3.1.3.1 Hazard Substances and Chemicals

Details
No. List of Laws Laws
24 Issues of Hazard Substances Act B.E. 2535
1 The law specifies all actions to be done concerned with the hazardous matrial including the Hazardous substance Committee, controlling hazardous matrial, duties and responsibilities in civil case, and punishment [2]
2 Add the Convention on The forbidden of Development, Production, Accumulation, and Use of Chemicals and on the Destroy of these Weapons, made on 13 January, 1993. [3]
3 Add and revise details of the Hazardous substance Committee, importing, exporting, or possessing the hazardous substance. [1],[2],[3],[6]
4 The manufacturer for commercial purpose, importer for commercial purpose, exporter for commercial purpose, or the person in charge of storage for commercial purpose of second-type and third-type hazardous substance, shall pay annual fee on the day when informing of production, import, export, or storage for commercial purpose, and shall pay annual fee for every year. [1],[2],[3],[7]
5 The law specifies fee of document for registration, license, permit, certificate concerned with hazardous substance. [1],[2],[3],[8]
6 The one who intends to apply for permission to produce, import, export, or possess hazardous matrial, shall submit the application and document as specified in WorAor.1 Form, WorAor.3 Form, WorAor. 5 Form, WorAor. 7 Form as specified by law. [1],[2],[3],[8]
7 The anufacturer, importer, exporter, or the possessor of hazardous substance shall have license for production, import, export of hazardous substance for each product or each name of hazardous substance and license to possess hazardous substance for each storing place or each product or each name of the hazardous substance. [1],[2],[3],[8]
8 The licensee to produce, import, export, or possess the hazardous substance which is is required to change the particulars in such licnese, shall submit the letter and the old license as permitted and the document concerned to the division under responsibility in controlling hazardous substance for requesting for change; the request for change of name of hazardous chemicals, chemical formula, proportion, characteristics and formula of hazardous matrial cannot be done. [1],[2],[3],[8]
9 Anyone who intends to renew the license to produce, import, export, or possess the hazardous substance shall submit application and document as specified in WorAor. 9 Form. [1],[2],[3],[5]
10 The law specifies details on application, reules for consideration of application, permission, and duty of the licensee, correction or change and renewal of license. [1],[2],[3],[9]
11 The manufacturer or importer of the hazardous substance which is single substance or mixture substance shall take action under the requirement on classification system of the danger of hazardous substance as specified by law. [1],[2],[3],[9]
12 The export of hazardous substance shall have the classification of the danger, label or dangerous material, and shall prepare for document on safety information to be under requirement on classification system and communication about the hazardous of the hazardous substance. [1],[2],[3],[9]
13 The producer, expoeter, and the possessor of hazardous substance has duty to communicate the hazard of hazardous matrial in form of label and document on safety prepared by the manufacturer and the importer. [1],[2],[3],[10]
14 The person who possess the hazardous substance for retailing, who store the same type of the hazardous substance or many types totaling for more than 1,000 kg shall be exempted from informing of the operation for type-2 hazardous chemicals, or does not have to request for permission for type-3 hazardous substance. [1],[2],[3],[10]
15 The possessor of hazardous substance for personal use or industrial use or which is the components in the tool controlled by production control law, import or emergency transportation for prevention, or dealing with serious danger, shall be exempted from informing the operation for type-2 hazardous substance or does not have to apply for permission for type-3 hazardous substance. [1],[2],[3],[10]
16 The possession or import of the hazardous substance for use in agencies including ministry, department, local government administration, state enterprise, government organization, Thai Red Cross Society, international red cross committee, and international organization of Thailand under the specification of the law on protection and operation of the UN and special department in Thailand, shall be exempted from informing the operation for type-2 hazardous substance or does not have to apply for permission for type-3 hazardous substance. [1],[2],[3],[19]
