Quyết định 48/2007/QD-BYT

DECISION

PROMULGATING THE REGULATION ON MANAGEMENT OF COSMETICS

THE MINISTER OF HEALTH

Pursuant to the Governments Decree No. 49/2003/ND-CP of May 15, 2003, defining the functions, tasks, powers and organizational structure of the Ministry of Health;
Pursuant to December 24, 1999 Ordinance No. 18/1999/PL-UBTVQH10 on Goods Quality;
Pursuant to the Governments Decree No. 179/2004/ND-CP of October 21, 2004, stipulating the state management of goods quality;
Pursuant to the Governments Decree No. 89/2006/ND-CP of August 30, 2006, stipulating goods labels;
Pursuant to the Governments Decree No. 24/2003/ND-CP of March 13, 2003, detailing the implementation of the Advertisement Ordinance;
Pursuant to the Governments Decree No. 12/2006/ND-CP of January 23, 2006, detailing the implementation of the Commercial Law regarding international goods purchase and sale, purchase and sale agency, processing and transit of goods with foreign countries;
Pursuant to the September 2, 2003 Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme;
At the proposal of the Director of the Drug Administrator of Vietnam,

DECIDES:

Article 1. To promulgate together with this Decision the Regulation on management of cosmetics.

Article 2. This Decision takes effect 15 days after its publication in CONG BAO and annuls the Health Ministers Decision No. 35/2006/QD-BYT of November 10, 2006, promulgating the Regulation on management of cosmetics and Decision No. 13/2007/QD-BYT of January 30, 2007, amending Article 2 of the Health Ministers Decision No. 35/2006/QD-BYT of November 10, 2006, promulgating the Regulation on management of cosmetics, and Decision 3113/1999/QD-BYT of October 11, 1999, promulgating standard limits of bacteria and molds in cosmetics and methods of skin reaction test.

This Decision replaces the provisions on information and advertisement on cosmetics directly affecting human health issued together with the Health Ministers Decision No. 2557/2002/QD-BYTof July 4, 2002, promulgating the Regulation on information and advertisement on medicines for human use and cosmetics directly affecting human health; provisions on labeling of cosmetics directly affecting human health issued together with the Health Ministrys Circular No. 14/2001/TT-BYT of June 26, 2001, guiding the labeling of medicines and cosmetics directly affecting human health; and provisions on import and export of cosmetics issued together the Health Ministrys Circular No. 06/2006/TT-BYT of May 16, 2006, guiding the import and export of medicines and cosmetics.

Article 3. The director of the Office, the chief inspector of the Ministry of Health, the director of the Drug Administration of Vietnam, heads of units attached to the Ministry, directors of provincial/municipal Health Services, and heads of health agencies within all branches shall implement this Decision.

REGULATION

ON MANAGEMENT OF COSMETICS
(Promulgated together with the Health Ministers Decision No. 48/2007/QD-BYT of December 31, 2007)

Chapter 1

GENERAL PROVISIONS

Article 1. Scope of regulation and subjects of application

This Regulation provides the management of cosmetic products that are manufactured in the country and cosmetics that are imported for circulation in Vietnam.

This Regulation applies to all organizations and individuals engaged in manufacturing, importing, trading in, importing and exporting cosmetics for trading in Vietnam.

Article 2. Interpretation of terms

In this Regulation, the terms below are construed as follows:

1. Cosmetic product means a substance or preparation used in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth, gums or mucous membranes of the oral cavity for exclusively or mainly cleaning them, perfuming them, changing their appearance or the body odor and/or protecting or preserving them in good conditions.

2. Organization or individual responsible for placing a product on the market means a manufacturer, importer or registered agent responsible for the imported goods or distributing that cosmetic product in the Vietnamese market, specifically:

a/ For domestically manufactured cosmetics, it is the organization or individual manufacturing that cosmetic product.

b/ For cosmetics imported for circulation in Vietnam, it is the organization or individual notifying the cosmetic product it/he/she directly imports or authorizing another organization or individual to import that cosmetic product.

c/ For cosmetics directly imported into Vietnam by an organization or individual acting as a direct sale agent for a foreign trader, it is the organization or individual acting as a sale agent for that cosmetic.

3. Product stability means the stability capability of a product which is preserved in appropriate conditions to maintain its original characteristics, especially guaranteeing safety-requirements.

4. Name of a cosmetic means the name given to a cosmetic product, which may be an invented name, together with a trade mark or the name of the manufacturer.

5. Cosmetic packaging specification (goods quantity) means the quantity of cosmetic expressed in net weight, real volume or number.

6. Cosmetic label means a written, printed, drawn and photographed letter, drawing and image directly glued, printed, pinned, cast, embossed or carved on goods or merchandise package of goods or on other materials affixed to the goods or merchandise package of goods.

7. Cosmetic labeling means the display of basic and necessary information on a cosmetic product on its label for users to recognize the product, select and properly use it; for manufacturers and traders to advertise their goods, and as a basis for functional agencies to conduct examination and control.

8. Original label means a primary label affixed on the merchandise package of cosmetics.

9. Auxiliary label means a label displaying the mandatory contents in Vietnamese translated from the foreign-language original label, added with mandatory contents in Vietnamese required by this Regulation which the original label still lacks.

