"Assistant Deputy Minister"removed and replaced with
"Assistant Deputy Minister"to
"Minister"affect my business?
"manufacturer"changed? What is the difference?
"as amended from time to time,"what does that mean?
"may contain"provision for colourants?
"come into force two years after the day of which they are registered,"what does that mean?
On December 1, 2004, Health Canada published the new 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, at which time they become law. This means that businesses selling cosmetic products in Canada will have to be in compliance with all the new requirements by that time.
INCI stands for the International Nomenclature for Cosmetic Ingredients. It is a system for naming cosmetic ingredients that is multilingual, multinational and based on the Latin language. 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.
Previously, the Cosmetic Regulations did make a number of requirements concerning the labelling of cosmetic products, however, they did not require ingredient listing. Mandatory ingredient listing will enhance the safety of the Canadian public by making available to the public valuable information concerning the composition of cosmetics. Ingredient lists will provide the public with information that will allow them to avoid products which contain an ingredient to which they may be sensitive. Additionally, this initiative will provide medical professionals with ready access to the ingredients in the product, thus allowing them to provide effective medical care should the need arise. The use of the INCI system allows uniform and consistent information to be delivered to both health professionals and the public.
All references to the
"Assistant Deputy Minister" in the Cosmetic Regulations were changed to
"Minister," which aligns the Regulations with modern practice. The assignment of duties to the Assistant Deputy Minister began before amendments to the Interpretation Act made the practice unnecessary. Section 24 of the Interpretation Act permits the Minister to delegate a task or decision to any person serving
"in the department or ministry of state over which the Minister presides," who has sufficient seniority and training.
Changing the reference from
"Assistant Deputy Minister" to
"Minister" will have little impact on industry as it is an administrative change, which allows the Cosmetics Program to work more quickly and efficiently.
The definition of
"manufacturer" was clarified, since the previous definition was complicated and difficult to understand. The definition of manufacturer includes the manufacturer and distributor as before.
Acetonitrile has been added to the List of Restricted and Prohibited Cosmetic Ingredients (the Hotlist) as an ingredient that is prohibited for use in cosmetics. Therefore, a warning label is not needed because the ingredient can not be used.
The address of the manufacturer or distributor, whoever is responsible for the cosmetic in Canada, must appear on the label.
The International Cosmetic Ingredient Dictionary and Handbook can be obtained through the Canadian distributor at: Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) at 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 email@example.com or by fax at 905-890-2607. It can also be obtained directly from the publisher: Cosmetic, Toiletry, and Fragrance Association (CTFA) at 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.
"as amended from time to time,"what does that mean?
"As amended from time to time" means that each time a new edition is published, the new edition is the one that must be used. This ensures that the Regulations require the most up-to-date dictionary to be used without having to amend the Cosmetic Regulations each time a new edition is published. This benefits both Health Canada and cosmetic businesses.
Health Canada recognizes that it takes time for businesses to change their labels to reflect changes to the nomenclature. A reasonable amount of time will be allowed for businesses to change their labels.
An ornamental container is one that, except on the bottom, does not have any promotional or advertising material on it other than a trade-mark or common name, and that appears to be a decorative ornament because of a design that is on its surface or because of its shape or texture, and is sold as a decorative ornament in addition to being sold as the container of a cosmetic. An example of this type of product is perfume.
An ingredient is any substance that is one of the components of a cosmetic and includes colouring agents, botanicals, fragrance and flavour. An ingredient does not include substances which are used in the preparation of the cosmetic but which are not found in the final product as a result of a chemical process. (See incidental ingredient)
A botanical is an ingredient that is directly derived from a plant and that has not been chemically modified before it is used in the preparation of a cosmetic.
A fragrance is an ingredient that has been added to the cosmetic product in order to produce or mask a particular odour.
A flavour is an ingredient that has been added to the cosmetic product in order to produce or mask a particular taste.
An incidental ingredient is a substance that is used in the preparation of the cosmetic but which is not found in the final product as a result of the chemical process. Incidental ingredients do not need to be listed on the label of a cosmetic.
The ingredient list needs to appear on the outer label of the cosmetic product, or, if the cosmetic has only one label, on that label. The panel on which the label is affixed needs to be visible under normal conditions of display.
No. The ingredient list only needs to appear on the outer label of the cosmetic, or, if the cosmetic has only one label, on that label.
No. Health Canada's requirement is that the ingredients need to be listed using the INCI system, which is considered to be a multilingual, technical nomenclature. However, it is important to note that some provinces may have their own specific labelling requirements that must also be followed.
All information required by the Regulations to appear on the label must be shown in both official languages except for the INCI name.