17 The law specifies the cancellation of POLYCHLORINATED BIPHENYL (PCBs) [1],[2],[3],[20]
18 The person who intends to have consult concerned with chemicals/ product that may be controlled under the Hazardous substance Act B.E. 2535 (1992) can consult this through computer system into the computer network of the Department of Industrial Works, as specified by law. [1],[2],[3],[20]
19 The consultation concerned with chemicals/ product via computer signal sytem into computer network system of the Department of Industrial Works shall be for only chemicals/ product in form of solid and liquid only. [1],[2],[3],[24]
20 The law specifies and method of imposing fine under the Hazardous substance Act B.E. 2535 (1992) [1],[2],[3],[17]
21 The law specifies deviation criteria from the specified quantity of the key ingredient in the hazardous substance used in public health to be used as criteria for the analysis of hazardous substance product. [1],[2],[3],[16]
22 The law specifies criteria of deviation from specified quantity of the key ingredient in the hazardous substance at the THE FOOD AND DRUG ADMINISTRATION. [1],[2],[3],[18]
23 The law specifies the informing of facts concerned with type-q hazardous substance at the THE FOOD AND DRUG ADMINISTRATION; the person who intends to take action in production, or importing the first-type hazardous substance of each product shall inform of facts concerned with such hazardous substance to the official under the Form of WorAor./ SorTor5. [1],[2],[3],[18]
24 The informing of fact shall be done at the THE FOOD AND DRUG ADMINISTRATION for the entrepreneur with the manufacturing place or storage place in Bangkok or inform via the computer signal system into the computer network system of the THE FOOD AND DRUG ADMINISTRATION, or informing through the registered mail or at the Provincial Public Health Office for the entrepreneur who has production place or storage place of such province. [1],[2],[3],[11],[12],[13],[14],[15]
25 The law specifies the exemption on the importing that does not have to follow the Hazardous Mateiral Act B.E. 2535 (1992) concerned with the informing and application for permission and registration of hazardous substance at the THE FOOD AND DRUG ADMINISTRATION who is responsible. [1],[2],[3],[21]
26 The manufacturer of first-type hzarous material or second-type hazardous substance or third-type hazardous substance, who intends to apply for certification of production place under GMP rules on the hazardous substance shall follow the good criteria, method, and procedure in producing producing hazardous matieal under the specification of the law. [1],[2],[3],[22]
27 The private division that inspects and analyzes the hazardous substance for registration shall be qualified under the specification of the law. [1],[2],[3],[23]
Details
No. List of Laws Laws
24 Issues of Hazard Substances Act B.E. 2535
1 The law specifies all actions to be done concerned with the hazardous matrial including the Hazardous substance Committee, controlling hazardous matrial, duties and responsibilities in civil case, and punishment [2]
2 Add the Convention on The forbidden of Development, Production, Accumulation, and Use of Chemicals and on the Destroy of these Weapons, made on 13 January, 1993. [3]
3 Add and revise details of the Hazardous substance Committee, importing, exporting, or possessing the hazardous substance. [1],[2],[3],[6]
4 The manufacturer for commercial purpose, importer for commercial purpose, exporter for commercial purpose, or the person in charge of storage for commercial purpose of second-type and third-type hazardous substance, shall pay annual fee on the day when informing of production, import, export, or storage for commercial purpose, and shall pay annual fee for every year. [1],[2],[3],[7]
5 The law specifies fee of document for registration, license, permit, certificate concerned with hazardous substance. [1],[2],[3],[8]
6 The one who intends to apply for permission to produce, import, export, or possess hazardous matrial, shall submit the application and document as specified in WorAor.1 Form, WorAor.3 Form, WorAor. 5 Form, WorAor. 7 Form as specified by law. [1],[2],[3],[8]
7 The anufacturer, importer, exporter, or the possessor of hazardous substance shall have license for production, import, export of hazardous substance for each product or each name of hazardous substance and license to possess hazardous substance for each storing place or each product or each name of the hazardous substance. [1],[2],[3],[8]
