Permitted Freckle-removing and Whitening Ingredients in Cosmetics in Major Countries/Regions Worldwide

1. Chinese Mainland

In China, cosmetics are classified into “general cosmetics” and “special cosmetics” according to the Cosmetic Supervision and Administration Regulation. Freckle-removing and whitening cosmetics fall under the category of special cosmetics due to their higher risk level, requiring registration approval from the National Medical Products Administration (NMPA) before production or importation.

It's worth noting that in China, products that achieve skin whitening effects solely through physical covering are also categorized as freckle-removing and whitening cosmetics. However, such products offer temporary covering whitening effects and do not actually alter the natural skin color. Consequently, they must be labeled as "freckle-removing and whitening type (only with physical covering effect)" to indicate this distinction.

Currently, China does not maintain a separate official list of freckle-removing and whitening agents and their concentration limits. However, the following notices and announcements have addressed requirements related to these ingredients:

1.1 Announcement of the China Food and Drug Administration (the Former CFDA, Now NMPA) on Approving 4-(1-Phenylethyl)1,3-Benzenediol for the Use as Cosmetic Ingredients (CFDA Announcement No. 71 of 2012)

On December 5, 2012, the CFDA approved phenylethyl resorcinol (also known as SymWhite 377) as cosmetic ingredient in China. The ingredient is used for skin whitening, with a maximum concentration limit of 0.5%. Subsequently, this ingredient was included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) for 2021.

Basic Information of the Whitening Agent Phenylethyl Resorcinol

1.2 NMPA’s Popular Science Article “A Brief Talk on Whitening Cosmetics and Whitening Agents" on December 16, 2021

This article highlights several commonly used whitening agents in China, including Arbutin, Niacinamide, Glabridin, Phenylethyl Resorcinol (Symwhite 377), Ascorbic Acid, Ascorbyl Glucoside, 3-O-Ethyl Ascorbic Acid, Magnesium Ascorbyl Phosphate, Kojic Acid, Tranexamic Acid, Potassium Methoxysalicylate, Bisabolol, and more.

In addition to chemical ingredients, plant extracts with whitening effects are also utilized in China, such as Glycyrrhiza Glabra (Licorice) Root Extract, Broussonetia Kazinoki Root Extract, Oil-Soluble Glycyrrhiza Uralensis (Licorice) Extract, Broussonetia Papyrifera Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extract, among others. Common physical covering whitening ingredients include Titanium Dioxide, Zinc Oxide, Mica, Talc, etc.

1.3 Notice of the China National Institutes for Food and Drug Control (NIFDC) on Soliciting Public Opinions on the Technical Guidelines for Research on Freckle-removing and Whitening Cosmetics (Draft for Comments) on March 17, 2023

The NIFDC issued a notice introducing two drafts for comments: Technical Guidelines for Research on Freckle-removing and Whitening Cosmetics (Draft for Comments) and Technical Guidelines for Research on Functional Ingredients of Freckle-removing and Whitening Cosmetics (Draft for Comments). The former provides technical guidance on the research and development, safety assessment, efficacy evaluation, production, quality control, and labeling of freckle-removing and whitening cosmetics. The latter proposes evaluation requirements for the safety and effectiveness of freckle-removing and whitening agents. The launch of these guidelines aims to refine the registration requirements for freckle-removing and whitening cosmetics, and establish an independent regulatory framework for such products.

1.4 NMPA’s Notice on the Inclusion of 21 Formulation and Revision Projects Including the "Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and Other Ten Components in Cosmetics" into the "Safety and Technical Standards for Cosmetics (2015 Edition)" (No. 41 of 2023)

On August 23, 2023, the NMPA issued an announcement regarding the revision of the Safety and Technical Standards for Cosmetics (STSC). It added the testing method "Determination of L-Ascorbic Acid 2-Phosphate Magnesium Ester and Other Ten Components in Cosmetics" and revised the method "α-Arbutin and Other 3 Kinds of Components in Cosmetics." Although this announcement neither presented a specific list of permitted freckle-removing and whitening agents, nor explicitly mentioned "whitening" and "freckle removing," the 13 ingredients involved in these two testing methods are generally ingredients with a history of use for freckle removal and whitening. As a result, this list can be considered as whitening and freckle-removing agents accepted or recognized by the public at the current stage. Industry experts recommends that companies consider these 13 ingredients as whitening agents for freckle-removing and whitening products, as the introduction of testing methods for these 13 ingredients suggests that the added content of such ingredients may be regulated in the future.

