KEY REGULATORY UPDATES of Chemical Management in Taiwan

Jowitt Li, Ph.D. Director, Chemical Safety

Safety and Health Technology Center (SAHTECH)

2021/10/12-14

Five Year Reviews and 2021 Key Update

1. Major Reforms and Implementation since 2016New Chemicals Registration

Existing Chemicals Management

TCSI Inventory

2. 2021 Key Updates plus CBI practice

3. Take-home message

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Major Reforms and Implementation since 2016

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Major Reforms and Implementation (1)• New chemicals are subject to registration

• Existing chemicals are subject to annual reporting and designated key management arrangement*

• Toxic Chemical Substance remains the same 4 categories: indecomposable/bioaccumulation; CMR/Chronic; acute toxicity; EDC/ environmental pollution concerns

• Concerned Chemical Substance is the 5th category to address public concerns, similar management requirements as toxic chemicals

• CBI application is applicable to new, inventory, and SDS withholding/disclosure, subject to conditions and fee/no fee

• Full GHS implementation, National Standard the 4th edition Purple Book

• Combining Descriptive and Prescriptive management approach*: see see Page 8 for appointed key management chemicals under TCCSC Act and OSH Act

Major Reforms and Implementation(2)

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Chemical Management Scheme under EPA and MOLMajor Amendments under MOL and EPA

Management of new and existing chemical substances• Occupational Safety and Health Act (OSH Act) : Title and the complete text of 55 articles amended

and promulgated by Presidential Order on July 3rd, 2013

• Toxic Chemical Substance Control Act (TCSC Act): Revisions of Articles promulgated by Presidential Order on December 11th, 2013; further renamed the new Toxic and Concerned Chemical Substances Control Act (TCCSC Act) on Jan 16th, 2019

• Single national inventory TCSI since 2014

• Unified window for receiving/approving new chemical registration since 2016, one-stop submission for OSH Act and TCCSC Act

GHS Implementation under MOL OSH Act, plus EPA toxic/concerned chemicals

• Full GHS implementation, classification and labelling of hazardous chemicals: January 1st , 2016 (stipulated under the OSH Act)

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New Chemicals RegistrationUnder TCCSC Act and OSH Act; single window for dossier submission

>= 1 ton/y

PLC

< 1 ton/y

Notified R&D: 8,000+

Pre-registration: 18,000+

Source: TW EPA Annual Reports

Existing Chemical ManagementAnnual reporting subject to TCCSC Act and OSH Act

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OSH ActPriority Management Chemicals

TCCSC ActNew and existing chemical substances

Designated CMR and high hazards 1,371chemicals and their mixtures

New and existing substances with valid registration numbers over 1 ton/y, 2,0000+ substances

Manufacturers, importers, downstreamusers, and storages, by employers

Manufacturers and importers only, + TPR

Since 2015, during April to September Since 2020, during April to September

Previous year annual total tonnages of manufacturing, importation, using, and storage, as well as maximum amounts

Require SDS and exposure assessment results

Previous year annual tonnage bands of manufacturing and importation,

Existing Chemical Managementappointed key management chemicals under TCCSC Act and OSH Act

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OSH Act TCCSC Act

Priority Management Chemicals, 1173 Toxic Chemical Substances, 4 categories,341

Controlled Chemicals, 13 Concerned Chemical Substances, 3

Material health protection chemicals, 29 -Chemicals subject to workplace monitoring, 91

-

Chemical with PEL, 492 -

Chemicals with GHS Health hazards are all subject to exposure assessment for worker protection

-

Hazard Communication, SDS, label, inventory of all GHS hazardous chemicals

SDS/Label/emergency response, 341+3

TCSI renewal and its CBI extensionTaiwan Chemical Substance Inventory

Taiwan Chemical Substance Inventory (TCSI) CBI protection extension application ended on Sep. 7th,2020

• The TCSI is updated online, November, 2020, CBI protection up to to 2025

9https://csnn.osha.gov.tw/content/home/Substance_Home.aspx

• CASNO series• N series: no CASNO• P and C series: CBI

protection

101,000+ entries1,200+ CBI

Five year Reviews-Industry Perspectives (1)

EPA TCSB was expected to take over ALL chemical management tasks, nevertheless, interagency coordination/cooperation is rather practical.

