ICPHSO Symposium
Korea Conformity Laboratories
- Safety Standards of Children's Products in Korea and
Introduction of Testing Methods and Equipment -
Chemical Testing dept
Choi In Seak
Ver1101-1
Contents
Ⅰ. Need for taking action against regulations
Ⅱ. Trends for safety standards in Korea and regulations (Phthalate)
Ⅲ. Cases of detected children's products and trends
Ⅳ. Appendix
Needs for taking action against regulations
Phthalates ?
Additive for making plastic more flexible
Widespread use in our everyday lives as floor paper, various kinds of toys, sheath, etc.
Danger of defect of the endocrine system and reproduction of male
4
Needs for taking action against regulations
 Background of regulation (Directly affecting human body)
- Direct contact to skin
- Has been regulated since 90s
- A lot of hazardous substances are regulated (phthalates,
etc.)
Direct harm
5
Evaluation of toxicity of phthalates by overseas government & organizations
U.S. Consumer Product Safety
Commission (CPSC)
Recommended not to use teether and rattle made of PVC
for safety precaution
U.S
US Environmental
Agency (EPA)
DEHP was classified as probable human carcinogen
U.S
Protection
Health Canada
Evaluated the quantity of DINP extracted from PVC toys
may threaten the safety and health of children under 12
months
Canada
Scientific Committee on Toxicity,
Ecotoxicity and the Environment
(CSTEE)
Less than 100 ppm of threshold value of DINP and DEHP
is considered to be dangerous.
Europe
Consensus Group
Safety of children against phthalates cannot be
guaranteed because daily intake of DINP of children under
12 months exceeds TDI in some cases.
Netherlands
Consumers Union
Recommended to parents that teethers made of PVC shall
not be used and shall use products not including
phthalates instead according to CPSC
U.S
Requested to government that use of DINP shall be
ceased immediately and required manufacturers to label
the components affecting health on toys
U.S
Argued that hazardous substances as phthalates shall not
be used immediately on PVC toys.
They especially mentioned that this hazardous substance
does not need to be used in defiance of its danger
because PVC substituting substances are available which
are safe with reasonable price.
Organization for
world
environmental
movement
U.S Environmental
Union
Green Peace
Movement
6
Needs for taking action against regulations
 Regulatory developments => Tightening up global environmental regulations
- - Enacting new regulation worldwide
China RoHS
PFOS
China REACH
N. AMERICA
EUROPE
RoHS
ASIA
CHINA
WEEE (05.8.13)
EuP (Eco-design Requirements for Energy
using Products)
REACH
(Registration Evaluation Authorization and
Restriction of Chemicals)
PFOS(08.06.27)
DMF
(2003)
A
JAPAN
J-Moss
AFRICA
ELV
Resource Recycling Law
K- REACH
KORE
WEEE
(2005~)
California REACH
California RoHS
AMERICA
CPSIA
(Consumer Product Safety
Improvement Act)
S. AMERICA
OCEANIA
RoHS
(2006~)
REACH
(2008~)
DMF
(2009)
7
Needs for taking action against regulations
- Most exporting industry is subject to environmental regulations.
ELV
REACH
DMF
RoHS, WEEE
PFOS
CPSIA
Oeko Tex
EN71 Part 3
Most products are
regulated
8
Trends for safety standards in Korea
and regulations (Phthalate)
Change in paradigm of product safety management
Initial stage of
industrialization
Economy
development
Becoming developed
country (After 2000s)
Expanding self-regulatory safety
management system
Strengthening social accountability (Recall)
(80s - 90s)
60~70 s
Inspection for
export
Complying to
minimum quality
standards
80~90 s
Type approval
Improvement of
product quality
(After 2010)
After
2000 s
After
2010 s
Safety
standards
Guarantee of
consumer
safety
Confirmation of
compliance of
manufacturers
Tightening up
consumer
safety and selfregulation of
manufacturers
10
Industrial products subject to safety certification
- Article 2
To protect consumers against danger of life or injury to persons, and losses of
property occurred from the poor or illegal products
Periodical inspection : More than once a year
Category
Products (14 items)
Textiles
False eyelashes
Chemicals
Automobile Retreaded tires
Metals
Domestic pressure pans and pressure pots, Metal
blades for portable brush cutters
Household & leisure
articles
Gas lighters, Aquatic equipment, BB Guns,
Playground equipments, Protective equipments for
automobiles
11
Industrial products subject to self-regulatory safety confirmation
Industrial products causing danger or injury of human body due to structure, materials,
and usage, whose danger can be prevented by inspection.
