Cosmetics label and product file checks for EU and US sales

Last updated: 17 October 2026. Rules change and differ by product type. Confirm each point with the authority or a regulatory specialist.

A cosmetic label has to agree with the records behind it. The EU expects a responsible person, a product information file and a notification. The US expects a responsible person, product listing and safety substantiation records. This guide lists what each side asks for and the mismatches to look for.

EU: what the Cosmetics Regulation asks for.

Regulation (EC) No 1223/2009 applies to cosmetic products placed on the EU market.

• A responsible person established in the EU. For an imported product, the importer is the responsible person. By written mandate, the importer may designate a person established in the EU to take that role, and that person must accept in writing (Article 4).
• A product safety report, prepared before the product is placed on the market.
• A product information file. Article 11 lists a product description, the safety report, a description of the manufacturing method with a good manufacturing practice statement, proof of claimed effects where justified, and data on any animal testing. It is kept for ten years after the last batch is placed on the market and must be readily accessible at the address on the label to the competent authority.
• A notification through the EU cosmetic products notification portal (CPNP) before the product is placed on the market (Article 13). It includes the responsible person's name and address and, for imports, the country of origin.

EU: what the label must show.

Article 19(1) lists these items:

• the name or registered name and the address of the responsible person, and for imported products the country of origin
• the nominal content by weight or volume, with some exemptions
• the date of minimum durability, or the period after opening where durability exceeds 30 months
• particular precautions for use
• the batch number or another reference that identifies the product
• the function of the product, unless clear from its presentation
• the list of ingredients, preceded by the word "ingredients"

The Commission also says nanomaterials must appear in the ingredients list with "nano" in brackets after the substance name, for example "titanium dioxide (nano)".

US: what MoCRA asks for.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) added duties that FDA describes as follows:

• Facility registration for manufacturers and processors, renewed every two years.
• Product listing by the responsible person, including ingredients, with annual updates. FDA defines the responsible person as the manufacturer, packer or distributor whose name appears on the label.
• Safety substantiation. Neither the law nor FDA regulations require specific tests, but the responsible person must ensure that adequate safety substantiation exists and keep the records.
• Serious adverse event reports within 15 business days, with a copy of the label.
• Fragrance allergen labeling. MoCRA requires FDA to set requirements by regulation. FDA's page does not state the status of that rule, so check it before you print.

FDA says certain small businesses are exempt from the registration, listing and good manufacturing practice requirements. The exemption does not cover products that regularly contact the eye's mucous membrane, injected products, products for internal use, or products meant to alter appearance for more than 24 hours without consumer removal.

US: what the label must show.

FDA's summary of cosmetic labeling requirements, which rests on 21 CFR Part 701, lists these items:

• Statement of identity on the principal display panel: the product name and its nature or use, by descriptive name or illustration (21 CFR 701.11).
• Net quantity on the principal display panel, distinct and in the bottom area of the panel. Solids and semisolids use pounds and ounces and liquids use US gallon-based measures. Metric units may be added (21 CFR 701.13).
• Name and place of business of the firm marketing the product, on an information panel. If that firm did not manufacture or pack the product, the label says so, for example "Manufactured for" or "Distributed by" (21 CFR 701.12).
• Ingredient declaration on an information panel for retail products, in order of predominance, with established names. Color additives and ingredients at 1 percent or less may be listed out of order. Letters are at least one sixteenth of an inch tall, or one thirty-second on small packages (21 CFR 701.3).
• Warnings and directions for products that may be hazardous when misused. If the safety of a product has not been substantiated, the label must carry the statement "Warning--The safety of this product has not been determined."
• English. Every statement required by regulation must be in English.
• Country of origin in English for imported products, according to FDA.

The principal display panel is the part of the label most likely to be displayed at retail (21 CFR 701.10). Read Part 701 and Part 740 for exceptions and format details.

Mismatches to look for.

1. The responsible person differs between the label, the CPNP notification and the product file. In the US, the name on the label differs from the party that lists the product.
2. No EU address, or no country of origin on an imported product's label.
3. The ingredient list differs from the formula in the product information file or the product listing, for example after a supplier or grade change.
4. A nanomaterial in the formula without "(nano)" in the ingredient list.
5. Claims on the label with no supporting evidence in the file.
6. The file or the substantiation records cannot be produced at the address on the label, or on request.
7. Net quantity, batch reference or durability information missing, or shown differently on the outer carton and the container.
8. A facility or product that is not registered or listed in the US, where the exemption does not apply.

Checks to run before you ship.

1. Confirm who the responsible person is in each market, and that the same name and address appear on the label and in the notification or listing.
2. Compare the ingredient list on every pack with the current formula, including nanomaterials and fragrance components.
3. Check every Article 19(1) item for the EU and every Part 701 item for the US, on the pack as it will be printed.
4. Compare each claim on the label with the evidence in the file.
5. Confirm that the CPNP notification, the FDA facility registration and the product listing are in place and current.
6. Confirm who holds the product file and the safety records, and that they can be produced when asked.
7. Keep a dated record of each check, and repeat it whenever the formula, supplier, label or responsible person changes.

Common questions.

Who is the responsible person for a cosmetic imported into the EU?

The importer, unless it designates by written mandate a person established in the EU who accepts the role in writing. The responsible person's name and address, and the country of origin for imports, appear on the label.

How long must the EU product information file be kept?

For ten years after the last batch of the product is placed on the market. It must be readily accessible at the address on the label to the competent authority.

Does the US require specific safety tests for cosmetics?

FDA says neither the law nor its regulations require specific tests, but the responsible person must ensure adequate safety substantiation exists and keep records that support it.

Sources.

• European Union, Regulation (EC) No 1223/2009 on cosmetic products
• European Commission, Cosmetics legislation
• FDA, Modernization of Cosmetics Regulation Act of 2022 (MoCRA)
• FDA, Summary of cosmetics labeling requirements
• eCFR, 21 CFR Part 701, cosmetic labeling

This guide is information, not legal advice. Confirm the rules for your product type and destination with the authority or a regulatory specialist. Fragrance allergen labeling rules and other MoCRA regulations were still developing when this page was written.