Post on 21-Jan-2018
CIRS
Your Compliance Expert
Taiwan Chemical Substance Registration Analysis and
Supervision Measures Update
Ethan Zheng
CIRS
ethan.zheng@cirs-group.com
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Taiwan Chemical Control Regulations Introduction
Late Pre-registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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Taiwan Chemical Control Regulations Introduction
TCSCA OSHA Other Regulations
Taiwan EPADecember 11th , 2013-Toxic Substance-New Substance-Existing Substance
Taiwan MOLJuly 3rd , 2013-Priority Substance-Prohibited Substance-New Substance
Other governments-Food-Drug-Agro-…
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Taiwan Chemical Control Regulations Introduction
Registrant
1. Importer or manufacturer located in Taiwan2. Third party representative (TPR) located in
Taiwan3. Companies located outside of Taiwan can
appoint a TPR to work with importer to submit the registration
* Each Taiwan importer needs to register
Importer A
Importer B
Importer C
Foreign Manufacturer EPA & OSHA
Foreign Countries Taiwan
TPR
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Taiwan Chemical Control Regulations Introduction
Substance
In TCSINot in TCSI
Exempted New Substance Registration
Small Quantity Registration
Simplified Registration
Standard Registration
Assessment and Review of the submitted dossier
Phase 1 Registration if >= 0.1 t/y
Designated Substance based on the
prioritization process
Phase-in Standard Registration of
designated substance
Approved
Post Registration Management
TCSI: Taiwan Chemical Substance Inventory
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Taiwan Chemical Control Regulations Introduction
R&D Substance Polymer
PPORD R&D CMR RegularOn-Site
IntermediatePolymer PLC
STD1 STD1
STD4
STD4
STD1 STD1Small
Quantity
STD3
STD3 STD2
Simplified Simplified STD2 STD1 Simplified Simplified
Small Quantity
STD1
SimplifiedSmall
QuantitySmall
QuantityPre-
ApprovalSmall Quantity
0.1 t
1 t
10 t
100 t
1,000 t
Annual Tonnage
New Substance Registration
Small Quantity Registration Simplified Registration Standard Registration
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Taiwan Chemical Control Regulations Introduction
New Substance Registration
TCSCA and OSHA are using one submission window to
collect registration documents
One dossier for both regulations
One payment for both regulations
One registration number for both regulations
Payment Submit Review Issue Management
OSHA
TCSCA
Managed separately
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Finish Phase 1 Standard
Registration before due time
Taiwan Chemical Control Regulations Introduction
Existing Substance Registration
Pre-Registration Late Pre- Registration Standard Registration
List of substancesrequiring phase 1
standard registration will be published
Pre-Registration of Existing Substance
2015.09.01 2016.03.31
Implementation of the Actof Registration of Existingand New Substance underTCSCA
2014.12.11 2017.12.31
Late Pre-Registration
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Taiwan Chemical Control Regulations Introduction
Registration Progress
800+
7 6
330270
New Substance
Small Quantity Simplified
STD PLC
R&D
10,000+
150,000+
Application Substances
Existing Substance Phase I Registration
During Dec. 11th , 2014 to March 31st, 2016 9
Unofficial
Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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Late Pre-Registration for Existing Substance
What if you missed the Pre-Registration? (Ended on 31st March 2016)
What is Pre- Registration?
Phase I Registration = Pre-Registration Under EU REACH
Phase I Registration Conditions- Existing Substance- The average annual tonnage of import/manufacture exceeds 0.1 t/y for the previous three years -The annual tonnage of one year of the past three years exceeded 0.1 t/y
- You can still submit the Pre-Registration if you meet the conditions above. - Send a paper application to EPA, based on the EPA review, EPA will open the Pre-Registration again for applicant
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Pre-Registration making up process and detail published by EPA
on May 10th 2016.
Late Pre-Registration for Existing Substance
Late Pre- Registration
Conditions- Starting from April 1st 2016, manufacturing or importing existing substance larger than 0.1 t/y for the first time;
- The amount of existing substance manufactured or imported smaller than 0.1 t/y for the previous years, but the amount exceeds 0.1 t/y after April 1st 2016.