No. The ingredient list is reserved exclusively for ingredient labelling terminology and it is unacceptable to place descriptive or promotional terms in the list. Descriptive terminology can, however, be used elsewhere on the label.
No. Only cosmetics that are considered to be makeup, nail polish or nail enamel can use the
"may contain" provision for colourants which allows a business to list all the colourants for a product sold in a range of colour shades. All other products (e.g. hair dyes) must list the exact colouring agents that are present in the cosmetic product. Examples of makeup include eyebrow pencil, eyeliner, eye shadow, mascara, blushers, face powders, foundations, leg and body paints, lipstick, rouges, etc.
Makeup includes eyebrow pencil, eyeliner, eye shadow, mascara, blushers, face powders, foundations, leg and body paints, lipstick, rouges, etc.
Botanical ingredients must show at least the genus and species portion of the INCI name. A business may also include the common name, plant part and preparation method if they wish. This additional information does not need to be translated as it is part of the INCI name and subsection 18(b) exempts INCI names from translation.
A trivial name is the Latin version of the INCI name assigned to certain ingredients by the European Union. This means that there are, in fact, two INCI names for some cosmetic ingredients: one typical INCI name and one European trivial name. There are a total of 60 European trivial names, which correspond to 93 typical INCI names. All of these terms are INCI names. All trivial names can be found in the schedule at the end of the Cosmetic Regulations with their corresponding equivalents.
There are two choices for listing trivial names on the label. A trivial name, which can be found in the schedule at the end of the Cosmetic Regulations, can be listed using the EU trivial name set out in column 1 of the schedule. If a business chooses not to use the EU trivial name, they must list both the English and French equivalents set out in columns 2 and 3. It is also possible that a business may want to include all three terms, which is also acceptable. However, it is unacceptable for the English equivalent to appear without the appropriate French equivalent or vice versa.
No. If the English equivalent is used, the French equivalent must also appear. However, the EU trivial name may be used on its own. Example: vinegar/vinaigre or acetum.
Yes. While it is not necessary to use all three terms, it is acceptable to do so. Example: acetum/vinegar/vinaigre.
Health Canada is not prescribing a specific method for writing the English and French equivalents. While some businesses find it convenient to use a
"/" in between the two terms, other businesses may prefer to use a different method. The requirement is that both terms need to appear on the label in such a way that the public will understand that they are equivalent terms.
The only ingredients which may be listed using French and English terms instead of INCI terms are those found in the schedule at the end of the Cosmetic Regulations. The terms found in the schedule can be listed using either the EU trivial name or both the English and French equivalents as provided. All other ingredients are to be listed using their INCI name, which should not be translated.
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:
Some of the following hyperlinks are to sites of organizations or other entities that are not subject to the Official Languages Act. The material found there is therefore in the language(s) used by the sites in question.
Ingredients must be listed in descending order of predominance, in their concentration by weight. This is the internationally accepted practice for cosmetics. Ingredient lists must also be clearly legible and remain so throughout the useful life of the cosmetic under normal conditions of sale and use.
No. The ingredient list must appear in descending order of predominance, in their concentration by weight, for all cosmetics sold in Canada. Alphabetical listing is not acceptable for cosmetics.
Ingredients present at a concentration of 1% or less may be listed in random order after the ingredients that are present at a concentration of more than 1%. It is also acceptable, if a business prefers, to continue to list these ingredients in descending order of predominance, in their concentration by weight, as is done with all ingredients present at a concentration of more than 1%.
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%. It is also acceptable, if a business prefers, to continue to list colouring agents in descending order of predominance, in their concentration by weight, as is done with all ingredients present at a concentration of more than 1%.
Colouring agents must be listed using their INCI names as listed in the ICI Dictionary. If more than one name is listed in the dictionary for a colouring agent, the business may use whichever name they prefer from the list of choices.
Fragrance ingredients may either be listed individually following the rules for all other ingredients, or they may be listed under the term
"parfum." This term may be used at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic to produce or to mask a particular odour. It is also acceptable to use the term
"parfum" at the appropriate point in the ingredient list following the rule of descending order of predominance, in concentration by weight.
No. It is acceptable to either list each fragrance ingredient individually or to use the term
Flavour ingredients may either be listed individually following the rules for all other ingredients, or they may be listed under the term
"aroma." This term may be used at the end of the list of ingredients to indicate that such ingredients have been added to the cosmetic to produce or to mask a particular taste. It is also acceptable to use the term
"aroma" at the appropriate point in the ingredient list following the rule of descending order of predominance, in concentration by weight.
Products that are too small to be labelled in such a way as to be clearly legible may list the ingredients on a tag, tape or card that is affixed to the container.
If a cosmetic in an ornamental container has an outside package, the ingredient list must appear on the outside package. If a cosmetic in an ornamental container does not have an outside package, the ingredient list may appear on a tag, tape or card affixed to the container.