10. Merchandise package of cosmetics means a package containing cosmetics and circulated together with cosmetics. There are two kinds of merchandise package of cosmetics, immediate package and outer package.

a/ Immediate package means a package containing goods, immediately in contact with goods, forming a cubic shape or tightly wrapping the cubic shape of goods.

b/ Outer package means a package used to wrap one or more than one unit of goods with immediate, package.

11. Cosmetic circulation means displaying, transporting and storing goods in the process of goods trading, except the case of goods transportation by goods importing organizations and individuals from a border gate to a storehouse.

12. Manufacturers batch number means a symbol expressed in numbers or letters or a combination of both numbers and letters to enable identification of a product batch and permit tracing of the entire history of a product batch covering all stages of the manufacturing process, quality examination and distribution of that batch.

13. Date of manufacture means the time of completing the manufacture, processing, packing or other forms in order to finish the final stage of a product lot.

14. Expiry date means the time set for a cosmetic batch after which the cosmetic is prohibited from circulation.

15. Best before a date means the time recommended by the manufacturer before which the product should be used to guarantee its optimal quality.

16. Origin of cosmetics means a country or territory in which cosmetics are wholly manufactured or in which the final and basic processing stage is carried out for cosmetics of which the manufacturing process involves many countries and territories.

17. Use instructions means necessary information to guide users how to use cosmetics safely and properly. Use instructions may be printed on immediate packages or documents attached to merchandise packages of cosmetics which show use instructions and other contents as prescribed.

18. Cosmetic advertisement means introducing and promoting cosmetics in order to speed up the manufacture, sale and/or use of cosmetics.

19. Cosmetic introduction seminar/event means a meeting to introduce and discuss with consumers on specialized issues related to cosmetics.

20. Advertiser means an organization or individual wishing to advertise cosmetics which it/he/she manufactures or distributes.

21. Advertisement carrier means an organization or individual running cosmetic advertisement products to consumers, including press agencies, publishers, computer network management organizations, organizers of cultural and sports programs, fairs and exhibitions, and an organization or individual using other means of advertisement.

22. ASEAN Cosmetic Committee means a body representing the ASEAN member countries to oversee, decide and resolve disputes related to the implementation of the ASEAN Cosmetic Agreement.

Chapter II

NOTIFICATION OF COSMETIC PRODUCTS

Article 3. Organizations and individuals responsible for placing cosmetic products in the market are responsible for notifying cosmetic products at the Drug Administration of Vietnam according to a set form (Appendix No. 01-MP) before circulating products on the market. These organizations and individuals may only place products in the market after making such notification and having it accepted by the Drug Administration of Vietnam (obtaining a cosmetic product notification number) and shall take full responsibility for the safety and effectiveness of marketed cosmetic products and comply with the provisions of Vietnamese law.

Article 4. Organizations and individuals that undersign cosmetic notification dossiers must have business registration certificates showing their cosmetic trading function.

Article 5. Organizations and individuals that undersign cosmetic notification dossiers shall submit such dossiers together with a copy of the business registration certificate or investment license (for the first-time notification) and notified data in softcopy. Dossiers and documents may be submitted directly or sent by mail to the Drug Administration of Vietnam. The Drug Administration of Vietnam shall issue a dossier receipt number within 3 working days after receiving a valid notification dossier and a notification fee according to the current provisions of Vietnamese law.

Article 6. Language used in notifications

Notifications submitted to the Drug Administration of Vietnam must be in Vietnamese and/or English (according to Form No 01-MP).

Article 7. Three copies of a notification must be submitted for each cosmetic product. After issuing a receipt number, the Drug Administration of Vietnam shall keep 02 copies for filing and return 01 copy to the submitting unit. In the following cases, cosmetic products may be notified in a single notification:

1. Products packaged under a common name and sold in a product kit.

2. Products with similar formulas but different colors or odors.

3. Different products packaged in a single package like a packaging unit.

4. Other cases to be decided by the Drug Administration of Vietnam pursuant to the decision of the ASEAN Cosmetic Committee.

Article 8. When changing any notified detail specified in Appendix No. 4-MP of this Regulation, organizations and individuals shall send a new notification to the Drug Administration of Vietnam and pay a fee as prescribed.

Article 9. A receipt number for a cosmetic quality notification dossier is valid for three years. Organizations and individuals shall make a re-notification at least 01 month before the dossier receipt number expires and pay a fee as prescribed.

Chapter III

REQUIREMENTS ON PRODUCT SAFETY

Article 10. Organizations or individuals responsible for placing products in the market shall ensure that their products are not harmful to human health when used under normal conditions or instructed appropriate conditions suitable to the form of preparation, label information, use instructions, special caution and other information supplied by the manufacturer or an authorized place or the person responsible for circulating products in the market.

Manufacturers shall evaluate the safety of each cosmetic product under the ASEAN cosmetic safety evaluation guidance.