Category
Products
Household &
Walking aids for the elderly, Walker for the elderly, Digital
Leisure Articles door lock, Roller skates, Protector for roller sports users,
Roller shoes, Wallpapers and floor coverings, Shopping
trolleys, Snow board, Skate board, snow-ski equipment,
Children's two-stage beds, Children's jewelry, Toys,
Children's tricycles, Children's high-chair, Children’s
carrier,
Bicycles, Disposable diapers, School things
(including crayon, pastel crayon, stationery articles,
stationery clay), Stationary training equipment, Portable laser
devices, Portable ladders, Motor Board, Moist tissues,
Heating pad, Baby walking frames, Protective helmets for
vehicles, Protective helmets for sports users, Baby carriages,
Children's cots, In-line roller skates, Kick board
12
Related regulations (KOREA)
􀂾 Notification No. 2009-202 of Ministry of Environment
- Environmentally hazardous factors of children's play space
􀂾 Quality Management Safety and Control of Industrial Products Act, Article 19, Clause 2
- Safety standards of industrial products subject to self-regulatory confirmation
Protective items for children– Self-regulatory confirmation safety
standards Appendix 14
Children’s jewelry- Self-regulatory confirmation safety standards
Appendix 35
Toys - Self-regulatory confirmation safety standards Appendix 36
School stationery - Self-regulatory confirmation safety standards
Appendix 44
Baby walking frames - Self-regulatory confirmation safety
standards Appendix 51
Baby carriages - Self-regulatory confirmation safety standards
Appendix 54
Children's cots - Self-regulatory confirmation safety standards
Appendix 55
Aquatic equipment – Self-regulatory confirmation safety standards
Appendix 7
13
※ Comparison of requirements of children's products in Korea (Heavy metal and phthalates)
- Requirements for
phthalates content of
Requirements of children's
jewelry according to Quality
heavy metal and
Management Safety and Control
children's products of Industrial Products Act
Results of Comparison
Overseas management
requirements of children's
products are classified according
to exposure path (ex) hand-tomouth activity
or sucking or swallowing) or age
grades depending on each product
• Management requirements of
children's products in Korea will
follow the above trend (After Jan.
1, 2012)
Amendment of industrial
products management standards
(Dec. 27, 2010)
Effective as of Jan. 1, 2012
14
Cases of detected children's products
Hazardous
substances
Product
Korea
School supplies
Marker/Highlighter
Formaldehyde
Eraser
Plasticizer
Glue
Formaldehyde
Pencil case
1
Bis(2-ethylhexyl)phthalate(DEHP),
Dibutyl phthalate(DBP)
2
Formaldehyde
2
Heavy metal
Lead
2
Color pencil
Heavy metal
Cadmium (163 ppm)
3
Clip
Heavy metal
Lead (30,838 ppm), Cr (8,182 ppm)
3
Tub paint
Heavy metal
Lead (4~40 ppm)
4
Sticker
Plasticizer
Bis(2-ethylhexyl)phthalate(DEHP)(4.4~23.3 %)
3
Wood toy
Heavy metal
Lead
10
Suction plate
Plasticizer
Bis(2-ethylhexyl)phthalate(DEHP)(17.1 %)
3
Plasticizer
Bis(2-ethylhexyl)phthalate(DEHP)(24.8~31.8 %),
Di – isononyl phthalate(DINP)(28.5~34.9 %)
7
Heavy metal
Ba(0.1~37.8 mg/kg)
7
Heavy metal
As6.6~6.9 mg/kg)
7
Heavy metal
Lead
6
Heavy metal
Lead
8
Formaldehyde
8
Bis(2-ethylhexyl)phthalate(DEHP)(8.3~14.6 %)
3
Playing mat for children
Children’s cosmetic
Children’s jewelry
Necklace, etc.
Carrier for baby
Others
Source
Formaldehyde (124 ppm)
Toys
Craftwork materials
Detected substances
(Detected concentration)
Spoon bag
Formaldehyde
Plasticizer
Source : 1~10 - Korean Consumer Agency, report for children's products submitted to KATS, Ministry of Knowledge and Economy
15
State of children's products in Korea - toys, children's products, school supplies (1)
Results of surveillance through market sampling Mar. 2007~ Present 2011
- Safety standards of industrial products subject to
self-regulatory confirmation
(The number of items detected is decreasing every year.)
- Most detected substances are DBP, DEHP, and DINP.
Country of origin: China
Testing
substance
Testing result (%)
PLASTE
Body
DINP
N/D
2.3
DEHP
N/D
18.1
DNOP
N/D
N/D
DIDP
N/D
N/D
DBP
N/D
0.2
BBP
N/D
N/D
◆ Inspection item: Hazardous chemicals
- Phthalates
☞ Plastic clay, eraser, teether, toys
◆ Critical control items
- Goods on the market having high frequency of fail :
Eraser, clay, PVC toys, sticker
16
State of children's products in Korea - toys, children's products, school supplies (2)
Results of surveillance through market sampling Mar. 2009~ Present 2011
`Baby carriage
- Phthalates were detected in handle, brim, and foothold.
