A Review of 2021 Supervision Updates of Cosmetics in China

Li Neng

Shanghai Weipu Testing International Group Co.,Ltd.,China

Abstract The update of Chinese cosmetics regulations in 2021 was introduced in detail.Sorted out and analyzed the requirements of supporting documents issued after the issuance of the “Regulations on Cosmetics Supervision and Administration”,which can help cosmetics companies to deeply analyze and understand the changes in cosmetics regulatory policies after the issuance of the new regulations.Regulatory requirements,so as to more smoothly respond to changes in cosmetics regulations.

Key words cosmetics;regulatory status;review

Since the “Regulation on the Supervision and Administration of Cosmetics” (hereinafter referred to as the “New Regulation”) was released on June 29,2020,and implemented on January 1,2021,the supporting regulatory documents were published in 2021,such as “Measures for the Administration of Cosmetics Registration and Notification”,“Regulations on Cosmetics Registration and Notification Data” and “Cosmetic classification rules and classification catalog”.In addition,the updated list of banned ingredients for cosmetics in “Safety and Technical Standards for Cosmetics” (2015)was published.The inventory of used cosmetic raw materials 2021 version was also published and replaced the 2015 version.

The above-mentioned series of changes have overturned the existing cosmetic supervision mechanism to a certain extent,such as changes in the prohibited raw materials of cosmetics.In addition,the new cosmetic registration and notification information service system was launched on April 1,2021.the supporting documents mentioned the actions which need to be supplemented or performed for the products that have been registered or notified at different time point when published Therefore,the author collects,summarizes,and analyzes the regulatory trends related to cosmetics in China in 2021.At the same time,the required actions that need to be performed at different time points were also sorted out to help cosmetics companies know and grasp the latest regulatory trends of domestic cosmetics under the New Regulation.According to the new policy changes,the companies can adjust their own products,including formulas,to meet the new requirements as soon as possible.

1 Supporting documents of the New Regulation released

1.1 Measures for the Administration of Cosmetics Registration and Notification

The “Measures for the Administration of Cosmetics Registration and Notification” was reviewed and approved at the 14th executive meeting in 2020 of the State Administration for Market Regulation on December 31,2020.and came into force on May 1,2021.This measure is the first departmental regulation specifically for the management of cosmetics registration and notification in China.Its impact on the industry:implement of post-notification supervision and management responsibilities and clarify work requirements;set legal responsibilities reasonably,increase the penalties for violations of laws and regulations for registered or notified products;encourage innovation,clarify that the cosmetics registrant and notifier can use the new raw materials in cosmetics production after the new raw materials in the safety monitoring approved by the new raw material registrant and notifier,to protect the enthusiasm of new raw material research and development enterprises.

1.2 Regulation on the registration and notification of new cosmetic raw materials

The Cosmetics Supervision Department of the National Medical Products Administration issued the"Regulation for the Registration and notification of New Cosmetic Materials" final version was released on March 4,2021 and took effect on May 1,2021.This regulation specified further the policy on the implementation of risk-based management model for new cosmetic raw materials in the New Regulation.On the basis of considering the history of use,consumption history,and raw material functions/characters in domestic and foreign cosmetics,the required documents data that need to be submitted was cleared when applying for new raw materials in different situations,such as a certain history of safe use or consumption in foreign markets,safety assessment by a foreign authority,or a new raw material approved by a foreign regulatory authority.Corresponding toxicological test data requirements are scientifically and reasonably exempted according to the different risk levels of the raw material.The regulation did standardize such requirements on the basis of instructing registrants or notifiers of new cosmetic raw materials to apply for registration or notification,such as detailed reporting document examples and data submission requirements.

1.3 Regulation on Cosmetics Registration and Notification Data

On March 4,2021,the National Medical Products Administration issued the “Regulation on Cosmetics Registration and Notification Documents”,which took effect on May 1,2021.This regulation mainly stipulates the specific requirements on the format and normative requirements of the data,user application data,cosmetic registration and notification data,changing and continuation data,and so on.It specifies the format of application forms,information forms,overview forms required in the registration and notification process.It also makes samples for the domestic responsible person’s authorization letter,the standards for product implementation,and the selfinspection report on registration renewal,clarifies the technical requirements for the preparation of standards for product implementation and the submission of information on raw materials in details.

1.4 Technical Guideline for Safety Risk Assessment of Cosmetics (2021 Edition)

On April 9,2021,the National Medical Products Administration announced the “Technical Guidelines for Cosmetics Safety Assessment (2021 Edition)”,which took effect from May 1,2021.This guideline is the first such guideline issued in China.It clarifies the requirements on cosmetic safety assessors,provides assessment report examples,and specifies each step in the risk assessment process.When writing a simplified version of the safety assessment report,it is recommended to pay attention to the order of the assessment evidence,that is,the first is the cosmetic safety technical specification,followed by the assessment conclusion of domestic and foreign authoritative institutions,the third is the historical usage of the enterprise,and the last is the highest historical usage of raw materials published by the cosmetic regulatory authority.

