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
Piyatida (Tung) Pukclai, Ph.D.
Chemical Substance Management Meeting 2019 18 – 19 September 2019 | PACIFICO Yokohama
Outline
Updates on Hazardous Substance Act and draft of new Chemical Substances Act
CLASS Regulation and current update for Hazardous Chemical Legislation
Chemical Management Regulation and the Latest trends in the PICCS and PMPIN Process
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Business Areas
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Industrial Chemicals Crop Protection Biocides Training Regulatory Software Solutions Medical Devices Veterinary Medicine Cosmetics Food and Feed Contact Materials
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1st issued in B.E. 2535, the 4th revision of Hazardous Substance Act announced on 30th 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)
Thailand – Updates on Hazardous Substance Act
Hazardous Substance Act
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List of Hazardous Substances Year Link List of Hazardous Substances No. 1 B.E. 2556 (2013)
http://oaep.diw.go.th/haz/wp- 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)
(announced on 11-Jan- 2018)
http://www.diw.go.th/hawk/news/haz/4-61.pdf
List of Hazardous Substances No. 5 B.E. XXXX (XXXX) Draft version:
http://www.diw.go.th/hawk/news/haz/law.html
MOI Notifications: List of Hazardous Substances
Draft of List of Hazardous Substances No. 5, B.E. XXXX
Proposed changes;
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).
impurity and not exceed 50 ppm (0.005% w/v) For other substances, please check from here
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Classification & Hazardous Substance Import Procedure
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Type 1
Notify before import (can be done within 1 day) customs procedures
(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
How to determine hazard type under DIW
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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
Online Consultation by importer (submission of 100% composition to DIW) Type 1 Type 2 Type 3 Type 4 List 5.6 Non-Haz
Not under Type 1-4
Proposed inventory inclusion
CBI submission by supplier
Current situation on the Thailand Existing Chemicals Inventory (TECI)
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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
2019: E-licensing 2020: (or later) Thailand Existing Chemicals Inventory (TECI)
The Hazardous Substance Act (No. 4), B.E. 2562 (2019)
(will come into force on October 27th, 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
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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 1st January 2015 - 31st 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 30th September 2019.
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Receiving No.
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The date that supplier sent the CBI to HSMD
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Email of sender Company can get the old documents within this time. Otherwise, HSMD will reject (or consider as invalid)
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Draft of new chemical regulation: “Chemical Act”
FDA organized the seminar on 26 April 2019 The 1st draft for public hearing: 26 April 2019 (comments can be submitted until 7th June 2019) By: Sub-committee on the chemical substances law development, consist of;
Crop Protection Association (TCPA)
(PHDF), and Thai Pesticide Alert Network(Thai-PAN)
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Draft of new Chemical Act
Covers substance, mixture, and article Chemical management process; 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
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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!!
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Chemical Assessment Flowchart
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Production, import, export, transit, re-import, re-export, having in possession, sales, transport, use, treatment, disposal, recycling
Chemical Assessment Committee (CAC) set the registration criteria (HS code & business type) Thailand Existing Chemical Inventory Yes No New chemical Chemical Assessment
CAC set the assessment criteria
List 1 List 2 List 3
Control advertisement & label for list 1, 2.1, 2.2, 2.3
2.1 Agriculture 2.2 Public Health 2.3 Industrial and etc.
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
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Hazardous Substance Act (and the amendments)
List 1 DOA (1.1, 1.2) List 2 DOF (2.1, 2.2, 2.3) List 3 DLD (3.1, 3.2) List 4 FDA (4.1, 4.2, 4.3) List 5 DIW (5.1, 5.2, 5.3, 5.4, 5.5, 5.6) For 5.6;
Explosive Flammable substance Oxidizing agent or Peroxide Toxic Substance Mutagen Corrosive Irritant Carcinogen Toxic substance to reproductive organ Environmentally hazardous substance
List 6 DOE
Draft of Chemical Act
Thailand Existing Chemical Inventory List 1 (Low risk) List 2 (High risk)
