Taiwan chemical substance registration analysis and supervision measures update

CIRS
Your Compliance Expert
Taiwan Chemical Substance Registration Analysis and
Supervision Measures Update
Ethan Zheng
CIRS
ethan.zheng@cirs-group.com
1

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
2

TCSCA OSHA Other Regulations
Taiwan EPA
December 11th , 2013
-Toxic Substance
-New Substance
-Existing Substance
Taiwan MOL
July 3rd , 2013
-Priority Substance
-Prohibited Substance
-New Substance
Other governments
-Food
-Drug
-Agro
-…
3

Registrant
1. Importer or manufacturer located in Taiwan
2. Third party representative (TPR) located in
Taiwan
3. 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
4

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
5

R&D Substance Polymer
PPORD R&D CMR Regular
On-Site
Intermediate
Polymer PLC
STD1 STD1
STD4
STD4
STD1 STD1
Small
Quantity
STD3
STD3 STD2
Simplified Simplified STD2 STD1 Simplified Simplified
Small
Quantity
STD1
Simplified
Small
Quantity
Small
Quantity
Pre-
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
6

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
7

Finish Phase 1
Standard
Registration
before due time
Existing Substance Registration
Pre-Registration Late Pre- Registration Standard Registration
List of substances
requiring phase 1
standard registration
will be published
Pre-Registration of
Existing Substance
2015.09.01 2016.03.31
Implementation of the Act
of Registration of Existing
and New Substance under
TCSCA
2014.12.11 2017.12.31
Late Pre-Registration
8

Registration Progress
800+
7 6
330
270
New Substance
Small Quantity Simplified
STD PLC
R&D
10,00
0+
150,0
00+
Application Substances
Existing Substance Phase I
Registration
During Dec. 11th , 2014 to March 31st, 2016 9
Unofficial

Late Pre-Registration for Existing Substance
R&D Application
CBI Protection
10

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
11
Pre-Registration
making up process and
detail published by EPA
on May 10th 2016.

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
12
* Annual tonnage counting
starts from Jan 1st 2016

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 passed
Review not passed
Resubmit
supporting
document
Review passed
Review not passed
Resubmit
dossier and
POA
13

Late Pre- Registration Documents
Supporting
Documents
Registration
Documents
Product
Information
-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
14

R&D Application
CBI Protection
15

R&D Application
1. Scientific Research purpose
2. 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
16

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
17

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.
18

R&D Application
CBI Protection
19

CBI Protection
Information can be kept confidential
1. Applicant information
2. Substance identity information
3. Substance manufacture or import information
4. Substance usage information
CBI Protection Duration
1. Standard Registration: 5 years
2. 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
20

CBI Protection
Information must be disclosed
1. Substance hazard classification information
2. Substance physical and chemical property information
3. Substance toxicological and eco-toxicological information
4. Substance hazard assessment information
5. 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
21

R&D Application
CBI Protection
22

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
23

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 website
Chemreg-border.epa.gov.tw
Step 1 read agreement
Step 2 fill in information
1. Applicant information
2. Product information
3. 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
24

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 code
2. CAS number
3. Components
4. …
1. Registration code
2. CAS number
3. Components
4. …
1. CAS number
2. Components
3. Exemption reason
4. …
Finish CCIP 25

Who can use the CCIP platform to do the pre-confirmation?
CCIP user can be:
1. Taiwan importer
2. Third party representative
3. Foreign company
4. 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.
26

27

28

29

R&D Application
CBI Protection
30

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.
31

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

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.
33

What if I do not do the CCIP?
Case Study 4
Can still get through the customs
Currently, the CCIP is not mandatory, products can still get through without
the CCIP.
Priority post inspection
Post inspection will be prioritized for the products without CCIP
Punishment will be made for illegal behaviors
If importers are found with illegal behaviors (not compliant to the chemical
regulations in Taiwan), related punishment will be made
34

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.
35

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-cym
36

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
CIRS
Your Compliance Expert

Thank You!
CIRS will be ready to help!
Ethan Zheng
My email: ethan.zheng@cirs-group.com
39

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 …
41

Supplementary
OSHA
Priority Substance
Category
Requirement
Annex 1
15 Items
CMR
83 Items
Physicochemical & Health
Hazardous Substance 420 Items
Reporting
Prohibited Substance
Annex 1
20 Items
Approval
42

Taiwan chemical substance registration analysis and supervision measures update

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