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Platform Cloudesk andOverview of chemical regulations in Asia-Pacific region
12-7-2017, Milan, Italy
Bo Bi| REACH24H Consulting Group China
Company Overview
Dublin• Ireland
Hangzhou•ChinaVirginia•USA
Taiwan
REACH Regulatory
GHS Regulatory
AP Chemical Registration
EHS Regulatory
Technical Department
组织架构Company Structure
Industrial Chemical Division (ICD)
Agrochem & Material Division(AMD)
Consumer Products Service Department(CPSD)
Technical Center
Cosmetics
Food
Medical Device
Consumer Service
Internet
Taiwan Office
Japan Office
Information
Research Center
Disinfectant and Pesticide
Food Contact Material
Our Achievements
Eu Compliance
3500+ Eu REACH registration
25 Lead registrant
12000+ Eu CLP SDS and eSDS
Chinese Compliance
20000+ Chinese SDS、label
1200+ China New Substance
Notification
4000+ Dangerous registration
Other compliance
230+ International Meetings
3000+ SDS、labels for other
countries
200+ Regulation translation
4000
6000
8000
10000
12000
2000
14000
16000
2009
96
38385189
2042
7299
11673
13293
9673
2010 2011 2012 2013 2014 2015 2016
2000
3000
4000
5000
6000
1000
7000
2009
93
29103493
1478
3986
5245
6061
4599
2010 2011 2012 2013 2014 2015 2016
Clients
Projects
Our Customers
Overview
Designed by REACH24H Consulting Group,
CLOUDESK is a friendly all-in-one solution for
chemical regulatory compliance. On REACH24H’s
CLOUDESK, you are able to conduct your
compliance work simple, fast and secure overthe
internet. CLOUDESK has backups of all the data
stored on our system in case any unexpected
situation. To implement project management,
obtain the most up-to-date information,
communicate directly to regulatory experts from
REACH24H, or browse interested conference and
training program with only one account.
Protected with SSL EncryptionTo secure system logins and any sensitive
information exchanged online, CLOUDESKsecure
your data and networks by deploying the Secure
Socket Layer (SSL)protocol.
CLOUDESK-One Portal for All Needs of
Regulatory AVairs
NEWRSCCThe best REACH tool forthe
EU chemicalbusiness
SDS CLOUDGreat way ofmanaging
SDS documents
CHEMLINKEDThe most popularregulatory
database in AP
CRCSRegulationbulletins for
food, cosmetic andmore
Commercial Insurance Insured REACH24H insured Professional Liability Insurance
with the Huatai Insurance worth 1 million dollars,
and the insurance coverage is available for every
conceivable risk REACH24H might face to avoid
anylosses.
Security MechanismFormulatedIn order to protect confidential information, not
only mutual non-disclosure agreement will be
signedbetween REACH24H and potential clients,
but also one-way non-disclosure agreementswill
be signed byeach employee.
Highest Security Standards
Https://www
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China New Chemical Substance Notification (2010)
South-Korean K-REACH (2015)
Taiwan Toxic Chemical Substance Control Act (2014), OSHA (2015)
ASEAN countries: Thailand, Malaysia, Philippines, Indonesia, Vietnam, etc.
Japan Chemical Substance Control Law (1973)Industrial Safety and Health Act (1972)
China New Chemical Notification01
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Timeline
"Measures" (Order No.7) comes into effect, administered by the MEP and implemented by Chemical Registration Center (CRC‐MEP)
Mar
. 27
,20
08
SEPA was upgraded to Ministry of Environmental Protection (MEP)
Measures for the Environmental Management of New Chemical Substances (Order No.17) came into effect, administered by State Environmental Protection Agency (SEPA)
2003 2013
Oct
. 15
,2
003
EU REACH (EC 1907/2006)came into force,implemented byECHA Ju
n. 1
, 20
07
The revised version of Measures (Order No.7, “Measures”) ‐ draft released
Oct
. 15
,20
10
May
15
,20
09
Hazard‐basedEmphasis on Registration
Risk‐based Registration & InspectionConcept shift
No
v.3
0,2
010
1ST Registration deadline:>=1000 T/Y;CMR >1 T/Y;R50/53 >100 T/Y
Ch
ina
EUM
ay3
1,2
0132nd Registration
deadline: 100~1000 T/Y
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9
IECSC 2013 (pdf only)45,612 substances
3,270 confidential substances8,486 substances without CAS number
Step 2: Searching the Inventory of Existing Chemical Substance in China (IECSC)
Chemical Inventory and updates
Download the Public IECSC (PDF version) http://www.mep.gov.cn/gkml/hbb/bgg/201301/t20130131_245810.htm
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WWW.REACH24H.COM
On‐going work: Listing in IECSC: For substances with regular notification certificate, if it has
been 5 years since the first actual activity, the registrant can apply for the IECSC listing. The 1st batch of such substances are announced by MEP on 2016/3/10;.
