The global cosmetics industry is expanding at an unprecedented pace, driven by innovation, evolving consumer expectations, and cross-border trade. However, this growth comes with increasing regulatory complexity, as cosmetic manufacturers must comply with diverse and country-specific cosmetic regulations governing product safety, ingredient compliance, manufacturing practices, labelling, and post-market surveillance. 

For organizations seeking global cosmetic market entry, regulatory compliance is not optional, it is a strategic imperative. Understanding how cosmetic regulations vary across regions such as the European Union (EU), United States, Japan, ASEAN countries, and India is essential for ensuring product approvals, avoiding enforcement actions, and maintaining consumer trust. 

This comprehensive guide from Maven Regulatory Solutions provides an in-depth overview of global cosmetic regulatory frameworks, recent regulatory updates, and best practices for achieving compliance while maintaining operational agility. 

Global Cosmetic Regulation: International Standards & Harmonization Efforts 

While cosmetic regulations are enforced at the national or regional level, global alignment is supported by several international bodies that establish baseline standards and guidance. 

Key International Regulatory Organizations 

ISO 22716: Good Manufacturing Practices (GMP) is widely recognized as the global benchmark for cosmetic manufacturing, covering raw materials, production, quality control, storage, and distribution. 

Although harmonization efforts exist, each jurisdiction maintains unique regulatory obligations, making region-specific expertise essential. 

 European Union (EU): The World’s Most Comprehensive Cosmetic Framework 

The EU operates under one of the most stringent cosmetic regulatory systems globally. 

Regulation (EC) No 1223/2009 on Cosmetic Products 

Key Compliance Requirements 

• Cosmetic Product Safety Report (CPSR) 
• Cosmetic Product Notification Portal (CPNP) submission 
• Ingredient compliance with Annex II–VI 
• Mandatory Responsible Person (RP) within the EU 
• GMP compliance aligned with ISO 22716 
• Clear labeling and claims substantiation 

Role of the Responsible Person (RP) 

The RP ensures: 

• Product safety and regulatory compliance 
• Accurate labeling and claims 
• Timely adverse event reporting 
• Regulatory authority liaison 

Failure to appoint a compliant RP can result in market withdrawal or penalties. 

United States: Cosmetic Regulation Under MoCRA 

The U.S. cosmetic regulatory landscape has undergone a major transformation with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) the most significant update since 1938. 

Key MoCRA Requirements 

• FDA facility registration (renewed biennially) 
• Cosmetic product listing with ingredient disclosure 
• Mandatory Serious Adverse Event (SAE) reporting 
• FDA authority to suspend facility registrations 
• Mandatory safety substantiation 

State-Level Regulations 

In addition to federal oversight, companies must comply with state laws such as: 

• California Safe Cosmetics Act 
• Washington Toxic-Free Cosmetics Act 

These laws often introduce ingredient bans beyond federal requirements, increasing compliance complexity. 

Japan: Cosmetics vs. Quasi-Drugs Regulatory Model 

Japan maintains a two-tier cosmetic classification system regulated by the Ministry of Health, Labour and Welfare (MHLW). 

Product Categories 

Key Requirements 

• Pre-market documentation for quasi-drugs 
• Japanese-language labeling only 
• Ingredient compliance with MHLW standards 
• Manufacturing and quality documentation 

Quasi-drugs often include functional cosmetics such as anti-acne, whitening, and anti-dandruff products. 

ASEAN Cosmetic Regulations: Harmonized Market Access 

The ASEAN Cosmetic Directive (ACD) harmonizes cosmetic regulation across Southeast Asia. 

Key Features 

• Based on EU Regulation (EC) No 1223/2009 
• Unified ingredient restrictions 
• Safety assessment requirements 
• Labeling harmonization 
• Inclusion of herbal and traditional cosmetics 

The ACD supports intra-ASEAN trade while maintaining safety standards. 

India: Cosmetic Regulation Under CDSCO & Cosmetics Rules, 2020 

India’s cosmetic industry is governed by: 

• Drugs and Cosmetics Act, 1940 
• Cosmetics Rules, 2020 

Regulatory Authorities 

Key Compliance Requirements 

• Import Registration Certificate (IRC) 
• Labeling per Cosmetics Rules 2020 
• Compliance with Legal Metrology Rules 
• Ingredient safety as per BIS standards 

Comparative Snapshot: Global Cosmetic Regulations 

Why Global Cosmetic Compliance Matters 

Non-compliance can lead to: 

• Market bans and recalls 
• Regulatory penalties 
• Brand reputation damage 
• Delayed product launches 

With rising consumer awareness around ingredient safety, sustainability, and transparency, regulatory compliance is now a brand differentiator. 

How Maven Regulatory Solutions Supports Cosmetic Compliance 

Maven Regulatory Solutions delivers end-to-end cosmetic regulatory services, including: 

• Global regulatory strategy 
• Ingredient compliance & gap analysis 
• Safety assessments & documentation 
• Market authorization support 
• Post-market surveillance guidance 
• Regulatory intelligence & updates 

Our experts help cosmetic brands enter, expand, and sustain their presence across global markets with confidence. 

Frequently Asked Questions (FAQs) 

Q1. Is ISO 22716 mandatory for cosmetics? 

While not legally mandatory in all regions, ISO 22716 is widely recognized and often expected by regulators. 

Q2. What is the biggest change under MoCRA? 

Mandatory FDA facility registration, product listing, and enhanced safety oversight. 

Q3. Are herbal cosmetics regulated differently? 

Yes. Regions like ASEAN and India have specific provisions for herbal and traditional cosmetic products. 

Q4. Can one formulation work globally? 

Rarely. Ingredient restrictions vary significantly across regions, requiring formulation adaptation. 

Final Thoughts 

Global cosmetic regulations continue to evolve as science advances and consumer expectations rise. Companies that invest in proactive regulatory compliance gain faster market access, reduced risk, and long-term brand credibility. 

Partnering with Maven Regulatory Solutions ensures your cosmetic products meet global regulatory expectations today and tomorrow.