Zhang Xi,Cao Lihua,Zhao Hua,Tang Ying

Department of Cosmetics,College of Chemistry and Materials Engineering,Beijing Technology and Business University,China

Abstract In order to cooperate with the implementation of the relevant cosmetic safety and efficacy evaluation as regulated according to the Regulations on the Supervision and Administration of Cosmetics,the National Medical Products Administration has successively promulgated The Technical Guide of Safety Assessment for Cosmetics and the Standard for Evaluation of Cosmetic Efficacy Claims.This paper comprehensively summarizes the requirements and methods for the evaluation of cosmetic safety and efficacy claims under the new regulations,and puts forward suggestions for relevant enterprises and practitioners,which provides useful guidance and reference for the cosmetic safety and efficacy claim evaluation.

Key words cosmetic;regulation;cosmetic safety;efficacy claim evaluation

The State Council of the People’s Republic of China promulgated Regulations on Supervision and Administration of Cosmetics (shorted as RSAC) on June 29,2020,which has been officially implemented since January 1,2021.The new regulations consolidate the achievements of reform in the cosmetic field into regulations and thereby open a new chapter in the cosmetic supervision.RSAC,as the first comprehensive amendment to the Regulations on the Supervision of Cosmetics Hygiene issued in 1989,contain a total of 80 articles,of which 22 articles explicitly mention the "cosmetic quality and safety"and 11 articles definitely refer to the “efficacy claim”.Therefore,the cosmetic safety and efficacy claim evaluation have become highlights of RSAC.

In order to regulate and guide the cosmetic safety and efficacy claim evaluation and support the implementation of RSAC,the National Medical Products Administration promulgated Technical Guide of Safety Assessment for Cosmetics (2021 version,hereinafter referred to as the TGSA) and Standard for Evaluation of Cosmetic Efficacy Claims(shorted as the evaluation SECEC),which both have been implemented since May 1,2021.TGSA and SECEC further clearly normalize the optional evaluation methods and scientifically provide basic principles for the cosmetic safety and efficacy claim evaluation.Therefore,they have become important standard for the development of safety and efficacy evaluation in the cosmetics industry and will benefit for the effective protection of the legitimate rights and interests of consumers.This paper combs cosmetic safety and efficacy claim evaluation under the new regulations and supporting measures.

1 Technical guide of safety assessment for cosmetics and cosmetic safety evaluation

Before the promulgation of RSAC,there have been a series of guidelines for cosmetic safety assessment,such as Guidelines for the Safety Evaluation of Cosmetics (Exposure Draft,shorted for GSEC) published in 2015,Review Principles for Substances with Possible Safety Risks in Cosmetics (Exposure Draft) and Notice on Printing and Distributing Guidelines for Risk Assessment of Substances with Potential Safety Risks in Cosmetics (Licence of National Medical Products Administration[2010]No.339) published in 2010.Significantly,TGSA strengthens the responsibilities of safety assessor,optimizes the assessment methods,simplifies the assessment contents of series formulations,and also supplements the safety assessment for children’s cosmetics.

1.1 Responsibility and professionalism of safety assessor enhancement

The safety assessors are required to have a university degree or above or other formal qualification certificates according to GSEC,while no degree restriction but relevant professional experience over 5 years is required according to TGSA.Meanwhile,TGSA stresses the accountability and professionalism of the safety assessors,who are responsible for the safety assessment report’s scientificity,accuracy,authenticity and reliability.In addition,the resume and signature of the safety assessor shall be attached to the assessment report to implement the responsibility.TGSA also requires that cosmetic registrants and filing applicants should conduct safety assessment by themselves or by professional institutions entrusted to form safety assessment reports,and be responsible for their authenticity and scientificity.

1.2 Sensitization risk assessment addition

The risk assessment procedure for cosmetic raw materials and risk substances is divided into four steps,three of which are further supplemented and improved according to TGSEC.Specifically,for the first step,called hazard identification,the health hazard effects such as photoallergy,corrosively,repeated dose toxicity and inhalation exposure are supplemented.This is consistent with the indicators of hazard identification adopted in toxicological assessment and risk assessment in the Safety and Technical Standards for Cosmetics(2015 edition,shorted as STSC).The second step,called dose response relationship evaluation,is supplemented with the evaluation method of No Expected Sensitization Induction Level (NESIL)as to the sensitizing raw materials.The fourth step,called exposure assessment,refers to the transdermal absorption experimental method in the latest version of the guidelines for the safety assessment of cosmetic raw materials by the Scientific Committee On Consumer Safety (SCCS),clarifies the method for obtaining experimental data of transdermal absorption of raw materials and/or risk substances and replenishes the calculation principle of absorption rate of raw materials with different molecular weight.

