Information on Ingredients Used in Marketed Products Expanded in China - Additional 1,344 Ingredients Have been Added

On November 15, 2024, the National Institutes for Food and Drug Control (NIFDC) released the "Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" to solicit public comments. Companies can submit their comments and related materials via email to hzpylfjw@nifdc.org.cn by November 30, 2024.

What are the adjustments in the "Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" compared to the "Information on Ingredients Used in Marketed Products"?

Scope of Inclusion

"Information on Ingredients Used in Marketed Products" (Released on April 30)

Objectively records the usage of ingredients in special cosmetics within the validity period of approval in China, which are not included in the "Safety and Technical Standards for Cosmetics" and lack evaluation reports from international authoritative cosmetic safety assessment bodies. This involves 2,234 ingredients.

"Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" (Released on November 15)

Objectively records the usage information of ingredients applied in registered or filed cosmetics in China and are not included in the "Safety and Technical Standards for Cosmetics" or the "Index of Cosmetic Safety Assessments by International Authorities". This involves 3,578 ingredients.

Usage Principles

"Information on Ingredients Used in Marketed Products" (Released on April 30)

• Principle One:

For same ingredient used on the same site, if the usage data is for leave-on products only, then rinse-off products may also use the data as a reference.

• Principle Two:

For same ingredient with the same use method, the usage amount of ingredients in products for the subsequent application sites can refer to that of the previous site in sequences of whole body skin, trunk, face, lips, eyes, or whole body skin, trunk, hands and feet, head, hair. However, if the product is used around the eyes, yet the usage amount refers to those for other sites, an additional eye irritation assessment is required.

If an ingredient is used in multiple application sites (including two), refer to Principle Two and choose the usage amount for the previous application site with the same usage method.

"Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" (Released on November 15)

• Principle One

Remains unchanged.

• Principle Two

For the same ingredient used in the same method, the usage amount for the subsequent application sites can make reference to that of the previous site in sequences of whole body, trunk, face (including neck), hands and feet, head, hair, lips, eyes, and nails. However, if the product is used around the eyes, yet the usage amount refers to those for other sites, an additional eye irritation assessment is required.

The usage amounts of ingredients for lip and eye products cannot refer to that for hands and feet, head, or hair. The usage amount for body hair can only refer to that for the whole body or trunk. If the application sites cover both head and hair, the usage amount for the head can be referred. If the sites include face (including neck), eyes, and/or lips, the usage amount for the face (including neck) can be referred. If the application site includes the eyes, an additional eye irritation assessment is required. For ingredients used on multiple sites simultaneously, choose the usage amount for the previous application site with the same usage method.

Other Changes

• Increased Concentration of Ingredient: Compared to the previous version, the draft for comments shows an increase in usage amounts for the ingredients.
• Increased Plant-Derived Ingredients: Of the 1,344 new ingredients added, more than half, approximately 700, are plant-derived.

How to Correctly Understand and Use the "Information on Ingredients Used in Marketed Products"?

Scope of Use

• According to management requirements, the usage amounts in the "Information on Ingredients Used in Marketed Products" can only be used for comprehensive safety assessments and not for simplified safety assessments.
• Ingredients used as anti-freckle and whitening agents or anti-hair loss agents cannot utilize the usage information published by regulatory authorities.
• If the ingredient usage exceeds the amounts listed in the "Information on Ingredients Used in Marketed Products," cosmetic registrants and filers should conduct a safety assessment according to the "Technical Guidelines for Cosmetics Safety Assessment (2021 Edition)" or use other types of ingredient data as outlined in the "Guidelines for the Use of Cosmetic Ingredient Data".

Examples

Example 1: How to use the "Information on Ingredients Used in Marketed Products" ("Ingredients Information") for rinse-off hair products?

Current requirement: The amount of ingredients used in rinse-off hair products can refer to the amount of the same ingredient used in rinse-off hair products as listed in the "Ingredient Information". If it is not listed, according to usage Principle One, the amount used in leave-on hair products can be referred to. If that is not listed either, according to usage Principle Two, the amount used in products for the whole body skin or trunk or hands and feet or head can be used.

Note: Once the usage principles of the "Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" are implemented, the amount of the ingredient used for the whole body, trunk, face (including neck), hands and feet, or head can be referred to.

Example 2: How to use the "Ingredients Information" for leave-on eye products?

Current requirements: For leave-on eye products, the usage amount of an ingredient can be based on its usage in similar eye products from the "Ingredient Information" without needing to assess eye irritation. If such information is unavailable, according to usage Principle Two, the amount used for whole body skin, trunk, face, or lips can be referenced, but an additional eye irritation assessment is required.

Note: The "Information on Ingredients Used in Marketed Products (Revised Draft for Comments)" clearly states that the usage amounts for lips and eyes cannot be referenced from those for hands, feet, head, or hair.

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