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ThailandHazardousSubstanceControlAct(HSCA)|chemical
Removing Regulatory
Roadblocks, Expediting
Market Access
China GHS
Thailand HSCA
Taiwan TCSCA
CHEMICAL
China REACH
Decree 591
FOOD
COSMETIC
AGROCHEM
K-REACH
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Two overarching regulations were promulgated by the Department of Industrial Works (DIW) under Thailand Ministry of Industry to
regulate chemicals and hazardous substances to reduce risk that could be harmful to human health, life, property and the
environment.
As one of the main legislative pieces involved in the chemical management in Thailand, Hazardous Substance Act B.E. 2535 (1st issue)
took effect since Apr 7th, 1992.
Two key goals are meant to be realized with the implementation of HSCA:
To ensure hazardous substances are only handled by authorized operators, and appropriately handled, transported and
disposed.
The concept of from cradle to grave is integrated. Supervision over the entire supply chain to prevent misuse and abuse of
hazardous substances.
A spectrum of obligations are prescribed for chemicals categorized into type 1, 2, 3 and 4 chemicals, including notification,
registration, Thailand GHS duties, prior inform declaration, etc. Those involved in the manufacture, import, export, having in
possession (sale, use, storage, transport or dispose) are covered in the HSCA.
Contents
1
2
3
4
5
Introduction
Historical Development
Competent Authorities
Who are Affected
Regulatory Scope
5.1 Definitions
5.2 List of Hazardous Chemicals
5.3 Types of Chemicals
6 Industry Obligations
6.1 Different Obligation for 4 Types of Chemicals
6.2 A Wide Range of Obligations for 4 Types of
Chemicals
6.3 Obligations prescribed on Different Roles
7 Future Amendment
2. Historical Development
The Hazardous Substance Act was promulgated in place of the Toxic Substance Act, B.E.
2510 and Toxic Substance Act (No.2), B.E. 2516 in 1992. The most recent amendment
occurred in 2008, which resulted in the 3rd version of the HSCA.
3. Competent Authority
A total of 6 relevant regulatory bodies from 4 ministries are involved in the
implementation of the HSCA, including Department of Industrial Works, Department of
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Thailand regulation:
Hazardous Substance Control Act
Passed by
1992
(replaced)
Hazardous Substance
Control Act (1st version)
1995
Hazardous Substance
Control Act (2nd revision)
2008
Hazardous Substance
Control Act (3rd revision)
Main supporting legislation in force
2012
2010
2008
2004
Notification of MOI
B.E. 2547
1994
2000
2013
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2556
Ministry
Scope
Monitoring the operations of factory
and industrial chemicals
Dept. of Industrial
Works (DIW)
Ministry of Industry
Dept. of Agriculture
(DOA)
Ministry of Agriculture
and Co-operatives
Ministry of Public
Health
Dept. of Fisheries
(DOF)
Ministry of Agriculture
and Co-operatives
Dept. Of Livestock
Development (DLD)
Ministry of Agriculture
and Co-operatives
Dept. of Energy
Business
Ministry of Energy
5. Regulated Scope
5.1 Definition:
Under HSCA, hazardous chemicals are defined as:
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
an explosive;
an inflammable substance;
an oxidizing agent and a peroxide substance;
a toxic substance;
an infectious substance;
a radioactive substance;
a mutagen;
a corrosive substance;
an irritating substance;
other substances, whether chemical or else, which may be harmful to person, animal, plant, property or environment;
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Annex
Annex
Annex
Annex
ThailandHazardousSubstanceControlAct(HSCA)|chemical
3
4
5
6
6. Obligations
6.1. Different Obligations for 4 Types of Chemicals
Type 1:
Manufacturers and importers are required to notify the product information to the authorities.Besides, business operators must
comply with the specified criteria and procedures, such as labeling, rules and conditions for manufacturing and storage.
Type 2:
Must be registered accordingly ;
Notification to the authority on the action taken for production , import, export or having in possession in compliance with
notification of DIW subject: notice on operation of hazardous substances type 2 which are under the responsibility of the
ministerial regulation, B.E. 2538 (1995);
Notification of quantity of production, import, export and having in possession to the authority in accordance with MOI's
ministerial notification on criteria for the notification of fact by producer, importer, exporter and possessor of hazardous
substances which fall within the responsibility of the DIW;
Type 3:
Must be registered accordingly;
Submit application of a license to produce, import or to possess such a hazardous substance
Notification of quantity of production, import, export and having in possession to the authority with the MOIs ministerial
notification on criteria for the notification of facts by producer, importer, exporter and possessor of hazardous substances which
fall within the responsibility of the DIW
Type 4:
Production, import, export and having in possession by anyone is absolutely prohibited.
Obligations for different types of chemicals are summarized in the diagram below:
A detailed interpretation of the range of obligations mentioned here is provided in the following section, including their
requirements, exemption cases, etc.
6.2 A Wide Range of Obligations for 4 Types of Chemicals
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Registration
Fig. 3- Key Obligations under HSCA and their Scope
Substance Scope
Type 2, 3
Producer, Importer
Any person who produces or imports type 2 and type 3 hazardous substances shall get these hazardous substances registered with
the DIW, MOI or other agencies designated by the MOI.
