Shu Tingting

Zhejiang Zhongmao Co.,Ltd.,China

Abstract Regulations on the supervision and administration of cosmetics (hereinafter referred to as “CSAR”) will be formally implemented on January 1,2021,and there are more than 10 related regulations and normative documents draft has been issued,these new rules will be built to form a new cosmetics regulatory system,the CSAR for the first time put forward the "cosmetic notification person and registration person system",improve the barriers to entry for cosmetic notification person and registration person.This paper summarizes and analyzes the new regulations on cosmetics issued in 2020,and briefly discusses the new requirements and suggestions on setting up quality management system,quality safety responsible person,adverse reaction monitoring and evaluation system,cosmetic efficacy evaluation and other new requirements for cosmetics notification person and registration person after the implementation of the new regulations.

Key words Regulations on the Supervision and Administration of Cosmetics; CSAR; registration person and notification person; cosmetic regulation; adverse reaction of cosmetic; efficacy evaluation of cosmetics

2020 is the year of the replacement of old and new regulations for cosmetics in China; So 2021 will be a year of more strict regulation for the cosmetics industry? In September 2020,National Medical Products Administration issued a notice on launching the first phase of the cosmetics “combating illegal and criminal activities online and offline” special action.Taking the upcoming implementation of the CSAR as an opportunity,before the entry into force of CSAR,that is,from October to December,the first phase of the special action for cosmetics “combating illegal and criminal activities online and offline ” was organized all over the country.After CSAR are officially implemented,the next stage of special actions will be organized.At the time of the systematic reform of the new cosmetic regulations,the cosmetic market supervision has begun to shift from focusing on pre-marketing approval to focusing on post-marketing supervision.Cosmetics companies also need to update their knowledge of regulations in a timely manner,the entire life cycle of cosmetics production must comply with new regulations.

Regulations on the supervision and administration of cosmetics will be formally implemented on January 1,2021.CSAR establish multiple systems such as cosmetic registrants,cosmetic raw materials classification management,cosmetic efficacy claims management,quality and safety responsible person,e-commerce platform sales management,product safety assessment,product sales records,credit files,safety risk monitoring and evaluation,and adverse reaction monitoring.CSAR have made very comprehensive provisions on the entire life cycle of cosmetics,including the use of raw materials,product registration and filing before the market,product production and operation,postmarket supervision,and related legal responsibilities.In order to implement the CSAR deeply,more than 10 drafts of relevant supporting regulations and normative documents have been issued after the new regulations.These new regulations will form a new cosmetics regulatory system,and the implementation of the new regulations will also become an important driving force for the development of the cosmetics market industry.CSAR fully reflect the "four most stringent"requirements,and the risks and responsibilities,systems and capabilities embodied in its content involve both producers and operators as well as supervision and management departments[1].For the first time,CSAR propose a cosmetics recorder and registrant system,which makes the safety and efficacy supervision of cosmetics is undoubtedly more scientific and more retrospective.There is no doubt that the legal liability regulations for the cosmetic notification person and registration person are more detailed and the penalties have increased significantly.These are undoubtedly major challenges for cosmetics companies.

1 New trend in cosmetics regulations in 2020

The CSAR have 6 chapters 80 articles which based on the current status of the cosmetics industry and it will open a new chapter in cosmetics supervision.The main contents are summarized in Table 1.Many new regulatory systems have been proposed in CSAR.In order to help cosmetic companies and regulators implement them better,the regulatory authorities have successively issued many supporting regulations and documents covering the registration of cosmetic raw materials,cosmetics production and operation,cosmetics classification,and cosmetics for registration,cosmetic safety evaluation,cosmetic efficacy evaluation,cosmetic labeling,etc.,see Table 2 for details.