Baby walking frames
- Phthalates were detected in teether.
Aquatic equipment
Country of origin: China
- About 70 ~ 80 % of DBP, DEHP, and DINP were
detected.
Testing result (%)
Testing
substance
Stopper
Handle
Body
DINP
N/D
N/D
5.8
DEHP
9.2
1.5
23.1
DNOP
N/D
N/D
N/D
DIDP
N/D
N/D
N/D
DBP
N/D
N/D
0.1
BBP
N/D
N/D
N/D
- Products manufactured until 2009 are not subject to
industrial products safety standards.
Safety certification standards Appendix 7
17
Testing Methods and Equipment
KS M 1991:2008, Self-regulatory safety & safety certification
Sample 1.0 g
Sample 1.0 g
Hexane 60 mL
Hexane 50 mL
Soxhlet 6 hour
Ultrasonic wave
1 hour
100mL V.flask
100mL V.flask
GC/MS
GC/MS
1. Sample preparation
2. Weighing of sample
3. Soxhlet extraction
4. Extracted solution
5. Filtering
6. Analysis by GC-MSD
19
CPSC-CH-C1001-09.03
Sample 0.05 g
Health Canada Method C-34
Sample 1.0 g
DCM 20 mL (2hour)
THF 5 mL (30min)
Hexane 10 mL
(5min)
BBP 10 ppm
(200 ul)
Methanol 100 mL
(12 hour)
Concentrating
DBEP 10mg/kg (200uL)
50mL V.flask
GC/MS
GC/MS
20
Gas Chromatography
Column
HP-5MS, 30 m × 250 μm × 0.25 μm, Capillary column (Max. Temp.: 325 oC)
Injection mode
Splitless
Pulse pressure
21 psi
Pulse time
1.0 min
Purge flow
51.5 mL/min
Purge time
1.0 min
Injection amount
2 μL
Carrier gas
He
Injection port temp
300 oC
Purge flow & time
40 mL/ min, 2.0 min
Solvent delay
2.5 min
Initial oven temp, Hold time
100 oC, 0 min
100 oC to 250 oC at 20 oC/min, hold 5 min 250 oC to 310 oC at 40 oC/min, hold 1 min 310 oC to
Temperature program
320 oC at 50 oC/min, hold 2 min
Transfer line temp.
280 oC
21
Appendix
Follow-up management (1)
◆ Managing product safety portal system(www.safetykorea.kr)
☞ Providing real-time product safety information to consumers
◆ Tightening up surveillance through market sampling and release of
information of violators
☞ Periodical survey with interval of 6 months for products subject
to "critical control items"
◆ Setting up product safety monitoring system
☞ Launching a product safety monitoring group and a safety
morning group consisting of college students
☞ Safety monitoring of industrial products by Quality
Management Team of Seoul-city
◆ Holding workshop for product safety
☞ Establishing cooperative network of consumer union, officials,
and experts of product safety
23
23
Follow-up management (2)
◆ Expanding items subject to regulations of customs
☞ All types of toys including battery operated toys
currently being regulated and non-battery operated toys
◆ Structuring fast follow-up system
☞ For accidents for new released products not subject
to safety management
◆ Providing information of recall cases to portal sites
☞ Sharing and collecting information for overseas cases
☞ Cases in Korea
24
24
Strengthening Penalty
◆ Strengthening penalty for violators of safety certification system (Article 38)
☞ Imprisoned for a maximum of two years and fined twenty million won
⇒ Imprisoned for a maximum of three years and fined thirty million won
◆ Enactment of new penalty according to safety management system
☞ Labeling without declaration of self-regulatory safety confirmation
⇒ Imprisoned for a maximum of three years and fined thirty million won
☞ Arbitrary modification or eliminating labeling of industrial products subject
to self-regulatory safety confirmation
⇒ Imprisoned for a maximum of one year and fined ten million won
☞ Not labeling safety certification and self-regulatory safety confirmation :
Fined for a maximum of ten million won
☞ Being involved with the business using industrial products subject to selfregulatory safety confirmation without proper labeling
⇒ Fined for a maximum of five million won
25
More Information
www.kcl.re.kr
Global Brand for Construction Materials,
Consumer Goods and Environment Testing Lab.
Enhancement of competitiveness,
Focus on higher value, Global Standard
Choi In Seak
459-28 Gasan-dong, Geumcheon-gu, Seoul, 153-803, KOREA
Tel : 82-2-2102-2677 Fax :82-2-855-1802, E-mail : sea3186@kcl.re.kr