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Canadian NHP Regulations - Current Experiences

NPIcenter> The excitement and enthusiasm regarding the new regulations in Canada for the Natural Health Products (NHP) industry cannot be overstated.The industry has enjoyed a history of safety and efficacy in its products for years and years; the new regulations, however, deliver the official proof of this safety and efficacy that the industry has for so long deserved, to the public. With their own distinct framework, natural health products can now bear a full range of health claims, based on appropriate levels of evidence. They can also have appropriate and identifiable good manufacturing practices, which will boost consumer confidence in the quality and safety of these products. Full Text>>

OTTAWA (Canada) Overview: “Regulations Amending the Cosmetic Regulations”

On March 27, 2004, the proposed amendment to the Cosmetic Regulations was published in the Canada Gazette Part I (Saturday, March 27, 2004; Vol. 138, No. 13). This latest version of the proposed new regulation takes into consideration the comments received by health Canada after the publication of the initial proposal last year.

The publication in the Canada Gazette Part I opened another comment period of 75 days. Health Canada will consider all inputs received by June 11, 2004. Following a review of the comments, Health Canada will make appropriate modifications (if necessary) before publishing the proposed regulatory amendment in Part II of the Canada Gazette such that it will become law in Canada.

The main provision of the new regulation would require manufacturers to declare ingredients on a label or exterior wrapping of all cosmetics. Other amendments would clarify existing requirements or administrative processes.

Despite the fact that Canada does not require ingredient disclosure at this time, several companies distributing cosmetic products in Canada include a list of ingredients on some (or all) of their products. However, according to Health Canada, many companies do not do so because it is not required by law. Health Canada is proposing that manufacturers use the International Nomenclature for Cosmetic Ingredients (INCI) system for ingredient disclosure.

It is also proposed that the regulatory amendment would reference the INCI system as found in the International Cosmetic Ingredient Dictionary and Handbook (9th edition), published by the U.S. Cosmetic, Toiletry, and Fragrance Association (CTFA). However, there would be slight modifications to ensure that it meets Canadian bilingual requirements. For instance, it is proposed that botanical ingredients would be listed using at least the Latin genus and species portion of their INCI name as they appear in the Dictionary. Such a requirement would correspond to the European practice. Concerning the substances or compounds, referred to as "trivial" or "common" names that are listed in both Latin and English in the Dictionary (e.g. water / aqua), the proposed amendments would require trivial names to be listed using either their Latin names, or using the English and the equivalent French terms. A list of trivial names in Latin, English and French is annexed to the proposed text.

In the case of a cosmetic 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 the phrase "may contain/peut contenir".

The text also provides that an ingredient that has no INCI name would be listed by its chemical name. Ingredients would be listed in descending order of predominance, in their concentration by weight. Ingredients present at a concentration of 1% or less and 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%. In the case of fragrance and flavour, the words "parfum" and "aroma", respectively, may be inserted 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 or flavour.

Another important requirement would concern hair dyes containing paraphenylenediamine or other coal tar dye base or coal tar intermediate that should be labelled with a specific French / English bilingual warning on both the inner and outer labels.

Other provisions of the new text also quote that: “The Minister may request in writing that a manufacturer submit to the Minister, on or before a specified day, evidence to establish the safety of a cosmetic under the recommended or the normal conditions of use. »

Furthermore, the information to be notify within the 10 days following the first sell of a cosmetic product would be extended to :

- a notification form
- a copy or facsimile of labels used in conjunction with the cosmetic, when they bear any warnings or precautionary directions for use ;
- the name and address of the manufacturer that appears on the label of the cosmetic;
- the name under which the cosmetic is sold;
- the function of the cosmetic;
- a list of the cosmetic's ingredients and, for each ingredient, its exact concentration or the concentration range that includes its concentration, as set out in the table to this section;
- the form of the cosmetic;
- the name and address in Canada of the manufacturer, importer or distributor;
- if the cosmetic was not manufactured or formulated by the person whose name appears on the label, the name and address of the person who manufactured or formulated it; and
- the name and title of the person who signed the notification form.

The amended regulation should come into force two years after publication in the Canada Gazette Part II.

