In both the US and the EU, there are regulations in place regarding the use of certain ingredients in cosmetics. These regulations aim to ensure the safety of consumers by restricting or prohibiting the use of potentially harmful ingredients.
For example, in the US, the Food and Drug Administration (FDA) has a list of prohibited and restricted ingredients for cosmetics. Some of the prohibited ingredients include bithionol, chlorofluorocarbon propellants, and mercury compounds, while some of the restricted ingredients include lead acetate and formaldehyde.
Similarly, in the EU, cosmetic ingredients are regulated under the Cosmetics Regulation. The regulation includes a list of prohibited substances, such as cadmium and asbestos, as well as restricted substances, such as fragrances and preservatives.
Cosmetic companies are required to comply with these regulations by collecting information on the ingredients used in their products, including their safety profiles and potential risks. They must also ensure that their products do not contain any prohibited ingredients and that the levels of restricted ingredients are within the permitted limits.
In addition, cosmetic companies often conduct their own safety assessments of their products’ ingredients and monitor any new research or information that becomes available regarding their safety. This ensures that their products are safe for consumers to use and that any potential risks are identified and addressed promptly.
The US FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act gives the FDA authority to oversee the safety of cosmetics, including the ingredients used in them, and to take action against any products that are found to be adulterated or misbranded.
The FDA has a list of prohibited and restricted cosmetic ingredients that are not allowed to be used in products sold in the US. Prohibited ingredients are those that have been found to be harmful, while restricted ingredients are those that are allowed to be used only under certain conditions, such as in limited concentrations or with warnings on the label.
Some of the prohibited ingredients include bithionol, which has been linked to skin irritation and is also a suspected endocrine disruptor; chlorofluorocarbon propellants, which can deplete the Earth’s ozone layer; mercury compounds, which can be toxic to the nervous system; vinyl chloride, which is a known human carcinogen; and zirconium-containing complexes, which have been linked to skin irritation and allergies.
Some of the restricted ingredients include lead acetate, which can be toxic to the nervous system and is only allowed in hair dyes with specific labeling requirements; formaldehyde, which is a known human carcinogen and can be found in some hair straighteners and nail hardeners but is restricted to a maximum concentration of 0.2%; methylene glycol, which can release formaldehyde gas and is restricted to a maximum concentration of 0.2% in hair smoothing products; and several types of parabens, which are preservatives that have been linked to hormone disruption and are restricted to certain concentrations.
Cosmetic companies are responsible for ensuring that their products comply with these regulations and are safe for consumer use. They must conduct safety tests on their products and monitor any new research or information that becomes available regarding the safety of their ingredients. The FDA also has the authority to inspect cosmetic manufacturing facilities and to take action against companies that violate these regulations.
here is the list of prohibited and restricted cosmetic ingredients according to the US FDA:
Prohibited Ingredients:
- Bithionol
- Chlorofluorocarbon Propellants
- Chloroform
- Halogenated Salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide)
- Hexachlorophene
- Mercury Compounds (with some exceptions)
- Methylene Chloride
- Vinyl Chloride
- Zirconium-containing Complexes
Restricted Ingredients:
- Aluminum Acetate
- Benzyl Alcohol
- Bithionol
- Chlorhexidine
- Chloroacetamide
- Coal Tar
- Formaldehyde (and Formaldehyde-releasing Preservatives)
- Hydroquinone (with some exceptions)
- Lead Acetate
- Methylene Glycol (with some exceptions)
- Phenol (greater than 1.5%)
- Phenylenediamine (greater than 6%)
- Resorcinol (greater than 2%)
- Thimerosal (with some exceptions)
Please note that this list is subject to change, and the FDA may update it as new information becomes available. Also, some of these ingredients may be allowed under certain conditions, such as specific labeling requirements or maximum concentration limits.
Here is a list of prohibited and restricted cosmetic ingredients in the EU:
Prohibited Ingredients:
- Chloroform
- Halogenated Salicylanilides (di-, tri-, metabromsalan, tetrachlorosalicylanilide)
- Hexachlorophene
- Mercury and its compounds (with some exceptions)
- Phenylenediamines (when used as a hair dye)
- Vinyl chloride
- Zirconium-containing complexes
Restricted Ingredients:
- Aluminum (only certain forms are restricted)
- Benzyl alcohol (only for use in oral hygiene products, lip products, and hair lotions at a maximum concentration of 1%)
- BHA (butylated hydroxyanisole) and BHT (butylated hydroxytoluene) (only for use in certain types of products and at certain maximum concentrations)
- Boric acid and borates (only for use in certain types of products and at certain maximum concentrations)
- Coal tar (only for use in certain types of products and at certain maximum concentrations)
- Formaldehyde (only for use in certain types of products and at certain maximum concentrations)
- Hydrogen peroxide (only for use in certain types of products and at certain maximum concentrations)
- Hydroquinone (only for use in certain types of products and at certain maximum concentrations)
- Methylisothiazolinone and Methylchloroisothiazolinone (only for use in certain types of products and at certain maximum concentrations)
- Nanomaterials (only certain types are allowed, and they must be labeled as such)
- Parabens (only certain types are restricted)
- Phenylmercuric salts (only for use in eye and eye contour products at a maximum concentration of 0.0075%)
- Retinol (only for use in certain types of products and at certain maximum concentrations)
- Salicylic acid and its salts (only for use in certain types of products and at certain maximum concentrations)
- Triclosan (only for use in certain types of products and at certain maximum concentrations)
This list is subject to change, and the EU regularly reviews and updates its list of prohibited and restricted cosmetic ingredients to ensure the safety of consumers. It’s always a good idea to check with the relevant regulatory authorities or a qualified regulatory expert to ensure that your cosmetic product complies with all applicable regulations.
As of October 2021, California has passed a law (known as the Toxic-Free Cosmetics Act) that will prohibit the sale of certain cosmetic products containing 24 specific ingredients beginning in 2025. These ingredients include:
- Dibutyl phthalate
- Diethylhexyl phthalate
- Formaldehyde
- Paraformaldehyde
- Methylene glycol
- Quaternium-15
- Mercury and mercury compounds
- Isobutylparaben
- Isopropylparaben
- m-Phenylenediamine and its salts
- o-Phenylenediamine and its salts
- Per- and polyfluoroalkyl substances (PFAS)
- Toluene
- Triclosan
- Carbon black
- Lead and its compounds
- Asbestos
- Ethylene oxide
- 1,4-Dioxane
- Cocamide diethanolamine
- Butylated hydroxyanisole (BHA)
- Butylated hydroxytoluene (BHT)
- Phthalates other than dibutyl phthalate (DBP) and diethylhexyl phthalate (DEHP)
- Formaldehyde-releasing preservatives (excluding methylene glycol)
The law is intended to protect public health and the environment by reducing exposure to harmful chemicals in personal care products. It’s worth noting that California has previously been a leader in enacting stricter regulations on cosmetic ingredients, and other states and countries may follow their lead in the future.