Health Canada MI/MCI Update

On May 10th, 2016, Health Canada published an alert regarding the “Risks related to certain preservatives in cosmetic, non-prescription and natural health products”.  This posting took an extremely strong stance informing consumers about the potential risks associated with the combination of methylisothiazolinone and methylchloroisothiazolinone (MI/MCI) within leave-on consumer products.

Leave-on consumer products can be anything from skin moisturizers to diaper rash products.  According to this news update, symptoms such as itching, swelling, burning or blisters can occur when someone uses a product containing MI/MCI and may even become more severe with prolonged use.  These preservatives can also be found in rinse-off products, such as shampoos and body washes but are not subject to this regulatory action.

Health Canada has asked consumers to check the ingredient lists on product labels of their leave-on cosmetics in order to make sure that that the combination of MI/MCI is not present.  If these preservatives are found in rinse-off products and are causing sensitivity, the consumer is asked to discontinue use.  They have also provided points of contact in case of an adverse reaction related to consumer products containing this combination.  In our consulting practice we have seen very few issues with this preservative system and were surprised with the urgency of the regulatory actions taken.

Health Canada has stated that they are making several changes in order to better protect consumers and this industry.  On December 14th, 2015, they changed the Cosmetic Ingredient Hotlist to include MI/MCI in combination along with the maximum permitted concentration levels in leave-on products.  This list is created by Health Canada and contains ingredients that the government of Canada believes may cause injury to the health of the user and is in compliance with the Food and Drugs Act.  This act requires all manufacturers and importers to disclose all ingredients found in their products so that consumers can make informed choices.  As of June 14th, 2016 all products containing MI/MCI preservatives intended for use by children should no longer be available for purchase. All other products may not be available after December 31, 2016.

We hope that this information is helpful to you and your company.  If you have any questions about requirements or repercussions to your product feel free to contact Focal Point Research.  We are industry leading Health Canada Consultants and work very closely with these types of products.  You can trust FPR to help guide your company in the right direction.