Differences between cosmetic regulations in the United States and the European Union

Daniel Jiménez
Aug 1
5 min read

Updated: Aug 6

Marketing cosmetic products in international markets requires compliance with distinct and sometimes divergent regulatory frameworks. While the European Union is governed by a harmonized EU regulation (Regulation (EC) No. 1223/2009), the United States recently reformed its legislation with the passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article provides a structured comparison of the main requirements in both countries.

General regulatory framework
Market access
Safety and GMP evaluation
Control of ingredients
Labeled
Nanomaterials
Market surveillance and adverse effects
Animal testing
Claims

Differences between cosmetic regulations in the United States and the European Union — Diferencias entre la normativa cosmética de Estados Unidos y la Unión Europea

1. General regulatory framework

European Union The applicable legislation is Regulation (EC) No. 1223/2009, which is directly applicable in all Member States. It lays down detailed rules on safety, technical documentation, pre-market notification, labeling, permitted/restricted ingredients, market surveillance, and legal liability.
United States The primary legal framework is the FD&C Act, updated through MoCRA. For the first time, it introduces a more robust structure for cosmetics, including establishment registration requirements, product listing, safety documentation, adverse event management, and mandatory recall authority from the FDA.

2. Market access

Requirement	European Union	USA
Legal designation	Responsible Person (RP) in the EU mandatory	Responsible Person (who appears on the label)
Obligation of domicile	PR must be established in the EU	May be outside the US if it meets label requirements
Pre-marketing	Mandatory CPNP notification	Product listing in FDA (MoCRA)
Technical documentation	PIF with mandatory CPSR	Safety substantiation documented, not fixed format
Foreign manufacturing	No additional intermediary required	Requires US Agent for foreign installation

Note: Responsible Person (EU) and Responsible Person (US) are not equivalent or interchangeable. Furthermore, the US Agent is a requirement solely related to the registration of foreign facilities with the FDA, not to product liability.

3. Safety and GMP evaluation

EU: The PR must ensure the product safety assessment and prepare a Cosmetic Product Safety Report (CPSR) in accordance with Annex I of the Regulation. The product must be manufactured according to Good Manufacturing Practices (GMP), preferably in accordance with the harmonized standard ISO 22716.

U.S.: MoCRA requires adequate documentation supporting product safety, which must be maintained and available for inspection by the FDA. Specific federal GMP regulations for cosmetics are currently under development.

4. Control of ingredients

EU: The regulation includes five binding annexes:

Annex II : prohibited substances
Annex III : Restricted Substances
Annex IV, V and VI : positive lists of permitted colorants, preservatives and UV filters

The Commission periodically updates these annexes based on opinions from the SCCS (Scientific Committee on Consumer Safety).

USA : There is no general negative or positive list for cosmetics, except for colorants , which do require prior FDA approval . Many require batch certification before use.

5. Labeling

Mandatory in the EU (Article 19 of Regulation 1223/2009):

Name and address of the Responsible Person
Nominal content
Minimum Duration Date or PAO
Batch number
List of ingredients (INCI)
Product function (if not obvious)
Indication of nanomaterials with “[nano]”
Individual declaration of fragrance allergens above thresholds (updated in 2023 by Regulation (EU) 2023/1545)

Mandatory in the USA (MoCRA and 21 CFR 701):

Product identity
Net content
List of ingredients
Name and address of the Responsible Person
Contact information for reporting adverse events: physical or electronic address pursuant to § 609(a)
(Coming soon) : Future regulation on fragrance allergens in development

6. Nanomaterials

EU : They require specific prior notification (Article 16) and must be labeled as “[nano].” Only nanomaterials assessed by the SCCS and authorized by the Commission are permitted.

USA : There are no specific regulations for labeling nanomaterials, although the FDA monitors their use in cosmetics through best practice guidelines.

7. Market surveillance and adverse effects

EU : The PR is required to report Serious Undesirable Effects (SUE) to the competent authority of the Member State. Authorities may order the withdrawal or suspension of non-compliant products.

U.S.: The Responsible Person must report serious adverse events to the FDA within 15 business days and retain records for at least six years. MoCRA grants the FDA the authority to order mandatory recalls of products that pose serious risks.

8. Animal testing

EU : There is a total ban on animal testing for finished cosmetics and ingredients for exclusively cosmetic purposes (Article 18).

USA : Although the use of animals is not required to demonstrate the safety of a cosmetic, there is no blanket federal ban. Some states (such as California) have adopted stricter restrictions.

9. Claims

A key difference between cosmetic regulations in the European Union (EU) and the United States (US) lies in how claims used in product marketing are controlled and permitted.

European Union

In the EU, cosmetic claims are very precisely regulated under Regulation (EU) No. 655/2013, which establishes common criteria for justifying claims on cosmetic products.

Claims must comply with six fundamental principles:

Legal compliance
Truthfulness
Evidence
Sincerity
Fairness
Informed decision-making

In addition, all claims must be justified by adequate and verifiable evidence. It is not permitted to attribute properties to the product that it cannot fulfill, nor to confuse the consumer with exaggerated or unsupported claims. The use of “free from” claims (e.g., paraben free) is also regulated.

However, Europe generally allows a wider range of claims and assertions of effects in cosmetics than the US.

United States

In the US, the FDA only allows cosmetic claims restricted to cleansing, moisturizing, and improving the overall appearance of the skin, prohibiting any type of claim that affects the functioning or structure of the skin or, of course, medical claims.

Furthermore, the line between a cosmetic and an over-the-counter drug in the US is very fine, and using terms common in Europe such as “anti-acne,” “anti-aging,” or with structural or functional properties can automatically place the product under the regulation of Drugs or OTCs.

Conclusion: two regulatory frameworks with different approaches

EU regulations are more prescriptive, with well-defined pre-marketing requirements and legally responsible figures. The US system, now modernized with MoCRA, is moving toward stricter documentation requirements, although it remains more flexible in certain areas.

For companies operating in both markets, it is essential:

Align technical documentation (PIF vs. safety substantiation)
Create labeling tailored to each jurisdiction
Check ingredients and colorings according to the specific lists
Have a US Agent and a qualified PR if manufactured outside the respective territories