Detailed Interpretation: Vietnam Cosmetics Regulation

On September 2nd 2003, on behalf of the Government of Vietnam, the Vietnam Minister of Trade and Commerce signed an agreement on the ASEAN harmonized Cosmetic Regulatory Scheme, in which, the terms specified in the agreement is fully implemented since January 1st 2008. The agreement aims to unify cosmetic management in the ASEAN countries, and is toward a common market of ASEAN, strengthen cooperation between member States in ensuring safety, quality and beneficial feature of all cosmetic products on the ASEAN market and remove the restrictions on the cosmetic business between member States through the harmonization of technical regulations.

The agreement on the ASEAN Harmonized cosmetic regulatory scheme is considered a cosmetic treaty representing the unity of regulations on management of cosmetic member countries of the agreement. Being a member of the agreement, Vietnam cosmetic regulations are fully compatible with the ASEAN cosmetic regulations.

Definition and classification of cosmetics

The definition of cosmetic in Vietnam regulations is currently compatible with the definition of ASEAN Cosmetic Convention provided in Article 2.1 of Schedule B of ASEAN Cosmetic Directive. Accordingly, cosmetic product is a substance or a preparation which is used for touch with outside parts of human body (skin, hair system, finger nails, toenails, lip, and outside reproduction organ) or teeth and mouth mucous membrane with main purpose in order to cleanse, aromatize, change the outward characteristics, form, adjust body's smell, safeguard body, or maintain the human body in good condition.

For the classification of cosmetic, under the current Vietnam regulations, the criteria for the classification of cosmetic products based on the features, uses, recipe ingredients, route of administration of the product and the definition of cosmetic. Namely, beauty products are classified into 20 groups of products as the follow:

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 include: hair tints and bleaches, products for waving, straightening and fixing, setting products, cleansing products (lotions, powders, shampoos), conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines)
Shaving product (creams, foams, lotions, etc.)
Products for making-up and removing make-up 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 sun
Skin whitening products
Anti-wrinkle products
Others.

Besides, some products are not classified as cosmetic as the follow:

The product permanently adjust, restore or alter the function of the body by the immune mechanism, metabolic or pharmacological mechanism
Products sweetened oral, injection or contact with other parts of the body (i.e. the nasal mucous membranes, genitals in, ...)
The mosquito, air fresheners, fabric softeners, water, toilet bowl cleaner, liquid oxygen aging, alcoholic antiseptic 70 0, 90 0 alcohol, product Clean dentures are not exposed to the oral cavity, false eyelashes, eye cleaning solution/nose/ear protection products nasal congestion, anti-snoring products, vaginal lubrication gel, ultrasound gel, the exposure in genital, rectal enema, anesthesia, reduce/ control the swelling/edema, dermatitis treatment, hypoallergenic, anti-fungal, anti-viral, stimulates hair growth products/grow eyelashes products removed/reduced fat/reduced fat/reduced body size, weight loss products, prevent/stop the growth of hair, the process stops sweating, permanent tattoo ink, product remove scars, keloids reduction, wound cleaning products, ...

The cosmetic label

For cosmetic label content, Vietnam Law provides that the cosmetic product's label must be suitable for requirements of the cosmetic label writing set by the ASEAN. The following contents must be presented on the label:

The product's name and function, unless the presented form of product has been displayed clearly the product's function;
The usage instruction, unless the presented form clearly been displayed the product's using manner;
The full formula ingredients: must write clearly ingredients according to the international nomenclature regulated for latest printed forms;
The country where the product was made;
The name and the address of organizations or individuals who are responsible for putting products on market (written fully in Vietnamese according to the business registration certificate or the investment license);
Quantification is presented with weight or volume, in regard to the meter system or the meter system and the British system;
The manufacture lot number;
The manufacture day or the expiry must be clearly presented (i.e.: day/month/year). The date writing way must clearly be presented and involved of month/year or day/month/year in right order. The "expiry" or "the best using before date" can be exerted, if necessary, can add the instructed condition needs obey to make sure of the product's stability.

Referring to products with the stability below 30 months, the writing of expiry day is compulsory;

Warning about safety for usage; especially, warnings in the "usage condition and required alarms are compelled to be printed the product's label" column is referred in Appendices of ASEAN Cosmetic Treaty; these alarms are compelled to be printed on the label.

