New Horizon for Cosmetic Safety: Adapting to Regulation (EU) 2023/1545 on Fragrance Allergen Labelling
Executive Summary
The European cosmetics industry is entering a new era of transparency and scientific precision. The European Commission’s Regulation (EU) 2023/1545, effective from 16 August 2023, fundamentally reshapes the way fragrance allergens must be identified and labelled in cosmetic products. Expanding the list from 24 to 80 allergens, this regulation imposes significant operational, technical and strategic obligations on all cosmetic manufacturers and Responsible Persons in the EU and UK markets. This article explains how manufacturers can adapt efficiently – balancing compliance with innovation – while demonstrating how Annel supports partners in meeting these evolving challenges.
I. Operational Actions – Compliance with Regulation (EU) 2023/1545
1. Understanding the New Fragrance Allergen Requirements
The regulation extends Annex III of Regulation (EC) 1223/2009, based on SCCS Opinion 1459/11, which reassessed sensitisation data for hundreds of fragrance ingredients.
Key points include:
- Number of allergens: expanded from 24 to 80 entries (adding 56 new substances).
- Scope: includes both synthetic and natural ingredients, such as Menthol, Camphor, Vanillin, and essential oils (Lavandula angustifolia oil, Citrus limon peel oil).
- Thresholds:
- 0.001% for leave-on products,
- 0.01% for rinse-off products.
- Grouped Concept: allows declaration of structurally related allergens under a single INCI name (e.g. Citral grouping Citral, Geranial, Neral).
- Pre- and pro-haptens: substances that become allergens after oxidation or biotransformation must also be treated as equivalent allergens.
These changes demand a full review of formulation data, supplier documentation, and labelling.
2. Portfolio Analysis
Manufacturers should immediately evaluate their entire product portfolio to determine the impact of the new allergen list. Special attention must be paid to:
- Products with fragrance mixtures, essential oils, botanical extracts, and hydrolates.
- “Hypoallergenic” or “sensitive skin” claims, which may no longer be valid once the extended allergen list applies.
- Historical formulations using natural ingredients – trace allergens must now be declared.
3. Supplier Documentation and Data Verification
Reliable supplier documentation is the cornerstone of compliance. Each supplier of fragrance materials, essential oils or blends must provide updated data, including:
- Full list of the 80 allergens present in the material.
- IFRA Certificate of Conformity (IFRA 51st Amendment).
- Fragrance Safety Evaluation (FSE) or statement of conformity with Regulation (EC) 1223/2009.
- Safety Data Sheet (SDS) compliant with CLP classification.
- Certificate of Quality.
If suppliers delay or fail to update documentation, the Responsible Person bears full liability for any non-compliance. Where necessary, manufacturers may need to change suppliers and reformulate products.
For guidance on managing documentation updates, visit Regulatory Compliance for Cosmetic Products.
4. Product and Documentation Updates
Every cosmetic product containing fragrance components will require updated technical documentation and labelling:
- INCI list: must reflect new allergens and group naming conventions.
- Concentration calculations: re-evaluate total allergen concentrations in the finished product.
- CPSR update: both Part A (quantitative composition) and Part B (toxicological assessment) must reflect revised exposure and sensitisation data.
- Labelling design: ensure consistent use of grouped INCI terms and accurate thresholds.
Learn more about the Responsible Person’s role in maintaining regulatory files on Responsible Person Service.
5. Managing Timelines and Market Deadlines
The European Commission has set transitional periods to allow manufacturers to adapt:
- Until 31 July 2026: products not yet compliant may still be placed on the market.
- Until 31 July 2028: those already placed may continue to be made available for sale.
This means companies have up to five years for full transition, but proactive action is critical — portfolio reviews, supplier coordination and relabelling take significant time.
II. Strategic Adaptation and Innovation
Beyond compliance, this regulation marks a broader shift towards safer, more transparent and science-driven product development.
1. R&D Strategy and Reformulation
Regulation (EU) 2023/1545 forces manufacturers to re-evaluate fragrance design and overall formulation strategy. At Annel we guide clients in integrating compliance with R&D innovation through:
- Reformulation of fragrance systems to reduce declared allergens.
- Selection of safe, stable, and sensorially equivalent alternatives.
- Validation of substitutes through safety and stability testing.
- Maintaining the olfactory identity of each product using analytical profiling (GC-MS).
Manufacturers investing early in Clean Beauty-driven R&D will future-proof their brands while complying with evolving standards such as IFRA 51 and the upcoming 52nd Amendment.
2. Integrating Technology and Digital Tools
Digitalisation accelerates compliance. Manufacturers can benefit from systems that automate allergen tracking and documentation management, such as:
- CosmetoSAFE Assist – automatic calculation of allergen concentrations and generation of safety data.
- ERP and APS tools (e.g. Asprova APS) for production planning and traceability.
Annel helps clients structure data workflows and documentation to streamline audits and market notifications.
3. Marketing, Claims and Borderline Products
Every product must be correctly classified before market placement — whether as a cosmetic, medical or biocidal product. Ambiguous cases (borderline products) require a case-by-case analysis considering:
- Product function and mode of action.
- Intended use and application method.
- Ingredient profile and presentation.
- Marketing and consumer perception.
Manufacturers must ensure that claims such as “dermatologically tested”, “hypoallergenic” or “natural” are substantiated and consistent with the product’s regulatory category. Misleading claims or implying medicinal effects may lead to fines or product withdrawal.
For expert guidance on claim substantiation and borderline compliance, contact Annel’s Regulatory Team.
4. Continuous Collaboration Between Departments
Successful implementation requires alignment between:
- Regulatory Affairs,
- R&D,
- Supply Chain, and
- Marketing.
Cross-functional cooperation ensures that changes in ingredient sourcing, formulation, labelling and communication all remain consistent and compliant.
5. Awareness of the Broader Regulatory Context
Manufacturers should remain aware of the wider legislative environment shaping cosmetic formulation in the EU:
- Ongoing restrictions on microplastics under Regulation (EU) 2023/2055.
- Forthcoming limits for PFAS under REACH.
While Annel focuses exclusively on cosmetic regulatory compliance, we encourage clients to monitor these related developments for long-term planning.
III. Education and Industry Leadership
At Annel, we believe compliance is not a static checklist but a dynamic process driven by scientific understanding. Through our cross-disciplinary team of regulatory and toxicology specialists, we support manufacturers in building internal competence across areas such as:
- Interpretation of SCCS opinions,
- Toxicological evaluation of fragrance allergens,
- IFRA updates and classification changes,
- Integration of compliance into early-stage R&D.
Learn more about our experience and team at About Annel.
Conclusion
The implementation of Regulation (EU) 2023/1545 is more than a regulatory update — it is a catalyst for innovation, transparency and trust. Manufacturers who adapt early will not only avoid disruption but also strengthen brand credibility and consumer confidence.
Key takeaways:
- Review all fragrance-containing products and documentation now.
- Engage suppliers to update allergen and IFRA data.
- Update CPSRs, INCI lists and product labels.
- Align R&D and marketing teams under a unified compliance strategy.
- Treat this as a long-term opportunity to modernise formulations and embrace Clean Beauty.