1. Definition of cosmetics and important terms
1.1 Definition of cosmetics
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. Comparing the above regulations with the regulations in Article 2.1 Schedule B – ASEAN Cosmetics Decree, ASEAN Cosmetic Management Harmonization Agreement, Vietnamese law has certain adjustments. However, in terms of overall meaning and understanding, this regulation corresponds to the provisions of the ASEAN Cosmetic Management Harmonization Agreement.
The area and method of use of cosmetic products are limited to contact with external body parts. The primary purpose of use is to clean, perfume, change appearance, shape, regulate body odor, protect the body or keep the body in good condition. A cosmetic product can fulfill one or more of the above purposes. Intended use is closely related to the evaluation of cosmetic product features. Currently, there are many cases where products have special features, such as products that border drugs, cosmetics, medical equipment, and antibacterial chemicals, leading to confusion in product classification. Evaluating and determining the product type are significant in complying with current legal regulations, such as the subject’s conditions when participating in one and/or several of these activities processes such as production, distribution, purchase, and sale of products and product circulation conditions.
1.2 Some important terms
- 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.
- Cosmetic Product Owner is an organization or individual which owns formulas, process of production, standards of the product quality.
- The receipt number of Cosmetic product proclamation is a number issued by the competent state management agency, when receiving the cosmetic product announcement dossier.
- The announcement receipt number is useful in order to prove cosmetic product have been declared by organizations, individuals who are responsible for circulation products in market, just about cosmetic shall be circulated in market, are not value to certify that such product have been guaranteed of the safety, the effectiveness, and meeting all requirements of the ASEAN Cosmetic Association and the Annexes attached.
- Cosmetic circulation is the display operation, transportation, and saving of goods in the goods selling or buying process, except case of transportation import goods of organizations, individuals from border gate to storehouse.
- Certificate of free sale (CFS) is a certify issued by an authority agency in the export country for the export domestics trader stated in CFS to confirms that the cosmetic is freely produced and sold in the export country.
2. Regulations of cosmetic product proclamation
2.1 Obligation to proclaim cosmetic products
To put cosmetic products into circulation, including domestically produced or imported cosmetics, the entity responsible for proclaiming the product is the organization or individual responsible for putting the cosmetic products to market. This means that the product owner and the organization responsible for putting the product to market can be the same entity or independent parties. Establishing agreements, delineating rights and responsibilities, and limiting liability in cooperation contracts between parties are also issues that parties need to consider carefully.
Organizations or individuals who are responsible for putting the products on the market must have the function of cosmetic business in Vietnam.
Carrying out proclamation procedures is mandatory and a prerequisite before putting the product into circulation. Circulation will be carried out when the cosmetic product has been issued a receipt number for the Cosmetic Product Proclamation Form by the competent authority.
Organizations and individuals responsible for putting cosmetic products to market must be fully responsible for the product’s safety, effectiveness, and quality.
Competent authorities will conduct after-sale inspections when products circulate on the market.
2.2 Product information file
Organizations and individuals responsible for putting products to market are obliged to create and store product information files (PIF – Product Information File).
Corresponding to each cosmetic product put into circulation, the organization or individual responsible for putting the product to market must prepare and store the quantity of the cosmetic product.
Regarding content, the preparation of product information records must comply with ASEAN guidelines and be kept at the address of the organization or individual responsible for putting the product to market.
The cosmetic product information profile includes 04 parts as follows:
| Part 1 |
Administrative documents and a summary of product
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Administrative documents:
- A copy of the cosmetic product proclamation form with the receipt number of the competent authority.
- Power of authorization from the manufacturer or product owner or letter of agreement related to the product.
- Certificate of Free Circulation – CFS.
- Other relevant administrative documents, such as the Business Registration Certificate or Investment License of the organization or individual responsible for putting the product to market.
- Ingredients and percentages of all ingredients in the formula.
Label and product information:
- Label of product.
