Which Fragrance Allergens in Baby Skincare Must Be Declared in the EU
EU rules on fragrance allergens in baby skincare now name 81 substances for individual declaration. The list held 26 entries from 2005 until 2026. A baby lotion, wash or balm placed on the EU market from 31 July 2026 must carry every listed allergen above its threshold.
The original list came through Directive 2003/15/EC. That act wrote the contact allergens from the SCCNFP opinion of 1999 into Annex III. It held 24 single chemicals and 2 moss extracts. Those were Evernia prunastri and Evernia furfuracea. A transition period ended on 11 March 2005. Regulation (EC) No 1223/2009 then carried the list 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 exceeds the threshold. The leave-on threshold is 0.001%, which covers lotions and barrier creams. The rinse-off threshold is 0.01%, which covers washes and shampoos. Below those figures the substance stays inside the umbrella term Parfum or Aroma.
Commission Regulation (EU) 2023/1545 was published on 26 July 2023. It added 56 allergens and regrouped several existing entries, taking the declared list to 81. Products placed on the EU market from 31 July 2026 must comply. Stock placed before that date may stay on sale until 31 July 2028. A correction published on 13 November 2025 renamed one entry to Damascenone. It also updated the INCI names for geranium and patchouli oils.
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, lemongrass, now also capped by concentration |
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 already reported as frequent contact allergens, and 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 still counts as a legacy allergen because it stays on the declaration list.
Where Do Fragrance Allergens Enter a Baby Formula Without a Fragrance Being Added?
A baby lotion with no added fragrance can still carry six or more declarable allergens. The rule 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, and cold-pressed citrus brings limonene and citral. Preservation systems are the third, with benzyl alcohol the clearest case. Time is the fourth, because 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. Disclosure then triggers on the sum of their concentrations, not on each one. Synthetic and natural forms can share a single name, so Limonene covers both the isolated molecule and the fraction carried in an essential oil. A Melissa officinalis extract whose geraniol fraction crosses the threshold forces both the extract and geraniol onto the label.
DEVA Skincare works this problem from the raw material side rather than the label 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 in the same group, which keeps an allergen review inside one development file.
What Do US Labeling Rules Require for Fragrance Allergens in Baby Skincare?
US federal law lets a cosmetic declare its whole fragrance blend as one word. As of September 2026 it still requires no individual allergen to be named. 21 CFR 701.3 sets the ingredient declaration and allows fragrance or parfum as one entry. That position has always rested on trade secret protection rather than on safety. A cosmetic that breaks the rule is misbranded under 21 U.S.C. 362.
The change buyers expect has not landed yet. 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 2026 regulatory agenda places a notice of proposed rulemaking later in 2026. That puts a final rule in 2027 or later. Until then no federal duty exists to disclose a specific allergen.
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.
When a baby product is a drug, not a cosmetic
A baby sunscreen and a diaper rash treatment are over-the-counter drugs in the US, not cosmetics. Their labeling follows the Drug Facts format under 21 CFR 201.66 rather than the cosmetic panel. A baby wash, a lotion and a barrier cream stay on the cosmetic side.
Requirement | EU | United States |
Individual allergen declaration | Yes, 81 entries above the threshold | No federal requirement yet |
Umbrella fragrance term allowed | Yes, as Parfum or Aroma | Yes, as fragrance or parfum |
Concentration thresholds | 0.001% leave-on, 0.01% rinse-off | None set at federal level |
Product notification | CPNP entry, with a safety report | FDA product listing and facility registration |
Safety file | Cosmetic Product Safety Report | Safety substantiation records held by the responsible person |
State layer | Not applicable | California reporting under SB 312, plus Prop 65 |
What Does California Require That US Federal Law Does Not?
California requires cosmetic companies to report fragrance allergens to the state public health department. Its thresholds match the EU. The duty also reaches a substance that carries no scent at all. 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 reporting duty differs from a label duty in three ways. It reaches an ingredient that does no scent work. It reports to the California Department of Public Health rather than to the consumer. It requires no change to the pack. A rinse-off product triggers at 0.01%, or 100 ppm. A leave-on product triggers at 0.001%, or 10 ppm. The company named on the label under 21 CFR 701.12 carries the duty.
Two practical details slow brands down. The CDPH Reportable Ingredients List updates twice a year, and companies get six months to comply. Since 27 March 2024 the list has flagged the EU newly listed allergens with an asterisk. Manufacturers must report those by the EU deadlines of 2026 or 2028. Each product also needs its universal product code recorded, including every separately sold item inside a kit. Proposition 65 sits alongside the reporting duty.
Which Other Markets Follow the EU 81-Entry List?
Canada phases the same EU list into law across three dates. Great Britain still runs on the original 26. Both matter to a brand that plans one range for several markets.