Table 1.The summary of CSAR

Table 2.The summary of related supporting regulations and normative documents for CSAR

continued

2 The “cosmetic notification person and registration person management system” raises the barriers to entry for cosmetics producers and operators

2.1 The cosmetic notification person and registration person shall establish and implement the corresponding quality management system and set up a person in charge of quality and safety

What is the notification person and registration person? According to the “Administrative Measures for Cosmetics Registration” (Draft),cosmetic notification person and registration person are enterprises or other organizations that can promote the products to the market in their own name and bear the related liabilities independently.In the current regulations on cosmetics supervision,the entities responsible for corporate responsibilities are often expressed as “manufacturing enterprises”,“producers”,“cosmetics producers”,“cosmetics distributors”,and “cosmetics operators” which makes it not only inconsistent in expression,but also unclear what responsibilities should be borne by the participants in various production and business activities in terms of product quality and safety.[2]CSAR clarify the main responsibility of the registration person or notification person which will help improve regulatory efficiency.[3]

At present,there are more than 70,000 cosmetics registration person or notification person in China,of which more than 5,000 companies hold production licenses.According to incomplete statistics,more than 90% of enterprises use commissioned methods to organize production,and more than 75% of products are commissioned products.[4]The “ cosmetic notification person and registration person management system” proposed by the CSAR will increase the entry barrier for cosmetics producers and operators comprehensively.This system is somewhat similar to the cosmetics responsible person system stipulated in the EU Cosmetics Regulation (EC) 1223/2009.The EU’s regulation is to designate a legal or natural person as the responsible person in the EU member states,that is to say,the cosmetics manufacturer,the brand of cosmetics commissioned production,the importing company or the distributor can be the responsible person.As the responsible person,you need to comply with the regulations on cosmetic safety,good manufacturing practices,product safety assessments,product information documents,reported information,restrictions on the use of cosmetic raw materials,animal experiments,labels,product efficacy claims,and reports of serious adverse events.[5]CSAR require the establishment and implementation of a cosmetics quality management system,which can realize the control and traceability of the entire process of cosmetics material procurement,production,inspection,storage,sales and recall.However,the current regulations only require that the registration person or notification person who has a business license which as long as has cosmetic sales and related.The implementation of the new regulations is imminent,the cosmetic notification person and registration person should start to reserve professionals as soon as possible,that is,the responsible person in charge with more than 5 years of relevant work experience,and build a practical cosmetics quality management system in line with the actual situation of the enterprise,including the corresponding organizational structure,quality management system(registered product management system,supervision system for entrusted production enterprises,product sample management system,product release system for marketing,product storage and transportation management system,etc.) .It is also indispensable for the entrusted production company to conduct qualification file management and related cosmetics quality and safety activity records.The relevant requirements of cosmetic notification person and registration person are shown in Table 3.

Table 3 The summary of cosmetic notification person and registration person system

2.2 The cosmetic notification person and registration person has the main responsibility for the product efficacy claims

On November 4,2020,the “Guideline for the Evaluation of Cosmetic Efficacy Claims” (the second draft) was released.The document has more detailed requirements for efficacy evaluation and inspection agencies and inspection methods.The document stipulates that cosmetics that claim to have anti-freckle(whitening),anti-hair loss,sunscreen,anti-acne,nourishment,and repair effects,or have a specific claim(such as a tear-free formula),must be tested through human efficacy testing methods.Those cosmetics claim for anti-wrinkle,firming,soothing,oil control,exfoliation (non-physical effect),and anti-break of air,anti-dandruff efficacy and which claim that mild (such as no irritation) or quantitative indicators (such as efficacy retention time,statistical data,etc.) can be tested by nonhuman test or research data analysis.Of course,the document is still in the stage of soliciting comments,and there may be changes in subsequent formal publications.We use these keywords to search in the Chinese name of the product on the publicity system of the National Medical Products Administration’s official website.The number of imported and domestic general cosmetics that contain these words as the Chinese name of the product is shown in Figure 1.The most advertised words are repairing,nourishing,firming,soothing,and oil control.According to the initial estimate of the Chinese name of the product,nearly 500,000 products need to be tested for product efficacy.

Figure 1.The illustration of the product number of imported and domestic general cosmetics’ product Chinese names covering the efficacy claims

At present,what does not match the requirements of the upcoming regulations is that there are fewer cosmetic efficacy evaluation and testing institutions,and the national standards have fewer requirements for testing methods for efficacy evaluation.Moisturizing cosmetics have “QB/T 4256-2011 moisturizing cosmetics efficacy evaluation guideline”,sunscreen cosmetics in accordance with the “Cosmetic Safety Technical standard” 2015 version.Cosmetic efficacy promotion is basically indispensable in the cosmetics sales process,but the mandatory requirements for cosmetic efficacy promotion have just begun.The new regulations advocate social supervision which through a specified website to announce the summary documents of efficacy evaluation.As the cosmetic notification person and registration person,they must pay attention to the product's efficacy claims to be supported by scientific evidence.

