Guide to Cosmetic Ingredient Labelling

2009
ISBN: 978-1-100-10897-1
Cat. No.: H128-1/08-556E
HC Pub.: 4109

The information in this guide has been prepared to provide an overview of the INCI labelling requirements of the Cosmetics Regulations under the Food and Drugs Act. It is not intended to substitute for, supersede or limit the requirements under the legislation. This guide is prepared for convenience of reference only and as such has no official sanction. In case of discrepancy between this guide and the legislation, the legislation will supersede the guide. In order for a product to comply, all conditions of the Act must be met. A copy of the Food and Drugs Act and the Cosmetics Regulations may be obtained by contacting your nearest Product Safety Offices found on the Health Canada Web site. Go to www.healthcanada.gc.ca/cosmetics and click on "Contact Us".

Table of Contents

• 1.0 Introduction
• 2.0 Cosmetic Regulations
• 3.0 Ingredient Labelling - 21.1
• 4.0 Presence and Location - 21.2(1), 21.5(1-3)
  • 4.1 Small Containers
  • 4.2 Ornamental Containers
  • 4.3 Testers
  • 4.4 Hotel Amenities
  • 4.5 Gift Sets and Kits
  • 4.6 Samples
• 5.0 Shades and Colours - 21.2(2)
• 6.0 Botanical Ingredients - 21.2(3)
• 7.0 Ingredients on the Schedule- 21.2(4)
• 8.0 Descending Order -21.4(1)
• 9.0 Ingredients Less than 1% Concentration - 21.4(2)
• 10.0 Parfum and Aroma - 21.4(3)
  • 10.1 Parfum and Fragrance
  • 10.2 Aroma and Flavour
• 11.0 Other Points of Interest
• 12.0 Hints and Tips
• 13.0 Questions
• Appendix 1: Schedule of the Cosmetic Regulations

1. Introduction

This document is a guide to help understand the nuances of the International Nomenclature of Cosmetic Ingredients (INCI) system of ingredient labelling. It is based on what is required as per the Cosmetic Regulations. This guide includes tables to clarify common questions, ingredient label examples, and tips to verify proper INCI labelling.

This document is intended to help clarify the Cosmetic Regulations with respect to ingredient labelling. It is not intended to substitute requirements under the applicable legislation. In case of any discrepancy between this document and the legislation, the legislation will prevail.

2. Cosmetic Regulations

3. Ingredient Labelling--section 21.1

Cosmetic products are required to have mandatory ingredient labelling as per the Cosmetic Regulations. Please note that mandatory INCI ingredient labelling only applies to cosmetic products, and does not apply to drugs or natural health products. The label must be legible and follow all other labelling requirements outlined in the Cosmetic Regulations and the Consumer Packaging and Labelling Act.:

The list of ingredients may be preceded by the word "Ingredient" or "Ingredients/ Ingrédients". Although this is not a regulatory requirement, it is considered acceptable.

Incidental ingredients do not need to be included on the label. Incidental ingredients are defined as: any processing aid added and removed or converted to a declared ingredient, or any ingredient of another ingredient or processing aid present at an insignificant level and having no technical or functional effect.

4. Presence and Location--section 21.2(1), 21.5(1-3)

All cosmetic products require the ingredient names to be listed on the outer label. INCI nomenclature is not required for non-cosmetic products (however it is acceptable for drugs and natural health products in order to list non-medicinal ingredients). Since most cosmetics have packaging, the ingredient list should be on the outer label, and clearly visible to the consumer at the time of purchase of the product.

Note:

• The intention of the Regulations is to have ingredients clearly visible and in an obvious location such that consumers can read them at the point of sale.
• An ingredient list should not be placed on the underside/bottom of a container if it can be easily placed on a display panel.
• The information required by the Regulations takes precedence and is of greater priority than voluntary information listed on the product label.

Legibility:

A box listing ingredients that is wrapped in clear cellophane would be considered acceptable since the ingredients are clearly visible. Products with ingredients listed on the back surface of an outer label that are read through a transparent container and clear liquids are considered acceptable unless the container and contents distort the lettering and affect the legibility of the ingredient list.

Bottom Labels/Peel-back Labels:

The outer label is the one that is most easily visible, usually with the largest surface area. The bottom of a container may be considered acceptable in cases where the shape of the container is flat (e.g. shoe polish container shape). Accordion and peelback labels are acceptable as long as they are not destroyed and can be put back into place in its original condition. Also, it must be indicated that the ingredient list can be found behind the label (i.e. top portion of peel-back label states "Ingredients here", and can be stuck on again after being peeled). The label must clearly indicate the ingredients or where the ingredients are listed, and must remain permanently affixed to the container such that consumers can view the list of ingredients at the point of purchase.

