What Do Fragrance-Free Claims in Baby Skincare Have to Prove in the EU

Two rules decide whether fragrance-free claims in baby skincare survive a market check. One governs the words on the pack. The other governs the molecules in the batch. A brand has to satisfy both, and the two duties live in different files.

Commission Regulation (EU) No 655/2013 sets six common criteria for every cosmetic claim. Article 20 of Regulation (EC) No 1223/2009 forbids any text or image that gives a product properties it does not have. Regulators judge the claim against the finished product as sold. Evidence built on one ingredient does not carry over to the batch.

The second rule is the declaration list. Annex III of Regulation (EC) No 1223/2009 names the fragrance allergens that must appear on the label above a fixed concentration. A product can hold a fragrance-free claim and still print linalool or benzyl alcohol in the ingredient list. The claim describes intent. The declaration follows measurement.

Criterion under (EU) No 655/2013	What it means for a fragrance-free baby product
Legal compliance	The claim must not rest on meeting a minimum legal duty
Truthfulness	The finished batch must match the claim on the pack
Evidential support	Adequate and verifiable data must exist before launch
Honesty	Nothing in the wording may reach beyond that data
Fairness	The claim must not disparage a competitor formula
Informed decision-making	A buyer must understand what the claim covers

This claim type carries a structural risk. Fragrance-free says nothing about a botanical extract, a carrier oil or a preservative. Any of those can push a declarable allergen past the threshold. The claim stays valid and the label still changes.

Which Fragrance Allergens Must Baby Skincare Declare in the EU From 31 July 2026?

The EU list of individually declared fragrance allergens holds 81 entries as of 31 July 2026. That date governs products placed on the EU market. Stock already on the market may stay on sale until 31 July 2028. Both dates come from Commission Regulation (EU) 2023/1545.

The list began as 26. Directive 2003/15/EC wrote the contact allergens from the SCCNFP opinion of 1999 into Annex III. It held 24 single chemicals and 2 moss extracts, Evernia prunastri and Evernia furfuracea. A transition period closed on 11 March 2005. Regulation (EC) No 1223/2009 later carried the same set into Annex III as entries 67 to 92.

Declaration turns on concentration, not on intent. A listed allergen must appear in the ingredient list once it passes the threshold. The leave-on threshold is 0.001%, or 10 ppm. The rinse-off threshold is 0.01%, or 100 ppm. Below those figures the substance stays inside the umbrella term Parfum or Aroma.

Legacy allergen (INCI name)	SCCNFP 1999 group	Where it usually comes from
Amyl cinnamal	List A	Synthetic jasmine-type note
Amylcinnamyl alcohol	List A	Synthetic floral note
Anisyl alcohol	List B	Anise and fennel-type note
Benzyl alcohol	List A	Fragrance note and a common preservative
Benzyl benzoate	List B	Balsamic fixative
Benzyl cinnamate	List B	Balsamic note
Benzyl salicylate	List A	Balsamic fixative, now also capped by concentration
Cinnamal	List A	Cinnamon-type note
Cinnamyl alcohol	List A	Cinnamon-type note
Citral	List A	Citrus oils and lemongrass, now also capped
Citronellol	List B	Geranium and rose notes
Coumarin	List A	Tonka, lavender, sweet clover
Eugenol	List A	Clove oil
Farnesol	List B	Many essential oils
Geraniol	List A	Geranium and rose notes
Hexyl cinnamal	List B	Jasmine-type note
Hydroxycitronellal	List A	Lily of the valley note
Hydroxyisohexyl 3-cyclohexene carboxaldehyde	List A	Lily of the valley note, known as HICC
Isoeugenol	List A	Clove and carnation notes
Butylphenyl methylpropional	List B	Lily of the valley note, known as Lilial
d-Limonene	List B	Citrus oils
Linalool	List B	Lavender and citrus oils
Methyl 2-octynoate	List B	Violet-type note
Alpha-isomethyl ionone	List B	Iris and violet notes
Evernia prunastri extract	Natural extract	Oakmoss absolute
Evernia furfuracea extract	Natural extract	Treemoss absolute

The SCCNFP opinion split the 26 into List A and List B. List A held 13 substances with the strongest patch test record. List B held 11 with thinner documentation. Two moss extracts completed the set. Butylphenyl methylpropional was classified as CMR category 1B and moved to Annex II as entry 1666. Regulation (EU) 2021/1902 applied that ban from 1 March 2022. The substance stays on the declaration list even though its use is prohibited.

What changed between the 26-entry list and the 81-entry list

Commission Regulation (EU) 2023/1545 was published on 26 July 2023. It added 56 allergens and regrouped several existing entries. A correction published on 13 November 2025 renamed one entry to Damascenone and updated the INCI names for geranium and patchouli oils.

