Regulatory Amendment Frequently Asked Questions - Health Care Professionals

• What is a cosmetic?
• What amendments have been made to the Cosmetic Regulations?
• What is the INCI system?
• Why have the amendments to the Cosmetic Regulations been made?
• Under the new Regulation, how will the ingredients be listed?
• How will my patients understand the INCI ingredient disclosure system?
• My patient has had a reaction, now what do I do?
• How do I obtain a copy of the International Cosmetic Ingredient Dictionary and Handbook?
• Why is there a two-year implementation period?
• Why can companies use ingredients that cause reactions?
• What ingredients are allowed in cosmetics?
• Prior to this amendment, were manufacturers required to list ingredients, but not necessarily using INCI nomenclature?
• What information was mandatory on cosmetic labels previously?
• Will this information continue to be required in addition to the new ingredient listing?
• Contact Us

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. Along with other changes to the Cosmetic Regulations, the protection of the health and safety of the Canadian public with regard to the use of cosmetic products will be strengthened. The new requirements come into force on November 16, 2006. This means that businesses selling cosmetic products in Canada will have to be in compliance with all the new requirements by that time.

What is a cosmetic?

A cosmetic is a product which cleanses, improves or alters the complexion, skin, hair or teeth, but which does not make therapeutic claims. Regardless of whether the product is a beauty preparation (make-up, perfume, skin cream, nail polish) or a grooming aid (shaving gel, soap, shampoo, deodorant), all cosmetics sold to the Canadian public must meet the requirements of the Food and Drugs Act and the Cosmetic Regulations and the Consumer Packaging and Labelling Act and Regulations.

What amendments have been made to the Cosmetic Regulations?

Health Canada has amended the Cosmetic Regulations to require that ingredient lists appear on all cosmetic product labels. This supports Health Canada's commitment to protect the health and safety of the Canadian public. Ingredients must be listed using the International Nomenclature for Cosmetic Ingredients (INCI) system. Other amendments have clarified existing requirements or administrative processes.

What is the INCI system?

INCI is a system for naming cosmetic ingredients that is multilingual, multinational and based on Latin language. It consists of a common, single nomenclature for each ingredient used in a cosmetic product. It is a nomenclature based on international lists of ingredients known and used by pharmacists and scientists worldwide. It has been developed in the United States and Europe and it is used extensively throughout the world. 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.

Why have the amendments to the Cosmetic Regulations been made?

The labelling of cosmetic ingredients enables the Canadian public to make more informed decisions about the cosmetics they use as they are able to easily identify ingredients to which they may have sensitivities.

Mandatory ingredient labelling enables health care professionals to refer to one common name for the purpose of treatment and incidence reporting.

Because many other countries also use the INCI system, Canadians travelling abroad will be able to recognize and avoid ingredients, as necessary, without needing to know additional terminology.

Canada's cosmetic labelling has now been brought into line with international standards. This will contribute to health protection, while helping to lessen trade barriers and increase trade opportunities for Canadian businesses.

Under the new Regulation, how will the ingredients be listed?

All ingredients must be listed in descending order of predominance on the outer label of the cosmetic, or if a cosmetic has only one label, on that label. Therefore, if a product is in a box, the labelling must at least be on the box; if it is not in a box, the labelling must be on the container itself. If the product is small or in an ornamental container, a tag, tape or card may be attached to the container. In the case of a cosmetic for which the size, shape or texture (i.e. bath beads) renders it impractical for a tag, tape or card to be attached, the list of ingredients may appear in a leaflet that must accompany the cosmetic at the point of sale.

In the case of fragrances and flavours, businesses may choose to either list the individual ingredients which make up the fragrance or flavour, or they may use the expressions "parfum" and "aroma" (respectively) to represent these groups of ingredients.

Makeup products (e.g. lipstick, eyeshadow, blush, etc), nail polish and nail enamel, which are sold in several different colour shades, may list all the colouring agents in the range on the label, provided they use the symbol "±" or "+/-" or the phrase "May contain/Peut contenir".

How will my patients understand the INCI ingredient disclosure system?

Most of the names for cosmetic product ingredients are technical chemical names that might not be readily understood by the Canadian public. However, the INCI system was designed with the notion that INCI names act as universally-recognized symbols that represent a substance that may otherwise appear under many different trade names. By only allowing INCI names, the Canadian public needs to know only one "symbol" for an ingredient instead of having to remember a number of different technical or trade names. Should an individual have a reaction to a cosmetic product, they will need to work with their health care professional to determine which ingredient is problematic. A list of the priority allergens (peanut, tree nuts, milk, egg, soy, wheat, fish, crustaceans/shellfish, sesame and sulphites) with their associated INCI names is available on Health Canada's website at www.hc-sc.gc.ca/cosmetics.

