Cyclical Enforcement Project 2015-16: Cosmetic Regulations

Fiscal Year 2015/2016

Summary

The Consumer Product Safety Program (CPSP) administers and enforces the Cosmetic Regulations under the Food and Drugs Act.

The purpose of this Cyclical Enforcement (CE) project was to verify industry's compliance of cosmetic products containing methylisothiazolinone (MI) and the combination of methylisothiazolinone/methylchloroisothiazolinone (MI/MCI) with current Cosmetic Ingredient Hotlist ("the Hotlist") restrictions through sampling and testing of cosmetic products. In addition, the project aimed to verify industry compliance with the requirements for notification and labelling and any other relevant requirements under the Food and Drugs Act and the Cosmetic Regulations.

For this project, compliance of select cosmetic products with current Hotlist restrictions for MI/MCI was determined through a sampling and testing process by which Health Canada inspectors visited establishments and sampled relevant products. Compliance to the Hotlist requirements was then verified through testing at the Product Safety Laboratory.

Prior to initiating this CE project, the CPSP carried out a market survey to identify cosmetic companies in Canada. Targets were then selected from that list of companies.

Over the course of the 2015/2016 fiscal year, testing of forty-two different products for MI and MI/MCI in combination and assessment for compliance with the labelling and notification requirements was carried out. The project resulted in one recall, one stop distribution and eight voluntary commitments to address non-compliance. There were thirty-two instances where no corrective action was required.

Results

Readers should consult the individual recall notices, if applicable, for details of the products subject to this enforcement action.

The explanation of "Determination" for this CE project is as follows:

• "Notification" means at the time of inspection, Health Canada had not received a notification from the manufacturer/importer that the product was being sold in Canada. As per the Cosmetic Regulations, notifications must be submitted within 10 days of first sale of the product in Canada.
• "Labelling" means that the labelling was missing, incorrect, incomplete or required modification to be compliant.
• "Hotlist" means that the product contained a Hotlist ingredient which required follow-up such as confirmation of the concentration in the product, addition of warning statements, submission of information, or reformulation of the product.
• "No Issues" means that no non-compliances related to notification and labelling and Hotlist issues were identified.

Disclaimer: A systematic bias is applied during inspection and sampling. Products are not randomly selected but are chosen because they are deemed by the inspector to be more likely to not meet health and safety requirements due to characteristics that are observed.  Due to this biased nature of sampling and the fact that sample sizes within CE projects are very small, the findings of CE projects are not intended to reflect overall market compliance unless otherwise stated. Note that these summary reports relate only to the product(s) actually tested and the specific criteria indicated.  Testing by Health Canada does not represent approval or endorsement of the product(s).

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