In the coming years, the European regulatory landscape for cosmetic products will undergo significant changes, setting the tone for manufacturers and regulatory compliance officers. From restrictions on specific ingredients to new regulations on labeling and recycling, this article provides a detailed overview of key regulations and associated deadlines to help industry professionals stay prepared.
Regulations with Deadlines in 2025: A New Phase for the Cosmetic Industry
Regulation 2024/996 establishes compliance deadlines by introducing new obligations to ensure the safety and traceability of cosmetic products. Below are the detailed changes in Annexes III and V of Regulation (EU) 1223/2009 on cosmetic products.
| Substance | Maximum Allowed Concentration | Affected Products | Additional Warnings/Requirements | Application Dates |
| 4-Methylbenzylidene Camphor
(Annex II/1730) |
Prohibited | All cosmetic products | – | Market introduction: 05/01/2025 Full marketing: 05/01/2026 |
| Genistein
(Annex III/373) |
0.007% | General cosmetic products | – | Market introduction: 02/01/2025 Full marketing: 11/01/2025 |
| Daidzein (Annex III/374) | 0.02% | General cosmetic products | – | Market introduction: 02/01/2025 Full marketing: 11/01/2025 |
| Kojic Acid
(Annex III/375) |
1% | Facial and hand products | Only as a skin-lightening agent. | Market introduction: 02/01/2025 Full marketing: 11/01/2025 |
| Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) (Annex III/376) | – 0.05% ER in body lotions
– 0.3% ER in other products (leave-on and rinse-off) |
Body lotions, leave-on, and rinse-off products | Products must include the warning: “This product contains Vitamin A. Consider your daily intake before using.” | Market introduction: 11/01/2025 Full marketing: 05/01/2027 |
| Alpha-Arbutin (Annex III/377) | – 2% in facial creams
– 0.5% in body lotions |
Facial creams and body lotions | Hydroquinone levels in products with Alpha-Arbutin must remain at the unavoidable minimum (traces). | Market introduction: 02/01/2025 Full marketing: 11/01/2025 |
| Arbutin
(Annex III/378) |
7% in facial creams | Facial creams | Hydroquinone levels in products with Arbutin must remain at the unavoidable minimum (traces). | Market introduction: 02/01/2025 Full marketing: 11/01/2025 |
| Triclocarban
(Annex V/23) |
– 0.2% as a preservative
– 1.5% for other purposes in rinse-off products |
All cosmetics (excluding mouthwash) | Toothpaste containing Triclocarban must include the warning: “Not suitable for children under six years.” | Market introduction: 04/23/2024 Full marketing: 10/31/2025 |
| Triclosan
(Annex V/25) |
– 0.3% in toothpaste, soaps, shower gels, and other specific products.
– Not allowed in mouthwash or toothpaste for children under 3 years |
Toothpaste, liquid soaps, gels, deodorants | Products containing Triclosan must include the warning: “Not suitable for children under three years.” | Market introduction: 04/23/2024 Full marketing: 10/31/2025 |
Regulation 2024/858 (OMNIBUS NANO) has similar deadlines of February 1 and November 1, 2025, with a focus on the use and management of nanomaterials in cosmetics, emphasizing responsible innovation.
