Kozmetični izdelki so postali nepogrešljiv del našega vsakdana. Proizvajalci kozmetičnih izdelkov želijo ugoditi željam potrošnikov, hkrati pa si prizadevajo svoje izdelke tržiti na vseh večjih svetovnih kozmetičnih trgih. Pred tem se morajo seznaniti z zahtevami za kozmetične izdelke, ki veljajo v posamezni državi. V diplomski nalogi smo s pregledom regulatornih dokumentov za kozmetične izdelke ugotavljali razlike za uvoz in trženje kozmetičnih izdelkov v državah članicah Evropske unije, Združenih državah Amerike, Kanadi in na Kitajskem. Osredotočili smo se na definicijo kozmetičnega izdelka, obveznosti proizvajalcev in uvoznikov, zagotavljanje varnosti, postopek priglasitve/registracije/ odobritve, označevanje in oglaševanje kozmetičnih izdelkov ter poročanje o (resnih) neželenih učinkih. Za kozmetične izdelke v Evropi velja Uredba (ES) št. 1223/2009 Evropskega parlamenta in sveta z dne 30. novembra 2009 o kozmetičnih izdelkih. Uredba natančno definira kozmetični izdelek in odgovorno osebo za kozmetični izdelek ter njene obveznosti. Proizvajalec ali uvoznik mora pred trženjem kozmetičnega izdelka obvezno pripraviti dokumentacijo o kozmetičnem izdelku in kozmetični izdelek priglasiti na Evropsko komisijo, v Sloveniji pa je obvezna še priglasitev dejavnosti. Poročanje o resnih neželenih učinkih je za proizvajalce in uvoznike obvezno. Kozmetične izdelke v Združenih državah Amerike regulira Uprava za živila in zdravila v skladu z Zveznim zakonom o živilih, zdravilih in kozmetiki (Federal Food, Drug, and Cosmetic Act) in Zakonom pravilnega pakiranja in označevanja (Fair Packaging and Labeling Act). Izdelki za osebno nego so na ameriškem trgu kategorizirani kot kozmetični izdelki in zdravila brez recepta (z izjemo mil). Za kozmetični izdelek je odgovoren proizvajalec ali uvoznik, odgovorna oseba pa ni uradno definirana. Preskušanje kozmetičnih izdelkov in priprava dokumentacije nista obvezna, registracija pa je prostovoljna. Veliko pozornosti namenjajo uporabi barvil v kozmetičnih izdelkih – proizvajalec mora za njihovo uporabo v kozmetičnem izdelku pridobiti dovoljenje s strani regulatornega organa. V Kanadi za kozmetične izdelke velja Zakon o živilih in zdravilih (Food and Drugs Act) ter Predpisi o kozmetičnih izdelkih (Cosmetic Regulations). Podatke o varnosti in kakovosti kozmetičnega izdelka se mora hraniti kot del dokumentacije o kozmetičnem izdelku, ki jo pripravi proizvajalec na osnovi smernic dobre proizvodne prakse. Proizvajalec ali uvoznik mora vladno organizacijo Health Canada obvestiti o kozmetičnem izdelku na kanadskem trgu. V Kanadi in Združenih državah Amerike je mogoče poročati o neželenih učinkih in o drugih problemih s kozmetičnim izdelkom. Na Kitajskem za kozmetične izdelke veljajo Predpisi o higienskem nadzoru kozmetike (Regulations Concerning the Hygiene Supervision over Cosmetics), ki so še dodatno podprti s pravili, smernicami in standardi. Predpisi kategorizirajo izdelke za osebno higieno na kozmetične izdelke za običajno uporabo in posebno uporabo, definicija pa izključuje zobne paste in ustne vode. Kozmetične izdelke in nove kozmetične sestavine je treba registrirati oziroma prijaviti, kar je obveznost kitajskega zastopnika oziroma odgovorne osebe. Obvezna dela odobritvenega postopka sta priprava dokumentacije o kozmetičnem izdelku in testiranje na živalih. Poročanje o neželenih učinkih kozmetičnih izdelkov je nekoliko nejasno. Ugotovili smo, da uvoz in trženje kozmetičnih izdelkov na različnih koncih sveta urejajo različni regulatorni organi v skladu z veljavno zakonodajo o kozmetičnih izdelkih. Poenotenje zahtev za kozmetične izdelke po svetu bi olajšalo njihov uvoz na do sedaj težko dostopne trge, predvsem pa zagotovilo visoko stopnjo varnosti njihovih uporabnikov. 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.