Canada’s Cosmetic Regulations1 were amended in November 2004 to require the listing of ingredients on cosmetics sold in Canada.2 According to Health Canada, there are roughly 900,000 adverse reactions per year related to unlabeled cosmetic use.3 The vast majority of these reactions are mild and readily resolved, whereas about 10% of these adverse reactions are more serious. The new regulations will enable consumers to avoid products to which they are sensitive and will ensure that an ingredient’s details are available to medical personnel called on to treat adverse reactions. This requirement brings Canada in line with the United States, Japan, the countries of the European Union, and other jurisdictions, where the mandatory disclosure of cosmetics ingredients on product labels has existed for some time. The new regulations will not come into force until the fall of 2006, to allow businesses time to use up existing stock and to prepare new labels for their products, where necessary.
Effective November 16, 2006, however, manufacturers of cosmetics and personal care products sold in Canada must list the product ingredients on the product labels. The new labeling requirements will apply to all products regulated as cosmetics by the Consumer Product Safety Program of Health Canada under the Cosmetic Regulations of the Food and Drugs Act.4 Cosmetics are defined 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."5 This definition covers personal care products such as shampoo, face and skin creams, and other grooming aids, as well as makeup, nail products, perfume, and other beauty preparations.
The new requirements will not apply to products for which ingredients listing already is regulated under the Food and Drug Regulations6 or Natural Health Products Regulations.7 For example, products that have a cosmetic effect but that are regulated as drugs (e.g., face or skin creams containing sunscreen), as food (e.g., chewing gum that whitens teeth) or as natural health products (e.g, certain toothpastes) will not be required to comply with the ingredients listing requirements of the amended Cosmetic Regulations.
The amended regulations will require that a list of ingredients appear on the product label of a cosmetic, including professional-use products not for retail sale. An ingredient is defined in the regulations as any substance that is a component of a cosmetic, but does not include a substance used in the preparation of the cosmetic but not present in the final product as a result of the chemical process. Ingredients include coloring agents, botanicals, fragrance, and flavor additives.8
The ingredients must be listed on the outer label of the cosmetic. If a product has both an inner and an outer label, the ingredient list need only appear on the outer label. If the cosmetic’s container or outside package is too small to list the ingredients or if the container is ornamental and there is no outside package, the ingredients can be listed on a tag, tape, or card affixed to the container or package. For example, a perfume bottle (an ornamental container) with no outer package could be labeled in this manner. Cosmetic samples—which will be required to have their ingredients listed on the product label in accordance with the amended Regulations—also could be labeled using tags, tapes, or cards.
If there is no outside package, and a tag, tape, or card would be impractical due to the size, shape, or texture of the cosmetic or its container, the ingredients can be listed in a leaflet that accompanies the cosmetic at the point of sale. Hotel amenities that fall within the definition of cosmetics (e.g., body lotion, shampoo, and conditioner) also will be required to comply with the new labeling requirements. Tags, tapes, or cards could be used for these types of products, or alternatively a list of ingredients could be made available in the form of a card left in the guest room or at the hotel check-in or service desk.
Cosmetic testers will not be required to carry ingredient lists. Because the tester ordinarily would be located close to a display of the actual product—which will have the ingredients listed on its label—the consumer will be able to check the product ingredients before testing it.
Ingredients must be listed using International Nomenclature Cosmetic Ingredient (INCI) names as set out in the International Cosmetic Ingredient [ICI] Dictionary and Handbook, published by the Cosmetic, Toiletry, and Fragrance Association. The INCI system simplifies ingredient labeling by providing one name for each ingredient, which otherwise may have many trade names or chemical descriptions. The use of a standardized nomenclature should make it much easier for consumers to avoid products containing ingredients to which they are sensitive. It also may assist health professionals in treating patients who have an allergic reaction. Furthermore, because many other countries use the INCI system, Canadians traveling abroad may be assisted in recognizing and avoiding ingredients, without needing to know additional terminology. The INCI system is mandatory nomenclature in the United States and countries of the European Union.
The INCI system is considered to be a multilingual technical nomenclature, so Health Canada does not require INCI names to be listed in both official languages. A number of compounds in the ICI Dictionary and Handbook, however, are listed by their "trivial" name in Latin and English (e.g., "aqua," "water"). In these cases, the manufacturer may choose to use either the Latin trivial name or the English trivial name, but if the English name is chosen, the equivalent French term (i.e., "eau," for the previous example) also must be listed. A list of trivial names and their English and French equivalents are set out in the schedule to the amended Cosmetic Regulations.
