Q&A on Cosmetic Supervision and Administration (VII)

Question: What are the labeling requirements for allergens introduced by ingredients such as fragrances and plant extracts in the Chinese labeling of cosmetics?

Answer: Cosmetic ingredients like fragrances and plant extracts may introduce allergenic components, which can be labeled according to the following rules.

For allergens introduced by fragrances:
According to the Regulations on the Management of Cosmetic Registration and Filing Documentation, fragrance ingredients in a product formula can be filled out in two ways:

1. If only "fragrance" is listed in the product formula table, there is no need to submit the specific types and contents of fragrance components. However, if the label indicates specific fragrance components—or if the original packaging of an imported product lists specific fragrance components—this should be noted in the remarks column of the formula table.

2. If both "fragrance" and its specific components are listed in the product formula table, documentation from the fragrance manufacturer specifying all fragrance components and their contents must be submitted.

Under these regulations:

• If the product registration/filing materials list only "fragrance," the label’s "ingredients" section may simply state "fragrance." However, if Chinese or exporting country regulations (e.g., the Technical Guidelines for Children’s Cosmetics) require allergen labeling, these allergens should be listed individually in the "safety warning" section of the Chinese label.

• If the product registration/filing materials list both "fragrance" and its specific components, the label’s "ingredients" section must include both "fragrance" and the specific components.

For allergens introduced by other ingredients (e.g., plant extracts), the same rules apply.

Question: What are the labeling requirements when multiple general cosmetics, already filed separately, are sold as a gift set?

Answer:
Article 35 of the Measures for the Supervision and Administration of Cosmetic Production and Operation stipulates that the smallest sales unit of cosmetics must have a Chinese label, and its content must match the product label sample in the registration or filing materials.

According to Article 32 of the Regulations on the Management of Cosmetic Registration and Filing Documentation, if registered or filed products are sold as gift sets or combination packages without direct contact with the product contents, and the labeling does not exceed the original product labels (except for adding the name of the combined product), and the combined packaging’s label covers the label information of all included products, there is no need to re-upload label images for the combined packaging.

Question: Do products labeled as "microcrystalline" or "microneedle" fall under the definition of cosmetics?

Answer:
Under the Cosmetic Supervision and Administration Regulations, cosmetics are defined as daily-use chemical industrial products applied to human surfaces such as skin, hair, nails, and lips. If a product marketed as "microcrystalline" or "microneedle" is determined—based on its formula, usage method, or physical form—not to be applied to human surfaces, it does not fall within the regulatory definition of cosmetics under the Cosmetic Supervision and Administration Regulations.