Under Article 19 of Regulation (EC) No 1223/2009, an EU label must show the name and address of the Responsible Person within the EU, the country of origin of imported products, the nominal content, the date of minimum durability or the period after opening (PAO), the precautions for use, the batch number, the function of the product and the list of ingredients. Under 21 CFR Parts 701 and 740 and MoCRA, a US label must be in English and show the product name, the net quantity of contents in both metric and inch/pound units, the name and place of business of the manufacturer, packer or distributor, the ingredient list, mandatory warnings, and a domestic address, domestic phone number or electronic contact information (such as a website) through which adverse event reports can be received. Ingredient names are largely the same in both markets (most derive from INCI nomenclature), but the US requires English common names: water must be declared as "Water", botanical ingredients need an English common name, and colorants must use US color additive names. EU terms such as "Aqua" and "Parfum", Latin botanical names and CI numbers may appear only in parentheses, as a supplement. Shelf life, batch number and fragrance allergens are mandatory only in the EU. Country of origin is a cosmetic label particular in the EU; in the US it falls under the customs rules on country-of-origin marking (19 U.S.C. 1304, 19 CFR Part 134). Both markets require it. One artwork can therefore usually serve both markets, provided it combines the mandatory particulars of each.
What each set of rules covers
In the EU, the core of cosmetic labelling is Article 19 (Labelling) of Regulation (EC) No 1223/2009. For fragrance allergens, Regulation (EU) 2023/1545 expanded Annex III.
In the US, cosmetic labelling requirements sit in three places:
- 21 CFR Part 701 (Cosmetic Labeling), issued under the FD&C Act (Federal Food, Drug, and Cosmetic Act) and the FPLA (Fair Packaging and Labeling Act);
- 21 CFR Part 740 (Cosmetic Product Warning Statements);
- MoCRA (Modernization of Cosmetics Regulation Act of 2022), which added the labeling requirements of FD&C Act § 609 (21 U.S.C. 364e).
This guide compares only what is printed on the label. Duties such as the Responsible Person's qualifications, notification and registration never appear on the pack. They are covered in a separate section below.
EU and US cosmetic labels compared, element by element
The last column answers the question brands ask most often: can one artwork serve both markets?
One artwork for both?
- Responsible person
- Country of origin
- Net quantity of contents
- Shelf life
- Batch number
- Fragrance allergens
- Professional-use statement
Function
The local EU language is a separate matter
Ingredient list
The wording needs adjusting
Precautions and warnings
Print each market’s prescribed wording in full; one does not replace the other
Language
Adding French or German claims to the US version triggers the full foreign-language requirement of 701.2(b)(2)
| Element | EU | US | Provision | One artwork for both? |
|---|---|---|---|---|
| Responsible person | Name or registered name and address of the Responsible Person, who must be established in the EU. May be abbreviated, provided the person and address can still be identified. Where several addresses are given, the one where the product information file (PIF) is readily available must be highlighted | Name and place of business (street address, city, state, ZIP code) of the manufacturer, packer or distributor; a firm that is not the manufacturer must add a phrase such as "Manufactured for" or "Distributed by". The label must also give a domestic address, domestic phone number or electronic contact information (which may be a website) through which the responsible person can receive adverse event reports | EU: Article 19(1)(a), Article 4(1) of Regulation (EC) No 1223/2009; US: 21 CFR 701.12; FD&C Act § 609(a) (21 U.S.C. 364e(a)) | Yes. Show both the EU Responsible Person's address and the US distributor's details, and add a website or US phone number for adverse event reports |
| Country of origin | Imported cosmetics must state the country of origin | Not required by 21 CFR 701; origin marking of imported goods is a US customs requirement (19 U.S.C. 1304, 19 CFR Part 134), which RegaaS reports as out of scope | EU: Article 19(1)(a); US: 19 U.S.C. 1304, 19 CFR 134.11 | Yes. One line, "Made in Taiwan", is enough |
| Net quantity of contents | Nominal content at the time of packaging, by weight or by volume; not required for packs under 5 g or 5 ml, free samples or single-application packs | In the bottom 30% of the principal display panel (PDP) (this placement requirement does not apply where the PDP is 5 square inches or less); fluid measure for liquids, weight for solids and semisolids; both inch/pound and SI metric units are required; type height depends on PDP area (minimum 1/16 inch) | EU: Article 19(1)(b); Directive 80/181/EEC Article 3; US: 21 CFR 701.13(a), (f), (i), (j); FPLA § 4(a)(2) (15 U.S.C. 1453(a)(2)) | Yes. Declare "50 mL (1.69 fl. oz.)" on the lower part of the front. The EU allows inch/pound units as supplementary indications, provided the metric unit predominates and the inch/pound characters are no larger than the metric ones; US rules set no order for the two units |
| Shelf life | Minimum durability of 30 months or less: the date of minimum durability (month and year, or day, month and year), preceded by the hourglass symbol (Annex VII, point 3) or the words "best used before the end of". More than 30 months: the open-jar symbol (Annex VII, point 2) followed by the period in months or years (PAO), unless the concept is not relevant | No general requirement. FDA states that current US regulations do not require an expiration date on cosmetic labels | EU: Article 19(1)(c), Annex VII; US: FDA "Cosmetics Labeling" page | Yes. The EU date or PAO symbol does not breach US rules |
| Batch number | The batch number of manufacture or the reference identifying the product; if the container is too small, it may appear on the packaging alone | Neither 21 CFR 701 nor 740 requires a batch number | EU: Article 19(1)(e) | Yes. Keeping the batch number also helps with recalls and adverse event tracing in the US |
| Function | The function of the product, unless it is clear from the presentation | No "function" particular, but the PDP must show the product name in bold type (statement of identity), which may be a common name, a descriptive name or an illustration | EU: Article 19(1)(f); US: 21 CFR 701.11 | Mostly. An English product name such as "Hydrating Face Cream" also states the function; the local EU language is a separate matter (see the "Language" row) |
| Precautions and warnings | At least the text required in the "Conditions of use and warnings" column of Annexes III to VI, and any special precautionary information for professional-use products. Where space is insufficient, it may go on an enclosed leaflet, with the "hand and book" symbol (Annex VII, point 1) on the pack | A warning is required wherever necessary or appropriate to prevent a health hazard the product may present. Specific products have prescribed wording: aerosol containers (740.11), feminine deodorant sprays (740.12), foaming detergent bath products (740.17) and suntanning preparations without sunscreen (740.19). A product whose safety has not been adequately substantiated must carry "Warning—The safety of this product has not been determined." on the PDP (740.10). Warnings must be prominent and conspicuous, in bold type, at least 1/16 inch high | EU: Article 19(1)(d), Article 19(2), Annexes III–VI; US: 21 CFR 740.1, 740.2, 740.10–740.19 | Combine. Print each market's prescribed wording in full; one does not replace the other |
| Ingredient list | Headed "Ingredients", using the names in the common ingredient names glossary (i.e. INCI names); in descending order of weight at the time of addition; ingredients below 1% may follow those above 1% in any order; colorants other than hair dyes may be listed last, in any order, using CI numbers; multi-shade products may use "may contain" or "+/-"; perfume as "parfum" or "aroma"; nanomaterials followed by "(nano)". May appear on the packaging alone | In descending order of predominance; ingredients at or below 1% may follow in any order; color additives may be listed last, in any order; fragrance may be declared as "fragrance" and flavor as "flavor"; ingredients FDA has accepted as trade secrets may be declared as "and other ingredients"; names follow 701.30, then the CTFA Cosmetic Ingredient Dictionary and the other listed sources, in that order; FDA does not accept "Aqua", "Parfum", Latin botanical names or CI numbers in place of the English common name, and these may appear only in parentheses after the English name; letters at least 1/16 inch high (1/32 inch where less than 12 square inches of surface area is available to bear labeling); shaded products may use "may contain" | EU: Article 19(1)(g), Article 19(6), Article 33; US: 21 CFR 701.3(a), (b), (c), (f), (g), (p); 21 CFR 720.8; FDA "Cosmetic Ingredient Names" page | Mostly, but the wording needs adjusting. For fragrance, "Fragrance (Parfum)" is suggested (FDA's own example), keeping the "parfum" the EU requires. For colorants, give the US color additive name first and the CI number after it in parentheses, for example "FD&C Yellow No. 5 (CI 19140)". Check with the Responsible Person whether the EU accepts these combined forms. Keeping "(nano)" on the US version does not breach US rules |
| Fragrance allergens | Allergens listed in the "Other" column of Annex III must be named individually in the ingredient list when they exceed 0.001% in leave-on products or 0.01% in rinse-off products. Regulation (EU) 2023/1545 expanded the list: non-compliant products could be placed on the market only until 31 July 2026 (that date has passed), and those already placed may be made available until 31 July 2028. The exception is Annex III entry 70, which Regulation (EU) 2026/909 rewrote: non-compliant Citral products may not be placed on the market from 1 January 2027 or made available from 1 July 2028; for Geranial and Neral, the dates are 1 January 2027 and 1 August 2028. The labelling threshold for "Citral" is unchanged | MoCRA requires fragrance allergens to be disclosed on the label, but which substances count as allergens is for FDA to set by regulation (FDA may also set disclosure thresholds). As of October 2026, no proposed rule has been published in the Federal Register (RIN 0910-AI90; the Unified Agenda gives a planned date of November 2026 for the proposed rule). There is currently no enforceable labelling obligation | EU: Article 19(1)(g), Annex III (as amended by Regulation (EU) 2023/1545 and 2026/909); US: FD&C Act § 609(b) (21 U.S.C. 364e(b)) | Yes. Allergens listed under EU rules are ingredients in their own right; listing them on the US label does not breach US rules |
| Professional-use statement | Professional-use products must carry special precautionary information | A product intended to be used only by professionals must bear a clear and prominent statement that the product shall be administered or used only by licensed professionals. A "professional" is an individual licensed by an official State authority to practice cosmetology, nail care, barbering or esthetics. The other label requirements (product name, name and address of the firm, net quantity of contents) still apply under 15 U.S.C. 1453(a); FDA notes that products intended only for professional use are not subject to the FPLA ingredient labelling requirement | EU: Article 19(1)(d); US: FD&C Act § 609(c) (21 U.S.C. 364e(c)) | Yes. For example, "For use only by licensed professionals", plus the precautionary information the EU requires |
| Language | The language of particulars such as function, content, durability and precautions is set by the law of the Member State where the product is sold. RegaaS does not cover Member State language rules and reports them as out of scope | All mandatory label statements must be in English (except in territories where another language is predominant, such as Puerto Rico); if any representation on the label appears in a foreign language, all mandatory statements must also appear in that language | EU: Article 19(5); US: 21 CFR 701.2(b) | Take care. Adding French or German claims to the US version triggers the full foreign-language requirement of 701.2(b)(2) |
Fragrance allergens
Named individually in the ingredient list above 0.001% in leave-on products or 0.01% in rinse-off products
16 Aug 2023
Regulation (EU) 2023/1545 entered into force
31 Jul 2026
Non-compliant products could be placed on the market only until this date (that date has passed)
1 Aug 2026
Every product newly placed on the EU market must label allergens according to the new list
31 Jul 2028
Non-compliant products placed on the market before 31 July 2026 may be made available until this date
Exception: Annex III entry 70, rewritten by Regulation (EU) 2026/909
The labelling threshold for “Citral” is unchanged.
1 Jan 2027
Non-compliant products may not be placed on the market from this date
1 Jul 2028
Citral: may not be made available from this date
1 Aug 2028
Geranial and Neral: may not be made available from this date
There is currently no enforceable labelling obligation
MoCRA
Requires fragrance allergens to be disclosed on the label; which substances count as allergens is for FDA to set by regulation (FDA may also set disclosure thresholds)
As of October 2026
No proposed rule has been published in the Federal Register (RIN 0910-AI90)
November 2026
Planned date for the proposed rule in the Unified Agenda
Three things the table shows
First, the US version cannot show only the EU Responsible Person. A Dutch or German address for the EU Responsible Person is not the "domestic" address MoCRA requires. Without a US distributor, the simplest option is a website or US phone number that can receive adverse event reports.
Second, EU-only particulars are usually safe on the US version. US rules prohibit none of the batch number, the PAO symbol and "(nano)", and US customs already requires the country of origin. CI numbers are the exception: the US does not accept a colorant identified only by its CI number, so give the US color additive name first and the CI number after it in parentheses. The other way round, the US-only fl. oz. inch/pound quantity may also appear on the EU version. Article 3 of Directive 80/181/EEC allows inch/pound units as supplementary indications, provided the metric unit predominates and the inch/pound characters are no larger than the metric ones. Hence "50 mL (1.69 fl. oz.)". This falls under EU units-of-measurement law, outside the scope of Regulation (EC) No 1223/2009 and of RegaaS checks.
Third, what really needs separate versions is usually language and warnings. In the US, 701.2(b)(2) makes multilingual artwork risky, and the prescribed US warnings for aerosol containers and foaming bath products must be printed word for word.
Ingredient lists: the finer differences
The two ingredient lists look alike, but four points tend to be raised in review.
The 1% boundary differs. The EU text lets ingredients "less than 1%" be listed in any order; the US text says "not exceeding 1%". An ingredient at exactly 1% may go into the any-order group in the US. The EU gives no clear latitude, so listing it in descending order of weight is the safer choice.
Fragrance is declared differently. The EU prescribes "parfum" or "aroma". The US allows "fragrance" or "flavor", and mandatory labelling must be in English. FDA requires foreign-language names to appear only in parentheses after the English name; FDA's own example is "Fragrance (Parfum)". For shared artwork, "Fragrance (Parfum)" is suggested, keeping the "parfum" the EU requires. The EU text does not say whether it accepts this combined form, so check with the Responsible Person.
Trade secrets. In the US, "and other ingredients" may replace ingredients FDA has accepted as confidential (21 CFR 701.3(a), 720.8). Article 19 of Regulation (EC) No 1223/2009 has no equivalent, so the EU version must list every ingredient.
Nanomaterials and colorants. The EU requires "(nano)" after nanomaterial ingredients, and CI numbers for colorants. Keeping "(nano)" on the US version does not breach US rules. But the US does not accept a colorant identified only by its CI number: give the US color additive name first (for example FD&C Yellow No. 5 or Yellow 5), and the CI number may follow in parentheses, for example "FD&C Yellow No. 5 (CI 19140)".
Ingredient lists: the finer differences
The 1% boundary
EU
Ingredients “less than 1%” may be listed in any order
US
“not exceeding 1%”: an ingredient at exactly 1% may go into the any-order group
For shared artwork
The EU gives no clear latitude, so listing it in descending order of weight is the safer choice
Fragrance
EU
“parfum” or “aroma”
US
“fragrance” or “flavor”; foreign-language names only in parentheses after the English name
For shared artwork
“Fragrance (Parfum)” is suggested (FDA’s own example). Check with the Responsible Person whether the EU accepts this combined form
Trade secrets
EU
No equivalent, so the EU version must list every ingredient
US
“and other ingredients” may replace ingredients FDA has accepted as confidential
Nanomaterials
EU
“(nano)” after nanomaterial ingredients
For shared artwork
Keeping “(nano)” on the US version does not breach US rules
Colorants
EU
CI numbers
US
The US color additive name first (for example FD&C Yellow No. 5 or Yellow 5); a colorant identified only by its CI number is not accepted
For shared artwork
“FD&C Yellow No. 5 (CI 19140)”
Obligations not printed on the label
The following obligations never appear on the pack, so artwork cannot show whether they have been met. RegaaS returns them as a checklist for the responsible person to confirm, not as label findings.
| Market | Obligation | In one sentence | Provision |
|---|---|---|---|
| EU | Responsible Person (RP) | Each product must have a designated Responsible Person within the EU, who ensures that it complies | Article 4, Article 5 of Regulation (EC) No 1223/2009 |
| EU | PIF (product information file) | The Responsible Person must keep the product information file at the address on the label, for 10 years after the last batch was placed on the market | Article 11 |
| EU | CPSR (cosmetic product safety report) | Before the product is placed on the market, a qualified safety assessor must complete a safety assessment, and a safety report must be drawn up in line with Annex I | Article 10, Annex I |
| EU | CPNP notification | Before the product is placed on the market, the Responsible Person must notify the product information to the Commission by electronic means | Article 13 |
| US | Facility registration | Facilities that manufacture or process cosmetics for sale in the US must register with FDA and renew every two years | FD&C Act § 607(a) (21 U.S.C. 364c(a)) |
| US | Product listing | The responsible person must submit a listing to FDA for each product, including its ingredients, and update it every year | FD&C Act § 607(c) (21 U.S.C. 364c(c)) |
| US | Safety substantiation | The responsible person must ensure that each product's safety is adequately substantiated, and keep the related records | FD&C Act § 608 (21 U.S.C. 364d) |
MoCRA also requires serious adverse events to be reported to FDA within 15 business days (FD&C Act § 605), and provides for GMP rules that FDA has yet to issue (§ 606). RegaaS returns these as checklist items too. The small business exemption (§ 612: average gross annual US sales below USD 1,000,000 over the previous three years, adjusted for inflation) exempts only from § 606 and § 607. It does not exempt anyone from the label requirements, adverse event reporting or safety substantiation. It does not apply to products that regularly come into contact with the mucus membrane of the eye, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours.
Common mistakes
These are common mistakes on dual-market cosmetic labels. Each one maps to a provision in the table above.
How RegaaS checks this
RegaaS applies the rules for the product category and the markets where it is sold. Every finding cites its provision, is marked on the label image and comes with suggested replacement text.
- EU: RegaaS applies Regulation (EC) No 1223/2009. It checks the mandatory particulars on container and packaging, the alternatives where space is insufficient, the prohibited and restricted substances, colorants, preservatives and UV filters of the annexes, the order and terms of the ingredient list, "(nano)" labelling, and fragrance allergen labelling as expanded in 2023. The Responsible Person, PIF, CPSR and CPNP notification are returned as a checklist.
- US: RegaaS applies the FPLA and 21 CFR Parts 701 and 740. It checks the product name, net quantity of contents, the responsible firm's name and place of business, the ingredient list and ingredient names, and mandatory warnings. Under MoCRA, it checks the adverse-event contact and the professional-use statement. Fragrance allergen labelling still awaits an FDA rule, so it is raised as a watch item, not as a finding. Facility registration, product listing, safety substantiation, GMP and adverse event reporting are returned as a checklist.
Every rule applied gets one of four results: Compliant, Needs review, Potential risk or Not applicable. Where the information provided is not enough to decide, or the case is borderline, RegaaS marks the rule Needs review and refers it to regulatory staff instead of reaching a conclusion. Each Potential risk shows where the issue is on the label, the provision and the version in force, and a suggested revision. Whether a finding stands, and what to do about it, is decided by regulatory staff. When a provision is amended, RegaaS identifies the products already reviewed against it so they can be checked again.
What this guide does not cover
- Member State language requirements. Article 19(5) leaves language to each Member State. RegaaS does not cover this and reports it as out of scope.
- US sunscreen (SPF) products. In the US, sunscreens are OTC (over-the-counter) drugs, and a cosmetic that makes sunscreen claims generally becomes a drug as well. These are outside RegaaS coverage. The EU version of the same product is still a cosmetic, and the Annex VI rules on UV filters are within the RegaaS EU checks.
