New EU Draft Amending The EU Cosmetics Regulation 2026: Preparing For Ingredient Restrictions, CMR Compliance & Market Readiness

How the Latest EU Draft Regulation, SCCS Opinions, Omnibus Ingredients III, and Omnibus CMR IX Are Reshaping Cosmetic Product Compliance

The European Union has taken another major step toward strengthening cosmetic product safety. On 8 July 2026, the EU notified the World Trade Organization (WTO) of a draft Regulation amending Regulation (EC) No. 1223/2009 on cosmetic products.

The proposal combines the latest Scientific Committee on Consumer Safety (SCCS) opinions under Omnibus Ingredients III with Omnibus CMR IX, introducing new ingredient prohibitions, updated restrictions, and revised compliance timelines for cosmetic manufacturers placing products on the EU market.

As the Regulation progresses toward adoption, cosmetic companies should proactively assess formulations, supply chains, regulatory documentation, and product portfolios to ensure continued market access.

Why This Draft Regulation Matters

The proposed amendment reflects the EU's continued commitment to consumer safety by incorporating:

• Updated SCCS scientific assessments 
• New CMR classifications 
• Ingredient-specific prohibitions 
• Revised concentration limits 
• Stronger chemical risk management 
• Harmonized compliance across the EU 

Companies marketing cosmetics in Europe should begin preparing well before the Regulation becomes applicable.

Executive Overview

The draft Regulation introduces:

• New ingredient prohibitions 
• Additional CMR substance bans 
• Updated Annex II and Annex III requirements 
• New restrictions on selected ingredients 
• Revised transition timelines 
• Greater emphasis on formulation reviews 
• Increased regulatory scrutiny 
• Stronger product safety expectations 

Organizations that prepare early can minimize reformulation delays, reduce compliance risks, and maintain uninterrupted EU market access.

Key Changes Introduced in the Draft Regulation

1. New CMR-Related Prohibitions

The proposal introduces new prohibitions for substances classified as Carcinogenic, Mutagenic, or Reprotoxic (CMR) under Commission Delegated Regulation (EU) 2025/1222.

These prohibitions are intended to further strengthen consumer protection by restricting the use of newly classified hazardous substances in cosmetic products.

2. New Ingredient Prohibitions Following SCCS Opinions

Based on recent SCCS scientific assessments, the draft proposes banning:

• Benzophenone-1 
• Benzophenone-2 
• Basic Brown 16 
• Basic Blue 99 
• Prostaglandins and their analogues 

These ingredients would no longer be permitted in cosmetic formulations once the Regulation becomes applicable.

3. Mercury-Containing Preservatives to Be Banned

The proposal also introduces prohibitions for mercury-containing preservatives, including:

• Thimerosal 
• Phenylmercuric salts 

This reflects the EU's continued efforts to eliminate mercury-containing substances from cosmetic products wherever safer alternatives are available.

4. New Restrictions for CBD and BHA

Rather than complete prohibitions, the draft introduces revised restrictions for:

• Cannabidiol (CBD) 
• Butylated Hydroxyanisole (BHA) 

Manufacturers should review formulation concentrations, intend product use, and support safety data.

5. Updated Restrictions for Existing Ingredients

The proposal also revises existing requirements for:

• Hydroxyapatite (nano) 
• Propylparaben 
• Butylparaben 

Companies using these ingredients should reassess formulation compliance against the updated Annex requirements.

Proposed Regulatory Timeline

The draft outlines separate implementation timelines.

1. CMR-Related Measures

• Applicable from 1 February 2027 
• Aligns with Commission Delegated Regulation (EU) 2025/1222 

2. Remaining Measures

Following entry into force:

• 12-month transition period for placing products on the market 
• Additional 12-month period for making products available on the market 

The draft Regulation is currently expected to be adopted during Q4 2026.

Summary of Proposed Changes

Why Companies Should Prepare Now

Even before formal adoption, organizations should begin evaluating their cosmetic portfolios.

