Natural Health Products Directorate Advises Not to Label Products as 'NPN Pending'

Canada's Natural Health Products Directorate (NHPD) has issued a bulletin advising companies with products awaiting evaluation for product licenses not to label products these products with language describing the status as 'NPN Pending'. Companies with products already labelled in this mannner, the Directorate advises should not include this statement in future shipments.

The directorate notes that while this circumstance is not specifically covered in the regulations, the statement is a violation of Part 1, Section 9 of the Food and Drugs Act which prohibits individuals and companies from "labelling, packaging, treating, processing, selling or advertising any drug or natural health product in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

The directorate goes on to note that the label NPN Pending implies that the product will eventually receive an NPN license, a fate which is far from certain and therefore misleading.

Source: NPIcenter is an on-line business resource for the natural and nutritional products industries.

Health Canada's Regulations Amending the Cosmetic Regulations

On December 1, 2004, Health Canada published the "Regulations Amending the Cosmetic Regulations" in the Canada Gazette, Part II. These new regulations will make ingredient labeling mandatory for all cosmetic products sold in Canada.

The new regulations will become effective November 16, 2006. All cosmetic products will have to be in compliance with all the new requirements.

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Cosmetic Industry Supports Health Canada's New Law To Require Ingredient Labelling On Cosmetics

TORONTO, Dec. 2 (SOAPWIRE via CNW) - As a partner in the development of Health Canada's new requirements for cosmetic ingredient labelling, the Canadian Cosmetic, Toiletry and Fragrance Association (CCTFA) supports mandatory ingredient labelling for cosmetics using the INCI (International Nomenclature for Cosmetic Ingredients) nomenclature system. Consumers can now expect to see a complete list of ingredients on all cosmetic packaging sold in Canada by November 16, 2006.

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Health Canada to Require Cosmetics Ingredient Listings Within Two Years

Canadian cosmetic manufacturers will be required to list cosmetic ingredients on product labels within two years, Health Canada will soon announce...

According to the Canadian Press, changes to the cosmetic regulations are based on cases in which consumers have suffered adverse effects of some products and the government estimates that users of these products are victims of at least 900,000 minor undesirable effects annually, with only about 50 cases reported to authorities.

Department documents say that even though most ingredients contained in cosmetics are harmless, some of them can cause unwanted reactions. The Canadian Cosmetic, Toiletry, and Fragrance Association, which represents manufacturers and marketers, welcomed the regulatory change, recognizing that consumers have for many years wanted to know the ingredients of cosmetics. And since the requirements already exist in Europe and the United States, many companies already list ingredients. Health Canada anticipates ingredient labeling will reduce reactions and save $7.5 million in annual health-care costs.

Source: thecosmeticsite.com

Canadian Ingredient Labelling Update

As you may remember, on March 27, 2004, Health Canada published their proposed Cosmetic Ingredient Labelling Regulations in Canada Gazette Part I. The document is titled "Regulations Amending the Cosmetic Regulations" and can be found online at:
http://canadagazette.gc.ca/partI/2004/20040327/html/regle2-e.html
http://canadagazette.gc.ca/partI/2004/20040327/pdf/g1-13813.pdf (Official Version)

Heath Canada has reviewed the stakeholders' comments and is making appropriate "modifications to the proposal in order to reflect some of the suggestions that were raised during the consultation phase."

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Health Canada Might Swat Citronella From Shelves

MONTREAL - Health Canada is considering a proposal to phase out citronella, the popular insect repellent.

It says the manufacturers have not provided the government agency with enough proof that the product is safe.

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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. Full Text>>

Source: NPIcenter
NPIcenter is an on-line business resource for the natural and nutritional products industries

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.

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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