Article 11. Organizations and individuals placing cosmetic products in the market shall ensure that their products do not contain ingredients specified in the following annexes to the ASEAN Cosmetic Agreement:

1. Substances banned from use in cosmetics, listed in Annex II.

2. Substances listed in the first part of Annex III, beyond the limits or outside the conditions permitted.

3. Other coloring agents listed in Annex IV, Part 1 with the exception of cosmetic products containing coloring agents intended solely to color hair.

4. Coloring agents listed in Annex IV, Part 1 used outside the specified conditions, with the exception of cosmetic products containing coloring agents intended solely to color hair.

5. Preservatives other than those listed in Annex IV, Part 1.

6. Preservatives listed in Annex VI, Part 1 beyond the limits and outsides the conditions permitted, unless they are used for special purposes not related to the function of preservatives.

7. UV filters other than those listed in Annex VII, Part 1.

8. UV filters listed in Annex VII, Part 1 beyond the limits or outside the conditions permitted.

The presence of traces of substances listed in Annex II is permitted provided that such presence is technically unavoidable in good cosmetic manufacturing practice and ensures cosmetic safety requirements stated in Article 10 of this Regulation.

Article 12. Cosmetic products containing the following ingredients may be permitted for marketing

1. Ingredients or materials listed in Annex III, Part 2, within the limits and under the conditions stated, until the date specified in column g of this Annex.

2. Coloring agents listed in Annex VI, Part 2 within the limits permitted and the conditions accepted, until the date specified in this Annex.

3. Preservatives listed in Annex VI, Part 2 within the limits and under the conditions accepted, until the date given in column f of this Annex. However, some of these ingredients may be used with other concentrations for specific purposes clearly stated in the presentation of the product.

4. UV filters listed in Part 2 of Annex VII, within the limits permitted and the conditions stated, until the date given in column f of this Annex.

By the lime fixed by the ASEAN Cosmetic Committee, ingredients, coloring agents, preservatives and UV filters shall be:

a/ Allowed for use in cosmetics.

b/ Definitely prohibited (Annex II).

c/ Maintained for a given period specified in Part 2 of Annexes III, IV and VII.

d/ Removed from all the Annexes, on the basis of available scientific information or because they are prohibited from use.

Chapter IV

COSMETIC LABELING

Article 13. Positions of cosmetic labels

1. Cosmetic labels must be affixed onto goods and merchandise packages of goods in positions which enable easy and full observation of the prescribed contents of labels without having to detach details and parts of goods.

2. In case outer packages must not or cannot be opened, labels with all compulsory contents must be affixed onto outer packages.

Article 14. Sizes and contents of labels

Organizations and individuals responsible for placing cosmetic products in the market shall ensure that information printed on labels can be read with naked eyes. Contents of labels and auxiliary labels (if any) must be truthful, clear, accurate and true to product properties.

Article 15. Colors of letters, numerals, drawings, images, signs and symbols presented on labels must be clear. Colors or letters and numerals must contrast with the label background.

Article 16. Organizations or individuals responsible for placing products in the market shall ensure that product labels comply with the cosmetic labeling requirements of the ASEAN Cosmetic Agreement. The following contents must he indicated on product packages:

1. The name of the product and its function, unless it is clear from the presentation of the product.

2. Use instructions, unless it is clear from the presentation of the product.

3. Full ingredient listing. Material ingredients must be written in descending order of weight at the time they are added. Perfume and aromatic compositions and their materials may be referred to by the word huong lieu (aroma or flavor). Ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of more than 1%. Coloring agents may be listed in any order after the other ingredients, in accordance with the color index (CI) number or denomination adopted in Annex IV of the ASEAN Cosmetic Agreement. For decorative cosmetic products marketed in several color shades, all coloring agents used in the range may be listed, provided that the terms may contain or +/- be added.

The ingredients shall be specified using the nomenclature from the latest edition of standard references: International Cosmetic Ingredient Dictionary; British Pharmacopeia; United States Pharmacopeia; and Chemical Abstract Services. Botanicals and extracts of botanicals must be identified by its line, genus and species. The genus may be abbreviated.

The following substances shall not be regarded as cosmetic ingredients:

a/ Impurities in the raw materials used;

b/ Subsidiary materials used for technical purposes but not present in the final products;

c/ Materials used in large quantities as solvents, or as carriers, for perfume and aromatic compositions.

4. Country of manufacture.

5. The name and address of the organization or person responsible for placing the product in the market.

6. The contents given by weight or volume, in either metric or both metric and imperial system.

7. The manufacturers batch number;

8. The manufacturing or the expiry date of the product in clear terms (e.g. date/month/year). The date must be clearly expressed and consist either of the month and year or the day, month and year in that order. The words expiry date or best before may be used. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the product stability.

Indication of the expiry date is mandatory for cosmetic products the stability of which is less than 30 months.

9. Special precautions to be observed in use, especially those listed in the column Conditions
of use and warnings which must be printed on the label in the Annexes to the ASEAN Cosmetic Agreement, which must appear on the label as well as any special precautionary information on the cosmetic products.

Article 17. Languages used to present cosmetic labels prescribed in Article 16 of this Regulation must be English and/or Vietnamese. Information in Clauses 2, 5 and 9 of Article 16 must be in Vietnamese.

