The Technical Requirements for Anti-freckle and Whitening Cosmetics May Soon be Settled in China

On August 1, National Institutes for Food and Drug Control (NIFDC) issued a notice to seek comments on the Technical Guidelines for Anti-freckle and Whitening Cosmetics (Draft for Comment). It was accepting comments until August 16.

Anti-freckle and whitening cosmetics belong to special cosmetics in China and are subject to registration. The draft Technical Guidelines consist of three parts:

• The basic principles;
• The definition of anti-freckle and whitening cosmetics;
• The technical requirements of anti-freckle and whitening cosmetics, including basic product information, product name, formula and related standards for the use of ingredients and manufacturing of products, packaging labels, product testing reports, and safety assessment data.

This article provides details on the draft technical guidelines.

1. The Action Mechanism and Definition

Anti-freckle and whitening cosmetics mainly refer to cosmetics that help reduce the marks of hyperpigmentation or slow down the format of pigmentation, thus making the skin whiter/brighter. Products that reduce acne marks by fading pigmentation should also be registered as anti-freckle and whitening products. If one product can only cover the marks physically, making the skin looks whiter and brighter, it can be registered as “anti-freckle and whitening (only with physical covering effect)" and this kind of product does not need to comply with the draft guidelines.

It may promote the keratinocytes containing melanosomes to move towards the stratum corneum by exfoliation or other means, which helps to speed up melanin excretion from the skin. Therefore, the proper use of an “exfoliating agent” in anti-freckle and whitening cosmetics can help strengthen its anti-freckle and whitening effect. But as this method is not considered as the action mechanism of anti-freckle and whitening cosmetics, relevant ingredients should not be notified as anti-freckle and whitening agents.

Products that lighten the skin or accelerate the renewal of skin by improving hydration, cleaning, or exfoliating, cannot be classified as anti-freckle and whitening cosmetics because the action mechanism of these kinds of products is different from that of anti-freckle and whitening cosmetics.

Products that contain sunscreen agents yet do not contain anti-freckle and whitening agents in their formulas can claim that the products help reduce skin darkening and pigmentation caused by sun exposure, but they cannot directly claim anti-freckle and whitening effects.

2. Technical Requirements

2.1 Basic Information

When choosing the product classification code, the efficacy claim must cover “anti-freckle and whitening”.

Imported products whose product formula is specially designed for the Chinese market (except entrustment abroad by domestic company), should submit the instructions for formula design according to the skin type and consumption demand of Chinese consumers, and select Chinese consumers for consumer testing or use human efficacy test data collected from Chinese consumers. For example, Fitzpatrick skin types, the characteristics of skin darkening or pigmentation spots of Chinese consumers.

2.2 Product Name

Trade name implying the use of certain ingredients:

• If the product contains such ingredients, the purpose of use must be explained on the visible surface of the sales package;
• If the product does not contain such ingredients, it shall be clearly stated on the visible surface of the sales package that the product does not contain such ingredients, and the relevant wording is only used as the product's trade name.
• If the name of ingredients or words indicating the category of cosmetic ingredients is the generic name of the products, the ingredients must be in the products. The efficacy of the ingredients should also be consistent with the product efficacy claim.

2.3 Product Formula

The Use of Anti-freckle and Whitening Agents

The product formula of anti-freckle and whitening cosmetics shall contain anti-freckle and whitening agents. If multiple components are used, specific components with anti-freckle and whitening efficacy must be clearly recorded in the formula table.

In addition to the new cosmetic ingredients that have been approved as anti-freckle and whitening agents, a certain basis for use should be provided.

There are two ways of doing this:

Option 1: Regulatory Data

In countries or regions with similar skin types to the main population in China, relevant regulatory data can be provided as the basis for the use of functional ingredients for those that have been published by regulations or approved by regulatory authorities to be used as anti-freckle and whitening agents.

Option 2: Scientific Basis of the Action Mechanism and the Efficacy Evaluation Report of Ingredients

The scientific basis of the action mechanism should be the experimental data of the ingredients, published literature, and the research data from testing institutions that conforms to the principles of good laboratory practices (GMP). Common action mechanisms and research models of anti-freckle and whitening agents include:

• Reducing the level of tyrosinase and other key enzymes or proteins required for melanin synthesis;
• Reducing or inhibiting the activity of key enzymes or proteins such as tyrosinase required for melanin synthesis;
• Helping inhibit the oxidation of key substances such as DOPA;
• Helping inhibit the maturation or transport of melanosomes.

