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Cosmetics Compliance Service

We provide one-stop solutions for importing cosmetics to China.

Product compliance is a prerequisite for brands to enter the Chinese market. In the face of Chinese regulations and policies, we use professional and strict system operations to escort customers’ brands into the Chinese market.

CFDA Registration of Cosmetics in China
Registration of New Cosmetic Ingredient in China
Toxicology Safety Assessment
Review of Product Formula and Label
Home Care Products Compliance
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Provide consultation on product regulations in China.
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Compliance consultation and monitoring for your business.
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Regulatory Consulting for Personal and Home Care Products.
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On-demand online and offline training.
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  • Registration & Filing
  • Ingredient Compliance
  • Safety Assessment
  • Training Service
  • FAQ

Imported Cosmetics Filing Process

China’s imported cosmetics compliance business.
01
Definition and classification of cosmetics

Cosmetics: refers to the daily chemical products which can spread on any part of the human body surface (skin, hair, nails, lips, etc.) by means of rubbing, spraying or other similar methods, so as to achieve the purpose of cleaning, eliminating bad smell, skin care, beauty and modification.(cosmetic hygiene supervision ordinance (Cosmetics MOH order no. 3) .

Special Use Cosmetics: specifically refers to the anti-freckle category (whitening), sunscreen category, hair-growing category, breast beauty category, bodybuilding category, hair-dying category, hair-perming category, hair removal category, deodorization category, and these nine products.

General Cosmetics: except for special purpose cosmetics.

Imported Cosmetics: refers to the products which the final product process which can contact content are finished outside China (including Hong Kong, Macao and Taiwan) .

Domestic cosmetics: refers to the products which the final product process which can contact content are finished in Chin.

02
China’s cosmetics regulatory model

Approved by the State Council in 1989, the Ministry of Health issued Order No. 3 of the “Regulations on Hygiene Supervision of Cosmetics” (hereinafter referred to as the “Regulations”), which came into effect on January 1, 1990. The “Regulations” is divided into six chapters, which stipulate the definition of cosmetics, and the production and operation hygiene supervision and licensing system. In 2008, the State Council’s institutional reform, the responsibility of cosmetic hygiene supervision and management was transferred from the Ministry of Health to the National Food and Drug Administration (CFDA), and from August 29, 2018, the CFDA was officially changed to the National Drug Administration (NMPA).

According to the requirements of the “Announcement Concerning the Implementation of the Administration of Imported Non-special Use Cosmetics on a Nationwide Scale” (No. 88 of 2018) issued by the National Medical Products Administration, starting from November 10, 2018, the first import of non-special use cosmetics The current examination and approval management and the trial implementation of filing management in the pilot free trade zone will be adjusted to unified nationwide filing management. The State Drug Administration will no longer accept applications for administrative licenses for importing non-special use cosmetics. Overseas cosmetics manufacturers should entrust the domestic responsible person ( RP ) to complete the relevant procedures before importing non-special cosmetics. The registered place of the domestic responsible person is in, Liaoning, Shanghai, Zhejiang, Fujian, Henan, Hubei, Guangdong, Chongqing, Sichuan, Shaanxi, and other provinces (municipalities) that have carried out pilot free trade zone pilot zones in the early stage to implement the record management of imported non-special use cosmetics If it is within the administrative area, it shall file with the provincial Food and Drug Administration of the place where it is located. If the registration place of the domestic responsible person is within the administrative area of ​​other provinces (autonomous regions, municipalities), the registration shall be filed with the State Drug Administration. Products that have been filed and are intended to be imported at ports outside the administrative region of the province (city, district) where the responsible person in the country is located must be added to the port of import and consignee through the filing system before importing.

Special cosmetics will continue to implement the examination and approval system, and they can entrust the reporting unit ( RA ) in China (for overseas companies) to submit to the National Medical Products Administration for administrative license review. After expert review, they can obtain administrative license approval for imported special-purpose cosmetics. Domestic non-special use cosmetics can be put on the market after being put on record by the Provincial Drug Administration Department.

