Regulations restricting the use of ‘free-from’ claims were incorporated into Annex lll of European Regulation 655/2013, and went into effect as of July 1, 2019.1 The Technical Document on cosmetic claims2 lists common criteria for cosmetic claims, along with detailed descriptions and examples of the new restrictions. Although these regulations are only applicable to the European Union, similar restrictions could be considered by other regulatory bodies over time. This would not be out of the realm of possibility, considering that ’free-from’ cosmetic claims, liberally used in today’s marketplace, are often not based on sound scientific data; but are inspired by mis-information perpetuated via the internet and other channels. Most would also not meet one or more of the criteria outlined in the Technical Document.2
Consider this laundry list of ‘free-from’ claims appearing on a commercially available Liquid Hand Soap:
- Titanium Dioxide
- Artificial Colorants
- Animal By-Products
As with all ‘free-from’ claims, the implication is that this product is better or safer for the consumer or the environment because of the absence of these ingredients. Although, a person skilled in the art might query why some of these claims would be relevant to this type of product. Let’s examine the scientific rationale, or lack thereof, of a few of these.
By far the most ubiquitous of the ‘free-from’ claims, sulfate-free appeared to have originated because of an internet rumor associating sulfates with cancer. This myth was researched and debunked by the America Cancer Society in1998.3 Studies conducted by renowned scientific organizations have also concluded that sulfates are safe for use in formulations intended for brief use4. The general scientific consensus is that, outside of possible skin and eye irritation, sulfates do not pose a health risk. The environmental impact of sulfates has also been a matter of ongoing concern. But an environmental toxicological assessment of SLS, a representative of the class, established that sulfates do not pose a risk to the environment.5
Parabens found themselves on the ‘free-from’ list based on a 2004 study that associated parabens with breast cancer. Multiple subsequent studies have since refuted that study, but the reputation of parabens remains tainted. The FDA asserts that “no information showing that parabens as they are used in cosmetics have an effect on human health”.6
In 2016, the FDA prohibited the use of triclosan in antibacterial soaps and followed this action in 2017 with a ban in OTC antiseptic products.7 Although the agency has not weighed in on its use in other personal care categories, manufacturers are preemptively removing this ingredient, possibly as a result of consumer pressure.
Dimethicone is approved by the FDA as a skin protectant when used between 1% and 30%. However, a cloud of skepticism still lingers over this and other members of the silicone class, primarily due to results of studies conducted on the cyclosiloxanes. Based on environmental concerns, the EU commission is imposing severe restrictions on the concentration of D4/D5 that can be used in rinse-off products.8 The European Chemicals Agency (ECHA) is currently considering similar restrictions for leave-on products.
Given that consumers are now conditioned to expect the absence of certain ingredients when deciding on products, it is a consideration for marketers to make ‘free-from’ claims to maintain a competitive advantage. In this environment, ‘free-from’ claims will likely continue to proliferate, whether they are based on sound scientific data or not.
- EU Cosmetic Claims: Updated Guidelines on “Free-From” Claims: https://knowledge.ulprospector.com/7603/pcc-eu-cosmetic-claims-updated-free-from-claims/
- Technical document on cosmetic claims [PDF]
- American Cancer Society Debunking the Myth. 1998. [Accessed July 8, 2015]. Available at:http://web.archive.org/web/20030803065801/http://www.cancer.org/docroot/nws/content/nws_2_1x_debunking_the_myth.asp.
- Final Report on the Safety Assessment of Sodium Lauryl Sulfate and Ammonium Lauryl Sulfate: Journal of The American College of Toxicology, Volume: 2, Issue: 7, Issued published: December1, 1983
- Human and Environmental Toxicity of Sodium Lauryl Sulfate (SLS): Evidence for Safe Use in Household Cleaning Products. Cara AM Bondi, Julia L Marks, Lauren B Wroblewski, Heidi S Raatikainen, Shannon R Lenox, Kay E Gebhardt
- Federal Drug Administration (FDA). FDA issues final rule on safety and effectiveness of antibacterial soaps (September 02, 2016) https://www.fda.gov/news-events/press-announcements/fda-issues-final-rule-safety-and-effectiveness-antibacterial-soaps
- Regulation Update: Silicones in the EU: https://knowledge.ulprospector.com/7724/pcc-cyclosiloxane-d4-d5-regulation-update/
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2 Responses to “Shedding Light on the ‘Free-From’ Madness”
My understanding is that “sulfate free” was introduced by a hair care formulator that believed mild surfactants (non alkyl sulfate or alkyl ether suflate) would allow hair dye to remain on the follicle longer. The cancer rumor came from the “free from” language, with consumers assuming “sulfates” cause cancer.
Thanks Priscilla for an enlightening article. Next we need people to understand why there are no poisons, only poisonous doses. Although I never used them, I believe parabens should be restored to their rightful place as safe and effective chemicals to use.