EU Cosmetics Regulation Amendment 2026: What Manufacturers Must Review

Key data

Manufacturers, importers and distributors of cosmetics in the EU working with ingredients such as Benzyl Salicylate, HC hair dyes or the DHHB UV filter face a concrete problem: Regulation (EU) 2026/909, published on April 28, 2026, contains errors that have just been corrected through publication on May 5, 2026. The correction affects the Regulation (EC) No. 1223/2009, the base regulation that governs all cosmetic products in Europe.

The real risk is this: any company that has begun to adapt its compliance processes to the original text—with the errors—may be applying incorrect values or conditions without knowing it.

What does this regulation establish?

Regulation (EU) 2026/909 amends Regulation (EC) No. 1223/2009 to update the conditions of use and concentration limits of a set of substances in cosmetic products. The corrigendum published on May 5, 2026 amends data from the original text that may include numerical values or application conditions.

The substances regulated by Regulation 2026/909—and to which this corrigendum applies—are as follows:

The corrigendum may have modified specific numerical values (maximum concentration percentages, for example) or application conditions (product type, mandatory warnings, category restrictions). The corrected text is the only one valid for legal purposes from its publication.

Economic and operational impact

The impact is not theoretical. A corrigendum to a cosmetic ingredients regulation generates real operational costs on several fronts:

• Formulation review: Formulators must check each affected ingredient against the corrected text, not the original.
• Technical file updates: The product safety file (PSR) must reflect the correct values. If it was already updated with the incorrect text, it must be corrected.
• Risk of market withdrawal: If a product on the market does not comply with the limits or conditions of the corrected text, national authorities may require its withdrawal.
• Risk of sanctions: Non-compliance with Regulation (EC) 1223/2009 and its amendments may result in sanctions by the competent authorities of each Member State.

The cost of a market withdrawal—including reverse logistics, communication, loss of sales and possible reputational damage—far exceeds the cost of a preventive review of technical files.

Who does it affect?

• Cosmetics manufacturers that produce or have produced products with any of the 12 listed ingredients or groups of substances.
• Cosmetics importers in the EU that market products formulated with these substances, regardless of the country of manufacture.
• Distributors that place on the European market products affected by Regulation 2026/909.
• Product safety managers (Safety Assessors) who have prepared or validated safety reports based on the original text with errors.
• Formulators and R&D departments that have adjusted concentrations or conditions of use to the text published on April 28, 2026.
• Regulatory advisors and cosmetic compliance consultancies that manage their clients' compliance.

Practical example

Imagine a Spanish company that manufactures hair dyes and that, following the publication of Regulation 2026/909 on April 28, 2026, updated its formulations of HC Blue No. 18 and HC Red No. 18 to comply with the new concentration limits published. It also updated the technical files for those products and sent them to its safety manager for validation.

On May 5, 2026, the corrigendum is published. If any of the values that this company incorporated into its formulations or files correspond to incorrect data from the original text, that company is technically out of compliance, even though it acted in good faith. It must now: identify which values were corrected, compare with what it implemented, and correct formulations and files if there is a discrepancy. Failing to do so exposes it to an inspection with an unfavorable result or to a product withdrawal.

What should companies do now?

1. Access the corrected text: Download and read the corrigendum published on May 5, 2026 in the Official Journal of the EU and compare it with the original Regulation 2026/909 from April 28, 2026.
2. Identify affected ingredients: Review the product portfolio to detect which products contain any of the 12 regulated substances or groups (Benzyl Salicylate, Triphenyl Phosphate, Ammonium Silver Zinc Aluminium Silicate, aluminium, 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).
3. Verify implemented values: Check whether the concentration limits or conditions of use already incorporated into formulations and files correspond to the original text with errors or to the corrected text.
4. Update technical files: Product safety managers must review and, if necessary, correct safety reports (PSR) and technical documentation for each affected product.
5. Evaluate products already on the market: If there are marketed products that do not comply with the values of the corrected text, assess with regulatory advice whether corrective action or communication to authorities is necessary.
6. Document the review process: Keep a record of when the corrigendum was detected, which products were reviewed and what changes were made. This protects the company in case of future inspection or regulatory inquiry.