June 8, 2023 – On May 23, 2023, the European Commission notified the World Trade Organisation (WTO) of a draft regulation on the use of several nanomaterials. This draft is the update of a previous version sent to the WTO in February 2022 and never adopted. Revising the original content was necessary in view of the latest SCCS opinions.
What is new from the first version?
Precisely as in the first version, the new draft regulation confirms that the use of the following nanomaterials will be prohibited in cosmetic products:
- Styrene/Acrylates copolymer (nano);
- Sodium Styrene/Acrylates copolymer (nano);
- Copper (nano);
- Colloidal Copper (nano);
- Gold (nano);
- Colloidal Gold (nano);
- Gold Thioethylamino Hyaluronic Acid (nano);
- Acetyl heptapeptide-9 Colloidal gold (nano);
- Platinum (nano), Colloidal Platinum (nano);
- Acetyl tetrapeptide-17 Colloidal Platinum (nano).
Additionally, the updated draft regulation foresees the ban of Colloidal silver (nano) and some restrictions on the use of Hydroxyapatite (nano).
According to the original draft, Hydroxyapatite (nano) should have been prohibited. However, in March 2023, the SCCS adopted a new opinion on this ingredient considering the additional data submitted by the industry to support its use in oral products. Thus, the SCCS concluded that Hydroxyapatite in nano form is safe up to a maximum concentration of 10% in toothpaste and 0.465% in mouthwash when the substance has the following characteristics:
- It is 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.
The European Commission has included these conclusions in the new draft regulation. Consequently, Hydroxyapatite (nano) will be subject to use restrictions and added to Annex III of the EU Cosmetics Regulation.
Moreover, the text mentions that Hydroxyapatite (nano) cannot be used in applications that may lead to exposure of the end-user’s lungs by inhalation (e.g., sprays) because the SCCS could not assess their safety.
What are the application deadlines?
The European Commission will likely publish the official regulation in the third quarter of 2023, and it will enter into force 20 days from its publication in the Official Journal of the European Union.
Furthermore, the regulation provides cosmetic brands with some time to adapt to the new requirements. Hence, the deadlines to comply with these requirements are the following:
- 9 months for new cosmetic products that enter the EU market for the first time;
- 18 months for cosmetic products already on the EU market. Therefore, before the end of this period, economic operators must withdraw non-compliant products on shelves.
As a cosmetic manufacturer, you should check your formulations. If your products contain any of these ingredients in nano forms, you should proceed with the necessary steps to ensure their compliance.
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SCCS. (2023). SCCS Opinion on Hydroxyapatite (nano). Retrieved on 31/05/2023
WTO. (2023). Notification G/TBT/N/EU/872/Rev.1. Retrieved on 31/05/2023