Thailand Regulatory News

Thailand’s Food and Drug Administration (FDA) has implemented new regulations on titanium dioxide (TiO₂) in cosmetics, focusing on its use as a colorant, UV filter, and ingredient in various formu...

Thailand’s Food and Drug Administration (FDA) has implemented new regulations on titanium dioxide (TiO₂) in cosmetics, focusing on its use as a colorant, UV filter, and ingredient in various formulations. Officially published in Thailand’s Royal Gazette on 18 November 2024 and effective 19 November 2024, the updated rules introduce stricter labeling requirements, ingredient classification, and sunscreen regulations, as well as enhanced compliance measures. These changes aim to strengthen consumer safety and align Thailand’s cosmetic standards with international guidelines. 

Key Regulatory Updates 

1. Labelling & Consumer Warnings 

• New labelling requirements differentiate between regular and nano TiO₂. 

• Warnings emphasize that sunscreen alone is not enough for sun protection and advise consumers to follow the directions for use carefully. 

• Manufacturers must include warnings for face powders and aerosol sprays containing TiO₂. 

2. Concentration Limits Based on Product Type 

• Face powders and dust-based products: Max 25% w/w. 

• Hair sprays (compressed gas): 

• 1.4% for general consumer use. 

• 1.1% for professional hairdresser use. 

• TiO₂ should be avoided in products where there is a risk of lung inhalation. 

3. TiO₂ as a Colorant & UV Filter 

• As a colorant: Allowed in all types of cosmetics but must meet particle size restrictions of ≤10μm in powder form. 

• As a UV filter: Permitted up to 25% w/w, including when combined with nano-TiO₂ (total must not exceed 25%). 

4. Stricter Conditions for Nano-TiO₂ 

Nano-TiO₂ is subject to additional safety conditions: 

• Prohibited in inhalation-risk products. 

• Must be at least 99% pure. 

• Crystalline structure must be rutile (anatase ≤5%). 

• Particle properties: 

• D50 ≥ 30 nm (by number). 

• Aspect ratio: 1 to 4.5. 

• Volume-specific surface area ≤ 460 m²/cm³. 

• Photocatalytic activity ≤ 10% compared to an uncoated reference. 

• Coatings allowed if they do not impact UV protection. 

Compliance & Implementation Timeline 

A 180-day transition period has been granted, requiring manufacturers, importers, and contract manufacturers to comply by mid-May 2025. Noncompliance may result in regulatory action. These updates align Thailand’s cosmetic safety standards with international norms, particularly in the regulation of nanomaterials. By differentiating between nano and non-nano forms of titanium dioxide (TiO₂) in line with EU and ASEAN guidelines, the regulations enhance consumer safety through clearer labeling, stricter conditions of use, and controlled concentration limits. This reinforces Thailand’s commitment to high safety standards while ensuring industry compliance with evolving global regulations. 

On January 6, 2025, the Department of Industrial Works (DIW) issued a formal reminder to Category 3 factory operators to comply with the Ministry of Industry’s updated Safety Measures for Chemical M...

On January 6, 2025, the Department of Industrial Works (DIW) issued a formal reminder to Category 3 factory operators to comply with the Ministry of Industry’s updated Safety Measures for Chemical Management in Industrial Plants (No. 2), under the B.E. 2566 regulations. This compliance mandate requires factories to report their hazardous chemical use and storage data annually.  

What are Category 3 Factories? 

Category 3 factories are industrial facilities with machinery over 50 horsepower, more than 50 workers, or significant pollution generation regardless of workforce size or machinery horsepower. 

Reporting Requirements and Deadlines 

Factory operators must submit their hazardous chemical reports to the Ministry of Industry's central data reporting system by April 30, 2025. Reporting is required for all hazardous chemicals in quantities of one tonne or more per year per type. Even facilities that use smaller quantities or no hazardous chemicals are required to report.  

Failure to comply with the reporting requirements may lead to penalties for non-compliance under Section 46 of the Factory Act B.E. 2535, carrying fines of up to 20,000 baht or potential administrative orders, including suspension or closure of the factory. 

Guidelines for Reporting to the Ministry of Industry’s Central Data System 

In order to comply with the reporting requirements, operators are required to: 

• Register with the Ministry of Industry’s i-Industry system, providing their 13-digit business number or national ID/juristic person registration number. 

1. Add their business and factory details. 

2. Submit chemical information via the iSingleForm system. 

A user manual and detailed guidance on hazard classification (GHS codes) and storage classification are available via the Ministry's platform. For further assistance, factory operators can access a FAQ section provided by the Department in the user manual. 

Promoting Compliance Throughout Thailand’ Industrial Sector 

The Department of Industrial Works urges all factory operators to complete the process within the stipulated time to avoid legal or administrative action. Compliance will help maintain safety and legal compliance throughout Thailand's industrial sector. Businesses that have already fulfilled their obligations were thanked for their cooperation. 

Thailand’s Department of Industrial Works (DIW), under the Ministry of Industry, launched a public consultation regarding a draft ministerial announcement on December 2, 2024. This proposal seeks to...