Information needed to be submitted together with the Application form for registration (annex of Notification of MOI B.E. 2543)
1. Material Safety Data Sheet (MSDS), in accordance with the form WoAo./AoKo.3 annexed to this Ministerial Notification or with
that of ISO 11014-1 (should be updated to the GHS requirements)
2. Specification of the hazardous substance
3. Document or photograph evidencing characteristic of containers or tanks
4. Document or photograph evidencing methods used to secure the containers (if any)
5. A specimen of the hazardous substance for analysis of its specification, or the
6. analysis result issued by an analytical laboratory, which is approved by Department of Industrial Works, or a document proven
of the specification.
A sample may be submitted as a substitute for the documents in (3) and (4), nonetheless the specimen, the analysis result or the
document in (5) shall be as prescribed by the competent official.
Exemption Scenarios:
A hazardous substance has been registered
A hazardous substance is permitted to be produced or imported under other laws
There is distinct and reliable information about the hazardous substance in question
Notification
Substance Scope
Type 1, 2, 3
Type 3
Any person who intends to produce, import, export or have in possession of type 3 hazardous substances need to submit the
application for corresponding permit/license.
5 separate application forms for producer, importer, exporter and having in possession, storage need to be filled out and submitted,
respectively.
Exemption could be applied if the person has already been granted a permit for production, import or export of hazardous
substance, a permit for the possession of the particular hazardous substance could be exempted.
Basic information on the substance to be submitted include:
Importer - name, address and commercial license
Chemical identification - trade name, formula name, quantity to import/export, country of origin, producer company and means
of transportation.
Material safety data sheet (in the case of industrial chemicals) or the results of efficacy trial, residue trial, quality analysis,
toxicological data assessment (in the case of pesticides)
Warehouse - address, location, protective and preventive measures on warehouse structure and occupational health and safety
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Transportation
If the recipient of a permit is also a carrier of hazardous substances, MSDS, a symbol or a mark indicating the properties of the
transported hazardous substance must be displayed on both sides of the vehicle
Prior Inform Declaration (The Notification of MOI B.E. 2547 (2004) replacing the MOI Notification B.E. 2543 (2000)
Substance Scope
Import/Export Declaration
Each shipment of Hazardous substance has to submit import/export declaration to DIW before their custom clearance accroding
to The Notification of MOI B.E. 2547 (2004).
An importer or an exporter of the hazardous substance shall declare the following information of the particular substance to the
DIW prior to their custom clearance: (see form WoAo./AoKo.6 in the regulation of DIW B.E. 2547)
Chemical identification: name, chemical formula and proportion, trade name, common name or abbreviation (if any)
Quantity (of the chemical imported or the container), characteristic of containers
Location of storage facility
Transportation means
Customs port, anticipated arrival date to or departure date from the port
Invoice
Bill of loading
Specific document for the restricted control chemicals
100% Composition Disclosure
As one of the unique features incorporated in Thailand hazardous chemicals management system, DIW would require 100%
composition disclosure for evaluation. Companies may choose to keep some composition information to themselves due to CBI
concern. Under such circumstances, the company has to take its own risk since the DIW could only evaluate the chemicals are
hazardous or not based on the information provided. This undoubtedly could give rise to potential risks of incompliance. The
recommended strategy would be to compare the chemicals of your concern against the hazardous control list.
For importers, it should also be specially noted that Thailand Customs would also inspect the 100% concentration disclosure
declaration, to make sure the information provided are consistent with those on the SDS.
(More details about the 100% concentration disclosure, please click here (http://chemlinked.com/new-webinar/how-comply-chemicalregulations-thailand) to access ChemLinked Thailand webinar materials.)
How to Submit the Import/Export Declaration
DIW works closely with the Customs Department to facilitate the declaration procedure. DIW can record and transmit the
acknowledgement to the Customs Departments database to facilitate enterprise to clear the Customs processes.
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(http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp)
Declaration Deadline
Jan to Jun
Jul to Dec
Operational Personnel
To ensure that hazardous substances are operated appropriately, a specialized person needs to be assigned, certain criteria and
methodology needs to be adopted for the designation procedure, according to (The Notification of MOI Re: Designation of a
specialized person responsible for safety of hazardous substance storage under Authorization of Department of Industrial Works at
the Hzardous Substance Business Facility B.E. 2551 (2008); Notification of DIW Re: Criteria and Method for Notifying and Registration
of Specialized Person Responsible for Safety Storage of Hazardous Substance under Authorization of Department of Industrial Works
and Reporting of Safety Storage of Hazardous Substance B.E. 2551 (Criteria and Method) which were effective since Apr 18, 2011, as
well as The Notification of DIW Re: The Examination for a Registration of Specialized Person Responsible for Safety Storage of
Hazardous Substances B.E. 2553 (2010).
Scope:
Producer, importer, exporter of hazardous substance type 1, type 2 or type 3 in total amount from 1,000 metric ton/year.
