SAFETY AND QUALITY FOR TOYSKey Learnings from EU Recalls2015 Edition

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Foreword

Making Toys SaferIt is crucial that toys and childcare products are of good quality and safe for use by children. For this reason, UL is dedicated to working to protect our children and leading the way in toy safety and quality. Our comprehensive quality assurance services can mitigate potential product risks and help parents safeguard their children.

This booklet offers:• an overview of the potential dangers involved with children’s products that

identifies common risk categories• an understanding of which points to pay attention when designing

products• suggestions of testing packages to get help minimize the potential risks

associated with toys and children’s products

Weekly overview reports of RAPEX notifications, published free of charge in English on http://ec.europa.eu/RAPEX, © European Union, 2005 – 2015.

The official contact points of the Member and EFTA-EEA States provide the information published in these weekly overviews. Under the terms of Annex II.10 to the General Product Safety Directive (2001/95/EC) responsibility for the information provided lies with the notifying party. The Commission does not take any responsibility for the accuracy of the information provided.

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Table of Contents

Key statistics Pg 4Summary of 2014 recall cases Pg 5Common risk categories Choking hazard: small parts Pg 6 Choking hazard: expandable toys Pg 7 Strangulation Pg 8 Microbiological risk in liquid toys Pg 9 Damage to hearing Pg 10 Burns Pg 11 Electric shock Pg 12 Chemical hazard Pg 13Case Studies Pgs 14-15 Plush toys Wooden toys Cosmetic toys CostumesAppendix Test for coating Pg 16 Sample size requirement Pgs 17-18 EN71 Part 9 organic chemical compounds Pg 19 – requirements and requested sample size

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Key Statistics

In 2013, EU Member States sent a total of 2364 notifications on dangerous products through RAPEX.

64%

33% Toys

10% 44% Clothing

15% 27% Motor Vehicles

11%

22% Clothing

China, including Hong Kong

EU and EEA

Unknown

Other

NOTIFICATION BY COUNTRY OF ORIGIN OF NOTIFIED PRODUCTS

TOP 5 MOST NOTIFIED PRODUCT CATEGORIES

2364 NOTIFICATIONS+2147 FOLLOW-UP ACTIONSon dangerous products transmitted through RAPEX

4% Cosmetics

7% MotorVehicles

9% ElectricalAppliances

25% Toys

25% ClothingTextiles

Chemical

Microbiological

BurnsFire

Injuries

BurnsFire

Electric Shock

Chemical InjuriesChoking

Chemical

Choking

Strangulation

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Summary of 2014 Recall Cases

By studying 2014 recall cases, UL has identified key hazards that need particular attention. We analyzed what risks were incurred, the related number of recall cases, and what products are likely to be recalled. We’ve also referenced related regulations wherever possible.

The following serious hazards were found to occur most often:• Choking

▪ Small parts ▪ Expandable toys

• Strangulation• Microbiological Risk • Hearing Damage• Burns• Electric shock

Moreover, we selected several popular toy categories and created examples to demonstrate aspects of design and production requiring special attention. We also provide recommendations for testing plans to help assure quality and safety for these types of products. We will look at: • Plush toys• Wooden toys• Cosmetic toys• Costumes

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Common Risk Categories

Choking hazard: small parts Number of recall cases in 2014: 233

Why it’s dangerous: Small parts of the toy pose a risk of choking by blocking the airway at the back of the child’s mouth and upper throat.

How to define small parts: If the product (or separate part) fits completely into the small part cylinder shown as below, it will be defined as a small part.

Exemption: There are exemptions like paper, fabric, elastics, yarn, strings, fuzz, crayons, and chalk as per certain testing methods.

Requirement: According to The European Toys Safety Directive 2009/48/EC, the manufacturer shall place warnings in a clearly visible, easily legible and understandable and accurate manner on the toy, on an affixed label or on the packaging and, if appropriate, within the instructions for use accompanying the toy.

Also, the Toy Safety Directive forbids all kinds of removable or detachable small parts in toys which are intended to be put in the mouth, regardless of the age of the child. Any such small parts are more likely to be inhaled from a mouth- actuated toy, with a serious risk of choking for children of all ages.

Small Part Cylinder

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Choking hazard: expandable toys Number of recall cases in 2014: 3

Why it’s dangerous: Such products may pose a risk of choking if they are put into the mouth and swallowed by children. When the toy expands, it can cause fatal occlusion of the respiratory track of small children or blockage of the gut.

