Revised Restriction and New Prohibition of Methylisothiazolinone in Cosmetics

Posted Date: 11-July-2018

Updates to the UK Cosmetics Regulation Notified to WTO (Benzophenone-3)

It has come to Cosmetics Alliance’s attention that Health Canada’s Consumer Products Safety Directorate (CPSD) has begun issuing an “Industry Update Email” pertaining to methylisothiazolinone (MI) in cosmetics.  This update follows the recent amendments to the Canadian Cosmetic Ingredient ‘Hotlist’, as published and circulated to members, June 2018

If you manufacture, import, distribute, wholesale or are otherwise responsible for cosmetic products that contain or may contain MI in Canada, please review this important update.

 

No transition provisions were included with the Final Amendment on June 14, 2018 (despite CA’s recommendation to ensure that such provisions be clearly outlined).  This has been the subject of CA’s follow-up activities, as clearly it would be unreasonable for in-market products to be ‘instantaneously put out of compliance’ with this publication.

 

Only those members with products notified in the CNS as containing MI should receive this INDUSTRY UPDATE E-MAIL.

 

Members should consider this CPSD communique as an initial courtesy notice, to affirm awareness of these changes to the Hotlist.

 

Although corresponding compliance enforcement action may not be imminent at this time, members need to consider the following:

 

  • Develop and implement a compliance action plan to address product compliance in light of this new guidance as soon as possible
    • Recommend that this plan reflect any proactive planning that members may have already been or are in the process of pursuing (since becoming aware of the original Notice, and certainly since earlier this year, when it was signaled that the proposal would be finalized as recommended)
    • Be prepared to proactively share details of these and corresponding commitments, as appropriate (either through a formal response to this Notice, or if/when asked)
    • If pursuing a formal response, recommend at a minimum (with the base objective to confirm awareness of these developments and commitment to compliance action as members deem adequate and appropriate)
      • Acknowledge receipt of e-mail
      • Confirm awareness of amendments and new guidance
      • Confirm intent to engage with appropriate compliance activities

 

  • Submit, as appropriate, any updated notifications per Section 31 of the Cosmetic Regulations (statutory obligations), including
    • Notice of discontinuances for products no longer on market
    • Amendments reflecting product reformulations, as appropriate

 

  • Establish a plan in consultation with vendors to clear pre-existing stock (thereby minimizing potential business losses)
  • Be prepared to update existing product safety dossiers that leverage CIR assessment and existing post-market experience as evidence for compliance with the General Prohibition and justify an orderly transition to the revised guidance, as appropriate
  • Follow-up with Cosmetics Alliance with input on what would be an appropriate, realistic and reasonable transition period to procure and/or update formulations and clear existing stock (see below).NOTE:  Given that Health Canada’s e-mail is a courtesy notice, a formal response (outside of any statutory obligations, as outlined above) is not necessary.  Any follow-up engagement would be at the discretion of individual members.  Proactive engagement with Health Canada is encouraged, as this could build good will in line with the cooperative spirit that officials are seeking regarding these compliance activities.
  • CA will continue to pursue additional guidance for members providing greater certainty and predictability in transitional considerations, recognizing a tiered compliance approach, as outlined in our discussions with officials.  This guidance will facilitate members’ internal compliance activities and external interactions across the supply chain.

 

  • In an effort to work collaboratively with officials, CA will be issuing a Member Survey to determine reasonable timelines to manage/update product portfolios and to clear existing stock from the marketplace.  We encourage members to complete this survey to help ensure that we have a comprehensive understanding of transitional recommendations for HC to consider
  • We will continue to work with CPSD to ensure that we are aware of and engaged in their follow-up compliance promotion activities. We will keep Members informed of any developments.