8 The licensee to produce, import, export, or possess the hazardous substance which is is required to change the particulars in such licnese, shall submit the letter and the old license as permitted and the document concerned to the division under responsibility in controlling hazardous substance for requesting for change; the request for change of name of hazardous chemicals, chemical formula, proportion, characteristics and formula of hazardous matrial cannot be done. [1],[2],[3],[8]
9 Anyone who intends to renew the license to produce, import, export, or possess the hazardous substance shall submit application and document as specified in WorAor. 9 Form. [1],[2],[3],[5]
10 The law specifies details on application, reules for consideration of application, permission, and duty of the licensee, correction or change and renewal of license. [1],[2],[3],[9]
11 The manufacturer or importer of the hazardous substance which is single substance or mixture substance shall take action under the requirement on classification system of the danger of hazardous substance as specified by law. [1],[2],[3],[9]
12 The export of hazardous substance shall have the classification of the danger, label or dangerous material, and shall prepare for document on safety information to be under requirement on classification system and communication about the hazardous of the hazardous substance. [1],[2],[3],[9]
13 The producer, expoeter, and the possessor of hazardous substance has duty to communicate the hazard of hazardous matrial in form of label and document on safety prepared by the manufacturer and the importer. [1],[2],[3],[10]
14 The person who possess the hazardous substance for retailing, who store the same type of the hazardous substance or many types totaling for more than 1,000 kg shall be exempted from informing of the operation for type-2 hazardous chemicals, or does not have to request for permission for type-3 hazardous substance. [1],[2],[3],[10]
15 The possessor of hazardous substance for personal use or industrial use or which is the components in the tool controlled by production control law, import or emergency transportation for prevention, or dealing with serious danger, shall be exempted from informing the operation for type-2 hazardous substance or does not have to apply for permission for type-3 hazardous substance. [1],[2],[3],[10]
16 The possession or import of the hazardous substance for use in agencies including ministry, department, local government administration, state enterprise, government organization, Thai Red Cross Society, international red cross committee, and international organization of Thailand under the specification of the law on protection and operation of the UN and special department in Thailand, shall be exempted from informing the operation for type-2 hazardous substance or does not have to apply for permission for type-3 hazardous substance. [1],[2],[3],[19]
17 The law specifies the cancellation of POLYCHLORINATED BIPHENYL (PCBs) [1],[2],[3],[20]
18 The person who intends to have consult concerned with chemicals/ product that may be controlled under the Hazardous substance Act B.E. 2535 (1992) can consult this through computer system into the computer network of the Department of Industrial Works, as specified by law. [1],[2],[3],[20]
19 The consultation concerned with chemicals/ product via computer signal sytem into computer network system of the Department of Industrial Works shall be for only chemicals/ product in form of solid and liquid only. [1],[2],[3],[24]
20 The law specifies and method of imposing fine under the Hazardous substance Act B.E. 2535 (1992) [1],[2],[3],[17]
21 The law specifies deviation criteria from the specified quantity of the key ingredient in the hazardous substance used in public health to be used as criteria for the analysis of hazardous substance product. [1],[2],[3],[16]
22 The law specifies criteria of deviation from specified quantity of the key ingredient in the hazardous substance at the THE FOOD AND DRUG ADMINISTRATION. [1],[2],[3],[18]
23 The law specifies the informing of facts concerned with type-q hazardous substance at the THE FOOD AND DRUG ADMINISTRATION; the person who intends to take action in production, or importing the first-type hazardous substance of each product shall inform of facts concerned with such hazardous substance to the official under the Form of WorAor./ SorTor5. [1],[2],[3],[18]