Deadline for Late Pre-Registration- Application should be submitted within 90 days after the first manufacture or import takes place after April 1st 2016
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* Annual tonnage counting starts from Jan 1st 2016
Late Pre-Registration for Existing Substance
Late Pre- Registration Procedures
Applicant (manufacturer/importer)
First manufacture/import > 0.1 t/y since April 1st
2016. Application submitted within 90 days
Submit related registration and supporting documents and POA
Authority review of the supporting documents
Make payment
Authority review of dossier
Phase I registration code issued
Review passedReview not passed
Resubmit supporting document
Review passedReview not passed
Resubmit dossier and POA
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Late Pre-Registration for Existing Substance
Late Pre- Registration Documents
Supporting Documents
Registration Documents
ProductInformation
-Declaration of Import-Trade certificate-Contract-Shipping approval
-Applicant information-Substance information-Substance manufacture and usage information-Power of Attorney
-SDS-or product content sheet
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Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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R&D Application
1. Scientific Research purpose2. PPORD: Product and Process Orientated Research and Development
On March 10th 2016, Taiwan EPA published the new version, version 2 of the R&D application guideline
Changes:Enterprise is allowed to apply for scientific research purpose if manufactured or imported amount is less than 1 t/y
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R&D Application
R&D Application Procedures
PPORD Scientific Research
> 1 ton per year
Submit registration according to tonnage
EnterprisesResearch Institute
R&D Testing Appointed
EPA Review
Registration Exempted
NoYes
R&D Usage ApplicationNo application needed
Approved
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R&D Application
A Case Study
A Taiwan importer wants to import a new substance and sell the substance to its downstream user for the R&D purpose, is the Taiwan importer able to apply for the R&D exemption?
-If the importer is appointed by a scientific research institute to import the new substance, and the amount of the new substance is < 1t/y, it is able to apply for the R&D exemption for the importer with sufficient related documents.
-If the importer only imports the new substance to sell to the downstream users, the new substance has to be registered normally.
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Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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CBI Protection
Information can be kept confidential
1. Applicant information2. Substance identity information3. Substance manufacture or import information4. Substance usage information
CBI Protection Duration1. Standard Registration: 5 years2. Simplified/Small Quantity Registration: 2 years* Application for CBI Protection extension should be submitted 3
months before expiration date. * 15 years is the longest time for CBI protection
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CBI Protection
Information must be disclosed
1. Substance hazard classification information2. Substance physical and chemical property information3. Substance toxicological and eco-toxicological information4. Substance hazard assessment information5. Substance exposure assessment information
* Information regards to human and environmental safety and health must be disclosed
* Details about how the information be disclosed is still under discussion by Taiwan authorities, and will be released in the future
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Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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Chemical Commodity Importation Pre-Confirmation (CCIP)
Taiwan authorities want to make sure that all the imported commodities have complied with the
related requirement before entering the customs
Chemical Commodity Importation Pre-Confirmation (CCIP) Platform
Helps enterprises get familiar with the importation processes
More smooth and efficient post inspections
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Chemical Commodity Importation Pre-Confirmation (CCIP)
Importation management processes
Enterprises self confirmation CCIP confirmation Authority post inspection
Substance regulated by other laws?
Substance registered and registration code
received?
Finish related substance registration
Go to CCIP websiteChemreg-border.epa.gov.tw
Step 1 read agreement
Step 2 fill in information1. Applicant information2. Product information3. Substance information
Finish CCIP
EPA receives monthly import record with
C.C.C.code
Carry out inspection according to company
names/C.C.C.code
Check CCIP information and substance
compliance
Yes
End No
No Yes
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Chemical Commodity Importation Pre-Confirmation (CCIP)
CCIP process details Go to CCIP website
Step 1 read agreement
Confirm new substance information in the
product
Fill in applicant information
Fill in product information
Confirm existing substance information
in the product
Confirm other substance information
in the product
1. Registration code2. CAS number3. Components4. …
1. Registration code2. CAS number3. Components4. …
1. CAS number2. Components3. Exemption reason4. …
Finish CCIP 25
Chemical Commodity Importation Pre-Confirmation (CCIP)
Who can use the CCIP platform to do the pre-confirmation?
CCIP user can be:1. Taiwan importer2. Third party representative3. Foreign company4. Other
* The “registrant name” in the submitted CCIP information should be the same as the “taxpayer” on the customs declaration form. Different names may cause false post inspection.
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Chemical Commodity Importation Pre-Confirmation (CCIP)
Chemreg-border.epa.gov.tw
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Chemical Commodity Importation Pre-Confirmation (CCIP)
Chemreg-border.epa.gov.tw
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Chemical Commodity Importation Pre-Confirmation (CCIP)
Chemreg-border.epa.gov.tw
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Taiwan Chemical Control Regulations Introduction
Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
Chemical Commodity Importation Pre-Confirmation (CCIP)
Case Study and Take Home Messages
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Case Study and Take Home Messages
Company A wants to import a batch of product into Taiwan now. The substance contained in this product is existing substance with the amount of 120 kg. How does company A comply with the chemical regulation in Taiwan?
