What is the CPNP and do I need it to sell cosmetics in the EU?

The Cosmetic Product Notification Portal (CPNP) is a mandatory online notification system for all cosmetic products sold in the EU. You must notify your product on the CPNP before placing it on the EU market. You also need a designated Responsible Person established within the EU.

Are sunscreens regulated as cosmetics or drugs?

It depends on the market. In the US, sunscreens are classified as over-the-counter drugs regulated by the FDA. In the EU, Korea, Japan, and most other markets, sunscreens are regulated as cosmetics (or functional cosmetics in Korea). This distinction significantly affects testing requirements and claims.

What is an INCI list and why is it important?

INCI (International Nomenclature of Cosmetic Ingredients) is a standardized system for naming cosmetic ingredients. An INCI list is required on product labels in virtually all markets worldwide. Ingredients must be listed in descending order of concentration, using official INCI names from the Personal Care Products Council dictionary.

How many ingredients does the EU ban compared to the US?

The EU bans over 1,600 substances from use in cosmetics, while the US FDA currently prohibits about 11. This significant difference means products formulated for the US market may not comply with EU regulations. Many global brands formulate to EU standards as a baseline for multi-market compliance.

Do I need to do animal testing for cosmetics?

The EU completely bans animal testing for cosmetics and ingredients. The US does not require animal testing but does not ban it either. China historically required animal testing for imported cosmetics but has been easing requirements since 2021 for certain general cosmetics categories. Always check current requirements for your target markets.

Cosmetics Regulations: Global Compliance Guide

Why Regulatory Compliance Can Make or Break Your Cosmetics Brand

Selling cosmetics internationally means navigating a complex patchwork of regulations that vary dramatically from market to market. An ingredient that is perfectly legal in one country might be restricted or banned in another. A label that complies with US requirements might violate EU law. And a product that ships successfully to one market might be seized at customs in another.

Regulatory compliance is not optional. It protects consumers, builds brand credibility, and prevents costly recalls, fines, or market bans. This guide breaks down the essential regulations for the world's major cosmetics markets and provides practical guidance for ensuring your products meet all requirements.

United States: FDA Regulations

The US Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The regulatory framework was significantly updated with the Modernization of Cosmetics Regulation Act (MoCRA) of 2022.

Key FDA Requirements

Facility registration: All cosmetic manufacturing and processing facilities must register with the FDA (required under MoCRA)
Product listing: Each cosmetic product must be listed with the FDA, including ingredient information
Good Manufacturing Practices: Facilities must follow GMP requirements
Adverse event reporting: Serious adverse events must be reported to the FDA within 15 business days
Labeling requirements: Product identity, net quantity, ingredient declaration (in descending order), distributor information, and any required warnings
Prohibited and restricted ingredients: Currently about 11 prohibited ingredients, far fewer than the EU

US Labeling Specifics

INCI names must be used for ingredient declaration
Ingredients listed in descending order of predominance (ingredients at 1% or less can be listed in any order)
Color additives must be from FDA-approved sources
SPF claims require FDA OTC drug monograph compliance (sunscreens are regulated as drugs in the US)

Important: In the US, sunscreens are classified as over-the-counter drugs, not cosmetics. This requires separate compliance with FDA OTC drug regulations, including specific SPF testing protocols and labeling requirements.

European Union: The Strictest Global Standard

The EU Cosmetics Regulation (EC) No 1223/2009 is widely regarded as the most comprehensive cosmetics regulatory framework in the world. Many brands use EU compliance as their baseline because meeting EU standards typically ensures compliance in most other markets.

Key EU Requirements

Cosmetic Product Notification Portal (CPNP): All cosmetic products must be notified on the CPNP before being placed on the EU market
Responsible Person (RP): Every product must have a designated Responsible Person established within the EU who is legally accountable for compliance
Product Information File (PIF): A comprehensive dossier containing product description, safety assessment, manufacturing method, proof of claims, and animal testing information
Cosmetic Product Safety Report (CPSR): Conducted by a qualified safety assessor, this is mandatory for every product
Ingredient restrictions: Over 1,600 banned substances and extensive lists of restricted ingredients with maximum concentration limits

EU Labeling Requirements

Product function (unless obvious from presentation)
INCI ingredient list
Net content
Date of minimum durability (BBE date, or PAO symbol if shelf life exceeds 30 months)
Batch number
Country of origin (for imported products)
Responsible Person name and address
Precautions for use

South Korea: MFDS Requirements

South Korea's Ministry of Food and Drug Safety (MFDS) classifies cosmetics into two categories: general cosmetics and functional cosmetics. Understanding this distinction is critical.

