Importing Skincare to the EU & US: Key Compliance Rules

Why Compliance Matters

Bringing skincare products into the EU or US means entering two of the world’s most regulated beauty markets. Compliance isn’t optional—it’s the only way your products can pass customs, reach shelves, and build trust with consumers.

Why Skincare Imports Face Strict Rules

Skincare touches the skin every day, so regulators want to make sure products are:

• Safe to use

• Made with approved ingredients

• Accurately labeled

• Produced under clean, reliable conditions

These rules protect consumers from harmful substances and protect brands from expensive mistakes.

Risks of Not Meeting Requirements

If your products don’t meet EU or US standards, problems can happen fast:

• Customs detention (1) or delays

• Forced relabeling because of incorrect packaging

• Recalls if products reach the market

• Fines and legal issues

• Shipments returned or destroyed

Non-compliance not only costs money—it damages your brand’s reputation.

EU Skincare Regulations (EC 1223/2009)

The European Union has one of the world’s strictest cosmetic laws, known as the EU Cosmetics Regulation (EC 1223/2009) (2). If you want to import skincare into the EU, this regulation tells you exactly what your product must meet before it can be sold.

Scope and Definition of Cosmetics

Under EU law, a product is considered a cosmetic if it is applied to the body for cleaning, perfuming, changing appearance, correcting body odors, protecting, or keeping the skin in good condition.

The EU also draws a clear line between:

• Cosmetics — normal skincare and beauty products

• Borderline products — items that could be cosmetics or medicines depending on claims (e.g., strong whitening, anti-acne, SPF)

• Medicinal/OTC-drug products — regulated separately under medical law

Understanding this definition is important because your claims decide your product category. If you make drug-like claims, your product may be rejected or reclassified.

Responsible Person (RP) Requirements

To sell skincare in the EU, every product must have a European-based Responsible Person (RP). This is required under the EU Cosmetics Regulation and ensures that someone inside the EU is legally accountable.

What the RP Is Responsible For

The RP must make sure your product:

• Is safe to use

• Has all required documentation

• Meets EU labeling rules

• Passes ingredient compliance checks

• Is ready for CPNP notification

The RP also serves as the official contact for EU authorities if questions or safety issues arise.

Who Can Be the RP?

Depending on your setup, the RP can be:

• Your EU importer

• Your EU distributor

• A third-party compliance agency specializing in cosmetic regulations

Choosing a reliable RP is essential—they control market access.

Product Information File (PIF)

Before any skincare product enters the EU market, it must have a complete PIF, or Product Information File. This is a legal requirement and must be available for inspection at any time.

What the PIF Contains

A compliant PIF typically includes:

• Full formula breakdown (INCI)

• Toxicology and ingredient safety profiles

• Microbiological testing results

• Stability test reports

• Cosmetic Product Safety Report (CPSR) — a key document proving safety

• GMP evidence, usually aligned with ISO 22716 Good Manufacturing Practices

This file shows that your product is safe, stable, and produced under controlled conditions.

Ingredient Restrictions & Approved Lists

The EU has one of the world’s largest lists of banned and restricted substances—over 1,300 banned ingredients—as part of its commitment to consumer safety.

Common Restricted Categories

• Allergens

• Preservatives

• Colorants

• UV filters

To check ingredient compliance, brands often refer to:

• The official annexes of the EU Cosmetics Regulation

• Ingredient compliance tools from regulatory companies

• Safety assessors who review formulas during the CPSR process

Even a single non-compliant ingredient can block your product from entering the EU.

EU Labeling & Packaging Requirements

The EU demands clear and complete labeling. Missing or incorrect information is one of the most common reasons for customs delays.

What Must Appear on the Label

Your EU-compliant label must include:

• RP name and address

• Country of origin

• Net contents

• Batch/lot number

• Product function

• INCI ingredient list

• Warnings and mandatory instructions

• PAO (Period After Opening) symbol or expiration date

Language Requirements

All labels must be in the official language(s) of the countries where the product is sold.

Selling in France? French is required.

Selling in Germany? German is required.

CPNP Notification (Before Market Entry)

Before you can sell skincare in the EU, the product must be uploaded to the Cosmetic Products Notification Portal (CPNP).

What CPNP Is

The CPNP is an online database where brands submit essential product information to EU authorities. This step ensures traceability and safety monitoring.

What Must Be Uploaded

Typically, the CPNP entry includes:

• Product name

• Category

• Label files

• Ingredient list

• RP contact details

• Product packaging images

Who Submits the Notification?

