Product Formula
The product formula constitutes one of the essential documents required for the registration and notification of cosmetic products. The product formula shall represent the batch manufacturing formula and must satisfy the following requirements:
(I) Requirements for the Formula Sheet
The product formula sheet shall include the following information: raw material serial number, raw material name, percentage content, purpose of use, and other relevant details.
Ingredient Name: The product formula shall list the names of all raw materials used. Raw material names shall be provided as the standard Chinese name, the International Nomenclature of Cosmetic Ingredients (INCI name), or the English name.
Percentage Content: The product formula shall state the content of each raw material. Content shall be expressed as a percentage by mass, and all raw materials shall be arranged in descending order of content. For raw materials composed of two or more components (excluding fragrance), each constituent component and its respective content shall be specified.
Purpose of Use: The primary function of each raw material in the product shall be indicated based on its actual purpose. For products claiming skin whitening or spot correction, sunscreen, hair dyeing, hair perming, or anti-hair loss effects, the relevant functional ingredients shall be identified in the "purpose of use" column. Where a functional raw material is not a single component, the specific functional component(s) shall be clearly designated.
Remarks Column: The following circumstances shall be noted in the remarks column:
If denatured alcohol is used, the name and quantity of the denaturant shall be specified.
If a category raw material is employed, the specific raw material name shall be provided.
For raw materials derived directly from plants, the specific plant part used shall be indicated.
(II) The registrant, notifier, or domestic responsible person shall furnish the manufacturer information for each raw material incorporated in the product and upload the raw material safety information documentation issued by the respective raw material manufacturer.
(III) Where a new cosmetic ingredient that remains under safety monitoring is utilized, the registrant, notifier, or domestic responsible person shall secure confirmation from the registrant or notifier of the new ingredient prior to submitting the registration application or proceeding with notification.
(IV) The declaration of fragrance in the product formula may be made in one of the following two manners, with corresponding documentation submitted accordingly:
Where only "fragrance" is entered as a raw material in the product formula sheet, submission of the specific fragrance component types and their contents is not required. However, if the product label or the original packaging label of an imported product identifies specific fragrance components, an explanation shall be provided in the remarks column.
Where both "fragrance" and the individual fragrance components contained therein are listed in the product formula sheet, documentation issued by the fragrance raw material manufacturer detailing the types and contents of all fragrance components shall be submitted.
(V) When patch or film-type carrier materials are used, the material composition of the primary carrier shall be specified in the remarks column, accompanied by documentation concerning its source, preparation process, quality control specifications, and other relevant information.
(VI) Where extracts derived from animal organ tissues or blood products are employed as raw materials, documentation regarding their source, composition, and preparation process shall be provided, together with official documents confirming that their use is permitted in the country of origin of the raw material.
For Imported Products with Formulations Exclusively Designed for the Chinese Market (excluding products manufactured overseas under domestic entrustment), the following documentation shall be submitted:
Explanatory materials describing how the formulation design addresses the skin types, preferences, and needs of Chinese consumers.
Data obtained from consumer testing studies or human efficacy trials conducted within China using Chinese participants.
Product Packaging
When notifying general cosmetics or prior to the marketing of special cosmetics, the registrant, notifier, or domestic responsible person shall upload images of the labeling on the product's sales packaging. Such images shall meet the following criteria:
The images shall include flat views of all visible faces of the packaging as well as a three-dimensional representation illustrating the product's appearance. All images shall be complete and clearly legible.
Where electronic labeling is adopted, the content of the electronic label shall be submitted, and the graphic code displayed on the sales packaging shall be a pre-generated code issued by the registration and notification information service platform.
The content of the labeling and any accompanying instructions depicted in the uploaded images shall not exceed the content set forth in the draft product label.
If multiple versions of the sales packaging exist, labeling images for each version shall be submitted.
