1. Introduction

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.

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 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

 4. 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. 2556 on 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. 

Fig. 1 - Hazardous Substances under DIW

· Annex 1 Department of Agriculture: 698 items

· Annex 2 Department of Fishery: 21 items

· 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 MOI’s 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:

Fig. 2 - Obligations for 4 different types of chemicals 

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

Fig. 3- Key Obligations under HSCA and their Scope  

Registration 

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

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

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

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.

Fig. 4 -Procedure for 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 corresponding parts of MOI Notification B.E. 2543 (2000)

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 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 Department’s database to facilitate enterprise to clear the Customs processes. 

Fig. 5 - Procedure to submit the import/export declaration

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

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.

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: Chemicals on the list of hazardous substances that are regulated by different authorities.

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. More information please refer to the Chempedia: Thailand GHS.

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

Fig. 6 -Obligations for Manufacturer

·  Type1: Comply with specified criteria and procedures

·  Type2: Registration—Notification—Import/Export Declaration per shipment

· Type3: Registration—License (Inspect locations and warehouse)—Import& Export Declaration per shipment

HS Importer

Fig. 7 - Obligatoins for Importer

· Type1: comply with specified criteria and procedures

· Type2: Registration—Notification—Import/Export Declaration per shipment

· Type3: Registration—License (Inspect locations and warehouse)—Import& Export Declaration per shipment

7. Annex 5.6 and Latest Amendments

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;

In April 2019, Thailand released the Hazardous Substance Act (No.4), which entered into effectd on 27^th October 2019. The fourth revision focused on stating the definition of "transit" and separating it from "import" and speeding up the customs process by reducing repeat steps. Here are some key points for stakeholders about the revision: 

1. The specific customs border for "transit" of hazardous substances are identified. The respected commodity shall be set out of the port within 5 days after the completion of transit activity and custom inspection.

2. The requirements for damage insurance are established and the provisions in accordance with the payment of preliminary damage are stipulated. Those who have been adversely affected by hazardous substances shall be compensated. In case the commodity has been insured, the compensation shall be paid beforehand without liability approval. (WTO Notification)

3. The provisions aimed at exemption for unitizations of hazardous substances under the purposes of the study, analysis, research, and development are established, which will help reduce the undue burden and make the practice of the Act more efficient. 

7.2 Annex 5.6 -- List of Hazardous Substances Amendment

On Feb 19th, 2015, Ministry of Industry (MOI) published a notification pertaining to the List of Hazardous Substances (No. 2) B.E. 2558 (2015). According to the notification, manufacturers and importers of chemical substances that meet certain criteria will have to notify chemical substances to the Department of Industrial Works (DIW). By gathering enterprise notification information, DIW aims to prepare Thailand’s inventory of existing chemicals and determine the appropriate approaches for chemicals management in Thailand.

Notifications should be submitted within 60 days from the date of manufacture or importation of any listed hazardous materials that exceed a designated quantity threshold. The notification could be submitted on-line or through other means as prescribed by MOI. 

Once notified, the substances will be added into a new Annex (Annex 5.6) of the current list of hazardous substances. Moreover, the notified substances will be exempted from some compliance duties stipulated by HSCA B.E. 2535 (1992).

The notification procedures and requirements are outlined in the illustration on the right.

8. The Draft Chemical Substance Act

8.1 Chemical Substance Act

The draft Chemical Substance Act contains these parts: 

• The foundation of the National Chemical Policy Committee, Chemical Assessment Committee (CAC), Specific Sector of Chemical Management Committee and National Chemical Agency and their qualification, power and responsibilities.

• Chemical management process. In this part, chemicals are sorted into three lists and requirements for chemicals in each list are detailed, as well as the provisions on chemicals assessment, qualification, control, and inspection.

• Measures to promote and support chemical management. It stipulates that the Chemical Information Centre under the National Chemical Agency will be responsible for the preparation and dynamic update of the Thailand chemical inventory.