In case, the size, the form, or the package material cannot be fully printed information on the original label, these required contents have to be printed on the auxiliary label attached with the cosmetic product and on the original label must figure out the position in which these contents are printed. The following information is compelled to be printed on the original label of product's the direct packing: the product's name and the product lot number.

The current regulations also allow organizations and individuals to present other information on the label with the conditions that these information must not be opposite to the law and guarantee the honesty, the accuracy, the true reflection of the product's quality without causing the imperative content or the cosmetic label hidden or deviated.

For the presented language on the cosmetic label, the contents of the usage instruction, the name and the address of organizations and individuals who are responsible for putting the cosmetic products on market, and the warning about safety for usage must be written in Vietnamese. For the remaining information, the language presented on the cosmetic label must be written in English or Vietnamese.

For the label location, the cosmetic label must be printed on the commodity, package of commercial article on a location which is easy be seen of full regulated contents without disconnecting details or parts of the commodity. In case the outward package is not permitted or impossible to open, there must be the label with the required information on the package.

Besides, the organizations and individuals who are responsible for putting products on the market may identify the size of cosmetic product label but must assure that the information written on the label must be readable by the ordinary customers at the time of purchase and usage.

Cosmetic product safety requirements

Compatible with the Combination Convention in the cosmetic management which has been signed by countries are member of the Association of Southeast Asian Nations on September 2nd, 2003 (ASEAN Cosmetic Convention), Vietnam law not only requires the organization or the individual which delivers the product to the market must guarantee that its product shall be harmless for people’s health when exerted in normal or appropriate conditions supplied by the producer or the owner, but also requires the producer or the owner must have obligation in evaluating the safety of every cosmetic product in accordance with the ASEAN safety norm. Besides, the heavy metal limit and the microorganisms in the cosmetic must satisfy the ASEAN's requirements. The cosmetic Ingredients must satisfy the Appendix requirements (Annexes) – new version of the ASEAN Cosmetic Convention.

Cosmetic product proclamation

Under Vietnam law, a cosmetic product made in Vietnam or imported into Vietnam must go through procedure of proclamation before being sold on the market. Organizations or individuals selling the cosmetic product on the market are permitted when being issued the number of cosmetic product proclamation receiving by the authority agencies. The organization or individuals are also responsible for safety, effectiveness, and quality of product.

Organizations, individuals who are responsible for putting products on market are organizations, individuals have name written in the cosmetic product announcement dossier and be responsible for cosmetics product in the market and must have the function of cosmetic business in Vietnam.

The cosmetic product manufacturers or importer may themselves conduct procedure in cosmetic product announcement or authorize for other organizations, individuals satisfying conditions as regulated to do this.

The cosmetic proclamation dossier includes the following documents:

Cosmetic product proclamation report (02 versions) with the proclamation data (soft version of proclamation report);
Copy of business registration certificate of organizations, individuals who are responsible for circulation products into the market (with the enterprise’s signature and seal). In case the cosmetic domestic produced, but organizations, individuals who be responsible for putting products on the market are not the manufacturer must have a copy of business registration certificate of the producer (have legal notarized);
Original or notarized copy of letter of attorney from the producers or the owners of products authorized for organizations, individuals are responsible of putting products on the market in Vietnam (applied to the import or domestic cosmetic of which organizations or individuals are responsible of putting products on the market, be not the manufacturer). For the import product, the letter of attorney must be a copy notarized sign and consul legalized as provisions of law, except for being exempted of the consul legalization in regard to international treaties in which Vietnam is a member. The letter of attorney must satisfy requirements regulated at the Article 6 of this Circular.
Certificate of free sale (CFS) is only applied for import cosmetic product proclamation which satisfies the following requirements: (i) 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; (ii) CFS must be consul legalized according to provisions of the law, except consul legalization immunity case according to the international treaties in which Vietnam is a member.

Depending on type of cosmetic, Vietnam law requires different competent state management agencies responsible for receiving dossier of cosmetic announcement. Regarding to the export cosmetic, the medicine Management Bureau – the Ministry of Health is responsible for receiving proclamation dossier. Regarding to the cosmetic produced by domestic organizations, individuals, organizations or individuals who are responsible for bringing cosmetic into market shall apply the cosmetic product proclamation dossier at the Department of Health in which production factory is located. The note is that the product which is produced, packed from the import semi finished products shall be considered domestic produced products.

