Pursuant to Decree No. 45/2020/ND-CP dated 08 April 2020 of the Government on implementation of administrative procedures in the electronic environment;

Pursuant to Decree No. 69/2024/ND-CP dated 25 June 2024 of the Government on electronic identification and authentication;

Pursuant to Decree No. 42/2022/ND-CP dated 24 June 2022 of the Government on provision of information and online public services by state agencies in the network environment;

Pursuant to Decree No. 42/2025/ND-CP dated 27 February 2025 of the Government prescribing the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of the Drug Administration of Viet Nam;

The Minister of Health promulgates this Circular amending and supplementing a number of articles of Circular No. 06/2011/TT-BYT dated 25 January 2011 of the Minister of Health on cosmetic management.

Article 1. Amendments and supplements to a number of articles of Circular No. 06/2011/TT-BYT dated 25 January 2011 of the Minister of Health on cosmetic management (hereinafter referred to as Circular No. 06/2011/TT-BYT)

1. Clause 1 Article 4 is amended and supplemented as follows:

“1. Cosmetic product proclamation form: 01 electronic copy for online submission of cosmetic product proclamation dossiers; 02 paper copies for submission in person or by postal service.”.

2. Article 5 is amended and supplemented as follows:

“Article 5. Preparation of the cosmetic product proclamation form

1. The cosmetic product proclamation form shall comply with Appendix No. 01-MP enclosed with this Circular. Instructions for completing the contents of the cosmetic product proclamation form shall comply with Appendix No. 02-MP enclosed with this Circular.

For online submission of cosmetic product proclamation dossiers: the proclamation form must be signed by the legal representative or a person authorized by the legal representative, with full name and seal affixed (electronic signature or digital signature is accepted). Where the organization or individual responsible for placing the product on the market is a household business, the seal of such household business is not mandatory on the proclamation form.

For submission in person or by postal service: the proclamation form must be signed by the legal representative or a person authorized by the legal representative, with full name and seal affixed (stamp-signature is not permitted), and must bear a seal across adjoining pages where the proclamation form consists of 02 pages or more. Where the responsible organization or individual is a household business, the seal of the household business is not mandatory, but the household business owner must sign all pages containing information of the proclamation form.

2. Each cosmetic product shall be proclaimed in one proclamation form.

A cosmetic product completely manufactured at different manufacturing companies shall be proclaimed separately. Where two or more companies participate in manufacturing stages to produce a finished product, they shall be included in one proclamation form and the full name, address and manufacturing stage of each participating company must be clearly stated.

Products of the same product owner falling into one of the following cases may be proclaimed in one proclamation form:

a) Products packaged under a common name and sold as a set;

b) Products bearing the same name and belonging to the same product line with similar formulas but different colors or scents, except hair dye products and perfumes, which shall be proclaimed separately for each color or scent;

c) Other forms as decided by the Drug Administration of Viet Nam – Ministry of Health based on decisions of the ASEAN Cosmetic Committee.

3. Declaration of formula ingredients in cosmetic products:

a) Ingredients in the product formula must be fully listed in descending order of content. Perfume, fragrance, flavour and aroma ingredients and their raw materials may be stated as “perfume, fragrance, flavour, aroma”. Ingredients with a content of less than 1% may be listed in any order after ingredients with a content greater than 1%. Colorants may be listed in any order after other ingredients according to the Color Index (CI) or their names as set out in Annex IV of the ASEAN Cosmetic Agreement. Cosmetic products used for make-up in different colors may list all colorants under “may contain” or “+/-”;

b) The percentage of ingredients subject to concentration or content limits under the Annexes of the ASEAN Cosmetic Agreement must be fully stated. A comma (“,”) shall be used between the integer part and decimal part;

c) Ingredient names must be stated according to the International Nomenclature of Cosmetic Ingredients (INCI) as provided in the latest publications: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, and Japanese Cosmetic Ingredients Codex. Names of plants and plant extracts must be written by scientific name including genus and species (the genus name may be abbreviated). Ingredients of animal origin must state the exact scientific name of the animal species;

d) The following substances shall not be regarded as cosmetic ingredients:

– Impurities in the raw materials used;

– Subsidiary materials used for technical purposes but not present in the finished product;

– Materials used in necessary quantities as solvents or carriers for fragrance ingredients.

