EU Fragrance Allergen Labeling: What the 2023 Annex III Update Means for Your Cosmetics Range

Commission Regulation (EU) 2023/1545 added 54 new fragrance substances to Annex III of Regulation (EC) No 1223/2009 in July 2023 — effectively tripling the list European cosmetics brands must monitor for on-label disclosure. Before that update, the labeling-trigger allergen list contained 26 substances. Since the regulation entered into force, there are 80. And for many EU brands, particularly those working with complex blends or sourcing natural extracts, the practical audit work of confirming compliance against the full expanded list is still incomplete.

The transitional deadlines are closing in. Under the regulation’s phased implementation, products manufactured for EU sale must meet the updated labeling requirements within the compliance windows specified in the Official Journal. If your Product Information File hasn’t been reviewed against all 80 substances — and if your fragrance suppliers haven’t issued updated disclosure documents dated after August 2023 — you may be placing non-compliant products on European shelves right now.

What Commission Regulation (EU) 2023/1545 Actually Changed

The 54 new allergens didn’t appear from nowhere. The Scientific Committee on Consumer Safety (SCCS) had been evaluating fragrance sensitisation data for more than a decade, building on its 2011 opinion (SCCS/1459/11) and several subsequent position papers. The 2023 regulation formalised recommendations the SCCS had been signalling since at least 2012, which is why some formulators felt it was long overdue and others felt blindsided.

The regulation made four concrete changes to Regulation (EC) No 1223/2009:

• Added 54 new substances to Annex III, requiring on-label disclosure when concentration thresholds are exceeded in the finished product
• Added 2 substances to Annex II (prohibited substances — benzyl cyanide and styrene) with immediate effect
• Maintained the existing threshold logic: Annex III substances must be declared on product labels when present above 0.001% (10 ppm) in leave-on products, or above 0.01% (100 ppm) in rinse-off formulas
• Preserved the INCI-name labeling requirement under Article 6(1)(g), meaning each allergen above its threshold must appear individually in the ingredient list — not hidden under “fragrance” or “parfum”

The 54 new substances include a substantial number that appear commonly in natural fragrance ingredients. Citrus-derived terpenes, conifer resin fractions, and certain ester components found in floral absolutes all feature in the updated list. If your brand markets “naturally derived” fragrances as a point of differentiation, this is precisely where your compliance exposure is most concentrated.

The Threshold Arithmetic That Catches Brands Off Guard

The 0.001% and 0.01% thresholds are not hard to understand in principle. In practice, brands make three recurring calculation errors that turn into labeling non-conformities.

Error one: applying the fragrance concentration to the finished product without accounting for what’s inside the fragrance blend.

A body lotion formulated at a 1% fragrance load that contains a rose absolute may carry linalool — which appears on both the original and expanded lists — at a level well above the leave-on threshold. A formulator who records “fragrance at 1%” and moves on without requesting a full allergen breakdown from the supplier is working without the data needed to make an accurate label declaration. Regulation (EC) No 1223/2009 requires disclosure in the finished product INCI list. That calculation must account for concentration in the finished formula, not just in the fragrance-as-supplied.

Error two: failing to aggregate contributions from multiple fragrance ingredients.

A complex eau de parfum might draw on a head note blend, a floral absolute, and a woody fixative — each of which independently contributes linalool or citronellol. The INCI declaration requires analysis of total allergen load across all ingredients in the formula. We see this most often with brands that purchase fragrance components from multiple suppliers and never model the combined contribution to a single allergen. The threshold is assessed at finished-product level, not per-ingredient.

Error three: assuming that a compliant 2021 formula is still compliant today.

It almost certainly hasn’t been checked against 54 substances that weren’t on any labeling list at the time of the original assessment. A fragrance audit from 2021 was valid against 26 allergens. Against the current Annex III list of 80, it simply tells you nothing about the 54 new entries. The only valid basis for compliance today is supplier disclosure prepared after August 2023, or a third-party analysis of the finished product against the full current list.

What a Valid Supplier Allergen Certificate Should Contain

Under Article 6(1)(g) of Regulation (EC) No 1223/2009, each fragrance allergen above its threshold must appear in the product’s ingredient list using its INCI name. This means your supplier’s IFRA (International Fragrance Association) certificate — while necessary — is not sufficient on its own.

An IFRA certificate tells you whether a fragrance is formulated within safe-use guidelines for its product category and usage level. It does not give you the concentration of each individual Annex III allergen in your finished product at your specific usage rate. That calculation is the Responsible Person’s obligation.

