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Fragrance-free, sensitive-skin and pregnancy-safe skincare: how to formulate and what you can claim

The difference between fragrance-free and unscented, the fragrance allergen labels that changed in 2026, how chemists build gentle formulas, and how careful you must be with "hypoallergenic" and "pregnancy safe".

Not legal or medical adviceThis guide explains rules and published evidence in plain words. It does not replace a safety assessor, a lawyer or a doctor; pregnant customers should always be told to ask their doctor.

Short answer

"Fragrance-free" should mean the product contains no ingredient used to give it a scent, including essential oils and masking fragrance; "unscented" only means it has no noticeable smell and may still contain a masking fragrance, and neither term is defined in US law. In the EU, Regulation (EU) 2023/1545 expands the fragrance allergens that must be named in the ingredient list to more than 80, above 0.001% in leave-on and 0.01% in rinse-off products, for new products placed on the market from 31 July 2026 (existing products until 31 July 2028); Canada applies a similar list from 2026. A sensitive-skin formula keeps the ingredient list short, leaves out fragrance and common irritants, sits close to skin pH and is proven by a patch test or HRIPT. "Pregnancy safe" has no legal definition and implies a safety promise for a vulnerable group, so most careful brands instead say what the product is formulated without (for example retinoids and hydroquinone) and tell customers to ask their doctor.

Fragrance-free vs unscented vs no added fragrance

The three phrases sound alike but promise different things. In US law, a fragrance is "any natural or synthetic substance or substances used solely to impart an odor to a cosmetic product" (21 CFR 700.3). The FDA has no definition of "fragrance-free" or "unscented", and it warns consumers that even some products labeled "unscented" may contain fragrance ingredients added to mask the smell of other ingredients.

Phrase	What customers expect	What it should mean in your formula
Fragrance-free	Nothing added to make it smell	No perfume, no masking fragrance, no essential oil or extract added for its scent. The product may still have a faint base odor from its ingredients.
No added fragrance	Same as fragrance-free	Same rule; this wording is a little more precise because it admits a natural base odor.
Unscented	Has no smell	No noticeable scent. Some unscented products contain a small amount of masking fragrance, which defeats the purpose for people with fragrance allergy.
Scented with essential oils	"Natural" scent	Still fragrance. Essential oils are perfuming ingredients and often carry labeled allergens.

The EU is stricter on the wording. The European Commission's technical document on cosmetic claims (the guidance national authorities use to apply Regulation (EU) No 655/2013) says a "free from perfume" claim should not be used when the product contains an ingredient that exerts a perfuming function, regardless of its other functions. So a "fragrance-free" cream with lavender oil "for soothing" is not fragrance-free in the EU.

For a brand selling to sensitive or allergic customers, the safe choice is simple: if you say fragrance-free, add nothing for scent at all, and say "no added fragrance" if you want to be precise about the base odor.

Where fragrance hides: essential oils and extracts

Fragrance allergens are specific molecules such as linalool, limonene, citral, geraniol, eugenol and coumarin. They are in perfume blends, but they are also natural parts of many essential oils and some plant extracts. Lavender oil is rich in linalool and linalyl acetate; citrus peel oils are mostly limonene; rose and geranium oils contain geraniol and citronellol; clove contains eugenol.

Three consequences for your formula:

Labeled allergens can come from any ingredient
In the EU and Canada, a listed allergen must be named in the ingredient list once it passes the threshold, whatever ingredient it comes from, including essential oils and extracts. Ask your manufacturer for the allergen statement of every raw material, not only of the perfume.
"Natural" is not gentler
An essential oil blend can carry more allergens than a designed perfume. For a sensitive-skin product, leave both out.
Masking agents are fragrance too
Some bases smell of fatty acids, ferments or actives. A tiny masking fragrance fixes the smell but ends the "fragrance-free" claim. The alternatives are choosing purer raw materials, accepting a light base odor, or using a scent-neutral packaging such as an airless pump that keeps the smell in.

Fragrance allergen labels: EU, Canada, US

Allergen labeling changed in 2026 in two major markets. As of October 2026:

Market	Rule	Thresholds	Dates
EU	Regulation (EU) 2023/1545 expands the list of fragrance allergens that must be named individually to more than 80 (earlier rule: 24, named in Annex III)	Above 0.001% in leave-on and 0.01% in rinse-off products	Products placed on the market from 31 July 2026 must comply. Products already placed before that date may stay on the market until 31 July 2028, and the responsible person must update labels, the safety report and the product information file by then.
UK	Great Britain follows its own version of the cosmetics regulation; check the UK position with your UK Responsible Person	Check	See UK cosmetics regulation
Canada	Cosmetic Regulations amended: List 1 (24 allergens), then List 2 (the expanded list), named in the ingredient list outside the word "parfum"	Above 0.001% leave-on and 0.01% rinse-off	List 1 for new and existing products from April 12, 2026; List 2 for new products from August 1, 2026 and for existing products from August 1, 2028
US	MoCRA requires the FDA to issue a rule on fragrance allergen labeling. Until then, fragrance may be listed as "Fragrance"	Not set yet	The FDA missed the statutory deadline; its regulatory agenda targets a proposed rule in November 2026. Check FDA's MoCRA page before you print.