My patient has had a reaction, now what do I do?

Health Canada recommends that anyone who suffers an adverse reaction to a cosmetic should stop using the product immediately and to contact their health care professional if the reaction is severe or prolonged. The incident should also be reported to the Product Safety Program. The list of ingredients should help you to determine which ingredient may have caused the reaction.

How do I obtain a copy of the International Cosmetic Ingredient Dictionary and Handbook?

The International Cosmetic Ingredient Dictionary and Handbook can be obtained directly from the publisher:  Cosmetic, Toiletry, and Fragrance Association (CTFA) at http://www.ctfa.org or by mail at 1101 17th Street, NW, Suite 300, Washington, D.C., 20036-4702 or by telephone at 202-331-1770 or by fax at 202-331-1969. It can also be obtained through the Canadian distributor at:  Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) at http://www.cctfa.ca or by mail at 420 Britannia Road East, Suite 102, Mississauga, Ontario, L4Z 3L5 or by telephone at 905-890-5161 or by email cctfa@cctfa.ca or by fax at 905-890-2607. To find out more information about a specific ingredient, contact the company whose address can be found on the label. A list of the priority allergens (peanut, tree nuts, milk, egg, soy, wheat, fish, crustaceans/shellfish, sesame and sulphites) with their associated INCI names is available on Health Canada's website at www.hc-sc.gc.ca/cosmetics.

Why is there a two-year implementation period?

While many businesses are already listing the ingredients on the label using the INCI system, some have not yet started. Health Canada realises that it is impossible for businesses to change their labels overnight. In order to facilitate the change, businesses will have two years to design new labels and use up existing stock. However, Health Canada highly recommends that businesses start making changes immediately and do not wait until the end of the two-year period.

Why can companies use ingredients that cause reactions?

Cosmetics are made up of some 10,000 different ingredients (excluding flavours and fragrances). It has been estimated that North American adults use, on average, seven different cosmetic products every day. Given the composition and use of most cosmetics, the potential health hazard is very low, and most people who use them will experience no ill effects. To ensure the safety of cosmetics in Canada, Health Canada maintains a list of ingredients that are either prohibited or restricted in cosmetic products. This can be found on Health Canada's website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/hot-list-critique/hotlist-liste-eng.php. Only ingredients that do not pose an unreasonable health and safety risk to the general population, when used according to directions, are allowed in cosmetic products. While the vast majority of cosmetic ingredients are considered to be harmless, some of these ingredients do have the potential to cause adverse reactions in a small percentage of the population with sensitivities. The nature of the reactions and the ingredients which trigger them vary widely. Mandatory ingredient listing on cosmetics is designed to help protect those with sensitivities without limiting choices for the Canadian public.

What ingredients are allowed in cosmetics?

Only ingredients that do not pose an unreasonable health and safety risk to the Canadian public, when used according to directions, are allowed in cosmetic products. Health Canada maintains a list of ingredients that are either prohibited or restricted in cosmetic products. This can be found on Health Canada's website at http://www.hc-sc.gc.ca/cps-spc/person/cosmet/info-ind-prof/hot-list-critique/hotlist-liste-eng.php

Prior to this amendment, were manufacturers required to list ingredients, but not necessarily using INCI nomenclature?

No. While the previous Cosmetic Regulations did contain a number of requirements concerning the labelling of cosmetics, they did not require ingredient listing.

What information was mandatory on cosmetic labels previously?

Labelling is regulated by the Food and Drugs Act, the Cosmetic Regulations and the Consumer Packaging and Labelling Act and Regulations.

To comply with these requirements, cosmetic labels must show the following:

• the identity of the product, in English and French, in terms of common or generic name or function;
• a statement of net quantity in metric units of measurement;
• the name and address of the manufacturer or distributor; and
• directions, warnings or cautions, in English and French, for the safe use of the product.

There were also specific labelling requirements for the safe use of special products, such as hair dyes. In addition, the Consumer Packaging and Labelling Act prohibits false and misleading representation or deceptive packaging.

Will this information continue to be required in addition to the new ingredient listing?

Yes. Mandatory ingredient lists are in addition to all other information that must appear on the label.

Contact Us:

For more information on the safety of cosmetics or on the ingredient labelling regulation, please visit our website: www.hc-sc.gc.ca/cosmetics

Or contact us:

Cosmetics Division
Consumer Product Safety Bureau
Health Canada
123 Slater Street, A.L. 3504D
Ottawa, Ontario, K1A 0K9
Email: cosmetics@hc-sc.gc.ca
Fax: (613) 952-3039
Phone: 1-866-662-0666 (toll-free within Canada and the United States)

To report an adverse reaction please contact your Local Regional Product Safety Office