Bulk and Loose Cosmetics:

A cosmetic that has no outside package (or no packaging altogether) and whose size, shape or texture, 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. An example of such a product is bath beads, and other bulk or loose products.

4.1 Small Containers

Examples of small containers are those for lipstick, eye liner, lip balm, or anything that may be too small to list all the ingredients in the product on the packaging. Small containers should have a tag, tape or card affixed to it which lists the ingredients if they are not on the outer label. Tear-away tags or leaflets accompanying the product at point of sale are not acceptable.

4.2 Ornamental Containers

An ornamental container is a container that, except on the bottom, does not have any promotional or advertising material on it other than a trade-mark or common name. It is considered 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 is a perfume bottle.

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.

4.3 Testers

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 public to review the ingredients prior to testing the product.

4.4 Hotel Amenities

Hotel amenities that meet the definition of a cosmetic are subject to all requirements under the Food and Drugs Act and Cosmetic Regulations. There are no special provisions for hotel amenities, therefore they must adhere to the ingredient labelling requirements as described in this guide.

4.5 Gift Sets and Kits

Gift sets and kits that contain multiple cosmetics need to list the ingredients of all the cosmetics comprising the kit on the outer packaging such that they are available to the consumer at the time of purchase of the product. Gift baskets that have multiple products and are wrapped decoratively (i.e. with cellophane), may have a card affixed to them, since this would be considered an ornamental container.

4.6 Samples

The cosmetic ingredient labelling requirements apply to samples in the same manner that they apply to other cosmetic products.

5. Shades and Colours--section 21.2(2)

Cosmetics such as makeup or nail polish/enamel that come in various shades can
list all colouring agents used in the range of products if preceded by the symbols
"±" or "may contain/peut contenir". It is recommended that when the symbol "±"
or "may contain/peut contenir" is used, the colouring agents be the last ingredients
listed, in order to reduce the confusion over what substances are included under
"may contain/peut contenir". Note that this does not apply to hair dye colourants,
but can apply to all makeup, hair mascara, and temporary coloured hair sprays that
can be rinsed off.

• Colouring agents should be listed as CI numbers, or colour names (formerly "FD&C" names). For example: CI 42090 (Blue 1). The order of listing them as either CI# or colour name first does not matter.
• Either naming conventions can be used (if they are in the International Cosmetic Ingredient [ICI] Dictionary), however it must be clear if both are listed that they are the same ingredient and not separate ingredients. For example: CI 42090 (Blue 1). The two synonymous names for the ingredient can be separated by brackets or a slash, e.g. CI42090/Blue 1, CI 15985/Yellow 6. Note that the use of slash for colouring agents does not have the same meaning as the use of a slash for ingredients.
• Please note that not all colours have both the name and CI index listed, there are some colours which do not have a corresponding CI number in the ICI Dictionary (e.g. Basic Blue 99).
• Please note that "FD&C" is not part of any INCI name.

6. Botanical Ingredients--section 21.2(3)

Botanical and herbal ingredients must be listed using the genus and species names
(at minimum) or the complete INCI name. Examples of proper INCI names of plants
with the genus and species listed are as follows:

• Aesculus hippocastanum
• Salix alba
• Sambucus nigra
• Mentha piperita
• Melaleuca alternifolia
• Chamomilla recutita

As stated previously, only the genus and species of the INCI name OR the entire name should be listed. A complete INCI name may include genus and species, common name, plant part, and/or method of preparation. There should not be any partial INCI names listed, however "partial" can vary depending on what the complete name is in the ICI Dictionary (e.g. some botanical INCI names may not include method of preparation). The common names of the botanical ingredients should not be translated.

An example is provided in Table 2 on the next page to clarify this concept.

In most cases, a slash does not mean "and" or "or" but rather indicates a reaction between each ingredient on either side of the slash, e.g. Acrylates/Styrene Copolymer. In the case of botanical ingredients, where a slash is between plant parts, this means that all the indicated plant parts are used in the preparation. For example, for Camellia sinensis flower/leaf extract, the flower and leaves were used in the extraction.

If a vendor requires an INCI name for a plant part (alone) or a combination that is not currently published to the Dictionary, that vendor should submit an INCI name application at: www.ctfa-inciapplication.org

7. Ingredients on the Schedule--section 21.2(4)

The names listed in the Schedule to the Cosmetic Regulations (Appendix 1)
are considered "Trivial Names". There are three columns in the Schedule. The
manufacturer must use names exactly as they are mentioned in the Schedule of
the Cosmetic Regulations. They can use either the:

• European Union (EU) trivial name (column 1): e.g. aqua; or
• English AND French equivalent name (columns 2 and 3): e.g. water/eau; or
• names in all three columns (columns 1 and 2 and 3): e.g. aqua/water/eau.