ExampleA 50 mL rinse-off body wash with 0.5% of a perfume that contains 2% linalool has 0.01% linalool in the finished product. That is right at the rinse-off threshold, so the perfume supplier's allergen certificate decides whether "Linalool" must appear on the label. The same perfume at the same dose in a leave-on body lotion is ten times over the 0.001% leave-on threshold, so it must be named. Your manufacturer calculates this from the supplier's IFRA and allergen certificates.

The ingredient list itself is covered in INCI lists, PAO and claims on labels and, market by market, in cosmetic label requirements by country. EU detail is in the EU cosmetics regulation guide.

Formulating for sensitive skin, step by step

"Sensitive skin" is not a diagnosis. Customers use it for skin that stings, burns, reddens or itches easily, often with a weak barrier. A gentle formula lowers the number of things that can trigger that reaction.

Keep the ingredient list short
Fewer ingredients mean fewer possible triggers and easier troubleshooting when a customer reacts. Every ingredient should have a job; drop the ones that are only there for a marketing story.
Leave out fragrance and essential oils
Fragrance ingredients are a well-known cause of allergic skin reactions to cosmetics, which is why the EU and Canada require allergen labels. Leave out perfume, essential oils used for scent and masking fragrance.
Avoid or limit the usual irritants
High levels of denatured alcohol in leave-on products, strong surfactants in leave-on or face cleansers (for example sodium lauryl sulfate), high-strength acids, physical scrubs, menthol and other cooling agents, and sensitizing preservatives such as methylisothiazolinone (in the EU allowed only in rinse-off products, at up to 0.0015%).
Support the barrier
Barrier ingredients such as ceramides, cholesterol, fatty acids, panthenol, glycerin, squalane and centella are common in sensitive-skin lines. See ceramides, centella and hyaluronic acid.
Keep the pH close to the skin's
Healthy skin surface is slightly acidic (about pH 4.7 by one published estimate). Leave-on products and cleansers for sensitive skin are usually formulated in a mildly acidic range; very alkaline soaps and very low pH acid products are the opposite of gentle.
Choose a well-tolerated preservative system and prove it
A water-based product needs a preservative. Common gentle choices include phenoxyethanol (up to 1% in the EU) with a booster such as ethylhexylglycerin, or organic acids such as sodium benzoate and potassium sorbate at the right pH. Whatever you choose, prove it works with a challenge test; read shelf life, PAO and preservatives.
Pick protective packaging
An airless pump or tube keeps fingers and air out, which lets the formula use a lighter preservative load and keeps it stable. Single-dose packs avoid repeated opening altogether.
Test on people before you claim
A patch test or HRIPT (human repeat insult patch test) under a dermatologist's supervision shows how the product behaves on skin and backs claims like "dermatologist tested". See patch test and HRIPT and the testing overview.

Hypoallergenic, dermatologist tested, sensitive skin claims

These are the claims sensitive-skin brands want most, and the ones regulators look at closely.

"Hypoallergenic" in the US. The FDA says there are no federal standards or definitions for the term; it "means whatever a particular company wants it to mean". That does not make it free to use: the FTC expects any objective claim in advertising to be backed by competent and reliable evidence.
"Hypoallergenic" in the EU. The Commission's claims guidance says it can be used only when the product was designed to minimize its allergenic potential, the responsible person has scientifically sound and statistically reliable data showing a very low allergenic potential, and known allergens and sensitizers are left out. It must not suggest there is no risk of allergy at all.
"Dermatologist tested". Means a test was run under a dermatologist's supervision, usually a patch test or HRIPT. Say what was tested; "dermatologist approved" or "dermatologist recommended" suggests more and needs more proof.
"For sensitive skin" and "suitable for sensitive skin". Support them with the formula design above and a test on people who describe their skin as sensitive. "Non-irritating" is an absolute claim; "low irritation potential" or "tested for irritation" is easier to support.
"Free from" lists. In the EU, "free from parabens" or "free from phenoxyethanol" is discouraged because it denigrates legal ingredients. "Free from fragrance" or "no added fragrance" is fine if true, because it helps people with fragrance allergy choose.

