The topic is short and compact
Fragrance-free means that no ingredient serves a perfuming function; a masking fragrance does not make a product fragrance-free.
As of August 1, 2026, 80 fragrance allergens must be individually labeled instead of 24, starting at 0.001% in leave-on and 0.01% in rinse-off products.
Essential oils and extracts such as lavender oil are themselves listed in Annex III, so even formulations without "perfume" can contain allergens.
If a fragrance with antimicrobial properties is removed, the preservation system must be verified with a new challenge test on the final formulation.
Without fragrance, the inherent odor, batch-to-batch variations, and oxidation become noticeable; odor should therefore be included in raw material specifications and stability testing.
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What does fragrance-free mean in cosmetics?
The Cosmetics Regulation does not define "fragrance-free" as a specific claim. It only regulates how fragrances appear in the list of ingredients: according to Article 19(1)(g) of Regulation (EC) No. 1223/2009, perfume and aromatic compositions and their raw materials are indicated by the terms "parfum" or "aroma". Substances separately required by Annex III are also listed under their specific names.
What a claim such as "fragrance-free" requires is described in the Technical Document on Cosmetic Claims by the Working Group on Cosmetics chaired by the European Commission. Its Annex III on "free-from" claims has been applied since July 1, 2019. According to this, "free from fragrance" should not be used if an ingredient in the product performs a perfuming function, regardless of any other functions it may have. The document is not legally binding, but serves as an interpretation guide for the supervisory authorities of the Member States in case-by-case assessments.
Fragrance-free and unscented are not the same
"Unscented" is sometimes used in the market for products that smell neutral because a masking agent covers the inherent odor of the base. The scientific committee SCCS classifies masking agents as equivalent to fragrances with regard to allergies; at the time of its opinion, the CosIng database listed 2,587 ingredients with a perfuming function. For a brand targeting fragrance-sensitive customers, a masked product is therefore not a fragrance-free product.
Why are brands switching formulations to fragrance-free?
The most important technical driver is fragrance allergy. According to the opinion SCCS/1459/11 on fragrance allergens in cosmetic products, the frequency of contact allergy to fragrances in the European general population is 1 to 3%; among eczema patients, around 16% are sensitized to fragrance ingredients. In the recitals of Regulation (EU) 2023/1545, the proportion of the population in the Union allergic to fragrances is estimated at 1 to 9%. A contact allergy persists for life, and sensitized individuals rely on avoiding the triggering substance.
The population-based EDEN Fragrance Study involving 3,119 tested adults from Sweden, Germany, the Netherlands, Italy, and Portugal found at least one positive test reaction to a fragrance allergen in 7.2%. Exposure to scented leave-on products remained associated with fragrance allergy even after adjusting for age and sex (odds ratio 2.43), whereas this was not the case for rinse-off products.
For product range planning, this results in a clear order of priority: leave-on products with daily, large-scale application, such as complexion products, concealers, face creams, and serums, are the obvious candidates for a fragrance-free version. For cleansing products, the correlation in the data is weaker, and the labeling threshold for fragrance allergens is ten times higher.
What changes with the new fragrance allergen labelling?
With Regulation (EU) 2023/1545, Annex III to the Cosmetics Regulation was revised. In addition to the 24 fragrance allergens previously required to be listed individually, there are now 56 more that the SCCS has classified as clearly allergenic in humans. They must be named in the list of ingredients as soon as their concentration exceeds 0.001% in leave-on products and 0.01% in rinse-off products. Prehaptens and prohaptens, which are converted into known contact allergens through air oxidation or bioactivation, are treated the same as fragrance allergens.
The transition periods are staggered: products that do not meet the new requirements were allowed to be placed on the market until July 31, 2026, and may be made available on the Union market until July 31, 2028. The Federal Office of Consumer Protection and Food Safety points out that the extended labeling requirement has been in effect since August 1, 2026.
