SUMMARY

Сosmetic products are regulated differently in different regions of the world, making it difficult to synchronize compliance in all countries at once. To overcome these problems, several efforts have been made to harmonize regulatory frameworks worldwide and facilitate international trade. For instance, in the EU, all member states follow the same legislation. The cosmetic regulatory framework is provided by Regulation (EC) No. 1223/2009 of the European Commission, which has the overall responsibility for cosmetic legislation and is then enforced by the National Competent Authority ( NCA or NRA) of each member state. This Regulation, which replaced the previous Directive 76/768/EC, adopted in 1976, was a step towards regulatory harmonization across all EU states and also an adaptation to much-needed technical progress. However, such progress has not yet been observed in other regions. In the USA, the two most important laws related to cosmetic products and regulated by the Food and Drugs Administration (FDA)—the Federal Food, Drug and Cosmetic Act (FD&C Act), and the Fair Packaging and Labeling Act (FPLA)—have been enforced, respectively, since 1938 and 1966, and have remained essentially unchanged with just a few amendments. A similar situation is observed in Canada, where regulations—the Cosmetic Regulation Act (1977) and Food and Drugs Act (1985)—have undergone only a few amendments over the years.
In contrast, Japan and China have undergone recent modifications. In Japan, since 2014, cosmetic products are regulated under the Pharmaceutical and Medical Devices Law (PMDL) by the competent authority, the Ministry of Health, Labor and Welfare; this replaced the previous Pharmaceutical Affair Law (PAL), dating from 1960. Likewise, China is undergoing a large institutional reform that started in 2018. Currently, there are three major competent authorities in the cosmetic sector: the State Administration for Market Regulation (SAMR), the National Medical Products Administration (NMPA) and the General Administration of Customs (GAC). The new cosmetic regulation, Cosmetic Supervision and Administration Regulation (CSAR) was implemented on 1 January 2021, replacing the former Cosmetics Hygiene Supervision Regulations (CHSR), from 1990. As a follow-up to this general regulation, several subsidiary regulations have been announced, notably related to the registrations and notification process, good manufacturing practices (GMPs), and monitoring of adverse reactions, among others. In Brazil, cosmetic products/sector are regulated by three authorities, the Ministry of Health, the Brazilian Health Regulatory Agency (ANVISA), and the Hygiene, Perfume, Cosmetics and Sanitizing Products Management (GHCOS), through a number of resolutions, which have been amended over the years.
In many countries cosmetic products do not require pre-market approval but must be safe for use and properly labeled, in other countries, MAH must submit product notifications, and certain high-risk ingredients are subject to approval, while in a few countries pre-market registration or license is required.