Thailand Regulatory News

On 1 June 2022 the Thailand Ministry of Public Health (MOPH) published a notification regarding Quality or Standard of Plastic Containers in the Royal Gazette. The notification was previously announc...

On 1 June 2022 the Thailand Ministry of Public Health (MOPH) published a notification regarding Quality or Standard of Plastic Containers in the Royal Gazette. The notification was previously announced in G/SPS/N/THA/484 on 27 January 2022. The notification has been effective since the day after its publication in the Government Gazette which was 18 June 2022 and the previous Notification (No. 295) B.E. 2548 (2005) on the Determination of Quality or Standards of Plastic Containers (dated 30 December 2005) was repealed.

The new standards, which entered into force include definitions, general safety requirements, quality standards for food packaging made from recycled plastic, as well as labelling and other requirements.

This addendum deals with:

• Modification of final date for comments
• Withdrawal of proposed regulation
• Modification of content and/or scope of previously notified draft regulation
• Change in proposed date of adoption, publication, or date of entry into force

In case the addendum extends the scope of the previously notified measure in terms of products and/or potentially affected members, a new deadline for receipt of comments should be provided, normally of at least 60 calendar days.

Thailand published some new requirements regarding Food Contact Materials (FCMs) which will enter into force on January 3, 2023. The Thai Industrial Standards Institute (TISI) published these five man...

Thailand published some new requirements regarding Food Contact Materials (FCMs) which will enter into force on January 3, 2023. The Thai Industrial Standards Institute (TISI) published these five mandatory standards in the Royal Gazette on April 8, 2022 to  replace some previous voluntary standards as described below:

• Plastic utensils for food part 1 – polyethylene, polpropylene, polystyrene, poly (ethlene terephthalate), poly (vinyl alcohol) and poly (methyl pentene) – TIS 655 Part 1-2553 (2010) 
• Plastic utensils for food part 2 – poly (vinyl chloride) polycarbonate polyamide and poly (methylmethacrylate) – TIS 655 Part 2-2554 (2011) 
• Plastic utensils for food part 3 – acrylonitrile-butadiene-styrene and styrene-acrylonitrile – TIS 655 part 3-2554 (2011) 
• Plastic food containers for microwave oven part 1 – for reheating – TIS 2493 Part 1-2554 (2011) and 
• Plastic food containers for microwave part 2 – for single reheating –TIS 2493 Part 2-2556 (2013). 

Details on the types of plastics permitted in the FCMs utensils and containers are provided in all five standards, and they have as well specified migration limits for ingredients used. The date of entry is the deadline for concerned companies to ensure the products’ compliance with the new standards. A product conformity assessment process is necessary, after which the conformity mark shall be placed on labels and packaging, once certified.

Without a conformity mark, the products will be banned from the market introduction and/or importation to Thailand. Fabricated marks – namely, products with marks without a legally approved conformity assessment are considered non-compliant and liable to penalties.

The Thailand Department of Industrial works and Ministry of Industry Recently published a notification, in the Royal Gazette on 11 April 2022.  This notification is referred to as “Notification of ...

The Thailand Department of Industrial works and Ministry of Industry Recently published a notification, in the Royal Gazette on 11 April 2022.  This notification is referred to as “Notification of Department of Industrial works regarding criteria and Method for Registration and Notification of Specialized Person Responsible for Safety Storage of Hazardous Substance under Authorization Of Department of Industrial Works and Reporting of Safety Storage of Hazardous Substance B.E 2565 (2022)”. It prescribes responsibilities of the hazardous substance storage facility and the qualified licensed person responsible for safety. This notification shall enter into force on 1 May 2022.

The new set of appendices consist of the following;

A report of hazardous chemicals’ safe storage is to be submitted by the Hazardous Substance entrepreneurs using the BorChor.6 form annually for the period of a calendar year. The submission is expected by 31 March next year via an online system of the Department of Industrial Works. However, in 2022, entrepreneurs are allowed to submit the annual report by 31 August 2022 as part of the transition measures.

On March 25, 2022, a regulation mandating toys to conform with the Thai industrial standard for toys, TIS 685 Part 1-2562 (2019) Toys: Safety requirements Part 1 – Requirements, was published in the...

On March 25, 2022, a regulation mandating toys to conform with the Thai industrial standard for toys, TIS 685 Part 1-2562 (2019) Toys: Safety requirements Part 1 – Requirements, was published in the Royal Gazette of Thailand by the Ministry of Industry. This published regulation, “Ministerial Regulation regarding designation of Toys as industrial products which shall conform to the industrial standard” is effective from September 22, 2022.