Case Study 1
Late Pre-Registration condition:For the first time importation/manufacturing after April 1st 2016, with the amount >0.1 ton per year, Late Pre-Registration is applicable.
Company A should do the Late Pre-Registration and submit the related documents (product information, substance information, POA, supporting document, etc.)After finishing the Late Pre-Registration, company A will also need to finish the CCIP.
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Case Study and Take Home Messages
Company B wants to import a product that contains new substance into Taiwan. The annual amount of the new substance is 5 ton per year. How does company B comply with the chemical regulations in Taiwan?
Case Study 2
For new substance:All the new substance should be registered before being imported or manufactured.
Based on the information of annual amount of 5 ton per year. The substance is subject to both TCSCA and OSHA standard new substance registration level 1. Related documents should be prepared by company B.
Documents includes: testing report (physicochemical data, toxicological data and eco-toxicological data) and application form of standard registration.
* Only two re-submission chances available 32
Case Study and Take Home Messages
Company C has already completed the new substance registration of their product, and the substance has been added into the TCSI. Does company C need to do the Phase 1 Registration for their substance?
Case Study 3
If company C has already finished the new substance registration, and the substance has been added into TCSI, then there is no need to do the existing substance registration.
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Case Study and Take Home Messages
What if I do not do the CCIP?
Case Study 4
Can still get through the customsCurrently, the CCIP is not mandatory, products can still get through without the CCIP.
Priority post inspectionPost inspection will be prioritized for the products without CCIP
Punishment will be made for illegal behaviorsIf importers are found with illegal behaviors (not compliant to the chemical regulations in Taiwan), related punishment will be made
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Case Study and Take Home Messages
Do we need to do CCIP each time we import our product?
Case Study 5
If the imported product are the exactly same product as the one imported before (same chemical composition, same substances), CCIP is only required at the first importation
If the chemical composition changes, or other substances are added, companies need to re-do the CCIP since the product will be considered as a new product.
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Useful Links
1. TCSI search engine:
https://csnn.osha.gov.tw/content/home/Substance
_Home.aspx
2. Search Engine for Chemical Inventory in China:
http://cciss.cirs-group.com/
3. Regulatory Related Materials Download:
http://freedoc.cirs-group.com/en/
4. Regulatory News Updates:
http://www.cirs-reach.com
Find us on LinkedIn: https://www.linkedin.com/company/chemical-
inspection-and-regulation-service-limited?trk=biz-companies-cym36
Our Services
Taiwan- (Late) Pre-registration- Existing substance registration- New substance registration- CCIP application- Taiwan GHS- Regulatory training
China- New substance notification- Hazardous substance registration- Environmental administration
registration- China GHS- Regulation training
Korea- Existing substance registration- New substance registration- Annual reporting- Korean GHS- Regulatory training
Global GHS- EU CLP- China, Japan, Korea, Taiwan- US, Canada- Malaysia, Thailand, Indonesia- Others like Turkey, Brazil, Mexico,
Russia, Australia, New Zealand, etc.
Next Webinar: China Chemical Regulations Overview
• Main Contents New Substance Notification
Hazardous Substance Registration
Environmental Administration Registration of Hazardous Substance
Licence System
GHS, SDS and Label
Language Date Time Speaker
English
(EU Area)
June 7th 2016 16:30 – 17:30 pm
(Beijing Time)
Ms. Grace Chen
English
(US Area)
June 7th 2016 23:00 – 00:00 pm
(Beijing Time)
Mr. Ethan Zheng
Please visit www.cirs-reach.com for registration information.http://www.cirs-reach.com/news-and-articles/chemical-regulations-and-compliance-in-china.html
CIRSYour Compliance Expert
Thank You!
CIRS will be ready to help!
Ethan ZhengMy email: ethan.zheng@cirs-group.com
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Supplementary
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Supplementary
TCSCA
Toxic Substance: 310 Regulated Substances
Classification
Requirement
Handling
Class 1 Class 2 Class 3 Class 4
Low Degradability Chronic Toxicity Acute Toxicity Possible Toxicity
Manufacture Import Export Sale
DisposalUseTransport Storage
Permit Registration Approval Reporting
GHS Emergency Plan Operation Personnel …
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Supplementary
OSHA
Priority Substance
Category
Requirement
Annex 115 Items
CMR83 Items
Physicochemical & Health Hazardous Substance 420 Items
Reporting
Prohibited Substance
Annex 120 Items
Approval
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