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A few members have recently approached CA Canada regarding a possible escalation of enforcement attention on synthetic waxes (or waxes) as Microbeads.
As members are aware, Microbeads in cosmetics and personal care products are regulated under Canada’s Microbeads in Toiletries Regulations (published 2017).
As a reminder, under these Regulations:
- La fabrication et l'importation de produits d'hygiène (cosmétiques) contenant des microbilles sont interdites depuis le 1er juillet 2018.
- La fabrication et l'importation de produits d'hygiène personnelle (médicaments/produits de santé naturels) contenant des microbilles sont interdites depuis le 1er juillet 2019.
Recall, that these Regulations are intended to target specific Microbeads (in line with similar Legislation then passed in the US under their Microbeads Free Waters Act)
Specifically, the regulated Microbeads in Canada are:
“The plastic microbeads that are the focus of these Regulations are solid plastic particles known to be equal to or less than 5 mm in size (in the largest external dimension) that are added to toiletries, including non-prescription drugs and natural health products… and intended to exfoliate or cleanse the human body” [Microbeads in Toiletries Regulation, 2017]
In 2019, 2022 and 2023, CA Canada issued a number of member updates regarding targeted Environment and Climate Change Canada (ECCC) enforcement activity regarding microbeads, in addition to ensure members were aware of the publication (following significant pressure by CA Canada and other stakeholders for greater transparency around this testing methodology) of the internal Test Method 623.1 (2023) that ECCC had developed to support their compliance and enforcement activities regarding these Regulations.
For ease of reference, members are directed to the corresponding CA Canada communications (links available via our CA Canada Member Portal):
- Publication of ECCC Microbeads Test Method [Décembre 2023]
- ECCC Blitz on Microbeads [Novembre 2022]
- Preparing for Compliance Enforcement – Microbeads in Toiletries Regulation [Octobre 2019]
EMERGING DEVELOPMENT – WHAT MEMBERS NEED TO KNOW
ECCC Microbeads Test Method 623.1 (2023) outlines a “List of Common Plastics in Toiletries” [Table 1] and a supplemental “List of Other Possible Plastics in Toiletries” [Table 2]. These are the specific substances that CA Canada understands ECCC will likely target when verifying compliance. You will note that synthetic waxes and waxes in general are NOT included in either of these Tables. This is important, as these substances are not considered to be plastic, nor has any evidence been presented to suggest that the use of these substances contribute to ‘microbead litter’, as intended to be address by the Regulations. On this basis, synthetic wax(es) and wax(es) have been understood to be out of scope of these Regulations.
Contrary to this general understanding, it would appear ECCC may now be looking to broaden its enforcement approaches on products that identify ‘synthetic wax’ or maybe even ‘wax’ within ingredient listings. Given the above representations, this is a very concerning development that members need to be aware of and prepare for, as this could have significant implications on our member’s product portfolios.
VERY IMPORTANT NOTE: Although synthetic waxes/waxes are very common ingredients across our industry, the large majority of uses of these ingredients fall OUTSIDE of exfoliating and/or cleansing products – which are the intended target of the Microbeads in Toiletries Regulations. Corresponding, any compliance and enforcement activity related to these emerging developments should be limited to the key parameters that define the “microbeads” that are subject to these Regulations.
POSSIBLE RATIONALE FOR INCREASED SCRUITY OF SYNTHETIC WAXES/WAXES
A long time has passed since the original representations industry and other stakeholders advanced in relation to these Regulations. When ECCC was developing their test method, CA Canada expressed significant concerns with the possibility that the processing of test samples could yield significant false positives (e.g., creating solid particles, not otherwise present in the finished formula; or revealing analytical artefacts suggesting the presence of a plastic, when a substance is in fact not plastic, as would be the case for waxes). Differentiated and unique properties of waxes relative to plastics suggest that these substances would behave very differently in the environment, and as such, should be outside of scope of related risk management.