The proposed regulation is available at: http://canadagazette.gc.ca/partI/index-e.html

(CCTFA) Cosmetic Ingredient Labeling Consultation; Ottawa, Canada May 6

The Canadian Cosmetic, Toiletry & Fragrance Association (CCTFA) has been working with Health Canada officials since 1996 to develop and implement mandatory ingredient labeling for cosmetics and personal care products in Canada. With the regulatory amendment published in the Canada Gazette Part I on March 27th, the definitive rules for ingredient labeling in Canada are now one-step closer to becoming law. As part of the regulatory process, and in order to expedite passage to final regulation, CCTFA is providing a forum on this key industry issue, within the 75-day comment period.

Join CCTFA members, Health Canada officials and other interested parties for this one-day session on the proposed cosmetic ingredient labelling regulations. Health Canada will also be looking for feedback and will be available to answer questions in a Q&A panel at the end of the session. This will be the LAST chance to provide comments on the long-awaited amendment to Health Canada, and member comments will form the basis of CCTFA's written response. THIS IS ONE SESSION YOU CANNOT AFFORD TO MISS!

All cosmetic manufacturers, distributors, importers and marketers will need to know about these important changes, and why industry, government, consumers and health professionals have been highly supportive to date.

Cosmetic Ingredient Labelling Consultation
Thursday, May 6, 2004, 10:00 am - 2:30 pm
Fairmont Chateau Laurier, Ottawa
1 Rideau Street, MacDonald Room
613-241-1414

Canadian Cosmetic, Toiletry & Fragrance Association
http://www.cctfa.ca/

Canada Gazette Publishes Proposed Ingredient Labeling Regulations

Canada Gazette reports, "The purpose of this initiative is to enhance the safety of Canadians by making available to consumers valuable information concerning the composition of cosmetics. Health Canada is proposing that manufacturers use the International Nomenclature for Cosmetic Ingredients (INCI) system for ingredient disclosure. Ingredient listing on product labels will provide Canadians with information that will allow them to avoid products that contain an ingredient that may cause an adverse reaction. Additionally, this initiative will provide medical professionals with ready access to the names of the ingredients in the product, thus allowing them to provide effective medical care should the need arise. The use of INCI would provide for uniform and consistent information to be delivered to both health professionals and consumers.

Currently, many countries including the United States and the members of the European Union require ingredient disclosure on cosmetic products. Furthermore, the majority of these countries require that the ingredients be listed using the INCI system. Despite the fact that Canada does not require ingredient disclosure at this time, several companies distributing cosmetic products in Canada include a list of ingredients on some (or all) of their products. However, many companies do not do so because it is not required by law.

The INCI system was designed in 1973 and developed over a period of more than 25 years. It was created by the American Cosmetic, Toiletry and Fragrance Association (CTFA), and it is the mandatory nomenclature in both the United States and the European Union. Under the INCI system, most of the names for cosmetic product ingredients are technical chemical names that might not be readily understood by the consumer. However, this system was designed with the notion that INCI names act as universally understood symbols that can be recognized as representing a substance that may otherwise appear under many different trade names.

It is proposed that the regulatory amendment would reference the INCI system as found in the International Cosmetic Ingredient (ICI) Dictionary and Handbook, Ninth edition. However, there would be slight modifications to ensure that it meets Canadian needs. It is proposed that botanical ingredients would be listed using at least the Latin genus and species portion of their INCI name as they appear in the Dictionary. There are also a number of compounds, referred to as "trivial names," that are listed in both Latin and English in the Dictionary. The proposed amendments would require trivial names to be listed using either their Latin names, or using the English, provided that the equivalent French term is also used. The proposed amendment has been designed in such a way as to allow cosmetic companies enough flexibility to comply with the requirements of other countries, including the United States and the European Union.

The proposed amendment would also require that all ingredients be listed in descending order of predominance on the outer label of the cosmetic. In the case of fragrances and flavours, manufacturers would have the opportunity to make use of the expressions "parfum" (meaning fragrance) or "aroma" (meaning flavour) to represent these groups of ingredients. When products are sold in several colour shades, all possible colouring agents in the entire colour range could be listed, provided the symbol "±" or the phrase "may contain/peut contenir" is used. In the case of cosmetics sold in an ornamental container, the list of ingredients would be permitted to appear on a tag, tape, or card that is attached to the container. In the case of cosmetics for which the size, shape or texture renders it impractical for a tag, tape, or card to be affixed, the list of ingredients may appear in a leaflet that accompanies the cosmetic at the point of sale. This proposed regulatory amendment would come into force two years after its registration.
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"Regulations Amending the Cosmetic Regulations." Canada Gazette 27 03. 2004. 31 03. 2004