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Thailand Hazardous Substance Control Act (HSCA)

  •   16 May 2014
  •    Matt Lyu

    Last Update on: 2016-11-23

    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.

     
    Thailand regulation:
    Hazardous Substance Control Act
    Passed byDIW under Ministry of Industry
    Legislative evolution
    1992 (replaced)Hazardous Substance Control Act (1st version)
    1995Hazardous Substance Control Act (2nd revision)
    2008 Hazardous Substance Control Act (3rd revision)
    Main supporting legislation in force
    2015Notification of MOI B.E. 2558
    2013Notification of MOI B.E. 2556
    2012Notification of MOI B.E. 2555
    2010Notification of DIW B.E. 2553
    2008Notification of DIW B.E. 2551
    2004Notification of MOI B.E. 2547
    2000Notification of MOI B.E. 2543
    1994Ministerial Regulation B.E. 2537

    DIW - Dept. of Industrial Works under Ministry of Industry (Thailand)

    Contents

     

    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

    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 Health

    Monitoring the consumer chemicals

    Dept. of Fisheries (DOF)

    Ministry of Agriculture and Co-operatives

    Monitoring chemicals used in fisheries

    Dept. Of Livestock Development (DLD)

    Ministry of Agriculture and Co-operatives

    Monitoring chemicals used in livestock development

    Dept. of Energy Business

    Ministry of Energy

    LPG (liquid petroleum gas) and NGV (Natural gas vehicle)

     

    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 

    Substance ScopeAffected Role in Supply Chain
    Type 2, 3Producer, 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 ScopeAffected Role in Supply Chain
    Type 1, 2, 3Manufacturer, importer, exporter, having in possession

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

    Substance ScopeAffected Role in Supply Chain
    Type 3Manufacturer, 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.

    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)

    Substance ScopeAffected Role in Supply Chain
    hazardous substance designated in the annex of MOI Notification B.E. 2547 (2004)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
    • 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.

    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: 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.

    • 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 and FDA

    DIW is the first authority to enforce GHS, followed by FDA.

    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
    • 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:

    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;

    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.

    7.3 GHS implementation progress countrywide

    DIW is the first authority to implement GHS on chemicals used for industrial purpose. FDA also has required the manufactures and importers follow the GHS rules on hazard classification, labels and SDS when notifying the chemical substances. Other authorities such as DOLD will soon follow the suit. GHS committee will be established to guarantee the consistency in GHS implementation countrywide.

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