Thailand Regulatory News

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 Products that do not meet the updated standards must be withdrawn immediately.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. 

On 2 February 2024, the Thai Food and Drug Administration (FDA) submitted two draft notifications to the World Trade Organization (WTO). The goal of both drafts is to protect human health and provide ...

On 2 February 2024, the Thai Food and Drug Administration (FDA) submitted two draft notifications to the World Trade Organization (WTO). The goal of both drafts is to protect human health and provide an update on the overall proportion of alcohol in alcohol-based hand sanitizers.  

Notification 1: Determining the Characteristics of Cosmetics Containing Alcohol for Hand Sanitizing Prohibited for Manufacture, Import, or Sale 

The draft notification prohibits the manufacture, import, or sale of cosmetics containing alcohol for hand sanitizing purposes if they have a concentration of either ethanol, isopropanol, n-propanol, or a mixture thereof of less than 70% by volume or less than 65% by weight. These products are intended to clean hands without the use of water. 

Notification 2: Determining the Criteria for Deviation Limits of Main Ingredients in Cosmetics Containing Alcohol for Hand Sanitizing 

This draft notification sets out the criteria for deviation limits of alcohol in cosmetics containing alcohol for hand sanitizing, specifying that they must contain not less than 15% and not more than 18% as notified to the Regulatory Body. 

In both notifications "alcohol" refers to ethyl alcohol (ethanol), isopropyl alcohol (isopropanol), and n-propyl alcohol (n-propanol) in cosmetics containing alcohol for hand sanitizing. 

The drafts will be available for public comment for the next sixty days. The day following their publication in the Government Gazette will mark the effective date which has not yet been determined. 

Thailand notifies WTO of draft regulation to restrict mercury in electrical and electronic equipment On 12 February 2024, the Thai Industrial Standards Institute (TISI) notified the World Trade Org...

Thailand notifies WTO of draft regulation to restrict mercury in electrical and electronic equipment

On 12 February 2024, the Thai Industrial Standards Institute (TISI) notified the World Trade Organization (WTO) of a draft Ministerial Regulation Prescribing Industrial Products for Mercury-Added Electrical and Electronic Equipment to Conform to the Standards B.E. The deadline for comments is 60 days from the date of notification.

Objective:

The proposed draft Ministerial Regulation aims to ensure the protection of human health and the environment by restricting the use of mercury in certain electrical and electronic equipment. With a focus on public wellfare, this regulation aims to reduce potential health risks associated with mercury exposure and to reduce environmental contamination.

Rationale:

Mercury, a toxic heavy metal, poses significant risks to human health and the environment. Exposure to mercury can lead to serious health problems, including neurological disorders, developmental disorders, and environmental pollution. By restricting the use of mercury in specific electrical and electronic equipment, the Regulation aims to address urgent concerns public health and environmental safety concerns.

Responsible Agency:

The Thai Industrial Standards Institute (TISI), under the Ministry of Industry, will be responsible for overseeing the implementation and enforcement of the proposed regulation. As a regulatory body, TISI plays a crucial role in ensuring compliance with industrial standards to protect public health and environmental integrity.

Description of Content:

According to the WTO notification released on 12 February 2024, the draft Ministerial Regulation mandates adherence to the TIS 3604–25XX (20XX) Mercury-Added Product – Restriction of the Use of Mercury for the following electrical and electronic equipment:

• Button zinc silver oxide batteries
• Button zinc air batteries
• Inclination switches
• Temperature switches
• Electronic acceleration switches (G sensors)
• Overcurrent protection switches
• Switches and relays for measurement, control, and transmission
• Compact fluorescent lamps (CFLs)
• Linear fluorescent lamps (LFLs)
• Cold cathode fluorescent lamps (CCFL) and external electrode fluorescent lamps (EEEL)

Timeline:

The adoption date for the regulation is yet to be determined. The regulation will enter into force 270 days after publication in the Government Gazette.

Thailand's Department of Industrial Works (DIW) has held a public consultation on the proposed amendments to the List of Hazardous Substances under the Hazardous Substances Act B.E. 2535 (1992). The d...

Thailand's Department of Industrial Works (DIW) has held a public consultation on the proposed amendments to the List of Hazardous Substances under the Hazardous Substances Act B.E. 2535 (1992). The draft amendments published on 1 November 2023, include the addition of "perfluorohexane sulfonic acid (PFHxS), its salts, and PFHxS-related compounds" to Annex 5.1 of the List, designating them as Type 3 hazardous substances. In total, 147 substances would be added to the List.

Stakeholders and the public were invited to provide comments and feedback on the proposed changes until 15 November 2023. If approved, the amendment would take effect upon publication in the Government Gazette.

Under the proposed regulations, manufacturers, importers, exporters, or individuals in possession of these per- and polyfluoroalkyl substances (PFAS) would be required to obtain a license within 30 days of the notification's entry into force.

The move is in line with Thailand's commitment as a signatory to the Stockholm Convention on Persistent Organic Pollutants (POPs). Notably, the United Nations countries, including Thailand, collectively imposed a global ban on PFHxS under the Stockholm Convention in June 2022, with no exemptions, and included them in Annex A of the Convention.