Questions? 10 seconds to sign up
Join the platform
Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
March 7, 2026
Approximately 5 minutes
Thailand FDA Regulation of Hazardous Substances under the Hazardous Substances Act
Thailand FDA Regulation of Hazardous Substances under the Hazardous Substances Act
1. Background and policy intent
Thailand regulates hazardous substances under the Hazardous Substances Act B.E. 2535 (1992) to protect persons, animals, plants, properties, and the environment. Hazardous substances include explosive, inflammable, oxidizing, toxic, pathogenic, radioactive, mutagenic, corrosive, irritative, and other harmful substances. The FDA is responsible for household and public health uses. The system categorizes substances by severity to impose controls on manufacture, import, sale, and possession. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
2. Target products and eligibility types
Hazardous substances are divided into 4 types according to severity:
Type 1 hazardous substance
Lower severity; no registration required but declaration to the competent official and compliance with labeling, manufacturing, and storage rules.
Type 2 hazardous substance
Higher risk; registration and prior notification to the competent official required.
Type 3 hazardous substance
Higher risk; registration and license from the competent official required.
Type 4 hazardous substance
Highest risk (e.g., carcinogens); prohibited for manufacture, importation, exportation, transit, or possession.
The FDA oversees specific lists (4.1 chemicals, 4.2 chemical groups, 4.3 product groups) under the Ministry of Industry Notification. To check applicability, verify active ingredient CAS No. against lists or purpose of use. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
3. Consultation pathway before approval
To confirm if a product falls under FDA responsibility, submit a request for hazardous substance analysis to the One Stop Service Center (OSSC). Links to forms provided. For detailed lists and notifications, refer to Ministry of Industry announcements. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
4. Approval application and review expectations
- Type 1: Declaration only.
- Type 2: Register and notify prior to undertaking.
- Type 3: Register and obtain license prior to undertaking.
- Type 4: Prohibited.
Applications follow risk-based procedures in public manuals. Specific lists announced by Department of Industrial Works; FDA handles household/public health groups. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
5. Procedure after approval (post-marketing obligations)
Comply with labeling, packaging, manufacturing, and storage rules (especially Type 1). Post-market surveillance by competent officials ensures ongoing safety. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
6. Practical considerations and positioning versus other pathways
Six agencies divide responsibility (FDA for household/public health). Use OSSC for analysis if unclear. Type 4 substances have no approval path. Consult public manuals at https://www.info.go.th for full procedures. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
7. Effective date
Framework under Hazardous Substances Act B.E. 2535 (1992); current lists via Ministry of Industry Notifications. Page reflects ongoing FDA services. Source: https://en.fda.moph.go.th/our-services-new/category/hazardous-substances
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Thailand FDA Pharmaceutical Product Registration and Approval Process
Thailand’s Food and Drug Administration (FDA) requires registration for all finished pharmaceutical products (human/animal) before manufacture, import, or ordering, with specific lot release for vaccines/biologicals, API notifications, and provisions for clinical trial samples, donations, or exhibitions under the Drugs Act B.E. 2510.
Approximately 5 minutes
Frequently Asked Questions on Pharmaceutical and Veterinary Drug Registration by Thailand FDA
Thailand FDA FAQs cover certificate formats for vaccines and biological products, special procedures for COVID-19 drugs, and detailed registration categories, forms, timelines, fees, and steps for modern veterinary drugs under the Drugs Act B.E. 2510.
Approximately 5 minutes
Thailand FDA Cosmetics Definition Regulation Notification and Ingredient Reference Requirements
Thailand FDA defines cosmetics under the Cosmetics Act B.E. 2558 (2015) as articles for external human body use (including teeth and oral mucosa) for cleaning, beautifying, changing appearance, preventing body odors, or protecting/maintaining condition, plus ingredients and other prescribed items, with specific reference documents required for ingredients and full compliance with the Act.
Approximately 5 minutes
Thailand FDA Food Product Categorization and Regulatory Requirements under the Food Act
Thailand FDA classifies food into four risk-based categories under the Food Act B.E. 2522, with Category 1 (specifically controlled) and Category 2 (quality/standard) requiring stricter controls, while Category 4 (general food) generally needs no registration unless voluntarily obtained, ensuring safety through labeling, standards, and notifications.