Technical Points of Imported Makeup Record

With the further opening of trade policies and the rapid development of the economy, there is an increasing demand for cosmetics and their qualities, the market scale of cosmetics keeps growing and prompts government supervision. China is an emerging cosmetics production base and one of the most potential consumer markets in the world. Its cosmetic market becomes mature with opportunities and crises coexisting during the transition. The cosmetics industry will step into a new stage. It's vital for cosmetic enterprises to grasp opportunities and rise to the occasion under the legal and compliance operation.

China's cosmetics supervision statute system is mainly composed of laws, administrative regulations, department rules, normative documents and technical standards, including some major laws such as Customs Law of the People's Republic of China, Law of the People's Republic of China on Import and Export Commodity Inspection, Advertisements Law of the People's Republic of China, Law of the PRC on Product Quality, Criminal Law of the People's Republic of China, and E-Commerce Law of the People's Republic of China that comes into force on January 1, 2019, etc. Administrative regulations, department rules and normative documents mainly include Regulations on Supervision and Administration of Cosmetics, Safety and Technical Standards for Cosmetics, and Administration and Supervision of Inspection and Quarantine over Import and Export Cosmetics, etc.

The current Regulations on Hygiene Supervision of Cosmetics (hereinafter "Current Regulations") which was prepared nearly thirty years ago, is no longer sufficient to meet the innovative development and management needs of modern cosmetics. The Ministry of Justice issued the second written exposure draft of Regulations on Supervision and Administration of Cosmetics" (Draft) in August 2018, which further clarifies the classification of cosmetics compared to the Current Regulations; emphasizes enterprise responsibility, including the management of product R&D, production, registration or filing, and safety monitoring after listing; and strengthens in-process and post-event supervision, and puts forward requirements for adverse cosmetic reaction reports and recalls. In June 2020, the State Council officially released the Regulations on Supervision and Administration of Cosmetics, which will be formally enforced on January 1, 2021; In the second half of June 2020, the National Medical Products Administration successively released exposure drafts of a series of supporting regulations, including Administration of Cosmetic Registration, the Specifications for Cosmetic Registration and Filing Materials, the Administration and Supervision of Cosmetic Productive Operation, and the Technical Guide for Cosmetic Safety Assessment, etc.

While the cosmetics market booms, the government regulators are also facing a new complexion and unprecedented challenges posed by the cosmetics industry. In recent years, the frequent cosmetic safety accidents and the quality of cosmetics has led to the public attention. For example, financial losses, mental shocks and health hazards to consumers are also caused by products that have not been issued with administrative and registration certificates and have not been scientifically inspected before listing, discrepancy between cosmetics label and their approval/certificate, illegal use of banned substances, sales of counterfeit products that are highly imitative of high-end products, etc. It has been a norm that the continuous flight inspection of cosmetics enterprises, timely exposure to illegal enterprises and strict supervision and punishment. Therefore, compliance becomes the most basic and important requirement for enterprises in production, import, export and sale of cosmetics.

政府：依法行政，科学监管。	Government: Advance law-based scientific administration and supervision.
媒体：健康舆论,正确导向。	Media: Maintain the correct orientation for public opinion.
化妆品	Cosmetics
企业：加强产品质量安全管理，提升竞争力。	Enterprises: Strengthen quality and safety management to enhance competitiveness.
消费者：理性认知，恰当使用	Consumers: Keep rational and use properly

 

With regard to cosmetics safety regulatory system, China has enforced a production licensing system, a product registration/register system and a market surveillance system, and has established a safety regulatory system jointly supervised by multiple authorities. For example, the product application system takes the form of the registration or record management of cosmetics and new raw materials by risk level.

The State Commission Office of Public Sectors Reform issued the Regulations of Function configuration, Internal institutions and staffing of the National Medical Products Administration with regard to cosmetics regulator in September 2018: It announced the constitution and responsibilities of the National Medical Products Administration, which has nine business divisions. The Cosmetics Supervision and Management Division was founded, being responsible for the implementation of registration and filing of cosmetics, and the formulation of cosmetic standards, the supervision of the implementation, etc.; preparation of cosmetics inspection system and investigation of the significant discipline; being charge of quality inspection, the monitoring of adverse reaction and legal intervention.

