Official Answers to FAQs on the New Cosmetic Ingredients Compliance in China

In recent years, the cosmetic industry in China has witnessed a significant shift in regulations pertaining to the compliance of new cosmetic ingredients, especially since the implementation of the Rules on the Management of Dossier of New Cosmetic Ingredients (Hereinafter referred to as the Rules) on 1 May 2021. Many questions and confusion continue to rise during the actual application of new cosmetic ingredients in China.

Therefore, in June 2023, National Institute for Food and Drug Control issued an announcement to answer some frequently asked questions (FAQs).

ZMUni translates some key questions into English to equip foreign businesses with the knowledge needed to navigate the ever-evolving world of cosmetic ingredient compliance in China.

Q1: What ingredients are considered New Cosmetic Ingredients (NCI)?

According to the Cosmetics Supervision and Administration Regulations (hereinafter referred to as the Regulations), natural or artificial ingredients used for the first time in cosmetics in mainland China are considered new cosmetic ingredients.

For these new cosmetic ingredients that have been registered and filed, they are still managed as new cosmetic ingredients before being included in the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021).

It should be noted that only if the expected use method, use part, and use purpose of the ingredients conform to the relevant attributes of cosmetics can they be registered or filed as new cosmetic ingredients.

If the method of use of a certain ingredient is through oral administration or injection, this does not conform to the description of the method of use of cosmetics in the Regulations, that is, "smearing, spraying or other similar methods", or if the use part and purpose of the ingredient do not belong to the scope of cosmetics definition, it cannot be registered or filed as a new cosmetic ingredient.

At the same time, according to the requirements of the Rules, the registration and filing information of new cosmetic ingredients should be based on scientific research with an objective and accurate description of the characteristics and safety requirements of new ingredients. The composition of new cosmetic ingredients applied for registration or filing should be relatively clear.

The registrant, filer or domestic responsible person should submit registration and filing information for new cosmetic ingredients as required and be responsible for the legality, authenticity, accuracy, completeness, and traceability of the submitted information.

Q2: What ingredients will not be considered NCI?

Ingredients that meet one of the following conditions are not considered new cosmetic ingredients:

1.Ingredients included in the IECIC 2021.

When using ingredients from this list, the registrant and filer of cosmetics should comply with the relevant requirements of national laws and regulations, mandatory national standards, and technical specifications. They shall also assume product quality and safety responsibilities.

If it is necessary to use more than the "highest historical usage amount", its safety should be proved according to the procedures and requirements of the Technical Specification for Safety Evaluation of Cosmetics (hereinafter referred to as the Technical Specification).

2.Specific parts of ingredients listed in IECIC 2021.

For example, the ingredient "collagen" is included in IECIC 2021. Since collagen is a general term for a certain category of ingredients,  it includes collagen from different process sources such as animal tissue extraction and gene recombination, as well as different subtypes such as type I collagen and type III collagen.

Another common example is the "plant extract of a certain plant", such as "ginseng extract". This indicates that ginseng and its extracts are already used ingredients. Thus, the application for "ginseng juice" or a specific part of ginseng will not be accepted.

3.Ingredients that have been defined as prohibited components in the Technical Specification, such as human cells, tissues or human-derived products, antihistamines, hormone-like substances, etc.

4.Ingredients whose actual functions exceed the scope of cosmetics definition. Such as ingredients with medical effects such as "activating cells", "regenerating cells", "reducing pigment deposition in wound sites", "promoting healing", and "promoting heavy metal excretion".

Q3. What is the administrative framework of NCI?

According to the Regulations, the state implements classified management of cosmetic ingredients according to the degree of risk.

New cosmetic ingredients with high-risk levels are subject to registration, and other new cosmetic ingredients are subject to filing.

After the applicant of new cosmetic ingredients completes the filing through the online government service platform of the NMPA, the filing is completed.

Thus, the true meaning of filing is that the applicant submits information for inspection to the drug regulatory department. After the applicant completes the filing, NMPA will publish information on the filing of new ingredients, which only represents that the raw material has completed the submission of the dossier and meets formal requirements. However, its authenticity, scientificity, and sufficiency may not have been verified. This does not mean that the safety and functionality of this new ingredient are recognized, nor is there any "successful approval for filing" statement.

According to the Regulations and the Rules, after a new cosmetic ingredient completes filing, the drug regulatory department will organize technical review agencies to conduct technical reviews on the filing dossier and evaluate the use and safety of new cosmetic ingredients.

If it is found that the filing dossier does not meet the requirements, it shall be ordered to make corrections within a time limit. Among them, if it is related to safety, it can also be ordered to suspend sales and use of new ingredients at the same time. 

If it is found that a new cosmetic ingredient does not belong to the scope of filing or submits false materials during filing, etc., its filing will be canceled. 

If a new cosmetic ingredient is ordered to suspend use or cancel its registration, cosmetics registrants and filers should also suspend or stop the production and use of cosmetics containing this new ingredient.

Q 4: How do I know if my products are subject to registration or notification?

According to the Regulations, new cosmetic ingredients with functions such as anti-corrosion, sun protection, coloring, hair dyeing, freckle-removing, and whitening, can only be used after being registered with the NMPA; other new cosmetic ingredients should be filed with the NMPA before use. This is based on the principle of risk management.

In the process of developing new cosmetic ingredients, it is often found that a new ingredient may have multiple functions. The registrant or filer of new cosmetic ingredients should comprehensively sort out and fully study the actual functions that the new ingredient may have before applying for registration or filing, and make a scientific and reasonable judgment on whether the new ingredient should be declared for registration or notification.

Generally speaking, for new ingredients with multiple functions at the same time, as long as one of the functions should be declared for registration, they should be declared for registration.

If multiple functions do not involve high risk, no matter how many types of functions there are, they can be filed with the NMPA.  

The registrant or filer of new cosmetic ingredients shall not deliberately conceal the actual functions of new ingredients, nor shall they only file for cosmetics that should be declared for registration and then use for cosmetics production. Once such behavior is verified, it will be punished in accordance with Article 59(3) of the Regulations.

If you have other questions or confusion about the compliance of new cosmetics in China, feel free to contact: info@zmuni.com.