The standard restricts the migration of chemicals in TIS 685 Part 1-2562 (2019) for toy products. A stricter threshold was found for finger paint except for Barium, in contrast to “TIS 685 Part 1-2540 (1997) Toys Part 1 General requirements”. The specific requirements stated in the regulation are as follows:

The standard also introduced new requirements on phthalates in plastic, rubber, and coating.

The Hazardous Substance Act B.E. 2535 is one of the main legislative bases involved in chemical management in Thailand. The first issue of B.E. 2535 came into force on April 7th, 1992. The Act has...

The Hazardous Substance Act B.E. 2535 is one of the main legislative bases involved in chemical management in Thailand. The first issue of B.E. 2535 came into force on April 7th, 1992. The Act has been revised several times. The Ministry of Industry (MOI) in Thailand, the main authority responsible for the Act, has approved the 5th revision in early 2021 and it will be announced soon.

As a part of the revision, there are several upcoming amendments, including more substances are being added to the inventory and announcement of the Draft of MOI Notification on the declaration of the List 5.6 hazardous substances and The Draft of MOI Notification on R&D Exemption B.E. 2559.

For controlling purposes and administrative reasons, the Hazardous Substance Act B.E. 2535 divides chemicals into 4 types according to the severity of toxicity (see graph below). Manufacturers and importers of hazardous substances exceeding 1 ton per year are required to notify their hazardous substances to the Department of Industrial Works (DIW) via DIW's online system. The notification shall be submitted within 60 days from the date of manufacture or importation (only once). This notification is also called Thailand Chemical Inventory Notification.

The chemical inventory in Thailand is called Thailand Existing Chemicals Inventory and it has been published on an online platform http://inventory.diw.go.th/hazardous61/. The inventory includes 11,481 entries. Users can search chemicals via Chemical name, molecular formulas, hazardous substance type, chemical type, CAS number or chemical code. The search results, as well as the entire inventory, could be exported and downloaded as a PDF or Excel document. The substance information in the inventory also includes the import quantity, production volume, and the physical/health/environmental hazards of the substance. As a part of the upcoming amendment, the Thailand government will add more substances to the existing chemical inventory.

According to the Draft of MOI Notification on the declaration of the List 5.6 hazardous substances, manufacturers or importers of substances or mixtures which have the total amount of the single substance in all products> 1,000 kg/year must provide the information in compliance with the WoAo/AoKo20 Form (currently, it is mandatory if the total amount of the product exceeds 1000 kg/year).

The Draft of MOI Notification on R&D Exemption B.E. 2559 will be revoked and replaced with the new one, the changes including applicants need to mention R&D & for education, testing, and analysis in their application. The volume remains the same as the current one, which is more than 1 kg. As for Type 2 substance, no notification and registration are required. As for type 3 substances, no licensing and registration are required. Applications need to comply with the GHS classification and labelling. The certification will be valid for 6 months and no possibility for renewal.

Following are the upcoming updates in the chemical management in Thailand that we can expect:

• According to the Amendment of the declaration of the List 5.6 hazardous substances, declaration will be required for single substance, rather than just a product.
• It will be new measurements for new chemicals such as Cut-off date (chemicals being introduced to Thailand), Chemical Analysis, and Chemical Risk Assessment.
• Review the classification of hazardous substances (update List of Hazardous Substances No._ (B.E. 256X))
• The new Hazardous Substance Act (the latest amendment) will be reviewed by parliament.
• Amendment of the related regulations by The National Committee on Strategy Development for Chemical Management amend Master Plan on Chemical Management (2019-2037) https://online.fliphtml5.com/bcbgj/cklz/#p=3
• We see chemical management in Thailand in line with the classification and prioritization of management of hazardous substances.

Last update: 2021-03-30

The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted subs...

The Thailand Cosmetic Regulation or Cosmetic Act B.E. was officially finalized in the year 1992. Thailand’s Ministry of Public Health has updated its lists of prohibited and restricted substances for use in cosmetic products. 

Many of the changes bring the country into line with the Association of South-east Asian Nations (Asean) Cosmetic Directive (ACD), to which Thailand is a signatory. To change the status the act was legitimately amended in the year 2015 and was published in Royal Thai government Gazette on 8th September 2015 and came into force from 9th September 2015.

The Act was amende by the Thailand’s FDA on June 26, 2020 and was enforced on June 27, 2020, It requires information on those that contain specific thresholds, conditions of use and product types for each substance.

The substances on the list which are subject to updates are: 

• triclosan – the ministry set an allowable concentration limit of 0.3 % for 11 types of rinse-off products and 0.2% limit for mouthwash. These limits are lower than those imposed by some Asean countries;
• tagetes minuta flower extract/oil – the ministry set a maximum concentration limit of 0.01% for leave‐on products and 0.1% for rinse‐off products; and 
• tagetes patula flower extract/oil – the ministry set a maximum concentration limit of 0.01% for leave‐on products and 0.1% for rinse‐off products.