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IECSC Search 1—Chemlinked
New Substance? Confidential? 15
Examples
Who can notify?
Chinese entities only can notify and foreign entities cannot directly notify anymore
CN‐Entity Foreign Entity
Chinese Legal entities eligible for notification
Domestic Manufacturers
Domestic Importers
Chinese representative agent can notify on behalf of non‐Chinese companies
“OR‐like” Agent
• Definite, fixed place of work.• 3,000,000+ RMB registered capital.• Staff who have experience in new chemical substance notification.• Must not have violated chemical regulations within the last 3 years etc.
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12
Step‐Mode Notification
Level 4: >1000 t/a
Level 3: 100~1000 t/a
Level 2: 10~100 t/a
Level 1: 1~10 t/a
General : Domestic testing data required <1 t/a
Special: Notification w/o data
Intermediates < 1 t/a Manufacture for export only < 1 t/a Polymer of low concern(PLC) or with low new substance
monomer conc. (<2%) Scientific Research: 0.1 t/a – 1 t/a Process development <10 t/a, valid no more than 2 years
R & D < 0.1 t/a;
Sim
plif
ied
No
tifi
cati
on
Reg
ula
r N
oti
fica
tio
n
dat
are
qu
ire
me
nt
incr
eas
es
wit
hto
nn
age
ban
dTo
nn
age
Pri
nci
ple
(Art
. 11
)
SRR
N
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Regular Notification
Testing data(substance identification, physico‐chemical, toxicology and eco‐ toxicology)
C&L, SDS for hazardous substances(based on
China GHS criteria) Risk Assessment Report
Simplified Notification
Situation statement (for special case)
Eco‐toxicological testing reports (for general case)
SRRN
Business license or legal person Notification Form Research
Information
Notification Dossier Requirements
Basic documents for non‐Chinese notifiers: POA(Power of attorney) Signature authorization letter business license copy of domestic agentNotification Form
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22
Notification Certificate
Notification Number
Notification Type
Notification certificate holder
Notifier
English/Chinese name of the Chemical substance
CAS number
Notified Tonnage
Notified Use
Activity type
Management category
Notification reason
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Notification Statistics 2011‐2016
24
www.reach24
Taiwan TCSCA/OSHA
h.com | www.Chemlinked.com
02
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Taiwan TCSCA（Toxic Chemical Substance Control Act ）
Taiwan OSHA（Occupational Health and Safety Act ）
Taiwan EPA’s Department of Environmental Sanitation and Toxic
Substance ControlTaiwan MOL
ERI(registration office) SAHTECH (registration office)
TCSCA Article 7‐6 OSHA Article 13
New& Exit Chemical Substance New Chemical Substance
December 11, 2014 January 1, 2015
Back ground‐ Governance and regulatory Matrix
Pre‐check: Are my products required to be register?
Step 1: Rule out the possibility of Exemption (similar to EU REACH)
Finished products covered by other laws and regulations (i.e. cosmetics, pesticides, foodstuffs, food additives, pharmaceuticals , tobacco etc.)
Naturally occurring substances(Natural rubber)
Articles (not applicable for intentionally released
substance)
Non‐isolated intermediates
Chemicals for national defense purpose…..
Step 2: Searching the Taiwan Existing Chemical Substance Inventory (TCSI)
TCSI 2015 (pdf only) Can only search by CAS# or Serial# 101,089 substances
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http://tcscachemreg.epa.gov.tw/Epareg/OpenDat
a/content/NewChemistPage.aspx
Pre‐check:
Taiwan Inventory Search
1. Latest update on September 9th, 2015;
2. Currently 101,089 substances, including
general new chemicals, polymers, UVCB;
3. Around 800 confidential chemical
substances with generic name or serial
number;
4. On‐line version, self inquiry, NO selectable
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20
PDF or WORD version;
Pre‐CheckWho can register?
