Key data
| Regulation | Commission Regulation (EU) 2026/909 of 27 April 2026 |
|---|---|
| Modified standard | Regulation (EC) No. 1223/2009 of the European Parliament and of the Council |
| Publication | 28 April 2026 |
| Entry into force | Not specified (each substance may have different deadlines) |
| Affected substances | 12 substances (restrictions and prohibitions) |
| Affected parties | Manufacturers, distributors and importers of cosmetics in the EU |
| Category | European Regulation |
| Source | CELEX:32026R0909 — EUR-Lex |
If your company manufactures, imports or distributes cosmetics in the European Union, Regulation (EU) 2026/909, published on 28 April 2026, requires you to immediately review your ingredient catalog. The regulation amends Regulation (EC) No. 1223/2009 —the European cosmetics safety framework— and imposes new maximum concentration restrictions and direct prohibitions on 12 substances widely used in the industry.
This is not a minor adjustment: four hair dyes are removed from the market due to genotoxic or sensitizing risks, and substances as common as aluminum, Benzyl Salicylate or Citral see their concentrations limited according to product type. Non-compliance can result in mandatory product withdrawal from the market.
What does this regulation establish?
The Regulation updates the conditions of use of 12 substances in cosmetic products. The modifications are organized into three major blocks:
Substances with new maximum concentration restrictions according to the type of cosmetic product:
- Benzyl Salicylate: new maximum concentrations according to product category
- Triphenyl Phosphate: restricted use with concentration limits
- Ammonium Silver Zinc Aluminium Silicate: updated conditions of use
- Aluminum: maximum concentrations limited by product type
- Water-soluble zinc salts: new concentration limits by category
Substances with modified conditions of use:
- Acetylated vetiver oil: modification of conditions of use
- Citral: update of conditions of use
- DHHB: modification of conditions of use
Hair dyes prohibited or restricted due to genotoxic or sensitizing risks:
| Substance | Reason for restriction/prohibition | Affected use |
|---|---|---|
| HC Blue No. 18 | Genotoxic or sensitizing risk | Hair dye |
| HC Red No. 18 | Genotoxic or sensitizing risk | Hair dye |
| HC Yellow No. 16 | Genotoxic or sensitizing risk | Hair dye |
| Hydroxypropyl-p-phenylenediamine and its dihydrochloride | Genotoxic or sensitizing risk | Hair dye |
Companies must reformulate affected products and update their labeling before the deadlines established in the regulation. Non-compliant products must be withdrawn from the market.
Economic and operational impact
The impact of this regulation is not only regulatory: it has direct consequences on the production chain, circulating inventory and reformulation costs.
- Product reformulation: Companies using any of the 12 affected substances must initiate reformulation processes, which involve R&D costs, new safety testing and updating of the Product Information File (PIF).
- Labeling update: Any change in formulation requires reviewing and updating the labeling, with design, printing and packaging inventory management costs.
- Withdrawal of non-compliant products: Products containing prohibited substances or exceeding new maximum concentrations must be withdrawn from the market, which can result in significant inventory losses.
- Impact on hair dyes: The hair dye and coloring segment is the most affected, with four ingredients directly prohibited or restricted. Brands specialized in this segment must review their entire range.
- Supplier review: Importers and distributors must verify that the products they market, manufactured by third parties, comply with the new conditions before the adaptation deadlines.
Who does it affect?
- Cosmetics manufacturers that use any of the 12 regulated substances in their formulations (Benzyl Salicylate, Triphenyl Phosphate, Ammonium Silver Zinc Aluminium Silicate, aluminum, water-soluble zinc salts, acetylated vetiver oil, Citral, HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, Hydroxypropyl-p-phenylenediamine and its dihydrochloride, and DHHB).
- Hair dye and colorant manufacturers, especially those using HC Blue No. 18, HC Red No. 18, HC Yellow No. 16 or Hydroxypropyl-p-phenylenediamine.
- Cosmetics distributors and importers in the EU that market products of their own brands or third parties containing these substances.
- Responsible Persons designated in the EU for cosmetic products imported from outside the European Economic Area.
- R&D, Regulatory Affairs and Quality departments of cosmetics companies that must update product files and technical documentation.
Practical example
A Spanish hair dye manufacturer that markets a permanent coloring range with HC Blue No. 18 and HC Yellow No. 16 in its formulation faces the following scenario:
- It must identify all products in its catalog that contain these substances.
- Since they are prohibited or restricted due to genotoxic or sensitizing risk, it cannot simply reduce the concentration: it must replace them with alternative dyes compliant with the updated Regulation (EC) 1223/2009.
- Each reformulated product requires a new safety assessment, update of the Product Information File (PIF) and new labeling.
- The stock of finished product with the old non-compliant formulation must be withdrawn from the market before the established deadline, assuming the cost of that inventory.
- If it distributes to other EU countries, it must coordinate the withdrawal with its local distributors.
The same process applies to an importer bringing hair coloring products from outside the EU: as Responsible Person, it is responsible for ensuring compliance before marketing.
What should companies do now?
- Audit the ingredient catalog: Review all active formulations to identify whether they contain any of the 12 substances affected by Regulation (EU) 2026/909.
- Classify impact by substance: Distinguish between prohibited substances (hair dyes HC Blue No. 18, HC Red No. 18, HC Yellow No. 16, Hydroxypropyl-p-phenylenediamine) and those with new concentration limits.
- Establish reformulation timelines: Define priority order based on product sales volume, market presence and complexity of reformulation.
- Engage R&D and Regulatory Affairs: Initiate reformulation projects with alternative ingredients and conduct necessary safety assessments.
- Update Product Information Files (PIF): Prepare updated technical documentation for each reformulated product.
- Plan labeling changes: Coordinate with packaging suppliers to update labels before market launch of reformulated products.
- Manage inventory transition: Plan the withdrawal of non-compliant products and the transition to reformulated versions.
- Communicate with distributors and customers: Inform distribution channels and end customers about product changes and transition dates.
- Monitor compliance deadlines: Track the specific entry into force dates for each substance to ensure timely compliance.