Chemical Regulatory Services 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.

In Thailand, these products are regulated by Food and Drug Administration Thailand (FDA Thailand) under the ambit of the Hazardous Substance Act. Further, as per the act, these products, depending on the chemical and use, can fall under the below-mentioned types:

Type 1

Type 2

Type 3

Type 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 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 hazardous substances, the GMP requirement is mandatory as per the act.

Summary Table

Categories

Biocide/ Disinfectant

Detergents/Cleaning Products

General Consumer Products

Chemicals

Regulation

 

Hazardous Substance Act, B.E. 2535

Consumer Protection Act, B.E. 2522

Hazardous Substance Act B.E. 2535

Registration Requirement

Yes

No

Yes

Process Brief

An 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 Representative

Yes

N/A

N/A

Yes

 

 

Key Data Requirements

  1. Proof of compliance (Efficacy studies, safety

Summary, etc.)

  1. Product details and product characteristics
  2. Manufacturer/applicant full details
  3. Full ingredients sheet
  4. Safety Data Sheet (SDS)
  5. Product labels artwork
  6.  Letter of supply/Article 95 declaration
  7. Company registration letter
  8. GHS classification
  9. Other R&D documents as an additional requirement

 

 

 

 

-

 

 

 

 

  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 to or departure date 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.

Expertise

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)
Freyr Advantages
Advantages

Freyr Advantages

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