Important Emerging Developments – Enforcement Action: Microbeads in Toiletries Regulations

Posted Date: 22-August-2019

The Court of Justice of the European Union has dismissed appeals from France and the European Commission, upholding a previous judgment that annulled the classification of titanium dioxide as a carcinogen by inhalation from powdered products. The classification, which was initiated in 2016 by the National Agency for Food, Environmental and Occupational Health and Safety (ANSES, France) submitted to the European Chemicals Agency (ECHA) a proposal for classification of titanium dioxide as a carcinogen by inhalation. ECHA adopted an opinion stating that the classification of the substance was justified. In 2019 European Commission adopted regulations proceed with the classification that substance was carcinogenic to humans by inhalation in powder form containing 1% or more of particles of diameter equal to or below 10 µm. The Court of Justice's decision confirms the annulment, concluding that the Committee for Risk Assessment (RAC) failed to consider all relevant factors when evaluating the scientific evidence. In a ruling on November 23, 2022, the General Court nullified the classification and labeling of a substance, finding that the European Commission had made a significant error. The court determined that the Commission's assessment of a key scientific study, which was the basis for the classification, was flawed. Both France and the Commission appealed this decision to the Court of Justice. However, in a judgment delivered today, the Court of Justice rejected both appeals. This means the General Court's initial ruling is upheld, and the classification of titanium dioxide as a carcinogen is annulled. EUCJ on CMR Classification

Posted By:  Linitha Ganesh

 

Environment and Climate Change Canada (ECCC) may be knocking on your door requesting access to samples and action regarding Microbeads in Toiletries Regulations.

 

As Cosmetics Alliance (CA) Canada members are well aware, the FULL prohibition regarding Microbeads in Toiletries (including both cosmetic products as well as natural and non-prescription products) has now come into effect, as of July 1, 2019.  As previously reported, we anticipate that officials will at some point likely be kicking off a cyclic enforcement program following some rather aggressive and unprecedented compliance promotion initiatives that ECCC has been pursuing over the course of the past year (as highlighted in various corresponding highlights as published in Regulatory Essential).

We would like to advise our membership that yesterday, we were advised by one of members that they received a visit from ECCC Enforcement Branch expressing concerns that products in their portfolio contained microbeads and were therefore “out of compliance” with the Microbeads in Toiletries Regulations.  In this regard, we understand that ECCC was looking to assert the following:

  • Stop Ship Order for a list of products suspected of containing prohibited microbeads
  • Request for submission of samples (for testing) for a list of products suspected of containing prohibited microbeads

 

IMPORTANT TO NOTE:

The majority of the products subject to this request were clearly OUTSIDE THE SCOPE of “microbeads of concern” as defined under the Final Order enabling the Microbeads in Toiletries Regulations, in that the products in question were not at all related to exfoliating or cleansing products.  As recommended previously (see Regulatory Essentials Communiques – June 14, 2017 and September 19, 2018; members-only website), members are encouraged to object to any scope of action that goes beyond the ‘microbeads’ of concern as reflected in the corresponding guidance to the Final Order (i.e. Regulatory Impact Assessment).

 

Specifically,

“Plastic Microbeads of concern are solid plastic particles that are less than or equal to 5 mm (in the largest external dimension) which are added to personal care products to exfoliate or cleanse the human body” [Final Order Adding “Microbeads” to the List of ‘Toxic’ Substances under EPA – Canada Gazette II, Vol. 150, No. 13, June 2016]

 

Therefore, the request being made by the enforcement officers were NOT in line with the scope of their authority and should NOT be applicable to any such action.

 

WHAT MEMBERS NEED TO DO

 

BE PREPARED FOR A VISIT!

 

This is likely to be the first of many similar points of action – as we know officials are keen to pursue these compliance activities.

 

The process by which officials decide whether or not they visit your site is not clear; however, based on past precedent, you may be singled out because:

 

  1. Compliant identifying a product attributed to your company as to ‘containing’ microbeads
  2. Random on-shelf product audits by ECCC compliance officers
  3. Random/partially random selection by ECCC based on a number of other factors

 

As recommended previously…

 

MEMBERS ARE ENCOURAGED TO CONSIDER THE FOLLOWING:

  • Prepare a formulation defense narrative that addresses why your formulas do not contain any “microbeads of concern” as per the original intent of the CEPA Schedule 1 Listing, specifically:
      • “Plastic Microbeads of concern are solid plastic particles that are less than or equal to 5 mm (in the largest external dimension) which are added to personal care products to exfoliate or cleanse the human body” [Final Order Adding “Microbeads” to the List of ‘Toxic’ Substances under EPA – Canada Gazette II, Vol. 150, No. 13, June 2016]
      • Members are encouraged to review the list of substances that appear in the appendix to the “microbeads” test method as previously circulated to help identify substances that may be targeted (as previously reported September 19, 2018 – Regulatory Essentials)
      • Recall that bio-polymers that meet the definition of “microbeads” (per above) are NOT exempt; although members may wish to consider providing evidence to justify that these uses would ‘biodegrade’ in aquatic environments and therefore should not be subject to these risk mitigation efforts
  • Work with Legal Counsel (as appropriate) to identify key observations to reflect on (if challenged) regarding your approach to the management of “microbeads of concern” as per the underlying intent of the Regulations and the commitment as articulated by ECCC officials in representations before CA membership regarding their intent to model the scope of actions to be similar to those delivered in the corresponding US Federal Legislation (i.e. product in Canada intent to meet both the Canadian and US regulatory construct – underpinning the legislative approaches taken in both jurisdictions)
      • For members who have attended the multitude of CA Canada/CCTFA Regulatory or PCPC Workshops over the course of the past three or so years, whereby this topic has been addressed many times; recall that the key message from ECCC policy representatives was that the intent of this action was to be ‘consistent and in-line’ with the scope of action as per the US Microbeads Free Waters Act – which is also intended to be limited to microbeads used to exfoliate or cleanse the human body.
  • Recall, in the consultation leading up to the finalization of the “Listing Name” ultimately reflected under Schedule 1 of CEPA, officials made it clear to CA Canada that this Schedule was a “list of substances” and as such, it was not in their purview to include ‘functionality or use’ to further qualify this listing.  This is the reason why we and other parties insisted that these details be integrated in corresponding policy guidance (i.e. explanatory note, specifically outlining the “microbeads of concern” subject to the Order)

 

NOTE:  The above recommendations are not intended to be comprehensive, but rather are intended to initiate further dialogue.  Furthermore, none of the observations outlined reflect legal advice of any kind.  Members are encouraged to discuss any actions with their respective Legal Counsel in the event of any C&E activities that may implicate individual products/formulations.

 

IF YOU RECEIVE A VISIT IN THIS REGARD – PLEASE LET US KNOW (e-mail: regulatory@cosmeticsalliance.ca)

 

In the interim, we will be looking to work with ECCC officials to clarify and manage the scope of these actions to those “microbeads” of concern as intended to be subject to this regulatory action.

 

If you have any questions or would like to discuss these developments in further detail, please do not hesitate to contact your Cosmetics Alliance Regulatory Team (regulatory@cosmeticsalliance.ca)