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How does China regulate cosmetic ingredients?

China mainly adopts 8 lists to regulate the cosmetic ingredients:

1) Inventory of Existing Cosmetic Ingredients in China 2021 (8972 ingredients included);

2) Inventory of Prohibited Ingredients Used in Cosmetics 2021 (1284 ingredients included);

3) Inventory of Prohibited Plant and Animal-Derived Cosmetic Ingredients 2021 (109 ingredients included);

4) List of Restricted Ingredients Used in Cosmetics 2015 (47 ingredients included);

5) List of Permitted Preservatives Used in Cosmetics 2015 (51 ingredients included);

6) List of Permitted Sunscreens Used in Cosmetics 2015 (27 ingredients included);

7) List of Permitted Colorants Used in Cosmetics 2015 (157 ingredients included);

8) List of Permitted Hair Dyes Used in Cosmetics 2015 (75 ingredients included).

What does it mean if an ingredient is included in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)?

Ingredients listed in the IECIC are regarded as "existing" ingredients, otherwise, they are new cosmetic ingredients.

In China, new cosmetic ingredients require registration or notification with the NMPA prior to use in cosmetic products. The notified/registered new cosmetic ingredients will be subject to a 3-year safety monitoring period. If there are no safety issues found within the 3 years, the ingredients will be included in the IECIC. Therefore, in the future, the IECIC will be dynamically updated.

What’s the difference between the Inventory of Existing Cosmetic Ingredients in China (IECIC) and the Inventory of Existing Chemical Substances in China (IECSC)?

IECIC serves as the basis to judge whether a cosmetic ingredient is new or existing, while IECSC is the basis to judge whether a substance is identified as a new chemical substance subject to registration requirements. Since cosmetic ingredients are chemical substances, a cosmetic ingredient not listed in the IECSC (even if it is included in the IECIC) will require registration of new chemical substances prior to manufacture or import.

What’s the difference between the Inventory of Existing Cosmetic Ingredients in China (IECIC) and the INCI Chinese Version?

The INCI Chinese Version is translated to standardize the Chinese translation of INCI name, cosmetic labeling and instructions, which is certainly not a criterion for illustrating the regulatory status of an ingredient.

What does the highest historical use concentration refer to in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021)?

The highest historical use concentration refers to the maximum usage concentration of cosmetic ingredients used in existing cosmetics in China, which is not equal to the maximum allowable or safe usage concentration. The highest historical use concentration can be used as recognized evidence in the simplified safety assessment report to provide a reference for cosmetic safety assessment. For ingredients without declaring the highest historical use concentration in the Inventory, cosmetic registrants and notifiers can provide corresponding materials as assessment evidence or conduct safety assessment in accordance with the requirements in Technical Guidelines for Cosmetic Safety Assessment to ensure the safety of the ingredient.

If the ingredient only has the highest historical use concentration in leave-on products, the use concentration in rinse-off products can refer to that in leave-on products.

What is the Safety and Technical Standards for Cosmetics 2015 (STSC 2015)?

Safety and Technical Standards for Cosmetics 2015 serves as the overarching technical standard for cosmetics safety supervision and testing in China. The Standards contains the prohibited, restricted, and permitted cosmetic ingredients, physical and chemical testing methods for cosmetics, microbiological testing methods, toxicological testing methods, human body safety testing methods, and human body efficacy evaluation testing methods.

Are there any exceptions for the Inventory of Prohibited Ingredients Used in Cosmetics?

Radioactive substances which are natural or caused by man-made environmental pollution are not included in the Inventory. But the content percentage of these radioactive substances shall not be increased in the cosmetics production process, and shall not exceed the limits set for protecting workers and the public from radiation damage.

What should we pay attention to when searching the Inventory of Prohibited Plant and Animal-Derived Cosmetic Ingredients?

Prohibited ingredients in this Inventory include their extractions and preparations.

If the detailed parts are indicated, the prohibition is only imposed on the specified parts; otherwise, the whole plant is prohibited including the flower, stem, leaf, fruit, seed, root and their preparations.

Some ingredients are marked as prohibited ingredients in the IECIC 2021, but are not included in the two prohibited ingredient inventories. Are such ingredients prohibited in China?

The ingredients with notes of “prohibited ingredient” in the Inventory of Existing Cosmetic Ingredients 2021 (IECIC 2021) are all prohibited for use in cosmetics, even though they are not included in the Inventory of Prohibited Ingredients Used in Cosmetics and Inventory of Prohibited Plant and Animal-Derived Cosmetic Ingredients (2021).

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