Canada 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. The trigger is 0.01% in a rinse-off product or 0.001% in a leave-on product. From 1 August 2026, new cosmetics must declare the full expanded list. From 1 August 2028, the expanded list reaches products already on the market. The Canadian definition of a fragrance allergen points to Annex III of Regulation (EC) No 1223/2009. That reference is ambulatory, so it tracks later EU amendments. Health Canada also requires the allergens in the Cosmetic Notification Form, where the concentration field is optional since March 2026.
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 to the UK Cosmetics Regulation. Comments closed on 30 December 2025, and the expanded list had not entered UK law by September 2026. Northern Ireland applies the EU regulation, so one brand can face two clocks inside the same country. A GB-only product has no current duty to name the 56 additions. That is a timing advantage and not a permanent one.
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 |
What Belongs on the Retailer Spec Sheet for Fragrance Allergens in Baby Skincare?
A retailer onboarding pack for one fragranced 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.
Why the ppm figure matters more than the percentage
A fragrance house works in percentages inside a compound, and a retailer needs a concentration inside the finished product. The two figures differ by the dosage and by any allergen arriving through another raw material. 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 enter 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. EU safety assessors use them as scientific justification, so a safety report built without an IFRA certificate invites a question. 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.
Document | What it proves | Who issues it | Where it usually fails |
Final INCI list | What the pack says, in the printed order | Brand and contract manufacturer | Website text drifts from the printed pack |
Fragrance allergen declaration | Which Annex III entries exceed the threshold and at what ppm | Fragrance house and each raw material supplier | Given as a compound percentage, or as one umbrella statement |
IFRA certificate of conformity | The compound meets the applicable IFRA standard | Fragrance house | Issued against an older amendment |
Certificate of analysis | The batch matches specification | Manufacturer quality unit | Odor and volatile markers missing from the specification |
Safety data sheet | Hazard and handling information | Raw material supplier | Older format than the current regulation requires |
Cosmetic Product Safety Report | The product is safe for its intended use | Qualified safety assessor | Not updated after a reformulation |
Stability and preservative efficacy data | The formula and the preservation hold across shelf life | Manufacturer laboratory | Accelerated data only, no real-time point |
Impurity and heavy metals screening | Trace contaminants sit inside limit | Third-party or in-house laboratory | Tested on raw materials, not on the finished batch |
GMP certificate | The site runs a certified quality system | Certification body | Certificate expired, or the address does not match |
FDA registration and listing | The US legal preconditions are met | FDA, through the responsible person | Listing not updated after a formula change |
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.
How Do You Substantiate Fragrance-Free and Hypoallergenic Claims?
Neither fragrance-free nor hypoallergenic has a legal definition in the EU or the US. Each claim stands on the evidence behind it. Regulation (EU) No 655/2013 sets six common criteria for a cosmetic claim. A claim must be legally compliant, truthful, supported by evidence, honest, fair and useful for an informed decision. The FTC applies a similar standard in the US, and Directive 2005/29/EC covers the EU.
Fragrance-free is the more defensible claim of the two. It 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 be declared as Parfum or Aroma, even when the lotion smells of nothing. Unscented is the weaker claim and describes only what the consumer smells.
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. A fragrance-free claim needs support of a different kind, because the risk sits in a sensitizer that nobody added. 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 panel and a formula and stability protocol sit inside the same 150 protocol set.
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 |
What Do Fragrance Allergens 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 in a DEVA Skincare program 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, and ampoule formats 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 labelling 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 fragrance allergens in baby skincare your formula has to declare. We will also map the market list and the sample date.
What Else Do Brands Ask About Fragrance Allergens 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 follow it. The 26 substances remain the foundation of the list. Great Britain still applies the original 26, because the UK has not yet written the expansion into law.
Are essential oils exempt from allergen declaration?
No. Natural origin does not create an exemption. Many listed allergens occur naturally in essential oils. An all-natural baby balm therefore 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. A supplier declaration for the oil is the only way to know the level.
What is the difference between the 0.001% and 0.01% thresholds?
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.
Does a fragrance-free baby skincare 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. Repeat it after any change in supplier or concentration.
Do US retailers require allergen disclosure even when federal law does not?
Many do. Clean at Sephora requires brands to list all 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. All three ask for documentation before a product goes on shelf. The retailer standard usually sits above the federal floor.
How long does an allergen declaration take to prepare for a new baby skincare SKU?
Start with the fragrance house and the raw material suppliers. A complete declaration needs an allergen breakdown per raw material, not one statement for the finished product. Sampling takes about one week from a confirmed brief. Screening and analytical work run four weeks. Mass production starts about six weeks after sample approval.
Can one allergen face both a labeling rule and a concentration cap?
Yes. Commission Regulation (EU) 2026/909 sets maximum concentrations for Benzyl Salicylate and Citral in addition to the declaration duty. Products placed on the EU market from 1 January 2027 must meet the new caps. Existing stock may sell through until 1 August 2028. Each product category has its own ceiling.
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