Specific risk: The expanding materials in toys or components of toys can fit entirely in the small part cylinder (as mentioned in page 6) either before or after testing in accordance with generic abuse tests, and expand more than 50% in any dimension when tested accordingly to EN71-1 can pose a risk.

Requirement: Materials that expand excessively after soaking in water for 72 hours are not permitted as small toys or small parts within any toys (regardless of age grading) either before or after torque, tension, drop, impact and compression testing.

In previous versions of EN71-1, the soaking period was 24 hours. This has now been extended to 72 hours after it was shown that an object could remain in the child’s digestive tract for longer periods than was first anticipated.Abuse tests are applied to the expanding materials before the soaking test, regardless of the intended age range of the toy. If the expanding material is enclosed by a material intended to break during soaking, the requirement in EN71-1 shall be fulfilled also when the test is performed after removal of the breakable material.

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StrangulationNumber of recall cases in 2014: 15

Why it’s dangerous: Obviously it can cause suffocation or death.

Specific risk: The following products may pose a risk of strangulation due to the presence of a fixed noose: • Cords connected to a self-retraction mechanism• Cords in pull-along toys• Toys with cords intended to be strung across a cradle, cot or pram• Cords and chains with attachments or a free end (i.e. with no attachments)• Toys with electrical cables• Straps intended to be worn fully or partially around the neck

Requirement: There are certain requirements on the length of cords, perimeter of loops and self-retracting force (if applicable) depending on the nature and age grading of products. Breakaway feature or warning must be marked on the product label.

Example of warning: “Warning: Not suitable for children under 18 months. Long cord/Long chain. Strangulation hazard.”

Exemption: Toys intended to be strung across a cradle, cot, or perambulator, where the cords of such toys are intended to be out of reach of the children.

Other cases: Besides infant toys, yo-yo balls (defined as toy made from elastic material consisting of a tether usually having a loop at one end to place around a finger and a flexible object at the other end) may also present a potential hazard for strangulation as the elasticated tether may be wound around the neck. There is a particular testing method within EN71- 1 specifically for such items.

For costumes, products must also comply with the relevant European standard EN14682 as the presence of functional cords that are to be tied at the back and around the waist area may pose an injury risk as the cords may become caught.

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Microbiological risk in liquid toysNumber of recall cases in 2014: 17

Why it’s dangerous: Risk of infection is posed if the liquid is swallowed or comes into contact with skin when microbiological content exceeds the limit of Toys Safety Directive.

Specific risk: Microbiological contents contain the following:• Mesophilic Aerobic Micro-organism• Pseudomonas Aeruginosa• Pseudomonas Species• Aerobic Colony • Enterobacteriaceae• Pathogenic Micro• Staphylococcus Haemolyticus• Staphylococcus Warneri

Requirement:Microbiological Safety of Toys (Rev 1 v2) under the Notified Bodies Recommendations and Protocols specifies microbiological requirements for:1. toys containing aqueous liquid (bubble soap), 2. modeling clays based on aqueous formulations, 3. finger paints, 4. gels & semi-liquids based on aqueous formulations.

Limitations on different microbiological contentsMicrobiological Content Limits

Total Aerobic Microbial Count ≤ 1000 cfu/g or ml Yeast and Mould ≤ 10 cfu/g or mlStaphylococcus Aureus Absent in 1 ml or g Pseudomonas Aeruginosa Absent in 1 ml or gCandida Albicans Absent in 1 ml or g

Escherichia Coli or Enterococci Faecalis in Liquids Absent in 1 ml or g

Salmonella SPP Absent in 1 ml or g

Enterobacteriaceae ≤ 10 cfu/g or ml

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Damage to HearingNumber of recall cases in 2014: 10

Why it’s dangerous: When the sound level is too high, or there is prolonged exposure to elevated levels over a period of time, a child’s hearing can be damaged.

Requirement: The European Committee for Standardization (CEN) has amended the EN 71-1 standard, which covers the mechanical and physical properties of toys.

EN 71-1 Acoustics requirements have recently changed under the A2:2013 amendment. This is in effective since September 30, 2014.

