What does fragrance-free baby skincare require under EU law
Fragrance-free baby skincare has to clear two legal tests at once. The first is an accurate allergen declaration under Regulation (EC) No 1223/2009. The second is a claim you can prove under Commission Regulation (EU) No 655/2013. EU law does not ban fragrance in a product for a baby. It requires you to name the allergens above a threshold, and it controls what you may print on the pack. Since 31 July 2026 every new product placed on the EU market must carry the expanded allergen list. Stock already on the market has until 31 July 2028.
The claim rule is stricter than most brands assume. The Technical Document on Cosmetic Claims accepts the words fragrance-free only when no ingredient performs a perfuming function. It does not matter what else that ingredient does in the formula. If the product contains a substance that Annex III requires you to declare, regulators treat the claim as misleading. That covers fragrance-free, unscented and no perfume added. A masking fragrance added only to cover the smell of a base oil therefore breaks the claim.
Regime | Legal instrument | What it governs | Key date |
Allergen declaration | Regulation (EC) No 1223/2009, Annex III | Which substances must be named on the label | New products 31 July 2026, stock 31 July 2028 |
Concentration limits | Annex III entries 24, 70 and 75, amended by Regulation (EU) 2026/909 | The maximum percentage of one allergen in one product type | Products placed on the market from 1 January 2027 |
Age-specific limits | Annex III entry 380, hexyl salicylate | Product type limits for children under three | 1 May 2026 |
Claims | Commission Regulation (EU) No 655/2013 | Whether you may say fragrance-free, unscented, hypoallergenic or allergen-free | In force and enforced |
For fragrance-free baby skincare, that combination turns the words into a formulation constraint rather than a marketing position. You cannot print fragrance-free on a pack that declares limonene in the same ingredient list.
Which allergens must a baby skincare label declare?
A fragrance-free baby skincare label must name each Annex III fragrance allergen using its INCI name. The duty starts at 0.001% in a leave-on product and 0.01% in a rinse-off product. The first list held 26 substances. It came from the SCCNFP opinion of 8 December 1999. Directive 76/768/EEC brought it into EU law in 2003, with a transition period that ended in March 2005. Regulation (EC) No 1223/2009 later carried the list into Annex III.
The original 26, and what remains of them today
INCI name | Status today |
Amyl cinnamal | Declarable |
Amylcinnamyl alcohol | Declarable |
Anise alcohol | Declarable |
Benzyl alcohol | Declarable |
Benzyl benzoate | Declarable |
Benzyl cinnamate | Declarable |
Benzyl salicylate | Declarable, capped from 1 January 2027 |
Cinnamal | Declarable |
Cinnamyl alcohol | Declarable |
Citral | Declarable, capped from 1 January 2027 |
Citronellol | Declarable |
Coumarin | Declarable |
Eugenol | Declarable |
Farnesol | Declarable |
Geraniol | Declarable |
Hexyl cinnamal | Declarable |
Hydroxycitronellal | Declarable |
Hydroxyisohexyl 3-cyclohexene carboxaldehyde, HICC or Lyral | Prohibited, off the market since 23 August 2021 |
Isoeugenol | Declarable |
Butylphenyl methylpropional, BMHCA or Lilial | Prohibited since 1 March 2022 |
Limonene | Declarable |
Linalool | Declarable |
Methyl 2-octynoate | Declarable |
Alpha-isomethyl ionone | Declarable |
Evernia prunastri extract, oakmoss | Declarable |
Evernia furfuracea extract, treemoss | Declarable |
Two entries no longer apply. HICC moved to Annex II through Commission Regulation (EU) 2017/1410. Products containing it left the EU market after 23 August 2021. BMHCA moved to Annex II through Commission Regulation (EU) 2021/1902, applicable from 1 March 2022. That left 24 substances in force before the 2023 overhaul.
Regulation (EU) 2023/1545 of 26 July 2023 replaced, deleted and added entries in Annex III. The Commission added individual labelling for 56 additional fragrance substances. Industry counts put the declarable list at 81 substances. You will see 80 or 82 in supplier documents, because grouped entries are counted differently.
