- January 25, 2024
- Posted by: MDSS Cosmetics
- Categories: Cosmetics, USA MoCRA
Cosmetics in the EU, UK and USA: Legal background and definitions
The legal definitions of “cosmetic product” in the European Union (EU), United Kingdom (UK) and the United States of America (USA) show notable differences reflecting distinct regulatory approaches.
For the EU and UK, the legal definition of a cosmetic product are outlined in Article 2 of the Regulation (EC) No. 1223/2009 , or respectively in the Product Safety and Metrology etc. Regulations 2019 (Schedule 34). According to the Regulations, a “cosmetic product” is defined as “any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips, and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours“.
This definition covers a wide range of consumer products, including perfumes, fragrances and makeup, as well as personal care products like lotions, soaps, deodorants, and hair care products.
In the USA, the legal definition of a cosmetic product is provided by the Federal Food, Drug, and Cosmetic Act (FD&C Act). According to the FD&C Act, a “cosmetic” is defined as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance“.
Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
There may be also products meeting the definitions of both cosmetics and drugs when a product has more than intended use. For example, a shampoo can be a cosmetic only when its only intended use is to clean the hair. If also including an antidandruff function, the same products can be also a drug. Thus, an antidandruff shampoo may be considered both a cosmetic and a drug. This also applies to toothpastes with fluoride, deodorants with antiperspirants, or lotions with additional sun protection functions.
In general, the legal requirements in the EU/UK and the USA reflect different regulatory approaches. The EU/UK Regulation highlights product safety and requires compliance with specific safety requirements before a cosmetic product can be placed on the EU/UK market, including ingredient restrictions and prohibitions, product testing, etc.
On the other hand, especially before MoCRA had been published, the USA’s regulatory approach for cosmetics is guided by principles of freedom and responsibility. The FD&C Act also indicated certain requirements for product safety and labelling, however, it generally provided more flexibility to manufacturers compared with the EU regulations. MoCRA and its enforcement by the FDA will help align requirements here.
While both the EU and the USA share the common goal of ensuring the safety of cosmetic products, their legal definitions and regulatory frameworks indicate significant differences.
Manufacturer and distributors seeking to market cosmetic products in both the EU/UK and the USA must carefully navigate through the specific requirements outlined by each regulatory authority.