How many fragrance allergens must be labeled in the EU?

Under the expanded requirements of Regulation 2023/1545, over 80 fragrance allergens must be individually declared on cosmetic labels when present above threshold concentrations. This includes the original 26 allergens plus approximately 56 newly added substances, including specific natural extracts and pre-haptens/pro-haptens.

What are the concentration thresholds for allergen labeling?

Leave-on products require allergen declaration when concentration exceeds 0.001% (10 ppm). Rinse-off products require declaration when concentration exceeds 0.01% (100 ppm). These thresholds apply to concentration in the finished product, calculated from fragrance compound allergen content multiplied by usage level.

When must I comply with Regulation 2023/1545?

Products newly placed on the market must comply by July 31, 2026. Products already on the market before this date must comply by July 31, 2028. This allows brands to use existing labeled stock while transitioning to new labels.

What is the difference between leave-on and rinse-off thresholds?

Leave-on products have a 10× lower threshold (0.001% vs 0.01%) because they remain in contact with skin for extended periods, increasing sensitization risk. Rinse-off products are quickly washed away, reducing exposure and allowing a higher threshold before labeling is required.

How do I label allergens from natural extracts?

You must list both the natural extract (e.g., 'Lavandula Angustifolia Oil') AND declare all individual allergens present above threshold (e.g., 'Linalool, Limonene'). Request quantitative allergen content from your extract supplier to calculate finished product concentrations.

Can I use 'parfum' instead of listing all allergens?

No. 'Parfum' or 'Aroma' may be used for the overall fragrance composition, but declarable allergens present above thresholds must be individually listed by INCI name in addition to 'parfum.' You cannot hide allergens under the 'parfum' designation.

What allergens were added in 2023?

Key additions include: atranol and chloroatranol (oakmoss constituents), various natural extracts with specified allergen content (citrus oils, mint oils, cinnamon, clove), methyl salicylate, and several synthetic fragrance ingredients. The full list is in Annex III of the updated regulation.

Do pre-haptens and pro-haptens need labeling?

Yes. Pre-haptens (e.g., limonene, linalool) that oxidize to allergens and pro-haptens that metabolize to allergens must be declared. The parent compound is listed even though the allergenic species forms after application. This is why proper storage and antioxidant use is important for products containing these substances.

Fragrance Allergen Labeling: EU Requirements Guide 2026

Why Fragrance Allergen Labeling Matters

Fragrance allergies affect millions of Europeans, with contact allergy to fragrance ingredients being one of the most common causes of cosmetic-related adverse reactions. According to EU Regulation 1223/2009, certain fragrance allergens must be individually labeled on cosmetic products to enable sensitive consumers to avoid them.

Major Changes Coming

Commission Regulation 2023/1545 significantly expands the list of declarable fragrance allergens from 26 to over 80 substances. The first compliance deadline is July 31, 2026, with full compliance required by July 31, 2028.

Fragrance allergen labeling serves multiple purposes:

Consumer protection — Enabling informed choice for sensitive individuals
Medical diagnosis — Helping identify allergens responsible for reactions
Product development — Encouraging reformulation to reduce sensitization
Transparency — Providing ingredient information beyond "parfum/fragrance"

Legal Basis: Article 19 and Annex III

Article 19: Labeling Requirements

Article 19 of Regulation 1223/2009 establishes general labeling requirements, including that certain substances must be listed by specific INCI name rather than grouped under "parfum" or "aroma."

Article 19 Allergen Labeling Requirements

Allergens must appear in the ingredient list by INCI name
Position follows normal descending order by concentration
Thresholds differ for leave-on vs. rinse-off products
Applies regardless of whether allergen is added intentionally or is part of fragrance compound
Natural extract-derived allergens must also be declared

Annex III: Restricted Substances

Annex III lists fragrance allergens with mandatory labeling requirements. Entries 45-111 specifically cover fragrance allergens with concentration thresholds.

Regulation 2023/1545: The Expansion

Commission Regulation (EU) 2023/1545 dramatically expands allergen labeling based on updated scientific evidence from the SCCS.

What Changed?

Before and After Regulation 2023/1545
Aspect	Before	After
Number of declarable allergens	26 substances	80+ substances
Categories of allergens	Individual synthetic substances mostly	Includes natural-derived, pre-haptens, pro-haptens
Scientific basis	SCCS 1999 opinion	SCCS 2012 opinion + updates
Natural extract coverage	Limited	Expanded with specific allergen declarations

Transition Timeline

Two Distinct Compliance Deadlines

The regulation establishes different deadlines for new vs. existing products. This is a critical distinction for compliance planning.

