Toy Safety Requirement Demonstrate Your Commitment to Safer Toys

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. The CE ALL tracking labels must contain certain basic information, marking shall be at least 5 mm high and shall consist of the including: initials 'CE' taking the following form. 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.

arning 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 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— Signal 3 1 3 7 1 5 1 1 64in. 16in. 32 in. 64 in. in. 32in. 4 in. 2 in. Word 8 Type Size— Statement 3 3 1 3 3 7 5 1 64 in. 64 in. 16 in. 32 in. 32 in. 64in. 32 in. 4 in. of Hazard Type Size— Other 1 3 1 1 5 3 7 5 32 in. 64 in. 16 in. 16 in. 64 in. 32 in. 64 in. 32in. 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 15 Appendix 3 - Migration of Certain Elements Requirements of EN-71-3 & ASTM F963 The European Commission set out the migration limit values In the United States, the limits for 8 soluble heavy metals are for 19 elements for different toy materials under Toy Safety laid down in the toy standard ASTM F963 mandated under Directive, and the harmonised standard EN 71-3 adopted the Consumer Product Safety Improvement Act (CPSIA). 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) ASTM F963-17 (mg/kg)

ELEMENTS CAT. 1 CAT. 2 CAT. 3 GENERAL MODELLING CLAY dry, brittle, powder-like or liquid or sticky toy scraped-off toy material pliable toy material material Aluminium 5625 1406 70000 - - Antimony 45 11.3 560 60 60 Arsenic 3.8 0.9 47 25 25 Barium 1500 375 18750 1000 250 Boron 1200 300 15000 - - Cadmium 1.3 0.3 17 75 50 Chromium - - - 60 25 Chromium (III) 37.5 9.4 460 - - Chromium (VI) 0.02 0.005 0.2 / 0.053** - - Cobalt 10.5 2.6 130 - - Copper 622.5 156 7700 - - Lead 2.0 0.5 23 90 90 Manganese 1200 300 15000 - - Mercury 7.5 1.9 94 60 25 Nickel 75 18.8 930 - - Selenium 37.5 9.4 460 500 500 Strontium 4500 1125 56000 - - Tin 15000 3750 180000 - - Organic tin 0.9 0.2 12 - - Zinc 3750 938 46000 - -

** To be effective from 18 November 2019.

16 17 Appendix 4 - Organic Chemical Compounds in EU Toys of different types of toys. These organic chemical compounds The European standard EN 71 part 9 sets out requirements for include solvents, preservatives, plasticisers, flame retardants, certain organic chemical compounds in specific toys and toy monomers, biocides, processing aids and colouring agents. materials. The requirements are determined by evaluating the The corresponding sample preparation and methods of relative toxicity of the substances and the exposure scenarios analysis are specified in EN 71 part 10 and part 11.

EN 71-9:2005+A1:2007

LIMIT TABLE

TOY SPECIFIC TOY / TOY COMPONENT MATERIAL FLAME RETARDANTS COLOURANTS PRIMARY AROMATIC AMINES MONOMERS MIGRATION SOLVENTS- INHALATION SOLVENTS- WOOD PRESERVATIVES WOOD PRESERVATIVES PRESERVATIVES PLASTICISERS FORMALDEHYDE PH VALUE TRA Toys intended to be mouthed 1 Polymeric# √ √ √ by children under 3 years of age 2 Toys, or accessible toy Polymeric# √ √ √ components, with a mass of 3 150 g or less intended to be Wood √ √ √ √ √ played with in the hands by 4 Paper √ √ √ children under 3 years of age 5 Toys and accessible Textiles √ √ √ √ components of toys intended 6 for children under 3 years Leather √ √ √ 7 of age Wood √ 8 Paper √ 9 Mouthpiece components of Polymeric# √ √ √ mouth-actuated toys 10 Wood √ √ √ √ 11 Paper √ √ Inflatable toys with a surface 12 greater than 0.5 sq.m when Polymeric# √ fully inflated 13 Toys worn over the mouth or Polymeric# √ √ nose 14 Textile √ √ √ 15 Paper √ √ 16 Toys which the child can enter Polymeric# √

# Excluding polymeric coatings with a thickness of less than 500 µm

18 19 Organic Chemical Compounds in EU Toys (Con't)

