Post on 12-Mar-2018
Comply with Product Safety Standard for Toy Manufacturers
Mr. Julian Kwok
Senior Technical Manager, CHK, Hardlines – Toy, SGS Hong Kong
Ltd.
2
Content
� Comply with the requirements in the worldwide market
� US / EU Product Safety Regulation / Directive - Framework
� US / EU Product Safety Regulation / Directive - Update
� Common failure cases and experience sharing
� US CPSC / EU RAPEX Product Recalls
� Tips & Critical Points during Merchandising
3
Disclaimer
� This publication is intended to provide technical information and shall not be considered an exhaustive treatment of any subject treated. It is strictly educational and does not replace any legal requirements or applicable regulations. It is not intended to constitute consulting or professional advice. The information contained herein is provided “as is” and SGS does not warrant that it will be error-free or will meet any particular criteria of performance or quality.
Comply with the requirements in the worldwide market
� US / EU Product Safety Regulation / Directive -Framework
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United States
Consumer Product Safety Act (CPSA), enacted in 1972, Section 15
Products distributed in the United States must be safe under reasonable foreseeable use.
Section 15(b) of the Consumer Product Safety Act requires companies to report
any safety incident related to their products, and Section 15(d) authorizes the
Consumer Product Safety Commission to order companies to remove unsafe
products from the market.
Consumer Product Safety Improvement Act (CPSIA), enacted in Aug2008, 15 U.S.C. 2051
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Toys Safety Standards in US
United States • ASTM F963
• Essential regulations for toys in Title 16 of Code of Federal Regulation (16 CFR)
• Consumer Product Safety Improvement Act (CPSIA)
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Overview of ASTM F963-08
• Physical and mechanical tests
• Battery operated toys
• Flammability for solid (16 CFR 1500.44)
• Flammability for fabric (16 CFR 1610)
• FDA and cosmetic regulation
• Microbial cleanliness and preservative effectiveness
• Stuffing material cleanliness
• DEHP for pacifiers, rattles and teethers
• Total lead (16 CFR 1303) and soluble heavy metals
• Etc.
8
European Union
General Product Safety Directive(2001/95/EC), GPSD, enacted in Dec2001
Require products distributed in the markets to be “Essentially Safe” under reasonable foreseeable use conditions. Risk assessments should be performed and products should present little to no risk to consumer.
GPSD is the legal foundation that governs the product safety rules in Europe. It is
drafted and implemented by the Council of European Communities. Adopted by
member states of the EU. Also enforced in additional countries (EFTA).
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EU General Product Safety Directive
General Product
Safety Directive 2001/95/EC
Toy
Directive 88/378/EEC
Cosmetics
Directive 76/768/EEC
Low Voltage
Directive 2006/95/EC
EN 71-1
EN 71-2
EN 71-3
.
.
.
“The General Products Safety Directive shall apply in so far as there are no specific provisions with the same objective… governing the safety of the products concerned.”
EN 581-1
EN 14872
EN 13138-2
.
.
.
Harmonized under GPSD
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Toys Safety Standards in EU
European Union • Toy Safety Directive
• EN 71 Part 1 to 8
• EN 62115
• EN71-9 to 11
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Structure of EN 71
• Part 1 – Mechanical and physical properties
• Part 2 – Flammability
• Part 3 – Migration of certain elements
• Part 4 – Experimental sets for chemistry and related activities
• Part 5 – Chemical toys (sets) other than experimental sets
• Part 6 – Graphical symbol for age warning labelling
• Part 7 – Finger paints
• Part 8 – Swings, slides and similar activity toys for indoor and outdoor
family domestic use
• Part 9 – Organic chemical compounds – Requirements
• Part 10 – Organic chemical compounds – Sample preparation and
extraction
• Part 11 – Organic chemical compounds – Method of analysis
Comply with the requirements in the worldwide market
� US / EU Product Safety Regulation / Directive -
Update
• US Consumer Product Safety Improvement Act (CPSIA)
• EU New Toy Directive (2009/48/EC)
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� Public Law 110-314 (HR 4040)
�Title 1 – Children’s product safety
�Title 2 – Consumer product safety commission reform
� Significant impacts Involving toys and children’s products
�Bans on lead and phthalates
�Mandatory third party testing and certification
�Mandatory product tracking labels & product registration
�New warnings in advertisements for toys and games
�New Safety standards and test procedures
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA)