Cosmetics products must be labelled properly according to the  requirements of Thai legal labelling. It should be done within  30 days before placing it to Thailand’s market. According to the ACD, these limits will be effective from 19 December.

In Thailand the following enforcement dates apply:

• 27 June 2020 – for new products entering the market; and
• 27 June 2021 – for products already existing on the market prior to 27 June 2020.

Cosmetic products cannot exceed these concentration limits and conditions of use without prior approval from the authorities.

Prohibited chemicals

The ministry has also added seven chemicals to its list of those banned for use in cosmetic products. These include: 

• ketoconazole;
• 3- and 4-(4-hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde (HICC);
• 2,6-dihydroxy-4-methyl-benzaldehyde (atranol); and
• 3-chloro-2,6-dihydroxy-4-methyl-benzaldehyde (chloroatranol).

The following are banned from use in hair dye products in line with restrictions under the ACD:

• 2 -chloro-p-phenylenediamine (INCI) 2 -chlorobenzene -1,4 -diamine;
• 2 -chloro-p-phenylenediamine (INCI) 2 -chlorobenzene -1,4 -diamine and its sulfate; and 
• dihydrochloride salts.

Manufacturers, importers, distributors and retailers are all prohibited from using these chemicals in cosmetic products. The restrictions came into force on 27 June, 2020. 

The Ministry of Industry in Thailand published its new regulation B.E. 2558 on the notification of the production and import of hazardous substances in Government gazette regarding production and impo...

The Ministry of Industry in Thailand published its new regulation B.E. 2558 on the notification of the production and import of hazardous substances in Government gazette regarding production and import of hazardous substances which come into force on 19th Feb 2015.

Manufacturers and importers of hazardous substances exceeding 1 ton per year are required to notify their hazardous substances to the Department of Industrial Works (DIW) via DIW's online system. The notification shall be submitted within 60 days from the date of manufacture or importation (only once). This notification is also called Thailand Chemical Inventory Notification.

Information Required for Thailand Chemical Inventory Notification

The following info is required:

• Legal entity info;
• Type of activity: production or import;
• Type of hazardous substances: substance or mixture;
• Trade name and HS code;
• Transport info: UN number, class;
• Composition<;/li>
• Packaging details;
• Manufacturer name and country of origin;
• GHS classification;
• Content in SDSs: physio-chemical properties, toxicological info, eco-toxicological info and disposal considerations.
• A copy of GHS SDS prepared in Thai or English needs to be provided when submitting the notification.

For hazardous substances: substance or mixture:

Thailand has implemented GHS through the Hazardous Substance Act and Hazard Classification and Communication System of Hazardous Substances B.E. 2555 (2012).

Notification is only required for >1t/y hazardous substances (including both substances and mixtures) listed in the annex 5.6 of Thailand Hazardous Substances List that the Department of Industrial Works (DIW) is responsible for. Annex 5.6 is a new generic entry covering industrial chemicals meeting the definition of hazardous substances in accordance with the second paragraph of Article 18 of the Hazardous Substances Act B.E. 2535.

For controlling purpose and administrative reasons, the Hazardous Substance Act B.E. 2535 divides chemicals into 4 types according to the severity of toxicity.

Registration of Hazardous Substances:

Any person who produces or imports type 2 or type 3 hazardous substances shall submit an application for registration of such hazardous substance to the Department of Industrial Works (DIW) of Ministry of Industry (MOI), or to other authorities designated by Ministry of Industry (MOI).

The following info is required:

• Application form;
• Safety data sheet;
• Specification of the hazardous substance;
• Document or photograph evidencing characteristic of containers or tanks;
• Document or photograph evidencing methods used to secure the containers (if any);
• A document proving specification (i.e., an analytical lab approved by DIW) or sample.

No person shall produce, import or export, or have in possession of type 3 hazardous substances without a license granted by the competent authority. This license is valid for 3 years. Also, DIW would require 100% composition disclosure for evaluation.

License:

No person shall produce, import or export, or have in possession of type 3 hazardous substances without a license granted by the competent authority. This license is valid for 3 years.

100% Composition Disclosure:

DIW would require 100% composition disclosure for evaluation.

Companies may choose to keep some composition information to themselves due to confidential business information (CBI) concerns.

Under such circumstances, the company has to take its own risk since the DIW could only evaluate the chemicals are hazardous or not based on the information provided.

Exemption could be applied if the person has already been granted a permit for production, import or export of hazardous substances, a permit for the possession of the particular hazardous substance could be exempted.

Hazardous Substance type 4 used for R&D could be exempted.