toy-safety-requirement

Toy Safety Requirement Demonstrate your commitment to safer toys TÜV SÜD Greater China

Contents  Introduction............................................................................ 3  Highlights of Toy Related Requirements in EU and US......... 4  Appendix 1 - Physical and Mechanical Requirements Highlight (EU and US)........................................................... 10  Appendix 2 - Labeling Requirement (EU and US)............. 12  Appendix 3 - Migration of Certain Elements Requirements (EU and US)............................................................................ 16  Appendix 4 - Organic Chemical Compounds in EU Toys. 18  Appendix 5 - Phthalates Requirements (EU and US)....... 22  Appendix 6 - Heavy Metals requirement in Packaging Materials (EU and US).......................................................... 24  Global Toy Standards............................................................ 26  TÜV SÜD Certification Mark for Toy................................... 30 TÜV SÜD offers a one-stop solution for testing, auditing, certification and advisory on regulatory testing standards for the toy industry. Our global network of accredited laboratories provides testing services in line with the various regulatory standards and directives. We can support you from the beginning of the product lifecycle, starting at the design stage prior to prototyping. This, combined with our in-depth understanding of standards, enables you to achieve safety compliance and save on costly rework. 2

Introduction The European Union and the United States are two major markets for toys. To protect children’s health playing with toys, their toy safety requirements are comparatively more stringent than other countries or regions. While there are overlap in the toy regulatory requirements in the EU and US, there are also some differences in scope and limits. This leaflet will provide you an overview with comparison of some highlighted requirements in these two markets. For example the reporting obligation in the EU, if an article contains any substances of very high concern (SVHC) on the candidate list exceeding 0.1 % by weight, the supply chain communication is required. In case the tonnage threshold of such SVHC is over 1 tonne / year, then notification to the European Chemical Agency (ECHA) may also be required. In the US, there is similar reporting obligation of hazardous substances in children’s products in Washington, Maine, Vermont and Oregon states. If you operate a business in California and your products may expose Californians to any chemical that are listed under Proposition 65, you should provide clear and reasonable warnings on the products or pass along the written notice with warning materials. The EU requires toys to comply with Toy Safety Directive 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. 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: Cadmium Limit: 500 mg/kg Surface coating: 90 mg/kg Substrate: 100 mg/kg Phthalates (See Appendix 5) Azo dyes REACH Annex XVII – Entry 23 ASTM F963-17 PAHs 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. REACH Annex XVII – Entry 51, 52 CPSIA, section 108, 16 CFR 1307 REACH Annex XVII – Entry 43 – Textile and leather: 30 mg/kg – 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 – Benzene Nickel Release Limit: 1000 mg/kg – REACH Annex XVII – Entry 5 Flame-retardants Limit: 5 mg/kg ASTM F2923-14 for children’s jewellery REACH Annex XVII – Entry 27 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 Restricted in various States including i) Toy Directive 2009/48/EC Appendix C* California, Washington, New York, Limit: 5 mg/kg each of TCEP, TCPP, TDCP Minnesota, Vermont, etc.

Bisphenol A ii) REACH Regulation (EC) No 1907/2006, Restricted in various States including Phenol Annex XVII Entries 4, 7, 8 California, Vermont, Minnesota, etc. Textile articles: Not used – Formamide Toy Directive 2009/48/EC Appendix C* Limit: 0.04 mg/l – 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) 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

Toy standard for electric toy safety EN 62115 ii) Various State Laws also restricted mercury content in button cells Microbiological safety Toy Directive 2009/48/EC ASTM F963-17 Toxicological Risk Assessment Toy Directive 2009/48/EC ASTM F963-17 (TRA) ASTM F963-17 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) Abuse test Torque test – 0 to ≤ 18 > 18 to ≤ 36 > 36 to ≤ 96 Tension test 0.34 Nm 2 in-lbf 3 in-lbf 4 in-lbf Compression test Accessible Dimension ≤ 6 mm : 50 N 10 lbf 15 lbf 15 lbf Drop test Accessible Dimension > 6 mm : 90 N Tip over test (for large Protective components : 60 N and bulky toys) Seams: 70 ± 2 N Flexure test 110 N 20 lbf 25 lbf 30 lbf 850 mm x 5 times 4.5 ft x 10 times 3.0 ft x 4 times 3.0 ft x 4 times 3 times 3 times 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 6 steps for 4 attitudes x 2 times tip over Tumble test for wheeled N/A toys (for toy weight between 3-10 lb) Bite test (for mouth toys) N/A 25 lbf 50 lbf 100 lbf N/A Soaking test (For glued At 20℃ for 4 min x 4 times wooden toys & glued plastic decals) 11