The new regulations will also increase the cost in applying for registration of special cosmetics.The new regulations stipulate that special cosmetics include cosmetics for hair coloring,perming,freckle removal(whitening),sunscreen,and antihair loss,as well as cosmetics that claim new effects.According to the “Cosmetic Registration and Filing Inspection Work Regulations” implemented in 2019,special cosmetics products such as freckle removal(whitening),anti-hair loss,and sunscreen should undergo human efficacy evaluation tests during product registration and inspection.However,there has been no official efficacy evaluation test method for anti-freckle and anti-hair loss products,so the product has not been tested for efficacy during the actual registration process.In addition,there is a note in the cosmetic administrative license issued by the National Medical Product Administration“The National Medical Product Administration has not organized an audit of the claimed efficacy of this product,and this approval is not regarded as an endorsement of the claimed efficacy of the product”After the implementation of the new regulations,these words should hopefully be removed.On November 12,the China National Institutes for Food and Drug Control issued the “Evaluation Method of Anti-Hair Loss Cosmetics” and “Evaluation Method of Anti-Freckle (Whitening) Cosmetics” (draft).This is also the first time that anti-hair loss and antifreckle (whitening) cosmetics have uniform efficacy evaluation methods and standards.At present,from the notification and registration data published on the official website of the National Medical Products Administration,there are 11,365 approvals for freckle removal (whitening) and hair growth products within the validity period,see Table 4 for details.Whether these products that are still within the validity period need to be supplemented with efficacy evaluation experiments have yet to be further clarified in the supporting documents of the CSAR.

Table 4.Number of freckles removing and hair growth products CFDA certificate within the period of validity

2.3 The cosmetic notification person and registration person should establish a cosmetic adverse reaction monitoring and evaluation system

Adverse reaction monitoring of cosmetics is one of the important means of safety supervision for post-market.The CSAR propose that the cosmetic notification person and registration person should have the ability to monitor and evaluate cosmetic adverse reactions.According to the “Administrative Measures for Cosmetic Adverse Reaction Monitoring” (draft),cosmetic notification person and registration person should establish and implement a cosmetic adverse reaction monitoring system,appoint professionals,actively collect adverse reactions reports,and carry out analysis and evaluation of cosmetic adverse reactions,and investigations that the reason caused adverse effects,establish and keep the monitoring records of cosmetic adverse reactions,etc.Similar to the EU’s current adverse reaction requirements,the EU’s adverse reaction supervision includes voluntary reporting of nonserious adverse reactions,key supervision of serious adverse reactions,a complete information notification system for serious adverse reactions,a unified serious adverse reaction reporting form,Adverse reaction related information is included in the cosmetic safety assessment report and can be obtained by the public,relevant evaluation standards,confidentiality regulations for adverse reaction related information,and clear follow-up measures.[6]It is recommended that cosmetics companies should be equipped with corresponding professionals as soon as possible,and at the same time establish and implement a cosmetic adverse reaction monitoring and evaluation system.

3 Conclusion

CSAR first proposed the “ cosmetic notification person and registration person management system”,which combines the supervision of cosmetics with reality and clarifies the main responsibilities of cosmetics companies,especially cosmetics brands company in the production and business activities.It traces back from the source to ensure the safety and efficacy of cosmetics.However,the current status is the cosmetic notification person and registration person’s quality management system,product efficacy evaluation and adverse reaction monitoring system,product quality and safety management and product research and development basically rely on cosmetic manufacturers,and product efficacy evaluation largely depends on the research on the efficacy supporting data of raw materials,and the cosmetic notification person and registration person lacks the ability of the management related to the quality and safety of cosmetics and the evaluation of efficacy.According to the requirements of the new regulations,cosmetics efficacy claims must have a scientific basis,among which freckle whitening,anti-hair loss,acne removal,repair,etc.must be evaluated on the human body.It is recommended that cosmetics companies establish a cosmetics quality management system,a cosmetics adverse reaction evaluation system,hires a cosmetics quality and safety responsible person,and conduct cosmetic efficacy evaluations for registered products in accordance with the requirements of the new regulations as soon as possible.