Current status of the chemical management regulations in ASEAN - PowerPoint PPT Presentation

Current status of the chemical management regulations in ASEAN countries Piyatida (Tung) Pukclai, Ph.D. Chemical Substance Management Meeting 2019 18 – 19 September 2019 | PACIFICO Yokohama

Outline  Thailand Updates on Hazardous Substance Act and draft of new Chemical Substances Act  Malaysia CLASS Regulation and current update for Hazardous Chemical Legislation  Philippines Chemical Management Regulation and the Latest trends in the PICCS and PMPIN Process  Others 2

Business Areas Food and Regulatory Feed Software Contact Solutions Materials Biocides Training Crop Protection Industrial Medical Chemicals Devices Veterinary Cosmetics Medicine 3

Thailand – Updates on Hazardous Substance Act Hazardous Substance Act 1 st issued in B.E. 2535, the 4 th revision of Hazardous Substance Act announced on 30 th April 2019!! Under the responsibility of the Ministry of Industry (MOI) Diverse characteristics & usages of substances, enforcement is split over 6 authorities: Department of Agriculture (DOA), Ministry of Agriculture and Cooperatives (MOAC) Department of Fisheries (DOF), MOAC Department of Livestock Development (DLD), MOAC Food and Drug Administration (FDA), Ministry of Public Health (MOPH) Department of Industrial Works (DIW), MOI Department of Energy Business (DOEB), Ministry of Energy (ENERGY) 4

MOI Notifications: List of Hazardous Substances List of Hazardous Substances Year Link http://oaep.diw.go.th/haz/wp- List of Hazardous Substances No. 1 B.E. 2556 (2013) content/uploads/2016/12/announce56.pdf List of Hazardous Substances No. 2 B.E. 2558 (2015) http://oaep.diw.go.th/haz/wp- content/uploads/2016/12/announce58.pdf List of Hazardous Substances No. 3 B.E. 2559 (2016) http://www.diw.go.th/hawk/news/haz/4-60.pdf List of Hazardous Substances No. 4 B.E. 2560 (2017) http://www.diw.go.th/hawk/news/haz/4-61.pdf (announced on 11-Jan- 2018) List of Hazardous Substances No. 5 B.E. XXXX (XXXX) Draft version: http://www.diw.go.th/hawk/news/haz/law.html 5

Draft of List of Hazardous Substances No. 5, B.E. XXXX  Draft Notification: http://www.diw.go.th/hawk/news/haz/Draft_Notification.pdf (in Thai language)  Link for comments: http://php.diw.go.th/rubfung/show.php Proposed changes; Decabromodiphenyl ether to be Hazardous substance type 3 (link) • Short-chain chlorinated paraffins to be Hazardous substance type 3 (link) • Methoxyacetic acid; MAA to be Hazardous substance type 4* (link) • MAA is a toxic for reproduction category 1B. The MAA which is an unavoidable impurity from the glycolic acid (not include if its concentration is ≤ 0.3% w/v). Hexachloro benzene; HCB to be Hazardous substance type 4** (link), unless it is an unavoidable • impurity and not exceed 50 ppm (0.005% w/v) For other substances, please check from here 6

Classification & Hazardous Substance Import Procedure Notify before import (can be done within 1 day)  customs procedures Type 1 (Wo.Ao./Ao.Ko.6 form) Type 2 Register  get registration certificate  Type 2 notification submission  Notify before import (Wo.Ao./Ao.Ko.1 form) (17 working days) (Wo.Ao./Ao.Ko. 5 form) (Wo.Ao./Ao.Ko.6 form) Type 3 Register  storage inspection  get registration cert.  submit before import  get Permit (Wo.Ao./Ao.Ko.1 & approve & (Wo.Ao./Ao.Ko.6 form) Wo.Ao.3 or 5 or 7 forms) appeal to Minister in 30 days Type 4 Prohibited  Registration License: valid for 6 years  License Permit: valid for 3 years 7 7

How to determine hazard type under DIW Online Consultation by importer CBI submission (submission of 100% composition to DIW) by supplier Not under Type 2 Type 3 Type 4 Type 1 Type 1-4 List 5.6 Proposed inventory inclusion Non-Haz Apply for 15 digits code for Type 1 (only in sub-list 5.1 and 5.4) Registration for hazardous substance Type 2 and 3 Notify the DIW for Type 2 or Apply for license for Type 3 Submit “Prior Informed Consent” before proceeding Customs clearance process Comply with safety measures in the ministerial notifications (*GHS-SDS and Labeling) * March 2013 for substance, March 2017 for Mixtures 8