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� Definitions for Toys and Children’s Products
� Children’s products
� Designed or intended primarily for children up to 12 years old
� Children’s Toys
� Products designed or intended by manufacturer for a child up to 12 years old for use when child plays
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA) - Definition
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� Definitions for Toys and Children’s Products
� Childcare Articles
� Consumer products designed or intended by manufacturer to facilitate sleep or the feeding of children up to the age of 3
or
� Help children with sucking and teething
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA) - Definition
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14 Aug
2009
≤ 90 ppm
(may be lowered after scientific studies)
≤ 2 µg
(XRF or alternative methods)
(Complete study of alternative methods by 14 Aug 2009)
Lead Paint / surface coating
(modify 16 CFR 1303.1)
Small paint areas
≤ 10 mg or ≤ 1 cm² of
surface area
≤ 600 ppm
≤ 300 ppm
≤ 100 ppm
(if technologically feasible)
Requirement
10 Feb, 2009
14 Aug, 2009
14 Aug, 2011
Products for children
up to 12
Lead
Effective DateScope Substance
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA) – Lead Requirements
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2
1
Group
≤ 0.1 %DNOP
≤ 0.1 %DINP
≤ 0.1 %Interim Ban
Toys for children that can
be placed in the mouth
or childcare articles
DIDP
≤ 0.1 %BBP
≤ 0.1 %DBP
10 Feb
2009
≤ 0.1 %
Toys for children or
childcare articles
DEHP
Effective DateRequirementScope Phthalate
� Ban on Phthalates
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA) – Phthalates Requirements
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� CPSIA Tracking Label
� Section 103(a) of CPSIA
� Manufacturers to have a tracking label or other distinguishing permanent mark on any consumer product primarily intended for children twelve and younger
� The tracking label must contain certain basic information, including
• the source of the product,
• the date of manufacture,
• and more detailed information on the manufacturing process such as a batch or run number
� Effective Date: The requirement for tracking labels is effective one year after the date of enactment or August 14, 2009.
‘Consumer Product Safety Improvement Act of 2008’ (CPSIA) – Tracking Label
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A new European Toy Safety Directive 2009/48/EC has been published on the 30th of June in the Official Journal of the EU. The Directive will replace the 20 year old 88/378/EEC Toy Directive.
Reasons:-Since 1988, the Directive has been amended only once.-To harmonize the safety levels of toys throughout the Member States and to remove obstacles to trade in toys between Member States-Chemicals substances used in toys
Goals:-To improve the quality and efficiency of the toys safety regulations -To simplify the current legislation for both economic operators and market surveillance authorities
New Toy Directive
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New Toy Directive
� New Toy Directive (2009/48/EC) will come into force on the 20th of July
� Transitional periods
• 2 years: Both the old end the new Directive may be used
during the transitional period (until 20th of July 2011)
• 4 years: For the chemical requirements; the transitional
period is 4 years (until 20th of July 2013)
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New Toy Directive
Main elements of the revision
� Enhanced safety requirements
� More efficient and coherent enforcement of the Directive
Major Changes
� New Definitions
� Physical & Mechanical Properties
� Chemical Properties
� Hygiene
� CE marking and its affixing
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New Toy Directive – New Definitions
New Definitions
� “manufacturer” means any natural or legal person who
manufactures a toy or has a toy designed or manufactured, and
markets that toy under his name or trademark
� “importer” means any natural or legal person established within
the Community, who places a toy from a third country on the
Community market
� “hazard” means a potential source of harm
� “harm” means the physical injury or any other damage to health,
including long term effects
� “intended for use by" means that a parent or supervisor shall
reasonably be able to assume by virtue of the functions,
dimensions and characteristics of a toy that it is intended for use
by children of the stated age group
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� Toys in food
Toys contained within food or co-mingled with a food must have their own packaging. This packaging, in its supplied condition, must be of such dimensions as to prevent it being swallowed and/or inhaled.
� Toys firmly attached to a food product shall be prohibited.
