China Consults on Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy

Freckle-removing and whitening cosmetics

1. Products helpful in reducing or slowing down skin pigmentation to achieve skin lightening and whitening effects;

2. Products achieving skin lightening and whitening effect through physical covering;

3. Products aiming to improve acne marks caused by pigmentation.

Sunscreen products

Products formulated with only sunscreen agents and no freckle-removing or whitening agents shall be registered as sunscreen products rather than freckle-removing and whitening cosmetics.

They are allowed to claim to help reduce skin blackening and pigmentation caused by sun exposure, but cannot directly claim freckle-removing or whitening effects.

Cleansing or exfoliating products

Products that improve skin brightness or accelerate keratin exfoliation and renewal only by improving hydration, cleansing, and/or exfoliation do not belong to freckle-removing and whitening cosmetics.

Product’s Basic Information

• The product classification code shall include the efficacy code for freckle-removing and whitening;

• For imported products whose product formulas are specifically designed for the Chinese market (except the products manufactured by entrusted overseas manufacturers), explanatory documents for formula design according to skin types and consumer demands of Chinese consumers, and documents of consumer testing research or human efficacy test conducted on Chinese consumers in China shall be submitted.

Product Name

• If a term that implies the inclusion of a certain type of ingredient is used as the trade name, and that type of ingredient is contained in the product formula, the use purpose of such ingredient shall be described on the visible panel of the sales packaging. If the implied type of ingredient is not contained, it shall be indicated on the visible panel of the sales packaging that the product does not contain such ingredient, and the relevant term is only used as a trade name;

• If the name of a specific ingredient or any other vocabulary indicating the category of the ingredient is used, the ingredient shall be consistent with that in the product formula, and the actual efficacy of such ingredient shall be in line with the product’s efficacy claim.

Product Formula

The use of freckle-removing and whitening agents

The freckle-removing and whitening agent shall be specified when filling out the product formula during the registration application. If it is an ingredient with multiple components, the freckle-removing and whitening components shall be specified.

The use of freckle-removing and whitening agents shall be scientific and rational. The use basis shall be provided to explain the rationality of their use as freckle-removing and whitening agents (except for newly registered ingredients and notified ingredients). The use basis can be one of the following:

1. Regulatory documents

In countries or regions with similar skin types to the main population in China, for those ingredients that have been published by regulations or approved for use as freckle-removing and whitening agents, registrants can provide relevant regulatory documents as the use basis.

2. The scientific basis for the mechanism, and efficacy evaluation report of the ingredient

1) The scientific basis for the mechanism should be the experimental research using the ingredient as the experimental object, which can be published literature or data, or laboratory data in compliance with good laboratory practices;

2) The efficacy evaluation of the ingredient shall be carried out in accordance with the evaluation methods included in Safety and Technical Standards for Cosmetics (STSC). If other methods are used, the registrant should provide evidence that the methods used have been validated and the results are consistent with the methods included in STSC.

The ingredient efficacy evaluation report should be issued by testing institutions that obtained qualification accreditation (CMA or CNAS) or conform to the internationally accepted Good Clinical Practice (GCP) or Good Laboratory Practice (GLP).

Ingredient’s safety information

If plant extracts are used as freckle-removing and whitening agents, the ingredient safety information should include characteristic control indicators such as quantitative requirements for index components.

If there are clear functional components in the plant extract, control indicators should be set; if there are no clear functional components, the extraction process and production steps should be specific and clear.

Executive Standard

In combination with product characteristics and the actual production process, the production technique should highlight the characteristic steps. For freckle-removing and whitening cosmetics in creams and emulsions, the emulsification steps should be specified. Special attention should be paid to the steps of adding freckle-removing and whitening agents. In addition, the influence of temperature should be considered.

In terms of physical, chemical, and microbial indicators as well as quality control measures, at least microorganisms, harmful substances (heavy metals), and pH indicators should be included.

Labeling and Packaging

• The product's efficacy claims shall be scientific, reasonable, and avoid exaggeration. Claims on the ingredient’s efficacy or mechanism should be consistent with the ingredient’s efficacy basis;

• Medical terms or implication that products have medical effects are not allowed, such as removing chloasma, removing ephelis, removing pigmented nevus, anti-inflammatory, etc.;

• Exaggerated or absolute claims are not allowed, such as achieving whitening effect immediately, eliminating melanin, blocking melanin transport, reaching the underlying skin, intelligent targeted black suppression, etc.

*Products that only have sunscreen, cleansing, and/or exfoliating efficacies, and are not registered as freckle-removing and whitening cosmetics shall not directly claim freckle-removing and whitening efficacies.

Product Testing

• In addition to microbial and harmful substances (heavy metals) testing, the pH value of freckle-removing and whitening cosmetics shall also be tested;

• Freckle-removing and whitening cosmetics shall be tested for toxicology and human safety, and shall not have obvious positive results;

• Efficacy evaluation can be based on the "test method for efficacy measurement of skin whitening cosmetic products through a pigmentation model induced by ultraviolet in human," "test method for efficacy measurement of skin whitening by open use of the human body," or equivalent evaluation method. The equivalent evaluation conditions and requirements can be referred to in Appendix II of Standards for Cosmetic Efficacy Claim Evaluation.

Safety Assessment

Before May 1, 2024, registrants can submit a simplified safety assessment report in accordance with Technical Guidelines for Cosmetics Safety Assessment. However, it should be noted that the recognized evidence for a simplified safety assessment report does not apply to freckle-removing and whitening agents.

When assessing the safety of freckle-removing and whitening agents in the formula, registrants can choose to

• adopt the safety limits announced by regulations or approved by the regulatory authorities in other countries/regions to prove the ingredient safety;

• fully assess the ingredient safety according to the risk assessment procedures specified in Technical Guidelines for Cosmetics Safety Assessment.