EU Perfume Allergen Labeling (Reg. 2023/1545): What Changes and How to Prepare

If you sell perfumes, eaux de toilette, or any fragranced cosmetic product in the European Union, a significant regulatory update is on the horizon. EU Regulation 2023/1545 amends the Cosmetic Products Regulation (EC) No 1223/2009, introducing stricter allergen labeling rules for fragrance substances. This change directly impacts your product development, sourcing, and compliance timelines. This guide breaks down what you need to know and the actionable steps to prepare your brand.

Key Changes in Regulation 2023/1545

The new regulation expands the list of fragrance allergens that must be declared on the ingredient list (INCI) when present above specific thresholds. The goal is to provide greater transparency for consumers with sensitivities.

Expanded Allergen List

The number of individually listed fragrance allergens increases from 26 to 82. This includes many substances commonly used in perfumery. They are divided into two groups with different labeling requirements:

• Group 1 (Existing & New Substances): 66 allergens that must be labeled individually by name.
• Group 2 (Additional Substances): 16 allergens that can be labeled individually or under the collective term “perfumery allergen systems” until a future review.

New Concentration Thresholds

The threshold for mandatory labeling is now based on the product’s concentration and type:

Note: For “perfume” and “eau de toilette” specifically, the threshold is > 0.01% regardless of leave-on/rinse-off classification.

How to Prepare Your Brand: A Step-by-Step Checklist

Preparation should start now to ensure a smooth transition before the enforcement date.

1. Review Your Fragrance Formulas

Engage with your fragrance house or manufacturer to obtain a full quantitative breakdown (disclosure) of the fragrance formula used in each of your products. This is non-negotiable for compliance.

• Action: Request a full allergen disclosure statement from your supplier.
• Evidence Needed: A signed document listing all substances present above 0.01% in the fragrance concentrate, cross-referenced against the new list of 82 allergens.

2. Reformulate or Relabel

Based on the disclosure, you have two paths:

• Reformulate: If you wish to avoid labeling certain allergens, work with your perfumer to modify the formula to keep specific substances below the mandatory thresholds.
• Update INCI Lists: If the formula remains unchanged, you must add all relevant allergens from the expanded list that exceed the thresholds to your product’s ingredient list on the packaging.

3. Update Packaging and Digital Assets

This is the most visible and costly step. Plan for:

• Physical Packaging: All primary and secondary packaging must feature the updated INCI list.
• Product Listing Pages (PLPs): Update ingredient lists on your website, Amazon, and other online marketplaces.
• PIF & CPSR: Your Product Information File and Cosmetic Product Safety Report must be updated to reflect the new formula assessment and labeling.

4. Manage Inventory and Timeline

The regulation applies to products placed on the market from July 31, 2026. Products already on shelves before this date can be sold until exhaustion.

• Action: Create a phase-out plan for old packaging and a production schedule for new, compliant stock.
• Critical Path: Lead times for fragrance reformulation, safety assessment updates, and packaging printing are your key timeline drivers.

Frequently Asked Questions (FAQ)

When does the new rule come into force?

The regulation was published in July 2023. The new labeling rules apply to products placed on the EU market from July 31, 2026.

Do I need a new safety assessment (CPSR)?

Yes. Any change in fragrance composition or allergen labeling that affects the safety evaluation requires an update to your Cosmetic Product Safety Report by a qualified safety assessor.

Can my fragrance supplier refuse to disclose the full formula?

For compliance with EU law, you are entitled to receive the information necessary for the safety assessment and labeling. Suppliers often provide this via a confidential allergen disclosure letter, not the complete proprietary formula.

What about products sold in the UK?

The UK has not yet adopted this specific regulation. However, UK rules (UK CPR) currently mirror the old EU list of 26 allergens. It is prudent to monitor for potential alignment or divergence.

What is the biggest risk if I don’t prepare?

Non-compliant products placed on the market after July 31, 2026, face the risk of regulatory action, including market withdrawal, recalls, and fines, enforced by national authorities in EU member states.

Next Steps for Compliance

Navigating this change requires close coordination with your manufacturer, fragrance supplier, and safety assessor. The key is to start the dialogue early, obtain the necessary data, and plan your packaging updates with the 2026 deadline in mind.

Request a Quote to discuss how we can support your compliance strategy, from formula review and testing to compliant manufacturing and packaging.

Hi, I'm Alex Zong, hope you like this blog post.

With more than 20 years of experience in OEM/ODM/Private Label Cosmetics, I'd love to share valuable knowledge related to cosmetics & skincare products from a top-tier Chinese supplier's perspective.