The global cosmetics industry—encompassing skincare, haircare, fragrances, makeup, and personal hygiene products—is one of the most dynamic and highly regulated sectors in the world. Because cosmetics are applied directly to the human body and often contain complex chemical formulations, regulatory compliance is essential to ensure product safety, quality, and truthful marketing.

While consumer demand for cosmetics continues to grow across every region, the expansion of global trade has also increased the need for harmonized standards and transparent regulatory frameworks. Compliance in this industry extends far beyond aesthetics—it involves scientific safety assessment, accurate labeling, responsible advertising, ethical sourcing, and protection of human health.

1. Definition and Purpose of Cosmetic Regulation

Globally, the definition of a cosmetic product varies slightly by jurisdiction, but it generally includes substances or preparations intended for cleaning, perfuming, changing appearance, protecting, or keeping parts of the body in good condition.

The key objectives of cosmetic regulation are to:

• Ensure that products are safe for human use under normal or foreseeable conditions.

• Guarantee truthful labeling and advertising, avoiding misleading claims.

• Require traceability of products throughout the supply chain.

• Control the use of restricted or prohibited substances.

• Protect public health and consumer trust through effective market surveillance.

These goals are achieved through pre-market registration or notification, ingredient control, post-market surveillance, and enforcement mechanisms specific to each region.

2. Global Harmonization and International Cooperation

Although each country maintains its own regulatory system, international organizations have made significant progress in promoting harmonization:

• International Cooperation on Cosmetics Regulation (ICCR) brings together authorities from the EU, U.S., Japan, Canada, and Brazil to align safety evaluation methods and regulatory principles.

• ISO (International Organization for Standardization) publishes standards such as:

  • ISO 22716: Good Manufacturing Practices (GMP) for cosmetics.

  • ISO 16128: Guidelines on natural and organic cosmetic ingredients.

  • ISO/TR 18811: Safety assessment principles for cosmetic products.

• OECD provides testing guidelines for toxicological and environmental safety assessment.

• ASEAN Cosmetic Directive (ACD) represents one of the most successful regional harmonization efforts outside Europe, creating a unified regulatory system among Southeast Asian countries.

These international efforts promote consistency in product safety evaluation, labeling, and quality systems, helping manufacturers enter multiple markets with reduced duplication.

3. Major Regional Regulatory Frameworks

a. European Union (EU)

The European Union is home to one of the most stringent and advanced cosmetic regulatory systems. The primary law governing cosmetics is Regulation (EC) No 1223/2009, which applies directly across all EU member states.

Key requirements include:

• Safety Assessment: Every product must undergo a safety evaluation by a qualified assessor before being placed on the market.

• Product Information File (PIF): Manufacturers must compile and maintain a PIF containing safety data, test results, manufacturing details, and labeling information.

• Responsible Person: A designated individual or entity within the EU is legally accountable for product compliance and safety.

• Notification: Products must be registered in the Cosmetic Products Notification Portal (CPNP) before marketing.

• Good Manufacturing Practice (GMP): Compliance with ISO 22716 is mandatory.

• Ingredient Control: The EU maintains comprehensive lists:

  • Annex II: Prohibited substances.

  • Annex III: Restricted substances.

  • Annex IV–VI: Approved colorants, preservatives, and UV filters.

• Labeling: Labels must include ingredient lists (INCI names), shelf life, precautions, and manufacturer details.

• Animal Testing Ban: The EU strictly prohibits animal testing for finished cosmetics and ingredients, as well as the marketing of products tested on animals.

The EU model has influenced many regions worldwide due to its scientific rigor, transparency, and consumer protection emphasis.

b. United States (U.S.)

In the United States, cosmetics are regulated by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Modernization of Cosmetics Regulation Act (MoCRA, 2022)—the most significant update to U.S. cosmetic law in more than 80 years.

Key regulatory aspects include:

• Product Safety: Manufacturers must ensure products are safe for intended use, although pre-market approval is not generally required (except for color additives).

• Facility Registration and Product Listing: MoCRA introduced mandatory registration of manufacturing facilities and product listings with the FDA.

• Good Manufacturing Practices: The FDA is developing mandatory GMP requirements aligned with international standards.

• Adverse Event Reporting: Serious adverse events must be reported to the FDA within 15 days.

• Recordkeeping: Companies must maintain safety substantiation and documentation.

• Labeling: Must include ingredients, manufacturer details, warnings, and expiration if applicable.

• Claims: Misbranding or misleading claims (e.g., implying medical benefits) can result in enforcement actions.

While the U.S. system is less pre-market restrictive than the EU’s, MoCRA significantly strengthens oversight, traceability, and consumer safety.

c. Canada

Health Canada regulates cosmetics under the Food and Drugs Act and Cosmetic Regulations.
Manufacturers or importers must:

• Submit a Cosmetic Notification Form (CNF) within 10 days of first sale.

• Ensure products are safe and do not contain any substances on the Hotlist (a list of prohibited and restricted ingredients).

• Comply with labeling requirements, including bilingual (English/French) information.
  Canada’s system aligns closely with the EU and U.S. frameworks and participates actively in ICCR initiatives.

d. Asia-Pacific Region

The Asia-Pacific market is the fastest-growing region for cosmetics, with increasingly harmonized regulations:

• Japan: Cosmetics are regulated under the Pharmaceutical and Medical Devices Act (PMD Act). Products are classified as either cosmetics or quasi-drugs. Quasi-drugs require pre-market approval for ingredients and efficacy claims.

• China: Overseen by the National Medical Products Administration (NMPA) under the Cosmetic Supervision and Administration Regulation (CSAR) (effective 2021).

  • Introduced an online registration system for imported and domestic cosmetics.

  • Divides products into special and general cosmetics, with differing approval procedures.

