thailand hazardous substance control act (hsca) _ chemical

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12/17/2014 Thailand Hazardous Substance Control Act (HSCA) | chemical

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Removing Regulatory

Roadblocks, Expediting

Market Access

CHEMICAL FOOD COSMETIC AGROCHEM

China GHS Thailand HSCA Taiwan TCSCA China REACH Decree 591 K-REACH

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Thailand regulation:

Hazardous Substance Control Act

Passed by DIW under Ministry of Industry

Legislative evolution

1992(replaced)

Hazardous SubstanceControl Act (1st version)

1995 Hazardous SubstanceControl Act (2nd revision)

2008 Hazardous SubstanceControl Act (3rd revision)

Main supporting legislation in force

2012 Notification of MOI B.E.2555

2010 Notification of DIW B.E.2553

2008 Notification of DIW B.E.2551

2004 Notification of MOIB.E. 2547

1994 Ministerial Regulation B.E.2537

2000 Notification of MOI B.E.2543

2013 Notification of MOI B.E.

hailand Hazardous Substance Control Act (HSCA)Editor: Matt Lu Last Update: 15 Oct 2014

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 categorizedinto 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 Introduction

2 Historical Development

3 Competent Authorities

4 Who are Affected

5 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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2556

DIW - Dept. of Industrial Works under Ministry

of Industry (Thailand)

Agriculture, Department of Fisheries (DOF), Food and Drug Administration (FDA),

Department of Energy Business (DOEB), Department of Livestock development (DLD).

Please note that in Thailand, same substances which are used differently will be

controlled by different authorities differently.

Table 1. Competent authorities and their management scope in Thailand

Competent Authority Ministry Scope

Dept. of Industrial

Works (DIW)Ministry of Industry

Monitoring the operations of factory

and industrial chemicals

The Factory Act B.E. 2535

(1992)

The Hazardous Substance Act

B.E. 2535 (1992)

Dept. of Agriculture

(DOA)

Ministry of Agriculture

and Co-operatives

Monitoring the agricultural

chemicals

Food and Drug

Administration (FDA)

Ministry of Public

HealthMonitoring the consumer chemicals

Dept. of Fisheries

(DOF)


and Co-operativesMonitoring chemicals used in

fisheries

Dept. Of Livestock

Development (DLD)


and Co-operatives

Monitoring chemicals used in

livestock development

Dept. of Energy

BusinessMinistry of Energy

LPG (liquid petroleum gas) and NGV

(Natural gas vehicle)

. Who are Affected

Those involved in the manufacture, import, export, having in possession (sale, use, storage, transport or dispose) should comply with

the HSCA.

5. Regulated Scope

5.1 Definition:

Under HSCA, hazardous chemicals are defined as:

1. an explosive;

2. an inflammable substance;

3. an oxidizing agent and a peroxide substance;

4. a toxic substance;

5. an infectious substance;

6. a radioactive substance;

7. a mutagen;

8. a corrosive substance;

9. an irritating substance;10. other substances, whether chemical or else, which may be harmful to person, animal, plant, property or environment;

5.2 Hazardous Substance List:

Only substances in hazardous substance control lists are subject to HSCA. New control list has been enforced since the publication of

B.E. 2556on Aug 2013, with all the existing control lists repealed.

List of Hazardous Substances (Notification of Ministry of Industry Re: List of Hazardous Substances B.E. 2556 (2013), Annex:

Schedules 1-6)

There are 6 annexes in the most recently published control list consisting of 1,585 chemicals, regulated under different authorities.

See details in Figure 1.

Annex 1 Department of Agriculture: 698 items

Annex 2 Department of Fishery: 21 items
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Fig. 1 - Hazardous Substances

under DIW

Fig. 2 - Obligations for 4 different

types of chemicals

Annex 3 Department of livestock Development: 36 items

Annex 4 Food and Drug Administration: 258 items

Annex 5 Department of Industrial Works: 570 items

Annex 6 Department of Energy Business : 2 items

5.3 Types of Chemicals

Under HSCA, chemicals are classified into type 1, 2, 3 and 4, following 4 different factors below:

1. Toxicological data and dangerous properties of substances such as acute effect, chronic effect,

LD50 value, carcinogenicity, flammability and explosive properties.

2. Obligations under the applicable international conventions and covenants. For instance, CFCs

are classified as hazardous substances type 3 according to the Montreal Protocol.3. In the case that some hazardous substances are necessary to be used as raw materials in

domestic industry they cannot be substituted by any other substances having less toxic or hazardous properties, and such

substances may be classified on a temporary basis as type 3 with some additional strict safety measures.

4. In the case that some hazardous substances are necessary to be controlled but they are not covered by any other acts or laws,

the Hazardous Substance Act B.E. 2535 (1992) shall be applied.

Annex 5 was published by the DIW, which classifies chemicals into 4 types and lists the cut-off concentration to be considered as

hazardous. Please note that 1% should be taken as default when the cut-off concentration is not provided.

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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Fig. 3- Key Obligations under HSCA and their Scope

Registration

Substance Scope Affected Role in Supply Chain

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 withthat 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 lawsThere is distinct and reliable information about the hazardous substance in question

Notification


Type 1, 2, 3 Manufacturer, importer, exporter, having in possession

Permit/License(The Ministerial Regulation B.E. 2537 (1994))


Type 3 Manufacturer, importer, exporter, having in possession

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.

Exemptioncould 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 informationon 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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Fig. 4 -Procedure for License

Application

Procedure for license application

On-site inspection would be conducted by competent officials once the application for permit/license has been received with

complement materials submitted. The following diagram presents the procedure of license application.

For producer, the inspection will cover the site of the production facility, storage facility,

machinery and the accuracy of documents.

For importer, exporter or having in possession, inspection would be conducted on the site of

storage facility and the accuracy documents.

Accompanying Duties

On-site safety facilities

The obligation does not end with the permit/license obtained. The recipient of a permit for

production, import, export or possession of hazardous substance should be equipped with safety

facilities including emergency shower and eyewash, personal protection equipment (PPE), first-aid

kit together with first-aid advice, etc.

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)


hazardous substance designated in the annex of

MOI Notification B.E. 3542 (2000) Manufacturer, Importer, Exporter, Possessor

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

InvoiceBill 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-chemical-regulations-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.

There are two choices to submit the import/export declaration:

1. Single window of DIW. It takes 15 minutes to complete all processes by one stop

service.

2. Submit the application online

http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp
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Fig. 5 - Procedure to submit the import/export

declaration

Ebook 33: Overview of GHS

Development in Asia-Pacific in

2013

(http://haz2.diw.go.th/HazLicense/jsp/login/login_vk6.jsp)

A producer, importer, exporter, or processor should declare the following to the

competent authority (WoAo./AoKo.7):

Chemical Identification: name, chemical formula and proportion, trade name,

common name or abbreviation (if any)

Registration number(if any)

Produced, imported, exported, or possessed quantity, sold quantity, its customer

and his/her purpose of purchasing

Activities need to be reported to the competent authority within the corresponding

deadline.

Period during which Activities are Conducted Declaration Deadline

Jan to Jun Jul of the same year

Jul to Dec Jan of the next year

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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Fig. 6 -Obligations for Manufacturer

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 ToxicitySkin 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

Substance pre-screening Notification of Hazardous Substances

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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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