Vietnam Cosmetic Regulation
Apr 01, 2021
Angelita Hu
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CONTENTS

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

RegulationsImplementation DateStatus
Circular 06/2011/TT-BYT Providing Cosmetic Management2011-04-01In force
Amendments to Circular 06/2011/TT-BYT Providing Cosmetic Management2020-02-01In force
Consolidated Document 07/2021/VBHN-BYT Consolidating the Circular on Cosmetic Management/In force
Official Letter 1609/QLD-MP Guiding the Cosmetic Classification and Announcement of Cosmetic Characteristics2012-02-10In force
Official Letter 15002/QLD-MP Acceptance of Cosmetic Notification Online2015-10-01In force
Decree 93/2016/ND-CP Conditions for Manufacture of Cosmetic Products2016-07-01In force

2 Competent Authority of Cosmetics

The Ministry of Public 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:

No.

Information

Details

1

Cosmetic notification report with the notification data

  • Brand name and product name

  • Product types

  • Purpose of use

  • Product format

  • Particulars of manufacturer and packaging company

  • Name of exporting country and whether the products are free sold in the exporting country or manufacturing country (only apply to imported cosmetics)

  • Particulars of the applicant

  • Full ingredient list

2

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.

3

Certificate of free sale (CFS) which should have at least the following information:

  • Name of the CFS issuing agency

  • No. and issuing date of the CFS

  • Product names

  • Product types

  • Name and address of the manufacturer

  • The CFS must clearly state that the products are manufactured and allowed to be sold freely in the manufacturing country or the country where the CFS is issued

  • Full name and signature of the CFS signer and seal of the CFS issuing agency

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:

  • Cosmetics manufactured in CPTPP member states;

  • Cosmetics circulated and exported from CPTPP member states, but legal documents proving that the cosmetics are circulated in CPTPP member states (cosmetics circulation permit, cosmetics notification report with a notification receipt number), which are issued by the competent authority and legalized by the consulate are required;

  • Cosmetics obtaining the cosmetic notification receipt number in ASEAN member states, but the cosmetics notification report with a notification receipt number legalized by the consulate is required.

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:

  • A registration form

  • A copy of the cosmetic notification report issued

  • A copy of the business registration certificate

  • The authorization letter

  • Written explanations of features and utilities of the product

  • Advertisement scripts or advertisement models to be released

Only after getting the approval can the applicants start to advertise their cosmetics. The content of cosmetic advertising shall include the cosmetic’ name, functions and efficacy, name and address of the applicant, and warnings of use.

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