2.1 Agriculture 2.2 Public Health 2.3 Industrial and etc.
List 3 Prohibit (Dangerous)
New chemical shall be evaluated/ assessed on the risks posed to health & environment by the CAC prior to commencing any kind of activity related to the substance
Under the 1st draft version of the New Chemical Act
Covers the entire chemical life cycle Covers substance, mixture, and article Risk-based Have the Chemical Assessment Committee (CAC) , Specific Sector of Chemical Management Committee, and National Chemical Agency License validity: valid according to a period specified in such license but shall not exceed 6 years Covers surveillance and monitoring Insurance & compensation for the damages arising from chemicals Advertisement New penalty scheme (more strict)
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Transitional provisions
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Review of chemicals listed in existing chemical inventory and the classification from current Hazardous Substance Act to this new Act Transfer the notification/ registration applications under the Hazardous Substance Act to this new Act The existing permit licenses and registration licenses from the Hazardous Substance Act shall valid until the expiration date The Hazardous Substance Act and related regulations are being effective until the Chemical Substance Act is approve
Malaysia chemical control management
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DOA: Pesticide Act 1974 DOSH: Petroleum Act 1984 DOE: Environmental Quality Act 1974 KPDNKK: Consumer Protection Act 1999 KLN: Chemical Weapons Convention 2005 MOH: Poison Act 1952, Food Act 1983, Dangerous Drug Act 1952 KLN:Ministry of Foreign Affairs KPDNKK: Ministry of Domestic Trade, Co-operatives and Consumerism
Authority: Department of Occupational Safety and Health (DOSH) Under the Occupational Safety and Health Act 1994 (OSHA)
Under the Factories and Machinery Act 1967 (FMA)
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Malaysia – Overview On Current Chemical Legislation
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CLASS Regulations 2013
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Link: http://www.dosh.gov.my/index.php/en/chemical-management/class-regulations Classification, Labelling and Safety Data Sheet of Hazardous Chemicals >> CLASS Gazetted on 11th October 2013, and on fully enforcement on 17th April 2015 To control classification, packaging, labeling, SDS and inventory of hazardous chemicals Manufacturer or importer is required to prepare a hazardous chemical inventory, imported or supplied in a quantity of 1 T/Y or above for each calendar year. Such an inventory shall be submitted to the DOSH no later than 31 March in the following year CLASS regulations also require chemical manufacturers/ importers to classify, label & package chemicals, and compile SDS according to the ICOP Classification Packaging Labeling SDS Inventory
Manufacturer & importer only
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ICOP 2014
Industry Code of Practice (ICOP) on Chemicals Classification and Hazard Communication 2014 The ICOP was adapted from the 3rd revised edition of GHS purple book Under CLASS Regulation 2013, on 16th April 2014, government gazetted the ICOP CHC 2014 Purpose: detailing requirements specified in CLASS Regulations ICOP is promulgated as a guidance to help the industry comply with CLASS Regulations. It sets
Part 1 – List of Classified Chemicals Part 2 – Chemicals Classification Part 3 – Hazard Communication : Labeling and SDS Part 4 – Confidential Business Information (CBI)
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Chemicals Information Management System (CIMS)
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http://cims.dosh.gov.my/
Note:
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Current Update for Hazardous Chemical Legislations
approval from ministry
provision for special handling methods and control measure
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Year
2017 2018 2019
Number of classified chemicals
229 3 662
CHRA SiRAC
Full assessment Simple assessment Q: When to decide to perform CHRA or SiRAC*? not for foreign supplier A: Assessor can choose to perform assessment by using CHRA or SiRAC. However, SiRAC is not applicable to chemical classified as CMR and are only applicable for chemical in solid and liquid form. *SiRAC: an alternative approach of chemical health risk assessment and may be conducted if the chemicals hazardous to
health is listed in the chemical register; and not classified as carcinogenicity cat. 1, mutagenicity cat 1 or 2, or respiratory sensitization cat 1
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Current Update for Hazardous Chemical Legislations
Flow Chart on Approach of Assessment of Risk to Health
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USECHH regulations >> CHRA and SiRAC
Current Update for Hazardous Chemical Legislation
Factories and Machinery Act 1967
Nanotechnology Centre (NNC) for the coordination of R&D and all activities of nanotechnology
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Philippines – Overview On Current Chemical Legislation
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Under the responsibility of the Department of Environment and Natural Resources (DENR) Republic Act 6969 (Toxic Substances and Hazardous and Nuclear Waste Control Act) Title II of RA 6969 is the regulations for new chemicals, regulated and controlled chemicals, focused on management and control of industrial chemicals (regulations, restriction, prohibition) RA 6969 is a risk-based system
Polymer Exemption Pre-Manufacturing and Pre- Importation Notification (PMPIN) Philippine Inventory of Chemicals and Chemical Substances (PICCS) Chemical Control Order (CCO) Priority Chemical List (PCL) DAO 29 Title II. Toxic Chemical Substances (Existing Chemicals) (New Chemicals) Small Quantity Importation (SQI)
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Is it exempted? Is it on PICCS?
Exempted!