The new establishment of the Cosmetics Supervision and Management Division sends a signal from the national level the further enhanced supervision of the cosmetics industry. It will help improve cosmetics market supervision that the Cosmetics Supervision and Management Division is responsible for the registration and supervision of cosmetics with huge consumer demand. Meanwhile, since April 20, 2018, the competent authorities for inspection and quarantine of imported cosmetics have been changed from the entry-exit inspection and quarantine department of the Administration of Quality Supervision, Inspection and Quarantine to the General Administration of Customs of the People's Republic of China, which will be responsible for the inspection, quarantine, and supervision of imported food and cosmetics.

China's regulatory system is becoming more scientific and advanced with the trend of streamlining administration and delegating more powers to lower-level governments, and society and clarifying responsibilities compared with other major countries and regions in the world. The major difference with foreign cosmetics import management is the difference in the classification of cosmetics:

Claims	China	USA	Japan	Korea
Hair grown	Drug approval proposed	NDA drug approval	Quasi-drug	Quasi-drug
Hair dyeing	Cosmetics for special use	Cosmetics	Quasi-drug	Quasi-drug
Hair removal	Ordinary cosmetics	Cosmetics	Quasi-drug	Quasi-drug
Sunscreen	Special cosmetics	OTC monographs drugs	Quasi-drug	Functional cosmetics
Deodorization	Ordinary cosmetics	Cosmetics and antiperspirant (OTC monographs drugs).	Quasi-drug	Cosmetics, quasi-drug (preventing body odor by inhibiting sweating)
Perm	Special cosmetics	Cosmetics	Quasi-drug	Cosmetics
Whitening/ freckle removal/ melanin removal	Special cosmetics	NDA's drug approval or OTC monographs drugs or cosmetics, depending on efficacy propaganda language	Quasi-drug	Functional cosmetics
Weight loss, bodybuilding and breast care	Drug approval proposed	NDA's drug approval or cosmetics, depending on the efficacy propaganda language.		Bodybuilding: Cosmetics (decompose subcutaneous fat to prevent the creation and remove of cellulite)
Dandruff removal	Ordinary cosmetics	OTC monographs drugs	Quasi-drug
Anti-aging, anti-wrinkle	Ordinary cosmetics		Quasi-drug	Functional cosmetics

 

To successfully enter the Chinese market, it is first and foremost for foreign cosmetics to obtain administrative license approval and registration certificate in compliance. Analysis should be based on the specific situation of the applicant. Generally speaking, if the applicant has no requirements for the application period, it can declare by itself; otherwise, it can establish its own registration department. If the applicant is in a hurry to focus on the market, it is better to find a professional agency. Because the agency is relatively rich in experience and there will be fewer mistakes and unnecessary steps in the process of application. In addition, due to the huge differences in industrial policies, market environment and registration procedures between China and foreign countries, it is best for enterprises abroad to choose an agency. Standardized compliance can to great extent help enterprises obtain product licenses to enter China and lay the foundation for product expansion in China. If the compliance is not enforced in place, it may not only delay the product marking, but also bring great potential hazards to the subsequent technical evaluation and market surveillance.

According to the Regulations on Supervision and Administration of Cosmetics, cosmetics refer to daily chemical industrial products applied to the skin, hair, nails, lips and other human surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying. The registration or record management of cosmetics and cosmetic raw materials shall be enforced by risk level. Cosmetics used for hair dyeing, perming, spot whitening, sunscreen, anti- hair loss, as well as cosmetics claiming new efficacy are considered as special cosmetics. Cosmetics other than special cosmetics are called as ordinary cosmetics. The State Council drug regulatory authority formulates and publishes cosmetic classification rules and classification catalogues based on factors such as cosmetics efficacy claims, sites of action, product formulations, and users.

Different types of cosmetics have different application methods and requirements in China: Special cosmetics are registered and cannot be produced and sold without permission; The filing system is adopted to ordinary cosmetics, and the products can be imported for sale after the technical information is complete, and the technical evaluation and market surveillance will be carried out later; From the application system and the government window that accepts the documents: Since 2017, the domestic filing system for imported cosmetics has been differentiated from the original unified filing system, divided into a special cosmetics filing system and an ordinary cosmetics filing system, and the filing of ordinary cosmetics has been delegated to provinces and cities. The filing will be more detailed and more convenient to strengthen supervision. The technical requirements for the two types of products are different in emphasis:

1.    Registration of imported special cosmetics. Countries with such products pay more attention to safety evaluation and efficacy claims. There must be sufficient scientific literature to prove the safety of the product formula, and administrative licensing inspections in accordance with the efficacy claims: basic toxicology, hygienic chemistry, microorganisms, special efficacy and necessary confirmatory tests brought by raw materials.

