The year 2025 will significantly change the European cosmetics industry due to new compliance deadlines established by Regulation 2024/996 and the OMNIBUS nano and VII regulations. These updates will introduce new bans, ingredient restrictions, and labeling requirements that will impact formulators, brands, and regulatory professionals.
At CE.way, we are committed to assisting you in navigating these regulatory changes. This article highlights the most important updates, their deadlines, and practical strategies to ensure compliance.
Overview of Major 2025 Regulatory Changes
The upcoming amendments affect:
✅ Annex II – Prohibited substances
✅ Annex III – Restricted substances
✅ Annex V – Preservatives
✅ OMNIBUS Nano & VII – New restrictions on nanomaterials and high-risk chemicals
🔎 New Banned Substances (Annex II Updates)
| Substance | Common Use | Regulatory Action | Market Introduction Deadline | Full Marketing Ban |
| 4-Methylbenzylidene Camphor | UV filter in sunscreens | Prohibited | 05/01/2025 | 05/01/2026 |
| Styrene/Acrylates Copolymer (nano) | Film former in cosmetics | Prohibited | 02/01/2025 | 11/01/2025 |
| Colloidal Copper (nano) | Anti-aging & skincare | Prohibited | 02/01/2025 | 11/01/2025 |
| Gold & Colloidal Gold (nano) | Anti-aging, luxury skincare | Prohibited | 02/01/2025 | 11/01/2025 |
| Platinum & Colloidal Platinum (nano) | Anti-aging, luxury skincare | Prohibited | 02/01/2025 | 11/01/2025 |
* Impact: Brands must remove these ingredients from existing formulations and reformulate affected products.
| Substance | New Limit (2025) | Affected Products | Additional Requirements | Compliance Deadline |
| Genistein | 0.007% | General cosmetics | – | 11/01/2025 |
| Daidzein | 0.02% | General cosmetics | – | 11/01/2025 |
| Kojic Acid | 1% | Facial & hand products | Only as a skin-lightening agent | 11/01/2025 |
| Vitamin A (Retinol, Retinyl Acetate, Retinyl Palmitate) | 0.05% in body lotions, 0.3% in other products | Body lotions, leave-on, rinse-off | Must include a warning: “This product contains Vitamin A. Consider your daily intake before using.” | 05/01/2027 |
| Alpha-Arbutin | 2% in facial creams, 0.5% in body lotions | Facial & body creams | Hydroquinone must remain at unavoidable minimum levels. | 11/01/2025 |
Preservative Restrictions (Annex V Updates)
| Substance | New Limit (2025) | Affected Products | Additional Requirements | Full Compliance Deadline |
| Triclocarban | 0.2% as a preservative, 1.5% in rinse-off | Toothpaste, soaps, gels | Toothpaste must include: “Not suitable for children under six years.” | 10/31/2025 |
| Triclosan | 0.3% in toothpaste, soaps, deodorants | General cosmetics | Not allowed in mouthwash or toothpaste for children under 3 years. | 10/31/2025 |
Regulatory Impact on Cosmetic Segments
The following chart illustrates the percentage of cosmetic categories affected by the 2025 ingredient bans and restrictions:
This bar chart highlights the cosmetic categories most impacted by the 2025 EU cosmetic regulations:
- Sunscreens and UV Filters (35%) will undergo significant changes due to the ban on 4-Methylbenzylidene Camphor and future updates regarding ethylhexyl methyl cinnamate (EHMC).
- Anti-aging & Luxury Skincare (30%) are significantly impacted by nanomaterial restrictions (Gold, Colloidal Copper, Platinum).
- Skin-lightening products (25%) need reformulation due to new Kojic Acid, Alpha-Arbutin, and Arbutin limits.
Beyond 2025: Upcoming Regulatory Trends
Looking ahead to 2026 and 2027, expect more restrictions and labeling updates:
- 2026:
✅ Regulation 2024/2564 (OMNIBUS VIII) extends substance restrictions.
✅ Regulation 2024/2462 (PFAS Ban) limits perfluoroalkyl substances in cosmetics.
✅ Regulation 2023/1545 expands allergen labeling requirements (from 24 to 81 allergens). - 2027:
✅ Regulation 2024/197 (OMNIBUS VII) restricts Trimethylbenzoyl Diphenylphosphine Oxide (reprotoxic) and Dimethyltolylamine (carcinogenic).
✅ Siloxane restrictions: Cyclopentasiloxane (D5) and Cyclohexasiloxane (D6) face 0.1% limits in leave-on products.
Final Thoughts: Staying Compliant in a Changing Regulatory Landscape
The 2025 EU regulatory updates emphasize:
✅ Safer cosmetic formulations with reduced exposure to CMR and endocrine-disrupting substances.
✅ Stricter nano-material regulations ensuring responsible innovation.
✅ More transparency for consumers through labeling and ingredient concentration limits.
How is your company preparing for these regulatory changes? Let us know in the comments or contact CE.way for expert guidance on compliance!
