Vietnam Draft Cosmetic Decree Signals Tougher Compliance Environment

On February 2, 2026, Vietnam’s Ministry of Health published a draft “Decree on Cosmetic Management” that would replace the country’s long-standing cosmetic rules under “Circular No. 06/2011/TT-BYT” and consolidate related requirements now scattered across multiple instruments, including “Decree No. 93/2016/NĐ-CP” and “Circular No. 34/2025/TT-BYT”.

For foreign cosmetic manufacturers, the draft points to a more structured Vietnam cosmetic regulation system with stronger post-market oversight, clearer product safety expectations, and more defined accountability across the supply chain.

Vietnam’s Cosmetic Regulatory Framework Is Moving Toward Consolidation

Vietnam’s cosmetic regulatory framework has developed through a series of circulars and decrees issued at different times and addressing different aspects of cosmetic oversight. While these rules largely reflect ASEAN cosmetic regulatory principles, their fragmented structure has created practical challenges for both regulators and industry.

Compliance Challenges Under Vietnam’s Current Cosmetic Regulations

Vietnam’s current regime still relies heavily on “Circular No. 06/2011/TT-BYT”, which governs product notification, Product Information Files (PIF), labeling, advertising, quality control, and company responsibilities. Manufacturing conditions are regulated separately under “Decree No. 93/2016/NĐ-CP”, while “Circular No. 34/2025/TT-BYT” recently amended parts of the earlier circular.

In practice, several issues have emerged under this framework:

• Five-year validity of product notification numbers without periodic review
• Limited CGMP documentation requirements for imported cosmetic notifications
• Weak coordinated enforcement against misleading advertising
• Practical difficulties classifying borderline products based on intended use

These gaps have created compliance uncertainty for businesses and enforcement challenges for regulators, as companies often must interpret overlapping rules rather than operate under a single consolidated compliance framework.

How the Draft Decree Would Reshape Cosmetic Regulation in Vietnam

The draft decree would consolidate these requirements into a single legal instrument while introducing tighter lifecycle oversight of cosmetic products placed on the Vietnamese market.

A central feature of the proposal is its reliance on a “businesses take responsibility first — authorities inspect later” model. Under this approach, greater responsibility would fall on the declaring entity at the start of the product lifecycle, while regulators retain broad powers to:

• Review records afterward
• Revoke previously issued declarations
• Conduct surprise inspections
• Order recalls
• Impose penalties where dossiers are incomplete or noncompliant

For importers, brand owners, and local representatives, the implication is clear: a successful cosmetic notification will not shield products from regulatory scrutiny. Companies must ensure that Product Information Files, safety documentation, labeling, and supporting records are complete and inspection-ready from the outset.

While broadly aligned with ASEAN cosmetic regulatory principles, the draft introduces more detailed compliance procedures and clearer accountability mechanisms than those currently applied in Vietnam.

Key Regulatory Changes Proposed in Vietnam’s Cosmetic Draft Decree

The draft decree introduces a more detailed regulatory framework covering product safety, product declarations, manufacturing oversight, imports, labeling, advertising, and enforcement.

Stronger Cosmetic Safety and Quality Standards

The draft states that cosmetic products must meet ASEAN requirements on heavy metals, microorganisms, and trace impurities. It also ties formulations to the annexes of the ASEAN Cosmetic Agreement in their latest updated version and requires safety assessment in line with ASEAN cosmetic safety guidance. In addition, manufacturers’ internal product quality standards would need to be maintained and published in accordance with Vietnam’s law on standards and technical regulations.

For companies marketing products in Vietnam, this would make technical file preparation more important, especially where formulations, safety substantiation, and internal specifications must stand up to later review.

A More Documentation-Driven Cosmetic Notification Process

The draft would require a cosmetic product declaration dossier to include product quality standards in cases where the applicable standard is a company standard and has not yet been published in the national database on standards, measurement, and quality. The draft also indicates that the receiving authority would publish the declaration information or receipt number within a short administrative timeline once a complete dossier is received.

This is likely to increase scrutiny of dossier quality at the company level, even if the legal structure remains notification-based rather than pre-approval-based.

Consolidated Rules for Cosmetic Manufacturing in Vietnam

The draft would unify the conditions for granting the Certificate of Eligibility for Cosmetic Production and CGMP certification. It also introduces periodic reassessment of production facilities every three years and more specific rules on certificate revocation.

This would be especially relevant for companies using Vietnam-based production partners, contract manufacturers, or semi-finished product operations.

Clearer Import Requirements for Cosmetics Entering Vietnam

The draft states that imported cosmetic products must be declared before customs clearance, while carving out exceptions such as research and testing imports, diplomatic imports, and personal gifts not intended for commercial use. It also adds a framework for issuing Certificates of Free Sale for domestically manufactured cosmetics intended for export.

For overseas manufacturers, that reinforces the need to align customs, notification, and local representative arrangements before product launch.

Stronger Control of PIF, Cosmetic Labeling, and Advertising

The draft requires the Product Information File to be kept at the declaring facility and made readily available to the competent authority. It also links labeling to Vietnam’s labeling laws while requiring mandatory content consistent with the ASEAN cosmetic framework, including product name, origin, uses, ingredients, directions, warnings, and expiry date. Advertising would not require prior content verification, but it would have to remain consistent with the declared product information.

This is an important point for multinational cosmetic brands. Even without pre-clearance of advertising content, authorities would have a clearer basis to challenge claims that overstep the notified product scope.

