China Consults on the First Regulation for Freckle-Removing and Whitening Cosmetic Ingredients

On March 17, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Research on Freckle-removing and Whitening Cosmetics (the “Guidelines for Whitening Cosmetics”) and the draft Technical Guidelines for Research on Functional Ingredients of Freckle-removing and Whitening Cosmetics (the “Guidelines for Whitening Ingredients”) for public consultation. ¹ Stakeholders with any suggestions can fill out the Feedback Form and send it to [email protected] by April 2.

The two guidelines are devised to further regulate and guide the research and evaluation of cosmetics and ingredients with freckle-removing and whitening efficacies, so as to improve the safety and quality of cosmetics and promote industry research and innovation.

Highlights of the "Guidelines for Whitening Cosmetics"

The "Guidelines for Whitening Cosmetics" summarizes the technical points and principles that need attention in general principles, product attributes, formula design, product safety assessment, production process and quality control, efficacy evaluation and product labels, etc. of freckle-removing and whitening cosmetics. Specifics are shown in the table below:

Items	Key Points
1. Applicable Scope	The Guidelines applies to freckle-removing and whitening cosmetics, which refer to cosmetics added with "freckle-removing agents" or "whitening agents" to their formulas to help reduce or slow down skin pigmentation. It does not apply to products with physical covering effect only.
2. General Principle	Both safety and effectiveness of freckle-removing and whitening cosmetics should be taken into account in the process of research and evaluation. The freckle-removing and whitening cosmetics should have relatively mild effect, not be used for medical purposes, and not have severe or irreversible effects on human physiological functions (such as local skin pigmentation loss, premature facial aging, etc.).
3. Product Attribute	In the research process, the product positioning of freckle-removing and whitening cosmetics should be determined first, followed by product attributes. Then, the development and design should be carried out around the product attributes. As per the requirements of product attributes in the Cosmetic Classification Rules and Catalogs, The application area of freckle-removing and whitening cosmetics shall not include lips; the target users of that shall not include infants and toddlers or children. Products that improve skin brightness or accelerate the exfoliation and renewal of cutin only by increasing hydration, cleansing, exfoliating, etc. are not freckle-removing and whitening cosmetics. Products added with sunscreen agents only and without freckle-removing agents or whitening agents are not freckle-removing and whitening cosmetics, and cannot directly be claimed with freckle-removing and whitening effects.
4. Formula Design Principle	The specific “freckle removing agent" and "whitening agent" used in the product should be clarified in the formula. If such agent is not a single-component ingredient, the components with freckle-removing and whitening efficacy thereof shall be specified. Those who use new cosmetic ingredients (NCIs) to develop products should pay attention to the purpose of use, scope of application, safe dosage, and other restrictions of NCIs. In the case of using NCIs with freckle-removing and whitening efficacies, it’s necessary to ensure that the ingredients have passed NCIs registration. For freckle-removing and whitening ingredients, attention should be paid to possible risk substances such as hydroquinone and phenol, as well as the quality information of the ingredient. For non-single-component whitening agents such as plant extracts, the Guidelines sets higher requirements. Its ingredient safety information shall include control indicators of the corresponding functional components, such as the content index of Glabridin in Glycyrrhiza Glabra (Licorice) Root Extract, the Vitamin C index of Citrus Limon (Lemon) Extract, etc. For the use of carrier materials such as packs and masks in freckle-removing and whitening cosmetics, attention should be paid to the material composition, source, preparation process, quality control indicators, and other key information of the main carrier materials, as well as the possible impact of using such carrier materials and their safety and effectiveness.
5. Product Safety Assessment	In view of the high risk of whitening cosmetic ingredients, the safety of the whitening agents used in the formula should be fully considered when conducting safety assessments, such as: whether it is safe to jointly use whitening agents with the same whitening mechanism; whether the amount of whitening agent added that exceeds the permitted level of other countries is safe, etc. When necessary, toxicological data of the ingredients should be collected, and a complete risk assessment should be conducted to ensure the safety of the material for use.
6. Production Process and Quality Control	The Guidelines requests stakeholders to develop a scientific and reasonable production process. Attention should be paid to whether the parameters in the relevant production steps will affect the safety and effectiveness of the whitening ingredients. To ensure the quality of freckle-removing and whitening cosmetics, enterprises are encouraged to set relevant control indicators for specific functional component in the whitening agents, such as Arbutin content and Glabridin content.
7. Efficacy Evaluation and Product Labels	The freckle-removing and whitening efficacy should be evaluated through human efficacy evaluation test. The product’s efficacy claims related to freckle-removing and whitening shall be scientific, reasonable, and non-exaggerated. It shall not include medical terms or imply that the product has medical effects, such as removing melasma, removing ephelis, removing pigmented nevus, anti-inflammatory, etc.; and shall not use exaggerated or absolute claims, such as whitening immediately, eliminating melanin, blocking melanin transport, etc. Products that only have sunscreen, cleansing, and exfoliating effects but have not been registered as freckle-removing and whitening products cannot directly claim freckle-removing and whitening effects.