A2:2013 includes new requirements for toys which were previously not within the scope, such as percussion toys and wind toys (e.g. drums, whistles, and xylophones). Revised test methods have also been introduced for voice toys such as megaphones and walkie-talkies. All toys that deliberately produce sounds are now required to be assessed, and have been separated into 11 product types and 3 exposure categories.

The product types are:• Close-to-the-ear toys• Table-top or floor toys• Hand-held toy• Toys using headphones or earphones• Rattles• Squeeze toys • Pull-along or push toys• Percussion toys• Wind toys• Cap-firing toys• Voice toys

The 3 exposure categories are:• Toys emitting sound during time periods typically longer than 30 seconds

after each initiation; • Toys emitting sound during time periods typically shorter than 30 seconds

but longer than 5 seconds after each initiation; • Toys emitting sound during time periods typically shorter than 5 seconds

after each initiation.

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BurnsNumber of recall cases in 2014: 24

Why it’s dangerous: The risk of burning from a toy itself is low. However batteries within a toy could overheat and are create a condition where a child could be burnt.

Requirement: Electric toys placed on the market must comply with EN 62115. Rises in temperature are one of the main concerns in EN 62115 which may pose certain difficulties for battery manufacturers.

The table below shows EN 62115 A11 Clause 9 – Heating, abnormal operation and temperature rise after limits

Toy intended

for

Metal (uncoated)

surface

Metal with coating

thickness greater

than 50 µm

Metal with coating

thickness greater than

100 µm

Metal with coating

thickness greater than

150 µm

Ceramics, glass & stone

surfaces

Plastic, wood

& other surfaces

Children < 3 years 29 K 29 K 29 K 30 K 39 K 44 K

Children 3 years to < 8

years33 K 36 K 39 K 41 K 46 K 50 K

Children 8 years and

above36 K 43 K 48 K 53 K 50 K 55 K

Note 1: The limits for metal (uncoated) surfaces apply to batteries with coated metal surfaces.Note 2: The temperature of the terminals of switches is measured if the switch is tested in accordance with Annex C.Note 3: For coatings less than 50 µm, the values for uncoated surfaces are used.

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Electric Shock Number of recall cases in 2014: 1

Why it’s dangerous: Insulation is insufficient, or the clearance/creepage distances between the primary and secondary circuits are insufficient and can create conditions where the user may get an electric shock.

Requirement: Electrical toy power supplies must comply with the Low Voltage Directive and the relevant European standard EN 61558 in addition to any relevant national standards.

Transformers for toys shall comply with EN 61558-2-7 for linear types or EN 61558-2-7 and EN 61558–2-16 for switch mode types.

Battery chargers supplied with a toy shall comply with IEC 60335-2-29 and if they are battery chargers for use by children they shall comply with annex AA of that standard.

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Chemical HazardNumber of recall cases in 2014: 279

Why it’s dangerous: Children may ingest carcinogenic, mutagenic and repro-toxic chemical substances from toys. Children have a different metabolism to adults. Chemicals may appear to be more toxic to children than an equivalent amount to adults.

Requirement: The restriction of chemical substances is wide and specific to toys and children’s articles, included EN71 Part 3, Nickel Released, Azo Dyes and Phthalate. Challenge: PAH, REACH Annex XVII entry was entered into force on the 27th of December, 2013 and will be effective on the 27th of December, 2015. The limit value is 0.5mg/kg for EACH restricted PAH. PAHs are classified as carcinogens and can be found in the plastic and rubber parts of a wide range of consumer articles.

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Case Studies

Plush ToysUL recommended testing plan includes:• EN 71 Part 1 – Mechanical & Physical

properties • Total Phthalate (REACH Annex

XVII, item 51,52) • EN 71 Part 2 – Flammability

Test• Total Cadmium (REACH Annex

XVII, item 23)• EN 71 Part 3 – Migration of certain

elements• EN71 Part 9 - Organic Chemical

Compounds Requirements• Azo Dyes (REACH Annex XVII,

item 43)

Pay Attention:• If a child manages to pull open a seam and can access the filling material;

the fibrous filling material is considered to be a potential hazard as it can be taken into the mouth and may cause choking.

• A toy intended for use by children under 36 months must be designed and manufactured in such a way that it can be cleaned.

