What are the regulatory differences between the European Union and other countries around the world?

The definition of a cosmetic varies slightly from country to country, which lays the initial groundwork for the differences observed between legislations.

In theEuropean Union, cosmetics are defined as "any substance or mixture intended to be brought into contact with the external parts of the human body, such as the skin, hair, nails, lips or external genital organs, or with the teeth and oral mucous membranes, with the exclusive or primary aim of cleaning, perfuming, changing the physical appearance, protecting, keeping in good condition or correcting body odours." This definition is stated in Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products.

In the United States, the Food and Drug Administration (FDA) defines a cosmetic as "any substance or preparation intended to be applied to the human body for cleansing, perfuming, changing the appearance, protecting, or maintaining in good condition." Furthermore, it is interesting to note that in the United States, a sunscreen is not considered a cosmetic product but an "over the counter (OTC) drug", that is, a medication that the consumer can purchase without a prescription.

In China and in Japan, cosmetics are defined as "any substance or preparation intended to be applied to the human body for the purposes of cleaning, perfuming, altering appearance, protection, or maintaining in good condition." Furthermore, cosmetic products are divided into two categories: "special" cosmetics, including hair dyes, perms, whitening products, depigmenting products, anti-hair loss products, sun products, and any product with a new efficacy, and "general" cosmetics, referring to all other products. It is also worth noting that toothpastes are not considered cosmetic products in China, unlike in Europe.

In the European Union, legislation concerning cosmetics is defined by Regulation (EC) No 1223/2009 of the European Parliament and Council. Since 2004, animal testing has been prohibited in the European Union for cosmetic products. Furthermore, since 2009, it has also been forbidden to market within the European Union cosmetic products containing ingredients that have been tested on animals.

Unlike the European Union, the United States has not implemented a total ban on animal testing for cosmetics. Although the Food and Drugs Administration (FDA) does not explicitly require animal testing, it does not prohibit their use either. However, the situation is changing as some states have recently begun to ban the sale of cosmetics tested on animals within their territory. This is the case for California, Nevada, Illinois, Hawaii, Maryland, Maine, New Jersey, Virginia, and Louisiana.

In China and Japan, animal testing for cosmetics remains widely practiced. For a long time, it was necessary for imported products, but this requirement was lifted in 2021 for China. However, this only applies to cosmetics classified as "general", such as shampoos, shower gels, or makeup. "Special" cosmetics, meaning hair dyes, sunscreens, anti-hair loss products, or depigmenting treatments, must still be tested on animals to be marketed in China.

For a cosmetic product to be introduced to the European market, manufacturers or importers are required to compile and maintain a Product Information File (PIF). This file contains detailed information about the product, its composition, manufacturing specifications, safety evaluation results, evidence of compliance with good manufacturing practices, as well as other safety-related information. These details must be made available to the relevant authorities upon request.

In the United States, although the FDA does not specifically require the creation of a PIF, manufacturers are obliged to maintain records on the safety of their cosmetic products. These records may include data on ingredient safety, stability testing, safety assessments, and evidence of compliance with good manufacturing practices. Although PIFs are not required, manufacturers must be able to provide this information to the FDA in the event of an inspection or request.

In China, manufacturers and license holders of cosmetic products are also required to compile registration and notification files for each product with the National Medical Products Administration (NMPA), the Chinese agency responsible for the regulation and supervision of health products and cosmetics. The files must contain information about the safety, composition, manufacturing, labelling and testing of the product. These files must be submitted to the Chinese regulatory authorities for approval before the product can be placed on the market.

In Japan, manufacturers or importers of cosmetic products are required to maintain records on the safety and quality of their products, and to provide Japanese authorities with a pre-approval dossier before a new cosmetic product is launched on the market. These dossiers contain information on the composition, manufacturing, safety tests and evidence of compliance with Japanese regulations.

Cosmetic products are subject to strict rules regarding labelling in the European Union. Indeed, labels must imperatively specify the volume of the product, usage precautions, the shelf life after opening (PAO), as well as the batch number and the contact details of the manufacturer responsible for placing it on the market. Furthermore, the list of ingredients, or list INCI, must be specified by arranging the ingredients in descending order of concentration (with the exception of ingredients whose concentration is less than 1% which are listed last in the order desired by the supplier). Moreover, allergens must be mentioned if their concentration in the product exceeds 0.01% in rinse-off products and 0.001% in leave-on products.

In the United States, the FDA's requirements for cosmetic product labelling are largely the same as in Europe. An example illustrating the few existing differences: cosmetic products do not need to indicate a PAO (Period After Opening) in the United States. It should be noted that, since 2023, allergens must be specified on the labels, which was not previously the case. The list of concerned allergens and the thresholds are still under study and are expected to be published in the course of 2024.

In China, the rules for labelling cosmetic products are similar to those of the European Union. Indeed, the same information found on labels for products marketed in the European market is also present on Chinese labels. A slight difference lies in the list of ingredients. Indeed, it is mandatory to indicate the standard Chinese names of ingredients whose content is greater than 0.1% in descending order. For ingredients present in a percentage less than 0.1%, their standard Chinese names must be labelled separately under the heading "other trace ingredients", and it is not necessary to list these ingredients in descending order. Finally, indications such as "for stretch marks", "for pregnancy mask", "for scars" are prohibited on products in China, as are terms with a medical connotation like "antibacterial" or "allergy".

• WILKED P. Legislation and safety regulations for cosmetics in the United States, the European Union and Japan. Poucher’s Perfumes, Cosmetics and Soaps (2000).

• Regulation (EC) No 1223/2009 of the European Parliament and the Council.

• Cosmetic Regulation in China, Cosmetic Supervision and Administration Regulation (CSAR), 2020.

• Cosmetic Regulation in the United States, Modernization of Cosmetic Regulation Act (MoCRA), 2022.