Regulation 2023/1545 Compliance Deadlines
Product Status	Deadline	Requirement
NEW products	July 31, 2026	Products newly PLACED ON the EU market must comply with expanded allergen labeling
EXISTING products	July 31, 2028	Products already on shelves must be withdrawn if non-compliant

* 'Placed on market' = first made available in EU (manufacturer/importer action)

* 'Made available' = any subsequent distribution (retailer sales)

The 80+ Allergen List

The expanded allergen list includes several categories:

Original 26 Allergens (Already Required)

Original 26 Declarable Allergens
INCI Name	CAS Number	Common Source
Amyl cinnamal	122-40-7	Synthetic
Benzyl alcohol	100-51-6	Natural/Synthetic
Cinnamyl alcohol	104-54-1	Cinnamon oil
Citral	5392-40-5	Lemon oil, lemongrass
Eugenol	97-53-0	Clove oil
Hydroxycitronellal	107-75-5	Synthetic
Isoeugenol	97-54-1	Ylang ylang
Amylcinnamyl alcohol	101-85-9	Synthetic
Benzyl salicylate	118-58-1	Synthetic
Cinnamal	104-55-2	Cinnamon
Coumarin	91-64-5	Tonka bean, lavender
Geraniol	106-24-1	Rose oil, geranium
Hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC)	31906-04-4	Synthetic (now banned)
Anise alcohol	105-13-5	Anise
Benzyl cinnamate	103-41-3	Synthetic
Farnesol	4602-84-0	Many essential oils
Butylphenyl methylpropional (Lilial)	80-54-6	Synthetic (now banned)
Linalool	78-70-6	Lavender, rosewood
Benzyl benzoate	120-51-4	Peru balsam
Citronellol	106-22-9	Rose, geranium
Hexyl cinnamal	101-86-0	Chamomile
Limonene	5989-27-5	Citrus oils
Methyl 2-octynoate	111-12-6	Synthetic
Alpha-isomethyl ionone	127-51-5	Synthetic
Evernia prunastri (oakmoss) extract	90028-68-5	Natural
Evernia furfuracea (treemoss) extract	90028-67-4	Natural

Newly Added Allergens (Post-2023/1545)

Key Newly Added Allergens (Selection)
INCI Name	CAS Number	Notes
Atranol	526-37-4	Oakmoss constituent
Chloroatranol	57074-21-2	Oakmoss constituent
Methyl salicylate	119-36-8	Wintergreen oil
Salicylaldehyde	90-02-8	Bitter almond
Carvone	99-49-0	Spearmint, caraway
Citrus aurantium amara oil	Various	Bitter orange
Laurus nobilis oil	8007-48-5	Bay laurel
Mentha piperita oil	8006-90-4	Peppermint
Eugenia caryophyllus oil	8000-34-8	Clove
Cinnamomum cassia oil	8007-80-5	Cassia/cinnamon

Concentration Thresholds

Leave-On vs. Rinse-Off

Labeling is required only when allergen concentration exceeds specified thresholds:

Allergen Labeling Thresholds
Product Type	Threshold	Rationale
Leave-on products	0.001% (10 ppm)	Prolonged skin contact increases sensitization risk
Rinse-off products	0.01% (100 ppm)	Shorter contact reduces exposure

Threshold Calculation

The threshold applies to the concentration in the finished product, not in the fragrance compound. If a fragrance containing 5% limonene is used at 1% in product, the limonene concentration is 0.05% (500 ppm) — above the threshold for both leave-on and rinse-off.

Calculation Example

Example Calculation

Fragrance compound: Contains 8% linalool Usage level in product: 0.5% Linalool in finished product: 8% × 0.5% = 0.04% (400 ppm) Result: Linalool must be declared for both leave-on (>10 ppm) and rinse-off (>100 ppm) products.

