Regulatory Amendment Frequently Asked Questions - Industry

• What is INCI?
• Why do we need mandatory ingredient labelling?
• Why were the references to the "Assistant Deputy Minister" removed and replaced with "Minister"?
• How does changing "Assistant Deputy Minister" to "Minister" affect my business?
• Why was the definition of "manufacturer" changed? What is the difference?
• Why was the requirement for the mandatory warning label for cosmetics containing acetonitrile removed?
• Whose address must appear on the label?
• Where can I find the International Cosmetic Ingredient Dictionary and Handbook?
• In the definition of ICI Dictionary it says that the Tenth edition must be used "as amended from time to time," what does that mean?
• How much time will I have to change my labels with each new edition of the ICI Dictionary?
• What is an ornamental container?
• What is an ingredient?
• What is a botanical?
• What is a fragrance ingredient?
• What is a flavour ingredient?
• What is an incidental ingredient?
• Where does the ingredient list need to appear?
• Does the ingredient list need to appear on both the inner and outer label of the cosmetic product?
• Does the ingredient list need to appear in both official languages?
• What sections of the label must appear in both official languages?
• Can descriptive words be added in addition to the INCI name in the ingredient list?
• Can all cosmetics use the "may contain" provision for colourants?
• What is makeup?
• How do I label botanical ingredients?
• What is a trivial name?
• How do I label trivial names?
• Can only the EU trivial name and the English equivalent be used?
• Can the EU trivial name and both the English and French equivalents be used?
• How do I list the English and French equivalents?
• What ingredients need to be listed in French and English?
• Where can I find the chemical name of an ingredient if there is no INCI name?
• How do I list ingredients on the label?
• Can I list the ingredient alphabetically as is done for drugs?
• How do I list ingredients with a concentration of less than 1%?
• How do I list colouring agents?
• What nomenclature do I use to list colouring agents?
• How do I list fragrance ingredients on the label?
• Can I use the term "fragrance" instead of "parfum"?
• How do I list flavour ingredients on the label?
• How do I label small products?
• How do I label a product that is in an ornamental container?
• How do I label a product, with no outside package, that is of a size, shape or texture that makes it impractical to attach a tag, tape or card?
• How do I label a cosmetic with no outside package?
• Do samples need to have ingredients listed on the label?
• Do testers need to have ingredient listed?
• Do ingredient lists need to be provided on hotel amenities?
• Do cosmetic chewing gums (e.g. gums making whitening claims) and other foods with cosmetic effects need to list ingredients on the label using INCI?
• If the ingredients must be listed on the label, do I still need to complete a notification form for Health Canada?
• Do both the manufacturer and importer have to send in separate notification forms?
• It says that the Regulations "come into force two years after the day of which they are registered," what does that mean?
• My products have life-cycle that is longer than two years, what will happen to products that were put on the market before the Regulations were finalized and are still on the market at the end of the two year implementation period?
• For a cosmetic-like drug (with a Drug Identification Number), will the new INCI ingredient labelling requirements apply, or will the current drug labelling rules continue to apply?
• Is it permissible to use the INCI nomenclature for other personal care products such as drugs or natural health products?
• How will the Regulations be enforced?
• Can I still comment on the Regulations?
• Do professional use products that are not intended for retail sale need to include ingredient lists on the label?
• If there is no INCI name, how do I get one?

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.

What is INCI?

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.

Why do we need mandatory ingredient labelling?

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.

Why were the references to the "Assistant Deputy Minister" removed and replaced with "Minister"?

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.

How does changing "Assistant Deputy Minister" to "Minister" affect my business?

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.

Why was the definition of "manufacturer" changed? What is the difference?

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.

Why was the requirement for the mandatory warning label for cosmetics containing acetonitrile removed?

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.

Whose address must appear on the label?

The address of the manufacturer or distributor, whoever is responsible for the cosmetic in Canada, must appear on the label.

Where can I find the International Cosmetic Ingredient Dictionary and Handbook?

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 cctfa@cctfa.ca 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.

In the definition of ICI Dictionary it says that the Tenth edition must be used "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.

How much time will I have to change my labels with each new edition of the ICI Dictionary?

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.

What is an ornamental container?

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.

What is an ingredient?

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)

What is a botanical?

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.

What is a fragrance ingredient?

A fragrance is an ingredient that has been added to the cosmetic product in order to produce or mask a particular odour.

What is a flavour ingredient?

