Recently, The European Union is taking decisive steps to enhance consumer safety in cosmetics with the introduction of Omnibus Act VIII, a sweeping update to the EU Cosmetics Regulation. This act bans or restricts dozens of ingredients deemed hazardous, including widely used substances such as sodium perborate, silver, and hexyl salicylate. The regulation reflects recent scientific assessments and reclassifications of CMR (carcinogenic, mutagenic, or reprotoxic) substances and enforces the Scientific Committee on Consumer Safety’s (SCCS) recommendations.
Starting 1 May 2026, all cosmetic products that do not comply with the updated rules must be withdrawn from the EU market, regardless of whether they are already on store shelves or in distribution channels. Brands and manufacturers will need to reformulate affected products promptly, as the changes will impact ingredient selection, labeling, and product viability.
The regulation modifies four critical annexes of the Cosmetics Regulation:
Annex II (Banned Substances): Newly banned substances include several forms of sodium perborate, a bleaching agent now classified as toxic to reproduction, multi-walled carbon nanotubes, which pose respiratory risks, and acetone oxime, used in fragrances and industrial applications.
Annex III (Restricted Substances): This introduces stringent usage limits for silver powder (non-nano), capped at 0.05% in toothpaste and mouthwash, and hexyl salicylate, a popular fragrance ingredient. Limits for hexyl salicylate vary by product type, including 2% in perfumes, 0.001% in oral care, and 0.1% in children’s products.
Annex IV (Colorants): Limits silver powder in lip and eye products to 0.2%, citing risks related to particle accumulation and potential long-term health effects such as kidney damage and tissue discoloration.
Annex V (Preservatives): Updates include new concentration limits for o-phenylphenol and its sodium salts, now restricted to 0.2% in rinse-off and 0.15% in leave-on products. These preservatives are banned in inhalation and oral products, and any use must include the label warning: “Avoid contact with eyes.”
With this legislative overhaul, the EU continues to set the global standard for cosmetic safety, reinforcing its commitment to protecting consumers through science-based regulation and proactive ingredient oversight.
