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Thailand updated restricted and prohibited substance lists for cosmetics

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. 

Updates on Thailand Chemical Regulation

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.

Hazard Degree

 

Type I

 

  • Notification

 

Operational Personnel

 

GHS

Type II

 

  • Notification
  • Registration

Type III

 

  • Notification
  • License
  • Registration

Type IV

 

  • Prohibited

 

 

 

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.