Circular No. 34/2025/TT-BYT amends Circular No. 06/2011/TT-BYT of the Minister of Health on cosmetic management.

CIRCULAR

Amending and supplementing some articles of Circular No. 06/2011/TT-BYT dated January 25, 2011, issued by the Minister of Health on cosmetic management

Pursuant to Decree No. 45/2020/NĐ-CP dated April 8, 2020, issued by the Government on implementing administrative procedures in an electronic environment;

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

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

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

At the proposal of the Director of the Drug Administration Department;

The Minister of Health hereby issues this Circular amending and supplementing some articles of Circular No. 06/2011/TT-BYT dated January 25, 2011, issued by the Minister of Health on cosmetic management.

Article 1. Amending and supplementing some articles of Circular No. 06/2011/TT-BYT dated January 25, 2011, issued by the Minister of Health on cosmetic management (hereinafter referred to as Circular No. 06/2011/TT-BYT)

1. Amending and supplementing Clause 1 of Article 4 as follows:

"1. Declaration form for cosmetic products: One electronic copy in case of online submission of declaration forms for cosmetic products; two paper copies in case of direct submission or submission through postal services."

2. Amending and supplementing Clause 5 as follows:

"Article 5. Method of preparing Declaration Forms for Cosmetic Products

1. Declaration Forms for Cosmetic Products shall be prepared in accordance with Appendix No. 01-MP attached hereto. The method of recording contents in Declaration Forms for Cosmetic Products shall be carried out in accordance with Appendix No. 02-MP attached hereto.

In cases of online submission of declaration forms for cosmetic products: The Declaration Form must be signed by the legal representative or a person authorized by the legal representative to sign, clearly stating their name and affixing a seal (electronic signature or digital signature accepted). In cases where the entity or individual responsible for bringing the product to market is a business household, it is not mandatory to affix the business household's seal on the Declaration Form.

In cases of direct submission or submission through postal services: The Declaration Form must be signed by the legal representative or a person authorized by the legal representative to sign, clearly stating their name and affixing a seal (seal imprint not allowed), and affixing a cross-seal (in cases where the Declaration Form consists of two pages or more). In cases where the entity or individual responsible for bringing the product to market is a business household, it is not mandatory to affix the business household's seal on the Declaration Form, the head of the business household must sign on all pages containing information of the Declaration Form.

2. Each cosmetic product shall be declared in one Declaration Form.

Cosmetics produced completely at each different manufacturing company shall be declared separately. In cases where two or more companies participate in production stages to produce a complete product, they shall be declared jointly in one Declaration Form and must specify the full name, address, and production stage of each company.

Products under the same owner in any of the following cases may be declared in one Declaration Form:

a) Products packaged with a common name and sold as a set of products;

b) Products with the same name, from the same product line with similar formulas but different colors or scents, except hair dye and perfume which must be declared separately for each color or scent;

c) Other cases will be decided by the Drug Administration Department of the Ministry of Health based on the decision of the ASEAN Cosmetics Council.

3. Method of recording ingredients in cosmetic products:

a) Ingredients in the formula must be listed in descending order of concentration. Fragrance and flavoring substances and their components can be written as "fragrance" (perfume, fragrance, flavor, aroma). Ingredients with concentrations less than 1% may be listed in any order after those with concentrations greater than 1%. Colorants may be listed in any order after other ingredients according to the color index (CI) or by name as in Annex IV of the ASEAN Cosmetics Agreement. Cosmetics used for makeup, in different colors, may list all colorants in the "may contain" section or "+/-".

b) Fully state the percentage of ingredients with concentration limits specified in the Annexes of the ASEAN Cosmetics Agreement. A comma (",") shall be used between the unit and decimal places;

c) Ingredient names must be recorded using the International Nomenclature of Cosmetic Ingredients (INCI) as defined in the latest editions: International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, Japanese Cosmetic Ingredients Codex. Plant names and plant extracts must be written in scientific names including genus and species (genus name of plants may be abbreviated). Animal-derived ingredients must specify the scientific name of the animal species;

d) The following substances shall not be considered as ingredients of cosmetics:

- Impurities in raw materials used;

- Auxiliary materials used for technical purposes but not present in the final product;

- Materials used in necessary quantities such as solvents or carriers for fragrant components.