1.5 Cosmetic Classification Rules and Classification Catalog

On April 9,2021,the National Medical Products Administration announced the “Cosmetic Classification Rules and Classification Catalog”,which was implemented from May 1,2021.This catalog clarifies the specific claims of infants (newborn to 3 years old) and children (3 to 12 years old).If a claim is beyond the scope,it will be managed as a new efficacy product,that means,a special cosmetic product.It is also an important basis for judging whether a claim is a new efficacy.At the same time,it clearly pointed out that if a dosage form is not one of the existing dosage forms which include 14 different forms,it will be managed as a special cosmetic product.

1.6 Guide Specifications for the Evaluation of Cosmetic Efficacy Claims

On April 9,2021,the National Medical Products Administration issued the “Guide Specifications for the Evaluation of Cosmetic Efficacy Claims”,which was implemented from May 1,2021.The guide specifies the claim evaluation requirement on the evaluation form,evaluation methods,evaluation reports,etc.It also clarifies that a summary of the abstract for the efficacy claim of a product needs to be published in general.However,under certain circumstances,it can be exempted from publication,such as the claims which can be directly identified by sight,smell and other senses.

1.7 Technical Guidelines for Submission of Cosmetics Registration and Notification Documents (Trial)

The new registration and notification system has been officially launched on May 1,2021.However,the use process is not smooth,such as “unable to submit notification documents”.Therefore,the National Medical Products Administration issued the trial guide on April 25,2021,to guide the acquisition of registered users,activation of user permissions,information filling and data submission.

1.8 Work Regulation on the Research and Drafting of Cosmetic Supplementary Inspection Methods Management and Technical Guidelines Cosmetics Supplementary Inspection Methods

On April 28,2021,in order to standardize the management of cosmetic supplementary testing methods,the National Medical Products Administration published “Work Regulation on the Research and Drafting of Cosmetic Supplementary Inspection Methods Management” and “Technical Guidelines Cosmetics Supplementary Inspection Methods” in according to the New Regulation.The work regulation was a companion document to the provisions of Article 50 of the New Regulation and was implemented from July 1,2021.It clearly pointed out that the supplementary inspection method for cosmetics can be used for sampling inspection of cosmetics,investigation and handling of quality and safety cases,and investigation and handling of adverse reactions,and the inspection results can be used as the basis for law enforcement.It also pointed out that the procedures for project approval review and drafting unit selection can be simplified according to the needs of the work in the investigation and handling of major cosmetic cases and the emergency response;and the company with the corresponding technical capabilities can be entrusted;then speed up the work procedure such as method verification,method review.It should be noted that once the supplementary inspection method for cosmetic products published,it will apply to all cosmetic products,including those previously produced.Therefore,the enterprises should not take any chances and think that substances which currently have no testing methods can be added at will.

1.9 The Inventory of Existing Cosmetic Ingredients in China 2021 Edition

The National Medical Products Administration revised the “Inventory of Existing Cosmetic Ingredients in China (2015 Edition)” and announced the 2021 edition,which came into force on May 1,2021.The call of this inventory is different from the 2015 edition,which is an important basis for judging whether a raw material is new.There is also a bright spot,that is,the inventory has the highest history usage of some raw materials in the leave-on and rinse-off category.The published highest historical usage is the fourth-ranked evidence type mentioned in the safety assessment guideline,which is a great reference to enterprises,but it cannot be based solely on the historical usage,and attention should be paid to the order of evidence types.

1.10 The list of banned ingredients for cosmetics updated

On May 28,2021,the National Medical Products Administration issued an announcement on updating the list of prohibited raw materials for cosmetics,which took effect on the published date May 28.The newly released list of banned ingredients supplements and adjusts the banned raw materials in the 2015 edition.It mainly reflects as below:

According to the strict principle,substances which may have safety risks and can be replaced are listed as banned substances,such as boric acid with reproductive toxicity,TAGETES ERECTA flowers extract/oil with skin phototoxicity,and cannabis raw materials banned because of the National anti-drug management related policy requirements.

The names of plant raw materials are unified and standardized,and the format of the Latin literary name of the plant genus is unified as “genus (family)Latin name”.

