‘From Brussels To Sacramento’: EU-Inspired Cosmetic Ingredient Bills Moving Through US States
Executive Summary
From PFAS to key preservatives, cosmetic ingredients are in state lawmakers’ crosshairs around the US, and not just substances prohibited in the European Union. Industry insiders discussed the situation at the Independent Beauty Association’s Cosmetic Technical/Regulatory Forum last month.
The cosmetics industry is facing unprecedented levels of US state-level legislation to restrict the ingredients they can use in products.
California continues to lead, while other states including Washington, New York, Vermont, Oregon, Illinois and Georgia have joined the movement.
The historic US Modernization of Cosmetic Regulations Act (MoCRA) signed into law in 2022 includes preemption provisions, but does not bar states from setting their own rules for cosmetic ingredients. (Also see "Compliance Clock Starts Ticking Under Historic Modernization of Cosmetic Regulations Act" - HBW Insight, 3 Jan, 2023.)
"Sooner or later we're going to run out of the preservatives that can be used." – Vic Mencarelli, director of global regulatory affairs at Orveon Global
The good news for industry is that proposed ingredient blacklists are looking very similar from state to state, according to industry insiders at the Independent Beauty Association’s Cosmetic Technical/Regulatory Forum in March.
“I've been following this legislation for years, and typically you get one state with one list of chemicals, another state with another list of chemicals,” noted Craig Weiss, co-CEO and president of Consumer Product Testing Company, during a session on state regulatory matters. “Now you're getting multiple states with basically the same list, pretty much in the same order too.”
Weiss pointed to the European Union’s influence in state bills that seek prohibitions on formaldehyde, paraformaldehyde and methylene glycol for example, all prohibited substances in cosmetics sold in the EU. California’s Toxic-Free Cosmetics Act banned those ingredients’ use in 2020, effective 1 January 2025, and now Washington state is trying to do the same. (Also see "Washington State Continues Taking Cues From California; Toxic-Free Cosmetics Act Is Back" - HBW Insight, 26 Jan, 2023.)
In fact, all cosmetic ingredients banned in California under the TFCA are prohibited substances in the EU, and so are the cosmetic ingredients targeted by follow-up bill AB-496, which passed California’s Assembly on 23 March. (Also see "California Eyeing More Cosmetic Ingredient Bans To Align With EU" - HBW Insight, 13 Feb, 2023.)
“There’s a saying, ‘From Brussels to Sacramento,’ then it moves east,’” Weiss said.
But some states aren’t confining their proposed ingredient bans to prohibited substances in Europe. For example, Washington’s HB 1047 would ban ortho-phthalates, exceeding California’s TFCA ban on dibutyl phthalate and diethylhexyl phthalate, consistent with EU regulations.
Debbie Waite, co-CEO of cosmetic and OTC drug consultancy Steinberg and Associates, suggested that this ingredient group “trips people up,” as most have stopped using dibutyl phthalate, which she characterized as the “poster child for the bad phthalates.”
But firms should be careful regarding diethyl phthalate, which is used as a solvent in fragrances.
While fragrance houses have moved away from use in response to external pressures, finished product manufacturers “want to document that you don't have [DEP] in your fragrances” because it is going to be regulated away, said Waite. “It’s a good practice to get a statement from your fragrance supplier that it does not contain diethyl phthalate,” she said.
According to the Personal Care Products Council’s cosmeticsinfo.org, dimethyl phthalate may also have uses in cosmetic and personal-care products.
Meanwhile, New York’s S 4265 is targeting parabens – butyl, ethyl, methyl, and propyl – in addition to the isobutyl and isopropyl parabens prohibited in cosmetics sold in California and the EU.
Further, the Empire State is taking aim not only at quaternium-15, already banned by California and the EU, but also formaldehyde releasers diazolidinyl urea, DMDM hydantoin, imidazolidinyl urea, and sodium hydroxymethylglycinate.
PFAS
In some instances, the precise impacts to cosmetics companies will depend on how states define ingredients of concern, according to presenters at the IBA event.
That includes per- and polyfluoroalkyl substances (PFAS), whose definition varies in proposed bills from fluorinated organic chemicals containing one to at least three fluorinated carbon atoms. Setting the bar at one fluorinated carbon, 10,000 chemicals are affected, Weiss said.
California used that definition in legislation passed last year, AB 2771, that banned PFAS use in cosmetics beginning 1 January 2025. (Also see "California’s PFAS Ban In Cosmetics Limited To Intentionally Added Substances, Effective In 2025" - HBW Insight, 30 Aug, 2022.)