4. The language used in the Declaration Form shall be Vietnamese or English. Contents recorded in Item 3 (Purpose of Use), Item 8 (Information about entities or individuals responsible for bringing the product to market), Item 9 (Information about the legal representative of the Company), and Item 10 (Information about Import Companies) in the Declaration Form must be recorded in Vietnamese or Vietnamese and English."

3. Amend and supplement the guiding clause of Clause 1 and Point b, Clause 2, Article 7 as follows:

a) Amend and supplement the guiding clause of Clause 1, Article 7 as follows:

"1. The basis for submitting one set of cosmetic product registration files to the competent state management agency in accordance with Article 15 of Decree No. 118/2025/NĐ-CP dated June 9, 2025, of the Government on implementing administrative procedures under the single-window mechanism at the One-Stop Service Center and the National Public Service Portal.

In cases where the files are submitted through the National Public Service Portal, the entity shall comply with the provisions of Decree No. 45/2020/NĐ-CP dated April 8, 2020, on implementing administrative procedures in the electronic environment, amended and supplemented in 2022 and 2025, Decree No. 68/2024/NĐ-CP dated June 25, 2024, of the Government on specialized digital signatures for public service, and Decree No. 69/2024/NĐ-CP dated June 25, 2024, of the Government on electronic identification and authentication.";

b) Amend and supplement Point b Clause 2 Article 7 as follows:

"b) In cases where the registration file does not meet the requirements stipulated in this Circular, within five working days from the date of receipt of the file, the agency receiving the file shall notify in writing the organization or individual making the registration about the contents that have not been met so that they can amend and supplement the file (specifying the specific contents that have not been met).

Within five working days from the date of receipt of the supplementary file meeting the requirements stipulated in this Circular, the competent state management agency shall be responsible for issuing the receipt number for the Cosmetic Product Registration Form.

In cases where the amended and supplemented file does not meet the requirements stipulated in this Circular, within five working days from the date of receipt of the supplementary file, the agency receiving the file shall notify in writing that it will not issue the receipt number for the Cosmetic Product Registration Form for this product.

The supplementary file of the entity includes:

- A written explanation regarding the amendments and supplements made by the organization or individual named in the registration;

- The Cosmetic Product Registration Form accompanied by other documents that have been amended and supplemented."

4. Amend and supplement Point a Clause 2 Article 35 as follows:

"a) Organizations and individuals importing cosmetics for research and testing shall submit the Import Order for Cosmetics Used for Research and Testing in accordance with Appendix No. 14-MP issued together with this Circular to the health-related department under the provincial People's Committee where the establishment's headquarters is located. The maximum quantity for each product is ten samples.

For online submission: one electronic copy of the Import Order signed by the legal representative or a person authorized by the legal representative to sign, clearly stating their name and affixing a seal (accepting electronic signature or digital signature). In cases where organizations or individuals are sole proprietorships, there is no mandatory requirement to affix the sole proprietorship's seal on the Import Order, but the sole proprietor must sign all pages containing information of the Import Order.

For direct submission or submission via postal services: two paper copies of the Import Order signed by the legal representative or a person authorized by the legal representative to sign, clearly stating their name and affixing a seal (no stamp signature allowed), with a cross-stamp seal (in cases where the Import Order consists of two or more pages). In cases where organizations or individuals are sole proprietorships, there is no mandatory requirement to affix the sole proprietorship's seal on the Import Order, but the sole proprietor must sign all pages containing information of the Import Order. After approval, one copy shall be kept by the health-related department under the provincial People's Committee, and one copy shall be sent to the establishment. The copy sent to the establishment shall bear the stamp "Copy for Establishment" to present to the Customs Office when processing clearance procedures.

Within three working days from the date of receipt of the Import Order for Cosmetics Used for Research and Testing, the health-related department under the provincial People's Committee shall approve the Import Order. In cases where the Import Order is not approved, a written notification must be issued specifying the reasons.

Imported cosmetic products for research and testing must be used for their intended purpose and may not be released for circulation on the market."

