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Reformulating skincare for the US and EU: one global formula or two versions

Why a product that sells legally in one market can be illegal in the other, what to check ingredient by ingredient, how to decide between one global formula and market versions, and how the labels differ.

Not legal adviceThis guide summarizes US and EU rules as of October 2026. Ingredient lists change several times a year; confirm every ingredient with your EU safety assessor, your US regulatory adviser or the authority before you sell.

Short answer

The EU regulates cosmetics with lists: more than a thousand banned substances (Annex II), restricted substances with maximum levels and warnings (Annex III), and positive lists of the only colorants, preservatives and UV filters allowed (Annexes IV, V and VI), updated several times a year, most recently by CMR "omnibus" acts in 2025 and 2026, plus the microplastics restriction and the expanded fragrance allergen labels. The US has almost no ingredient lists for cosmetics, but it treats sunscreens, acne, dandruff and many other claims as over-the-counter drugs with fixed active ingredients, requires approved color additives, and adds California Prop 65 warnings and state ingredient bans. Most brands that sell in both build one global formula that meets the EU lists and US state bans and avoids drug claims, and only split into market versions when the product is a US drug (such as sunscreen) or needs an ingredient one market forbids.

Why the two systems clash

The EU Cosmetics Regulation (Regulation (EC) No 1223/2009) controls ingredients before sale through annexes, and every product needs a safety report signed by a qualified assessor, a Responsible Person in the EU and a CPNP notification. The US Federal Food, Drug, and Cosmetic Act, updated by MoCRA in 2022, controls cosmetics mostly after sale: the brand must have safety substantiation, register facilities and list products, but there are few ingredient lists. Instead, the US draws a sharp line between cosmetics and drugs based on claims. So the failure points are different in each direction.

Background on each market: EU cosmetics regulation, US MoCRA compliance and cosmetic vs drug claims.

US formula into the EU: what fails

Check a US formula against each EU annex and recent act:

Annex II, prohibited substances
Well over a thousand entries, including substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR). Examples that catch US formulas: hydroquinone in skin care (it is no longer allowed in US over-the-counter skin lighteners either), zinc pyrithione (a US anti-dandruff drug active, banned in EU cosmetics since 2022) and some botanicals and fragrance materials.
Recent CMR omnibus acts
The 7th omnibus act (Regulation (EU) 2025/877) moved 22 substances, including TPO used in nail gels, into Annex II from 1 September 2025 with no sell-through. The 8th (Regulation (EU) 2026/78) added 18 substances to the prohibited or restricted lists from 1 May 2026, again with no difference between placing and making available, so non-compliant stock had to leave shelves by that date. Expect another act each year.
Annex III, restricted substances
Maximum levels, product types and mandatory warnings. Examples: retinol and its esters (Regulation (EU) 2024/996: 0.05% retinol equivalent in body lotions and 0.3% in other products, with "Contains Vitamin A. Consider your daily intake before use." on the label; new products from 1 November 2025, existing stock until 1 May 2027); alpha-arbutin and kojic acid limits from the same act; salicylic acid limits (3% rinse-off hair, 2% most other products, 0.5% in body lotion and some others, not for children under 3).
Annex IV, colorants
Only listed colorants may be used, with purity criteria and some product limits. A US FD&C color is not automatically allowed; check its CI number on the EU list.
Annex V, preservatives
Only listed preservatives, at the listed maximum. Methylisothiazolinone is allowed only in rinse-off products at up to 0.0015%. See shelf life and preservatives.
Annex VI, UV filters
Only listed filters. US sunscreen filters such as avobenzone, homosalate and octocrylene are on the EU list but with their own limits, so a US sunscreen formula needs checking filter by filter.
Microplastics
The EU restriction on intentionally added synthetic polymer microparticles (Regulation (EU) 2023/2055) applies to cosmetics after transition periods: from October 2027 for rinse-off and from October 2029 for leave-on products (later for make-up, lip and nail products). Some film formers, thickeners and glitters in US formulas may be in scope; ask your raw material suppliers for a microplastics statement.
Fragrance allergens
More than 80 allergens must be named on the label above 0.001% (leave-on) or 0.01% (rinse-off) for products placed on the market from 31 July 2026 (Regulation (EU) 2023/1545). A US label that says only "Fragrance" is not enough. See fragrance allergens.
Nanomaterials and animal testing
Nanomaterials other than listed colorants, preservatives and UV filters must be notified six months before the product is placed on the market. The EU bans animal testing of cosmetics and their ingredients for cosmetic purposes, and the marketing of products tested on animals for that purpose.

