Thailand Regulatory News

The Thai Food and Drug Administration (FDA) has launched a nationwide public consultation to assess and improve the current regulatory framework governing cosmetics. The review centers on the Cosmetic...

The Thai Food and Drug Administration (FDA) has launched a nationwide public consultation to assess and improve the current regulatory framework governing cosmetics. The review centers on the Cosmetics Act B.E. 2558 (2015) and related legislative instruments, with the consultation period running from December 27, 2024 to March 31, 2025. 

Thai FDA Seeks Input form Industry and the Public 

This initiative marks a significant step in Thailand’s efforts to ensure that its cosmetics regulations remain relevant, effective, and in line with international standards. The consultation seeks feedback from a wide range of stakeholders, including cosmetics businesses, general consumers, provincial health officials, academics, consumer advocacy groups, and FDA personnel. 

Background on Thailand’s Cosmetics Act 

The Cosmetics Act B.E. 2558, which came into force on September 9, 2015, replaced the previous 1992 legislation with a more modern framework aimed at harmonizing regulations with ASEAN standards, supporting the growth of the cosmetics industry, and enhancing consumer protection. Key reforms included the introduction of a notification-based system for the manufacture and import of cosmetic products, as well as restrictions on harmful substances, labelling requirements, and mandatory product information reporting by businesses. 

Challenges Identified by the FDA 

However, after nearly a decade of implementation, the FDA has identified several challenges that warrant reform. As of September 30, 2024, identified issues include: 

• Ambiguities in the legal definition of cosmetics under Section 4(2). 

• Inadequate mechanisms for promptly publicizing non-compliance findings. 

• The need to reassess the interpretation of terms such as “active ingredients” and the handling of product deviations. 

• An outdated notification process that no longer reflects global best practices. 

• Regulatory gaps in addressing new marketing trends and technological advances in the cosmetics sector. 

Public Input and Next Steps 

To support the review, the Thai FDA is collecting public input via an online survey hosted on the Thai central legal system platform and conducting stakeholder engagement meetings to gather qualitative insights. The agency aims to use this feedback to determine whether specific provisions of the existing law should be amended or repealed, with the goal of reducing unnecessary regulatory burdens while ensuring consumer safety and industry competitiveness. Stakeholders are encouraged to participate in the consultation process before the deadline of March 31, 2025.

In a significant move to enhance cosmetic safety and align with regional standards, Thailand’s Ministry of Public Health (MOPH), through its Food and Drug Administration (FDA), has announced a serie...

In a significant move to enhance cosmetic safety and align with regional standards, Thailand’s Ministry of Public Health (MOPH), through its Food and Drug Administration (FDA), has announced a series of regulatory updates. These include a proposed ban on 17 additional hazardous substances in cosmetics, new labelling requirements for fluoride toothpaste, restrictions on microneedle-based products, and draft guidelines for the evaluation of novel cosmetic ingredients. These initiatives are designed to bring Thailand’s cosmetic regulations in line with the ASEAN Cosmetic Directive (ACD) and the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS), reinforcing the country's commitment to consumer safety and regional harmonization. 
 
Thailand Proposes Ban on 17 Additional Substances in Cosmetics 

As part of ongoing efforts to align with the ASEAN Cosmetic Directive (ACD) and the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS). The Thai Ministry of Public Health (MOPH), through its Food and Drug Administration (FDA), has announced plans to expand the list of substances prohibited in cosmetic formulations by adding 17 more chemical entries. 

The newly proposed additions include seven substances—comprising various nickel compounds, quinoline, and imidazole—numbered 1,669 to 1,675 on the regulatory list. The remaining ten entries (1,676 to 1,685) include several benzene-based and petroleum-derived compounds. 

This regulatory move followed a public consultation conducted between 27 February and 13 March, during which concerns were raised regarding the potential health risks of these substances. The proposed ban is primarily due to their classification as carcinogenic, mutagenic, or toxic to reproduction (CMR). 

This proposal comes after a previous update earlier this year, in which MOPH had already added 56 substances to the prohibited list, reflecting the country’s ongoing efforts to ensure the safety of cosmetic products on the market. 
Review the news by clicking here. 

