Vietnam Regulatory News

Hanoi — October 2025. The Ministry of Industry and Trade (Vietnam Chemicals Agency) has issued three coordinated draft decrees to operationalize Law on Chemicals No. 69/2025/QH15. Together they es...

Hanoi — October 2025. The Ministry of Industry and Trade (Vietnam Chemicals Agency) has issued three coordinated draft decrees to operationalize Law on Chemicals No. 69/2025/QH15. Together they establish: (1) policy and planning for chemical-industry development and chemical safety–security; (2) operational rules for chemical activities and for hazardous chemicals in products and goods; and (3) consolidated annexed lists of managed chemicals that trigger licensing, declarations, training, and emergency-planning duties.

Decree 1 — Chemical-Industry Development & Chemical Safety–Security

Scope and structure. Spanning eight chapters and 44 articles, this decree translates high-level policy into practical levers for planning, approving, and supervising chemical projects. It defines national strategy processes, assigns roles across central ministries and provincial authorities, and sets expectations for professional consultancy, training, emergency preparedness, and security.

Core policy mechanisms

• Planning & siting: Project approvals tied to safety-distance and spatial-risk criteria; layouts that fail separation standards must be redesigned.
• Green-chemistry integration: Technology selection, feedstocks, and process design must evidence pollution prevention, safer alternatives where feasible, and energy/resource efficiency.
• Data & oversight: Periodic reporting into a national chemicals database to support supervision, benchmarking, and policy review.

Decree 2 — Management of Chemical Activities & Hazardous Chemicals in Products/Goods

Scope and structure. Organized into five chapters and 32 articles, this decree governs lifecycle controls for production, trade, storage, and use, and extends explicit oversight to hazardous chemicals contained in finished goods—aligning industrial regulation with market surveillance.

Operational mechanics

• Licensing and declarations: Risk-proportionate conditions (fit-and-proper, facility controls, competence, recordkeeping) tied to the national lists.
• Digital administration: Applications, renewals, declarations, and incident reporting handled via a centralized platform with standardized identifiers (e.g., CAS/HS) and supply-chain traceability.
• Inspections and enforcement: Risk-based scheduling prioritizing higher-hazard processes and operators with adverse histories; measures aimed at preventing loss/misuse or diversion (including to narcotics or weapons).
• Incident prevention and response: Formal accident-prevention and emergency-response plans required where listed chemicals and thresholds apply.
• Products and goods: Importers, manufacturers, and distributors must maintain evidence files (composition, safety data, conformity evidence) and cooperate with targeted checks and corrective actions.

Decree 3 — Consolidated Lists of Chemicals (Annex System)

Purpose of the annexes. The companion decree publishes five annexes that anchor obligations across the regime:

• Annex I: Basic chemicals in prioritized sectors (strategic planning lens).
• Annex II: Chemicals under conditional production/trade (licensing and competence triggers).
• Annex III: Special-control chemicals (heightened security, handling, and reporting).
• Annex IV: Chemicals requiring a Chemical Accident Prevention and Response Plan (threshold-based emergency-planning duties).
• Annex V: Recognized training disciplines (qualification standards for chemical-safety roles).

Timeline and Outlook

With comments open until 16 November 2025, authorities are moving on an accelerated but synchronized schedule. The three decrees are intended to be adopted together on 1 December 2025 and to take effect on 1 July 2026, ensuring that policy, operational controls, and annexed lists align on day one. For industry, this means a predictable transition to a lifecycle-based system that links spatial risk, licensing and declarations, product oversight, and digital reporting, while setting clearer expectations for competence and emergency readiness.

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, manufac...

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.

On September 5, 2025. Vietnam’s Ministry of Industry and Trade (MOIT) has opened consultation on a draft Government Decree that will operationalize the new Law on Chemicals No. 69/2025/QH15. The D...

On September 5, 2025. Vietnam’s Ministry of Industry and Trade (MOIT) has opened consultation on a draft Government Decree that will operationalize the new Law on Chemicals No. 69/2025/QH15. The Decree—described by MOIT’s Chemicals Agency as the “backbone” for implementation—details state management of chemical activities and control of hazardous chemicals in products and goods.

