Omnibus Act VIII published, amending the Cosmetics Regulation and the rules on certain CMR ingredients

Omnibus Act VIII (EU Delegated Regulation 2026/78), has been published, amending the Annexes to the Cosmetics Regulation (EU Regulation 2009/1223) on the basis of the new harmonised classifications of the 22nd ATP to the CLP (EU Regulation 2024/2564).

For years, the Omnibus has periodically updated the Cosmetics Regulation by introducing restrictions on ingredients for which adaptation to technical progress has identified a likely risk as Carcinogenic, Mutagenic or Reprotoxic. In most cases, these are substances that have no practical use in cosmetic formulations.

The current publication highlights, in particular, the following new restrictions on ingredients that may have an impact on companies:

CAS: 7740-22-4 – INCI: Silver

• Powdered silver, with particle diameters between 100 nm and 1 mm, has been included in Annex III, entry No. 379, with the introduction of a use restriction to a maximum concentration of 0.05% in toothpastes and mouthwashes.

• The rules governing silver as a colorant in Annex IV, entry No. 142, have been amended: it is now permitted only in powder form, with particle diameters between 100 nm and 1 mm, only in lip products and eyeshadows, at a maximum concentration of 0.2%.

• Annex II, entry No. 1727, has been amended to extend the ban on use to bulk (massive) silver (particles with diameter ≥ 1 mm), in addition to nano colloidal silver (particles with diameter < 100 nm), which had already been banned.

CAS: 6259-76-3 – INCI: Hexyl Salicylate

A restriction on the use of the substance has been introduced in Annex III, entry No. 380, limited to the following uses:

a) In hydroalcoholic fragrances, at a maximum concentration of 2%(Not to be used in preparations intended for children under 3 years of age)

b) In all rinse-off cosmetics not intended for children under 3 years of age (with the exception of shower gels/bath products, hand-washing products, hair conditioners and shampoos intended for children under 3 years of age), at a maximum concentration of 0.5%

c) In all leave-on cosmetics not intended for children under 3 years of age (with the exception of hair conditioners, body lotions, face creams, lipsticks/lip balms and perfumes intended for children under 3 years of age), at a maximum concentration of 0.3%

d) In toothpastes, at a maximum concentration of 0.001%

e) In mouthwashes, at a maximum concentration of 0.001%(Not to be used in preparations intended for children under 3 years of age)

f) In shower gels/bath products, hand-washing products, shampoos, hair conditioners, body, face and hand skincare products, lipsticks/lip balms and perfumes intended for children under 3 years of age, at a maximum concentration of 0.1%

CAS: 90-43-7 – INCI: o-PhenylphenolCAS: 132-27-4 – INCI: Sodium o-Phenylphenate

Entry No. 7 of Annex V concerning their use as preservatives has been amended:

a) Use is permitted in rinse-off cosmetics at a maximum concentration of 0.2%, expressed as phenol.b) Use is permitted in leave-on cosmetics at a maximum concentration of 0.15%, expressed as phenol.

When o-Phenylphenol and Sodium o-Phenylphenate are used together, the combined concentration (expressed as phenol) must not exceed 0.2% in rinse-off products and 0.15% in leave-on products.

Not to be used in applications that may result in exposure of the end user’s lungs by inhalation. Not to be used in products for the oral cavity.

Conditions of use and warnings to be indicated on the label:“Avoid contact with eyes.”

The Regulation enters into force on 2 February 2026 and applies from 1 May 2026.

From 1 May 2026, it will be prohibited to place on the market or make available cosmetics that do not comply with Omnibus VIII. Consequently, as of 1 May 2026, cosmetics that are not compliant with the new Regulation but have already been placed on the market must be withdrawn.