General Cosmetics

Standard cosmetics products (cleansers, moisturizers, makeup) require manufacturer or importer registration but do not need pre-market approval. Products must comply with the Cosmetics Act and relevant safety standards.

Functional Cosmetics

Products making specific functional claims must obtain pre-market approval from MFDS. Functional cosmetics categories include:

Whitening/brightening products
Anti-wrinkle products
Sunscreen products (SPF claims)
Hair dye products
Self-tanning products
Products for atopic skin

Functional cosmetics require efficacy testing data, safety data, and formulation stability data as part of the approval application.

Korean Labeling Requirements

Product name and category
Manufacturer and distributor information
Full ingredient list (INCI nomenclature)
Net content
Expiration date or manufacturing date with shelf life
Usage instructions and precautions
Price (for products sold domestically)

INCI: The Universal Language of Cosmetic Ingredients

The International Nomenclature of Cosmetic Ingredients (INCI) system provides standardized ingredient names used globally. Regardless of which market you sell in, INCI names are required on product labels.

INCI Best Practices

Use the official INCI dictionary maintained by the Personal Care Products Council
List ingredients in descending order of concentration (above 1%)
Ingredients below 1% can be listed in any order after the 1% threshold
Colorants are typically listed at the end using CI (Color Index) numbers
Fragrance compositions can be listed as "Parfum" or "Fragrance" but individual allergens must be declared in the EU if above threshold concentrations

Other Important Markets

China

China's National Medical Products Administration (NMPA) requires all imported cosmetics to be registered or filed. General cosmetics require filing notification; special-use cosmetics (hair dye, sunscreen, whitening, etc.) require full registration with efficacy and safety data. Notably, China has been easing its animal testing requirements for imported general cosmetics under certain conditions since 2021.

Japan

Japan's Pharmaceutical and Medical Devices Agency (PMDA) classifies products as cosmetics or quasi-drugs. Quasi-drugs (medicated cosmetics) with active ingredient claims require pre-market approval. Japan has its own positive list of approved ingredients.

ASEAN

ASEAN member states have harmonized cosmetics regulations through the ASEAN Cosmetic Directive (ACD). Products require notification to the national regulatory authority, and must comply with the ASEAN Cosmetic Ingredient Listings (positive, negative, and restricted lists).

Common Compliance Mistakes and How to Avoid Them

Using EU-banned ingredients for US-only products, then expanding to EU: Always formulate with your broadest potential market in mind
Incorrect INCI names: Using trade names instead of INCI names on labels is a common error. Always verify against the official INCI dictionary.
Making drug claims on cosmetics: Claiming a product "treats" or "cures" a skin condition makes it a drug by regulatory definition. Use cosmetic-appropriate language.
Ignoring fragrance allergen declarations: The EU requires declaration of 26 specific fragrance allergens if present above threshold levels
Skipping stability testing: Regulatory authorities expect evidence that your product remains safe and effective throughout its shelf life

Keeping track of regulations across multiple markets is a significant challenge, especially as rules evolve frequently. AI-powered platforms offer valuable assistance:

Ingredient screening: AI cross-references your formulation against regulatory databases for multiple markets simultaneously, flagging banned or restricted ingredients instantly
Label compliance checking: Automated review of label content against market-specific requirements
Regulatory updates: AI monitors regulatory changes and alerts you to new requirements affecting your products
Documentation support: Automated generation of required documentation templates (PIF outlines, safety assessment frameworks)

TQBM's platform integrates regulatory intelligence into the formulation process, so compliance considerations are addressed from day one rather than becoming costly surprises after production.

Building a Compliance-First Strategy

The most successful global cosmetics brands treat regulatory compliance as a competitive advantage, not a burden. Here is how to build compliance into your brand strategy:

Start with the strictest market: If you formulate to EU standards, you can typically enter most other markets with minimal modifications
Work with experienced manufacturers: Korean OEM/ODM manufacturers with export experience understand multi-market compliance requirements
Budget for regulatory costs: Allocate 5-15% of your product development budget for regulatory consulting, testing, and registration fees
Document everything: Maintain comprehensive records of formulation decisions, test results, and compliance documentation
Stay current: Regulations change. Subscribe to regulatory update services and review your compliance status annually

Conclusion

Navigating global cosmetics regulations requires attention to detail, proactive planning, and reliable expert guidance. While the regulatory landscape can seem daunting, understanding the core requirements for your target markets and building compliance into your product development process from the start will save you time, money, and potential legal issues.

By partnering with experienced manufacturers who understand international regulations and leveraging AI-powered compliance tools, you can confidently bring your cosmetics products to market anywhere in the world. The investment in compliance is an investment in your brand's credibility and long-term success.

Cosmetics Regulations for Global Markets: What Every Brand Owner Needs to Know