As a member state of ASEAN, Vietnam fully implemented the ASEAN Cosmetic Directive (ACD) by the release of Circular 06/2011/TT-BYT Providing Cosmetic Management on January 25th, 2011. Under the regulation, cosmetics are required to go through notification procedures, and only after authorities issue a cosmetic notification receipt number are the applicants permitted to sell cosmetic products. The notification applicants are also responsible for the safety, efficacy, and quality of their products.

Part 1 Regulatory Framework and Competent Authority

1 Existing Main Cosmetic Regulations in Vietnam

2 Competent Authority of Cosmetics

The Ministry of Health (MoH) is in charge of formulating and issuing the major cosmetic regulations in Vietnam.

The Drug Administration of Vietnam (DAV) under the MoH is responsible for issuing the specific enforcement rules and measures, processing the notifications, and conducting post-market surveillance.

Part 2 Cosmetic Products

1 Definition

The definition of Cosmetics in Vietnam is in accordance with ASEAN ACD is: "any substance or preparation intended placed in contact with the external parts of the human body, or with the teeth and the mucous membranes of the oral cavity for cleaning , perfuming , changing appearance, and/or correcting body odors and/or protecting or maintaining condition".

2 Classification

Cosmetic classification involves characteristics, intended use, the ingredient formula, and the application method of products (click here to find the cosmetic scope).

Products with the following characteristics are not cosmetics:

• contain ingredients with human origin

• permanently adjust, restore or alter the function of the body by immunologic, metabolic or pharmacologic mechanisms

• designed to be swallowed, injected, or placed in contact with internal parts of the human body (for example, the nasal mucous membrane, internal genital organs

The following are not cosmetics:

• anti-mosquito products

• room fragrance

• fabric softener

• toilet detergent

• hydrogen peroxide solution

• sanitizing alcohol 70% and alcohol 90%

• artificial teeth cleansing product which does not contact the oral cavity

• artificial eyelash

• liquid for eye/nasal/ear wash

• products preventing nasal congestion

• anti-snoring products

• lubricant gel

• ultrasonic gel

• products touching internal genital organ

• enema

• local anesthetics

• products reducing/controlling swelling/edema

• dermatitis treatment products

• allergy relief products

• fungicidal products

• virucidal products

• products stimulating for hair/eyelash grow

• products removing/burning fat/losing centimeters

• weight loss products

• hair growth prevention

• products stopping perspiration completely

• eternal tattoo ink

• products for removing/reducing scars

• wound cleaning product

3 Manufacturing Requirements

Before manufacturing, the cosmetic manufacturer must submit the application for issuance of a Certificate of eligibility for cosmetic manufacturing by hand or by post to the Department of Health in the same location as the cosmetic manufacturer's workshop. Within two working days from the receipt of the application, the Department of Health will issue a receipt note if the application is sufficient and valid or make a written notice to outline the shortcomings of the application. For valid applications, within 30 working days from the receipt note, the Department of Health will inspect the cosmetic manufacturer and grant a Certificate to qualified manufacturers. During manufacturing, cosmetic manufacturers shall implement a quality management system in compliance with “Cosmetic Good Manufacturing Practices (CGMP-ASEAN)” guidelines and standards.

3.1 Conditions for Issuance of the Certificate

A cosmetic manufacturer may be qualified to apply for a Certificate of eligibility for cosmetic manufacturing if it satisfies all of the following conditions:

1) Personnel requirement: The production manager must have adequate professional experience and relevant qualifications in one of the following majors: Chemistry, Biology, Pharmacy, or other relevant majors in order to meet job requirements.

2) Infrastructure requirement:

• Its location, area, workshop, and equipment must meet production line requirements, and the types of cosmetic products which will be produced by that manufacturer must be as described in the application dossier for Certificate of eligibility for cosmetic manufacturing

• There must be separate storage areas for raw materials, packaging materials, and finished products. There must also be separate areas for storing flammable and explosive materials, highly toxic substances and any discharged, recalled or returned materials or products

3) It is a quality management system must satisfy the following requirements:

• Raw materials and auxiliary materials used to manufacture cosmetic products must meet quality standards adopted by the manufacturer

• The water used in the production of cosmetic products must comply with the national technical regulations on drinking water quality promulgated by Minister of Health

• The quality standards of semi-finished products used in the production must meet the manufacturer's ones

• The production process must be available for each type of cosmetic product. Quality control divisions must monitor the quality of raw materials, semi-finished products, bulk products, and finished products

• The implementation of a documentation system is mandatory

3.2 Application Dossier Requirements

An application for issuance of Certificates of eligibility for cosmetic manufacturing shall consist of the following documents:

•  The application form

• The site plans and design drawings of the cosmetic manufacturer

• The list of existing equipment of the cosmetic manufacturer

• The list of types of cosmetic products which are undergoing production or will be produced, and quality standards of each product type 

4 Notification

Before putting cosmetics on the market, both manufacturers and importers are required to notify their products with the DAV online and obtain the notification receipt number. The notification receipt number is valid for five years.

The cosmetic notification dossiers include the following:

5 Product Information File (PIF)

Every cosmetic product must have a Product Information File (PIF) when delivered to the market per the ASEAN Cosmetic Directive. The PIF shall be kept at the address of organizations or individuals who are responsible for putting the product on the market.

The PIF has four parts:

• Part 1: Administrative documents and a summary of the product

• Part 2: Ingredient quality

• Part 3: Product quality

• Part 4: Safety and efficacy

Administrative documents and a summary of the product must immediately be presented to the inspection authority when required while other parts shall be presented within 15-60 days after the inspection day.

Specific documents for PIF can be referred to Coslist.

6 Labeling

Cosmetic product labels must conform to ASEAN cosmetic labeling requirements. The following information must be shown on the product label:

• Name of the product and its function

• Instructions for use

• Ingredients of the complete formula

• Name of the country of manufacture

• Name and address of the organization or individual responsible for bringing the product to the market (completely filled out in Vietnamese according to the business registration certificate or investment license)

• Quantity expressed as net weight or volume

• The date of manufacture or expiry date must be clearly stated. For products with the stability of fewer than 30 months, and the expiration date is required

• Warnings about safety when using

In case, the size, the form, or the package material does not permit full product information to be printed on the original label, the required contents (as listed above) have to be printed on an auxiliary label attached with the cosmetic product, and the original label must indicate where these contents are printed. The product's name and the product lot number must be printed on the original label of the product's package.

The contents of labels and supplementary labels (if any) must be truthful, clear, and accurate, accurately reflect product features, and offered in English or Vietnamese.

7 Advertising

Before the advertising of cosmetics, organizations or individuals have to register with the local Department of Health. The registration dossiers required are as follows:

Only after getting the approval can the applicants start to advertise their cosmetics.

Part 3 Cosmetic Ingredients

The organizations and individuals responsible for bringing cosmetic products to the market must ensure their products are not harmful to human health and evaluate the safety of each cosmetic product per ASEAN's Cosmetic Safety Guidelines. Cosmetic ingredients must comply with the latest version of Appendix (Annexes) of the ACD.

1. Annex II is a List of Substances Which Must Not Form Part of the Composition of Cosmetic Products
2. Annex III is a List of substances that cosmetic products must not contain except for the ones subject to restrictions and conditions laid down
3. Annex IV lists coloring agents allowed for use in cosmetic products
4. Annex VI lists the Preservatives Which Cosmetic Products May Contain
5. Annex VII is a list of UV Filters Which Cosmetic Products May Contain