Known as Omnibus VIII, this legislative act brings Regulation (EC) no 1223/2009 up to speed with contemporary criteria under the CLP Regulation, especially for ingredients found to be carcinogenic, mutagenic, or toxic to reproduction (known as CMR substances).
This may seem highly technical, but its impact on production and compliance is direct and immediate for businesses.
The Impact of the 2026 Amendment
EU law bars the inclusion of CMR-type chemicals in cosmetics, unless manufacturers can satisfy a narrow set of requirements. As the science behind toxicity and hazard evolves, ongoing classification updates mean that once-acceptable materials can enter a banned category, forcing rapid compliance measures.
Consequently, ingredients that once met legal benchmarks might suddenly become non-compliant. Cosmetics producers have to keep a watchful eye on regulation shifts and be prepared for swift, mandated changes.
Regulation (EU) 2026/78 brings amendments across multiple annexes of the Cosmetics Regulation. These revisions not only redefine which chemicals are admissible, but also clarify their legal concentrations and permissible use cases.
Overview of the main Changes
Through this Omnibus VIII regulation, several substances now face full prohibitions while others are subject to tighter restrictions and enhanced monitoring within existing cosmetic products. the most critical changes are summarized below.
Banned Ingredients in Annex II
The updated list in Annex II now outright bans certain substances from all cosmetic applications and concentrations. Examples include the following chemicals:
- N,N’-methylenediacrylamide
- Sodium 3-(allyloxy)-2-hydroxypropanesulphonate
After 1 May 2026, it will be illegal to introduce any cosmetic products that contain these banned substances to the EU marketplace.
Ingredients Facing New Usage Restrictions (Annex III)
Other commonly used compounds remain legal, but fall under a set of new, carefully defined conditions for formulation:
- Hexyl salicylate
Now subject to product-type-specific concentration caps such as:- Higher allowable amounts in luxury fragrances
- Stricter, much lower limits in oral hygiene products (toothpaste, rinse)
- In general, excluded from items for children under three years old, with very rare exceptions
- Silver (in powder form)
Now regulated based on particle dimensions:- Legal requirements differ depending on weather particles are nanoscale or larger
- Permissible in toothpaste and mouthwash only up to 0.05% by weight
Colorants with Newly Imposed Limits (Annex IV)
- CI 77820
Authorised as a colorant only:- For very specific categories such as makeup for lips and eyes
- Limited to a maximum content of 0.2%
- Rules based on particle characteristics,showing the growing regulatory focus on physical properties during safety assessments
Preservatives Under Stricter Rules (Annex V)
- o-Phenylphenol and Sodium o-Phenylphenate
Now constrained by tighter thresholds,including:- Top concentrations are set as follows:
- 0.2% in rinse-off formats
- 0.15% in leave-on items
- Combined exposure must not cross these maximums
- Prohibited use in oral care
- Usage restrictions tied to certain routes of exposure, including inhaled products
- Labels must state: “Avoid contact with eyes”
- Top concentrations are set as follows:
Complying With the New Legal Requirements
An significant rule in this regulation is tied to its implementation schedule. From 1 May 2026, only products that observe all new rules may legally enter or remain on the EU market.
This gives cosmetics businesses a strict deadline. Any item that does not align with the revised regulations cannot be marketed or sold. Companies need to manage product reformulation, update technical files, and handle inventory ahead of time to avoid interruptions.
Achieving compliance means more than just changing ingredients. Companies must re-examine formulations, assess supplier certificates, review or redo safety checks, and edit Product Details Files (PIFs). Labelling must be evaluated and adapted to match the new set of warnings or permitted uses as defined by law.
Occasionally, reformulating a product will involve further validation steps to confirm that new versions remain stable, effective, and safe for consumers.
Future trends in Cosmetic Product Regulation
the latest updates illustrate a broader direction in European regulation: continuous science-based reviews, detailed substance restrictions, and more frequent rules that consider user groups such as children or the risk of accidental oral or inhalation exposure.
These changes also show how different branches of EU chemicals law can have direct impacts on the cosmetics industry’s regulatory framework, quickly shaping what is legal to produce and sell.
For those in cosmetics manufacturing and marketing, staying up to date and planning ahead is now crucial. Routine regulatory updates, prompt risk evaluation of ingredients, and close work with suppliers are vital steps for maintaining legal compliance and protecting business continuity.
