Vietnam Regulatory News

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. 

On October 10, 2024, the Minister of Industry and Trade (MOIT) officially issued Amendment 1:2024 QCVN 05A:2020/BCT, which amends the National Technical Regulation on Safety in Production, Commerce, U...

On October 10, 2024, the Minister of Industry and Trade (MOIT) officially issued Amendment 1:2024 QCVN 05A:2020/BCT, which amends the National Technical Regulation on Safety in Production, Commerce, Use, Storage, and Transportation of Hazardous Chemicals (QCVN 05A: 2020/BCT), through Circular No. 19/2024/TT-BCT. The amendment, developed by the Drafting Team to address practical challenges in hazardous chemical management, was evaluated by the Ministry of Science and Technology and approved by the Vietnam Chemicals Agency. 

Background on QCVN 05A: 2020/BCT and Amendment Process 

The management of chemical activities in Vietnam has generally improved since December 21, 2020, when Circular No.48/2020/TT-BCT promulgated QCVN 05A: 2020/BCT. However, the practical implementation has shown that some of the provisions are incorrect or impractical, thus necessitating the amendment. 

After consulting on a proposed amendment to the National Technical Regulation, MOIT submitted it to the Vietnam Chemicals Agency for approval on March 22, 2024. Only a few of the provisions of QCVN 05A:2020/BCT were amended in Amendment 1:2024. The remaining elements of QCVN 05A:2020/BCT, which was issued in conjunction with the Minister of Industry and Trade's Circular No. 48/2020/TT-BCT on December 21, 2020, are retained. 

Key Provisions and Compliance Deadlines 

This Circular comes into force on April 15, 2025. All factories and warehouses containing hazardous chemicals that are put into operation before April 15, 2025, must meet the requirements laid down in Amendment 1:2024 QCVN 05A:2020/BCT by April 15, 2026, at the latest. 

Appropriate leak and spill warning devices must be installed in factories and warehouses handling hazardous chemicals in liquid and gaseous form. Surveillance cameras are required for solid poisons. Hazardous gas collection and treatment equipment or automatic sprinklers must be installed to respond to accidents involving hazardous substances that can be released into the environment in gas form. 

Chemical collecting systems are required in factories and warehouses containing liquid corrosive chemicals. The minimum capacity of the collecting system must be at least 110% of the capacity of the largest container. Water-reactive chemicals must be placed on pedestals or racks at least 0.3 m above the ground. The storage capacity of the dike system must be at least 110% of the capacity of the largest container. 

Safety Measures for Incident Response 

Every individual in the vicinity of a fire or explosion incident is required to wear personal protective equipment (PPE) in order to assist in victim rescue and incident response. Participation in incident response is prohibited for those without personal protective equipment to ensure safety. Additionally, the amendment requires the use of personal protective equipment (PPE) in the event of a fire or explosion. 

For more details, see Circular No. 19/2024/TT-BCT here. 

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committ...

On 21 November 2024, the two-year grace period for cosmetic products to comply with the updated ASEAN Cosmetic Directive (ACD) ended. The updates were introduced during the 36th ASEAN Cosmetic Committee (ACC) meeting and its related sessions in November 2022. Products that do not meet the updated standards must be withdrawn immediately. The amendments reflect the ASEAN region’s approach to aligning with global safety standards and protecting the health of consumers in its 10 member states.

Key Updates to the ACD

• Annex II – List of substances which must not form part of the composition of cosmetic products

A consolidated list of 37 substances previously banned in the EU, has been added to Annex II of the ACD. These include entries from EU regulations (2019/831, 2019/1966, 2021/850, 2021/1902) that are not currently used in ASEAN countries. Specific compounds such as perboric acid, sodium perborate, boron compounds, octamethylcyclotetrasiloxane (D4), and p-BMHCA have also been included in Annex II.

• Titanium Dioxide Regulation

Revised safety criteria for the use of titanium dioxide as a colouring agent (Annex IV) and as a UV filter (Annex VII) have been adopted as per EU standards.

• Salicylic Acid Regulation

New limits have been introduced for salicylic acid in the Restricted Substance List (Annexes III) and in the Preservatives list (Annex VI), used in body creams, lotions, and other specific applications.

Implications for Industry

Cosmetic manufacturers, traders, and distributors were granted a two-year grace period to reformulate, test and phase out non-compliant products. With the end of this period concluded, compliance is now mandatory, ensuring that products meet updated safety requirements.

