Labels & market rules

Fragrance-Free, Unscented and Hypoallergenic Claims: What a Brand Can Support

What a brand may claim as fragrance-free, unscented or hypoallergenic: what the FDA and EU claims guidance say, masking agents, and the records a claim needs.

Short answer

A brand can call a product "fragrance-free" only if no ingredient in it performs a perfuming function — masking agents and scenting essential oils included. "Fragrance-free" should mean that nothing in the product is there to give it a scent; "unscented" usually means only that it has no noticeable smell — and, as the US FDA points out, an unscented product may contain a little fragrance to mask the odor of its other ingredients. Neither term is defined in US law, and "hypoallergenic" is not defined either. In the EU, guidance agreed with the Commission says "free from perfume" should not be claimed when any ingredient performs a perfuming function, and that a hypoallergenic product should avoid known sensitizers altogether — which rules out almost every fragrance material. Use these words only for what the formula can prove.

For shoppers, the RUŌOD Journal explains the labels in unscented vs fragrance-free. This guide is for the brand or formulator deciding what the label may say.

Three terms, three meanings

Fragrance-related claims and what they can honestly mean
ClaimWhat a reader expectsWhat the formula must show
Fragrance-freeNo fragrance of any kindNo ingredient added to give or mask a scent — including essential oils, botanical extracts used for scent, and masking agents
UnscentedNo noticeable smellThe product smells of nothing in particular; it may contain a masking fragrance unless you also claim fragrance-free
HypoallergenicLess likely to cause allergiesIn the EU guidance: designed to minimize allergenic potential, supported by data, and free of known sensitizers

What the US FDA says

  • On fragrance: products labeled "unscented" may contain fragrance ingredients, because a manufacturer may add just enough fragrance to mask the smell of other ingredients without giving the product a noticeable scent. The FDA suggests that consumers concerned about fragrance sensitivities choose products that are fragrance-free and check the ingredient list.
  • On hypoallergenic: there are no federal standards or definitions governing the term; it means whatever a company wants it to mean, and manufacturers are not required to submit substantiation to the FDA. A federal court struck down an earlier FDA regulation that would have required testing to back the claim.

Undefined does not mean unregulated: a claim that misleads can still make a product misbranded, and false or unsubstantiated advertising claims are a matter for the FTC. The ingredient list must still declare the fragrance — as "fragrance" or "parfum", plus allergens where the market requires them; see perfume ingredient labeling.

What the EU guidance says

The EU's Technical document on cosmetic claims, agreed by a working group chaired by the European Commission (version of July 3, 2017, applied from July 1, 2019), interprets the legal common criteria for claims. It is guidance, not law, but enforcement authorities use it. Three points bear directly on fragrance:

  • "Free from perfume" should not be used when a product contains an ingredient that exerts a perfuming function in the product, regardless of its other functions. A masking agent or an essential oil added "for its properties" that also scents the product rules the claim out.
  • "Free from allergenic/sensitizing substances" is not allowed, because a complete absence of the risk of an allergic reaction cannot be guaranteed.
  • "Free from" what is not normally there is not allowed. The document's own example is fragrance: fine fragrances contain so much alcohol that preservatives are not needed, so it would be dishonest to advertise a perfume as preservative-free.

On hypoallergenic, the document says the claim can only be used where the product is designed to minimize its allergenic potential, with robust data supporting a very low allergenic potential, and that known allergens and allergen precursors should be totally avoided — including substances identified as sensitizers by the SCCS, classified as skin sensitizers under CLP, or generally recognized as sensitizers in the literature. Most perfumery materials, natural and synthetic, fall into at least one of those groups (the fragrance allergens list). A "hypoallergenic perfume" is therefore very difficult to support in the EU.

What this means for a fragrance formulator

  • If a client wants a "fragrance-free" product, nothing from your lab goes in it — including a "masking" fragrance. If the base smells, the base needs fixing.
  • If a client wants an "unscented" product with a masking fragrance, it is a fragrance like any other: it must pass the restriction check for its category, and its allergens count toward labeling thresholds. Masking blends are built from low-odor materials at low levels; record them as formulas with versions.
  • If a client wants a "low-allergen" perfume, the honest route is to reduce declarable allergens and sensitizers, and describe it accurately — not to call it hypoallergenic. The method is in reducing declarable fragrance allergens.
  • Natural is not hypoallergenic. Essential oils carry many listed allergens; see natural perfume claims.

Records that support the claim

  • The full composition of the product, with each ingredient's function, showing no perfuming function (for fragrance-free).
  • Supplier statements that bases and extracts contain no added fragrance or masking agent.
  • For a masking fragrance: its formula, version, restriction check and allergen calculation.
  • For any claim: the wording used, the markets, and the evidence, kept with the product's safety file (what a safety assessor needs).

Claims rules differ by market; the overview is in perfume regulations by market, and the related "vegan" and "cruelty-free" claims are in vegan and cruelty-free perfume claims.

Sources

Frequently asked questions

Can a product with lavender oil be fragrance-free?

Not honestly, if the lavender oil scents the product. In the EU guidance, any ingredient that performs a perfuming function rules out "free from perfume", whatever else it does.

Is "unscented" a safer claim than "fragrance-free"?

It claims less, which makes it easier to support. But a reader with a fragrance allergy may read "unscented" as "no fragrance", so state on the label or website if a masking fragrance is present.

Can a perfume be hypoallergenic?

In the US the word has no legal meaning, so it can be printed, but it should not mislead. Under the EU guidance it requires avoiding known sensitizers entirely, which is not realistic for a perfume.

Written and reviewed by the RUŌOD Lab team. This article is general education about perfume formulation and record-keeping; it is not legal, regulatory or safety advice, and the examples are illustrations, not validated commercial formulas. How we write and check these guides.

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