4. The language used in the proclamation form shall be Vietnamese or English. The contents stated in item 3 (Intended use), item 8 (Information on the organization or individual responsible for placing the product on the market), item 9 (Information on the legal representative of the company), and item 10 (Information on the importing company) in the proclamation form must be written in Vietnamese or in Vietnamese and English.”.

3. The introductory sentence of Clause 1 and Point b Clause 2 Article 7 are amended and supplemented as follows:

a) The introductory sentence of Clause 1 Article 7 is amended and supplemented as follows:

“1. An establishment shall submit 01 set of cosmetic product proclamation dossier to the competent state management agency in accordance with Article 15 of Decree No. 118/2025/ND-CP dated 09 June 2025 of the Government on implementation of administrative procedures under the single-window and inter-agency single-window mechanism at the Single-Window Section and the National Public Service Portal.

Where the dossier is submitted on the National Public Service Portal, the establishment shall comply with Decree No. 45/2020/ND-CP dated 08 April 2020 on implementation of administrative procedures in the electronic environment, as amended and supplemented in 2022 and 2025, Decree No. 68/2024/ND-CP dated 25 June 2024 on specialized digital signatures for public service, and Decree No. 69/2024/ND-CP dated 25 June 2024 on electronic identification and authentication:”;

b) Point b Clause 2 Article 7 is amended and supplemented as follows:

“b) Where the proclamation dossier does not satisfy the requirements of this Circular, within 05 working days from the date of receipt of the dossier, the receiving agency shall notify the declaring organization or individual in writing of the non-compliant contents for amendment and supplementation, clearly specifying such contents.

Within 05 working days from the date of receipt of a supplemental dossier satisfying the requirements of this Circular, the competent state management agency shall issue the receipt number of the cosmetic product proclamation form.

Where the amended or supplemented dossier does not satisfy the requirements of this Circular, within 05 working days from the date of receipt of the supplemental dossier, the receiving agency shall notify in writing that the receipt number of the cosmetic product proclamation form shall not be issued for such product.

The establishment’s supplemental dossier includes:

– A written explanation on the amendments and supplements made by the organization or individual named in the proclamation;

– The cosmetic product proclamation form together with other amended or supplemented documents.”.

4. Point a Clause 2 Article 35 is amended and supplemented as follows:

“a) Organizations and individuals importing cosmetics for research or testing shall submit an order for import of cosmetics for research and testing according to Appendix No. 14-MP enclosed with this Circular to the specialized health agency under the provincial People’s Committee where the establishment’s head office is located. The maximum quantity for each product is 10 samples.

For online submission: 01 electronic copy of the order signed by the legal representative or a person authorized by the legal representative, with full name and seal affixed (electronic signature or digital signature is accepted). Where the organization or individual is a household business, the seal of the household business is not mandatory on the order.

For submission in person or by postal service: 02 paper copies of the order signed by the legal representative or a person authorized by the legal representative, with full name and seal affixed (stamp-signature is not permitted), and bearing a seal across adjoining pages where the order consists of two pages or more. Where the organization or individual is a household business, the seal of the household business is not mandatory, but the household business owner must sign all pages containing information of the order. After approval, 01 copy shall be kept by the specialized health agency under the provincial People’s Committee and 01 copy shall be sent to the establishment. The copy sent to the establishment shall bear the stamp “Copy sent to establishment” for presentation to the customs authority when carrying out customs clearance procedures.

Within 03 working days from the date of receipt of the order for import of cosmetics for research and testing, the specialized health agency under the provincial People’s Committee shall approve the order. In case of refusal, it must notify in writing and clearly state the reason.

Cosmetic products imported for research and testing must be used for the correct purpose and must not be placed on the market.”.

5. Clause 1 Article 48 is amended and supplemented as follows:

“1. The organization or individual responsible for placing a cosmetic product on the market shall be fully responsible before law for the accuracy, legality and truthfulness of the contents declared in the cosmetic product proclamation form and documents in the cosmetic product proclamation dossier; shall be responsible for the conformity and consistency of information on the cosmetic product proclamation form prescribed in Clause 1 Article 5 of this Circular with information in documents in the cosmetic product proclamation dossier submitted to the receiving agency; and shall be fully responsible for the safety, efficacy and quality of the product, ensuring that the product placed on the market satisfies all requirements of the ASEAN Cosmetic Agreement and its Annexes.”.