Article 18. In case the size, shape or material of a package does not permit full display of the information specified in Article 16 of this Regulation, auxiliary labels may be used. However the following information must appear on immediate packages:

1. The name of the product.

2. The manufacturers batch number;

Article 19. Other contents indicated on cosmetic labels

Organizations and individuals may display other contents on cosmetic labels. These contents must not be contrary to law and must be truthful, accurate and true to the nature of goods, must neither hide nor mislead mandatory label contents.

Chapter V

COSMETIC INFORMATION AND ADVERTISEMENT

Article 20. Cosmetic advertisement may be conducted on the mass media such as television, radio, books, magazines, leaflets, panels, posters, aerial objects, aquatic objects or other means of advertisement by cosmetic trading establishments or their authorized or funded establishments.

Article 21. Cosmetic advertisement contents must be consistent with documents proving the safety and effectiveness of cosmetics and compliant with the ASEAN guidance on notification of characteristics of cosmetic products.

Article 22. A cosmetic advertisement must fully contain the following contents:

1. The name of the cosmetic (given by the manufacturer).

2. Uses (specifying major uses of the cosmetic which are not indicated in the name of the product).

3. The name and address of the organization or individual responsible for putting the cosmetic product in the market.

4. Precautions to be observed in use (if any).

Article 23. When advertising cosmetics on television or radio, the information specified in Clauses 1 and 4 of Article 22, and the name of the organization or individual responsible for putting the product in the market must be read loudly and clearly.

Article 24. Advertisement on the press and leaflets

At the bottom of the first page of a cosmetic advertisement document must be printed: a/ The number of the advertisement registration dossier receipt issued by the provincial-level Health Service...; xxxx/xx/YT-QC, date... month... year, b/ date... month... year of printing, and c/ place of printing.

Article 25. Contents of cosmetic introduction seminars/events must fully cover the following information:

1. The name of the cosmetic product.

2. Uses (unless already indicated in the name of the product).

3. Special precautions to be observed in use.

4. Instructions for use (unless clearly indicated in the name of the product).

5. The name and address of the organization or individual responsible for putting the cosmetic product in the market.

Article 26. Competence to receive and process cosmetic information and advertisement dossiers

The Ministry of Health authorizes the Health Services of provinces and centrally run cities (except for forms of advertisement regulated by Joint Circular No. 06/2007/TTLT/BVHTT-BYT-BNN-BXD of February 28, 2007, of the Ministry of Culture and Information, the Ministry of Health, Ministry of Agriculture and Rural Development and the Ministry of Construction, guiding the procedures for granting advertisement permits under the inter-agency one-stop-shop mechanism to perform the following tasks:

1. Receiving and processing cosmetic advertisement registration dossiers.

2. Receiving and processing cosmetic introduction seminar/event registration dossiers.

Article 27. Receipt and processing of cosmetic advertisement registration dossiers

1. Cosmetic trading establishments in Vietnam wishing to advertise cosmetic products shall send cosmetic advertisement dossiers to the Health Services of the places where the head offices of cosmetic product-notifying organizations or individuals are located. On the envelope containing such a dossier must be written: cosmetic advertisement registration dossier.

2. A cosmetic advertisement registration dossier comprises:

a/ The cosmetic advertisement registration paper (made according to a set form).

b/ A copy of the business license of the company applying for an advertisement permit.

c/ A letter of authorization issued by the cosmetic-notifying company to the advertisement-registering company (in case the advertisement-registering company is other than the company which has notified cosmetic quality standards).

d/ A company that registers a radio or television advertisement shall enclose the dossier with the following documents:

The script, video tape, audio tape and other information-storing devices; the script must clearly describe the image, story and music;

The television and/or radio station(s) expected to carry the advertisement and their telephone and fax numbers.

e/ All documents of a dossier must be appended with a stamp on every adjoining pages in their inner edges.

3. The order and procedures for granting advertisement registration dossier receipts: Upon receiving a complete and valid registration dossier as prescribed in this Regulation and a fee as currently prescribed, the provincial-level Health Service shall send to the submitter a cosmetic advertisement receipt (made according to a set form). The date of receipt indicated on the dossier receipt is the date the Health Service receives a valid dossier. After 10 working days from the date of receipt of the dossier, if the Health Service issues no written request for modification and supplementation, the unit may advertise its product according to the registered contents.

4. If a cosmetic advertisement registration dossier is invalid because it fails to comply with the provisions of this Regulation, the provincial-level Health Service shall issue an official letter asking the registering unit or individual to supplement and complete the dossier.

a/ The official letter must specify documents to be supplemented and contents to be modified and supplemented.

b/ The unit shall make modification and supplementation as requested and send the modified and supplemented dossier to the provincial-level Health Service. After the dossier is completed, the provincial-level Health Service shall send a dossier receipt indicating the date of receipt as the date it receives the supplemented dossier as requested. After five working days from the date of receipt of the modified or supplemented advertisement contents, if the provincial-level Health Service issues no written request for further modification and supplementation, the unit may advertise its product according to the modified contents.

c/ After 02 months, if the advertisement-registering unit neither modifies and supplements its dossier nor issues a written reply to the provincial-level Health Service, its cosmetic advertisement registration dossier will be no longer valid.

