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캐나다의 화장품 관련 규정에 대해
우리협회에서 Health Canada(캐나다의 화장품 규제 기관)에 문의하여 회신받은 내용입니다.
캐나다 화장품 관련 규정
Product Safety Officer-Consumer Product Safety, Regulatory Operations & Regions Branch
Health Canada / Government of Canada
karine.houde@hc-sc.gc.ca / Tel : 604-658-8243
Health Canada / Government of Canada
karine.houde@hc-sc.gc.ca / Tel : 604-658-8243
Cosmetic products include any substance or mixture of substances for use in cleansing, improving or altering the complexion, skin, hair or teeth. For example:
- · Beauty products such as make-up, fragrances, nail polish, etc.
· Skin care products such as soaps, shampoos, bath salts, skin creams, lotions, shaving creams, deodorants, etc.
In Canada, cosmetics are subject to two laws:
- 1) The Food and Drugs Act and the Cosmetic Regulations, which list, among other things, the requirements regarding safety, labelling and notification of cosmetics to Health Canada.
2) The Consumer Packaging and Labelling Act regarding bilingual labelling, packaging and misleading advertising, declarations of net quantities in metric measuring units and the standardization of container sizes. The latter Act is administered and enforced by the Competition Bureau: http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/00157.html.
Be advised that there are bilingual labelling requirements for products sold in Quebec under the Charter of the French Language. For more details, contact the Office québécois de la langue française: http://www.oqlf.gouv.qc.ca/english/charter/index.html .
Whoever manufactures, imports, distributes and/or sells cosmetic products in Canada must be familiar with the applicable regulations and comply with them. Manufacturers and/or importers must ensure that their products meet all the requirements of the Food and Drugs Act and the Cosmetic Regulations.
You can find all relevant information at Health Canada’s Cosmetics Program site: http://www.hc-sc.gc.ca/cps-spc/cosmet-person/index-eng.php. You will find below an overview of the requirements applicable to cosmetics:
- · Notification: Manufacturers and importers must notify Health Canada within 10 days after they first sell a cosmetic in Canada. The manufacturer, importer or any other authorized person can file a notification. The notification must include the name of the companies responsible, the function of the cosmetic as well as the ingredients and their concentrations.
- Notification of cosmetics is not a product evaluation or approval method. It is not a certification of compliance.
The Cosmetics Notification Form and the Guide to Completing Cosmetic Notification Forms are available on the Health Canada website:
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/index-eng.php
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/guide-eng.php
· Labelling: Labeling requirements are established in sections 17 to 27 of the Cosmetic Regulations. The labeling on cosmetics must include:- o The name of the product in English and French;
o The name and address of the manufacturer or distributor;
o The instructions for safe use, including warnings, in English and French;
o The list of ingredients, in INCI format (International Nomenclature of Cosmetic Ingredients);
o The net quantity, in metric measuring units (this requirement falls under the Consumer Packaging and Labelling Act. For more information, consult the Guide:http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/01248.html ).
- Notification of cosmetics is not a product evaluation or approval method. It is not a certification of compliance.
Cosmetic vs. Therapeutic Claims
The Food and Drugs Act clearly defines the terms “drug” and “cosmetic”. Following is a summary of these definitions:
- · Cosmetic: any substance or mixture of substances for use in cleansing, improving or altering the complexion, skin, hair or teeth.
· Drug: any substance or mixture of substances for use in the diagnosis or treatment of a disease, restoring organic functions or disinfection of premises.
These definitions have an impact on the classification of your product. In Canada, a product may be a drug or a cosmetic, but not both at the same time.
There are two factors that must be considered when determining whether a product is regulated as a cosmetic as opposed to a medication, natural health product, food etc
- · Its representation (labelling, advertising, etc.);
· Its composition (ingredients).
Products that claim to have a therapeutic effect, such as the prevention or treatment of a disease OR that contain certain ingredients that are authorized solely in medications or natural health products are not cosmetic products.
For example, if a manufacturer includes a sun protection factor (SPF) in a product such as a body cream, the product will be treated as a health product in Canada and must be subject to an application for a drug identification number (DIN) or a natural product number (NPN), depending on its composition, before being marketed.
Following is a list of the relevant documents available online.
- · Cosmetics Program
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/index-eng.php
· Guide to Cosmetic Ingredient Labelling
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/labelling_guide-etiquetage/index-eng.php
· The Cosmetic Regulations under the Food and Drugs Act
- · The Food and Drugs Act
http://lois-laws.justice.gc.ca/eng/acts/F-27/index.html
Guide to Completing Cosmetic Notification Forms
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/notification-declaration/guide-eng.php
· Cosmetic Notification Form
http://www.hc-sc.gc.ca/cps-spc/alt_formats/pdf/cosmet-person/notification-declaration/cnf-dcf-eng.pdf
· Help on how to use the forms (to assist you in completing a form in PDF format)
http://www.hc-sc.gc.ca/cps-spc/advisories-avis/incident/cpir-ricpc-help-aide-eng.php
· Hotlist of ingredients for which use is limited or prohibited in cosmetics.
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/hot-list-critique/hotlist-liste-eng.php
· The Directive titled “Labelling of Cosmetics”
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmetics-cosmetiques/index-eng.php
· Guidance Document: Classification of Products at the Cosmetic-Drug Interface
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/cosmet_drug_guide-drogue-ref/index-eng.php
· Guide to the Consumer Packaging and Labelling Act and Regulations
http://www.competitionbureau.gc.ca/eic/site/cb-bc.nsf/eng/01248.html
· Summary table: Labelling Requirements for Cosmetics in Pressurized Containers
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/person/cosmet/index-eng.php
· Good Manufacturing Practices (GMPs) for Cosmetic Products
http://www.hc-sc.gc.ca/cps-spc/cosmet-person/regulations-reglements/gmp_cosmet-bpf-eng.php
· Guidance on Heavy Metal Impurities in Cosmetics
http://www.hc-sc.gc.ca/cps-spc/pubs/indust/heavy_metals-metaux_lourds/index-eng.php