Thailand Regulatory News

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.

On 29 November 2023, the Thai Ministry of Public Health issued a Draft Notification outlining the registration, issuance, and renewal procedures for hazardous substances. The focus of this initiative ...

On 29 November 2023, the Thai Ministry of Public Health issued a Draft Notification outlining the registration, issuance, and renewal procedures for hazardous substances. The focus of this initiative is to streamline and improve the registration process through the implementation of an online submission system under the jurisdiction of the Food and Drug Administration (FDA).

Key Points of the Draft Notification:

Electronic Submission Requirement:

Business operators dealing with Type 2 and Type 3 hazardous substances will be required to submit applications and relevant documents through the FDA’s designated electronic system.

The application categories include registration of hazardous substances, permission to manufacture or import samples (for quantities exceeding 5 kilograms or 5 litres), self-certification for smaller quantities, amendment/change of registration information, and renewal of the registration certificate.

In cases where submission through the FDA's electronic system is not feasible, alternative procedures are allowed. These should be submitted to the FDA or to other designated agencies/locations/procedures as specified by the FDA.

Validity of Certificate:

The certificate of registration is valid until the end of the sixth calendar year from the year of issuance. However, officials may specify a different period of validity if necessary.

Change of Registration Details:

Changes to registration details will be noted on the permit or issued in writing. In some cases, a new certificate of registration may be issued.

The primary objective of this initiative is to improve the efficiency of the hazardous substance registration process by introducing an online submission system. This move is in line with global trends in regulatory practices and is expected to simplify procedures for businesses and ensure better compliance with safety standards.

Timeline:

The proposed date of adoption is yet to be determined, and the date of entry into force is set for the day following its publication in the Government Gazette. As per Thailand’s notification to World Trade Organization (WTO), stakeholders and interested parties have a 60-day window from the date of notification to provide their comments on the proposed draft.

Relevant documents:

The Hazardous Substances Act B.E. 2535 (1992)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration B.E. 2552 (2009)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 2) B.E. 2558 (2015)

Notification of the Ministry of Public Health regarding registration, issuance and renewal of the registration certificate of hazardous substances under the responsibility of the Food and Drug Administration (No. 3) B.E. 2561 (2018)

On 29 November 2023, Thailand has officially notified the World Trade Organization (WTO) of the Draft Notification of the Ministry of Public Health concerning the criteria, procedures, and conditions ...

On 29 November 2023, Thailand has officially notified the World Trade Organization (WTO) of the Draft Notification of the Ministry of Public Health concerning the criteria, procedures, and conditions for the possession of Type 1 hazardous substances. This notification specifically relates to refilling activities under the jurisdiction of the Food and Drug Administration (FDA) at refill stations.

The primary objective of this draft notification is to set criteria, procedures, and conditions for the possession of Type 1 hazardous substances during refilling activities under the jurisdiction of the FDA. The overarching goal is to protect human health and safeguard the environment.

Key provisions of the draft include:

• Definition of Hazardous Substances Refilling:

The draft prescribes the definition of refilling of hazardous substances at refill stations, focusing on the possession of Type 1 hazardous substances, specifically liquid cleaning products. This involves the sale of these substances by transferring or changing the container from a bulk product container to a refillable container at the refill station.

• Refill Process Requirements:

Prior to the refilling process, hazardous substances must have undergone a Type 1 hazardous substances fact notification. Additionally, the active ingredients of the refill products must belong to specific chemical groups, including amphoteric surfactants, anionic surfactants, non-ionic surfactants (except nonylphenol ethoxylate), and amine oxides.

• Notification Requirements:

Chapter 1 sets out the criteria, procedures, and conditions for notifying the authorities of the possession of Type 1 hazardous substances for sale through refilling activities. This includes notification of the refill products and the address of the refill station. Mobile refill stations require additional information about the storage location and the motor vehicle.