EU formula into the US: what fails

An EU formula usually has no banned ingredients in the US, but it can still fail on claims, colors and state law:

Drug claims and actives
In the US a product is a drug if it is intended to treat or prevent disease or to affect the structure or function of the body. Sunscreens, acne products, anti-dandruff shampoos, antiperspirants and skin lighteners are over-the-counter (OTC) drugs that must use the actives and levels in the FDA monographs, a Drug Facts label, drug registration and drug GMP. Example: an EU "anti-blemish serum with 2% salicylic acid" becomes a US acne drug (salicylic acid 0.5% to 2% is the monograph range) if it claims to treat acne.
Sunscreen filters
The US list of sunscreen actives is much shorter than the EU's. Bemotrizinol was added to the US monograph in 2026 (final order June 2026, up to 6%); many other modern filters common in Korean and EU sunscreens are still not permitted. An EU or Korean SPF formula usually needs a new US version. See sunscreen regulation and why Korean sunscreen is not sold in the US.
Color additives
Color additives in US cosmetics must be approved by the FDA for that use, and some need batch certification. A colorant allowed in the EU may not be approved in the US, and approved uses (for example around the eyes) differ.
California Prop 65
California requires a clear warning when a product exposes people to a listed chemical (about 900 chemicals) above safe harbor levels. It is a warning law, not a ban, but it affects impurities and raw materials, for example some plant extracts, and retailers often ask suppliers for Prop 65 statements.
State ingredient bans
California's Toxic-Free Cosmetics Act banned a list of intentionally added ingredients (including formaldehyde, mercury compounds and several PFAS) from 1 January 2025, and AB 496 adds 26 more from 1 January 2027. Washington, Maryland, Oregon, Vermont and others have their own lists and dates, and many states ban intentionally added PFAS. See Prop 65 and state bans.
MoCRA duties
Facility registration, product listing (with ingredients), adverse event reporting and safety substantiation records apply to every cosmetic sold in the US. Fragrance allergen labeling under MoCRA is still waiting for an FDA rule as of October 2026.

US and EU side by side

Topic	EU	US
Main law	Regulation (EC) No 1223/2009	FD&C Act as amended by MoCRA (2022)
Before sale	Safety report (CPSR), product information file, Responsible Person in the EU, CPNP notification	Facility registration, product listing, safety substantiation; drugs need monograph compliance or approval
Banned ingredients	Annex II, well over a thousand entries, updated yearly	A short federal list plus state bans
Restricted ingredients	Annex III with limits and warnings	Few federal limits; state laws
Preservatives	Positive list, Annex V	No positive list
Colorants	Positive list, Annex IV	FDA-approved color additives, some batch certified
Sunscreen	Cosmetic; filters from Annex VI	OTC drug; monograph filters only; Drug Facts
Acne, dandruff, antiperspirant claims	Usually cosmetic if the product is a cosmetic by function and presentation	OTC drugs
Fragrance allergens	More than 80 named on label (new products from 31 July 2026)	"Fragrance" allowed until the FDA rule
Microplastics	Restricted from October 2027 (rinse-off) and October 2029 (leave-on)	Microbeads in rinse-off products banned since the Microbead-Free Waters Act of 2015
Animal testing	Banned for cosmetics and ingredients	Not banned federally; several states ban it
Warnings	Annex warnings in the local language	Required warnings (for example aerosols), Prop 65 in California

One global formula or market versions

One formula for every market is simpler to manage: one stability file, one safety report, one production run, fewer label versions and less risk of shipping the wrong stock. Split only when you must.