• A textile toy shall be washable except if it contains a mechanism that may be damaged if soak washed. The toy must also fulfill the safety requirements after having been cleaned in accordance with this point and the manufacturer’s instructions. Therefore, physical tests should be conducted after certain washing procedures as per the care instructions (as the washing may increase the possibility of a test failure).

• Soft-filled toys shall have at least one covering such that, after tension testing for seams, it shall not be possible to insert the front part of a 12 mm diameter rod more than 6 mm.

Wooden ToysUL recommended testing plan includes:

• EN 71 Part 1 – Mechanical & Physical properties

• Total Phthalate (REACH Annex XVII, item 51,52)

• EN 71 Part 2 – Flammability Test

• Total Cadmium (REACH Annex XVII, item 23) on paints

• EN 71 Part 3 – Migration of certain elements

• Formaldehyde (EN71 Part 9)

Pay Attention:• Glued wooden toys and toys with glued-on plastic decals shall undergo the

soaking test before other generic abuse testing to check the strength of joints.

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• The soaking test submerges the toy or component in a container of demineralized water at a temperature of (20 ± 5) °C for 4 minutes. After that, the toy is taken out, excess water is shaken off, and the toy is kept at room temperature for 10 minutes. The test cycle must be performed four times. Immediately after the last cycle, we can determine whether any small parts are classified as released components.

Cosmetic Toys UL recommended testing plan includes: • EN 71 Part 1 - Mechanical & Physical Test

EN 71 Part 2 - Flammability Test• Microbiological

Contamination• EN 71 Part 3 - Migration of certain

elements• Toxicological Risk

Assessment (TRA)• EN71 Part 9 - Organic Chemical

Compounds Requirements• Heavy Metal Test: Lead

and Mercury• Total Cadmium (REACH Annex XVII, item

23) on paints• Total Phthalate (REACH

Annex XVII, item 51,52)• Efficacy Of Antimicrobial Preservation on

cosmetic• Flash Point Test

Pay Attention:Cosmetic toys always have a high number of recalled cases from RAPEX. We highly recommend that manufacturers pay particular attention to the safety requirements mentioned above.

Costumes UL recommended testing plan includes: • EN 71 Part 1 - Mechanical & Physical Test• EN 71 Part 2 - Flammability Test

• Total Phthalate (REACH Annex XVII, item 51,52)

• EN 71 Part 3 - Migration of certain elements

• Azo dyes (REACH Annex XVII, item 43)

• Formaldehyde• Total Cadmium (REACH Annex XVII, item 23)

Formaldehyde (EN71 Part 9)

Pay Attention:Manufacturers should pay particular attention to flammability safety requirements, as candles are very likely to be used for decoration during holiday or festival celebrations such as Halloween. Children do not pay much attention to these sources of fire and, if the costume catches fire and then burns vigorously, the child could be seriously injured.

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Appendix

Test for coatingWhy the need for testing?According to international standards like EN 71-3 & ASTM F963, the coating on a sample is under the test scope and thus, the coating has to be tested.

How to send a coating for testing?A sample size of 10g of ‘coating’ per color is needed. Normally, raw paint (wet paint) can be used for testing. But if sending raw paint by a courier service is problematic, dry paint is an alternative option and following the steps below is suggested.1. Prepare a hard & strong plastic film ideally using the same plastic used in

manufacture (preferred in A4 size)2. Apply wet paint on plastic film and dry it as it would be dried in

manufacture of the toy3. Repeat 2-3 times to make a certain thickness of dry paint4. Provide dry paint for each of the colors

Do:1. Use chemical-free plastic film so that it will not affect test result 2. Apply wet paint a couple of times so that there is sufficient sample size to

process the test 3. Dry the paint before sending so that it will not stick to any packaging

Don’t:1. Miss any color used on your sample2. Mix different paint colors on the same plastic film

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Sample Size RequirementTest Sample Size

Heavy Metal TestsSoluble Toxic Elements (EN 71-3 19 toxic elements)

1 pc of finished product + 10g if confirmation test required

Total Lead Content / Lead in Substrate** 10gTotal Cadmium Content** 10gTotal Phthalates Content test** 10gCONEG or Packaging Directive 94/62/EC 20g / 1 set of packaging materialsHeavy Metal Content in Battery per 2006/66/EC 6 batteries

RoHS (Lead, Cadmium, Chromium VI, Mercury & PBB/PBDE 15g of single material

Japan Toys Standards Part 3: Chemical Properties / Toxicological Material (excluding Soap Bubble Solution)

