The publication of Regulation (EU) 2026/78 (Omnibus VIII) on 13 January 2026 marks the formal update of the EU Cosmetics Regulation (EC) No 1223/2009 to incorporate the latest harmonized hazard classifications established by Regulation (EU) 2024/2564 (the 22nd ATP to the CLP Regulation). This aligns cosmetic ingredient rules with current CMR (Carcinogenic, Mutagenic, Toxic for Reproduction) classifications and introduces updated substance restrictions and prohibitions, applying from 1 May 2026.

Key updates for the cosmetics sector include new restrictions on Silver and Hexyl Salicylate, based on SCCS (Scientific Committee on Consumer Safety) findings. Silver has been categorized according to its particle size (granulometry), reflecting that its toxicological risk changes drastically depending on its physical form.

The banned substances: Annex II

In this section of the Regulation, the substances are officially eliminated from the formulator’s toolkit. Omnibus VIII rationalizes these prohibitions by consolidating existing entries and clarifying chemical families.

• Silver (nano) [1 nm < particle diameter ≤ 100 nm]: prohibited.
• Silver (massive) [particle diameter ≥ 1 mm]: prohibited.

Manufacturers must cross‑reference their formulas with the full list of modifications in Regulation (EU) 2026/78 to ensure no prohibited CMR substances are present in their portfolio.

The restricted substances: Annexes III, IV & V

Despite their hazard classifications, certain substances remain on the market thanks to specific derogations, within very rigid boundaries.

Annex III

Silver Powder (Entry 379)

• [100 nm < particle diameter < 1 mm]: max 0.05% in oral care (toothpaste and mouthwash).
• Not to be used in other cosmetic products without specific authorization.

Hexyl Salicylate (Entry 380)

• Hydroalcoholic‑based fragrances (except for children <3): max 2%.
• All rinse‑off products (except shower gel/bath, hand wash, hair conditioner and shampoo for children <3): max 0.5%.
• All leave‑on products (except hair conditioner, body lotion, face cream, hand cream, lipstick/lip balm and fragrance products for children <3): max 0.3%.
• Toothpaste and mouthwash: max 0.001%.
• Shower gel/bath, hand wash, shampoo, hair conditioner, body, face and hand care, lipstick/lip balm and fragrance products for children <3: max 0.1%.
• Not to be used in cosmetic products intended for children under 3 years of age, with the exception of toothpaste and the specific rinse‑off and leave‑on products listed above.

      Annex IV – Colorants

       Silver Powder as colorant (Entry 142)

• Lip products and eye shadow: max 0.2% (CI 77820).
• Not to be used in other product types as colorant.

Annex V – Preservatives 

O‑Phenylphenol and Sodium O‑Phenylphenate as preservatives (entry 7)

• Rinse-off:max 0,2 % (as phenol).
• Leave-on: max 0,15 % (as phenol).
• When used together, the combined concentration shall not exceed 0.2% (rinse‑off) or 0.15% (leave‑on).
• Not be used in applications that may lead to exposure of the end‑user’s lungs by inhalation. Not to be used in oral products.
• Warning to be displayed: “Avoid contact with eyes”.

The 1 May 2026 Deadline

Every non-compliant product must be withdrawn from the market by May 1, 2026. These provisions apply to both the placing on the market and the making available (retail sale) of cosmetic products.

In practical terms, this means that any product containing a prohibited substance must be removed from retail shelves by this date. Since the Regulation does not provide a specific derogation for existing inventory, no transition period for stock clearance (sell-through) is granted. This absolute cut-off makes immediate portfolio assessment mandatory to avoid severe legal risks, financial penalties, and forced market withdrawals.

Compliance roadmap: strategic actions

To navigate this transition safely, we recommend the following immediate steps:

1. Inventory & Gap Analysis: cross-reference your INCI lists against the modifications in Regulation (EU) 2026/78.
2. Raw material verification: confirm the particle size of specific ingredients, particularly Silver, to ensure they fall within the “powder” derogation.
3. Documentation update: revise your PIF (Product Information File) and CPSR (Cosmetic Product Safety Report) to reflect the new legal status and safety thresholds.
4. Distribution coordination: inform your distribution chain that non-compliant stock must be cleared up or recalled before the May 1 deadline.

>>> Complife – Member of GBA Group stands by your side during this transition with strategic regulatory consulting and advanced laboratory testing, including PIF updates, CPSR, and Safety Assessments (SA). Contact us to evaluate your ingredient portfolio and secure your market presence before the May 1 deadline.

SOURCE:
Regulation – EU – 2026/78 – EN – EUR-Lex