In 2019, our industry’s Global Plastics Task Force (GSPPTF, headed up at the time by PCPC), prepared a white paper seeking to address the differentiation between microbeads, polymers, and waxes (including both analytical and chemical rationale outlining how waxes are differentiated from plastics per se). CA Canada was a contributing member to this Task Force. This paper was originally developed in relation to developments in Taiwan, wherein a similar test method to that which ultimately ECCC adopted, was being developed. The purpose of this paper was to outline the technical challenges with the test method, including how analytical instrumentation choices can mistakenly reveal that a sample contains polyethylene, when in fact, the substance is a synthetic wax. Importantly, based on these discussed with ECCC policy makers at the time, we understand that it was understood that synthetic waxes/waxes were not plastic per se, and therefore unique and distinct from polyethylene, as one might believe on a cursory overview of certain analytical spectra. Correspondingly, these substances do not appear on either Tables 1 or 2 of common or possible plastics in cosmetics as referenced in ECCC Test Method.
Without taking these analytical nuances into account, it is possible (or even likely) that ECCC officers are acting on the premise that they have found ‘polyethylene’ in a product (regardless of it not appearing in ingredient listings), wherein, further analytical verification (using different analytical instrumentation) would reveal that the substance is in fact synthetic wax (as openly declared on ingredient labels).
This GSPPTF white paper is attached for your review. Kindly note that this paper is shared in confidence, as supporting technical documentation for member awareness only. We would respectfully ask that this paper not be shared externally for any use (beyond internal awareness purposes), and that any other use, reproduction, repurposing, or redistribution of this paper be first authorized by the Global Plastics Task Force, PCPC and individual Trade Associations contributing to the paper. In sharing this white paper, members are encouraged to explore the underlying technical rationale and corresponding lines of scientific evidence that help to delineate why synthetic waxes and waxes are chemically distinct from the plastics/microbeads of concern and therefore, considered outside the intended scope of these Regulations.
PREPARATIONS IF ECCC ENFORCEMENT KNOCKS AT YOUR DOOR – WHAT MEMBERS NEED TO DO
As previously outlined in 2019 and 2022, CA Canada continues to encourage members to remain vigilant with their microbeads compliance programs.
PRÉPAREZ-VOUS À RECEVOIR DE LA VISITE !
In this case, members are encouraged to survey their portfolios to understand potential products that may be pursued [Final Order Adding “Microbeads” to the List of ‘Toxic’ Substances under CEPA 99’ – Canada Gazette II, Vol. 150, No. 13, Juin 2016] (bolded and underlined considerations for emphasis).
- ACTION: Look for synthetic wax(es) or wax(es) in your product databases and/or ingredient listings
In assessing your portfolios, keep in mind the following:
- The microbeads of concern (as outlined in the Microbeads in Toiletries Regulations under CEPA)
“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”
- Implicated “Toiletries” are
“… any personal hair, skin, teeth or mouth care products for cleansing or hygiene, including exfoliants and any of those products that is also a natural health product as defined in the Natural Health Products Regulations or a non prescription drug”.
IMPORTANT NOTE: Focus on any potentially implicated products that are intended to exfoliate or cleanse the human body.
- ACTION: Prepare your compliance rationale
As we have previously recommended, members are encouraged to proactively prepare a formulation defense narrative that:
- Addresses why your formulas that contain synthetic wax(es) or wax(es) are not subjected to the regulations
- Why it is possible that ECCC Test Methods may suggest that polyethylene may be present in your formula
- Consider analytical testing using alternative analytical instrumentation to further demonstrating the absence of polyethylene or any other solid plastic in your formula
Finally, CA Canada again recommends that working with your Legal Counsel (as appropriate) to summarize your approach to the management of any “microbeads of concern” within your product portfolio (including considerations of synthetic waxes/waxes) in order to demonstrate your commitment to the underlying intent and understanding of the scope of applicability of the Regulations.
CA CANADA ENGAGEMENT
At present, CA Canada has only been made aware of only a few enforcement incidences regarding these substances. We have outreached to ECCC officials to confirm the policy intent as reviewed above, and to our knowledge to date, no policy shift or change in intent has been affirmed or signaled. We continue to pursue this dialogue with officials, including enforcement officials to clarify intent and ensure compliance and enforcement actions in line with the intended policy. We will continue to appraise members of any corresponding developments.
In the interim, members are encouraged to prepare accordingly, and please notify CA Canada in the event of any increased scrutiny that you may experience regarding this topic or any other ECCC compliance and enforcement activity.