5. If the cosmetic advertisement-registering unit makes modification and supplementation not as requested in the written request for modification and supplementation, the provincial-level Health Service shall ask the advertisement-registering unit or individual not to advertise according to the registered contents. In this case, the unit wishing to advertise cosmetic products shall re-submit a dossier; the process of registering and evaluating advertisement dossiers will restart and a fee shall be paid according to regulations.

Article 28. After receiving an advertisement registration dossier receipt, if wishing to advertise on means of advertisement in a locality other than the locality where it has sent the advertisement registration dossier, the cosmetic advertisement-registering unit shall send a written notice together with a copy of the advertisement registration dossier receipt (stamped by the unit) and all relevant declared advertisement contents to the provincial-level Health Service of that locality before conducting advertisement.

Article 29. Receipt and processing of cosmetic introduction seminar/event registration dossiers

1. Before holding a cosmetic introduction seminar/event in a locality, a unit shall compile and send a dossier to the provincial-level Health Service of that locality. On the envelope containing such a dossier must be written: Cosmetic introduction seminar/event registration dossier.

2. A cosmetic introduction seminar/event registration dossier comprises:

a/ A cosmetic introduction seminar/event registration paper (made according to a set form).

b/ The (tentative) seminar or event agenda.

c/ A copy of the business license of the organizing unit.

d/ A letter of authorization issued by the cosmetic-notifying company to the company requesting permission to hold a cosmetic introduction seminar or event (in case the cosmetic introduction seminar/event-registering company is other than the cosmetic product-notifying company).

e/ Documents intended for display or distribution at the seminar/event.

f/ All documents in the dossier must be appended with a stamp on every two adjacent pages in their inner edges.

3. Upon receiving a complete and valid registration dossier as prescribed in this Regulation and a fee according to current regulations, the provincial-level Health Service shall send to the seminar registration dossier-submitting unit a dossier receipt (according to a set form). The date of receipt indicated on the dossier receipt is the date the provincial-level Health Service receives a complete and valid dossier. After 10 working days from the date of receipt of the dossier, if the provincial-level Health Service issues no written request for modification and supplementation, the unit may hold the cosmetic introduction seminar/event according to the registered contents.

4. If a cosmetic introduction seminar/event registration dossier is incomplete and invalid as prescribed in this Regulation, the provincial-level Health Service shall issue an official letter asking the registering unit to supplement and complete the dossier.

5. If the provincial-level Health Service issues a written request for modification and supplementation:

a/ The written request must specify documents to be supplemented and contents to be modified and supplemented.

b/ The unit shall make modification and supplementation as requested and send the modified and supplemented documents to the provincial-level Health Service. After the dossier is completed, the provincial-level Health Service shall send a dossier receipt indicating the date of receipt as the date it receives the supplemented dossier as requested. After five working days from the date of receipt of the modified-and supplemented advertisement contents, if the provincial-level Health Service issues no written request for further modification and supplementation, the unit may hold a seminar according to the modified contents.

6. The seminar registration dossier-sending unit shall notify at least 03 working days in advance to the provincial-level Health Service which has received the dossier of the specific venue and official time of holding the seminar if there is any change in the intended venue and time.

Article 30. Cosmetic information/ advertisement documents cease to be valid in the following cases:

1. The cosmetic product has its standard notification numbers expired.

2. The cosmetic product is recommended by a competent state agency not to be used or is recalled.

3. There are changes in information affecting the quality of the cosmetic product.

Units and individuals having cosmetic advertisement documents and information which are no longer valid shall notify concerned agencies to immediately stop distributing such information and documents.

Chapter VI

COSMETIC EXPORT AND IMPORT

Article 31. The export of cosmetics shall be conducted at customs offices according to current provisions of law and requirements of the importing countries.

Article 32. Import of cosmetics

1. Cosmetics which have been notified to the Ministry of Health (the Drug Administration of Vietnam) and cosmetics that have been granted registration numbers for circulation in Vietnam may be imported into Vietnam according to demand without any quantity or value restrictions or having to apply for import permits or certification of import statements. When carrying out import procedures, enterprises shall produce to customs offices cosmetic product notification receipts with the notification numbers issued by the Drug Administration of Vietnam. The import of cosmetics that have been granted registration numbers for circulation in Vietnam shall be conducted according to the roadmap prescribed in Article 43 of this Regulation.

2. Organizations and individuals that wish to import cosmetics for research or test shall make a statement of cosmetics to be imported for research or test (according to a set form). Samples used for research or test are not required to be notified under the provisions of this Regulation. A statement of cosmetics to be imported for research or test shall be made in three copies. After approval, two copies will be filed at the Drug Administration of Vietnam and one copy sent to the enterprise. This copy will be affixed with a stamp copy sent to enterprise for production to the border-gate customs to carry out customs clearance procedures.

Article 33. Traders may import and export cosmetics regardless of their registered business lines.

