Toy Safety Requirement Demonstrate Your Commitment to Safer Toys
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Toy Safety Requirement Demonstrate your commitment to safer toys TÜV SÜD Greater China Introduction Contents The European Union and the United States are two major markets for toys. To protect children’s health playing with . Introduction............................................................................ 3 toys, their toy safety requirements are comparatively more . Highlights of Toy Related Requirements in EU and US......... 4 stringent than other countries or regions. While there are . Appendix 1 - Physical and Mechanical Requirements overlap in the toy regulatory requirements in the EU and Highlight (EU and US)........................................................... 10 . Appendix 2 - Labeling Requirement (EU and US)............. 12 US, there are also some differences in scope and limits. Appendix 3 - Migration of Certain Elements Requirements This leaflet will provide you an overview with comparison of (EU and US)............................................................................ 16 some highlighted requirements in these two markets. Appendix 4 - Organic Chemical Compounds in EU Toys. 18 . Appendix 5 - Phthalates Requirements (EU and US)....... 22 For example the reporting obligation in the EU, if an article . Appendix 6 - Heavy Metals requirement in Packaging contains any substances of very high concern (SVHC) on the Materials (EU and US).......................................................... 24 candidate list exceeding 0.1 % by weight, the supply chain . Global Toy Standards............................................................ 26 communication is required. In case the tonnage threshold . TÜV SÜD Certification Mark for Toy................................... 30 of such SVHC is over 1 tonne / year, then notification to the European Chemical Agency (ECHA) may also be required. TÜV SÜD offers a one-stop solution for testing, auditing, In the US, there is similar reporting obligation of hazardous certification and advisory on regulatory testing standards substances in children’s products in Washington, Maine, for the toy industry. Our global network of accredited Vermont and Oregon states. If you operate a business in laboratories provides testing services in line with the California and your products may expose Californians to any various regulatory standards and directives. We can chemical that are listed under Proposition 65, you should support you from the beginning of the product lifecycle, provide clear and reasonable warnings on the products or pass starting at the design stage prior to prototyping. This, along the written notice with warning materials. combined with our in-depth understanding of standards, enables you to achieve safety compliance and save on The EU requires toys to comply with Toy Safety Directive costly rework. 2009/48/EC and other relevant chemical regulations. Manufacturers can use the internal product control procedure or test their products at a third party laboratory to demonstrate the compliance. Looking back at the US market, toys must be certified by a CPSC-accepted third party laboratory unless the materials are exempted by the regulations. In this leaflet, we highlighted essential toy requirements in the EU and the US. Certain test parameters with high market concern are elaborated and compared in later appendix. 2 3 4 Highlights of Toy Related Requirements in EU and US TEST ITEM EU US Physical & Mechanical, Labeling EN 71-1:2014+A1:2018 ASTM F963-17 (See Appendix 1, 2) Cleanliness of Stuffing Material EN 71-1:2014+A1:2018 ASTM F963-17 There are also requirements in States Pennsylvania, Massachusetts, Ohio. Flammability EN 71-2:2011+A1:2014 ASTM F963-17 Soluble elements (See Appendix 3) EN 71-3:2013+A3:2018 ASTM F963-17 Organic chemical compounds EN 71-9:2005+A1:2007 – (See Appendix 4) Nitrosamines and nitrosatable EN 71-12:2013* ASTM F963-17 / ASTM F1313-90 (R2011) substances Limit: A test sample of nipples shall not contain i) Nitrosamines: 0.05 mg/kg for elastomer; more than 10 ppb in each of three aliquots 0.02 mg/kg for finger paint of any one nitrosamine. In addition, the total ii) Nitrosable substances: 1 mg/kg for nitrosamines shall not exceed 20 ppb. elastomer and finger paint Total Lead REACH Annex XVII – Entry 63 Total lead in CPSIA section 101, ASTM F963 jewelry Limit: Limit: 500 mg/kg Surface coating: 90 mg/kg Substrate: 100 mg/kg Cadmium REACH Annex XVII – Entry 23 ASTM F963-17 Limit: Limit: i) Plastic, paint, jewelry, hair accessories: i) Soluble cadmium for accessible 100 mg/kg; substrates: 75 mg/kg; ii) Painted articles: 1000 mg/kg ii) Soluble cadmium for small part metal: 200 µg unless total content < 75 mg/kg. Phthalates (See Appendix 5) REACH