� WARNING:
Toys contained in food or co-mingled with food shall contain the warning:
“Toy inside. Adult supervision recommended”
New Toy Directive - Physical and Mechanical Properties
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New Toy Directive - Chemical Properties
� EU Toy Directive revision - Chemical properties
� The revision strengthens the requirements for chemical properties:
� Allergenic fragrances
� Carcinogenic, Mutagenic or toxic to Reproduction substances (CMR)
� Migration of certain elements
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� Allergenic fragrances
� 55 fragrances are not allowed to be used in toys� Traces of these fragrances shall be allowed provided that
such presence is technically unavoidable under good
manufacturing practice and does not exceed 100 mg/kg
� Another 11 fragrances if added to a toy, as such, at concentrations exceeding 100 mg/kg in the toy or components
� The names of the allergenic fragrances shall be listed on the
toy, on an affixed label, on the packaging or in an
accompanying leaflet
New Toy Directive - Chemical Properties
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New Toy Directive
CE marking and its affixing
Existing Directive that the CE marking shall be marked either on the toy or the packaging or in case of small toys on a label or accompanying leaflet.
It adds one novelty: the CE marking shall always be affixed on the packaging if the marking on the toy is not visible from outside the packaging.
Adds more visibility to the CE-marking
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US CPSC Recall
Type of HazardType of Hazard
Describe the Incidents /
Injuries (user behavior); No. of reports received
Describe the Incidents /
Injuries (user behavior); No. of reports received
Join recall with Health
Canada
Join recall with Health
Canada
Post Recall ActionPost Recall Action
Recall Product Photos
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EU RAPEX Recall
Hazard Type, Hazard
Detail, Directives applied
(enforcement focus)
Hazard Type, Hazard
Detail, Directives applied
(enforcement focus)
Measure adopted, may
be sales ban, rejected by custom, … (government
reaction)
Measure adopted, may
be sales ban, rejected by custom, … (government
reaction)
Category, like Toys, Childcare Articles, …
Category, like Toys, Childcare Articles, …
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508
1713
Section 15 Recalls – Failed Essential Safety Requirements
CPSC Regulated Product Recalls - Failed Federal Regulations
*CPSC Recalls – October 1, 1997 – February 17, 2006 n=2,221
U.S. CPSC Recalls 1998 – 2006*
The majority of products met federally mandated requirements but were still recalled because they were not safe.
35*European RAPEX Recalls – Week 6, 2004 – Week 27, 2006 n=2,001
EU RAPEX Recall Rates*
0
50
100
150
200
250
300
350
400
Q1
2004
Q2
2004
Q3
2004
Q4
2004
Q1
2005
Q2
2005
Q3
2005
Q4
2005
Q1
2006
Q2
2006
Co
un
ts
Other
E&E
SL
HL
36
A 13-month-old girl reportedly suffocated when one-half of a Xxxxxxx ball
covered her nose and mouth. An 18-month-old girl reportedly also had a
ball-half stuck over her face, causing her distress. However, the girl's
father (on the second attempt) pulled the ball-half from her face.
The Xxxxxxx balls are plastic ball-shaped containers between 2 ¾" and
3" in diameter. They pull apart to reveal one of 57 different Xxxxxxx toys
inside. The balls were distributed in a variety of colors including red and
white, and hot pink. Packaging described them as safety tested and
recommended for all ages of children.
CPSC Recall of Xxxxxxx Ball
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CPSC recalls approximately 7,200 newborn and infant garments described
as Mini Fruit Girl's Rompers. The attached ornamental cherries on these
garments pose a choking hazard to young children.
The manufacturer is aware of one
incident in which a child started to
choke on one of the ornamental
cherries. It was pulled from the child's
throat by the attached string.
CPSC Recall of Children's Garments with
Ornamental Cherries
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CPSC Recall of Football
Units: About 294,000
Hazard: The football contains a hard plastic interior frame
that can pose a risk of facial cuts if a child is hit during play.
Incidents/Injuries: There have been nine reports of facial
injuries, including eight requiring stitches or medical
attention.
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CPSC Recall of Bottled Water with
Sport Caps
Name of product: Bottled Water with Push-Pull
Sports Cap in 8 oz., 8.5 oz. and .33 liter bottle sizes.
Units: 3.2 million
Hazard: When pulled to open, the drinking spout on
the sports cap can unexpectedly come off, posing a
choking hazard for young children.
Incidents/Injuries: There have been 10 complaints
with no injuries reported.
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Selling of the product stopped.
Risk of fire/burns. There is no indication that the item is also lighter. Pressing the trigger of the revolver activates the lighting mechanism and flashing lights across the top of the barrel – a 45mm flame appears from out of the end of the gun barrel. Therefore as the item’s design is appealing to children, accidents may happen when an unsuspected child ignites the lighter part.
