Chemical Registration in Thailand


Chemical Registration in Thailand - Overview

Cleaning and disinfectant products are called, identified, and regulated differently across various countries and regions, making it very challenging for the industry to place these products in different markets. Such products are regulated by Food and Drug Administration Thailand (Thailand FDA) under the ambit of the Hazardous Substances Act. Further, as per the act, these products, depending on the chemical and use, can fall under the below-mentioned types:

Table 1: Classification of Chemical Products Under the Hazardous Substances Act

Type 1Type 2Type 3Type 4

Very less impact on human and environmental health.

Does not require registration but reporting to a competent authority about the product facts/information.

For example: Some cleaning products, and Hypochlorite-based pool disinfectants

Some degree of risk to human and environmental health.

Requires product registration.

For example: Disinfectants not falling under Type 1 and carrying a higher degree of risk than Type 1.

A higher degree of risk than Type 2 classified products.

Requires registration and import license.

For example: Acid/ Aldehyde/Alkaline-based cleaners and disinfectants.

Carries very high risk due to their severe hazardous intrinsic properties like mutagens, carcinogens, etc.

Any kind of use is prohibited.

For example: DDT, Dieldrin, etc.

For all the manufacturers of products classified under the Hazardous Substances Act, the GMP requirement is mandatory as per the act.

Table 2: Chemical Regulations in Thailand

CategoriesBiocide/ DisinfectantDetergents/Cleaning ProductsGeneral Consumer ProductsChemicals
Chemical Regulation

 

Hazardous Substances Act, B.E. 2535

Consumer Protection Act, B.E. 2522.Hazardous Substances Act B.E. 2535.
Registration RequirementYesNoYes
Process BriefAn application must be submitted to the product control unit (Bureau of cosmetics and hazardous substances).Self-compliance responsibility.Manufacturers and importers of hazardous substances exceeding one (01) ton per year are now required to notify their hazardous substances to the Department of Industrial Works (DIW) via DIW's online system.
Local RepresentativeYesN/AN/AYes

 

 

Key Data Requirements

  1. Proof of Compliance (Efficacy Studies, Safety, etc.).
  2. Product Details and Product Characteristics.
  3. Manufacturer/Applicant Full Details.
  4. Full Ingredients Sheet.
  5. Safety Data Sheet (SDS).
  6. Product Labels Artwork.
  7. Letter of Supply/Article 95 Declaration.
  8. Company Registration Letter.
  9. GHS Classification.
  10. Other R&D Documents as an Additional Requirement.

 

 

 

 

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  1. Trade Name.
  2. Chemical Formula and Proportion.
  3. Common Name or Abbreviation (if any).
  4. Quantity
  5. Characteristic of Containers.
  6. Location of the Storage Facility
  7. Means of Transportation.
  8. Customs Port.
  9. Anticipated Arrival Date or Departure Date to/from the Port, etc.

A Globally Harmonized System (GHS) is mandatory in Thailand for the classification and communication of the hazards of chemicals and chemical products under the Hazardous Substances Act B.E. 2535, where SDS and labels should be compliant with the GHS practice.

Freyr Expertise

  • Product Classification and Regulatory Guidance.
  • Regulatory Strategies for Market Access/Product Launch.
  • Develop Product Notification/Registration Strategies.
  • Regulatory Applicability Review and Interpretation.
  • Prepare Technical Data Files (Specification, MSDS, Etc.) including Registration/ Notification Dossiers.
  • Application Preparation and Submission for Relevant Introductions and Renewals.
  • Sustainability and Packaging Solutions.
  • Regulatory Intelligence (RI) Services.

Freyr Advantages

  • Local presence in the market with relevant expertise and experience.
  • End-to-end Regulatory consultation on Thailand chemical regulations.
  • Easily navigate the complexities of Regulatory authorities.
  • Support for region-specific Regulatory complexities.
  • A structured and cost-effective approach to ensure compliance in multi-market scenarios.
  • Quick turnarounds and faster time-to-market.

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