December 2015 Changes to the Cosmetic Ingredient Hotlist

Important notice to those with Methylisothiazolinone (MI) or Methylchloroisothiazolinone (MCI) in their cosmetic products!

Health Canada has recently published “Changes to the Cosmetic Ingredient Hotlist” on their website.  The purpose of this update was to notify all manufacturers of products containing the preservatives MI/MCI in combination. This is a new addition to the Hotlist that highlights:

“MI/MCI in combination is no longer permitted for leave-on products.  The preservative can still be used in rinse-off products, to a maximum concentration of 0.0015 or 15 ppm.”

If this combination is found within your cosmetics, you are requested to immediately stop the distribution of this product and you must inform a Health Canada Officer of how you will dispose of or quarantine the product to ensure that it does not re-enter the market in Canada.

Products that break this new hotlist requirement contravene the general prohibition found in section 16 of the Food and Drugs Act along with a provision of the Cosmetic Regulations.  Products that include this combination must be off retail shelves by May 14, 2016 and companies must respond immediately with your Compliance Plan and conformation that the product has been removed from circulation.  If your company intends to submit an amendment for a reformulation that does not include the MI/MCI combination, you must include the cosmetic number within the notification.

However, it is important to note that completing a cosmetic notification and submission to the Cosmetics Program does not necessarily constitute approval from Health Canada, or agreement that the product is compliant with all regulatory requirements.

What to Do:

  • If you need help identifying if your products contain MI/MCI in combination within leave-on products OR rinse-off products at the maximum concentrations, feel free to ask FPR for assistance in identifying this Hotlist requirement

If you have any questions about requirements or repercussions to your product feel free to contact Focal Point Research Inc.  We are aware of your products and you can trust us to make sure that your products run into no problems with Health Canada.