Labelling of Cosmetics

8. Ingredients

On December 1, 2004, Health Canada published amendments to the Cosmetic Regulations in Part II of the Canada Gazette. The Regulations now require mandatory ingredient labelling on all cosmetic products sold in Canada. The requirements come into force on November 16, 2006, at which time they become law. This means that persons selling cosmetic products in Canada will have to be in compliance with all the new requirements by that time.

8.1 International Nomenclature for Cosmetic Ingredients (INCI) System

INCI stands for the International Nomenclature for Cosmetic Ingredients. It is a system for naming cosmetic ingredients that is multilingual, multinational and based on Latin. The INCI labelling system was designed in 1973 and developed over a period of more than 30 years. It was created by the American Cosmetic, Toiletry and Fragrance Association's International Nomenclature Committee and the INCI system forms the basis of the International Cosmetic Ingredient (ICI) Dictionary and Handbook (currently in its tenth edition). The Dictionary and Handbook presents, in detail, the bulk of INCI names juxtaposed with their corresponding empirical chemical formulas, technical/trade names, Chemical Abstracts System numbers (CAS No.), or alternate numbers. This allows for the unambiguous identification of ingredients Health Canada, along with other government and industry representatives, is a participant of the International Nomenclature Committee, which determines the INCI name assigned to each cosmetic ingredient. INCI is the mandatory nomenclature in the United States, the European Union, and now Canada.

8.2 Ingredient Nomenclature

The Cosmetic Regulations require that all cosmetic products sold in Canada must list the ingredients on the label using the International Nomenclature for Cosmetic Ingredients (INCI) labelling system as found in the most recent edition of the International Cosmetic Ingredient (ICI) Dictionary and Handbook. The list of ingredients must appear on the outer label of a cosmetic, or if the cosmetic has only one label, on that label. Extra descriptive or marketing terminology is not acceptable in the ingredient list, although it is permissible elsewhere on the label. For certain ingredients and products, such as botanicals and ornamental containers, the manner for listing these is prescribed by the Cosmetic Regulations.

8.2.1 Botanicals

Botanicals are ingredients that are directly derived from a plant and that have not been chemically modified before being used in the preparation of a cosmetic. In the INCI Dictionary, botanicals are listed using their genus, species, common name, plant part and extraction method. Therefore, the INCI name for orange peel extract would be Citrus aurantium dulcis (orange) peel extract. In Canada, botanicals must be listed using at least the genus and species portions of the INCI name.

e.g. INCI name: Citrus aurantium dulcis (orange) peel extract

The label must show at least "Citrus aurantium dulcis".

It is also acceptable to show the complete INCI name, however, it is not required at this time. Please refer to section 21.2(3) of the Cosmetic Regulations.

8.2.2 Ingredients Listed in the Schedule

An ingredient that is included in the schedule to the Cosmetic Regulations may be listed one of two ways: either by its EU trivial name set out in column 1 of the schedule or by the appropriate English and French equivalents set out in columns 2 and 3 (as described in section 21.2(4)). It is also acceptable for all three terms to be used together. Please note that it is not permissible to use the English equivalent without the French equivalent or vice versa.

For persons choosing to use the English and French equivalents, the Cosmetic Regulations do not prescribe a specific method for writing the English and French equivalents. While some persons find it convenient to use a slash "/" in between the two terms, other persons may prefer to use a different method. The requirement is that both terms need to appear on the label in such a way that it is clearly understood they are equivalent.

Please note that the ingredients listed in the schedule are the only ones which may need to appear in both French and English.

8.2.3 Ingredients Without INCI Names

Most cosmetic ingredients do have INCI names, so it is important to look through the INCI Dictionary carefully. However, if there truly is no INCI name, the ingredient must be listed by its chemical name from a recognized source. Such sources include:

British Medical Association and Royal Pharmaceutical Society of Great Britain Joint Formulary Committee. British National Formulary 47 (BNF 47). Oxon, UK: Pharmaceutical Press, 2004.
Source: www.bnf.org

British Pharmacopoeia Commission. British Pharmacopoeia. 2004 ed. United Kingdom: British Pharmacopoeia Commission, 2004.
Source: www.pharmacopoeia.org.uk

Committee on Food Chemicals Codex. Food Chemicals Codex.
5th ed. USA: Committee on Food Chemicals, 2003.
Source: www.iom.edu/report.asp?id=15730

European Pharmacopoeia Commission. European Pharmacopoeia. 5th ed. Strasbourg: Directorate for the Quality of Medicines, 2004.
Source: www.pheur.org

