China cosmetics registration

Cosmetic products in China are chemical products for daily use intended to be applied the skin, hair, nails, lips and other human surfaces by scrubbing, spraying or other similar methods for the purpose of cleaning, protection, beautification and modification.

The China cosmetics market is the 2nd largest with 12.7% global market share with analysts expecting a compound annual growth rate (CAGR) of 13% through 2024. The skincare sector in China alone will be worth a whopping US$58 billion in 2025 according to the latest China cosmetics market guide from GMA.

And with the children’s cosmetics market in China estimated to be worth US$6 billion in 2023, there are plenty of opportunities for overseas cosmetics manufacturers to take advantage of.  What’s more as China imports 80% of its cosmetic raw materials coupled with the fact that China is weak on cutting edge technology this means opportunities for cosmetics ingredient suppliers too.

 

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So how do you register cosmetics and cosmetics ingredients in China?

Below we outline the process of registering cosmetics and cosmetic ingredients in China in four simple steps.

 

Step 1: Appoint an NMPA Domestic Responsible Agent

As a foreign manufacturer, your first step is to nominate a local authorized representative known as the NMPA Domestic Responsible Agent (DRA). NMPA stands for the National Medical Products Administration and is the regulatory body responsible for cosmetics and cosmetic ingredients in China. 

The NMPA Domestic Responsible Agent is responsible for product and ingredient filing and registration, supervision of tests, post-market surveillance activities including the storage of product samples, amongst other activities. They are your point of contact and representative for all interactions with the regulator (NMPA) and so they should have a wealth of experience with relevant regulatory issues and cosmetic product standards, as well as a good working history with the responsible authorities.
 

Step 2: Determine whether the cosmetics ingredients are approved for use in China

The next step is to determine whether the cosmetic ingredient(s) are approved for use in China. As your DRA, Cisema will check the “Inventory of Existing Cosmetic Ingredients in China" (IECIC). The IECIC lists those ingredients which are porbably suitable for China's market, however, the list alone is insufficient to make a reliable analysis of ingredients and their China conformity.

If the ingredients are listed on the IECIC then:

- cosmetics manufacturers can proceed to filing or registering their products (see Step 4a below)

- cosmetic ingredient suppliers can apply to obtain a Cosmetic Ingredient Code for the ingredient or formula (see Step 4b below).

If the ingredients are not listed on the IECIC, then a new ingredient filing or registration application must be submitted (see Step 4c below). New cosmetic ingredients are any ingredients that are used in the Chinese market for the first time. 

 

Step 3: Determine whether your cosmetic product or ingredient is classed as "general cosmetic" or "special cosmetic"

The next step is to determine whether your ingredient or cosmetic product is classed as a “general cosmetic” or a “special cosmetic” in China.

“General cosmetics” are cosmetics other than “special” cosmetics, including: 

- fragrances

- make-up

- nail costumes

- hair care

- skin care, etc.

"Special cosmetics" include:

- sun protection

- hair dyes

- hair perming

- anti-hair loss

- freckle removal and whitening

- and cosmetics that claim new effects

 

Step 4A: Filing or registering a cosmetic product in China

The next step is to submit a cosmetic filing or registration application. A filing is undertaken for general cosmetics whereas a special cosmetic must undergo registration. 

Special cosmetics: As your DRA we will undertake an initial packaging and formula review for conformity with China specific standards. We will organize local sample testing of your cosmetics in China and then submit registration application to the National Medical Products Administration (NMPA) in Beijing. The NMPA undertakes an initial administrative review then a technical review. Once approved the registration certificate has a validity of 5 years only and so must be renewed. Typically, it will take between 8-12 months after the test samples arrive in China to obtain approval.

General cosmetics: The filing procedure for general cosmetics in China is the similar to that of special cosmetics, however, the filing certificate is issued before the NMPA undertakes the technical review.  This creates the impression of a shorter filing time. However, if the application does not meet the requirements, the license can be suspended. The validity of the filing certificate is unlimited now.  Typically, it will take between 3-5 months after the test samples arrive in China to obtain approval.

Step 4B: Filing or registering a new cosmetic ingredient in China

New ingredients which have not previously been approved for the Chinese market require separate pre-approval from the NMPA. New cosmetic ingredients are any ingredients that are used in the Chinese market for the first time. High-risk ingredients which require registration include the following functional ingredients: 

- antiseptic

- sunscreen

- coloring

- hair dyeing

- freckle removal and whitening. 

Whereas low-risk ingredients require filing. The turnaround time for approval can be up to 18 months due to substantial product testing locally in China. 

As your DRA we will organize local sample testing of your ingredient in China and then submit registration application to the National Medical Products Administration (NMPA) in Beijing. The NMPA undertakes an administrative and technical review. Typically, it can take up to 18 months after the test samples arrive in China to obtain approval due to substantial testing requirements for new raw materials. There will then be a period of observation of three years; if no safety problems arise then the ingredient will be included in the list of approved ingredients for use in cosmetics in China (IECIC).

 

Step 4C: Obtaining a cosmetic ingredient code in China

As of January 2022, cosmetic raw material and ingredient manufacturers have the opportunity to register their ingredients and formulas directly with the NMPA by submitting a Cosmetic Ingredient Code (CIC) application. The CIC is only applicable to cosmetic ingredients that are already listed on the IECIC (Inventory of Existing Cosmetics Ingredients in China). 

As your Domestic Responsible Agent, we will review latest the IECIC List. Then we will review and evaluate the ingredient’s technical specification, test reports and Material Safety Data Sheet (MSDS). The application will then be submitted to the NMPA. Typically, it can take up to 2 months to obtain the code.

Once accepted, you may give the code to your customer who will include the code in their final cosmetic product filing / registration application.

 

Does my ingredient or cosmetic product need to undergo animal testing in China?

Companies can apply for exemption of animal testing for imported “general” cosmetics if they fulfil certain conditions: 

- Firstly, the manufacturers must have obtained the relevant qualification certification of production quality management system (e.g., GMP, ISO, production license) issued by the cosmetic regulatory authority of the country (region) where they are located

- Secondly, the product safety assessment report must fully confirm the safety of the cosmetics.

“Special cosmetics” or baby cosmetics will continue to require animal testing. 

 

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