***** IF YOU MANUFACTURE NAIL POLISH OR NAIL CARE PRODUCTS – PLEASE REVIEW THIS MEMBER UPDATE *****
This past weekend (August 4, 2018), Environment and Climate Change Canada (ECCC) and Health Canada (HC) published their DRAFT SCREENING ASSESSMENT REPORT (DSAR)] and RISK MANAGEMENT SCOPING DOCUMENT (RM Scope) for BENZOPHENONE (CASRN: 119-61-9). We have also taken the liberty to attach the corresponding Public Information Summary that was published in conjunction with these documents.
PROPOSED CONCLUSIONS:
The draft assessment concludes that benzophenone be proposed to be ‘CEPA-Toxic’ on the basis of concerns that it may present a potential human health risk. The assessment affirms that benzophenone as a potential CMR substance (based on evidence that benzophenone is carcinogenic in rodent models) and outlines critical concerns with potential renal toxicity from a non-cancer perspective. These conclusions are consistent with the recent scientific scrutiny of this substance both domestically and abroad. On this basis, these conclusions are not surprising.
Although benzophenone occurs naturally and is used in a wide variety of applications, this draft assessment isolates concerns with only two specific use scenarios – use in cosmetics and use in paints and coatings. In both these use scenarios, a comparison of worst-case estimates of exposure associated with nail polish and interior paint with critical effect levels of concern are demonstrated to result in margins of safety that are inadequately protective.
The assessment also concludes that benzophenone does NOT present a risk to the environment nor is it entering the environment in quantities that pose a risk to ecological health.
NOTE: This is only a DRAFT assessment and as such, these proposed conclusions are subject to further consultation (see below). On this basis, it is early in the CMP publication process, and there will be significant opportunity for follow-up and scientific engagement, moving forward.
PROPOSED RISK MANAGEMENT:
On this basis, it is proposed that risk mitigation measures addressing both of these use patterns be considered. Specific to the nail polish use, Health Canada will consider the following risk management options:
- Designation of an appropriate RESTRICTION via addition to the Canadian Cosmetics Ingredient Hotlist (note: the attached synopsis and information sheet is generic and simply reports consideration of addition of benzophenone to the “Hotlist’; Cosmetics Alliance was notified by HC that the intent at this time is to limit their action to a product restriction, rather than an outright prohibition)
- Designation of a Significant New Activitiy Notice (SNAc) for ‘new’ uses/activity in cosmetics that would require information to be submitted prior to such new uses/activities to enable an assessment as to whether or not they would need to be managed, accordingly
- Specific risk management details will be finalized following publication of the Final Screening Assessment (scheduled for late Q1 2019), assuming these proposed conclusions are maintained, following consultation.
IMPLICATIONS:
The focus of any corresponding risk management activities from a cosmetic perspective will be on the use of this substance in NAIL POLISH. Consequently, the impact of these publications should only implicate those members that manufacture/import nail polishes containing benzophenone.
Furthermore, the scope of this assessment is specific to benzophenone as a discrete substance (CASRN: 119-61-9), and does not extend or apply to other benzophenone derivatives. This is important as it would NOT be appropriate to extend these conclusions in any way to other benzophenone derivatives that may be of interest from a cosmetic/personal care perspective.
NEXT STEPS:
- Following official publication of these documents this weekend, Cosmetics Alliance will be issuing a member brief (issue update) summarizing these developments. A courtesy copy of this update will be shared with the Allied Beauty Association (ABA), the Direct Sellers Association (DSA), Food and Consumer Products of Canada (FCPC) and the US Personal Care Products Council (PCPC)
- We will also update our international trade association partners of these developments, indicating the very limited scope of these publicaitons
- Monitor corresponding developments for possibilities of expansion in scope of coverage to other derivatives
FOR NAIL POLISH SPONSORS THAT MAY BE DIRECTLY IMPACTED:
- Cosmetics Alliance will undertake a detailed science review to investigate the possibilities of further engagement on the risk assessment
- In the interim, if you have any questions or concerns with the proposed risk assessment, please share your thoughts with your Cosmetics Alliance Team
- These publications are subject to a 60-day formal comment period which will come due October 2, 2018. Pending the outcomes of our internal review and input from our members, Cosmetics Alliance will consolidate feedback for submission, as appropriate
Note: Given the now confirmed limited scope of these publications, Cosmetics Alliance will not be producing any proactive, external communication materials regarding these pending publications.
Please do not hesitate to contact your Cosmetics Alliance Regulatory Team if you have any questions or would like to discuss these new developments in further detail.