- Instructions for use (if any).
- Production announcement:
Manufacturer’s declaration that the product is manufactured in accordance with the principles and standards of “Good Cosmetic Manufacturing Practices” of the Association of Southeast Asian Nations (CGMP-ASEAN) or equivalent.
- The system records batch numbers/product codes.
- Cosmetic product safety assessment: Safety announcement (with concluding comments with signature, name and certificate of the assessor).
- Summary of unwanted effects on humans (if any).
- Documents explaining the features and uses of cosmetic products (summary): Report on evaluating the features and uses of the product based on ingredients and test results.
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Part 02
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Material quality |
Quality standards and testing methods of raw materials. For flavor ingredients, clearly state the name and flavor code, supplier name and address, and commit to complying with the guidelines of the International Fragrance Association (IFRA).
Safety data of raw materials is based on information from suppliers, published data or reports from scientific committees (ACSB, SCCP, CIR).
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| Part 03 |
Product quality
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Product formula:
Record the full names of ingredients according to international nomenclature and the percentage of ingredients in the formula. Clearly state the uses of each ingredient.
Manufacturer:
Detailed information about the manufacturer: country, manufacturer name and address, packer.
Summary of the production process:
Additional detailed information about the production process, quality control and related production records should be prepared depending on the regulatory agency’s requirements.
Standards and testing methods of finished products:
Criteria used to check microbiological limits in finished products;
Test methods corresponding to quality standards to check the level of achievement;
Summary report on product stability (for products with a shelf life of less than 30 months): Report and data on stability research or stability assessment to explain the product’s shelf life.
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Part 04
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Safe and effective |
Safety assessment: Report assessing the human safety of the finished product based on the ingredients in the formula, the chemical structure of the ingredients and the harmful threshold (with name and signature of the assessor).
Product safety assessor’s resume.
Newest reports on side effects or unwanted effects (if any), are updated regularly.
Documents explaining the product’s features and uses published on the product packaging: Full report on the evaluation of the product’s features and uses based on ingredients and test results (with name and signature) of the auditor).
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2.3 Cosmetic product proclamation dossier
- A cosmetic product proclamation form;
- Authorization letter;
- Certificate of free circulation (CFS) for imported cosmetic products.
2.4 Order and procedures for proclaiming cosmetic products
Competent state authority is responsible for handling:
- For imported cosmetics: Drug Administration – Ministry of Health.
- For domestically produced cosmetics: Department of Health, where the manufacturing factory is located.
Note: Cosmetic products produced and packaged from imported semi-finished products are considered domestically produced products.
Assessment timeline:
Within 03 working days from the date of receiving the valid proclamation dossier and the state fee according to regulations, the competent authority is responsible for issuing the receipt number of the Cosmetic Product Proclamation Form.
If the dossier does not meet the regulations, within 05 working days from the date of receiving the dossier, the authority shall notify the publishing organization or individual in writing of the contents to request amendment and supplement the dossier.
Notes:
Within 03 months from the date of issuance of the notification document guiding amendments and supplements, the announced dossier is no longer valid if the competent authority does not receive the additional dossier.
2.5 Fees and charges
Cosmetic product proclaimation appraisal fee: 500,000 VND/01 dossier.
3. Changes to published content
Regarding to cosmetic products have already been declared and issued the receipt number of cosmetic product proclamation report, when have any change of content provided at Appendix 05-MP, organizations or individuals who are responsible for putting product on the market must establish a document to suggest supplementing (regarding to content which don’t need make a new proclamation), attached with data related to the supplementing content and must be permitted in writing by competent state agency or implement a new proclamation in regard to the regulation (regarding to contents need make a new proclamation).
