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On 12 January 2026, the European Commission adopted Commission Regulation (EU) 2026/78, amending Regulation (EC) No 1223/2009 on cosmetic products with regard to the use of certain substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). Once a substance is classified as CMR, its cosmetic use must be reassessed and, in most cases, either restricted or fully prohibited, unless specific rules are applied to them.
This type of amendment follows the standard EU approach of aligning the Cosmetics Regulation with updated hazard classifications under the CLP Regulation, this time including the substances published at Regulation (EU) 2024/2564, 21st ATP (Adaptation to Technical Progress) to the CLP Regulation, Omnibus VIII. Regulation 2026/78 introduces several relevant changes across Annexes II, III, IV and V of the Cosmetics Regulation, affecting commonly used ingredients and introducing new concentration limits, scope restrictions and warning requirements.
Substances newly prohibited (Annex II)
The Regulation adds new entries to Annex II (List of substances prohibited in cosmetic products). Among those of particular relevance for the cosmetics sector are:
- N,N’-methylenediacrylamide
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
These substances can no longer be used in cosmetic formulations placed on the EU market, regardless of concentration or product category.
This means that any products still containing these substances will need to be withdrawn from the market, as this time no adaptation period is settled.
New restrictions and conditions of use (Annex III): Hexyl Salicylate
Hexyl Salicylate is now subject to a detailed set of concentration limits depending on product type and target population, all stated at the new entry 380, at Annex III. The Regulation introduces differentiated thresholds for:
- Hydroalcoholic-based fragrances
- Rinse-off products
- Leave-on products
- Toothpaste
- Mouthwash
- Products intended for children under 3 years of age
Maximum concentrations range from 2% in certain fragrance applications to 0.001% in oral products such as toothpaste and mouthwash. In addition, its use is generally prohibited in products for children under 3 years of age, with limited exceptions.
This level of granularity significantly increases formulation complexity and reinforces the importance of product-type-specific compliance checks.
Silver (particle-size dependent classification)
Silver (powder) is now regulated under different Annex entries depending on its particle size:
- Annex II/1727, for Silver (nano) [1 nm < particle diameter ≤ 100 nm and Silver (massive) when particle diameter ≥ 1 mm.
- Annex III/379, when 100 nm < particle diameter < 1 mm, for toothpaste and mouthwash, a maximum concentration of 0.05% applies.
This illustrates the EU’s continued focus on particle size, nanomaterials, and exposure routes when assessing cosmetic ingredient safety. A different entry covers its use when used as a colouring agent.
CI 77820 (particle-size dependent classification)
CI 77820 (Silver) is now treated differently depending on particle size. When particle size is between 100 nm and 1 mm, it falls under the restricted use of Annex IV, entry 142 for colouring agents, and the permitted use of the substance will be in Lip products and Eye shadows up to 0.2%, similar to the entry in Annex III explained earlier.
Again, this reinforces the growing regulatory relevance of particle size, not just chemical identity, as the same substance could present different behaviour depending on its size.
Preservative restrictions updated (Annex V)
The Regulation also updates Annex V for the use of o-Phenylphenol and derivatives, such as Sodium o-Phenylphenate. The new text included at the entrance 7 of Annnex V set up a new maximum concentration of 0.2% (as phenol) for rinse-off products and 0.15% (as phenol) for leave-on products.
Additional rules include the combined use of o-Phenylphenol and Sodium o-Phenylphenate, that must not exceed the same thresholds, along with the prohibition in applications that may lead to inhalation exposure, prohibition in oral products and a mandatory warning: Avoid contact with eyes.
Why Regulation (EU) 2026/78 matters for cosmetic brands
This Regulation is another clear example of how CLP hazard classifications directly shape cosmetic compliance. Once a substance is classified as CMR, its use in cosmetics becomes legally fragile, even if it has been part of safe and well-established formulations for years. For brands, this often results in mandatory reformulation, new use restrictions and the need to reassess how products are positioned and marketed.
These changes go far beyond purely legal exercise. They affect formulation development, supplier choices, labelling, product timelines and long-term portfolio planning, with particularly high scrutiny on oral products, inhalable formats and children’s products.
Deadline for compliance: 1 May 2026
Unlike other amendments of the Cosmetic Regulation, which usually give a year or more to clear shelves, CMR bans are stricter. Clear non-compliant stock before the 1 May 2026 deadline.
This is not a regular amendment, the core of this regulation is the prohibition or restriction of substances from the 21st ATP (Omnibus VIII) to the CLP Regulation, the Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024.
The regulation entered into force on January 2026 and will apply across the EU from 1 May 2026 with no exceptions or adaptation period.
How Cosmeservice can support your compliance strategy
At Cosmeservice, we help brands anticipate regulatory change rather than react to it. The immediate action items should be the fragrance review, silver particle size review, along with the concentration of the preservatives listed at the new amendment.
If you need support adapting your formulations or reviewing your ingredient portfolio in light of Regulation (EU) 2026/78, you can contact us at: info@cosmeservice.com.
References
- Commission Regulation (EU) 2026/78 of 12 January 2026 amending Regulation (EC) No 1223/2009
- Commission Delegated Regulation (EU) 2024/2564 of 19 June 2024 amending Regulation (EC) No 1272/2008
- Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
FAQs
What is Commission Regulation (EU) 2026/78?
Commission Regulation (EU) 2026/78, also known in the industry as Omnibus VIII, is an amendment to the EU Cosmetics Regulation (EC) No 1223/2009. It prohibits or restricts cosmetic ingredients newly classified as carcinogenic, mutagenic or toxic for reproduction (CMR) under the 21st ATP to the CLP Regulation.
When does Regulation (EU) 2026/78 apply?
The Regulation applies across the EU from 1 May 2026, with no exceptions or adaptation period for the newly prohibited substances in Annex II.
What ingredients are banned under Regulation (EU) 2026/78?
N,N’-methylenediacrylamide and Sodium 3-(allyloxy)-2-hydroxypropanesulphonate are added to Annex II and can no longer be used in cosmetic products placed on the EU market, regardless of concentration or product category.
What are the new concentration limits for Hexyl Salicylate?
Under the new entry 380 of Annex III, maximum concentrations range from 2% in certain fragrance applications down to 0.001% in oral products such as toothpaste and mouthwash. Its use is generally prohibited in products for children under 3, with limited exceptions.
Does Regulation (EU) 2026/78 affect silver used in cosmetics?
Yes. Silver is now classified by particle size: nano and massive forms are prohibited under Annex II, powder form is restricted to 0.05% in toothpaste and mouthwash under Annex III, and its use as the colourant CI 77820 is restricted to 0.2% in lip products and eye shadows under Annex IV.