Taiwan Legal entities eligible for notification
Domestic Manufacturers
Domestic Importers
Taiwan representative agent (TPR)
TW‐Entity Foreign Entity x
“TPR” Concept: For CBI
“POA” to be notarized in the court
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21
01Exist Chemical registration
02 PLC advanced confirmation（less cost, no ton limit）
SQR/Simplify/Standard
Phase 1 registration(Late phase 1)
Phase 2 registration(31st of Dec., year
2017)
≥ 100kg/a
New Chemical Substance registration
Chemical Registration
22
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New Chemical Substance Management
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Korea REACH/OSHA/CCA03
Overview of chemical regulation in South Korea
products Laws Competent Authority
Industrial Chemicals The Act on Registration and Evaluation, etc. of Chemical Substances(K-REACH)
The ministry of environment (MOE)
Chemical control act (CCA) The ministry of environment (MOE)
Occupational Safety and Health Act (OSHA)
The ministry of Employment and Labor (MOEL)
Cosmetics Cosmetics law the Ministry of Health and Welfare
Pharmaceuticals Pharmaceutical Affairs Law the Ministry of Health and Welfare
Food additives Food Sanitation Law the Ministry of Agriculture
Pesticides Agrochemicals Control Act the Ministry of Agriculture
Ozone layer depleting substances and radioactive substances etc.
Other specific laws various ministries
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In this presentation
Korea REACH/OSHA/CCA
BackgroundPre‐ registration check
Exist chemical obligations; New Chemical obligations;
Case Study will be given
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Time line of legislation
2011 2015.1.1.
19
91
.2.2
K‐REACHdrafted by MOE2
01
1.0
2.2
5 20
12
.09.
28
K‐REACH(draft) submitted to National Assembly
20
13
.04
Implementation of TCCA
Humidifierdisinfectant accident
20
11
.04
MOE/National Assembly/MOEL review together
20
13
.04.
30
K‐REACHpassed National Assembly
20
13
.05
.22
K‐REACHpublished
20
14
.02
K‐REACH sub‐ decree draft published
20
14
.12 K‐REACH sub‐
decree officially published
20
14
.10.
31
first PEClist draftpublished
Hazard based emphasis on registration
Risk based registration & inspection
Concept shift
6
1991
K‐REACH scope
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substance：new substance and existing substance
• existing substance：
chemical substances distributed in the market and announced by the MOE in consulting with the
MOEL before 2 Feb, 1991
chemical substances finished hazard review under TCCA and announced by MOE after 2 Feb,
1991
•new substance：means all chemical substances excluding existing chemical substances
NCIS(National Chemical Information System)
NCIS website： http://ncis.nier.go.kr/main/Main.jsp
In this presentation
Korea-reach
Background Pre‐ registration check
Obligations under K‐reach; Penalty
registration
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annual report
Annual report
substance
•1 ton/yearfor existing chemicals
• New chemicals
Legal entity
• manufacture
• importer
• OR on behalf of foreign manufacture
• seller
time
• The volume during Jan. 1 –Dec. 31 of the previous year shall be reported until Jun 30 of every year
Data requirement
• Company information
（importer, manufacturer)
• OR information
• Substance information
• tonnage
• Specific use（55 types）
Reporting of manufacture (Article 8)A person who manufacture, import or sell all new chemical and existing chemical exceeding 1 ton/year shall report its amount and use etc. to the MOE (the local Environmental agency) annually
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Registration
substance
Existing substance subject to registration (above 1t/a) and New substance (no volume limit)
Legal entity
manufacturer
importer
OR on behalf of foreign manufacture
time
existing chemical subject to registration has 3 years transition period
New substance should be registered before manufacture or import
Registration (Article 10)• Existing chemicals subject to registration ≥1 ton/year and new chemicals required to
be registered prior to their manufacture or import; first PEC list 510 substances(30/6/2018)
• Even less than 1 ton/year, registration is required for substances with high concernsto human health and the environment as designated by MOE through the discussionof relevant ministries
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Data requirement for general registration
Company information Company name, address, name of representative, etc.
Only representative information name, address, contact person, etc.
Chemical identity information Chemical name, molecular formula, chemical structure, CAS No, Purity (%), etc.
Use information Use category, chemical specific use description, etc.