24 The informing of fact shall be done at the THE FOOD AND DRUG ADMINISTRATION for the entrepreneur with the manufacturing place or storage place in Bangkok or inform via the computer signal system into the computer network system of the THE FOOD AND DRUG ADMINISTRATION, or informing through the registered mail or at the Provincial Public Health Office for the entrepreneur who has production place or storage place of such province. [1],[2],[3],[11],[12],[13],[14],[15]
25 The law specifies the exemption on the importing that does not have to follow the Hazardous Mateiral Act B.E. 2535 (1992) concerned with the informing and application for permission and registration of hazardous substance at the THE FOOD AND DRUG ADMINISTRATION who is responsible. [1],[2],[3],[21]
26 The manufacturer of first-type hzarous material or second-type hazardous substance or third-type hazardous substance, who intends to apply for certification of production place under GMP rules on the hazardous substance shall follow the good criteria, method, and procedure in producing producing hazardous matieal under the specification of the law. [1],[2],[3],[22]
27 The private division that inspects and analyzes the hazardous substance for registration shall be qualified under the specification of the law. [1],[2],[3],[23]
Relavant Laws
No. List of Laws Laws
1 Hazard Substances Act, B.E.2535 (1992)
2 Hazard Substances Act (No.2), B.E.2544 (2001)
3 Hazard Substances Act (No.3), B.E.2551 (2008)
4 Ministerial Regulation, B.E.2537 (1994): Issued Under The Hazard Substances Act, B.E.2535 (1992)
5 Ministerial Regulation No.2, B.E.2537 (1994): Issued Under The Hazard Substances Act, B.E.2535 (1992)
6 Ministerial Regulation No.3, B.E.2537 (1994): Issued Under The Hazard Substances Act, B.E.2535 (1992)
7 Ministerial Regulation No.4, B.E.2537 (1994): Issued Under The Hazard Substances Act, B.E.2535 (1992)
8 Notification Of Ministry Of Industry: The Classification System And Communication About The Hazard Of Substances, B.E.2555 (2012)
9 Notification Of Ministry Of Industry: The Exception Of Hazard Substances Act, B.E.2535 (1992), According To Present Report, Permission Request And Registration Of Hazardous Substances As Responsible Of Department Of Industrial Works, B.E.2546 (2003)
10 Notification Of The Ministry Of Public Health: Exemptions Of Import Obligations Under The Hazardous Substance Act, B.E.2535 (1992), Concerning Notification Of Operations, Request For Permission, And Registration Of Hazardous Substances Under Responsibility Of The Thai Food And Drug Administration, B.E.2548 (2005)
11 Notification Of The Ministry Of Public Health: Exemptions Of Obligations Under The Hazardous Substance Act, B.E.2535 (1992), Under Responsibility Of The Thai Food And Drug Administration, B.E.2538 (1995)
12 Notification Of The Ministry Of Public Health: Exemptions Of Obligations Under The Hazardous Substance Act, B.E.2535 (1992), Under Responsibility Of The Thai Food And Drug Administration (No.2), B.E.2542 (1999)
13 Notification Of The Ministry Of Public Health: Exemptions Of Obligations Under The Hazardous Substance Act, B.E.2535 (1992), Under Responsibility Of The Thai Food And Drug Administration (No.3), B.E.2542 (1999)
14 Notification Of The Ministry Of Public Health: Exemptions Of Obligations Under The Hazardous Substance Act, B.E.2535 (1992), Under Responsibility Of The Thai Food And Drug Administration (No.4), B.E.2545 (2002)
15 Notification Of The Ministry Of Public Health: The Deviation Criteria From The Allowable Portion Of Important Elements In Hazardous Substances Under Responsibility Of The Food And Drug Administration, B.E.2555 (2012)
16 Notification Of The Ministry Of Public Health: The Deviation Criteria From The Allowable Portion Of Important Elements In Hazardous Substances Under Responsibility Of The Food And Drug Administration (No.2) B.E.2558 (2015)
17 Notification Of The Ministry Of Public Health: Declaration Of Fact Relating Hazardous Substance Type 1 Under Responsibility Of The Thai Food And Drug Administration, B.E.2549 (2006)
18 Notification Of Department Of Industrial Works: Classification Of The Disuse Of Polychlorinated Biphenyl
19 Notification Of Department Of Industrial Works: The Response Of Consultation Issue About Chemicals/Product Which Might Be Control Substances Following Hazardous Substances, Act B.E.2535 (1992), As Responsible Of Department Of Industrial Works, B.E.2551 (2008)
20 Notification Of The Thai Food And Drug Administration: The Criteria And Procedure For Good Manufacturing Practice Of Producing Hazardous Substances Under Responsibility Of The Thai Food And Drug Administration (GMP), B.E.2559 (2016)
