To ensure safety and efficacy, cosmetic products are regulated and controlled in the international market. However, each country’s regulatory approaches can differ significantly, impacting the industry’s competitiveness and economic viability.
The cosmetics industry is a growing and ever-changing global sector. In recent decades, the industry has experienced immense innovation, resulting in a wide range of new products and increased sales. In 2020 alone, the international cosmetics market was valued at USD 341.1 billion. It is expected to reach USD 560.5 billion by 2030, with a compound annual growth rate of 5.1% from 2021 to 2030.
As a highly innovative, fast-paced, and complex sector, the cosmetics industry must be regulated to ensure the safety and quality of cosmetic products, thus avoiding adverse impacts on consumer health. However, regulatory frameworks vary across markets and countries and are far from harmonized. This greatly challenges the possibility of a global industry selling the same product in all markets.
Brazil
- RDC 894/2024: New Cosmetovigilance Good Practices standard, effective August 28, 2025. Replaces RDC 332/2005.
- Law 15.154/2025: Recognizes ancestral knowledge in natural and organic cosmetics. Validates Indigenous and Afro-descendant knowledge as technical heritage.
- PL 1.281/2022: Simplifies regulation for artisanal cosmetics, exempting them from registration with ANVISA if they meet certain requirements.
Responsible entity: ANVISA (National Health Surveillance Agency)
Mexico
- Update of health regulations: COFEPRIS adjusts manufacturing and labeling to align with international standards.
- Self-Verification Guide: Manual for establishments that process cosmetics, focusing on safety and transparency.
- COFEPRIS–Secihti Alliance: promotes science and technology in cosmetics regulation.
Responsible entity: COFEPRIS (Federal Commission for the Protection against Sanitary Risks)
Colombia
- Decision 944/2025: modernizes the Andean Community’s sanitary framework for cosmetics.
- Resolution 2310/2022: Andean Technical Regulation for Cosmetic Labeling, effective December 2025.
- Law 1801/2016: standards for beauty establishments.
Responsible entity: INVIMA (National Institute for Food and Drug Surveillance)
Argentina
- Provision 3562/2025: ANMAT stops intervening in personal cosmetic imports.
- Provision 4033/2025: eliminates prior authorization for commercial imports of already approved products.
Responsible entity: ANMAT (National Administration of Drugs, Food, and Medical Technology)
Chile
- Law 21,646 (2025): prohibits animal testing for cosmetics and hygiene products.
- Review of the regulatory framework: alignment with international standards and clarity in claims such as “cruelty-free” are sought.
Responsible entity: ISPCH (Public Health Institute of Chile)
Peru
- Strategic Plan 2025: COPECOH promotes regulation and sector fairs.
- Andean Technical Regulation: mandatory labeling with INCI nomenclature, expiration date, country of origin, etc.
Responsible entity: COPECOH (Cosmetics and Personal Hygiene Association – Lima Chamber of Commerce)
Ecuador
- Resolution 2310/2022 and Decision 944/2025: harmonized labeling in the Andean Community.
- Mandatory Health Notification (NSO): requirements for marketing, importation, and certification.
Responsible entity: ARCSA (National Agency for Health Regulation, Control, and Surveillance)
Regulation in the international market
Major markets follow broadly similar regulatory elements; however, the existing differences are sufficient to impact the industry, restricting innovation and reducing potential market growth. Furthermore, such differences can also affect international trade and hinder the role of regulatory authorities.
United States
- MoCRA (Modernization of Cosmetics Regulation Act of 2022): first major reform since 1938, to be fully implemented in 2025.
- Mandatory registration of facilities and products with the FDA.
- Safety assessment, ingredient traceability, and designation of a “responsible person.”
- Good Manufacturing Practices (GMP) required for all manufacturers.
Responsible entity: FDA (Food and Drug Administration)
European Union
- Regulation (EU) 2025/877: amends Regulation (EC) 1223/2009, prohibiting substances classified as carcinogenic, mutagenic, or toxic to reproduction.
- Regulation (EU) 2024/858: strengthens control over nanomaterials in cosmetics.
- Implementing Decision (EU) 2025/1175: updates the glossary of ingredients for labeling and requires greater precision in INCI nomenclature.
- Regulation (EU) 2024/996: introduces strict limits on sensitizing ingredients and cumulative toxicity.
Responsible entity: European Commission (DG SANTE) and national authorities such as AEMPS (Spain), ANSM (France), BfArM (Germany), etc.
For these reasons, it is essential to find solutions that can lead to the alignment of cosmetics regulatory frameworks. This will foster innovation, enhance market growth, and eliminate trade restrictions. To achieve this goal, several international organizations have been making concerted efforts in this direction. One example is the International Cooperation on Cosmetics Regulation (ICCR), established in 2007, which is a voluntary group of regulatory authorities that meet annually to discuss various issues related to cosmetic safety and regulation.
Other examples include the Organization for Economic Cooperation and Development (OECD) and the International Organization for Standardization (ISO). These play a key role in the mutual acceptance of testing method guidelines and the development of international cosmetic standards.
Current regulatory framework
The international market is crucial for the cosmetics industry, contributing to its growth and innovation, and ensuring that consumer demands are met and that everyone has access to the same products.
In the EU, all member states follow the same legislation. The regulatory framework for cosmetics is provided by Regulation (EC) No. 1223/2009 of the European Commission, which has overall responsibility for cosmetics legislation. It is then enforced by the competent authority in each member state.
In the US, the two most important laws related to cosmetic products are regulated by the Food and Drug Administration (FDA). The Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). These have been enforced and maintained unchanged with only a few amendments. In Canada, the regulations, the Cosmetics Regulation Act and the Food and Drugs Act, have undergone only a few modifications over the years.
In Japan, cosmetic products are regulated by the Pharmaceutical and Medical Devices Act (PMDL) by the competent authority, the Ministry of Health, Labor, and Welfare. China is undergoing a major institutional reform that began in 2018. Currently, there are three competent authorities in the cosmetics sector: the State Administration for Market Regulation (SAMR), the National Medical Products Administration (NMPA), and the General Administration of Customs (GAC).
In Brazil, cosmetic products/sectors are regulated by three authorities: the Ministry of Health, the Brazilian Health Regulation Agency (ANVISA), and the Department of Hygiene, Perfumery, Cosmetics, and Sanitizing Products (GHCOS). These regulations have been amended over the years through a series of resolutions.
Future Visions of the Cosmetics Industry in the World
The cosmetics industry has aimed to achieve global cosmetic regulatory harmonization in recent decades. Currently, regulatory frameworks around the world are relatively similar, although several differences remain. Evidence from the Lisbon Medical Research Institute’s review suggests that the legislative measures of different international market regions are indeed different, affecting international trade.
It is also true that regulators, formulators, and other industry professionals have managed to navigate these differences. With the increasingly demanding and constantly changing global regulatory environment, there is a need for vigilance among companies and manufacturers to prevent non-compliance.
Maintaining ongoing dialogue between countries is essential to foster innovation, enhance market growth, and eliminate trade restrictions. This ensures consumer accessibility to safe cosmetic products.
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