As the global cosmetics industry is booming, the classification rules and management methods of cosmetics vary by region, showing a diversified pattern. Different countries and regions have constructed unique regulatory frameworks based on their own market environments, regulatory systems, consumer needs and other factors.
This article combs the relevant laws and regulations in China, the EU, ASEAN, the United States, and Taiwan, hoping to help everyone understand the basic compliance logic of cosmetics in different regions and help companies go global smoothly.
China
Cosmetic Definition
Cosmetics refer to daily chemical industrial products that are applied to skin, hair, nails, lips and other human body surfaces by rubbing, spraying or other similar methods for the purpose of cleaning, protecting, beautifying and modifying.
Classification Rules & Management Methods
In China, cosmetics are divided into special cosmetics and general cosmetics according to risk levels. The state implements registration management for special cosmetics and filing management for general cosmetics.
Chinese cosmetics classification rules and management methods
The European Union
Cosmetic Definition
‘cosmetic product’means 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.
Classification Rules & Management Methods
The current EU regulation "Cosmetics Regulation (EC) No. 1223/2009" does not clearly classify cosmetics. Generally, the EU definition of cosmetics can be used to determine whether a product is a cosmetic.
All cosmetics must be notified and registered through the CPNP, and PIF documents must be kept for reference.
In addition, EU cosmetics have the concept of "borderline products". Sometimes it may be unclear whether a product is a cosmetic under the cosmetics regulation or whether it belongs to other industries. For these "borderline products", the classification of the product must be determined based on the specific situation.
ASEAN
Cosmetic Definition
A cosmetic product means any substance or preparation intended by its manufacturer to be placed in contact with the various external parts of the human body such as the skin epidermis, hair, nails, lips and external genital organs or with the teeth or the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, per fuming them, changing their appearance, correcting body odours, protecting them or keeping them in good condition.
Classification Rules & Management Methods
Referring to Annex 1 of the ASEAN Cosmetics Directive (ACD), ASEAN classifies cosmetics into 20 categories, and all its member states refer to this classification.
However, cosmetics companies must complete individual notifications in each ASEAN country before they can be put on the market for sale, and each member country formulates corresponding regulatory measures for different categories of cosmetics.
The United States
Cosmetic Definition
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.
Classification Rules & Management Methods
The U.S. FDA classifies cosmetics into 17 categories. Starting from July 1, 2024, the US FDA requires that cosmetics sold in the United States must complete FDA facility registration and product listing.
In addition, in the United States, many personal care products are both cosmetics and over-the-counter (OTC) drugs, such as sunscreen products, acne products, and anti-dandruff products.
Over-the-counter (OTC) products must meet the requirements specified in their specific category monographs (OTC drug monographs) to be considered safe and effective (GRASE), and in addition to FDA facility registration (Facility Registration) and product listing (Product Listing), they also need to apply for a National Drug Code (NDC).
Taiwan, China
Cosmetic Definition
Cosmetics refer to preparations applied to the human body, teeth or oral mucosa to moisturize the hair and skin, stimulate the sense of smell, improve body odor, modify the appearance or clean the body. However, those that are recognized as drugs under other laws are not included in this restriction.
Classification Rules & Management Methods
On July 1, 2024, Taiwan, China abolished the inspection and registration system for specific-purpose cosmetics and began to implement a product registration system, stipulating that all cosmetics, except solid handmade soaps produced by cosmetic manufacturing sites that are exempt from factory registration, are required to be registered, and no distinction will be made between special and general purposes.
In addition, on November 12, 2024, the Ministry of Health and Welfare of Taiwan, China issued an announcement to revise the "Cosmetics Scope and Category List", which will officially take effect on July 1, 2026.
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