December 2015 Changes to the Canadian Cosmetic Ingredient Hotlist

On December 14th, 2015, Health Canada amended the Cosmetic Ingredient Hotlist entry related to MI/MCI. The Hotlist is a list of ingredientsthat Health Canada believes may cause injury to the health of the user when used in cosmetics under certain conditions. Such use of an ingredient in cosmetics may be in violation of the Food and Drugs Act – Section 16, which states:

“16 No person shall sell any cosmetic that

  • has in or on it any substance that may cause injury to the health of the user when the cosmetic is used,
    • according to the directions on the label or accompanying the cosmetic, or
    • for such purposes and by such methods of use as are customary or usual therefore,
  • consists in whole or in part of any filthy or decomposed substance or of any foreign matter, or
  • was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.”
ChemicalCASConditions of Use by product typeMaximum Concentration Permitted
Methylisothiazolinone / Methylchloroisothiazolinone, in combination26172-55-4; 2682-20-4Methylchloroisothiazolinone is only permitted in combination with methylisothiazolinone.
Methylisothiazolinone / Methylchloroisothiazolinone, in combination26172-55-4; 2682-20-4a) Not permitted in leave-on products.
Methylisothiazolinone / Methylchloroisothiazolinone, in combination26172-55-4; 2682-20-4b) Rinse-off productsb) 0.0015% (15 µg/mL or 15 ppm)

After June 14th, 2016, all leave-on products intended for use by children under the age of three that contain MI/MCI must no longer be available for purchase. All other leave-on products containing MI/MCI should no longer be available for purchase after December 31st, 2016.

As part of the implementation of the Hotlist update, it is the expectation of Health Canada that industry has taken steps to discontinue the distribution and sale of leave-on cosmetics containing MI/MCI, at minimum by June 30th , 2016. Companies requiring additional time to sell through existing product on store shelves may submit a Compliance Action Plan to Health Canada. However, after submitting a Compliance Action Plan, no company may distribute affected products after June 30th, 2016 or sell affected products after December 31st, 2016.

In addition to this change in the hotlist, some items were amended and added. Cyanoacrylate-based adhesives were amended in order to reflect the policy change in requirements for cyanoacrylatebased eyelash adhesives. Notifiers of these ingredients for the application of false eyelashes will no longer be required to submit descriptions of their training methods and training materials to Health Canada upon notification. However, these materials should be kept on hand.
In order to better reflect current use patterns for tooth whitening products, the entry Peroxide and peroxide generating compounds was amended by updating the cautionary statements.
For p-Phenylenediamine and its salts, a maximum authorized concentration of 3% after dilution with an oxidizer was added.
Finally, Prostaglandins and their analogs were added to the list as prohibited ingredientsin cosmetic products due to their presence on the Prescription Drug List and their sole therapeutic functions.

Any questions?