Earlier this year, the European Parliament and Council announced changes to EC Regulation 1223/2009 on cosmetics. Such changes would affect the use of common ingredients in skincare products, most notably three key retinoids.
The regulation, which was published on April 3rd 2024 in the Official Journal of the European Union, introduced new rules regarding the use of Vitamin A, Alpha-Arbutin, Arbutin, and other substances with potential endocrine-disrupting properties in cosmetic products. The substances had not previously been recognised under Regulation (EC) No 1223/2009.
One ruling called out three commonly used retinoids: Retinol, Retinyl Acetate and Retinyl Palmitate. It found that these ingredients “should be restricted to a maximum concentration of 0.05% Retinol Equivalent (RE) in body lotion and 0.3% RE in other leave-on and rinse-off products.”
Scientific assessments found that while Vitamin A is generally safe, high concentrations could pose risks due to overall exposure from food and supplements. The restrictions were implemented in light of findings that suggest “there is a potential risk to human health arising from the use of vitamin A in cosmetic products when its concentration exceeds certain levels.”
The impact of the ruling on cosmetic brands
Vivien Gardiner RN BA GAICD is the Managing Director at Jan Marini Skin Research (JMSR) Australia. The Jan Marini brand, which is manufactured in The United States, is stocked in 44 countries – including throughout Europe. In light of the rulings, Jan Marini is one such globally available skincare brand whose formulations are set for an update. “As part of JMSR’s Current Good Manufacturing accreditation with the FDA, JMSR ensures all its formulations adhere to the various global regulatory environments,” Vivien tells Professional Beauty.
“JMSR has a unique retinol delivery system which alters the retinol equivalent calculation. We are currently working on the final formulation changes to comply with the new rules. The changes will be enforced in the EU after November 2025,” Vivien reveals. “There will also be changes to percentages of Alpha-Arbutin and Kojic Acid, which JMSR already complies with.”
Why vitamin A?
Vitamin A in skincare is highly regarded for its anti-aging benefits. There is more than one type of vitamin A, as Vivien explains: “Vitamin A in skincare is a highly effective way to initiate skin cell renewal in both the epidermis and dermis. Active vitamin As are known collectively as retinoids and they have quite a profound effect on skin texture, discolouration and fine lines, depending on the type of retinoid, and the specific formulation. Retinoids assist with resurfacing the skin via desquamation, clearing follicular debris, stabilising oil flow and thickening the dermis.”
Types of vitamin A
Cosmeceutical brands regularly found in the backbars and on the retail walls of Australian beauty salons and clinics often utilise some form of vitamin A in its formulas. Retinol, Retinyl Acetate and Retinyl Palmitate are all vitamin A derivatives, and those flagged by The European Parliament and Council. Common retinoid alternatives include Hydroxypinacolone Retinoate (HPR) and Bakuchiol.
“Retinol is the most effective of the three, but can cause some irritation, which is why JMSR formulates their retinol products with anti-inflammatory peptides. Our chief scientist was awarded the patent for (and still holds the rights to) retinol encapsulation, which also mitigates the inflammatory response. Another issue when formulating retinol is how quickly it’s degraded when not formulated in the dark, or under a certain wavelength of light,” Vivien explains.
Retinyl Acetate and Retinyl Palmitate
“Retinyl Acetate (RA) and Retinyl Palmitate (RP) are derivatives of retinol. Retinyl Palmitate is a retinol molecule esterified with palmitic acid. This makes them more tolerable but not as effective. Both RA and RP are highly unstable and break down rapidly in the presence of light and oxygen.” Vivien also notes three types of retinol receptors in our skin cells: alpha, beta and gamma. “Gamma receptors are the most abundant and this is the receptor retinol binds to most effectively.”
While HPR and Bakuchiol are also commonly found, Vivien says there is no substantial independent scientific literature on either, other than a few papers by scientists affiliated with the manufacturers. “There is more scientific literature on retinoids and their positive effect on skin than any other topical cosmetic ingredient. This recent paper summarises the current accepted science on retinoids in skin repair.”
The team at JMSR see that the key to the best cosmetic vitamin A is formulation expertise. “There is still a misconception in the market that higher levels of actives equate to better performance of the product. This is not the case as the effectiveness of the end formulation is dependent on many factors including pH, vehicle, delivery systems and chaperone ingredients.”
“There is still a misconception in the market that higher levels of actives equate to better performance of the product.
The risks of vitamin A overexposure
“If people are taking high dose vitamin A supplements, eating foods rich in vitamin A (ie carrots, spinach, fish, dairy, liver) as well as using high strength vitamin A topicals, there might be a perceived risk,” Vivien says. “There is no substantial scientific evidence showing retinol absorption from topicals, although the European Commission may have access to more recent and as yet unpublished studies.”
Vivien cites specific risks of vitamin A toxicity to be:
- teratogenic effects in pregnancy
- liver damage
- osteoporosis and hypercalcaemia (which can cause abnormal heart rhythms)
- vision loss
- nausea
“The maximum daily recommendation for vitamin A is 700 – 1400mcg (that’s MICRO-grams, not milligrams. Divide by 0.001 for mg equivalent) or 2,300 to 3000 International Units. Dosage is dependent on body weight.”
Vivien adds, “The risk of vitamin A toxicity would be extremely low from topical use, although the EU regulators might have evaluated products which are poorly formulated and contain high percentages of retinoids of dubious quality. Data falsification in the industry is rife.”
Will the same rulings be made in Australia?
Vivien says Australia’s Therapeutic Goods Association (TGA) “has flagged it will be harmonising regulations with the EU, FDA and Canada”. Therefore “it’s quite possible they will implement this regulation at some point in the future.” She does see that a maximum of 0.3 retinol equivalent units seems “a little over the top”.
“It’s just as possible the EU will reverse course on this and perhaps turn their attention to dietary supplements which would have a far higher risk of leading to vitamin A toxicity than a topical product.”
What should Australian aestheticians do?
Despite moves overseas, Vivien does not advise skincare providers to fret just yet. “If therapists are recommending vitamin A supplements, be sure to understand the vitamin A maximum daily intake. Talk to clients about their diet, or what other supplements they may be taking.”
“My thoughts are that people should always have blood work done before taking daily supplements, so the risks of toxicity are well managed. Remember, the gut is a much more effective route for systemic absorption than the skin.”
Citing recent research out of Johns Hopkins Medicine, Vivien says the verdict is still out on the effectiveness of daily supplementation on those not experiencing dietary deficiencies, malabsorption issues or disease. “If diet and lifestyle is good, there really shouldn’t be a need to take supplements regularly. All the major university medical institutes advise against supplements if individuals have a reasonably healthy and diverse diet.”
Commission Regulation(EU) 2024/996 also outlines restrictions on other substances used in cosmetics not discussed in this article. To read the full document, visit this link.
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