A properly constructed allergen disclosure document from your fragrance supplier should include:

1. A full breakdown of all 80 Annex III allergens (26 original plus 54 new), listed by substance name and percentage concentration in the fragrance blend as supplied
2. A date of preparation after August 2023 — any certificate issued before the regulation entered into force cannot be considered current against the full list
3. Usage level guidance, indicating at what application percentage in the finished product each allergen’s labeling threshold would be crossed

If your supplier is providing a generic written statement that the fragrance “complies with Annex III of Regulation (EC) No 1223/2009” without quantitative data, that statement cannot support your PIF. Push back. Some suppliers now provide a structured “fragrance allergen certificate” or “INCI allergen table” that lists all 80 substances with in-blend concentrations — that is the format to request. If a supplier cannot provide it, that’s a supply chain documentation gap that creates direct liability for the Responsible Person.

What Your Product Information File Needs to Reflect Now

The PIF required under Article 11 of Regulation (EC) No 1223/2009 must contain a cosmetic product safety report — which in turn must address safety data for all substances in the formulation, including fragrance allergens. The qualified safety assessor who signs Part B of the safety report is responsible for confirming that the product is safe and that the labeling is accurate.

Any PIF prepared before Commission Regulation (EU) 2023/1545 entered into force needs to be reviewed. This is true even for formulas that haven’t changed at all. The regulatory landscape changed; the safety assessment documentation must reflect current requirements to remain valid.

Specifically, updated PIF documentation should include:

• The finished-product concentration of each of the 80 Annex III substances, calculated using supplier allergen certificate data and the formula usage level
• The INCI names that will appear on the product label, with confirmation they match the allergen disclosures above threshold
• The reference and date of the supplier allergen certificate used for that calculation
• Confirmation from the safety assessor that the label declaration is consistent with the current version of Article 6(1)(g) and Annex III

For a brand with 30 or 40 SKUs using different fragrance blends, this is a meaningful documentation exercise. The only practical way to structure it is systematically: supplier by supplier, fragrance by fragrance, formula by formula.

Prioritising the Audit: Where to Look First

From working through these reviews with EU cosmetics brands, a few observations on where to focus effort.

Start with your fragrance suppliers, not your labels. The label is the output of the analysis; the analysis starts with the supplier data. Build a simple matrix: every product, every fragrance ingredient, the usage level in each formula, and a reference to the allergen certificate for that fragrance. Once that data exists, the label review and PIF update follow directly from it.

Prioritise leave-on products. The 0.001% threshold — which applies to face creams, body oils, serums, and leave-in hair products — is a full order of magnitude lower than the 0.01% rinse-off threshold. You will find more labeling gaps in leave-on categories, because the margin for undisclosed allergens is ten times smaller.

Don’t assume natural is simpler. In practice, “naturally derived” fragrance ingredients generate more compliance uncertainty, not less. A rose absolute, a bergamot oil, or a sandalwood extract contains dozens of constituent aroma chemicals, several of which now appear on the Annex III list, and supplier-level disclosure for natural materials is frequently less granular than for synthetic aroma chemicals. The more “natural” your fragrance brief, the more rigorous your allergen verification process needs to be.

Check your retail and e-commerce obligations. If you sell through French retailers, large-format German drugstore chains, or any major EU e-commerce platform with cosmetics compliance requirements, you may face allergen documentation requests from the platform’s quality teams independently of regulatory enforcement. Several large European retailers have begun requesting updated allergen certificates from suppliers as part of their own market surveillance programmes — and they’re specifically asking for documents dated post-2023.

French market surveillance authorities, notably the DGCCRF, have historically been among the most active in EU cosmetics labeling enforcement. A labeling non-conformity surfaced during a DGCCRF inspection — particularly one involving a substance newly added to Annex III — creates a significantly more disruptive compliance event than identifying it during an internal PIF review.

Getting This Done

The 2023 Annex III update represents the largest single expansion of the EU fragrance allergen labeling list since the original 26 substances were codified in the early 2000s. It requires active compliance work — it’s not something that self-resolves through ongoing supplier relationships or periodic label refreshes.

If you haven’t yet audited your fragrance portfolio against all 80 Annex III substances, start with the supplier certificates this week. Request documents explicitly dated after August 2023 and covering the full current list. Build your formula-level concentration matrix and have your safety assessor confirm that your labels and PIFs reflect what’s actually in each product. Don’t assume that the fragrance supplier’s IFRA certificate or a pre-2023 compliance statement covers this — it doesn’t.

The products on your current production line are the ones that matter most. Those are where you can correct labeling before they reach retail shelves, distribution partners, or a market surveillance inspector.

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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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