International Toys Safety Regulatory Standard

Group members: Yan yip, Leo, Francis | Dr. Lee | THEi

 What difference of toys regulatory
safety test between US, EU and
P.R.C. is?
Presentation of :
• US CPSIA and ASTMF963-16:2017
• EU Toy Safety Directive 2009/48/EC and EN 71-1:2011+A3:2014 -3:2013, -12:2016
• P.R.C. GB 6675.1-2014 China Compulsory Certification (CCC) from the nation's Certification and Accreditation Administration (CNCA)
 Presentation Content

• US Toys Safety Regulation and Standard Test

• EU Toys Safety Directive and Standard Test

• P.R.C. Toys Regulation and Standard Test

• Comparison of toys safety regulation and standard test methods (focus on

chemicals migration) between
 US CPSIA and ASTMF963-16:2017

 EU Toy Safety Directive 2009/48/EC and EN71:2014

 China Compulsory Certification (CCC) from the nation's Certification and
Accreditation Administration (CNCA) and Toys Safety Regulation GB 6675.1-
2014
 US Federal Regulatory Toys Safety under CPSA - CPSIA
and ASTMF963:2017
• The Scope of Toys Safety Regulation:
 Definition of Toy - any object designed, manufactured, or marketed as a plaything for children aged under 14 years
 Children product - consumer product designed or intended primarily for children aged 12 years or younger
 CPSIA - Federal Regulation
 Part 1520 – Mandatory ASTM F963-17
 CPSIA Section 101 Total Lead Content in Substrate Material
 CPSIA Section 108 Ban of Phthalate
 16 CFR Part 1303 Ban of Lead-Containing Paint
 16 CFR Part 1308 Prohibition of Phthalates in Children’s Toys and Child care article
 Toxic Substances Control Act (TSCA) gave EPA more power to control chemicals used in consumer products

• US State Regulation on chemicals restricted limits e.g. California Pros65, Washington Chemicals of High Concern to
Children (CHCC), Vermont, Maine, Oregon (HPCCs), New York (7 Heavy Metals Formaldehyde Banned) , etc.

• ASTM F963-17 Standard Consumer Safety Specification for Toy Safety

 Toys intended for use by children under 14 years of age
 ASTM F963-Part 1 A1:2011 Mechanical & Physical Test
 ASTM F963-Part 2 Flammability Test
 ASTM F963-Part 3 Migration Soluble Test

• ASTM D4236 standards

 Art materials
 children's art and drawing products
US Federal Regulatory Toys Safety and State Law’s Toys Safety

• Washington's Department of Ecology (DOE)

enforcement guideline for compliance with :
lead, cadmium, phthalates falling under the Children’s Safe Products Act (CSPA)
The DOE will enforce state limits for children’s products that are not covered by a limit
under the Consumer Product Safety Improvement Act of 2008 (CPSIA)

Consumer Product Safety Improvement Act (CPSIA)

for the most seasoned regulatory and quality assurance expert.
New certification requirements, phthalate and lead limits

• Mandatory third-party testing requirements

•
Proposition 65 is the ‘Safe Drinking Water and Toxic Enforcement Act of 1986’
publish a list of chemical known to cause cancer

• Birth defects or other reproductive harm

 Heavy Elements – Migration Test with Total Soluble method and
Restricted Limits

• Total lead
• Washington children’s Safe Products Act (CSPA)-chapter 70.240.020 on lead requirements (Limit: 90 ppm)
• CPSIA Section101 & 16 CFR 1303, Total Lead Content in Paints and Surface Coating (Limit :90 mg/kg)
• CPSIA Section 10 Total Lead Content in Substrate Materials (Limit: 100 mg/kg)
• ASTM F963-16 Total lead content:
• Surface coating : 90ppm Non Surface coating : 100ppm
• California Props 65 total lead:
• Surface coating : 90ppm Non Surface coating : 100ppm

• Total cadmium
• Washington children’s Safe Products Act (CSPA)-chapter 70.240.020 on cadmium requirements (Limit: 40ppm)
• ASTM F963-11 Extractable Cadmium (Limit of the Cd is 200µg)
Heavy Elements – Migration Test with Soluble Method and
Restricted Limits

• ASTM F963-16 4.3.5.2 Soluble migrated elements

• Limit: Soluble migrated Elements for substrate other than modelling clay

• Limit: Soluble migrated elements for modelling clay

• ASTM F963 (4.3.5 &8.3) Soluble Heavy Metal in Coating and Substrate Materials:
Sampling from one completely product on principle
 Phthalates’ Restricted Limits and Test Method

