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
EMAIL ALERTS