New Labelling Standards for Fluoride Toothpaste 

To reflect the newly increased fluoride limit of 1,500 ppm, Thailand will require clearer labelling on fluoride-containing toothpaste. Labels must now: 

• Include the statement “toothpaste with fluoride” 

• Specify fluoride concentration in parts per million (ppm) 

• Name the specific fluoride compound used 

• Carry child-safety usage warnings for different age groups 

• Recommend medical advice from doctor or dentist, if children are exposed to additional fluoride sources 

Toothpaste manufacturers will have one year to update their packaging in compliance with the new regulations. 

Restrictions on Microneedle-Based Cosmetics 

Another key proposal includes a ban on the production, import, and sale of cosmetics containing microneedles or microneedle-like crystals, except for dissolvable microneedle patches with needle lengths under 100 micrometers. These permitted products must include cautionary labels about potential skin irritation and allergic reactions, discourage daily use, and restrict application on sensitive areas or by users under the age of 15. A compliance period of 180 days will follow the official announcement. 

On 4 April 2025, Thailand’s Food and Drug Administration (Thai FDA) issued a draft notification proposing significant amendments to the labelling requirements for fluoride-containing cosmetics, incl...

On 4 April 2025, Thailand’s Food and Drug Administration (Thai FDA) issued a draft notification proposing significant amendments to the labelling requirements for fluoride-containing cosmetics, including toothpaste and mouthwash. The proposed regulation will take effect the day after its publication in the Royal Gazette. These changes aim to strengthen consumer protection, particularly for young children, by enhancing product safety and information. 

Revocations: Previous Warning Statements Repealed 

Under the new draft notification, Thailand will revoke several previous labelling requirements related to fluoride compounds used in cosmetic products. Specifically, entries 23–40, 44, and 52 of the 2018 Notification on Cosmetic Labelling will be repealed. These entries previously mandated specific warnings for various fluoride-containing substances, such as ammonium monofluorophosphate, sodium fluoride, and calcium fluoride. The revocation of these entries paves the way for new, standardized warning statements to ensure consistency across product categories. 

Revised Warning Requirements for Fluoride-Containing Products 

The new regulation introduces standardized labelling requirements for products containing fluoride substances. Key updates include: 

• For children under the age of three: The recommended amount of toothpaste should be the size of a grain of rice. 

• For children aged three to under six years: An amount the size of a pea or corn kernel should be used. 

• Supervision by adults: Children in both age groups should be supervised while brushing their teeth. 

• Additional medical advice: If children are exposed to fluoride from other sources, parents or guardians should consult a doctor or dentist. 

Furthermore, mouthwash products containing fluoride should not be used by children under the age of six, and appropriate warnings must be displayed on the product label. 

Transition Period for Industry Compliance 

Manufacturers, importers, and contractors producing fluoride-containing cosmetics will be required to update their product labelling in accordance with the new regulation within one year from the effective date. This transition period will provide businesses with sufficient time to adapt their processes and ensure full compliance. 

Implications for Global Cosmetic Industry Stakeholders 

The revised labelling requirements will have significant implications for the global cosmetic industry. Companies that manufacture, import, or distribute fluoride-containing products in Thailand will need to review and update their product labels to align with the new standards. Failure to comply within the specified timeline may result in regulatory penalties. Businesses are encouraged to take immediate steps to ensure that their products meet the new labelling guidelines and to consult the full draft text for detailed requirements. 

On 18 March 2025, Thailand’s Ministry of Industry has issued a major update to its List of Hazardous Substances (No. 8), which will come into effect the day after its publication in the Royal Gazett...

On 18 March 2025, Thailand’s Ministry of Industry has issued a major update to its List of Hazardous Substances (No. 8), which will come into effect the day after its publication in the Royal Gazette. This revision introduces significant changes to the classification and management of hazardous chemicals. These changes will affect manufacturers, importers, exporters, and stakeholders throughout the global chemical industry. The changes aim to enhance public safety, environmental protection, and regulatory compliance. 

Revocations: Key Substances Removed 

In the latest revision, two hazardous substances have been officially removed from the hazardous substances list. These substances were previously classified as hazardous but will no longer be subject to regulatory control. 