| Substance | Maximum Allowed Concentration | CAS Number | EC Number | Application Date |
| Styrene/Acrylates Copolymer (nano)
(Annex II/1725) |
Prohibited | 9010-92-8 | 927-710-1 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Sodium Styrene/Acrylates Copolymer (nano)
(Annex II/1725) |
Prohibited | 9010-92-8 | 927-710-1 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Copper (nano)
(Annex II/1726) |
Prohibited | 7440-50-8 | 231-159-6 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Colloidal Copper (nano)
(Annex II/1726) |
Prohibited | 7440-50-8 | 231-159-6 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Colloidal Silver (nano)
(Annex II/1727) |
Prohibited | 7440-22-4 | 231-131-3 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Gold (nano)
(Annex II/1728) |
Prohibited | 7440-57-5 | 231-1659-9 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Colloidal Gold (nano)
(Annex II/1728) |
Prohibited | 7440-57-5 | 231-1659-9 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Gold Thioethylamino Hyaluronic Acid (nano)
(Annex II/1728) |
Prohibited | 1360157-34-1 | – | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Acetyl Heptapeptide-9 Colloidal Gold (nano)
(Annex II/1728) |
Prohibited | – | – | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Platinum (nano)
(Annex II/1729) |
Prohibited | 7440-06-4 | 231-116-1 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Colloidal Platinum (nano)
(Annex II/1729) |
Prohibited | 7440-06-4 | 231-116-1 | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Acetyl Tetrapeptide-17 Colloidal Platinum (nano)
(Annex II/1729) |
Prohibited | – | – | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
| Hydroxyapatite (nano)
(Annex II/372) |
– 10% in toothpaste
– 0.465% in mouthwash |
a) toothpaste and
(b) mouthwash |
For both (a) toothpaste and (b) mouthwash: Do not use in applications that may lead to consumer lung exposure by inhalation. Only nanomaterials with the following characteristics are allowed: — particles in rod shape, of which at least 95.8% (by particle number) have an aspect ratio of less than 3, and the remaining 4.2% have an aspect ratio not exceeding 4.9; — particles are neither coated nor surface-modified. | Market introduction: 02/01/2025
Full marketing: 11/01/2025 |
Regulation 2024/197 (OMNIBUS VII) for Cosmetic Products
With a deadline of September 1, 2025, this regulation introduces significant changes to the list of prohibited substances, such as:
- Trimethylbenzoyl Diphenylphosphine Oxide: Classified as a Category 2 reprotoxic and will be moved from Annex III/311 to Annex II, prohibiting its use.
- Dimethyltolylamine: Will be added to Annex II due to its classification as a category 1B carcinogen.
Toward 2026: Extended Restrictions and Labeling for Cosmetic Products
By 2026, regulations will further tighten ingredient restrictions and implement changes in labeling.
-
- Regulation 2024/2564 (OMNIBUS VIII) will extend key substance restrictions by May 2026.
- Regulation 2024/2462 (PFAS) will strictly regulate the use of perfluoroalkyl substances (PFAS) in cosmetics due to their environmental persistence.
-
- Regulation 2023/1545 will expand the list of allergens required to be declared on cosmetic product labels from 24 to 81 substances. New products must comply with this regulation by July 31, 2026, while existing products on the market will have until July 31, 2028, to adapt.
2027 and Beyond: Restrictions on Siloxanes in Cosmetic Products
With a deadline of June 6, 2027, this regulation establishes the following restrictions:
- Cyclotetrasiloxane (D4): Already prohibited and added to Annex II/1388 of banned substances.
- Cyclopentasiloxane (D5): Its concentration will be limited to a maximum of 0.1% in leave-on products. For rinse-off products, the compliance deadline for this restriction was January 30, 2020.
- Cyclohexasiloxane (D6): Its concentration will be limited to a maximum of 0.1% in both leave-on and rinse-off products.
These restrictions reflect a growing trend toward controlling ingredients that may have adverse impacts on human health and the environment.
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In such a highly regulated environment, SHAPYPRO stands out as a strategic partner to ensure your company meets the latest European standards. Our team of experts provides tailored solutions and comprehensive support at every stage of the process. We help companies anticipate regulatory changes, ensuring their products reach the market without interruptions and comply with all legal requirements.
Our commitment to sustainability and responsible innovation also enables us to help you meet environmental regulations, such as those related to PFAS and recycling, strengthening consumer trust.
Transform regulatory challenges into a competitive advantage with SHAPYPRO. Contact us today and discover how we can help your business excel in a highly demanding market.