[Updated] China Implements Technical Guidelines for Filling in and Submitting Cosmetic Formula

1. Foreword

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2. Applicable Scope

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3. General Principle

Clarifying the principle of judging whether ingredients or ingredient components are considered part of the formula.

Cosmetic formula ingredients refer toingredients intentionally added to the product formula during production that play a role in the final product, such as preservatives, sunscreens, hair dyes, colorants, moisturizers, pH regulators, viscosity regulators, etc.

Extremely trace components (such as antioxidants, etc.) added to ensure ingredient quality, unavoidable trace impurities, and processing aids that do not react chemically with other ingredients, have no effect on the final product and are removed in subsequent production steps are not considered part of the formula.

Ingredients or ingredient components that are not considered part of the formula are not required to be filled in in the formula table (except for the ingredients listed in the List of Permitted Preservatives and List of Permitted Sunscreens), but they should still be fully analyzed and assessed for safety.

4. Formula Filling Form

Clarifying the requirements for filling in single-component ingredients, compounds and group ingredients.

Notes: Group ingredients refer to a category of ingredients that includes multiple subcategories of ingredients.

• When filling in the formula, for ingredients containing two or more components (except fragrance and ingredient components that are not considered part of the formula), the specific components and corresponding concentration must be indicated;

• For group ingredients, the name should be filled in according to the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC), and the specific components should be indicated. If the specific component is not included in IECIC, proof must be provided that the component has been used in registered or notified cosmetics in China.

5. Ingredient Name

Clarifying the requirements for filling in the ingredient name.

• The ingredient name should be indicated in accordance with the standard Chinese name and INCI name/English name listed in IECIC. For new cosmetic ingredient (NCI) that is still under safety monitoring, the name of the registered or notified NCI should be filled in;

• The Chinese name of the ingredient should correspond to its INCI name/English name. If the INCI name labeled on the original packaging of imported products does not match the name filled in the formula, an explanation should be made in the “Remarks” column of the formula table.

6. Ingredient Concentration

Clarifying the requirements for filling in the ingredient concentration.

• Ingredients should be listed in descending order according to their concentration, expressed as the percentage by weight, with 100% as the total concentration of all ingredients;

• If the formula contains a propellant that comes into direct contact with the product, the composition and concentration of the propellant should be filled in separately. The total concentration of propellant should be 100%, and the filling ratio of the propellant and material body should be indicated;

• For pH regulators and viscosity regulators whose concentrations fluctuate within a certain range, the registrant, notifier and Chinese domestic responsible person have the option to either fill in the typical value of the dosage or indicate the range of the actual amount added below the formula table. It is crucial to perform a safety assessment based on the maximum amount added when noting the range of the actual amount added.

7. Ingredient Use Purpose

Clarifying the requirements for filling in the ingredient use purpose.

• For ingredients included in the List of Permitted Preservatives, List of Permitted Sunscreens, List of Permitted Hair Dyes and List of Permitted Colorants, the use purpose should be filled in according to the corresponding ingredient's function in the list, unless otherwise specified;

• The registrant, notifier, and Chinese domestic responsible person should fill in the main use purpose of ingredient based on its actual function in the product;

• Cosmetics that claim the efficacies of hair dyeing, hair perming, freckle-removing and whitening, sunscreen, anti-hair loss, acne removal, anti-wrinkle, anti-dandruff, deodorant, as well as cosmetics claiming new efficacies (excluding cosmetics for special groups), the functional ingredients should be indicated in the "Use Purpose" column of the formula table. For functional ingredients other than single-component ingredients, the specific functional components should be specified.

8. Formula Remarks

For the first time clarifying the requirements for filling in the“Remarks” column in the formula table.

• “Remarks” column of the formula table: Further explanations for ingredients should be indicated in the “Remarks”column in the formula table. For example: if the product label identifies specific components in the fragrance, but only "fragrance" is filled in the formula table, an explanation should be provided in the “Remarks” column in the formula table;

• “Remarks” column below the formula table: For pH regulators and viscosity regulators whose concentrations are low and fluctuate within a certain range, the registrant and notifier can indicate the concentration range in the “Remarks” column below the formula table.

9. Ingredient Safety Information

Clarifying the requirements for filling in the ingredient safety information.

• Starting from Jan. 1, 2024, cosmetics registrants and notifiers must provide safety information about all ingredients used in the formula;

• For ingredients that are required to provide the quality specification in the safety assessment report, if the ingredient safety information has been filled in, there is no need to include it repeatedly in the safety assessment report;

• For ingredients that have been filled in with safety information, there is no need to provide the ingredient quality specification certificate;

• If an ingredient has already been assigned an ingredient submission code, the registrant, notifier and Chinese domestic responsible person can associate the safety information by filling in the code.

10. Safety Assessment of Ingredients /   Components Not Considered Part of the Formula

Clarifying that the safety of ingredients or ingredient components that are not considered part of the formula should also be explained and fully assessed in the safety assessment report.

• Ingredients and ingredient components that are not considered part of the formula are not required to be filled in the formula table, but their safety should still be fully assessed and explained in the safety assessment report;

  For instance, the residual content of processing aids used during product production, which are subsequently removed, should be comprehensively assessed. Similarly, components present in low concentrations in ingredients produced using innovative technologies, such as trace cholesterol and phospholipids in liposomes, require safety assessment to identify potential risks. Additionally, ingredients used in children's cosmetics warrant an assessment of potential safety risks;

• If the composition or proportion of these ingredients changes without affecting product quality and safety, the registrant, notifier, and Chinese responsible person must update and maintain the product formula and safety assessment report accordingly. However, if the composition or proportion of these ingredients changes and impacts product quality and safety, the registrant, notifier, and Chinese domestic responsible person must revise the product safety assessment report to reflect the updated information.

Annex 1: Template of Formula Table

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Annex 2: Sample of Formula Table (without ingredient components that are not considered part of the formula)

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