China Consults on Guidelines for Determination of New Cosmetic Ingredients

Although China has clearly specified the definition of new cosmetic ingredients and released the reference inventory to figure out the status of ingredients -Inventory of Existing Cosmetic Ingredients in China (IECIC), during the actual compliance work, various companies encounter difficulties in correctly determining if an ingredient is a new cosmetic ingredient.

To solve the difficulties in practice, on Jan. 19, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft of Technical Guidelines for Determination of New Cosmetic Ingredients. Currently the draft is under public consultation until Feb. 10, 2023. Any comments can be emailed to [email protected].

The draft regulates the principles for the determination, classification and naming of new cosmetic ingredients. All notifiers and registrants of new cosmetic ingredients shall conduct research and safety assessment in accordance with the requirements prescribed.

Determination of New Cosmetic Ingredients

According to the draft, new cosmetic ingredients’ notifiers and registrants shall determine if an ingredient is a new cosmetic ingredient by comprehensively researching the characteristics, composition, source, expected use methods, application sites, use purposes, and actual functions of the ingredient.

The specific principles for the determination are as follows:

Status

Conditions

New cosmetic ingredients

Any of the following conditions applies:

1. Natural or artificial ingredient used in cosmetics for the first time in China, and its intended use method, application site, and use purpose falling into the scope of cosmetics as per its definition

2. Existing cosmetic ingredient with adjusted use purpose or safe amount

3. Ingredient that has been registered or notified, but not included in IECIC

Not new cosmetic ingredients

Any of the following conditions applies:

1. Ingredient with the intended use method (i.e., oral/inhaled/injected), application site (i.e., mucosa) or use purpose (i.e., scar repair) not falling into the scope of the defined cosmetics

2. Ingredient included in IECIC

3. The prohibited ingredients specified in the Safety and Technical Standards for Cosmetics 2015

4. The ingredient whose actual function or objective effect is beyond the definition of cosmetics, i.e., EGF, FGF, IGF-2, VEGF, PDGF, CTGF, and TGF-β1

Classification of New Cosmetic Ingredients

Notifiers and registrants are required to classify new cosmetic ingredients scientifically and rationally from four dimensions: ingredient composition, source attribute, preparation process, and actual function.

Dimension	Classification
Ingredient composition (chemical structure and purity)	Single component whose content ≥ 80%) Non-single component, i.e., polymers, plant extracts, fermentation products, and hydrolysates
Source attribute	Plant Animal Mineral Synthetic
Preparation technology	Chemical synthesis technology Extraction and separation technology Biotechnology Hydrolysis technology Other technologies
Actual function	The actual function shall be decided after sufficient research on the ingredient’s efficacy and function combined with literature and previous research. For an ingredient with multiple functions, as long as it involves one of the following functions, a safety assessment shall be conducted in accordance with the requirements for the corresponding function: Preservative Sunscreen Colorant Hair dye Freckle-removing/whitening Anti-hair loss Anti-acne Anti-wrinkle (except for physical anti-wrinkle) Anti-dandruff Deodorant

If you need more detailed information on the classifications, please feel free to contact us at [email protected] for translation service.

Naming of New Cosmetic Ingredients

For the naming of new cosmetic ingredients, the draft regulates that the name of the new cosmetic ingredient shall include standard Chinese name, English name/INCI name, and its ID, for example:

Standard Chinese name	甘油
English name/INCI name	Glycerin
ID	1077

Notifiers and registrants can find the standard Chinese name in the Catalogue of Standard Chinese Name of International Cosmetic Ingredients. For new cosmetic ingredients already listed in the International Cosmetic Ingredient Dictionary and Handbook, it is mandatory to provide their INCI names and ID.

New cosmetic ingredients directly derived from plants should be named according to the format of “Chinese name + Latin scientific name + part of use + form of use”, for example, 马鞭草（VERBENA OFFICINALIS）叶/茎水, 岩兰草（VETIVERIA ZIZANOIDES）根粉。

Full name	马鞭草（VERBENA OFFICINALIS）叶/茎水
Chinese name	马鞭草
Latin scientific name	VERBENA OFFICINALIS
part of use	叶/茎 (leaf/ stem)
form of use	水 (toner)

If a new cosmetic ingredient has an alias, common name, trade name, abbreviation, etc. that are more commonly or widely used in the cosmetics industry (i.e., SymWhite 377), the name and relevant explanations should be provided together. For new cosmetic ingredients with isomers, their configuration (i.e., α-type or β-type) should be specified in the name. Taking arbutin for example: α-熊果苷；β-熊果苷.