Change | Before | After 31 July 2026 |
Declarable substances | 26 in 2003, 24 in force by 2022 | 81 |
Entries replaced | Not applicable | 17 |
Entries deleted | Not applicable | 10 |
Entries added | Not applicable | 45 entries covering 56 substances |
Natural materials named | Oakmoss and treemoss | Lavender, peppermint, eucalyptus, lemon peel, jasmine, rose, neroli, sandalwood and more |
Naming rule | One name per substance | Related substances share a name, so Citral covers citral, geranial and neral |
New products | Not applicable | Comply by 31 July 2026 |
Products already on the market | Not applicable | Comply by 31 July 2028 |
Where the 2023 expansion hits baby formulas hardest
Essential oils stopped being a safe harbour. Lavender oil, peppermint oil, eucalyptus oil and lemon peel oil all sit on the declarable list now. So do jasmine extract, rose oil and neroli. A baby formula that smelled of lavender needs a quantified answer for every one of those materials. Menthol, camphor and vanillin joined the list too. That catches mint notes and vanilla accords built from nature-identical raw materials.
Why does leave-on versus rinse-off change the threshold?
The declaration threshold is ten times stricter for a product that stays on the skin. It is 0.001% in a leave-on product against 0.01% in a rinse-off product. Inside a 200 ml baby lotion, 0.001% works out at two thousandths of a gram of a single allergen. Trace carry-over from a plant extract becomes a labelling question, not a technical footnote.
Product type | Declaration threshold | Typical baby product |
Leave-on | 0.001%, equal to 10 ppm | Baby lotion, nappy cream, baby oil, baby wipe, baby sun care |
Rinse-off | 0.01%, equal to 100 ppm | Baby wash, baby shampoo, bubble bath |
Use frequency matters as much as the classification. A baby wash is rinse-off, yet it goes on once or twice a day. The SCCS Notes of Guidance sets separate default exposure values for children rather than reusing adult figures. It includes a dedicated group for infants from 0 to 6 months. One concentration can clear a comfortable margin of safety on an adult panel. Assessed against an infant default, the same figure can fall below the threshold. That is why fragrance-free baby skincare work leans on the finished formula.
Do baby wipes count as leave-on products in the EU?
Yes, and that single classification sets the compliance path for the whole wipe range. Regulation (EU) 2026/909 gives leave-on products for the anogenital area their own category. It names baby wipes and intimate wipes inside it. A wipe therefore sits in the strictest box in the regulation, at a 0.001% declaration threshold.
Preservative limits follow the same logic. The EU cut methylisothiazolinone to rinse-off use only, at 15 ppm, after the SCCS found no safe leave-on concentration. That assessment named wet wipes. Treat a wipe as a rinse-off product and you get two things wrong: the allergen declaration and the preservative system.
What do the 2026 amendments change for baby products?
Two amendments in 2026 add hard concentration caps on top of the declaration duty. Both reach fragrance-free baby skincare directly. Commission Regulation (EU) 2026/909 of 27 April 2026 rewrote Annex III entries 24, 70 and 75. It applies to products placed on the EU market from 1 January 2027. A second amendment added hexyl salicylate to Annex III entry 380, applicable from 1 May 2026.
Citral: a 0.063% cap written for baby wipes
Citral, geranial and neral now carry product-specific maximum concentrations. The lowest figure in the entry belongs to baby wipes. The cap for leave-on products in the anogenital area is 0.063%. A leave-on skin product elsewhere carries 0.15%. Rinse-off skin and hair products sit at 1.2%. Citral occurs naturally in lemon oil and lemongrass oil, so a natural citrus note needs a quantitative check against the wipe category. Benzyl salicylate, another of the original 26, picked up caps in the same regulation. Body lotion carries a 0.7% limit and other leave-on skin and hair products 0.5%.
Hexyl salicylate: an under-three ban on a fragrance allergen
Hexyl salicylate is the clearest current example of the EU treating babies as a separate population. Annex III entry 380 restricts the substance. For a product intended for children under three, the entry does not permit it at all. A short list of product types is exempt. The exempt list covers shower gel, hand wash, shampoo and conditioner. It also covers body lotion, face and hand cream, lip care and fragrance products. Each carries a 0.1% limit for that age group. Toothpaste for children under three carries 0.001%. Adult rinse-off products sit at 0.5% and adult leave-on products at 0.3%.