Appendix 2 - Labeling Requirements (EU) General information Toy shall bear  the name and address of Manufacturer and/or Importer  the product identification: type, batch, serial or model number or other element allowing their identification CE mark The CE marking shall be affixed visibly, legibly and indelibly to the toy, to an affixed label or to the packaging. The CE marking shall be at least 5 mm high and shall consist of the initials 'CE' taking the following form. Warning Statement Small part warning Toys which are not intended for but might be dangerous for children under 36 months shall be accompanied by a warning, such as: \"Warning. Not suitable for children under 36 months\" or \"Warning. Not suitable for children under three years\" together with a brief indication of the specific hazard calling for this restriction. Example: \"Warning. Not suitable for children under 36 months. Small parts\" The phrase: \"Not suitable for children under 36 months\" or \"Not suitable for children under three years\" may be substituted by the symbol as follow: 12

Labeling Requirements (US) CPSIA Tracking label Children’s products that are designed or intended primarily for use by children ages 12 or younger must have distinguishing permanent marks that are  Affixed to the product and its packaging and  Provide certain identifying information. ALL tracking labels must contain certain basic information, including: 1. Manufacturer or private labeler name; 2. Location and date of production of the product; 3. Detailed information on the manufacturing process, such as a batch or run number, or other identifying characteristics; and 4. Any other information to facilitate ascertaining the specific source of the product. 13

ASTM F963-17 Warning statement Safety labeling shall consist of: 1. an alert symbol (an exclamation mark within an equilateral triangle); 2. a signal word (CAUTION or WARNING); 3. text that describes the hazard that is present. and may contain text about what to do or not to do to avoid injury (e.g. “Keep out of baby’s reach”). All labeling statements shall comply with the type size requirements based on the computed area of the principal display panel according to the standard. For these purposes, Signal Word means the word “Warning” and the words “Safety Warning”; Statement of Hazard means “Choking Hazard”; Other Material means all other remaining statements. Area, in.2 0-2 +2-5 +5-10 +10-15 +15-30 +30-100 +100-400 +400 Type Size— 3 64in. 1 16 in. 3 32 in. 7 64 in. 1 8 in. 5 32in. 1 4 in. 1 in. Signal 3 64 in. 3 64 in. 116 in. 3 32 in. 3 32 in. 7 64in. 5 32 in. 2 Word 1 32 in. 3 64 in. 116 in. 116 in. 5 64 in. 3 32 in. 7 64 in. 1 4 in. Type Size— Statement 5 32in. of Hazard Type Size— Other Material Small part warning For toys and games intended for children at least 3 years old but less than 6 years of age, and which contain as-received small part(s), the labeling shall read: WARNING: CHOKING HAZARD—Small parts. Not for children under 3 yrs. 14

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Appendix 3 - Migration of Certain Elements Requirements of EN-71-3 & ASTM F963 The European Commission set out the migration limit values for 19 elements for different toy materials under Toy Safety Directive, and the harmonised standard EN 71-3 adopted the same set of limits. The limit values are revised from time to time depending on the latest scientific research outcome. EN 71-3:2013+A3:2018 (mg/kg) ELEMENTS CAT. 1 CAT. 2 dry, brittle, powder-like or liquid or sticky toy Aluminium pliable toy material material Antimony 5625 1406 Arsenic 45 11.3 Barium 3.8 0.9 Boron 1500 375 Cadmium 1200 300 Chromium 1.3 0.3 Chromium (III) - - Chromium (VI) 37.5 9.4 Cobalt 0.02 0.005 Copper 10.5 2.6 Lead 622.5 156 Manganese 2.0 0.5 Mercury 1200 300 Nickel 7.5 1.9 Selenium 75 18.8 Strontium 37.5 9.4 Tin 4500 1125 Organic tin 15000 3750 Zinc 0.9 0.2 3750 938 ** To be effective from 18 November 2019. 16

