Vietnam: Draft Decree on the Management of Cosmetics

 

Vietnam has published a draft Decree on the Management of Cosmetics.

This draft Decree establishes the regulatory framework for the management of cosmetic products in Vietnam. It sets out rules governing the declaration, manufacture, import, export, labeling, advertising, safety monitoring, and recall of cosmetics.

Specifically, the Decree regulates:

• the declaration and notification of cosmetic products;
• the manufacture of cosmetics within Vietnam;
• the management of imported cosmetics and the issuance of Certificates of Free Sale (CFS) for exported cosmetic products;
• product information dossiers, labeling requirements, and advertising of cosmetics;
• the use of online dossiers, administrative procedures, and electronic record retention;
• inspection, monitoring, and measures to ensure the safety and quality of cosmetic products;
• procedures for recalling cosmetic products, revoking notification receipt numbers, and suspending the acceptance of cosmetic product declaration applications.

The draft Decree applies to both domestic and foreign agencies, organizations, and individuals involved in activities related to cosmetic products in Vietnam.

The document is structured into 10 Chapters comprising 52 Articles, as outlined below.

Chapter I – General Provisions (2 Articles)

This chapter defines the scope of the Decree and the entities to which it applies. It also provides definitions and interpretations of key terms used throughout the regulation.

Chapter II – Cosmetic Product Notification (12 Articles)

This chapter sets out the requirements related to the notification of cosmetic products, including:

• safety and quality requirements applicable to cosmetic products;
• the obligation for cosmetic products to be notified to the competent state authority before they are placed on the market;
• documentation requirements and procedures for product notification, amendments to notification dossiers, and renewal of notification validity.

After notification and public disclosure of product information, the competent authority will conduct post-notification dossier reviews and monitor cosmetic products circulating on the Vietnamese market through inspection and supervision activities.

Chapter III – Manufacture of Cosmetics in Vietnam (7 Articles)

This chapter regulates cosmetic manufacturing activities in Vietnam. It provides that cosmetic manufacturers must meet requirements relating to personnel qualifications, facilities, equipment, and quality management systems.

Manufacturing establishments will be subject to periodic assessments every three years, as well as extraordinary inspections when necessary.

The chapter also:

• establishes unified conditions for the issuance of the Certificate of Eligibility for Cosmetic Manufacture and the Cosmetic Good Manufacturing Practices (CGMP) Certificate;
• assigns provincial People’s Committees the authority to issue, amend, and revoke these certificates;
• specifies circumstances under which the Certificate of Eligibility for Cosmetic Manufacture may be revoked.

Chapter IV – Management of Imported Cosmetics and Certificates of Free Sale (3 Articles)

This chapter governs the management of imported cosmetic products and the issuance of Certificates of Free Sale for exported products.

Imported cosmetics must be notified before customs clearance, except in certain cases such as imports for research or testing, imports by diplomatic missions, or personal gifts not intended for commercial use.

The chapter also outlines procedures for issuing Certificates of Free Sale for cosmetic products manufactured in Vietnam and intended for export.

Chapter V – Product Information File, Advertising, and Labelling (3 Articles)

This chapter establishes requirements concerning product documentation, labeling, and advertising.

Cosmetic products placed on the market must have a Product Information File (PIF) prepared in accordance with ASEAN guidelines.

Product labeling must comply with the legislation on goods labeling and meet the mandatory requirements set out under the ASEAN Cosmetic Agreement.

Cosmetic advertising must comply with applicable advertising laws, and prior approval of advertising content is not required.

Chapter VI – Online Dossiers and Electronic Record Retention (3 Articles)

This chapter introduces provisions on digital administrative procedures, including requirements for submitting dossiers online, conducting administrative procedures electronically, and maintaining electronic records.

Chapter VII – Inspection, Supervision, and Safety Assurance (4 Articles)

This chapter provides rules on monitoring and ensuring the safety and quality of cosmetic products.

It includes:

• procedures for post-notification dossier reviews;
• provisions governing specialized inspections;
• risk-based prioritization of quality inspections based on the level of risk associated with different cosmetic products;
• designation of competent authorities responsible for sampling and testing cosmetic products for quality control purposes.

Cosmetic products that have undergone compliant post-notification dossier review will not be subject to repeated inspection.

Chapter VIII – Product Recall and Revocation Measures (4 Articles)

This chapter sets out the procedures for recalling cosmetic products from the market, revoking notification receipt numbers, and suspending the acceptance of product notification dossiers.

It specifies the circumstances in which recalls or revocations may occur and defines the forms, authority, and responsibilities of relevant parties involved in product recall procedures.

Chapter IX – Organization of Implementation (9 Articles)

This chapter outlines the responsibilities of ministries, government sectors, organizations, and individuals engaged in the manufacture and trade of cosmetic products.

Chapter X – Implementation Provisions (5 Articles)

The final chapter contains provisions regarding the implementation of the Decree, including transitional arrangements, the entry into force of the regulation, reference provisions, and the responsibilities of relevant authorities and stakeholders.

To find out more about compliance for cosmetics in Vietnam and worldwide, do not hesitate to contact the Product Compliance Institute directly.