From May 28,2021,cosmetics registrants and notifiers shall not produce or import cosmetics which use prohibited raw materials specified in the “Catalogue of Prohibited Raw Materials for Cosmetics” and “Catalogue of Prohibited Plant(Animal) Raw Materials for Cosmetics”.When select plant raw materials,enterprises should pay special attention to the requirement that the prohibited parts which are not clearly marked in the prohibited raw materials,indicating that the prohibited parts are the whole plant,including flowers,fruits,roots,etc.It is recommended that if use the prohibited raw materials in the updated catalogue,such as cannabis raw materials,the company should adjust the relevant notification information as soon as possible.

1.11 Measures for the Administration of Cosmetics Labeling

On June 3,2021,the National Medical Products Administration issued the “Measures for the Administration of Cosmetics Labeling”,which will be officially implemented on May 1,2022.Compared with the former labeling requirements,this measure has four major highlights:first is the ingredient identification method,the ingredients which were not exceed 0.1% (w/w) should be marked with “other trace ingredients” as the preceded terms;Second is the labeling of the gift,trial products,and exchangeable products is same as the labeling requirements for sales products,and there are no exemption conditions;Third is to implement the dynamic management of prohibited claim words;Last is to allow electronic labels.After the implementation of this measure,it is undoubtedly a heavy blow to the conceptual addition.

1.12 Measures for the Supervision and Administration of the Cosmetics Production and Operation

On August 6,2021,the National Medical Products Administration issued the “Measures for the Supervision and Administration of Cosmetics Production and Operation”,which took effect on January 1,2022.It is the first departmental regulation specifically for the production,operation and management of cosmetics in China.It does clearly stipulate the requirements on cosmetic production license,production management,operation management,supervision and management,legal responsibility,especially that the cosmetic register/notifier and the entrusted production enterprise should establish a cosmetic production quality management system and ensure continuous and effective operation.For cosmetics operators,there are also specific requirements for the purchase inspection record system.Another highlight of the measures is that children cosmetics and eye cosmetics are key products,and special regulations are made in terms of production conditions,which need to be marked on the production license.

1.13 Supplementary Test Methods for Cosmetics"Determination of Benvimod in Cosmetics" and"Determination of five Components including Bimatoprost in Cosmetics"

On September 2 and September 13,2021,the National Medical Products Administration separately announced the “Determination of Benvimod in Cosmetics” and “Determination of five Components including Bimatoprost in Cosmetics” supplementary test methods for cosmetics.Taking bimatoprost as an example,this raw material belongs to prostaglandin analogues and was originally used to treat glaucoma.During clinical use,it was unexpectedly discovered that it has the side effect of promoting eyelash growth.It is easily claimed by eyelash growth liquid products as “promoting eyelash growth”,but the raw material is not listed in the “Inventory of Existing Cosmetic Ingredients in China (2021 Edition)”,and the use of this raw material is illegal to add.

1.14 "Regulation on the Supervision and Administration of Children Cosmetics" and the Mark of Children Cosmetics

On October 8,2021,the National Medical Products Administration organized the formulation of the “Regulation on the Supervision and Administration of Children Cosmetics”.The labeling requirements will take effect May 1,2022,and other regulations on children cosmetics was implemented from January 1,2022.The Mark of Children Cosmetics has been released on December 1,2021.The regulation,have carried out all-round control from definition,labeling to production and operation supervision;labeling requirements for children cosmetics have become more stringent.It cleared that in addition to safety assessment,necessary toxicological tests are also required.If claimed “applicable to the whole family” and other implied users,including children,the products need to comply with this provision;in addition,words or patterns such as “food grade” and “edible” shall not be claimed.It is recommended that enterprises conduct self-correction and self-examination as soon as possible to minimize risks.

2 Regulatory hot topics

2.1 Analysis of the reasons for unqualified cosmetics issued by the National Medical Products Administration

From January to December 2021,the National Medical Products Administration released 221 batches of unqualified cosmetics in total.The categories are mainly hair dye and sunscreen products,followed by skin care products.The top unqualified reason of the list is labeling.The specific distribution of unqualified reasons is shown in Table 1.

Table 1.Specific distribution of unqualified reasons

It can be seen from Table 1 that the control on the requirements of permitted preservatives in Safety and Technical Standards for Cosmetics is not ideal in some companies.When choose preservatives,it is recommended that do pay special attention to the scope of application,users and the requirements of corresponding warnings.

2.2 Hot issues in the notified products used raw material phenethyl resorcinol 377

It needs to be clear that Raw material 377 was originally approved for use as a whitening agent.Therefore,if the raw material is used in common cosmetics,and the purpose of use or the amount of use is changed,it should be registered or notified in accordance with the requirements of the new raw material.It is recommended that companies cancel the common cosmetics used this raw material as soon as possible and re-notify after adjustment.

