Li Yanan,Jiang Ligang

Research &Innovation Center,Proya Cosmetics Co.Ltd.,China

Abstract The supervision and administration of cosmetics and its two supporting documents related to efficacy,cosmetics classification rules and classification catalogue and evaluation standard of cosmetic efficacy claims,have been successively introduced and implemented,making China’s cosmetics industry officially enter the era of efficacy evaluation.In the time window when the new era is coming,the definitions of cosmetics in China and other countries are compared.The latest status and progress of regulations on cosmetic efficacy claims in China and other countries are summarized,and the standard methods or guidance of cosmetic efficacy evaluation at home and abroad are introduced.The enlightenment from the supervision systems of cosmetic efficacy in other cosmetic consumer markets around the world are discussed.In addition,the opportunities and challenges for cosmetic enterprises under the background of cosmetic law reform in China are also prospected.

Key words cosmetics;efficacy claims;laws and regulations;China;Europe and America;standard methods;evaluation guidelines

In recent years,the beauty economy is booming and China’s cosmetics market is growing rapidly,but the per capital consumption level is only 1/5 of that of developed countries such as the U.S.and Japan,leaving a wide space for future development.At the same time,with the strong rise of ingredient parties and cosmeceuticals,the competition pattern and current situation of the industry place higher and higher requirements on the safety and efficacy of cosmetics.

Efficacy and safety of cosmetics are of great significance to consumers,but due to historical reasons,there has been a phenomenon of focusing on safety and neglecting efficacy for a long time.Following the official implementation of the supervision and administration of cosmetics on January 1,2021,on April 9,2021,the State Drug Administration officially released three supporting documents,including the cosmetics classification rules and classification catalogue and the evaluation standard of cosmetic efficacy claims,which came into effect on May 1,2021.It is bringing China’s cosmetics industry into the era of efficacy evaluation.

With the introduction and implementation of the supervision and administration of cosmetics and its related supporting regulations,China’s cosmetics regulatory system is undergoing tremendous changes and innovations that would profoundly affect the future of the cosmetics industry in China and the world.The new regulations are a summary and distillation of the industry’s development over the past 30 years,and would lead the industry to new heights,and would make the entire Chinese cosmetic industry to be more scientific,truthful,rigorous and reliable in terms of safety and efficacy.In the time window when a new era is dawning,this paper highlights the current status and development of regulations related to cosmetic efficacy claims in China and the EU,outlines regulations and evaluation guidelines related to cosmetic efficacy claims in Japan,Korea,and the U.S.,and the enlightenment from the supervision systems of cosmetic efficacy in other cosmetic consumer markets around the world are discussed.

Despite the differences in policies and regulations regarding cosmetic efficacy claims and the different guidelines for evaluating cosmetic efficacy in different countries,governments all over the world actually share the same responsibility to ensure that cosmetic products are safe for consumers to use and to ensure consumer benefits.In the context of the supervision and administration of cosmetics,the majority of cosmetic companies should take advantage of the environment and impetus of regulatory changes to pay more attention to research and development,focus on technology,and dedicate to providing Chinese consumers with more safer and effective skin solutions.

1 Comparison of the definition of cosmetics between China and other countries

There is no international uniformity regarding the definition of cosmetics,and countries have defined cosmetics mainly from method,location and purpose(Table 1).Different purposes make the scope of the definition inconsistent,such as keeping it in good condition and increasing its charm,etc.all have broader extents.Although the definition of cosmetics varies slightly from country to country,it has a common definition that cosmetics are used for cleansing and beauty purposes.

Table 1.A comparison of the definition of cosmetics in China and other countries

2 Chinese cosmetic regulations on efficacy claims

2.1 China - supervision and administration of cosmetics

The supervision and administration of cosmetics officially implemented on January 1,2021.Among them,the 22nd article has attracted the attention of the industry:“Efficacy claims for cosmetics shall be based on sound scientific evidence.”

2.2 China - cosmetics classification rules and classification catalogue

On April 9,2021,the National Medical Products Administration issued two supporting documents related to the efficacy of the supervision and administration of cosmetics,namely the cosmetics classification rules and classification catalogue and the evaluation standard of cosmetic efficacy claims,which came into force on May 1,2021.The cosmetics classification rules and classification catalogue provides a classification catalog of efficacy claims,including 26 cosmetic efficacy claims,which do not meet the 26 cosmetic efficacy claims belong to the new efficacy.Thus,the latest pattern of special cosmetic efficacy claims in China is now “5+n”(“5” includes hair dye,perm,skin whitening,sun protection,anti-hair loss,and n new efficacy).