• Federal regulation:
• CPSIA Section 108, Phthalates content- Mouthable (DBP, BBP, DEHP, DnOP, DINP, DIDP)
• CPSIA Section 108, Phthalates content- Non-Mouthable (DBP, BBP, DEHP)
• Limit: 0.1% w/w for individual phthalate

• State regulation:
• Washington children’s Safe Products Act (CSPA)-chapter 70.240.020 on phthalate requirements
• BBP, DBP, DEHP, DIDP, DINP or DNOP
• Limit: 0.1% w/w for individual phthalate

• California proposition 65 for toys-phthalate content

• (DBP, DEHP, BBP, DIDP, DNHP, DINP)
• Limit: 0.1% w/w for individual phthalate
 European Toys Safety Directive

• The Toy Safety Directive 2009/48/EC lays down the safety criteria that toys must meet before they
can be marketed in the EU.

• The essential safety requirements cover:

• the health and safety of children

• physical and mechanical, flammability, chemical, electrical, hygiene and radioactivity risks

• Toy Safety Directive 2009/48/EC Standard Consumer Safety Specification for Toy Safety

• Under 14 years of age

• applies to toys for children, toys being any product or material designed or intended

• specific requirements for toys intended for children under 36 months and under 18 months
 European EN71: 2014

European standard EN 71 specifies safety requirements for toys. Compliance with the standard is
legally required for all toys sold in the European Union.

Battery and/or mains powered electronic toys :

• EN 71-1 Part 1: Mechanical and physical properties
• Toy Safety Directive 2009/48/EC (EN 62115:2005)
• EN 71-2 Part 2: Flammability
• EN 71-3 Part 3: Migration of certain elements • EMC recast Directive 2014/30/EU
• EN 71-4 Part 4: Experimental sets for chemistry and related activities • R&TTE Directive and RED 2014/53/EU
• EN 71-5 Part 5: Chemical toys (sets) other than experimental sets • RoHS2 Directive 2011/65/EU
• EN 71-7 Part 7: Finger paints - Requirements and test methods
• WEEE recast Directive 2012/19/EU
• EN 71-8 Part 8: Activity toys for domestic use
• EN 71-1 Part 12: N-Nitrosamines and N-nitrosatable substances • Battery Directive 2006/66/EC
• EN 71-13 Part 13: Olfactory board games, cosmetic kits and gustative games
• EN 71-14 Part 14: Trampolines for domestic use

This standard specifies the requirements and methods of tests for mechanical and physical properties of toys, and
specifies requirements for packaging, marking and labelling.
 Compliance of Chemicals in EU

• EN 71 Part 3 – Migration of certain elements

• EN 71-4 Experimental Sets for Chemistry and Related Activities

• EN 71-5 Chemical toys (sets) other than experimental sets

• EN 71-7 Finger paints – Requirements and test methods

• EN 71-12 N-Nitrosamines and N-nitrosatable substances

• EN 71-13 Olfactory board games, cosmetic kits and gustative games

• REACH Annex XVII (REACH Restricted Substance List)

• REACH SVHCs and Annex XIV(candidate list)

• Toxic Risk Assessment (TRA)

• RoHS(Electrical and Electronic Equipment)

In EU toy standard , all the toy must required to both of EN71 and REACH chemical standard, and CMRs are prohibited.
 Compliance of Chemicals (EN71- Part 3)

Toy materials are now divided into three categories, as follows, based on their type, which determines the extent to
which they may be ingested by the child.

Category I - Dry, brittle, powder-like or pliable materials

Category II - Liquid or sticky materials

Category III - Scraped-off materials

.
 Compliance of Chemicals (REACH)

Products likely to contain any of the following hazardous substances should be lab tested:

• Lead

• AZO dyes

• DMF (Dimethyl fumarate)

• PAHs (Polycyclic aromatic hydrocarbons)

• Phthalates (Plasticizers)

• PFOS (Perfluorooctanoic acid)

• Nickle release

• Textiles and AZO dyes(soft toy )

 Compliance of Chemicals in other European Countries

Most of the European country will model their safety standards on the EU's EN 71 standard,
but some country will have different chemical standard. here are some example.