Annex XVII – Entry 51, 52 CPSIA, section 108, 16 CFR 1307 Azo dyes REACH Annex XVII – Entry 43 – Textile and leather: 30 mg/kg PAHs REACH Annex XVII – Entry 50 – 5 Limit: 0.5 mg/kg 6 Highlights of Toy Related Requirements in EU and US (Con’t) TEST ITEM EU US Organotin compounds REACH Annex XVII – Entry 20 – Limit: 1000 mg/kg Benzene REACH Annex XVII – Entry 5 – Limit: 5 mg/kg Nickel Release REACH Annex XVII – Entry 27 ASTM F2923-14 for children’s jewellery Limit: Limit: i) Body piercing components: 0.2 µg/cm2/ i) Body piercing components: 0.2 µg/cm2/ week; week. ii) Parts with direct and prolonged skin ii) Parts with direct and prolonged skin contact: 0.5 µg/cm2/week contact: 0.5 µg/cm²/week. Flame-retardants i) Toy Directive 2009/48/EC Appendix C* Restricted in various States including Limit: 5 mg/kg each of TCEP, TCPP, TDCP California, Washington, New York, Minnesota, Vermont, etc. ii) REACH Regulation (EC) No 1907/2006, Annex XVII Entries 4, 7, 8 Textile articles: Not used Bisphenol A Toy Directive 2009/48/EC Appendix C* Restricted in various States including Limit: 0.04 mg/l California, Vermont, Minnesota, etc. Phenol Toy Directive 2009/48/EC Appendix C* – i) Polymeric materials Limit: 5 mg/l (migration limit); ii) Aqueous toy materials Limit: 10 mg/kg (content limit) Formamide Toy Directive 2009/48/EC Appendix C* – Limit: 200 mg/kg (content limit) If content limit is exceeded, shall perform emission testing for a maximum of 28 days from commencement. Limit: 20 µg/m3 (emission limit) 7 * Only applicable to toys or parts of toys intended for use by children under 36 months or intended to be placed in the mouth." 8 Highlights of Toy Related Requirements in EU and US (Con't) TEST ITEM EU US Short-chain chlorinated paraffins REGULATION (EC) No 850/2004 (POPs) Reporting obligation of chemicals of (SCCPs) Limit: 0.15 % by weight in articles concern in children products: Washington and Oregon Preservatives (BIT, Reaction mass Toy Directive 2009/48/EC Appendix C* – of CMI and MI (3:1), CMI, MI) Limit: BIT: 5 mg/kg CMI: 0.75 mg/kg MI: 0.25 mg/kg CMI and MI in a ratio of 3:1(Katone): 1 mg / kg Hazardous substances in electrical RoHS Directive 2011/65/EU California State has adopted regulations and electronic equipment restricting heavy metals in certain electronic devices, in line with EU RoHS Battery Directive 2006/66/EC i) US Public Law 104–142, Mercury- Containing and Rechargeable Battery Management Act ii) Various State Laws also restricted mercury content in button cells Toy standard for electric toy safety EN 62115 ASTM F963-17 Microbiological safety Toy Directive 2009/48/EC ASTM F963-17 Toxicological Risk Assessment Toy Directive 2009/48/EC ASTM F963-17 (TRA) 16 CFR 1500.3 (b)(5) and 1500.3 (b)(7)-(9) LHAMA evaluation in art materials – 16 CFR 1500.14(b)(8) ASTM D4236-94(2016)e1 Heavy metals in packaging material Directive 94/62/EC Toxics in Packaging Clearinghouse (See Appendix 6) *Only applicable to toys or parts of toys intended for use by children under 36 months or intended to be placed in the mouth. 9 10 Appendix 1 - Physical and Mechanical Requirements Highlight (EU and US ) TEST ITEM EU (EN 71-1:2014+A1:2018) US (ASTM F963-17, 16 CFR 1500.51-53) Age grade (months) – 0 to ≤ 18 > 18 to ≤ 36 > 36 to ≤ 96 Abuse test Torque test 0.34 Nm 2 in-lbf 3 in-lbf 4 in-lbf Tension test Accessible Dimension ≤ 6 mm : 50 N 10 lbf 15 lbf 15 lbf Accessible Dimension > 6 mm : 90 N Protective components : 60 N Seams: 70 ± 2 N Compression test 110 N 20 lbf 25 lbf 30 lbf Drop test 850 mm x 5 times 4.5 ft x 10 times 3.0 ft x 4 times 3.0 ft x 4 times Tip over test (for large 3 times 3 times and bulky toys) Flexure test Metallic wires and other metallic 10 lbf x 30 15 lbf x 30 15 lbf x 30 components that are designed and cycles cycles cycles intended to be bent: ≤ 70 N x 30 cycles Metallic wires likely to be bent: ≤ 70 N x 1 cycle Impact test 1 kg from height of 100 mm N/A Tumble test for wheeled N/A 6 steps for 4 attitudes x 2 times tip over toys (for toy weight between 3-10 lb) Bite test (for mouth toys) N/A 25 lbf 50 lbf 100 lbf Soaking test (For glued At 20℃ for 4 min x 4 times N/A wooden toys & glued plastic decals) 11 Appendix 2 - Labeling Requirements (EU) Labeling Requirements (US) General information CPSIA Toy shall bear Tracking label . the name and address of Manufacturer and/or Importer Children’s products that are designed or intended . the product identification: type, batch, serial or model primarily for use by children ages 12 or younger must have number or other element allowing their identification distinguishing permanent marks that are . Affixed to the product and its packaging and CE mark . Provide certain identifying information. The CE marking shall be affixed visibly, legibly and indelibly to the toy, to an affixed label or to the packaging.