Processor of hazardous substance whose storage area of hazardous substance is from 300 m2;
Producer, importer, exporter or processor of hazardous substance that is flammable substance or oxidizing agent and peroxide.
Exemption: a hazardous substance producer, importer, exporter or processor who keeps hazardous substance in tank, silo,
portable/bulk container cryogenic liquefied gas or refrigerated liquefied gas should be exempted.
GHS:
Scope: Only hazardous substances in DIWs control list (ANNEX 5)
Thailand adopted GHS in 2012 for the purpose of hazard communication for chemicals by promulgating the ministerial notification
B.E. 2555 (2012). The implementation of GHS is two-step action, with GHS taking effective on Mar 13, 2013 for single substances and
Mar 13, 2017 for mixtures.
The ministerial notification B.E.2555 (2012) on GHS is promulgated by the DIW under the Hazardous Substance Act
in compliance with 3rd revision of UN GHS
currently only applicable for chemicals under the scope of DIW (regulates industrial chemicals)
DIW is the first authority to enforce GHS, it is expected that FDA will announce GHS soon, followed by
DOLD.
Classification& Labelling
In consistence with UN GHS 3rd revision, Thailand GHS adopted 28 hazard class categorized into
physical hazard (16), health hazard (10) and environmental hazard (2):
Physical Hazard
Explosives
Flammable gases
Flammable aerosols
Oxidizing gases
Gases under pressure
Flammable liquids
Flammable solids
Self-reactive substances and mixtures
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Pyrophoric liquids
Pyrophoric solids
Self-heating substances and mixtures
Substances and mixtures, which in contact with water, emit flammable gases
Oxidizing liquids
Oxidizing solids
Organic peroxides
Corrosive to metals
Health Hazard
Acute Toxicity
Skin corrosion/irritation
Serious eye damage/eye irritation
Respiratory or skin sensitization
Germ cell mutagenicity
Carcinogenicity
Reproductive toxicity
Specific target organ toxicity-single exposure
Specific target organ toxicity-repeated exposure
Aspiration hazard
Environmental Hazard
Hazard to the aquatic environment
Hazard to the ozone layer
Table 1 of B.E.2555 lists the classification criteria of 28 hazards and the corresponding label elements of hazard communication.
SDS
Table 2 of B.E2555 lists the 16 headings required in the Safety data sheet with their sub-sections specified.
Useful Information Inquiry portal:
http://ghs.diw.go.th/knowledge.html (http://ghs.diw.go.th/knowledge.html)
http://ghs.diw.go.th:8080/GHSThaiUser/servlet/ChemServlet?action=QCL (http://ghs.diw.go.th:8080/GHSThaiUser/servlet/ChemServlet?
action=QCL)
http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp (http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp)
Transportation management
The Notification of MOI B.E. 2546 Announcement of the resolution of the Committee on Hazardous Substance, regarding land
transportation of hazardous substance B.E. 2545 (2002) dated 15th August B.E. 2545 (2002)
6.3 Obligations prescribed on Different Roles
HS Manufacturer
Type1: Comply with specified criteria and procedures
Type2: RegistrationNotificationImport/Export Declaration per shipment
Type3: RegistrationLicense (Inspect locations and warehouse)Import& Export
Declaration per shipment
HS Importer
Type1: comply with specified criteria and
procedures
Type2: RegistrationNotification
Import/Export Declaration per shipment
Type3: RegistrationLicense (Inspect
locations and warehouse)Import&
Export Declaration per shipment
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Fig. 7 - Obligatoins for Importer
7. Future Amendment
7.1 HSCA Amendment
In 2013, DIW initiated the HSCA amendment project, which aimed to improve the current version by identifying the existing hurdles
and consulting all stakeholders. Chemical regulations in other countries/region will be reviewed, including EU, USA, Japan, China and
ASEAN.
Several hightlights of the amendement could include:
Add "Transit" in scope and definition (there are only "import" and "export" in the existing regulation);
HS type 4 used for R&D could be exempted;
7.2 GHS implementation progress countrywide
DIW is currently the first and only authority to implement GHS on chemicals used for industrial purpose. Other authorities such as
FDA and DOLD will soon follow the suit. According to ChemLinked sources, FDA has already its draft regulations ready for discussion
among stakeholders. GHS committee will be established to guarantee the consistency in GHS implementation countrywide.
News
11 Oct 2014 Thailand HSCA to Expand Its Regulated Scope
5 Jun 2014 Thailand GHS: 100% Component Disclosure Could Be the Hurdle in Preparing SDS
30 Oct 2013 Thailand Prepares a Comprehensive List of Hazardous Substances
25 Oct 2013 Thailand's DIW Requires Complete Chemical Composition for Hazardous Items Certification
24 Oct 2013 Thailand to Implement GHS for Household and Agriculture Chemicals
16 Jul 2013 Thailand Issued Draft Amendment on Hazardous Substance Act for Public Comment
1 Mar 2013 Grace Period of Thailand GHS about to End for Substances
12 Dec 2012 Thailand Re-Classifies Household Hazardous Substances
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