2. Taiwan, China

Taiwan follows a positive list management approach for freckle-removing and whitening ingredients in cosmetics. These ingredients must comply with specific requirements outlined in the “List of Specific Purpose Ingredients in Cosmetic Products” and “List of Ingredients Restricted in Cosmetic Products.”

Cosmetics in Taiwan are categorized as "general cosmetics" or "specific purpose cosmetics" based on whether they contain ingredients listed in the “List of Specific Purpose Ingredients in Cosmetic Products.” Until July 1, 2024, specific purpose cosmetics are subject to registration. However, starting from July 1, 2024, they will be managed through notification and the establishment of product information files (PIF).

At present, the Taiwan Food and Drug Administration (TFDA) has approved 13 freckle-removing and whitening ingredients. Except for cosmetics containing Ascorbyl Tetraisopalmitate, which are classified as special purpose cosmetics, products containing the remaining 12 ingredients are considered general cosmetics. These general cosmetics are not subject to prior registration but only need to undergo a simple notification process.

It is important to note that the TFDA announced its intention to adjust the current cosmetic ingredient lists on January 4, 2024. The plan involves abolishing the existing “List of Specific Purpose Ingredients in Cosmetic Products” and reallocating its ingredients to other lists. The draft proposal is expected to come into effect on July 1, 2024. After this date, all cosmetics, whether general or specific purpose, will be subject to unified management through a notification system and the establishment of a PIF, similar to the approach used by the EU and ASEAN.

3. Japan

In Japan, cosmetics are categorized into two groups under the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. The two categories are cosmetics and quasi-drugs. Quasi-drugs encompass various products such as hair growth treatments, depilatories, hair dyes, deodorants, and medicated cosmetics. Freckle-removing and whitening products fall under the quasi-drug category and are subject to review and approval from the Ministry of Health, Labour and Welfare (MHLW) before they can be marketed. The review process involves assessing the formula, manufacturing process, ingredient content, usage, dosage, efficacy, and other factors.

Currently, the MHLW has specific lists of permitted active ingredients for hair dyes, permanent wave products, bath products, and certain medicated cosmetics. However, there is no publicly available list of active freckle-removing and whitening agents permitted for use in cosmetics.

Nevertheless, it's important to note the existence of a hidden list of permitted ingredients for quasi-drugs, including freckle-removing and whitening ingredients. This list is known as the "List of Patented Quasi-drug Ingredients of Enterprises.", involving ingredients that are individually applied for by enterprises and approved by the MHLW. Due to intellectual property rights protection, this list is not accessible to the public but controlled by the MHLW. The listed ingredients can only be used by the applicants who obtained approval, and they are considered new ingredients for other enterprises. Applications for quasi-drugs containing new ingredients are subject to more rigorous requirements comparing to applications for quasi-drugs not containing new ingredients, including the submission of documents on the efficacy, safety, ingredient formulation, use purpose, and other relevant information regarding the new ingredient.

Below is a summary of active ingredients approved for quasi-drugs to date that are specifically targeted for freckle removal and skin whitening.

4. South Korea

In South Korea, cosmetics are categorized as "general cosmetics" and "functional cosmetics" under the Cosmetics Act. Functional cosmetics include products that aid in skin whitening by preventing skin pigmentation, fading melanin pigmentation, and thinning red lines caused by striae distensae, as well as anti-wrinkle, sunscreen, tanning, hair dyeing, depilating, and anti-hair loss products, among others. General cosmetics refer to all cosmetic products that do not fall under the category of functional cosmetics.

