Canada Puts Prostaglandins on Ingredient Hotlist

December 17, 2015 | Contact Author | By: Nicole Urbanowicz
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Keywords: Canada ingredient Hotlist | prostaglandin | methylisothiazolinone | methylchloroisothiazolinone | p-Phenylenediamine | cyanoacrylate-based eyelash adhesives | Health Canada

Abstract: Health Canada adds to its Cosmetic Ingredient Hotlist of restricted cosmetics ingredients, including comments on prostaglandins, methylisothiazolinone and more.

National public health watchdog Health Canada has recently made several changes to its Cosmetic Ingredient Hotlist, a science-based document which lists substances that are restricted or prohibited from use in cosmetics in the country.

Prostaglandins Added to Hotlist 

As of December 2015, Canada has added prostaglandins, their salts, derivatives and analogs to the Hotlist. Prostaglandins and their analogs were added as a prohibited ingredient in cosmetic products due to their presence on the Prescription Drug List and their sole therapeutic functions, Health Canada said. Certain types of prostaglandins, such as prostaglandin (F2alpha), have been used in formulas for the treatment of hair loss. 

Items Amended

Health Canada has amended its ruling on methylisothiazolinone/methylchloroisothiazolinone (MI/MCI) in order to add a new condition for MI/MCI when used in combination, as a prohibited substance in leave-on cosmetic products. The preservative used in cosmetics and other household products can still be used in rinse-off products, to a maximum concentration of 0.0015% or 15 ppm.

Similarly, the EU has already banned a mixture of methylchloroisothiazolinone (and) methylisothiazolinone (MCI/MI) from leave-on products, although the preservative can still be used in rinse-off products at a maximum concentration of 0.0015% of a mixture in the ratio 3:1 of MCI/MI as part of Commission Regulation (EU) No. 1004/2014 amendment published on Sept. 18, 2014. The measure is aimed at reducing the risk from and the incidence of skin allergies. 

Cyanoacrylate-based Adhesives

Health Canada has made a policy change in requirements for cyanoacrylate-based eyelash adhesives. Notifiers of cyanoacrylate-based adhesives 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, the agency said. 

Peroxide and Peroxide-generating Compounds

Health Canada updated the cautionary statements for the whitening ingredient p-Phenylenediamine and its salts in order to better reflect current use patterns for tooth whitening products. This entry was amended to include the "addition of a maximum concentration limit of 3% after dilution with an oxidizer, and addition of p-Phenylenediamine salts to the list of synonyms and related compounds."

If a cosmetic contains an ingredient which appears on the Hotlist, Health Canada has issued guidelines saying the manufacturer may be advised to:

  • Remove the ingredient from the formulation
  • Reduce the concentration of the ingredient to an acceptable level
  • Provide evidence that the product is safe for its intended use
  • Confirm that the product is labeled as required
  • Confirm that the product is sold in a child-resistant package

"Depending on the response of the manufacturer, the cosmetic may be found to be unacceptable for sale in Canada," Health Canada stated. In this case it advised: