The first step in cosmetic product registration in any country across the world is product classification. Before you get started with the registration process, it is important to check whether the product, you wish to register, is indeed a cosmetic product in the country, where you want to register and sell your product.
In order to do so, you have to know the definition of a cosmetic product. Cosmetic regulations, including the definition of a cosmetic product, vary from country to country.
Only by knowing the definition, you can make the appropriate classification of your product and make sure that it does not fall under a different regulation.
Although the regulations differ, it is always important to take into consideration the claims used to market the product. Any use of a therapeutic claim will make your product fall outside of the cosmetic regulation.
EU definition of a cosmetic product
The EU Cosmetics Regulation 1223/2009 defines 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 of exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.’
This definition includes a huge variety of products, from creams, soaps, perfumes, deodorants and antiperspirants, to hair care products, nail products, makeup, toothpaste, sunscreens, and many more.
Sometimes a product may seem a cosmetic, but it does not check off all the criteria set out in the definition. Cosmetic products can sometimes be borderline with pharmaceuticals, biocides, medical devices and even toys. Many times, the assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, considering all characteristics of the product.
How does Canada define a cosmetic?
A cosmetic in Canada is defined as ‘any substance used to clean, improve or change the complexion, skin, hair, nails or teeth.’ According to this definition, cosmetics include beauty preparations (makeup, perfume, skin cream, nail polish), grooming aids (soap, shampoo, deodorant, shaving cream) as well as cosmetics for professional use only, bulk institutional products and handmade cosmetics sold at craft sales or home-based businesses.
As we pointed out before, many products may look like cosmetics, but when looking closely, they are not entirely in line with the definition of a cosmetic.
Below are some examples of products, which all fall outside of the scope of cosmetic definition in Canada and are therefore not regulated by the set of Cosmetic Regulations:
- Products with therapeutic claims (e.g. to prevent or treat diseases) are considered drugs
- Products that contain natural active ingredients that claim to have a therapeutic effect are considered natural health products
- Repellent lotions and sprays for insect are pesticides
- Products, which have a therapeutic benefit for animals, are veterinary drugs.
In cases where the classification of the product is not clear, Health Canada, the competent authority for cosmetics in Canada, makes a case by case classification, based on different factors, such as representation, the composition of the product and product’s level of action.
Cosmetic product definition in the USA
Cosmetics in the USA are defined as ‘articles 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.’
This definition includes a variety of products – skin moisturisers, perfumes, lipsticks, nail polishes, makeup, cleansing shampoos, permanent waves, hair colours and deodorants.
It is important to add that soap is not a cosmetic product and has its own definition and regulations.
In the USA, it is also possible for a product to be both a cosmetic and a drug. That may happen if a product has two intended uses, for example, antidandruff shampoo, which is intended to cleanse the hair and also to treat dandruff. Such a product must, therefore, comply with both cosmetic and drug requirements.
What is a cosmetic product in China?
China defines cosmetic products as ‘products intended to be applied on the surface of human body (skin, hair, nails, lips etc), by spreading, spraying or other similar ways for the purpose of cleansing, protecting, beautifying or grooming the skin or maintain a good condition of skin.’
Under current regulation, the cosmetic product definition doesn’t include products that are applied to teeth or oral mucosa, which means toothpaste and mouthwashes are not cosmetics.
However, looking at the draft version of the new regulation in China, the cosmetic definition will soon include products applied to teeth and oral mucosa, as is the case in many other countries.
Once you establish that your product is in line with the Chinese definition of a cosmetic product, you must further classify the product as either a non-special use cosmetic product, which includes skincare, haircare, nail care, makeup and perfumes, or special use cosmetic product, which includes hair growth products, hair dyes, hair perming products, depilating products, breast beauty products, slimming products, deodorants, skin whitening products and sunscreens.
Special use cosmetics will soon be simplified to include only five categories – hair dyes, hair perming products, skin whitening products, sunscreens and products with new functions. The remaining categories will be reclassified either as non-special use cosmetics or as drugs.
