What is happening with retinol in Europe?

Pharmacist specialising in cosmetics and regulatory affairs
10 of July of 2023
Retinol

You have probably heard various reports about retinol in recent days: is it banned, is it safe to use, will we find cosmetics with retinol on the market?  Beware, because not everything that circulates on the net is true.

What is retinol?

Retinol is the anti-ageing active ingredient par excellence. If you are looking for a cosmetic ingredient to fight against skin ageing, it is your best ally. Derived from vitamin A, it inhibits and prevents collagen degradation and stimulates the synthesis of cutaneous glycosaminoglycans. It also increases epidermal volume while refining the surface of the stratum corneum, resulting in a more turgid skin, free of irregularities and with a more even tone.

That is why it has become the preferred ingredient to improve wrinkles, hyperpigmentation and "slow down the passage of time".

The dose, does it make the poison?

Different concentrations are currently available on the market, ranging from 0.1% to 1%. Depending on the needs of the skin and the degree of retinitisation of the patient, the appropriate one will be selected.  Derivatives have also appeared, the best known being retinyl palmitate and retinyl acetate.

In recent years, the use of this ingredient in cosmetic products has increased, and authorities have deemed it necessary to evaluate it to ensure its safety.

In 2016 the SCCS, the Scientific Committee on Consumer Safety at European level, issued an opinion on vitamin A and concluded that it was safe when used in cosmetics at maximum use concentrations:

  • 0.05% RE (Retinol Equivalents) in body lotions.
  • 0.3% RE in all other rinse-off and non-rinse-off products, including hand and face creams.

This view has been maintained as a recommendation until the last few months, as a regulatory draft has just been published that would make it a standard. By the end of this year, this ingredient and its derivatives (those mentioned above) are expected to become part of Annex III of restricted substances of the Cosmetics Regulation 1223/2009. 

Does this mean that we will no longer use retinol?

No. This restriction arises because it is considered that in people with a high vitamin A intake (5% of the world's population), it may add to the overall exposure of the ingredient, and exceed its recommended limits.

For this reason, cosmetic products containing this active ingredient should be labelled with an information label, as vitamin A exposure is considered to be cumulative with food and food supplements.

However, we must not forget that high concentrations of retinol in cosmetics also have a lower skin tolerance, so their use must be monitored by a professional.

When will this new regulation come into force?

As mentioned above, it is open for comments and is scheduled for adoption in the fourth quarter of 2023. Transitional periods will apply, ranging from:

  • 18 months (from the publication of the regulation) for laboratories not to place on the market products with concentrations higher than recommended.
  • and 36 months for withdrawal from the market.

This is a clear example that cosmetics follow strict controls on a regular basis, and that we can be fully convinced that they are safe for human health.