Myanmar Cosmetic Regulation

Myanmar aligns its cosmetic regulatory system with regional standards through its participation in the ASEAN Harmonised Cosmetic Regulatory Scheme. Overseen by the Department of Food and Drug Administration (FDA) of Myanmar, the country incorporates key ASEAN principles to ensure the safety and quality of cosmetic products. Through a combination of national orders and ASEAN-referenced requirements, Myanmar regulates products across their full lifecycle, covering market authorization, ingredient management, labelling and claims, and post-market monitoring. For companies seeking to enter the Myanmar market, understanding both national provisions and ASEAN-aligned rules is essential to ensure smooth and compliant operations.

Part 1 Regulatory Framework and the Competent Authority

1.1 Main Regulations

1.2 Competent Authority

The Myanmar FDA, operating under the Ministry of Health, serves as the main regulatory authority for cosmetics in the country. It is responsible for guaranteeing that cosmetic products are safe, effective, and of good quality, while facilitating their production, importation, and distribution in line with ASEAN cosmetic regulations. To fulfill these responsibilities, the FDA issues regulatory orders and guidelines and actively monitors compliance, ensuring that products available on the market adhere to both national requirements and ASEAN-aligned standards.

Part 2 Cosmetic Compliance Requirements

2.1 Definition

As defined by the Regulation on Cosmetic Product, a "cosmetic product" refers to any substance or preparation intended for application to the external parts of the human body (including the skin, hair, nails, lips, and external genital organs), or to the teeth and mucous membranes of the oral cavity, with the primary or exclusive purpose of cleansing, perfuming, altering appearance, correcting body odors, and/or protecting or maintaining them in good condition.

2.2 Classification

All cosmetic products in Myanmar are subject to the same national requirements, as the country does not apply differentiated regulatory classification. However, when notifying products to the Myanmar FDA, companies are required to specify the cosmetic category. For this purpose, the FDA provides a list of product categories from which applicants can select, as follows:

• Creams, emulsions, lotions, gels, and oils for skin (hands, face, feet, etc.)

• Face masks (with the exception of chemical peeling products)

• Tinted bases (liquids, pastes, powders)

• Make-up powders, after-bath powder, hygienic powders, etc.

• Toilet soaps, deodorant soaps, etc.

• Perfumes, toilet waters, and eau de cologne

• Bath or shower preparations (salts, foams, oils, gels, etc.)

• Depilatories

• Deodorants and anti-perspirants

• Hair care products

• Shaving product (creams, foams, lotions, etc.)

• Products for making up and removing makeup from the face and the eyes

• Products intended for application to the lips

• Products for care of the teeth and the mouth

• Products for nail care and make-up

• Products for external intimate hygiene

• Sunbathing products

• Products for tanning without the sun

• Skin whitening products

• Anti-wrinkle products

• Others

2.3 Notification

The company or individual responsible for placing a cosmetic product on the Myanmar market shall notify the FDA through the designated e-Submission System. To access the system, applicants shall first create a user account by providing the following information:

After verifying their email to complete account creation, applicants can log in to the system and proceed with the notification. Completion of the notification requires filling out an online application form, providing information on the local responsible company, product presentations, product specifications, ingredients, product type, intended use, manufacturer(s), and assembler(s). Before submitting the notification, the applicant shall also upload the following documents:

1) Authorization letter from the product owner or manufacturer;

2) Certification of importer registration;

3) Relevant supporting certificates, which may include a Free Sale Certificate, notification certificate from other ASEAN countries, manufacturing license, Good Manufacturing Practice (GMP) certificate, or ISO certificates.

Upon verifying that the notification application is complete and factually accurate, the FDA issues an "Acknowledgement of Cosmetic Notification". Importantly, this certificate does not constitute a guarantee of the product's safety, quality, or claimed effects. The notification remains valid for two years. To maintain continuity, the certificate holder shall submit a renewal application at least one month before expiry. Renewal requirements mirror those of the initial application, with updated information provided where relevant. Upon approval, the FDA issues an "Acknowledgement of Cosmetic Notification Revalidation".

2.4 Product Information File (PIF)

Importers of cosmetic products intended to be placed on the Myanmar market, as well as wholesalers of cosmetic products manufactured domestically or abroad for the Myanmar market, shall establish and maintain a PIF in Burmese or English. The PIF shall be readily available for submission to the Myanmar FDA upon request, and shall include the following information and data:

1) Detailed specifications of ingredients and finished products;

2) Information on the quality and quantity of ingredients contained in the product;

3) Records demonstrating that the product is manufactured in accordance with GMP;

4) Safety records of the cosmetic product;

5) Records of any adverse effects or harm to human health arising from the use of the cosmetic product;

6) Evidence substantiating the claimed or advertised efficacy of the cosmetic product;

7) Records relating to the methods required for laboratory testing of the cosmetic product; and

8) Records of the distribution and sale of the cosmetic product;

9) Product artwork.

2.5 Ingredients

In line with its participation in the ASEAN Harmonised Cosmetic Regulatory Scheme, Myanmar has adopted the ingredient annexes of the ASEAN Cosmetic Directive (ACD), including all subsequent amendments, as part of its national cosmetic requirements, as outlined below. Accordingly, cosmetic products placed on the Myanmar market shall not contain substances prohibited under Annex II, and shall comply with the applicable restrictions and conditions specified in Annex III, Annex IV, and Annex VI.

1) Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products;

2) Annex III: List of Substances Which Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down;

3) Annex IV: List of Colouring Agents Allowed for Use in Cosmetic Products;

4) Annex VI: List of Preservatives Which Cosmetic Products May Contain;

5) Annex VII: List of Permitted UV Filters Which Cosmetic Products May Contain.

2.6 Labelling and Claims

According to the Regulation on Cosmetic Product, cosmetic labels are required to include the following information, in Burmese and/or English, regardless of whether the product is produced in Myanmar or imported:

1) Product name and brand name;

2) Full ingredients list;

3) Name of manufacturer, and country of origin;

4) Net contents (weight/volume);

5) Batch number;

6) Manufacturing and expiry dates;

7) Registration number issued by the country of origin;

8) Instructions for use; and

9) Special precautions.

With respect to advertising, claims relating to the efficacy of cosmetic products shall be supported by practical use or scientific testing. Cosmetic products shall not be promoted as possessing medicinal properties or as being effective in the prevention or treatment of diseases.

2.7 Post-market Surveillance

As part of post-market surveillance in Myanmar, the local company responsible for placing a cosmetic product on the market is required to report serious adverse events to the competent authority in a timely manner. Where a cosmetic product is associated with a fatal or life-threatening serious adverse event, the responsible local company shall report the event to the authority as soon as possible, and in any case, no later than seven calendar days after first becoming aware of the event. Such an initial report may be made by telephone, facsimile, email, or in writing.

Following the initial report, the responsible local company shall complete and submit the Adverse Cosmetic Event Report Form within eight calendar days. The company shall also provide any additional information or documentation as may be requested by the authority during the follow-up process. For serious adverse events that are not fatal or life-threatening, the responsible local company shall report the event to the authority as soon as possible, and in any case, no later than fifteen calendar days after first knowledge of the event, using the Adverse Cosmetic Event Report Form.

In addition, the local responsible company shall actively cooperate with the competent authority regarding any post-marketing interventions. Where directed, it shall recall the product from the market, and discontinue its sale or supply in line with the authority's instructions.