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, may list the ingredients on a leaflet that must accompany the product at the point of sale.
A cosmetic that does not have an outside package must have the ingredients listed on the container. Please see the exceptions for small products, ornamental containers, and other specific products.
Yes. Samples of cosmetic products must abide by all the requirements of the Cosmetic Regulations, including ingredient disclosure.
No. Product testers, which allow the public to try the product prior to purchase, do not need to supply ingredient lists. Testers usually appear in close vicinity to the cosmetic that is available for sale. The ingredient list would appear on the label of the product for sale, thus allowing the the public to review the ingredients prior to testing the product.
Yes. Hotel amenities, such as soap, shampoo, conditioner, body lotion, are generally considered to be cosmetics. Therefore, hotel amenities must comply with all the requirements in the Food and Drugs Act, Cosmetic Regulations, Consumer Packaging and Labelling Act and Regulations and would need to provide ingredient lists on the label. If this is not possible due to size or an ornamental container, a tag, tape or card may be attached. If the size, shape or texture of the product makes it impractical for a tag, tape or card to be attached, the list of ingredients may appear on a leaflet that must accompany the product.
Under the Food and Drugs Act, cosmetic chewing gums are considered to be both a food and a cosmetic. Therefore, these products must comply with both the Food and Drug Regulations and the Cosmetic Regulations. Cosmetic chewing gums (and other foods that have cosmetic effects) have been listing ingredients on the label under the Food and Drug Regulations for a long time. There is no added safety benefit to the the public for requiring two ingredient lists. Therefore, all products that require ingredient listing under the Food and Drug Regulations are exempt from the ingredient labelling requirements of the Cosmetic Regulations.
Yes. It is still necessary to notify all cosmetic products to Health Canada. The notification form contains important information that is necessary for Health Canada to best protect the health and safety of the Canadian public.
No. Only one notification form needs to be sent to Health Canada, however, it is the responsibility of both the manufacturer and importer to ensure that this is done promptly and that Health Canada is informed of any changes to the product once it is on the market (including discontinuation).
"come into force two years after the day of which they are registered,"what does that mean?
Health Canada realises that it is impossible for businesses to change their labels overnight. In order to facilitate the change, companies are being given two years from the time that the new Regulations are published in Canada Gazette Part II to design new labels and to use up old stock. However, it is highly recommended that businesses start making the changes immediately and do not wait until the end of the two year period.
Health Canada recognises that some cosmetics have a long life-cycle and that there may still be a few products on the market at the end of the two year implementation period. If products are found that do not comply, Health Canada will contact the business and work out the best way to resolve the situation. However, there should be few products left without ingredient lists at the end of the implementation period. It is in the best interest of businesses to start making the required modifications to their labels without delay.
The Cosmetic Regulations apply only to cosmetic products sold in Canada. Therefore, this regulatory change has no effect on the requirements for drug products (including cosmetic-like drugs). Please see the Food and Drugs Act and the Food and Drug Regulations or contact the Therapeutic Products Directorate for information on the requirements for drug products.
No. The Cosmetic Regulations apply only to cosmetic products sold in Canada. Therefore, this regulatory change has no effect on the requirements for drug products (including cosmetic-like drugs) or natural health products. Please see the Food and Drugs Act and its Regulations for more information. Contact the Therapeutic Products Directorate for information on the requirements for drug products or the Natural Health Products Directorate for more information concerning the sale of natural health products.
Compliance with the requirements of the Regulations is presently monitored by Product Safety Inspectors designated by the Minister. When non-compliance is detected, there are a number of different options available such as voluntary measures, warning letters, import refusal, public advisories, product seizure, and, ultimately, prosecution in the courts. The severity of the health and safety risk, the previous compliance history of the business, whether or not the business acted with indifference or premeditation, the likelihood that non-compliance will recur, and the probability of success of the enforcement action being contemplated are all taken into account in selecting the most appropriate course of action.
While Health Canada is always pleased to receive feedback from stakeholders, the official comment period for these Regulations has ended. The new Cosmetic Regulations have now become law in Canada.
Yes. Professional use products must meet all the same requirements as cosmetics sold at the retail level. This includes 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; directions, warnings or cautions, in English and French, for the safe use of the product; and a list of ingredients.
The International Nomenclature Committee is responsible for determining the INCI name assigned to each cosmetic ingredient. Health Canada, along with other government and industry representatives, is a participant of the International Nomenclature Committee. Requests for assignment of an INCI name must be submitted to the Cosmetic, Toiletry and Fragrance Association using the form (formTN) available on their website at http://www.ctfa.org. INCI names are assigned to ingredients based on their chemical structure and composition.