The first revocation involves plant extracts used for pest control, including substances such as neem, galangal, and citronella, which were previously listed under List 1.2 and controlled by the Department of Agriculture. The second revocation affects citronella oil, a substance previously listed under List 4.1 under the jurisdiction of the Food and Drug Administration (FDA). With these revocations, the Ministry of Industry has reclassified these substances, removing them from the list of regulated hazardous substances. 

Revised Control Measures for 17 Hazardous Substances 

In addition to the revocations, the announcement also includes extensive revisions to the control measures for 17 other hazardous substances. These revisions affect substances listed under the control of several government agencies. Notably, 10 substances under the Department of Industrial Works (List 5.1) have had their control measures updated, along with several substances under the Department of Agriculture (Lists 1.1 and 1.2) and the Food and Drug Administration (Lists 4.1 and 4.2). These changes reflect ongoing efforts to align Thailand’s regulatory framework with international safety standards and to address evolving concerns regarding chemical safety and environmental risks. 

New Hazardous Substances Added to the List 

Two new substances have been added to the hazardous substances list. Both pentachlorobenzene (CAS No. 608-93-5) and hexachlorobutadiene (CAS No. 87-68-3) are now classified under List 1.1 and are under the regulatory control of the Department of Agriculture. The inclusion of these substances signals Thailand's proactive approach to managing emerging chemical risks and ensuring that potentially harmful substances are adequately regulated. 

Implications for Global Chemical Industry Stakeholders 

The changes to Thailand’s hazardous substances list have important implications for the global chemical industry. Manufacturers, importers, exporters, and anyone involved in the trade or handling of hazardous chemicals must ensure compliance with the updated regulations. In particular, businesses dealing with substances that have been revoked or added to the list must take immediate action. For substances that have been added to the list, businesses will need to apply for permits and registrations within 30 days from the date of publication in the Royal Gazette. Companies managing previously listed chemicals should also ensure that they comply with the revised control measures. 

The Ministry of Public Health and the Cosmetics Committee of Thailand have introduced significant regulatory updates affecting the cosmetics industry. The latest announcements, published in the Royal ...

The Ministry of Public Health and the Cosmetics Committee of Thailand have introduced significant regulatory updates affecting the cosmetics industry. The latest announcements, published in the Royal Gazette in January 2025, mandate warning labels for cosmetics containing the preservative Climbazole and expand the list of substances prohibited in cosmetic formulations. These updates aim to enhance consumer safety and ensure compliance with international standards. Businesses involved in the manufacture, import, and sale of cosmetics must adhere to these new regulations within the specified transition period. 

Mandatory Labelling / Warnings for Cosmetics Containing Climbazole 

On January 31, 2025, the Cosmetics Committee published a announcement regarding the labelling of cosmetics containing preservatives (No. 5). This update, issued under the authority of the Cosmetics Act B.E. 2558, was decided during the 4/2567 Committee meeting held on August 26, 2024. 

Under this announcement, the warning label requirements for Climbazole (CAS Number: 38083-17-9) have been revised. Cosmetics containing this preservative must now include the following warning on their labels: 

“Contains Climbazole. Be careful not to get in your eyes. If irritation occurs, stop using the product and consult a doctor or pharmacist.” 

Manufacturers, importers, and contract manufacturers who have prepared labels prior to the enforcement date must comply with this new labelling requirement within 180 days of the effective date of the announcement. 

Expanded List of Prohibited Cosmetic Ingredients 

In a separate announcement, the Ministry of Public Health introduced new restrictions on prohibited substances used in cosmetics. The regulation, published on January 31, 2025, under the authority of the Cosmetics Act B.E. 2015, were enacted following recommendations from the Cosmetics Committee at its 4/2024 meeting on August 26, 2024. 

This update expands the list of prohibited cosmetic ingredients by adding 56 newly prohibited substances. Manufacturers, importers, and contract manufacturers who have received notification certificates for cosmetics containing these newly prohibited ingredients must ensure compliance within 180 days of the effective date of this announcement. 

The expanded prohibited list can be accessed here 

Implementation and Compliance 

Both announcements are now in effect following their publication in the Royal Gazette. The Thai authorities have emphasized that non-compliance will lead to regulatory actions, reinforcing their commitment to consumer safety in the cosmetics industry. Industry stakeholders are urged to review their formulations and labelling practices to ensure alignment with these updated regulations. 

The Department of Industrial Works (DIW) has released an evaluation of Thailand’s Hazardous Substances Act, following an extensive public consultation held between August and September 2024. The rev...

The Department of Industrial Works (DIW) has released an evaluation of Thailand’s Hazardous Substances Act, following an extensive public consultation held between August and September 2024. The review assessed enforcement of the Act from 1992 to 2023 and incorporates feedback from businesses, regulators, and industry experts to address concerns and propose regulatory improvements. The goal is to enhance compliance efficiency, maintain industry competitiveness, and strengthen public safety. 

Key Issues Identified in the Consultation 

1. Licensing and Permit Regulations 

A major point of debate was the suspension and revocation of licenses for hazardous substances. Under the current law, a revoked license cannot be reapplied for until five years have passed. While some stakeholders supported this measure as a deterrent for non-compliance, others argued that it could disproportionately impact businesses. Additionally, there was strong opposition to permitting Type 4 hazardous substances for laboratory analysis under any circumstances. 

2. Clarity in Hazardous Substance Classification 

Stakeholders emphasized the need for a clearer definition of "hazardous substances" under Section 4 of the Act. The existing definition includes terms such as explosive, toxic, corrosive, and irritative, but businesses argued that it is too broad, leading to inconsistent enforcement. A revised classification system was proposed to improve regulatory certainty. 

3. Coordination Among Regulatory Agencies 

The Hazardous Substance Committee, composed of representatives from nine ministries—including Defence, Industry, Public Health, and Environment—was widely seen as a source of bureaucratic delays. Participants suggested including private sector representatives in the decision-making process to enhance efficiency. Businesses also proposed the creation of a centralized Hazardous Substance Information Centre within the Ministry of Industry to improve regulatory coordination and database management. 

4. Compliance Costs and Business Impact 

Companies raised concerns about high compliance costs associated with permits, labelling, storage, and disposal. These expenses increased product prices and operational burdens, prompting some businesses to seek alternatives. Additionally, mandatory insurance requirements were met with opposition, as stakeholders argued they would place unnecessary financial pressure on businesses handling hazardous substances. 

5. Advertising, Labelling, and Enforcement Mechanisms 

A major concern was advertising restrictions. While stakeholders supported bans on misleading claims, many opposed pre-approval requirements for advertisements, suggesting that regulatory agencies should bear the costs of approval rather than businesses. Regarding labelling compliance, some industry representatives expressed concerns about administrative burdens and suggested clearer documentation requirements for corrections. 

6. Enforcement, Penalties, and Exemptions 

Opinions were divided on increasing penalties for non-compliance. While some stakeholders were in favour of stricter penalties, others called for clearer enforcement criteria to prevent arbitrary fines. There was broad agreement for the creation of a subcommittee to handle minor offenses and to ensure consistent enforcement across agencies. Businesses also requested research and analysis exemptions for hazardous substances in transit or possession. Additionally, industry representatives argued that authorities should not impose extra fees for requesting official regulatory opinions before advertising hazardous substances. 

Proposed Amendments to the Hazardous Substances Act 

Based on stakeholder feedback, the following reforms have been proposed: 

• Improved coordination between regulatory agencies to streamline enforcement. 

• Clearer classification of hazardous substances under Section 4. 

• A unified import guarantee letter across agencies to simplify approval processes. 

• Bilingual guidelines (Thai & English) to enhance accessibility for businesses. 

• Updated storage and transport criteria reflecting modern industry standards. 

• Practical transition periods for new regulations to allow businesses to adapt. 

• Incentives for compliant businesses, including expedited approvals and dedicated application channels. 

Next Steps 

The DIW has acknowledged these concerns and has assured stakeholders that future amendments will incorporate these recommendations while aligning with international standards. As Thailand moves forward with regulatory updates, businesses and policymakers anticipate a more balanced, efficient, and fair hazardous substance management system. Draft amendments are expected to be released in the coming months for further public consultation before implementation. 

The full text of the evaluation can be found here. 

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.