"Functional skincare products" refer to products helpful for dealing with skin problems, and their main functions include moisturizing, acne removing, freckle-removing and whitening, sunscreen, etc. With consumer's increasing demand for healthy and effective skin care, functional skincare products industry has ushered in a stage of rapid development since 2018.
Compared to consumer's rising demand for functional skincare products and the booming market, the supervision on these products appeared to be lagged behind. Before the release of Cosmetic Supervision and Administration Regulation (CSAR), only the sunscreen efficacy and the waterproof efficacy of sunscreen products were required to be evaluated in accordance with Safety and Technical Standards for Cosmetics (2015). Therefore, there were cosmetic enterprises exaggerating or even falsely advertising the efficacies of cosmetics, while consumers had no means of accessing the certification documents for the claimed efficacies.
On January 1, 2021, CSAR officially came into force. Valuing product safety as the top priority, CSAR opens a new chapter for cosmetics supervision. In this new chapter, cosmetic enterprises are responsible for the quality, safety and efficacy claims of cosmetics. In addition, cosmetic's efficacy claims shall be supported by sufficient scientific basis, and the summary of efficacy's evaluation documents shall be publicized and accessible for consumers. Since then, the efficacy claim evaluation has become a must-have ticket for cosmetic stakeholders to enter the market.
Part 1 Efficacy Claims
1.1 Existing Regulatory Framework for Efficacy Claims
Generally appear on products (packages, labels, product instructions, etc.) or in advertisements, cosmetic's efficacy claim is used to describe or imply product's effect in text, picture, illustration or trademark. It plays an important role in cosmetics marketing, for it is an effective means for enterprises to promote products and for consumers to understand products. Possessing these features, it has been a focus of supervision under China's new cosmetic regulatory framework. Currently, for the supervision of efficacy claim, there are five regulations involved in total.
|Regulation||Efficacy-related Key Points||Effective Date|
|Cosmetic Supervision and Administration Regulation||January 1, 2021|
|Cosmetic Classification Rules and Catalogs||May 1, 2021|
|Standards for Cosmetic Efficacy Claim Evaluation||May 1, 2021|
|Administrative Measures on Cosmetics Labeling||May 1, 2021|
|Advertising Law of the People's Republic of China||September 1, 2015|
1.2 Allowable Efficacy Claim Scope
Cosmetic Classification Rules and Catalogs (the Catalogs) specifies that the classification of cosmetics adopts a coding system that has five layers, including efficacy claims, application areas, target users, dosage forms and application methods. For these five layers, a detailed classification catalog is provided for each of them.
In terms of efficacy claims, the Catalogs introduces a total of 27 categories of allowable efficacy claims. To help cosmetic stakeholders better understand these categories, the Catalogs also provides interpretation and guideline for each of them.
Interpretations and Guidelines
Efficacy that does not belong to the following specifications.
Used for changing the hair color, and the original hair color will not be restored when the product gets rinsed off immediately after use.
Used for changing the curvature degree of hair (to bend or straighten the hair), and maintaining the curvature state.
Freckle-removing and whitening
Helpful in achieving skin lightening and whitening effect by reducing or slowing down skin pigmentation, or by physical covering.
Used for protecting skin and lips from the damage caused by specific UV rays.
Used for reducing or removing body hair.
Assisting to shaving and barbering
Used to soften and swell the beard and hair, and helpful in lubricating skin at the time of shaving and barbering.
* For the full list of cosmetic's allowable efficacy claims, please refer to the cosme-list.
In addition to 26 specific categories, there is a category named "new efficacy". This category includes those whose efficacy claims, application areas, and/or target users are beyond the specified items in each catalog. In addition, the products that claim to be applicable to pregnant and breastfeeding women are also products with new efficacy.