Administrative license approval or filing certificate is an important review basis for product import and marketing, and cosmetics registration/ filing is an indispensable step before its successful sale.

03
Application Materials for Registration

1) Application form for hygiene approval of import generally used cosmetics

2)Basis for Chinese name

3)Quantitative formula

4)The requirements or standards for quality control

5)Pictures of the product original package (including product label and specification); If the product is going to design a new package for the China market, the product design package (including product label and specification) shall be submitted at the same time.

6)Brief manufacturing process

7)Product technical requirements;

8)Test reports issued by test authority

9)Safety assessment of some risky ingredients

10)BSE guarantee letter

11)Free Sales Certificate

12)Overseas manufacturing country relevant certification materials for production quality management;

13)Other documents possibly beneficial to product evaluation

Additionally, one piece of sample product which sealed by licensed test authority

04
Declaration process

Imported special purpose cosmetics

Imported non-special purpose cosmetics

Responsible unit for reporting in China (RA)

Domestic Responsible Person (RP)

Qualification requirements: a unit that is legally registered in mainland China and has independent legal personality.

Qualification requirements: corporate legal persons registered in mainland China and responsible for product quality and safety in accordance with the law.

[ Note: The business scope of the domestic responsible person company must cover cosmetics sales and import and export business ]

Responsibility: Responsible only for the cosmetic product registration process.

Responsibilities: Responsible for the registration application, import and operation of related products, and bear the corresponding product quality and safety responsibilities in accordance with the law.

Authorization: An overseas company should only appoint one responsible entity for reporting in China.

Authorization: An overseas company can entrust multiple domestic responsible persons to be responsible for different products, but there is only one domestic responsible person for the same product.

05
Relevant regulatory authorities:

National Medical Products Administration (NMPA): Responsible for supervising the production, declaration, and post-marketing supervision of cosmetics

Provincial Food and Drug Administration: Responsible for non-special cosmetics filing approval and post-marketing supervision

Administration for Industry and Commerce: business license application, trademark application, advertising supervision

Customs and Entry-Exit Inspection and Quarantine Bureau: import and export customs clearance inspection and quarantine

General Administration of Quality Supervision, Inspection, and Quarantine: Cosmetics label review

06
Our service

Acting for the responsible unit for reporting in China

Compliance audit of finished cosmetics formulations

Compliance audit of finished cosmetics labels

Schedule required tests

Preparation of filing dossiers

Submit application and respond to review comments

For more questions, please refer to ” FAQ ” or send an email to info@zmuni.com

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ZMUni Cosmetics Compliance Team

Provide efficient compliance services with solid knowledge and regulatory experience.

ZMUNI is a consulting company specialized in providing registration consulting services for imported products. With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.

Your Best Choice

We will provide new value and services to the cosmetics.
688 Banan Roda Binjiang Hangzhou, CN

Registration of New Cosmetic Ingredient in China

According to Regulations Concerning the Hygiene Supervision over Cosmetics (1990), a new cosmetic ingredient means a natural or artificial ingredient has never been used in China. In this case, a new cosmetic ingredient needs to be registered before use in cosmetics in China. Besides cosmetics regulations, chemical regulations should be complied as well.
01
China cosmetics new raw material declaration

The definition of new cosmetic raw materials in my country is listed in the “Regulations on Cosmetics Hygiene Supervision”, which means that new cosmetic raw materials in my country refer to natural or artificial raw materials used in cosmetics production for the first time in China.

02
China’s cosmetic raw material supervision model

Approved by the State Council in 1989, the Ministry of Health issued Order No. 3 of the “Regulations on Hygiene Supervision of Cosmetics” (hereinafter referred to as the “Regulations”), which came into effect on January 1, 1990. The “Regulations” is divided into six chapters, which stipulate the definition of cosmetics, and the production and operation hygiene supervision and licensing system. In 2008, the State Council’s institutional reform, the responsibility of cosmetics hygiene supervision and management was transferred from the Ministry of Health to the National Food and Drug Administration (CFDA), and from August 29, 2018, the CFDA was officially changed to the National Medical Products Administration (NMPA).