In addition to the above action mechanism and research model, a registrant may also choose other methods or indicators according to the actual research and development situation, but additional background information, methodological data, and explanatory materials are required.

The ingredient efficacy evaluation must be carried out in accordance with the test method for anti-freckle and whitening efficacy specified in the Safety and Technical Standards for Cosmetics. If other methods are adopted, documents certifying that the methods provided have been verified and the results arising from the methods are consistent with that included in the Safety and Technical Standards for Cosmetics. The efficacy evaluation report must be issued by testing institutions with China Metrology Accreditation (CMA) or China National Accreditation Service (CNAS) qualifications or those that conform to the principles of internationally accepted Good Clinical Practices (GCP) or Good Laboratory Practices (GLP).

Ingredients Safety Information

From January 1, 2022, registrants must provide relevant information on the safety of anti-freckle and whitening agents in accordance with the requirements of the Provisions on the Management of Cosmetic Registration and Filing Data. Registrants can either fill in the cosmetic ingredients safety information or fill in the Cosmetic Ingredient Quality and Safety Information Code collected via the NMPA service platform regarding the quality and safety information of the cosmetic ingredients to affiliate the quality and safety information file of cosmetic ingredients.

If plant extracts are used as anti-freckle and whitening agents, the safety information should include characteristic control indicators such as quantitative requirements for index components. When the functional ingredients are clear and are used for anti-freckle and whitening, control indicators related to the functional ingredients should be set; if there are no clear functional ingredients, the extraction and production process should be specific and clear.

2.4 Labels

Cosmetic labels must meet the requirements of the Measures for Administration of Cosmetics Labeling.

Anti-freckle or whitening claims must be scientific and reasonable. Do not use medical terms or imply that products have medical effects, such as removing melasma, removing freckles, and removing pigmented moles; do not use exaggerated or absolute claims, such as skin-whitening immediately, eliminating melanin, and blocking melanin transport.

2.5 Product Testing

Physicochemical and microbiological tests

In addition to nine routine items, PH value testing is also needed for anti-freckle or whitening cosmetics. Additional test items may also be needed, if necessary.

Toxicological tests

Anti-freckle or whitening cosmetics are special cosmetics and cannot be exempted from toxicological tests. Results of toxicological tests must meet the following:

• Results of the skin irritation test must be non-irritant or mildly irritating;
• Results of the skin sensitization test must be weak sensitization or below;
• Results of the skin phototoxicity test must be no phototoxicity;
• Results of the acute eye irritation tests (if any) must be non-irritating, slightly irritating, or mildly irritating.
• Anti-freckle or whitening products require a human skin patch test.
• Rinse-off products claiming anti-freckle efficacy should also undergo human trial tests for safety evaluation.

The efficacy evaluation tests must meet the requirements of the Inspection Specifications, “Safety and Technical Standards", and the “test method for the efficacy of anti-freckle and whitening in the model of human skin melanization induced by ultraviolet rays” or “test method for anti-freckle and whitening efficacy of open use in human body” can be used. If the anti-freckle and whitening efficacy evaluation is carried out using the equivalent evaluation principle, the conditions and requirements of the equivalent evaluation must be met. Please refer to Appendix 2 of the Standards for the Evaluation of Cosmetics Efficacy Claims.

2.6 Safety Assessment Data

Product safety assessment must comply with the Technical Guidelines for Cosmetics Safety Assessment and relevant technical requirements. Applicants can submit a simplified version of the product safety assessment report in accordance with the relevant requirements of the “Technical Guidelines for Cosmetics Safety Assessment” before May 1, 2024.

When evaluating the anti-freckle and whitening agents, the safety limit for anti-freckle and whitening agents may refer to the standards published by other countries or regions or approved by regulatory authorities. A complete assessment of relevant raw materials should be made according to the risk assessment procedures specified in the “Technical Guidelines for Cosmetics Safety Assessment”. Other types of evidence in the simplified version of the safety assessment report are not allowed.

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