Interagency coordination to prevent redundancy, e.g. the designation of concerned chemical substances.

Longer than expected Review Time for approval is the most common uncertainty concern regarding registration of new and PECs

The expectations of PECs deadline extension (proposed) are divided; proposed extensions of Review Time are most worried by industries.

Five year Reviews-Industry Perspectives (2)

Alternative methods are recognized as supplementary, subjectively discouraged in dossier submission process

Practical improvement of on-line annual reporting platforms and dossier tools (version Chemist 4.1 and PECX 1.1) ongoing

Strategy on UN Purple Book version adoption issue

Encourage supply chain communication for SDS information/quality and compliance requirements.

2021 Key Updates and CBI practice

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2021 Key Updates and CBI practice (1)Key points of proposed amendments of PEC registration regulation1. The deadline for 106 PECs standard registration will be extended to 4 years, till the end of

year 2023.

2. The on-site isolated intermediates of existing chemical substances will be exempted from standard registration.

3. The valid and confidential periods of the registration approval will be harmonized as 5 years for all. Furthermore, for a new chemical substance that has been included in the TCSI, the maximum confidential period will be 15 years.

4. The review periods for new chemical registration will be amended, and the number of the application correction will be amended from 2 to 3 times.

5. PEC Completion Numbers for the standard registration of existing chemical substances will be issued to those who apply and complete information items regarding registrants and substances (Ch1~Ch7).

6. The registrants shall complete the remaining information items (CH8 hazard and CH9 exposure assessment) proactively or before a future appointed due date (not specified yet in this draft proposal).

7. There will be NO “Only Representative" provision

8. Joint registration is NOT mandatory

2021 Key Updates and CBI practice (2)

New chemical registration• Registrant is eligible for CBI application for new chemicals subject to a fee for 5 years

• Approved CBI series number can be used on SDS and label

• Over 30% cases applied

SDS CBI withholding• Chemicals with PEL or GHS health hazards class 1 etc. are NOT eligible

• Applicant to provide or cite reference

• Free of charge, no expiring date (yet)

• Over 100 substances approved, out of 200+ application attempts

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(1) A certificate/declaration that is recognized as national security or

commodity business secret.

(2) Countermeasures taken to protect national security or commodity

business secrets.

(3) Evaluation of the economic interests of the applicant and its competitors.

(4) Description and certification/proven evidence of the hazardous

classification of hazardous chemical components in the product.

2021 Key Updates and CBI practice (3)

SDS CBI withholding application and its conditions

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2021 Key Updates and SDS practice (4)

Hazard Communication Regulation and SDS

To encourage downstream users to check the contents of the SDS they received, and source manufacturers and suppliers to check the contents of the SDS prepared by themselves as product stewardship, OSHA promotes the checklists and checking principles as reference for the purposes.

1. Compliance check of required items and contents2. Rationales of hazardous components3. Rationales of GHS classifications4. Rationales of test results and their figures5. Rationales of instruction and description

https://ghs.osha.gov.tw/CHT/intro/AnnounceData4Detail.aspx?id=326

Article15: The manufacturer, importer, supplier or employer shall review the correctness of the SDS according to the actual situation, update it in a timely manner, and review it at least once every 3 years.

Take-home Message

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Take-home Message1. Chemical management schemes are generally in place as planned.

2. Expecting lengthy Review Time and communication for registration dossier submission

3. Annually reporting (Apr.-Sept.) will be continued as a routine to support key management designation.

4. Individual or group registrations of 106 PECs are optional, deadline is to be extended to the end of 2023 subject to amendment.

5. Newer than the 4th edition of GHS Purple Book is acceptable as equivalent or higher standards.

6. Expecting inquiries from your downstream buyers, check your SDS for compliance, and their rationales of safety information

7. Combination of prescriptive and descriptive approaches

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Embracing Global Challenges Toward Achieving 2030 SDGs

SAHTECH is dedicating key resources to extend technical supports and services to private sectors and stakeholders beyond competent authority partners, aiming to align with and achieve ESG sustainability, SDG 8, 12 and 17, towards 2030 common global goals.

財團法人安全衛生技術中心

Safety and Health Technology Center (SAHTECH)

+886-6-293-7770

Thanks for your attention

Jowitt Li, SAHTECH

joli@sahtech.org