Toy Safety – A Guide to the Latest Updates to ASTM F963

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Supplier Audit Programs 1

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1Laboratory Testing Product InspectionsSupplier Audit Programs

[email protected] – AsiaInspection ©

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Toy Safety – A Guide to the Latest

Updates to ASTM F963

Karolyn Helda, Managing Director, AI ANSECO

Chris Goller, Manager - Client Services and Global Programs, AI ANSECO

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We Assess Product Safety andCompliance to International Standards

Four ISO 17025-accredited in-house labs in the U.S., Hong Kong and China: 130 lab engineers and technicians catering to your compliance needs for Toys, Softlines, Eyewear, Gifts and Accessories.

A network of accredited lab associates worldwide, offering physical and chemical tests.

Safety testing to international, national and regional standards: ISO, EN, ASTM, ANSI, CPSIA, FDA, AS/NZ, GB, REACH, RoHS.

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Introduction to ASTM F963

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Introduction to ASTM F963: Purpose

Purpose of Standard:

Establish nationally recognized safety

requirements for toys

Establish testing procedures or methods for

the corresponding safety requirements (various

requirements for different age limits)

Establish guidelines and requirements for

labeling, instructional literature and

producer’s markings

Reduce hazards associated with normal,

intended use and reasonably foreseeable

abuse of the toys

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Introduction to ASTM F963: Scope

ASTM F963 regulates toys, defined as:

Any object designed, manufactured or marketed as a plaything for children

under 14 years of age (excluding products listed in the next slide)

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Articles that are NOT covered by this standard:

1. Bicycle or Tricycle

2. Non-powered Scooters

3. Recreational Powered Scooters or Pocket Bikes

4. Sling Shots or Sharp-pointed Darts

5. Playground Equipment

6. Non-powder Guns

7. Kites

8. Hobby and Craft Item (Finished item not primarily of play value)

9. Model Kit (Finished item not primarily of play value)

10. Crayons, Paints, Chalks and other similar art materials (The material and finished item not

primarily of play value) except that all art materials, whether or not a component of a toy, must

comply with LHAMA

11. Sporting Goods, Camping Goods, Athletic Equipment, Musical Instruments, Juvenile Products

or Furniture (However toys that are their counterparts are covered)

12. Powered Models of Aircraft, Rockets, Boats or Land Vehicles (However toys that are their

counterparts are covered)

13. Constant Air Inflatables

Introduction ASTM F963

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Overview of Changes:

From ASTM F963-11 to ASTM F963-16

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Requirements with Significant Changes

Publication of

ASTM F963

version 2016

ASTM formally

notified the CPSC

CPSC will make decision

on the adoption of the

updated standard

The standard will

become mandatory if it

is adopted by CPSC

October 20, 2016 November 1, 2016 Before January 29, 2017 April 29, 2017

Time Line:

Requirements that have significant changes from ASTM F963-11

1. Chemical Requirements

2. Microbiological Requirements

3. Physical Requirements

4. Electrical Requirements

5. Magnet Requirements

6. Labeling, Instruction and Producer Marking Requirements

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Heavy Elements

Extend the use of alternative screening method for homogenous polymers (from Total

Lead to All 8 Heavy Metals):

– X-ray Fluorescence Spectrometry using Multiple Monochromatic Excitation Beams

(HD-XRF)

Chemical Requirements

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Heavy Elements - Clarifications

Exemption under 16 CFR 1500.91:

– Exemption of certain materials from testing for total lead is extended to soluble lead only, not

the other elements

(except for paper and paperboard which are exempt from soluble testing for all elements)

Stickers:

1. Stickers consisting of a paper substrate with no laminate coating are exempt from substrate

testing per paper exemption

2. Stickers printed on a plastic or nonporous substrate or have a laminated plastic coating are to

be tested as a single polymeric material

3. If scrapeable, ink or surface coating is tested as surface coating

Textile material:

– If printing is easily separated from the textile substrate, it shall be separated from the

substrate and be tested as a surface coating

Metallic toys or metallic toy components:

– If the result of total screening test for cadmium is below 75 ppm, metal small part components

are deemed compliant to the extraction of cadmium test (200µg)

Chemical Requirements

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Cosmetic, Liquids, Pastes, Putties, Gels, Powders and Items of Avian Feather Origin

1. Updated and expanded the scope of microbiological safety through adding Items of Avian Feather Origin

2. Provided additional test protocol:

– Microbiological cleanliness testing: CTFA Microbiology Guidelines M-1 and M-2

– Preservative Effectiveness: CTFA Microbiology Guidelines M-3 and M-6

3. Test method citation updated to the latest version:

– Microbiological cleanliness testing : USP 24 USP 35 <61> and <62>

– Preservative Effectiveness: USP 24 USP 35 <51>

4. Added microorganism requirements and specified acceptable microbial limits for cleanliness of materials and preservative effectiveness:

– To specify acceptable microbial loads for various product categories.

