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According to statistics, China has become the largest country in cosmetics consumption. The pursuit of beauty is not only about appearance, but also a way to show personal character and value. People with different personalities have different needs for beauty. What's more, people's needs for beauty will be different at every age and every important occasion. China is a dynamic, consuming and inclusive market. The core of different cosmetic brands is the difference in the use of New Cosmetic Ingredients. The use of new cosmetic ingredients will bring new feelings and convey new brand concepts to consumers.  

You may ask, how to apply for and make new cosmetic ingredient listed in China? 

We can help you. 

We can provide one-stop registration and  services for new cosmetic ingredients.  

Some answers and situations you might want to know.  

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Related  Services:

· Application for new cosmetic ingredients  in China

· In vitro efficacy evaluation

· Safety evaluation

· Clinical efficacy evaluation

Q1.How to understand and define New  Cosmetic Ingredient in China? The regulations in China?


In China, a new cosmetic ingredient is a natural or artificial ingredient that is applied in cosmetic products for the first time in China.


The Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) issued by the National Medical Products Administration on April 27, 2021, replaced  by the previous version (IECIC 2015) as the standard for judging cosmetic ingredients in China. Ingredients not listed on IECIC 2021 have to be registered or notified before their use in cosmetics.

Existing or listed cosmetic ingredients that are modified for purpose of use or used safely should also be registered with NCI.

Q2.What need to be prepared if appling for a new cosmetic ingredient in China?

In the submissionthe source and research situation of new raw materials, manufacturing process and its quality control situation and safety assessment situation should be clearlystated.Under limited conditions of use, the safety and risk controllability of using NCI should be fully demonstrated.When citing scientific literature or regulatory data, it should be relevant to the new ingredient for registration or filing.


The source of NCI, purpose of use,specification of use, scope of application and other restrictive conditions stated therein shall apply to the NCI registered or filed.

Information List

No.

File Name

Key Information

1

Overview of the Safety Risk Monitoring and Evaluation System for NCI   Registrants/Filers

The registrant/filer of overseas NCIs   should also briefly describe the mechanisms and measures for information exchange, data sharing, and risk linkage with domestic responsible persons in terms of safety risk monitoring and evaluation. The domestic responsible person should briefly describe the specific measures for cooperating with the registrant/filer of NCIs   in safety risk monitoring and evaluation, including the setting of job responsibilities, and relevant systems for safety risk monitoring and evaluation.

2

Information Application Form For NCI Registrant/filer

NCI   name / usage information/registrant/filer/domestic responsible person information

3

Development Report

Basic information: NCI   name, source, composition, relative molecular mass, molecular formula, chemical structure, physical and chemical properties, etc.

4

Usage information: usage specifications, purpose of use, application or scope of use, safe use amount, duration of use, precautions, warnings, etc.

The status and approval status of NCI   used in cosmetics overseas.

5

Functional basis: Judging from scientific literature, regulatory data, laboratory research data or human efficacy evaluation test data, it can be proved that NCI   has the same purpose of use.

6

Brief Description of Preparation Process

Whether the safety risk substances and their control measures are likely to be introduced in the main process steps, process parameters, and production processes.

7

Stability Test Data

Stability test data: destructive test, accelerated test, long-term storage test

8

Quality Control Standards

Quality specifications and inspection methods, possible safety risk substances and their control standards, etc.

9

Security Assessment Report

Toxicological safety evaluation data, safety risk evaluation data

10

Skills Requirement

Prepared in combination with relevant technical information of NCI   for registration/filing information disclosure

11

Other information useful for filing

Other relevant information that is helpful for registration/filing.





Q3. If it is a foreign company, can it apply for new cosmetic raw materials in China on its own?

An overseas institution applying for the filing or registration of new raw materials must designate an enterprise legal person in China. According to Chinese laws and regulations, if the registrant or filing person is overseas, an enterprise legal person in my country shall be designated as the domestic responsible person. Domestic responsible persons shall perform the following obligations: (1) To handle the registration and filing of cosmetics and NCIS in the name of the registrant and filing person; (2) Assist registrants and filers to carry out adverse reaction monitoring of cosmetics, safety monitoring and reporting of NCIS; (3) Assist registrants and filers in implementing the recall of cosmetics and NCIS; (4) In accordance with the agreement with the registrant and the filing party, assume the corresponding quality and safety responsibilities for the cosmetics and NCIS put on the domestic market; (5) Cooperate with the supervision and inspection of the drug supervision and administration department.




Q4. Anything that need to be attentioned? The registration and filing of NCIS in China is divided into six situations. The toxicology tests required for each situation are different. Some toxicological experiments have high costs and long periods. A detailed analysis of the situation of NCIS and proper screening are very important for those companies who want to put them on the market as soon as possible.


Q5. What can Wintest help you do?



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Web:wintest@winkey-china.com Add.:3rd Floor, Building 7, Phase III, Yangbei Industrial Zone, Huangtian, Huangtian Community, Hangcheng Street, Baoan District, Shenzhen

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