Botanicals must be listed using at least the genus and species portion of their INCI name.
Ingredients that truly have no INCI name must be listed by their chemical name from a recognized source in both English and French. Recognized sources include the British Pharmacopoeia, European Pharmacopoeia, U.S. Pharmacopeia, and U.S. Adopted Names Council.
It should be noted that the INCI nomenclature may not be used for naming the ingredients of food, drugs, or natural health products. The use of the INCI system applies only to the labeling of cosmetics.
Ingredients must be listed in descending order of concentration by weight. An alphabetic listing is not permitted. Ingredients with a concentration of one percent or less and all coloring agents regardless of their concentration may be listed in random order after the ingredients with concentrations of more than one percent. If makeup or nail polish and enamel are sold in a range of shades, all coloring agents used in the range may be listed if they are preceded by the symbol "+/–" or "±" or the phrase "may contain/peut contenir." Products other than makeup, nail polish, and nail enamel are not permitted to use these provisions. With respect to fragrance and flavor, the words "parfum" and "aroma" may be inserted at the end of the list of ingredients to indicate that these ingredients have been added to the cosmetic. Other words (e.g., "fragrance") are not acceptable. If the manufacturer wishes to list the individual flavor or fragrance ingredients separately, they must be listed in accordance with the general rules for ingredients—that is, they must be listed at the appropriate point in the ingredients list, according to the rule of descending order of predominance in concentration by weight.
The amended regulations also will modify the hazard labeling requirements for certain products.
The language of the hazard labeling requirements for hair dyes, cosmetics in pressurized containers, and other hazardous cosmetics has been revised slightly to make the requirements easier to read and to reflect various new definitions in the amended regulations. The substance of these requirements has not changed.
Under the old Regulations, products containing acetonitrile were required to carry a warning. This requirement has been repealed in the amended Regulations because the use of acetonitrile is now prohibited. Prohibited ingredients and ingredients that can be used only in accordance with certain restrictions (e.g., concentration limits or the use of cautionary statements) appear on the List of Restricted and Prohibited Cosmetic Ingredients (also known as the "Hotlist").9
The notification requirements for importers of cosmetics into Canada also have been modified. Under the old Regulations, importers were required to deliver a notification form containing certain information before any cosmetic could be imported into Canada. Under the amended Regulations, the notification will have to be provided no later than 10 days after the first sale of the cosmetic. This is the same notification deadline for domestic cosmetic manufacturers.
The information to be provided in the notification will be similar to the information currently required: the name and address of the manufacturer that appears on the product label (and if the cosmetic was not manufactured or formulated by the person whose name appears on the label, then the name of the person who manufactured or formulated it); the name and address in Canada of the manufacturer, importer, or distributor; the function and form of the cosmetic and the name under which it is sold; a list of the cosmetic’s ingredients and the exact concentration or concentration range for each; and the name and title of the person signing the notification.
The new rules for importation notification also come into effect on November 16, 2006.
1. Available at http://laws.justice.gc.ca/en/f-27/c.r.c.-c.869/text.html (last visited Aug. 24, 2005).
2. Regulations Amending the Cosmetic Regulations, available at http://canadagazette.gc.ca/partII/2004/20041201/html/sor244-e.html (last visited Sept. 13, 2005).
3. Regulatory Impact Analysis Statement, which follows the Regulations Amending the Cosmetic Regulations, id.
4. Available at http://laws.justice.gc.ca/en/f-27/61279.html (last visited Aug. 24, 2005).
5. As defined in the Food and Drugs Act, available at http://laws.justice.gc.ca/en/f-27/61279.html (last visited Sept. 15, 2005).
6. Available at http://laws.justice.gc.ca/en/f-27/c.r.c.-c.870/text.html (last visited Aug. 24, 2005).
7. Available at http://laws.justice.gc.ca/en/f-27/sor-2003-196/text.html (last visited Aug. 24, 2005).
8. As defined in the Regulations Amending the Cosmetic Regulations, available at http://canadagazette.gc.ca/partII/2004/20041201/html/sor244-e.html (last visited Sept. 14, 2005).
9. Available on the Health Canada website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/hotlist-liste_e.html(last visited Sept. 13, 2005).
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.