EU Allergen Labeling Changes 2026-2028: What Cosmetic Brands Must Know

The clock is running. EU Regulation 2023/1545 — which more than triples the list of declarable fragrance allergens — has hard deadlines for both new and existing products. If your brand sells cosmetics in the EU and hasn't audited your formulations yet, this is the article you need to read.

For full background on EU cosmetic labeling requirements, see our Complete Guide to EU Cosmetic Label Requirements. This article focuses specifically on the allergen expansion and what your brand must do before the 2026 and 2028 deadlines.

What Is EU Regulation 2023/1545?

Published in July 2023 and entering into force in stages, Regulation (EU) 2023/1545 amends Annexes II and III of the Cosmetics Regulation (EC) No 1223/2009. Its central change: expanding the mandatory fragrance allergen declaration list from 26 substances to 82 substances.

The expansion is based on years of scientific work by the Scientific Committee on Consumer Safety (SCCS), which identified an additional 56 fragrance allergens with sufficient evidence of sensitization potential to warrant mandatory disclosure on cosmetic labels.

Some of the newly regulated substances had already been voluntarily restricted or flagged by industry bodies. Others will come as a surprise to smaller brands that don't have dedicated regulatory affairs teams monitoring SCCS opinions.

The 2026 and 2028 Deadlines Explained

The regulation uses a two-phase approach to give brands time to transition:

Product Category	Compliance Deadline	Status
New products placed on the EU market	July 31, 2026	Approaching
Existing products already on shelf/in distribution	July 31, 2028	2 years out

The practical implication: any cosmetic product you manufacture or import after July 31, 2026 must carry labels that declare all 82 allergens above the relevant thresholds. Products already in the supply chain before that date have until July 31, 2028 to sell through or be relabeled.

Most brands will need to start acting now. Lead times for label redesign, printing, and reformulation — especially for contract manufacturers — can easily run 12 to 18 months.

The New Allergens: What Was Added

The 56 new allergens span a wide range of fragrance families. Several of the additions are significant because they are widely used in commercial fragrance blends. For the complete table of all 56 new allergens — INCI names, CAS numbers, and product categories — see our dedicated guide: 56 New Fragrance Allergens: Complete List, Thresholds & Compliance Deadline.

High-Profile Additions

• Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC) — also known as Lyral, this was one of the most common contact allergens in Europe and is now banned or severely restricted in leave-on products. It must be declared and its use is subject to concentration limits.
• Atranol and chloroatranol — naturally occurring in oakmoss and treemoss extracts, these are among the most potent fragrance sensitizers known. Both are now prohibited in cosmetic products above trace levels, and their presence must be declared.
• Methyl heptine carbonate (methyl oct-2-ynoate) — a violet-type material used in fine fragrance, now restricted due to sensitization risk.
• Isoeugenol — commonly found in clove and ylang ylang, with known sensitization potential; already on the original 26 list, its companion substances are now added.
• Allylanisole (estragole), basil oil (high estragole), and several related naturally derived extracts — now subject to declaration.

Declaration Thresholds

The same thresholds from the original regulation apply to the expanded list:

• Leave-on products: declare when present at > 0.001% (10 ppm)
• Rinse-off products: declare when present at > 0.01% (100 ppm)

Below these concentrations, no declaration is required — but you still need to know what's in your fragrance blend at that level of detail. Many brands discover they don't have this data from their fragrance suppliers.

How Brands Should Prepare: Three Scenarios

Your compliance path depends on what's actually in your formulations. There are three typical scenarios:

Scenario 1: Relabeling Only

If your formulas already comply — meaning none of the newly restricted substances exceed the thresholds — you may only need to update your label to declare the newly listed allergens that are present. This is the lowest-cost path and involves:

1. Auditing your formulas against all 82 allergens
2. Identifying any substances above threshold that weren't previously declared
3. Updating ingredient lists on packaging to add the newly required declarations
4. Working with your label printer on revised artwork

Scenario 2: Reformulation Required

If your formulas contain substances that are now prohibited or subject to strict concentration limits — such as HICC, atranol, or chloroatranol — you must reformulate before July 2026. This means:

1. Identifying which ingredients need to be removed or replaced
2. Working with your perfumer or fragrance house to develop compliant alternatives
3. Stability testing and consumer testing on the reformulated product
4. Updating your Product Information File (PIF) and safety assessment
5. Relabeling the reformulated product

Reformulation is significantly more expensive and time-consuming than relabeling. If this applies to you, the July 2026 deadline is tight. Start now.

Scenario 3: Both

Many brands will need a mix — some products require only relabeling, others need reformulation. Prioritize by volume and market importance. Products with the longest lead times or largest label print runs should move first.

Penalties for Non-Compliance

The EU Cosmetics Regulation is enforced at the member state level, meaning penalties vary by country. However, the consequences of non-compliance are consistently serious:

• Market withdrawal: National enforcement authorities can order products removed from sale
• Fines: Penalties range from €5,000 to over €100,000 depending on jurisdiction and severity. Germany, France, and the Netherlands are among the most active in enforcement
• Recall costs: Pulling products from retail and distribution channels is expensive, and the brand bears this cost
• Reputational damage: Enforcement actions are public in most member states, and press coverage of a recall can cost far more than the fine itself
• Criminal liability: In extreme cases involving deliberate misrepresentation or harm to consumers, criminal sanctions apply in several EU jurisdictions

The Responsible Person (the EU-established entity legally responsible for the product) bears primary liability. If your responsible person is a third-party distributor or importer, ensure your contracts are clear on who bears compliance obligations. See our dedicated guide on EU Cosmetic Responsible Person duties and requirements for the full picture.

How LabelCheck Verifies Allergen Declarations Automatically

Manually auditing a product formulation against 82 allergens — especially when ingredients come from complex fragrance blends — is error-prone and time-consuming. LabelCheck automates this process.

When you run an audit, LabelCheck:

1. Parses your INCI ingredient list — identifying every declared ingredient including parfum components and essential oil derivatives
2. Cross-references against the full 82-allergen list under Regulation 2023/1545 — both the original 26 and the 56 new additions
3. Flags missing declarations — highlighting allergens that should be declared based on your ingredient composition but are absent from the label
4. Checks for prohibited substances — identifying ingredients like HICC and atranol that are now banned or restricted above certain levels
5. Generates a compliance report — a clear breakdown of what passes, what needs updating, and what needs immediate action

The result: in under 60 seconds, you get an actionable checklist instead of spending days cross-referencing SCCS opinions and regulatory annexes.

Need a step-by-step process to verify your whole label — not just allergens? Our practical guide on how to check EU cosmetic label compliance in 5 steps walks through the full verification workflow before production.