ASTM F updates Chemical part

Transcription

1 ASTM F updates Chemical part Presenter Name: Dr. S.P. Chan Date: Oct., 2016

2 Content CPSIA Refresh ASTM F timeline Chemical related updates in ASTM F Q&A 2

3 CPSIA refresh 3

4 CPSIA CPSIA text: Signed into law on 14 August Sec Children s products containing lead, lead paint rule. Sec Certification and Mandatory third party testing for certain children s product. Sec Tracking labels for children s products. Sec Standards and consumer registration of durable nursery products. Sec Labeling requirement for advertising toys and games. Sec Mandatory toy safety standards. Sec Prohibition on sale of certain products containing specific phthalates. 4

5 Key definitions 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. 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. 5 5

6 Sec Children s products containing lead, lead paint rule Lead in surface coating (paint) 16 CFR 1303 from 600 ppm to 90 ppm on 14 Aug Lead in non-surface coating (substrates) 600 ppm on 10 February ppm on 14 August ppm on 14 August

7 ASTM F Timeline 7

8 Sec 106 Mandatory Toys Safety Standard 2 Feb 2009, ASTM F (except section 4.2 and annex 4) became mandatory toy safety standard. 16 Aug 2009, ASTM F became mandatory toy safety standard. 12 Jun 2012, ASTM F became mandatory toy safety standard. 20 Oct 2016 ASTM F published (US time) April 2017 ASTM F may become mandatory toy safety standard. 8 8

9 ASTM F Oct 2016 (US time) [Publication of revised standard] 180 days after publication (April 2017) [The revised standard becomes mandatory] 90 days after publication (Jan 2017) [CPSC can fully or partially accept or reject the revision] Manufacturing/Testing-Certification/Lab- Accreditation/Rules-Requiring-Third-Party- Testing/ 9

10 Ref: Business-- Manufacturing/Testin g-certification/lab- Accreditation/Rules- Requiring-Third- Party-Testing/ 10

11 Chemical related updates in ASTM F

12 Heavy metals Component testing 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 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

13 Heavy metals Component testing 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.); 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

14 Heavy metals HD-XRF Screening 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 F ɛ1 (X-ray Fluorescence Spectrometry Using Multiple Monochromatic Excitation Beams, commonly known as HDXRF) Care must be taken in using this method

15 Heavy metals Exemption Clarification Exemption clarification: Exemptions in 16 CFR 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. 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

16 Heavy metals Exemption Clarification 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 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

17 Stuffing Cleanliness Removed reference to Pennsylvania stuffed toys regulation requirement. Simplified evaluation procedure to visual inspection using microscope under adequate illumination Fiber Filler Test Item under Pennsylvania stuffed toy regulation 1. Materials that indicate prior use of a previous manufacturing process 2. Dirt and foreign matter 3. Oil and grease 4. Lead (Pb) content 5. Arsenic (As 2 O 3 ) content 6. Ammonia (NH 3 ) content 7. Urea content 8. Plastic or metal ornaments 9. Stones or other materials having jagged or sharp edges 10. Electrostatic charge 11. Rate of surface burning 17 17

18 Cosmetic 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 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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