5 pcs

Organic Toy TestsPhenol Content 20gTotal Phthalates Content 20gVOC / Organic Residue 30gStuffing (PA) 45gStuffing (AOAC) 45gGCMS Screening 20gEN 71-9 Organic Chemicals Depends on what test appliedFood Contact Article / Nickel TestsFDA Food Grade Plastic 3 pcs

Extractable Lead & Cadmium Content / RIM 4 pcs (EU) / 6 pcs (FDA) / 12 pcs (CA65)

Heavy Metal Migration / Specific Migration 3 pcsFood Grade Plastic per EU 10/2011 2 pcs per simulantNickel Rubbing Test 3 setsNickel Release 3-5 pcs

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Sample Size Requirement Cont.Test Sample Size

Microbiological TestsUSP <61> & <62> / BP APP XVI – B 50ml/50gUSP <51> / BP APP XVI – C 150ml/150gAATCC 147 A4 size of fabricAATCC 100 A4 size of fabricOrganic Garment TestsChromium VI 20g/A sheet with 2 x A4 sizepH 30g/A sheet with 2 x A4 sizeFormaldehyde 20g/A sheet with 2 x A4 sizeAzo Dye** 20g/A sheet with 2 x A4 sizeDisperse Dye (Allergenic & Carcinogenic Dye) 20g/A sheet with 2 x A4 size

PCB 30g/A sheet with 2 x A4 sizeTBT 40g/A sheet with 2 x A4 sizePCP/TeCP/OPP 30g/A sheet with 2 x A4 sizeOther TestsREACH – 161 SvHC Screening Test ## 3 pcsToxicological Risk Assessment Chemical Composition

**Max. 3 composite is allowed.##Max 3 composite for raw material testing and Max. 10 composite for finished product testing

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EN71 Part 9 Organic Chemical Compounds – Requirements and Requested Sample Size

Flam

e re

tard

ants

Colo

rant

s

Prim

ary

Arom

atic

Am

ines

Mon

omer

s

Solv

ents

- m

igra

tion

Solv

ents

- in

hala

tion

Woo

d pr

eser

vativ

es

(Out

door

)

Woo

d pr

eser

vativ

es

(Indo

or)

Pres

erva

tives

Plas

ticis

ers

Sam

ple

size

Toys intended to be mouthed by children under 3 years of age POLYMERIC X X X 6pcs

Toys, or accessible toy components, with a mass of 150g or less intended to be played with in the hands by children under 3 years of age

POLYMERIC X X X 6pcs

WOOD X X X X 8g

PAPER X X 3g

Toys and accessible Components of toys intended for children under 3 years of age

TEXTILE X X X 4g

LEATHER X X X 5g

Mouthpiece components of mouth-actuated toys

POLYMERIC X X X 6pcs

WOOD X X X X 8g

PAPER X X 3g

Inflatable toys with a surface greater than 0.5 m2 when fully inflated

POLYMERIC X 20g

Toys worn over the mouth or nose POLYMERIC X X 20g +

2pcs

TEXTILE X X X 23g

PAPER X X 3g

Toys which the child can enter POLYMERIC X 20g

TEXTILE X 20g

Components of graphic instruments sold as toys or used in toys

POLYMERIC X X X 6pcs

Toys and Accessible Components of toys for indoor use WOOD X X 5g

Toys and Accessible Components of toys for outdoor use WOOD X 5g

Toys and components of toys which mimic food POLYMERIC X X X 6pcs

Solid toy materials intended to leave a trace ALL X X 3g

Colored accessible liquids in toys LIQUID X X X 5g

Non-colored accessible liquids in toys LIQUID X 2g

Modelling clay, play clay and similar, except those chemical toys addressed by EN 71-5

ALL X X X 13g

Balloon-making compounds ALL X X X 23g

Imitation tattoos with adhesive ALL X X X X 5g+ 2pcs

Imitation jewelry POLYMERIC X X X 6pcs

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Since 1894, UL has been a respected leader in safety science. Today, UL is advancing its commitment to protecting people, products and places through expert advisory and independent quality assurance testing, inspections, and assessments for a wide range of consumer products. Our network of more than 152 laboratory testing and certification facilities in 40 countries helps drive the integrity of global supply chains, optimize product performance and protect brands.

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