More in what skincare can and cannot claim.

Pregnancy-safe skincare: what is commonly avoided

Many customers look for skincare to use while pregnant or breastfeeding. There are few studies in pregnant women for most cosmetic ingredients, so advice is based on how much of an ingredient passes through the skin and on what is known from the drug versions of the same molecules. What published reviews and health services say, as of October 2026:

Ingredient	What sources say	What careful brands do
Prescription retinoids (tretinoin, adapalene, tazarotene, oral isotretinoin)	The EU medicines regulator (EMA) says topical retinoid medicines must not be used during pregnancy or by women planning a pregnancy, even though absorption is low. Oral isotretinoin is a known cause of birth defects.	Never in a pregnancy-focused product (they are drugs, not cosmetics, in most markets anyway).
Cosmetic retinoids (retinol, retinal, retinyl esters)	Sources differ. A 2011 review in Canadian Family Physician advises not encouraging topical retinoids in pregnancy until more data exist. An Australian hospital service (MotherSafe, NSW) says vitamin A in cosmetics is generally in small amounts and minimally absorbed. In the EU, products with retinol or its esters must carry "Contains Vitamin A. Consider your daily intake before use."	Most pregnancy-focused lines leave all retinoids out and use alternatives such as bakuchiol, peptides or niacinamide, with "ask your doctor" advice.
Salicylic acid (BHA)	Low-strength topical use is generally judged unlikely to pose a risk because little is absorbed; high-strength peels and large-area use are treated with more caution.	Leave it out of pregnancy lines, or keep it to low levels in rinse-off products and say so.
Hydroquinone	The 2011 review estimates 35% to 45% is absorbed through the skin and advises minimizing exposure. In the US it is no longer allowed in over-the-counter skin lighteners; in the EU it is not allowed in skin care.	Never use it. It is not a cosmetic ingredient for skin in the US or EU.
Benzoyl peroxide	About 5% is absorbed and it is converted to benzoic acid; systemic effects are not expected.	It is an acne drug ingredient in the US, so it rarely belongs in a cosmetic line.
Essential oils	There is little good evidence either way for most oils at cosmetic levels.	Many pregnancy and baby lines leave them out, which also helps sensitive skin.
Sunscreen filters	Reviews describe low absorption; sunscreen is advised to stop melasma (pregnancy dark patches) getting worse.	Some brands prefer mineral filters (zinc oxide, titanium dioxide) for this audience.

This is a summary of public sources for product planning, not medical advice. Ingredient choices also change by market: retinol limits in the EU, for example, are covered in retinol vs retinal.

Why "pregnancy safe" is a risky claim

"Pregnancy safe" has no legal definition anywhere we have checked. It is still a claim, and a strong one: it promises safety for a mother and an unborn child, a group that is almost never studied.

EU and UK. Every claim must meet the common criteria of Regulation (EU) No 655/2013, including evidential support and honesty. The safety assessment must also consider exposure of specific populations, so a product marketed to pregnant women needs a safety report that addresses that use.
US. FTC rules require competent and reliable scientific evidence for health-related claims, and a claim of safety for pregnancy is health-related. If a customer has a problem, the claim is the first thing a lawyer will read.
Platforms. Marketplaces and ad platforms review health-related claims more strictly; vague safety claims can lead to listing or ad rejections.

Safer wording describes what you did, not a promise of outcome:

State the formula choices
"Formulated without retinoids, salicylic acid, hydroquinone and essential oils."
State the tests, if you have them
"Dermatologist tested" (after a patch test or HRIPT), "tested for irritation on 50 volunteers".
Point to the doctor
"If you are pregnant or breastfeeding, ask your doctor before use." This is common practice and it is honest.
Keep the safety assessor in the loop
Tell your EU or UK safety assessor that the product is marketed to pregnant women so the CPSR covers it.

Common mistakes

Calling a product "fragrance-free" while it contains an essential oil or a masking fragrance.
Checking the perfume for allergens but forgetting that essential oils and plant extracts carry labeled allergens too.
Printing EU labels in 2026 with the old 24-allergen list for a product launched after 31 July 2026.
Using "hypoallergenic" with no test data, or with fragrance or known sensitizers in the formula.
Writing "pregnancy safe" or "safe for babies and moms" without evidence, a safety assessment that covers that use, or "ask your doctor" advice.
Adding "free from parabens" and "free from phenoxyethanol" to EU packs; the EU guidance treats these as denigrating.
Making a gentle formula with an untested preservative system, then finding mold in jars after launch.