The results of handling the cosmetic product proclamation dossier is that the competent state agencies shall issue or refuse to grant the number of receiving the cosmetic product proclamation report.

The receipt number of cosmetic product proclamation report shall be valid for 05 years since issuing day. After 05-year-expiry, if organizations or individuals want to continue selling product in the market, they must make a proclamation again before the expiry of the receipt number of cosmetic product proclamation report and pay a regulated cost fee.

Cosmetic Advertising

The cosmetic advertising is implemented on the public device i.e. television, radio, internet, book, newspaper, magazine, pamphlet, pano, poster, air body, water body, or the other advertising means which are implemented or supported or authorized by the cosmetic enterprise organization as well as the seminar, the information, the product introduction activities.

Organizations are allowed to advertise or organize the seminar and the cosmetic product introduction event when having the permission according to the regulations.The cosmetic advertising content must be appropriate which affirm the safety and the efficiency of the cosmetic and be obedient to the ASEAN's instruction of declaring quality of the cosmetic product.

The registration dossiers of cosmetic advertising, seminar organization, and cosmetic introduction event are inclusive of the following documents:

The registration applying of cosmetic advertising, seminar organization, and cosmetic introduction event;

The copy of the issued cosmetic product proclamation report (sealed by organization or individual who registers to advertise);

The copy of the business registration certificate of organization or individual who registers to advertise (sealed by organization or individual who registers to advertise);

The authorization letter of organization or individual who proclaims cosmetic for organization or individual who registers for advertisement, cosmetic introduction event, seminar operation (in case, organization or the individual who registers for advertisement, cosmetic introduction event, seminar operation is not organization or individual who proclaims cosmetic);

The subtitles materials of the product's properties and utilities in case the advertised content and the presented content at the seminar or the cosmetic introduction event show the cosmetic's properties and utilities which are outside the presented content in the cosmetic product proclamation report;

Advertisement scenarios (scenario must clearly describe the picture, callouts and music which are going to be put into the advertisement) or advertising models which are going to be published (applied to the cosmetic advertisement registration file) or documents intend to show, publish in the seminar, cosmetic introduction event (applied to the cosmetic introduction event, seminar operation registration file). The file must get the joint pages stamp of organization or the individual who registers for advertisement, cosmetic introduction event, and seminar operation.

The authority of receiving and handling registration file of cosmetic advertising is the Health Department of place where the main office of organizations, individual proclaiming cosmetic products is located; except advertising forms which are under the licensing competence of provincial/municipal Culture and Information Services.

After receiving the file receipt of cosmetic advertising registering, if the organization wish to advertise on other advertising devices under local authorities of places different from the place where advertisement registration file is sent, must send an announcement in writing with the notarized copy of the regular cosmetic registration file receipt and all registered equivalent advertising content to the local Health department where the advertising is going to be put into process before advertisement implementation at least 03 working days.

Cosmetic product information dossier

Vietnam Law provides that every cosmetic product must get a Product Information File (PIF) when delivered to the market in accordance with ASEAN's instruction which is saved at the address of organizations or individuals who are responsible for putting the product on the market.

The Product InformationFile involves of the following 04 parts: administrative documents and a summary of product; material quality; product quality and safety and efficiency.

The administrative documents and the summary of product of the Product Information File must immediately be presented to the agency of Consideration, Investigation when required; others, if inefficiently, must be presented within 15-60 days since the consideration day in regard to the Functional agency’s request.

Export and import of cosmetic

(1) For exporting cosmetic

Export of cosmetic must be implemented at the Customs agency in accordance with the current law regulation and the import country's requirements.

The exporter needs to obtain the Certificate of Free Sale (CFS) as regulated. CFS is issued when such domestic cosmetic is issued the cosmetic product proclamation receipt number by competent state management agency. Moreover, the export trader must register the trader file at the Health department where have cosmetic manufacturing plant and make CFS issuing procedure for export cosmetic goods.The Health department in central-affiliated cities and provinces are competent agencies in issuing and managing CFS of export cosmetics which are manufactured in that area (where the manufacturing plant is placed).The CFS issuing request file includes:

The CFS issuing request must be fully regularly enumerated;
The copy of the cosmetic product proclamation report has been issued the receipt No (the copy sealed by trader who suggest for the CFS granting).