Thailand’s Department of Industrial Works (DIW), under the Ministry of Industry, launched a public consultation regarding a draft ministerial announcement on December 2, 2024. This proposal seeks to classify certain chemicals as Type 3 (controlled) hazardous substances in accordance with the Stockholm Convention, with the aim of strengthening the regulation of hazardous substances in Thailand. The consultation specifically addresses the proposed classification of four chemicals as Type 3 hazardous substances under the Hazardous Substances Act B.E. 2535.

Chemicals under Consideration

The chemicals proposed for Type 3 classification are:

1. Dechlorane Plus

2. Dechlorane Plus (syn-isomer)

3. Dechlorane Plus (anti-isomer)

4. UV-328

Background to the Ministerial Announcement

Thailand has been a Party to the Stockholm Convention since 2005 and is committed to the elimination of persistent organic pollutants (POPs) to safeguard human health and the environment. At the 11th Conference of the Parties to the Stockholm Convention in May 2023, three substances were recognized as POPs and added to Annex A (the Elimination List), including:

• Dechlorane Plus (syn- and anti-isomers)
• UV-328
• Methoxychlor

Subsequently, the Stockholm Convention Subcommittee met on July 18, 2023, and tasked DIW with classifying Dechlorane Plus (both syn- and anti-isomers) and UV-328 as Type 3 hazardous substances under the Hazardous Substances Act B.E. 2535, with strict controls to phase out their production, use, and release.

Purpose and Survey Details for the Public Consultation

The public consultation aims to gather feedback from a wide range of stakeholders to ensure that the regulation of hazardous substances is well informed and practical. The draft announcement proposes stricter controls on the import, export, production, possession, and transit of these substances.

DIW has called for participation from a range of stakeholders, including:
• Government agencies such as the Department of Agriculture and the Food and Drug Administration
• Academics, independent organizations, and the public
• Operators dealing with hazardous substances (importers, manufacturers, distributors)
• Other interested parties

Stakeholders are invited to comment on the classification of four substances as Type 3 hazardous substances. They may agree or disagree with the proposal, either fully or partially, and are encouraged to provide justifications, suggestions, or alternatives. The feedback collected will help the authorities to assess the potential impact of the proposed measures, ensuring a balanced approach that addresses both regulatory needs and stakeholder concerns. This inclusive process will ensure that the final ministerial announcement is transparent, practical, and informed by diverse perspectives.

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committ...

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committee (ACC) meeting and its related sessions in November 2022. Products that do not meet the updated standards must be withdrawn immediately. The amendments reflect the ASEAN region’s approach to aligning with global safety standards and protecting the health of consumers in its 10 member states. 

Key Updates to the ACD  

• Annex II – List of substances which must not form part of the composition of cosmetic products 

A consolidated list of 37 substances previously banned in the EU, has been added to Annex II of the ACD. These include entries from EU regulations (2019/831, 2019/1966, 2021/850, 2021/1902) that are not currently used in ASEAN countries. Specific compounds such as perboric acid, sodium perborate, boron compounds, octamethylcyclotetrasiloxane (D4), and p-BMHCA have also been included in Annex II. 

• Titanium Dioxide Regulation 

Revised safety criteria for the use of titanium dioxide as a colouring agent (Annex IV) and as a UV filter (Annex VII) have been adopted as per EU standards. 

• Salicylic Acid Regulation 

New limits have been introduced for salicylic acid in the Restricted Substance List (Annexes III) and in the Preservatives list (Annex VI), used in body creams, lotions, and other specific applications. 

Implications for Industry 

Cosmetic manufacturers, traders, and distributors were granted a two-year grace period to reformulate, test and phase out non-compliant products. With the end of this period concluded, compliance is now mandatory, ensuring that products meet updated safety requirements. 

Detailed guidelines for compliance can be found here. 

The Ministry of Public Health and the Ministry of Industry in Thailand have jointly issued a new Ministerial Regulation under the Narcotics Code Act B.E. 2564, which establishes new labelling requirem...

The Ministry of Public Health and the Ministry of Industry in Thailand have jointly issued a new Ministerial Regulation under the Narcotics Code Act B.E. 2564, which establishes new labelling requirements for containers and packages containing volatile substances. Published in the Government Gazette on August 23, 2024, the regulation will take effect 120 days later and is a significant step in controlling the use and distribution of volatile substances.  

Key Updates on Volatile Substances Classification 

Earlier in January 2024, the authorities published an announcement detailing the identification and classification of chemicals and products as volatile substances. 

These include: 

1. Aliphatic and Aromatic Hydrocarbons: Such as toluene (methylbenzene). 

2. Ketones: Including acetone, methyl ethyl ketone (MEK), and methyl isobutyl ketone (MIBK). 

3. Esters: Such as ethyl acetate, methyl acetate, and butyl acetate. 

4. Volatile Alkyl Nitrites: Including amyl nitrite, isopropyl nitrite, and others. 

5. Ethers: Examples are ethylene glycol derivatives such as 2-butoxyethanol. 

Additionally, products containing these chemicals, such as thinners, lacquers, adhesives, and scientific balloons were categorized under volatile substances. This announcement reflects the government’s initiative to address the risks associated with volatile substances by clearly identifying these chemicals and their derivatives.  

