CIR ‘Watchdog’ Women’s Voices For The Earth To Remain On Guard In 2021
Executive Summary
NGO says the Expert Panel for Cosmetic Ingredient Safety’s conclusion on methylisothiazolinone in 2020 was among decisions “not in the interest of public health.” However, other assessments highlighted by the group suggest that the Cosmetic Ingredient Review is working as an open forum for public input and discussion.
Women’s Voices for the Earth will continue to act as Cosmetic Ingredient Review “watchdog” in 2021, following a number of decisions last year that it believes were not in the public’s interest, the group’s director of science and research Alex Scranton says.
The NGO’s chief complaint is with the Expert Panel for Cosmetic Ingredient Safety’s reassessment of preservative methylisothiazolinone (MI), which the panel determined safe with qualifications at its September 2020 meeting.
Specifically, the CIR’s independent experts found MI safe for use in rinse-off cosmetic products at concentrations up to 100 parts per million and safe in leave-on cosmetic products when formulated to be non-sensitizing, which can be determined through a quantitative risk assessment, the panel says. (Also see "CIR Expert Panel Reaches Tentative Decision On Benzophenones, Final On Methylisothiazolinone" - HBW Insight, 23 Sep, 2020.)
In Europe, MI’s use in rinse-off cosmetics is restricted to 15 ppm, and the preservative cannot be used in leave-on products, as dictated by the Cosmetic Products Regulation.
WVE's Alex scranton, director of science and research
In her 22 February post on WVE’s website, Scranton says MI “has become well known in the last decade for causing an epidemic of skin sensitization and allergies.” (Also see "Allergy To Preservative MI “Epidemic”; U.K. Docs Urge Industry Action" - HBW Insight, 15 Jul, 2013.)
Regulations in the European Union and other jurisdictions to prohibit MI’s use in leave-on cosmetic products and permit only low levels of the substance in rinse-off products have had “incredibly fast results for public health,” reportedly reducing new allergies to MI by 50% in a matter of years, according to Scranton.
“Despite the overwhelming available evidence of success of the international bans … the CIR inexplicably chose a different decision,” Scranton says, adding, “This decision will likely lead to very few if any changes in the use of MI in US products, and as a likely result we will see continued high rates of allergy to MI, with new sensitizations in children rising.”
WVE will look to bring updated data on MI allergy prevalence in the US the CIR’s attention if and when the information becomes available.
The CIR has explained that the Expert Panel’s recommendations for MI use in cosmetic products are intended to prevent the induction of sensitization to MI. Adhering to the panel’s guidelines may not necessarily prevent the elicitation of allergic reactions in individuals who are already allergic to MI, the group says.
Thus, individuals sensitized to MI should avoid products that contain the substance, according to the panel, which has provided similar caveats in assessments of other cosmetic ingredients linked to sensitization risks.
As for the panel’s stipulation that MI can be safely used in leave-on products provided that they are formulated to be non-sensitizing, WVE maintains that such language – commonly used in CIR decisions – constitutes “a fairly vague recommendation as we see it.”
WVE no doubt will continue to closely follow CIR activities related to cosmetic preservatives safety, a longstanding issue of interest to the nonprofit. (Also see "CIR Panel Not Changing Its Mind About Parabens Safety, Renewing NGO Accusations Of Bias " - HBW Insight, 4 Oct, 2018.)
WVE Data Delivery Pays Off
WVE continues to have issues with the CIR process and what Scranton calls "inherent bias towards the needs of manufacturers" as a result of the organization's industry funding base and administration.
However, the NGO was able to inform CIR work in 2020 potentially to the benefit of public health, she says.
According to Scranton, WVE alerted the Expert Panel to cosmetic products sold by major retailers such as Sephora and Ulta Beauty that contained acetyl hexapeptide-8 amide at levels 2,000 to 6,000 times higher than the concentration identified by the CIR as the maximum level in cosmetic products, 50 ppm, based on the Personal Care Products Council’s survey of member companies.
“While perhaps not manufactured by PCPC members, these wrinkle creams are well known and have been popularized in beauty magazines and even touted by Dr. Oz on his television show as ‘Botox in a jar,’” Scranton says.
At its December 2020 meeting, the Expert Panel changed direction in its assessment of acetyl hexapeptide-8 amide to consider the ingredient’s safety at levels exceeding 0.005%, noting that the substance “may have drug activity (ie, anti-wrinkle effect)” in amounts of 10% or higher.
“The Panel agreed that a no-observed-adverse-effect-level (NOAEL) for type I and type III collagen synthesis would be needed in order to evaluate the safety of Acetyl Hexapeptide Amide in cosmetic products at concentrations > 0.005%,” the CIR says in its post-meeting announcement.
The acetyl hexapeptide-8 amide report is slated to be finalized at the Expert Panel’s 11-13 March meeting online.
According to WVE, it also swooped in with crucial data in the Expert Panel’s evaluation of methicones, surfacing new research on the respirability of droplets/particles emitted by airbrush makeup devices, “which as it turns out are very likely to be deeply respirable into the lungs,” Scranton says.
Many brands of airbrush makeup contain methicones, the safety of which will be taken up again by the Expert Panel with a coming revised draft report, according to WVE.
While the NGO paints the foregoing examples as evidence of CIR data limitations, Scranton is pleased that WVE was able to “get [the panel’s] attention on a few things” in 2020 and looks forward to continued fruitful exchanges in 2021.
The CIR’s future role and extensive body of work over 45 years could be subject to discussion in the 117th Congress, which is expected to resume negotiations around cosmetics regulatory modernization. (Also see "PCPC Leadership On US Legislative Landscape, EU Microplastic Restriction, Other 2021 Concerns" - HBW Insight, 9 Feb, 2021.)
Proposals in the previous congressional meeting included provisions for US Food and Drug Administration review of cosmetic ingredients, which stakeholders listed among the legislation’s most contentious points, along with federal preemption of state and local cosmetic requirements. (Also see "US House Cosmetics Hearing: Preemption, FDA Ingredient Review Could Be Regulatory Reform Snags" - HBW Insight, 5 Dec, 2019.)