The classification of products is very important in navigating the regulatory landscape. Cosmetic products are often borderline with other classifications of products on the market. Furthermore, cosmetics are not an exclusive class of products – meaning they can be both cosmetics and another type of product. In this article we will go into the varying product types which border cosmetics and discuss their classification.
Classification of Cosmetic Products Series
To learn more about the differences in classification across regional regulations, explore our classification of cosmetic products series:
Classification of Cosmetic Products
Regulation
All cosmetic products are regulated under the Food and Drugs Act (R.S.C., 1985, c. F-27) which contains the Cosmetic Regulations (C.R.C., c. 869).
Definition
The Food and Drugs Act defines cosmetics as:
“any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”
Examples of Cosmetic Classification
Antiperspirant
Aluminum-based antiperspirant preparations are regulated as cosmetics provided that the requirements (e.g. claims, directions for use, presentation) are of a cosmetic nature and that the product is represented as intended for the reduction of normal underarm perspiration. This is based on the mechanical mode of action (composition) and to a lesser degree its representation (e.g. to minimize body odour). Antiperspirants indicated for hyperhidrosis are regulated as drug products, as hyperhidrosis is a medical condition.
Soap
Soaps and other body/face cleansing agents fit the definition of a cosmetic according to the Food and Drugs Act. They fulfill the cleansing function of the skin as part of the definition. There is no distinction between synthetic or traditional soaps.
Makeup Products
Makeup (eyeliners, foundations, lipsticks etc.) fall under the classification of cosmetics as they temporarily improve/alter the complexion. Some pigments are found on Health Canada’s Cosmetic Ingredient Hotlist, so it should be checked in case a product contains any of these prohibited or restricted ingredients.
Classification of General Products
Regulation
All general products are regulated under the Consumer Product Safety Act (S.C. 2010, c. 21). This act over-arches regulations which relate to general products such as kettles, lighters and mattresses.
Definition
The Consumer Product Safety Act defines a consumer product as:
“a product, including its components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, including for domestic, recreational and sports purposes, and includes its packaging.”
Examples of General Product Classification
Christmas Advent Calendar (with Cosmetics)
Advent calendars fall under the classification of general products, however, if they also contain cosmetics, then the product as a whole is regulated by the Consumer Product Safety Act and the Cosmetic Regulations. This is an example of a product being dual-regulated by the Consumer Product Safety Act and the Food and Drug Act.
Brushes (Tooth, Hair, Makeup)
Products which facilitate cosmetics like toothbrushes for toothpastes, hair brushes for leave-in conditioner and makeup brushes for makeup application are all considered as general products. They are not chemical products and although they are in contact with the human body, they do not persist on the human body (unlike chemical substances – including wash off products). Chemical substances have retention factors (a measure of how much of the chemical is absorbed into/persistent on the surface of the human body), whereas general products should not have retention factors.
Cotton Pads & Wipes
Cotton pads/buds, similarly to brushes, are not chemical substances. Cotton pads can be used as a device to apply these chemicals (cosmetics) onto the human body, but the integrity of these products should not persist on the human body. Similarly, makeup or baby wipes are a device used to deliver the cosmetic product, but themselves are not cosmetics. A makeup wipe may be soaked in a cosmetic formulation, but the wipe itself is not a cosmetic. It’s the chemical component of the product which interacts and persist on the human body that is considered a cosmetic.
Classification of Non-Prescription/Prescription Drugs
Regulation
All drug products are regulated under the Food and Drugs Act (R.S.C., 1985, c. F-27) which contains the Food and Drug Regulations (C.R.C., c. 870).
Definition
The Food and Drugs Act defines drugs as:
“any substance or mixture of substances manufactured, sold or represented for use in
- (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,
- (b) restoring, correcting or modifying organic functions in human beings or animals, or
- (c) disinfection in premises in which food is manufactured, prepared or kept;”
Examples of Drug Classification
Sunscreen
UV radiation, more specifically UVB radiation, is linked to skin cancer. Skin cancer is caused by the unregulated division (mitosis) of skin cells – different skin cell division causes different forms of skin cancer. This can be prevented through the use of UV filters, also known as sunscreens. One of the functions of a medicinal product is to prevent diseases and disorders, whereas this is not the case for cosmetics.
Anti-caries Toothpaste
Caries (also known as early cavities), are caused by poor dental hygiene including bacteria build up, consumption of acidic substances and erosion of the enamel. Most toothpastes contain fluoride, which binds to calcium and phosphate in the oral cavity during enamel remineralization to form hydroxyfluorapatite which demineralizes at a pH of 4.5, compared to 5.5 for hydroxyapatite. This mechanism increases the resilience of the enamel to acidic substances (the main cause of caries) which is a preventative measure.
Anti-dandruff Shampoo
Dandruff is a condition caused by the excessive buildup of the fungus Malassezia. Anti-dandruff ingredients remove, kill or render inactive these fungi, which consequently prevents the buildup of dandruff on the scalp. This mechanism is technically classified as a biocidal action, but because this takes place on the scalp, anti-dandruff products are not considered biocides, but medicines.