Toothpaste does not fall in the scope of cosmetics, while it is currently regulated with reference to CSAR. To standardize the production and operation activities of toothpaste, as well as to ensure their quality and safety, NMPA devises the classification system and allowable efficacy claims for toothpastes in the draft Administrative Measures on Toothpastes (the draft Measures). In total, there are nine categories of efficacies stipulated in the draft. Likewise, under each category, allowable efficacy claim terms are listed for enterprise to refer to.
|Serial Number||Efficacy Category||List of Allowable Efficacy Claim Terms|
|01||Basic cleaning||Cleaning teeth/mouth, maintaining oral hygiene, maintaining oral health, reducing soft odontolith and freshening breath.|
|02||Caries prevention||Preventing dental caries, strengthening teeth, preventing tooth decay, inhibiting tooth demineralization, and promoting tooth remineralization.|
|03||Inhibiting dental plaque||Inhibiting dental plaque and reducing plaque formation.|
|04||Anti-dentin sensitivity||Anti-dentin sensitivity, reducing the hot/cold/sour/sweet irritations to the teeth, relieving tooth sensitivity, comforting, repairing sensitive teeth, and sealing dentin tubules.|
|05||Reducing gum problems||Clearing and dispelling excessive internal heat, improving gum health, and protecting gums.|
|06||Whitening||Whitening and brightening teeth, whitening teeth through oxidation reaction, reducing exogenous staining, mechanically reducing exogenous staining, chemically reducing exogenous staining, and achieving brightening/whitening effects through optical effects.|
|07||Anti-tartar||Reducing tartars, decreasing calculus, decomposing tartars, reducing tartar formation, preventing tartars, and inhibiting tartars formation.|
|08||Reducing halitosis||Reducing halitosis, decreasing bad odor, removing volatile sulfur compounds and other compounds, and inhibiting bad breath-causing bacteria.|
|09||Other efficacies||Moisturizing the mouth, and improving dry mouth.|
Considering the different needs of children and adult, limitations have been imposed on the efficacies that can be claimed for children cosmetics and toothpastes. According to the Catalogs, the allowable claims for children cosmetics are divided into two groups based on different age ranges.
Infants and toddlers (0-3 years): efficacy claims are limited to cleaning, moisturizing, hair care, sunscreen, soothing and body refreshing.
Children (3-12 years): efficacy claims are limited to cleaning, makeup removing, moisturizing, beautifying and embellishing, perfuming, hair care, sunscreen, repairing, soothing and body refreshing.
The draft Measures, which is currently under review by State Administration for Market Regulation (SAMR), details the administrative provisions of children toothpaste. Subject to it, the allowable efficacies for children toothpaste shall be only limited to basic cleaning and caries prevention.
1.3 Prohibited Efficacy Claims
To help cosmetic stakeholders fully comply with the regulatory requirements for efficacy claims, the Administrative Measures on Cosmetics Labeling specifies the scope of labeling or claim which may constitute a violation. To sum up, the prohibited claims specified in the scope can be summarized as follows:
False and exaggerated claims
Claims beyond the product's purposes
Claims involving belittling other legal products
Medical claims involving disease's name, medical specialty, pharmaceutical specialty, etc., and claims expressing or implying medical effects
Claims involving fabricating concepts or claims using terms or mechanisms that have not been widely accepted by the scientific community
Before applying for registration and notification, cosmetics registrants and notifiers shall make sure their product's efficacy claim is not in any violation described above. Besides, ChemLinked has compiled a list of prohibited words and expressions in claims on cosmetic packaging or advertisements. More information about this list can refer to CL News.
Part 2 Efficacy Claims Evaluation
2.1 Applicable Efficacy Claims
According to the Standards for Cosmetic Efficacy Claim Evaluation (the Standards), the cosmetic efficacy claim evaluation refers to the process to conduct scientific testing and reasonable evaluation of cosmetic's efficacy claims under normal use conditions by means of literature review, research data analysis, or cosmetic efficacy claim evaluation test, and then to draw corresponding evaluation conclusions.
Implemented from May 1, 2021, the Standards details the evaluation requirements for 20 efficacy claims, including:
Compared to the allowable efficacy categories listed in the Catalogs, there are 11 categories not given specific requirements for evaluation, for they meet the conditions for exemption. This knowledge is detailed in "2.5 Efficacy Evaluation Exemption".