New Labelling Requirements for Volatile Substances 

The Ministerial Regulation on Labelling of Volatile Substances Containers or Packages B.E. 2567 requires mandatory labelling information, including:   

• The phrase "Volatile Substance" 

• Manufacturer/importer details 

• Contents (in metric units) 

• Chemical composition 

• Instructions for use and storage 

• A bold red warning: "Do not inhale; it may be life-threatening" 

• Warning symbol featuring a black skull and crossbones within a red circle with the warning text. 

Products above 550 ml or 550 g that meet alternative legal standards are exempt from the labelling requirements. 

Regulatory Updates to Mitigate Health Risks 

The two announcements released in 2024 are designed to address the health risks associated with volatile substances, particularly inhalation abuse. By ensuring clear labelling and a comprehensive chemical classification system, the government aims to promote responsible use and protect public health. The coordinated approach by the Ministries of Public Health and Industry highlights the importance of interagency collaboration in regulatory oversight. These regulatory updates mark a significant step toward addressing the hazards posed by volatile substances, while establishing a robust legal framework for future enforcement. 

Thailand is undertaking a detailed review of its Hazardous Substance Act, which governs the management of chemicals and hazardous substances in the country. The Department of Industrial Works (DIW) an...

Thailand is undertaking a detailed review of its Hazardous Substance Act, which governs the management of chemicals and hazardous substances in the country. The Department of Industrial Works (DIW) and other government agencies responsible for hazardous substances, including the Departments of Agriculture, Fisheries, Livestock Development, Energy Business, Industrial Works and the Food and Drug Administration, initiated this review. Feedback was sought from industry and public stakeholders from August 1 to September 30, 2024. 

Evaluating the effectiveness and challenges of Thailand’s Hazardous Substance Act 

This review focuses on evaluating the effectiveness of the Act from its first enforcement on April 7, 1992, up until the end of 2023. The DIW aims to ensure that the Act remains in line with current societal needs, international standards, and social justice principles. Major areas under review include the definitions of hazardous substances, regulatory oversight by various ministries, and the role of enforcement bodies such as the Hazardous Substance Committee. 

Additionally, the review aims to address the challenges of enforcing the law across different agencies and to clarify the regulations for the registration, handling, and supervision of hazardous substances. Stakeholders were invited to provide feedback on a number of issues, such as the classification of hazardous materials, import/export requirements, registration validity periods, and coordination between government entities and private industries. 

Key areas for feedback in the review 

• Current definitions of hazardous substances and their production, import, export, sale, possession and labelling. 

• Oversight by nine ministries of DIW operations and the role of the Ministry of Industry in issuing regulations, setting fees, and complying with international standards 

• The structure and duties of the Hazardous Substance Committee, including whether the law provides clear enforcement guidelines. 

• The role of the Hazardous Substance Information Centre in coordinating government agencies and the private sector. 

• The system for managing hazardous substance categories ensuring specialized personnel in relevant establishments. 

• The need for advance notifications or permissions for transporting hazardous substances in categories 1 to 3, and the review of the six-year validity period for registration certificates. 

On 18 September 2024, Thailand’s Department of Industrial Works (DIW) introduced new regulatory guidelines on the advertising of hazardous substances under its authority. These regulations which aim...

On 18 September 2024, Thailand’s Department of Industrial Works (DIW) introduced new regulatory guidelines on the advertising of hazardous substances under its authority. These regulations which aim to improve public safety and environmental protection, follow the most recent amendments to the Hazardous Substances (No 4) BE 2562 (2019) and will take effect the day after the announcement is published in the Government Gazette. This draft guideline is now subject to public consultation from 18 September to 5 October 2024.  

New Guidelines for Advertising of Hazardous Substances 

Under the new announcement, hazardous substances under the responsibility of DIW must adhere to stringent guidelines when advertised. The guidelines focus on providing clear instructions, safety warnings and relevant hazard symbols to safeguard human health and the environment. 

Key Requirements for Advertising Hazardous Substances: 

1. Product Information: Advertisements must clearly display the name, trade name, ratio, use, importer/distributor details of the hazardous substances. 

2. Safety Warnings: All ads must include appropriate advice and warnings about the dangers of hazardous substances, including the required pictograms, signal words and hazard statements. 

3. Prohibition of Misleading Information: Advertisement must not contain ambiguous or misleading content that could lead to improper use of hazardous substances. 

4. Restricted Media Use: Advertising through electronic media such as radio, television, online platforms and digital platforms is strictly prohibited. 

5. Prohibition of Advertising: Advertising of hazardous substances that are fake, substandard, deteriorated, or unregistered are completely banned. 

List of Regulated Hazardous Substances 

The list of hazardous substances regulated under these guidelines includes various cyanides and other potentially dangerous chemicals. This move by the DIW is in line with Thailand's continued efforts to enhance public safety and ensure that the use of hazardous substances is well regulated. The Department encourages all manufacturers and distributors to strictly adhere to the new regulations to avoid penalties.