Society of Japanese Pharmacopoeia. Japanese Pharmacopoeia.
14th ed. (JPXIV). Japan:Yakuji Nippo Ltd, 2001.
Source: www.yakuji.co.jp/yakuji/publications200101.html

United States Pharmacopoeia. USP 28-NF. USA: The United Stated Pharmacopoeia Convention Inc., 2004.
Source: www.usp.org

United States Adopted Names Council. 2004 Published USAN. USA: American Medical Association, 2004.
Source: www.ama-assn.org/ama/pub/category/12409.html

8.3 How to List Ingredients on the Label

All information required by the Cosmetic Regulations must be clearly legible and remain so throughout the useful life of the cosmetic. While there is no prescribed font size or type face for the ingredient lists, the list must be clearly legible to the consumer under normal conditions of sale and use.

8.3.1 Descending Order of Predominance

Ingredients must be listed on the label in descending order of predominance, in their concentration by weight (as described in section 21.4(1) of the Cosmetic Regulations). This means that the ingredients at the beginning of the list are present in the product in a greater amount than those at the end of the list. Please see sections 8.3.2 through 8.3.5 of these guidelines for exceptions to this rule.

8.3.2 Ingredients with Concentrations of 1% or Less

Ingredients that are present at a concentration of 1% or less may be listed in random order after the ingredients present at a concentration of more than 1% (as described in section 21.4(2) of the Cosmetic Regulations). While it is acceptable to continue to list ingredients present at such small amounts in descending order of predominance, it is not necessary, as long as they are present in the ingredient list.

8.3.3 Colouring Agents

All colouring agents, regardless of their concentration, may be listed in random order after the ingredients that are present at a concentration of more than 1% (as described in section 21.4(2) of the Cosmetic Regulations). It is also acceptable to list colouring agents in descending order of predominance.

8.3.4 Fragrance

In the case of fragrances, the word "parfum" may be used to indicate that ingredients have been added to the cosmetic to produce or mask a particular odour. The term "parfum" may either be inserted at the end of the list of ingredients or inserted at the appropriate point in descending order of predominance. If persons do not choose to use the term "parfum" to indicate the presence of fragrance ingredients, they must list each fragrance ingredient individually.

8.3.5 Flavour

In the case of flavours, the word "aroma" may be used to indicate that ingredients have been added to the cosmetic to produce or mask a particular flavour. The term "aroma" may either be inserted at the end of the list of ingredients or inserted at the appropriate point in descending order of predominance. If persons do not choose to use the term "aroma" to indicate the presence of flavour ingredients, they must list each flavour ingredient individually.

8.3.6 Make-up, Nail Polish and Nail Enamel

For make-up products (e.g. lipstick, blush, eyeshadow), nail polish and nail enamel, which are sold in a range of colour shades, all colouring agents used in the range may be listed if they are preceded by the symbol "+/-" or "±" or the phrase "may contain/peut contenir" (as described in section 21.2(2) of the Cosmetic Regulations). It is unacceptable to use this notation for other cosmetic products, such as hair dyes.

8.3.7 Cosmetics in Small Packages or Containers

It is of paramount importance that the information required to be shown on the label of a cosmetic be clearly legible. However, some cosmetics are so small that requiring the ingredient list to appear on the label would make it difficult to see the information. Therefore, for cosmetics whose immediate container or outside package is so small that the information would not be clearly legible, the list of ingredients may appear on a tag, tape or card affixed to the container.

8.3.8 Cosmetics in Ornamental Containers

In the case of a cosmetic in an ornamental container that has no outside package (i.e. a perfume bottle without a box), the list of ingredients may appear on a tag, tape or card affixed to the container.

8.3.9 Oddly-Shaped Cosmetics

In the case of a cosmetic that has no outside package and whose size, shape or texture, or that of its immediate container, makes it impractical for a tag, tape or card to be affixed to the container (e.g. bath beads), the list of ingredients may instead appear in a leaflet that must accompany the cosmetic at the point of sale.

8.4 Products Exempted from Mandatory Ingredient Labelling

Some products can have a dual purpose and, as a result, will fall under more than one piece of legislation simultaneously. An example of such a product would be a chewing gum that claims to whiten the teeth. Under the Food and Drugs Act, a chewing gum is a food, but it must also adhere to the requirements of the Cosmetic Regulations because it also makes cosmetic claims (to whiten teeth). Because many of these dually-classified products already require ingredient listing under other Regulations, the decision was made to exempt them from the provision to list the ingredients using the INCI system. Therefore, the requirements to list the ingredients under the Cosmetic Regulations do not apply to any product whose ingredient labelling is regulated under the Food and Drug Regulations or the Natural Health Product Regulations.