• Premise and Equipment Guidelines:

Chapter 2 outlines guidelines for premises and equipment, emphasizing the need for cleanliness and sanitation. Installations involved in preparations and controls must be checked before each use to ensure proper functioning, and all equipment must be maintained in good working order.

• Labelling Requirements:

Chapter 3 establishes labelling requirements applicable to refill hazardous substances products.

• Characteristics of Refillable Containers:

Chapter 4 details the characteristics of refillable hazardous substances containers.

Timeline

The proposed date of adoption is yet to be determined. The entry into force will come 180 days after its publication in the Government Gazette. Stakeholders and interested parties have a 60 days from the date of notification to provide their comments on the proposed draft.

On 29 November 2023, Thailand has officially informed the World Trade Organization (WTO) about its intention to seek exemption from complying with the Hazardous Substances Act B.E. 2535 (1992). The Dr...

On 29 November 2023, Thailand has officially informed the World Trade Organization (WTO) about its intention to seek exemption from complying with the Hazardous Substances Act B.E. 2535 (1992). The Draft Notification, submitted by the Ministry of Public Health and falling under the purview of the Food and Drug Administration, outlines a crucial amendment that aims to streamline regulatory processes.

The proposed exemption specifically pertains to type 2 and type 3 hazardous substances that are imported solely for export purposes, with a clear stipulation that these substances are not intended for distribution within Thailand. The key change involves the waiver of the requirement to submit "the samples of label of hazardous substance (product labels)" for the registration of hazardous substances.

The primary objective behind this proposed amendment is to alleviate the regulatory burden on businesses. By exempting certain hazardous substances destined for export from the requirement to submit product labels for registration, the Thai government seeks to facilitate smoother and more efficient processes for business operators involved in international trade.

The rationale behind this move is to cut down on unnecessary documentation, providing relief to businesses engaged in the import and export of type 2 and type 3 hazardous substances. The regulatory adjustment is expected to enhance the ease of doing business, fostering a more conducive environment for trade while maintaining adherence to international safety standards.

The proposed date of adoption is yet to be determined, and the entry into force is set for the day following its publication in the Government Gazette. Stakeholders and interested parties have a 60-day window from the notification date to provide their comments on the proposed draft.

On 12 March 2023 Thailand's Food and Drug Administration (FDA) has announced plans to outlaw the use of 13 per- and polyfluoroalkyl substances (PFASs) despite the fact that none of the 13 substanc...

On 12 March 2023 Thailand's Food and Drug Administration (FDA) has announced plans to outlaw the use of 13 per- and polyfluoroalkyl substances (PFASs) despite the fact that none of the 13 substances are currently used in cosmetics products in Thailand.

The FDA proclaimed in a draft gazette notification (B.E. 2566–2023) that the country's Cosmetics Committee had authorised the intervention. The FDA asserted that after gazing over cosmetics that that had been registered as being manufactured and imported for sale in Thailand, it unearthed and none of them contained the components noted below. Before releasing a final version, the Authority needs authorization from the Minister of Public Health.

The 13 per- and polyfluoroalkyl substances listed in the draft are:

1. Perfluorooctane sulfonate (PFOS)

2. Potassium perfluorooctanesulfonate (potassium heptadecafluorooctane-1 -sulfonate)

3. Diethanolamine perfluorooctane sulfonate

4. ammonium perfluorooctane sulfonate (ammonium heptadecafluorooctanesulfonate)

5. Lithium perfluorooctane sulfonate (lithium heptadecafluorooctanesulfonate)

6. Perfluorooctanoic acid (PFOA)

7. Ammonium pentadecafluorooctanoate

8. Nonadecafluorodecanoic acid

9. Ammonium nonadecafluorodecanoate

10. Sodium nonadecafluorodecanoate

11. Perfluorononanoic acid (PFNA)

12. Sodium heptadecafluorononanoate

13. Ammonium perfluorononanoate