2.3 China - evaluation standard of cosmetic efficacy claims

The sixth regulation of the evaluation standard of cosmetic efficacy claims:“Cosmetic registrants and record holders can,by themselves or by entrusting evaluation agencies with corresponding capabilities,to carry out cosmetic efficacy claims evaluation in accordance with the requirements of cosmetic efficacy claims evaluation items(Annex 1).” Efficacy claims are evaluated on the basis of human efficacy evaluation tests,consumer using tests,laboratory tests,literature or research data,which are four different levels of evidence.The evaluation standard of cosmetic efficacy claims stipulates that six efficacy of skin whitening,sun protection,anti-hair loss,antiacne,nourishment,and repair must be evaluated using human efficacy evaluation tests as the basis for evaluation,thus recognizing that human efficacy evaluation tests have the strongest evidence.The cosmetic industry and dermatologists also generally recognized that the human efficacy evaluation test of the finished product has the strongest evidence.

2.4 China - Cosmetic safety and efficacy evaluation methods:national standards,industry standards,group standards

Cosmetic efficacy evaluation is to provide scientifically rigorous technical support for the effectiveness of product claims and advertising claims.Currently in China,for special cosmetic efficacy claims the relevant national standards are provided in the “Safety and technical standards for cosmetics,the 2015 edition”,such as sun protection,skin whitening,and anti-hair loss(Table 2).For other cosmetics,especially ordinary cosmetics,there are no unified national standards and requirements for unified norms,and some industry standards and group standards are available for industry reference,such as the industry standard“Guidance for evaluation of cosmetics moisturizing efficacy”released in 2011,and in 2018 and 2019,the Zhejiang Health Products and Cosmetics Industry Association and Proya Cosmetics Co.,Ltd.jointly developed and released six group standards,including cosmetic whitening,oil control,impact on transepidermal water loss,skin surface pH,skin tensile,and anti-wrinkle efficacy test methods(Table 3).Although such standards are voluntarily adopted by society and are not mandatory,they can play a leading role in market orientation and industry selfregulation in the industry field.

Table.2 The national standards for human safety and efficacy testing in the Safety and Technical Standards for Cosmetics,the 2015 edition

Table 3.China - industrial standards and group standards for human efficacy testing

3 EU cosmetic regulations on efficacy claims

3.1 EU(European Union)-Regulation(EC)No 1223/2009

The establishment of technical regulations for cosmetics in China has to some extent use the EU regulatory system for reference.The basic framework of the “Safety and technical standards for cosmetics the 2015 edition” is very similar to that of Regulation(EC)No 1223/2009,[1]referred to and followed the requirements of many EU cosmetics regulations.Regulation(EC)No 1223/2009 is the first EU cosmetic regulation that came into force in July 2013,which states in(51)that “The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products.” Article 20.1 states,“In the labelling,making available on the market and advertising of cosmetic products,text,names,trade marks,pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.” “Claims shall not mislead consumers” is also a common requirement for claims in regulations all over the world.

3.2 EU - Commission Regulation(EU)No 655/2013

In 2013,the European Union specially issued the“common criteria for the justification of claims used in relation to cosmetic products”,namely Commission Regulation(EU)No 655/2013[2],which puts forward the six famous common criteria of claims,namely the“l(fā)egal compliance ,truthfulness,evidential support,honesty,fairness,and informed decision-making”.

In order to harmonize the understanding and implementation of the regulation by relevant parties,the EU also published a supporting guidance to Commission Regulation(EU)No 655/2013,[3]which provides “Best practice for claim substantiation evidence” in Annex II,which states that “It is usual to substantiate claims by using either experimental studies or consumer perception tests and/or published information or,indeed,a combination of these.”

3.3 EU-CE“Guidelines for the evaluation of the efficacy of cosmetic products”&EEMCO Guidance for the Evaluation of Efficacy

In 2008,the Cosmetics Europe the personal care association(CE,formerly known as COLIPA)issued the “Guidelines for the evaluation of the efficacy of cosmetic products”,which set forth the guidance requirements for in vivo test,in vitrotest and ex vivo test used in the evaluation of cosmetic efficacy.In terms of efficacy assessment methods,CE has also worked with the International Organization for Standardization(ISO)to draft international standards for sun protection and human fitness and promote their use in the European Union market.In addition,the European Expert Group on Efficacy Measurement of Cosmetics and Other Topical Products(EEMCO)has published a series of guidelines for the evaluation of the efficacy of cosmetics,including guidelines for the evaluation of skin surface pH,the evaluation of dry skin(xerosis)and ichthyosis by strippings,skin microcirculation,skin tensile functional properties,transepidermal water loss,skin color,skin greasiness,skin topography and hair shedding and alopecia(Table 4).

