FAQ Vol. 29 | China NMPA Clarifies Labeling Requirements for Fragrance Allergens

Cosmetic ingredients such as fragrances and plant extracts may introduce allergenic components into finished cosmetic products.

1. Labeling Requirements for Fragrance Allergens

According to the Provisions for the Management of Cosmetic Registration and Notification Dossiers, fragrance ingredients can be filled in the product formulation sheet in two ways during the product registration or notification process. The labeling requirements for fragrance allergens depend on which method is used.

1) Listing Only “Fragrance”

If the formulation sheet lists only “fragrance” as an ingredient, there is no need to specify individual fragrance components or their concentrations. However, if specific fragrance components are listed on the product label, or if the original packaging of an imported product indicates such components, then those components must be noted in the remarks section of the formulation sheet.

For labeling requirements, if only "fragrance" is listed in the formulation sheet of the registration or notification dossiers, "fragrance" can be marked under the "Ingredients" section of the Chinese label. If labeling of specific allergens is required under Chinese regulations or technical standards (e.g., the Technical Guidelines for Children’s Cosmetics) or under the exporting country’s requirements, the names of the allergenic components must be marked individually in the “Safety Warning Statement” section of the Chinese label.

2) Listing “Fragrance” and Its Components

If the formulation sheet includes both “fragrance” and the specific fragrance components, supporting documentation from the fragrance supplier must be submitted, indicating the types and concentrations of all fragrance components.

In this case, both "fragrance" and its individual fragrance components should be marked in the "Ingredients" section of the product label.

2. Labeling Requirements for Plant Extract Allergens

For allergenic substances introduced by other ingredients, such as plant extracts, labeling requirements should refer to the principles as those for fragrance allergens described above.

According to Article 35 of the Supervision and Administration Measures on Cosmetics Manufacture and Operation, each minimum sales unit of a cosmetic product must carry a Chinese label, and the labeling content must be consistent with the label sample submitted in the product’s registration or notification dossiers.

Furthermore, Article 32 of the Provisions for the Management of Cosmetic Registration and Notification Dossiers states that:

When separately registered or notified products are sold in the form of a set, gift box, or similar combined packaging, and the combination process does not involve direct contact with the product contents, the combined package is not required to upload additional label images, provided the following conditions are met:

• The only additional labeling content is the name of the combined packaged product;

• The combined label does not contain more information than what is already present on the labels of the individual products;

• The combined packaging label adequately reflects the labeling information of each individual product inside.

According to the Cosmetic Supervision and Administration Regulation (CSAR), cosmetics are defined as daily chemical products intended to be applied to the skin, hair, nails, lips, or other external parts of the human body.

If a product claimed as “microcrystal” or “microneedle” is determined—based on factors such as its formulation, method of application, and product form—not to be applied to the external parts of the human body, then it falls outside the scope of cosmetics as defined under the CSAR.