Chapter VII

EXAMINATION AND INSPECTION OF COSMETIC QUALITY

Article 34. The Ministry of Health assigns the Drug Administration of Vietnam to coordinate with the Ministrys Inspectorate, the Central Drug Test Institute, the Ho Chi Minh City Drug Test Institute and provincial-level Health Services to conduct and supervise post-examination of cosmetic products.

The Drug Administration of Vietnam shall assist the Minister of Health in making conclusions on cosmetic quality nationwide.

Article 35. Forms of inspection and supervision

Periodical inspection and supervision: Periodical inspection and supervision shall be notified in advance by management agencies to to-be-inspected companies to make preparations before inspection and supervision activities are carried out.

Unexpected inspection and supervision: Unexpected inspection and supervision may be conducted upon detecting products which are of poor quality or fail to comply with regulations when marketed or are subject to customer claims. In case of urgency, competent agencies may conduct inspection without advance notice.

Article 36. Contents of inspection and supervision include:

1. Compliance with the law on cosmetic quality:

a/ Conditions of manufacture of cosmetic products: Compliance with the Good cosmetic manufacturing practice principles and standards issued by the Association of Southeast Asian Nations (CGMP-ASEAN) or the equivalent recognized by the ASEAN Cosmetic Council.

b/ Cosmetic labeling;

c/ Relevant contents in the Product Information Files (PIF) according to the regulations of the ASEAN Cosmetic Agreement on product information files;

d/ Cosmetic information and advertisement.

2. Consideration and settlement of disputes, claims and denunciations related to cosmetic quality.

Article 37. Cosmetic quality examination agencies of the State

The Central Drug Test Institute, the Ho Chi Minh City Drug Test Institute and drug, cosmetic and food safety and hygiene test centers of provinces and centrally run cities are state agencies competent to examine cosmetic quality.

Heads of cosmetic quality examination agencies are responsible for cosmetic quality examination conclusions before law.

Article 38. Conclusions of quality examination of cosmetic samples

1. For cosmetic samples which are taken by state agencies competent to conduct quality examination and ensure representation for the whole cosmetic batch and which are analyzed at accredited testing laboratories, quality examination conclusions are legally valid for the whole cosmetic batch.

2. Cosmetic samples which are sent by organizations or individuals to state agencies in charge of quality examination for quality certification, quality examination conclusions are legally valid for the sent samples only.

Article 39. Termination of circulation and recall of cosmetics

1. Cosmetics are subject to termination of circulation in one of the following cases:

a/ Cosmetics in circulation are of poor quality.

b/ Cosmetics in circulation have a formula inconsistent with the notified dossier.

c/ Cosmetics in circulation have a label which fails to comply with this Regulations provisions on product labeling may be subject to termination of circulation, depending on the severity of violation.

d/ Cosmetics which are unsafe for users.

2. Recall of cosmetics: On the basis of cosmetic quality inspection and examination results, the Drug Administration of Vietnam shall issue a decision to recall cosmetic products which fail to meet quality standards.

a/ The Drug Administration of Vietnam shall issue notices of recall of cosmetics which fail to meet quality standards nationwide.

b/ Provincial-level Health Services and health agencies under the management of other sectors shall implement notices of the Drug Administration of Vietnam of recall of cosmetics which fail to satisfy quality standards, handle violations in accordance with law and report thereon to the Drug Administration of Vietnam.

c/ Responsibilities of cosmetic trading organizations and individuals: Upon receiving recall notices, cosmetic trading organizations and individuals shall:

Immediately and thoroughly recall cosmetic batches that fail to satisfy quality standards.

Send reports on the recall and handling of recalled cosmetic batches to the Drug Administration of Vietnam and concerned functional agencies.

Remedy consequences caused by cosmetics that fail to satisfy quality standards.

Chapter VIII

RESPONSIBILITIES OF ORGANIZATIONS AND INDIVIDUALS MANUFACTURING, TRADING IN AND IMPORTING COSMETICS AND RIGHTS OF COSMETIC CONSUMERS

Article 40. Responsibilities of organizations and individuals manufacturing, trading in, and importing cosmetics for marketing in Vietnam

1. Organizations and individuals placing cosmetics in the market shall monitor, discover and promptly recall cosmetics that fail to satisfy quality standards: immediately settle customer claims about cosmetic quality; and pay compensations in accordance with law for damage caused to customers. If detecting any adverse side effect affecting human life caused by the quality of a cosmetic, the organization or individual placing that product in the market shall report it to the Drug Administration of Vietnam within 07 days from the date of receiving the first information on the side effect (according to a set form). A detailed report on this adverse side effect must be sent to the Drug Administration of Vietnam within 08 subsequent days.

2. Organizations and individuals placing cosmetics in the market shall comply with the Vietnamese regulations and laws on intellectual property. Upon receiving conclusions of the National Office of Intellectual Property under the Ministry of Science and Technology on marks or industrial designs that infringe upon intellectual property rights, organizations or individuals shall cease manufacture, trading or import so as to change those marks or industrial designs according to regulations, pay indemnities and remedy consequences (if any).

3. Cosmetic trading organizations and individuals shall comply with the requests of competent state agencies that conduct cosmetic quality examination and inspection and may lodge complaints about the latters conclusions and forms of handling of violations in accordance with the law on complaints and denunciations.