6. Appendix No. 14-MP is replaced by the Appendix enclosed with this Circular.

Article 2. Replacement of a number of phrases in Circular No. 06/2011/TT-BYT

1. The phrase “Department of Health” is replaced with “specialized health agency under the provincial People’s Committee” at Point b Clause 1 Article 7.

2. The phrase “Ha Noi Department of Health” is replaced with “specialized health agency under the Ha Noi People’s Committee” in Article 8 and Appendix No. 11-MP enclosed with Circular No. 06/2011/TT-BYT.

3. Relevant phrases referring to provincial Departments of Health in Clause 4 Article 33, Point b Clause 1 Article 41, Point b Clause 2 Article 45, Point b Clause 2 Article 46, Points a and b Clause 1 Article 41, Clauses 2 and 3 Article 50, Clause 4 Article 50, and Appendices No. 10-MP, 11-MP, 15-MP, 16-MP and 17-MP enclosed with Circular No. 06/2011/TT-BYT are replaced with “specialized health agency under the provincial People’s Committee”.

4. The phrase “by post” is replaced with “by postal service” in Clause 1 Article 38.

5. The phrase “Directors of Departments of Health of provinces and centrally-run cities” is replaced with “Heads of specialized health agencies under provincial People’s Committees” in Clause 3 Article 53.

6. The phrase “(PROVINCIAL / MUNICIPAL) HEALTH SERVICE” is replaced with “PROVINCIAL HEALTH SERVICE” in Appendix No. 12-MP enclosed with Circular No. 06/2011/TT-BYT.

Article 3. Effect

This Circular takes effect from 18 August 2025.

Article 4. Transitional provisions

Dossiers submitted before the effective date of this Circular may continue to be processed in accordance with the regulations applicable at the time of submission, or may apply the provisions of this Circular from its effective date in a manner that facilitates and simplifies administrative procedures for enterprises, organizations and individuals.

Article 5. Reference clause

Where legal normative documents and provisions referred to in this Circular are amended, supplemented or replaced, the new legal normative documents shall apply.

Article 6. Implementation responsibility

1. Provincial and centrally-run municipal People’s Committees shall direct specialized health agencies under provincial People’s Committees to implement the settlement of administrative procedures for issuance of cosmetic product proclamation receipt numbers for domestically manufactured cosmetics and approval of orders for import of cosmetics for research and testing under this Circular in online form.

2. The Chief of the Ministry Office, the Director of the Drug Administration of Viet Nam, heads of units under and affiliated to the Ministry of Health, heads of specialized health agencies under provincial People’s Committees, and relevant agencies, organizations and individuals shall be responsible for implementing this Circular.

If difficulties or problems arise during implementation, agencies, organizations and individuals are requested to report them to the Ministry of Health (Drug Administration of Viet Nam) for consideration and resolution./.

FOR THE MINISTER
DEPUTY MINISTER

Do Xuan Tuyen

APPENDIX
Enclosed with Circular No. 34/2025/TT-BYT dated 03 July 2025 of the Minister of Health

Appendix No. 14-MP: Form of order for import of cosmetics for research and testing

NAME OF ESTABLISHMENT
No.: …

SOCIALIST REPUBLIC OF VIET NAM
Independence – Freedom – Happiness
…, date … month … year …

ORDER
FOR IMPORT OF COSMETICS FOR RESEARCH AND TESTING

To: Specialized health agency under the provincial People’s Committee⁽¹⁾…

(Name of establishment) … requests the specialized health agency under the provincial People’s Committee⁽¹⁾… to approve import of the following cosmetics for research and testing:

The specialized health agency under the provincial People’s Committee⁽¹⁾… approves the import order consisting of … pages … items attached to Official Letter No. …………. dated … month … year … of the specialized health agency under the provincial People’s Committee⁽¹⁾.

The order for import of cosmetics for research and testing is valid for one time only./.

⁽¹⁾ Specialized health agency under the provincial People’s Committee where the establishment’s head office is located.

⁽²⁾ The maximum quantity for each product is 10 samples.