Title: heavy metal content specification


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GLOBAL QUALITY ASSURANCE

SAFETY & RELIABILITY SPECIFICATIONS
TITLE: HEAVY METAL CONTENT SPECIFICATION

NUMBER: SRS-018
REVISION: Initial

AUTHOR: J.HUXLEY

DATE: 12/17/12
Hasbro RI Approval:

Hasbro UK Approval:

Hasbro FE Approval:



  1. PURPOSE



    1. To set requirements for the heavy metal content of various materials in all Hasbro products to ensure compliance with US federal and state regulations as well as Global regulatory requirements such as the European (EN), ISO and Canadian CCPSA.


  2. SCOPE



    1. All components and materials used in Hasbro products must comply with the requirements of this SRS.



    2. Additional requirements for Heavy Metals exist in the following specifications:

SRS-082 Heavy Metals Requirements for Packaging.



    1. These specifications will indicate if compliance with this SRS is still required.



    2. This SRS replaces the following specifications in their entirety:
      SRS-012 Heavy Metal in Surface Coatings,
      SRS-044 Heavy Metals in Plastics, Metallics & Wood Materials Specification,
      SRS-047 Heavy Metals in Fabric, Paper & Paperboard Specification,
      SRS-052 Heavy Metals in Modeling Clay, Finger Paints, Gels and other Mass-Colored Materials Specification,
      SRS-099 Heavy Metals in Cosmetics Specification.



    3. This SRS replaces the sections relating to Heavy Metal requirements in the following specifications:
      SRS-040 Food Contact and Oral Contact Product Specifications
      SRS-060 Global Arts & Crafts Specification
      SRS-062 Battery Operated Products – Battery Compartment Specification




  1. DEFINITIONS



    1. Accessible
      Materials that are accessible using the probes in SRS-002.

      NOTE: A children’s product that is or contains a part which is enclosed, encased, or covered by fabric and passes the appropriate use and abuse tests on such covers, is inaccessible to a child unless the product or part of the product in one dimension is smaller than 5 cm.



    2. Required limits
      Heavy metal content limits which materials are not allowed to exceed.



    3. Action limits
      Heavy metal content limits that, if exceeded, require some further action such as testing against other requirements.



    4. Coating
      A fluid, semi-fluid, or other material, with or without a suspension of finely divided colouring matter, which changes to a solid film when a thin layer is applied to a metal, wood, stone, paper, leather, cloth, plastic, or other surface. Exempt from this definition are materials which actually become an integral part of the substrate, such as colorants in plastic articles, or those materials which are actually bonded to the substrate such as by electroplating or ceramic glazing.



    5. General materials
      These materials are solid toy materials and substrates with or without a coating which can be ingested as a result of biting, tooth scraping, sucking or licking. This definition includes all plastics, textiles and paper and any materials not covered under the other definitions of this SRS or other related heavy metal SRSs.



    6. Liquid and sticky materials
      These materials are fluid or viscous toy material which can be ingested and/or to which dermal exposure occurs during playing. Includes such materials as glues, gels, slimes, marker inks and modelling compounds.



    7. Dry, Brittle and Powder like materials
      These materials are solid toy materials from which powder-like material is released during playing and so contamination of the hands with powder contributes to enhanced oral exposure. Includes such materials as chalks, crayons, graphite, paint powders or tablets, the graphite materials in pencils and plaster of paris.



    8. Wood, Metallic, Glass and Ceramic materials
      Any components or materials that are made of metals, glass or ceramic materials.



    9. Cosmetic Product
      Any substance or mixture intended to be placed in contact with the external parts of the human body or with the teeth and the mucous membranes of the oral cavity with the intention of cleaning, perfuming, promoting attractiveness, protection, maintaining or altering the appearance thereof.

      NOTE: Cosmetic products are separate from the categories defined in sections 3.6 or 3.7 for the purposes of testing and have category specific requirements.


  2. EXEMPTIONS

    No specific exemptions.



  3. SPECIFICATIONS



    1. Materials where the total heavy metal concentration exceeds the specified required limit of table 1 fail the requirements of this specification.



    2. Materials where the soluble heavy metal concentration exceeds the specified required limit of table 2 fail the requirements of this specification.



    3. Materials where the soluble heavy metal concentration exceeds the specified required limit of table 3 fail the requirements of this specification.



    4. Materials where the heavy metal concentration exceeds the specified action limits in any of the listed tables, one or more of the following actions shall be taken, as specified by the action code:

Code A – Retest and confirm result, agree a corrective action plan to ensure the actual content is below the action limit with QA management and the development team.

Code B – Perform a Canadian soluble retest and check against soluble limit values in table 3.

Code C – Certain art materials have specific action and required limits that are listed in Table 4.


