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Taiwan chemical substance registration analysis and supervision measures update

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How is the progress of Taiwan chemical regulations? How are the Taiwan Customs supervision measures going? What are the differences between Pre-Registration and Late Pre-Registration? What about the CBI protection under Taiwan chemical regulations? Experts from CIRS will make interpretations of all the above mentioned contents and will bring you some take home messages for enterprises.

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Taiwan chemical substance registration analysis and supervision measures update

  1. 1. CIRS Your Compliance Expert Taiwan Chemical Substance Registration Analysis and Supervision Measures Update Ethan Zheng CIRS ethan.zheng@cirs-group.com 1
  2. 2. 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
  3. 3. Taiwan Chemical Control Regulations Introduction 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
  4. 4. Taiwan Chemical Control Regulations Introduction 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
  5. 5. 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 5
  6. 6. Taiwan Chemical Control Regulations Introduction 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
  7. 7. 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 7
  8. 8. 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 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
  9. 9. Taiwan Chemical Control Regulations Introduction 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
  10. 10. 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 10
  11. 11. 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 11 Pre-Registration making up process and detail published by EPA on May 10th 2016.
  12. 12. 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 12 * Annual tonnage counting starts from Jan 1st 2016
  13. 13. 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 passed Review not passed Resubmit supporting document Review passed Review not passed Resubmit dossier and POA 13
  14. 14. Late Pre-Registration for Existing Substance 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
  15. 15. 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 15
  16. 16. 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
  17. 17. 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
  18. 18. 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
  19. 19. 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 19
  20. 20. 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
  21. 21. 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
  22. 22. 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 22
  23. 23. 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 23
  24. 24. 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 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
  25. 25. 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 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
  26. 26. Chemical Commodity Importation Pre-Confirmation (CCIP) 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. 27. Chemical Commodity Importation Pre-Confirmation (CCIP) Chemreg-border.epa.gov.tw 27
  28. 28. Chemical Commodity Importation Pre-Confirmation (CCIP) Chemreg-border.epa.gov.tw 28
  29. 29. Chemical Commodity Importation Pre-Confirmation (CCIP) Chemreg-border.epa.gov.tw 29
  30. 30. 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 30
  31. 31. 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. 31
  32. 32. 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
  33. 33. 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. 33
  34. 34. Case Study and Take Home Messages 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
  35. 35. 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. 35
  36. 36. 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
  37. 37. 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.
  38. 38. 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
  39. 39. Thank You! CIRS will be ready to help! Ethan Zheng My email: ethan.zheng@cirs-group.com 39
  40. 40. Supplementary 40
  41. 41. 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
  42. 42. 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

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