What this means for fragrance-free formulations
The list does not only affect perfume oils. Essential oils and extracts are also included, such as lavender oils and extracts or flower and peel oils from bitter and sweet orange (Citrus aurantium amara and dulcis), which are to be indicated as "Lavandula Oil/Extract" or "Citrus Aurantium Peel Oil". For limonene, the entry also specifies a peroxide value of less than 20 mmol/L. A formulation without "Parfum" in the INCI may therefore still have to declare fragrance allergens if it contains a listed oil or extract above the thresholds. Any plant extract with its own scent should therefore be included in the raw material review, including the allergen information in the raw material data sheet. The article on cosmetic labeling with INCI and mandatory information shows how the list of ingredients must be structured overall.
What formulation problems arise without perfume?
Perfume serves two functions in many formulations: it gives the product a scent and masks the base's inherent odor. If it is omitted, the odor of the raw materials themselves becomes a quality feature. Fatty alcohols and emulsifiers, unsaturated plant oils, protein hydrolysates, plant extracts, and individual active ingredients can all contribute to the inherent odor.
Raw material selection and specification: Without masking, olfactory variations between raw material batches become noticeable. It is advisable to include odor in the raw material specification and to inspect incoming goods accordingly.
Oxidation over shelf life: Unsaturated oils can oxidize during storage. A rancid odor that a perfume would have masked becomes noticeable early on without perfume. Antioxidants, manufacturing with low air incorporation, and packaging such as airless dispensers or tubes reduce contact with atmospheric oxygen.
sensory profile: Without fragrance, the texture alone carries the initial impression: absorption, spreadability, stickiness, and skin feel after application. For complexion products, coverage and blendability are also factors.
Stability testing: According to Annex I Part A No. 2 Regulation (EC) No 1223/2009, the safety report verifies stability under reasonably foreseeable storage conditions. For fragrance-free formulations, it is recommended to evaluate odor and color against a retention sample at each test interval.
Test point | Perfumed formulation | Fragrance-free formulation |
|---|---|---|
Inherent odor of the base | masked by perfume | determined by raw material selection and raw material quality |
Initial sensory impression | fragrance and texture | only texture and skin feel |
Odor during stability testing | deviations partly masked | any deviation noticeable |
Information in the safety report | Name, code number, and supplier of the perfume composition (Annex I Part A No. 1) | not applicable; allergen details for extracts remain |
How does avoiding fragrances affect preservation?
Some fragrances are also used as biocides according to the SCCS, and individual substances have multiple functions under the Cosmetics Regulation. Benzyl Alcohol is approved as a preservative in Annex V No. 34 at up to 1.0% and is also listed in Annex III, entry 45 as amended by Regulation (EU) 2023/1545. This entry covers use for a purpose other than preservation, such as a solvent or fragrance; this purpose must be apparent from the presentation of the product, and allergen labeling applies from 0.001% (leave-on) or 0.01% (rinse-off). Such multi-functional ingredients deserve special attention in a fragrance-free formulation: whether a substance performs a perfuming function in the specific product should be assessed and documented before the product is claimed to be fragrance-free.
If an existing formulation is reformulated, the preservation system may also change. If a perfume oil or an essential oil contributed to inhibiting microbial growth, this contribution is missing after its removal, and the overall system must be substantiated anew. The results of the preservation challenge test are part of the safety report according to Annex I Part A No. 3; in practice, testing is carried out according to ISO 11930 on the final formulation. The challenge test runs over several weeks and should therefore be scheduled early, ideally in parallel with stability testing in the intended packaging.
Conversely, anyone who retains an essential oil in the formulation for preservation reasons must label it as an allergen starting from the aforementioned thresholds and generally cannot claim the product as fragrance-free if the oil has an odor in the product.
Which advertising claims are permitted for fragrance-free products?
Advertising claims for cosmetics follow Article 20 of the Cosmetics Regulation and the common criteria of Regulation (EU) No 655/2013: legal compliance, truthfulness, evidential support, honesty, fairness, and informed decision-making. For "free from" claims, the Technical Document on Cosmetic Claims specifies these criteria in Annex III, and for "hypoallergenic" in Annex IV.
Truthfulness: "free of perfume" requires that no ingredient exerts a perfuming function, not even a masking agent.
No guarantee of skin compatibility: "free from allergenic substances" is not permitted because the risk of an allergic reaction cannot be completely excluded.
