July 23, 2026

How Regulation (EU) 2023/1545, Fragrance Allergen Labeling, CPSR, PIF, IFRA Compliance, and Regulatory Readiness Are Transforming Cosmetic Compliance in the EU

From 31 July 2026, Commission Regulation (EU) 2023/1545 significantly expands the fragrance allergen labeling requirements under the EU Cosmetics Regulation (EC) No. 1223/2009.

The number of fragrance allergens that must be individually declared on cosmetic product labels will increase from 24 to more than 80, marking one of the most significant labeling changes for the cosmetics industry in recent years.

For cosmetic manufacturers, fragrance houses, brand owners, importers, and Responsible Persons, this is more than a labeling update it requires a comprehensive review of formulations, safety documentation, supplier information, and compliance processes to ensure products remain market-ready across the European Union.

Why This Regulatory Change Matters

The new allergen disclosure requirements are designed to improve consumer transparency and better protect individuals with fragrance allergies by providing more detailed ingredient information.

Beginning 31 July 2026:

  • All new cosmetic products placed on the EU market must comply with the updated allergen labeling requirements. 
  • Cosmetic products already placed on the market before the deadline may continue to be sold until 31 July 2028 under the transitional provisions. 

Failure to comply may result in:

  • Non-compliant product labeling 
  • Market withdrawal or recalls 
  • Regulatory enforcement actions 
  • Delayed product launches 
  • Increased compliance costs 
  • Supply chain disruptions 
  • Re-labeling and reformulation expenses 
  • Reputational risk 

Executive Overview

The new requirements affect them much more than product labels.

A future-ready fragrance compliance program should be:

  • Regulatory complaint 
  • Consumer-focused 
  • Scientifically supported 
  • Risk-based 
  • Inspection ready 
  • Well documented 
  • Globally aligned 
  • Lifecycle managed 
  • Supported by regulatory intelligence 
  • Continuously monitored 

Organizations that begin preparations early can minimize business disruption while maintaining market access across Europe.

Understanding Regulation (EU) 2023/1545

The Regulation amends Annex III of the EU Cosmetics Regulation by expanding the list of fragrance allergens that require individual disclosure on cosmetic labels.

The updated requirements apply across all EU Member States and Northern Ireland.

The objective is to improve consumer awareness by ensuring that individuals with fragrance allergies can more easily identify substances that may trigger allergic reactions.

New Labeling Requirements

Products containing listed fragrance allergens above specified thresholds must identify each allergen individually on the product label.

Disclosure thresholds:

Product TypeMandatory Disclosure Threshold
Leave-on products0.001%
Rinse-off products0.01%

Compliance Timeline

MilestoneDate
New labeling requirements become mandatory31 July 2026
Existing products may continue under transitional provisionsUntil 31 July 2028
Non-compliant products may no longer be placed on the market after transitionAfter 31 July 2028

Key Areas Impacted

The updated regulation affects:

  • Cosmetic manufacturers 
  • Fragrance manufacturers 
  • Brand owners 
  • Importers 
  • Private label companies 
  • Responsible Persons 
  • Contract manufacturers 
  • Regulatory Affairs teams 

Products commonly impacted include:

  • Perfumes 
  • Body sprays 
  • Creams 
  • Lotions 
  • Shampoos 
  • Conditioners 
  • Deodorants 
  • Soaps 
  • Oral care products 
  • Hair care products 

Core Compliance Requirements

Organizations should review:

  • Product formulations 
  • Raw material specifications 
  • Supplier documentation 
  • IFRA Standards 
  • Product Information Files (PIF) 
  • Cosmetic Product Safety Reports (CPSR) 
  • Ingredient declarations 
  • Product labels 
  • CPNP notifications 
  • Change management procedures 

Cosmetic Compliance Readiness

Assessment AreaObjective
Formulation ReviewVerify allergen content
Labeling ComplianceUpdate ingredient declarations
PIF & CPSRMaintain complete documentation
Supplier ManagementConfirm raw material information
Regulatory IntelligenceMonitor future amendments
Lifecycle ManagementMaintain ongoing compliance

Traditional Labeling vs. New Requirements

Previous RequirementsNew Requirements
24 fragrance allergensMore than 80 fragrance allergens
Limited disclosureExpanded transparency
Lower documentation complexityGreater regulatory oversight
Fewer formulation reviewsMore extensive ingredient assessments
Standard labeling updatesComprehensive compliance reviews

Building a Future-Ready Compliance Strategy

Successful organizations should focus on:

  • Early formulation reviews 
  • Ingredient verification 
  • Supplier engagement 
  • IFRA compliance 
  • PIF and CPSR updates 
  • Label redesign 
  • CPNP notification reviews 
  • Ongoing regulatory intelligence 

Best Practices

1. Review Formulations

Identify fragrance allergens requiring declaration under the updated Regulation.