Early preparation helps:

• Reduce reformulation delays 
• Avoid product withdrawals 
• Improve regulatory planning 
• Strengthen supply chain readiness 
• Support uninterrupted market access 
• Minimize compliance risks 
• Improve management change 
• Protect business continuity 

Regulatory Readiness Checklist

A proactive compliance program should include:

Portfolio Review

• Identify affected products 
• Prioritize high-risk formulations 
• Evaluating impacted ingredients 

Formula Assessment

• Reviewing ingredient concentrations 
• Assess alternative raw materials 
• Confirm safety data availability 

Regulatory Documentation

• Update Product Information Files (PIF) 
• Review Cosmetic Product Safety Reports (CPSR) 
• Revise technical documentation where required 

Supplier Management

• Request updated ingredient specifications 
• Obtain revised declarations 
• Verify raw material compliance 

Labeling & Claims

• Confirm ingredient declarations 
• Review of product claims 
• Update artwork if necessary 

Market Transition Planning

• Monitor transition deadlines 
• Manage inventory 
• Coordinate reformulation activities 

Readiness Assessment

Common Challenges

Companies may encounter:

• Reformulation complexity 
• Alternative ingredient sourcing 
• Supplier data gaps 
• Portfolio-wide impact assessments 
• Documentation updates 
• Inventory management 
• Tight implementation timelines 
• Global formulation alignment 

Best Practices

Successful organizations should:

• Begin ingredient gap assessments early 
• Monitor regulatory developments 
• Engage suppliers proactively 
• Review affected product portfolios 
• Update technical documentation 
• Strengthen change control processes 
• Coordinate Regulatory, R&D, Quality, and Procurement teams 
• Develop phased implementation plans 

Future Regulatory Outlook

The proposed amendment reflects the EU's broader movement toward:

• Stronger chemical safety standards 
• Increased SCCS-driven restrictions 
• Continuous CMR updates 
• Greater consumer protection 
• Enhanced ingredient transparency 
• Ongoing modernization of the EU Cosmetics Regulation 

Organizations should expect additional ingredient reviews and regulatory updates in the coming years.

Business Benefits of Early Preparation

Frequently Asked Questions

1. What is the purpose of this draft Regulation?

To update the EU Cosmetics Regulation by introducing new ingredient prohibitions and restrictions based on recent SCCS opinions and CMR classifications.

2. Which ingredients are newly prohibited?

The proposal includes prohibitions for:

• Benzophenone-1 
• Benzophenone-2 
• Basic Brown 16 
• Basic Blue 99 
• Prostaglandins and their analogues 
• Certain newly classified CMR substances 
• Mercury-containing preservatives including Thimerosal and Phenylmercuric salts 

3. Which ingredients face updated restrictions?

The draft proposes revised requirements for:

• CBD 
• BHA 
• Hydroxyapatite (nano) 
• Propylparaben 
• Butylparaben 

4. When will the new rules apply?

CMR-related measures are proposed to apply from 1 February 2027, while other measures would follow a staged transition after the Regulation enters into force.

5. How should companies prepare?

Organizations should:

• Review ingredient portfolios 
• Assess formulations 
• Engage suppliers 
• Update regulatory documentation 
• Plan reformulations 
• Monitor adoption progress 

6. Why start preparations now?

Early planning reduces compliance risks, avoids supply disruptions, and supports continued access to the EU cosmetics market.

7. How can Maven Regulatory Solutions help?

Maven supports:

• Cosmetic regulatory gap assessments 
• Ingredient compliance reviews 
• SCCS impact assessments 
• Product Information File (PIF) updates 
• CPSR documentation support 
• Reformulation readiness 
• Regulatory strategy 
• Global cosmetics compliance consulting 

Conclusion

The proposed amendment to the EU Cosmetics Regulation represents another significant evolution in European cosmetic ingredient regulation. By combining Omnibus Ingredients III and Omnibus CMR IX, the EU is strengthening consumer protection through new ingredient prohibitions, revised restrictions, and updated compliance requirements.

Organizations that begin reviewing formulations, regulatory documentation, supplier information, and transition plans now will be better positioned to maintain compliance, reduce business disruption, and ensure uninterrupted access to the EU market.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions helps cosmetic manufacturers navigate evolving EU regulatory requirements through ingredient compliance assessments, formulation reviews, PIF and CPSR support, regulatory gap analyses, transition planning, and global cosmetics compliance strategies. Our expert team enables organizations to stay ahead of regulatory changes while maintaining product safety, compliance, and market continuity.