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Retinol regulations

What do the changes in EU regulations for retinoids mean for the UK beauty industry? Kezia Parkins investigates

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.

The new rules are due to come into effect from November 1, 2025, for any new products launched to market. However, for existing products containing retinoids at higher levels, brands have been given a three-year grace period from the end of 2024 to reformulate in order to continue trading in Europe.

Will the EU 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.”

Understanding retinoids

Part of the vitamin A family, retinoids are used in many topical products and have become hugely popular, thanks to their well-researched anti-ageing 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-used ingredients in skincare, the 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.”

Safety concerns

Despite most of our vitamin A exposure coming from food and supplements, 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, chief product officer and director of research at 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% 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 as well as wider concerns about the overuse of topical retinoid products causing skin sensitivities. The new legislation doesn’t necessarily mean the current legal percentages in retinol are harmful – instead, it aims to minimise overall exposure and decrease any sensitivity risks that come with using a higher percentage than tolerable.

Professional vs retail 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”.

Efficacy impact

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, Dr Humble adds, “When using or recommending professional-grade products with higher concentrations, they must ensure these products are used under medical supervision. This helps 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.”

What does this mean for beauty therapists?

While not yet confirmed, it is expected that higher doses of retinoids could eventually be classed as prescriptiononly medicines in the UK, which could be of concern to some beauty therapists using retinoids in their treatments and homecare.

“One thing that we can say is that 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 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 for our patients but therapist-led businesses may face challenges with this in the future.”

Additionally, 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.

Retinol alternatives and boosters

These new regulations limit 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 alternative 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 also 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 means it can be 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.”

Medik8, a brand known for its retinoid products, has recently started a major campaign 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. 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.

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 clients sooner rather than later. “Give adequate time to discuss and consider viable alternatives 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,” advises Yilmaz.

As we move into a new era of vitamin A, brands will likely prioritise other forms such as retinal, as well as retinol alternatives like bakuchiol and Lanablue, which Dr Humble says “can still achieve effective skin rejuvenation without the risks associated with high concentrations of retinol”. He adds, “While the new retinol regulations in the EU may initially seem restrictive, they ultimately may promote safer skincare practices.”

This article appears in September 2024

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September 2024
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