Filing for cosmetic formulas in China - New technical guidelines issued

Filing for cosmetic formulas in China has new technical guidelines issued by the National Institutes for Food and Drug Control (NIFDC) on September 4, 2023, which came into effect immediately. These guidelines provide insights into the requirements for cosmetic formula components, shaping how companies report their cosmetic formulations.

General principle

Cosmetic formula ingredients refer to those intentionally added during the production process and serving a role in the final product. These include preservatives, sunscreens, hair dyes, colorants, moisturizers, pH regulators, and viscosity regulators, among others. This definition excludes ingredients added to raw materials to ensure quality, those in extremely small amounts, the raw material itself, or residue of unavoidable trace impurities. It also excludes processing AIDS added in the production process but don't chemically react with other ingredients and are removed in subsequent production steps.

Percentage of formula raw materials

When the amount of additives in the formula fluctuates within a certain range, such as pH regulators and viscosity regulators that play a role in the final product, cosmetics registrants, filers, or domestic responsible individuals can either enter the typical value of these additives in the formula table or note the actual additive range below it. Safety assessments are conducted at the maximum addition amount to ensure product safety and quality control within the specified range.

Purpose of using formula raw materials

Cosmetics claiming specific efficacy, like hair color, perm, freckle whitening, sun protection, anti-hair loss, acne treatment, anti-wrinkle, anti-dandruff, deodorant, and new efficacy claims (excluding special groups) should mark the corresponding efficacy of raw materials in the formula table. If the efficacy of raw materials isn't a single component, specific functional ingredients should be specified in the purpose of use column.

Safety assessment of raw materials/ingredients not used in formulations

Raw materials or ingredients not part of the formulation should be individually described in the product safety assessment data. The cosmetics registrant, record holder, or domestic responsible individual is responsible for the quality of selected raw materials. Raw materials not used in the formula need not be reported, but their safety should be assessed. For instance, processing AIDS added in the production process and removed later should be fully assessed for residues. Additionally, the safety of low-content components (e.g., trace cholesterol, phospholipids) in raw materials produced using innovative technologies should be evaluated. Safety risks of raw materials/ingredients not reported as formula ingredients in children's products should also be assessed to ensure product safety and quality control.

Updates to raw materials/ingredients

If the type and/or content of raw materials not used in the formula change without affecting product quality and safety, cosmetics registrants, record holders, or domestic responsible individuals should update and maintain product formula and safety assessment data. If these changes may affect the safety assessment conclusion, updates to the product safety assessment data are required.