Breaking! China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)

On April 30, 2021, China National Medical Products Administration (NMPA) finalized the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021), which is one of the significant subsidiary regulations of Cosmetic Supervision and Administration Regulation (CSAR) and will come into force on May 1, 2021.

Introduction of IECIC

IECIC is an objective and comprehensive collection of ingredients that have been used in cosmetics produced and sold in China. It serves as the sole reference for determining the regulatory status of cosmetic ingredients. All ingredients excluded from the Inventory are deemed "new ingredients" and subject to mandatory pre-market registration or notification with the NMPA under new cosmetic regulations.

It was first introduced in 2014 and last updated in 2015. Compared with the 2015 version, the IECIC 2021 not only lists the Chinese name, INCI name/English name of the ingredients, but also newly added the ingredients’ highest historical use concentration in rinse-off products, highest historical use concentration in leave-on products and notes.

(IECIC 2021)

The notes are divided into five types, which include:

• Prohibited ingredients in the Safety and Technical Standards for Cosmetics (STSC) (35 ingredients in total);

• To be adjusted as prohibited ingredients in the STSC (17 ingredients in total);

• Used in accordance with the requirements of the STSC (723 ingredients in total);

• Former name (20 ingredients in total);

• Blank.

Noteworthy Points of the IECIC 2021

1. 8972 Cosmetic Existing Ingredients

The IECIC 2021 increases the total number of existing cosmetic ingredients from the original 8783 to 8972. When using ingredients listed in this 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 responsibility for product quality and safety.

2. Highest Historical Use Concentration of Ingredients

The IECIC 2021 newly increases the information of cosmetic ingredients’ highest historical use concentration, which can be used as recognized evidence in the simplified safety assessment report to provide a reference for cosmetic safety assessment.

It is worth noting that the highest historical use concentration listed in the Inventory is not equal to the maximum safe usage concentration. This means that if the amount of an ingredient used in the product formula is the same as or lower than its highest historical use concentration announced by the cosmetic regulatory authority, there is no need to provide safety assessment data for this ingredient. If the amount of an ingredient used in the product formula exceeds its highest historical use amount, even if it is an existing ingredient, it is necessary to conduct safety assessment of the ingredient in accordance with the Technical Guidelines for Cosmetic Safety Assessment.

For ingredients that do not provide the highest historical use concentration in the Inventory, cosmetic registrants and notifiers can provide corresponding materials as evaluation evidence in accordance with the requirements of Technical Guidelines for Cosmetic Safety Assessment, or conduct safety risk assessment according to risk assessment procedures to ensure the safety of the ingredient.

In addition, in cases where the ingredients in the Inventory only have the highest historical use concentration for leave-on products, the rinse-off products shall be used with reference to the limits for leave-on products.

3. 35 Prohibited Ingredients

According to the IECIC 2021, the following 35 ingredients are listed as prohibited ingredients in the STSC. 

4. 3 Cannabis Sativa-derived ingredients and other 14 ingredients are proposed to be banned in cosmetics

In the IECIC 2021, 17 ingredients are marked as "proposed to be adjusted as prohibited ingredients in the STSC", as shown below: 

Significantly, Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, and Cannabis Sativa Leaf Extract are to be banned.

Earlier in March this year, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation to outlaw the use of these 3 Cannabis Sativa-derived ingredients and Cannabidiol (CBD) in cosmetics. This time, the IECIC 2021 did not directly remove the cannabis ingredients but listed them as "Ingredients proposed to be banned ", which means that these three cannabis ingredients can continue to be used for some time, but whether it will be banned and when will ultimately depend on the STSC.

5. Requirements for ingredients whose name have special forms