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Which ingredients will be banned in EU cosmetics from 2027?
The European regulatory environment for the cosmetics sector is characterized by its dynamism and an increasingly demanding approach to safety. Omnibus Act IX represents a key new update that will have a direct impact on the formulation and marketing of cosmetic products in the European Union starting February 1, 2027. These changes are increasingly referred to across the industry simply as the substances that will be banned in EU cosmetics from 2027.
This new regulation focuses on aligning Regulation (EC) No 1223/2009 with the new harmonized classifications of CMR substances (carcinogenic, mutagenic, or toxic for reproduction) introduced through ATP 23 of the CLP Regulation. This may translate into new prohibitions or restrictions for ingredients used in cosmetics.
Its objective is to ensure that cosmetic products marketed in the EU meet the highest safety standards, in line with the latest scientific advances.
For manufacturers, product responsible persons, distributors, and raw material suppliers, these changes not only represent a compliance challenge but also an opportunity to strengthen their positioning in a highly regulated and competitive market.
What is Omnibus Act IX?
Omnibus Act IX is a new update within the ongoing process of aligning European cosmetics legislation with the hazardous substance classifications defined in the CLP Regulation (1272/2008).
This new update will make it possible to swiftly integrate scientific advances into the legal framework, avoiding gaps between chemical and cosmetic legislation. In practice, this translates into periodic amendments to the annexes of Regulation (EC) No 1223/2009, which list prohibited and restricted substances.
In this specific case, Omnibus Act IX stems from the 23rd Adaptation to Technical Progress of the CLP Regulation (ATP 23), adopted through Commission Delegated Regulation (EU) 2025/1222, which introduces new classifications of substances as CMR. These classifications must be transposed into the cosmetics field to ensure regulatory consistency and consumer protection.
Regulatory framework: how CMR substances are managed
The treatment of CMR substances in cosmetics is governed by Article 15 of Regulation (EC) No 1223/2009. This establishes that substances classified as CMR categories 1A, 1B, or 2 are generally prohibited in cosmetic products, except in exceptional cases where their safe use can be demonstrated under very strict conditions.
It is important to note that the classification of a substance as CMR is not carried out within the cosmetics framework, but rather under the CLP Regulation, which assesses the intrinsic hazards of chemical substances. The Cosmetics Regulation subsequently incorporates these classifications to regulate their use in consumer products.
This system ensures cross-cutting regulatory consistency, where scientific evidence is translated into concrete regulatory measures.
Which cosmetic ingredients will be prohibited in 2027?
The main impact of Omnibus Act IX will be the addition of new substances to Annex II of the Cosmetics Regulation, which lists prohibited ingredients.
These substances:
- Have recently been classified as CMR under the CLP Regulation.
- Are subject to the prohibition regime set out in Article 15 of the Cosmetics Regulation, unless they meet the conditions established for an exception.
- May need to be removed from formulations before the date of application (February 1, 2027).
Although ATP 23 of the CLP Regulation has already established the classification of certain substances as CMR, the definitive scope of the impact will depend on how these are incorporated into the Cosmetics Regulation through Omnibus Act IX. Depending on this integration, raw materials used across different categories – such as fragrances, preservatives, or colorants – could be affected.
From an operational standpoint, this means companies will need to thoroughly review their formulations and anticipate possible substitutions.
This analysis requires both a regulatory and technical assessment of each formula. In this context, specialized companies such as Cosmeservice support manufacturers and cosmetic brands in identifying affected ingredients, evaluating alternatives, and adapting the documentation necessary to ensure regulatory compliance within the established deadlines.
Key regulatory changes introduced by Omnibus Act IX
1. Expansion of the list of prohibited substances
The most significant change is the update to Annex II, which increases the number of substances not authorized in cosmetic products. This process is automatic whenever a substance is classified as CMR and does not meet the criteria for safe use.
2. Specific restrictions for certain ingredients
In some cases, when the risk can be managed, substances are not fully prohibited but instead restricted through:
- Concentration limits.
- Conditions of use.
- Labeling requirements.
One example of an ingredient subject to specific restrictions in the European Union is Ethoxydiglycol, whose use is regulated in certain categories of cosmetic products due to safety considerations.
3. Date of application and transition
The expected date of application is February 1, 2027, from which point onward products that do not comply with the new regulation may no longer be marketed.
As with previous regulations, transitional periods are expected to allow companies to adapt their products, although these periods are typically limited and require advance planning.
Impact on the B2B cosmetics industry
1. Cosmetic reformulation ahead of the 2027 Omnibus Act IX deadline
Reformulation will be one of the main challenges arising from Omnibus Act IX. This is not simply a matter of replacing an ingredient, but of ensuring that the final product retains its functionality, stability, and consumer acceptance.