Starting June 30, 2014, the “China Used Cosmetic Ingredients Catalog (IECIC)” is the only basis for judging the use of cosmetic ingredients. Raw materials that are not in this catalog are considered new raw materials for cosmetics, and they must be registered before they can be added to cosmetics. In addition, cosmetic raw materials sold in China must also meet the requirements of China’s new chemical substance regulations. Compliance with cosmetic formulations and raw materials is a crucial step for the successful registration/filing of cosmetic products.

Relevant regulatory authorities:

National Medical Products Administration (NMPA): Responsible for supervising the production, declaration and post-marketing supervision of cosmetics

Provincial Food and Drug Administration: Responsible for non-special cosmetics filing approval and post-marketing supervision

Ministry of Environmental Protection of China: Supervise the production or import and sale of new chemical substances in China, including cosmetic raw materials or intermediates

Customs and Entry-Exit Inspection and Quarantine Bureau: import and export customs clearance inspection and quarantine

03
Application materials for new cosmetic raw materials

1. Application form for hygiene administrative license of new cosmetic raw materials;

2. Development report:

3. Brief description and diagram of production process

4. Raw material quality and safety control requirements, including specifications, testing methods, substances that may have safety risks and their control, etc.;

5. Toxicological safety evaluation data, including relevant safety evaluation data of substances that may have safety risks in the raw materials;

6. In case of agency application, a copy of the authorization letter of the entity responsible for filing an administrative license in China and a copy of its business license shall be provided, and the official seal shall be affixed;

7. Other information that may help the review. A sample for review is also attached.

04
Our service

Acting for the responsible unit for reporting in China

Compliance audit of finished cosmetics formulations

Compliance audit of finished cosmetics labels

Schedule required tests

Preparation of filing dossiers

Submit application and respond to review comments

For more questions, please refer to ” FAQ ” or send an email to info@zmuni.com

“Product compliance is a prerequisite for brands to enter the Chinese market. In the face of Chinese regulations and policies, we use professional and strict system operations to escort customers’ brands into the Chinese market.”

ZMUNI team is a diverse network of consultants and industry professionals with a global mindset and a collaborative culture. We work to understand your issues and are driven to ask better questions in the pursuit of making your business work better.

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Your Best Choice

We will provide new value and services to the cosmetics.
688 Banan Roda Binjiang Hangzhou, CN

Toxicology Safety Assessment

Cosmetic safety assessment service.
01
Introduction to Cosmetic Safety Assessment Service

On December 16, 2013, the State Food and Drug Administration issued the “Notice on Adjusting the Management of Cosmetics Registration and Filing Management” (2013 No. 10), proposing that if the risk assessment of domestic non-special use cosmetics can confirm the safety of the product, Can be exempted from relevant toxicological tests of the product.

Through this service, we help companies meet the requirements of Chinese cosmetics laws and regulations while avoiding animal testing. At the same time, through a comprehensive evaluation of cosmetics, we help companies better control the quality of raw materials, optimize product formulations, and ensure product quality And safety.

02
Why conduct a product safety assessment?

The main basis of cosmetic safety evaluation is to evaluate the safety of products through the toxicological data of raw materials. In addition to the application of most cosmetic raw materials in the field of cosmetics, they are also widely used in other fields such as chemical industry and food, and have accumulated a lot of available data. By analyzing the existing data of each raw material, it not only ensures the safety of the final product, but also eliminates the need to carry out animal tests and avoid unnecessary waste of resources. Therefore, cosmetic safety assessment is a scientific and effective alternative to product animal testing.