21 Notification Of The Thai Food And Drug Administration: Private Organizations Conducting Inspection And Analysis For Hazardous Substances Registration, B.E.2553
22 Notification Of The Food And Drug Administration: Requirements Of Warning Sign On Manufacturing Equipment, At Hazardous Substance Storage Area, And At Neighboring Area
23 Regulation Of Hazardous Substances Committee: The Criteria And Method Regarding To Paying Fine In Accordance With Hazard Substances Act, B.E.2535 (1992), B.E.2555 (2012)
24 Notification Of Ministry Of Industry: Hazardous Substances Following “Division 3 Duty And Civil Liability”, B.E.2538 (1995)
25 Notification Of The Ministry Of Finance: Classification And Deduction Rate Of Fine Prior To Delivering To The Ministry Of Finance
26 Notification Of The Food And Drug Administration: Display Of Hazardous Substance Registration Number
27 Order Of The Food And Drug Administration No.398/2544: The Practices For Certificate Of Free Sale: CFS For Importation Of Health Care Products
28 Order Of The Food And Drug Administration No.185/2541: Authorization Of Power To Grant Approval Or Permission To Perform Official Functions Within The Food And Drug Administration
29 Order Of The Food And Drug Administration No.232/2541 (1998): Authorization Of Power To Provincial Governors To Grant Certificate Renewal Under The Hazardous Substance Act, B.E.2535 (1992)
30 Order Of The Food And Drug Administration No.279/2542 (1999): Authorization Of Power To Pharmacist 9 Wor Chor. For Safety Of Hazardous Substances, And To The Director Of Hazardous Substance Practices To Act On Behalf Of The Secretary-General Of The Food And Drug Administration
31 Order Of The Food And Drug Administration No.112/2547 (2004): Authorization Of Power Granted To The Secretary-General Of The Food And Drug Administration Under Specific Laws To Provincial Governors
32 Order Of The Food And Drug Administration No.43/2548 (2005): Authorization Of Power Granted To The Secretary-General Of The Food And Drug Administration Under Specific Laws To Provincial Governors (No.2)
33 Order Of The Food And Drug Administration No.519/2548 (2005): Entrustment And Authorization Of Power To Conduct Official Functions Concerning Hazardous Substances Within The Food And Drug Administration
34 Order Of The Food And Drug Administration No.82/2549 (2006): Assignment Of Duty To Competent Officials At Food And Drug Stations To Consider Importation Of Hazardous Substances
35 Order Of The Food And Drug Administration Number 217/2549 (2006): Authorization Of Power Granted To The Secretary-General Of The Food And Drug Administration Under Specific Laws To Provincial Governors (No.4)
Forms
No. List of Forms Forms
1 The application of permission request for manufacturing the hazardous substance (the form of Wor Or 1)
2 The permit of manufacturing the hazardous substance (The form of Wor OR 2)
3 The application of permission request for importing the hazardous substance (the form of Wor Or 3)
4 The permit of importing the hazardous substance (The form of Wor OR 4)
5 The application of permission request for exporting the hazardous substance (the form of Wor Or 5)
6 The permit of exporting the hazardous substance (The form of Wor OR 6)
7 The application of permission request for possessing the hazardous substance (the form of Wor Or 7)
8 The permit of possessing the hazardous substance (The form of Wor OR 8)
9 The application of renewing the permit (the form of Wor Or 9)
10 The application of annual fee payment (the form of Wor Or 10)
11 The testimonial record of accuser (the form of Por Por Wor 01)
12 The testimonial record of offender (the form of Por Por Wor 02)
13 The report of fine penalty (the form of Por Por Wor 03)
14 The letter of notifying the fine payment following the hazardous substance Act 1992 (the form of Por Por Wor 04)
15 The fact notice of the hazardous substance type 1 which is in the responsible of the Food and Drug Administration (the form of Wor Or/Sor Tor 5)
16 The application of permission request for manufacturing the hazardous substance (the form of Wor Or 1)
17 The permit of manufacturing the hazardous substance (The form of Wor OR 2)
18 The application of permission request for importing the hazardous substance (the form of Wor Or 3)
19 The permit of importing the hazardous substance (The form of Wor OR 4)
20 The application of permission request for exporting the hazardous substance (the form of Wor Or 5)