COSMETICS & PERSONAL CARE PRODUCTS: REGULATION AND COMPLIANCE
R&C: How would you characterise the complexity of the regulatory requirements that manufacturers must meet before they can place cosmetics and personal care products on the market?
Eyler: Premarket requirements for cosmetics and personal care products in the US are limited. Except for colour additives, which must be approved by the US Food and Drug Administration (FDA), and certain ingredients whose use is prohibited or limited by FDA regulations, any cosmetic product may be marketed if it and its ingredients are safe for use under the labelled conditions of use or under customary or usual conditions of use. Cosmetic product manufacturers and processors must register their facilities within 60 days of first engaging in manufacture or processing, to be updated every two years; and they must submit cosmetic product listings within 120 days of marketing, to be updated annually.
Greiss: Canada has a streamlined approach for introducing cosmetics or other beauty products that do not make health claims. The manufacturer or importer must ensure that the product label meets all requirements under the regulations, including any requirements found under the ‘cosmetic ingredient hotlist’. Manufacturers must submit a ‘cosmetic notification form’ to Health Canada outlining the product’s label, instructions for use and ingredient list. Where a product wishes to make health claims for a skin condition, such as acne cream or dandruff shampoo, the product will be regulated as a drug and not a cosmetic. This will require the manufacturer to make submissions and obtain an approval for the product prior to sale. A more complex approval process is required where the product includes an ingredient or chemical that has not been imported or sold in Canada before.
Jan-Mar 2024 Issue
Gibson, Dunn & Crutcher
Osler, Hoskin & Harcourt