提交资料	Materials to be submitted
受理	Acceptance
技术评审	Technical evaluation
通过	Passed
5个工作日内	Within 5 days
3个工作日内	Within 3 days
90个工作日内	Within 90 days

 

 

2.        Record of imported ordinary cosmetics

On November 7, 2018, the National Medical Products Administration Announcement on Issues Concerning the Implementation of the Administration of Imported Ordinary Cosmetics on a Nationwide Scale (No. 88, 2018) announced that the record management policy was decentralized nationwide. After the policy was issued, the number of applications for imported ordinary cosmetics has increased rapidly, but the prerequisite for successful application must be a thorough understanding of the technical requirements for filing. The following key points are given:

2.1 The first step in the ordinary application is to obtain the username and password of the responsible person in China. Many enterprises delay time because the authorization letter does not meet the requirements. A qualified authorization letter should meet: the production enterprise's information (name, address) is correct, the domestic responsible person's information is consistent with the latest business license, and the authorized content should meet the current requirements-the domestic responsible person needs to bear all legal responsibilities related to the product. The scope of authorization should include the authorization date, the signature of the responsible person of the production enterprise, and the authenticity of the signature.

授权资料准备	Preparation of authorized materials
授权境内责任人	Authorized person in charge in China
境内责任人在线申请	Online application of authorized person in charge in China
不通过	Fail
在线反馈	Online feedback
所在地在线初审	Online preliminary evaluation in the place where is applicant is located
不符合要求不发用户名	The user name will not be sent if non-conformance
通过	Passed
国家局在线审核	Online evaluation by NMPA
境内责任人递交资料	Authorized person in charge in China submits materials
服务窗口核对信息	Check the information in the service window
符合要求发放用户名	The user name will be sent if conformance

 

备案	Record
提交备案资料起5个工作提	5 days from submission of the filing materials
备案完成	Record completed

2.2 There are a total of 13 items of ordinary cosmetics record technical material that will also be distinguished from different types of cosmetics. The biggest difference lies in the materials of the outer packaging and production process.

Ordinary skin care products: The products will mostly be promoted on the outer packaging of the efficacy and ingredients. Since most of the commercial packaging is in foreign languages, the publicity on the outer packaging is our translation and understanding of other texts. Sometimes there will be some deviations. When preparing translations, descriptions, Chinese labels and other content of commercial packaging, you need resin China's regulatory requirements for cosmetics promotion, so as to avoid deviations in translation understanding that cause products to fail the later review requirements. In the production process, most of the products are in the normal process, but some of the products will add some novel substances, such as gold silk, gold powder or beautiful rose petals, this time attention should be paid to the reasonable expression in the product formula or process.

Facial masks: There are two types of these products. The first is the commonly used facial masks on the market that contain facial mask paper. This one sometimes advertises the material of the facial mask on the outer packaging. At this time, special attention should be paid to whether the material of the facial mask matches the promotion. The manufacturer provides the relevant material certification, because the film materials of the facial masks are also part of the cosmetics. There is also a gel sheet type film which is the same as ordinary skin care products on the outer packaging. In the process, the key links such as the formation of mask liquid, the addition of facial mask paper, and the formation of gel sheets should be reflected.

Stamping cylinder spray: Such products sometimes advertise that they provide pressure ingredients on the outer packaging, and we should review and confirm their ingredients. Particular attention should be paid in the production process. Take a type of nitrogen filling as an example of the booster component. The formula of this product may not contain Nitrogen. Nitrogen is only used as a booster and does not contact the formula components, however, in the production process, the specific production steps of the Nitrogen charging should be reflected.

进口非特殊用途化妆品	Imported ordinary cosmetics
检验	Inspection
受理	Acceptance
药监局指定检测机构	Testing agency designated by National Medical Products Administration
形式审查	Formal examination
获得备案凭证	Obtain the registration certificate
评审委员会	Evaluation committee
技术审评	Technical evaluation
实质性审评	Substantive evaluation

 

 

Girls who don't wear makeup will also buy lipstick because of the charm of makeup. In 2013, China became the world's second largest consumer of cosmetics, overtaking Japan. In the following years, as people pay more and more attention to their own image regardless of men and women, makeup has become a rigid demand.

