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According to the Cosmetic Classification Rules and Catalogs, cosmetics can be classified as cream, lotion, liquid, powder, spray, aerosol, etc., based on their forms.
Aerosols refer to products with contents not exceeding 1L sealed in a container equipped with a valve. When applied, the content is released in a predetermined form through spraying under the pressure of the propellant. The spray can be solid, liquid, or gaseous with shapes of mist, foam, powder, or micelle. An aerosol that meets the definition of cosmetics is considered an aerosol cosmetic.
There are two types of aerosols:
General aerosol: It is a traditional aerosol that is produced by filling the mixture of the concentrate (the content) and the propellant into the aerosol can.
Bag-on-value aerosol: It is an increasingly popular bag-on-value aerosol whose concentrate (the content) and propellant are filled separately. The concentrate is contained within a bag in the can while compressed gas is filled around the bag.
According to the Provisions for Management of Cosmetic Registration and Notification Dossiers, the formula of aerosol cosmetics should be submitted following the guidelines below:
For general aerosol cosmetics in which the propellant directly contacts the concentrate:
i. The propellant ingredients and their concentration should be filled separately in the “the use of propellants in direct contact with contents” section. The total percentage of propellant should be 100%.
ii. The ratio of propellant to concentrate should be specified.
For bag-on-value aerosol cosmetics, the propellant information is not reqiured to be listed.
Cosmetic formula refers to ingredients intentionally added to the product during the production process and serve a certain purpose in final products, including preservatives, sunscreens, hair dyes, colorants, moisturizers, pH adjusters, viscosity adjusters, etc.
For general aerosol cosmetics, the propellant is in direct contact with the contents and may contact the human body surface. It is purposefully included during production and functions to propel and project the final product. Propellant ingredients are therefore required to be listed on product labels. Specifically, they can be listed either as part of regular ingredients or separately identified as “propellant ingredients”.
For bag-on-value aerosol cosmetics, the propellant ingredients are not required to be listed on the label.
Propellants in aerosol products are typically highly volatile, only leaving a little residue on the human body surface after application. Therefore, safety assessments for aerosol cosmetics shall be conducted on propellants and other ingredients separately. According to the Guidelines for Submission of Cosmetics Safety Assessment Dossiers, these assessments should adhere to following guidelines:
Propellants shall be assessed separately or assessed according to their use concentrations in the formula.
The non-propellant ingredients should be calculated as 100% as a new whole after deducting the propellant, and their concentration should be recalculated accordingly. Subsequently, the ingredient exposure to the human body should be assessed based on the adjusted concentration.
Propellants that may pose a risk of inhalation toxicity shall also undergo a safety assessment of their inhalation toxicity.
When filling the “product execution standards” for aerosol cosmetic products, it’s flexible to choose whether to include the propellant when submitting the relevant physicochemical indicators. Regardless of the chosen method, it’s necessary to specify whether propellants are contained following the statement of the control range.
For example, for a hair removal mousse product with a propellant-to-concentrate ratio of 1:10. The concentration of the hair removal agent, thioglycolic acid, is 5.0% (excluding propellants). The control range of physicochemical indicators can be expressed in two manners:
4.0 - 6.0% (excluding propellants)
3.6 - 5.5% (including propellants)
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