4. Organizations and individuals responsible for placing cosmetics in the market shall annually report on their manufacture and trading activities to the Drug Administration of Vietnam (according to a set form). Reports shall be sent to the Drug Administration of Vietnam before January 30 every year.

Article 41. Rights of cosmetic consumers

Consumers are entitled to be informed of cosmetic quality, to lodge complaints and denunciations, and to request cosmetic trading units to pay compensations in accordance with law for damage caused by manufactured or marketed poor-quality or unsafe cosmetics.

Chapter IX

HANDLING OF VIOLATIONS

Article 42. Handling of violations

Organizations and individuals violating regulations on cosmetics shall, depending on the nature and severity of their violations, be administratively sanctioned or examined for penal liability: if causing any damage, they shall pay compensations in accordance with law.

Chapter X

IMPLEMENTATION PROVISIONS

Article 43. Implementation roadmap

1. From the effective date of this Regulation, all new kinds of cosmetics (cosmetics not yet registered for circulation or notified to the Drug Administration of Vietnam, and products already marketed but having changes in their ingredients and formulas) shall be notified in accordance with this Regulation to the Drug Administration of Vietnam.

2. Foreign cosmetic products which have been granted by the Drug Administration of Vietnam registration numbers for circulation in Vietnam before the effective date of this Regulation:

a/ If the registration number is valid until December 31, 2010, before the expiry of this number, organizations or individuals that wish to continue placing the product in the Vietnamese market shall notify the product in accordance with this Regulation.

b/ If the registration number is valid beyond December 31, 2010, organizations and individuals may continue manufacturing and distributing products until the end of December 31, 2010.

3. All domestically manufactured cosmetic products for which quality standard notifications have been made and notification receipts have been issued by the Drug Administration of Vietnam may continue to be manufactured and distributed until the end of December 31, 2010.

4. Products which have been notified or registered and imported into Vietnam before December 31, 2010, may continue to be marketed until their expiry date if they meet all requirements stated in this Regulation. For products which fail to meet the requirements stated in this Regulation, organizations and individuals placing them in the market shall modify or recall all of these products before January 1, 2011.

Article 44. Implementation provisions

1. The Drug Administration of Vietnam shall update and implement decisions related to the ASEAN Cosmetic Agreement on its website www.dav.gov.vn. It shall frequently inform concerned units and cosmetic manufacturing and trading organizations and individuals in Vietnam of changes in technical criteria as well as decisions of the ASEAN Cosmetic Council related to the ASEAN Cosmetic Agreement, and at the same time, coordinate in introducing these changes and implementing these decisions in Vietnam. All decisions adopted by the ASEAN Cosmetic Council on cosmetic management must be applied in Vietnam.

2. The Drug Administration of Vietnam shall coordinate with the Health Ministrys Inspectorate, provincial/municipal Health Services and health agencies under the management of other sectors in guiding and organizing the supervision and inspection of the implementation of this Regulation.

3. In the course of implementation, any problems and difficulties shall be reported to the Drug Administration of Vietnam, 138A Giang Vo, Ba Dinh, Hanoi, for synthesis and report to the Minister of Health for consideration and decision.

Appendix No. 01-MP

TEMPLATE FOR NOTIFICATION OF COSMETIC PRODUCT

Tick-where applicable

PARTICULARS OF PRODUCT

1. Name of brand & product:

1.1. Brand

1.2. Product Name

1.3. List of Variants or Shade. Names

2. Product type(s)

3. Intended use

4. Product presentation(s)

PARTICULARS OF MANUFACTURER (S)/ASSEMBLER(S)(1)

(Please attach in a separate sheet if there are more than one manufacturer/assembler)

5. Name of manufacturer:

Address of manufacturer (state country):

6. Name of assembler (Please tick accordingly. May tick more than one box):

(Address of assembler (state country):

(1) A manufacturer is a company which is engaged in any process carried out in the course of making the cosmetic product. The manufacturing process includes all operations of purchase of starting materials, bulk intermediates and products, formulation and production (such as grinding, mixing, encapsulation and/or packaging), quality control, release, storage and distribution of cosmetic products and the related controls.

A primary assembler is a company which is engaged in a process of enclosing the product in a primary/immediate container which is labelled or to be labelled before the product is sold or supplied in it.

A secondary assembler is a company which is engaged only in a process of labeling the product container where the product is already enclosed in its primary container and/or packing the product which is already enclosed in its labelled primary container into a carton which is labelled or to be labelled, before the product is sold or supplied.

PARTICULARS OF LOCAL COMPANY RESPONSIBLE FOR PLACING THE COSMETIC PRODUCT IN THE MARKET

7. Name of company:

Address of company:

Business Registration Number/License to Operate Number (if applicable, submit a copy of the Business Registration Certificate):

PARTICULARS OF PERSON REPRESENTING THE LOCAL COMPANY

8. Name of person:

Designation in the company:

Note: If the applicant is a service provider authorized by the company, he is required to provide a letter of authorization or any additional particulars as required by the regulatory authority.