The complete list of ingredients on the Schedule is given in Appendix 1. The highlighted cell is used as an example in Table 4 (see next page).

8. Descending Order--section 21.4(1)

Ingredients must be listed in decreasing order of predominance in their concentration by weight. Descending order of concentration does not necessarily apply to fragrance agents, flavouring agents or colouring agents (unless the company wishes to state them in decreasing order of concentration). Colouring agents should be listed at the very end of the list if all the colouring agents will be listed using the "±" sign or "may contain/peut contenir" provision.

9. Ingredients Less than 1% Concentration--section 21.4(2)

Ingredients at a concentration less than 1%, and colouring agents may be listed in random order after the ingredients present at greater than 1%. Flavouring and fragrance agents in products at levels greater than 1% may be listed as "aroma" and "parfum" at the end of the ingredient list, or can be placed in descending order of concentration.

10. Parfum and Aroma--section 21.4(3)

The Cosmetic Regulations require that the INCI terms "parfum" and "aroma" are
used for fragrance and flavour ingredients, respectively.

The following are INCI names listed in the ICI Dictionary :

• Parfum
• Aroma
• Fragrance
• Flavor

Note: The term "flavour" (Canadian spelling) does not appear in the ICI Dictionary. It is not an official INCI name, however this spelling will be accepted because of its reference as "flavour" in the Cosmetic Regulations.

10.1 Parfum and Fragrance

The use of the term "parfum" alone or with "fragrance" is permitted, however the term "fragrance" alone is not acceptable. This term is used to indicate that ingredients have been added to the cosmetic to produce or to mask a particular odour. Another alternative is to list the components of the fragrance ingredients as individual ingredients.

Acceptable options for listing fragrance agents:

• Using the term "parfum" at the end of the ingredient list.
• Using the term "parfum" at the appropriate point in the ingredient list following the rule of descending order of predominance, in concentration by weight.
• Listing each fragrance ingredient individually by descending order of predominance.

10.2 Aroma and Flavour

The use of the term "aroma" alone or with flavour (or flavor) is permitted. The ICI Dictionary has the spelling "flavor" whereas the Cosmetic Regulations uses the spelling "flavour". Therefore, both spellings of the word will be considered acceptable, but they cannot be used on their own. "Aroma" is used in an ingredient list to indicate that substances have been added to the cosmetic to produce or to mask a particular taste.

Acceptable options for listing flavouring agents:

• Using the term "aroma" at the end of the ingredient list.
• Using the term "aroma" at the appropriate point in the ingredient list following the rule of descending order of predominance, in concentration by weight.
• Listing each flavour ingredient individually by descending order of predominance.

11. Other Points of Interest

• Ingredients that have been translated into French, or ingredients listed in foreign languages must be listed separately, not mixed with INCI names. A separate (but identical) ingredient list using another nomenclature system or language may follow the INCI list.
• Ingredients in cosmetics must not be separated as medicinal and non-medicinal ingredients (or active/inactive ingredients), since this would imply that the product is a drug or natural health product.
• Ingredients must not have descriptions (e.g. super-oxygenated water).
• Order of ingredients: [ingredients in descending order of concentration] + [flavour] + [fragrance] + [± or "may contain/peut contenir" colouring agents].
• Punctuation: the difference between different ingredients must be clear. The following are acceptable means of expressing ingredients:
  • e.g.: water/eau, butyrospermum parkii, cetearyl alcohol, acid blue 1/CI 42045...
  • e.g.: water(eau), butyrospermum parkii, cetearyl alcohol, CI 42045 (acid blue 1)...
  -- note that different ingredients are separated by a comma;
  -- note that different names for the same ingredients are expressed with a slash, or brackets.

12. Hints and Tips

Follow these steps when verifying ingredient labelling:

• ensure ingredients are on the outer label and clear, visible, and legible;
• are any ingredients on the Schedule to the Cosmetic Regulations (i.e. Trivial Names)? If so, verify that they are labelled properly. Check if Aqua/Water/Eau is listed correctly;
• are there any botanical ingredients? Verify that a genus and species are listed;
• ensure "parfum", "aroma" and colouring agents are listed correctly.

13. Questions

Label reviews:

Requests for pre-market label reviews may be directed to a consultant. A list of consultants is available through the Canadian Cosmetic Toiletry and Fragrance Association (CCTFA) Web site. Consultants are listed under "Associate members". This list is available to the public. www.cctfa.ca/en/cctfa/members.php

Consultants can also be found through the local yellow pages, and by internet search.

Appendix 1: Schedule of the Cosmetic Regulations