Overview of Skin Whitening Cosmetic Regulations Across ASEAN

I. Introduction

In many ASEAN countries, there is a prevailing preference for fair and radiant skin, which is further amplified by the influence of Western and Korean media as well as celebrities. Consequently, the demand for skin whitening cosmetics has surged across ASEAN, which aim to lighten the skin tone and achieve a more even complexion by reducing melanin concentration. As per a research report cited by Bloomberg, the global skin whitening market reached an estimated $8 billion in 2020, with the Asia-Pacific region contributing to over half of the total revenue. ¹

Given the substantial market presence and consumer’s demand for skin whitening cosmetics in ASEAN, it is crucial to examine the regulatory landscape surrounding these products in the region. While preferences for fair skin persist, so do concerns related to product safety, efficacy, and potential health risks. The regulatory frameworks established by ASEAN countries play a pivotal role in ensuring the quality and safety of skin whitening cosmetics. In the subsequent sections, ChemLinked delves into the specific regulations governing these products across ASEAN nations.

II. ASEAN Regulatory Requirements for Skin Whitening Cosmetics

1. Overview

Although skin whitening cosmetics are popular among the ASEAN region, they may pose potential health risks if they contain harmful ingredients such as mercury, hydroquinone, or steroids.

The ASEAN member states have harmonized their cosmetic regulations under the ASEAN Harmonized Cosmetic Regulatory Scheme, specially the ASEAN Cosmetic Directive (ACD).

The ACD implements a notification system for cosmetic products, which means that a cosmetic product can be marketed in any ASEAN country after notifying the local authority. The ACD also provides technical documents that specify the definition, categories, ingredient lists, labelling requirements, claims guidelines, good manufacturing practices, safety assessment, adverse event reporting, product information file, and contaminant limits for cosmetic products.

For more details about general regulations on cosmetics, please refer to ChemLinked’s article:

ASEAN Cosmetic Regulation | ChemLinked

Skin whitening cosmetics must adhere to common technical requirements under the ACD, encompassing product notification; the use of banned, restricted, and permitted ingredients; labeling; product claims; and good manufacturing practices. The following part of this article focuses on ASEAN’s notification, ingredient use, and claim requirements applicable to skin whitening cosmetics. Additionally, this article provides information on country-specific requirements within ASEAN member states.

2. Definition of Skin Whitening Cosmetics in ASEAN

The ASEAN Cosmetic Directive (ACD) does not provide an official definition for skin whitening cosmetics. However, the ASEAN Consumer Information Handbook on Cosmetic Products identifies “skin whitening or skin lightening products” as those designed to lighten skin tone or provide a more even skin complexion by lessening epidermal melanin. To be more specific, there are two main mechanisms for lightening skin tone and reducing pigmentation:

(i) by reducing the concentration of existing melanin;

(ii) by preventing the formation of new melanin.

In the context of categorization, these products fall under the broad category of cosmetic products according to the ACD. Therefore, products intended for purposes beyond the scope of cosmetics, such as those meant for oral consumption or injection, are explicitly excluded from the category of skin whitening cosmetics.

3. Identification of Skin Whitening Cosmetics in ASEAN

ACD also provides guidelines for a simple 5-step decision-making process that helps to identify products and claims which can be considered to be cosmetics. This process is equally applicable to skin whitening cosmetics. The 5-step decision-making process is specified as below:

• Composition: Whitening cosmetic products should contain only ingredients that comply with the annexes of ACD, and does not contain any ingredients that are banned in the ACD.

• Target site: The products should be intended for contact with the various external parts of the human body. In other words, skin whitening cosmetics exclude products for oral or injection administration.

• Main function: skin whitening cosmetics are used to change the appearance by making the skin lighter or keep it in good condition (to maintain the whiteness).

• Product presentation: The product should not be used to treat or prevent disease in human beings, for example, treating skin discoloration.

• Physiological effects of cosmetics: Cosmetic products typically have effects that are not permanent, and have to be used regularly to maintain their effects. Consequently, the products that permanently restore, correct or modify physiological function by exerting a pharmacological, immunological or metabolic action are not considered cosmetics, which shall not bear claims for cosmetics / cosmetic claims. For example, the following claim for skin whitening cosmetic is not acceptable: "inhibit the production of melanin directly at the melanocyte."

4. Notification Requirements

As skin whitening cosmetics fall within the category of cosmetic products, they are subject to the notification process for marketing in each member state, the same as other cosmetic products. The entity responsible for introducing these cosmetic products into the market must notify the regulatory authority of each member state where the product will be sold. This notification is carried out through the prescribed Product Notification Form provided by the relevant authority.

Due to variations in the review requirements among competent authorities across member states, special attention is warranted during the preparation of notification documents, particularly product claims. Details are elaborated below in Section 6: Claim Requirement.

5. Ingredient Use Requirements

All cosmetics sold on the ASEAN market shall comply with the ingredient lists attaching to ACD, which include:

1) Annex II: List of Substances Which Must Not Form Part of the Composition of Cosmetic Products

2) Annex III: List of Substances that Cosmetic Products Must Not Contain Except Subject to Restrictions and Conditions Laid Down

3) Annex IV: List of Coloring Agents Allowed for Use in Cosmetic Products

4) Annex VI: List of Preservatives Which Cosmetic Products May Contain

5) Annex VII: List of UV Filters Which Cosmetic Products May Contain

However, there is no specific whitening ingredient list in ASEAN. In general, whitening cosmetic products should contain only ingredients that comply with the annexes of ACD, and does not contain any ingredients that are banned in the ACD. For instance, skin-whitening cosmetics should not include specific substances such as hydroquinone, tretinoin, or azelaic acid, which are prohibited for use, as outlined in Annex II of the ACD.

Some commonly used and widely accepted skin-whitening agents in cosmetic products within ASEAN include niacinamide (vitamin B3), arbutin, and kojic acid, linolenic acid, linoleic acid, and oleic acid and ascorbic acid (Vitamin C).

While the majority of ASEAN member states closely adhere to the ACD annexes outlining the ingredient lists for cosmetic products, each country has the discretion to supplement this list to align with its specific considerations. A notable instance is Thailand, which imposes additional restrictions on banned ingredients. It is imperative for enterprises to be attentive to these variations to ensure compliance when operating within different member states.

6. Claim Requirements

The variations among ACD and regulations in member states primarily pertain to permissible claims and product communication. The table below outlines the claim-related regulations of key ASEAN countries and their specific requirements concerning whitening cosmetics.

III. Conclusion

Skin-whitening cosmetics are highly popular in the ASEAN region, where many consumers aspire to achieve a fairer and more even complexion. The regulations governing skin-whitening cosmetics in ASEAN are rooted in the ACD and the ASEAN Cosmetic Claim Guideline, with additional modifications unique to each country. As a result, cosmetic manufacturers and marketers should consistently check the latest regulations and guidelines in the countries where they intend to sell or use their products. By doing so, they can avoid potential legal issues, safeguard consumer health, and enhance customer loyalty.

Further Reading

• Unlocking the Malaysian Market: Cosmetic Notification Procedures

• Comprehensive Guide to Cosmetic Notification Requirements for Market Entry in Vietnam

• Mastering Cosmetic Notification Procedures for Singaporean Market Entry

• Webinar | Decoding ASEAN’s Cosmetic Labeling Regulation