What we examined (see Focus of the audit)

This audit examined the extent to which Health Canada’s Consumer Product Safety Program was working to protect the public by addressing or preventing dangers to human health and safety posed by chemicals of concern in household consumer products and cosmetics. Specifically, we examined the Program’s detection and rapid response activities.

Why we did this audit

This audit is important because effective oversight of products containing chemicals of concern is essential to protect the health and safety of Canadians.

What we concluded

We concluded that Health Canada’s Consumer Product Safety Program could not fully assure Canadians that its post-market oversight activities were working to protect the public by addressing or preventing dangers to human health or safety posed by chemicals of concern in household consumer products and cosmetics.

What we found

Detection of risks to human health

Overall, although we found that Health Canada made progress in improving its oversight approach, we found a number of information gaps that limited the Consumer Product Safety Program’s ability to detect and assess risks to human health and safety posed by chemicals of concern in consumer products and cosmetics:

• The Department had not assessed the scope and magnitude of risks associated with international e-commerce, and its oversight of the growing e-commerce market was very limited.
• The Department had not assessed the scope and magnitude of the health and safety risks posed by counterfeit consumer products and cosmetics, despite concerns raised in Canada and internationally.
• The Department does not regularly test cosmetic products to verify the accuracy of product labels or to check for the presence of prohibited substances, microbial contaminants, and heavy metals.
• The chemical components of cosmetic ingredients characterized as “parfum,” “aroma,” “fragrance,” or “flavour,” which might contain chemicals of concern, are not required to be disclosed to Health Canada or consumers.
• In contrast to consumer products, where industry is required to report health and safety incidents to Health Canada, there is no legal requirement to report such incidents related to cosmetic products.

These findings are important because the information gaps we identified limited Health Canada’s ability to prevent, detect, assess, and respond to potentially important threats to human health and safety posed by consumer products and cosmetics. They also mean that consumers have less information upon which to make informed choices to protect their health and safety.

• Health Canada improved its oversight approach

  Recommendation. We made no recommendations in this area of examination.

• Information gaps limit Health Canada’s ability to detect and assess risks to human health and safety

  Recommendation. Health Canada should:

  • assess the scope and magnitude of risks posed by e-commerce products, and
  • inform consumers and retailers about the risks and the limitations of regulatory oversight and recourse in these areas.

  Recommendation. Health Canada should:

  • assess the scope and magnitude of health and safety risks posed by counterfeit products, and
  • inform consumers and retailers about any significant risks identified.

  Recommendation. Health Canada should inform consumers that it does not regularly test cosmetic products for prohibited and restricted substances, microbial contamination, and heavy metals.

  Recommendation. To improve Health Canada’s ability to detect and assess risks, and to provide information to consumers so that they can make informed choices, the Department should:

  • do product testing to determine the extent to which cosmetics include prohibited and/or unsafe concentrations of substances under the labels “fragrance,” “parfum,” “aroma,” or “flavour”;
  • consider options to encourage manufacturers to provide the Department, on a confidential basis, with the complete list and concentrations of substances that comprise ingredients listed under these terms; and
  • inform consumers that marketing terms such as “hypoallergenic,” “preservative-free,” “fragrance-free,” and “unscented” should not be confused with health and safety claims.

Response to incidents and regulatory violations

Overall, we found that Health Canada could not demonstrate rapid response in some critical areas. While we found that prioritization and assessment of incident reports were well managed and generally timely, the Department did not know whether industry was respecting the legislated timelines to ensure rapid reporting of potential health and safety incidents, and for submitting cosmetic notifications. It was also slow to respond to cosmetic notifications that included prohibited substances, and slow to follow up on product recalls to confirm that non-compliant products were no longer available to Canadians.

It is important that Health Canada fulfill its commitment to ensure rapid response to incidents and regulatory violations, to minimize the time that Canadians are exposed to dangerous products, and to hold industry accountable for non-compliance.

• Health Canada managed the initial assessment and prioritization of safety incident reports efficiently

  Recommendation. We made no recommendations in this area of examination.

• Health Canada did not ensure industry compliance with reporting requirements for health and safety incidents and cosmetic notifications

  Recommendation. To assist the Department in tracking compliance and prioritizing its oversight and response activities, Health Canada should:

  • verify the extent of industry compliance with incident reporting requirements for consumer products, and
  • update its cosmetic notification form to request voluntary disclosure of the actual or expected date of first sale in Canada.

• Health Canada was slow to respond when cosmetic notifications included prohibited substances

  Recommendation. Health Canada should improve its follow-up on cosmetic notifications with prohibited substances by verifying that companies have implemented corrective actions and that non-compliant products are no longer available to Canadians.

• Health Canada was slow to confirm compliance after requesting product recalls

  Recommendation. Health Canada should improve the verification of product recalls and the documentation of overall recall effectiveness.

Verifying effectiveness by measuring results

Overall, we found that the mechanisms Health Canada had in place to measure results were not sufficient to verify the effectiveness of the Consumer Product Safety Program. Specifically, the Program could not demonstrate that it was achieving expected results in:

• addressing or preventing dangers to human health and safety,
• reducing adverse health incidents, and
• ensuring industry compliance with regulatory reporting and product safety requirements.

This finding is important because it is through measuring results that Health Canada can demonstrate the success of its Consumer Product Safety Program in protecting Canadians from chemicals of concern in household consumer products and cosmetics. This is essential to enable the Department to:

• understand which oversight activities are working and which are not;
• verify where there may be opportunities to improve the Program’s economy, efficiency, or effectiveness; and
• provide assurance to parliamentarians and Canadians that expected outcomes are being achieved.

• Health Canada had not measured whether its Consumer Product Safety Program was achieving expected results

  Recommendation. Health Canada should ensure that it collects the data needed to answer fundamental questions about Consumer Product Safety Program effectiveness, including whether:

  • industry compliance with key regulatory requirements is improving, declining, or staying the same;
  • the Program’s oversight approach is working to reduce adverse health incidents; and
  • the Program’s oversight approach is working to address or prevent dangers to health and safety from chemicals of concern in consumer products and cosmetics.

Entity Responses to Recommendations

The audited entity agrees with our recommendations, and has responded (see List of Recommendations).

Related Information

Report of the	Commissioner of the Environment and Sustainable Development
Type of product	Performance audit
Topics	Health Safety and Security Toxics
Audited entities	Health Canada
Completion date	31 March 2016
Tabling date	31 May 2016
Related audits	N/A

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