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 Type | Mandatory Disclosure Threshold |
| Leave-on products | 0.001% |
| Rinse-off products | 0.01% |
Compliance Timeline
| Milestone | Date |
| New labeling requirements become mandatory | 31 July 2026 |
| Existing products may continue under transitional provisions | Until 31 July 2028 |
| Non-compliant products may no longer be placed on the market after transition | After 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 Area | Objective |
| Formulation Review | Verify allergen content |
| Labeling Compliance | Update ingredient declarations |
| PIF & CPSR | Maintain complete documentation |
| Supplier Management | Confirm raw material information |
| Regulatory Intelligence | Monitor future amendments |
| Lifecycle Management | Maintain ongoing compliance |
Traditional Labeling vs. New Requirements
| Previous Requirements | New Requirements |
| 24 fragrance allergens | More than 80 fragrance allergens |
| Limited disclosure | Expanded transparency |
| Lower documentation complexity | Greater regulatory oversight |
| Fewer formulation reviews | More extensive ingredient assessments |
| Standard labeling updates | Comprehensive 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
| Activity | Timeline | Benefit |
| Review formulations | Immediately | Identify affected products |
| Obtain supplier declarations | Early | Accurate allergen assessment |
| Update PIF & CPSR | Before July 2026 | Documentation readiness |
| Redesign labels | Before product release | Regulatory compliance |
| Verify CPNP notifications | Before market placement | Market readiness |
| Train regulatory teams | Ongoing | Continuous 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 Function | Key Benefit |
| Regulatory Affairs | Stronger compliance |
| Product Development | Faster regulatory readiness |
| Quality Assurance | Improved documentation |
| Marketing | Greater consumer trust |
| Executive Leadership | Reduced compliance risk |
| Consumers | Better 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.
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