Checklist

I decided whether the product is fragrance-free (nothing for scent) or only unscented, and the label says which.
No essential oil, extract or masking agent is in the formula for its smell if I claim fragrance-free.
I have the allergen statement for every raw material, not only the perfume.
My EU labels name every allergen on the 2023/1545 list above 0.001% (leave-on) or 0.01% (rinse-off).
My Canada labels use List 1 now and List 2 for products launched from August 1, 2026.
The formula is short, leaves out common irritants and sits in a mildly acidic pH range.
The preservative system passed a challenge test.
I ran a patch test or HRIPT before printing "dermatologist tested" or "hypoallergenic".
Pregnancy wording says what the product is formulated without, not that it is "safe".
The label or listing tells pregnant and breastfeeding customers to ask their doctor.
My EU or UK safety assessor knows the target users, including pregnant women if I market to them.

How KoreanOEM helps

KoreanOEM is a Korean skincare OEM and private label manufacturer: our formulation chemists in Busan develop the formula, and production runs in Korea under ISO 22716 (cosmetics GMP). For gentle lines we help in four places:

Formula. Start from one of 160+ ready formulas in our formula library, or remove the fragrance, change the preservative system or the actives on a library base as an adjusted formula (USD 399 per SKU, from 1,000 units). A fully custom formula is USD 399 per SKU from 2,000 units. First lab samples and 3 revision rounds are included and the fee is credited against your first production order.
Tests. Challenge test (ISO 11930) from USD 1,000 per formula; patch or low-irritation dermatological test from USD 1,000; HRIPT from USD 3,000 with 50 people for "dermatologist tested" or USD 5,500 with 100 people for "hypoallergenic". COA and microbiology come with every batch.
Label check. Before printing, our label proof check compares your label with the target market's rules, including the ingredient list and allergens, and sends corrections.
EU and UK files. CPSR and PIF through our partner for USD 1,250 per formula (UK notification included), so the safety assessor sees your target users and claims.

Tell us your target users (sensitive skin, pregnancy, babies) in the quote form. Our team checks the formula, tests and claim wording with the lab before anything is promised.

Get a free quote Order a sample box

Frequently asked questions

What is the difference between fragrance-free and unscented?

Fragrance-free means nothing was added to give the product a scent, including essential oils and masking fragrance. Unscented only means the product has no noticeable smell, and it may contain a small masking fragrance, which the FDA itself warns consumers about.

Do essential oils count as fragrance?

Yes. An essential oil added for its smell is a fragrance ingredient, and the EU claims guidance says "free from perfume" should not be used when any ingredient has a perfuming function. Essential oils also contain allergens such as linalool and limonene that must be labeled above the EU and Canadian thresholds.

When do the new EU fragrance allergen labels apply?

Under Regulation (EU) 2023/1545, products placed on the EU market from 31 July 2026 must name the expanded list of more than 80 allergens when they exceed 0.001% in leave-on or 0.01% in rinse-off products. Products placed on the market before that date can stay on the market until 31 July 2028.

Does the US require fragrance allergens on the label?

Not yet, as of October 2026. MoCRA requires the FDA to make a fragrance allergen labeling rule, and its regulatory agenda targets a proposed rule in November 2026, so check the FDA's MoCRA pages before you print a new US label.

Can I call my product hypoallergenic?

In the US the term has no legal definition, but advertising claims still need evidence. In the EU it needs a formula designed to minimize allergenic potential, no known sensitizers and solid data such as an HRIPT on enough volunteers; KoreanOEM's 100-person HRIPT (USD 5,500) is the test usually used for this claim.

Which skincare ingredients are usually avoided during pregnancy?

Prescription retinoids and hydroquinone are the clearest; many brands also leave out cosmetic retinol and retinal, high-strength salicylic acid and essential oils because data are limited. Customers should always ask their doctor, and this is planning information, not medical advice.

Is it legal to label a product pregnancy safe?

There is no legal definition, so the claim falls under the general rules: in the EU it needs evidential support under Regulation 655/2013 and a safety assessment that covers pregnant users, and in the US the FTC requires competent and reliable evidence. Most careful brands list what the product is formulated without and add "ask your doctor" instead.

Is retinol safe in pregnancy?

Sources differ: one medical review advises not encouraging topical retinoids during pregnancy until more data exist, while an Australian hospital service says cosmetic vitamin A is minimally absorbed. Because of that uncertainty, most pregnancy-focused skincare lines leave retinoids out.

Sources

Checked against these sources in October 2026. Rules and fees change; check with the authority or your importer before you sell.