FDA registration of cosmetic product ingredients
Data di pubblicazione:
10 min read | Lucio Miranda
The use of certain ingredients is prohibited in the United States. The admissibility of these must be analyzed before the cosmetic can be imported into America
It is essential to ensure that all the ingredients contained in the cosmetic products to be exported to America are admissible and compliant with FDA regulations before importing them into the United States
There is no need to request advance FDA approval for the ingredients contained in the product, except for some colorants
However, there are some ingredients whose use in cosmetic products is prohibited or whose use is limited to the cases and quantities specified by the law
The presence of any of the following substances in the ingredients of a cosmetic will result in its rejection by the FDA and in a sales ban in America.
If even only one of the following substances is found to be contained in a cosmetic product to be imported and subsequently sold in the United States, the goods will be blocked at customs and a ban will be issued on their sale in the United States:
Chlorofluorocarbon propellants (CFCs)
Prohibited ingredients in cosmetic products for inhalation:
Compounds containing zirconium
Prohibited bovine materials
Ingredients allowed in specific cases
The following ingredients may only be used in cosmetics in the cases and amounts specified by the FDA regulations:
This can only be used if no other preservative has been proven to be just as effective. Hexachlorophene may not be used as a preservative in cosmetic products usually applied to, or destined for use on mucus membranes, such as the lips. Under no circumstances may the concentration of hexachlorophene exceed 0.1%.
Compounds containing mercury
These can only be used as a preservative in cosmetic products or as a skin lightening agent if no alternative preservatives are available. The use of mercury compounds is however limited to eye cosmetics with a maximum concentration of mercury, measured as a metal, of 0.0065%.
Sunscreens in cosmetics In contrast to the provisions issued by the European Union, where sunscreens are considered cosmetics, sunscreens are classified as over-the-counter (OTC) medicines in the United States. Importers of cosmetic products containing sunscreens must therefore follow the FDA guidelines on OTC medicines.
In some cases, the use of sunscreens is permitted for non-therapeutic and non-physiological purposes, for example to color the product or to protect its color. In this case, however, the label of the cosmetic must define its specific purpose, for example, the words "contains a sunscreen to protect product color" must be indicated on the label”.