A flavour is an ingredient that has been added to the cosmetic product in order to produce or mask a particular taste.

What is an incidental ingredient?

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.

Where does the ingredient list need to appear?

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.

Does the ingredient list need to appear on both the inner and outer label of the cosmetic product?

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.

Does the ingredient list need to appear in both official languages?

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.

What sections of the label must appear in both official languages?

All information required by the Regulations to appear on the label must be shown in both official languages except for the INCI name.

Can descriptive words be added in addition to the INCI name in the ingredient list?

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.

Can all cosmetics use the "may contain" provision for colourants?

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.

What is makeup?

Makeup includes eyebrow pencil, eyeliner, eye shadow, mascara, blushers, face powders, foundations, leg and body paints, lipstick, rouges, etc.

How do I label botanical ingredients?

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.

What is a trivial name?

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.

How do I label trivial names?

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.

Can only the EU trivial name and the English equivalent be used?

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.

Can the EU trivial name and both the English and French equivalents be used?

Yes. While it is not necessary to use all three terms, it is acceptable to do so. Example: acetum/vinegar/vinaigre.

How do I list the English and French equivalents?

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.

What ingredients need to be listed in French and English?

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.

Where can I find the chemical name of an ingredient if there is no INCI name?

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.

• 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: http://www.bnf.org/
• British Pharmacopoeia Commission.  British Pharmacopoeia. 2004 ed. United Kingdom: British Pharmacopoeia Commission, 2004. Source: http://www.pharmacopoeia.org.uk/
• Committee on Food Chemicals Codex.  Food Chemicals Codex. Fifth ed. USA: Committee on Food Chemicals, 2003. Source: http://www.iom.edu/report.asp?id=15730
• European Pharmacopoeia Commission. European Pharmacopoeia: Fifth ed. Strasbourg:  Directorate for the Quality of Medicines, 2004. Source: http://www.pheur.org/
•  Japanese Pharmacopoeia: Fourteenth ed. (JPXIV). Japan: Society of Japanese Pharmacopoeia, Yakuji Nippo, LTD., 2001. Sources: http://www.yakuji.co.jp/e/publications/index.html
• United State Pharmacopoeia. USP 28-NF. USA:  The United Stated Pharmacopoeia Convention, Inc., 2004. Source: http://www.usp.org/
•  United States Adopted Names Council. 2004 Published USAN. USA: American Medical Association, 2004. Source: http://www.ama-assn.org/ama/pub/category/2956.html

How do I list ingredients on the label?

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.

Can I list the ingredient alphabetically as is done for drugs?

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.

How do I list ingredients with a concentration of less than 1%?

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%.

How do I list 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%. 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%.

What nomenclature do I use to list colouring agents?

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.

How do I list fragrance ingredients on the label?

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.

Can I use the term "fragrance" instead of "parfum"?

No. It is acceptable to either list each fragrance ingredient individually or to use the term "parfum."

How do I list flavour ingredients on the label?

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.

How do I label small products?

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.

How do I label a product that is in an ornamental 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.

How do I label a product, with no outside package, that is of a size, shape or texture that makes it impractical to attach a tag, tape or card?

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.

How do I label a cosmetic with no outside package?

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.

Do samples need to have ingredients listed on the label?

Yes. Samples of cosmetic products must abide by all the requirements of the Cosmetic Regulations, including ingredient disclosure.

Do testers need to have ingredient listed?

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.

Do ingredient lists need to be provided on hotel amenities?

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.

Do cosmetic chewing gums (e.g. gums making whitening claims) and other foods with cosmetic effects need to list ingredients on the label using INCI?

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.

If the ingredients must be listed on the label, do I still need to complete a notification form for Health Canada?

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.

Do both the manufacturer and importer have to send in separate notification forms?

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).

It says that the Regulations "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.

My products have life-cycle that is longer than two years, what will happen to products that were put on the market before the Regulations were finalized and are still on the market at the end of the two year implementation 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.

For a cosmetic-like drug (with a Drug Identification Number), will the new INCI ingredient labelling requirements apply, or will the current drug labelling rules continue to apply?

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.

Is it permissible to use the INCI nomenclature for other personal care products such as drugs or natural health 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.

How will the Regulations be enforced?

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.

Can I still comment on the Regulations?

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.

Do professional use products that are not intended for retail sale need to include ingredient lists on the label?

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.

If there is no INCI name, how do I get one?

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.