4. The effect time of the receipt number of 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.
5. Confiscating the cosmetic product proclamation receipt number
The cosmetic product proclamation receipt number is confiscated in one of the following situations:
The circulated cosmetic gets two unqualified lots which are concluded by the Government’s Cosmetic Quality Management Office;
The circulated cosmetic gets the formula which is not exact as the proclaimed one in the file;
The circulated cosmetic gets the label in which the origin and the source are written erroneously;
The circulated cosmetic gets the label in which the cosmetic existing properties are written erroneously;
The cosmetic unsafe for the consumer;
The cosmetic which contains the prohibited substance, or the concentration, the content exceeds the permissible level;
The cosmetic which is concluded of breaking the intellectual ownership right or falsifying another delivery-permissible product’s label;
The product which is prohibited in the current country;
The organizations or the individuals who put the cosmetic to the market gives out a request document of confiscating the cosmetic product proclamation receipt No;
No Product Information File (PIF) for presenting to the Authority Office;
Forging the document, using fake seal or forging the signature, the seal of the Authority Office of Vietnam or foreign country, of the manufacturer or the product owner;
Dishonest declaring about contents referred in the cosmetic proclamation receipt.
6. Suspending the cosmetic circulation and confiscation
The cosmetic which is suspended circulation and confiscated when one in two following situations happens:
The cosmetic which is put into the market has not yet been issued with a cosmetic proclamation receipt No by the Government’s Authority Office;
The cosmetic which is unqualified or unsafe for the consumer;
The delivered cosmetic gets the formula which is written not exact as the proclaimed in the file;
The cosmetic which contains the prohibited substance, or the concentration, the content exceeds the permissible level;
The circulation of cosmetic which gets a inappropriate usage label compared to the proclamation file or is unsatisfying the regulation in writing on the label of this Circular; dependent on the level of violation, the product can be suspended of circulation and confiscated;
The circulation of cosmetic is produced at a factory which is unsatisfying the regulation, “cosmetic good manufacturing practice” standard of the Asian Southeast Association Nations (CGMP-ASEAN) or the ASEAN Cosmetic Association equivalent admits; dependent on the level of violation, the product can be suspended of deliver and confiscated;
The expired or over-expired cosmetic in accordance with the producer’s warning;
The countterfeit, illicitness-imported, unclear-sourced, origin, and imperfection-packaged product;
The cosmetic is voluntarily confiscated in written by organization or individual who is responsible for putting it on the market.
7. The obligation of the organization, the individual who manufacture, trade, and import the cosmetic in order to put them on the Vietnam market
- Be responsible for putting cosmetic on the market, must be responsible for all contents declared in the cosmetic product proclamation report, for the safety, the efficiency, and the quality of the product; as well as guarantee that the circulated products satisfy all requirements of the ASEAN Cosmetic Treaty and the attached Appendixes.
- Be responsible to follow, to discover, and to 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.
- In case finding side-effects which are serious and able to damage the consumer’s life because of the cosmetic product’s quality, the organizations, the individuals who put the cosmetic on the market must report to the Medicine Management department – the Health Ministry within 07 days since the day or receiving the first feedback from this side-effect in accordance with the version at Appendix No 18-MP. The announcement in detail on this serious side-effect must be sent back to the Medicine Management department – the Health Ministry within next 08 days.
- The organizations, the individuals who put the cosmetic on the market must save 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 is requested.
- 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).
- The organizations, the individuals who business on the cosmetic must conduct requirements of state competent offices about checking and inspecting the cosmetic quality, confiscating the violation cosmetics, and be entitle to complain about the conclusion and the law-breaking judgment form in accordance with the law regulation on the complaint and the denouncement.
- The organizations, the individuals who put the cosmetic on the market must 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-style, The organizations, the individuals must stop manufacturing, trading, and importing in order to conduct of changing the label and the industrial style as provided, and be responsible for refunding and resolving all damages (if any).
Disclaimers:
This article is for general information purposes only and is not intended to provide any legal advice for any particular case. The legal provisions referenced in the content are in effect at the time of publication but may have expired at the time you read the content. We therefore advise that you always consult a professional consultant before applying any content.
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