Why it matters

The Decree will translate the 2025 Law on Chemicals (effective January 1, 2026) into practice—setting procedures for new-chemical registration, information management and confidentiality, and controls on hazardous chemicals in products. It will also modernize the regulatory regime following Decree 113/2017/ND-CP and its 2022 amendments, with an emphasis on administrative simplification and digital government.

Structure at a glance

According to MOIT, the draft features 5 Chapters and 32 Articles:

• Chapter I — Scope, definitions, and allocation of state management responsibilities.
• Chapter II — Management of chemical activities (e.g., manufacture, import, trade, use).
• Chapter III — Chemical information: new-chemical registration and evaluation, management of new chemicals, confidential business information (CBI) protections, and digital transformation in state oversight.
• Chapter IV — Hazardous chemicals: list management, production/process controls, and public disclosure requirements for hazardous chemical content in products.
• Chapter V — Implementation clauses: transitional provisions and effective date.

Legal basis and timetable

• The National Assembly adopted the Law on Chemicals No. 69/2025/QH15 on June 14, 2025 (effective January 1, 2026).
• On July 14, 2025, the Prime Minister issued Decision No. 1526/QD-TTg, assigning MOIT to draft the implementing Decree and submit it to the Government by October 15, 2025.
• MOIT convened the drafting taskforce on August 29, 2025 to review the first consultation draft and affirmed the accelerated timeline.

Policy orientation

MOIT notes the Decree is being built in the spirit of Resolution 66-NQ/TW (April 30, 2025) of the Politburo on renewing law-making and law-enforcement to drive development—emphasizing practical, system-wide, and pro-growth reforms, including stronger decentralization and streamlined procedures.

What could change for businesses

• New-chemical regime: Clearer rules for registration and evaluation of substances not yet on Vietnam’s lists; governance of new chemicals after approval.
• CBI handling: Formalized pathways to protect sensitive information while meeting disclosure and safety obligations.
• Product controls: A framework to list and control hazardous chemicals in products/goods, including disclosure of hazardous contents and controls across manufacturing processes.
• Digital oversight: Movement toward digitalized submissions and supervision in chemical management.
• Continuity and transition: Alignment with and eventual replacement/overhaul of procedures under Decree 113/2017/ND-CP (and Decree 82/2022/ND-CP amendments), with transitional clauses anticipated in Chapter V.

Administrative reform focus

In line with Government directives on cutting business conditions, simplifying administrative procedures, and decentralizing decision-making, the drafting team is reviewing additional reductions and simplifications beyond those already approved under national programs (e.g., Decisions 1661/QD-TTg and 1015/QD-TTg).

Next steps

• Consultation: MOIT and the Chemicals Agency are receiving comments to refine the first-round draft.
• Submission target: The drafting taskforce plans to submit the dossier by October 15, 2025 to keep the Decree on track ahead of the January 1, 2026 law effective date.

On 23 June 2025, Vietnam’s Ministry of Industry and Trade (MOIT) issued Decision 1781/QD-BCT, introducing revised procedures for granting, amending, and re-granting licenses for the transport of dan...

The Vietnamese Ministry of Health has released a new draft decree on cosmetics management. The proposed decree aims to improve the safety of cosmetics and how products are controlled in the market. It...

The Vietnamese Ministry of Health has released a new draft decree on cosmetics management. The proposed decree aims to improve the safety of cosmetics and how products are controlled in the market. It also aligns Vietnam’s requirements with ASEAN regional standards.

Key Highlights

1. Scope and Definitions

• The decree governs the classification, declaration, production, import/export, labeling, advertising, quality control, and recalls of cosmetic products.

• Defines terms such as “cosmetics,” “responsible entity,” and “product owner.”

• Declaration forms certify eligibility for market circulation but are not proof of safety or efficacy.

2. Safety and Quality Standards

• Products must be safe for normal use.

• Ingredients must comply with ASEAN limits on heavy metals, microbes, and banned substances.

• The Ministry of Health will maintain and update lists of restricted substances.

