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

[email protected]

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mailto:[email protected]



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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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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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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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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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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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


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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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


Late Pre-Registration for Existing Substance

R&D Application

CBI Protection



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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

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 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 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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R&D Application

CBI Protection



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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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R&D Application

CBI Protection



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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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R&D Application

CBI Protection



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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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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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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


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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Chemreg-border.epa.gov.tw

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R&D Application

CBI Protection



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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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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.

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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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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

https://csnn.osha.gov.tw/content/home/Substance_Home.aspx

https://csnn.osha.gov.tw/content/home/Substance_Home.aspx







http://www.cirs-reach.com/



https://www.linkedin.com/company/chemical-inspection-and-regulation-service-limited?trk=biz-companies-cym















Our Services

Taiwan- (Late) Pre-registration- Existing substance registration- New substance registration- CCIP application- Taiwan GHS- Regulatory training

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registration- China GHS- Regulation training

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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

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Thank You!

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Ethan ZhengMy email: [email protected]

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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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Taiwan chemical substance registration analysis and supervision measures update

Environment

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