– To specify pathogens which must be absent for various product categories.

– To clarify how and specify a method by which formulations are to be evaluated to determine the need for microbial challenge testing and thus which products must be tested.

– To specify a minimum standard set of organisms to be utilized for microbial challenge testing.

5. Clarified the microbiological requirements for process water

Microbiological Requirements

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Cleanliness of Materials


Product Categories Microbial Limits (cfu/mL or cfu/gm)

Infant product 100 (500)1

Product such as face paints or cosmetics intended for use by a child or on a doll

or similar product (excluding lip balms, lip glosses, lipsticks and the like items)

which have a high likelihood of being used in the area of the eye

100 (500)1

Avian feather products 5000

All other products 1000 (5000)1

1 Due to the variability introduced by the dilution process, up to 5 x 102 cfu/mL or cfu/gm for infant or face paint and up to 5 x 103 cfu/ml or

cfu/gm for all other products can be considered to be an acceptable result.

Additionally, following organisms shall not be detected:

– Pseudomonas sp.

– Escherichia coli

– Coagulase-positive Staphylococcus sp.

– Salmonella sp.

– Shigella sp. (for Avian Feathers only)

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Preservative Effectiveness

Added following example products that would NOT be subjected to microbial challenge

tests (products with a low likelihood of supporting microbial growth are anhydrous, or

have a water activity below 0.5, or have some other characteristic which serves to

inhibit microbial growth):


– Wax based products

– Siloxane and its derivative

based products

– Lip balms

– Pomades

– Ointments

– Powders (anhydrous or nearly so,

and non-hygroscopic)

– Products with an alcohol content

equal to or greater than 20% (v/v)

– Products with a pH of less than 3 or

greater than 10

– Avian feather products

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Preservative Effectiveness

Added following criteria used to evaluate the preservative effectiveness:

– Sampling is to be performed (at a minimum) at the following intervals: at inoculation plus 14

days and 28 days after inoculation

– Bacteria must exhibit a log reduction of >2 (that is population must be less than 1% of initial

inoculum) at 14 days, and show no increase from the 14-day result at 28 days

– Fungi, yeast and molds must exhibit no increase from the initial inoculum at either 14 or 28 days

Test methods:

– USP 35 <51>

– CTFA Microbiology Guidelines M-3 and M-6

Minimum list of organisms used to challenge preservative effectiveness:

– Staphylococcus aureus

– Escherichia coli

– Pseudomonas aeruginosa

– Candida albicans

– Aspergillus brasiliensis


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Process Water

Added requirements for process water used in the manufacturing and filling of

toys:

– Heterotrophic plate count: < 10 cfu/ml

– The absence by test of coliform bacteria


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Stuffing Material

Removed Pennsylvania (PA) state requirements due to the reason that state laws

should not be referenced in the ASTM standard adopted by CPSC

Evaluation method of stuffing is simplified by allowing visual inspection using

Stereo Widefield Microscope or equivalent apparatus

Physical Requirements

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Acoustics

Evaluation procedure is updated to be better aligned with:

– ISO 8124-1

– EN 71-1

Phrases “continuous sounds” and “impulsive sounds” replaced by measurement

type: LAeq and LCpeak, respectively.

