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MINISTRY OF HEALTH OF VIETNAM |
THE SOCIALIST REPUBLIC OF VIETNAM |
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No. 34/2025/TT-BYT |
Hanoi, July 03, 2025 |
ON AMENDMENTS TO SOME ARTICLES OF CIRCULAR NO. 06/2011/TT-BYT DATED JANUARY 25, 2011 OF THE MINISTER OF HEALTH ON MANAGEMENT OF COSMETICS
Pursuant to Decree No. 45/2020/ND-CP dated April 08, 2020 of the Government on administrative procedures by electronic means;
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/ND-CP dated June 24, 2022 of the Government provision of online information and online public services by regulatory bodies;
Pursuant to Decree No. 42/2025/ND-CP dated February 27, 2025 of the Government on functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam;
At the request of the head of Drug Administration of Vietnam;
The Minister of Health promulgates the Circular on amendments to some articles of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health on management of cosmetics.
Article 1. Amendments to some articles of Circular No. 06/2011/TT-BYT dated January 25, 2011 of the Minister of Health on management of cosmetics (hereinafter referred to as Circular No. 06/2011/TT-BYT)
1. Amendments to clause 1, Article 4:
“1. A notification of cosmetic product: 01 electronic copy if the dossier is submitted online; 02 physical copies if the dossier is submitted in person or via postal service;”.
2. Amendments to Article 5:
“Article 5. Methods for preparation of cosmetics product notification
1. The notification of cosmetic product shall be prepared in accordance with the Annex No. 01-MP attached to this Circular. The notification of cosmetic product shall be filled in according to the Annex No. 02-MP attached to this Circular.
If the cosmetic notification dossier is submitted online: the notification of cosmetic product must bear the signature of the legal representative or the signature, full name and seal of the person authorized by the legal representative (electronic or digital signature is accepted). If the organization or individual responsible for placing a product in the market is a household business, it is not required to affix the seal of the household business to the notification.
If the cosmetic notification dossier is submitted in person or via postal service: the notification of cosmetic product must bear the signature of the legal representative or the signature, full name and seal of the person authorized by the legal representative (signature seal is not permitted) and the stamp across the margins of sheets (if the notification consists of at least 02 sheets). If the organization or individual responsible for placing a product in the market is a household business, it is not required to affix the seal of the household business to the notification. The household business owner must affix his/her signature to all pages of the notification.
2. Each cosmetic product shall have its own notification.
A separate notification shall be made for each finished cosmetic product of a manufacturer. Where two or more manufacturers engage in the manufacture of a finished cosmetic product, a notification shall be made for such product and shall clearly state the name and full address of each manufacturer and the manufacturing stage in which it engages.
Products of the same owner may be covered by a single notification in any of the cases below:
a) The products are packaged under a common name and sold as a kit;
b) Products with the same name and in the same product line have similar formulas but vary in color or scent, except for hair dyes and perfumes whose color or scent must be covered by a separate notification;
c) Other types may be decided by the Drug Administration of Vietnam under the Ministry of Health according to the ASEAN Cosmetic Committee’s decision.
3. Methods of specifying ingredients present in the formulation of a cosmetic product:
a) Ingredients president in a product formulation must be specified in full in descending order of content. Perfume and aromatic compositions and their raw materials may be referred to by the word “hương liệu” (“perfume”, “fragrance”, “flavor” or “aroma”). Ingredients in concentrations of less than 1% may be listed in any order after those of concentration of more than 1% content. Coloring agents may be listed in any order after the other ingredients, in accordance with the color index number (CI) or denomination adopted in Annex IV of the ASEAN Agreement on Cosmetics. 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.
b) All percentages of ingredients for which limits of concentration and content are prescribed under the Annexes to the ASEAN Agreement on Cosmetics shall be specified. A comma (“,”) may be used as a decimal separator.
c) The ingredients must be specified using the International Nomenclature of Cosmetic Ingredients (INCI) from the latest edition of International Cosmetic Ingredient Dictionary, British Pharmacopoeia, United States Pharmacopoeia, Chemical Abstract Services, Japanese Standard Cosmetic Ingredient, and Japanese Cosmetic Ingredients Codex. Botanicals and extract of botanicals should be identified by its genus and species (the genus may be abbreviated). For ingredients of animal origin, scientific name of the animal must be accurately stated;
d) The following shall not be regarded as ingredients of a cosmetic product:
– Impurities in the raw materials used;
– Subsidiary technical materials used in the preparation but not present in the final products;
– Materials used in strictly necessary quantities as solvents, or as carriers, for perfume and aromatic compositions.
4. Language used in the notification shall be either Vietnamese or English. Details in Section 3 (Intended uses), Section 8 (Particulars of local company responsible for placing the cosmetic product in the market), Section 9 (Particulars of person representing the local company), and Section 10 (Particulars of importer) in the notification must be written in Vietnamese or both Vietnamese and English.
3. Amendments to the first part of clause 1 and point b, clause 2, Article 7:
a) Amendments to the first part of clause 1, Article 7:
“1. The applicant shall submit 01 cosmetic product declaration dossier to the competent regulatory agency as prescribed in Article 15 of the Government’s Decree No. 118/2025/ND-CP dated June 09, 2025.
In case the dossier is submitted via the National Public Service Portal, the applicant shall comply with the provisions of the Government’s Decree No. 45/2020/ND-CP dated April 08, 2020, Government’s Decree No. 68/2024/ND-CP dated June 25, 2024 and Government’s Decree No. 69/2024/ND-CP dated June 25, 2024:”;
b) Amendments to point b, clause 2, Article 7:
“b) In case the notification dossier fails to satisfy the regulations of this Circular, within 05 working days from the date on which the dossier is received, the receiving authority shall inform the applicant in writing of inadequate details for revision (specify the inadequate details).
