COSMETICS

US

In US, cosmetical products is regulated by FDA under the Federal Food, Drug and Cosmetics Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA) with major recent updates from the Modernization of Cosmetics Regulation Act (MoCRA). Although FDA does not pre-approve most cosmetics, the manufacturers are responsible for ensuring products are safe and properly labeled and are required to register their facilities and products with the FDA. Product ingredients and finished products must be substantiated for safety before being marketed and FDA may request additional safety testing and for companies to maintain safety records. Products must be properly labeled, including all ingredients in descending order of predominance as well as information about the net quantity of contents, fragrance allergens, and the business contact information.

CANADA

For all cosmetic manufacturers interested in selling their products in Canada, Health Canada requires an electronic submission of a Cosmetic Notification Form (CFN) prior to or within 10 days of first selling the cosmetic in Canada. This form includes essential information about the product (such as the full list of product ingredients, the product name, its form and intended application areas) as well as information about the manufacturer (name and address). In response to the submission, Health Canada assigns a Cosmetic Number to the manufacturer.

The submission of a CNF is a notification not an approval. While this allows Health Canada to monitor the cosmetics sold in the country the manufacturers and imports are responsible for making sure their cosmetics meet the regulatory requirements. Some major retailers may request proof of CNF submission and custom officials may check import declarations against a filed CNF. Thus, failure to notify may result in a product being denied entry in Canada or being removed from sale. When changes occur (such as modifications in the cosmetic formulation, in the product name, in the company name or its contact information. etc.), the manufacturers and importers are required to resubmit the CNF application.

Cosmetic product labels must comply with Health Canada regulations and list accurate information including details about its intended use and application. All labels must be legible, clear, in English (and French, as applicable), and must be displayed on the outer package or the container of the cosmetic product. A cosmetic number is not required to be listed on a cosmetical product sold in Canada.

AlephAstra LLC

info@alephastra.com

cosmetics@alephastra.com