Cosmetic Products – definition and brief notes on how they are regulated in some of the world’s key-markets

The EU Cosmetics Regulation (which came fully into force in July 2013 repealing Directive 76/768/EEC) characterizes a cosmetic product 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”.

 “The regulation gives consumers a uniform level of protection in a single market and brings unprecedented clarity for industry” – Bertil Heerink, director-General of Cosmetics Europe. While strengthening and harmonizing the requirements for safety, ensuring a higher level of consumer protection (all member states must comply with the same requirements, leaving no room for transposition), the new legislation has adopted a centralized procedure for the notification of all cosmetics placed on the EU market, implying less paperwork and allowing a free circulation of goods.

United States’ Federal Food, Drug and Cosmetic Act (FD&C Act), defines cosmetic products by their intended use – “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 their appearance”. As certain products fall under the definitions of both cosmetics and drugs, due to their intended uses, such products have to be compliant with the requirements of both categories. These are usually products possessing two intended uses: e.g. shampoo, which is a cosmetic, given the fact that its primary use is to cleanse the hair, while, if supplemented with a medical claim as “antidandruff”, it becomes a drug. Other examples include products with SPF claims, deodorants which are also antiperspirants, toothpastes with fluoride, essential oils intended for aromatherapy. On the other hand, cosmetics which claim to reduce or eliminate cellulite, regenerate skin cells, encourage hair growth or treat a skin condition are considered drugs.

Drugs are “articles intended for use in diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”.

In the US, cosmetics do not require a pre-market approval, unlike drugs which must receive one, either through the New Drug Application process, or conform to a “monograph” for a specific category of drugs, as set by the FD&C Act.

In Japan, the law describes cosmetics as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other method, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition”. Cosmetics are classified into six categories:

  • Perfume and eau de cologne
  • Makeup products (foundation creams, lipsticks, eye makeup, and others)
  • Skin care (skin lotions, essences, skin milk, cleansing creams etc)
  • Hair care (hair dye, shampoo, hair treatment)
  • Special-purpose cosmetics (sunscreen, shaving cream)
  • Cosmetic soaps

Quasi-Drugs are defined as articles for the purpose of: preventing nausea and other types of discomfort; preventing heat rash, soreness etc; encouraging hair growth or hair removal, or exterminating and preventing mice, flies, mosquitoes, fleas etc. Products which fall under quasi-drugs: deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, cosmetics with medicinal claims such as anti-ageing, acne treatments, products with whitening effects.

While the Ministry of Health, Labour and Welfare (MHLW), under the Pharmaceutical Affairs Law regulates the two beauty categories differently, in reality, the difference between cosmetics and quasi-drugs is still vague, unclear and questionable.

In South Korea, the Ministry of Food and Drug Safety through the Korean Cosmetic Products’ Act, places cosmetic products in two major categories: general cosmetics and functional cosmetics (anti-wrinkle, skin brightening, those which promote gentle tanning or protect the skin from UV radiation).

General cosmetics can be marketed after they have been registered by the manufacturer/ importer, but are subjected to post-marketing surveillance. Functional cosmetics though, have to undergo a strict evaluation on safety and efficacy and be approved by the MFDS. They cannot be imported prior to the ministry’s approval.

In South-East Asia, in order to facilitate the free movement of cosmetics in the ASEAN region and eliminate the technical barriers, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand and Vietnam have worked together and committed to a harmonized set of principles in regards to product safety, quality and efficacy. The ASEAN Cosmetics Directive follows the EU Cosmetics Directive, having established similar criteria for product safety and identical definition for cosmetics.