Health Canada Enforcement Actions (MI & MCI)

If your company currently uses the ingredients methylisothiazolinone (MI) and/or methylchloroisothiazolinone (MCI), you need to be aware of recent Health Canada enforcement actions for products containing these substances.

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ISSUE – HEALTH CANADA ENFORCEMENT ACTIONS (MI & MCI)

Although Health Canada formally added restrictions for both of these ingredients to the Hot List as of December 14th, 2015, they did not advise stakeholders nor build into the formal Hot List amendment an implementation process as specifically requested by the CCTFA and various brand owners.

Late last week (Friday, January 29, 2016), CCTFA learned that Health Canada’s Consumer Product Safety Directorate (CPSD) has initiated two parallel projects (highlighted below) related to MI and MCI.

The CCTFA is therefore notifying our membership of these emerging developments on an urgent basis to ensure that ALL our members are aware of these activities by Health Canada, and of the actions, we are taking in response.

By way of background, restrictions for MI & MCI were added to the Canadian Hot List based on concerns with the potential allergenic risk that these ingredients may pose to consumers.  Health Canada’s decision to add these ingredient restrictions to the Hot List follows similar actions in other jurisdictions including the European Union where these ingredients have already been restricted.  They are also now currently being reviewed by the U.S. FDA.

HEALTH CANADA’s TWO PARALLEL ENFORCEMENT PROCESSES

1. Notice to Notifiers of Cosmetic Products Containing MI and/or MCI

If you have filed a cosmetic notification for a product containing MI and/or MCI you should receive shortly (if you have not already) a Notice outlining CPSD’s compliance expectations regarding products containing MI and/or MCI. CPSD has indicated to CCTFA that they have been sending out these Notices over the course of the past couple of weeks – but it is possible that members may not yet be in receipt of these important communiques.

Health Canada’s expectation for compliance came into effect on December 14, 2015 (when the official Hotlist Amendment was posted) – despite only just being communicated to stakeholders now (late January 2016).   Obligations moving forward include:

• STOP DISTRIBUTION of products no longer complying with the newly revised restrictions for MI and/or MCI.
• Ensure that non-compliant products do NOT RE-ENTER the Canadian supply chain.
• Notify Regional Enforcement Officers outlining a COMPLIANCE PLAN to quarantine and dispose of non-complaint product(s), and signal intent to submit an notification amendment (re-formulation or discontinuation), as appropriate. Product already in distribution channels or on retail shelves will be subject to a 6-month sell-through period (from the official posting date of the amendment, i.e. May 14, 2016).

2. Compliance and Enforcement, Cyclical Enforcement Program (MI and MCI)

Concurrently, a few members may have received a Notice from their Regional Enforcement Office indicating that they have been selected to take part in a project under the CPSD’s Cyclical Enforcement Program looking at specific products that may contain MI and/or MCI. This project is INDEPENDENT of the activities outlined under #1 above, although it has been clarified that outcomes of this work could lead to enforcement provisions that are identical to those activities highlighted above. As per normal practice, due to the nature of these audits, no advanced communication was provided to any impacted stakeholders.

A small number of Notifiers with products containing MI and/or MCI were selected for compliance audits to be conducted prior to the end of January 2016 (15 sites; approx. 2 sites/region) for a representative national sampling. As part of this audit, select product containing MI and/or MCI would be requested and analyzed for compliance. Based on these audits, 3 possible outcomes could materialize:

• Product found to be non-compliant with the previous Hotlist restriction. Under these circumstances, serious enforcement action will be taken; leading to an immediate stop distribution and recall order.
• Product is in compliance with previous Hotlist restriction but now considered non-compliant with the revised restriction. Under these circumstances, similar action, in line with the Notifier obligations outlined under #1 above will be ordered.
• Products in compliance with present restriction, resulting in no further action.

This project was slated to be completed by the end of January, and no indications have been provided by CPSD that would indicate that additional samplings would be considered under this program, at least for this fiscal year (ending March 2016). It is possible, that a similar program may be contemplated for the 2017 fiscal year.

IMPLICATIONS & CONCERNS FOR CCTFA MEMBER COMPANIES

The CCTFA has identified the following implications for our member companies and has conveyed these concerns to Health Canada from which we are now seeking some redress:

• This Notice was delivered almost 2 months following the official posting of the Hotlist amendments; effectively truncating the practical sell-through period to a 4-month window. These transition provisions should have been integrated into the official Hotlist amendment, as was formally requested by the CCTFA.
• There is no provision to reformulate or deplete existing inventories (apart from those already in distribution channels or on retail shelves). Given that the risk being mitigated is not immediate or considered to be ‘serious’, greater flexibility should be afforded to support a more progressive transition plan.
• Requirements for quarantine and disposal can lead to significant economic loss which may not be justified on the basis of the risk identified.
• Communications have been ineffective with Health Canada proceeding with individual notices (letters) rather than a general advance notification.

Consequently, the CCTFA is seeking revisions from Health Canada to their implementation schedule.

WHAT WE NEED FROM YOUR COMPANY

It would assist our negotiations with Health Canada officials if we could have the following feedback from your company as soon as possible:

• Confirm with CCTFA receipt (or non-receipt) of the Notice to Notifiers as outlined above
• Provide, if you are able, on a confidential basis, some analysis or estimate of the monetization of potential losses from the quarantine and disposal of already manufactured/imported product not able to be sold through; and
• Forward any insights or experience that your company may have had with the transition provisions in other jurisdictions.

In the interim, members should note that the current compliance/enforcement expectations as outlined in the attached Notice template remains the most current guidance to industry (until the implementation of any policy changes that may materialize as a result of CCTFA’s current efforts).  On this basis, members are advised that the current Stop Distribution Order and sell-through window (ending May 14, 2016) are in effect until notified otherwise.

Reprinted with permission from CCTFA

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