Regulation 1223/2009's Expanded Fragrance Allergen List: 56 New Substances and a Deadline Three Months Away

Three months from now — on 1 August 2026 — any cosmetic product placed on the EU market must comply with a substantially longer list of fragrance allergens under Regulation (EC) No 1223/2009. Commission Regulation (EU) 2023/1545, published in July 2023 and in force since August 2023, added 56 new substances to Annex III. Many brands knew this was coming. A surprising number still aren’t ready.

We work with cosmetics manufacturers and brand owners across France, Germany, Italy, Spain, and the Benelux region. And in the past six months, we’ve seen a consistent pattern: formulators who understood the labeling implications early did the easy part. The harder work — updating safety assessments, renegotiating supplier disclosures, and reformulating products where allergen levels exceed the new thresholds — is where most teams are still behind.

This is a practical walkthrough of what’s changed, which products are most at risk, and what your team needs to deliver before the August 2026 market placement deadline.

What Commission Regulation (EU) 2023/1545 Actually Changed

Annex III of Regulation (EC) No 1223/2009 has listed fragrance allergens requiring mandatory labeling since Directive 2003/15/EC — the “7th Amendment” — introduced 26 substances over two decades ago. The SCCS (Scientific Committee on Consumer Safety) spent years reviewing sensitization data submitted by the International Fragrance Association (IFRA) and independent academic sources before publishing Opinion SCCS/1611/19 and its subsequent revisions. That work identified 56 additional fragrance compounds with documented sensitization potential significant enough to warrant mandatory disclosure.

The practical outcome is a dramatically longer Annex III. Leave-on products — face creams, body lotions, hair oils, fine fragrances — now require labeling any of these 56 substances if present above 0.001% (10 ppm). Rinse-off products — shampoos, shower gels, cleansers — carry a slightly higher threshold of 0.01% (100 ppm). These are the same concentration tiers that have applied to the original 26 allergens for the past 20-plus years.

What’s new in character, not just in quantity: many of the 56 additions are naturally derived compounds commonly found in essential oils, botanical extracts, and CO₂ extracts. Compounds from sandalwood, vetiver, labdanum, and various citrus-derived fractions appear across natural, organic, and conventional product lines alike. Brands marketing themselves as “natural” or “clean” are discovering that their formulations can be more allergen-dense under the expanded list than conventional competitors. The irony is significant, and we’ve seen it cause real disruption in product pipelines.

Which Product Categories Carry the Most Compliance Risk

Not all categories are equally exposed. Here’s where we’re seeing the heaviest reformulation burden:

Fine fragrances and EDPs/EDTs. By definition, these are allergen-rich. Most established fragrance houses already maintain detailed allergen disclosure documents as standard trade practice. But the 56 additions mean existing allergen profiles need re-screening — especially for accord components built from natural isolates or complex botanical absolutes.

Leave-on skincare with essential oils. Lavender, bergamot, ylang-ylang, rose, neroli — these are ubiquitous in premium skincare. Many contain naturally occurring levels of newly listed allergens above the 10 ppm labeling threshold. If a botanical ingredient contributes a listed substance at a concentration that, in your finished formula, exceeds the threshold, labeling is mandatory regardless of how the ingredient is sourced or certified.

Baby and sensitive-skin products. Products positioned for vulnerable populations attract disproportionate attention from national market surveillance authorities — France’s ANSM, Germany’s BfR, and the Netherlands’ RIVM all run targeted inspection programmes on this segment. Even trace levels of newly listed allergens in these products generate scrutiny.

Natural and organic certified lines. Certifications like COSMOS-Organic and NATRUE do not exempt a brand from Regulation (EC) No 1223/2009. Your COSMOS certification does not update your Annex III labeling automatically. This is one of the most common misconceptions we encounter.

The single most underestimated risk is in multi-component raw materials — botanical extracts, fixed oils, and CO₂ extracts — where allergen content isn’t disclosed at the component level in your supplier’s technical documentation. A supplier declaration that lists total fragrance content tells you nothing useful for Annex III compliance.

Your Five-Step Compliance Checklist Before August 2026

There’s no shortcut here, but there is a logical sequence. If you’re starting today, this is the order that wastes the least time.

Step 1: Screen your entire portfolio against the 56 additions. Every finished product containing a fragrance component — whether labeled as “parfum/fragrance”, an essential oil, or a multi-component botanical ingredient — needs to be screened. If you’re managing more than 30 SKUs, this is a database exercise against the updated Annex III list, not a manual review.

