China's new overarching cosmetic regulation—Cosmetic Supervision and Administration Regulation (CSAR)—officially took effect on January 1, 2021, with the related administrative measures, standards, and guidance documents entering into force on May 2021. These new rules bring significant overhauls to the regulatory regime of cosmetics in China. One of the most high-profile changes is the introduction of new compliance lists for cosmetic ingredients.
On April 30, 2021, China NMPA released the latest version of the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021), which is a list of ingredients that have been already used in cosmetics manufactured and sold in China. All ingredients excluded from the list are deemed "new ingredients" and subject to mandatory pre-market registration or notification before being legally used in cosmetics in China. The list has officially come into effect on May 1, 2021.
The key highlights of IECIC 2021 are as follows:
- It increases the total number of existing cosmetic ingredients from the original 8783 to 8972.
- It adds the information of cosmetic ingredients’ highest historical use concentration as one of the references for cosmetic safety assessment.
- It adds the notes related to ingredient safety reviews, which are divided into five types: prohibited ingredients, to be adjusted as prohibited ingredients, used in accordance with the requirements of Safety and Technical Standards for Cosmetics, former name, and blank.
Prohibited Cosmetic Ingredient Inventories
On May 28, 2021, China NMPA issued the finalized Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics with immediate effect. From that date, cosmetic registrants and notifiers are not allowed to produce or import products containing prohibited ingredients stipulated in the new inventories.
These two new inventories replaced the previous inventories of banned cosmetic ingredients and were included in the corresponding chapters of Safety and Technical Standards for Cosmetics. The key highlights of the new inventories are as follows:
- There are a total of 1393 ingredients, including 1,284 prohibited ingredients and 109 prohibited ingredients derived from plant or animal sources.
- 24 prohibited cosmetic ingredients have been added to the two new inventories, including CBD and three Cannabis Sativa derived ingredients (Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, and Cannabis Sativa Leaf Extract).
- The product information of some prohibited ingredients, such as the names, CAS numbers, and notes, has been revised.
- Some prohibited drug ingredients have been recategorized into Anti-infectives, Antihistamines, Hormones, and Adrenergic Agents, with reference to Chinese Pharmacopoeia 2020, Clinical Medication Instructions 2015, and Martindale the Extra Pharmacopoeia.
From the release of IECIC 2021 to the revision of the prohibited ingredient inventories, Chinese cosmetic regulatory departments’ control measures towards cosmetic ingredients are gradually enforced. This is a clear sign that China is giving increasing weight to the management of ingredients. Cosmetics enterprises must therefore be extra vigilant about the ingredients they use if they wish to enter the Chinese market successfully.
To help stakeholders keep up with the evolving regulations of cosmetic ingredients and mitigate compliance risks, ChemLinked developed a Chinese cosmetic ingredient regulatory database platform, the Cosmetic Ingredient Search Tool.
With this tool, users can:
- Easily search cosmetic ingredients by INCI/English name, Chinese name, and CAS number;
- Have a quick lookup of ingredients’ regulatory status, such as whether it is listed in IECIC 2021 and whether it is banned or subject to restrictions;
- Track the most up-to-date regulations on ingredients;
- Generate an ingredient report in one click;
- Get alerts on recent updates to ingredients lists.
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