Is it < 1 t/a? Is it a PLC? Apply for PICCS certificate (not mandatory) Small quantity import certification
Polymer exemption certificate
No No No No
Yes Yes Yes Yes PMPIN
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Philippine Inventory of Chemicals and Chemical Substances (PICCS)
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There are 2 types of PICCS: 1) Public PICCS: uploaded in the EMB website https://emb.gov.ph/online-services/ for free access 2) Confidential PICCS: available only to notifier/authorized person for confirmation, request letter required Updating of the PICCS is done annually, and includes all new chemicals that have been issued non- confidential PMPIN Clearance Certificates In Mar, 2019, EMB published drafts on additional chemicals in PICCS 33 chemicals are added and amendment to EMB MC 2016-011 to allow the issuance of certification for PICCS
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Philippine Inventory of Chemicals and Chemical Substances (PICCS)
regulated by other laws in the Philippines
imported) for market test and research and development in quantities less than 1,000 kg/ year
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Exemption to PICCS
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Pre-Manufacturing and Pre-Importation Notification (PMPIN)
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Online-application: Detailed and abbreviated Forms Only local importers/ manufacturers may apply for new chemical substances not yet listed in PICCS Purpose is to screen harmful substances before they enter the Philippine’s commerce A process where the safety of the chemical to be introduced must be adequately documented Assessment is based on Hazard identification, Dose-response assessment, Exposure assessment, Risk characterization Sufficient information on Physicochemical properties, toxicological & ecological data
Detailed PMPIN Chemicals not listed in any countries 120 – 180 working days (Processing Time) Abbreviated PMPIN Chemicals listed in any of these countries; USA, Japan, Canada, Australia, EU, Korea 90 working days (Processing Time)
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PMPIN requirements
1. Submission of complete information of MSDS 2. Annual volume of import 3. Specific Use of the Chemical 4. Complete information in the Abbreviated and Detailed Form should be provided with data focus on:
5. For Detailed Form, laboratory reports for the above mentioned information are required include:
6. Interagency Chemical Review Committee assist EMB in the review of Detailed PMPIN Form Log-on to : http://210.213.80.213 Q: WHO SHALL APPLY? A: Only local importers, local manufacturers, or the 3rd Party (Ph) applicants on behalf of local importers
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PMPIN and the Confidential Business Information (CBI)
SDS of the products and not the individual chemical
www.emb.gov.ph
NCR, EMB – Region 4A, and EMB – Region 3
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Pending EMB Memorandum Circular on PMPIN Data Requirements
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Update existing requirements for PMPIN Proposed data for Physicochemical properties Proposed data for Toxicological and Environmental/Ecological Properties Confidential Business Information;
name of the product to be imported
chemicals@emb.gov.ph
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Small Quantity Importation (SQI)
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Online-application available This is an exemption to the PMPIN Process SQI is required prior to importation of less than 1,000 kg./yr of pure chemical substances or component chemicals in percentage by weight of product, mixtures not listed in the PICCS. Requirements: Letter of SQI request, notarized application form, and Safety Data Sheet (SDS) of chemicals Renewed yearly The 1st SQI application + 4 SQI renewal further, industries shall proceed with the PMPIN
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Applicant can apply for the Polymer exemption if; Meet the Polymers definition A substance composed of more than 50% of molecules containing a sequence of at least 3 monomer units covalently bound to at least one other monomer unit or other reactant; Has molecules distributed over a range of MW; and Has no single MW molecule reaching 50% (w/w) of total molecules Polymer of Low Concern (PLC); Meet the Polymers definition Cationic polymer can be exempted if the FGEW is >5000 Daltons; and Must not be unstable, degradable, decompose, or depolymerize
Polymer Exemption to the PMPIN Process
Implementation on hold! Draft Policy for Polymers
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Priority Chemical List (PCL)
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It is a list of existing & new chemicals that DENR has determined to potentially pose unreasonable risk to public health, workplace & the environment Users/ Importers/ Manufacturers/ Distributors of chemicals included in the PCL are required to register their hazardous wastes & chemical substances & submit biennial report PCL Compliance Certificate required for importation/manufacture of: New & existing chemicals listed in the PCL or chemicals/mixtures containing PCL chemicals Exemption: PCL chemical is equal or less than 1%, laboratories using PCL chemicals
Draft of the 3rd revised PCL
DAO 98 – 58 28 chemicals DAO 2005 – 27 (Current) 48 chemicals DAO 20XX – XX (Draft) 92 chemicals
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Chemical Control Order (CCO)
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Chemicals under the CCO; Prohibits, limits, or regulates the use, manufacture, import, export, transport, processing, storage, possession, and wholesale of those priority chemicals that DENR determined to be regulated, phased-
Required to register with DENR, secure Import Clearance and submit annual report (production & management information) Asbestos PCBs Cyanide and cyanide compounds ODS Lead and lead compounds Mercury and mercury compounds Cyanide and Cyanide compounds Chemicals for inclusion in CCO e.g.
compounds
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Requirements for CCO Importation Clearance
CCO Registration e.g. Fully-accomplished Importation Clearance Form Environmental permits e.g. ECC, Discharge permit, permit to operate/ exemption, etc. Summary of previous importation/distribution/usage List of customers (for importers) Registration of CCO
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PHILIPPINES: Current status
Online Permitting and Monitoring System (OPMS): https://210.213.80.213/accounts/login/ Development of policy for Polymer Exemption and Polymer of Low Concern (PLC) New approved policy on Clarifications on Permitting Regulations for SQI, PMPIN, PCL, CCOs ( MC 2017-009);
chemicals in the mixture is ≤1%
and once PMPIN is approved then the PCL Compliance Certificate shall be applied
for the chemical with the higher weight percentage
applied for the mixture but in the certificate all the PCL chemicals in the mixture will be indicated in the mixture
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Asia-Pacific Business Development & Regulatory Policy Director
4th Floor Unit 407 Airport Business Park (B-Building) 92/1 Mahidol Road T. Haiya
Phone: +66 (0)52 080454 Mobile: +66 (0)8 82510303 Fax: +66 (0)52 080452 E-mail: PPukclai@knoell.com Internet: http://www.thailand.knoell.com/en