2.2 Evaluation Basis
Regulated in the Standards, the efficacy claims of cosmetics shall be supported by sufficient scientific basis, which may include literatures, research data or cosmetic efficacy claim evaluation test results, etc. The efficacy claims evaluation test includes the human trial, consumer use test and laboratory test.
Among the efficacy claims subject to specific requirements, the human body efficacy evaluation test is required for a few claims, which have strong functions and are strictly managed as drugs or quasi-drugs in most countries and regions (e.g., freckle-removing and whitening, sunscreen, anti-hair loss, acne removing, nourishing, repairing, etc.). For other efficacy claims, the evaluation can be based on literature review, research data analysis, or efficacy claim evaluation tests as appropriate.
|Requirements for Cosmetic Efficacy Claim Evaluation Items|
|No.||Efficacy claim||Human trial||Consumer use test||Laboratory test||Literatures / research data|
|1||Freckle-removing and whitening||✓|
|12||Hair breakage prevention||*||*||*||△|
|16||Specific claims (claiming suitable for sensitive skins, tear-free formula)||*||*|
|17||Specific claims (efficacy of an ingredient)②||*||*||*||*|
|18||Claim gentle (no stimulation)||*||*||*||△|
|19||Claim quantitative index (time, statistics, etc.)||*||*||*||△|
|20||Claim new efficacy||The evaluation method should be selected according to the specific efficacy claim.|
1. ✓ means mandatory;
2. * means optional, but it is a must to choose at least one of them;
3. △ means "can be combined", but it is a must to conduct human trial, consumer use test or laboratory test simultaneously.
① If the effect area of the efficacy claim is hair, real hair in vitro can be chosen for evaluation.② The ingredient must be validated to have the claimed efficacy, and the efficacy claim of the ingredient should be fully related to that of the cosmetic product.
2.3 Evaluation Institutions & Testing Methods
Cosmetics registrants and notifiers can carry out the efficacy claim evaluation by themselves or by entrusting an evaluation institution with corresponding capabilities. As for the entrusted institutions, they are required to establish good laboratory practices, complete the efficacy claim evaluation and issue the reports, and be responsible for the authenticity and reliability of the reports.
Besides, regarding the evaluation institutions, special attention shall be paid to cosmetics with freckle-removing and whitening, sunscreen and anti-hair loss efficacy, as well as cosmetics claiming new efficacy. For these cosmetics, cosmetics registration and notification testing institutions in China shall be entrusted to conduct human trials in accordance with requirements of mandatory national standards and technical norms.
While choosing testing methods for cosmetic efficacy claim evaluation test, except for special provisions, priority shall be given to the following testing methods in (i) and (ii). If no methods are prescribed in (i) and (ii), the testing methods in (iii) and (iv) can be discretionarily selected:
Methods prescribed in mandatory national standards or technical norms for cosmetics in China;
Methods specified in other relevant regulations, national standards or industry standards in China;
Methods prescribed in relevant foreign regulations or technical norms;
Methods released by authoritative organizations, technical institutions and industry associations in China or abroad, methods published in professional academic journals and magazines, or self-drafted and developed methods. Evaluation institutions shall complete the necessary testing method transfer, confirmation or validation before carrying out efficacy evaluation to ensure the scientificity and reliability of the evaluation.
It should be noted that if a testing method is not specified in mandatory national standards and technical norms, it shall be validated by entrusting two or more cosmetics registration and notification testing institutions. Only when the validation result is compliant, the efficacy evaluation can be carried out. The effectiveness, reliability and other parameters of the method shall be described in the product efficacy claim evaluation report.
To provide sufficient and appropriate testing methods to fulfil the evaluation needs, the standardization process of testing methods is constantly advancing, and the methods under establishment and research are increasing. The table below compiles some of the published testing methods based on different efficacy categories.