The Standards and Testing Methods of Functional Cosmetics (Korean Functional Cosmetics Codex, KFCC), the Functional Cosmetics Evaluation Regulation, and other relevant standards determines the regulatory pathway for functional cosmetic companies. If the primary functional ingredients meet these standards, companies can simply submit a report to the Ministry of Food and Drug Safety (MFDS) without evaluation by the authority. Otherwise, they must provide the functional ingredient’s origin, safety and efficacy data, etc. for MFDS’s evaluation and review.

Freckle-removing and whitening products belong to the category of functional cosmetics. Currently, South Korea has published a list of whitening agents and their concentration limits, as shown below. Stakeholders whose products meet the corresponding ingredient requirements can be exempt from submission of relevant ingredient safety documents and MFDS’s evaluation.

5. ASEAN

Within ASEAN, member countries follow the Agreement on the ASEAN Harmonized Cosmetic Regulatory Scheme (AHCRS) and the ASEAN Cosmetics Directive (ACD). The ACD neither provides an official definition of whitening cosmetics, nor includes a specific list of whitening ingredients. In general, whitening cosmetics in ASEAN should only contain ingredients that comply with the ACD Annex and should not include any ingredients prohibited by the ACD. 

Some commonly used and widely accepted whitening agents in cosmetics across ASEAN countries include Niacinamide (Vitamin B3), Arbutin, Kojic Acid, Linoleic Acid, Linolenic Acid, Oleic Acid, and Ascorbic Acid (Vitamin C).

6. Australia

In Australia, beauty products are legally classified into two main categories: cosmetics and therapeutic goods. The classification depends on factors such as the product's primary purpose, formula ingredients, and claims. Skin-whitening lotions that inhibit the physiological process of melanin production are regulated as medicines for therapeutic use. Some skin-whitening products without SPF sunscreen are considered cosmetics.

Australia neither has a comprehensive list of banned or restricted ingredients specifically for cosmetics, nor provides a list of permitted cosmetic whitening agents.

7. New Zealand

In New Zealand, skin whitening products are considered cosmetics under the Cosmetic Products Group Standard 2020. However, the current regulatory framework does not include a specific list of approved cosmetic whitening agents.

8. EU

In the European Union (EU), as per the Borderline Products Manual on the Scope of Application, skin-whitening products commonly found on the market are considered cosmetics. Cosmetics are not divided into specific categories but rather regulated based on the management and classification of cosmetic ingredients. The Regulation (EC) No 1223/2009 on Cosmetic Products is the main regulatory framework in the EU for cosmetics. It has established various ingredient lists, including the list of prohibited ingredients, the list of restricted ingredients, and lists for permitted colorants, preservatives, and UV filters.

However, products intended for improving skin pigmentation disorders such as melasma, chloasma, and lentigo would be classified as medicinal products.

The EU does not have a separate list of permitted whitening agents specifically for skin-whitening products. Currently, the Scientific Committee on Consumer Safety (SCCS) provides scientific advice on the use of certain whitening ingredients. The following summarizes some of the SCCS evaluation opinions on skin lightening agents: 

9. US

In the United States, cosmetics and drugs can overlap in their regulation under the Federal Food, Drug, and Cosmetic Act. The classification of a product as a cosmetic, a drug, or both depends on factors such as intended use, efficacy claims, ingredients, and consumer perceptions.

Products that achieve a skin whitening effect through physical covering are considered cosmetics in the US. However, products that lighten dark discolorations in the skin (e.g., freckles, age spots, and liver spots) by affecting the structure or function of the human body, such as inhibiting the production of melanin in skin cells, fall under the category of drugs.

Currently, the latter cannot be exempted from pre-market approval by the US Food and Drug Administration (FDA) as there is no dedicated over-the-counter (OTC) Monograph for these products. Instead, such skin bleaching drugs must go through a strict new drug application (NDA) process before they can be marketed.

As of now, the FDA has only approved hydroquinone as an active substance in skin bleaching drugs. There is no specific list of approved whitening agents for cosmetics in the US.