This process involves:
- Identifying affected ingredients.
- Evaluating viable alternatives.
- Conducting the necessary laboratory testing.
- Validating the safety of the reformulated product before its market launch.
This makes cosmetic reformulation a strategic priority ahead of the 2027 Omnibus Act IX deadline, rather than a last-minute compliance task.
2. Cosmetic supply chain compliance for the 2027 EU deadline
Regulatory pressure will also extend to the supply chain. Manufacturers will need to work closely with their suppliers to ensure that raw materials meet the new requirements.
This includes:
- Updating technical specifications.
- Verifying regulatory compliance.
- Improving ingredient traceability.
Ensuring cosmetic supply chain compliance well ahead of the 2027 EU deadline will be essential to avoid last-minute sourcing disruptions.
3. EU cosmetics compliance and the 2027 Omnibus Act IX deadline
Regulatory compliance becomes the differentiating factor, as companies that manage these changes correctly will be able to reduce risk, avoid product recalls, and strengthen their market reputation.
For many organizations – particularly those with extensive product portfolios or an international presence – having access to specialized regulatory support enables them to manage these changes more efficiently. Cosmeservice offers comprehensive cosmetic compliance services, including formula review, technical documentation, safety assessments, and ongoing regulatory monitoring.
Strong EU cosmetics compliance ahead of the 2027 Omnibus Act IX deadline will separate market leaders from companies facing late-stage disruption.
How to prepare for the new european cosmetics regulation
Anticipation will be key to successfully managing the impact of Omnibus Act IX. For many cosmetics companies, this process involves coordinating regulatory, technical, and documentary aspects. Cosmeservice provides comprehensive support in these areas, helping manufacturers, brands, and product responsible persons adapt their cosmetics to the new European requirements through specialized regulatory services such as:
1. Portfolio Audit
Reviewing current formulations to identify potential regulatory risks.
2. Ongoing regulatory monitoring
Tracking updates to the CLP Regulation and the Cosmetics Regulation to anticipate changes.
3. Collaboration with experts
Conducting technical reviews of already-adapted formulations to verify that new ingredients meet applicable regulatory requirements.
Regulatory trends: toward a more demanding model
Omnibus Act IX is not an isolated change, but part of a structural trend in European regulation. This trend is characterized by:
- An increasingly preventive approach.
- Greater integration between different regulations.
- An increase in restrictions on chemical substances.
- Continuous adaptation to scientific evidence.
In this context, companies must adopt a long-term view, integrating regulation into their business strategy rather than treating it merely as a legal obligation.
The new prohibited cosmetic ingredients in the EU in 2027 will set a new standard for the industry. Omnibus Act IX reinforces the European Union’s commitment to consumer safety, while also posing significant challenges for the industry.
However, it also opens up opportunities for companies capable of adapting quickly, innovating in their formulations, and positioning themselves as leaders in regulatory compliance. In an increasingly regulated environment, the ability to anticipate and adapt will be a key factor in competitiveness.
FAQs
Which cosmetic ingredients will be banned in the EU in 2027?
Mainly substances classified as CMR that will be added to Annex II of Regulation (EC) No 1223/2009 and that do not meet the safety requirements needed for use in cosmetic products.
What is Omnibus Act IX in cosmetics?
It is a regulatory update that aligns European cosmetics legislation with the new hazardous substance classifications established under the CLP Regulation, ensuring consistency between the two frameworks.
What are CMR substances?
These are carcinogenic, mutagenic, or reproductively toxic substances that may pose risks to human health and are therefore subject to strict regulatory restrictions in the European Union.
When does the regulation come into force?
The expected date of application for Omnibus Act IX is February 1, 2027, although certain measures may be accompanied by specific transitional periods.
How does this affect cosmetics companies?
It requires companies to review formulations, analyze affected ingredients, update technical documentation, and ensure compliance with the new regulatory requirements. At Cosmeservice, we help companies manage this process through regulatory assessment, compliance, and product adaptation services.
How can Cosmeservice help with adapting to Omnibus Act IX?
Cosmeservice supports cosmetics companies throughout the entire adaptation process for Omnibus Act IX. Its services include reviewing formulas and raw materials, identifying potentially affected substances, analyzing reformulation alternatives, and updating technical and regulatory documentation.
Cosmeservice also provides support in product safety assessment, updating regulatory notifications, and ongoing monitoring of regulatory changes, with the goal of ensuring that cosmetic products continue to meet applicable requirements in the European Union.
Why does the EU prohibit these substances?
To ensure a high level of protection for human health, based on the latest scientific evidence and the precautionary principle that characterizes European legislation on chemicals and cosmetics.
