Regulation of essential oils : master's thesis

Cilj ovoga istraživanja bio je prikazati trenutni zakonski okvir eteričnih ulja u Hrvatskoj. Obrađeni su pojedini zakoni i pravilnici prema kojima su eterična ulja stavljena u promet, ili pojedinačno ili u kombinaciji s drugim tvarima te su dani primjeri za navedene zakone ili pravilnike. Materijali i metode: Retrospektivna analiza zakonodavstva u RH koje regulira područje eteričnih ulja. Rezultati: Prema rezultatima retrospektivne analize, eterična ulja u Hrvatskoj su regulirana sa sedam različitih Zakona i Pravilnika. Zakonu o lijekovima podliježu Gelomyrtol forte, CARMOL kapi, Rowatinex želučanootporne kapsule, meke i Rowachol želučanootporne kapsule meke. Jedini primjer medicinskog proizvoda s eteričnim uljima je Aqua Maris refresh, sprej za nos koji podliježe Zakonu o medicinskim proizvodima. Oléocaps 1 i Oléocaps 2 jedini su registrirani dodaci prehrani u RH regulirani Zakonom o hrani. Zakonom o biocidnim pripravcima u promet su stavljeni repelenti s eteričnim uljima kao što je Prana BB, gel za djecu. Kozmetika je široko područje u kojemu eterična ulja imaju vrlo važnu ulogu, načešće radi mirisa. Pravilnikom o aromama regulirane su dopuštene i nedopuštene tvari u aromama. Pošto eterična ulja pripadaju kemijskim tvarima, na tržištu RH regulirani su Zakonom o kemikalijama. Zaključci: Eterična ulja nemaju jasan zakonski okvir u Hrvatskoj te podliježu regulaciji različitih zakona i pravilnika poput Zakona o lijekovima, Zakona o medicinskim proizvodima, Pravilnika o dodacima prehrani, Zakona o biocidnim pripravcima, Pravilnika o zdravstvenoj ispravnosti predmeta široke potrošnje, Pravilnika o aromama i Zakona o kemikalijama. Eterična su ulja prema definiciji kemijske tvari te kao takve većinom podliježu Zakonu o kemikalijama te se s njima tako i ophodi. U Hrvatskoj se još uvijek nedovoljno iskorištava njihov farmakološki učinak, što pojedinačno, tako i u sinergiji s konvencionalnim lijekovima. The objective of this study was to show the current legal framework of essential oils in Croatia. The study included some laws and regulations according to which essential oils are placed on the market, individually or in combination with other substances, and there are examples of the mentioned laws or regulations. Materials and Methods: A retrospective analysis of the legislation in the Republic of Croatia that regulates essential oils. Results: According to the results of a retrospective analysis, the essential oils in Croatia are regulated by seven different laws and regulations. Gelomyrtol forte, Carmol stroke, gastro-resistant capsules Rowatinex soft, and Rowachol gastro-resistant capsule, soft are regulated by Law of medicines. The only example of a medical device with the essential oils is Aqua Maris refresh nasal spray, which subject to the medical products. Oléocaps 1 and 2 Oléocaps are only registered nutritional supplements in Croatia that are regulated by the Food Act. With the Law on biocidal products on the market there are repellent with essential oils such as Prana BB, gel for children. Cosmetics is a large area in which essential oils have a very important role, most often smell. Ordinance on flavorings are regulated by legal and illegal substances in flavors. Essential oils belong to chemical substances and on the Croatian market are regulated by the Chemicals Act. Conclusions: The essential oils do not have a clear legal framework in Croatia and are subject to the regulation of various laws and regulations such as the Law on Medicinal Products, Medical Devices Act, the Ordinance on food supplements, the Law on biocidal products, the Ordinance on the sanitary safety of consumer products, the Ordinance on flavorings and Law on chemicals. Essential oils as defined chemical substances, and as such are subject to a maximum of the Chemicals and with them and treats. In Croatia is still insufficiently exploited their pharmacological effect, individually and in synergy with conventional drugs.