France

• Banned BPA in food contact materials – under 3-year-old

Denmark

• Banned phthalates in toys and childcare articles for children aged 0-3 years in
concentrations higher than 0.05%

Germany

• Ba, Cd limits lowered

• PAHs, limit value of 0.5mg/kg in concentration

 Toys Safety Regulation, Standard and CCC Program in P.R.C.
• China GB (Guo Bio) standards are Chinese national standards issued by the Standardization Administration of China (SAC)*, the Chinese
National Committee of the ISO and IEC.
• Chinese standards may be either mandatory or voluntary.
 Prefix code: GB – Mandatory national standard,
 GB/T – Voluntary national standard and
 GB/Z – National standardization technical guide
• Compliance of toys production from raw materials control up to consumers by applying factory audit and toys safety testing and labelling in
the China Compulsory Certificate (CCC) program voluntarily since 2003
• The Central Chinese authorities announced a compulsory policy on toys safety regulatory by enforcing comprehensive safety and labeling
standards and China Compulsory Certification (CCC) program since 2007
• Then, central government announced an updated children’s toys safety on May 6, 2014 the “Standardization Administration of China”
(SAC, Chinese: 会员委 理管 化准标 家国) issued GB Standard 6675-2014 and require mandatory test by 1st Jan, 2016
• The scope of toys is one among categories of CCC List that contains of:
 Toy Products (total 6 subcategories)
 Children cars, including children bicycles, tricycles, perambulators, baby walking frames, etc.
 Electric toys
 Plastic toys
 Metal toys
 Projectile toys
 Baby dolls * Source: http://www.sac.gov.cn/sacen/
 Toys Safety Regulation, Standard and CCC Program in P.R.C.

• ISO 8124-1:2012
Safety of Toys—Part 1: Safety Aspects Related to Mechanical and Physical Properties
• GB 9832-2007
Safety and Quality of Sewn, Plush and Cloth Toys
• GB 5296.5-96
Labeling and Instructions for Toys
• GB 6675-2014
National Safety Technical Code for Toys
• GB/T 27708-2011 (national voluntary standard)
General Technical Requirements of Inflatable Toys
• GB/T 27730-2011 (national voluntary standard)
Determination of Dimethyl Fumarate in Toys—Gas Chromatography-mass Spectrometry Method c.
• GB/T 28495-2012 (national voluntary standard)
General technical requirements for bamboo and wooden toys
• GB 28482-2012 (national compulsory standard)
Safety Requirements of Soothers for Babies and Young Children
• GB 29281-2012 (national compulsory standard)
Safety Requirements for Playpens and Similar Cribs was implemented on May 1st, 2014.
• GB/T 30419-2013 (national voluntary standard)
Determination of Antimony, Arsenic, Barium, Cadmium, Chromium, Lead, Mercury, Selenium Element Migration from Toy Materials—Inductively
Coupled Plasma Atomic Emission Spectrometry was implemented on December 1st, 2014.
• GB/T 30400-2013 (national voluntary standard)
Safety and Hygiene Requirements of Filling Materials in Toys was implemented on December 1st, 2014.
 Toys Safety Regulation, Standard and CCC Program in P.R.C.

• Electric toys shall comply mandatory standard GB 19865-2005 Electric Toys:

 Labeling – shall comply with mandatory toy labeling standard GB 5296.5,
 General labeling requirements for consumer products GB 5296.1, and related clauses in
Product Quality Law of People’s Republic of China.

 Quality – The quality and performance related mandatory standards test

 material, age, intended use, style and more, and to be declared as “Executive Standard” on the
label.

• China Compulsory Certificate (CCC)

Six toy categories are required to be certified by authorized certification centers and to display the
CCC
 China Compulsory Certificate (CCC) Program - GB 6675-2014

• GB6675.1-2014 Toy Safety Part 1 – Basic Code

• GB 6675.2-2014 Toy Safety Part 2 - Mechanical and
Physical Properties
• GB 6675.3-2014 Toy Safety Part 3 – Flammability
• GB 6675.4-2014 Toy Safety Part 4 - Migration of certain
elements
 shall comply with soluble heavy metal requirement regardless
appropriate or labelled age grade
- intended food or oral contact toys, cosmetic toys and writing
instruments categorized as toys
- all accessible coatings, accessible liquids, pastes, gels, etc.