Pull and push toys: added definition and updated test parameters:

– Definition: a toy with a cord / tether or a handle attached to the toy and where the

toy is intended for use on the ground with the child in a standing / upright position,

typically walking, while using the toy

– Speed at which the pull and push toy are operated to product maximum sound

level is lowered from 2m/s to 1m/s

Updated the C-weighted peak limit for close-to-the-ear toys:

– The limit is raised from 95 dB to 110 dB (to align with EN 71-1)

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Ride-on Toys and Toy Seats

Product with multiple wheels centered on the same axle with spacing 150 mm or less

is considered as a single wheel and does not require to test for stability of ride-on

toys and toy seats

The overload test for ride-on toys intended to accommodate multiple children is

modified to provide a more stringent test (Now, all seating/standing are tested

simultaneously instead of tested individually)

Cords, Straps and Elastics in Ride-on Toys

Added exemption from the free length and loop requirements for straps used in

waist restraints on ride-on toys


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Mouth-actuated Projectile Toys Small part requirements and test methods for mouth-actuated projectile toy

which may lead to choking hazard is added

The toy must have a permanently installed means to prevent passage of the

projectile backwards into the user’s mouth


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Projectile Toys

Updated and added definition related to projectile (I):

– Projectile: an object intended to be launched into a free flight.

Does not include self-propelled flying toys such as remote control helicopters and

wind-up airplanes


– Projectile toy with stored energy: toy with a

projectile launched by means of a discharge

mechanism capable of storing energy

independent of the user and typically requiring

at least one discrete action by the user to

launch the projectile.

Example: rockets propelled by a chemical

reaction or compressed gases where the

energy can be stored independent of the

user.

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Projectile Toys

Updated and added definition related to projectile (II):

– Projectile toy without stored energy: toy with a projectile propelled by energy

imparted by the user or by means of a discharge mechanism incapable of storing

energy independent of the user


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Projectile Toys

In general, changes are made to align with standards, ISO 8124-1 and EN 71-1

Clarified that the following products are not applicable to the projectile toy requirement:

– Ground-based toys or components of toys

– Projectiles that travel less than 300mm

Apparatus tip assessment gauge is added for projectile with a ridged leading edge:

– All projectiles with rigid leading edges shall not protrude through the gauge


Tip Assessement Gauge

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Projectile Toys

A minimum length requirement of 57 mm is established for suction cup projectiles

which pass through the same ball gauge


Example of Suction Cup with a Foam Shaft

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Projectile Toys

For projectile toys with stored energy:

– Any projectile that has a kinetic energy that exceeds 0.08J shall have a resilient

leading edge

– The maximum Kinetic Energy Density (KED), also known as kinetic energy per unit

area of contact, shall not be greater than 2500 J/m2

– Exemption to small part requirements are established for the following projectiles

toys that are intended for children three years old or older:

1. Projectiles that travel 100 mm or less when tested for Projectile Launched Distance

2. Small parts that are released from a projectile after abuse testing and that are either not

capable of being launched or travel 100 mm or less when tested according to Projectile

Launched Distance

3. Small parts of foam that are released from projectiles whose shafts are completely made

of foam after abuse test

For both projectiles with stored energy and arrows fired without stored energy

– Testing conditions are added for impact test


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Projectile Toys

Added requirements that rotors on projectiles intended to rotate in a horizontal plane

shall be protected. Examples include:

– Design of the rotor prevents access to the blade ends during operation

– Rotor blades are curved or swept back

– Blade ends are clutched or loosely attached to the rotor so that the ends are not

directly powered by the rotor drive

– Rotors are designed to have resilient leading edge


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Squeeze Toys

The impaction hazard requirement is clarified to only apply to the portion of the toy

which has the squeeze function.

For example if a squeeze toy is attached to another toy which is not a squeeze toy,

only the squeeze toy parts are subject to the requirement

This change is intended to address products where a squeeze toy is attached to a ring.

The ring would not be subject to the squeeze toy requirements because it is not a

squeeze toy.


Expanding Material Toys

New requirements are added for a small part

expanding material toy which may expand

significantly after being swallowed by a child,

creating a gastrointestinal blockage:

– The expanding material shall completely

pass through the gaugeExpanding Toy Test Template

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Toy Chests

Reincorporated requirements for toy chest from ASTM F963-07e1 (exempted in 2011

version)

Added procedure for lid support mechanism:

Check the complete arc of travel of the lid from the 2 in. (50 mm) opened position to

the 60° position at 5° increments. Repeat the evaluation starting at the 60° opened

position to within 2 in. (50 mm) from closed position at 5° increments.