Substance | Product category | Maximum concentration |
Citral, with geranial and neral | Leave-on products for the anogenital area, including baby wipes and intimate wipes | 0.063% |
Citral, with geranial and neral | Leave-on skin products, excluding fragrance, eye, lip and deodorant products | 0.15% |
Citral, with geranial and neral | Rinse-off skin and hair products | 1.2% |
Benzyl salicylate | Body lotion | 0.7% |
Benzyl salicylate | Other leave-on skin and hair products, non-aerosol | 0.5% |
Hexyl salicylate | Products intended for children under three, outside the groups below | Not permitted |
Hexyl salicylate | Shower gel, hand wash, shampoo, conditioner, body lotion, face and hand cream, lip care, fragrance, for children under three | 0.1% |
Hexyl salicylate | Toothpaste for children under three | 0.001% |
Hexyl salicylate | Adult rinse-off products | 0.5% |
Hexyl salicylate | Adult leave-on products | 0.3% |
Under-three products for anogenital use now attract the tightest limits in the annex. The EU has started writing age-specific rows into entries instead of one figure for everyone.
Can a baby product claim hypoallergenic, unscented or allergen-free?
The claim rules are the hard part of fragrance-free baby skincare, because the words are not interchangeable. Fragrance-free and unscented mean different things, and allergen-free is not available at all. Six common criteria in Regulation (EU) No 655/2013 apply to each claim: legal compliance, truthfulness, evidential support, honesty, fairness and informed decision making. The Commission's Technical Document sets out how they apply. Annex III covers free-from claims and Annex IV covers hypoallergenic.
Claim | Allowed | What you have to show |
Fragrance-free | Yes, on conditions | No ingredient performs a perfuming function, and no declarable Annex III allergen sits above the threshold |
Unscented | Yes, but weaker | Only that the product has no perceptible odour; a masking fragrance may still be present |
No added fragrance | Yes, but read as the same promise | Evidence that nothing went in for scent, since consumers read it as fragrance-free |
Hypoallergenic | Yes, with evidence | A formula designed to cut allergenic potential, no known allergens or precursors, and sound statistically reliable data |
Allergen-free | No | Nobody can guarantee the absence of allergy risk, so the claim counts as unverifiable |
Free from parabens or another permitted ingredient | Generally no | Claims must not denigrate ingredients EU law allows |
For hypoallergenic, the evidence route matters as much as the conclusion. The guidance prefers a Repeated Open Application Test on the finished product. It treats an HRIPT used for hazard assessment of an ingredient as unethical and to be prohibited. Enforcement has tightened as well. French authorities published joint guidance on free-from claims in April 2020 and updated it on 1 October 2025. A 2025 court decision treated free-from and zero-percent claims about allergens and parabens as a breach of commercial diligence.
What changes in the formula and the tests when fragrance comes out?
A fragrance-free baby skincare brief changes the raw material list, the smell of the base and the evidence pack. Reformulation therefore starts in the laboratory, not on the artwork. The usual shortcut is a masking fragrance. It removes the smell without adding a perceptible scent, and it breaks the claim. The rule looks at the function of the ingredient, not at what a consumer can smell.
Three points decide whether a fragrance-free baby formula holds up. First, trace allergens travel in unscented raw materials. A shea butter, a botanical extract or a fermented active can carry linalool or limonene. Nobody added fragrance to it. Ask for per-batch allergen declarations across the fragrance-free raw materials, because one certificate from a fragrance house is not enough. Second, a fragrance-free base smells of its own ingredients. Glycerin, plant oils and butters all have odours you cannot mask without breaking the claim. Third, fragrance-free baby skincare analysis sits on the finished formula, not on the concentrate.
That is where a factory's testing stack becomes the argument. DEVA Skincare runs 150 efficacy and safety testing protocols. They include cell-based efficacy and toxicity testing, the chorioallantoic membrane irritation assay and preservative challenge testing. Six laboratories cover cell testing and product efficacy. They also cover plant extraction and fermentation, active ingredient analysis, packaging testing and heavy metal testing. Analysis runs on HPLC, GC and UV-Vis instruments, product efficacy uses VISIA imaging across 12 skin indicators, and packaging testing uses xenon lamp ageing. Core laboratories follow CNAS standards, and production runs in 100,000-class GMPC cleanrooms. For a product intended for children under three, EU law expects particular attention to the preservative challenge test result. That protocol belongs in the plan from the first sample.
What does a fragrance-free brief change in sampling, MOQ and lead time?