    1. The total and soluble heavy metal requirements for metal, glass and ceramic materials only apply to components that are Hasbro small parts (as defined in SRS-001) before and after test plan testing, with the exception of the requirements in table 1 for total Pb and Cd which apply to each metal, glass or ceramic component regardless of size.



    2. Children’s Jewelry products must comply with a total lead (Pb) requirement specific to this product type and must be tested for total Cd (Pb, Cd in Table 1) and for “soluble” on all heavy elements (Table 2).



    3. Cosmetic products have category specific requirements that are listed in the Cosmetic sections of Table 1 and Table 2. The listed metals must not be intentionally added ingredients in cosmetic products used in Hasbro, Inc products.



    4. Food Contact Products and Finger Paints have category specific soluble heavy metals requirements that are listed in Table 5 – Food Contact and Finger Paints Soluble Limits.

      NOTE: Total heavy metals requirements for Food Contact Products and Finger Paints are covered in Table 1 in accordance with the requirements listed for Cosmetics.



    5. Oral Contact Products have category specific soluble heavy metals requirements that are listed in Table 6 – Oral Contact Products Soluble Limits.

      NOTE: Total heavy metals requirements for Oral Contact Products are covered in Table 1 in accordance with the requirements listed for Cosmetics.


  1. TEST METHODS



    1. All accessible materials used in Hasbro products are sampled using the procedures as described in the relevant standards below.



    2. Each material is tested for the total content and the soluble content of the metals listed in tables 1 and 2 (with reference to tables 3 & 4 as applicable).



    3. Materials with a total heavy metal concentration exceeding the action limits of table 1 must be subjected to the stated actions (e.g. Canadian Soluble testing). Materials with a Soluble heavy metal concentration exceeding the action limits of table 2 must be subjected to the stated actions.



    4. Testing is carried out in accordance with the latest version of the referenced standards. Test methods are as follows:

      1. Total testing is carried out in accordance with ISO8124 or any other validated test method.

      2. Soluble testing is carried out in accordance with EN71-3.

      3. Canadian soluble testing is carried out in accordance with method C03 of part 5 of the Canadian product safety reference manual.



    5. For the purposes of this specification more than one product may be used to obtain sufficient sample mass for testing. Should obtaining sufficient sample mass be problematic for mechanical reasons (e.g. coating spots on dice), testing may be carried out on raw materials at the discretion of Reliability Engineering.
      Solvent recovery techniques may be used to take sample coatings provided it can be shown the results of the heavy metal extraction are not affected.



    6. Printed materials using CMYK or similar printed techniques shall always be tested as a cross section.
      NOTE: even though large areas of single colour are available they are always likely to have been a mix of the CMYK colours.



    7. Components made from Metal, Glass or Ceramic materials that are Hasbro small parts as received or after testing, are subject to the limits of table 1 and table 2. Metal components that are not Hasbro small parts as received or after testing are only subject to the total Cadmium and Lead limits of table 1.



    8. Materials may be tested as a composite of no more than 3 materials, where analytically feasible to do so, for the total requirements. If any of the heavy metals are detected at levels that would exceed the limits if the weights were calculated individually (i.e. one third of the limit for three samples of equal weight) then individual retests are required.
      NOTE: due to the low limits specified, composite soluble testing may not be analytically feasible.



    9. All limit values in this specification are given in milligrams per kilogram mg/kg (parts per million or ppm).



    10. Screening testing to total levels may be utilized; when a total test result is determined to be lower than the soluble test action level (or required level if no action level is listed in table 2), then additional soluble testing is not required for compliance.



  2. REFERENCES



    1. 16 CFR 1303

    2. CPSIA Section 101

    3. Toys Safety Directive, 2009/48/EC

    4. Canada Consumer Product Safety Act (CCPSA)

    5. Canada Product Safety Reference Manual, Book 5 - Laboratory Policies and Procedures, Part B, Determination of Leachable Arsenic (As), Selenium (Se), Cadmium (Cd), Antimony (Sb), and Barium (Ba) in Applied Coatings

    6. ISO 8124

    7. ASTM F963

    8. EN71-3

    9. ASTM F2923

    10. 21 CFR 73, 74, 81, 82 and 700

    11. European Cosmetics Regulation EC No. 1233/2009



  1. REVISION LOG




Revision Letter

Section Revised

Revision Summary

By

Date














































APPENDIX 1 – Limit Values

Table 1 – Total heavy metal limits



Coatings




Action

Req

code

Pb

-

20

-

Sb

750

-

B

As

30

-

B

Ba

750

-

B

Se

750

-

B

Cd

30

40

A

Cr

500

750

A

Hg

-

<5

-


General materials




Action

Req

code

Pb

301

40

-

Sb

-

-

-

As

-

-

-

Ba

-

-

-

Se

-

-

-

Cd

30*

40*

A

Cr

500*

750*

A

Hg

-

<5*

-
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