New York is targeting intentionally added PFAS, defined as having at least one fully fluorinated carbon atom, with proposed legislation A 4600, which would jump ahead of California, outlawing PFAS-containing cosmetic sales beginning 1 June 2024.
Meanwhile, MoCRA requires the US Food and Drug Administration to assess use of PFAS in cosmetic products and scientific evidence supporting their safety and publish a report summarizing its findings by 2026. How such undertakings at the federal level could affect state and local-level requirements regarding PFAS isn’t fully understood.
craig weiss, co-CEO and president of Consumer Product Testing Company
Weiss addressed the vast universe of chemicals that could be considered PFAS, some of which are present in ingestible drug products such as Prozac and Lipitor. “I know that this is not a ban on drug products. But I think it's interesting to note that you can take these things internally, but you're not going to be able to put it in your [cosmetic] product,” he said. “The definitions are a huge part of the problem.”
Waite remarked, “I'm wondering when that [FDA report] comes out, if as an industry we can advocate for a reasonable definition, one that's actually doable and that makes sense.”
California’s AB 2771 notes the EU’s goal of phasing out non-essential PFAS uses under its Chemicals Strategy for Sustainability, an instrument of the European Green Deal unveiled in October 2020. (Also see "EU’s Sustainable Chemicals Strategy Lacks Industry ‘Game Plan’ To Support Innovation, Competitiveness" - HBW Insight, 15 Oct, 2020.) At this point, the European Commission and European Chemicals Agency are exploring two options for restricting more than 10,000 PFAS under the EU Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation. (Also see "EU Restriction Proposal Targets 4.4M Tons Of PFAS Headed For Environment Over Next 30 Years" - HBW Insight, 15 Feb, 2023.)
“So a complete ban on PFAS may be coming, but I’m not quite sure how that's going to work,” Weiss said. “Methodology is a huge part of the problem.”
Cosmetics companies are being hit with class action complaints in US courts by plaintiffs citing trace PFAS levels, identified in their own, or third-party, testing, as evidence of product defects or false advertising. (Also see "Not So Clean Beauty? False Advertising Lawsuits Allege PFAs In CoverGirl, BareMinerals Products" - HBW Insight, 21 Jan, 2022.)
New York’s A 4600 would prohibit any PFAS detected by total organic chlorine analysis, which is not only a method that’s complex to run but would likely flag chemicals that are not PFAS as PFAS, according to Weiss. Further, there’s no accepted test method for that process by the state of New York. Weiss advised firms to ensure the method they are using “have been validated to whatever degree it can.”
PFAS testing can be expensive, and small businesses may be challenged to make formulation changes under the tight timelines proposed in state bills, Weiss noted.
Vic Mencarelli, director of global regulatory affairs at Orveon Global, advised firms to get expert help to assess formulations against state-by-state definitions and have it documented, and to avoid declaring products “PFAS-free” if there’s any possibility the substances exist in a product.
Keith Edgett, vice president R&D, regulatory and program management at Carma Labs, noted that state-to-state variations in characterizing PFAS “creates a litigation risk for all companies making those types of claims.”
Preservatives Crisis
Panelists expressed concern over the narrowing of preservative ingredients available to cosmetic product formulators, with a growing number in state lawmakers’ crosshairs, including parabens and formaldehyde releasers.
“If you look at the list of chemicals that are shared in common by most of the bills out there, that formaldehyde, paraformaldehyde, methylene glycol, and any free formaldehyde is really being tamped down to nothing or next to nothing,” Weiss said.
That presents a problem for formulators, as it essentially “kills” another category of preservatives.
Antioxidants butylated hydroxytoluene (BHT) and butylated hydroxyanisole (BHA) also would be banned from use in cosmetics sold in New York under S 4265. BHT is permitted as a preservative in food by the FDA, and Edgett said it has been a “go-to” preservative solution for many natural cosmetics brands.
“If it's in foods that we're ingesting, I think we're probably okay in the small amounts we use in cosmetics,” Waite said.
Mencarelli ventured, “Sooner or later we're going to run out of the preservatives that can be used. And when you do that, what you're going to end up with is what caused all the ruckus back in the 1970s with FDA coming down hard on the industry, because you've got all these products being contaminated because they're under- or not preserved.”
