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:

Compliance Timeline

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

Traditional Labeling vs. New Requirements

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

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

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.

EU Cosmetic Fragrance Allergen Regulation 2026: New Labeling Requirements, 31 July 2026 Deadline, INCI Updates & Compliance Strategy

Fragrances are an essential part of the consumer experience for cosmetic products, from perfumes and deodorants to creams, shampoos, body washes and skincare products. However, certain fragrance ingredients can cause allergic contact dermatitis, particularly in consumers who have already become sensitized.

To strengthen consumer protection and improve ingredient transparency, the European Union has significantly expanded its requirements for the individual labeling of fragrance allergens in cosmetic products.

The key regulatory development is Commission Regulation (EU) 2023/1545, which amended Annex III of Regulation (EC) No 1223/2009, the EU Cosmetics Regulation. The amendment introduces individual labeling requirements for 56 additional fragrance allergens, while also updating and grouping certain existing entries and their substance-identification information.

For cosmetic manufacturers, Responsible Persons, importers, distributors and brand owners, the transition is now critical.

31 July 2026 is the deadline for placing non-compliant new cosmetic products on the EU market, while products placed on the market before this date can continue to be made available until 31 July 2028, subject to the applicable transitional conditions.

This makes EU fragrance allergen labeling compliance an immediate priority for businesses selling cosmetic products across the European market.

What Is EU Regulation (EU) 2023/1545?

Commission Regulation (EU) 2023/1545 amended the fragrance allergen provisions in Annex III of Regulation (EC) No 1223/2009.

Historically, certain fragrance allergens had to be individually declared when present above specified concentrations, while perfume and aromatic compositions could generally be declared using terms such as “Parfum” or “Aroma.”

The 2023 amendment substantially expanded the list of fragrance allergens requiring individual disclosure.

The European Commission confirms that the amendment introduces labeling requirements for 56 additional fragrance allergens.

The objective is to ensure that consumers who are sensitized to fragrance ingredients can identify them from the cosmetic product's ingredient list.

Why Do Fragrance Allergens Matter?

Fragrance ingredients are among the important causes of allergic contact dermatitis associated with cosmetic exposure.

Once sensitization has occurred, exposure to a relevant allergen may result in symptoms such as:

• Redness
• Itching
• Skin inflammation
• Irritation
• Rash
• Allergic contact dermatitis

The purpose of individual fragrance allergen labeling is therefore not to prohibit all fragrance ingredients.

Instead, it provides consumers with more detailed information so that individuals who are already sensitized can identify ingredients they may need to avoid.

The European Commission notes that the presence of an individually declared fragrance allergen on a cosmetic label does not by itself mean that the product is unsafe.

What Changed Under the Expanded EU Fragrance Allergen Rules?

The most important change is the substantial expansion of fragrance allergens that may require individual disclosure.

Key Changes

The applicable threshold remains 0.001% for leave-on cosmetic products and 0.01% for rinse-off cosmetic products for the relevant fragrance allergens.

31 July 2026: The Critical EU Compliance Deadline

For cosmetic companies, 31 July 2026 is a major regulatory milestone.

From this date, cosmetic products that do not comply with the updated fragrance allergen labeling requirements may no longer be placed on the EU market.

However, the regulation provides a longer transition for products that were already placed on the market before the new requirements became applicable.

Such products may continue to be made available on the EU market until 31 July 2028, subject to the regulation's transitional provisions.

This creates two important compliance questions:

Was the product placed on the EU market before 31 July 2026?

Does the product comply with the updated fragrance allergen labeling requirements?

Cosmetic companies should document their answers carefully.

The 0.001% and 0.01% Fragrance Allergen Thresholds

One of the most important elements of the EU fragrance allergen regulation is the concentration threshold for individual disclosure.

Leave-On Products

For leave-on products, applicable fragrance allergens must be individually identified when presented above:

0.001%

This can apply to products such as:

• Face creams
• Body lotions
• Serums
• Deodorants
• Perfumes
• Skin treatments

Rinse-Off Products

For rinse-off products, the corresponding threshold is:

0.01%

Examples include:

• Shampoos
• Shower gels
• Body washes
• Cleansers
• Conditioners

The threshold should be evaluated based on the concentration of the relevant allergen in the finished cosmetic product, not simply the concentration in the fragrance compound supplied by the fragrance house.

Why “Parfum” Alone May No Longer Be Enough

Under the EU Cosmetics Regulation, fragrance compositions can generally be identified in the ingredient list using terms such as “Parfum” or “Aroma.”

However, where a regulated fragrance allergen is present above the applicable threshold, that allergen must be individually identified.

Therefore, a formulation may require an ingredient declaration that goes beyond simply listing:

Parfum

The finished ingredient list may also need to identify relevant fragrance allergens individually.

This makes accurate fragrance composition data essential for regulatory compliance.