Table 4.European expert group on efficacy measurement of cosmetics and other topical products(EEMCO)guidance

4 Japan -“Revision of the Range of Cosmetics Efficacy”&Japan Cosmetic Science Society(JCSS)Efficacy Evaluation Guidelines

“Revision of the Range of Cosmetics Efficacy”issued by the Ministry of Health,Labour and Welfare in July 2011 limits the range of declared cosmetics efficacy claims to 55 types.Since 2008,the Japan Cosmetics Industry Association(JCIA)has issued the “Guidelines for Appropriate Advertisement of Cosmetics and Other Products” to the industry,providing a very detailed guidance for cosmetics manufacturers and operators.The Japan Cosmetic Society(JCSS)has also developed guidelines for the industry on the evaluation of sunscreening,whitening,and anti-wrinkle efficacy and guidelines for the evaluation of safety of functional cosmetology(Table 5).

Table 5.Japanese Cosmetic Science Society(JCSS)efficacy evaluation guidelines

5 Korea -“Functional cosmetics inspection regulations”&the Korea National Institute for Food and Drug Safety Evaluation Guidelines

According to relevant Korean regulations,human clinical test data,in vitro test data,survey data above the same level(relevant papers,academic literature,etc.),consumer survey results,and expert organization survey results can be used as confirmation data for the reasonable basis of cosmetic efficacy claims.And make provisions for all kinds of information requirements.In June 2019,the Korean Ministry of Food and Drug Safety(MFDS)issued a newly revised “Functional Cosmetics Inspection Regulations”,proposing that the efficacy of cosmetic ingredients(raw materials)can be used as the scientific basis for cosmetic efficacy claims.In addition,the Korea National Institute for Food and Drug Safety Evaluation has also issued a series of efficacy evaluation guidelines,including guidelines for efficacy evaluation of whitening,anti-wrinkle,anti-hair loss,anti-mosquito products,and teeth whitening products(Table 6).

Table 6.The Korea National Institute for Food and Drug Safety Evaluation has issued guidelines for efficacy evaluation of functional cosmetics

6 U.S.-OTC monograph &The FDA has relatively loose management over the efficacy claims of cosmetics

In the United States,the US Food and Drug Administration(FDA)is mainly responsible for the supervision of cosmetics,which is mainly based on the “Federal Food,Drug and Cosmetics Act,FD&C Act”[19]and “Fair Packaging and Labeling Act”[20]on the labeling of cosmetics,the import and export of cosmetics,and cosmetics inspection standards for supervision.The management of cosmetics efficacy in the United States focuses on the main responsibility of enterprises.The FDA has relatively loose control over the efficacy claims of cosmetics.There are no specific verification requirements in the regulations.For the promotion of moisturizing and cleaning,companies can develop their own methods of use.

Fluoride toothpaste,antibacterial hand sanitizer,sunscreen products,anti-dandruff shampoo,etc.are Over-The-Counter drugs(OTC)and are regulated by the OTC Monograph in the United States.The advertising claims of the above two types of products must comply with the Federal Trade Commission(FTC)issued in 2006,the“Federal Trade Commission Act” regulations,the act requires the advertising must be true,can not deceive the consumer,the function claim should have the corresponding evidence to prove.[21]In terms of efficacy evaluation methods,the FDA has clear requirements for OTC products(such as sunscreen products)in terms of ingredients,usage methods,and test methods in the OTC Monograph.The FDA has a looser management of the efficacy claims of ordinary cosmetics,while the management of OTC products is more stringent.For example,the FDA has very strict management of the types of sunscreen ingredients,and there are more restrictions on the combination of different sunscreens.These limitations are a challenge for formulators who want to achieve higher UV protection.The FDA’s strict regulation of sunscreen ingredients may limit the choice of formulators and discourage technological innovation.