He added, “You're using all of these preservative boosters and adjuvants and stuff that really doesn’t give you preservation, it just kind of helps boost what’s going on.”
Weiss agreed, noting that the cosmetics industry is specifically running short on options to protect against yeast and mold contamination.
At the Consumer Product Testing Company, Weiss said they rarely saw contamination, but “now we see contamination on a regular basis,” including products failing preservative efficacy tests during batch releases, “which is not good.”
He noted that some of the newer adjuvants or preservatives have not held up well in stability testing, especially under heat conditions of approximately 40 degrees Celsius.
To that point, Mencarelli observed that a product traveling via container ship from California to South Korea will almost certainly be exposed to temperatures in excess of that 40 degrees Celsius in the summer.
Edgett noted that industry’s preservative issues have created a new opportunity for packaging innovations, for instance airless dispensers, to minimize contamination potential. “Knowing that the preservative options are becoming more and more limited, we need to turn to other solutions,” he said.
Carcinogens
Some state bills also include prohibitions on known carcinogens, such as benzene, ethylene oxide, styrene, carbon black and coal tar – most of which are not intentionally added to cosmetic products in the first place.
Ethylene oxide is a substance industry will need to keep track of as there’s often a residual amount left after a substance is ethoxylated, according to Weiss. Ethoxylation is the process of reacting ethylene oxide with other chemicals to make them less harsh.
California’s bill looks to ban a number of boron substances, all of which have very little use in cosmetics, according to Waite.
Weiss added, “It's kind of like all these states that are banning mercury, which has been federally banned since 1973.”
Waite said she was surprised by carbon black’s appearance on the New York bill.
“I'm hoping that by the listing of carbon black, they're talking about the non-certified FDA colorant because [Black No. 2] is the certified colorant that's used in mascaras and eyeliners, and it's very dominant in that category,” she said.
Oxybenzone
Georgia’s Safe Cosmetics Act, H 390, seeks to prohibit oxybenzone use in cosmetic products, raising questions about interference with the FDA’s OTC drug regulations, which expressly preempt state and local requirements that depart from federal law.
Oxybenzone is used not only as an active ingredient for OTC drug sunscreen products, but also as a UV absorber to protect cosmetic formulations, noted Weiss.
Waite said Georgia’s proposed ban “is one of those weird things where it might be doing something, but it might be doing nothing.”
Body care and sunscreen products containing oxybenzone already are forbidden in Whole Foods stores across the US due to concerns about impacts on marine environments and ecosystems, including coral reefs, a policy announced by the retailer in March 2019.
“We need to look at both sides of the fence because sometimes, with retailers, they're self-governed and it doesn't necessarily harmonize with local or even federal legislation,” Edgett said.
Toluene
While most companies have formulated nail products away from toluene, which lawmakers in Georgia want out of cosmetics, its use to clean manufacturing equipment could put companies at risk.
“You need to be aware of that and maybe work with your manufacturer to make sure that's not what they're using,” Waite advised.
California is taking a look at toluene as part of its Safer Consumer Products program, and manufacturers of nail products containing the substance are required to “demonstrate and certify” that their products do not exceed an alternatives analysis threshold of 100ppm. (Also see "California DTSC Begins Taking Notifications Of Nail Products Containing Toluene" - HBW Insight, 4 Jan, 2023.)
At such a small threshold, “you could get tripped up either by a raw material with a trace or the cleaning of manufacturing equipment,” Waite cautioned.
Asbestos
MoCRA dictates that the FDA must establish and require standardized methods for detecting and identifying asbestos in talc-containing cosmetic products, issuing proposed regulations by the end of 2023 and final regulations 180 days after the date on which the public comment period closes. (Also see "NSF Leaders On How New Cosmetics Certification Could Bolster MoCRA Compliance" - HBW Insight, 9 Mar, 2023.)
Meanwhile, S 4265 in New York would ban use of “asbestos and asbestos-containing compounds” in cosmetics, among other substances of concern.
Mencarelli noted the bill “doesn't actually specify which forms of asbestos are actually problematic.” (Also see "US FDA Says White Paper Could Inform Rulemaking For Cosmetic Talc-Asbestos Testing" - HBW Insight, 13 Jan, 2022.)
Asbestos is almost ubiquitous in substances that have been mined. “You can look at anything and come up with one of the forms of asbestos,” Mencarelli suggested.
Waite characterized New York’s broad approach to asbestos as “scary.” In her view, “if we're going to have laws on ingredients, we need some specificity.”