ASTM F963-16 updates – Chemical part

Date: Oct., 2016

updates – Chemical part

Presenter Name: Dr. S.P. Chan

CPSIA Refresh01

Content

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ASTM F963-16 timeline

Chemical related updates in ASTM F963-16

Q&AQ&AQ&AQ&A

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CPSIA refresh

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CPSIA refresh

CPSIA text: www.cpsc.gov/cpsia.pdf

Signed into law on 14 August 2008.

• Sec. 101. Children’s products containing lead, lead paint rule.

• Sec. 102. Certification and Mandatory third party testing for certain children’s product.

CPSIA

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• Sec. 103. Tracking labels for children’s products.

• Sec. 104. Standards and consumer registration of durable nursery products.

• Sec. 105. Labeling requirement for advertising toys and games.

• Sec. 106. Mandatory toy safety standards.

• Sec. 108. Prohibition on sale of certain products containing specific phthalates.

Consumer product:any article produced or distributed for sale to a consumer for use in or around a household or school.

Children’s products: a consumer product designed or intended primarily for children 12 years of age or younger.

Key definitions

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Children’s toy: a consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays.

Childcare article: a consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.

• Lead in surface coating (paint)• 16 CFR 1303 from 600 ppm to 90 ppm on 14 Aug.

2009

• Lead in non-surface coating (substrates)

Sec. 101. Children’s products containing lead, lead paint rule

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• Lead in non-surface coating (substrates)• 600 ppm on 10 February 2009 • 300 ppm on 14 August 2009 • 100 ppm on 14 August 2011

ASTM F963-16 Timeline

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ASTM F963-16 Timeline

• 2 Feb 2009, ASTM F963-07 (except section 4.2 and annex 4) became mandatory toy safety standard.

• 16 Aug 2009, ASTM F963-08 became mandatory toy safety standard.

Sec 106 Mandatory Toys Safety Standard

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• 12 Jun 2012, ASTM F963-11 became mandatory toy safety standard.

• 20 Oct 2016 ASTM F963-16 published (US time)

• April 2017 ASTM F963-16 may become mandatory toy safety standard.

ASTM F963-16

20 Oct 2016 (US time)[Publication of revised

standard]

180 days after publication (April 2017)[The revised standard becomes mandatory]

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90 days after publication (Jan 2017)

[CPSC can fully or partially accept or reject

the revision]

https://www.cpsc.gov/Business--

Manufacturing/Testing-Certification/Lab-

Accreditation/Rules-Requiring-Third-Party-

Testing/

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Ref: https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Lab-Accreditation/Rules-Requiring-Third-Party-Testing/

Chemical related updates in ASTM

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Chemical related updates in ASTM F963-16

Component testing: explicitly states component testing is acceptable.

•Raw materials or components are accepted for compliance test

•It can established that the results obtained are representative of those which would be obtained by testing finished items.

1) the manufacturing process does not in any way affect the test results obtained; and

Heavy metals – Component testing

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obtained; and

2) the materials tested are representative of those in the final toy. For example, if the above conditions are met, it would be possible to demonstrate compliance with this standard for a surface coating by applying the coating to a clean glass plate, allowing it to dry, then testing the scraped-off material per section 8.3.1.

Need to consider:

1) Substitution of raw materials occurring during production;

2) Contamination of the raw material occurring during production (for example, spray guns contaminated by lead used to apply compliant paint thereby rendering it noncompliant, use of contaminated thinners or solvents to thin paint or clean silk screens, etc.);

Heavy metals – Component testing

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3) Migration of elements and their compounds from substrate (especially plasticized ones) to surface coating.

• While component testing is an entirely valid approach, care must be exercised to be certain that the production process subsequent to component testing does not create any change which might affect compliance.

Allowance of HD-XRF as procedure for total heavy metals testing for homogeneous polymeric materials.

Test for the 8 heavy metal content is allowed by using ASTM F2853 –10ɛ1 (X-ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams, commonly known as HDXRF)

Care must be taken in using this method.

Heavy metals – HD -XRF Screening

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Exemption clarification:

Exemptions in 16 CFR 1500.88 are applies to this standard. But it only applies for Total Lead and the soluble Lead content. The other 7 soluble heavy metals are not exempted. Except 7 Soluble elements are also exempts for paper.

Heavy metals – Exemption Clarification

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Details of paper exemption:

•Stickers which are printed on a plastic or other nonporous substrate or have a laminated plastic coating are to be tested as a single polymeric material.

•If scrapeable, the ink or other surface coating is tested as a surface coating and the underlying substrate is tested separately unless the substrate is exempt because it is composed of paper.

Exemption clarification:

•Pressure-sensitive adhesive applied to a porous substrate is not a surface coating (as defined in 16CFR1303.2(b)(1)] in that it does not dry to a solid film, but instead exists as viscous liquid. Due to the risk Since pressure-sensitive adhesives are not likely to contain appreciable amounts of any of the proscribed heavy elements, they are exempt from testing except when inseparable from and tested as part of a composite

Heavy metals – Exemption Clarification

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testing except when inseparable from and tested as part of a composite substrate.

•Printed textiles where the printing can be easily separated (for example, pigment prints, screen inks, etc.) should have the printed matter removed and tested separately

• as a surface coating,

• and the remaining textile substrate

•All other textiles, (such as unprinted/undyed fabrics, textiles) the entire material should be tested as a single item.

Removed reference to Pennsylvania stuffed toys regulation requirement. Simplified evaluation procedure to visual inspection using microscope under adequate illumination

Stuffing Cleanliness

Fiber Filler Test Item under Pennsylvania stuffed toy regulation

1. Materials that indicate prior use of a previous manufacturing

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1. Materials that indicate prior use of a previous manufacturing process

2. Dirt and foreign matter3. Oil and grease4. Lead (Pb) content5. Arsenic (As2O3) content6. Ammonia (NH3) content7. Urea content8. Plastic or metal ornaments9. Stones or other materials having jagged or sharp edges10. Electrostatic charge11. Rate of surface burning

• Added definition for cosmetics with refers to Federal Food, Drug, and Cosmetic Act (FD&C Act) and clarification that cosmetics intended for toys are within scope of the requirements.

• Cosmetic also includes temporary tattoos.

• Added cleanliness requirements for bird feathers

Cosmetic

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• Added cleanliness requirements for bird feathers

• Updated USP standard references for cleanliness of material to USP 35 <61> & <62>

• Preservative effectiveness testing is not required for products with a low likelihood of supporting microbial growth like anhydrous materials or materials with low water activity.

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