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Update on Regulation 2024/858
The update to EU Cosmetics Regulations,specifically Regulation (EU) 2024/858 published on 15th March 2024, is a significant development for cosmetic companies operating within the EU market.
This regulation introduces stricter controls and safety requirements for the use of nanomaterials in cosmetic products. Compliance ensures not only consumer safety but also helps maintain market access and company reputation within the EU.
Which nanomaterials are affected?
Regulation 2024/858 targets specific nanomaterials whose usage in cosmetics has raised health concerns due to their nano-sized properties, which can alter their interaction with biological systems. The materials specified include:
- Styrene/Acrylates Copolymer (nano)
- Copper (nano) & Colloidal Copper (nano)
- Colloidal Silver (nano)
- Gold (nano) & Colloidal Gold (nano)
- Thioethylamino Hyaluronic Acid Gold (nano)
- Platinum (nano) & Colloidal Platinum (nano)
The Regulation (EU) 2024/858 also restricts the use of Hydroxyapatite (nano) in different cosmetic products, allowing its use in the specified cases below:
- Maximum 10% in toothpaste and 0.465% in mouthwash.
- Must not allow inhalation exposure.
- Particles must be rod-shaped with a controlled aspect ratio.
- Must not be coated or modified.
- Mandatory withdrawal of non-compliant products before the 1st of November 2025.
The regulation emphasizes the need for rigorous safety assessments of these nanomaterials to ensure they do not pose health risks to consumers. Cosmetic companies are required to demonstrate that their use of these materials is safe and consistent with the regulation’s guidelines on concentration and exposure levels.
Key Deadlines for Compliance
Cosmetic products containing the specified nanomaterials must not be placed on the EU market after the 1st of February 2025.
Furthermore, such products must not be available on the market from the 1st of November 2025. These deadlines are crucial for companies to adjust their product formulations and ensure compliance.
Regulation (EU) 2024/996, adopted on the 4th of April 2024.
Regulation (EU) 2024/996 introduces substantial amendments to European cosmetics regulation, especially regarding Vitamin A, Alpha Arbutin, Arbutin, and certain substances suspected of having endocrine-disrupting properties.
Key modifications to Annexes II and III of Regulation (EC) No 1223/2009 of the EU will come into effect. These restrictions impact the substances used in cosmetic products listed below:
- Genistein: Maximum 0.007% in ready-to-use products.
- Daidzein: Maximum 0.02% in ready-to-use products.
- Kojic Acid: Allowed up to 1% in facial and hand products.
- Alpha-Arbutin: Up to 2% in facial creams and 0.5% in body lotions.
- Arbutin: Up to 7% in facial creams.
Key Deadlines for Compliance
The listed substances cannot be placed on the European Union market from the 1st of February 2025, and they must not be available on the market beginning on the 1st of November 2025.
Vitamin A, related to retinol, listed in the same table, will follow a similar trajectory, with non-compliant products barred from placement starting from the 1st of November 2025, and must not be available on the market from the 1st of May 2027.
Regulation (EU) 2022/2195 targeting Homosalate
Considering the SCCS scientific advice, Regulation (EU) 2022/2195 of 10 November 2022 was adopted. It can be concluded that there is a potential risk to human health arising from the use of Homosalate as a UV filter in cosmetic products in the concentration previously allowed. Therefore, the use of Homosalate is now allowed only in face products (non-spray and pump spray products) up to a maximum concentration of 7,34 %
Key Deadlines for Compliance
From the 1st of January 2025, cosmetic products containing Homosalate and not complying with the conditions specified in Regulation (EU) 2022/2195 of 10 November 2022 shall not be placed on the Union market. From the 1st of July 2025, cosmetic products containing that substance and not complying with the conditions shall not be made available on the Union market.
UK Cosmetics: February 2025 BHT Deadline
From the 24th of February 2025, cosmetic products containing Butylated Hydroxytoluene (BHT) that exceed new limits stated in the UK Regulation can no longer be placed on the market, and products placed on the market can be made available until the 24th of June 2025. In this case, stricter limits on BHT in oral care products are in force, compared to the EU.
The concentration of BHT in cosmetic products was amended in April 2024, and BHT in cosmetic products must not exceed 0.1% in toothpaste, 0.001% in mouthwash and leave-on oral care products, and 0.8% in other leave-on and rinse-off products.
The EU restricted BHT in 2022, under Commission Regulation (EU) 2022/2195. While most limits align, a key difference exists for leave-on oral care products. In the UK, BHT is limited to 0.001% in leave-on oral care products while in Europe, the limit is 0.8%, consistent with other leave-on and rinse-off products.
Steps to Ensure Compliance with EU Regulation
- Review Product Formulations: Companies should review their current product lines to identify any use of the specified nanomaterials.
- Conduct Safety Assessments: Perform safety assessments as required by the regulation to prove that the products are safe for consumer use.
- Update Product Registrations: Amend product registrations with the EU to reflect any changes in formulation or compliance status.
- Educate Staff and Partners: Ensure that all relevant company personnel and partners are informed about the new regulations and compliance requirements.
How Cosmeservice Can Help
At Cosmeservice, we specialize in navigating the complex landscape of cosmetic regulations. Our team of experts is ready to assist your company in understanding and complying with EU Regulation 2024/858, Regulation 2024/996, and Regulation (EU) 2022/2195, also with the UK Regulation.
If you need guidance on reformulating products or updating registrations, do not hesitate to contact us at info@cosmeservice.com or filling the below form. We are here to ensure that your cosmetic products meet all required standards and regulations, allowing you to focus on what you do best – creating outstanding beauty solutions.
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