Four changes matter most to a baby skincare brief. Camphor, vanillin and several rose ketones now carry their own entries. Some entries cover a group of related chemicals, so the sum of their concentrations triggers disclosure. Terpene-rich botanical oils now generate more declared names than they did under the 26. One legacy entry, HICC, sits in the group of substances banned from use.

Where Do Declarable Allergens Enter a Product Labelled Fragrance-Free?

A baby lotion with no added fragrance can still carry six or more declarable allergens. The list follows molecules, not the word Parfum. Four routes put a listed allergen into a formula that no perfumer touched.

Botanical extracts are the first route. Calendula, chamomile, oat and lavender carry their own volatile fraction. Carrier and base oils are the second. Cold-pressed citrus brings limonene and citral. Preservation systems are the third, and benzyl alcohol is the clearest case. Time is the fourth. Oxidation in an oil phase generates new volatiles across shelf life.

Route into the formula	Example raw material	Allergen it can carry	Control measure
Botanical extract	Chamomile, calendula, oat	Linalool, limonene, geraniol	Extract-grade odor and volatile specification per lot
Essential oil	Lavender, geranium, citrus	Linalool, citronellol, limonene, citral	Allergen declaration from the supplier at ppm level
Carrier or base oil	Citrus and some nut oils	Limonene, citral, benzyl benzoate	Cold-press grade, peroxide value and free fatty acid limits
Preservative	Benzyl alcohol systems	Benzyl alcohol	Lowest effective dose inside a buffered system
Oxidative drift	Any unsaturated oil phase	Volatiles that appear only at month 9 or 12	Nitrogen blanket, chelating agent, airless packaging

Grouped entries add a second trap. One Annex III entry can cover several substances, and disclosure then triggers on their total. Synthetic and natural forms can share a single name, so Limonene covers the isolated molecule and the fraction carried in an essential oil. A botanical extract whose geraniol fraction crosses the threshold puts both the extract and geraniol on the label.

DEVA Skincare works this question from the raw material side. The active ingredient analysis laboratory runs HPLC, GC and UV-Vis, so an allergen question becomes a measured number on a finished batch. Six laboratories sit inside the group. That setup keeps an allergen review inside one development file.

How Do You Substantiate Fragrance-Free Claims in Baby Skincare?

Fragrance-free claims in baby skincare need a file with two kinds of evidence, not one sentence on the pack. Neither the EU nor the United States defines fragrance-free in law. The claim stands on the data behind it, and Regulation (EU) No 655/2013 requires that data before the product reaches the market.

Fragrance-free describes what entered the batch. A formula with no odorant keeps the claim. A non-odorant neutralizer such as zinc ricinoleate also keeps it, because the neutralizer declares under its own INCI name. A masking fragrance breaks it. The masking agent is an odorant and must declare as Parfum or Aroma, even when the lotion smells of nothing.

Analytical evidence versus clinical evidence

Hypoallergenic needs a number and a population. The usual package pairs a human repeated insult patch test with a use test on the target group. Fragrance-free needs evidence of a different kind, because the risk sits in a sensitizer that nobody added on purpose. A headspace GC-MS screen covers the marker volatiles. The practical list is linalool, limonene, geraniol, citronellol, eugenol, coumarin and benzyl alcohol.

DEVA Skincare runs a 28 day human use test and a transepidermal water loss measurement with texture imaging. A multi-active compatibility protocol and a formula and stability protocol sit inside the same set of 150 efficacy and safety protocols. Six laboratories sit inside the group, including cell testing and a product efficacy centre.

How Do Fragrance-Free, Unscented and Hypoallergenic Claims Differ?

Three claims look interchangeable on a pack and carry three different evidentiary burdens. Fragrance-free describes the batch. Unscented describes what a consumer smells. Hypoallergenic describes a measured response in a test population. Only the third needs clinical data.

Claim	What supports it	What breaks it
Fragrance-free	Every odorant absent from the batch, with an allergen declaration to show it	A masking fragrance, or an undeclared allergen arriving through an extract
Unscented	A sensory panel scoring the finished product against a reference	A base note that drifts late in shelf life
Hypoallergenic	A human repeated insult patch test plus a use test on the target group	A claim with no clinical file behind it
Suitable for sensitive skin	Irritation testing on the finished formula	A fragrance load carried over from a generic base
Allergen-tested	A named analytical panel and the limits applied	A vague statement with no method named

Why unscented is the weaker claim

A base note can drift late in shelf life. An unscented product that develops a faint odor at month twelve still sits inside the legal envelope. The claim simply stops matching the sensory panel result. Fragrance-free rests on the batch record instead, and that record does not drift.

