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Thailand’s Compliance with the ASEAN Harmonized Cosmetics Regulatory Scheme

  • September 2, 2016
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Background:

The import and production of cosmetics in Thailand has long been regulated under the Cosmetics Act B.E. 2535 (1992) (the “Cosmetics Act 1992”), which has remained unchanged for more than twenty years.  Thailand, as a member of the Association of Southeast Asian Nations (“ASEAN”), entered into what is known as the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (“AHCRs”) on 2 September 2003, and was therefore required to amend its current laws on cosmetics control in order to comply with the AHCRs.  On 8 September 2015, amendments to the Cosmetics Act 1992 were enacted as the Cosmetics Act B.E. 2558 (2015) (the “Cosmetics Act 2015”) and became effective on 9 September 2015.

Definition of Cosmetics:

Under the Cosmetics Act 2015, “Cosmetics” are defined as:

(1) articles intended to be used by applying, rubbing, massaging, sprinkling, spraying on, dropping, introducing into, perfuming or by any other means to any part of human body including treatments designed for using with teeth and oral mucosa for cleansing, beautifying, or promoting beauty change to an appearance, or deodorization or protection, including skin-care products, but shall not include ornaments and clothing which are accessories outside the human body;

(2) articles intended for use as a specific component in the manufacture of cosmetics; or

(3) other articles prescribed as cosmetics by the Ministerial Regulation;

All of the aforementioned “Cosmetics” are treated as controlled cosmetics and are subject to the Cosmetics Act 2015.

Registration:

Any proposed producer or importer of “Cosmetics” must first register with the Thai Food and Drug Administration (the “FDA”) in order to obtain a license for each particular product and comply with a variety of announcements from the Ministry of Public Health covering the following:

  • Characteristics of factories, equipment, tools, packaging and place of import.
  • Rules, procedures and conditions to produce and import cosmetics, including
    – ministerial regulations regarding prohibition of solution, color, preservative and sun protection factors
    – ministerial regulations regarding advertising
    – ministerial regulations regarding labeling
    – consumer protection law
  • Rules, procedures and conditions on notification and reporting dissatisfaction from using cosmetics.
  • Rules, procedures and conditions for maintaining and storing cosmetics data for FDA investigation.

The FDA does not prohibit foreigners from registering and obtaining a license for a cosmetics product line (however, if the foreigner is a juristic person, then it will need to register with the Department of Business Development (DBD) and obtain a foreign business license from the DBD).

Once a license is granted by the FDA for a particular product, a maximum government fee of THB 5,000 will apply.  The license is valid for a three-year period and renewable thereafter subject to an additional maximum government fee of THB 5,000.

The FDA has the power to revoke a product license and impose a fine not exceeding THB 20,000 if the actual producer or importer is different from the name listed in the registration.  The Cosmetics Act 2015 imposes fines as well as possible criminal penalties for other violations as well.

The holder of a cosmetics license will need to be aware of the various compliance requirements issued by the FDA and others, including, following good manufacturing practice (GMP), creating a database for program information files (PIF), complying with regulations concerning product labels (FDA and OCPB Announcement), complying with advertising regulations (FDA and OCPB Announcement), and complying with regulations on hazardous cosmetic substances (FDA Announcement)

A producer or importer may produce and export cosmetics which are part of an original equipment manufacturer (OEM) order and of a quality below FDA standards, but may not sell those cosmetics in Thailand.