The domestic non-special safety assessment policy came into being under the background that national laws and regulations attach importance to the protection of animal welfare. European Union Cosmetics Regulation EC No. 1223/2009 banned animal testing of finished cosmetic products and some animal testing of raw materials on March 11, 2009, and fully implemented the animal testing ban and sales ban on finished cosmetics and raw materials on March 11, 2013. Since then, more countries have implemented animal bans on cosmetics, and both Israel and India have now issued animal testing bans.

03
Which products can replace toxicology tests with safety assessments?

At present, only domestic non-special use cosmetics can replace toxicological tests with product safety assessments.

04
What are the requirements for security assessors?

The safety evaluation personnel shall have relevant professional knowledge of medicine, pharmacy, nursing, etc. and a certain period of working experience, and shall be responsible for the scientificity and authenticity of the safety evaluation materials.

05
Our advantage

At present, there is no guidance document for the safety assessment of cosmetics in China. The safety assessment report we provide mainly refers to the safety assessment report framework of the EU cosmetics regulations, from the physical and chemical, toxicological data, impurities and packaging of the raw materials, and adopts the exposure parameters suitable for the Chinese to conduct a comprehensive safety assessment.

Our technical team has many years of experience in regulatory compliance and professional background in pharmacy, traditional Chinese medicine and other related fields, and actively participate in foreign safety assessment training.

06
When can non-special use cosmetics not accept toxicology test?

If the risk assessment can confirm the safety of the product, the relevant toxicology test of the product can be exempted.

07
our service
  • Provide product safety assessment report
  • Provide comprehensive raw material safety control requirements
  • Optimize product formula
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ZMUNI Cosmetics Compliance Team

Provide efficient compliance services with solid knowledge and regulatory experience.

ZMUNI is a consulting company specialized in providing registration consulting services for imported products. With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.

Your Best Choice

We will provide new value and services to the cosmetics.
688 Banan Roda Binjiang Hangzhou, CN

Cosmetic Compliance And Quality Management Training

The new regulations of the cosmetics industry have ushered in the 2.0 era of supervision. The cosmetics business needs to keep pace with changing regulations, advanced management systems, and technical standards. We tailor-made courses for everyone..
01
Open Class And Meeting Services

Free public classes and conference services for cosmetics compliance and quality management

According to the laws, regulations, and standards of the cosmetics industry, inviting relevant experts and teachers to plan and organize online and offline training, conferences, seminars, and other activities to provide industry practitioners with opportunities for learning and communication, skill improvement, etc., and provide exchanges on cosmetics compliance and quality management The communication platform contributes to the healthy development of the cosmetics industry.

02
Enterprise Customized Training

Customized compliance and quality management training for enterprises

According to customer needs, customize cosmetics regulations and policies, and quality management-related learning courses, including regulations and policies, quality and safety, market supervision, product development compliance, online transaction supervision, product labeling and advertising, raw material use and efficacy science Statement, public account, website, business platform compliance training, etc., set up targeted course content, customized training activities tailored for customers. It is suitable for enterprise internal training, customized courseware and test questions.

03
Career Development Training Course

Career development training courses for the cosmetics industry

Learning and mastering the regulations and standards of the cosmetics industry is a basic and compulsory course for practitioners. By studying the relevant standards and regulations of the cosmetics industry at home and abroad, a systematic and comprehensive cosmetics compliance and quality management curriculum system is formed, presented in the form of intuitive and clear training courses, and equipped with supporting test questions. Effectively assist enterprises in training quality management personnel, inspection personnel, record registration personnel, and quality and safety persons in charge, so as to achieve rapid improvement of domestic and foreign standards and regulations awareness and application capabilities.

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Regulatory Training

Cosmetics Regulations Training, Compliance Best Practices and Standards.

Cosmetics must comply with the regulations of the country/region of sale! By completing the essentials of cosmetics regulations, understand how to comply with China’s cosmetics regulations.

Ideal for those who wish to export cosmetic brands of cosmetics, as well as those who work in companies selling cosmetics in China.