Step 2: Request updated allergen declarations from all fragrance and raw material suppliers. Your fragrance supplier should be providing declarations against the full updated Annex III — not just the original 26. If they aren’t offering this documentation proactively, that’s a gap in your supplier qualification programme. Allow at least 4 weeks for supplier response; some fragrance houses with complex accord portfolios are taking longer under current demand.

Step 3: Update your Cosmetic Product Safety Reports (CPSRs). Every affected product’s CPSR requires review by a qualified safety assessor (Part B of the safety report, as defined in Annex I of the Regulation). If any newly listed allergen is present above the labeling threshold, the assessor must evaluate its significance in context. If a substance is present at levels beyond what labeling alone can adequately address, reformulation may follow. Good assessors are currently booked 6–10 weeks out — factor that into your timeline now.

Step 4: Revise your Product Information Files (PIFs). The PIF must contain the current, accurate formulation and the updated CPSR. An outdated CPSR in your PIF is a primary finding in market surveillance inspections — and it’s straightforward for inspectors to identify, since the CPSR date is visible.

Step 5: Update labels and CPNP notifications. Under Article 13 of Regulation (EC) No 1223/2009, any change to ingredient labeling requires an updated entry on the Cosmetic Products Notification Portal (CPNP) before the product is placed on the market. Build 2–3 weeks for this into your project plan; the portal itself is fast, but internal artwork approval cycles rarely are.

This sequence assumes you haven’t identified any allergens that require reformulation. If you do — and a portion of brands will, especially in fine fragrance and essential oil–heavy skincare — add 8 to 16 weeks for stability testing on any reformulated product. At this point in the calendar, that’s a tight but achievable window if you start immediately.

What Market Surveillance Authorities Are Looking For

France’s ANSM, Germany’s BfR, and the DGCCRF (Direction Générale de la Concurrence, de la Consommation et de la Répression des Fraudes) all have authority to pull products from shelves, issue public safety notices, and refer cases to the European Commission’s SAFETY Gate rapid alert system. Fragrance allergen labeling errors appear consistently among the top findings in DGCCRF’s annual cosmetics compliance surveys — alongside stability and preservation issues.

After 1 August 2026, products newly placed on the market without updated labeling aren’t just non-conforming. They’re illegal. The sell-through period extends to 1 August 2028 for products already legitimately placed on the market before the deadline — but that window applies only to stock that was placed on the market before August 2026. New production batches manufactured and released after that date must comply in full, from day one.

One practical point that catches some brands off guard: if you’re a contract manufacturer producing for multiple brand owners, each brand owner carries the legal responsibility under the Regulation. Your technical documentation obligations don’t transfer to the contract manufacturer, even if they also act as your Responsible Person. Confirm in writing who is managing CPNP updates for each product.

The One Compliance Mistake We See Most Often

Brands consistently confuse “we use certified fragrance houses” with “we’re compliant.” They aren’t the same thing.

Your fragrance supplier’s adherence to IFRA (International Fragrance Association) standards is a quality practice — not a legal declaration of conformity with Regulation (EC) No 1223/2009. IFRA standards regulate use levels based on sensitization risk, expressed as a percentage of the finished formula. But the EU labeling obligation under Annex III is independent of IFRA compliance. A substance can be used at an IFRA-compliant level and still require labeling under Annex III if it exceeds the 10 ppm threshold in the finished product.

We see this confusion most acutely in brands that source complete fragrance accords from third-party suppliers. The accord is IFRA-compliant. The finished product uses it below the IFRA usage limit. But within the accord itself, three newly listed allergens are present at concentrations that, in the finished formula, exceed the labeling threshold. The product label lists only “parfum.” That’s a non-conformity under the Regulation — and the IFRA certificate attached to your PIF doesn’t resolve it.

The fix is straightforward: require your fragrance supplier to provide a full allergen declaration against the complete updated Annex III, expressed as percentage contribution to the finished formula. If your supplier can’t or won’t provide that, you need a different supplier.

Start Today

If you haven’t begun your Annex III screening, the time is now. Three months disappears quickly when you account for supplier response lead times, safety assessor availability, label artwork revision cycles, and CPNP notification updates. The brands that will be genuinely compliant on 1 August 2026 aren’t necessarily the largest — they’re the ones that ran this as a structured quality project with clear ownership, not an administrative task assigned to whoever had capacity.

Map your portfolio against the expanded list this week. Identify your highest-risk SKUs by the end of the month. The August deadline is real, and market surveillance authorities have been watching this transition for three years.

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Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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