Twelve nanomaterials banned and one restricted in European cosmetics

European regulation 2024/858 has been published, more than two years after the draft submitted to a public consultation and three years after the opinions of the Scientific Committee on Consumer Safety (SCCS). It bans the use of 12 nanomaterials (styrene acrylate copolymer, copper, silver, gold and platinum) and restricts the use of one nanomaterial (hydroxyapatite) in cosmetics. Manufacturers have until 2025 to make the necessary adjustments to product formulation and labeling.

Twelve nanomaterials banned from cosmetics

In response to health concerns highlighted by the Scientific Committee on Consumer Safety (SCCS), the European Commission has issued a regulation banning the use of a total of five groups of twelve nanomaterials in cosmetics:

  • styrene/acrylates copolymer, sodium styrene/ acrylates copolymer,
  • copper, colloidal copper,
  • colloidal silver,
  • gold, colloidal gold, gold thioethylamino hyaluronic acid, and acetyl heptapeptide-9 colloidal gold,
  • platinum, colloidal platinum, and acetyl tetrapeptide-17 colloidal platinum.

In order to protect human health, these twelve nanomaterials will be included in Annex II of the Cosmetics Regulation, which lists the substances prohibited in cosmetic products.

Cosmetics containing thess substances will no longer be :

  • be placed on the European Union market by manufacturers or importers as of February 1, 2025
  • be made available by distributors, wholesalers or retailers from November 1, 2025.

Restricted nano hydroxyapatite in toothpastes and mouthwashes

The same regulation restricts the hydroxyapatite nanomaterial (HAP) by adding it to Annex III of the Cosmetics Regulation, which lists substances which cosmetic products must not contain except subject to the restriction laid down. In this case, nano PAH can only be used in toothpastes in concentrations of less than 10%, and in mouthwashes in concentrations of less than 0.465%. It should not be used 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,
  • particles are not coated or surface modified.

The same deadlines apply here: cosmetics containing this substance and not complying with these restrictions may no longer be placed on the EU market from February 1, 2025, nor made available from November 1, 2025.

According to the regulation, the length of these periods has been determined considering the SCCS concerns and the potential risk to human health associated to the nanomaterials concerned, as well as the number of cosmetic products concerned.

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