CIR Expert Panel Issues Three Final Safety Assessments, Six Tentative, At 152nd Meeting
Partner Content: HBW article
Monday, September 30, 2019
by: Ryan Nelson

Section: Articles




Executive Summary
A group of 20 parabens and preservative mixture MCI/MI are safe for use in cosmetics under specified conditions, according to final and tentative assessments issued by the Cosmetic Ingredient Review Expert Panel at its 16-17 September meeting in Washington. HBW Insight provides an overview of the meeting and a table of panel findings.


The Cosmetic Ingredient Review Expert Panel met for the 152nd time in Washington 16-17 September.

The group used the occasion to finalize three safety assessments, advance six tentative reports and issue three insufficient data announcements (see table below).

Notably, a group of 20 parabens was deemed safe with qualifications, finalizing a report that was reopened more than two years ago to consider new data, in what proved to be a contentious process at its interface with NGO interests. (Also see "CIR Experts Close Book (For Now) On Parabens: Safe Individually Or At Sum Concentration Of ≤0.8%" - HBW Insight, 22 Sep, 2019.)

The panel also wrapped its evaluation of brown algae ingredients, determining 68 safe as currently used in the industry, while 14 others are in need of additional data to support a safety decision.

Palm- and pomegranate-derived ingredients received tentative assessments, as did mannitol, sorbitol and xylitol, skin-conditioning agents with more than 2,800 known uses in the US cosmetics sector.

The panel also tentatively found the preservative mixture methylchloroisothiazolinone/methylisothiazolinone (MCI/MI) safe for use in cosmetic products – at least those that do not represent potential for incidental inhalation – when formulated to be non-sensitizing and limited to specified maximum concentrations.

CIR’s experts elected to reopen two safety assessments that have not been revisited in the last 15 years.

The panel last considered quaternium-18 and quaternium-18 bentonite in 2003, reaffirming its 1982 conclusion that the ingredients are safe in present practices of use and concentration described in the assessment. Now the panel would like to have another look, focusing specifically on the potential for inhalation risks.

The group noted associated data gaps and specifically requested information on aerosolized quaternium-18 bentonite, according to CIR’s post-meeting announcement.

According to the Personal Care Products Council, quaternium-18 functions as an antistatic agent. Quaternium-18 bentonite is an organic modified clay compound that helps distribute or suspend an insoluble solid in a liquid. The ingredients feature in various makeup, skin-care, hair-care and personal cleanliness products, the trade group says at CosmeticsInfo.org.

PCPC’s members report decreased concentrations of use for both ingredients, and according to data from the US Food and Drug Administration’s Voluntary Cosmetic Registration Program, the ingredients’ overall use in the cosmetic industry is on the decline.

The CIR Expert Panel also decided to reopen its assessment of sulfites, which it found safe as used in 2003.

Sodium sulfite is the most used ingredient in the group, with nearly 1,700 reported uses predominantly in hair dyes and colors, based on 2019 FDA/VCRP data highlighted by CIR. Sodium bisulfate is a distant second, with 59 known cosmetic uses.

CIR’s experts decided to reopen the sulfites report based on toxicity data that has emerged since 2003 regarding genotoxicity, dermal sensitization, reproductive toxicity and “enhancement of the allergic response to dust mites,” according to the post-meeting announcement.

“Of particular interest are both the positive in vivo and in vitro genotoxicity data (mostly on Sodium and Potassium Metabisulfite) that were reviewed. The Panel noted that positive in vitro, but not in vivo, genotoxicity data are found in the published report,” CIR says.

The CIR Expert Panel’s next meeting is slated for 9-10 December in Washington.