Classification of Biocides
Regulation
All biocidal products are regulated under the Food and Drugs Act (R.S.C., 1985, c. F-27) which contains the Biocides Regulations SOR/2024-110.
Definition
The Biocides Regulations defines a biocide as:
“a drug that is manufactured, sold or represented for use in destroying or inactivating micro-organisms, or in reducing or controlling their number, on a non-living and non-liquid surface, but it does not include…” (go to link for further quote)
Examples of Biocides Classification
Antibacterial Surface Wipes
The definition of biocidal products only applies to products applied on non-living surfaces. This means that a product cannot be both a cosmetic and a biocidal product, as cosmetics are applied onto the human body, but biocides are only applied on hard surfaces. Antibacterial surface wipes are classified as biocides as they destroy or inactivate microorganisms.
Classification of Natural Health Products
Regulation
All natural health products are regulated under the Food and Drugs Act (R.S.C., 1985, c. F-27) which contains the Natural Health Products Regulations (SOR/2003-196).
Natural health products are a subcategory of medicinal products which have a natural origin.
Definition
The Natural Health Products Regulations defines a natural health product (NHP):
“a substance set out in Schedule 1 or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in
- (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
- (b) restoring or correcting organic functions in humans; or
- (c) modifying organic functions in humans.
However, a natural health product does not include a substance set out in Schedule 2, any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2”
Examples of Natural Health Product Classification
Aromatherapy Cosmetics
Aromatherapy products are those which claim to have a psychological effect, for example relaxing, calming or energising. There is no set category for aromatherapy products, although they need to contain a chemical element (fragrance). Cosmetics may have additional aromatherapy claims, however, the primary function must still be that of a cosmetic (“…for use in cleansing, improving or altering the complexion…”). So a skin oil designed to moisturise the skin but also has additional aromatherapy benefits such as claiming the senses would be considered both a cosmetic and natural health product. However, even though the product has a cosmetic function and may be considered a cosmetic by the consumer, natural health products are an exclusive class – because they fall under the category of a medicine. This means that skin oils with aromatherapy claims will be regulated as natural health products and not cosmetics, although brands may choose a dual-regulatory approach especially in the product’s labelling.
Natural Sunscreen
Sunscreens are regulated as medicines as a whole, however, if the actives used to block the UV radiation, they can be considered natural health products.
View further information here.
Medicinal ingredient name | UV protection | Source material | Quantity |
Titanium dioxide (TiO2) |
| Titanium dioxide CAS No. 13463-67-7 | ≤ 25% |
Zinc oxide (ZnO) |
| Zinc oxide CAS No. 1314-13-2 | ≤ 25% |
Para-aminobenzoic acid |
| Para-aminobenzoic acid CAS No. 150-13-0 | ≤ 15% |
Natural Anti-caries Toothpaste
Anti-caries toothpastes fall under the category of a medicinal product for reasons outline above, however, if the mechanism of action (prevention of caries) is done by natural ingredients (outlined below), they are considered natural health products.
View further information here.
Natural Health Product Type | Medicinal Ingredient(s) | Quantity of Medicinal Ingredient(s) |
Toothpastes | Potassium nitrate | 5% w/w |
Sodium fluoride | 0.188-0.254% w/w | |
Sodium monofluorophosphate | 0.654-0.884% w/w | |
Tin difluoride | 0.351-0.474% w/w |
Natural Anti-dandruff Shampoo
Anti-dandruff shampoos are considered medicine, unless the ingredients are from natural origin (outlined below).
View further information here.
Natural Health Product Type | Medicinal Ingredient(s) | Quantity of Medicinal Ingredient(s) |
Anti-Dandruff Products | Salicylic acid | 1.8-3.0% |
Selenium disulfide | 0.5-2.5% | |
Sulfur | 2-5% |
Hand Sanitiser
Alcohol-based hand sanitizers are natural health products (NHPs) in Canada and are regulated under the Natural Health Products Regulations (NHPR). They contain these medicinal ingredients:
- ethanol, also known as anhydrous alcohol, ethyl alcohol or grain alcohol.
- isopropanol, also known as isopropyl alcohol or 2-propanol.
Classification of Toys
Regulation
All toy products are regulated under the Consumer Product Safety Act (S.C. 2010, c. 21) which contains the Toys Regulations (SOR/2011-17).
Definition
The Toys Regulations defines toys as:
“a product that is intended for use by a child under 14 years of age in learning or play.”
Examples of Toy Classification
Bath Wand
A bath wand is classified as a cosmetic because it is designed to clean the human body, however, it also has an element of play. These products are marketed for use by children under the age of 14 years old – often containing child-appealing colours and illustrations, and the wand element provides an element of play. The classification of a bath wand would be primarily a toy, but because of its cosmetic function, it’s recommended that the product also complies to the Cosmetic Regulations.
Disney Makeup Kit
Makeup kits are classified as cosmetics, however, if they are clearly designed for children, then an element of play is presumed, making them both toys and cosmetics.