  • Requires safety assessment, GMP certification, and ingredient submission.

  • Since 2021, animal testing exemptions are available for certain imported cosmetics that meet specific safety and certification criteria.

• Korea: Managed by the Ministry of Food and Drug Safety (MFDS) under the Cosmetic Act, with strong emphasis on labeling, safety, and functional claims.

• ASEAN: The ASEAN Cosmetic Directive (ACD) harmonizes cosmetic regulation among 10 member states, establishing uniform safety, labeling, and GMP requirements, closely modeled on the EU system.

• Australia: The National Industrial Chemicals Notification and Assessment Scheme (NICNAS) (now AICIS) regulates cosmetic ingredients as industrial chemicals. Cosmetics must comply with labeling and safety standards under the Australian Consumer Law.

e. Latin America

In Latin America, harmonization efforts are led by MERCOSUR (Southern Common Market), which includes Argentina, Brazil, Paraguay, and Uruguay.

• Brazil: The National Health Surveillance Agency (ANVISA) regulates cosmetics under RDC No. 752/2022, classifying products as Grade 1 (low risk) or Grade 2 (high risk). Higher-risk products require registration, while lower-risk ones only need notification.

• Mexico: The Federal Commission for Protection against Sanitary Risks (COFEPRIS) regulates cosmetics under the General Health Law, emphasizing safety and labeling compliance.

These frameworks are increasingly aligning with international norms and ISO standards.

f. Middle East and Africa

In the Middle East, the Gulf Cooperation Council (GCC) has developed a unified Gulf Technical Regulation for Cosmetics and Personal Care Products (GSO 1943/2016), requiring safety substantiation, labeling in Arabic, and adherence to ingredient restrictions similar to the EU model.

In Africa, regulatory capacity varies.

• South Africa: Oversees cosmetics under the Foodstuffs, Cosmetics and Disinfectants Act (Act No. 54 of 1972).

• African Medicines Agency (AMA) and African Union initiatives are working toward harmonized cosmetic regulations based on international best practices.

4. Key Elements of Compliance

Across all regions, successful compliance programs share core elements:

1. Safety Assessment: Toxicological evaluation of ingredients and finished products.

2. Good Manufacturing Practice (GMP): Implementation of ISO 22716 standards to ensure product quality and consistency.

3. Ingredient Control: Verification against prohibited and restricted substances lists.

4. Labeling and Claims: Compliance with local language, format, and truth-in-advertising requirements.

5. Product Registration or Notification: Depending on jurisdiction, pre-market submission to authorities.

6. Post-Market Surveillance: Monitoring of adverse events, recalls, and consumer complaints.

7. Traceability and Documentation: Maintenance of technical files, product information, and safety records.

5. Emerging Trends and Challenges

Global cosmetics regulation is rapidly evolving in response to new scientific, ethical, and consumer demands:

• Sustainability and Green Claims: Growing regulation of environmental claims, packaging materials, and eco-certifications.

• Clean Beauty Movement: Stricter scrutiny of ingredient transparency and “free-from” claims.

• Animal Testing Alternatives: Expansion of validated in vitro and computational models for safety testing.

• Nanomaterials and Biotechnology: Increasing regulatory focus on nanotechnology safety and biotech-derived ingredients.

• Digitalization: Online product registration systems and electronic labeling initiatives improving traceability.

• Global Harmonization: ICCR and ISO collaborations continue to reduce market entry barriers and promote consistent safety standards.

6. Conclusion

Worldwide regulatory compliance for cosmetics represents a delicate balance between consumer safety, innovation, and market freedom. While frameworks differ between jurisdictions, a universal foundation of safety evaluation, quality management, labeling transparency, and post-market vigilance unites global cosmetic regulation.

For manufacturers, achieving compliance means more than meeting legal obligations—it embodies corporate responsibility, scientific integrity, and respect for consumer well-being.

As sustainability, ethical sourcing, and technological advances reshape the beauty industry, regulators around the world are moving toward more harmonized, science-driven, and transparent frameworks. The future of cosmetic regulation lies in global cooperation, innovation within compliance, and a shared commitment to ensuring that beauty remains safe, sustainable, and trustworthy for consumers everywhere.

Examples of various regulations affecting cosmetics worldwide:

• Ukraine: Order of the Ministry of Health of Ukraine “On Approval of the Procedure for Submission Information on Cosmetic Products”
• United Kingdom: The Cosmetic Products (Restriction of Chemical Substances) Regulations 2024
• Israel: Pharmacists’ Regulations (Cosmetics) 5783-2022
• New Zealand: Cosmetics Products Group Standard 2020
• EAEU: Customs Union Technical Regulation “On safety of Perfume and Cosmetic Products” (CU TR 009/2011)
• GCC: GCC draft regulation for (Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products)
• GCC: Cosmetic products – Technical Regulation of cosmetic and personal care products claims
• Peru, Colombia, Bolivia, Ecuador: Proyecto de Reglamento Técnico Andino sobre Etiquetado de Productos Cosméticos (Draft Andean Technical Regulation on the labelling of cosmetic products)
• Korea: Regulation on Safety Standards etc. of Cosmetics
• Mexico: PROY-NOM-259-SSA1-2014, Productos y servicios. Buenas prácticas de fabricación en productos cosméticos (Draft Mexican Official Standard PROY-NOM-259-SSA1-2014, “Products and services. Good manufacturing practices for cosmetic products”)
• EU: Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products
• China: Safety and Technical Standards for Cosmetics (2022)
• Türkiye: Draft Implementing Regulation on Cosmetic Products and Communiqué on Cosmetic Ingredients
• Myanmar: The Cosmetics Order (1/2010) dated 15 October 2010
• Australia: Consumer Goods (Cosmetics) Information Standard 2020

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