Regulation (EU) 2024/197: New CMR Substance Restrictions And Their Impact On Cosmetics

The European Union continues to strengthen cosmetic safety standards with the introduction of Regulation (EU) 2024/197 (Omnibus Regulation VII). This update amends Regulation (EC) No 1223/2009 by adding 31 new CMR (Carcinogenic, Mutagenic, Reprotoxic) substances to the list of prohibited ingredients.

From September 1, 2025, cosmetic products containing these substances cannot be placed on or sold in the EU market, unless extremely strict and limited conditions are met.

EU CMR Cosmetics Ban 2025

EU Regulation 2024/197 bans 31 CMR substances in cosmetics under Annex II of Regulation (EC) 1223/2009. From September 1, 2025, products containing these chemicals cannot be marketed in the EU, requiring reformulation, updated safety assessments, and full regulatory compliance.

Key Highlights of Regulation (EU) 2024/197

• Adds 31 CMR substances to Annex II (prohibited list) 
• Applies to all cosmetic products in the EU market 
• Mandatory compliance deadline: September 1, 2025 
• Requires product reformulation and safety reassessment 
• Impacts manufacturers, importers, and distributors 

What Are CMR Substances?

CMR substances are chemicals classified based on their potential to cause serious health risks:

• Carcinogenic (C): Can cause cancer 
• Mutagenic (M): Can induce genetic mutations 
• Reprotoxic (R): Can affect fertility or fetal development 

CMR Classification Categories

These classifications are aligned with the EU’s CLP Regulation (Classification, Labelling and Packaging) framework.

Regulatory Scope and Legal Impact

Regulation (EU) 2024/197 directly updates Annex II (prohibited substances) of the EU Cosmetics Regulation.

What This Means

• Immediate ban on listed substances in cosmetics 
• Mandatory reformulation of affected products 
• Updated Cosmetic Product Safety Reports (CPSR) 
• Revised Product Information Files (PIF) 

Key CMR Substances Impacting Cosmetics

Below are examples of commonly used substances now restricted:

Selected Banned CMR Substances

Note: Restrictions may vary based on particle size, concentration, and product type.

Why Are These Substances Restricted?

The EU’s decision is based on:

• Scientific evidence of long-term health risks 
• Potential for dermal exposure hazards 
• Availability of safer alternative ingredients 
• Alignment with precautionary regulatory principles 

What Cosmetic Companies Must Do

To comply with Regulation (EU) 2024/197, companies must take immediate action.

1. Ingredient Compliance Review

• Audit all formulations 
• Identify presence of banned CMR substances 

2. Product Reformulation

• Replace restricted ingredients with compliant alternatives 
• Ensure performance and stability are maintained 

3. Labeling and Documentation Updates

• Update product labels and claims 
• Revise Safety Data Sheets (SDS) 
• Ensure compliance with labeling standards 

4. Regulatory File Updates

• Update CPSR (Cosmetic Product Safety Report) 
• Revise PIF (Product Information File) 
• Maintain complete compliance documentation 

5. Supply Chain Alignment

• Obtain declarations from raw material suppliers 
• Ensure distributors are informed and compliant 

Compliance Action Plan

Are There Any Exceptions?

Yes, but only under strict conditions:

• No safer alternatives available 
• Substance meets food-grade safety standards 
• Approved by the Scientific Committee on Consumer Safety 

Current Status

• No exemptions apply to the newly added 31 substances 
• Full compliance is mandatory 

Challenges for Industry

• Reformulation without affecting product performance 
• Managing supply chain transitions 
• Updating large product portfolios 
• Ensuring timely compliance before deadline 

Regulatory Expertise in EU Cosmetics Compliance

Maven Regulatory Solutions provides specialized support in navigating EU cosmetic regulations, ingredient restrictions, and safety assessments.

Global Compliance Experience

Our expertise includes:

• EU Cosmetics Regulation Compliance 
• CMR substance risk assessment 
• Global cosmetic regulatory frameworks 

Scientific Authority

Our team includes:

• Toxicologists and safety assessors 
• Regulatory affairs experts 
• Cosmetic compliance specialists 

Trust Through Safety and Transparency

We assure you:

• Accurate ingredient safety evaluation 
• Transparent documentation 
• Continuous regulatory monitoring 
• Long-term compliance strategy 

Ensure CMR Compliance with Maven

Partner with Maven Regulatory Solutions

Facing challenges with EU cosmetic compliance?

We will help you.

• Identify and eliminate CMR substances 
• Reformulate products efficiently 
• Update CPSR and PIF documentation 
• Achieving full EU regulatory compliance 

Our Services

• Ingredient compliance assessment 
• Toxicological risk evaluation 
• Regulatory documentation support 
• Labeling and claims review 
• EU market entry strategy 

Why Choose Maven

• Deep expertise in EU cosmetic regulations 
• End-to-end compliance solutions 
• Scientific and regulatory integration 
• Proven industry experience 

Conclusion

Regulation (EU) 2024/197 marks a significant advancement in consumer safety and regulatory oversight in the cosmetics industry.

To remain compliant, companies must:

• Reformulate products 
• Update safety documentation 
• Ensure full regulatory alignment 

before September 1, 2025, deadline.

Proactive compliance is essential to maintain market access, consumer trust, and regulatory approval in the EU.

FAQs

1. What is Regulation (EU) 2024/197?

EU regulation banning 31 CMR substances in cosmetics.

2. What are CMR substances?

Chemicals that can cause cancer, genetic mutations, or reproductive harm.

3. When does the regulation apply?

September 1, 2025.

4. Are there any exceptions?

No current exceptions for the newly listed substances.

5. What is CPSR?

Cosmetic Product Safety Report required for EU compliance.

6. What is PIF?

Product Information File containing product safety and compliance data.

7. How can Maven help?

By providing complete EU cosmetic regulatory compliance support.