Sampling takes about one week, and mass production takes about six weeks after sample approval. Each required test protocol takes about four weeks. A fragrance-free baby skincare brief extends the front end rather than the line. The extra time goes into three places: raw material allergen data, a finished formula check, and a safety file covering the under-three age group.
Stage | Standard scented brief | Fragrance-free baby brief |
Formula | A fragrance blend plus a masking agent | Functional raw materials only, none performing a perfuming function |
Raw material data | One fragrance house certificate | Per-batch allergen declarations across every fragrance-free raw material |
Analytical check | Fragrance conformity | GC-MS and HPLC on the finished formula against the current Annex III list |
Safety file | CPSR written for the general population | CPSR covering children under three with children-specific exposure values |
Packaging | A standard label | A full allergen declaration, and no claim the formula cannot support |
Minimum order quantity follows the pack, not the claim. It is 5,000 units for most skincare, 10,000 for aluminium cans, 50,000 for sheet masks and 200,000 for ampoules. Baby care is a category where DEVA Skincare has volume behind it. Our baby physical sunscreen and our amino acid foam cleanser each ship 13 million units a year. Euromonitor certified one baby care brand we manufacture for as Asia's number one baby sun care brand in 2024. That recognition belongs to the brand, not to us.
How do you start a fragrance-free baby line?
Four inputs set the whole schedule: product category, target market, first-order volume and launch date. With those we confirm MOQ, choose a formulation route and issue a dated sampling plan within a few working days. A reference sample usually saves one full sampling round.
If you are building fragrance-free baby skincare for the EU, use the enquiry form on this page. Tell us the category you have in mind: baby lotion, nappy cream, baby wipes, baby wash or baby sun care. Add your target market and first-order volume. We will come back with the allergen position of the proposed formula. You also get the test protocols it needs and the dates attached to each step.
Does EU law ban fragrance in baby skincare?
No. Regulation (EC) No 1223/2009 allows fragrance in a product for a baby, but it requires every Annex III allergen above 0.001% in a leave-on product or 0.01% in a rinse-off product to be named in the ingredient list. Specific substances carry age-based limits. Hexyl salicylate is currently not permitted in most product types intended for children under three.
How many fragrance allergens must be declared in 2026?
Eighty one substances. Regulation (EU) 2023/1545 added 56 fragrance substances to the list, which stood at 26 when it was introduced in 2003 and at 24 in force once HICC and BMHCA were prohibited. The deadline for new products placed on the EU market passed on 31 July 2026. Existing stock has until 31 July 2028.
What is the declaration threshold for a baby lotion?
0.001%, which is 10 ppm, because a baby lotion is a leave-on product. A rinse-off product such as a baby wash or baby shampoo uses the higher threshold of 0.01%, or 100 ppm. Baby wipes sit in the leave-on group, so the stricter figure applies to them as well.
What is the difference between fragrance-free and unscented?
Fragrance-free means no ingredient in the formula performs a perfuming function, so no fragrance material is present. Unscented means only that the product has no perceptible smell. An unscented product may still contain a masking fragrance and its allergens. Under Commission Regulation (EU) No 655/2013 the two claims carry different evidence duties for fragrance-free baby skincare.
Can a baby product be labelled allergen-free?
No. The Technical Document on Cosmetic Claims treats a complete absence of allergy risk as something no product can guarantee, so allergen-free and free from allergens are not acceptable. A formula can still be fragrance-free, which is a statement about formulation rather than about the risk of an allergic reaction.
Can baby skincare be labelled hypoallergenic in the EU?
Yes, on two conditions. The formula must be designed to reduce allergenic potential, and you must hold sound, statistically reliable evidence for that. The guidance also states that a product claiming hypoallergenic will not contain known allergens or allergen precursors. That rules out both fragrance and the newly declarable essential oils.
Does the 31 July 2026 deadline apply to stock already on shelves?
No. Products placed on the EU market before 31 July 2026 may continue to be made available until 31 July 2028. That window closes for a product the moment it is reformulated, rebranded or newly placed on the market, because those acts make it a new product under the regulation.
What documents should a brand ask its manufacturer for?
Ask for four items: a per-batch allergen declaration for each fragrance-free raw material, a GC-MS or HPLC report on the finished formula against the current Annex III list, the preservative challenge test result, and confirmation that the Cosmetic Product Safety Report covers the under-three age group. Together they support the label and the claim.
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