Detailed guidelines for compliance can be found here.

On August 1, the Committee on Science, Technology, and Environment held a workshop at the National Assembly Office Headquarters, to provide input on the updated draft Law on Chemicals. Le Quang Huy, t...

On August 1, the Committee on Science, Technology, and Environment held a workshop at the National Assembly Office Headquarters, to provide input on the updated draft Law on Chemicals. Le Quang Huy, the Committee Chairman, presided over the workshop. As a result, a wealth of information was provided, including how the chemical industry is developed, managed, and used to ensure compliance with existing laws and standards. 

Conference Participants 

The workshop was attended by members of many National Assembly committees, as well as representatives of the Nationality Council and the Committee on Science, Technology, and the Environment.. Mr. Phung Manh Ngoc, Director of the Chemical Department (Ministry of Industry and Trade), delegates, specialists, and scientists, as well as representatives from several other key ministries and branches, were present on the side of the drafting agency of the Chemical Law project. 

Scope of the Updated Law 

The updated Law on Chemicals covers agencies, organizations, and individuals involved in chemical activities within the borders of the Socialist Republic of Vietnam; Vietnamese organizations and individuals; foreign organizations and individuals involved in chemical activities; and individuals investing in and building chemical projects. 

Key Objectives  

Based on political, legal, and practical considerations, the Government suggests to amend the 2007 Law on Chemicals in order to: ensure legal consistency; comply with international treaties to which Vietnam is a party; overcome obstacles and shortcomings in the implementation of the 2007 Law on Chemicals; and concretize the Party’s guidelines on the development of the chemical industry as a fundamental industry that meets the demand for basic manufacturing supplies of the economy and serves industrialization and modernization of the nation. 

The 89 articles that make up the updated draft Law on Chemicals are divided into 10 chapters. The regulatory scope of the Law covers chemical activities, industry development, items containing hazardous chemicals, chemical activity safety, rights and obligations of organizations and individuals engaged in chemical activities, and state administration of chemicals. 

On June 11, 2024, Vietnam promulgated Decision No. 496/QD-TTg, establishing a national plan for the management and removal of restricted substances that deplete the ozone layer and greenhouse gases, w...

On June 11, 2024, Vietnam promulgated Decision No. 496/QD-TTg, establishing a national plan for the management and removal of restricted substances that deplete the ozone layer and greenhouse gases, which took effect immediately upon its announcement. 

Commitment to International Protocols 

The study of ozone levels is critical for human activities and manufacturing worldwide. Vietnam is preparing to approve its membership of the Montreal Protocol on Substances that Deplete the Ozone Layer and the Vienna Convention for the Protection of the Ozone Layer. This includes the implementation of the 19th Project, which focuses on substances that deplete ozone levels and their complete regulations, policies, phase-out and control. 

Classification and Regulation 

The Montreal Protocol classifies substances and compounds into two main categories:  

1. Products and substances, machinery and materials from the production, import, export and consumption, gathered, such as methyl chloroform, carbon tetrachloride (CTC), halon, hydrobromofluorocarbons (HBFCs), bromochloromethane and chlorofluorocarbons (CFCs).  

2. Conditions of control and detergents. 

Only methyl bromide is imported for use in accordance with the licence; export goods' translation and sterilization; hydrofluorocarbons (HFCs) substances are only imported in accordance with the quota distributed in accordance with ten regulations in 2024; hydrochlorofluorocarbon (HCFC) substances are only imported in accordance with strict quality standards, classified according to ten regulations, and used for import and export in 2040. 

Consumption Targets 

Hydrochlorofluorocarbons (HCFCs): By December 31, 2024, national consumption will not exceed 2,600 tonnes per year, representing a 35 % decrease in consumption relative to the base consumption. 

Hydrofluorocarbons (HFCs): Between 2024 and 2029, the country's total consumption should not exceed 14.0 million tonnes of CO2 equivalent or the baseline consumption level. 

Objectives 

The objective is to make a good faith commitment to refrain from producing, importing, exporting, or using waste materials; goods and machinery made from or containing chemicals such as phenol chloroform, cyclohexane, halon, HBFC, methyl chloroform, HCFC 141 b, and HCFC-141 b in polyol products; import and export of other HCFC compounds not to exceed 2040. Methyl bromide should be used specifically for antibacterial and anti-inflammatory applications. Reduce HFC emissions by 20% by 2045 and keep the reduction going.