Powerful Laser Pointer/ Lighter.Type/model: P57.Country of origin: China.
United Kingdom
30139/06
Measures adopted by notifying country
Danger ProductNotifying Member States
No.Ref.
RAPEX Recall Example
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CPSC Recall of Paperweights
The paperweights can leak petroleum distillates, which can pose
ingestion and flammability hazards to consumers.
This recall is being conducted to prevent the possibility of
injuries.
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Making sure you're getting what you pay for
� Paying the right money for the right thing
� “Better Buying” strategy
Companies can achieve extensive purchase cost reductions by employing "Better Buying"
strategies.
It is typical that a 5% reduction in purchase costs can result in a 50% profit improvement.
"Better Buying" involves better aggregating and leveraging buying power, better buying
processes and implementing technologies such as supplier reverse auctions.
44
3P’s in the Supply Chain
Product
Design Failure
Start upFailure
MaterialFailure
Measurement System Failure
Process Out-of Control
Superficial Failure Analysis
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Product Control: Risk Assessment Process
� Review of Legal and Voluntary Standards– CPSIA
– REACH
– EU new toys directive
� Review of Customer Specific Requirements
� Review of Essential Safety Requirements• Design Failure Modes Effect Analysis (Complex Products)
• Risk Assessment Process (Simple Products)
– Data Analysis
– Foreseeable Use Analysis
– Hazard Identification and Analysis
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Product Control : Managing Product
Related Risks
There is a variety of options available to manage risk:
� Design Out the Potential Hazard• Requires action early in the process
• Best and most cost effective approach
� Provide Effective Warnings or Instructions• Provides the least protection since hazard still exists
• Most effective for products with inherent hazards
� Accept the Risk Based on an Educated and Informed Fact-Based Decision
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Process
3P’s in the Supply Chain
Product
Design Failure
Start upFailure
MaterialFailure
Measurement System Failure
Process Out-of Control
Superficial Failure Analysis
Wrong Mark/Label
Package Failure(Qty, type…)
Miss/DelayShipment
Transportation Damage
49
Process Control: Defining the level of suppliers –
The Grade
4 Grading for Suppliers
Gra
de D
Gra
de C
Gra
de
B
Gra
de A
BestNew or Developing
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Process Control: Monitoring – Actions after
grading
� Release the supplier from the supplier list if no improvement in next review or failed in 2 factory audit.
� Closely monitor the supplier.
� Supplier can be asked to pay for inspection after no. of times …
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People
3P’s in the Supply Chain
ProcessProduct
Design Failure
Start upFailure
MaterialFailure
Measurement System Failure
Process Out-of Control
Superficial Failure Analysis
Wrong Mark/Label
Package Failure(Qty, type…)
Miss/DelayShipment
Transportation Damage
Productivity
ArtificialQuality System
Social Compliance
EHS
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The Human Factor - Common Ethical Issues
� Excessive working hours
� No rest day in seven-day period
� Inadequate overtime premium paid
� Minimum wage not paid
� Inadequate benefits and/or paid leave
� Poor health and safety performance
� Child & young Labor Issues (especially in Summer school holiday)
� Incomplete records of working hours and wages
� Freedom of association (no parallel means)
� Waste discharge not according to legal requirements
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The Human Factor – Common Quality Issues
� No documented inspection testing procedures
� No incoming inspection records
� No work instruction and approved sample
posted on site
� Poor on-site material and product labeling
� No in-process and final product inspection records
� Final inspection not conducted
� Testing / measuring equipment not calibrated
� No clear procedure about client complaint handling
� No documented corrective and preventive actions
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The Human Factor - Training
Training is the key to quality. Build skill sets that translate into improved product
safety and quality, quicker time to market and reduced manufacturing costs.
�Ethical Issues
• Social Accountability and Code of Conduct
• Corporate Social Responsibility
�Technical Issues
• Comply to the latest and regulations and requirements
• Identify Restricted substances
• Establishing QA system in place
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3P’s throughout your supply chain
Design Failure
Start upFailure
MaterialFailure
Measurement System Failure
Process Out-of Control
Superficial Failure Analysis
Wrong Mark/Label
Package Failure(Qty, type…)
Miss/DelayShipment
Transportation Damage
Productivity
ArtificialQuality System
Social Compliance
EHS
Supplier SystemFailure
Distribution or Delivery Failure
Product or Production Failure
RISK