5. Amend and supplement Clause 1 Article 48 as follows:

"1. Organizations and individuals responsible for bringing cosmetic products to the market shall be fully liable under the law for the accuracy, legality, and truthfulness of the contents declared on the Cosmetic Product Registration Form and the documents in the cosmetic product registration file; they shall be responsible for the consistency and uniformity of the information on the Cosmetic Product Registration Form prescribed in Clause 1 Article 5 of this Circular and the information of the documents in the cosmetic product registration file submitted to the receiving agency; they shall be fully responsible for the safety, efficacy, and quality of the product, ensuring that the product brought to the market meets all the requirements of the ASEAN Cosmetics Agreement and its appendices."

6. Replace Appendix No. 14-MP with the Appendix issued together with this Circular.

Article 2. Replacing some phrases in Circular No. 06/2011/TT-BYT

1. Replace the phrase "Department of Health" with the phrase "health administration body under the provincial People's Committee" at point b, Clause 1, Article 7.

2. Replace the phrase "Hanoi Department of Health" with the phrase "health administration body under the Hanoi People's Committee" at Article 8 and Appendix No. 11-MP issued together with Circular No. 06/2011/TT-BYT.

3. Replace the phrase "Department of Health of provinces and centrally governed cities" at Clause 4, Article 33, point b, Clause 1, Article 41, point b, Clause 2, Article 45, and point b, Clause 2, Article 46; replace the phrase "Departments of Health of provinces and centrally governed cities" at point a, point b, Clause 1, Article 41 and Clause 2, Clause 3, Article 50; replace the phrase "Department of Health" at Clause 4, Article 50, Appendix No. 11-MP, Appendix No. 15-MP, and Appendix No. 16-MP issued together with Circular No. 06/2011/TT-BYT; replace the phrase "Department of Health of province / city" at Appendix No. 10-MP, Appendix No. 11-MP, Appendix No. 15-MP, Appendix No. 16-MP, and Appendix No. 17-MP issued together with Circular No. 06/2011/TT-BYT with the phrase "health administration body under the provincial People's Committee."

4. Replace the phrase "postal service" with the phrase "postal services" at Clause 1, Article 38.

5. Replace the phrase "Director of Departments of Health of provinces and centrally governed cities" with the phrase "head of health administration body under the provincial People's Committee" at Clause 3, Article 53.

6. Replace the phrase "(PROVINCIAL / MUNICIPAL) HEALTH SERVICE" with the phrase "PROVINCIAL HEALTH SERVICE" at Appendix No. 12-MP issued together with Circular No. 06/2011/TT-BYT.

Article 3. Effectiveness

This Circular takes effect from August 18, 2025.

Article 4. Transitional Provisions

Files submitted before this Circular takes effect shall continue to be processed according to the regulations at the time of submission or apply the provisions of this Circular from the date it takes effect, in a manner that facilitates and simplifies administrative procedures for businesses, organizations, and individuals.

Article 5. Reference Provisions

In case the legal normative documents and regulations cited in this Circular are amended, supplemented, or replaced, they shall be implemented according to the new legal normative documents.

Article 6. Responsibility for Implementation

1. The People's Committees of provinces and centrally governed cities are responsible for directing the health administration bodies under the provincial People's Committees to implement the handling of administrative procedures for receiving acceptance numbers for Product Declaration Forms for domestically produced cosmetics and approving Import Orders for cosmetics used for research and testing as stipulated in this Circular through online methods.

2. The Heads of the Ministry’s Office, the Director of the Drug Administration Department, the Heads of units under and affiliated with the Ministry of Health; the Heads of health administration bodies under the provincial People's Committees; relevant agencies, organizations, and individuals are responsible for implementing this Circular.

During implementation, if there are difficulties or obstacles, agencies, organizations, and individuals are requested to reflect them to the Ministry of Health (Drug Administration Department) for consideration and resolution.

ANNEX

(Attached to Circular No. 34/2025/TT-BYT dated July 3, 2025, issued by the Minister of Health)

Appendix No. 14-MP: Sample Import Order for Cosmetics Used for Research and Testing

 

ORDER
IMPORTING COSMETICS FOR RESEARCH AND TESTING

Respectfully sent to: Health administration body under the provincial People's Committee⁽¹⁾ ...

(Name of establishment) ... requests the health administration body under the provincial People's Committee⁽¹⁾ ... to approve the establishment to import cosmetics for research and testing as follows:

____________________

⁽¹⁾ Health administration body under the provincial People's Committee where the establishment's headquarters is located.

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