2. Strengthen Documentation

Maintain:

  • Product Information Files (PIF) 
  • Cosmetic Product Safety Reports (CPSR) 
  • Supplier documentation 
  • Technical specifications 

3. Verify Supplier Information

Work closely with fragrance suppliers to obtain updated allergen declarations.

4.Update Product Labels

Ensure ingredient listings accurately reflect the new allergen disclosure requirements.

5.Strengthening Regulatory Intelligence

Continuous monitor:

  • European Commission updates 
  • SCCS opinions 
  • IFRA Standards 
  • Cosmetic Regulation amendments 

Common Challenges

Organizations frequently encounter:

  • Complex fragrance compositions 
  • Incomplete supplier data 
  • Label redesign timelines 
  • Documentation updates 
  • Resource constraints 
  • Multiple market requirements 
  • Reformulation needs 
  • Change management complexity 

Common Mistakes

Avoid:

  • Waiting until the implementation deadline 
  • Using outdated supplier information 
  • Failing to update PIFs and CPSRs 
  • Incomplete allergen declarations 
  • Weak document control 
  • Limited regulatory monitoring 

Implementation Roadmap

ActivityTimelineBenefit
Review formulationsImmediatelyIdentify affected products
Obtain supplier declarationsEarlyAccurate allergen assessment
Update PIF & CPSRBefore July 2026Documentation readiness
Redesign labelsBefore product releaseRegulatory compliance
Verify CPNP notificationsBefore market placementMarket readiness
Train regulatory teamsOngoingContinuous compliance

Future Trends

Emerging developments include:

  • Increased ingredient transparency 
  • Digital cosmetic labeling 
  • Enhanced traceability 
  • Greater consumer information 
  • Sustainability reporting 
  • AI-assisted formulation reviews 
  • Expanded ingredient restrictions 
  • Stronger post-market surveillance 

Business Benefits

Business FunctionKey Benefit
Regulatory AffairsStronger compliance
Product DevelopmentFaster regulatory readiness
Quality AssuranceImproved documentation
MarketingGreater consumer trust
Executive LeadershipReduced compliance risk
ConsumersBetter allergen transparency

Frequently Asked Questions

1. What changes on 31 July 2026?

New cosmetic products placed on the EU market must comply with expanded fragrance allergen labeling requirements under Regulation (EU) 2023/1545.

2. How many allergens must now be declared?

The number increases from 24 to more than 80 fragrance allergens.

3. What are the disclosure thresholds?

  • 0.001% for leave-on products 
  • 0.01% for rinse-off products 

4. What is the transition period?

Products already placed on the EU market before 31 July 2026 may continue to be sold until 31 July 2028.

5. How can companies prepare?

  • Review formulations 
  • Obtain updated supplier information 
  • Update labels 
  • Revise PIFs and CPSRs 
  • Verify CPNP notifications 
  • Monitor future regulatory updates 

6. How can Maven Regulatory Solutions help?

Maven supports:

  • Cosmetic regulatory strategy 
  • Fragrance allergen assessments 
  • Product Information File (PIF) preparation 
  • Cosmetic Product Safety Report (CPSR) coordination 
  • Label compliance reviews 
  • Ingredient and formulation gap assessments 
  • CPNP notification support 
  • IFRA compliance guidance 
  • Regulatory intelligence 
  • Global cosmetic lifecycle management 

Conclusion

The implementation of Regulation (EU) 2023/1545 represents one of the most significant cosmetic labeling changes in recent years. Organizations that proactively review formulations, update documentation, strengthen supplier collaboration, and revise product labels will be better positioned to maintain compliance, avoid market disruptions, and continue serving consumers across the European market.

Why Choose Maven Regulatory Solutions?

Maven Regulatory Solutions helps cosmetic and fragrance companies navigate evolving EU regulations through ingredient compliance assessments, fragrance allergen reviews, PIF and CPSR support, labeling compliance, CPNP notification assistance, IFRA guidance, regulatory intelligence, and end-to-end cosmetic lifecycle management. We help organizations build scalable, inspection-ready compliance programs that support successful market access.