Within 05 working days from the date on the dossier revised according to this Circular is received, the competent regulatory agency shall issue a cosmetic product notification number.
In case the notification dossier fails to satisfy the regulations of this Circular, within 05 working days from the date on which the dossier is received, the receiving authority shall inform the applicant in writing of inadequate details for revision (specify the inadequate details).
Additional documents include:
– Written explanation for the revision provided by the organization or individual notifying cosmetics in their name;
– A notification of cosmetic product enclosed with other documents revised.”
4. Amendments to point a, clause 2, Article 35:
“a) Any organization or individual that imports cosmetics for research or testing must send the order for import of cosmetics for research or testing according to the regulations in Annex No. 14-MP to this Circular to the specialized health authority affiliated to the People’s Committee of the province where the establishment’s head office is located. The maximum quantity for each product is 10 specimens.
If the manifest is submitted online: 01 electronic copy of the order must bear the signature of the legal representative or the signature, full name and seal of the person authorized by the legal representative (electronic or digital signature is accepted). If the importer is a household business, it is not required to affix the seal of the household business to the order.
If the order is submitted in person or via postal service: 02 physical copies of the order must bear the signature of the legal representative or the signature, full name and seal of the person authorized by the legal representative (signature seal is not permitted) and the stamp across the margins of sheets (if the order consists of at least 02 sheets). If the importer is a household business, it is not required to affix the seal of the household business to the order. The household business owner must affix his/her signature to all pages of the order. After obtaining the approval, 01 copy shall be kept at the specialized health authority affiliated to the provincial People’s Committee while 01 copy is sent to the importer. The copy sent to the importer must bear the seal that reads “Copy for importer” in order to be presented to the customs authority upon following customs clearance procedures.
Within 03 working days from the date of receiving the order for import of cosmetics for research or testing, the specialized health authority affiliated to the provincial People’s Committee shall approve the order. If the order is not approved, it is required to provide a written explanation.
Cosmetic products Imported for research and testing must be used for their intended purposes and not be placed in the market for circulation.”.
5. Amendments to clause 1, Article 48:
“1. Organizations and individuals responsible for placing cosmetic products in the market must be totally responsible before the law for the accuracy, legitimacy and truthfulness of particulars specified in notifications of cosmetic product and documents in the cosmetic product notification dossiers; be responsible for the conformity and consistency of particulars on the notification of cosmetic product specified in clause 1 Article 5 of this Circular and particulars of documents in the cosmetic product notification dossiers submitted to receiving authorities; be totally responsible for the safety, efficacy and quality of products in order to guarantee that circulated products satisfy all requirements of the ASEAN Agreement on Cosmetics and Annexes attached thereto.”.
6. Replacement of Annex No. 14-MP with Annex attached to this Circular.
Article 2. Replacement of some terms of Circular No. 06/2011/TT-BYT
1. The term “Department of Health” is replaced by “specialized health authority affiliated to the People’s Committee of the province” in point b, clause 1, Article 7.
2. The term “Department of Health of Hanoi” is replaced by “specialized health authority under People’s Committee of Hanoi City” in Article 8 and Annex No. 11- MP attached to Circular No. 06/2011/TT-BYT.
3. (1) The term “Department of Health of province or central-affiliated city” in clause 4, Article 33; point b, clause 1, Article 41; point b, clause 2, Article 45; point b, clause 2, Article 46; (2) The term “Departments of Health of provinces and central-affiliated cities” in points a and b, clause 1, Article 41; clauses 2 and 3, Article 50; (3) The term “Department of Health” in clause 4, Article 50; Annex No. 11-MP; Annex No. 15-MP; Annex No. 16-MP attached to Circular No. 06/2011/TT-BYT; (4) The term “Department of Health of province/city” in Annex No. 10-MP; Annex No. 11-MP; Annex No. 15-MP; Annex No. 16-MP; Annex No. 17-MP attached to Circular No. 06/2011/TT-BYT are replaced with ” specialized health authorities affiliated to provincial People’s Committees”.
4. The phrase “đường bưu điện” is replaced with the phrase “dịch vụ bưu chính” in clause 1, Article 38.
5. The phrase “Directors of Departments of Health of provinces and central-affiliated cities” is replaced by “Heads of specialized health authorities affiliated to provincial people’s Committees” in clause 3, Article 53.
6. The term “(PROVINCIAL / MUNICIPAL) HEALTH SERVICE” is replaced by “PROVINCIAL HEALTH SERVICE” in Annex No. 12-MP attached to Circular No. 06/2011/TT-BYT.
This Circular comes into force from August 18, 2025.
Article 4. Transitional provision
The dossiers submitted before the effective date of this Circular shall be effective in accordance with regulations at the time that the dossiers are submitted, or in accordance with this Circular from the effective date of this Circular in a manner that facilitates and simplifies administrative procedures for enterprises, organizations and individuals.
If reference legislative documents and regulations in this Circular is amended or replaced, the newer documents shall prevail.
1. People’s Committees of provinces and cities are responsible for directing specialized health authorities affiliated to provincial People’s Committees to carry out online administrative procedures for issuing a cosmetic product notification number for domestic cosmetic products and approving the order for import of cosmetics for research or testing as prescribed in this Circular.
2. The Chief of Ministry Office; Head of Drug Administration of Vietnam; Heads of units affiliated to the Ministry of Health; Heads of specialized health authorities affiliated to provincial People’s Committees; relevant authorities, organizations and individuals are responsible for implementing this Circular.
Authorities, organizations, individuals shall report any issues arise during the implementation to the Ministry of Health (Drug Administration of Vietnam) for consideration and resolution./.
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PP. MINISTER Do Xuan Tuyen |