Risk-Based Post-Market Surveillance for Cosmetic Products

One of the most significant changes in the draft decree is the expansion of Vietnam’s post-market surveillance system for cosmetics. Under the proposal, authorities would apply a risk-based oversight model to monitor cosmetic safety and regulatory compliance after products enter the market.

Post-market inspections may examine multiple aspects of compliance, including:

• Product declaration and notification compliance
• Manufacturing conditions
• Product Information File (PIF) documentation
• Cosmetic labeling and advertising practices
• Complaint handling procedures
• Product recall implementation

To support this oversight framework, the draft also establishes clearer timelines for regulatory dossier inspections following cosmetic notification.

The proposed system distinguishes between two categories of products:

• Priority cosmetics: The declaring entity must submit specified PIF documents within 30 days of receiving an inspection request. Authorities must complete the dossier and PIF review within 45 days of that request.
• Other cosmetic products: The receiving authority must complete inspection of the cosmetic notification dossier within three months from the date the product information is published.

Together, these provisions signal a shift toward more structured and predictable post-notification oversight. For companies marketing cosmetics in Vietnam, maintaining complete, inspection-ready documentation — particularly the PIF and supporting technical records — will become increasingly important under the evolving regulatory framework.

Expanded Recall and Enforcement Powers

The draft also strengthens the enforcement side of Vietnam cosmetic regulation. This is where foreign manufacturers need to pay close attention to local partner performance.

The proposal would authorize recalls for products that violate quality, composition, or labeling requirements. It also sets out responsibility for testing costs where violations are confirmed and would allow authorities to temporarily suspend acceptance of registration applications from establishments that repeatedly violate the rules, intentionally provide false information, or are repeatedly sanctioned.

For overseas applicants, these provisions increase the importance of choosing a competent local declaring entity and maintaining strong control over the accuracy of submitted information and marketed claims.

Higher Scrutiny for Certain Cosmetic Product Categories

The draft introduces additional post-distribution testing requirements for certain higher-risk cosmetic categories, including:

• Skin-whitening products
• Talcum powder
• Sunscreens
• Cosmetics intended for use by pregnant women or children

Within 30 days after market placement, distributors must send product samples to independent laboratories meeting Good Laboratory Practice (GLP) standards or accredited under ISO/IEC 17025.

This requirement may not apply if the manufacturer’s own laboratory has already tested all relevant quality indicators and meets GLP, ISO/IEC 17025, or GMP standards.

The provision introduces a defined testing timeline that companies must factor into product launch and post-market compliance planning.

Clearer Defined Supply Chain Responsibilities

The draft distinguishes the responsibilities of the declaring entity, manufacturer, importer, and seller. It also places express responsibility on establishments to handle customer complaints about cosmetic quality.

Where a sample fails to meet quality standards, the establishment must compensate customers in line with consumer protection law and notify the Ministry of Health and the relevant provincial People’s Committee in writing within 24 hours of receiving the test result.

That level of procedural detail is important for foreign cosmetic manufacturers. It means complaint handling, adverse quality events, and local escalation procedures should be documented contractually with Vietnamese importers, distributors, or authorized representatives.

What Foreign Manufacturers Should Do Now

Although the draft decree has not yet replaced the current regulatory framework, it clearly signals the future direction of Vietnam cosmetic regulation. Therefore, companies currently selling or planning to sell cosmetics in Vietnam should begin reviewing their compliance strategies.

Key preparation steps include:

• Review whether current product dossiers and PIFs could withstand post-notification inspection
• Check whether product claims, labeling, and advertising are fully aligned with declared product information
• Reassess technical documentation for higher-risk product categories
• Confirm the roles and contractual responsibilities of the local declarant, importer, distributor, and manufacturer
• Plan for stronger complaint handling, recall response, and testing readiness

Vietnam’s Draft Decree Points to a More Demanding Compliance Environment

Vietnam’s February 2, 2026 draft “Decree on Cosmetic Management” signals a shift toward a more structured and enforcement-driven regulatory system. By consolidating existing rules and strengthening post-market oversight, the proposal would align Vietnam’s cosmetic framework more closely with international regulatory practices while increasing accountability across the supply chain.

For foreign manufacturers, this creates a practical challenge: ensuring that cosmetic notifications, Product Information Files, labeling, and local market oversight remain fully compliant under a more inspection-driven regulatory environment.

For expert support with local representation, cosmetic notification strategy, and ongoing compliance management in Vietnam as the regulatory framework continues to evolve, contact Cisema today.

Further Information

Explore Cisema’s services for cosmetic registration in Vietnam, including regulatory representation, cosmetic notification, and compliance support for foreign manufacturers.

Explore our insights on cosmetic registration in Vietnam:

• Vietnam Cosmetic Registration & Notification Guide: Process, Fees, and Timelines
• Vietnam Cosmetics Registration: What Japanese Cosmetics Manufacturers Need to Know

Read related news:

• Vietnam Strengthens Enforcement of Cosmetic Notification and PIF Compliance

References

• “Draft Decree on the Management of Cosmetics” (February 2, 2026) — Ministry of Health of Vietnam.
• “Circular No. 06/2011/TT-BYT on Cosmetic Management” (January 25, 2011) — Ministry of Health of Vietnam.
• “Decree No. 93/2016/NĐ-CP on Conditions for Cosmetic Production” (July 1, 2016) — Government of Vietnam.
• “Circular No. 34/2025/TT-BYT Amending Circular No. 06/2011/TT-BYT on Cosmetic Management” (July 3, 2025) — Ministry of Health of Vietnam.