Which Markets Set Their Own Rule for Baby Skincare Allergen Declaration?

Six regulatory regimes apply to one baby skincare line sold across the EU, the UK and North America. Five diverge on timing. One still has no individual disclosure duty at all.

Canada phases the EU list into law across three dates. It amended its Cosmetic Regulations through SOR/2024-63, published in the Canada Gazette in April 2024. From 12 April 2026, new and existing cosmetics must declare 24 fragrance allergens. From 1 August 2026, new products must declare the full expanded list. From 1 August 2028, the expanded list reaches products already on the market. The Canadian definition points to Annex III of Regulation (EC) No 1223/2009 and tracks later EU amendments. Health Canada also asks for the allergens in the Cosmetic Notification Form.

Great Britain kept the 26. The Office for Product Safety and Standards notified the World Trade Organization on 31 October 2025 of a draft amendment. Comments closed on 30 December 2025, and the expansion had not entered UK law by September 2026. Northern Ireland applies the EU regulation. One brand can therefore face two clocks inside the same country.

US federal law demands no individual disclosure. 21 CFR 701.3 sets the ingredient declaration and allows fragrance or parfum as one entry. MoCRA directed the FDA to publish fragrance allergen labeling requirements. The statutory deadline for the proposed rule passed on 29 June 2024 without a publication. The FDA lists the proposal in its 2026 regulatory agenda, with a notice of proposed rulemaking late in 2026 and a final rule in 2027 or later. A cosmetic that breaks the labeling rule is misbranded under 21 U.S.C. 362.

California acts where federal law stays silent. The Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020, known as SB 312, took effect on 1 January 2022. It sits in Health and Safety Code section 111792.6. The duty reaches an ingredient that does no scent work, reports to the California Department of Public Health, and requires no change to the pack. A rinse-off product triggers at 0.01%. A leave-on product triggers at 0.001%.

Market	Legal basis	What must be declared	Key dates
EU	Regulation (EC) No 1223/2009, Annex III, as amended by (EU) 2023/1545	81 fragrance allergens above threshold	31 July 2026 for products placed on the market, 31 July 2028 for earlier stock
Great Britain	Retained Regulation (EC) No 1223/2009	26 fragrance allergens above threshold	Expansion drafted, not yet in force
Northern Ireland	EU Cosmetics Regulation	81 fragrance allergens above threshold	Follows the EU timeline
Canada	SOR/2024-63, referencing EU Annex III	24 allergens, then the full expanded list	12 April 2026, then 1 August 2026 for new products and 1 August 2028 for existing stock
United States, federal	21 CFR 701.3, MoCRA	None individually, fragrance as one entry	Rulemaking pending
United States, California	Health and Safety Code section 111792.6	Report EU Annex III allergens to the CDPH, no label change	In force since 1 January 2022

Several MoCRA duties do apply today, and a retailer will ask for them at onboarding. The responsible person must hold safety substantiation records. A serious adverse event must reach the FDA within 15 business days. The facility must register with the FDA, and the product must be listed.

What Documents Do Retailers Ask For Before Listing a Baby Skincare SKU?

A retailer onboarding pack for one baby skincare SKU runs to nine documents or more. The allergen declaration is the one that most often comes back incomplete. Retailers build their programs on top of the legal floor, so the file has to satisfy both.

The documents split into three groups. The identity group carries the final INCI list, the batch certificate of analysis and the safety data sheet. The compliance group carries the safety report with the CPNP number, the FDA registration and listing, and the GMP certificate. The evidence group carries stability data, preservative efficacy testing, impurity screening, the allergen declaration and the IFRA certificate.

Document	What it proves	Where it usually fails
Final INCI list	What the pack says, in the printed order	Website text drifts from the printed pack
Fragrance allergen declaration	Which Annex III entries exceed the threshold, and at what ppm	Given as a compound percentage, or as one umbrella statement
IFRA certificate of conformity	The compound meets the applicable IFRA standard	Issued against an older amendment
Certificate of analysis	The batch matches specification	Odor and volatile markers missing from the specification
Safety data sheet	Hazard and handling information	Older format than the current regulation requires
Cosmetic Product Safety Report	The product is safe for its intended use	Not updated after a reformulation
Stability and preservative efficacy data	The formula and the preservation hold across shelf life	Accelerated data only, with no real-time point
Impurity and heavy metals screening	Trace contaminants sit inside limit	Tested on raw materials instead of the finished batch
GMP certificate	The site runs a certified quality system	Certificate expired, or the address does not match
FDA registration and listing	The US legal preconditions are met	Listing not updated after a formula change

A fragrance house works in percentages inside a compound. A retailer needs a concentration inside the finished product. Ask for the declaration per raw material, at finished-product ppm, with the threshold named next to it. One umbrella statement hides the case that causes trouble, because an allergen can arrive through a botanical extract or a preservative rather than through the fragrance.

