Health Canada informing Canadians of risks related to certain preservatives in cosmetic, non-prescription and natural health products
- Starting date:
- May 10, 2016
- Type of communication:
- Information Update
- Cosmetics, Drugs, Natural health products, Affects children, pregnant or breast feeding women
- Source of recall:
- Health Canada
- Identification number:
- What you should do
- Report health or safety concerns
- Related AWRs
- Media enquiries
- Public enquiries
- What Health Canada is doing
Health Canada is informing consumers of potential risks related to the combination of methylisothiazolinone and methylchloroisothiazolinone (MI/MCI) used as a preservative in certain leave-on cosmetic, non-prescription and natural health products. Examples of leave-on products include skin moisturizers, massage products, make-up, antiperspirants/deodorants, sunscreen lotions, antiseptic cleansers, topical pain relief, acne creams and diaper rash products.
For some people, use of these substances can lead to symptoms including:
- a red rash or bumps;
- itching (which may be severe);
- swelling, burning, or tenderness of the skin;
- dry, cracked or scaly skin; and/or
- blisters (draining fluid and crusting).
These symptoms may occur each time someone uses a product containing MI/MCI and may become more severe with repeated use.
These preservatives are also used in rinse-off products, such as shampoos and shower gels. Based on current information, there are no identified risks with the use of MI/MCI in rinse-off products when concentrations are at or below levels currently permitted in cosmetics.
What you should do
Consumers should check the ingredient list on the product labels of their leave-on cosmetic, non-prescription or natural health products to verify whether the combination of MI/MCI is present. Consumers who experience sensitivities or allergic reactions to products containing MI/MCI should avoid using products that contain this preservative.
Report health or safety concerns
If you experience an adverse reaction related to a cosmetic product, or a non-prescription or natural health product, report it to Health Canada as well as the establishment where the product or service was purchased.
What Health Canada is doing
On December 14, 2015, Health Canada amended the Cosmetic Ingredient Hotlist entry related to MI/MCI. The Hotlist is a list of ingredients that 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.
After June 14, 2016, all products intended for use by children under the age of three that contain MI/MCI should no longer be available for purchase. All other leave-on products containing MI/MCI should no longer be available for purchase after December 31, 2016.
Health Canada will monitor the marketplace for information about health or safety concerns involving products with MI/MCI. The Department will follow up with companies if their products are related to an incident and will take compliance and enforcement actions where appropriate.
Under the Food and Drugs Act (FDA) and its Regulations, manufacturers and importers are required to disclose all ingredients on cosmetic, non-prescription and natural health product labels so consumers can make informed choices.
- Date modified: