Cosmetic products had become an indispensable part of our daily lives. Cosmetic manufacturers want to meet the wishes of consumers, and at the same time, they strive to import and market their products in all major global cosmetic markets. However, before importing, they must familiarize themselves with the requirements for cosmetic products that apply in each country. In the diploma thesis, we reviewed the legislation of cosmetic products in the European Union, the United States, Canada, and China, and established differences for the import and marketing of cosmetic products in these countries. We focused on the definition of a cosmetic product, the obligations of manufacturers and importers, ensuring safety, the notification, registration and approval process, labeling and advertising of cosmetic products, and reporting of (serious) adverse reactions. Cosmetic products in Europe are subject to Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products. Before placing a cosmetic product on the market, the responsible person must prepare documentation on the cosmetic product and notify the cosmetic product to the European Commission. In Slovenia, notification of activities is mandatory. Reporting of serious adverse reactions is mandatory for manufacturers and importers. Cosmetic products in the United States are regulated by the Food and Drug Administration under the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. Personal care products are categorized as cosmetic products or OTC drugs (excluding soaps). The cosmetic product is the responsibility of the manufacturer or importer. Testing of cosmetic products and preparation of documentation on the cosmetic product is not mandatory. The registration of cosmetic products is voluntary. Much attention is given to the use of color additives in cosmetic products which are a subject of approval in the United States. In Canada, cosmetic products are subject to the Food and Drugs Act and the Cosmetic Regulations. Data on the safety and quality of the cosmetic product must be kept as part of the documentation on the cosmetic product prepared by the manufacturer on the basis of the GMP guideline. The manufacturer or importer must notify the government organization Health Canada of the cosmetic product on the Canadian market. Adverse reactions and other problems with cosmetic products can be reported in Canada and the United States. In China, cosmetic products are subject to the Regulations Concerning the Hygiene Supervision over Cosmetics, which are further supported by the rules, guidelines, and standards. Chinese regulations categorize personal care products into Non-Special Use Cosmetics and Special Use Cosmetics. Oral hygiene products are not cosmetic products in China. Cosmetic products and new cosmetic ingredients require pre-market registration. Registration is done by an assigned responsible agent or responsible person. Mandatory parts of the approval procedure are the preparation of documentation on the cosmetic product and animal testing. Reporting of adverse effects is rather unclear. We have found that cosmetic products are regulated by different regulatory authorities following the regulation on cosmetic products that apply in each country. Global harmonization of requirements for cosmetic products would facilitate their import into hard-to-reach markets and ensure a high level of safety of consumers.
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