The IFRA layer is voluntary and still decisive. The 51st Amendment to the IFRA Standards covers fragrance compounds, with new creations applying from 30 March 2024 and existing creations from 30 October 2025. The standards cover baby creams and oils explicitly. Retailer standards go further on their own. Clean at Sephora requires brands to list the EU fragrance allergens and to follow IFRA standards. Target Clean, Ulta Conscious Beauty and Whole Foods Premium Body Care each publish their own restricted lists.

DEVA Skincare holds the pieces a retailer asks for before a brand has to go looking. Production runs in a 100,000 grade GMPC cleanroom under 72 inspection and process control steps. Six laboratories sit inside the group, and 150 efficacy and safety protocols sit behind the release decision.

What Do Fragrance-Free Claims in Baby Skincare Cost in Time and MOQ?

An allergen-reviewed baby skincare program runs about three months from brief to bulk. Sampling takes one week from a confirmed brief. Allergen screening, the formula and stability protocol, multi-active compatibility testing, and transepidermal water loss with texture imaging each run four weeks, and they overlap. Mass production starts about six weeks after sample approval.

MOQ follows the pack format rather than the claim. Standard MOQ is 5,000 units for emulsion, lotion and wash formats. Aluminium can formats start at 10,000 units. Sheet masks start at 50,000 units. Ampoule formats start at 200,000 units.

Four cost drivers separate an allergen-reviewed baby line from a generic one. Odor and allergen specifications narrow the approved supplier list, so dual sourcing takes longer to set up. Airless pumps and barrier tubes cost more than a standard tube. The pack is the largest single line in most baby skincare projects. Reformulation after a concentration cap costs more than the labeling work that triggered it. Run the review at the brief, not at the artwork stage.

Planning a baby lotion, baby wash, barrier cream or baby sunscreen? Send the brief through the inquiry form on this page. We will confirm which allergens your formula has to declare, and which fragrance-free claims in baby skincare your evidence file can support. We will also map the market list and the sample date.

What Else Do Brands Ask About Fragrance-Free Claims in Baby Skincare?

Does the 26-entry EU list still apply?

No. Commission Regulation (EU) 2023/1545 expanded the individually declared list to 81 entries. Products placed on the EU market from 31 July 2026 must carry the expanded list. The 26 substances remain the base of that list. Great Britain still applies the original 26, because the UK has not written the expansion into law.

Does a fragrance-free baby product still need an allergen declaration?

Yes. The declaration follows the finished formula, not the claim on the front panel. Botanical extracts, carrier oils and preservatives can carry a listed allergen above the threshold. Benzyl alcohol is the clearest case, and it arrives inside a preservation system. Run the calculation on the batch, then repeat it after any change in supplier or concentration.

Are essential oils exempt from allergen declaration?

No. Natural origin creates no exemption. Many listed allergens occur naturally in essential oils, so an all-natural baby balm often carries more declarable names than a synthetic one. Lavender oil brings linalool. Citrus oils bring limonene and citral. Geranium oil brings geraniol and citronellol. Only a supplier declaration tells you the level.

What is the difference between the 0.001% and 0.01% thresholds?5

The threshold tracks exposure time. A leave-on product must name a listed allergen above 0.001%, or 10 ppm. Baby lotions, balms and barrier creams sit in that group. A rinse-off product must name it above 0.01%, or 100 ppm. Baby washes and shampoos sit there. Below the threshold the allergen stays inside Parfum or Aroma and never reaches the label.

Can a product carry a fragrance-free claim and still declare an allergen?

Yes. The two duties are separate. Fragrance-free describes what a formulator added. The declaration follows what the finished batch contains. A chamomile extract can push linalool past 10 ppm in a lotion with no fragrance compound at all. The claim stays valid and the ingredient list still changes.

What evidence supports a hypoallergenic claim on a baby product?

A human repeated insult patch test plus a use test on the target group. Babies are the intended users, so the panel has to include infant or paediatric skin. A single in-vitro irritation assay does not carry the claim on its own. The report belongs in the Product Information File before launch.

Does US law require fragrance allergen disclosure today?

No. 21 CFR 701.3 allows a cosmetic to declare its whole fragrance blend as fragrance or parfum. MoCRA directed the FDA to write a disclosure rule, and the statutory deadline passed on 29 June 2024. The FDA lists a proposed rule in its 2026 agenda. Until a final rule lands, no federal duty exists.