SAFETY AND QUALITY
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.
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.
2
Table of Contents
Key statisticsPg 4
Summary of 2014 recall cases
Pg 5
Common risk categories
Choking hazard: small parts
Pg 6
Choking hazard: expandable toys
Pg 7
StrangulationPg 8
Microbiological risk in liquid toys
Pg 9
Damage to hearingPg 10
BurnsPg 11
Electric shockPg 12
Chemical hazardPg 13
Case StudiesPgs 14-15
Plush toys
Wooden toys
Cosmetic toys
Costumes
Appendix
Test for coatingPg 16
Sample size requirementPgs 17-18
EN71 Part 9 organic chemical compounds Pg 19
– requirements and requested sample size
3
Key Statistics
In 2013, EU Member States sent a total of 2364 notifications on dangerous
products through RAPEX.
TOP 5 MOST NOTIFIED
PRODUCT CATEGORIES
2364 NOTIFICATIONS
+
2147 FOLLOWUP ACTIONS
on dangerous products
transmitted through
RAPEX
25% Clothing
Textiles
Strangulation
Chemical
Choking
Chemical
Choking
Fire
Burns
Injuries
Electric
Shock
Fire
Chemical
Microbiological
9% Electrical
Appliances
7% Motor
Vehicles
Injuries
Burns
25% Toys
4%
Cosmetics
NOTIFICATION BY COUNTRY OF
ORIGIN OF NOTIFIED PRODUCTS
10%
44% Clothing
33% Toys
China, including Hong Kong
EU and EEA
Unknown
Other
4
64%
22% Clothing
11%
15%
27% Motor Vehicles
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.
Small Part Cylinder
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 mouthactuated toy, with a serious risk of choking for children of all ages.
6
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.
7
Strangulation
Number 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.
8
Microbiological risk in liquid toys
Number 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 contents
Microbiological Content
Limits
Total Aerobic Microbial Count
≤ 1000 cfu/g or ml
Yeast and Mould
≤ 10 cfu/g or ml
Staphylococcus Aureus
Absent in 1 ml or g
Pseudomonas Aeruginosa
Absent in 1 ml or g
Candida 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
9
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.
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.
10
Burns
Number 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
Metal with Metal with
Metal with
coating
coating
coating
Ceramics,
thickness
thickness
thickness
glass &
greater
greater than greater than
stone
than 50 µm
100 µm
150 µm
surfaces
Plastic,
wood
& other
surfaces
Toy
intended
for
Metal
(uncoated)
surface
Children < 3
years
29 K
29 K
29 K
30 K
39 K
44 K
Children 3
years to < 8
years
33 K
36 K
39 K
41 K
46 K
50 K
Children 8
years and
above
36 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 Hazard
Number of recall cases in 2014: 279
Why it’s dangerous: Children may ingest carcinogenic, mutagenic and reprotoxic 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 Toys
UL recommended testing plan includes:
•
•
•
•
EN 71 Part 1 – Mechanical & Physical
properties
EN 71 Part 2 – Flammability
Test
EN 71 Part 3 – Migration of certain
elements
Azo Dyes (REACH Annex XVII,
item 43)
•
•
•
Total Phthalate (REACH Annex
XVII, item 51,52)
Total Cadmium (REACH Annex
XVII, item 23)
EN71 Part 9 - Organic Chemical
Compounds Requirements
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
properties
EN 71 Part 2 – Flammability
Test
EN 71 Part 3 – Migration of certain
elements
•
•
•
Total Phthalate (REACH Annex
XVII, item 51,52)
Total Cadmium (REACH Annex
XVII, item 23) on paints
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.
14
•
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
EN 71 Part 3 - Migration of certain
elements
EN71 Part 9 - Organic Chemical
Compounds Requirements
Total Cadmium (REACH Annex XVII, item
23) on paints
Efficacy Of Antimicrobial Preservation on
cosmetic
•
Microbiological
Contamination
Toxicological Risk
Assessment (TRA)
Heavy Metal Test: Lead
and Mercury
Total Phthalate (REACH
Annex XVII, item 51,52)
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
EN 71 Part 3 - Migration of
certain elements
Formaldehyde
•
•
Total Phthalate (REACH
Annex XVII, item 51,52)
Azo dyes (REACH Annex
XVII, item 43)
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.
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 toy
3. Repeat 2-3 times to make a certain thickness of dry paint
4. 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 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
elements)
1 pc of finished product
+ 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
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 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
Extractable Lead & Cadmium Content / RIM
4 pcs (EU) / 6 pcs (FDA) / 12 pcs
(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
Dye)
20g/A sheet with 2 x A4 size
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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POLYMERIC
Toys and accessible Components
of toys intended for children
under 3 years of age
TEXTILE
Mouthpiece components of
mouth-actuated toys
POLYMERIC
WOOD
X
X
PAPER
X
X
X
X
X
X
WOOD
X
X
PAPER
X
X
LEATHER
Inflatable toys with a surface
greater than 0.5 m2 when fully
inflated
POLYMERIC
Toys worn over the mouth or
nose
POLYMERIC
X
X
X
X
X
X
Sample size
6pcs
8g
X
5g
X
X
X
6pcs
8g
3g
X
20g
X
20g +
2pcs
X
23g
3g
POLYMERIC
X
20g
TEXTILE
X
20g
POLYMERIC
Toys and Accessible Components
of toys for indoor use
WOOD
X
Toys and Accessible Components
of toys for outdoor use
WOOD
X
Toys and components of toys
which mimic food
POLYMERIC
Solid toy materials intended to
leave a trace
ALL
X
X
X
X
X
X
Colored accessible liquids in toys
LIQUID
Non-colored accessible liquids
in toys
LIQUID
Modelling clay, play clay and
similar, except those chemical
toys addressed by EN 71-5
ALL
X
X
Balloon-making compounds
ALL
X
X
ALL
X
X
Imitation jewelry
X
X
4g
Components of graphic
instruments sold as toys or used
in toys
Imitation tattoos with adhesive
6pcs
X
X
PAPER
X
3g
X
TEXTILE
Plasticisers
X
Preservatives
X
Wood
preservatives
(Indoor)
X
Wood
preservatives
(Outdoor)
X
Solvents inhalation
Solvents migration
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
Toys which the child can enter
Primary Aromatic
Amines
POLYMERIC
Monomers
Toys intended to be mouthed by
children under 3 years of age
Colorants
Flame retardants
EN71 Part 9 Organic Chemical Compounds –
Requirements and Requested Sample Size
POLYMERIC
X
X
X
6pcs
5g
5g
X
X
6pcs
3g
X
5g
X
2g
X
13g
X
X
X
X
23g
5g+
2pcs
X
X
6pcs
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contact [email protected].
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