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

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Safety regulations in the toy and children’s products industry are subject to frequent updates, to become more harmonized and reflect the latest new scientific data.

ASTM F963-11, the mandatory US standard for toy safety, has undergone significant revisions, with the new version, ASTM F963-16, due to become mandatory in April 2017. In our free webinar, we reviewed key updates to ASTM F963 to help you maintain compliance in your supply chain.

Why attend this webinar?

• Get a recap of ASTM F963 purpose and scope of application
• Learn about significant changes to Chemical, Microbiological, Physical, Electrical, Labeling, Instruction, and Producer Marking requirements
• Understand the purpose of changes from ASTM F963-11 to F963-16 and the steps you need to take to stay compliant

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

  1. 1. 1 Supplier Audit Programs 1 1 1Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   11 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
  2. 2. 2 Supplier Audit Programs 2 2 2Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   2 We Assess Product Safety and Compliance 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.
  3. 3. 3 Supplier Audit Programs 3 3 3Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   3 Introduction to ASTM F963
  4. 4. 4 Supplier Audit Programs 4 4 4Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   4 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
  5. 5. 5 Supplier Audit Programs 5 5 5Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   5 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)
  6. 6. 6 Supplier Audit Programs 6 6 6Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   6 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
  7. 7. 7 Supplier Audit Programs 7 7 7Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   7 Overview of Changes: From ASTM F963-11 to ASTM F963-16
  8. 8. 8 Supplier Audit Programs 8 8 8Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   8 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
  9. 9. 9 Supplier Audit Programs 9 9 9Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   9 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
  10. 10. 10 Supplier Audit Programs 10 10 10Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   10 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
  11. 11. 11 Supplier Audit Programs 11 11 11Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   11 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
  12. 12. 12 Supplier Audit Programs 12 12 12Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   12 Cleanliness of Materials Microbiological Requirements 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)
  13. 13. 13 Supplier Audit Programs 13 13 13Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   13 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): Microbiological Requirements – 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
  14. 14. 14 Supplier Audit Programs 14 14 14Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   14 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 Microbiological Requirements
  15. 15. 15 Supplier Audit Programs 15 15 15Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   15 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 Microbiological Requirements
  16. 16. 16 Supplier Audit Programs 16 16 16Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   16 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
  17. 17. 17 Supplier Audit Programs 17 17 17Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   17 Physical Requirements 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)
  18. 18. 18 Supplier Audit Programs 18 18 18Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   18 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 Physical Requirements
  19. 19. 19 Supplier Audit Programs 19 19 19Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   19 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 Physical Requirements
  20. 20. 20 Supplier Audit Programs 20 20 20Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   20 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 Physical Requirements – 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.
  21. 21. 21 Supplier Audit Programs 21 21 21Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   21 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 Physical Requirements
  22. 22. 22 Supplier Audit Programs 22 22 22Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   22 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 Physical Requirements Tip Assessement Gauge
  23. 23. 23 Supplier Audit Programs 23 23 23Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   23 Projectile Toys  A minimum length requirement of 57 mm is established for suction cup projectiles which pass through the same ball gauge Physical Requirements Example of Suction Cup with a Foam Shaft
  24. 24. 24 Supplier Audit Programs 24 24 24Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   24 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 Physical Requirements
  25. 25. 25 Supplier Audit Programs 25 25 25Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   25 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 Physical Requirements
  26. 26. 26 Supplier Audit Programs 26 26 26Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   26 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. Physical Requirements 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 gauge Expanding Toy Test Template
  27. 27. 27 Supplier Audit Programs 27 27 27Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   27 Physical Requirements 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.
  28. 28. 28 Supplier Audit Programs 28 28 28Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   28 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
  29. 29. 29 Supplier Audit Programs 29 29 29Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   29 Battery Operated Toys  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) Electrical Requirements – Single fault charging test – Short circuit protection test
  30. 30. 30 Supplier Audit Programs 30 30 30Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   30 Battery Operated Toys  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 Electrical Requirements
  31. 31. 31 Supplier Audit Programs 31 31 31Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   31 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
  32. 32. 32 Supplier Audit Programs 32 32 32Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   32 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
  33. 33. 33 Supplier Audit Programs 33 33 33Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   33 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
  34. 34. 34 Supplier Audit Programs 34 34 34Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   34 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
  35. 35. 35 Supplier Audit Programs 35 35 35Laboratory Testing Product InspectionsSupplier Audit Programs info@asiainspection.com – AsiaInspection ©   35 Q & A

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