3. Classification and Product Declarations

• Cosmetics are classified by ingredients, purpose, and application method.

• Products intended for internal use or for permanently altering body functions are not considered cosmetics.

• Declaration forms are valid for 3 years and businesses must be legally registered.

• Import declarations are handled by the Ministry of Health and domestic declarations by Provincial Committees.

4. Certificates and Facility Requirements

• Certificate of Free Sale (CFS): Required for imports unless exempted for CPTPP or ASEAN countries with proper proof.

• Good Manufacturing Practice (GMP): Foreign manufacturers must have valid GMP certificates.

• Cosmetic production facilities must meet stringent standards for hygiene, personnel qualifications, equipment, and quality control.

• Existing facilities certified under previous decrees have a transition period until mid-2028.

5. Labeling and Advertising

• Labels must be clear, truthful, in Vietnamese, and display mandatory information such as ingredients, batch numbers, and expiry dates.

• Advertising must avoid misleading claims or phrases such as ‘miracle cure’ or ‘instant whitening’.

• No references to medical professionals or endangered species are allowed.

6. Product Sampling, Testing and Recall

• Random sampling by authorities ensures compliance.

• Recall procedures are clearly defined, including mandatory and voluntary recall processes.

• Non-compliant products must be recalled and destroyed, and the responsible parties must bear the costs.

7. Enforcement and Penalties

• Suspension of declaration dossiers is possible for violations such as smuggling or the use of banned ingredients.

• Penalties include revocation of certificates, product withdrawal, and fines.

• Authorities will conduct regular inspections and enforce compliance.

8. Import and Export Regulations

• Export of Vietnamese cosmetics is encouraged with proper CFS documentation.

• Imports must have valid declarations; restricted use applies to imports for research/testing.

• Customs rules apply to gifts, personal luggage, and diplomatic consignments.

9. Organizational Responsibilities

• The Ministry of Health is responsible for state management, policy issuance, training, and inspection.

• Provincial Committees handle local inspections and enforcement.

• Other ministries, including Industry and Trade, Culture and Tourism, Science and Technology, and Finance), support relevant oversight roles.

• Marketers, manufacturers, and importers must ensure product compliance, maintain records, and cooperate with authorities.

10. Implementation Timeline

• Decree effective July 1, 2026.

• Existing certificates remain valid until June 30, 2028.

• Post-2028, all manufacturers must comply with the updated requirements and reapply.

On March 5, 2025, the National Assembly of Vietnam published the second draft of the amended Law on Chemicals, scheduled to take effect on January 1, 2026. This revision amends the 2007 Law on Chemica...

On March 5, 2025, the National Assembly of Vietnam published the second draft of the amended Law on Chemicals, scheduled to take effect on January 1, 2026. This revision amends the 2007 Law on Chemicals and introduces sweeping changes to strengthen the regulatory framework, enhance public safety, and bring it into line with global chemical safety standards.

The updated law simplifies the structure into 8 chapters and 50 articles, significantly broadening its scope to include hazardous chemicals in consumer products, chemical usage across industries, and newly regulated areas such as chemical consulting and risk prevention. Key provisions also address environmental sustainability, public transparency, and emergency response requirements.

Key Legislative Changes:

Expanded Scope and Modern Definitions

• Includes hazardous chemicals in products, not just pure substances.

• Introduces new definitions, including green chemistry, chemical security, industrial chemical zones, and chemical databases.

• Formally defines and regulates activities such as consulting, risk prevention, and emergency planning.

 Prohibited Activities

• Bans unauthorized use, production, or storage of dangerous chemicals.

• Prohibits concealing hazards, illicit chemical trade, and use in unapproved sectors (e.g., food, pharmaceuticals).

National Strategy for Industrial Development

• A national strategy will be developed for chemical industry growth with 10-year planning cycles and a 30-year vision.

• Focus areas include basic chemicals, petrochemicals, pharmaceuticals, and renewable-based materials.

• Emphasizes alignment with green chemistry and national defense priorities.

Mandatory Compliance Requirements

• Projects must comply with laws on environmental protection, construction, fire safety, and chemical security.

