Retinoids including retinol have recently come under scrutiny due to changes in European Union (EU) cosmetics regulations.
In an investigation, the Scientific Committee for Consumer Safety (SCCS) concluded that “overall consumer exposure, although low, may be of concern for consumers with the highest exposure to vitamin A (5 % of the total population) from food and food supplements” (European Union Commission Regulation, 2024).
Therefore, retinol, retinyl acetate and retinyl palmitate will face restrictions in concentrations, with new levels set at 0.3% for face products (previously 1%) and 0.05% for body products. However, currently, the regulations are not set to apply to retinal.
When will changes to retinol regulations come into force?
Retinol products in higher concentrations are not about to be pulled off the shelves immediately. Brands have been given a three-year grace period from the end of 2024 to reformulate existing products containing retinoids at a higher concentration in order to continue trading in Europe. However, the new rules are set to come into effect from November 1, 2025, for any new products launched to market.
Will changes to EU retinol rules affect the UK?
“While these regulations only concern the EU, their influence is likely to be felt on a global scale,” says chemical engineer and founder of Skin Masterclass Cigdem Kemal Yilmaz.
“This is because skincare brands aiming to distribute products in the EU while complying with the new regulations are unlikely to want to invest significant resources in creating market-specific formulations.
“As a result, it is likely that brands will sell their EU compliant formulations across all markets.”
What are retinoids?
Part of the Vitamin A family, retinoids are considered by many as the gold standard of anti-ageing ingredients.
Their use in topical cosmetic products has become hugely popular with both healthcare professionals and patients thanks to their effective and well-researched benefits.
“The umbrella term ‘retinoids’ refers to compounds of both natural, biologically active forms of vitamin A (retinol, retinal, and retinoic acid) as well as synthetic analogues of adapalene,” says Yilmaz.
“This holy grail ingredient helps to treat pigmentation, acne, and ageing concerns. It increases cell turnover rates, reduces the appearance of fine lines and wrinkles, stimulates collagen synthesis, reduces sebum production, improves skin firmness, and targets uneven texture.”
While currently one of the most hailed ingredients in skincare, the recent regulatory changes regarding retinol were prompted by concerns over its potential side effects and toxicity.
“While retinol is known for its effectiveness in promoting skin cell turnover and collagen production at higher concentrations (above 0.3%), it can cause significant side effects,” says Dr Stephen Humble, medical director of the Hedox Clinic in London.
“These include redness, peeling, increased sun sensitivity, and potential toxicity to the liver, brain, and bones and these risks have led to restrictions on the availability of higher-concentration retinol products without medical supervision.”
What are some of the safety concerns?
Despite most of our vitamin A exposure coming from food and supplements, this in combination with the rising usage of topical retinoids has called safety into question.
"In recent years changing consumer attitudes in the EU have prompted skincare regulators to relook at what they consider to be the optimal levels of vitamin A exposure," says Daniel Isaacs, Medik8 Chief Product Officer & Founding Partner of Medik8.
"The regulators have looked at ‘worst case’ scenarios of vitamin A exposure levels; that’s people who eat high amounts of vitamin A in their diet, apply high doses of vitamin A in their skincare and have lots of exposure to vitamin A from other areas such as medicines; and have put the 0.3% retinol cap in place as a precaution to help reduce the risk of overexposure to vitamin A."
There have also long been concerns around Vitamin A and pregnant women, although the evidence surrounding pregnancy and the use of topical retinoids is still inconclusive, but the possibility of it being absorbed into the bloodstream and causing vitamin A toxicity in the unborn baby means the ingredient is not recommended for this group.
Then are the concerns of the overuse of topical retinoid products causing skin sensitivities and some of the side effects mentioned previously.
The new legislation doesn’t necessarily mean the current legal percentages in retinol are harmful – rather it aims to minimise overall exposure and decrease any sensitivity risks that come with using a higher percentage than tolerable.
Do the regulatory changes affect professional-grade retinol products?
“The regulatory changes mean that over the counter (OTC) retinol products will generally be less potent than professional-grade options,” says Dr Ifeoma Ejikeme, founder and medical director of Adonia Medical Clinic in London.
“But, they are still effective for many skin concerns. Professional-grade products, used under supervision, can offer higher concentrations and, therefore, more significant results but require careful management to avoid adverse effects.”
Dr Humble adds that while OTC retinol products are set to be less powerful than the pro products “they will be safer when used unsupervised.”
What is the impact of these changes in practice?
Yilmaz says that while there will inevitably be some concern from professionals and patients that lowered concentrations of active retinoid ingredients will reduce efficacy, adversely affecting treatment outcomes, the change could be a positive one, especially at a time when clients are confused and teenagers are reaching for retinoids they have been influenced to buy on social media but don’t need.
“It’s important to remember that retinoid tolerance between individuals varies, and that it may be that gentler formulations will help to minimise undesirable effects for those with low tolerability or highly sensitive skin,” says Yilmaz.