The National Medical Products Administration also plans to establish a list of whitening agents.In the popular science article “talking about whitening cosmetics and whitening agents”,it is mentioned that “whitening agents commonly used in cosmetics in China,Japan and South Korea include:arbutin,nicotinamide,Glabridin,Phenethyl Resorcinol,Ascorbic Acid (i.e.Vitamin C),Ascorbyl Glucoside,3-O-Ethyl Ascorbic Acid,Magnesium Ascorbyl Phosphate,Traexamic Acid,Potassium Methoxysalicylate,Myrrh alcohol,etc.”.If a raw material currently used is not listed in the “Inventory of Existing Cosmetic Ingredients in China”,it is likely to be identified as a new raw material or illegally added.Therefore,it is recommended that companies pay special attention to this point.

3 Summary

The cosmetics industry has also undergone a major reshuffle in 2020,and the introduction of many supporting documents in 2021 also overwhelms enterprises.In order to help enterprises cope with the requirements of the New Regulation and its supporting documents more smoothly,the author has sorted out the required actions at different time points.The details as below:

A from Jan.1,2022

To apply for new product registration or notification,it is mandatory:provide safety-related information on raw materials with antiseptic,UV filters,colorants,hair dyeing,freckle-removing and whitening functions;for claim efficacy evaluation,upload a summary of the abstract for product efficacy claims;submit product safety assessment report (simplified or full version);if applying for the registration of freckle,whitening and anti-hair loss cosmetics,an additional human efficacy test report needs to be submitted.

Cosmetics registrants and notifiers should keep samples and record of each batch of products produced from January 1,2022.

From January 1,2022,the new cosmetics production license and license renewal should be implemented in accordance with the provisions of the“Measures for the Supervision and Administration of the Cosmetics Production and Operation”;newly established enterprises that only engage in the preparation of cosmetic contents should report to the provincial drug supervision and administration department where they are located and obtains a cosmetic production license before production.

Except from the labelling requirements,other regulations on children cosmetics took effect from January 1,2022.

B Before Mar.1,2022

From January 1 to March 31,2022,the annual report of common cosmetics which have been notified one year should be summitted by the new registration and notification system.The confirmation content includes product production,import overview and production suspension during the period,self-examination of product compliance with regulations,mandatory national standards,and technical specifications.

C Before/ After May 1,2022

Cosmetics that have been registered or notified on the original registration and notification system should be submitted product implementation standards and product label samples,filled in the product formula of domestic common cosmetics,and uploaded label images of special cosmetics sales packaging before May 1,2022 by the new registration and notification system.

Cosmetics that have been registered or notified before May 1,2021 should be supplemented the product classification code by the cosmetics registration and notification system before May 1,2022.

Cosmetics which have been registered or notified on May 1,to 31 Dec,2021,evaluate the efficacy claims of the cosmetics,and upload the products.Cosmetics registrants and notifiers should upload the abstract of the abstract for the efficacy claims before May 1,2022 and submit a supplementary human efficacy test report for new application for the registration of freckle whitening,anti-hair loss cosmetics,before May 1,2022.

From May 1,2022,application for registration or notification of children cosmetics should be labeled in accordance with the “Regulation on the Supervision and Administration of Children Cosmetics”,including the small golden mark.

D Before July 1,2022

The production license which does not state the production conditions for children skin care cosmetics and eye cosmetics should be replaced with a new version of the cosmetics production license before July 1,2022.

E Before/ After Jan.1,2023

For only engaged in formulating cosmetic contents before January 1,2022,the enterprises should obtain a cosmetic production license before January 1,2023.

From January 1,2023,the register or notifier should submit the safety-related information of all raw materials when applying for registration or notification.

F After May 1,2023

Cosmetics that have been registered or notified before May 1,2021 should be uploaded a summary of the abstract for product efficacy claims before May 1,2023.

For anti-freckle,whitening,and anti-hair loss cosmetics that have been registered before May 1,2021,a supplementary human efficacy test report should be submitted before May 1,2023.

If registered or notified before January 1,2023,the safety-related information of all raw materials in the product formula should be supplemented before May 1,2023.

G After May 1,2024

Before May 1,2024,when applying for registration or notification,the company should submit a simplified or full version of the product safety assessment report.

After May 1,2024,when applying for registration or notification,the company should submit a full version of the product safety assessment report.

It is recommended that enterprises should do the required actions that need to be performed at different time points as soon as possible.In the new era of cosmetics supervision,the regulatory policy has undergone major changes.Therefore,enterprises have to take advantage of the training opportunities provided by official and third-party organizations to gain an in-depth understanding of new changes,adjust formula and product requirements as soon as possible to avoid being notified later to avoid reputation and economic losses.CDC