Preservatives, UV Filters and Colorants in Cosmetics – Top 7 Powerful Compliance Requirements for Cosmetic Notification in Vietnam

1. Introduction

Preservatives, UV filters and colorants in cosmetics are essential ingredient categories strictly regulated under the ASEAN Cosmetic Directive (ACD), which Vietnam has fully adopted. When introducing cosmetic products to the Vietnamese market, businesses must comply with the ASEAN Cosmetic Directive (ACD)—a regional regulatory framework that Vietnam has fully adopted. Among the various ingredient categories, colorants, preservatives, and UV filters are strictly regulated due to their potential impact on human health and product safety. Understanding which substances are allowed and under what conditions is crucial for a successful product notification.

This article aims to provide comprehensive guidance on the regulatory framework, compliance procedures, and best practices for using colorants, preservatives, and UV filters in cosmetics, as required under Vietnamese law.

2. Overview of ASEAN Cosmetic Directive (ACD)

The ASEAN Cosmetic Directive (ACD) is a legally binding framework implemented across all ASEAN member states, including Vietnam. Its purpose is to ensure a uniform regulatory environment for cosmetics that prioritizes consumer safety and product quality.

The ACD organizes cosmetic ingredient regulations into specific annexes:

• Annex II: Lists substances that are completely prohibited in cosmetics.
• Annex III: Specifies substances allowed only with certain restrictions.
• Annex IV: Contains the list of colorants approved for use.
• Annex VI: Provides the list of permitted preservatives.
• Annex VII: Enumerates UV filters that may be used under defined conditions.

Each annex sets specific criteria such as maximum concentrations, required labeling, and conditions of use. Companies must reference these annexes when formulating or notifying cosmetic products in Vietnam.

3. Colorants in Cosmetics

3.1 What Are Colorants?

Colorants are ingredients added to cosmetics to provide or alter color. They are essential in products like lipsticks, foundations, eyeliners, and hair dyes. Colorants can be derived from synthetic chemicals or natural sources such as plants and minerals.

3.2 Approved Colorants (Annex IV)

Annex IV of the ACD lists all colorants allowed in cosmetic products sold in ASEAN countries, including Vietnam. Each entry includes the Color Index (CI) number, purity standards, and specific usage conditions. Only substances appearing in this annex are legally permitted.

3.3 Common Examples

• CI 77491, CI 77492, CI 77499 (Iron Oxides): Iron oxides are among the most common colorants used in cosmetics. They are widely used in makeup products such as foundations, blushes, and lipsticks. These substances are stable and permitted for use in a variety of leave-on products, including makeup and moisturizers.
• CI 15850 (Red 7): This is a red colorant used in cosmetics, including in lipsticks and other skincare creams. It is approved for use in leave-on products with adherence to the maximum concentration guidelines.

3.4 Key Compliance Rules

• Use only colorants listed in Annex IV.
• Do not exceed the concentration limits specified in the annex.
• Ensure that the colorant is not listed in Annex II (prohibited substances).
• Maintain proper documentation for ingredient identity and safety.

4. Preservatives in Cosmetics

4.1 Purpose of Preservatives

Preservatives are crucial for preventing microbial growth in cosmetic products, especially those that are water-based or contain natural ingredients. They help extend shelf life and ensure the product remains safe for use throughout its intended duration.

4.2 Approved Preservatives (Annex VI)

Annex VI of the ACD includes preservatives authorized for use, along with their permitted concentration levels and any applicable restrictions or labeling requirements.

4.3 Common Examples

• Phenoxyethanol: A widely used preservative with a maximum allowed concentration of 1%.
• Methylparaben and Propylparaben: Often used together in low concentrations due to their synergistic antimicrobial effect.

4.4 Regulatory Requirements

• Strictly follow the concentration limits defined in Annex VI.
• Add warning labels or instructions for use if required by the annex.
• Confirm compatibility of preservatives with other ingredients to avoid adverse reactions or reduced efficacy.

5. UV Filters in Cosmetics

5.1 Role of UV Filters

UV filters are active ingredients designed to protect the skin from ultraviolet radiation, which can cause sunburn, premature aging, and skin cancer. These substances are most commonly used in sunscreens, day creams, and facial moisturizers with SPF claims.

5.2 Approved UV Filters (Annex VII)

Annex VII of the ACD provides a list of UV filters that may be used in cosmetics. It includes detailed usage conditions such as maximum allowed concentrations and specific formulation requirements.

5.3 Common Examples

• Titanium Dioxide – Maximum concentration: 25% for non-nano formulations. Used in physical sunscreens, it acts as a physical block to both UVA and UVB radiation.
• Homosalate – Maximum concentration: 10%. Used in sunscreen products to absorb UVB rays.
• Benzophenone-3 (Oxybenzone) – Maximum concentration: 6%. A chemical filter primarily protecting against UVB radiation, commonly found in sunscreens.

5.4 Compliance Considerations

• Select UV filters based on the product’s function and formulation.
• Follow all conditions of use and concentration limits specified in Annex VII.
• Clearly declare the presence of UV filters on the product label in Vietnamese.
• Avoid combining UV filters that may reduce each other’s effectiveness or cause instability.

6. Practical Steps for Cosmetic Product Notification in Vietnam

To successfully notify a cosmetic product in Vietnam, follow these steps:

1. List all ingredients using INCI names. Ensure that each ingredient is accurately named according to international nomenclature.
2. Cross-reference ingredients with ACD annexes. Check Annex II for prohibited substances, Annex III for restricted substances, and Annexes IV, VI, and VII for approved additives.
3. Prepare a complete technical dossier. This should include the product safety report, Certificate of Free Sale (CFS), Safety Data Sheets (SDS), and any clinical or efficacy studies (if applicable).
4. Submit the notification dossier to the Drug Administration of Vietnam (DAV) or relevant authority. Use the online notification system if available.  
5. Ensure product labeling complies with Vietnamese regulations, including full ingredient disclosure, manufacturer/importer details, and usage instructions in Vietnamese.
6. Maintain ongoing compliance through post-market surveillance. Update your product formulation and labeling if the regulations change.

7. Risk of Non-compliance and Penalties

Failing to meet cosmetic product regulations in Vietnam can result in serious consequences, such as:

• Rejection of the product notification or suspension of previously approved notifications.
• Administrative fines and penalties for non-compliance.
• Mandatory recall of non-compliant or unsafe products from the market.
• Damage to brand reputation and loss of consumer trust.

Businesses should establish robust internal processes to regularly review product compliance and regulatory updates.

8. Conclusion

Navigating cosmetic regulations in Vietnam requires detailed knowledge of approved ingredients and ASEAN standards. The ASEAN Cosmetic Directive provides a clear framework, but businesses must be diligent in selecting only authorized substances—especially colorants, preservatives, and UV filters.

By following the proper steps and consulting the relevant annexes, companies can avoid compliance risks and ensure that their products are both legally accepted and trusted by consumers.

Need assistance with cosmetic product notification in Vietnam? Green NRJ offers professional support, including regulatory reviews, dossier preparation, and full compliance consulting. Contact us today to ensure your cosmetic products are market-ready and fully compliant.