Situation	Usual choice
Serum, toner, cream or cleanser with no drug claims	One global formula built to the EU annexes and the strictest US state bans
Retinol product above 0.3% retinol equivalent for the US	Two versions, or one at the EU limit for both markets
Sunscreen or SPF moisturizer	Two versions: an EU or Korean filter system and a US monograph version with Drug Facts
Acne treatment with salicylic acid or benzoyl peroxide	A US OTC drug version; an EU cosmetic version with cosmetic claims only (benzoyl peroxide acne products are medicines in the EU, not cosmetics)
Fragrance with many allergens	One formula; label lists allergens for the EU (and for Canada)
Product with a strong US "natural" or "free from" story	One formula; adjust claims per market (EU guidance limits some free-from claims)

ExampleA brand sells a 50 mL "retinol night cream" with 0.5% retinol in the US. For the EU it must fall to 0.3% retinol equivalent and carry the vitamin A warning. The brand compares two options: run a separate EU batch (two stability files, two labels, smaller runs) or move both markets to 0.3% with an encapsulated retinol and a peptide boost. It picks one formula at 0.3%, tests customer response with a sample run, and keeps one production line. See retinol vs retinal for the alternatives.

Step-by-step reformulation process

List your target markets and channels
EU countries, the UK, the US (and which states matter most), Canada and others. Each adds rules; Canada's Cosmetic Ingredient Hotlist and Korea's own lists are close to the EU in many cases but not identical.
Get the full formula with percentages and raw material data
Your manufacturer screens the formula; you need the INCI list, the raw material specifications and allergen, impurity and microplastics statements from suppliers.
Screen every ingredient
EU Annexes II to VI (current consolidated text and CosIng), recent omnibus acts, US federal restrictions and color rules, state bans and Prop 65 list, and other markets' lists. Mark each ingredient as allowed, limited (with level) or banned per market.
Screen the claims
Any claim that makes the product a US drug, any EU free-from claim, and anything you plan for the label and listing. See what you can claim.
Decide: one formula or versions
Use the table above. Choose the replacement ingredients for anything banned or over a limit.
Make and compare samples
Compare the reformulated sample with the original for texture, scent, color, pH and performance. Expect 1 to 3 revision rounds.
Run stability, compatibility and a challenge test
Any formula change, especially a new preservative or emulsifier, needs new stability data and usually a new challenge test. See stability and compatibility testing.
Update the regulatory files
New or updated CPSR and PIF, CPNP notification, MoCRA listing, Canadian notification and other filings.
Write market labels and check them
Use the differences below; get each label checked before print. See label proof check.
Track changes after launch
Subscribe to the EU authority newsletters (for example Ireland's HPRA) and US state law updates; plan one review of every live formula each year.

Label differences

Label item	EU	US cosmetic
Name and address	Responsible Person in the EU	Manufacturer, packer or distributor ("Distributed by"), plus a domestic contact for adverse event reports under MoCRA
Ingredients	INCI names, descending order, allergens named, nanomaterials marked "(nano)"	Descending order using FDA-recognized names; "Fragrance" allowed
Net content	Metric (mL or g)	US customary units and metric (fl oz and mL, oz and g)
Date	Best-before (30 months or less) or PAO	Not required for cosmetics; expiration date for OTC drugs
Batch	Required	Practical necessity for traceability
Function and directions	Function unless clear from presentation; precautions in the local language	Directions for safe use; required warnings
Language	Language of each member state where sold	English (other languages may be added)
Origin	Country of origin for imported products	Country of origin marking required by customs ("Made in Korea")

Full detail is in cosmetic label requirements by country.

Common mistakes

Assuming a product that sells on Amazon US is automatically legal in the EU.
Checking only Annex II and forgetting the restriction levels, warnings and positive lists in Annexes III to VI.
Missing a recent omnibus act; since 2025 these acts allow no sell-through for banned substances.
Using EU-style "anti-acne" or "treats dandruff" claims on a US cosmetic, which makes it an unapproved drug.
Selling one sunscreen formula in both markets; US sunscreens need monograph filters and a Drug Facts label.
Forgetting state laws: a product legal federally can be banned in California or Washington.
Changing the preservative or emulsifier to fit a market without new stability data and a challenge test.
Keeping two versions without clear batch and label control, then shipping the US version to the EU.