1.3 Application of new methods and historical evidence

In recent years,the natural extracts derived from animal and plant and also biological fermentation raw materials have attracted broad attention in the cosmetic market.However,due to their complex components,the safety risk assessment is a great challenge.In order to maximize safety and reduce the potential safety hazards of the complex biological raw materials in product application,TGSA improves the requirements for raw material specifications,safety assessment methods and the evidence sources of safety assessment reports.Regarding the raw material specifications,the content of active components should be specified in the physical and chemical property report of animal-derived raw materials,and the biotechnology type/mode is required for the biotechnological raw materials.In the safety assessment methods,new methods such as Threshold of Toxicological Concern (TTC) and grouping/cross reference methods used internationally are added;in particular,for raw materials or risk substances with clear chemical and no serious mutagenic warning structure,when they are present in low contents and in the absence of systematic toxicological research data,the toxicological concern threshold (TTC)method can be used for assessment,and as to nonfunctional components or risk substances lacking systematic toxicology research data,grouping/cross reference method can be used for evaluation.Among the evidences used in the cosmetics product safety assessment report,the concentration of raw materials in the products with the same use method that have been on the cosmetics market for at least 3 years (i.e.,the historical use concentration in the products) is allowed as the assessment evidence,but it needs to be fully analyzed and explained from the aspects of target population,use position and use method.

1.4 Evaluation requirements for children’s cosmetics

At present,children’s cosmetics in China vary considerably in quality,and safety problems occur frequently.To address these problems,both products and raw materials used in children's cosmetics should pass the safety risk assessment based on the physiological and use characteristics according to TGSA.Specifically,the particularity of children’s exposure should be considered in the exposure assessment and the microbial pollution in the microbial assessment.For this purpose,according to TGSA,the specific technical requirements for safety assessment of children's cosmetics include:① In terms of hazard identification and exposure calculation,it should be reviewed separately for children’s physiological characteristics such as skin barrier and incomplete development function;② In terms of formulation design principle,it is necessary to clarify and explain the necessity of raw materials used in the formulation;③ In terms of the raw materials,in principle,it is not allowed to use raw materials for the purposes of whitening,anti-acne,epilation,deodorization,dandruff removal,anti-hair loss,hair dyeing and perm;and if these are used for other purposes,the necessity and the safety shall be evaluated.④ Cosmetic raw materials with long term history of safe use should be selected.Those prepared by new technologies such as gene technology and nanotechnology are not encouraged,where there is no such alternative raw material that those materials must be used,the reasons should be explained and the safety of children’s cosmetics should be evaluated.

1.5 Simplification of evaluation requirements for a range of products

For multi-color,multiple flavor and other ranges of cosmetics products on the market,if the type,content of the basic formulation as well as the name of the products are the same but different in the type or content of the colorant or fragrance,TGSA regulates an separate evaluation on the adjusted components of series products with the reference of the existing data to ensure product safety.However,the cumulative exposure of raw materials should be considered in individual case analysis,if the mechanism of systemic toxicity of the different raw materials in the product formulation is identical.This measurement not only strictly supervises the product quality and safety,but also reduces the evaluation workload and improves the safety evaluation efficiency,thus reducing the burden on enterprises and providing innovative vitality for enterprises to develop series beauty products.

2 Standard for evaluation of cosmetic efficacy claims and efficacy claim evaluation

Before the promulgation of TGAS,it is required in China that,for sunscreen and sunscreen products,the waterproof function should be evaluated according to the STSC,but no relevant requirements on the efficacy claim evaluation for other cosmetics are proposed.Compared with STSC,the SECEC expounds and stipulates the efficacy claim evaluation in terms of the definition,evaluation category,basic principle,responsibility requirement,and responsibility and requirement of evaluation institution.

2.1 Definition and evaluation principle of efficacy claim evaluation

Cosmetic claim is a descriptive description of a product,which can be provided in a variety of forms,involving the functions,components and characteristics of products.The regulations on the management of cosmetic claim in China have been continuously improved—the Regulations on the Supervision of Cosmetics Hygiene clarify prohibited contents in advertisement;then,Regulations on the Administration of Cosmetics Labeling require that cosmetics labeling should be true,accurate,scientific and legal;furthermore,RSAC strengthen the management of cosmetic claims,emphasizing that the cosmetic efficacy claim should be based on sufficient scientific evidence.The scientific evidence is divided into three types according to SECEC:literature,research data and cosmetic efficacy evaluation test results,wherein the cosmetic efficacy evaluation tests involve human efficacy evaluation test,consumer use test and laboratory test.It is required that the experimental design should comply with the statistical principles,and experimental data should meet the statistical requirements.Based on this,SECEC defines the cosmetic efficacy claims evaluation as the process of scientifically testing and reasonably evaluating of the claimed content under normal use conditions and making corresponding evaluation conclusions by means of literature research,research data analysis or cosmetic efficacy evaluation test.

