Comply with Product Safety Standard for Toy Manufacturers

Comply with Product Safety Standard
for Toy Manufacturers
Mr. Julian Kwok
Senior Technical Manager, CHK, Hardlines – Toy, SGS Hong Kong
Ltd.

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
2

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.
3

Comply with the requirements
in the worldwide market
US / EU Product Safety Regulation / Directive -
Framework

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
5

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)
6

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.
7

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).
8

Toy
Directive 88/378/EEC
EN 71-1
EN 71-2
EN 71-3
.
.
.
EU General Product Safety Directive
General Product
Safety Directive 2001/95/EC
Harmonized under GPSD
EN 581-1
EN 14872
EN 13138-2
.
.
.
Cosmetics
Directive 76/768/EEC
Low Voltage
Directive 2006/95/EC
“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.”
9

Toys Safety Standards in EU
European Union • Toy Safety Directive
• EN 71 Part 1 to 8
• EN 62115
• EN71-9 to 11
10

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
11

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)

US Consumer Product Safety
Improvement Act (CPSIA)

Public Law 110-314 (HR 4040)
‘Consumer Product Safety Improvement
Act of 2008’ (CPSIA)
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
14

Definitions for Toys and Children’s Products
Children’s products
Designed or intended primarily for children up to 12 years old
Children’s Toys
‘Consumer Product Safety Improvement
Act of 2008’ (CPSIA) - Definition
Products designed or intended by manufacturer for a child up to 12
years old for use when child plays
15

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
‘Consumer Product Safety Improvement
Act of 2008’ (CPSIA) - Definition
Help children with sucking and teething
16

Substance
Lead
‘Consumer Product Safety Improvement
Act of 2008’ (CPSIA) – Lead Requirements
Scope
Products for children
up to 12
Lead Paint / surface coating
(modify 16 CFR 1303.1)
Small paint areas
≤ 10 mg or ≤ 1 cm² of
surface area
Requirement
≤ 600 ppm
≤ 300 ppm
≤ 100 ppm
(if technologically feasible)
≤ 90 ppm
(may be lowered after scientific studies)
≤ 2 µg
(XRF or alternative methods)
(Complete study of alternative methods
by 14 Aug 2009)
Effective Date
10 Feb, 2009
14 Aug, 2009
14 Aug, 2011
14 Aug
2009
17

Ban on Phthalates
Group
1
2
‘Consumer Product Safety Improvement Act
of 2008’ (CPSIA) – Phthalates Requirements
Phthalate
DEHP
DBP
BBP
DIDP
DINP
DNOP
Scope
Toys for children or
childcare articles
Interim Ban
Toys for children that can
be placed in the mouth
or childcare articles
Requirement
≤ 0.1 %
≤ 0.1 %
≤ 0.1 %
≤ 0.1 %
≤ 0.1 %
≤ 0.1 %
Effective Date
10 Feb
2009
18

CPSIA Tracking Label
‘Consumer Product Safety Improvement
Act of 2008’ (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.
19

EU New Toy Directive
(2009/48/EC)

New Toy Directive
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
21

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)
22

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
23

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
24

New Toy Directive - Physical and
Mechanical Properties
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”
25

Toys in food
New Toy Directive - Physical and
Mechanical Properties
26

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
27

Allergenic fragrances
New Toy Directive - Chemical Properties
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
28

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
29

Common failure cases and
experience sharing
US CPSC / EU RAPEX Product Recalls

US CPSC Recall
Company’s Recall
(Safety) History
31

US CPSC Recall
Recall Product Photos
Type of Hazard
Describe the Incidents /
Injuries (user behavior);
No. of reports received
Post Recall Action
Join recall with Health
Canada
32

EU RAPEX Recall
Category, like Toys,
Childcare Articles, …
Hazard Type, Hazard
Detail, Directives applied
(enforcement focus)
Measure adopted, may
be sales ban, rejected by
custom, … (government
reaction)
33

U.S. CPSC Recalls 1998 – 2006*
The majority of products met federally mandated requirements but were still
recalled because they were not safe.
508
Section 15 Recalls – Failed Essential Safety Requirements
1713
CPSC Regulated Product Recalls - Failed Federal Regulations
*CPSC Recalls – October 1, 1997 – February 17, 2006 n=2,221
34

Counts
400
350
300
250
200
150
100
50
0
Q1
2004
EU RAPEX Recall Rates*
Other
E&E
SL
HL
Q2
2004
Q3
2004
Q4
2004
Q1
2005
Q2
2005
*European RAPEX Recalls – Week 6, 2004 – Week 27, 2006 n=2,001
Q3
2005
Q4
2005
Q1
2006
Q2
2006
35

CPSC Recall of Xxxxxxx Ball
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.
36

CPSC Recall of Children's Garments with
Ornamental Cherries
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.
37

Units: About 294,000
CPSC Recall of Football
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.
38

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.
39

No.
Ref.
3
0139/06
Notifying
Member
States
United
Kingdom
RAPEX Recall Example
Product
Powerful Laser Pointer/
Lighter.
Type/model: P57.
Country of origin: China.
Danger
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.
Measures
adopted by
notifying
country
Selling of the
product
stopped.
40

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.
41

Tips & Critical Points during
Merchandising

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.
43

Product
3P’s in the Supply Chain
Design Failure
Start up
Failure
Material
Failure
Measurement
System Failure
Superficial
Failure Analysis
Process
Out-of Control
44

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
45

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
46

Product
3P’s in the Supply Chain
Wrong
Mark/Label
Process
Package Failure
(Qty, type…)
Design Failure
Miss/Delay
Shipment
Start up
Failure
Transportation
Damage
Material
Failure
Measurement
System Failure
Superficial
Failure Analysis
Process
Out-of Control
47

Controlling the Process:
Supplier Balance Score-card system
48

Process Control: Defining the level of suppliers –
The Grade
4 Grading for Suppliers
Grade D
New or Developing
Grade C
Grade B
Grade A
Best
49

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 …
50

Product
3P’s in the Supply Chain
Process
Artificial
Quality System
Social
Compliance
EHS
Wrong
Mark/Label
Productivity
Package Failure
(Qty, type…)
People
Design Failure
Miss/Delay
Shipment
Start up
Failure
Transportation
Damage
Material
Failure
Measurement
System Failure
Process
Out-of Control
Superficial
Failure Analysis
51

Controlling the
Human Factor
52

Excessive working hours
The Human Factor - Common Ethical Issues
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
53

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
54

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
55

Artificial
Quality System
Social
Compliance
EHS
Wrong
Mark/Label
3P’s throughout your supply chain
Productivity
Supplier System
Failure
Package Failure
(Qty, type…)
Design Failure
Miss/Delay
Shipment
RISK
Distribution or
Delivery Failure
Start up
Failure
Product or
Production Failure
Transportation
Damage
Material
Failure
Superficial
Failure Analysis
Measurement
System Failure
Process
Out-of Control
56

Q&A

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