Your Best Choice

We will provide new value and services to the cosmetics.
688 Banan Roda Binjiang Hangzhou, CN

Frequently asked questions about cosmetics declaration

01
Types of cosmetics in China?

Whether a product belongs to the category of cosmetics defined by my country’s laws and regulations is mainly considered from the following three aspects:

  1. The use method of the product should be rubbing, spraying, or other similar methods, such as rubbing, wiping, applying, etc., and products that achieve beauty purposes by oral, injection, etc. do not belong to the category of cosmetics.
  2. The part where the product is applied to the human body should be any part of the human body surface, such as skin, hair, nails, lips, etc., but teeth, oral mucosa, etc. are not in this category. At present, cosmetics defined by regulations do not include toothpaste and other products that come into contact with the oral mucosa.
  3. The function and purpose of use of the product should be for cleaning, eliminating bad odors, skincare, beauty, and modification. It does not have the function of preventing and curing diseases. This is also the essential difference between cosmetics and medicines. If the hand sanitizer has antibacterial and antibacterial publicity, it is a disinfection product.
02
What are special purpose cosmetics?

Special-purpose cosmetics refer to cosmetics with hair growth, hair dyeing, perming, hair removal, beauty milk, bodybuilding, deodorization, freckle whitening, and sun protection.

03
What tests need to be carried out for the product?

The cosmetics permit inspection report includes the sanitary safety inspection (microbiology, hygienic chemistry, toxicology) report and the human safety inspection report.

04
Can overseas reports be used?

Only the SPF report of special cosmetics can use the overseas report. The rest must be tested at the inspection agency designated by the administrative license (commonly include CDC, drug testing institutes, dermatological hospitals, etc.).

05
Product declaration fee composition and cycle?

The application fee consists of import formula label review, test supervision, and agency fees. The general declaration period for imported non-special cosmetics is 4-6 months, and the declaration period for imported special cosmetics is 6-8 months.

06
Are non-special use cosmetics subject to toxicological test?

If the risk assessment can confirm the safety of the product, the relevant toxicology test of the product can be exempted.

Cosmetic raw material declaration

01
What is the basis for judging new raw materials in China?

According to the “Name List of Used Cosmetic Ingredients” (2014.6.30 version)

02
The cycle and cost of new raw material declaration?

The cost of new raw material declaration consists of test supervision and file production, and the test cost depends on the specific substance. The reporting period is generally 1 to 2 years.

03
Can overseas test reports be used?

The overseas test report can be used for new raw material declaration, but the laboratory qualification certificate and its notarized copy are required, and the original test report shall be provided at the same time.

04
Is the in vitro toxicology test report available?

At present, CFDA only publicly solicits opinions on the 3T3 neutral red ingestion phototoxicity test. As the test method is still in the stage of soliciting opinions, the in vitro toxicology test report still cannot be used for new raw material declaration.

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Compliance is a prerequisite for brands to enter the Chinese market

Choose ZMUNI Compliance to accelerate the brand’s entry into the Chinese market.

ZMUNI is a consulting company specialized in providing registration consulting services for imported products. With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.

Your Best Choice

We will provide new value and services to the cosmetics.
688 Banan Roda Binjiang Hangzhou, CN
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If you have the idea we will find the right way

We provide a comprehensive range of cosmetic services. Help you understand your regulatory obligations to achieve compliance.
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Systematic Compliance Service

We can help you plan the best compliance plan for your company.

01We are able to give truly independent advice

Use our expertise to increase product accessibility.

02Provide suggestions based on your product category

Efficient service, accelerating product import access.

03We will help you during product access

Master the forefront of laws and regulations, shorten the application time.

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Create more leads and grow your business

We can provide a complete solution for importing your products to China.
Record pass rate95%
Application submission100%
Completion rate within specified time90%
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Be at the forefront of the innovation compliance

With high standards process service, integrity management, and simplified compliance process to make foreign cosmetics all-round efficiently import into China by general trade.
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Your Best Choice

We will provide new value and services to the cosmetics.

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