In the United States, the limits for 8 soluble heavy metals are laid down in the toy standard ASTM F963 mandated under Consumer Product Safety Improvement Act (CPSIA). ASTM F963-17 (mg/kg) CAT. 3 GENERAL MODELLING CLAY scraped-off toy material 70000 - - 560 60 60 47 25 25 18750 1000 250 15000 - - 17 75 50 - 60 25 460 - - 0.2 / 0.053** - - 130 - - 7700 - - 23 90 90 15000 - - 94 60 25 930 - - 460 500 500 56000 - - 180000 - - 12 - - 46000 - - 17

Appendix 4 - Organic Chemical Compounds in EU Toys The European standard EN 71 part 9 sets out requirements for certain organic chemical compounds in specific toys and toy materials. The requirements are determined by evaluating the relative toxicity of the substances and the exposure scenarios EN 71-9:2005+A1:2007 SPECIFIC TOY / TOY COMPONENT TOY FLAME RETARDANTS MATERIAL COLOURANTS PRIMARY AROMATIC AMINES 1 Toys intended to be mouthed Polymeric# by children under 3 years of age 2 Toys, or accessible toy Polymeric# Wood 3 components, with a mass of √√ 150 g or less intended to be 4 played with in the hands by Paper √√ children under 3 years of age 5 Toys and accessible Textiles √√√ Leather √√ 6 components of toys intended Wood for children under 3 years 7 of age 8 Paper 9 Mouthpiece components of Polymeric# √√ 10 mouth-actuated toys Wood 11 Paper √√ Inflatable toys with a surface Polymeric# √√ 12 greater than 0.5 sq.m when Polymeric# fully inflated Textile 13 Toys worn over the mouth or 14 nose 15 Paper √√ 16 Toys which the child can enter Polymeric# # Excluding polymeric coatings with a thickness of less than 500 µm 18

of different types of toys. These organic chemical compounds include solvents, preservatives, plasticisers, flame retardants, monomers, biocides, processing aids and colouring agents. The corresponding sample preparation and methods of analysis are specified in EN 71 part 10 and part 11. LIMIT TABLE MONOMERS SOLVENTS- MIGRATION SOLVENTS- INHALATION WOOD PRESERVATIVES WOOD PRESERVATIVES PRESERVATIVES PLASTICISERS FORMALDEHYDE PH VALUE TRA √√ √ √√ √√ √ √√ √ √ √ √ √ √ √ √√ √ √√ √ √ 19

Organic Chemical Compounds in EU Toys (Con't) EN 71-9:2005+A1:2007 SPECIFIC TOY / TOY COMPONENT TOY FLAME RETARDANTS MATERIAL COLOURANTS PRIMARY AROMATIC AMINES 17 Toys which the child can enter Textile Components of graphic Polymeric# 18 instruments sold as toys or used in toys 19 Toys and accessible components Wood of toys for indoor use Toys and accessible 20 components of toys for outdoor Wood use 21 Toys and components of toys Polymeric# which mimic food 22 Solid toy materials intended to All √√ leave a trace √√ 23 Coloured accessible liquids in Liquid √√ toys √√ √√ 24 Non-coloured accessible Liquid liquids in toys 25 Inaccessible liquids in toys Liquid Modelling clay, play clay and 26 similar, except those chemical All toys addressed by EN 71-5 27 Balloon-making compounds All 28 Imitation tattoos with adhesive All 29 Imitation jewellery Polymeric# # Excluding polymeric coatings with a thickness of less than 500 µm ^ Ink intended to be applied on writing device is not include R Recommended only 20

√ √ MONOMERS √ √√ SOLVENTS- MIGRATION √√ SOLVENTS- INHALATION √√ WOOD PRESERVATIVES √ WOOD PRESERVATIVES LIMIT TABLE √√ PRESERVATIVES PLASTICISERS √ √ FORMALDEHYDE √ PH VALUE √ TRA √ √ √ 21 √^ √ √^ √ R