Classification and labeling Korea GHS
PC/toxicological /environmental and eco‐toxicological data
Data requirement based on different tonnage
CSR(chemical safety report) Risk assessment report for registered substance ≥10 t/a
Guidance on safe use Risk management measures, such as protective equipment
Registration
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WWW.REACH24H.COM
Data requirement 0.1-1t/a(from 2020.1.1 for new chemical substances)
1-10t/a 10-100t/a 100-1000t/a >1000 t/a
PC 5 5 7 9 12
Toxicity 2 4 8 11 15
Eco-environment 2 2 5 13 19
In total 9 11 20 33 46
Data source requirement
• Local lab designated by MOE and non-Korea OECD-GLP lab for Log Kow/toxicological /environmental and eco-toxicological data
• Accept QASR and read across (only applied for below 10tpa) data with quality• Test plan submission for certain endpoint• Data protection period: 5 years(extendable for 2 times with 5 year per each time)
Registration
Data requirement for general registration
20
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Simplified registration – only for new chemical
Registration type Simplified registration General registration
Tonnage trigger <1t/a(before 2020)<100kg(after 2020)
100kg/a~1t/a(after 2020)
Process time 3~7d 30d
Risk assessment no no
Data requirement Company informationOnly representative informationImporter informationChemical substance informationUse categorySimple description of exposure informationNo test data requirement
Additionally,(Data requirement as 1-10t general registration)Physical-chemical dataHazard dataC&LGuidance on safe use
Registration
25
Deletion of Duplicated Items in the Form-exposure data in application form for small-volume registration, however NIER may request additional exposure information for evaluation.
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Polymer(non PLC) registration-registration for polymer , not monomer
Polymer registration
Data for Polymer properties other Data requirement(for general registration)
0.1-1t/a 1-10t/a 10-100t/a
1-10t/a • Number average molecular weight
• Monomer information• Remaining monomers(%)• The content of Mn less than 1,000 • Stability test in acid or alkaline
solution
• physical status• water solubility• melting/freezing point• boiling point• vapor pressure
10-100t/a √
100-1000t/a √
>1000t/a √
Registration
26
WWW.REACH24H.COM
Biocides registration
Biocides registration
Biocides scope other Data requirement(for general registration)
1-10t/a 10-100t/a 100-1000t/a >1000t/a
0.1-1t/a(from 2020)
• The use of the substance is the key factor to classify the substance to biocide;
• Substance is function as biocides rather than agriculture use
• Such as preservative, detergents
√
1-10t/a √
10-100t/a √
>100t/a √
Registration
27
Biocides: Any Product used for killing all hazardous organisms excluding human and animals for restricting or inhibiting activity of such organism, such as insecticide, disinfectant, preservative, etc.
Tonnage＜0.1t/a
• OSHA exemption application is required before import
• OSHA can direct exempt when K-REACH registration is finished.
Tonnage from 0.1-1t/a
• OSHA registration is required before import, with one toxic test (acute oral/inhalation test,
OECD GLP)
Tonnage≥1t/a
• OSHA registration is required before import
• OSHA can direct exempt when K-REACH registration is finished.
K‐OSHA (enforcement from May 1, 2016)
‐ Article 40 (Investigation of Harmfulness and Hazardousness of New Chemicals)
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CCA main content and obligations
Enforcement time passed national assembly in May in 2013 and it comes into force on 1 Jan 2015.
Application scope CCA apply to the substance in handing is hazardous chemical in all business areas in Korea
purpose ‐‐to control chemicals properly for preventing chemical accidents in all business areas in Korea;‐‐mainly manages the hazardous chemicals and the hazardous chemical's handling facilities in Korea
Competent authority MOE/KCMA
Obligations for manufacturer and importer in South Korea
No OR conception under CCA, TPR is applicable
require qualification
‐‐Manufacturer or Importer of chemicals shall submit a ‘Witten Confirmation of Details for Chemical Product’ to the KCMA prior to manufacture or import after careful self‐evaluation whether it contains any regulated chemical.（产品自查确认书）‐Article 9
In compliance with CCA Article 10, statistical survey on chemical substance is being conducted in
every two years by determining related contents on chemical handling facility, status, etc. for
workplaces where manufacturing, storing, preserving, using and importing/exporting being
operated and to use gathered information as preliminary data. (数据调查报告)‐Article 10
‐‐CCA also requires that any person who handles accident prone chemicals in excess of a certain amount prepare and submit a contingency plan every five years. （应急预案）‐require qualification
‐‐Under CCA, any person who intends to set up and operate toxic chemicals handling facilities shall prepare Off‐site consequence analysis report that evaluates the impact of a potential chemical accident on the surrounding environment and population.(化学事故场外影响评价书)‐ require qualification
CCA introduction