7 Enlightenment from other countries’cosmetic efficacy supervision systems

7.1 Enlightenment from the EU animal testing ban

Since March 11,2013,the EU has banned the sale of any cosmetic products(including cosmetic ingredients)that have been tested on animals for safety.Since then,more countries have followed the lead of the EU and enacted regulations banning animal testing for cosmetics.Currently,animal testing has not been abolished in China’s cosmetic industry,and the evaluation standard of cosmetic efficacy claims states that laboratory tests include but are not limited to animal testing,in vitro testing(including isolated organs,tissues,cells,microorganisms,physical and chemical tests),etc.At the same time,the general part of Annex 3 “Technical guidelines for the evaluation of cosmetic efficacy claims” of the evaluation standard of cosmetic efficacy claims also clearly states that animal testing should comply with animal welfare requirements and the 3R(replacement,reduction,refinement)principles.Validated alternative methods to animal testing are scientific practices that take into account both scientific objectives and animal welfare by using more scientific methods in accordance with scientific principles and in order to achieve the ultimate research objectives.From the perspective of international cosmetic industry trends,it is a general trend to reduce animal testing and find suitable alternative methods.

7.2 Enlightenment from the list of efficacy raw materials in Japan and Korea

Japan has a relatively clear list of raw materials that can be used to produce quasi-drug whitening cosmetics.Based on this,companies can develop their own products or develop new whitening active ingredients to enhance the technology and competitiveness of their products.The Korean government is responsible for formulating a list of “recognized functional raw materials”,including the types and contents of total active ingredients used in whitening cosmetics.

Japan and Korea’s regulatory systems for the list of functional ingredients can provide us with some inspiration.For some cosmetics with special functions,since the main decisive effect on their efficacy and safety is the raw materials they contain,a management system based on raw materials is established instead of adopting a unified application material requirement for all types of products.It will be an important reference for us to review the management methods of the existing special cosmetics in China(such as skin whitening and anti-hair loss cosmetics),and then make reasonable and scientific adjustments.

7.3 Enlightenment from the efficacy evaluation guidelines of other countries to improve the efficacy evaluation system of cosmetics in China

Looking at the cosmetic efficacy supervision system in other cosmetic consumer markets around the world,many foreign evaluation standards are evaluation guidelines,that is,only the principled and standardized requirements for each category of efficacy claims,and no specific standards are established.In addition to the current three national standards(sunscreen efficacy,skin whitening efficacy,and anti-hair loss efficacy),to improve our country’s efficacy evaluation standard system,it is recommended that some efficacy evaluation guidelines like the EU can be published for industry reference instead of mandatory national standards.The three national standards correspond to special cosmetics(sunscreen efficacy,skin whitening efficacy,and anti-hair loss efficacy).Because of the particularity of these three types of products,national standards have been formulated to provide industry standards to ensure product safety and consumer health.For other efficacy or common cosmetic efficacy,we look forward to following industry self-discipline,associations organization and government supervision,and encouraging the blooming of different methods to verify and screen out reliable methods,and then iterate step by step,and form a recognized method or evaluation guideline after revision and improvement.

8 Under the background of the new regulations,opportunities and challenges coexist for cosmetics enterprises

The government focuses on protecting the rights and interests of consumers and demonstrates the attitude and determination of a major country to be responsible to the people.This is also an inevitable trend for the development of the entire society.The cosmetic label claims are consistent with the actual efficacy,protect consumers’ clear consumption,and through the enhancement and guidance of laws and regulations in terms of efficacy,encourage the substantial innovation of cosmetics,the development of new cosmetic raw materials,the research of raw materials efficacy,and other independent intellectual property research and development work,strengthen the competitiveness of enterprises is the new opportunity brought to the industry by the new regulations.At the same time,the cost of new cosmetic product development in the future may increase significantly,the research and development cycle will be significantly longer,the new and updated products will be slowed down,and more attention will be paid to meet the actual needs of consumers,and product development will be more rational;more and more attention will be paid to promote star products,especially focusing on products with high efficacy and high unit price,will focus on shaping product strength in core products,and brands will turn to differentiated and personalized competition.This is the challenge that the new regulations may bring to the majority of cosmetics companies and the impact on the future trend of new cosmetics products.

Research creates value,and cognition drives progress.In the current time window when our country’s cosmetics regulatory system is undergoing tremendous changes,it is hoped that Chinese cosmetics companies can take this opportunity to promote the technological upgrading of their brand products,and develop more innovative and diversified products that are more in line with the skin conditions and needs of Chinese consumers,and to enhance the image of Made in China;it is also hoped that this regulation will create a good trend for the domestic cosmetics industry to go international,and the future of domestic cosmetics will be brighter.