Hypoallergenic: The claim requires that the product has been designed to minimise its allergenic potential, and that the responsible person proves a very low allergenic potential with scientifically sound data, such as from post-marketing surveillance.
Informed decision: "Free from" claims are permitted if they enable a specific target group to make an informed choice. A note stating "free of perfume" for consumers sensitive to fragrances falls under this category, provided the other criteria are met.
Honesty: A "free from" claim is not permitted for an ingredient that is typically not used in the respective product category anyway.
A claim such as "for sensitive skin" is an efficacy claim and requires its own substantiation, such as a skin compatibility study with the target group. How such evidence is structured and which formulations are no longer used is explained in the article on Cosmetic advertising claims in the EU.
Labtree is a B2B cosmetics developer and cosmetics manufacturer from Hamburg with its own laboratory and production facilities in Germany. Formulation development, in-house laboratory work, sampling, manufacturability testing, and cosmetics production are all under one roof. From the concept of a fragrance-free line, laboratory samples, a manufacturable formulation, and the finished product are created—from complexion products and concealers to creams and serums.
Sampling: Samples of pre-qualified formulations usually leave the sample warehouse within 24 hours. The inherent scent and texture of a fragrance-free base can only be assessed using the physical sample, not from a data sheet.
White Label: A tested Labtree formulation is adapted for the brand and, with standard packaging, is generally ready for delivery in 2 to 3 months; the formulation remains with Labtree.
Private Label: New development according to the brand's requirements, typically 3 to 6 months to market readiness. The schedule depends, among other things, on stability testing, challenge testing, and packaging availability.
Minimum order quantity: usually 1,500 units per product, depending on product type, fill size, and packaging.
During a product range changeover, the final composition of each affected product changes. The safety assessment according to Art. 10 Regulation (EC) No 1223/2009 refers to this composition, and modified details of the CPNP notification must be updated without delay pursuant to Art. 13(7). Which tests must be completed prior to launch is described in the article on stability and safety testing for cosmetics; the process of a project including a timeline is outlined on the page having cosmetics developed.
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FAQ
Is fragrance-free the same as unscented?
Not necessarily. According to the EU guidelines on advertising claims, a product is only considered fragrance-free if no ingredient has a perfuming function. A product that smells neutral due to a masking agent does not meet this requirement, and the SCCS considers masking agents to be equivalent to fragrances with regard to allergies.
Does a fragrance-free product have to label fragrance allergens?
Yes, if it contains a substance from Annex III above the thresholds. This also applies to essential oils and extracts, such as lavender oils or blossom and peel oils from bitter and sweet oranges, which have been listed themselves since Regulation (EU) 2023/1545. The thresholds are 0.001% for leave-on products and 0.01% for rinse-off products.
Until when can products with the old fragrance labeling be sold?
Products compliant with previous legislation were permitted to be placed on the market until July 31, 2026, and may be made available on the EU market until July 31, 2028. After that date, all products sold at retail must carry the extended labeling. Remaining inventory with old labels should therefore be sold off by then.
Can a fragrance-free product be advertised as hypoallergenic?
Evidence required. According to Annex IV of the Technical Document on Cosmetic Claims, the product must be formulated to minimize its allergenic potential, and the responsible person must demonstrate a very low allergenic potential with reliable data. Known allergens, including the fragrance allergens listed in Annex III, must be completely avoided in such products; simply omitting perfume is not sufficient.
Does a formulation switched to fragrance-free need a new safety report?
The safety assessment refers to the final composition, which is why a modified formulation must be re-evaluated. This usually includes new stability data and a challenge test on the final formulation, and the CPNP notification must be updated. Which tests are required prior to launch is explained in more detail in the magazine article “Stability and Safety Testing for Cosmetics”.
Does the extended fragrance labeling also apply to products manufactured outside the EU?
Yes. Annex III applies to every cosmetic product placed on the EU market, regardless of where it was manufactured. For imported products, under Article 4(5) of Regulation (EC) No 1223/2009, the importer is the responsible person unless they designate a person established within the EU in writing, and pursuant to Article 5(1), they must ensure compliance with labelling requirements under Article 19, among other things. Therefore, allergen information for all raw materials should be obtained before labels are printed.
