The Government of Vietnam has released a draft decree (“Draft Decree”) that proposes a new and more comprehensive legal framework for the management of cosmetic products. Once adopted, the Draft Decree is expected to replace the current regulations under Decree No. 93/2016/ND-CP (“Decree 93”), bringing Vietnam’s cosmetic regulatory framework in closer alignment with international standards, particularly those set out in the ASEAN Cosmetic Directive.
The Draft Decree introduces several notable changes, which are summarized below:
1. Expanded Scope of Regulation
The Draft Decree significantly broadens the scope of regulation beyond the provisions of Decree 93. Key changes include:
- Expanded regulatory coverage to include classification, product notification, manufacturing, import and export, labeling, advertising, quality control, and handling of non-compliant products;
- Adoption of standards under the ASEAN Cosmetic Harmonization Agreement, including mandatory compliance with CGMP-ASEAN and updated annexes on ingredients, heavy metal thresholds, microbial limits, and other impurities; and
- Reduction of the validity period for Cosmetic Product Announcement Certificates from five years to three years.
2. Advertisement and Labeling Controls
To enhance consumer protection and prevent misleading advertising, the Draft Decree sets out stringent requirements governing cosmetic advertisements:
- Therapeutic or medical claims, such as those suggesting treatment of diseases or modification of bodily functions, are strictly prohibited;
- Use of superlative or misleading terms—such as “100% safe,” “best,” “number one,” or “permanent cure”—is banned;
- Endorsements by medical professionals or use of imagery implying medical credibility are not allowed; and
- All advertisements must clearly disclose key product information, including the product name, function, and the responsible organization or individual.
3. Imports, Exports, and CFS Exemptions
The Draft Decree introduces new regulatory requirements for cross-border movement of cosmetic products:
- It provides comprehensive procedures for the import and export of cosmetics, including mandatory product notification prior to customs clearance and defined documentation requirements;
- A detailed import notification process replaces the limited procedural guidance under Decree 93;
- The Certificate of Free Sale (CFS) requirement is now subject to specific exemptions for products originating from CPTPP or ASEAN countries, provided alternative documentation such as legalized proof of circulation or a valid ASEAN-issued product announcement is submitted; and
- Temporary imports for non-commercial purposes—such as exhibitions, testing, and research—are now regulated, requiring prior approval, specific labeling, and formal undertakings from importers.
4. Product Information File (PIF)
Each cosmetic product must be supported by a PIF that complies with ASEAN guidelines. The PIF must include:
- Product summary;
- Raw material and finished product specifications; and
- Safety and efficacy evaluations.
Certain sections of the PIF must be available for immediate inspection upon request by the competent authorities, with the remaining sections to be submitted within 30 days.
Future Implications
The Draft Decree represents a significant step toward harmonizing Vietnam’s regulatory approach with international standards. It is expected to enhance consumer safety, improve transparency in product oversight, and streamline regulatory compliance for domestic and foreign cosmetic businesses operating in Vietnam.
The information provided here is for information purposes only and is not intended to constitute legal advice. Legal advice should be obtained from qualified legal counsel for all specific situations.