On the other hand, starting from December 1, 2017, the tariff for imported cosmetics was adjusted from 6.5%-10% to 2%-5%, with a decrease of 50%+. Among the imported cosmetics, the tax rates of perfume, and cosmetics for lip, eye, and nail, etc., have been greatly adjusted. Compared to ordinary skin care products, makeup is heavily influenced by the policy, especially in the current situation where domestic makeup brands are in a position of weakness, and many special-interest makeup brands in Europe, America, Japan or South Korea take this opportunity to boost their presence in the Chinese market on a large scale.

Since the import of non-special cosmetics were converted administrative license to filing in 2017, makeup is dominant in the cosmetics filed in Pudong, Shanghai in the first two years.

What is the first thing to do if overseas makeup wants to be imported into China for sale? The answer is as well "filing". For the makeup, some points that need to be paid attention to when filing imported makeup are listed as follows:

1. The outer package of makeup products is usually small, which leads to limited layout and space. Some product information that should be marked on the outer package can but be added as the product information descriptions to explain what product information is missing on the outer package and make corresponding compliance commitments.

2. One of the prominent issues in makeup products have various shades.

Ordinary cosmetics of Various shades series refer to those with the same types of ingredients and the same series names except for different types or contents of pigments (shade adjustment).

The name of makeup products of various shades should be paid attention to keeping the consistency on official documents: Sometimes there is a problem that the unnecessary or lacking "0" of names in other languages and names on the outer package of the products. Eyebrow pencil series often have the distinction of "No.01" and "No.02". If they become "No.1" and "No.2" when issuing a certificate of free sale. It seems to us that there is no difference. However, considering the standardization of the filing technical documents, it is equivalent of modifying the name of products, and the judges will not allow the filing to pass.

When making the security risk assessment of such products, we will encounter that the products contain various colorants, especially products such as lipstick. Makeup precisely has the color effect because of the colorants in the products. For components of colorant, we should display the normative name on the formula and outer package: Colorants are mostly expressed in the form of colorant index numbers in the Safety and Technical Standards for Cosmetics, just like CI 77891, CI 45410, etc. Components with index numbers should mark the index numbers after the names. There are also some colorants that need to provide their certificates of quality and specification according to the relevant requirements of laws and regulations.

In recent decades, China has successively promulgated many laws, regulations, technical standards and other normative laws and documents on cosmetics safety supervision, which are not only an important basis for government departments to carry out supervision work, but also a code of conduct followed by cosmetics production and operation enterprises in their production and operation activities. Cosmetic enterprises should always adhere to the legitimate and compliance operation and put product quality first, while bringing beauty to consumers, so that it can achieve long-term healthy and benign development.

On the road of cosmetics and compliance, Beijing Oriental Chemical Information Co., Ltd.(OCI) Cosmetics Department has developed for 14 years. It is one of the earliest and leading regulatory service providers in China and the Far East Region, and now it is the 120 service institutions of the world's top 500.

 

 

About the Author: Ms. Cindy,

 

Ms. Cindy, deputy general manager of technical execution, Beijing Oriental Chemical Information Co., Ltd. (OCI); postgraduate degree in chemistry. She is fully responsible for technology of product compliance and project support, and works for the application of administrative license for new cosmetic raw materials and the filing or application of imported cosmetic finished products. She has years of experience in cosmetics and chemical regulation services in China and the Far East, and is familiar with cosmetic systems of PCPC and INCI. She practices the chemical supervision mode of the United Nations and China, the law and regulation system of SDS-GHS and risk assessment

Ms. Cindy, on behalf of the Company, participated in the training of cosmetics regulations and technical and other related trainings of CFDA Institute for Advanced Study for more than 5 consecutive times. She is familiar with the policy changes of cosmetics regulations management from 2014 to 2019 and has assisted many well-known enterprises to obtain successful application of cosmetics. She focuses on the legal research, compliance construction and service of new cosmetics raw materials and finished products in China.

 

国家食品药品监督管理总局高级研修学院	National Medical Products Administration Institute of Executive Development
结业证书	Certificate of Completion