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

6

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)

7

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).

9

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)

US Consumer Product Safety

Improvement Act (CPSIA)

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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

EU New Toy Directive

(2009/48/EC)

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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 - Physical and Mechanical Properties

Toys in food

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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

Common failure cases and experience sharing

� US CPSC / EU RAPEX Product Recalls

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US CPSC Recall

Company’s Recall

(Safety) History

Company’s Recall

(Safety) History

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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

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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.

Tips & Critical Points during Merchandising

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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.

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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

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Controlling the Process:Supplier Balance Score-card system

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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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Controlling the Human Factor

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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

Q&A

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