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  • Writer's pictureDaniel Jiménez

Understanding Regulation (EU) 2024/858 on Nanomaterials

In a groundbreaking move that underscores its unwavering commitment to consumer safety and responsible innovation, the European Union has once again taken a significant step forward in the regulation of cosmetic products. With the unveiling of Regulation (EU) 2024/858 in the latest edition of the Official Journal, the EU has updated its stance on the use of nanomaterials in cosmetics, directly impacting a range of ingredients from styrene/acrylate copolymers to precious metals like gold and platinum in their nanoforms.

This regulation, affectionately dubbed the Omnibus Nano Regulation, introduces stringent bans and specifications that not only reflect the latest scientific understanding but also pave the way for a safer, more transparent cosmetics industry.

Understanding Regulation (EU) 2024/858 on Nanomaterials
Understanding Regulation (EU) 2024/858 on Nanomaterials

Introduction to the Omnibus Nano Regulation

In the latest legislative stride, the European Union has introduced Regulation (EU) 2024/858, a significant update to the existing cosmetics regulation that focuses on the management and use of specific nanomaterials in the cosmetics industry. Published on March 15, 2024, this regulation underscores the EU's proactive approach to safeguarding consumer health by addressing the potential risks associated with certain nanomaterials​​.

Nanomaterials Under Scrutiny: The Prohibited List

Regulation (EU) 2024/858 brings forth a decisive stance against certain nanomaterials, adding them to Annex II, which enumerates substances prohibited in cosmetics. Notably, this includes various forms of nanomaterials such as Styrene/Acrylates and Sodium Styrene/Acrylates copolymers in nanoforms, alongside nano forms of metals like Copper, Silver, Gold, and Platinum, even extending to specific compounds like Acetyl heptapeptide-9 and Acetyl tetrapeptide-17 in their colloidal forms​.

Balancing Innovation with Safety: Restricted Use Guidelines

The regulation also amends Annex III to introduce restrictions on Hydroxyapatite in nano form, setting concentration limits for its use in toothpaste and mouthwashes. This move aims to prevent potential lung exposure through inhalation, underscoring the EU's commitment to consumer safety without stifling innovation​​.

Navigating the Transition: Compliance Timelines

With the regulation set to enter into force on April 4, 2024, the cosmetic industry is provided with a clear timeline to ensure compliance. Products containing the newly prohibited substances will not be allowed on the EU market from February 1, 2025, and the sale of such products must cease by November 1, 2025. This timeline also applies to products containing substances under the new restrictions outlined in Annex III​.

Towards a Safer Cosmetic Landscape

Regulation (EU) 2024/858 reflects the EU's ongoing dedication to consumer safety and the responsible management of nanomaterials in cosmetics. By adhering to these updated regulations, cosmetic manufacturers not only ensure compliance but also contribute to a safer, more sustainable industry landscape.

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