EU Commission Regulation 2024/858 URGENT Deadline Approaching on Nanomaterials
A Reminder that the Deadline for Complying with EU Regulation on Nanomaterials is Fast Approaching
Understanding EU Commission Regulation 2024/858
The European Union has always been at the forefront of consumer safety, particularly in the cosmetics industry. The latest step in this ongoing commitment is the EU Commission Regulation 2024/858, commonly referred to as the Omnibus Nano Regulation.
This regulation amends EU Cosmetic Regulation No 1223/2009 in particular, bans or restricts the use of, certain nanomaterials used in cosmetic products to ensure consumer safety. It is often called the Omnibus Nano Regulation, “omnibus” because this regulation addresses multiple aspects of nanomaterials in cosmetics, including bans & restrictions, and compliance timelines, all within a single legislative act. In other words, it is a…
- Unified Framework: by addressing various nanomaterials and their specific uses in one regulation, it provides a unified framework for the cosmetics industry to follow, simplifying compliance and enforcement,
- Multiple Amendments: it amends ingredient Annexes of the existing cosmetics regulation (EU Cosmetic Regulation No 1223/2009), incorporating new scientific findings and safety measures.
The EU Commission Regulation 2024/858 was published in the European Official Journal (OJ) 14th March 2024 and came into force 4th April 2024.
Impact for Companies
The Regulation means that certain nano-materials will be either banned or restricted for use in your cosmetic products, the greatest impact being the banned nano’s.
It means that in all NPD projects, the banned nano-materials MUST either be removed or restrictions must be adhered to and for all existing products on the market, the non-conforming stock must be either sold though or withdrawn from the market.
For a FREE Consultation on how to comply, feel free to contact me.
KEY Provisions of the EU Commission Regulation 2024/858
Which Nanomaterials are Concerned (nano)?
Styrene/Acrylates copolymer ✪ Sodium Styrene/Acrylates copolymer ✪ Copper ✪ Colloidal Copper ✪ Colloidal Silver ✪ Gold ✪ Colloidal Gold ✪ Gold Thioethylamino Hyaluronic Acid ✪ Acetyl heptapeptide-9 Colloidal gold ✪ Platinum ✪ Colloidal Platinum ✪ Acetyl tetrapeptide-17 Colloidal Platinum and ✪ Hydroxyapatite.
What is the Change?
The nanomaterials listed will either be banned in Annex II or restricted in Annex III.
Annex II concerns…
- Styrene/Acrylates copolymer (nano) [INCI] (*)
- Sodium Styrene/Acrylates copolymer (nano) [INCI] (*)
- Copper (nano) [INCI] (*)
- Colloidal copper (nano) [INCI] (*)
- Colloidal silver (nano) [INCI] (*)
- Gold (nano) [INCI] (*)
- Colloidal gold (nano) [INCI] [1] (*)
- Gold Thioethylamino Hyaluronic Acid (nano) [INCI] [2] (*)
- Acetyl heptapeptide-9 Colloidal gold (nano) [INCI] [3] (*)
- Platinum (nano) [INCI] (*)
- Colloidal Platinum (nano) [INCI] [1] (*)
- Acetyl tetrapeptide-17 Colloidal Platinum (nano) [INCI] [2] (*)
Annex III concerns…
- Hydroxyapatite (nano)
- Restrictions:
- Toothpaste (10% maximum concentration)
- Mouthwash (0,465 % maximum concentration)
- Not to 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:
- 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.
- Restrictions:
Deadlines (*)
Placing on the Market: NEW Products
- Annex II: From 1 February 2025 cosmetic products containing that substance shall NOT be placed on the EU market.
- Annex III: From 1 February 2025 cosmetic products containing that substance and not complying with the restrictions shall NOT be placed on the EU market.
Market Withdrawal: Existing Products
- Annex II: From 1 November 2025 cosmetic products containing that substance shall not be made available on the EU market.
- Annex III: From 1 November 2025 cosmetic products containing that substance shall NOT be made available on the EU market.
Why the Bans or Restrictions?
The bans and restrictions to these nanomaterials used in cosmetic products in EU Commission Regulation 2024/858 are primarily based on safety concerns identified by the European Commission Scientific Committee on Consumer Safety (SCCS).
In fact, in the event that the EU Commission has concerns regarding the safety of a nanomaterial, the Commission is to make a request to the Scientific Committee on Consumer Safety (SCCS) for its opinion on the safety of the nanomaterial for use in cosmetic products. As a result the following was identified:
- Health Risks: The SCCS found that certain nanomaterials, such as Styrene/Acrylates copolymer, Sodium Styrene/Acrylates copolymer, and Colloidal Silver, can pose potential health risks when used in cosmetics.
- Insufficient Safety Data: For some nanomaterials, like Copper and Colloidal Copper, the SCCS concluded that there was insufficient data to perform a comprehensive safety assessment. However, the SCCS indicated that based on the available information from scientific literature and in the Cosmetic Product Notification Portal (CPNP), a systemic uptake of Copper nanoparticles is possible and they might also have mutagenic/genotoxic and immunotoxic/nephrotoxic effects. As there is not sufficient data at this stage proving otherwise the EU Commission has chosen to ban these ingredients.
- Inhalation Concerns: Specific nanomaterials, such as Hydroxyapatite in nano form, pose risks when inhaled. This is particularly relevant for products like toothpaste and mouthwashes, where there is a potential for lung exposure. Therefore this nano-ingredient has been restricted for use in these products and banned in inhalable products.
Conclusions
This EU Regulation 2004/858 underscores the EU’s commitment to balancing innovation with consumer safety in the cosmetics industry.By addressing the use of nanomaterials comprehensively, the EU aims to ensure that cosmetic products are safe for consumers while still allowing for innovation and development. As the regulation comes into force, it will be crucial for manufacturers, retailers, and consumers to stay informed and compliant with these new safety standards.
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