PARTICULARS OF IMPORTER

9. Name of importer:

Address of importer:

PRODUCT INGREDIENT LIST

10. Please check the following boxes

I have examined the latest revisions of Annexes II to VII of the ASEAN Cosmetic Ingredient Listing as published in the latest amendment of the ASEAN Cosmetic Directive and confirmed that the product in this notification does not contain any prohibited substances and is in compliance with the restrictions and conditions stipulated in the Annexes.

I undertake to respond to and cooperate fully with the regulatory authority with regard to any subsequent post-marketing activity initiated by the authority.

Product full ingredient list

(The list and percentage of all ingredients)

DECLARATION

1. I hereby declare on behalf of my company that the product in the notification meets all the requirements of the ASEAN Cosmetic Directive, its Annexes and Appendices.

2. I undertake to abide by the following conditions):

i. Ensure that the products technical and safety information is made readily available to the regulatory authority concerned (the Authority) and to keep records of the distribution of the products for product recall purposes;

ii. Notify the Authority of fatal or life threatening serious adverse event(2) as soon as possible by telephone, facsimile transmission, email or in writing, and in any case, no later than 7 calendar days after first knowledge;

iii. Complete the Adverse Cosmetic Event Report Form(3) within 8 calendar days from the date of my notification to the Authority in para 2ii, above, and to provide any other information as may be requested by the Authority;

iv. Report to the Authority of all other serious adverse events that are not fatal or life threatening as soon as possible, and in any case, no later than 15 calendar days after first knowledge, using the Adverse Cosmetic Event Report Form;

v. Notify the Authority of any change in the particulars submitted in this notification;

3. I declare that the particulars given in this notification are true, all data, and information of relevance in relation to the notification have been supplied and that the documents enclosed are authentic or true copies.

4. I understand that I shall be responsible for ensuring that each consignment of my product continues to meet all the legal requirements, and conforms to all the standards and specifications of the product that I have declared to the Authority.

5. I understand that I cannot place reliance on the acceptance of my product notification by the authority in any legal proceedings concerning my product, in the event that my product has failed to conform to any of the standards or specifications that I had previously declared to the Authority.

Name and signature of the person representing the local company

(2) As defined in the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products

(3)Set out in Appendix I to the Guide Manual for the Industry on Adverse Event Reporting of Cosmetics Products

GUIDANCE DOCUMENT ON PRODUCT NOTIFICATION TO THE REGULATORY AUTHORITY

Particulars of a product

1. Name of brand and product

The complete name of the product should be given, in the following sequence: brand name, line name (if applicable), product name, if a single shade is notified, the shade name/number (e.g., L oreal Feria Color 3D Hot Ginger). If there are different shades, the shade name/number for each shade shall be declared.

2. Product types

The illustrative list is not exhaustive and you can include other types of cosmetic products not in the list by selecting others and specifying what it is. More than one category can be selected. e.g., Bath or shower preparations and Hair-care products can be selected if your product is both a shower gel and hair shampoo.

3. Intended use

This refers to the function or use of the product and not the directions for use e.g., to moisturize the face, hand. etc.

4. Product presentation(s)

Please select only one out of the 4 choices that best fit the presentation type of the product. The following is an explanation of the presentation types:

A single product exists in a single presentation form.

(4) A range of colours is a range of cosmetic products, which are similar in composition and produced by the same manufacturer, and are intended for the same use but are available in different shades of colour (e.g. lipsticks, eye shadows or nail polish but not composite packs of different types).

Palette(s) in a range of one product type refers to a range of colors as defined above, which may be presented in a series of palettes.

Combination products in a single kit refer to similar and/or different product types packed and sold in a single kit. They cannot be sold separately (e.g. a make-up kit of eye and lip colors; a set of skin-care products sold in a single kit).

5. Particulars of the manufacturer(s)/ Assembler(s):

There may be more than one manufacturer and/or assembler for one product. The full names and contact details of each of them must be submitted.

(4) For these presentation types, only one notification needs to be submitted.

6. Particulars of company

It refers to the local company responsible for placing the cosmetic products in the market, which may be a local manufacturer or an agent appointed by a manufacturer to market the product or the company that is responsible for bringing in the product for sale in the country, etc. The business registration number or its equivalent should be indicated in the notification form, if applicable.

7. Particulars of the person representing the local company

The person who represents the company to submit the product notification must possess adequate knowledge or experience in accordance with the legislation and practice of the Member Country.

Product Ingredient list if required by regulatory authority

8. Full ingredient listing and nomenclature

a) All the ingredients in the product must be specified by using the nomenclature from the latest edition of standard references (Refer to appendix A). Botanicals and extract of botanicals should be identified by its genus and species. The genus may be abbreviated. The following are not regarded as ingredients:

Impurities in the raw materials used;

Subsidiary technical materials used in the preparation but not present in the final product;

Materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.

The percentage of ingredients must be declared if they are substances with restrictions for use as specified in the annexes of the ASEAN Cosmetic Directive.

b) For a range of colours/shades or products in a single kit, complete the Product Ingredient List in the following format:

List ingredients in the Base Formulation

May contain and list each color/shade

c) For combination products in a kit, list each product and its corresponding formulation individually. You can extend the form when more space is needed.