Appendix 5 - Phthalates Requirements in EU and US Phthalates are generally used as plasticisers and could be found as impurities. However, they are known to reduce fertility and can be very harmful to children. Currently in the EU, the use of 7 phthalates in toys and childcare articles is restricted under REACH Regulation (EC) No 1907/2006. In the United States, there are 8 phthalates being prohibited in toys and childcare articles under CPSC regulations. The final rule 16 CFR 1308 determines that seven specified plastics as follows are exempted from third party testing. Comparison of regulated phthalates in EU and US CHEMICAL NAME ABBREVIATION Bis (2-ethylhexyl) phthalate DEHP Dibutyl phthalate DBP Benzyl butyl phthalate BBP Di-isodecyl phthalate DIDP Di-n-octyl phthalate DNOP/DnOP Diisononyl phthalate DINP Diisobutyl phthalate DIBP Di-n-hexyl phthalate DnHP/DHP/DHEXP Dipentyl phthalate DPP/DPENP Dicyclohexyl phthalate DCHP Scope and limit of phthalates for toys and childcare articles Country/ Region Scope Any plasticised material EU Any plasticised material that can be placed into mouth US Any phthalates-containing material 22

However, Manufacturer still have to ensure that these plastics meet the phthalates requirement. 1. Polypropylene (PP) 2. Polyethylene (PE) 3. Acrylonitrile butadiene styrene (ABS) 4. High-impact polystyrene (HIPS) 5. General purpose polystyrene (GPPS) 6. Medium-impact polystyrene (MIPS) 7. Super high-impact polystyrene (SHIPS) EU US CPSIA 108/ 16 CFR 1307 REACH Annex XVII √ √ √ √ √ √ √ √ √ √ √ √ √ √ √ Phthalate Limit DEHP, DBP, BBP, DIBP 0.1% by weight DINP, DIDP, DNOP (sum or individual) DEHP, DBP, BBP, DINP, DIBP, DPENP, 0.1% by weight (individual) DHEXP, DCHP 23

Appendix 6 - Heavy Metals in Packaging Materials Apart from the product, the toxicity of the packaging material is also a concern. In order to reduce the impact from packaging and packaging waste to the environment, the restriction of heavy metals in packaging material are laid down in EU Directive 94/62/EC and Toxic Elements in Packaging Components (TPCH) in the United States. 24

Summary table of heavy metals in packaging material in EU and US EU US Toxic elements Directive 94/62/EC Toxics in Packaging Clearinghouse Pb, Cd, Hg and Sum of four elements: ≤ 100 ppm Chromium (VI) 25

Global Toy Standards Certification Country S-mark / Type Approval / Lot Argentina Approval Australia and New Zealand RCM (only for electrical toys) Brazil INMETRO Canada No scheme China CCC-mark Chile No scheme Colombia No scheme Customs Union EAC (Belarus, Kazakhstan, Russia, Armenia & Kyrgyzstan) Hong Kong No scheme India COC Israel SII Type Approval Japan ST-mark (for all toys) PSE mark (for electrical toys) Korea KC-mark Malaysia MC-mark 26

Highlights of Toy Standard / Legislation IRAM NM 300 AS/NZS ISO 8124 AS/NZS 62115 (voluntary in Australia but mandatory in New Zealand) ABNT NBR NM 300 ABNT NBR 16040 SOR/2011-17 SOR/2016-188 SOR/2018-83 GB 14746 - 14749 GB 6675 GB 19865 NCh3251 Decree No. 114/2005 Toy Resolution No. 686/2018 CU (TR TC 008/2011) ISO 8124 / EN 71 / ASTM F963 IEC 62115 or EN 62115 IS 9873 IS 15644 SI 562 SI 62115 ST-2016 Appendix 8 (PSE diamond mark) IEC60335-2-82 (PSE circle mark) Safety Confirmation Safety Standard Annex 6; Self-Regulatory Safety Confirmation Act Annex 36 MS ISO 8124 MS 1774 MS 62115 27

Global Toy Standards (Con't) Certification Country Mexico NOM-mark Philippines COC Saudi Arabia SASO COC and GCC GCC GSO (Saudi Arabia, GCTS-mark Kuwait, Oman, Qatar, UAE, No scheme Bahrain, Yemen) No scheme Singapore South Africa Taiwan BSMI-mark / RPC (II + III) Thailand TISI Vietnam CR-mark 28

Highlights of Toy Standard / Legislation NOM-015-SCFI-2007 NOM-252-SSA1-2011 NMX-J-175/1-ANCE-2005 PNS/ISO 8124 PNS 1408 IEC 62115 SASO 1063 - 1065 SASO 573 IEC 62115 TR BD131704-01 Consumer Good Safety Regulations (CGSR) SANS 8124 IEC 62115 CNS 4797 CNS 14276 CNS 15503 TIS 684 2549 TIS 685 TCVN 6238 QCVN 03:2009/BKHCN 29

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