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Keeping Watch on the Cosmetic Ingredient Review

Allergen MI found in cosmetics

Keeping Watch on the Cosmetic Ingredient Review

Alex Scranton
Director of Science
and Research

Cosmetic Ingredient Review (CIR) 2020 wrap-up.

For many years, WVE has played the role of watchdog to the Cosmetic Ingredient Review – (CIR) an industry run “expert panel” whose mission is to “assess the safety of individual ingredients as used in cosmetic products.” We have serious issues with their process, their inherent bias towards the needs of manufacturers over public health and in the end, their unfortunate conclusions of safety on chemicals of concern. (Click here for our CIR exposé from several years ago for more detail.) 

2020 was no different – the CIR’s Expert Panel for Cosmetic Safety made a number of decisions that are not in the interest of public health. But we did get their attention on a few things – and hope to continue those discussions in 2021.

A few highlights of 2020 at the CIR:

1. Methylisothiazolinone (MI) — putting the U.S. at a disadvantage to much of the rest of the world.

In 2020 the CIR finalized their review of the safety of Methylisothiazolinone (more commonly know as MI). This ingredient is a preservative – which has become well known in the last decade for causing an epidemic of skin sensitization and allergies. Across the world, regulators realized the terrible mistake of allowing this ingredient to be used in cosmetics– which led to MI (once relatively unknown to dermatologists) to become one of the top skin allergens discovered in their patients in a matter of years.

Methylisothiazolinone (MI) is well known for causing an epidemic of skin sensitization and allergies.

Regulations have been put in place in many places like the EU and Australia – largely to ban MI from leave-on cosmetic products and allow it only at very low levels (15 ppm) in rinse-off cosmetics. These bans and restrictions have had incredibly fast results for public health – leading to reports of new allergies to MI dropping by 50% in a matter of years in countries where these regulations are in place…. But then there is the United States – with no regulations in place – and only the recommendations of the CIR to guide manufacturers. And despite the overwhelming available evidence of success of the international bans (highlighted in WVE comments to the CIR found here) the CIR inexplicably chose a different decision – concluding that MI could continue to be safe in cosmetic products at 100ppm in rinse-off products, and is still safe in leave-on cosmetics as long as the manufacturer designed it to be “non-sensitizing” (a fairly vague recommendation as we see it).

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. Before long we expect the skin allergy monitoring data to show allergy rates to MI to be significantly more prevalent in the U.S. than other countries where this ingredient is banned in cosmetics. We will continue to bring this to the CIR’s attention as the data becomes available. In the meantime, we hope that manufacturers can see the clear evidence of success from the bans in other countries and address this significant health issue responsibly by eliminating MI from their products.

2. Acetyl Hexapeptide-8 amide – A case of inadequate use information

At the December 2020 CIR meeting, the CIR expert panel discussed an ingredient called acetyl Hexapeptide-8 amide, with plans to conclude it is “safe as used in cosmetics”.  Part of their safety decision was based on the CIR’s information that this ingredient was only used currently in very small concentrations (no more than .005%) in cosmetic products. They got this information from the concentration of use surveys conducted by the Personal Care Products Council (PCPC) of their member companies. While the PCPC’s data can be useful to get a sense of how ingredients are used, it is limited in that it only reflects the concentrations used in products made by the PCPC members who respond to the voluntary survey. So the CIR isn’t given the whole picture of the variety of cosmetic products actually on the market. In the case of this ingredient, that limitation was significant. 

WVE submitted comments indicating that there are several products on the market (sold by major cosmetic retailers like Sephora and Ulta Beauty) which market wrinkle creams that contain 10-30% concentrations of acetyl Hexapeptide-8 amide! (This is 2000 – 6000 times what the CIR thought was the maximum concentration in cosmetic products!). 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”.

But due to the CIR’s insistence on using the PCPC data, (and ONLY the PCPC data) the CIR didn’t know these products even existed until WVE brought it to their attention. This is just one of several times we have pointed out the limitations of the PCPC data over the years, strongly encouraging the CIR to seek additional information publicly available on the internet.

WVE found several mainstream products containing 2000-6000 times what the CIR thought was the maximum concentration of acetyl Hexapeptide-8 amide used in cosmetics.

While there was some resistance, the Expert Panel eventually decided that they could not ignore the information presented about the wrinkle creams, and also felt they could not justify concluding these products were safe, given the high concentrations of acetyl Hexapeptide-8 amide. A new conclusion for this ingredient, specifically mentioning these products, will be drafted and considered at the next meeting in Spring 2021.

3. Methicones – CIR finally waking up to the potential inhalation hazards of airbrush makeup.

Also at the December 2020 meeting, the CIR looked at a group of cosmetic ingredients called methicones, and planned to conclude they were “safe as used in cosmetics”. One of the specific conclusions, was that these chemicals did not pose an inhalation hazard, because “95-99% of droplets/particles would not be respirable to any amount”. This is a boilerplate phrase commonly used by the CIR in their safety assessments, that we have contested (unsuccessfully) several times over the years.

This year however, WVE was able to provide comments (see here and here) including brand new research to the CIR which has measured the droplets/particles emitted by airbrush makeup devices – which as it turns out are very likely to be deeply respirable into the lungs. Many brands of airbrush makeup (including one brand manufactured by PCPC member MAC Cosmetics) contain methicones. Once again, the CIR was taken by surprise by this new information, and clearly stated that they had little understanding or knowledge of airbrush makeup products. However, once presented with this information and the clear contradiction with their claims about inhalation hazards, they decided not to finalize the safety assessment, and to do their research on airbrush makeup.

A new conclusion and draft of the safety assessment for methicones will be discussed at a future meeting, as well as a reconsideration of the boilerplate language on inhalation of cosmetic particles.  WVE will continue to monitor this, and provide information to the CIR on this issue.

4. CIR panel rebranded as the “Expert Panel for Cosmetic Safety

Another change we noticed this year is that the CIR panel of experts is no longer called the “CIR Expert Panel”, but rather the “Expert Panel for Cosmetic Safety”. The CIR still exists as an institution, fully funded by industry. The CIR is made up of the staff that runs the Expert Panel meetings, collects the research and writes the draft safety assessments. The Expert Panel on the other hand is the panel of “independent” scientists and researchers paid by the CIR to meet four times a year to review the science and make the final determinations on safety of ingredients. The panel now even has their own website separate from the CIR website with bios and photos of the voting members and a new “conflict of interest” statement. It seems the rebranding is an attempt to clarify or make it appear that the Expert Panel is truly separate and independent from the rest of the CIR. (The fragrance industry did a similar rebranding of their expert panel a few years ago – to attempt to distinguish it from RIFM, the industry-run Research Institute for Fragrance Materials.) While we appreciate the more transparent approach, so far we haven’t noticed much of an actual difference in how they operate.

5. Two new Expert Panel members in 2020

The Expert Panel has been a remarkably consistent group of individuals for decades. According to their bios, 6 of the 9 members have been members of the panel for over 20 years, some as long as 30 years, and the chair has been involved with the Expert Panel for a record-breaking 43 years. So it is refreshing to see two new CIR members join this year after the retirement of two long-time members.  Naturally, there is still significant momentum on the panel to do things “as they have always been done”.  But we are hopeful that the new members can provide fresh perspectives on the panel’s approach to assessing cosmetic safety.

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