(2) For importing cosmetic

Enterprises are only allowed to import the cosmetic into Vietnam when presenting to the Customs agency thevalid receipt number of cosmetic product proclamation report which has been issued by the Medicine Management Department – the Health Ministry. However, Vietnam law also provide import of cosmetic in some special situations which are not obligated to implement the cosmetic product proclamation as the following:

Organization or individual who imports cosmetic in order to study and experiment;
The organizations, individuals who receive cosmetic as gifts;
The organizations, individuals who imports cosmetic for displaying at fair, gallery and other temporary import for re-export situations.

The obligations for manufacturers and importers

The manufacturers and importers who are responsible for putting cosmetic on the market have the obligations as the following:

Be responsible for all contents declared in the cosmetic product proclamation report, for the safety, the efficiency, and the quality of the product; and guarantee that the circulated products satisfy all requirements of the ASEAN Cosmetic Treaty and the Appendix of Vietnam law;
Follow, discover, and confiscate immediately the unqualified cosmetic, as well as implement the confiscation announcement from the state authority office and inform to the state authority office about the confiscation; punctually deal with the consumer's complaints of the cosmetic's quality and compensate for consumer's loss in accordance with the regulation; refund to the buyer the produced cost in the maintenance, transportation, and circulation process;
Report to the Medicine Management department – the Health Ministry within 07 days since the date receiving the first feedback from this side-effect in case finding side-effects which are serious and could damage the consumer's life because of the cosmetic product's quality;
File the Product Information File (PIF) in at least 03 years since the latest manufacture lot is put on the market and presented to the checking and inspecting functional office when requested;
Obey the Vietnamese Regulation and Law on the intellectual ownership. When having the conclusion of the state competent offices on the intellectual-ownership law-breaking label and industrial design, the organizations, the individuals must stop manufacturing, trading, and importing in order to conduct of changing the label and the industrial design as provided, and be responsible for refunding and resolving all damages (if any).

Besides, Vietnam law also provides that the organizations which manufacture the cosmetic must deploy to apply and satisfy principles, the "cosmetic good manufacturing practice" standard of the Asian Southeast Association Nations (CGMP-ASEAN).

Last but not least, the organizations, the individuals must conduct requirements of state competent offices about checking and inspecting the cosmetic quality, confiscating the violated cosmetics, and be entitle to complaints about the conclusion and the law-breaking judgment form in accordance with the law regulation on the complaint and the denouncement.

Checking, investigating and handling of violations

The cosmetic quality checking central agency is the Vietnam Medicine Management Department – the Ministry of Health. The Medicine Management Department coordinates with the inspector of the Health Ministry, the Medicine Analyzing Central Institute, Medicine departments of centrally – affiliated cities and provinces in order to carry out and supervise the post – sale promotion activities in regard to the cosmetic product. On the cosmetic analyzing result of the analyzing state agencies, the Medicine Management Department – the Ministry of Health is the agency who controls cosmetic quality in Vietnam.

The local cosmetic quality – checking agency is the Health Department of centrally – affiliated cities and provinces. The Health Departments of centrally – affiliated cities and provinces organize to carry out the post – sale promotion activities on the domestic cosmetic, the import cosmetic which is delivered in their area, and handle problems in relation to the cosmetic quality according to the law regulations; report on statistic of the cosmetic quality management situation in their localities

For the checking and inspecting form, Vietnam law provides two forms: the scheduled check and inspection and the ad-hoc check and inspection. The ad-hoc check and inspection shall be made when discovering the products which are unqualified, don’t obey provisions for being sold on the market, or because of the customer's complaints. In urgent cases, the competent agency has right of check and inspect without warning.

The check and inspection include contents as the following:

Check and inspection the obedience of laws on the cosmetic production and the trading, including: (i) the obedience of principle and standards of "cosmetic good manufacturing practice" of the Asian Southeast Association Nations (CGMP-ASEAN) or equivalence which are admitted by the ASEAN Cosmetic Association; (ii) the label writing; (iii) the Product Information File (PIF) regulated by the ASEAN; (iv) the cosmetic advertising;
The check and inspection of solving the dispute, the complaint, the denouncement on the quality and other contents related to the cosmetic (if any);
The check and inspection of implementing announcement of confiscation the cosmetic in regard to the regulation (if any).

The priority order in checking and supervising the post – sale promotion is based on the product's kind, origin source, label, company's brand name, formula ingredients.