New regulation has been implemented in the EU from late 2023 onwards that will put restrictions on the concentration of retinol found in over-the-counter skincare like retinol serums and moisturisers. With a final ruling due this summer regarding the ‘gold standard’ skincare ingredient, Dr Pam Benito, clinic owner and facial aesthetics specialist, shares her take:



What are the new Retinol and Vitamin A restrictions?

The new legislation has restricted over-the-counter retinol doses which will differ based on the product type, and will include setting a maximum strength of 0.3% for face and hand products, while body lotions to contain a lower dose, up to 0.05%. Any product containing these components must adapt their formulas within three years, and display a compulsory label, outlining contributions to daily Vitamin A intake. This regulation is intended to prevent potential health risks linked to excessive Vitamin A exposure from all lifestyle sources, not just cosmetics.

Why has the legislation changed around the strength of retinol in products?

The European Union Commission has proposed measures to mitigate overexposure to vitamin A compounds (including Retinol, Retinyl Acetate, Retinyl Palmitate), following recommendations from the Scientific Committee on Consumer Safety (SCCS). With a final ruling due this summer, the draft legislation highlights concern regarding the cumulative high intake of vitamin A from cosmetics, food, and dietary supplements. There is concern that consumers are exceeding the upper intake level established by the European Food Safety Authority.

What countries are affected by the ruling?

Countries affected by the European Union’s retinol restriction laws will include the 27 countries of the EU alongside countries that belong to the European Economic Area Free Trade Association. This does not include the United Kingdom or Switzerland. As non-EU members, the UK is not bound by these regulations, however it is likely the ruling will have a knock-on effect as it comes into play from June 2024. Generally speaking, global brands who sell into both EU and UK markets will likely look to save on production costs, as they phase out and adapt ineligible formulas, to comply.

Why is this good news for skincare aficionados?

We’ve become desensitised to the power of active ingredients. Over exfoliation is rife, and higher strength products do not necessarily mean better results – they are best in the hands of a professional.  If you do require something stronger, a professional consultation means your overall skin health is assessed thoroughly. The regulation aims to protect consumers from potential negative reactions, like redness, peeling, and heightened sensitivity to sunlight, which can occur more frequently with higher concentrations of retinol if not properly guided and supervised.

Will 0.3% retinol still give results?

Absolutely. Customers mistakenly believe that stronger ingredients equal superior results. However, the ultimate efficacy of any Retinol skincare product relies on its final formula. It’s important to seek out independent clinical studies on the completed formulation rather than focusing solely on individual ingredients.  Studies show Retinol+ Emulsion 0.3 is clinically proven to influence gene expression and repair the dermal-epidermal junction. In separate subject trials, 95% of patients reported their skin was more radiant and smoother, whilst 89% reported that their skin looked more youthful and the texture improved.

Does this mean Retinol is unsafe?

No, awareness is key. We should all consume enough vitamin A from plant or animal sources for a healthy, balanced diet. In cosmetics, natural and synthetic retinol and retinol derivatives have long been used as skin conditioners and anti-acne agents. Unlike other retinol formulas, iS Clinical’s Retinol+ Emulsion 0.3 is safe to use during pregnancy because it contains no ingredients that would cause systemic absorption, but not all Vitamin A skincare is, so checking with a medical expert is a prerequisite.


What happens if you have too much vitamin A/retinol?

Vitamin A stands as a crucial fat-soluble nutrient vital for supporting your immune system, vision, reproductive health, and foetal growth. While it’s imperative to meet your body’s needs for this vitamin, excessive intake can pose risks. Prolonged ingestion of high doses of vitamin A may lead to liver damage. There’s also evidence suggesting that prolonged overconsumption could potentially impact bone health, particularly concerning older women vulnerable to osteoporosis.


What does this mean for the future of other skincare ingredients?

The new regulations may well have a knock-on effect on the cosmetics market, for instance formulators may opt to use ingredient alternatives, as the anti-ageing market continues to evolve.


What are the retinol products you recommend that follow this new legislation?

Retinol+ Emulsion 0.3 is a unique resurfacing formula designed to deliver transformative results. Pregnancy safe, its boosted blend of Retinol and Bakuchiol, alongside potent botanical enhancers, antioxidants, and Extremozymes®, efficiently addresses fine lines, wrinkles, uneven skin tone, texture irregularities, and blemishes. Additionally, it refines the complexion, imparting a smoother, softer, and brighter appearance while promoting skin firmness and elasticity.