Thailand Regulatory News

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.

The Thai Ministry of Public Health launched a public survey to collect information on the Food Contact Materials (FCMs) currently on the market. According to Chemical Watch, the different types of mat...

The Thai Ministry of Public Health launched a public survey to collect information on the Food Contact Materials (FCMs) currently on the market. According to Chemical Watch, the different types of materials survey covers are glass, ceramics, metal – tin plate, chromium tin-free steel, and aluminum. All of these are subdivided into coated and uncoated, paper – coated and uncoated, polymers – several varieties specified, multi-layer, other – polymer blends, copolymers, and other polymers and cellophane.

This survey also asks the persons using the FCM or users and also the manufacturers to submit the information regarding their products on the average thickness and density of the container, its shape and size, such as width, length, height or radius, product or food name, volume or weight of packed food, ingredient formula as shown on the label, annual domestic production volume, annual domestic import volume and storage and use conditions. The survey allows the authorities to know the status and standard of plastics on FCMs and provides feedbacks to its FCMs policies.