The Responsible Person (RP) is legally responsible for completing the CPNP notification before the product enters the market.

US Skincare Regulations (FDA & MoCRA)

The United States has its own system for regulating skincare products. While the rules used to be more flexible than the EU, the new MoCRA law (3) now requires stronger oversight, better documentation, and more responsibility from manufacturers and importers.

Legal Framework for Cosmetics in the US

In the US, cosmetics are regulated by the Food and Drug Administration (4) under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

How the FDA Defines Products

The FDA separates products into three groups:

• Cosmetics — cleansers, moisturizers, lotions, makeup

• OTC drugs — SPF, acne treatments, anti-dandruff, whitening with active drug claims

• Cosmetic/drug hybrids — products that do both (e.g., tinted moisturizer with SPF)

If a product makes drug-like claims, such as “treats acne” or “heals eczema,” it is regulated as an OTC drug, not a cosmetic. This change in category affects testing, claims, ingredients, and labeling.

MoCRA (Modernization of Cosmetics Regulation Act)

MoCRA, signed into law in 2022, created the biggest update to US cosmetic regulations in decades. It introduces new requirements for both manufacturers and importers.

Key MoCRA Compliance Obligations

• Mandatory facility registration (renewed every two years)

• Mandatory product listings for all cosmetics sold in the US

• Safety substantiation — you must have evidence showing your product is safe

• Adverse event reporting — serious events must be reported to the FDA

• Recordkeeping and traceability — keeping documents for inspections

These updates make the US system more aligned with the EU while keeping a flexible structure.

Ingredient Rules & Restricted Additives

Though the US has fewer banned cosmetic ingredients compared to the EU, there are still important rules to follow.

Key Ingredient Compliance Points

• Color additives require FDA approval
  → If not approved, your product can be detained or refused.

• Prohibited or restricted substances
  → Some ingredients cannot be used in any cosmetic.

• Fragrance allergens
  → Less strict than the EU, but still monitored.

Brands must ensure all raw materials meet the safety standards outlined by the FDA cosmetic regulations.

Labeling Requirements

The US has clear rules for cosmetic labeling, outlined in the FDA Cosmetic Labeling Guide.

Required Label Elements

• Manufacturer/packer/distributor name & address

• Net contents (in US and metric units)

• Full ingredient list (descending order by weight)

• Warning statements where needed (e.g., eye irritation risks)

• Country of origin for imported products

Incorrect or missing label information is one of the top reasons cosmetics are stopped at the border.

Import Process & Customs Clearance

Imported skincare products are inspected by both:

• U.S. Customs and Border Protection (CBP)

• FDA Import Division

Common Reasons Shipments Are Detained

• Mislabeling or missing mandatory elements

• Unapproved color additives

• Claims that make the product an OTC drug (e.g., “treats acne”)

• Missing or incorrect importer information

• Products appearing unsafe or contaminated

A detainment slows down your shipment and may require relabeling, document review, or product return.

Tips to Avoid FDA Refusal

• Ensure labels fully follow FDA requirements

• Use only FDA-approved color additives

• Avoid drug-like claims unless the product meets OTC rules

• Work with a registered US importer or compliance partner

• Keep safety documentation ready for review

EU vs US Regulations: Key Differences

Best Practices for Long-Term Compliance

Keeping your skincare products compliant is an ongoing process. Here are the key habits that help brands stay safe and ready for inspections in both the EU and US.

Keep Your PIF and Records Updated

Anytime you change a formula, switch suppliers, update packaging, or adjust testing, make sure your PIF (EU) and product documents (US) are updated.

Accurate files protect you during audits and avoid delays.

Monitor Regulation Changes

Rules change often:

• The EU regularly updates ingredient bans and limits.

• The US continues rolling out new MoCRA requirements.

Checking updates helps you avoid last-minute reformulation or labeling issues.

Re-Check Safety When Formulas Change

Even small changes can affect safety.
When anything in the formula shifts, review:

• Ingredient safety

• Stability

• Micro testing

• EU CPSR

• US safety data

This keeps both markets fully covered.

Organize Supplier Documentation

Collect and store all supplier documents clearly, such as:

• COA

• SDS

• Allergen reports

• GMP proof

A clean system makes compliance faster and reduces risk.

Ready to Import Skincare to the EU or US?

If you want to enter the EU or US market with confidence, we’re here to help.

Contact us today to discuss your product, get expert advice, or request a tailored compliance plan.

Let’s help your skincare brand launch smoothly and grow globally.

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