LEGAL FRAMEWORK FOR COSMETIC PRODUCT MANAGEMENT IN VIETNAM - OTIS LAWYERS

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Definition of Cosmetics and Key Terms

Definition of Cosmetics

A cosmetic product is a substance or preparation intended to be applied to external parts of the human body (such as the skin, hair system, nails, lips, and external genital organs), or to the teeth and oral mucosa, for the primary purpose of cleaning, perfuming, altering appearance, protecting, maintaining, or keeping the body in good condition. According to Article 2.1 of Schedule B in the ASEAN Cosmetic Directive, which is part of the ASEAN Cosmetic Harmonization Agreement, Vietnamese law has certain adjustments. However, in general, the definitions and rules align with those in the ASEAN agreement.

The scope of use for cosmetic products is limited to external contact with the body. The main purposes include cleaning, perfuming, altering appearance, regulating body odors, protecting the body, or maintaining it in good condition. A cosmetic product may fulfill one or more of these purposes. The intended use is closely related to the product’s functional evaluation. Today, certain products with special features (e.g., products at the intersection of medicines, cosmetics, medical devices, and disinfectants) can create confusion in product classification. Determining the product type is crucial for compliance with current laws.

Key Terms

Organization or individual responsible for marketing the product: The organization or individual named in the cosmetic product declaration file who is responsible for the product in the market.

Cosmetic product owner: The organization or individual owning the formula, manufacturing process, and product quality standards.

Product declaration receipt number: The number issued by a competent state management agency when receiving a cosmetic product declaration file.

The product declaration receipt number certifies that the product has been declared to the competent state agency for circulation in the market but does not certify the product’s safety, effectiveness, or compliance with all ASEAN Cosmetic Directive requirements and annexes.

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Cosmetic circulation: The display, transport, and storage of goods during sales, excluding transport of imported goods from customs to storage by the importer.

Certificate of Free Sale (CFS): A certificate issued by the competent authority of the exporting country to certify that the cosmetic is manufactured and freely sold in the exporting country.

Regulations on Cosmetic Product Declaration

Obligation to Declare Cosmetic Products

To circulate a cosmetic product, whether domestically produced or imported, the entity responsible for the product must submit a product declaration. This means the product owner and the organization responsible for marketing may be the same or different entities. Establishing agreements and clarifying rights, responsibilities, and limits of liability in contracts between the parties is essential.

The organization or individual responsible for marketing the product must be legally registered to trade in cosmetics in Vietnam.

Declaring the product is mandatory and a prerequisite before product circulation. Circulation is allowed once the competent state agency has issued the product declaration receipt number.

The organization or individual responsible for marketing the product must be entirely accountable for the product's safety, effectiveness, and quality.

The competent state agency will conduct post-market checks after the product circulates in the market.

Product Information File (PIF)

The organization or individual responsible for marketing the product is obligated to prepare and maintain a Product Information File (PIF) for each cosmetic product in circulation. The PIF must comply with ASEAN guidelines and be kept at the location of the organization or individual responsible for marketing the product.

The PIF consists of four parts:

Part 01  

Administrative Documents and Product Summary 

 

 

Administrative Documents:

  • A copy of the Cosmetic Product Declaration Form with the receipt number from the competent state management authority.
  • Authorization letter from the manufacturer or product owner, or a relevant agreement related to the product.
  • Certificate of Free Sale (CFS).
  • Other related administrative documents such as the business registration certificate or investment license of the organization or individual responsible for marketing the product.
  • A list of all ingredients and their percentages in the formula.

Product Label and Information:

  • Product Label:
  • Instructions for use (if applicable).
  • Production Declaration: A declaration from the manufacturer stating that the product is produced according to the “Good Manufacturing Practice” (CGMP-ASEAN) principles of the Association of Southeast Asian Nations or equivalent standards.
  • Batch number or product code system.
  • Cosmetic Product Safety Assessment: Safety declaration (including a conclusion signed by a qualified assessor with their name and certification).
  • Summary of Undesirable Effects on Users (if any).
  • Summary of Product Features and Uses:A report evaluating the product's features and uses based on its ingredients and test results.

Part 02

 

Raw Material Quality

 

Quality Standards and Testing Methods of Raw Materials: For fragrance ingredients, specify the fragrance name and code, name and address of the supplier, and confirm compliance with the guidelines of the International Fragrance Association (IFRA).

Safety Data for Raw Materials: Based on supplier information, published data, or reports from scientific committees (ACSB, SCCP, CIR).

Part 03

Finished Product Quality 

Product Formula: List all ingredients with their full names according to international nomenclature and their percentages in the formula. Clearly specify the function of each ingredient.

Manufacturing: Detailed information about the manufacturer: country, name, and address of the manufacturer and packager.

Production Process Summary: Additional details on the production process, quality management, and related records, which must be available for inspection by regulatory authorities if required.

Standards and Testing Methods for Finished Products: 

  • Criteria used to check the microbial limits in the finished product.
  • Testing methods according to quality standards to ensure compliance.
  • Stability Report (for products with a shelf life of less than 30 months): Report and stability study data or stability evaluation to justify the product's shelf life. 

Part 04  

Safety and Effectiveness 

Safety Assessment: Safety assessment report on human subjects based on the product's formula, the chemical structure of the ingredients, and their harmful thresholds (signed by a qualified assessor).

Assessor's Resume: The resume of the person responsible for the product’s safety assessment.

Latest Report on Adverse Effects or Undesirable Effects (if any), updated regularly.

Documents Explaining the Product's Functions and Uses as Declared on the Packaging: A full report on the product's features and uses evaluation, based on its ingredients and test results (signed by the assessor).

 

Cosmetic Product Declaration File

The declaration file includes the product declaration form, authorization letter, and Certificate of Free Sale (CFS) for imported cosmetic products.

For any questions or comments, please contact:
OTIS AND PARTNERS LAW FIRM
Office address: 2nd Floor, CT3 Building, Yen Hoa Park View Urban Area, No. 3 Vu Pham Ham Street, Yen Hoa Ward, Cau Giay District, Hanoi
Email: info@otislawyers.vn
Hotline: 0987748111

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