• Duties and penalties. The insurance and compensation for the damages resulting from chemicals are emphasized.

• Transitional measures. 

In the Chemical Substance Act, Thailand's focus on chemicals management has shifted to management based on risk. In the new Act, substances will be classified into 3 Lists with reference to Thailand Existing Chemical Inventory and risk assessment conducted by the CAC. Here are the descriptions of the substances in these three Lists: 

• List 1: Low risk. Enterprises shall comply with the coming standards regarding import/export, production, transportation, storage and disposal/recycling of substances in List 1.

• List 2: High risk. Enterprises must obtain licensing from the competent authority before handling chemicals in this list.

• List 3: All activities are prohibited, while substances used for R&D purposes or chemicals where contamination at use is unavoidable with controlled risk may be exempt. 

The review of the chemicals in the hazardous substance list of HSA and Thailand's existing inventory from the current classification system to the new CSA system will also be conducted by CAC, as specified in the transitional provisions. Here are other proposed transitional provisions: 

• The notification or registration which was applied under HSA but still in process would be transferred to the new Act.

• The existing permits and qualifications under HSA will still be valid until expiration.

• The ministerial regulations and notices under HSA will still be effective until the new ones under CSA are approved. 

Besides the points mentioned above, here are some other developments in the new Act: 

• The Act covers the entire chemical life cycle and regulates not only substances but also mixtures and articles.

• The validity period of licenses is specified and shall not exceed 6 years.

• The insurance and compensation for the damages arising from chemicals are regulated, and the penalty scheme will be stricter. 

Only five months after the first one, the second draft of the Chemical Substance Act was released in September 2019. Compared with the previous version, many provisions have been adjusted to be more applicable and practical in the new draft. The most important amendments are shown as below: 

• The Only Representative system is proposed. Oversea manufacturers shall appoint a qualified representative to conduct the registration process according to the second draft. And the representative must be a Thai national, have an office in Thailand and have obtained relevant qualifications.

• The second draft clearly states that CAC has to sort the substances in the Hazardous Substance List and other related lists into the three new lists within one year from when the CSA comes into effect.

• Requirements for the members of the Committees have been revised. The power and responsibility of the Committees have been adjusted as well. 

News

· 18 Nov 2019 Understanding the Brand New Thailand Chemical Substance Act

· 14 Oct 2019 Brief on Recent Developments in Thailand's Hazardous Substance Act

· 10 Oct 2017 Thailand Made 2 Changes to Hazardous Substances List

· 16 Aug 2017 Thailand Revises List of Hazardous Chemicals

· 26 Jun 2017 Thailand to Publish 1st National Inventory Soon

· 9 Mar 2017 Thailand: GHS Mandatory For Mixtures From Mar 13th

· 23 Feb 2017 Thailand Requires Risk Management Measures for Certain Substances

· 7 Dec 2016 Thailand Inventory Nomination: How To Create An Account

· 5 Dec 2016 Thailand DIW Specifies CBI Protection Requirements

· 24 Nov 2016 Thailand Annex 5.6 Notification: Protecting Confidential Business Information

· 11 Nov 2016 Web Address Changed for Thailand Existing Chemicals Inventory

· 23 Sep 2016 Thailand DIW: “REACH-like Regulation”? Not Exactly

· 23 Aug 2016 FAQ About Thailand National Inventory: VOL 1

· 10 Aug 2016 Thailand Released Draft National Inventory

· 26 Jan 2016 Thailand Draft National Inventory Expected Soon

· 16 Oct 2015 Thai-REACH Already On Its Way?

· 18 May 2015 Thailand FDA Begins GHS Implementation

· 12 Mar 2015 Thailand Hazardous Chemical Substance List: Regulatory Obligations and Market Access Implications

· 11 Mar 2015 Thailand 2nd List of Hazardous Chemical Substances: 23 Substances Modified or Added

· 9 Feb 2015 Thailand DIW to update List of Hazardous Substances

· 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