Preservatives, UV Filters and Colorants in Cosmetics – Top Powerful Compliance Requirements for Cosmetic Notification in Vietnam

Introduction

Cosmetic product notification in Vietnam requires strict compliance with ingredient regulations, which is not merely a technical requirement but a critical factor determining whether a product can be legally placed on the market.

Among all ingredient groups, colorants, preservatives, and UV filters are subject to the strictest control under the ASEAN Cosmetic Directive (ACD) – the regulatory framework currently applied in Vietnam. These ingredients have a direct impact on product safety and consumer health, and therefore require careful selection, strict control, and thorough compliance assessment.

This article provides an overview of the regulatory framework, key compliance requirements, and the practical steps businesses should follow to successfully complete cosmetic product notification in Vietnam.

Overview of ASEAN Cosmetic Directive (ACD)

The ASEAN Cosmetic Directive (ACD) serves as a unified regulatory framework across Southeast Asian countries, including Vietnam, with the aim of harmonizing cosmetic regulations while ensuring product safety and quality.

Under the ASEAN Cosmetic Directive (ACD), cosmetic ingredients are classified into specific annexes, each with clearly defined regulatory scopes:

• Appendix II: List of substances prohibited in cosmetic products
• Appendix III: List of substances permitted with restrictions
• Appendix IV: List of approved colorants
• Appendix VI: List of permitted preservatives
• Appendix VII: List of approved UV filters

Each annex specifies detailed requirements, including maximum concentration limits, labeling obligations, and conditions of use; therefore, businesses planning to introduce cosmetic products to the Vietnamese market must cross-check their ingredients against the relevant annexes.

Colorants

Colorants are ingredients used to create or adjust the color of cosmetic products. They are commonly found in products such as lipsticks, foundations, eyeliners, and hair dyes, and may be of either synthetic or natural origin.

Only colorants listed in Annex IV are permitted for use in cosmetics within ASEAN countries. Each substance is identified by a Color Index (CI) code and is subject to specific purity requirements and conditions of use.

Common examples include iron oxides such as CI 77491, CI 77492, and CI 77499, which are widely used in cosmetic formulations due to their high stability and suitability for leave-on products. In addition, CI 15850 is a red colorant frequently used in lipsticks and certain skincare products.

To ensure compliance with regulatory requirements, businesses may only use substances listed in Annex IV, must strictly adhere to the applicable concentration limits, and ensure that such substances are not included in the list of prohibited substances under Annex II. In addition, maintaining complete technical documentation on ingredient composition and safety is a mandatory requirement.

Preservatives

Preservatives play a critical role in controlling the growth of microorganisms, particularly in products containing water or natural ingredients, thereby helping to maintain product safety and extend shelf life.

Annex VI sets out the list of permitted preservatives, along with maximum concentration limits and corresponding labeling requirements.

Common preservatives include phenoxyethanol (with a maximum concentration of 1%), as well as methylparaben and propylparaben, which are often used in combination to enhance antimicrobial effectiveness.

In practice, businesses must comply with the prescribed concentration limits, include warnings or instructions for use where required, and ensure compatibility between ingredients to maintain product stability and effectiveness.

UV filters

UV filters are active ingredients that help protect the skin from ultraviolet (UV) radiation, thereby contributing to the prevention of sunburn, premature aging, and long-term skin damage. They are commonly used in sunscreens and SPF-containing skincare products.

Only UV filters listed in Annex VII are permitted for use, and their application must fully comply with the specified concentration limits and formulation requirements.

For example, Titanium Dioxide is permitted at a maximum concentration of 25% (non-nano form) and functions as a physical barrier against both UVA and UVB radiation. Homosalate may be used at concentrations of up to 10% to absorb UVB radiation, while Benzophenone-3 is permitted up to 6% and is also widely used as a UVB absorber.

When formulating a product, businesses should select UV filters appropriate to the product’s intended function, comply with all conditions set out in Annex VII, and clearly declare such ingredients on product labels in Vietnamese. In addition, combinations of UV filters or other ingredients that may reduce effectiveness or compromise product stability should be avoided.

Cosmetic Product Notification in Vietnam: 6 Crucial Steps Businesses Cannot Overlook

To successfully complete cosmetic product notification in Vietnam, businesses should follow a clear and structured process consisting of the following steps:

Step 1: Prepare an ingredient list using INCI nomenclature
All ingredients must be listed in accordance with International Nomenclature of Cosmetic Ingredients (INCI), ensuring that each ingredient is accurately and consistently identified.

Step 2: Cross-check ingredients against relevant annexes
All ingredients should be verified against the applicable annexes, including Annex II (prohibited substances), Annex III (restricted substances), and Annexes IV, VI, and VII (permitted ingredients).

Step 3: Prepare a complete technical dossier
A comprehensive technical dossier must be prepared, including the Product Safety Report (PSR), Certificate of Free Sale (CFS), Safety Data Sheets (SDS), and supporting efficacy documentation (if applicable).

Step 4: Submit the notification dossier to the competent authority
The dossier must be submitted to the Drug Administration of Vietnam (DAV) or the relevant authority via the designated online system.

Step 5: Ensure compliant product labeling
Product labeling must comply with Vietnamese regulations, including full ingredient disclosure, details of the responsible organization, and instructions for use in Vietnamese.

Step 6: Maintain post-market compliance
Following market entry, businesses are required to conduct post-market surveillance and promptly update product documentation, labeling, or formulation in response to regulatory changes.

Risks of Non-Compliance

Failure to comply with cosmetic regulations in Vietnam can result in serious consequences. Businesses may face rejection or suspension of cosmetic product notification, administrative penalties, mandatory product recalls, as well as damage to brand reputation and consumer trust.

Therefore, establishing a robust internal compliance control system is essential to ensuring sustainable and compliant business operations.

Conclusion

Compliance with the ASEAN Cosmetic Directive (ACD) is not only a legal requirement but also a fundamental foundation for developing safe, reliable cosmetic products that are ready for market entry.

By selecting permitted ingredients appropriately—particularly colorants, preservatives, and UV filters—and adhering to the correct notification procedures, businesses can effectively minimize regulatory risks and accelerate time to market in Vietnam.

If your business is planning to introduce cosmetic products into the Vietnamese market and aims to ensure full compliance from the outset, Green NRJ offers end-to-end support, from ingredient review and dossier preparation to successful product notification. Contact Green NRJ to streamline your market entry and effectively manage regulatory risks.