Nano-substances in the light of new regulations

New legal regulations have appeared regarding the use of nano-substances in cosmetic products. On March 14th, 2024, Commission Regulation (EU) 2024/858 was adopted amending Regulation No. 1223/2009 in relation to the use of nanomaterials in cosmetic products: Styrene/Acrylates copolymer, Sodium Styrene/Acrylates copolymer, Copper, Colloidal Copper, Hydroxyapatite, Gold, Colloidal Gold, Gold Thioethylamino Hyaluronic Acid, Acetyl heptapeptide-9 Colloidal gold, Platinum, Colloidal Platinum, Acetyl tetrapeptide-17 Colloidal Platinum and Colloidal Silver. What impact will it have on the cosmetics industry? I invite you to read.

Ban on the use of many nano-substances

According to the new guidelines, many nano-substances have been added to the list of prohibited substances, i.e. to Annex II of the cosmetics regulation. The new prohibited ingredients include:

• Styrene/Acrylates Copolymer (nano), Sodium Styrene/Acrylates Copolymer (nano) (new entry in Annex II – 1725),

as well as many nano-metals and their compounds:

• Copper (nano), Colloidal Copper (nano) – pos. 1726,

• Colloidal Silver (nano) – pos. 1727,

• Gold (nano), Colloidal Gold (nano); Gold Thioethylamino Hyaluronic Acid (nano), Acetyl heptapeptide-9 Colloidal Gold (nano) – pos. 1728,

• Platinum (nano), Colloidal Platinum (nano), Acetyl tetrapeptide-17 Colloidal Platinum (nano) – pos. 1729.

In the case of Styrene/Acrylates Copolymer (nano) and Sodium Styrene/Acrylates Copolymer (nano), the ban is due to the lack of sufficient data to assess possible toxicity. It has been found that these nanomaterials may pose a health risk to consumers when used in cosmetic products.

However, the mentioned metal nanoparticles carry the risk of systemic absorption, which, combined with the lack of much data on their safety for humans, contributed to the SCCS Committee’s negative opinions about them. It turned out, among others that copper and gold nanoparticles can accumulate in the liver and spleen. A genotoxic potential for the mentioned nano-metals cannot be excluded, and an additional immunotoxic effect for nano-copper. All this meant that, according to the SCCS, the mentioned nano-compounds of copper, silver, gold and platinum may pose a threat to human health, and therefore they have been banned.

Limitations on the use of hydroxyapatite (nano)

In turn, Hydroxyapatite (nano) has been added to the position 372 of Annex III of the cosmetics regulation. So far, this substance has not been subject to any restrictions of use, but from now it will change.

The SCCS concluded that hydroxyapatite (nano) is safe when used at concentrations up to 10% in toothpastes and up to 0.465% in mouthwashes. It has been reported that there are potential risks to human health resulting from use of hydroxyapatite (nano) in cosmetics when the concentration of this substance exceeds certain levels or when it is used in sprayed products, which may lead to exposure of the consumer’s lungs to nanoparticles through inhalation.

Therefore, the use of hydroxyapatite (nano) in cosmetic products has been limited to maximum concentrations:

  • 10% – in toothpastes,
  • 0.465% – in mouthwashes.


  • hydroxyapatite (nano) cannot be used in in applications that may lead to exposure of the end-user’s lungs by inhalation;
  • only nanomaterials having the following characteristics are allowed:
    • composed of rod-shaped particles of which at least 95,8 % (in particle number) have an aspect ratio less than 3, and the remaining 4,2 % have an aspect ratio not exceeding 4,9;
    • the particles are not coated or surface modified.

Change dates

When will the new restrictions come into force? From February 1st, 2025, there will be a ban on placing cosmetic products on the market that do not meet the above new requirements. However, we will have the prohibition of making such cosmetics available on the EU market from November 1st, 2025.

Below you will find links to:

– SCCS opinion on nano-gold compounds:

– SCCS opinion on nano-platinum compounds:

– SCCS opinion on nano-hydroxyapatite:

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