China’s Draft Guidance on New Cosmetic Ingredients: Key Criteria Explained

The draft is intended to help new ingredient registrants and filers assess ingredient status and the research needed to support that assessment. It may affect whether a proposed ingredient follows a new ingredient registration or filing route, or whether its use can be supported through safety and functional research at the finished-product stage. Companies planning a China launch can review REACH24H's China new cosmetic ingredient registration and filing services for related support.

How the Draft Proposes to Assess Ingredient Identity

The draft says that an ingredient already included in the Inventory of Existing Cosmetic Ingredients in China (IECIC) would generally not be managed as a new ingredient, subject to specified exceptions. Its examples are intended to clarify how companies should compare an ingredient with existing inventory entries.

• Plant, animal and microbial materials: Where an entry covers a plant extract or a broader biological source, a particular plant part or a variety within the entry's stated scope would generally not make the ingredient new.

• Manufacturing differences: For complex mixtures such as botanical extracts and fermentation products, differences in non-key process parameters—such as extraction solvent, extraction method, fermentation duration or an additional centrifugation step—would generally not determine new ingredient status.

• Salts and ions: Introducing or changing certain ions would generally not lead to new ingredient management if it does not create a new safety risk. The draft says the use should be recorded in the product formula and assessed for safety.

• Purified single compounds: A single compound isolated from an extract, or obtained through another process such as biosynthesis, would require new ingredient registration if it is not listed in the IECIC and its content reaches 90% or more on a dry basis.

• Polymers and category entries: Differences in polymerization degree or other specifications would generally not, by themselves, make a listed polymer new. Ingredients covered by a broad category entry would generally remain within that entry, although a clearly defined single compound may be considered for a separate application if supported by sufficient research.

These examples do not replace an ingredient-specific assessment. The draft directs registrants and filers to consider the source, preparation process, chemical composition and quality control information, and to conduct qualitative or quantitative research where necessary. For further background, see REACH24H's overview of criteria and examples for determining new cosmetic ingredients in China.

Intended Use Can Affect the Regulatory Pathway

The draft distinguishes between ingredients in IECIC List I and List II, and between proposed use purposes. It specifically discusses the functions of preservation, sun protection, coloring and hair dyeing separately from other use purposes.

For an ingredient in List I, adding one of those four functions would require research into the ingredient's function, safety and technical distinction between uses, followed by an application under the new ingredient registration requirements. For other added purposes, companies may conduct safety assessment and functional research themselves and, where necessary, submit the supporting information with the finished cosmetic product's registration or filing materials.

For List II ingredients, the route also depends on the ingredient's existing use purpose and the proposed new purpose. The draft calls for a new ingredient application when certain listed functions are added, while some changes between general use purposes may be supported by company-conducted safety and functional research. An existing IECIC entry should not be assumed to cover every intended use. Companies should assess the applicable scenario against the draft text.

Safety Limits and Risk Considerations

The draft states that the safe-use levels recorded for List II ingredients are not, by themselves, a basis for determining whether an ingredient is new. If a finished cosmetic uses an ingredient above the level recorded in List II, the product registrant or filer may conduct a safety assessment without seeking an adjustment to that recorded level.

A request to adjust the List II safe-use conditions, however, would follow the new ingredient registration or filing requirements and require full supporting research. The draft also says that sufficient use at the proposed conditions should be demonstrated during the three-year safety monitoring period.

The draft identifies other boundaries, including prohibited ingredients and certain derivatives for which safety risks cannot be ruled out, ingredients or functions outside the legal definition of cosmetics, and substances with specified health hazards where safety under normal, reasonable and foreseeable conditions of use cannot be ensured. It also calls for careful consideration of the cosmetic–drug boundary when an ingredient has a known medical effect.

What Companies Can Do Before the Consultation Closes

Ingredient manufacturers, registrants and filers may wish to review candidate ingredients against the draft's three main dimensions:

1. Identity: Compare the ingredient's source, composition, preparation and quality specifications with relevant IECIC entries.

2. Purpose: Confirm the ingredient's actual function in the cosmetic and identify whether the proposed use changes its regulatory pathway.

3. Safety: Check whether the proposed use level or other conditions require additional assessment, and whether any risk or cosmetic–drug boundary could affect eligibility.

Recommended Reading

• Q&As About New Cosmetic Ingredient Registration in China Based on NIFDC's Guidelines

• China IECIC II Update 2026: Four Cosmetic Ingredients Added After Safety Monitoring

Official References

• NIDC consultation notice and draft attachments: Guidelines for the Determination of New Cosmetic Ingredients (Trial) (Draft for Comments)