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Electrical Requirements

Battery Operated Toys

Added definitions for cell and battery:

Primary battery: one or more primary cells, including case, terminals and markings

Primary cell: basic functional unit providing a source of electrical energy by direct

conversion of chemical energy, which consists of an assembly of electrodes,

separators, electrolyte, container and terminals, and that is not designed to be

electrically recharged

Secondary battery: assembly of secondary cell(s) ready for use as a source of

electrical energy characterized by its voltage, size, terminal arrangement, capacity

and rate capability

Secondary cell: basic functional unit providing a source of electrical energy by direct

conversion of chemical energy, which consists of electrodes, separators, electrolyte,

container and terminals, and that is designed to be electrically recharged

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New electrical test requirements for rechargeable cells and batteries, such as

lithium batteries and nickel metal hydride batteries:

– Battery overcharge test

– Repetitive overcharge test

For toys that contain secondary cells or secondary batteries:

– Clarified that requirements below do not apply to the main drive circuit of battery-powered ride-

on toys powered by batteries other than lithium batteries

– Added requirements for toys operated from lithium ion or lithium ion polymer batteries that the

cell / batteries shall comply with at least one of the following standards:

• ANSI C18.2M Part 2

• UL 1642 (cells used in lithium batteries) or UL 2054 (Lithium batteries)

• IEC 62133

– Added new reference standards for batteries charged outside of the toy:

• ANSI/UL 2595

• IEC 60950-1

(Compliance with the cells/batteries standards may be established by appropriate documentation

rather than third party testing)


– Single fault charging test

– Short circuit protection test

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Short Circuit Protection Requirements were added for batteries and chargers

– Includes test parameters for removable batteries, toys using lithium batteries and toys using

nickel metal hydride batteries

– Added to prevent short circuits which can cause overcharging and overheating


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Magnet Requirements

New definition of “magnetic/electrical experimental sets” is added.

– Definition: Toy containing one or more magnets intended for carrying out educational

experiments involving both magnetism and electricity

– Example: Electrical motors, loudspeakers, doorbell etc.

– “Magnetic/electrical experimental sets” replace “Hobby, craft, and science kit type items” in the

scope of product that could be exempted if specific safety labeling is present (Narrowed the

types of product that are applicable to the exemption)

Added magnet use and abuse tests which aligned with ISO 8124-1 and EN 71-1:

– Soaking test for wooden toys used in water and mouth pieces of mouth actuated toys with

magnet to be performed prior to other use and abuse tests

– Compression test

– Drop test

– Specified metal disk to use for cycle test when toy contains no mating metal part

Clarified that use and abuse tests on magnets for use by children aged over 8 should

follow the same test parameters as magnets for use by children between 3 and 8 years old.

Magnet Requirements

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New Button or Coin Cell Batteries Labeling

If the toy is operated with button or coin cell batteries of nominal 1.5 Volts or is

greater than 15mm in diameter, and fits within the small parts cylinder, the packaging

shall bear the following warning:

If the toy does not contain instructions, the label shall appear either on the package or

in an insert packed with product. The labeling shall consist of :

– WARNING This product contains a Button or Coin Cell Battery. A swallowed Button or Coin Cell Battery

can cause internal chemical burns in as little as two hours and lead to death. Dispose of used batteries

immediately. Keep new and used batteries away from children. If you think batteries might have been

swallowed or placed inside any part of the body, seek immediate medical attention.

Magnets Labeling

Magnetic / electrical experimental sets must contain warnings on packaging and in

operating instructions

The safety alert symbol is now required to appear before the hazard alerting

message

Labeling Requirements

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Toy Chests Instruction

Reincorporated the requirements for toy chests from ASTM F963-07e1 (it is exempted in 2011 version)

New Battery Powered Ride-on Toys Instruction

Instruction shall contain guidance for safe use and maintenance of the toy with the following information for safe use:

– Maximum weight and/or age limitations

– Kinds of appropriate surfaces

– Warning statement which appears on the product

– “Only use the battery(ies) specified by the manufacturer”

– “Only use the charger(s) specified by the manufacturer”

Modified Battery Operated Toys Instruction

Information that is required to be marked in the instructions is amended by removing the term “nickel-cadmium” as follows:

“Do not mix alkaline, standard (carbon-zinc), or rechargeable (nickel-cadmium) batteries”.

Instruction Requirements

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Toy Chests Producer’s Marking

Reincorporated the requirements for toy chest from ASTM F963-07e1 (it is exempted

in 2011 version)

Producer’s Markings Requirements

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Q & A

Education

Toy Safety – A Guide to the Latest Updates to ASTM F963