What Does This Mean for Cosmetic Manufacturers?

The expanded requirements can affect virtually every stage of the cosmetic product compliance process.

Manufacturers should review:

• Cosmetic formulations
• Fragrance compositions
• Supplier declarations
• Fragrance allergen concentrations
• INCI ingredient lists
• Cosmetic labels
• Packaging artwork
• Product Information Files (PIFs)
• Cosmetic Product Safety Reports (CPSRs)
• Safety assessments
• Product specifications
• Regulatory databases

The European Commission specifically advises businesses to review fragrance ingredients, determine whether covered allergens exceed applicable thresholds, correctly include allergens in ingredient lists, update packaging where necessary, and ensure consistency between the product's composition, labeling, PIF and safety assessment.

Supplier Data: A Critical Compliance Requirement

One of the biggest challenges for cosmetic companies is obtaining sufficiently detailed information from fragrance suppliers.

A fragrance supplier declaration stating only:

“Contains fragrance”

may not be sufficient for a complete regulatory assessment.

Companies should seek information that allows them to determine:

• Which regulated allergens are present
• Their concentrations in the fragrance
• Their expected concentration in the finished cosmetic
• Whether the composition has changed
• Whether updated allergen information is available
• Whether the fragrance formulation has been reformulated

Supplier information should be incorporated into a controlled regulatory workflow rather than maintained as disconnected documents.

Impact on Cosmetic Labeling and INCI Declarations

The expanded allergen list can create significant artwork and packaging implications.

Where disclosure is required, businesses may need to:

1. Review Existing INCI Lists

Compare current ingredient declarations against the latest Annex III requirements.

2. Update Packaging Artwork

Labels, cartons, tubes, bottles and other packaging may require revisions.

3. Review of Multilingual Labels

EU cosmetic labels commonly require information in languages determined by the Member States where the product is marketed.

4. Manage Artwork Change Control

Companies should establish a controlled process to prevent old artwork from being used after the applicable compliance deadline.

Impact on the Product Information File (PIF)

The Product Information File (PIF) should remain consistent with the finished formulation and labeling.

Fragrance allergen changes can therefore require a broader PIF review.

Relevant information may include:

• Product formulation
• Raw material specifications
• Fragrance documentation
• Allergen calculations
• Safety assessment
• Product labeling
• Manufacturing information
• Supporting regulatory documentation

A label update without reviewing the underlying PIF and safety documentation can create inconsistencies in the compliance file.

Impact on the Cosmetic Product Safety Report

The fragrance allergen update can also affect the Cosmetic Product Safety Report (CPSR) and safety assessment.

Safety assessors and regulatory teams should verify that the fragrance composition used for the assessment corresponds to the marketed product.

Where formulation or fragrance composition changes, the company should determine whether the existing safety assessment remains appropriate or requires updating.

EU Fragrance Allergen Compliance Workflow

A practical compliance process can follow these steps:

Step 1: Product Inventory

Identify all cosmetic products containing fragrance or aromatic compositions.

Step 2: Supplier Data Collection

Obtain updated fragrance composition and allergen information.

Step 3: Allergen Screening

Identify regulated fragrance allergens covered by Annex III.

Step 4: Threshold Calculation

Calculate concentrations in the finished cosmetic product.

Step 5: Label Review

Determine which allergens must be individually declared.

Step 6: PIF/CPSR Review

Check consistency between formulation, safety documentation and labeling.

Step 7: Artwork Update

Update packaging and ingredient declarations.

Step 8: Final Regulatory Verification

Complete a final EU Cosmetics Regulation compliance review before market placement.

EU Fragrance Allergen Compliance Checklist 2026

Common Challenges for Cosmetic Companies

1. Incomplete Fragrance Declarations

Fragrance mixtures can contain numerous individual substances, making complete composition analysis challenging.

2. Changing Supplier Formulations

Fragrance suppliers may modify compositions, potentially changing the allergen profile of a finished product.

3. Incorrect Threshold Calculations

Companies may incorrectly assess allergen concentration in the fragrance rather than the finished cosmetic product.

4. Outdated Packaging

Existing packaging may not reflect the expanded allergen disclosure requirements.

5. PIF and Label Inconsistency

The formulation, CPSR, PIF and final label must remain aligned.

6. Large Product Portfolios

Companies with hundreds of cosmetic SKUs may face significant workload when reviewing formulations and artwork.

How Cosmetic Companies Can Prepare

Businesses should establish a structured EU fragrance allergen compliance program covering the entire product lifecycle.

Recommended actions include:

• Conduct a portfolio-wide fragrance allergen assessment
• Obtain updated fragrance supplier declarations
• Map allergens to finished-product concentrations
• Classify products as leave-on or rinse-off
• Review of the latest Annex III requirements
• Update INCI declarations
• Revise packaging artwork where required
• Review PIF documentation
• Assess CPSR impact
• Implement supplier-change monitoring
• Maintain regulatory evidence
• Establish ongoing EU Cosmetics Regulation monitoring

Early implementation can reduce the risk of last-minute label changes, obsolete packaging inventory and EU market-access disruptions.

