into the scope

Accessible parts of electrical/electronic items may be

exempt from RoHS requirements per QSOP 3602,

RoHS

Deletes definition for Off-set printing inks as it is not

referenced within the document.

Adds total cadmium limit 75 ppm across the board

including for inaccessible portions of all products;

Reduces the total cadmium limit for

electrical/electronic products from 100 ppm to 75

ppm

Reduces total lead requirement for substrates to 100

ppm to meet new TRU requirements

Additional requirements for electrical/electronic parts

apply to accessible parts only. Inaccessible parts are

covered by QSOP 3602, RoHS

Accessible metal parts of electrical/electronic items

intended for use by adults require lead testing to

1000 ppm per RoHS requirements

Cd requirement removed from requirement for

surface coating of accessible parts of

electrical/electronic items. 75 ppm total Cd limit is

already required for all surface coatings per line 4 of

the table.

1000 ppm Pb limit added to additional requirements

for accessible electrical/electronic items.

Electrical/Electronic components that are exempt

from the overall limits of the upper part of the table

must still meet RoHS limits of 1000 ppm total.

Exempts glass beads from total testing due to nature

of Cd in glass. Required to continue to meet soluble

limits.

Revises the significance and reference of total

cadmium testing

Changes the name to Heavy Elements Testing Flow

Chart

Adds “plant” to table to clarifies IQC is based on

incoming inspection at a Mattel Plant.

Points to sections 2.5 and 2.6 which reference

Appendix 4.

Implementation date:

All products manufactured

on or after July 1, 2010.

Immediate

Editorial

All products manufactured

on or after July 1, 2010.

2.1 through

2.7

2.1, 2.4-2.7

All products shipped after

June 1, 2010

Editorial

2.1

Immediate

Editorial

2.4

4.2.1

2.5 - 2.7

Immediate

2.6

4.1 & 4.3

Appendix 1

Appendix 3

Appendix 4

All products manufactured

on or after July 1, 2010.

Editorial

Editorial

Editorial

Editorial

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Section

2.4

Revision R Implementation date:

All product manufactured

on or after March 15, 2010

Immediate

Adds requirement for Total cadmium in surface

coatings

Adds requirement for Total cadmium in plastics from

2.7

QSOP 0006-5010, Environmental – Total Cadmium

in Plastics. QSOP 5010 will be made obsolete

Reduces limit for total cadmium in plastics (from

2.7

QSOP 5010) from 100ppm to 75ppm to be aligned

with Swedish enforcement policies

Changes parameter for using Total data to satisfy

3.4.1,

Soluble limits, requiring ≤50% of respective soluble

Appendix 2

limit instead of 250ppm for both Soluble 1 and 2.

Modifies Appendix 2 accordingly.

Revises source of Total Cadmium requirement to

4.1

this section

All product manufactured

on or after March 15, 2010

Immediate

Editorial

4.3 The following documents contain requirements related to this procedure

• 16 CFR 1303

• EN71-3 1994 with amendment A1:2000

• ASTM F963-08 Standard Consumer Safety Specification for Toy Safety

• California Proposition 65

•

Canadian Hazardous Products Act and Health Canada’s Guideline for Lead in Children’s

Products

• ISO 8124-3, 1997

• Mexico NOM’s

• U.S. CPSC Policy on Lead in Certain Art Materials

• Official Methods of Analysis of the AOAC, 16th Ed, Section 25, 1995, standard method

974.02

• Health Canada Book 5, Laboratory Policies and Procedures, Part B, Test Method C-07,

Determination of Total Mercury in Paints and Applied Coatings and C03-1, Determination of

Leachable Cadmium, Barium, Antimony, Selenium and Arsenic in Applied Coatings

•

•

•

•

•

Directive 2002/95/EC – Restriction of Hazardous Substances (R.o.H.s)

Guidelines for Children’s Products – Wal-Mart (1/29/2008)

Washington state House Bill 2647

EPA Method 3051A, Microwave Assisted Digestion of Sediments, Sludge, Soils, and Oils

EPA Method 3052, Microwave Assisted Digestion of Siliceous and Organically Based

Matrices.

• Consumer Product Safety Improvement Act (CPSIA) of 2008

• EN71-7:2002

• Illinois Public Act 095-1019

• European Regulation (EC) No 1907/2006 Restriction, Evaluation, Authorization, and

Restriction of Chemicals (REACH)

• Danish Ordinance prohibiting the importation, sale and manufacture of cadmium containing

products (BEK nr 858 of 05 Sept 2009)

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Appendix 1, Heavy Elements Testing Flow Chart

Adult Accessories and Peripherals

Is the item an

accessory or

peripheral intended

for use by adults?

No

Surface Coating Level

Does the item

have a surface

coating?

No

Base Material Level

Is the item an Art

Material?

No

Is the base material

metal, glass, ceramic,

or gemstone?

No

Test per 2.7

*Fashion dolls intended for Brazil should not be tested according to §2.1. The

product should be tested according to all other applicable sections.

Yes

Test per 2.1*

Finish

Yes

Test per 2.4

Go to Base

Material

Level questions

Yes

Is the item a

finger paint?

Yes

No

Test per 2.3

Test per 2.2

Yes

Is the

item a small part

Yes

Test per 2.6

No

Test per 2.5

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Appendix 2, Totals Results to Satisfy Soluble Requirements

Example 1: Antimony Result in Surface Coating

Total Result

Antimony (ppm)

40

65

1200

Soluble Antimony Method 1

limit: 60 ppm

Less than soluble limit; do not test

Exceeds soluble limit; test

Exceeds soluble limit; test

Soluble Antimony Method 2

limit: 1000 ppm

Less than soluble limit; do not

test

Less than soluble limit; do not

test

Exceeds soluble limit; test

Example 2: Barium Result in Surface Coating

Total Result

Barium (ppm)

40

250

750

1200

Soluble Barium Method 1

limit: 500 ppm

≤ 250 ppm; do not test

≤ 250 ppm; do not test

Exceeds250 ppm; test

Exceeds 250 ppm; test

Soluble Barium Method 2

limit: 1000 ppm

≤ 500 ppm; do not test

≤ 500 ppm; do not test

Exceeds 500 ppm; test

Exceeds 500 ppm; test

Example 3: Lead Result in Surface Coating

Total Result Lead

(ppm)

30

100

Soluble Lead Method 1

limit: 90 ppm

Less than soluble limit; do not test

Exceeds total limit; sample fails,

no further testing

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Appendix 3, Heavy Elements Sample Requirements for Surface

Coatings

Start

AA/ICP Testing

required

YES

≥ 10 mg either

individual color

or composite

sample* (≤ 3

colors) on 12

samples

maximum

NO

AA/ICP Test

report from a

Mattel Certified

Supplier, a

MAPS Vendor

or a Mattel

PlantIQC

YES

AA/ICP Testing

not required

NO

Finish

Considerations:

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