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Safety and Quality For Toys: Key Learnings From EU Recalls 2015 Edition
Safety and Quality For Toys: Key Learnings From EU Recalls 2015 Edition
FOR TOYS
Key Learnings from EU Recalls
2015 Edition
Foreword
Making Toys Safer
It 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.
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 4
Summary of 2014 recall cases Pg 5
Common 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 13
Case Studies Pgs 14-15
Plush toys
Wooden toys
Cosmetic toys
Costumes
Appendix
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
Chemical 4%
Microbiological Cosmetics
NOTIFICATION BY COUNTRY OF
ORIGIN OF NOTIFIED PRODUCTS
10%
44% Clothing
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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.
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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.
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.
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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.
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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Strangulation
Number of recall cases in 2014: 15
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
Example of warning: “Warning: Not suitable for children under 18 months. Long
cord/Long chain. Strangulation hazard.”
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 toys
Number of recall cases in 2014: 17
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.
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Damage to Hearing
Number 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.
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.
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.
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Electric Shock
Number of recall cases in 2014: 1
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 Hazard
Number 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.
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 Toys
UL recommended testing plan includes:
• EN 71 Part 1 – Mechanical & Physical • Total Phthalate (REACH Annex
properties XVII, item 51,52)
• EN 71 Part 2 – Flammability • Total Cadmium (REACH Annex
Test XVII, item 23)
• EN 71 Part 3 – Migration of certain • EN71 Part 9 - Organic Chemical
elements 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 Toys
UL recommended testing plan includes:
• EN 71 Part 1 – Mechanical & Physical • Total Phthalate (REACH Annex
properties XVII, item 51,52)
• EN 71 Part 2 – Flammability • Total Cadmium (REACH Annex
Test XVII, item 23) on paints
• EN 71 Part 3 – Migration of certain • Formaldehyde (EN71 Part 9)
elements
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 • Microbiological
EN 71 Part 2 - Flammability Test Contamination
• EN 71 Part 3 - Migration of certain • Toxicological Risk
elements Assessment (TRA)
• EN71 Part 9 - Organic Chemical • Heavy Metal Test: Lead
Compounds Requirements and Mercury
• Total Cadmium (REACH Annex XVII, item • Total Phthalate (REACH
23) on paints Annex XVII, item 51,52)
• Efficacy Of Antimicrobial Preservation on • Flash Point Test
cosmetic
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 • Total Phthalate (REACH
• EN 71 Part 2 - Flammability Test Annex XVII, item 51,52)
• EN 71 Part 3 - Migration of • Azo dyes (REACH Annex
certain elements 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 coating
Why 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.
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 sample
2. Mix different paint colors on the same plastic film
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Sample Size Requirement
Test Sample Size
Heavy Metal Tests
Soluble Toxic Elements (EN 71-3 19 toxic 1 pc of finished product
elements) + 10g if confirmation test required
Total Lead Content / Lead in Substrate** 10g
Total Cadmium Content** 10g
Total Phthalates Content test** 10g
CONEG or Packaging Directive 94/62/EC 20g / 1 set of packaging materials
Heavy Metal Content in Battery per
6 batteries
2006/66/EC
RoHS (Lead, Cadmium, Chromium VI,
15g of single material
Mercury & PBB/PBDE
Japan Toys Standards Part 3: Chemical
Properties / Toxicological Material (excluding 5 pcs
Soap Bubble Solution)
Organic Toy Tests
Phenol Content 20g
Total Phthalates Content 20g
VOC / Organic Residue 30g
Stuffing (PA) 45g
Stuffing (AOAC) 45g
GCMS Screening 20g
EN 71-9 Organic Chemicals Depends on what test applied
Food Contact Article / Nickel Tests
FDA Food Grade Plastic 3 pcs
4 pcs (EU) / 6 pcs (FDA) / 12 pcs
Extractable Lead & Cadmium Content / RIM
(CA65)
Heavy Metal Migration / Specific Migration 3 pcs
Food Grade Plastic per EU 10/2011 2 pcs per simulant
Nickel Rubbing Test 3 sets
Nickel Release 3-5 pcs
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Sample Size Requirement Cont.
Test Sample Size
Microbiological Tests
USP <61> & <62> / BP APP XVI – B 50ml/50g
USP <51> / BP APP XVI – C 150ml/150g
AATCC 147 A4 size of fabric
AATCC 100 A4 size of fabric
Organic Garment Tests
Chromium VI 20g/A sheet with 2 x A4 size
pH 30g/A sheet with 2 x A4 size
Formaldehyde 20g/A sheet with 2 x A4 size
Azo Dye** 20g/A sheet with 2 x A4 size
Disperse Dye (Allergenic & Carcinogenic
20g/A sheet with 2 x A4 size
Dye)
PCB 30g/A sheet with 2 x A4 size
TBT 40g/A sheet with 2 x A4 size
PCP/TeCP/OPP 30g/A sheet with 2 x A4 size
Other Tests
REACH – 161 SvHC Screening Test ## 3 pcs
Toxicological 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
Primary Aromatic
Flame retardants
preservatives
preservatives
Preservatives
Sample size
Plasticisers
Monomers
inhalation
migration
(Outdoor)
Solvents -
Solvents -
Colorants
(Indoor)
Amines
Wood
Wood
Toys intended to be mouthed by
POLYMERIC X X X 6pcs
children under 3 years of age
PAPER X X 3g
TEXTILE X X X 23g
PAPER X X 3g
TEXTILE X 20g
Components of graphic
instruments sold as toys or used POLYMERIC X X X 6pcs
in toys
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contact ToyTeam@ul.com.
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