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How does China regulate cosmetic ingredients?

China mainly adopts 11 lists to regulate the cosmetic ingredients:

1) Inventory of Existing Cosmetic Ingredients in China I;

2) Inventory of Existing Cosmetic Ingredients in China II;

3) Inventory of Prohibited Ingredients Used in Cosmetics 2021;

4) Inventory of Prohibited Plant and Animal-Derived Cosmetic Ingredients 2021;

5) List of Restricted Ingredients Used in Cosmetics 2015;

6) List of Permitted Preservatives Used in Cosmetics 2015;

7) List of Permitted Sunscreens Used in Cosmetics 2015;

8) List of Permitted Colorants Used in Cosmetics 2015;

9) List of Permitted Hair Dyes Used in Cosmetics 2015;

10) Ingredient Usage Information of Marketed Products;

11) International Cosmetic Safety Assessment Data Index.

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

Ingredients listed in the IECIC (I&II) 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. The IECIC will be dynamically updated.

What do IECIC I and II refer to, respectively?

The IECIC is managed in two lists: IECIC I and IECIC II. IECIC I is an objective collection of ingredients that have been used in cosmetics produced and sold within China. IECIC II includes new cosmetic ingredients that have been registered or notified in China, have completed their safety monitoring period, and meet the criteria for inclusion in the IECIC.

When selecting ingredients from these Inventory, cosmetic registrants and notifiers shall comply with relevant requirements of the national laws and regulations, mandatory national standards, and technical specifications, and bear the primary responsibility for product quality and safety.

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 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?

1. 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;

2. If benzene is technically unavoidable to be present in cosmetics as an impurity, its limit should not exceed 2mg/kg;

3. If the presence of cyclotetrasiloxane as an impurity in cosmetics is technically unavoidable, its concentration shall not exceed 0.1% (w/w).

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, 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 I (IECIC I) 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).

What does it mean if an ingredient is included in the Index of Cosmetics Safety Assessment Data from Authoritative Organizations?

1. The Index is an objective collection of ingredients used in cosmetics available in China, and are not included in Safety and Technical Standards for Cosmetics (STSC). Authoritative agencies such as the Scientific Committee on Consumer Safety (SCCS) and Cosmetic Ingredient Review (CIR) have published assessment conclusions for these ingredients. The Index serves as a reference for enterprises conducting cosmetics safety assessments. Registrants and notifiers can utilize the assessment conclusions provided by authoritative agencies, including but not limited to SCCS and CIR, for these ingredients.

2. When adopting assessment conclusions, the following requirements should be met:

1) Analysis of assessment conclusions: Conclusions that comply with China's cosmetic regulations and usage conditions can be adopted;

2) Staying updated: Given advancements in science and technology and evolving knowledge, the types of ingredients assessed and their assessment conclusions may change. Enterprises should prioritize the latest assessment conclusions;

3) Handling diverging conclusions: In cases where different authoritative agencies offer different assessment conclusions, enterprises should scientifically and reasonably adopt relevant conclusions. The reliability and relevance of the data should be the principle of selection.

What does it mean if an ingredient is included in the Ingredient Usage Information of Marketed Products?

The Ingredient Usage Information is an objective collection of the usage information of ingredients in cosmetics within the validity period of registration and notification certificates in China, which have not been included in Safety and Technical Standards for Cosmetics and Index of International Authoritative Cosmetic Safety Assessment Data. No systemic evaluation has been conducted for the listed ingredients. Cosmetic registrants and notifiers shall comply with relevant national laws, regulations, standards, and specifications when using relevant ingredient information, conduct cosmetic safety assessments, and assume product quality and safety responsibilities.

The specified ingredient concentrations in Ingredient Usage Information of Marketed Products serve as a reference for enterprises conducting cosmetics safety assessments. Cosmetic registrants and notifiers should appropriately utilize the ingredient concentration based on the product's application method and site, following the following principles:

For the same ingredient used in products applied to the same site, if only its usage concentration in leave-on products is available, this data can be taken as a reference for rinse-off products.
For the same ingredient used in products with the same application method, reference should follow the order of whole body, trunk, face (including neck), hands and feet, head, hair, lips, eyes, and fingernails and toenails. The usage concentration for the former sites can be taken as a reference for that for the latter sites; however, when the product concerned is intended for application around the eyes and the usage concentration of the ingredient for other sites are referred to, the ingredient shall be assessed for the eye irritation separately. Among them, the usage concentration of the ingredient in a product for lips and eyes cannot be based on its usage concentration in a product for application on hands and feet, head, and hair. The usage concentration of the ingredient in a product for body hair can only be based on its usage concentration in a product for application on the whole body or trunk. The usage concentration of the ingredient in a product for application both on head and hair can be based on its usage concentration in a product for application on the head. The usage concentration of the ingredient in a product simultaneously applied on the face (including neck), eyes and/or lips can be based on its usage concentration in a product for application on the face (including neck); however, when the product concerned includes eye application, the ingredient shall be assessed for the eye irritation separately. The usage concentration of the ingredient in a product simultaneously applied on two or more sites can choose to adopt the usage concentration for the former sites under the same application method.