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
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".
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:
hydrogen peroxide solution
sanitizing alcohol 70% and alcohol 90%
artificial teeth cleansing product which does not contact the oral cavity
liquid for eye/nasal/ear wash
products preventing nasal congestion
products touching internal genital organ
products reducing/controlling swelling/edema
dermatitis treatment products
allergy relief 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
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:
Cosmetic notification report with the notification data
Original or notarized copy of letter of attorney from the producers or the owners of products authorizing organizations or individuals to put products on the market in Vietnam
1. Apply to imported cosmetics or domestically produced cosmetics in which the organization or individual responsible for bringing the product to the market is not a manufacturer;
2. For imported cosmetics, the letter of attorney must be a notarized copy and legalized by the consulate.
Certificate of free sale (CFS) which should have at least the following information:
1. Apply to imported cosmetics;
2. CFS which is issued by the current territory must have been original or legally notarized and still in the day of validity. In case CFS is not provided of the expiry day, it must be a certificate which has just been issued within 24 months;
3. Except for some special circumstances, CFS must be consul legalized;
4. The following three cosmetics can be exempted from CFS submission:
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.
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.
Before the advertising of cosmetics, organizations or individuals have to register with the local Department of Health. The registration dossiers required are as follows:
Application form for approval for advertisement contents
The Certificate of Business Registration of an enterprise or the license for representative office establishment of a foreign dealer
Contents of applications for approval for advertisements
Sample labels of these products or those approved by competent healthcare authorities, applicable to the case in which the law stipulates that product labels must be approved by competent healthcare authorities
If the authorized applicant is filing the application for approval for advertisement contents, the following documents must be shown:
- Legal authorization letter;
- The Certificate of business registration or the license for representative office establishment of a foreign dealer held by the authorized applicant.
Materials used for reference, demonstration and verification of information provided in the advertisement content
Notification of cosmetic products issued by competent authorities.
Valid and authoritative materials that demonstrate features and useful effects of these cosmetic products.
This will happen if the advertisement content provides information about features or useful effects of these products but such information are not included in the notification of cosmetic products of which the notification numbers have been issued by competent authorities.
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