Thailand Regulatory News

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 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, 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 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 

As required under the Hazardous Substance Act B.E. 2535 (1992), the Ministry of Industry of Thailand's Department of Industrial Works opened the first draft notification for the public hearing pro...

As required under the Hazardous Substance Act B.E. 2535 (1992), the Ministry of Industry of Thailand's Department of Industrial Works opened the first draft notification for the public hearing procedure on 20 May  2021. It has perfluorooctanoic acid (PFOA) included as part of the primary revision. On 3 May 2019, more than 180 nations decided to prohibit the manufacturing and use of PFOA, its salts, and PFOA-related chemicals at the international Stockholm Convention on Persistent Organic Pollutants (POPs) 

However, as unintended trace contamination is possible, to calculate this the Department of Industrial Works evaluates European Union Regulation (1019/1021) 

 The draft specifies the following exemptions under Type 4 (banned chemicals):

In the manufacturing of fluoropolymers, PFOA (a synthetic perfluorochemical) is produced as a byproduct. A class of substances known as perfluorochemicals (PFCs) is used to create fluoropolymer coatings and goods that withstand heat, oil, stains, grease, and water. For instance, PFOA was used in the manufacture of polytetrafluoroethylene (PFTE) better known as Teflon. People are most likely exposed to PFOA through the consumption of tainted water and perhaps through the use of PFOA-containing items. Compared to the general population, perfluorochemical industry workers may be exposed to higher levels of PFOA. 

Other PFOA-related chemicals on Thailand's List No. 5.1(Hazardous Substance Act's Annex 5) now have different classifications: Substances 523-533 are now Type 3 hazardous substances when certain conditions or exemptions apply, while Substances 534-541 are now Type 4 hazardous substances when such conditions or exemptions are not present, such as when the concentration is below 0.0000025% w/w. Industrial chemicals, chemical waste, discarded electrical and electronic equipment, and chemical weapons convention chemicals are all regulated by Annex 5. 

In addition, the first draft notification has two additional compounds with more accurate classifications: 

The classification of benzyl cyanide (Cas RN 140-29-4) has been changed from Type 1 (hazardous substance) to Type 3. Triethanolamine (Cas RN 102-71-6), which is already a Type 3 substance, has also had a threshold limit of > 30% w/w applied in accordance with list 3B (precursors) annexed to the Chemical Weapons Convention. 

In Thailand, the Ministry of Industry (MOI) is a cabinet ministry responsible for promoting and regulating industries. To ensure consumer safety, and safeguard human health, Thailand has published Tha...

In Thailand, the Ministry of Industry (MOI) is a cabinet ministry responsible for promoting and regulating industries. To ensure consumer safety, and safeguard human health, Thailand has published Thai Industrial Standard (TIS) 2622-2556 (2013) that will restrict the amount of lead and cadmium in fluoropolymer coatings for metal utensils used for cooking with heat. The standard will enter into force on 2^nd April 2023.

The standard only applies to utensils formed from a metal substrate where the side in direct contact with food is coated with a fluoropolymer and is to be used for cooking with heat. Cooking utensils and electric appliances that cook with electrical heating are excluded. The Fluoropolymer coated utensils in contact with food must comply with the Thai Industrial Standard (TIS) 2622-2556 (2013) (Fluoropolymer-coated utensils in contact with food), that outlines the migration limits for lead, cadmium, and certain volatile substances which must not exceed 100mg/kg.

The specifications also list the utensils’ coating materials, including polytetrafluoroethylene, tetrafluoroethylene/hexafluoropropylene, and perfluoro-alkoxyalkane. Furthermore, the standard TIS 656 must also be used to test leachable chemicals for heavy metals and substances that react with potassium permanganate.

In addition, the notification also specifies the requirements related to limitations on container evaporation, packaging and product labeling, properties of the surface, the hardness of the coating, and abrasion resistance.

The Hazardous Substance Act B.E. 2535 was issued in 1992 and is the most important chemical control law in Thailand. The purpose of this Act is to regulate the importation, production, marketing, and ...

The Hazardous Substance Act B.E. 2535 was issued in 1992 and is the most important chemical control law in Thailand. The purpose of this Act is to regulate the importation, production, marketing, and possession of all hazardous chemicals (including industrial chemicals, pesticides and biocides) used in Thailand. The Department of Agriculture (DOA) takes responsibility for the control of fertilizer products for manufacturing, sale, importation, exportation, and transit.  

In Thailand, adjuvants and soil amendments do not require registration as these are not classified as fertilizers or as hazardous substances according to the Hazardous Substance Act. Adjuvants and Soil amendments are currently regulated under the Consumer Protection Act B.E. 2522 and amendment (No. 2) B.E. 2541.  

The Consumer Protection Act prescribes the requirements of adjuvant and soil amendment products. In order to protect consumer rights, it is important to designate adjuvants and soil amendments as label-controlled products. Thus, it is important to have appropriate elements and information on the product label as provided by the Notification. This Notification shall come into force after completion of four months from the date of its publication in the Government Gazette. 

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