“Plus, for patients accustomed to high concentrations of retinoids, there are other options available that include incorporating additional ingredients that target signs of ageing.”
“Aestheticians will have to adhere to the new regulations by recommending only OTC retinol products that comply with the 0.3% limit,” says Dr Humble.
“When using or recommending professional-grade products with higher retinol concentrations, they must ensure these products are used under medical supervision. This helps to mitigate against the risks associated with higher retinol concentrations. The principle is to only use them in appropriate patients, use good SPF and start low and go slow.”
Dr Ejikeme echoes that ensuring clients understand the importance of using sun protection will be paramount when recommending retinol at any percentage.
“Plus, thoroughly assess clients' skin types and sensitivities before recommending or applying retinol products,” Dr Ejikeme adds. “And use professional-grade products within the permissible concentration limits and ensure they comply with the latest regulations while educating clients on the proper use of retinol and potential side effects.”
What does this mean for beauty therapists?
While not yet confirmed, it is expected that higher doses of retinoids could eventually be classed as prescription-only medicines in the UK, which could be of concern to some beauty therapists using retinoids in their client facials.
“One thing that we can say is the there will be a period of uncertainty,” says Dr Humble. “During a transitional time such as this it seems likely that some beauty therapists will continue as before and some will decide themselves that it’s safest for them to avoid the stronger retinols due to the general uncertainty.
Dr Ejikeme adds, “Any prescription product would need to be administered under the guidance of a prescriber and only ever prescribed by a prescriber. Doctor led clinics will likely see little change as we can prescribe and do for our patients but therapist-led businesses may face challenges with this in the future.”
Retinol alternatives and boosters
These new regulations limit over-the-counter (OTC) retinol products to concentrations below 0.3%.
As a result, skincare companies must reformulate their products to comply with these limits, often replacing higher concentrations of retinol with alternatives ingredients.
One such ingredient is bakuchiol. “Although not a direct substitute for retinol, bakuchiol can produce similar results by stimulating collagen synthesis, acting as an antioxidant, and firming the skin,” says Yilmaz.
“Additionally, using low concentrations of exfoliating acids, such as AHAs, alongside retinol, has been shown in numerous studies to yield impressive results, while adding copper peptides to retinol can compensate for the reduced concentration while still enhancing efforts to combat ageing.”
Dr Humble suggests that alternatives like Lanablue will see a rise in popularity. An algae extract produced in unpolluted lakes with highly exceptional nutritional properties, its composition of vitamins, amino acids, and trace elements are seeing it used as a natural retinol alternative without the unwanted side effects.
Another option is to switch clients to retinal or retinaldehyde. “Since the new regulations do not address retinal, its current concentrations remain unaffected, adds Yilmaz.
“Therefore, recommending retinal to clients, which is more potent and can meet the needs of experienced users, is a viable solution. Plus, with the recent surge in popularity, the availability of affordable and effective retinal products has significantly increased in recent years.”
Will there be changes in pricing?
Experts anticipate that companies may increase the pricing of retinol products due to the additional regulatory compliance costs and incorporate alternative ingredients.
“However, the increased use of safer and innovative ingredients may offset the negative impact of increased costs for consumers,” says Dr Humble.
The future of retinol
Although the changes around retinol regulation won’t come into effect until November 1, 2025, it’s advisable to start discussing different options with patients sooner rather than later.
“By doing so, it will give adequate time to discuss and consider viable alternative options that best suit the individual patient and manage their expectations about any potential changes to their treatment plans and outcomes before the new regulations come into place,” says Yilmaz.
“While the new retinol regulations in the EU may initially seem restrictive, they ultimately may promote safer skincare practices,” concludes Dr Humble.
“By using innovative alternatives like bakuchiol and Lanablue, consumers can still achieve effective skin rejuvenation without the risks associated with high concentrations of retinol.
“I feel that both consumers and aestheticians in the skincare industry should embrace these changes as a step toward safer and more effective skincare solutions.”
As we move into a new era of vitamin A, brands will likely prioritise other forms such as retinal. Medik8, a brand famed for its retinoid products has recently started a well-timed push to advertise its Crystal Retinal products in the wake of the changing regulatory landscape.
"The good news is that retinal and retinyl retinoate are not being restricted in skincare. Because retinal and retinyl retinoate act differently on the skin to retinol, we can use much lower concentrations in skincare to get even better results. These lower concentrations are within the optimum limits of vitamin A exposure; hence the Medik8 Crystal Retinal and r-Retinoate ranges will not be impacted by the new regulations," says Isaacs.
"For many years we have been focusing on Crystal Retinal as our gold-standard retinoid - our customers understand its power and are incredibly loyal to the product. Globally, 82% of our retinoid units sold are from our Crystal Retinal Franchise vs 18% of our retinol products."