• Reports must include details on technology selection, chemical safety, and compliance with green chemistry principles.

• Chemical facilities must maintain minimum safe distances from sensitive zones.

New Licensing and Compliance Controls

• Chemicals are categorized as follows:

  • Controlled chemicals

  • Special control chemicals

  • Prohibited chemicals

• Licensing is required for production, use, import/export, and even consulting services.

• Certification and competence requirements are introduced for individuals and organizations involved in specialized chemical consulting.

Management of Chemicals in Consumer Products

• Manufacturers must disclose hazardous substances in end products.

• Additional obligations for:

  • Product labelling according to the Globally Harmonized System (GHS)

  • Laboratory testing

  • Risk management

Integration with Global Standards

• Adopts GHS for labelling and classification.

• Aligns with relevant international treaties and chemical trade agreements.

Transitional Provisions

• Companies with existing permits for chemical manufacturing, trading, or import/export can continue operations until their permits expire.

• Businesses certified for conditional chemical manufacturing or trading may operate until December 31, 2027.

• Chemical storage operators must prepare accident prevention and response plans by December 31, 2027.

 On 4 March 2025, the Vietnam Food Administration (VFA) published a summary of urgent issues to be addressed in a forthcoming amendment to Decree 15/2018/ND-CP. The proposed amendments aim to streaml...

 On 4 March 2025, the Vietnam Food Administration (VFA) published a summary of urgent issues to be addressed in a forthcoming amendment to Decree 15/2018/ND-CP. The proposed amendments aim to streamline administrative procedures, delegate responsibilities, and strengthen post-market food safety supervision.

Decree 15/2018/ND-CP outlines the implementation of the Law on Food Safety in Vietnam. This decree has been amended and supplemented by several documents, ensuring enhanced food safety and efficient regulatory procedures for food production, trade, and imports.

Key Provisions of Decree 15/2018/ND-CP:

These are the key provisions of Decree 15/2018/ND-CP:

• Self-Declaration and Registration of Products: Procedures for self-declaration and registration of food products for safety compliance. 

• Genetically Modified Foods: Regulations to ensure the safety of genetically modified foods. 

• Food Safety Certificates: Issuance of certificates for establishments that meet food safety standards. 

• Imported and Exported Foods: State inspection on food safety for both imports and exports. 

• Food Labelling and Advertising: Guidelines on food labelling and advertising practices to ensure transparency and consumer safety. 

• Health-Protective Foods: Conditions ensuring safety in the production of health-protective foods. 

• Food Additives: Standards for the production, trade, and use of food additives. 

• Traceability: Ensuring the traceability of food origins to enhance safety. 

• State Management Responsibility: Clear allocation of state management responsibilities for food safety. 

State Inspection Authority for Imported Foods: 

Article 15 of Decree 15/2018/ND-CP designates the State Inspection Authority for Imported Foods as the relevant agency from the Ministries of Health, Agriculture and Rural Development, or Industry and Trade. The authority is responsible for: 

• Deciding inspection methods based on past successful inspections. 

• Ensuring food safety compliance during inspections. 

• Collecting and managing inspection-related fees. 

• Providing transparent and accurate inspection results. 

Recent Amendments and Supplementary Documents: 

• Decree 155/2018/ND-CP: Amends investment and business conditions within the scope of the Ministry of Health

• Decree 85/2019/ND-CP: Addresses the implementation procedures for administrative tasks under the national single-window mechanism. 

• Official Dispatch 2129/BCT-KHCN (2018): Guides the implementation of food safety regulations. 

Key Proposals in the 2025 Draft Amendment:

• Simplified Administrative Procedures: Acceptance of electronic copies of legal documents and removal of notarization requirements for consularized English documents.

• Acceptance of Manufacturer Test Results: Acceptance of product test results from Good Manufacturing Practice (GMP).

• Decentralization of Issuing Functions: Local authorities may be authorized to issue Certificates of Free Sale to reduce administrative burden.

• Strengthened Post-Market Surveillance: Increased emphasis on monitoring product quality after market entry to ensure compliance with food safety regulations.