Highlights of the “Guidelines for Whitening Ingredients”

Given that the rational use of freckle-removing and whitening ingredients is crucial to the quality and safety of the whole products, China NIFDC drafted an independent technical guideline "Guidelines for Whitening Ingredients" to provide scientific suggestions and technical guidance for cosmetic registrants to research and evaluate whitening ingredients.

This guideline consists of nine parts with key points as below:

Giving the definition of “freckle-removing and whitening ingredients” for the first time.
“Freckle-removing and whitening ingredients” are defined as ingredients that have the effect of freckle-removing and whitening, and are filled out as "freckle-removing agent" or "whitening agent" in the formula of freckle-removing products, or the functional components with freckle-removing and whitening efficacy in compound ingredients. It does not include ingredients that work through physical covering, or NCIs with freckle-removing and whitening functions.
Putting forward clear requirements for enterprises that independently research freckle-removing and whitening ingredients.
Cosmetic registrants mainly adopt three methods to ensure the rationality of using freckle-removing and whitening ingredients in cosmetics: 1) using registered NCIs with freckle-removing and whitening effects; 2) referring to relevant domestic and foreign regulations or technical standards; 3) conducting self-research on the freckle-removing and whitening ingredients intended to be used.
The Guidelines elaborates on the requirements for self-research on the action mechanism, use amount, and non-single-ingredient freckle-removing and whitening ingredients. For example,

It clarifies the difference between the action mechanism of freckle-removing and whitening effects and that of sun protection, exfoliating, and skin brightening effects.
It clarifies that dosage of freckle-removing and whitening ingredients in formulas should take into account both safety and effectiveness, and sets different requirements for human efficacy evaluation test and non-human testing-based in vitro experiment.
It encourages cosmetic registrants to conduct research on the specific functional components in non-single component freckle-removing and whitening ingredients such as plant extracts.

ChemLinked Comments

This is the second time that the NIFDC has launched a public consultation on regulation for freckle-removing and whitening products, after it first released the draft Technical Guidelines for Special Cosmetics with Freckle-removing and Whitening Efficacy in August last year.
Compared with last year’s draft, which provides the basis for registrants to prepare registration documents and the technical review administration to review registration documents, the two new drafts focus more on the management of the early research stage of freckle-removing and whitening cosmetics. In addition, NIFDC has sorted out ingredient-related provisions and developed the first separate regulation targeting the management of whitening ingredients research.
Notably, none of the three drafts of whitening cosmetics published so far contains the long-anticipated list of freckle-removing and whitening agents. Whether the list will be released remains to be seen.
In addition to the above-mentioned technical guidelines for whitening cosmetics, NIFDC also issued the draft Technical Guidelines for Determination of the Sun Protection Factor (SPF) of Sunscreen Products and the draft Technical Guidelines for Determination of the Waterproof Performance of Sunscreen Products on February 23, 2023. The release of these technical guidelines indicates that after nearly three years of implementation of the CSAR, China's cosmetics industry may enter the next stage, where the regulatory focus will be on the research and regulation of special cosmetics.