Cosmetics Alliance has become aware via two members of two compliance verification projects under way:
1. Advance Notification of Importation (ANI) + Re-Labelling
2. Eucalyptus Oil in Cosmetics
The Consumer Product Safety Program (CPSP) is responsible for the administration and enforcement of the Canada Consumer Product Safety Act (CCPSA) and its associated regulation. The CPSP is also responsible for cosmetic-related provisions of the Food and Drugs Act (FDA) and the Cosmetic Regulations.
Health Canada promotes, monitors, verifies and enforces compliance with the CCPSA and the FDA. One of the enforcement activities is targeted inspections on a cyclical basis conducted on establishments and products. A full listing of these compliance verification projects may be found here.
ANI + Re-Labelling
As a reminder the ANI process applies to cosmetics and drugs that need to be modified or relabeled to be sold in Canada per Section 9 of the Cosmetic Regulations and A.01.044 of the Food and Drug Regulations. Two important points to recall are:
- The ANI form, available by request from Health Canada, needs to be sent to Health Canada prior to the importation of the product, and
- The modification of the product must occur with 3 months of the importation of the product
Details of the Advance Notification of Importation can be found here and here.
What is happening:
- Regulatory, Operations & Enforcement Branch (ROEB) is pre-arranging site visits in relatively short order, although they may arrive unannounced.
- ROEB is selecting ANI forms that were submitted by the company
- During the visit they either inspect the samples on-site or take samples for further review off-site
- ROEB is confirming the product modification activities have been performed and have been performed within 3 months of importation
The last compliance verification for this activity occurred in FY 2020-2021, the results can be found here.
Eucalyptus Oil in Cosmetics
As a reminder, the Cosmetic Ingredient Hotlist contains an entry for Eucalyptus oil for cosmetics in solid form, other forms with > 0.022% and other forms with < 0.022 % with associated warning and cautionary statements for one of these conditions of use.
What is happening:
- ROEB appears to be visiting companies unannounced.
- ROEB is gathering information on cosmetic products containing eucalyptus ingredients, from a list of the company’s notified products containing the ingredient.
- Copies of the product artwork and quantitative ingredient information are requested to assess the levels of the eucalyptus ingredient in the product and assess whether the proper warnings and cautionary statements are on the label.
- The documents and labels are taken away or emailed to the inspector for assessment.
Should you experience compliance verification activities in these areas, or any other areas, feel free to reach out to regulatory@cosmeticsalliance.ca to share your experiences or concerns