Current situation on the Thailand Existing Chemicals Inventory (TECI) Only the DIW “Preliminary of Thailand Existing Chemicals Inventory” is available Contains information of sub-list No. 5.1, 5.4, and 5.5 only from the year 2012 - 2015 Chemical information data from DIW online consultation results with actual production/ import data will include in the chemical inventory but the DIW will verify the data before input in the inventory (criteria is under consideration) Year Action plan 2018: DIW launch the online for the registration of hazardous substance Type 2, 3 and licensing of Type 3  Hazardous Substance Single Submission (HSSS) 2019: E-licensing 2020: Thailand Existing Chemicals Inventory (TECI) (or later) 9

The Hazardous Substance Act (No. 4), B.E. 2562 (2019) (will come into force on October 27 th , 2019) Key points: Have clear definitions of import, export, transit, re-import, re-export, etc. For each transit of type 1,2 shall be declared to authority, and type 3 need permission. Not the same process as the import to such a substance Set up the criteria and rules for the transit Set the rules to waive for the “re-import”/ “re-export” of hazardous substance The transit license shall valid not over than 45 days (previously 90 days). The company must be a local entity The transit shall be sent out from the port within 5 days after the custom inspection. Regulate activities related to product advertising and sale promotion Definition of liability and compensation regarding any damages occurring from chemical products Adjustment of Hazard Substance committee (17 from gov. authorities and 12 max. from external experts ) to enhance and streamline requirements in the processing of license and permit, chemical managements, etc. Link (in Thai): http://www.ratchakitcha.soc.go.th/DATA/PDF/2562/A/056/T_0231.PDF 10

Confidential Business Information (CBI) update! Link: http://oaep.diw.go.th/haz/wp- content/uploads/2019/06/%E0%B8%9B%E0%B8%A3%E0%B8%B0%E0%B8%81%E0%B8%B2%E0%B8 %A8CBI.pdf Any companies who submitted the CBI from 1 st January 2015 - 31 st December 2016 and still want to get the evaluation and feedback from HSMD must provide the following information to authority at: cbidiw_59@diw.mail.go.th from now until 30 th September 2019 . Receiving No. 1. The date that supplier sent the CBI to HSMD 2. Email of sender 3. Company can get the old documents within this time. Otherwise, HSMD will reject (or consider as invalid) 11

Draft of new chemical regulation: “Chemical Act” FDA organized the seminar on 26 April 2019 The 1 st draft for public hearing: 26 April 2019 (comments can be submitted until 7 th June 2019) By: Sub-committee on the chemical substances law development, consist of;  16 Government representatives include FDA , DIW , DOA , TISI , Customs , PCD , OAP , etc.  2 Enterprise representatives which are The Federation of Thai Industries ( FTI ), and Thai Crop Protection Association ( TCPA )  2 Civil Society representatives which are Public Health and Development Foundation ( PHDF ), and Thai Pesticide Alert Network( Thai - PAN )  3 Legal experts  Secretary: DIW and FDA 12

Draft of new Chemical Act Covers substance, mixture, and article Chemical management process; • Chemical assessment 1 • Licensing and control 2 • Surveillance and monitoring 3 The draft covers the entire chemical life cycle – from produce, import, export, transport, transit, re-import, re-export, having in possession, sales, use, treatment, and disposal of chemical substances and mixtures, as well as to recycling 13

Chemical lists under the new Chemical Act The Chemical Assessment Committee (CAC) will classify chemicals present in the Chemical Inventory according to their risks posed to health and environment , and divide them into 3 lists: List 1: Enterprises must comply with criteria and conditions impacting produce, import, export, transit, re-import, re-export, having in possession, sales, transport, use, treatment, disposal or recycling issued by competent authority. This includes the current “ low-risk chemicals ” with regards to health and environment; List 2: Enterprises must obtain licensing from competent authority. This includes the “ high-risk chemicals ” with regards to health and environment; List 3: All activities are prohibited . However, certain chemicals, such as those used for R&D purposes, or chemicals where contamination at use is unavoidable but that are less dangerous may be exempted Note: currently, only the Prelimianary Thailand Existing Chemical Inventory is available!! 14

Chemical Assessment Flowchart Chemical Assessment Committee Production, import, export, transit, re-import, (CAC) set the registration criteria re-export, having in possession, sales, (HS code & business type) transport, use, treatment, disposal, recycling No CAC set the Chemical Thailand Existing Chemical Inventory assessment criteria Assessment New chemical Yes Chemicals in the list No. 1, 2, 3 are classified by the CAC from the Thailand Existing Chemical Inventory according to their risks posed to health & environment Control advertisement & label for list 1, 2.1, 2.2, 2.3 List 1 List 2 List 3 2.1 2.2 2.3 Agriculture Public Industrial Health and etc. 15