2.4 Evaluation Report & Abstract
After the completion of efficacy evaluation test, the institutions that undertake the efficacy evaluation shall issue the evaluation report of the cosmetic's efficacy claim. Most efficacy reports can be kept by companies, but for sunscreen, freckle-removing and whitening, and anti-hair loss products, they must submit the human efficacy evaluation reports together with registration documents to the review department.
In addition, when applying for registration and notification, an evaluation abstract of the product efficacy claim basis shall be complied and uploaded on the website designated by NMPA. The abstract shall concisely list the contents of product efficacy claim basis.
|Documents||Necessary Contents||Submission Requirements|
|Efficacy Evaluation Report|
a. The human efficacy evaluation test report of sunscreen, freckle-removing (whitening) and anti-hair loss products must be submitted to the review department together with the registration documents;
b. The reports of other efficacies effects should be archived by companies for future inspection.
|Efficacy Evaluation Abstract|
a. The evaluation abstract must be uploaded to the NMPA designated website for disclosure;
b. Evaluation abstracts shall be archived for future inspection together with the efficacy evaluation basis. If the efficacy evaluation basis is in a foreign language, it shall be translated into standard Chinese. The product formula for the efficacy evaluation shall be consistent with that for cosmetic registration and notification. The documents proving the consistency shall be archived together with the efficacy evaluation basis.
*If the test method used is prescribed by foreign regulations, or released by Chinese or foreign authoritative organizations, the full text of the test method shall be attached to the evaluation test report. Where the testing method or testing report are in a foreign language, it shall also be translated into standard Chinese.
The below is an example of the cosmetic efficacy evaluation abstract publicized by NMPA.
2.5 Efficacy Evaluation Exemption
As required by the Standards, cosmetics produced and operated within the territory of China shall fulfil the regulatory requirements for efficacy claim evaluation, while some exemptions are granted. If product's efficacy falls into the two categories listed below, then they can be exempted from the disclosure of evaluation abstracts.
|1||Efficacy that can be directly recognized by vision, smell or other senses|
− Makeup removing
− Beautifying and embellishing
− Body refreshing
− Hair dyeing
− Hair perming
− Hair color maintaining
− Deodorizing− Auxiliary shaving and barbering
|2||Efficacy that functions through simple physical application, adhesion, friction, etc., and is clearly indicated as "physical effects only" on the label|
− Whitening through physical application
− Physical exfoliation− Physical removal of blackheads
Of course, if relevant evaluations have been carried out for these exempted efficacy categories, their evaluation basis can also be provided when cosmetic enterprises apply for registration and notification.
2.6 Transitional Measures
To ensure a smooth transition, NMPA introduced phased transitional measures for the evaluation requirement for cosmetic's efficacy claim:
Starting from January 1, 2022, cosmetics registrants and notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts on the website specified by NMPA.
For cosmetics registered or notified successfully before May 1, 2021, the cosmetics registrants or notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts before May 1, 2023.
In an announcement released on March 10, 2022, NMPA added that, for the above-mentioned cosmetics, if the efficacy claim involved in the product name or label cannot be supported by the evaluation result, a change application can be filed before the expiry of the transitional period. In this case, enterprises are allowed to amend the product names or labels before May 1, 2023, which saves enterprises the trouble of cancelling previous application and re-applying for registration or notification.
For cosmetics registered or notified successfully between May 1, 2021 and December 31, 2021, the cosmetic registrants or notifiers shall evaluate the cosmetic efficacy claims in accordance with the Standards and upload the evaluation abstracts before May 1, 2022.
To respond to the impact of the COVID-19, some provincial MPAs released policies to extend the time period for submitting the abstract to December 31, 2022. Cosmetic stakeholders shall arrange the evaluation as soon as possible to avoid the penalty risk for failing to upload efficacy abstracts by the due date.
ChemLinked expects to assist companies in reviewing cosmetic product claims and registering/notifying cosmetics in China. If you have any further cosmetic compliance consultation needs, please contact us at email@example.com.