Vietnam Proposes Comprehensive Cosmetics Decree: New Rules on Notification, CGMP, Labeling, and Market Surveillance

On 4 September 2025, Viet Nam notified the WTO (G/TBT/N/VNM/357) of a Draft Decree on the Management of Cosmetics that would overhaul national requirements for cosmetic product notification, manufacturing conditions, labeling/advertising, market surveillance, and recalls—harmonized with the ASEAN Cosmetics framework. The Ministry of Health (Drug Administration of Viet Nam) targets adoption on 4 November 2025 with entry into force on 1 July 2026. Stakeholders have until 3 November 2025 (60 days from notification) to submit comments.

This proposal signals a shift to a unified, electronic, risk-based regime covering import/export, Certificates of Free Sale (CFS), Product Information Files (PIF), inspection/testing, and enforcement. The draft text spans 10 chapters and 60 articles, mapping responsibilities across central and provincial authorities with detailed transitional arrangements.

Scope and Alignment with ASEAN

The Decree expressly implements the ASEAN Harmonized Cosmetic Regulatory Scheme, adopting the latest ASEAN annexes for ingredient restrictions and safety assessment, and anchoring labeling/claims to ASEAN guidance and the Law on Advertising.

Key Regulatory Pillars

1) Product Notification & PIF

• Mandatory pre-market notification for domestically produced and imported cosmetics; validity 5 years with renewal pathway. PIF content and availability to authorities are prescribed; safety must be assessed per ASEAN guidance.

2) Import/Export and CFS

• Import allowed once the product is notified on the national portals; customs verifies notification status electronically.
• CFS exemptions for products produced in, or exported from, CPTPP or ASEAN member countries, subject to specified documentary alternatives (e.g., proof of legal sale or ASEAN notification).

3) Manufacturing Controls (CGMP/ISO 22716)

• Production sites must meet personnel, facility, and quality-system requirements consistent with CGMP; provincial Health Departments issue/adjust/revoke manufacturing licenses and may also issue CGMP certificates. Periodic/for-cause reassessments apply.

4) Labeling & Claims

• Mandatory label fields include product name, responsible company (in Vietnamese), origin, function/use, INCI ingredient list, manufacturer, batch/production date and expiry/use-after-opening rules, warnings where ASEAN annexes require, notification number, and product standard. Electronic labeling is permitted with conditions. Advertising must reflect notified information and substantiated claims.

5) Post-Market Controls, Testing, and Recalls

• Risk-based oversight: dossier review, targeted sampling/testing (GLP/ISO 17025), required independent testing for higher-risk categories (e.g., whitening, baby/toddler, sunscreen). Serious adverse events trigger expedited reporting and potential market actions. Detailed mandatory recall processes (voluntary or ordered) and suspension/blackout rules are specified.

Safety/Quality Benchmarks (Annexed Limits)

Appendix 1 sets maximum heavy metals (Hg 1 ppm; As 5 ppm; Pb 20 ppm; Cd 5 ppm), microbiological limits (stricter for <3-year-old/eye/mucosal products), and a 10 ppm cap for 1,4-dioxane as a trace impurity—mirroring ASEAN parameters.

Digital Administration

The draft enables full online procedures for notification, renewals, licensing, and archiving; electronic outcomes have equal legal effect to paper. Authorities will publish notified products and licensed manufacturers on official portals to support customs clearance and market surveillance.

Phased Transition

• Adoption: 4 Nov 2025 (proposed). Entry into force: 1 Jul 2026. Comment deadline: 3 Nov 2025.
• From 1 Jan 2027: Renewal procedures begin under the new Decree; shift of notification handling to provincial Health Departments for all products; legacy procedures before this date follow interim rules in Article 56.
• Manufacturing certificates issued under Decree 93/2016: Valid through 31 Dec 2027; from 1 Jan 2028 facilities must meet the new CGMP-based conditions and obtain certificates under the new Decree.
• By 1 Jul 2026: Provincial Health Departments must ensure notified product information is published on the national e-government portal per the digitalization mandate.

Implications for Industry Stakeholders

For importers/brand owners:

• Map all SKUs to ASEAN annex limits; ensure PIF completeness and claim substantiation. Prepare for CFS alternatives where CPTPP/ASEAN exemptions apply. Verify electronic notification visibility for customs.

For manufacturers/contract manufacturers:

• Gap-assess facilities and QMS against CGMP/ISO 22716; plan re-certification before 1 Jan 2028. Align batch control, retention samples, and adverse-event escalation procedures with the Decree’s post-market obligations.

For distributors/retailers and e-commerce:

• Sell only notified cosmetics; maintain traceability docs; be prepared to cooperate with sampling/recalls and to halt distribution upon notices.

Next Steps

Submit written comments by 3 November 2025 to the Viet Nam TBT Enquiry Point and the Drug Administration of Viet Nam using the contact details provided in the WTO notice. Monitor the finalization for any changes to adoption/entry dates and annex alignments.