EN 71-9:2005+A1:2007

LIMIT TABLE

TOY SPECIFIC TOY / TOY COMPONENT MATERIAL FLAME RETARDANTS COLOURANTS PRIMARY AROMATIC AMINES MONOMERS MIGRATION SOLVENTS- INHALATION SOLVENTS- WOOD PRESERVATIVES WOOD PRESERVATIVES PRESERVATIVES PLASTICISERS FORMALDEHYDE PH VALUE TRA 17 Toys which the child can enter Textile √ Components of graphic 18 instruments sold as toys or Polymeric# √ √ √ used in toys Toys and accessible components 19 Wood √ √ √ of toys for indoor use Toys and accessible 20 components of toys for outdoor Wood √ use Toys and components of toys 21 Polymeric# √ √ which mimic food Solid toy materials intended to 22 All √ √ leave a trace Coloured accessible liquids in 23 Liquid √ √ √ √ ^ √ toys Non-coloured accessible 24 Liquid √ √ ^ √ liquids in toys 25 Inaccessible liquids in toys Liquid R 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 21 Appendix 5 - Phthalates Requirements in EU and US However, Manufacturer still have to ensure that these Phthalates are generally used as plasticisers and could be plastics meet the phthalates requirement. found as impurities. However, they are known to reduce fertility and can be very harmful to children. Currently in the 1. Polypropylene (PP) EU, the use of 7 phthalates in toys and childcare articles is 2. Polyethylene (PE) restricted under REACH Regulation (EC) No 1907/2006. 3. Acrylonitrile butadiene styrene (ABS) 4. High-impact polystyrene (HIPS) In the United States, there are 8 phthalates being prohibited 5. General purpose polystyrene (GPPS) in toys and childcare articles under CPSC regulations. 6. Medium-impact polystyrene (MIPS) The final rule 16 CFR 1308 determines that seven specified 7. Super high-impact polystyrene (SHIPS) plastics as follows are exempted from third party testing.

Comparison of regulated phthalates in EU and US

EU US CHEMICAL NAME ABBREVIATION REACH Annex XVII CPSIA 108/ 16 CFR 1307 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 Phthalate Limit

Any plasticised material DEHP, DBP, BBP, DIBP 0.1% by weight EU Any plasticised material that can be placed (sum or individual) DINP, DIDP, DNOP into mouth DEHP, DBP, BBP, DINP, DIBP, DPENP, US Any phthalates-containing material 0.1% by weight (individual) DHEXP, DCHP

22 23 Appendix 6 - Heavy Metals in Packaging Materials Summary table of heavy metals in packaging material in Apart from the product, the toxicity of the packaging EU and US material is also a concern. In order to reduce the impact EU US from packaging and packaging waste to the environment, the restriction of heavy metals in packaging material are Toxics in Packaging Toxic elements Directive 94/62/EC laid down in EU Directive 94/62/EC and Toxic Elements in Clearinghouse Packaging Components (TPCH) in the United States. Pb, Cd, Hg and Sum of four elements: ≤ 100 ppm Chromium (VI)

24 25 Global Toy Standards

Country Certification Highlights of Toy Standard / Legislation S-mark / Type Approval / Lot Argentina IRAM NM 300 Approval AS/NZS ISO 8124 Australia and New Zealand RCM (only for electrical toys) AS/NZS 62115 (voluntary in Australia but mandatory in New Zealand) ABNT NBR NM 300 Brazil INMETRO ABNT NBR 16040 SOR/2011-17 Canada No scheme SOR/2016-188 SOR/2018-83 GB 14746 - 14749 China CCC-mark GB 6675 GB 19865 NCh3251 Chile No scheme Decree No. 114/2005 Colombia No scheme Toy Resolution No. 686/2018 Customs Union (Belarus, Kazakhstan, Russia, EAC CU (TR TC 008/2011) Armenia & Kyrgyzstan) ISO 8124 / EN 71 / ASTM F963 Hong Kong No scheme IEC 62115 or EN 62115 IS 9873 India COC IS 15644 SI 562 Israel SII Type Approval SI 62115 ST-2016 ST-mark (for all toys) Japan Appendix 8 (PSE diamond mark) PSE mark (for electrical toys) IEC60335-2-82 (PSE circle mark) Safety Confirmation Safety Standard Annex 6; Korea KC-mark Self-Regulatory Safety Confirmation Act Annex 36 MS ISO 8124 Malaysia MC-mark MS 1774 MS 62115

26 27 Global Toy Standards (Con't)

Country Certification Highlights of Toy Standard / Legislation NOM-015-SCFI-2007 Mexico NOM-mark NOM-252-SSA1-2011 NMX-J-175/1-ANCE-2005 PNS/ISO 8124 Philippines COC PNS 1408 IEC 62115 SASO 1063 - 1065 Saudi Arabia SASO COC and GCC SASO 573 IEC 62115 GCC GSO (Saudi Arabia, Kuwait, Oman, Qatar, UAE, GCTS-mark TR BD131704-01 Bahrain, Yemen) Singapore No scheme Consumer Good Safety Regulations (CGSR) SANS 8124 South Africa No scheme IEC 62115 CNS 4797 Taiwan BSMI-mark / RPC (II + III) CNS 14276 CNS 15503 TIS 684 2549 Thailand TISI TIS 685 TCVN 6238 Vietnam CR-mark QCVN 03:2009/BKHCN

28 29 TÜV SÜD Certification Mark for Toy

TESTED TOY

Safety tested

Toxic tested

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The TÜV SÜD Certification Mark is a widely recognised voluntary Further information about regulation updates and product certification mark specific for toys. It implies the compliance recall statistics, please scan below QR Code: with the EU as well as German mandatory requirements.

Today many companies in Europe use this mark for their products because it is a symbol of trust, well-known and an excellent sales tool.

Advantages of using the TÜV SÜD Toy Mark . A symbol of safety and quality recognised by consumers. . Provides competitive edge by creating purchase motivation as it provides confidence to consumers. TÜV SÜD E-ssentials Product Recall Statistics . Provides manufacturers with the confidence that their products are safe and of high quality. . Emphasises your company’s commitment to product safety and quality. . Assures end users that the product has been independently tested by an authorised third-party company.

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