Building Consumer Trust Through Fragrance Transparency

Regulatory compliance is only one reason fragrance allergen labeling matters.

Consumers increasingly want to understand what is contained in the cosmetic products they purchase.

Clear allergen disclosure can help:

• Improve ingredient transparency
• Support informed purchasing decisions
• Help sensitized consumers identify relevant ingredients
• Strengthen consumer confidence
• Demonstrate responsible product stewardship
• Support long-term brand credibility

The European Commission describes individual allergen labeling as a way for sensitized consumers to identify and avoid products containing fragrance substances to which they may react.

FAQs 

1. What is EU Regulation (EU) 2023/1545?
Regulation (EU) 2023/1545 expands EU cosmetic fragrance allergen labeling requirements by adding 56 fragrance allergens to the individual disclosure framework.

2. How many new fragrance allergens were added in the EU?
The EU fragrance allergen update introduces 56 additional fragrance allergens requiring individual labeling when the applicable concentration threshold is exceeded.

3. What is the EU fragrance allergen labeling deadline in 2026?
The key EU cosmetic labeling deadline is 31 July 2026 for placing products on the EU market that comply with the updated fragrance allergen requirements.

4. What is the fragrance allergen threshold for leave-on cosmetics?
For applicable fragrance allergens, the leave-on cosmetic threshold is 0.001% in the finished product.

5. What is the fragrance allergen threshold for rinse-off cosmetics?
For applicable fragrance allergens, the rinse-off cosmetic threshold is 0.01% in the finished cosmetic product.

6. Is “Parfum” enough for EU cosmetic labeling? 
Not always. If a regulated fragrance allergen exceeds the applicable threshold, it must generally be individually declared in the cosmetic ingredient list.

7. Does EU fragrance allergen labeling apply to all cosmetics?
The requirements can affect a wide range of fragranced cosmetic products, including perfumes, creams, shampoos, deodorants and body washes, depending on the presence and concentration of regulated allergens.

8. What is the EU fragrance allergen transition period?
Products placed on the EU market before 31 July 2026 may generally continue to be made available until 31 July 2028, subject to the applicable transitional provisions.

9. What documents should cosmetic companies review for fragrance allergens?
Companies should review fragrance supplier declarations, formulations, allergen calculations, INCI lists, labels, PIFs, CPSRs and safety assessments for consistency.

10. How can companies comply with EU fragrance allergen labeling requirements?
Manufacturers and Responsible Persons should conduct a fragrance allergen assessment, calculate finished-product concentrations, update INCI labeling and verify PIF/CPSR and artwork compliance.

Conclusion

The expanded EU fragrance allergen labeling requirements under Regulation (EU) 2023/1545 represent one of the most important recent changes for cosmetic manufacturers selling products in Europe.

With 56 additional fragrance allergens subject to individual labeling requirements, companies must go beyond a generic “Parfum” declaration where regulated allergens exceed the applicable thresholds.

The key deadline is 31 July 2026, after which non-compliant cosmetic products may no longer be placed on the EU market. Products already placed on the market before that date may benefit from the transition period until 31 July 2028, subject to the applicable conditions.

For manufacturers, Responsible Persons and brand owners, now is the time to review fragrance compositions, supplier documentation, finished-product concentrations, INCI declarations, cosmetic labels, PIFs and CPSRs.

A proactive fragrance allergen assessment can help companies avoid regulatory gaps, minimize packaging disruption and maintain continuous access to the EU cosmetics market.

How Maven Regulatory Solutions Can Help

Maven Regulatory Solutions supports cosmetic manufacturers, brand owners, importers and Responsible Persons with comprehensive EU Cosmetics Regulation compliance and fragrance allergen labeling support.

Our services can include:

• EU Fragrance Allergen Assessment
• Regulation (EU) 2023/1545 Compliance Review
• Cosmetic Formulation Review
• Fragrance Supplier Data Assessment
• Finished-Product Allergen Threshold Calculation
• INCI Ingredient List Review
• Cosmetic Labeling and Artwork Review
• Product Information File (PIF) Review
• Cosmetic Product Safety Report (CPSR) Support
• EU Cosmetics Regulation Compliance Assessment
• Regulatory Gap Assessment
• Product Portfolio Screening
• Ongoing Cosmetic Regulatory Monitoring

Whether you are preparing a new cosmetic product for the EU market or updating an existing portfolio, Maven Regulatory Solutions can help you identify fragrance allergen labeling gaps, documentation inconsistencies and EU Cosmetics Regulation compliance risks.

Prepare your cosmetic portfolio for the expanded EU fragrance allergen requirements before regulatory deadlines become a market-access issue.