 Phthalate Test – GB/T22048-2015 Method A (CPSC approved

as alternative Phthalate test Method**)

** Source: https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Lab-Accreditation/Test-Methods
http://www.codeofchina.com/gb/lightindustry/18893.html
China Compulsory Certificate (CCC) Program – Factory Audit

Submitting Application Form

Submitting Materials and Samples

Testing

Initial Factory Audit and Inspection

CCC Marking and Labelling

Factory Supervision

Issue CCC certificate and permission of showing

CCC Label to the package
* Source: https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Lab-Accreditation/Test-Methods
http://www.codeofchina.com/gb/lightindustry/18893.html
Case Study – Comparison of Toy Compliance between US, EU and China (1)

US CPSIA China Compulsory Certification (CCC) Program

EU Toys Directive 2009/48/EC of China Toys regulation
• Age Grade: < 36 months • Age Grade: under 6 • Age Grade: under 6
• CPSC – CPSIA Federal Regulation • The Scope of Heavy Metal Subs & Test
• The Scope of Heavy Metal Subs & Test • The Scope of Heavy Metal Subs & Test
Method: Method:
Method:
• Classified as Categories 3 • GB6675:2014 Part 3 Migration of Certain
• Yellow plastic and orange plastic
• 19 restricted elements (for example element
• 8 Soluble element
Lead, Cadmium, Mg) under (EN71-Part 3) • 8 heavy metal substances (Soluble)
• ASTM F9613-16 total lead content:
• Extraction Method:??? • Extraction Condition: as same as US
• Non surface coating :100ppm
• Cal prop 65 total lead: • Solvent for Extraction ??? CPSIA
• Non surface coating : 100ppm • Extraction Time??? • Solvent: as same as US CPSIA
• CPSIA Section 10 Total Lead Content in • Test Equipment: ICP-AES, ICP-AA, ICP- • Test Equipment: ICP-AA or ICP-MS
Substrate Materials limit: 100 mg/kg MS • Test Method: as same as US CPSIA
• Test Method / Extraction condition ??? • Different categories have different limit • Restricted Limited: as same as US
according Migration limits CPSIA
• State Law
• Washington children’s Safe Products Act
(CSPA)-chapter 70.240.020 on lead
requirements
• Black and white coating: >10mg , no test is
needed
• California Prop 65 total lead:
• surface coating : 90ppm
• ASTM F9613-16 total lead content:
• surface coating :90ppm
Case Study – Comparison of Toy Compliance between US, EU and China (2)
US CPSIA
• The Scope of Phthalates Subs & Test Method:
• CPSIA Section 108, Phthalates content-
• 1. DBP
2. BBP
3. DEHP <12 years of toys and child care
article, non-mouthable
4. DNOP
5. DINP
6. DIDP toys can placed in a child's mouth
and child care article
• State Law
• Washington children’s Safe Products Act
(CSPA)-chapter 70.240.020 on phthalate
requirements
• California proposition 65 for toys-phthalate
content
• Limit : 0.1% w/w for individual phthalate
• Test Method: CPSC-CH-C1001-09.3
• Extraction Solvent: Hexane
• Extraction Time; 2hr 30 min
• Instrument: HPLC or GC-MS
EU Toys Directive 2009/48/EC
• The Scope of Phthalates Subs & Test
Method:
• BBP, DBP, DEHP, DIDP, DINP and DNOP
• ISO8124-6:2014(Based on China
national standard GB/T 22048-2008)
• Extraction Solvent: Dichloromethane
• Method A
Soxhlet extractor, reflux, 6 hours
• Method B
Solvent extractor, 80 °C, 1.5 hours and
reflux, 1.5 hours
• Limit children under 3:
DEHP+DBP+BBP ≤0.1%
• can be placed in children’s mouth:
DINP + DIDP + DNOP≤ 0.1%
• Equipment: HPLC or Gas
Chromatography Mass Spectrometry
(GCMS)
China Compulsory Certification (CCC)
Program of China Toys regulation
• The Scope of Phthalates Subs & Test
Method:
• Phthalate Test – GB/T22048-2015
Method A (CPSC approved as
alternative Phthalate test Method**)
• Extraction Solvent: Dichloromethane
• Method A
Soxhlet extractor, reflux, 6 hours
• Method B
Solvent extractor, 80 °C, 1.5 hours and
reflux, 1.5 hours
• Limit children under 3:
DEHP+DBP+BBP ≤0.1%
• can be placed in children’s mouth:
DINP + DIDP + DNOP≤ 0.1%
• Equipment: HPLC or Gas
Chromatography Mass Spectrometry
(GCMS)
 Conclusion

• Sufficiently understanding global toys regulation and test methods on:

 Migration soluble heavy metal substances and phthalates, even though other substances

 Not only National Regulatory Standard Test, even concern State Law or Independent EU
country’s additional compliance requirements

• Carefully analyze the globally legislative requirements of the standardized testing if the
toy will be delivered to multiple countries:

 Q&A
Thanks you