It is noted that,the new regulations,although cosmetics are classified into ordinary cosmetics and special cosmetics according to the risk degree,the efficacy claim evaluation shall be conducted regardless of the classification of the cosmetics,as long as they are produced and marketed in the People’s Republic of China (including domestic and imported cosmetics that are publicly sold in China).In other words,the efficacy claim evaluation is not exempted according to the degree of risk.Meanwhile,cosmetics with different efficacy claims should be evaluated according to different evaluation evidence.A summary of efficacy claim evaluation principles is shown in Table 1.According to the requirements of RSAC,the cosmetic efficacy claims should be supported by scientific basis,and the human efficacy evaluation on the cosmetics with certain efficacy such as freckle whitening,sun-proof,anti-hair loss,anti-acne,repair and nourishment should be conducted.Where the cosmetic products claims are claimed through raw materials efficacy claim,rather than the formulation,literature research,research data analysis or efficacy claim evaluation test should also be carried out to confirm the claimed efficacy.At the same time,the efficacy claims of raw materials shall be fully related to the efficacy claims of products.

Table 1.Principles of cosmetic efficacy claim evaluation

2.2 Selection and requirement on evaluation institutions

The efficacy claims evaluation can be conducted by the cosmetic registrant,filing applicant and third-party evaluation institutions.Although the third-party evaluation institutions are not explicitly required to possess specific qualification of according to current laws and regulations,they are required to have corresponding capabilities.The State Food and Drug Administration has published a list of 14 cosmetic registration and filing testing institutions with capabilities of “human safety inspection and efficacy evaluation”,and has listed in detail the qualified inspection items for each institution.In addition,the organization undertaking the cosmetics efficacy claim evaluation should establish good laboratory specifications,complete the efficacy claim evaluation and issue a report according to the requirements of SECEC.Moreover,they should sort out,archive and keep the completed data or the issued test report for future reference,and be responsible for the authenticity and reliability of the report.

2.3 Guiding opinions on the abstract of the basis for the cosmetic efficacy claims

The main way for displaying cosmetic claim evaluation is the abstract document,which includes at least basic product information,efficacy claim evaluation items and evaluation institutions,evaluation methods and results,evaluation conclusions and other relevant information.After the cosmetic efficacy evaluation carried out by cosmetic registrant,filing applicant or evaluation institution,the abstract shall be prepared according to the evaluation conclusions and then be uploaded on the special website specified by the State Drug Administration for social supervision.However,the following two types of products can be exempted from publishing the evaluation abstract:one is those products that can be directly identified by senses,such as cleaning,makeup removal,beauty modification,etc;the other is those products that produce effects through the use methods such as simple physical covering,adhesion,friction,etc.and can be clearly identified with the efficacy claims of the only physical effects on the label.

2.4 Identification of the responsible subject of cosmetic efficacy evaluation

It is clearly stipulates in SECEC that the registrant and filing applicant are the responsible subjects for cosmetic efficacy claims,and are responsible for the scientificity,authenticity,reliability and traceability of the submitted abstract.In particular,it is specified according to Article 62 of RSAC that the relevant penalties:any entities failing to publish the abstract of the basis for the cosmetic efficacy claims shall be instructed to rectify,given a disciplinary warning and imposed a fine of more than RMB10,000 YUAN but less than RMB30,000 YUAN by the supervisory and administrative department;if the circumstances are serious,entity concerned shall be ordered to stop production and business,and imposed a fine of between RMB30,000 YUAN and RMB50,000 YUAN,and the legal representative or major principal,executive and other persons directly in charge of the entity violating the law or regulation shall be imposed a fine of not less than RMB10,000 YUAN but not more than RMB30,000 YUAN.

3 Conclusions

TGSA and SECEC are important supporting measures for RSAC in terms of cosmetic safety and efficacy.They are also the only regulations on safety risk assessment and efficacy claim evaluation promulgated and implemented so far in China.The implementation of TGSA and SECEC put forward the solutions and system requirements for the quality,safety and efficacy claims evaluations for the current cosmetics market from the practical level in China.They also trace back to the source to ensure the safety and efficacy of cosmetics.It is of great significance for establishing a scientific and effective cosmetics evaluation system.

In terms of risk assessment,those supporting measures help cosmetics practitioners to timely obtain the information released by the government and the interpretation of relevant policies,train professional risk assessors,establish and improve the product risk assessment procedure and risk management system,and learn from the advanced experience of the EU in the safety assessment of new cosmetic raw materials and new technologies.In terms of efficacy and safety evaluation,it is suggested that cosmetic enterprises should pay attention to the abstract of the basis for cosmetic efficacy claim according to TGSA and SECEC,accept social supervision,increase the investment in cosmetic efficacy evaluation,strengthen the control of raw materials and their production,and cultivate cosmetic efficacy evaluation personnel with relevant qualifications,and thereby establish and promote national cosmetics brands.