- Great Britain. Since EU exit, Great Britain has had its own cosmetics regime, which RegaaS reports as out of scope; Northern Ireland continues to apply EU rules. Switzerland is also out of scope.
- US import country-of-origin marking (19 CFR Part 134), weights and measures rules beyond FDA's net quantity rules, FTC advertising substantiation, and state laws such as California Proposition 65.
- This guide is not legal advice. A RegaaS report is a documented review against the provisions above. It does not replace sign-off by a qualified regulatory professional, nor, in the EU, sign-off by the Responsible Person or the safety assessor.
Frequently asked questions
Can one pack be sold in both the EU and the US? In most cases, yes, provided it combines the mandatory particulars of both markets. Language needs particular care: once any foreign-language representation appears on the US version, all mandatory statements must also appear in that language (21 CFR 701.2(b)(2)).
Must US cosmetics show a shelf life or batch number? No. FDA states that current US regulations do not require an expiration date on cosmetic labels, and 21 CFR 701 and 740 contain no batch number requirement. The EU requires both, under Article 19(1)(c) and (e).
Can the EU Responsible Person's address serve as the MoCRA contact? No. FD&C Act § 609(a) requires a domestic address, a domestic phone number or electronic contact information (which may be a website). Without a US presence, a website is the simplest option.
When will the US require fragrance allergens on the label? There is no firm date yet. MoCRA requires FDA to decide by regulation which substances are fragrance allergens (FDA may also set disclosure thresholds), but as of October 2026 no proposed rule has been published in the Federal Register.
When do the new EU fragrance allergen rules apply? Regulation (EU) 2023/1545 entered into force on 16 August 2023. From 1 August 2026, every product newly placed on the EU market must label allergens according to the new list. Non-compliant products placed on the market before 31 July 2026 may continue to be made available until 31 July 2028. The thresholds are 0.001% for leave-on products and 0.01% for rinse-off products. The exception is Citral, Geranial and Neral (Annex III entry 70, rewritten by Regulation (EU) 2026/909): non-compliant products may not be placed on the market from 1 January 2027, and may not be made available from 1 July 2028 for Citral or from 1 August 2028 for Geranial and Neral. The labelling thresholds for "Citral" are also 0.001% and 0.01%.
Do the CPNP notification number or the PIF go on the label? No. The PIF, CPSR and CPNP notification never appear on the pack. RegaaS returns them as a checklist for the Responsible Person to confirm.
Primary sources
- Regulation (EC) No 1223/2009 on cosmetic products (EUR-Lex)
- Regulation (EC) No 1223/2009 consolidated text, 18 May 2026 version (CELEX 02009R1223-20260518) (EUR-Lex)
- Commission Regulation (EU) 2023/1545, labelling of fragrance allergens (EUR-Lex)
- Regulation (EU) 2026/909, amending Annex III entry 70 (Citral) (EUR-Lex)
- Directive 80/181/EEC on units of measurement, consolidated text (EUR-Lex)
- 21 CFR Part 701 — Cosmetic Labeling (eCFR)
- 21 CFR Part 740 — Cosmetic Product Warning Statements (eCFR)
- FD&C Act § 609, 21 U.S.C. 364e — Labeling (GovInfo)
- FD&C Act § 607, 21 U.S.C. 364c — Registration and product listing (GovInfo)
- FD&C Act § 608, 21 U.S.C. 364d — Safety substantiation (GovInfo)
- FD&C Act § 612, 21 U.S.C. 364h — Small businesses (GovInfo)
- FPLA § 4, 15 U.S.C. 1453 (GovInfo)
- FDA — Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
- FDA — Cosmetics Labeling
- FDA — Cosmetic Ingredient Names
- 19 U.S.C. 1304 — Marking of imported articles (GovInfo)
- 19 CFR Part 134 — Country of Origin Marking (eCFR)