Checklist

I listed every target market and the states that matter in the US.
I have the full formula and supplier statements (allergens, impurities, microplastics).
Every ingredient is screened against EU Annexes II to VI and the latest omnibus acts.
Every ingredient is screened against US color rules, state bans and the Prop 65 list.
No US label or listing makes a drug claim for a cosmetic.
I decided: one global formula, or separate versions, and why.
Reformulated samples were compared with the original and approved.
New stability data and a challenge test cover any formula change.
CPSR, PIF, CPNP, MoCRA listing and other filings match the formula sold in each market.
Each market's label was checked before print.
I review every live formula against rule changes at least once a year.

How KoreanOEM helps

KoreanOEM is a Korean skincare OEM and private label manufacturer: our formulation chemists in Busan develop your formula, and we produce it in Korea. Tell us every market you plan to sell in, and the lab builds the formula for all of them from the start.

Formulas for several markets. 160+ ready library formulas in our formula library; an adjusted library formula (USD 399 per SKU, from 1,000 units) to change an ingredient for a market; a fully custom formula (USD 399 per SKU, from 2,000 units). First lab samples and 3 revision rounds included, fee credited against your first production order.
Remake a product you already sell so it meets EU and US rules: match an existing product for USD 199 per SKU.
EU and UK files through our partner: CPSR and PIF USD 1,250 per formula (UK notification included), CPNP notification USD 420 per product, Responsible Person USD 240 per product per year (UK) or USD 335 (UK and EU).
US: MoCRA product listing filed by our team for USD 150 per SKU; our production facility is FDA registered. US sunscreen is an OTC drug and is quoted case by case.
Canada: CNF filed for about USD 450 per product. A label proof check for each market before print.

Get a free quote Order a sample box

Frequently asked questions

Can I sell the same skincare formula in the US and the EU?

Often yes, if the formula meets the EU annexes and US state bans and makes no claims that turn it into a US drug. Sunscreens, acne treatments and products with ingredients over an EU limit usually need separate versions.

Why are some US cosmetics illegal in the EU?

The EU bans or restricts ingredients through Annexes II and III and only allows colorants, preservatives and UV filters from positive lists in Annexes IV to VI. A US formula can contain a substance that is banned, over an EU limit, missing a required warning, or not on a positive list.

Is sunscreen a cosmetic or a drug?

In the EU sunscreen is a cosmetic with filters from Annex VI. In the US it is an over-the-counter drug that must use FDA monograph filters, a Drug Facts label and drug manufacturing rules, which is why most Korean and EU sunscreens need a separate US version.

What is the EU limit for retinol?

Under Regulation (EU) 2024/996, 0.05% retinol equivalent in body lotions and 0.3% in other products, with the label warning "Contains Vitamin A. Consider your daily intake before use." New products had to comply from 1 November 2025, and existing stock may be sold until 1 May 2027.

Which ingredients did the EU ban recently?

The 7th CMR omnibus act banned 22 substances, including TPO, from 1 September 2025, and the 8th (Regulation (EU) 2026/78) added 18 substances to the prohibited or restricted lists from 1 May 2026, both without a sell-through period. Check the consolidated Annexes before every new production run.

Does Prop 65 ban ingredients?

No. California Prop 65 requires a clear warning when a product exposes people to a listed chemical above safe harbor levels. Ingredient bans come from separate state laws such as California's Toxic-Free Cosmetics Act.

How long does reformulating a product for a new market take?

Lab samples take about 2 to 4 weeks at KoreanOEM, then 10 to 14 days per revision round, followed by stability checks and updated regulatory files. A simple ingredient swap can be ready in a few months; a new sunscreen version for the US takes much longer because it is a drug.

Sources

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