Grouped Allergen Threshold Calculation

The regulation introduces a "grouped allergen" approach for certain substances that are chemically related or cross-sensitizing:

Grouped vs. Standalone Allergens
Type	Definition	Threshold Calculation
Standalone allergen	One substance = one label name	Label if individual concentration exceeds threshold
Grouped allergens	Multiple cross-sensitizing substances = one 'Group Name'	Sum ALL group member concentrations — label if TOTAL exceeds threshold

Important: Grouped Allergen Summation

For grouped allergens, calculate the sum of all group member concentrations. If the total exceeds the threshold, the group name must appear on the label. Example: "Citral" is a grouped allergen including Geranial and Neral: - Product contains 0.0008% Geranial + 0.002% Neral - Total "Citral group" = 0.0028% - This exceeds the 0.001% leave-on threshold - Result: "Citral" must be labeled even though neither individual substance alone exceeds the threshold

Natural Extract Allergens

Natural extracts present special challenges because they contain multiple allergens simultaneously.

How to Handle Natural Extracts

Allergen Declaration for Natural Extracts

Obtain Allergen Declaration from Supplier

Request quantitative allergen content for all 80+ declarable substances present in the extract.

Calculate Finished Product Concentration

Multiply extract allergen content by usage level in finished product.

Compare to Thresholds

Check each allergen against 0.001% (leave-on) or 0.01% (rinse-off) thresholds.

List All Above-Threshold Allergens

Include all allergens exceeding thresholds in the ingredient list by INCI name.

Common High-Allergen Natural Ingredients

Essential Oils with High Allergen Content
Essential Oil	Major Allergens	Typical Allergen Content
Lavender (Lavandula angustifolia)	Linalool, linalyl acetate, limonene	30-50% linalool
Rose (Rosa damascena)	Citronellol, geraniol, linalool	15-40% citronellol
Lemon (Citrus limon)	Limonene, citral	60-80% limonene
Cinnamon bark (Cinnamomum cassia)	Cinnamal, eugenol, coumarin	70-90% cinnamal
Ylang ylang (Cananga odorata)	Linalool, benzyl benzoate, geraniol	15-40% linalool
Tea tree (Melaleuca alternifolia)	Limonene, linalool	1-5% limonene

Pre-Haptens and Pro-Haptens

SCCS guidance addresses substances that are not directly allergenic but convert to allergens:

Pre-Haptens vs. Pro-Haptens
Type	Definition	Examples
Pre-hapten	Converts to allergen via air oxidation	Limonene → limonene hydroperoxides
Pro-hapten	Converts to allergen via skin metabolism	Isoeugenol → metabolic reactive species

Oxidation Products

Limonene and linalool are not strongly allergenic in pure form but become potent sensitizers when oxidized. Products should be formulated with antioxidants and stored properly to minimize oxidation.

Labeling Requirements: INCI Names

Allergens must be listed by their correct INCI name as defined in Article 33 and the CosIng database.

Correct Labeling Format

Allergen Labeling Best Practices

Use exact INCI names from CosIng database
Position in ingredient list by concentration (descending order)
May appear after 'parfum' if concentration is <1%
Capitalization follows standard INCI conventions
No abbreviations unless officially recognized
Natural extracts: list both extract name AND individual allergens

Example Ingredient List

Example Compliant Labeling

Ingredients: Aqua, Cetearyl Alcohol, Glycerin, Parfum, Phenoxyethanol, Citric Acid, Linalool, Limonene, Citronellol, Geraniol, Sodium Benzoate Note on allergen positioning: Article 19.1(g) allows companies discretion: - Option A: Include allergens in descending concentration order (integrated with other ingredients) - Option B: Place all allergen declarations at the end of the ingredient list Both approaches comply with the regulation. The example above uses Option B.

CPSR & PIF Updates Required

The safety assessment must address allergen presence:

CPSR Requirements for Allergens

Document all allergens present in formula (quantitative)
Include allergen declarations from fragrance/flavor suppliers
Assess sensitization risk for high-concentration allergens
Document threshold calculations for labeling decisions
Update if fragrance composition changes

Impact on Product Development

Reformulation Considerations

Strategies for Managing Allergen Content
Strategy	Approach	Considerations
Reduce fragrance level	Lower overall perfume concentration	May affect consumer appeal
Switch to low-allergen fragrances	Use fragrances with fewer declarable allergens	Limits creative palette
Synthetic alternatives	Replace natural extracts with targeted synthetics	Consumer perception of 'natural'
Encapsulation	Reduce direct skin contact with allergens	Technical complexity, cost
Fragrance-free	Eliminate perfume entirely	Some consumers prefer fragrance